83 FR 59836 - Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; Medicaid Promoting Interoperability Program; Quality Payment Program Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; Provisions From the Medicare Shared Savings Program Accountable Care OrganizationsPathways to Success; and Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 83, Issue 226 (November 23, 2018)

This major final rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This final rule also finalizes policies included in the interim final rule with comment period in ``Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year'' that address the extreme and uncontrollable circumstances MIPS eligible clinicians faced as a result of widespread catastrophic events affecting a region or locale in CY 2017, such as Hurricanes Irma, Harvey and Maria. In addition, this final rule addresses a subset of the changes to the Medicare Shared Savings Program for Accountable Care Organizations (ACOs) proposed in the August 2018 proposed rule ``Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations--Pathways to Success''. This final rule also addresses certain other revisions designed to update program policies under the Shared Savings Program. The interim final rule implements amendments made by the SUPPORT for Patients and Communities Act to the Medicare telehealth provisions in the Social Security Act and regarding permissible telehealth originating sites for purposes of treatment of a substance use disorder or a co-occurring mental health disorder for telehealth services furnished on or after July 1, 2019 to an individual with a substance use disorder diagnosis.

[Federal Register Volume 83, Number 226 (Friday, November 23, 2018)]
[Rules and Regulations]
[Pages 59452-60303]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-24170]



[[Page 59451]]

Vol. 83

Friday,

No. 226

November 23, 2018

Part II





 Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 405, 410, 411, et al.





 Medicare Program; Revisions to Payment Policies Under the Physician 
Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared 
Savings Program Requirements; Quality Payment Program; Medicaid 
Promoting Interoperability Program; Quality Payment Program--Extreme 
and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; 
Provisions From the Medicare Shared Savings Program--Accountable Care 
Organizations--Pathways to Success; and Expanding the Use of Telehealth 
Services for the Treatment of Opioid Use Disorder Under the Substance 
Use-Disorder Prevention That Promotes Opioid Recovery and Treatment 
(SUPPORT) for Patients and Communities Act; Final Rules and Interim 
Final Rule

Federal Register / Vol. 83 , No. 226 / Friday, November 23, 2018 / 
Rules and Regulations

[[Page 59452]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 410, 411, 414, 415, 425, and 495

[CMS-1693-F, CMS-1693-IFC, CMS-5522-F3, and CMS-1701-F]
RIN 0938-AT31, 0938-AT13, & 0938-AT45


Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule and Other Revisions to Part B for CY 2019; 
Medicare Shared Savings Program Requirements; Quality Payment Program; 
Medicaid Promoting Interoperability Program; Quality Payment Program--
Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS 
Payment Year; Provisions From the Medicare Shared Savings Program--
Accountable Care Organizations--Pathways to Success; and Expanding the 
Use of Telehealth Services for the Treatment of Opioid Use Disorder 
Under the Substance Use-Disorder Prevention That Promotes Opioid 
Recovery and Treatment (SUPPORT) for Patients and Communities Act

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rules and interim final rule.

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SUMMARY: This major final rule addresses changes to the Medicare 
physician fee schedule (PFS) and other Medicare Part B payment policies 
to ensure that our payment systems are updated to reflect changes in 
medical practice and the relative value of services, as well as changes 
in the statute. This final rule also finalizes policies included in the 
interim final rule with comment period in ``Medicare Program; CY 2018 
Updates to the Quality Payment Program; and Quality Payment Program: 
Extreme and Uncontrollable Circumstance Policy for the Transition 
Year'' that address the extreme and uncontrollable circumstances MIPS 
eligible clinicians faced as a result of widespread catastrophic events 
affecting a region or locale in CY 2017, such as Hurricanes Irma, 
Harvey and Maria. In addition, this final rule addresses a subset of 
the changes to the Medicare Shared Savings Program for Accountable Care 
Organizations (ACOs) proposed in the August 2018 proposed rule 
``Medicare Program; Medicare Shared Savings Program; Accountable Care 
Organizations--Pathways to Success''. This final rule also addresses 
certain other revisions designed to update program policies under the 
Shared Savings Program.
    The interim final rule implements amendments made by the SUPPORT 
for Patients and Communities Act to the Medicare telehealth provisions 
in the Social Security Act and regarding permissible telehealth 
originating sites for purposes of treatment of a substance use disorder 
or a co-occurring mental health disorder for telehealth services 
furnished on or after July 1, 2019 to an individual with a substance 
use disorder diagnosis.

DATES: Effective Dates: These regulations are effective on January 1, 
2019, except for the following:
     Revisions to Sec. Sec.  414.1415(b)(2) and (3), and 
414.1420(b), (c)(2), and (3), which are effective January 1, 2020; and
     Amendments to Part 425, which are effective on December 
31, 2018.
    Applicability Date: The following provisions related to Section 
II.I. of this final rule, Evaluation and Management Services, are 
applicable beginning January 1, 2021: Implementation of a blended 
payment rate for E/M visits levels 2-4; Payment to adjust the base E/M 
visit rate(s) upward to account for visit complexity associated with 
non-procedural specialty care and primary care; Payment to adjust the 
base visit rate(s) upward to account for the additional resource costs 
when practitioners need to spend significantly more time with 
particular patients; and Flexible documentation requirements related to 
Medical Decision Making, Time or Current E/M visit documentation 
framework. The amendment to the definition of ``low-volume criteria'' 
at Sec.  414.1305 is applicable at the start of the first Merit-based 
Incentive Payment System (MIPS) determination period for CY 2018 MIPS 
performance period.
    Comment date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on December 31, 2018.

ADDRESSES: In commenting, please refer to file code CMS-1693-IFC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address only: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-1693-IFC, P.O. Box 8010, 
Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address only: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-1693-IFC, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: 
    Jamie Hermansen, (410) 786-2064, for any physician payment issues 
not identified below.
    Lindsey Baldwin, (410) 786-1694, and Emily Yoder, (410) 786-1804, 
for issues related to evaluation and management (E/M) payment, 
communication technology-based services and telehealth services.
    Lindsey Baldwin, (410) 786-1694, for issues related to sections 
2001(a) and 2005 of the SUPPORT for Patients and Communities Act.
    Kathy Bryant, (410) 786-3448, for issues related to global surgery 
data collection.
    Isadora Gil, (410) 786-4532, for issues related to payment rates 
for nonexcepted items and services furnished by nonexcepted off-campus 
provider-based departments of a hospital, and work relative value units 
(RVUs).
    Ann Marshall, (410) 786-3059, for issues related to E/M 
documentation guidelines.
    Geri Mondowney, (410) 786-1172, for issues related to potentially 
misvalued services, geographic price cost indices (GPCIs), and 
malpractice RVUs.
    Donta Henson, (410) 786-1947, for issues related to geographic 
price cost indices (GPCIs).
    Tourette Jackson, (410) 786-4735, for issues related to malpractice 
RVUs.
    Patrick Sartini, (410) 786-9252, for issues related to radiologist 
assistants.
    Michael Soracoe, (410) 786-6312, for issues related to practice 
expense, work RVUs, impacts, and conversion factor.
    Pamela West, (410) 786-2302, for issues related to therapy 
services.
    Edmund Kasaitis, (410) 786-0477, for issues related to reduction of 
wholesale acquisition cost (WAC)-based payment.
    Marcie O'Reilly, (410) 786-9764, for issues related to the 
Potential Model for Radiation Therapy.

[[Page 59453]]

    Sarah Harding, (410) 786-4001, or Craig Dobyski, (410) 786-4584, 
for issues related to aggregate reporting of applicable information for 
clinical laboratory fee schedule.
    Amy Gruber, (410) 786-1542, or Glenn McGuirk, (410) 786-5723, for 
issues related to the ambulance fee schedule.
    Corinne Axelrod, (410) 786-5620, for issues related to care 
management services and communication technology-based services in 
Rural Health Clinics (RHCs) and Federally Qualified Health Centers 
(FQHCs).
    JoAnna Baldwin, (410) 786-7205, or Sarah Fulton, (410) 786-2749, 
for issues related to appropriate use criteria for advanced diagnostic 
imaging services.
    Fiona Larbi, (410) 786-7224, for issues related to the Medicare 
Shared Savings Program (Shared Savings Program) Quality Measures.
    Matthew Edgar, (410) 786-0698, for issues related to the physician 
self-referral law.
    Molly MacHarris, (410) 786-4461, for inquiries related to Merit-
based Incentive Payment System (MIPS).
    Benjamin Chin, (410) 786-0679, for inquiries related to Alternative 
Payment Models (APMs).
    David Koppel, (303) 844-2883, or Elizabeth LeBreton (202) 615-3816 
for issues related to the Medicaid Promoting Interoperability Program.
    Elizabeth November, (410) 786-8084, for inquiries related to the 
Medicare Shared Savings Program [Pathways to Success].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
II. Provisions of the Final Rule for PFS
    A. Background
    B. Determination of Practice Expense (PE) Relative Value Units 
(RVUs)
    C. Determination of Malpractice Relative Value Units (RVUs)
    D. Modernizing Medicare Physician Payment by Recognizing 
Communication Technology-Based Services and Interim Final Rule 
Expanding the Use of Telehealth Services for the Treatment of Opioid 
Use Disorder and Other Substance Use Disorders Under the Substance 
Use-Disorder Prevention That Promotes Opioid Recovery and Treatment 
(SUPPORT) for Patients and Communities Act
    E. Potentially Misvalued Services Under the PFS
    F. Radiologist Assistants
    G. Payment Rates Under the Medicare PFS for Nonexcepted Items 
and Services Furnished by Nonexcepted Off-Campus Provider-Based 
Departments of a Hospital
    H. Valuation of Specific Codes
    I. Evaluation & Management (E/M) Visits
    J. Teaching Physician Documentation Requirements for Evaluation 
and Management Services
    K. GPCI Comment Solicitation
    L. Therapy Services
    M. Part B Drugs: Application of an Add-On Percentage for Certain 
Wholesale Acquisition Cost (WAC)-Based Payments
    N. Potential Model for Radiation Therapy
III. Other Provisions of the Final Rule
    A. Clinical Laboratory Fee Schedule
    B. Changes to the Regulations Associated With the Ambulance Fee 
Schedule
    C. Payment for Care Management Services and Communication 
Technology-Based Services in Rural Health Clinics (RHCs) and 
Federally Qualified Health Centers (FQHCs)
    D. Appropriate Use Criteria for Advanced Diagnostic Imaging 
Services
    E. Medicaid Promoting Interoperability Program Requirements for 
Eligible Professionals
    F. Medicare Shared Savings Program Quality Measures
    G. Physician Self-Referral Law
    H. Physician Self-Referral Law: Annual Update to the List of 
CPT/HCPCS Codes
    I. CY 2019 Updates to the Quality Payment Program (Includes the 
Extreme and Uncontrollable Circumstances MIPS Eligible Clinicians 
Faced as a Result of Widespread Catastrophic Events Affecting a 
Region or Locale in CY 2017 IFC Policies)
IV. Requests for Information
V. Medicare Shared Savings Program; Accountable Care Organizations--
Pathways to Success
VI. Collection of Information Requirements
VII. Regulatory Impact Analysis
Regulations Text
Appendix 1: Finalized MIPS Quality Measures
Appendix 2: Improvement Activities

Addenda Available Only Through the Internet on the CMS Website

    The PFS Addenda along with other supporting documents and tables 
referenced in this final rule are available on the CMS website at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. Click on the 
link on the left side of the screen titled, ``PFS Federal Regulations 
Notices'' for a chronological list of PFS Federal Register and other 
related documents. For the CY 2019 PFS final rule, refer to item CMS-
1693-F. Readers with questions related to accessing any of the Addenda 
or other supporting documents referenced in this final rule and posted 
on the CMS website identified above should contact Jamie Hermansen at 
(410) 786-2064.

CPT (Current Procedural Terminology) Copyright Notice

    Throughout this final rule, we use CPT codes and descriptions to 
refer to a variety of services. We note that CPT codes and descriptions 
are copyright 2018 American Medical Association. All Rights Reserved. 
CPT is a registered trademark of the American Medical Association 
(AMA). Applicable Federal Acquisition Regulations (FAR) and Defense 
Federal Acquisition Regulations (DFAR) apply.

I. Executive Summary

A. Purpose

    This major final rule makes payment and policy changes under the 
Medicare PFS and implements certain provisions of the Bipartisan Budget 
Act of 2018 (Pub. L. 115-123, February 9, 2018) and the SUPPORT for 
Patients and Communities Act (Pub. L. 115-271, October 24, 2018) 
related to Medicare Part B payment, and except as specified otherwise, 
applicable to services furnished in CY 2019. This final rule also 
revises certain policies under the Medicare Shared Savings Program.
1. Summary of the Major Provisions
    The statute requires us to establish payments under the PFS based 
on national uniform relative value units (RVUs) that account for the 
relative resources used in furnishing a service. The statute requires 
that RVUs be established for three categories of resources: Work; 
practice expense (PE); and malpractice (MP) expense. In addition, the 
statute requires that we establish by regulation each year's payment 
amounts for all physicians' services paid under the PFS, incorporating 
geographic adjustments to reflect the variations in the costs of 
furnishing services in different geographic areas. In this major final 
rule, we establish RVUs for CY 2019 for the PFS, and other Medicare 
Part B payment policies, to ensure that our payment systems are updated 
to reflect changes in medical practice and the relative value of 
services, as well as changes in the statute. This final rule includes 
discussions regarding:
     Potentially Misvalued Codes.
     Communication Technology-Based Services.
     Provisions Expanding Telehealth Services for the Treatment 
of Opioid Use Disorder and Other Substance Use Disorders under the 
SUPPORT Act.
     Valuation of New, Revised, and Misvalued Codes.
     Payment Rates under the PFS for Nonexcepted Items and 
Services Furnished by Nonexcepted Off-Campus Provider-Based Departments 
of a Hospital.
     Evaluation & Management (E/M) Visits.

[[Page 59454]]

     Therapy Services.
     Part B Drugs: Application of an Add-on Percentage for 
Certain Wholesale Acquisition Cost (WAC)-based Payments.
     Potential Model for Radiation Therapy.
     Clinical Laboratory Fee Schedule.
     Ambulance Fee Schedule--Provisions in the Bipartisan 
Budget Act of 2018.
     Rural Health Clinics (RHCs) and Federally Qualified Health 
Centers (FQHCs).
     Appropriate Use Criteria for Advanced Diagnostic Imaging 
Services.
     Medicaid Promoting Interoperability Program Requirements 
for Eligible Professionals.
     Medicare Shared Savings Program Quality Measures.
     Physician Self-Referral Law.
     Physician Self-Referral Law: Annual Update to the List of 
CPT/HCPCS Codes.
     CY 2019 Updates to the Quality Payment Program (including 
the extreme and uncontrollable circumstances MIPS eligible clinicians 
faced as a result of widespread catastrophic events affecting a region 
or locale in CY 2017).
     Comments in response to the Request for Information on 
Promoting Interoperability and Electronic Healthcare Information 
Exchange through Possible Revisions to the CMS Patient Health and 
Safety Requirements for Hospitals and Other Medicare- and Medicaid-
Participating Providers and Suppliers.
     Comments in response to the Request for Information on 
Price Transparency: Improving Beneficiary Access to Provider and 
Supplier Charge Information.
    This rule also finalizes certain provisions from the ``Medicare 
Program; Medicare Shared Savings Program; Accountable Care 
Organizations--Pathways to Success'' proposed rule that appeared in the 
August 17, 2018 Federal Register (83 FR 41786). Under the Medicare 
Shared Savings Program, providers of services and suppliers that 
participate in an ACO continue to receive traditional Medicare fee-for-
service (FFS) payments under Parts A and B, but the ACO may be eligible 
to receive a shared savings payment if it meets specified quality and 
savings requirements. ACOs participating under a two-sided shared 
savings and shared losses model of the program may also be responsible 
for repaying shared losses if the Parts A and B FFS expenditures for 
their assigned beneficiaries exceed the ACO's historical benchmark. The 
revised policies for ACOs participating in the Medicare Shared Savings 
Program will ensure continuity of program participation for ACOs whose 
agreement periods expire on December 31, 2018 by allowing these ACOs 
the opportunity to elect a voluntary 6-month extension of their current 
agreement periods; supporting coordination of care across settings and 
strengthening beneficiary engagement; providing relief for ACOs 
impacted by extreme and uncontrollable circumstance in performance year 
2018 and subsequent years; and promoting interoperable electronic 
health record technology among ACO providers/suppliers. We plan to 
address the remaining proposals from the August 2018 proposed rule (83 
FR 41786) in a forthcoming second final rule.
2. Summary of Costs and Benefits
    We have determined that this major final rule is economically 
significant. For a detailed discussion of the economic impacts, see 
section VII. of this final rule.

B. Determination of Practice Expense (PE) Relative Value Units (RVUs)

1. Overview
    Practice expense (PE) is the portion of the resources used in 
furnishing a service that reflects the general categories of physician 
and practitioner expenses, such as office rent and personnel wages, but 
excluding MP expenses, as specified in section 1848(c)(1)(B) of the 
Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a 
resource-based system for determining PE RVUs for each physicians' 
service. We develop PE RVUs by considering the direct and indirect 
practice resources involved in furnishing each service. Direct expense 
categories include clinical labor, medical supplies, and medical 
equipment. Indirect expenses include administrative labor, office 
expense, and all other expenses. The sections that follow provide more 
detailed information about the methodology for translating the 
resources involved in furnishing each service into service-specific PE 
RVUs. We refer readers to the CY 2010 PFS final rule with comment 
period (74 FR 61743 through 61748) for a more detailed explanation of 
the PE methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
    We determine the direct PE for a specific service by adding the 
costs of the direct resources (that is, the clinical staff, medical 
supplies, and medical equipment) typically involved with furnishing 
that service. The costs of the resources are calculated using the 
refined direct PE inputs assigned to each CPT code in our PE database, 
which are generally based on our review of recommendations received 
from the RUC and those provided in response to public comment periods. 
For a detailed explanation of the direct PE methodology, including 
examples, we refer readers to the Five-Year Review of Work Relative 
Value Units under the PFS and Proposed Changes to the Practice Expense 
Methodology CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007 
PFS final rule with comment period (71 FR 69629).
    Comment: Several commenters requested that CMS include pharmacists 
as active qualified health care providers for purposes of calculating 
physician PE direct costs. The commenters stated that pharmacists need 
to be included in the calculation of direct PE expenses as an element 
of the clinical labor variable relating to physicians' services. The 
commenter stated that pharmacists are key members of the healthcare 
team supporting the advent of digital medicine and telehealth services 
and suggested that pharmacists should be recognized as staff included 
in practice expense inputs.
    Response: The direct PE input database contains the service-level 
costs in clinical labor based on the typical service furnished to 
Medicare beneficiaries. When these resource costs are typically 
incurred in furnishing services, we do not have any standing policies 
that would prohibit the inclusion of the costs in the direct PE input 
database used to develop PE RVUs for individual services, to the extent 
that inclusion of such costs would not lead to duplicative payments. 
Therefore, we welcome more detailed information regarding the typical 
clinical labor costs involving pharmacists for particular PFS services. 
We note, however, that in the case of many PFS services, especially 
care management services, certain elements of the services could be 
provided by clinicians other than the billing professionals, which 
could include services provided by pharmacists. As such, we encourage 
interested stakeholders to provide information through the RUC process 
or directly to us by February 10th prior to annual rulemaking about the 
inclusion of additional clinical labor costs for specific services 
described by HCPCS codes for which payment is made under the PFS, as 
opposed to clinical labor costs that may be typical only under certain 
circumstances.

[[Page 59455]]

b. Indirect Practice Expense per Hour Data
    We use survey data on indirect PEs incurred per hour worked, in 
developing the indirect portion of the PE RVUs. Prior to CY 2010, we 
primarily used the PE/HR by specialty that was obtained from the AMA's 
SMS. The AMA administered a new survey in CY 2007 and CY 2008, the 
Physician Practice Expense Information Survey (PPIS). The PPIS is a 
multispecialty, nationally representative, PE survey of both physicians 
and NPPs paid under the PFS using a survey instrument and methods 
highly consistent with those used for the SMS and the supplemental 
surveys. The PPIS gathered information from 3,656 respondents across 51 
physician specialty and health care professional groups. We believe the 
PPIS is the most comprehensive source of PE survey information 
available. We used the PPIS data to update the PE/HR data for the CY 
2010 PFS for almost all of the Medicare-recognized specialties that 
participated in the survey.
    When we began using the PPIS data in CY 2010, we did not change the 
PE RVU methodology itself or the manner in which the PE/HR data are 
used in that methodology. We only updated the PE/HR data based on the 
new survey. Furthermore, as we explained in the CY 2010 PFS final rule 
with comment period (74 FR 61751), because of the magnitude of payment 
reductions for some specialties resulting from the use of the PPIS 
data, we transitioned its use over a 4-year period from the previous PE 
RVUs to the PE RVUs developed using the new PPIS data. As provided in 
the CY 2010 PFS final rule with comment period (74 FR 61751), the 
transition to the PPIS data was complete for CY 2013. Therefore, PE 
RVUs from CY 2013 forward are developed based entirely on the PPIS 
data, except as noted in this section.
    Section 1848(c)(2)(H)(i) of the Act requires us to use the medical 
oncology supplemental survey data submitted in 2003 for oncology drug 
administration services. Therefore, the PE/HR for medical oncology, 
hematology, and hematology/oncology reflects the continued use of these 
supplemental survey data.
    Supplemental survey data on independent labs from the College of 
American Pathologists were implemented for payments beginning in CY 
2005. Supplemental survey data from the National Coalition of Quality 
Diagnostic Imaging Services (NCQDIS), representing independent 
diagnostic testing facilities (IDTFs), were blended with supplementary 
survey data from the American College of Radiology (ACR) and 
implemented for payments beginning in CY 2007. Neither IDTFs, nor 
independent labs, participated in the PPIS. Therefore, we continue to 
use the PE/HR that was developed from their supplemental survey data.
    Consistent with our past practice, the previous indirect PE/HR 
values from the supplemental surveys for these specialties were updated 
to CY 2006 using the Medicare Economic Index (MEI) to put them on a 
comparable basis with the PPIS data.
    We also do not use the PPIS data for reproductive endocrinology and 
spine surgery since these specialties currently are not separately 
recognized by Medicare, nor do we have a method to blend the PPIS data 
with Medicare-recognized specialty data.
    Previously, we established PE/HR values for various specialties 
without SMS or supplemental survey data by crosswalking them to other 
similar specialties to estimate a proxy PE/HR. For specialties that 
were part of the PPIS for which we previously used a crosswalked PE/HR, 
we instead used the PPIS-based PE/HR. We use crosswalks for specialties 
that did not participate in the PPIS. These crosswalks have been 
generally established through notice and comment rulemaking and are 
available in the file called ``CY 2019 PFS Final Rule PE/HR'' on the 
CMS website under downloads for the CY 2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Comment: Several commenters recommended that it was time to 
consider a new nationwide all specialty PE/HR survey, given the amount 
of time that has passed since the last survey was conducted. The 
commenters stated that the practice of medicine has significantly and 
substantially evolved in the past decade and that many specialties have 
had extensive changes in physician employment models during that time. 
The commenters stated that continued use of the outdated PPIS survey 
leads to an inappropriate and inaccurate distortion of the PE RVUs for 
current practice.
    Response: We have previously identified several concerns regarding 
the underlying data used in determining PE RVUs in the CY 2014 PFS 
final rule with comment period (78 FR 74246 through 74247). While we 
continue to believe that the PPIS survey data are the best data 
currently available, we continue to seek the best broad based, 
auditable, routinely updated source of information regarding PE costs. 
To that end, we have engaged a contractor, the RAND Corporation, to 
explore the feasibility of updating the data used in the development of 
PE RVUs.
    Comment: One commenter requested that CMS consider studying 
indirect PE associated with emergency departments including Emergency 
Medical Treatment & Labor Act (EMTALA)-mandated uncompensated care. The 
commenter stated that emergency physicians are not able to schedule 
their patients and therefore cannot maximize the use of staff and 
resources, and that there are costs associated with being open and 
having to pay shift differentials over nights, weekends, and holidays.
    Response: We will take the information under consideration for 
future rulemaking.
    For CY 2019, we have incorporated the available utilization data 
for two new specialties, each of which became a recognized Medicare 
specialty during 2017. These specialties are Hospitalists and Advanced 
Heart Failure and Transplant Cardiology. We proposed to use proxy PE/HR 
values for these new specialties, as there are no PPIS data for these 
specialties, by crosswalking the PE/HR as follows from specialties that 
furnish similar services in the Medicare claims data:
     Hospitalists from Emergency Medicine, and
     Advanced Heart Failure and Transplant Cardiology from 
Cardiology.
    These updates are reflected in the ``CY 2019 PFS Final Rule PE/HR'' 
file available on the CMS website under the supporting data files for 
the CY 2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    The following is a summary of the public comments we received on 
our proposal to use proxy PE/HR values for these two new specialties.
    Comment: One commenter stated that they supported the CMS proposal 
to crosswalk the Advanced Heart Failure and Transplant specialty to the 
cardiology PPIS data.
    Response: We appreciate the support from the commenter for our 
proposal.
    Comment: A few commenters wrote to detail their concerns with the 
current PE/HR assigned to home PT/INR monitoring services. Commenters 
stated that these services are provided by entities that are enrolled 
in Medicare as independent testing facilities because there is no other 
specialty category that currently describes these suppliers; however, 
home PT/INR monitoring services are fundamentally different in nature. 
Commenters stated that home PT/INR monitoring services tend to be

[[Page 59456]]

more therapeutic than diagnostic in nature, typically utilize different 
staffing types, and have a different ratio of direct to indirect costs. 
The commenters encouraged CMS to consider home PT/INR monitoring as a 
distinct specialty from independent testing facilities and to survey 
suppliers to determine accurate indirect cost factors for these 
services, while using either the Pathology or All Physicians specialty 
as a proxy for PE/HR in the meantime. One commenter suggested that CMS 
should consider holding payments harmless for home PT/INR monitoring 
services while additional analysis is completed.
    Response: We welcome suggestions from interested parties regarding 
new indirect PE surveys and the use of PE/HR proxies that could be 
considered for future rulemaking. Interested parties may wish to submit 
a physician specialty designation request per the instructions found in 
Pub. 100-04, Medicare Claims Processing Manual, Chapter 26, Section 
10.8 (available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c26.pdf). This section of 
the Medicare Claims Processing Manual includes the criteria that CMS 
uses to evaluate physician specialty designation requests.
    After consideration of the public comments, we are finalizing our 
proposal to use proxy PE/HR values for Hospitalists and Advanced Heart 
Failure and Transplant Cardiology as described above.
c. Allocation of PE to Services
    To establish PE RVUs for specific services, it is necessary to 
establish the direct and indirect PE associated with each service.
(1) Direct Costs
    The relative relationship between the direct cost portions of the 
PE RVUs for any two services is determined by the relative relationship 
between the sum of the direct cost resources (that is, the clinical 
staff, medical supplies, and medical equipment) typically involved with 
furnishing each of the services. The costs of these resources are 
calculated from the refined direct PE inputs in our PE database. For 
example, if one service has a direct cost sum of $400 from our PE 
database and another service has a direct cost sum of $200, the direct 
portion of the PE RVUs of the first service would be twice as much as 
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
    We allocate the indirect costs at the code level on the basis of 
the direct costs specifically associated with a code and the greater of 
either the clinical labor costs or the work RVUs. We also incorporate 
the survey data described earlier in the PE/HR discussion (see section 
II.B.2.b of this final rule). The general approach to developing the 
indirect portion of the PE RVUs is as follows:
     For a given service, we use the direct portion of the PE 
RVUs calculated as previously described and the average percentage that 
direct costs represent of total costs (based on survey data) across the 
specialties that furnish the service to determine an initial indirect 
allocator. That is, the initial indirect allocator is calculated so 
that the direct costs equal the average percentage of direct costs of 
those specialties furnishing the service. For example, if the direct 
portion of the PE RVUs for a given service is 2.00 and direct costs, on 
average, represent 25 percent of total costs for the specialties that 
furnish the service, the initial indirect allocator would be calculated 
so that it equals 75 percent of the total PE RVUs. Thus, in this 
example, the initial indirect allocator would equal 6.00, resulting in 
a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 
percent of 8.00).
     Next, we add the greater of the work RVUs or clinical 
labor portion of the direct portion of the PE RVUs to this initial 
indirect allocator. In our example, if this service had a work RVU of 
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we 
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 
clinical labor portion) to the initial indirect allocator of 6.00 to 
get an indirect allocator of 10.00. In the absence of any further use 
of the survey data, the relative relationship between the indirect cost 
portions of the PE RVUs for any two services would be determined by the 
relative relationship between these indirect cost allocators. For 
example, if one service had an indirect cost allocator of 10.00 and 
another service had an indirect cost allocator of 5.00, the indirect 
portion of the PE RVUs of the first service would be twice as great as 
the indirect portion of the PE RVUs for the second service.
     Next, we incorporated the specialty-specific indirect PE/
HR data into the calculation. In our example, if, based on the survey 
data, the average indirect cost of the specialties furnishing the first 
service with an allocator of 10.00 was half of the average indirect 
cost of the specialties furnishing the second service with an indirect 
allocator of 5.00, the indirect portion of the PE RVUs of the first 
service would be equal to that of the second service.
(3) Facility and Nonfacility Costs
    For procedures that can be furnished in a physician's office, as 
well as in a facility setting, where Medicare makes a separate payment 
to the facility for its costs in furnishing a service, we establish two 
PE RVUs: Facility and nonfacility. The methodology for calculating PE 
RVUs is the same for both the facility and nonfacility RVUs, but is 
applied independently to yield two separate PE RVUs. In calculating the 
PE RVUs for services furnished in a facility, we do not include 
resources that would generally not be provided by physicians when 
furnishing the service. For this reason, the facility PE RVUs are 
generally lower than the nonfacility PE RVUs.
    Comment: One commenter stated that it was not clear why the PE 
change would differ so greatly between the office and facility settings 
for CPT code 37227 (Revascularization, endovascular, open or 
percutaneous, femoral, popliteal artery(s), unilateral; with 
transluminal stent placement(s) and atherectomy, includes angioplasty 
within the same vessel, when performed). The commenter stated that the 
facility PE RVU for this CPT code was proposed to decrease by 4.8 
percent while the non-facility PE RVU was proposed to decrease by 10.6 
percent, and the commenter could not understand how these payment rates 
were determined.
    Response: As detailed above, the methodology for calculating PE 
RVUs is the same for both the facility and nonfacility RVUs, but is 
applied independently to yield two separate PE RVUs. It is not unusual 
for facility and nonfacility RVUs for a CPT code to change at different 
rates from year to year, as the direct costs associated with the 
facility and nonfacility settings are typically distinct from one 
another. For a more detailed description of the PE RVU methodology, we 
refer readers to the CY 2007 PFS final rule with comment period (71 FR 
69630 through 69643) and the CY 2010 PFS final rule with comment period 
(74 FR 61745 through 61746).
(4) Services With Technical Components and Professional Components
    Diagnostic services are generally comprised of two components: A 
professional component (PC); and a technical component (TC). The PC and 
TC may be furnished independently or by different providers, or they 
may be

[[Page 59457]]

furnished together as a global service. When services have separately 
billable PC and TC components, the payment for the global service 
equals the sum of the payment for the TC and PC. To achieve this, we 
use a weighted average of the ratio of indirect to direct costs across 
all the specialties that furnish the global service, TCs, and PCs; that 
is, we apply the same weighted average indirect percentage factor to 
allocate indirect expenses to the global service, PCs, and TCs for a 
service. (The direct PE RVUs for the TC and PC sum to the global.)
(5) PE RVU Methodology
    For a more detailed description of the PE RVU methodology, we refer 
readers to the CY 2010 PFS final rule with comment period (74 FR 61745 
through 61746). We also direct readers to the file called ``Calculation 
of PE RVUs under Methodology for Selected Codes'' which is available on 
our website under downloads for the CY 2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file 
contains a table that illustrates the calculation of PE RVUs as 
described in this final rule for individual codes.
(a) Setup File
    First, we create a setup file for the PE methodology. The setup 
file contains the direct cost inputs, the utilization for each 
procedure code at the specialty and facility/nonfacility place of 
service level, and the specialty-specific PE/HR data calculated from 
the surveys.
(b) Calculate the Direct Cost PE RVUs
    Sum the costs of each direct input.
    Step 1: Sum the direct costs of the inputs for each service.
    Step 2: Calculate the aggregate pool of direct PE costs for the 
current year. We set the aggregate pool of PE costs equal to the 
product of the ratio of the current aggregate PE RVUs to current 
aggregate work RVUs and the projected aggregate work RVUs.
    Step 3: Calculate the aggregate pool of direct PE costs for use in 
ratesetting. This is the product of the aggregate direct costs for all 
services from Step 1 and the utilization data for that service.
    Step 4: Using the results of Step 2 and Step 3, use the CF to 
calculate a direct PE scaling adjustment to ensure that the aggregate 
pool of direct PE costs calculated in Step 3 does not vary from the 
aggregate pool of direct PE costs for the current year. Apply the 
scaling adjustment to the direct costs for each service (as calculated 
in Step 1).
    Step 5: Convert the results of Step 4 to a RVU scale for each 
service. To do this, divide the results of Step 4 by the CF. Note that 
the actual value of the CF used in this calculation does not influence 
the final direct cost PE RVUs as long as the same CF is used in Step 4 
and Step 5. Different CFs would result in different direct PE scaling 
adjustments, but this has no effect on the final direct cost PE RVUs 
since changes in the CFs and changes in the associated direct scaling 
adjustments offset one another.
(c) Create the Indirect Cost PE RVUs
    Create indirect allocators.
    Step 6: Based on the survey data, calculate direct and indirect PE 
percentages for each physician specialty.
    Step 7: Calculate direct and indirect PE percentages at the service 
level by taking a weighted average of the results of Step 6 for the 
specialties that furnish the service. Note that for services with TCs 
and PCs, the direct and indirect percentages for a given service do not 
vary by the PC, TC, and global service.
    We generally use an average of the 3 most recent years of available 
Medicare claims data to determine the specialty mix assigned to each 
code. Codes with low Medicare service volume require special attention 
since billing or enrollment irregularities for a given year can result 
in significant changes in specialty mix assignment. We finalized a 
policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use 
the most recent year of claims data to determine which codes are low 
volume for the coming year (those that have fewer than 100 allowed 
services in the Medicare claims data). For codes that fall into this 
category, instead of assigning specialty mix based on the specialties 
of the practitioners reporting the services in the claims data, we 
instead use the expected specialty that we identify on a list developed 
based on medical review and input from expert stakeholders. We display 
this list of expected specialty assignments as part of the annual set 
of data files we make available as part of notice and comment 
rulemaking and consider recommendations from the RUC and other 
stakeholders on changes to this list on an annual basis. Services for 
which the specialty is automatically assigned based on previously 
finalized policies under our established methodology (for example, 
``always therapy'' services) are unaffected by the list of expected 
specialty assignments. We also finalized in the CY 2018 PFS final rule 
(82 FR 52982 through 59283) a policy to apply these service-level 
overrides for both PE and MP, rather than one or the other category.
    For CY 2019, we proposed to add 28 additional codes that we 
identified as low volume services to the list of codes for which we 
assign the expected specialty. Based on our own medical review and 
input from the RUC and from specialty societies, we proposed to assign 
the expected specialty for each code as indicated in Table 1. For each 
of these codes, only the professional component (reported with the -26 
modifier) is nationally priced. The global and technical components are 
priced by the Medicare Administrative Contractors (MACs) which 
establish RVUs and payment amounts for these services. The list of 
codes that we proposed to add is displayed in Table 1.

                    Table 1--New Additions to Expected Specialty List for Low Volume Services
----------------------------------------------------------------------------------------------------------------
                                                                                                       2017
      CPT code             Modifier            Short descriptor           Expected specialty        utilization
----------------------------------------------------------------------------------------------------------------
70557..............  26.................  Mri brain w/o dye.........  Diagnostic Radiology......             126
70558..............  26.................  Mri brain w/dye...........  Diagnostic Radiology......              32
74235..............  26.................  Remove esophagus            Gastroenterology..........              10
                                           obstruction.
74301..............  26.................  X-rays at surgery add-on..  Diagnostic Radiology......              73
74355..............  26.................  X-ray guide intestinal      Diagnostic Radiology......              11
                                           tube.
74445..............  26.................  X-ray exam of penis.......  Urology...................              26
74742..............  26.................  X-ray fallopian tube......  Diagnostic Radiology......               5
74775..............  26.................  X-ray exam of perineum....  Diagnostic Radiology......              80
75801..............  26.................  Lymph vessel x-ray arm/leg  Diagnostic Radiology......             114
75803..............  26.................  Lymph vessel x-ray arms/    Diagnostic Radiology......              41
                                           leg.
75805..............  26.................  Lymph vessel x-ray trunk..  Diagnostic Radiology......              50
75810..............  26.................  Vein x-ray spleen/liver...  Diagnostic Radiology......              46

[[Page 59458]]

 
76941..............  26.................  Echo guide for transfusion  Obstetrics/Gynecology.....              15
76945..............  26.................  Echo guide villus sampling  Obstetrics/Gynecology.....              31
76975..............  26.................  Gi endoscopic ultrasound..  Gastroenterology..........              49
78282..............  26.................  Gi protein loss exam......  Diagnostic Radiology......               8
79300..............  26.................  Nuclr rx interstit colloid  Diagnostic Radiology......               2
86327..............  26.................  Immunoelectrophoresis       Pathology.................              24
                                           assay.
87164..............  26.................  Dark field examination....  Pathology.................              30
88371..............  26.................  Protein western blot        Pathology.................               2
                                           tissue.
93532..............  26.................  R & l heart cath            Cardiology................              28
                                           congenital.
93533..............  26.................  R & l heart cath            Cardiology................              36
                                           congenital.
93561..............  26.................  Cardiac output measurement  Cardiology................              28
93562..............  26.................  Card output measure subsq.  Cardiology................              38
93616..............  26.................  Esophageal recording......  Cardiology................              38
93624..............  26.................  Electrophysiologic study..  Cardiology................              51
95966..............  26.................  Meg evoked single.........  Neurology.................              72
95967..............  26.................  Meg evoked each addl......  Neurology.................              61
----------------------------------------------------------------------------------------------------------------

    The complete list of expected specialty assignments for individual 
low volume services, including the assignments for the codes identified 
in Table 1, is available on our website under downloads for the CY 2019 
PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    The following is a summary of the public comments we received on 
our proposal to update the list of expected specialty assignments for 
low volume services.
    Comment: Several commenters supported the continued use of service-
level overrides for low volume codes, and stated that they agreed with 
the addition of the proposed 28 codes to the list of expected 
specialties.
    Response: We appreciate the support from the commenters.
    Comment: Several commenters stated that CPT code 22857 (Total disc 
arthroplasty (artificial disc), anterior approach, including discectomy 
to prepare interspace (other than for decompression), single 
interspace, lumbar) was missing from the proposed list. These 
commenters requested that CMS include CPT code 22857 in the low 
utilization category and permanently assign it to the orthopaedic 
surgery specialty to maintain payment stability and minimize annual 
fluctuations.
    Response: We agree with the commenters that CPT code 22857 
qualifies as a low volume code, with an annual Medicare utilization of 
roughly 20 services. We agree with the commenters that assigning this 
code to the orthopaedic surgery specialty will help to maintain payment 
stability, and we are finalizing the addition of CPT code 22857 to the 
low volume services list.
    Comment: One commenter stated that several of the proposed low 
volume services would be more accurately assigned to different expected 
specialties based on their practice patterns. The commenter stated that 
CPT codes 70557 and 70558 are intraoperative exams and are most often 
performed by neurosurgeons and that CPT code 74235 is a diagnostic 
radiology code rather than a gastroenterology code. The commenter 
stated that CPT code 75810 should be assigned to interventional 
radiology rather than diagnostic radiology, and that CPT codes 78282 
and 79300 should be assigned to nuclear medicine rather than diagnostic 
radiology.
    Response: We agree that these codes would be more accurately 
assigned to the expected specialties described by the commenter based 
on an examination of the claims data. We are finalizing changes in 
expected specialty to these six codes as described by the commenter.
    Comment: One commenter stated that there are four codes that are 
still not included in the proposed CY 2019 low volume override list and 
recommended that the following low volume procedures be added to the 
override list with the indicated specialty assignment:
     Cardiac Surgery: CPT code 35812, and
     Thoracic Surgery: CPT codes 32654, 33025 and 33251
    Response: We agree with the inclusion of CPT codes 32654 and 33251. 
These are services with very low annual utilization, and we are 
finalizing their addition to the low volume services list with the 
expected specialty as described by the commenter. We note that CPT code 
33251 is already on the low volume services list with an expected 
specialty of Cardiac Surgery; we are finalizing a change to the 
Thoracic Surgery specialty as requested by the commenter. We are not 
finalizing the addition of CPT code 35812 to the list, as it does not 
appear to be a current CPT code. We are also not finalizing the 
addition of CPT code 33025 to the list, as the code had a utilization 
of more than 5,000 services in the most recent year of claims data, and 
this would not qualify as a low volume service under the criteria that 
we have previously finalized through rulemaking.
    Comment: One commenter stated that the appropriate low volume 
overrides were not applied to a series of congenital/pediatric cardiac 
surgery codes. The commenter stated that each of these operations can 
only be performed by congenital heart surgeons classified as either 
cardiac or thoracic surgeons, and that they believe the malpractice 
RVUs had been improperly decreased as a result of the low volume 
service overrides not being applied.
    Response: Each of the CPT codes identified by the commenter was 
already present on the low volume services list with an expected 
specialty assignment of either Cardiac Surgery or Thoracic Surgery. The 
shifts in malpractice RVUs identified by the commenter were a result of 
proposed policies associated with E/M visits. We refer readers to 
section II.I. of this final rule for additional details on these 
policies.
    After consideration of the public comments, we are finalizing the 
addition of the proposed 28 codes to the low volume services list, with 
the expected specialty as proposed except where modified in response to 
comments. We are also finalizing the addition of CPT codes 32654 and 
33251 to the list with an expected specialty of Thoracic Surgery as 
detailed previously.

[[Page 59459]]

    Step 8: Calculate the service level allocators for the indirect PEs 
based on the percentages calculated in Step 7. The indirect PEs are 
allocated based on the three components: The direct PE RVUs; the 
clinical labor PE RVUs; and the work RVUs.
    For most services the indirect allocator is: Indirect PE percentage 
* (direct PE RVUs/direct percentage) + work RVUs.
    There are two situations where this formula is modified:
     If the service is a global service (that is, a service 
with global, professional, and technical components), then the indirect 
PE allocator is: Indirect percentage (direct PE RVUs/direct percentage) 
+ clinical labor PE RVUs + work RVUs.
     If the clinical labor PE RVUs exceed the work RVUs (and 
the service is not a global service), then the indirect allocator is: 
Indirect PE percentage (direct PE RVUs/direct percentage) + clinical 
labor PE RVUs.
    (Note: For global services, the indirect PE allocator is based on 
both the work RVUs and the clinical labor PE RVUs. We do this to 
recognize that, for the PC service, indirect PEs would be allocated 
using the work RVUs, and for the TC service, indirect PEs would be 
allocated using the direct PE RVUs and the clinical labor PE RVUs. This 
also allows the global component RVUs to equal the sum of the PC and TC 
RVUs.)
    For presentation purposes, in the examples in the download file 
called ``Calculation of PE RVUs under Methodology for Selected Codes'', 
the formulas were divided into two parts for each service.
     The first part does not vary by service and is the 
indirect percentage (direct PE RVUs/direct percentage).
     The second part is either the work RVU, clinical labor PE 
RVU, or both depending on whether the service is a global service and 
whether the clinical PE RVUs exceed the work RVUs (as described earlier 
in this step).
    Apply a scaling adjustment to the indirect allocators.
    Step 9: Calculate the current aggregate pool of indirect PE RVUs by 
multiplying the result of step 8 by the average indirect PE percentage 
from the survey data.
    Step 10: Calculate an aggregate pool of indirect PE RVUs for all 
PFS services by adding the product of the indirect PE allocators for a 
service from Step 8 and the utilization data for that service.
    Step 11: Using the results of Step 9 and Step 10, calculate an 
indirect PE adjustment so that the aggregate indirect allocation does 
not exceed the available aggregate indirect PE RVUs and apply it to 
indirect allocators calculated in Step 8.
    Calculate the indirect practice cost index.
    Step 12: Using the results of Step 11, calculate aggregate pools of 
specialty-specific adjusted indirect PE allocators for all PFS services 
for a specialty by adding the product of the adjusted indirect PE 
allocator for each service and the utilization data for that service.
    Step 13: Using the specialty-specific indirect PE/HR data, 
calculate specialty-specific aggregate pools of indirect PE for all PFS 
services for that specialty by adding the product of the indirect PE/HR 
for the specialty, the work time for the service, and the specialty's 
utilization for the service across all services furnished by the 
specialty.
    Step 14: Using the results of Step 12 and Step 13, calculate the 
specialty-specific indirect PE scaling factors.
    Step 15: Using the results of Step 14, calculate an indirect 
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor 
for the entire PFS.
    Step 16: Calculate the indirect practice cost index at the service 
level to ensure the capture of all indirect costs. Calculate a weighted 
average of the practice cost index values for the specialties that 
furnish the service. (Note: For services with TCs and PCs, we calculate 
the indirect practice cost index across the global service, PCs, and 
TCs. Under this method, the indirect practice cost index for a given 
service (for example, echocardiogram) does not vary by the PC, TC, and 
global service.)
    Step 17: Apply the service level indirect practice cost index 
calculated in Step 16 to the service level adjusted indirect allocators 
calculated in Step 11 to get the indirect PE RVUs.
    The following is a summary of the public comments we received on 
the indirect practice cost indices.
    Comment: Many commenters stated that they were opposed to the 
proposed significant shifts in the indirect practice cost indices at 
the specialty level. Commenters stated that the creation of a separate 
PE/HR rate for the E/M visits resulted in large unintended effects on 
specialties given the way that indirect PE is allocated, and that this 
was inconsistent with CMS' intent to maintain stability in payment. One 
commenter stated that the proposal to create a separate PE/HR rate for 
the E/M visits was based on statistically unsound methodology, had 
opaque analytics, and was not resource-based. Many commenters stated 
that the effects of the proposed changes to the indirect practice cost 
indices had not been sufficiently detailed in the proposed rule to 
allow for proper feedback from commenters. Commenters expressed concern 
that a reduction in payment due to shifts in the indirect PE allocation 
could affect patient access to critical services, such as but not 
limited to CPT codes 96360 (intravenous infusion, hydration; initial, 
31 minutes to 1 hour), 96372 (therapeutic, prophylactic, or diagnostic 
injection (specify substance or drug); subcutaneous or intramuscular), 
96374 (therapeutic, prophylactic or diagnostic injection IV push, 
single or initial substance/drug), 96375 (therapeutic, prophylactic or 
diagnostic injection; each additional sequential IV push of a new 
substance/drug), and HCPCS code G0416 (Surgical pathology, gross and 
microscopic examinations, for prostate needle biopsy, any method). A 
few commenters stated that the proposed indirect practice cost indices 
ignored statutory requirements that payments under the PFS must be 
resource based and failed to meet the transparency requirements of the 
Protecting Access to Medicare Act of 2014 (PAMA). Commenters urged CMS 
not to finalize the proposed changes to the indirect practice cost 
indices.
    Response: The proposed changes in the indirect practice cost 
indices identified by the commenters were a result of proposed policies 
associated with E/M visits, and specifically the proposal to establish 
a separate specialty for E/M visits. We refer readers to section II.I. 
of this final rule for additional discussion of these policies.
    Comment: One commenter stated that the level of detail in the CY 
2019 PFS proposed rule was insufficient to comment on several aspects 
of the proposed changes in coding and payment related to office/
outpatient E/M visits, which was a departure from past rules. The 
commenter specifically stated that there was insufficient information 
to model how the proposed changes in the office/outpatient E/M visit 
codes affected the indirect practice cost indices for all other 
services. Similarly, the commenter suggested that not enough 
information was provided to simulate the PFS ratesetting in a way that 
would isolate the impact of the proposed multiple procedure payment 
reduction (MPPR), in the proposed rates and associated estimates of 
specialty-level impact. The commenter requested that CMS provide 
additional technical information and files going forward to enable the 
commenter to better model proposed and future policies.
    Response: We agree with commenters regarding the importance of 
transparency and the need for detailed

[[Page 59460]]

information about proposed policies so that public commenters can 
provide a full and informed response. We also understand that there is 
merit to providing as much information as possible that would allow for 
complete reproduction of our proposed and final ratesetting 
methodologies. We also understand that the proposals related to office/
outpatient E/M visits are of great importance to the medical community 
and represent a significant portion of spending under the PFS. We do 
not agree with the commenter that the level of detail provided in the 
proposed rule, including the data provided as publicly available 
download files, was insufficient for public comment due to the 
extensive documentation associated with the E/M policy proposals, or 
that it represented a departure from past practice. Over several years, 
we have invested significant resources in improving the transparency of 
the data we use in developing proposed and final PFS rates. We intend 
to maintain a focus on increasing transparency, and believe the 
commenters' concerns will help us understand the kind of information 
that can be most helpful to stakeholders interested in the underlying 
data sets. While we are not finalizing the MPPR element of the E/M 
proposal, we appreciate the commenter's interest in the use of code-
level assumptions regarding proposed payment adjustments that are 
reflected in the discounts in the setup file, as discussed in section 
II.B.2.(5)(e) of this final rule.
(d) Calculate the Final PE RVUs
    Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs 
from Step 17 and apply the final PE budget neutrality (BN) adjustment. 
The final PE BN adjustment is calculated by comparing the sum of steps 
5 and 17 to the proposed aggregate work RVUs scaled by the ratio of 
current aggregate PE and work RVUs. This adjustment ensures that all PE 
RVUs in the PFS account for the fact that certain specialties are 
excluded from the calculation of PE RVUs but included in maintaining 
overall PFS budget neutrality. (See ``Specialties excluded from 
ratesetting calculation'' later in this final rule.)
    Step 19: Apply the phase-in of significant RVU reductions and its 
associated adjustment. Section 1848(c)(7) of the Act specifies that for 
services that are not new or revised codes, if the total RVUs for a 
service for a year would otherwise be decreased by an estimated 20 
percent or more as compared to the total RVUs for the previous year, 
the applicable adjustments in work, PE, and MP RVUs shall be phased in 
over a 2-year period. In implementing the phase-in, we consider a 19 
percent reduction as the maximum 1-year reduction for any service not 
described by a new or revised code. This approach limits the year one 
reduction for the service to the maximum allowed amount (that is, 19 
percent), and then phases in the remainder of the reduction. To comply 
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure 
that the total RVUs for all services that are not new or revised codes 
decrease by no more than 19 percent, and then apply a relativity 
adjustment to ensure that the total pool of aggregate PE RVUs remains 
relative to the pool of work and MP RVUs. For a more detailed 
description of the methodology for the phase-in of significant RVU 
changes, we refer readers to the CY 2016 PFS final rule with comment 
period (80 FR 70927 through 70931).
    Comment: We received many comments regarding the ongoing decrease 
in the technical component of CPT code 76881 (Ultrasound, complete 
joint (i.e., joint space and peri-articular soft tissue structures) 
real-time with image documentation). Commenters stated that this 
procedure is essential for making appropriate diagnosis and managing 
patients with various rheumatologic conditions and musculoskeletal 
disorders. Commenters stated that cutting the reimbursement for the 
code would not only result in poor patient care but also increase total 
costs through the use of more expensive MRI procedures. Commenters also 
disagreed with the RUC's recommended direct PE inputs for CPT code 
76881 from the CY 2018 rule cycle, citing concerns with the RUC's use 
of workforce data, and urged CMS not to make further reductions in 
payment.
    Response: The comments regarding CPT code 76881 are out of scope, 
as we did not make any proposals involving this code for CY 2019. The 
reductions in payment described by the commenters for CPT code 76881 
were finalized as part of the CY 2018 PFS final rule (82 FR 53058-
53059), and are continuing to be phased in over time as part of the 
transition policy described above. For a more detailed description of 
the methodology for the phase-in of significant RVU changes, we refer 
readers to the CY 2016 PFS final rule with comment period (80 FR 70927 
through 70931).
(e) Setup File Information
     Specialties excluded from ratesetting calculation: For the 
purposes of calculating the PE RVUs, we exclude certain specialties, 
such as certain NPPs paid at a percentage of the PFS and low-volume 
specialties, from the calculation. These specialties are included for 
the purposes of calculating the BN adjustment. They are displayed in 
Table 2.

                                               Table 2--Specialties Excluded From Ratesetting Calculation
--------------------------------------------------------------------------------------------------------------------------------------------------------
           Specialty code                                                           Specialty description
--------------------------------------------------------------------------------------------------------------------------------------------------------
49.................................  Ambulatory surgical center.
50.................................  Nurse practitioner.
51.................................  Medical supply company with certified orthotist.
52.................................  Medical supply company with certified prosthetist.
53.................................  Medical supply company with certified prosthetist[dash]orthotist.
54.................................  Medical supply company not included in 51, 52, or 53.
55.................................  Individual certified orthotist.
56.................................  Individual certified prosthetist.
57.................................  Individual certified prosthetist[dash]orthotist.
58.................................  Medical supply company with registered pharmacist.
59.................................  Ambulance service supplier, e.g., private ambulance companies, funeral homes, etc.
60.................................  Public health or welfare agencies.
61.................................  Voluntary health or charitable agencies.
73.................................  Mass immunization roster biller.
74.................................  Radiation therapy centers.
87.................................  All other suppliers (e.g., drug and department stores).
88.................................  Unknown supplier/provider specialty.

[[Page 59461]]

 
89.................................  Certified clinical nurse specialist.
96.................................  Optician.
97.................................  Physician assistant.
A0.................................  Hospital.
A1.................................  SNF.
A2.................................  Intermediate care nursing facility.
A3.................................  Nursing facility, other.
A4.................................  HHA.
A5.................................  Pharmacy.
A6.................................  Medical supply company with respiratory therapist.
A7.................................  Department store.
B2.................................  Pedorthic personnel.
B3.................................  Medical supply company with pedorthic personnel.
--------------------------------------------------------------------------------------------------------------------------------------------------------

     Crosswalk certain low volume physician specialties: 
Crosswalk the utilization of certain specialties with relatively low 
PFS utilization to the associated specialties.
     Physical therapy utilization: Crosswalk the utilization 
associated with all physical therapy services to the specialty of 
physical therapy.
     Identify professional and technical services not 
identified under the usual TC and 26 modifiers: Flag the services that 
are PC and TC services but do not use TC and 26 modifiers (for example, 
electrocardiograms). This flag associates the PC and TC with the 
associated global code for use in creating the indirect PE RVUs. For 
example, the professional service, CPT code 93010 (Electrocardiogram, 
routine ECG with at least 12 leads; interpretation and report only), is 
associated with the global service, CPT code 93000 (Electrocardiogram, 
routine ECG with at least 12 leads; with interpretation and report).
     Payment modifiers: Payment modifiers are accounted for in 
the creation of the file consistent with current payment policy as 
implemented in claims processing. For example, services billed with the 
assistant at surgery modifier are paid 16 percent of the PFS amount for 
that service; therefore, the utilization file is modified to only 
account for 16 percent of any service that contains the assistant at 
surgery modifier. Similarly, for those services to which volume 
adjustments are made to account for the payment modifiers, time 
adjustments are applied as well. For time adjustments to surgical 
services, the intraoperative portion in the work time file is used; 
where it is not present, the intraoperative percentage from the payment 
files used by contractors to process Medicare claims is used instead. 
Where neither is available, we use the payment adjustment ratio to 
adjust the time accordingly. Table 3 details the manner in which the 
modifiers are applied.

                         Table 3--Application of Payment Modifiers to Utilization Files
----------------------------------------------------------------------------------------------------------------
            Modifier                    Description              Volume adjustment           Time adjustment
----------------------------------------------------------------------------------------------------------------
80, 81, 82......................  Assistant at Surgery...  16%.........................  Intraoperative portion.
AS..............................  Assistant at Surgery--   14% (85% * 16%).............  Intraoperative portion.
                                   Physician Assistant.
50 or LT and RT.................  Bilateral Surgery......  150%........................  150% of work time.
51..............................  Multiple Procedure.....  50%.........................  Intraoperative portion.
52..............................  Reduced Services.......  50%.........................  50%.
53..............................  Discontinued Procedure.  50%.........................  50%.
54..............................  Intraoperative Care      Preoperative +                Preoperative +
                                   only.                    Intraoperative Percentages    Intraoperative
                                                            on the payment files used     portion.
                                                            by Medicare contractors to
                                                            process Medicare claims.
55..............................  Postoperative Care only  Postoperative Percentage on   Postoperative portion.
                                                            the payment files used by
                                                            Medicare contractors to
                                                            process Medicare claims.
62..............................  Co-surgeons............  62.5%.......................  50%.
66..............................  Team Surgeons..........  33%.........................  33%.
----------------------------------------------------------------------------------------------------------------

    We also make adjustments to volume and time that correspond to 
other payment rules, including special multiple procedure endoscopy 
rules and multiple procedure payment reductions (MPPRs). We note that 
section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments 
for multiple imaging procedures and multiple therapy services from the 
BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These 
MPPRs are not included in the development of the RVUs.
    For anesthesia services, we do not apply adjustments to volume 
since we use the average allowed charge when simulating RVUs; 
therefore, the RVUs as calculated already reflect the payments as 
adjusted by modifiers, and no volume adjustments are necessary. 
However, a time adjustment of 33 percent is made only for medical 
direction of two to four cases since that is the only situation where a 
single practitioner is involved with multiple beneficiaries 
concurrently, so that counting each service without regard to the 
overlap with other services would overstate the amount of time spent by 
the practitioner furnishing these services.
     Work RVUs: The setup file contains the work RVUs from this 
final rule.
(6) Equipment Cost per Minute
    The equipment cost per minute is calculated as:


[[Page 59462]]


(1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 + 
interest rate) [supcaret] life of equipment)))) + maintenance)

Where:

minutes per year = maximum minutes per year if usage were continuous 
(that is, usage = 1); generally 150,000 minutes.

usage = variable, see discussion in this final rule.
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of 
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion in this final rule.

    Usage: We currently use an equipment utilization rate assumption of 
50 percent for most equipment, with the exception of expensive 
diagnostic imaging equipment, for which we use a 90 percent assumption 
as required by section 1848(b)(4)(C) of the Act.
    Stakeholders have often suggested that particular equipment items 
are used less frequently than 50 percent of the time in the typical 
setting and that CMS should reduce the equipment utilization rate based 
on these recommendations. We appreciate and share stakeholders' 
interest in using the most accurate assumption regarding the equipment 
utilization rate for particular equipment items. However, we believe 
that absent robust, objective, auditable data regarding the use of 
particular items, the 50 percent assumption is the most appropriate 
within the relative value system. We welcome the submission of data 
that would support an alternative rate.
    Comment: A few commenters stated that equipment time associated 
with payment for diagnostic imaging services is not aligned with 
practice. The commenters disagreed with the CMS statement that certain 
highly technical equipment is less likely to be used during all of the 
preservice or postservice tasks performed by clinical labor staff, and 
stated that the CMS analysis of equipment time is not accurate based on 
their experience with imaging centers. Commenters stated that there are 
non-imaging functions that are required by CMS for payment, such as 
documentation requirements and the need for enrollment in Medicare by 
professionals, which add to their administrative burden and increase 
costs yet are underrepresented in the PE methodology. Commenters stated 
that they disagreed with how CMS defined room time as inconsistent with 
how imaging centers actually function, and indicated a preference for 
assigning equipment time based on the total technologist time.
    Response: We disagree with the commenters regarding the equipment 
time assigned to highly technical equipment. We continue to believe 
that certain highly technical pieces of equipment and equipment rooms 
are less likely to be used during all of the preservice or postservice 
tasks performed by clinical labor staff on the day of the procedure and 
are typically available for other patients even when one member of 
clinical staff may be occupied with a preservice or postservice task 
related to the procedure. For a more detailed description of this 
topic, we refer readers to the CY 2015 PFS final rule with comment 
period (79 FR 67639 through 67640).
    Maintenance: This factor for maintenance was finalized in the CY 
1998 PFS final rule with comment period (62 FR 33164). As we previously 
stated in the CY 2016 final rule with comment period (80 FR 70897), we 
do not believe the annual maintenance factor for all equipment is 
precisely 5 percent, and we concur that the current rate likely 
understates the true cost of maintaining some equipment. We also 
believe it likely overstates the maintenance costs for other equipment. 
When we solicited comments regarding sources of data containing 
equipment maintenance rates, commenters were unable to identify an 
auditable, robust data source that could be used by CMS on a wide 
scale. We do not believe that voluntary submissions regarding the 
maintenance costs of individual equipment items would be an appropriate 
methodology for determining costs. As a result, in the absence of 
publicly available datasets regarding equipment maintenance costs or 
another systematic data collection methodology for determining a 
different maintenance factor, we do not believe that we have sufficient 
information at present to propose a variable maintenance factor for 
equipment cost per minute pricing. We continue to investigate potential 
avenues for determining equipment maintenance costs across a broad 
range of equipment items.
    Comment: A commenter stated that they continue to believe that 
maintenance costs for imaging equipment are much higher than the 
current 5 percent assumption. The commenter stated that they were 
hopeful that the market-based research into equipment and supply 
pricing would result in a broad range, systematic data collection 
methodology that could be applied to collecting information on 
equipment maintenance costs.
    Response: As detailed above, we continue to believe that the 
current 5 percent maintenance factor likely understates the true cost 
of maintaining some equipment and overstates the maintenance costs for 
other equipment. We continue at this time to lack publicly available 
datasets regarding equipment maintenance costs or another systematic 
data collection methodology for determining maintenance factor. With 
regards to the market-based study, the StrategyGen contractors were 
tasked with updating the commercial pricing of supplies and equipment, 
and did not include an investigation of equipment maintenance rates as 
part of their research.
    Interest Rate: In the CY 2013 PFS final rule with comment period 
(77 FR 68902), we updated the interest rates used in developing an 
equipment cost per minute calculation (see 77 FR 68902 for a thorough 
discussion of this issue). The interest rate was based on the Small 
Business Administration (SBA) maximum interest rates for different 
categories of loan size (equipment cost) and maturity (useful life). We 
did not propose any changes to these interest rates for CY 2019. The 
interest rates are listed in Table 4.

                   Table 4--SBA Maximum Interest Rates
------------------------------------------------------------------------
                                                      Useful
                       Price                           life     Interest
                                                     (years)    rate (%)
------------------------------------------------------------------------
<$25K.............................................         <7       7.50
$25K to $50K......................................         <7       6.50
>$50K.............................................         <7       5.50
<$25K.............................................         7+       8.00
$25K to $50K......................................         7+       7.00
>$50K.............................................         7+       6.00
------------------------------------------------------------------------

3. Changes to Direct PE Inputs for Specific Services
    This section focuses on specific PE inputs. The direct PE inputs 
are included in the CY 2019 direct PE input database, which is 
available on the CMS website under downloads for the CY 2019 PFS final 
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
a. Standardization of Clinical Labor Tasks
    As we noted in the CY 2015 PFS final rule with comment period (79 
FR 67640-67641), we continue to make improvements to the direct PE 
input database to provide the number of clinical labor minutes assigned 
for each task for every code in the database

[[Page 59463]]

instead of only including the number of clinical labor minutes for the 
preservice, service, and postservice periods for each code. In addition 
to increasing the transparency of the information used to set PE RVUs, 
this level of detail would allow us to compare clinical labor times for 
activities associated with services across the PFS, which we believe is 
important to maintaining the relativity of the direct PE inputs. This 
information would facilitate the identification of the usual numbers of 
minutes for clinical labor tasks and the identification of exceptions 
to the usual values. It would also allow for greater transparency and 
consistency in the assignment of equipment minutes based on clinical 
labor times. Finally, we believe that the detailed information can be 
useful in maintaining standard times for particular clinical labor 
tasks that can be applied consistently to many codes as they are valued 
over several years, similar in principle to the use of physician 
preservice time packages. We believe that setting and maintaining such 
standards would provide greater consistency among codes that share the 
same clinical labor tasks and could improve relativity of values among 
codes. For example, as medical practice and technologies change over 
time, changes in the standards could be updated simultaneously for all 
codes with the applicable clinical labor tasks, instead of waiting for 
individual codes to be reviewed.
    In the CY 2016 PFS final rule with comment period (80 FR 70901), we 
solicited comments on the appropriate standard minutes for the clinical 
labor tasks associated with services that use digital technology. After 
consideration of comments received, we finalized standard times for 
clinical labor tasks associated with digital imaging at 2 minutes for 
``Availability of prior images confirmed'', 2 minutes for ``Patient 
clinical information and questionnaire reviewed by technologist, order 
from physician confirmed and exam protocoled by radiologist'', 2 
minutes for ``Review examination with interpreting MD'', and 1 minute 
for ``Exam documents scanned into PACS.'' Exam completed in RIS system 
to generate billing process and to populate images into Radiologist 
work queue.'' In the CY 2017 PFS final rule (81 FR 80184 through 
80186), we finalized a policy to establish a range of appropriate 
standard minutes for the clinical labor activity, ``Technologist QCs 
images in PACS, checking for all images, reformats, and dose page.'' 
These standard minutes will be applied to new and revised codes that 
make use of this clinical labor activity when they are reviewed by us 
for valuation. We finalized a policy to establish 2 minutes as the 
standard for the simple case, 3 minutes as the standard for the 
intermediate case, 4 minutes as the standard for the complex case, and 
5 minutes as the standard for the highly complex case. These values 
were based upon a review of the existing minutes assigned for this 
clinical labor activity; we determined that 2 minutes is the duration 
for most services and a small number of codes with more complex forms 
of digital imaging have higher values.
    We also finalized standard times for clinical labor tasks 
associated with pathology services in the CY 2016 PFS final rule with 
comment period (80 FR 70902) at 4 minutes for ``Accession specimen/
prepare for examination'', 0.5 minutes for ``Assemble and deliver 
slides with paperwork to pathologists'', 0.5 minutes for ``Assemble 
other light microscopy slides, open nerve biopsy slides, and clinical 
history, and present to pathologist to prepare clinical pathologic 
interpretation'', 1 minute for ``Clean room/equipment following 
procedure'', 1 minute for ``Dispose of remaining specimens, spent 
chemicals/other consumables, and hazardous waste'', and 1 minute for 
``Prepare, pack and transport specimens and records for in-house 
storage and external storage (where applicable).'' We do not believe 
these activities would be dependent on number of blocks or batch size, 
and we believe that these values accurately reflect the typical time it 
takes to perform these clinical labor tasks.
    Historically, the RUC has submitted a ``PE worksheet'' that details 
the recommended direct PE inputs for our use in developing PE RVUs. The 
format of the PE worksheet has varied over time and among the medical 
specialties developing the recommendations. These variations have made 
it difficult for both the RUC's development and our review of code 
values for individual codes. Beginning with its recommendations for CY 
2019, the RUC has mandated the use of a new PE worksheet for purposes 
of their recommendation development process that standardizes the 
clinical labor tasks and assigns them a clinical labor activity code. 
We believe the RUC's use of the new PE worksheet in developing and 
submitting recommendations will help us to simplify and standardize the 
hundreds of different clinical labor tasks currently listed in our 
direct PE database. As we did for CY 2018, to facilitate rulemaking for 
CY 2019, we are continuing to display two versions of the Labor Task 
Detail public use file: one version with the old listing of clinical 
labor tasks, and one with the same tasks cross-walked to the new 
listing of clinical labor activity codes. These lists are available on 
the CMS website under downloads for the CY 2019 PFS final rule at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    In reviewing the RUC-recommended direct PE inputs for CY 2019, we 
noticed that the 3 minutes of clinical labor time traditionally 
assigned to the ``Prepare room, equipment and supplies'' (CA013) 
clinical labor activity were split into 2 minutes for the ``Prepare 
room, equipment and supplies'' activity and 1 minute for the ``Confirm 
order, protocol exam'' (CA014) activity. These RUC-reviewed codes do 
not currently have clinical labor time assigned for the ``Confirm 
order, protocol exam'' clinical labor task, and we do not have any 
reason to believe that the services being furnished by the clinical 
staff have changed, only the way in which this clinical labor time has 
been presented on the PE worksheets.
    As a result, we proposed to maintain the 3 minutes of clinical 
labor time for the ``Prepare room, equipment and supplies'' activity 
and remove the clinical labor time for the ``Confirm order, protocol 
exam'' activity wherever we observed this pattern in the RUC-
recommended direct PE inputs. If we had received RUC recommendations 
for codes that currently include clinical labor time for the ``Confirm 
order, protocol exam'' clinical labor task, we would have left the RUC-
recommended clinical labor times unchanged, but there were no such 
codes reviewed for CY 2019. We note that there is no effect on the 
total clinical labor direct costs in these situations, since the same 3 
minutes of clinical labor time is still being used in the calculation 
of PE RVUs.
    The following is a summary of the public comments we received on 
our proposal to maintain the 3 minutes of clinical labor time for the 
``Prepare room, equipment and supplies'' activity and remove the 
clinical labor time for the ``Confirm order, protocol exam'' activity 
wherever we observed the aforementioned pattern in the RUC-recommended 
direct PE inputs.
    Comment: Several commenters supported CMS' proposal and requested 
that these clinical labor refinements should be finalized wherever the 
refinement had been proposed. These commenters noted that there was no 
change in the total clinical labor direct costs in these situations and 
urged CMS to finalize the proposal.

[[Page 59464]]

    Response: We appreciate the support for the proposal from the 
commenters.
    Comment: Other commenters disagreed with the proposal. Commenters 
stated that the standard clinical labor time for the CA013 ``Prepare 
room, equipment and supplies'' activity has always been 2 minutes, and 
that the occasional assignment of additional clinical labor time in 
individual procedures has not changed this standard.
    Response: We agree with the commenters that the standard clinical 
labor time for the CA013 activity code is 2 minutes. We noted in the 
proposed rule that 3 minutes has often traditionally been assigned for 
this clinical labor activity, and our proposal was intended to reflect 
this common practice pattern. In our table of direct PE refinements, we 
listed many of these clinical labor refinements using the refinement 
code ``L1: Refined time to standard for this clinical labor task.'' 
This was the incorrect refinement code to use in these situations, and 
we acknowledge that this was a technical error. The direct PE 
refinements would have more accurately employed the general refinement 
code ``G1: See preamble text'' instead. We wish to clarify that 
although we agree that the standard clinical labor time for the CA013 
activity is 2 minutes, we continue to believe that 2 minutes would not 
be typical for many of the codes currently under discussion.
    Comment: Commenters explained that when the new version of the PE 
worksheet introduced the activity codes for clinical labor, there was a 
need to translate old clinical labor tasks into the new activity codes. 
In the old version of the PE worksheet, there was a clinical labor task 
named ``Patient clinical information and questionnaire reviewed by 
technologist, order from physician confirmed and exam protocoled by 
radiologist.'' Commenters stated that this clinical labor task was 
split into two of the new clinical labor activity codes: CA007 
(``Review patient clinical extant information and questionnaire'') in 
the preservice period, and CA014 (``Confirm order, protocol exam'') in 
the service period. Commenters stated that the same clinical labor from 
the old PE worksheet is now divided into the CA007 and CA014 activity 
codes, with a standard of 1 minute for each activity. The commenters 
stated that they recognized that the proposal had no effect on the 
total clinical labor direct costs, but urged CMS not to finalize anyway 
due to concerns over inaccuracy and long term effects on the direct 
practice expense inputs across the PFS.
    Response: We agree with the commenters that in situations where a 
CPT code under review had the old clinical labor task ``Patient 
clinical information and questionnaire reviewed by technologist, order 
from physician confirmed and exam protocoled by radiologist'' on a 
prior version of the PE worksheet, and where that old clinical labor 
task was divided into the new CA007 and CA014 activity codes as 
described by the commenters, we will not finalize our proposed 
refinements to maintain 3 minutes of clinical labor time for the 
``Prepare room, equipment and supplies'' activity and remove the 
clinical labor time for the ``Confirm order, protocol exam'' activity, 
as we agree that the old clinical labor task is adequately accounted 
for by being divided into the new activity codes. In these cases, we 
will finalize the RUC-recommended 2 minutes of clinical labor time for 
the CA007 activity code and 1 minute for the CA014 activity code.
    However, when reviewing the clinical labor for the reviewed codes 
affected by this issue, we found that several of the codes did not 
include the old clinical labor task ``Patient clinical information and 
questionnaire reviewed by technologist, order from physician confirmed 
and exam protocoled by radiologist'' on a prior version of the PE 
worksheet. We also noted that several of the reviewed codes that 
contained the CA014 clinical labor activity code for ``Confirm order, 
protocol exam'' did not contain any clinical labor for the CA007 
activity (``Review patient clinical extant information and 
questionnaire''). In these situations, we believe that it is more 
accurate to finalize our direct PE refinements to maintain the 3 
minutes of clinical labor time for the ``Prepare room, equipment and 
supplies'' activity and remove the clinical labor time for the 
``Confirm order, protocol exam'' activity as proposed, since the 
rationale provided by the commenters does not appear to be the case. 
These codes do not appear to be an instance where the old clinical 
labor task was split into two new clinical labor activities. We do not 
understand how time assigned to an old clinical labor task could be 
divided between the CA007 and CA014 activity codes, as the commenters 
suggested, in situations where the code under review does not contain 
any clinical labor for the CA007 activity. We continue to believe that 
in these cases the 3 total minutes of clinical staff time would be more 
accurately described by the CA013 ``Prepare room, equipment and 
supplies'' activity code, as these codes do not currently have clinical 
labor time assigned for the CA014 ``Confirm order, protocol exam'' 
clinical labor activity.
    After consideration of the public comments, we are finalizing our 
proposal for the reviewed codes that did not include the old clinical 
labor task described above and do not contain any clinical labor for 
the CA007 clinical labor activity. We are therefore finalizing our 
proposal for CPT codes 27369, 38792, 76870, 77012, 77021, 92273, and 
92274. We are not finalizing our proposal for the reviewed codes where 
we were able to determine that the old clinical labor task had been 
divided into the CA007 and CA014 activity codes as described by the 
commenters. We are therefore finalizing the RUC-recommended CA013 and 
CA014 clinical labor for CPT codes 76978, 76981, and 76982.
b. Equipment Recommendations for Scope Systems
    During our routine reviews of direct PE input recommendations, we 
have regularly found unexplained inconsistencies involving the use of 
scopes and the video systems associated with them. Some of the scopes 
include video systems bundled into the equipment item, some of them 
include scope accessories as part of their price, and some of them are 
standalone scopes with no other equipment included. It is not always 
clear which equipment items related to scopes fall into which of these 
categories. We have also frequently found anomalies in the equipment 
recommendations, with equipment items that consist of a scope and video 
system bundle recommended, along with a separate scope video system. 
Based on our review, the variations do not appear to be consistent with 
the different code descriptions.
    To promote appropriate relativity among the services and facilitate 
the transparency of our review process, during the review of the 
recommended direct PE inputs for the CY 2017 PFS proposed rule, we 
developed a structure that separates the scope, the associated video 
system, and any scope accessories that might be typical as distinct 
equipment items for each code. Under this approach, we proposed 
standalone prices for each scope, and separate prices for the video 
systems and accessories that are used with scopes.
(1) Scope Equipment
    Beginning in the CY 2017 proposed rule (81 FR 46176 through 46177), 
we proposed standardizing refinements to the way scopes have been 
defined in the direct PE input database. We believe that there are four 
general types of scopes: Non-video scopes; flexible

[[Page 59465]]

scopes; semi-rigid scopes, and rigid scopes. Flexible scopes, semi-
rigid scopes, and rigid scopes would typically be paired with one of 
the scope video systems, while the non-video scopes would not. The 
flexible scopes can be further divided into diagnostic (or non-
channeled) and therapeutic (or channeled) scopes. We proposed to 
identify for each anatomical application: (1) A rigid scope; (2) a 
semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled 
flexible video scope; and (5) a channeled flexible video scope. We 
proposed to classify the existing scopes in our direct PE database 
under this classification system, to improve the transparency of our 
review process and improve appropriate relativity among the services. 
We planned to propose input prices for these equipment items through 
future rulemaking.
    We proposed these changes only for the reviewed codes for CY 2017 
that made use of scopes, along with updated prices for the equipment 
items related to scopes utilized by these services. We did not propose 
to apply these policies to codes with inputs reviewed prior to CY 2017. 
We also solicited comment on this separate pricing structure for 
scopes, scope video systems, and scope accessories, which we could 
consider proposing to apply to other codes in future rulemaking. We did 
not finalize price increases for a series of other scopes and scope 
accessories, as the invoices submitted for these components indicated 
that they are different forms of equipment with different product IDs 
and different prices. We did not receive any data to indicate that the 
equipment on the newly submitted invoices was more typical in its use 
than the equipment that we were currently using for pricing.
    We did not make further changes to existing scope equipment in CY 
2017 to allow the RUC's PE Subcommittee the opportunity to provide 
feedback. However, we believed there was some miscommunication on this 
point, as the RUC's PE Subcommittee workgroup that was created to 
address scope systems stated that no further action was required 
following the finalization of our proposal. Therefore, we made further 
proposals in CY 2018 (82 FR 33961 through 33962) to continue clarifying 
scope equipment inputs, and sought comments regarding the new set of 
scope proposals. We considered creating a single scope equipment code 
for each of the five categories detailed in this rule: (1) A rigid 
scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a 
non-channeled flexible video scope; and (5) a channeled flexible video 
scope. Under the current classification system, there are many 
different scopes in each category depending on the medical specialty 
furnishing the service and the part of the body affected. We stated our 
belief that the variation between these scopes was not significant 
enough to warrant maintaining these distinctions, and we believed that 
creating and pricing a single scope equipment code for each category 
would help provide additional clarity. We sought public comment on the 
merits of this potential scope organization, as well as any pricing 
information regarding these five new scope categories.
    After considering the comments on the CY 2018 PFS proposed rule, we 
did not finalize our proposal to create and price a single scope 
equipment code for each of the five categories previously identified. 
Instead, we supported the recommendation from the commenters to create 
scope equipment codes on a per-specialty basis for six categories of 
scopes as applicable, including the addition of a new sixth category of 
multi-channeled flexible video scopes. Our goal is to create an 
administratively simple scheme that will be easier to maintain and help 
to reduce administrative burden. We look forward to receiving detailed 
recommendations from expert stakeholders regarding the scope equipment 
items that would be typically required for each scope category, as well 
as the proper pricing for each scope.
(2) Scope Video System
    We proposed in the CY 2017 PFS proposed rule (81 FR 46176 through 
46177) to define the scope video system as including: (1) A monitor; 
(2) a processor; (3) a form of digital capture; (4) a cart; and (5) a 
printer. We believe that these equipment components represent the 
typical case for a scope video system. Our model for this system was 
the ``video system, endoscopy (processor, digital capture, monitor, 
printer, cart)'' equipment item (ES031), which we proposed to re-price 
as part of this separate pricing approach. We obtained current pricing 
invoices for the endoscopy video system as part of our investigation of 
these issues involving scopes, which we proposed to use for this re-
pricing. In response to comments, we finalized the addition of a 
digital capture device to the endoscopy video system (ES031) in the CY 
2017 PFS final rule (81 FR 80188). We finalized our proposal to price 
the system at $33,391, based on component prices of $9,000 for the 
processor, $18,346 for the digital capture device, $2,000 for the 
monitor, $2,295 for the printer, and $1,750 for the cart. In the CY 
2018 PFS final rule (82 FR 52991 through 52993), we outlined, but did 
not finalize, a proposal to add an LED light source into the cost of 
the scope video system (ES031), which would remove the need for a 
separate light source in these procedures. We also described a proposal 
to increase the price of the scope video system by $1,000 to cover the 
expense of miscellaneous small equipment associated with the system 
that falls below the threshold of individual equipment pricing as scope 
accessories (such as cables, microphones, foot pedals, etc.). With the 
addition of the LED light (equipment code EQ382 at a price of $1,915), 
the updated total price of the scope video system would be set at 
$36,306. We did not finalize this updated pricing to the scope video 
system in CY 2018, and indicated our intention to address these changes 
in CY 2019 to incorporate feedback from expert stakeholders.
(3) Scope Accessories
    We understand that there may be other accessories associated with 
the use of scopes. We finalized a proposal in the CY 2017 PFS final 
rule (81 FR 80188) to separately price any scope accessories outside 
the use of the scope video system, and individually evaluate their 
inclusion or exclusion as direct PE inputs for particular codes as 
usual under our current policy based on whether they are typically used 
in furnishing the services described by the particular codes.
(4) Scope Proposals for CY 2019
    We understand that the RUC has convened a Scope Equipment 
Reorganization Workgroup that will be incorporating feedback from 
expert stakeholders with the intention of making recommendations to us 
on scope organization and scope pricing. Since the workgroup was not 
convened in time to submit recommendations for the CY 2019 PFS 
rulemaking cycle, we proposed to delay proposals for any further 
changes to scope equipment until CY 2020 so that we can incorporate the 
feedback from the aforementioned workgroup. However, we proposed to 
update the price of the scope video system (ES031) from its current 
price of $33,391 to a price of $36,306 to reflect the addition of the 
LED light and miscellaneous small equipment associated with the system 
that falls below the threshold of individual equipment pricing as scope 
accessories, as we explained in detail in the CY 2018 PFS final rule 
(82 FR 52992 through 52993). We also proposed to update the name of the 
ES031

[[Page 59466]]

equipment item from ``video system, endoscopy (processor, digital 
capture, monitor, printer, cart)'' to ``scope video system (monitor, 
processor, digital capture, cart, printer, LED light)'' to reflect the 
fact that the use of the ES031 scope video system is not limited to 
endoscopy procedures.
    The following is a summary of the public comments we received on 
our proposals involving scopes and scope systems.
    Comment: Several commenters supported the decision to delay 
proposals for any further changes to scope equipment until CY 2020 in 
order to incorporate the feedback from the RUC's Scope Equipment 
Reorganization Workgroup. One commenter thanked CMS for adding a scope 
category for multi-channeled flexible video scopes. A different 
commenter supported the proposal to increase the price of the scope 
video system (ES03l) from its current price of $33,391 to a price of 
$36,306 and also supported the proposed update to the name of the ES03l 
equipment item since the use of the scope video system is not limited 
to endoscopy procedures.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: One commenter stated that they were concerned that the 
proposed pricing for both the scope video system (ES03l) and the 
stroboscopy system (ES065) are less than the true cost of the equipment 
items, and therefore do not accurately reimburse physicians for their 
direct overhead costs. The commenter stated that they had supplied more 
recent invoices for these equipment items, which should be taken into 
consideration for pricing, and reiterated their disagreement with the 
CMS proposal from the previous calendar year to create single scope 
equipment categories for all specialties, as scope equipment is not 
always comparable across specialties. A different commenter supplied 
invoices for several other scope equipment items and requested that CMS 
update the prices for these equipment codes and that the new pricing 
take effect for CY 2019.
    Response: We continue to believe that any further changes to scope 
equipment, including invoice submissions to update scope pricing, 
should be delayed until CY 2020 so that we can incorporate the feedback 
from the RUC's Scope Equipment Reorganization Workgroup.
    After consideration of the public comments, we are finalizing our 
scope proposals for CY 2019 without refinement.
c. Balloon Sinus Surgery Kit (SA106) Comment Solicitation
    Several stakeholders contacted CMS with regard to the use of the 
kit, sinus surgery, balloon (maxillary, frontal, or sphenoid) (SA106) 
supply in CPT codes 31295 (Nasal/sinus endoscopy, surgical; with 
dilation of maxillary sinus ostium (e.g., balloon dilation), transnasal 
or via canine fossa), 31296 (Nasal/sinus endoscopy, surgical; with 
dilation of frontal sinus ostium (e.g., balloon dilation)), and 31297 
(Nasal/sinus endoscopy, surgical; with dilation of sphenoid sinus 
ostium (e.g., balloon dilation)). The stakeholders stated that the 
price of the SA106 supply (currently $2,599.86) had decreased 
significantly since it was priced through rulemaking for CY 2011 (75 FR 
73351 through 75532), and that the Medicare payment for these three CPT 
codes using the supply no longer seemed to be in proportion to what the 
kits cost. They also indicated that the same catheter could be used to 
treat multiple sinuses rather than being a disposable one-time use 
supply. The stakeholders stated that marketing firms and sales 
representatives are advertising these CPT codes as a method for 
generating additional profits due to the payment for the procedures 
exceeding the resources typically needed to furnish the services, and 
requested that CMS investigate the use of the SA106 supply in these 
codes.
    When CPT codes 31295 through 31297 were initially reviewed during 
the CY 2011 and CY 2012 PFS rulemaking cycles (75 FR 73251, and 76 FR 
73184 through 73186, respectively), we expressed our reservations about 
the pricing and the typical quantity of this supply item used in 
furnishing these services. The RUC recommended for the CY 2012 
rulemaking cycle that CMS remove the balloon sinus surgery kit from 
each of these codes and implement separately billable alpha-numeric 
HCPCS codes to allow practitioners to be paid the cost of the 
disposable kits per patient encounter instead of per CPT code. We 
stated at the time, and we continue to believe, that this option 
presents a series of potential problems that we have addressed 
previously in the context of the broader challenges regarding our 
ability to price high cost disposable supply items. (For a discussion 
of this issue, we direct the reader to our discussion in the CY 2011 
PFS final rule with comment period (75 FR 73251)). We stated at the 
time that since the balloon sinus surgery kits can be used when 
furnishing more than one service to the same beneficiary on the same 
day, we believed that it would be appropriate to include 0.5 balloon 
sinus surgery kits for each of the three codes, and we have maintained 
this 0.5 supply quantity when CPT codes 31295-31297 were recently 
reviewed again in CY 2018.
    In light of the additional information supplied by the 
stakeholders, we solicited comments on two aspects of the use of the 
balloon sinus surgery kit (SA106) supply. First, we solicited comments 
on whether the 0.5 supply quantity of the balloon sinus surgery kit in 
CPT codes 31295-31297 would be typical for these procedures. We are 
concerned that the same kit can be used when furnishing more than one 
service to the same beneficiary on the same day, and that even the 0.5 
supply quantity may be overstating the resources typically needed to 
furnish each service. Second, we solicited comments on the pricing of 
the balloon sinus surgery kit, given that we have received letters 
stating that the price has decreased since the initial pricing in the 
CY 2011 final rule. See Table 5 for the current component pricing of 
the balloon sinus surgery kit.

                                Table 5--Balloon Sinus Surgery Kit (SA106) Price
----------------------------------------------------------------------------------------------------------------
                 Supply components                     Quantity                 Unit                   Price
----------------------------------------------------------------------------------------------------------------
kit, sinus surgery, balloon (maxillary, frontal,    ..............  kit.........................       $2,599.86
 or sphenoid).
Sinus Guide Catheter..............................               1  item........................          444.00
Sinus Balloon Catheter............................               1  item........................          820.80
Sinus Illumination System (100 cm lighted                        1  item........................          454.80
 guidewire).
Light Guide Cable (8 ft)..........................               1  item........................          514.80
ACMI/Stryker Adaptor..............................               1  item........................           42.00
Sinus Guide Catheter Handle.......................               1  item........................           66.00
Sinus Irrigation Catheter (22 cm).................               1  item........................          150.00
Sinus Balloon Catheter Inflation Device...........               1  item........................           89.46
Extension Tubing (High Pressure) (20 in)..........               1  item........................           18.00
----------------------------------------------------------------------------------------------------------------


[[Page 59467]]

    We are interested in any information regarding possible changes in 
the pricing for this kit or its individual components since the initial 
pricing we adopted in CY 2011. The following is a summary of the public 
comments we received on our comment solicitation regarding the balloon 
sinus surgery kit supply.
    Comment: Several commenters stated that the variability inherent in 
the underlying patient anatomy makes it extremely difficult to reliably 
assign a fixed number of sinuses that can be dilated per balloon or 
establish a supply quantity that would constitute the typical case. 
These commenters urged CMS to create a separate HCPCS code for the 
balloon sinus surgery kit that would be billable based on the number of 
balloons used per patient.
    Response: As we stated in the proposed rule, we continue to believe 
that this option presents a series of potential problems that we have 
addressed previously in the context of the broader challenges regarding 
our ability to maintain appropriate relativity while pricing high cost 
disposable supply items. For a discussion of this issue, we direct the 
reader to our discussion in the CY 2011 PFS final rule with comment 
period (75 FR 73251).
    Comment: One commenter provided extensive information regarding the 
pricing and composition of the balloon sinus surgery kit. This 
commenter stated that the components of the supply kit have changed 
from those listed in Table 5, and that there are multiple different 
types of this kit available for purchase. The commenter stated that the 
total cost of the balloon sinus surgery kit varies by sinus dilated, 
whether navigation is used, and by manufacturer, with the average price 
of a basic kit costing $2,204 and the average price of the kit used for 
navigation costing $2,850, not including the navigation device itself. 
The commenter stated that the kit components should not be individually 
priced and that invoices could be made available upon request.
    With regards to the number of sinus dilation procedures that 
typically can be performed per balloon, the commenter repeated that the 
variability inherent in the underlying patient anatomy makes it 
extremely difficult to assign a fixed number of sinuses that can be 
dilated per balloon. The commenter also urged CMS to consider a shift 
away from the current supply methodology and instead create a separate 
HCPCS code for the balloon sinus surgery kit which would be billable 
based on the number of balloons used per patient. The commenter stated 
that should CMS elect to preserve the current policy of assigning a 
fixed number of sinus dilations per kit, they recommended maintaining 
the current supply quantity that allows one kit for every two sinuses, 
as they were unable to find compelling evidence to support a more 
appropriate supply amount.
    Response: We are particularly interested in the feedback suggesting 
that there may be multiple types of balloon sinus surgery kits that 
have different prices, and we would be interested in further 
information, including invoice submissions, on this subject for future 
rulemaking.
    After consideration of the public comments, we are not finalizing 
any changes to the balloon sinus surgery kit (SA106) supply for CY 
2019, outside of the market-based supply and equipment pricing update 
to the supply cost. We do not believe that we have sufficient 
information to finalize any other changes to the supply cost or supply 
quantity in the associated CPT codes at this point in time.
d. Technical Corrections to Direct PE Input Database and Supporting 
Files
    Subsequent to the publication of the CY 2018 PFS final rule, 
stakeholders alerted us to several clerical inconsistencies in the 
direct PE database. We proposed to correct these inconsistencies as 
described below and reflected in the CY 2019 final direct PE input 
database displayed on the CMS website under downloads for the CY 2019 
PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    For CY 2019, we proposed to address the following inconsistencies:
     The RUC alerted us that there are 165 CPT codes billed 
with an office E/M code more than 50 percent of the time in the 
nonfacility setting that have more minimum multi-specialty visit supply 
packs (SA048) than post-operative visits included in the code's global 
period. This indicates that either the inclusion of office E/M services 
was not accounted for in the code's global period when these codes were 
initially reviewed by the PE Subcommittee, or that the PE Subcommittee 
initially approved a minimum multi-specialty visit supply pack for 
these codes without considering the resulting overlap of supplies 
between SA048 and the E/M supply pack (SA047). The RUC regarded these 
overlapping supply packs as a duplication, due to the fact that the 
quantity of the SA048 supply exceeded the number of postoperative 
visits, and requested that CMS remove the appropriate number of supply 
item SA048 from 165 codes. After reviewing the quantity of the SA048 
supply pack included for the codes in question, we proposed to refine 
the quantity of minimum multi-specialty visit packs as displayed in 
Table 6.

                    Table 6--Proposed Refinements--Minimum Multispecialty Visit Pack (SA048)
----------------------------------------------------------------------------------------------------------------
                                                                                                    Proposed CY
                                                                                      CY 2018          2019
                                                                  Number of post-   nonfacility     nonfacility
                            CPT code                                 op office      quantity of     quantity of
                                                                      visits       minimum visit   minimum visit
                                                                                   pack (SA048)    pack (SA048)
----------------------------------------------------------------------------------------------------------------
10040...........................................................               1               2               1
10060...........................................................               1               2               1
10061...........................................................               2               3               2
10080...........................................................               1               2               1
10120...........................................................               1               2               1
10121...........................................................               1               2               1
10180...........................................................               1               2               1
11200...........................................................               1               2               1
11300...........................................................               0               1               0
11301...........................................................               0               1               0
11302...........................................................               0               1               0

[[Page 59468]]

 
11303...........................................................               0               1               0
11306...........................................................               0               1               0
11307...........................................................               0               1               0
11310...........................................................               0               1               0
11311...........................................................               0               1               0
11312...........................................................               0               1               0
11400...........................................................               1               2               1
11750...........................................................               1               2               1
11900...........................................................               0               1               0
11901...........................................................               0               1               0
12001...........................................................               0               1               0
12002...........................................................               0               1               0
12004...........................................................               0               1               0
12011...........................................................               0               1               0
12013...........................................................               0               1               0
16020...........................................................               0               1               0
17000...........................................................               1               2               1
17004...........................................................               1               2               1
17110...........................................................               1               2               1
17111...........................................................               1               2               1
17260...........................................................               1               2               1
17270...........................................................               1               2               1
17280...........................................................               1               2               1
19100...........................................................               0               1               0
20005...........................................................               1               2               1
20520...........................................................               1               2               1
21215...........................................................               6               7               6
21550...........................................................               1               2               1
21920...........................................................               1               2               1
22310...........................................................             1.5             2.5             1.5
23500...........................................................             2.5             3.5             2.5
23570...........................................................             2.5             3.5             2.5
23620...........................................................               3               4               3
24500...........................................................               4               5               4
24530...........................................................               4               5               4
24650...........................................................               3               4               3
24670...........................................................               3               4               3
25530...........................................................               3               4               3
25600...........................................................               5               6               5
25605...........................................................               5               6               5
25622...........................................................             3.5             4.5             3.5
25630...........................................................               3               4               3
26600...........................................................               4               5               4
26720...........................................................               2               3               2
26740...........................................................             2.5             3.5             2.5
26750...........................................................               2               3               2
27508...........................................................               4               5               4
27520...........................................................             3.5             4.5             3.5
27530...........................................................               4               5               4
27613...........................................................               1               2               1
27750...........................................................             3.5             4.5             3.5
27760...........................................................               4               5               4
27780...........................................................             3.5             4.5             3.5
27786...........................................................             3.5             4.5             3.5
27808...........................................................               4               5               4
28190...........................................................               1               2               1
28400...........................................................               3               4               3
28450...........................................................             2.5             3.5             2.5
28490...........................................................             1.5             2.5             1.5
28510...........................................................             1.5             2.5             1.5
30901...........................................................               0               1               0
30903...........................................................               0               1               0
30905...........................................................               0               1               0
31000...........................................................               1               2               1
31231...........................................................               0               1               0
31233...........................................................               0               1               0
31235...........................................................               0               1               0

[[Page 59469]]

 
31238...........................................................               0               1               0
31525...........................................................               0               1               0
31622...........................................................               0               1               0
32554...........................................................               0               1               0
36600...........................................................               0               1               0
38220...........................................................               0               1               0
40490...........................................................               0               1               0
42800...........................................................               1               2               1
43200...........................................................               0               1               0
45330...........................................................               0               1               0
46040...........................................................               3               4               3
46050...........................................................               1               2               1
46083...........................................................               1               2               1
46320...........................................................             0.5             1.5             0.5
46600...........................................................               0               1               0
46604...........................................................               0               1               0
46900...........................................................               1               2               1
51102...........................................................               0               2               0
51701...........................................................               0               1               0
51702...........................................................               0               1               0
51703...........................................................               0               1               0
51710...........................................................               0               1               0
51725...........................................................               0               1               0
51736...........................................................               0               1               0
51741...........................................................               0               1               0
51792...........................................................               0               1               0
51798...........................................................               0               1               0
52000...........................................................               0               1               0
52001...........................................................               0               1               0
52214...........................................................               0               1               0
52265...........................................................               0               1               0
52281...........................................................               0               1               0
52285...........................................................               0               1               0
53601...........................................................               0               1               0
53621...........................................................               0               1               0
53660...........................................................               0               1               0
53661...........................................................               0               1               0
54050...........................................................               1               2               1
54056...........................................................               1               2               1
54100...........................................................               0               1               0
54235...........................................................               0               1               0
54450...........................................................               0               1               0
55000...........................................................               0               1               0
56405...........................................................               1               2               1
56605...........................................................               0               1               0
56820...........................................................               0               1               0
57061...........................................................               1               2               1
57100...........................................................               0               1               0
57420...........................................................               0               1               0
57500...........................................................               0               1               0
57505...........................................................               1               2               1
62252...........................................................               0               1               0
62367...........................................................               0               1               0
62368...........................................................               0               1               0
62370...........................................................               0               1               0
64413...........................................................               0               1               0
64420...........................................................               0               1               0
64450...........................................................               0               1               0
64611...........................................................               1               2               1
69000...........................................................               1               2               1
69100...........................................................               0               1               0
69145...........................................................             1.5             2.5             1.5
69210...........................................................               0               1               0
69420...........................................................               1               2               1
69433...........................................................               1               2               1
69610...........................................................               1               2               1
93292...........................................................               0               1               0

[[Page 59470]]

 
93303...........................................................               0               1               0
94667...........................................................               0               1               0
95044...........................................................               0           0.028               0
95870...........................................................               0               1               0
95921...........................................................               0               1               0
95922...........................................................               0               1               0
95924...........................................................               0               1               0
95972...........................................................               0               1               1
96904...........................................................               0               1               1
----------------------------------------------------------------------------------------------------------------

    In general, we proposed to align the number of minimum multi-
specialty visit packs with the number of post-operative office visits 
included in these codes. We did not propose any supply pack quantity 
refinements for CPT codes 11100, 95974, or 95978 since they are being 
deleted for CY 2019. We also did not propose any supply pack quantity 
refinements for CPT codes 45300, 46500, 57150, 57160, 58100, 64405, 
95970, or HCPCS code G0268 since these codes were reviewed by the RUC 
this year and their previous direct PE inputs will be superseded by the 
new direct PE inputs we establish through this rulemaking process for 
CY 2019.
    Comment: One commenter stated that they supported this effort as it 
serves to remedy any discrepancies/errors that may be in the PFS 
related to postoperative visits and the required multi-specialty packs 
needed to render those visits.
    Response: We appreciate the support for our proposal from the 
commenter.
    Comment: One commenter stated that removal of the SA048 supply pack 
was inappropriate for CPT code 43200 (Esophagoscopy, flexible, 
transoral; diagnostic, including collection of specimen(s) by brushing 
or washing, when performed (separate procedure)) as it is required for 
the esophagoscopy procedure and the supply is included in the other 
codes in the family (CPT codes 43201-43233) as well as for the other GI 
endoscopy code families. The commenter requested that CMS not remove 
the SA048 supply from CPT code 43200.
    Response: After reviewing the supply inputs for the group of codes 
identified by the commenter, we agree that it would not be consistent 
to remove the SA048 multi-specialty pack from CPT code 43200 while 
retaining the supply pack in CPT codes 43201-43233. As a result, we are 
not finalizing the removal of the SA048 multi-specialty pack from CPT 
code 43200. However, we note that many of the CPT codes in this range 
also contain SA048 supply packs without having any postoperative office 
visits included in their global periods. We believe that it may be more 
accurate to achieve consistency within this range of CPT codes by 
removing the SA048 supply pack from all of these codes, as opposed to 
adding the SA048 supply pack to CPT code 43200. In regard to this 
topic, stakeholders can always provide data to us if they believe the 
code is not bundled/valued/etc. correctly.
    After consideration of the public comments, we are finalizing our 
proposal to align the number of minimum multi-specialty visit packs 
with the number of post-operative office visits included in these CPT 
codes listed in Table 6, with the exception of CPT code 43200 as 
detailed above.
    A stakeholder notified us regarding a potential rank order anomaly 
in the direct PE inputs established for the Shaving of Epidermal or 
Dermal Lesions code family through PFS rulemaking for CY 2013. Three of 
these CPT codes describe benign shave removal of increasing lesion 
sizes: CPT code 11310 (Shaving of epidermal or dermal lesion, single 
lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion 
diameter 0.5 cm or less), CPT code 11311 (Shaving of epidermal or 
dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous 
membrane; lesion diameter 0.6 to 1.0 cm), and CPT code 11312 (Shaving 
of epidermal or dermal lesion, single lesion, face, ears, eyelids, 
nose, lips, mucous membrane; lesion diameter 1.1 to 2.0 cm). Each of 
these codes has a progressively higher work RVU corresponding to the 
increasing lesion diameter, and the recommended direct PE inputs also 
increase progressively from CPT codes 11310 to 11311 to 11312. However, 
the nonfacility PE RVU we established for CPT code 11311 is lower than 
the nonfacility PE RVU for CPT code 11310, which the stakeholder 
suggested may represent a rank order anomaly.
    We reviewed the direct PE inputs for CPT code 11311 and found that 
there were clerical inconsistencies in the data entry that resulted in 
the assignment of the lower nonfacility PE RVU for CPT code 11311. We 
proposed to revise the direct PE inputs to reflect the ones previously 
finalized through rulemaking for CPT code 11311.
    Comment: One commenter agreed that a significant clerical error 
occurred after the RUC recommended its valuation of CPT code 11311 and 
its final acceptance by CMS. The commenter recommended that the direct 
PE inputs of CPT code 11310 be replicated for CPT code 11311 and 
submitted a table with recommended values.
    Response: After reviewing this information, we found that the 
direct PE inputs requested by the commenter mostly, but do not 
entirely, match the direct PE inputs that CMS finalized through 
rulemaking for CY 2013. The commenter requested the inclusion of an 
additional SB007 (drape, sterile barrier 16in x 29in) supply and a 
SB011 (drape, sterile, fenestrated 16in x 29in) supply while leaving 
out a SK075 (skin marking pen, sterile (Skin Skribe)) supply, 3 SM022 
(sanitizing cloth-wipe (surface, instruments, equipment)) supplies, and 
4 SL463 (Aluminum Chloride 70%) supplies. Since we proposed to revise 
the direct PE inputs to match the ones previously finalized through 
rulemaking for CPT code 11311, we are not finalizing these five changes 
to the direct PE inputs requested by the commenter. In all other 
respects, the direct PE inputs recommended by the commenter matched the 
direct PE inputs previously finalized through

[[Page 59471]]

rulemaking. We are therefore finalizing our proposal to revise the 
direct PE inputs to reflect the ones previously finalized in CY 2013 
for CPT code 11311.
     In CY 2018, we inadvertently assigned too many minutes of 
clinical labor time for the ``Obtain vital signs'' task to three 
therapy codes, given that these codes are typically billed in multiple 
units and in conjunction with other therapy codes for the same patient 
on the same day, and we do not believe that it would be typical for 
clinical staff to obtain vital signs for each time a code is reported. 
The codes are: CPT code 97124 (Therapeutic procedure, 1 or more areas, 
each 15 minutes; massage, including effleurage, petrissage and/or 
tapotement (stroking, compression, percussion)); CPT code 97750 
(Physical performance test or measurement (e.g., musculoskeletal, 
functional capacity), with written report, each 15 minutes); and CPT 
code 97755 (Assistive technology assessment (e.g., to restore, augment 
or compensate for existing function, optimize functional tasks and/or 
maximize environmental accessibility), direct one-on-one contact, with 
written report, each 15 minutes).
    Therefore, we proposed to refine the ``Obtain vital signs'' 
clinical labor task for these three codes back to their previous times 
of 1 minute for CPT codes 97124 and 97750 and to 3 minutes for CPT code 
97755. We also proposed to refine the equipment time for the table, 
mat, hi-lo, 6 x 8 platform (EF028) for CPT code 97124 to reflect the 
change in the clinical labor time.
    Comment: Several commenters agreed with the CMS rationale for 
refining the clinical labor task times for each of these codes.
    Response: We appreciate the support for our proposal from the 
commenters.
    Comment: One commenter opposed the CMS proposal to refine the 
equipment time for the table, mat, hi-lo, 6 x 8 platform (EF028) for 
CPT code 97124 to reflect the change in the clinical labor time.
    Response: We continue to believe that changes in clinical labor 
time should be matched with corresponding changes in equipment time. 
Since the commenter did not supply a rationale as to why the EF028 
equipment time should not match the change in clinical labor time, we 
are finalizing our proposal to refine the ``Obtain vital signs'' 
clinical labor task for these three codes back to their previous times 
of 1 minute for CPT codes 97124 and 97750 and to 3 minutes for CPT code 
97755.
    We received a letter from a commenter alerting us to an anomaly in 
the direct PE inputs for CPT code 52000 (Cystourethroscopy (separate 
procedure)). The commenter stated that the inclusion of an endoscope 
disinfector, rigid or fiberoptic, w-cart equipment item (ES005) was 
inadvertently overlooked in the recommendations for CPT code 52000 when 
it was reviewed during PFS rulemaking for CY 2017, and that the 
equipment would be necessary for endoscope sterilization. The commenter 
requested that this piece of equipment should be added to the direct PE 
inputs for CPT code 52000.
    After reviewing the direct PE inputs for this code, we agreed with 
the commenter and we proposed to add the endoscope disinfector (ES005) 
to CPT code 52000, and to add 22 minutes of equipment time for that 
item to match the equipment time of the other non-scope items included 
in this code.
    Comment: One commenter supported the CMS proposal to add an 
endoscope disinfector to CPT code 52000 and to add 22 minutes of 
equipment time to match the equipment time of the other non-scope items 
included in the code. This commenter requested that this addition apply 
to all endoscopic urologic procedures that do not already include the 
endoscope disinfector.
    Response: We do not agree that the endoscope disinfector should be 
added to all endoscopic urologic procedures that lacked the equipment, 
as the addition of this equipment to CPT code 52000 is a technical 
correction to address a specific anomaly with the recommendations for 
CPT code 52000 and not the implementation of a new policy. After 
consideration of the public comments, we are finalizing the addition of 
22 minutes of equipment time for the endoscope disinfector (ES005) to 
CPT code 52000 as proposed.
    The following is a summary of the public comments we received on 
additional technical corrections to the direct PE input database and 
supporting files.
    Comment: A commenter stated that they had reviewed the CY 2019 
Proposed Rule physician work time file and discovered an issue with 13 
CPT codes that had incorrect work times. The commenter stated that 
these were technical errors in which the current work time values did 
not match what CMS had finalized through rulemaking, and the commenter 
requested that these services be corrected in the CY 2019 CMS work time 
file for the CY 2019 Final Rule.
    Response: We agree with the commenter that some of these CPT codes 
are subject to technical corrections, while disagreeing with the 
commenter with regards to other CPT codes, as described in more detail 
below.
    Listed in order, the commenter identified these issues:
    Comment: For CPT code 15220 (Full thickness graft, free, including 
direct closure of donor site, scalp, arms, and/or legs; 20 sq cm or 
less), the commenter stated that their records showed CMS missing 15 
min of positioning time from the Harvard study.
    Response: We are not finalizing a change in the work time of this 
code at this time, as we were unable to verify the positioning time of 
CPT code 15220 as originally measured by the Harvard study.
    Comment: For CPT code 22558 (Arthrodesis, anterior interbody 
technique, including minimal discectomy to prepare interspace (other 
than for decompression); lumbar), the commenter stated that the CMS 
work time file accidentally double counted postoperative visit time in 
the immediate postoperative time field.
    Response: We agree with the commenter that this is subject to a 
technical correction, and we are finalizing an immediate postservice 
work time of 25 minutes for CPT code 22558.
    Comment: For CPT code 43760 (Change of gastrostomy tube, 
percutaneous, without imaging or endoscopic guidance), the commenter 
stated that the code is being deleted for CY 2019 and should not appear 
in the work time file.
    Response: We agree with the commenter, and we are finalizing the 
removal of this code from the work time file.
    Comment: For CPT codes 61645 (Percutaneous arterial transluminal 
mechanical thrombectomy and/or infusion for thrombolysis, intracranial, 
any method, including diagnostic angiography, fluoroscopic guidance, 
catheter placement, and intraprocedural pharmacological thrombolytic 
injection(s)) and 61650 (Endovascular intracranial prolonged 
administration of pharmacologic agent(s) other than for thrombolysis, 
arterial, including catheter placement, diagnostic angiography, and 
imaging guidance; initial vascular territory), the commenter stated 
that CMS incorrectly applied 23 hour stay rule for these codes even 
though the RUC recommended these services as typically inpatient. The 
commenter stated that there are now available data to see that these 
CPT codes are done on an inpatient basis 98 percent and 86 percent of 
the time respectively.
    Response: We do not believe that the work times of these codes are 
subject to

[[Page 59472]]

a technical correction, as the work times finalized for these codes in 
the CY 2017 PFS final rule (81 FR 80307-08) were based on a 
disagreement in policy with the commenter and not a technical error.
    Comment: For CPT code 91200 (Liver elastography, mechanically 
induced shear wave (e.g., vibration), without imaging, with 
interpretation and report), the commenter stated that the RUC 
recommended 5 minutes of immediate postservice work time, not 3 
minutes, and that CMS had finalized the code without a time refinement. 
The commenter stated that the immediate postservice work time for CPT 
code 91200 should be 5 minutes in accordance with the RUC 
recommendations.
    Response: We investigated the RUC recommendations from the April 
2015 RUC meeting when CPT code 91200 was reviewed, and we found that 
the RUC recommended an immediate postservice work time of 3 minutes on 
the code family's cover sheet and the accompanying summary spreadsheet. 
Although the RUC may have intended to recommend an immediate 
postservice work time of 5 minutes for this code, we proposed and 
finalized an immediate postservice work time of 3 minutes for CPT code 
91200 without receiving any comments on the issue. Therefore we are not 
finalizing any changes to the work time of CPT code 91200 at this time, 
which will remain 3 minutes.
    Comment: For CPT codes 93281 (Programming device evaluation (in 
person) with iterative adjustment of the implantable device to test the 
function of the device and select optimal permanent programmed values 
with analysis, review and report by a physician or other qualified 
health care professional; multiple lead pacemaker system), 93284 
(Programming device evaluation (in person) with iterative adjustment of 
the implantable device to test the function of the device and select 
optimal permanent programmed values with analysis, review and report by 
a physician or other qualified health care professional; multiple lead 
transvenous implantable defibrillator system), and 93286 (Peri-
procedural device evaluation (in person) and programming of device 
system parameters before or after a surgery, procedure, or test with 
analysis, review and report by a physician or other qualified health 
care professional; single, dual, or multiple lead pacemaker system), 
the commenter stated that CMS has the wrong intraservice work times, 
despite the CY 2018 final rule indicating no time refinement for these 
codes.
    Response: After reviewing the work times for these codes, we agree 
with the commenter and we are finalizing a technical correction to the 
intraservice work times as recommended.
    Comment: For CPT code 97166 (Occupational therapy evaluation, 
moderate complexity), the commenter stated that the HCPAC recommended 
15 min of immediate postservice work time, not 10 minutes, and that CMS 
had finalized the code without a time refinement.
    Response: We investigated the RUC recommendations from the October 
2015 RUC meeting when CPT code 97166 was reviewed, and we found that 
the HCPAC recommendations contained two different values for the 
immediately postservice work time. The written recommendations stated 
that the immediate postservice work time was recommended at 15 minutes, 
while the data on the summary spreadsheet stated that the immediate 
postservice work time was recommended at 10 minutes. Although there 
were two conflicting HCPAC recommendations for this code, we finalized 
in the CY 2017 PFS final rule (81 FR 80331) an immediate postservice 
work time of 10 minutes for CPT code 97166 without receiving any 
comments on the issue. Therefore we are not finalizing any changes to 
the work time of CPT code 97166 at this time.
    Comment: For CPT code 33866 (Aortic hemiarch graft including 
isolation and control of the arch vessels, beveled open distal aortic 
anastomosis extending under one or more of the arch vessels, and total 
circulatory arrest or isolated cerebral perfusion (List separately in 
addition to code for primary procedure)), the commenter stated that the 
RUC recommendation was rescinded and that the code should be removed 
from the work time file.
    Response: We disagree with the commenter, and we are not finalizing 
the removal of CPT code 33866 from the work time file; we refer readers 
to the code valuation section of this final rule for additional details 
regarding CPT code 33866.
    Comment: For CPT code 96X11 (Psychological or neuropsychological 
test administration using single instrument, with interpretation and 
report by physician or other qualified health care professional and 
interactive feedback to the patient, family member(s), or 
caregivers(s), when performed), the commenter stated that the code is 
not being created for CY 2019 by the CPT Editorial Panel and should be 
removed from the work time file.
    Response: We agree with the commenter and we are finalizing the 
removal of this code from the work time file.
    Comment: For HCPCS code G0281 (Electrical stimulation, 
(unattended), to one or more areas, for chronic stage iii and stage iv 
pressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis 
ulcers not demonstrating measurable signs of healing after 30 days of 
conventional care, as part of a therapy plan of care), the commenter 
stated that their records show an intraservice time for this code of 11 
minutes and not 7 minutes as currently listed in the work time file.
    Response: We disagree with the commenter. As we stated in the CY 
2003 PFS final rule with comment period (67 FR 80014), the work, 
practice expense, and malpractice values G0281 are based on a crosswalk 
to CPT code 97014 (Application of a modality to 1 or more areas; 
electrical stimulation (unattended)), and the intraservice work time of 
CPT code 97014 remains 7 minutes.
    Comment: Many commenters raised concerns about the use of the 
portable X-ray machine (EF041) equipment in CPT code 71045 (Radiologic 
examination, chest; single view). Commenters stated that the use of the 
portable X-ray machine in CPT code 71045 understated the price of the 
equipment typically used in the service, and that the default equipment 
utilization rate of 50 percent did not reflect the experience of 
portable X-ray suppliers. Commenters supplied an invoice for a Digital 
Radiography portable X-ray machine, which they stated would be typical 
for use in this procedure, along with data on the equipment utilization 
rate that suggested a utilization rate significantly lower than 50 
percent would be typical. Commenters requested modifying the direct PE 
inputs for CPT code 71045 to include the use of the Digital Radiography 
portable X-ray machine at a distinctive utilization rate of 
approximately 22 percent, or alternatively, to use the same equipment 
as the other three codes in the Chest X-Ray code family (CPT codes 
71046-71048) as direct PE inputs for CPT code 71045.
    Response: We agree with the commenters and we are finalizing the 
replacement of the 9 minutes of equipment time for the portable X-ray 
machine (EF041) with 9 minutes of equipment time for a basic radiology 
room (EL012) for CPT code 71045. The equipment cost per minute of the 
basic radiology room (48.4 cents) is nearly identical to the equipment 
cost per

[[Page 59473]]

minute of the proposed Digital Radiography portable X-ray machine (46.0 
cents), and we believe that it would better serve the interests of 
relativity for CPT code 71045 to match the same equipment inputs as the 
rest of the Chest X-Ray code family. We previously updated the PE RVU 
of this code in the July 2018 Quarterly Update (CMS Change Request 
10644) based on the same information previously supplied by the 
commenters, and due to a technical error, this update to the direct PE 
inputs of CPT code 71045 was not included in the CY 2019 PFS proposed 
rule. We are finalizing this technical correction to the direct PE 
inputs of CPT code 71045 for CY 2019.
    Comment: One commenter stated that there was a typographical error 
in Attachment B of the proposed rule, which resulted in the 
misstatement of the total RVUs for CPT code 48554 (Transplantation of 
pancreatic allograft). The commenter recommended that we include 74.81 
total RVUs for CPT code 48554 to correct the error of 73.70 total RVUs.
    Response: We do not agree with the commenter that there was a 
typographical error in Addendum B for CPT code 48554, which appears to 
sum its component parts of the work RVU (37.80), PE RVU (27.72), and 
malpractice RVU (9.29) to the correct total RVU of 74.81.
    We also received comments regarding a variety of subjects about 
which we did not make proposals for CY 2019. These included comments 
regarding: The level of physician supervision for CPT code 99091, the 7 
percent reduction to the technical component of computed radiography 
services not performed using digital radiography, a request to migrate 
the RUC recommended RVU assignment of CPT code 77387 to HCPCS code 
G6017, a request that CMS not finalize the proposed changes in payment 
for the revascularization codes (CPT codes 37225-37231) that were a 
byproduct of the E/M proposals and the supply/equipment pricing update, 
a request that CMS should assign direct cost inputs and PE RVUs to 
several disposable negative pressure wound therapy codes (CPT codes 
97607-97608), a disagreement with previous reductions in the payment 
rate for HCPCS code G0416 from past calendar years, a request for 
clarification regarding the facility PE RVUs for CPT code 99153, a 
request for CMS to provide additional reimbursement stability for 
vascular access services by increasing the work RVUs and direct PE 
inputs for these codes (CPT codes 36901-36909), and a request for CMS 
to study the possible effect of tariffs on the cost of imaging 
equipment manufactured overseas. These comments are considered out of 
scope for the CY 2019 PFS final rule, as we did not make any proposals 
on these issues in the CY 2019 PFS Proposed Rule. We will take the 
feedback from the commenters under consideration for future rulemaking.
    After consideration of the public comments, we are finalizing 
technical corrections to the direct PE input database and supporting 
files as described above.
e. Updates to Prices for Existing Direct PE Inputs
    In the CY 2011 PFS final rule with comment period (75 FR 73205), we 
finalized a process to act on public requests to update equipment and 
supply price and equipment useful life inputs through annual 
rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2019, 
we proposed the following price updates for existing direct PE inputs.
    We proposed to update the price of four supplies and one equipment 
item in response to the public submission of invoices. As these pricing 
updates were each part of the formal review for a code family, we 
proposed that the new pricing take effect for CY 2019 for these items 
instead of being phased in over 4 years. For the details of these 
proposed price updates, please refer to section II.H. of this final 
rule, Table 15: Invoices Received for Existing Direct PE Inputs.
(1) Market-Based Supply and Equipment Pricing Update
    Section 220(a) of the Protecting Access to Medicare Act of 2014 
(PAMA) (Pub. L. 113-93) provides that the Secretary may collect or 
obtain information from any eligible professional or any other source 
on the resources directly or indirectly related to furnishing services 
for which payment is made under the PFS, and that such information may 
be used in the determination of relative values for services under the 
PFS. Such information may include the time involved in furnishing 
services; the amounts, types and prices of PE inputs; overhead and 
accounting information for practices of physicians and other suppliers, 
and any other elements that would improve the valuation of services 
under the PFS.
    As part of our authority under section 1848(c)(2)(M) of the Act, as 
added by PAMA, we initiated a market research contract with StrategyGen 
to conduct an in-depth and robust market research study to update the 
PFS direct PE inputs (DPEI) for supply and equipment pricing for CY 
2019. These supply and equipment prices were last systematically 
developed in 2004-2005. StrategyGen has submitted a report with updated 
pricing recommendations for approximately 1300 supplies and 750 
equipment items currently used as direct PE inputs. This report is 
available as a public use file displayed on the CMS website under 
downloads for the CY 2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    The StrategyGen team of researchers, attorneys, physicians, and 
health policy experts conducted a market research study of the supply 
and equipment items currently used in the PFS direct PE input database. 
Resources and methodologies included field surveys, aggregate 
databases, vendor resources, market scans, market analysis, physician 
substantiation, and statistical analysis to estimate and validate 
current prices for medical equipment and medical supplies. StrategyGen 
conducted secondary market research on each of the 2,072 DPEI medical 
equipment and supply items that CMS identified from the current DPEI. 
The primary and secondary resources StrategyGen used to gather price 
data and other information were:
     Telephone surveys with vendors for top priority items 
(Vendor Survey).
     Physician panel validation of market research results, 
prioritized by total spending (Physician Panel).
     The General Services Administration system (GSA).
     An aggregate health system buyers database with discounted 
prices (Buyers).
     Publicly available vendor resources, that is, Amazon 
Business, Cardinal Health (Vendors).
     Federal Register, current DPEI data, historical proposed 
and final rules prior to FY 2018, and other resources; that is, AMA RUC 
reports (References).
    StrategyGen prioritized the equipment and supply research based on 
current share of PE RVUs attributable by item provided by CMS. 
StrategyGen developed the preliminary Recommended Price (RP) 
methodology based on the following rules in hierarchical order 
considering both data representativeness and reliability.
    1. If the market share, as well as the sample size, for the top 
three commercial products were available, the weighted average price 
(weighted by percent market share) was the reported RP. Commercial 
price, as a weighted average of market share, represents a more robust 
estimate for each piece of

[[Page 59474]]

equipment and a more precise reference for the RP.
    2. If StrategyGen did not have market share for commercial 
products, then they used a weighted average (weighted by sample size) 
of the commercial price and GSA price for the RP. The impact of the GSA 
price may be nominal in some of these cases since it is proportionate 
to the commercial samples sizes.
    3. Otherwise, if single price points existed from alternate 
supplier sites, the RP was the weighted average of the commercial price 
and the GSA price.
    4. Finally, if no data were available for commercial products, the 
GSA average price was used as the RP; and when StrategyGen could find 
no market research for a particular piece of equipment or supply item, 
the current CMS prices were used as the RP.
    After reviewing the StrategyGen report, we proposed to adopt the 
updated direct PE input prices for supplies and equipment as 
recommended by StrategyGen. For the reasons subsequently discussed, the 
GSA price was not incorporated into the calculation for the StrategyGen 
recommended prices printed in the proposed rule. The proposed 
recommended price was developed as follows:
    Recommended CMS Price: The StrategyGen proposed recommended price 
was the researched-commercial price, when available. If not, the 
StrategyGen proposed recommended price was the current CMS price.
    StrategyGen found that despite technological advancements, the 
average commercial price for medical equipment and supplies has 
remained relatively consistent with the current CMS price. 
Specifically, preliminary data indicate that there was no statistically 
significant difference between the estimated commercial prices and the 
current CMS prices for both equipment and supplies. This cumulative 
stable pricing for medical equipment and supplies appears similar to 
the pricing impacts of non-medical technology advancements where some 
historically high-priced equipment (that is, desktop PCs) has been 
increasingly substituted with current technology (that is, laptops and 
tablets) at similar or lower price points. However, while there were no 
statistically significant differences in pricing at the aggregate 
level, medical specialties will experience increases or decreases in 
their Medicare payments if CMS were to adopt the pricing updates 
recommended by StrategyGen. At the service level, there may be large 
shifts in PE RVUs for individual codes that happened to contain 
supplies and/or equipment with major changes in pricing, although we 
note that codes with a sizable PE RVU decrease would be limited by the 
requirement to phase in significant reductions in RVUs, as required by 
section 1848(c)(7) of the Act. The phase-in requirement limits the 
maximum RVU reduction for codes that are not new or revised to 19 
percent in any individual calendar year.
    We believe that it is important to make use of the most current 
information available for supply and equipment pricing instead of 
continuing to rely on pricing information that is more than a decade 
old. Given the potentially significant changes in payment that would 
occur, both for specific services and more broadly at the specialty 
level, we proposed to phase in our use of the new direct PE input 
pricing over a 4-year period using a 25/75 percent (CY 2019), 50/50 
percent (CY 2020), 75/25 percent (CY 2021), and 100/0 percent (CY 2022) 
split between new and old pricing. This approach is consistent with how 
we have previously incorporated significant new data into the 
calculation of PE RVUs, such as the 4-year transition period finalized 
in CY 2007 PFS final rule with comment period when changing to the 
``bottom-up'' PE methodology (71 FR 69641). This transition period will 
not only ease the shift to the updated supply and equipment pricing, 
but will also allow interested parties an opportunity to review and 
respond to the new pricing information associated with their services.
    We proposed to implement this phase-in over 4 years so that supply 
and equipment values transition smoothly from the prices we currently 
include to the final updated prices in CY 2022. We proposed to 
implement this pricing transition such that one quarter of the 
difference between the current price and the fully phased in price is 
implemented for CY 2019, one third of the difference between the CY 
2019 price and the final price is implemented for CY 2020, and one half 
of the difference between the CY 2020 price and the final price is 
implemented for CY 2021, with the new direct PE prices fully 
implemented for CY 2022. An example of the proposed transition from the 
current to the fully-implemented new pricing is provided in Table 7.

                                Table 7--Example of Direct PE Pricing Transition
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
Current Price......................            $100  ...........................................................
Final Price........................             200  ...........................................................
Year 1 (CY 2019) Price.............             125  \1/4\ difference between $100 and $200.
Year 2 (CY 2020) Price.............             150  \1/3\ difference between $125 and $200.
Year 3 (CY 2021) Price.............             175  \1/2\ difference between $150 and $200.
Final (CY 2022) Price..............             200  ...........................................................
----------------------------------------------------------------------------------------------------------------

    For new supply and equipment codes for which we establish prices 
during the transition years (CYs 2019, 2020 and 2021) based on the 
public submission of invoices, we proposed to fully implement those 
prices with no transition since there are no current prices for these 
supply and equipment items. These new supply and equipment codes would 
immediately be priced at their newly established values. We also 
proposed that, for existing supply and equipment codes, when we 
establish prices based on invoices that are submitted as part of a 
revaluation or comprehensive review of a code or code family, they will 
be fully implemented for the year they are adopted without being phased 
in over the 4-year pricing transition. The formal review process for a 
HCPCS code includes a review of pricing of the supplies and equipment 
included in the code. When we find that the price on the submitted 
invoice is typical for the item in question, we believe it would be 
appropriate to finalize the new pricing immediately along with any 
other revisions we adopt for the code valuation.
    For existing supply and equipment codes that are not part of a 
comprehensive review and valuation of a code family and for which we 
establish prices based on invoices submitted by the public, we proposed 
to implement the established invoice price as the updated price and to 
phase in the new price over the remaining years of the proposed 4-year 
pricing transition. During the proposed transition period, where price 
changes for supplies and

[[Page 59475]]

equipment are adopted without a formal review of the HCPCS codes that 
include them (as is the case for the many updated prices we proposed to 
phase in over the 4-year transition period), we believe it is important 
to include them in the remaining transition toward the updated price. 
We also proposed to phase in any updated pricing we establish during 
the 4-year transition period for very commonly used supplies and 
equipment that are included in 100 or more codes, such as sterile 
gloves (SB024) or exam tables (EF023), even if invoices are provided as 
part of the formal review of a code family. We would implement the new 
prices for any such supplies and equipment over the remaining years of 
the proposed 4-year transition period. Our proposal was intended to 
minimize any potential disruptive effects during the proposed 
transition period that could be caused by other sudden shifts in RVUs 
due to the high number of services that make use of these very common 
supply and equipment items (meaning that these items are included in 
100 or more codes).
    We believed that implementing the proposed updated prices with a 4-
year phase-in would improve payment accuracy, while maintaining 
stability and allowing stakeholders the opportunity to address 
potential concerns about changes in payment for particular items. 
Updating the pricing of direct PE inputs for supplies and equipment 
over a longer time frame will allow more opportunities for public 
comment and submission of additional, applicable data. We welcomed 
feedback from stakeholders on the proposed updated supply and equipment 
pricing, including the submission of additional invoices for 
consideration. We were particularly interested in comments regarding 
the supply and equipment pricing for CPT codes 95165 and 95004 that are 
frequently used by the Allergy/Immunology specialty. The Allergy/
Immunology specialty was disproportionately affected by the updated 
pricing, even with a 4-year phase-in. The direct PE costs for CPT code 
95165 would go down from $8.43 to $8.17 as a result of the updated 
supply and equipment pricing information. This would result in the PE 
RVU for CPT code 96165 to decrease from 0.30 to 0.26. We are seeking 
feedback on the supply and equipment pricing for the affected codes 
typically performed by this specialty and whether the direct PE inputs 
should be reviewed along with the pricing. The full report from the 
contractor, including the updated supply and equipment pricing that we 
proposed to be implemented over the proposed 4-year transition period, 
will be made available as a public use file displayed on the CMS 
website under downloads for the CY 2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    The following is a summary of the public comments we received on 
our proposals associated with the market research study to update the 
PFS direct PE inputs for supply and equipment pricing.
    Comment: Many commenters were concerned with the transparency of 
the data used to calculate medical equipment and supply prices. The 
commenters were particularly concerned about the use of a subscription-
based benchmark database as a source for pricing data. The commenters 
stated that without identification of the database and access to the 
precise data used in determining the pricing update, they would have no 
systematic way to evaluate pricing accuracy. In addition, these 
commenters were concerned that small physician practices are not well 
represented in benchmark databases, with the consequence that the 
proposed repricing did not reflect the typical price paid by smaller 
stakeholders. Commenters stated a general concern that any methodology 
that more heavily weighs larger physician groups, group purchasing 
organizations (GPOs), or even hospital contract pricing would result in 
pricing that is significantly depressed compared to the pricing that 
can be obtained by an individual practitioner. The commenters asserted 
that this has the potential to pressure the financial viability of 
smaller physician practices and to force lower cost non-facility 
procedures into hospital outpatient or inpatient sites of service.
    Response: As to whether there is sufficient transparency to enable 
others to replicate and validate the proposed pricing, the StrategyGen 
contractors carried out a market research plan designed to estimate the 
typical discounted prices that physicians and other providers normally 
pay. The proprietary database of buyer reported pricing is one of the 
few sources of typical discounted price data available. Other potential 
sources of typical discounted pricing were other proprietary databases 
and the publicly available GSA pricing. For each item priced, the 
analysis from the contractors included research on as many as five 
current sources of prices: (1) A proprietary database of buyer reported 
pricing, (2) Prices reported by GSA, (3) Amazon Business, (4) Cardinal 
Healthcare, and (5) Vendors' and manufacturers' catalogs.
    The proprietary database of buyer reported pricing offers three 
advantages: (1) It represents discounted prices as opposed to retail 
pricing, (2) It has the largest sample sizes to represent a wider range 
of pricing as opposed to single invoices, and (3) The database provides 
variety with respect to the purchaser's geographic location, purchasing 
method, procedure volume and other purchasing arrangements. We 
initially assumed that GSA also represents typical discounted pricing 
across regions with smaller sample sizes, but subsequently rejected GSA 
data because we did not believe that its prices were typically 
representative of commercially available pricing. As a result, GSA data 
were not used to calculate the StrategyGen recommended prices included 
in the proposed rule. Amazon Business and Cardinal Healthcare represent 
typical retail pricing, with smaller sample sizes. In addition, the 
StrategyGen contractors utilized vendors' and manufacturers' catalogs 
to identify publicly available pricing. Table 8 summarizes sources of 
online pricing and characteristics of each source:

                     Table 8--Market-Based Supply and Equipment Pricing Update Data Sources
----------------------------------------------------------------------------------------------------------------
                                                                                             Variety (that is,
       Source of pricing data            Discounted pricing           Sample size          geography, purchasing
                                                                                            arrangement, etc.)
----------------------------------------------------------------------------------------------------------------
Buyers database.....................  Actual discounts.......  Largest..................  National footprint.
GSA.................................  Wholesale price........  3-5......................  Government purchasers
                                                                                           only.
Amazon Business (on-line)...........  Retail price...........  3-5......................  National footprint.
Cardinal Healthcare (on-line).......  Retail price...........  3-5......................  National footprint.
Catalogs (on-line)..................  Retail price...........  3-5......................  National footprint.
----------------------------------------------------------------------------------------------------------------


[[Page 59476]]

    The Buyers database provides the most accurate market pricing 
estimates that include market discounts for a range of buyer 
organizations. Its larger sample sizes provide more confidence that the 
proposed pricing is not skewed toward higher or lower pricing but 
toward the actual market price paid by purchasers.
    The StrategyGen contractors chose not to include invoice research 
in the market research plan as there is already an existing process to 
modify Direct Practice Expense Input (DPEI) prices based on invoices. 
Additionally, the contractors determined that providing specific models 
and other identifying data with the researched prices would offer a 
broader and more consistent source of pricing data. We do not agree 
with the commenters that the updated supply and equipment prices will 
pressure the financial viability of smaller physician practices, as we 
believe that the larger sample sizes obtained by StrategyGen's research 
provide more accurate and more consistent pricing of actual market 
conditions than the single invoices that we have traditionally been 
reliant upon for pricing.
    As to whether the proposed pricing is representative of prices 
available to small physician practices and non-facility practitioners 
generally, one of the objectives of the primary market research was to 
understand what kind of discounts are available to small physician 
practices similar to discounted pricing available to large health 
systems under GPOs. The market research plan included a series of 
questions to vendors designed to illuminate typical discounts they 
offer to large and small providers other than GPOs. This market 
research indicates that there are a variety of discount purchasing 
options available. Vendors indicated that both volume and timing can 
influence pricing discounts. Approximately 80 percent of respondents 
indicated that timing has some impact on the price of equipment, and 
about half of respondents indicated that timing had some impact on the 
price of supplies. Discussions with other subject matter experts also 
indicated that timing of purchase is an important factor in pricing. 
For example, the end of the sales cycle can drive discounts. Less than 
10 percent of vendors indicated that these timing discounts may not be 
available to smaller practices outside of a GPO. The vendor research 
also indicated that other factors beyond ``size and timing'' influence 
discounted pricing, such as service agreements and bundled purchases.
    Research indicates that service agreements often include discounts 
for equipment and supplies. For example, longer term service agreements 
generally result in larger discounts. However, some vendors indicated 
that the effect of service agreements was to reduce the size of the 
discounts, negatively impacting providers. This may be a difference in 
service agreement strategies across different vendors. Regardless, only 
3 percent of respondents indicated that the availability of service 
agreement discounts was dependent on a GPO.
    The vendors identified other factors that impact pricing decisions 
including:
     Market demand and competitive pricing;
     Contract renewal;
     Customer history and contract history; and
     Vendor considerations independent of the purchaser such as 
manufacturer and sales incentives, revenue goals, and new product 
releases.
    In conclusion, while volume purchasing and GPOs can drive down 
prices for many large providers, these are not the only drivers of 
discounts for providers. A number of additional factors applicable to 
large, small, and non-facility practices may result in discounts for 
the buying organizations. We believe that the pricing update required 
looking at a broad range of data that was collected from different 
sources, which included pricing data from both large and small 
organizations. We note that not all private practices are small in 
nature, and we do not agree that it would be more accurate to obtain 
prices only from small practices as opposed to the broader data 
collection undertaken by the StrategyGen contractor.
    Comment: Some commenters were concerned that the researched GSA 
price was incorporated into the recommended commercial price. These 
commenters expressed concern as to how the GSA price fit into the 
calculation of new recommended prices.
    Response: We want to clarify how the GSA price was used in 
developing the new recommended DPEI prices for equipment and supplies. 
We regret the confusion on this issue, which was due to a technical 
error in the drafting of the language in the proposed rule. We wish to 
clarify that the GSA price was not used to calculate the StrategyGen 
recommended prices printed in the proposed rule. Our use of the GSA 
website to research supply and equipment pricing was found to have a 
number of limitations. Only suppliers that meet stringent 
qualifications and that complete a lengthy and detailed application 
process are eligible to participate in GSA Advantage, GSA's online 
shopping and ordering system. These requirements sharply curtail the 
number and type of suppliers whose products may be accessed on the GSA 
Advantage website. In addition, only products that are purchased by 
federal agencies or other qualified government entities are listed on 
the GSA Advantage website, which has the effect of eliminating a number 
of medical supplies and equipment that are reflected in the CMS DPEI 
codes. This limitation was especially acute when researching bundled 
codes for equipment rooms and lanes, and supply packs, kits, and trays. 
The GSA website does not record comparable bundled purchasing of 
medical equipment or supplies, so no GSA pricing could be recovered for 
products included in the bundled codes organized as rooms, lanes, 
packs, kits or trays. Finally, the prices listed on the GSA Advantage 
website are required to be the supplier's best offer, which may often 
be lower than prices that are available to non-governmental purchasers.
    For these reasons, the GSA price was not incorporated into the 
calculation for the StrategyGen recommended prices printed in the 
proposed rule. The final recommended price for CY 2019 was the 
commercially researched price, if available. Otherwise the current CY 
2018 CMS price remained in place as the CY 2019 CMS price.
    Comment: Several commenters were concerned with the methodology 
used by StrategyGen to conduct market research to determine an updated 
price for medical equipment and supplies. There were significant 
concerns with the use of market research to supplement the current AMA/
Specialty Society RVS Update Committee (RUC) process. A number of 
commenters stated that CMS should only use invoices supplied by the 
specialty society via the RUC process, and should not finalize the 
updated prices researched by the StrategyGen contractor.
    Response: We determined that the most effective way to update the 
DPEI for CY 2019 was through comprehensive market research. The current 
RUC process has resulted in updates to many of the equipment and supply 
codes, but many of the prices in the CY 2018 DPEI are over a decade 
old, and a significant number date back to research conducted 15 years 
ago. Therefore, we requested a market research plan from the 
StrategyGen contractor designed to research current pricing to estimate 
the typical discounted prices that physicians and other providers 
normally pay.

[[Page 59477]]

    The comprehensive market research plan to update DPEI equipment and 
supplies was designed to supplement the AMA RUC process, not replace 
it. The current RUC process, while indispensable, does not provide for 
comprehensive pricing updates. Under the current process, physicians 
and other providers voluntarily submit invoices for items to RUC for 
consideration, and after review, the RUC submits these invoices to us. 
This process results in inherent biases due to the limited number of 
items represented by submitted invoices and due to the voluntary 
selection of reported invoices.
    The StrategyGen market research plan examined up to five online 
sources of current prices for each item of equipment or supply 
researched, including: (1) A proprietary database of buyer reported 
pricing, (2) Prices offered on GSA (Note: This data was subsequently 
excluded from the recommended 2019 CMS prices), (3) Amazon Business, 
(4) Cardinal Healthcare, and (5) Vendors' and manufacturers' catalogs. 
Each of these sources contains nationally reported vendor and buyer 
pricing data. The research plan also included vendor interviews to 
clarify the variety of discount programs available to physicians and 
other providers.
    The comprehensive research plan for the 2019 DPEI required 
researching approximately 2,000 supply and equipment codes. Qualitative 
and potentially quantitative research to include all the specialty 
societies impacted by the DPEI updates was beyond the resources and 
time allocated to this update. The market research plan did include a 
physician panel with specialists and a general practitioner to review 
the reasonableness of the researched data. In addition, the regulatory 
process remains available to all specialty societies to comment on the 
recommended prices. We encouraged interested stakeholders to continue 
to provide feedback on supply and equipment pricing, including the 
submission of invoices, throughout the 4-year pricing transition.
    Comment: Several commenters stated that there is an inherent bias 
to prioritizing the medical equipment and supplies based on spending 
and code utilization. These commenters stated that any attempt to 
accurately price items in the supply and equipment list should devote 
equal effort to each item of equipment or supply and should not devote 
additional attention to the most utilized codes. These commenters 
stated that using utilization data as the primary driver for 
identifying supply and equipment items to review suggests that there 
may have been specific intent to lower the cost of high utilization 
items, perhaps to the detriment of pricing accuracy. In addition, there 
was concern that some underutilized codes were not researched.
    Response: To control for potential research bias, the StrategyGen 
market research team used an identical online methodology to research 
commercial pricing data for each of the supply and equipment codes, 
regardless of the code's prioritization. The prioritization of high-
utilization supply and equipment codes was not designed to reduce 
prices for these codes.
    The prioritization of supply and equipment codes was designed to 
facilitate understanding and validation of the researched commercial 
prices for these items. Surveying other market entities, including 
vendors, as opposed to buyers, was used to more precisely identify the 
range of commercial pricing and factors impacting those prices. For 
example, additional priority research included a physician panel that 
reviewed the researched commercial prices for reasonableness. The 
prioritization of research for certain codes did not change the 
recommended commercial prices.
    In addition, limited time and resources required prioritizing the 
codes based on use. We recognize that a few medical supply and 
equipment codes do not have updated recommended prices, and we continue 
to welcome the submission of updated pricing information from 
stakeholders for these and other codes.
    Comment: Many commenters were supportive of the proposal to use a 
4-year pricing transition. Commenters agreed with using the transition 
period as an opportunity for specialty societies and other stakeholders 
to continue to evaluate the new pricing and submit invoices and other 
pricing data as needed. Commenters who disagreed with the use of the 4-
year pricing transition also requested that CMS not finalize the 
proposal. One commenter stated that CMS should phase in the new prices 
for equipment and supplies during a shorter transition period than the 
proposed 4-year transition, and suggested a 2-year transition instead.
    Response: Our proposal was intended to minimize any potential 
disruptive effects during the proposed transition period, and we 
continue to believe that implementing the proposed updated prices with 
a 4-year phase-in will improve payment accuracy, while maintaining 
stability and allowing stakeholders the opportunity to address 
potential concerns about changes in payment for particular items. 
Updating the pricing of direct PE inputs for supplies and equipment 
over a longer time frame will allow more opportunities for public 
comment and submission of additional, applicable data.
    Comment: Several commenters stated that CMS should consider 
delaying implementation of this proposal until there could be a more 
thorough and adequate review of the inputs and give medical societies 
and/or practices more time to gather invoices in order to determine if 
the proposed pricing is accurate. Some commenters similarly requested 
that the 4-year pricing transition should begin in CY 2020 to provide 
stakeholders with additional time to evaluate the approach used by 
StrategyGen. A few commenters stated that they would prefer a delay of 
more than 1 year before implementation began.
    Response: We disagree with the commenters that delaying the 
implementation of the pricing updates for a year or longer would lead 
to more accurate pricing. We believe that our proposal to update the 
pricing of direct PE inputs for supplies and equipment over a 4 year-
transition already allows many opportunities for public comment and the 
submission of additional, applicable data. We welcomed feedback from 
commenters on the proposed updated supply and equipment pricing, 
including the submission of additional invoices for consideration, and 
many commenters provided detailed feedback regarding the pricing of 
individual supply and equipment items. We note that we received 
feedback from commenters on approximately 65 individual supply and 
equipment codes, which is roughly 3 percent of the total number of 
items we proposed to update. We also note that commenters did not 
identify an alternative source for pricing information outside of the 
sources employed by the StrategyGen contractors, with commenters 
largely suggesting that we should continue to rely on invoice 
submissions included along with the review of individual codes via the 
RUC process.
    We continue to believe that a delay in implementation would be 
unlikely to result in more accurate pricing information. Therefore, we 
are finalizing the 4-year pricing transition, beginning in CY 2019. We 
look forward to working with commenters over the 4-year transition for 
assistance in identifying individual supply and equipment codes that 
may require additional research into their pricing. As a reminder, to 
be included in a given year's proposed rule, we generally need to 
receive invoices by the same February 10th

[[Page 59478]]

deadline used for consideration of RUC recommendations. However, we 
would consider invoices submitted as public comments during the comment 
period following the publication of the PFS proposed rule, and would 
consider any invoices received after February 10th or outside of the 
public comment process as part of our established annual process for 
requests to update supply and equipment prices for the following year.
    Comment: Many commenters addressed the proper pricing of some 
multi-component items, including supply kits, packs, and trays as well 
as some items of equipment. Several commenters noted some of the 
proposed prices for supply and equipment items that contain multiple 
components may not accurately reflect all the components, while other 
commenters noted that some of the components could be improperly 
priced. Commenters expressed concerns that some equipment may not 
possess precise components that are necessary for a specific procedure.
    Response: Using the information provided by these commenters, the 
StrategyGen contractors re-examined the pricing of the multi-component 
supply and equipment items that had been identified. In some instances, 
the additional research confirmed some commenters' concerns, as the 
contractors found that a limited set of these multi-item supply and 
equipment kits required further clarification of components. For 
example, an item within a kit, pack, or tray may have had an updated 
component, resulting in a mispriced item within that kit. To further 
clarify the prices of these kits, the kits were broken into their most 
basic components and priced individually. The total price of the kit 
was determined by adding the specific item prices together. If one of 
the items within a kit was misidentified, it resulted in an incorrect 
price of the entire kit.
    For example, a review of the recommended price for the ``Antigens, 
multi'' (SH007) supply code identified the need to add pricing data for 
additional antigens and to refine the unit of measurement used in 
calculating the price. For SH007, additional antigens were added and 
data analyzed for 1 milliliter vials of two allergy antigens. The first 
antigen is an allergy antigen for pollen and mites and contains 
antigens for Timothy, Birch, Ragweed, Cocklebur, MarshElde, and the 
mites Dermatophagoides pteronyssinus and Dermatophagoides farina. The 
second antigen is an allergy antigen for mold and cats and contains 
antigens for Alternaria, Helminth, Hormoden, Penicillium, and Fel d1. 
To determine the price of the allergy antigen, the StrategyGen 
contractor researched each component of the antigen separately and 
averaged the price of the separate vials as the recommended price to 
arrive at an updated recommended price of $8.96.
    In instances related to equipment, an item may have been improperly 
priced because a specific component was omitted but the items priced 
could perform the requisite task. An example of this occurred in the 
pricing of the ``SRS System, SBRT'' (ER083) equipment item where the 
equipment priced would retrofit a system to perform SBRT procedures, 
but pricing did not include the linear accelerator. When re-examining 
this specific medical equipment, we ensured it was a linear accelerator 
with SBRT capabilities and arrived at an updated recommended price of 
$2,973,721.83.
    We reexamined the recommended price of each multi-component item 
cited by a commenter. Table 9 at the conclusion of this section lists 
the supply and equipment codes with price changes based on feedback 
from the commenters and the resulting additional research into pricing.
    Comment: Several commenters questioned the prices of certain supply 
codes based on their conclusion that the quantity of the items priced 
was inaccurate. Depending on the type of supply, a number of different 
units of measurement are used to set prices for DPEI supply codes. 
Commenters stated that StrategyGen had used the incorrect unit of 
measurement in their recommended prices, and identified specific supply 
codes where they believed these errors had taken place.
    Response: In each instance in which a commenter questioned the 
accuracy of a DPEI code's recommended price based on a concern about 
the unit quantity of the item priced, the StrategyGen contractor 
conducted further research of the item and its price with special 
attention to ensuring that the recommended price was based on the 
clarified unit of measure. The price assigned to a given code may be 
for a single item, a kit, a tray, or it may be based on a per test or 
per ml basis. For example, the price for the SG055 supply is for a 
single sterile 4in x 4in gauze sponge; whereas the price for SG056 is 
for a tray/pack of 10 sterile 4in x 4in gauze sponges. In other 
situations, such as the ``Embedding Mold'' (SL060) supply, the price 
for a package of multiple molds was reported instead of the price of a 
single embedding mold. After consideration of comments received and 
additional price research, we have updated the recommended prices for a 
number of relevant supply codes identified by the commenters. Table 9 
at the conclusion of this section lists the supply and equipment codes 
with price changes based on feedback from the commenters and the 
resulting additional research into pricing.
    Comment: Several commenters addressed the subject of the proper 
pricing for certain items of medical supply and equipment. These 
commenters requested these specific CMS codes be reviewed again to 
ensure the correct items were being researched and priced accordingly.
    Response: Based on the commenters' requests, the StrategyGen 
contractor conducted an extensive examination of the pricing of any 
supply or equipment items that any commenter identified as requiring 
additional review. Invoices submitted by multiple commenters were 
greatly appreciated and ensured that medical equipment and supplies 
were re-examined and clarified. Multiple researchers reviewed these 
specified supply and equipment codes for accuracy and proper pricing. 
In most cases, the contractor also reached out to a team of nurses and 
their physician panel to further validate the accuracy of the data and 
pricing information. In some cases, the pricing for individual items 
needed further clarification due to a lack of information or due to 
significant variation in packaged items. An example of such 
clarification occurred with the ``Covered Stent (Viabahn, Gore)'' 
(SD254) supply, which encompasses a wide range of stents, with varying 
sizes and other qualities. In other cases, such as the ``Patient Worn 
Telemetry System'' (EQ340) equipment, an inpatient unit was originally 
priced as opposed to an outpatient unit. After an extensive review and 
validation process, we updated our recommended prices for a number of 
supply and equipment codes. Table 9 at the conclusion of this section 
lists the supply and equipment codes with price changes based on 
feedback from the commenters and the resulting additional research into 
pricing.
    Comment: Several commenters expressed concerns with the proposed 
prices for individual supply and equipment codes, and recommended that 
the price of these codes remain unchanged until additional research can 
be conducted.
    Response: The StrategyGen contractor investigated the accuracy of 
components or features included in an item by researching the identity 
of the item based on the description contained in the item's supply or 
equipment code, as well as the identity of any item's prices

[[Page 59479]]

in submitted invoices. Additional research into approximately half a 
dozen supply/equipment codes failed to produce reliable product data 
sufficient to calculate a recommended price. To price these equipment 
and supply items accurately, we believe additional information is 
required. Therefore, we will continue to use the current CMS price for 
these supply and equipment items pending additional research and 
analysis. We welcome the submission of updated pricing information 
regarding these supply and equipment items through submission of valid 
invoices from commenters and other stakeholders. These supply and 
equipment codes are also listed in Table 9 at the conclusion of this 
section.
    Comment: A few commenters stated that CMS should ensure that the 
direct practice expenses for HCPCS codes G6001-G6015 are applied 
consistent with the directives of the Patient Access and Medicare 
Protection Act (PAMPA) (Pub. L. 114-115) and the Bipartisan Budget Act 
(BBA) of 2018 (Pub. L. 115-123). Commenters stated that Congress 
established via statute that the direct PE inputs for these radiation 
treatment delivery services furnished in CY 2017, CY 2018, and CY 2019 
shall be the same as such inputs as established for these services in 
CY 2016. These commenters stated that the proposed changes to the PE 
RVUs for HCPCS codes G6001-G6015 were directly opposed to current law, 
and that CMS should revisit its analysis to ensure that the direct PE 
inputs are consistent with those used in 2016 as required by Congress.
    Response: We disagree with the commenters that the proposed direct 
PE inputs for HCPCS codes G6001-G6015 were not applied consistent with 
the directives established in the PAMPA and the BBA. The statute at 
section 1848(b)(11) of the Act (as added by the PAMPA and amended) 
specifies that the code definitions, work RVUs, and direct inputs for 
the practice expense RVUs for these services shall be the same as such 
definitions, units, and inputs for such services for the fee schedule 
established for services furnished in CY 2016. We did not propose to 
change the code definitions, work relative value units, or direct 
practice expense inputs from those established for CY 2016. We proposed 
to update the pricing of those same supply and equipment inputs as part 
of the market-based study of commercial pricing undertaken by the 
contractor, which was not a subject addressed by the statutory 
provisions concerning HCPCS codes G6001-G6015. We did not propose 
changes to the direct practice expense inputs for these services. We 
simply proposed to update pricing for these inputs; and to adopt the 
same prices for these supplies and equipment across the PFS for all 
codes that include them. We note that we estimate that the overall 
effect of incorporating the new prices in calculating the payment rates 
for these services results in higher overall RVUs for these services, 
on the whole, than the potential alternative of relying exclusively on 
pricing from prior years.
    After consideration of the public comments, we are finalizing our 
proposals associated with the market research study to update the PFS 
direct PE inputs for supply and equipment pricing. We continue to 
believe that implementing the proposed updated prices with a 4-year 
phase-in will improve payment accuracy, while maintaining stability and 
allowing stakeholders the opportunity to address potential concerns 
about changes in payment for particular items. We continue to welcome 
feedback from stakeholders on the proposed updated supply and equipment 
pricing, including the submission of additional invoices for 
consideration. However, while we are adopting most of the prices for 
supplies and equipment as recommended by StrategyGen and included in 
the proposed rule, in response to the initial feedback provided by the 
commenters, we are finalizing changes to the proposed pricing of 
approximately 60 supply and equipment codes as detailed in Table 9:

                      Table 9--Supply and Equipment Prices Updated in Response to Comments
----------------------------------------------------------------------------------------------------------------
                                                                                    Proposed CY    Final CY 2019
     Supply/ equipment code                Description             CY 2018 price    2019 price         price
----------------------------------------------------------------------------------------------------------------
ED033..........................  treatment planning system, IMRT    $350,545.000    $157,392.835    $197,247.000
                                  (Corvus w-Peregrine 3D Monte
                                  Carlo).
EF031..........................  table, power...................       6,153.630       5,438.120       5,906.760
EL015..........................  room, ultrasound, general......     369,945.000     130,252.571     369,945.000
EL016..........................  Room--Ultrasound, vascular/         466,492.000     199,449.308     466,492.000
                                  Original submission.
EP014..........................  flow cytometer.................     119,850.000     147,210.980     192,000.000
EP088..........................  ThermoBrite....................       6,120.000       3,467.000       4,795.000
EP116..........................  VP-2000 Processor..............      30,800.000      81,775.462      37,993.000
EQ031..........................  INR monitor, home..............       2,000.000       6,014.819         635.000
EQ125..........................  glucose continuous monitoring         1,170.540         835.527         850.000
                                  system.
EQ288..........................  ultrasonic cleaning unit.......         895.000      76,725.556         895.000
EQ312..........................  INR analysis and reporting           21,085.000       6,014.819      19,325.000
                                  system w-software.
EQ340..........................  Patient Worn Telemetry System..      23,537.000      18,565.719      23,494.000
EQ343..........................  Radioaerosol Administration           2,560.250          30.000         623.000
                                  System.
ER003..........................  HDR Afterload System,               375,000.000     111,425.876     132,574.780
                                  Nucletron--Oldelft.
ER083..........................  SRS system, SBRT, six systems,    4,000,000.000     931,965.479   2,973,721.836
                                  average.
ES052..........................  brachytherapy treatment vault..     175,000.000     134,998.000     193,114.250
SA026..........................  kit, radiofrequency introducer.          50.000         658.700          24.160
SA074..........................  kit, endovascular laser                 519.000         313.460         323.330
                                  treatment.
SA081..........................  pack, drapes, ortho, small.....           1.128           1.000           2.250
SA099..........................  Kit, probe, cryoablation,             4,700.000       1,539.560       1,539.560
                                  prostate (Galil-Endocare).
SA100..........................  kit, probe, radiofrequency, XIi-      2,695.000         753.420       1,966.670
                                  enhanced RF probe.
SA105..........................  UroVysion test kit.............         176.800         132.130         129.280
SA106..........................  Balloon Sinus Surgery Kit......       2,599.860       2,876.220       2,374.330
SA117..........................  Universal Detection Kit........           4.000           6.510           4.000
SA122..........................  Claravein Kit..................         890.000         575.000         883.330
SB019..........................  drape-towel, sterile 18in x               0.282           0.920           0.470
                                  26in.
SB026..........................  gown, patient..................           0.533           3.540           0.590
SD109..........................  probe, radiofrequency, 3 array        2,233.000         871.660       2,289.000
                                  (StarBurstSDE).
SD114..........................  sensor, glucose monitoring               53.080          43.950          59.310
                                  (interstitial).

[[Page 59480]]

 
SD134..........................  tubing, suction, non-latex                2.961           0.290           2.670
                                  (6ft) with Yankauer tip (1).
SD155..........................  catheter, RF endovenous                 725.000       1,010.550         550.000
                                  occlusion.
SD250..........................  introducer sheath, Ansel [45 cm          90.000          64.450          72.640
                                  6 Fr Ansel].
SD251..........................  Sheath Shuttle (Cook)..........           0.000           0.000         109.690
SD253..........................  atherectomy device                    4,979.670       2,293.100       3,048.330
                                  (Spectronetics laser or Fox
                                  Hollow).
SD254..........................  covered stent (VIABAHN, Gore)..       3,768.000       2,573.000       3,129.000
SD255..........................  Reentry device (Frontier,                 0.000           0.000       2,343.120
                                  Outback, Pioneer).
SD304..........................  IVUS catheter..................       1,025.000         727.750         858.330
SF040..........................  suture, vicryl, 3-0 to 6-0, p,            7.852           4.310           8.520
                                  ps.
SG055..........................  gauze, sterile 4in x 4in.......           0.159           0.030           0.190
SG056..........................  gauze, sterile 4in x 4in (10              0.798           0.030           1.200
                                  pack uou).
SH007..........................  antigen, multi (pollen, mite,             6.700           4.780           8.960
                                  mold, cat).
SH009..........................  antigen, venom.................          20.140          27.360          30.930
SH010..........................  antigen, venom, tri-vespid.....          44.050          51.320          60.240
SH033..........................  fluorescein inj (5ml uou)......           5.442          10.310          24.390
SJ055..........................  test strip, INR................           5.660           3.750           4.710
SL012..........................  antibody IgA FITC..............          41.180         274.090          30.025
SL060..........................  embedding mold.................           0.149           5.140           0.123
SL182..........................  mounting media (DAPI II                  67.000          14.420          54.000
                                  counterstain).
SL184..........................  slide, negative control, Her-2.          29.400          21.240          29.400
SL185..........................  slide, positive control, Her-2.          29.400          25.000          26.200
SL191..........................  ethanol, 85%...................           0.003           0.170           0.021
SL195..........................  kit, FISH paraffin pretreatment          20.850          23.290          20.850
SL196..........................  kit, HER-2/neu DNA Probe.......         105.000          80.450          79.050
SL258..........................  Control slides.................         228.000         279.000         203.730
SL261..........................  FISH pre-treatment kit.........         549.000         454.480         579.210
SL474..........................  Confirm anti-CD15 Mouse                   3.610           3.880           3.820
                                  Monoclonal Antibody (Ventana
                                  760-2504).
SL483..........................  Hematoxylin II (Ventana 790-              0.023           0.023           0.780
                                  2208).
SL484..........................  Bluing reagent (Ventana 760-              4.522           0.290           0.450
                                  2037).
SL488..........................  UltraView Universal DAB                  10.485          15.390           9.700
                                  Detection Kit.
SL493..........................  Antibody Estrogen Receptor               14.470         322.400          16.117
                                  monoclonal.
SL497..........................  (EBER) DNA Probe Cocktail......           8.570         420.060           8.189
SL498..........................  Kappa Probe Cocktail...........           0.095           0.070           0.910
----------------------------------------------------------------------------------------------------------------

    The updated supply and equipment pricing as it will be implemented 
over the 4-year transition period will be made available as a public 
use file displayed on the CMS website under downloads for the CY 2019 
PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    To maintain relativity between the clinical labor, supplies, and 
equipment portions of the PE methodology, we believe that the rates for 
the clinical labor staff should also be updated along with the updated 
pricing for supplies and equipment. We solicited public comment 
regarding whether to update the clinical labor wages used in developing 
PE RVUs in future calendar years during the 4-year pricing transition 
for supplies and equipment, or whether it would be more appropriate to 
update the clinical labor wages at a later date following the 
conclusion of the transition for supplies and equipment, for example, 
to avoid other potentially large shifts in PE RVUs during the 4-year 
pricing transition period.
    The following is a summary of the public comments we received on 
our comment solicitation regarding whether to update of the rates for 
the clinical labor staff types during the 4-year pricing transition for 
supplies and equipment.
    Comment: Most commenters were supportive of the idea of updating 
the clinical labor wages during the 4-year pricing transition for 
supplies and equipment. Several commenters requested that the updated 
pricing for clinical labor should continue to be based on Bureau of 
Labor Statistics wage data and remain open for public comment from 
interested commenters through the rulemaking process. One commenter 
supported updating the prices for the clinical labor staff types and 
stated that they had convened an expert physician panel that suggested 
that the clinical labor costs for radiation therapists and nurses are 
up to 33 percent higher than what is currently included in the CMS 
database. A few commenters did not support updating clinical labor 
wages during the 4-year pricing transition for supplies and equipment, 
in one case stating that the clinical labor pricing should be updated 
after the pricing transition for supplies and equipment was complete, 
and in another case stating that CMS should not make any changes to 
clinical labor costs for the foreseeable future.
    Response: We will take this information into account for future 
rulemaking on the subject of whether or not to update the clinical 
labor wages used in future calendar years alongside the 4-year pricing 
transition for supplies and equipment.
(2) Breast Biopsy Software (EQ370)
    Following the publication of the CY 2018 PFS final rule, a 
stakeholder contacted us and requested that we update the price for the 
Breast Biopsy software (EQ370) equipment. This equipment item currently 
lacks a price in the direct PE database, and when an invoice for the 
Breast Biopsy software was first submitted during CY 2014 PFS 
rulemaking, we stated that this item served clinical functions similar 
to other items already included in the Magnetic Resonance (MR) room 
equipment package (EL008) included in the same CPT codes under review. 
Therefore, we did not create new direct PE inputs for this equipment 
item (78 FR 74344

[[Page 59481]]

through 74345). The stakeholder suggested that this software is used to 
subtract the imaging raw data series from the MRI Scanner, reformat the 
images in multiple planes to allow accurate targeting of the lesion to 
be biopsied, identify the location of a fiducial marker on the 
patient's skin, and then target the location of the enhancing lesion to 
be biopsied. The stakeholder requested that EQ370 be renamed as 
``Breast MRI computer aided detection and biopsy guidance software'' 
and added to existing CPT codes 19085 (Biopsy, breast, with placement 
of breast localization device(s) (e.g., clip, metallic pellet), when 
performed, and imaging of the biopsy specimen, when performed, 
percutaneous; first lesion, including magnetic resonance guidance), 
19086 (Biopsy, breast, with placement of breast localization device(s) 
(e.g., clip, metallic pellet), when performed, and imaging of the 
biopsy specimen, when performed, percutaneous; each additional lesion, 
including magnetic resonance guidance), 19287 (Placement of breast 
localization device(s) (e.g., clip, metallic pellet, wire/needle, 
radioactive seeds), percutaneous; first lesion, including magnetic 
resonance guidance), and 19288 (Placement of breast localization 
device(s) (e.g., clip, metallic pellet, wire/needle, radioactive 
seeds), percutaneous; each additional lesion, including magnetic 
resonance guidance), as well as adding the equipment to two newly 
created MR breast codes with CAD, CPT codes 77048 (Magnetic resonance 
imaging, breast, without and with contrast material(s), including 
computer-aided detection (CAD-real time lesion detection, 
characterization and pharmacokinetic analysis) when performed; 
unilateral) and 77049 (Magnetic resonance imaging, breast, without and 
with contrast material(s), including computer-aided detection (CAD-real 
time lesion detection, characterization and pharmacokinetic analysis) 
when performed; bilateral). The stakeholder supplied an invoice with a 
purchase price of $52,275 for the equipment.
    After reviewing the use of the Breast Biopsy software (EQ370) 
equipment in these six codes, we did not propose to update the price or 
add the software to these procedures. As we stated in the CY 2014 PFS 
final rule with comment period (78 FR 74345), we continue to believe 
that equipment item EQ370 serves clinical functions similar to other 
items already included in the MR room equipment package (EL008), and 
that it would be duplicative to include this Breast Biopsy software as 
a separate direct PE input. We also note that the RUC recommendations 
for the new CPT codes 77048 and 77049 do not include EQ370 in the 
recommended equipment for these procedures, and we do not have any 
reason to believe that the inclusion of additional Breast Biopsy 
software beyond what is already contained in the MR room equipment 
package would be typical. However, we will update the name of the EQ370 
equipment item from ``Breast Biopsy software'' to the requested 
``Breast MRI computer aided detection and biopsy guidance software'' to 
help better describe the equipment in question.
    The following is a summary of the public comments we received on 
our proposal not to update the price of the Breast Biopsy software or 
add the software to the listed procedures.
    Comment: Several commenters stated that CAD or biopsy software is 
not part of any standard MRI room package available for purchase, and 
that these are different equipment items sold by different vendors. One 
commenter requested that CMS clarify the equipment items that make up 
the MR room (EL008) in order to verify whether or not legitimate 
duplication exists with the Breast Biopsy software. Another commenter 
stated that the new CAD Software equipment (ED058) in CPT codes 77048 
and 77049 is actually synonymous with the ``breast biopsy software'' 
(EQ370). This commenter stated that there had been a lack of 
consistency in identifying the equipment item between the breast biopsy 
codes and the MR breast codes, and requested updating the price of the 
equipment item consistent with the submitted invoices.
    Response: In response to the comment requesting that CMS clarify 
the equipment items that make up the MR room (EL008), we can state that 
the MR room contains a 1.5T MR Scanner as well as coils, NV array, 
torso array, shoulder, wrist, extremity, dual array, power injector, 
and a computer workstation.
    After consideration of the public comments, we are finalizing our 
proposal not to update the price of the Breast Biopsy software (EQ370). 
However, we note that in light of the information supplied by the 
commenter that the new CAD Software equipment (ED058) is actually 
synonymous with the Breast Biopsy software (EQ370), we had already 
proposed to include this equipment in CPT codes 77048 and 77049. We are 
finalizing the inclusion of the new CAD Software equipment (ED058) in 
these procedures, and we are finalizing an update in the price of the 
CAD Software to $43,308.12. This is based on a submitted invoice from 
the commenters which contained a price of $52,725 as averaged together 
with additional invoices for the same CAD Software equipment researched 
by the StrategyGen contractor. We are also finalizing the replacement 
of the time assigned to the EQ370 Breast Biopsy software in CPT codes 
19085, 19086, 19287, and 19288 with an equal amount of time assigned to 
the new ED058 CAD Software equipment. Finally, due to the continued 
confusion and lack of price for the EQ370 equipment item, and due to 
its redundancy with the new ED058 equipment code, we are deleting 
EQ370.
(3) Invoice Submission
    We routinely accept public submission of invoices as part of our 
process for developing payment rates for new, revised, and potentially 
misvalued codes. Often these invoices are submitted in conjunction with 
the RUC-recommended values for the codes. For CY 2019, we noted that 
some stakeholders have submitted invoices for new, revised, or 
potentially misvalued codes after the February 10th deadline 
established for code valuation recommendations. To be included in a 
given year's proposed rule, we generally need to receive invoices by 
the same February 10th deadline we noted for consideration of RUC 
recommendations. However, we would consider invoices submitted as 
public comments during the comment period following the publication of 
the PFS proposed rule, and would consider any invoices received after 
February 10th or outside of the public comment process as part of our 
established annual process for requests to update supply and equipment 
prices.
(4) Adjustment to Allocation of Indirect PE for Some Office-Based 
Services
    In the CY 2018 PFS final rule (82 FR 52999 through 53000), we 
established criteria for identifying the services most affected by the 
indirect PE allocation anomaly that does not allow for a site of 
service differential that accurately reflects the relative indirect 
costs involved in furnishing services in nonfacility settings. We also 
finalized a modification in the PE methodology for allocating indirect 
PE RVUs to better reflect the relative indirect PE resources involved 
in furnishing these services. The methodology, as described, is based 
on the difference between the ratio of indirect PE to work RVUs for 
each of the codes meeting eligibility criteria and the ratio of 
indirect PE to work RVU for the most commonly reported visit code. We 
refer readers to the CY 2018 PFS final

[[Page 59482]]

rule (82 FR 52999 through 53000) for a discussion of our process for 
selecting services subject to the revised methodology, as well as a 
description of the methodology, which we began implementing for CY 2018 
as the first year of a 4-year transition. For CY 2019, we proposed to 
continue with the second year of the transition of this adjustment to 
the standard process for allocating indirect PE.
    We received no comments specific to our proposal to continue with 
the 2nd year of the transition to the standard process for allocating 
indirect PE. Therefore, we are finalizing our proposal to proceed with 
the second year of implementing an alternative methodology for the 
allocation of indirect PE for some office-based services.

C. Determination of Malpractice Relative Value Units (RVUs)

1. Overview
    Section 1848(c) of the Act requires that the payment amount for 
each service paid under the PFS be composed of three components: Work; 
PE; and malpractice (MP) expense. As required by section 
1848(c)(2)(C)(iii) of the Act, beginning in CY 2000, MP RVUs are 
resource-based. Section 1848(c)(2)(B)(i) of the Act also requires that 
we review, and if necessary adjust, RVUs no less often than every 5 
years. In the CY 2015 PFS final rule with comment period, we 
implemented the third review and update of MP RVUs. For a comprehensive 
discussion of the third review and update of MP RVUs see the CY 2015 
PFS proposed rule (79 FR 40349 through 40355) and final rule with 
comment period (79 FR 67591 through 67596).
    To determine MP RVUs for individual PFS services, our MP 
methodology is composed of three factors: (1) Specialty-level risk 
factors derived from data on specialty-specific MP premiums paid by 
practitioners; (2) service level risk factors derived from Medicare 
claims data of the weighted average risk factors of the specialties 
that furnish each service; and (3) an intensity/complexity of service 
adjustment to the service level risk factor based on either the higher 
of the work RVU or clinical labor RVU. Prior to CY 2016, MP RVUs were 
only updated once every 5 years, except in the case of new and revised 
codes.
    In the CY 2016 PFS final rule with comment period (80 FR 70906 
through 70910), we finalized a policy to begin conducting annual MP RVU 
updates to reflect changes in the mix of practitioners providing 
services (using Medicare claims data), and to adjust MP RVUs for risk, 
intensity and complexity (using the work RVU or clinical labor RVU). We 
also finalized a policy to modify the specialty mix assignment 
methodology (for both MP and PE RVU calculations) to use an average of 
the 3 most recent years of data instead of a single year of data. Under 
this approach, for new and revised codes, we generally assign a 
specialty risk factor to individual codes based on the same utilization 
assumptions we make regarding the specialty mix we use for calculating 
PE RVUs and for PFS budget neutrality. We continue to use the work RVU 
or clinical labor RVU to adjust the MP RVU for each code for intensity 
and complexity. In finalizing this policy, we stated that the 
specialty-specific risk factors would continue to be updated through 
notice and comment rulemaking every 5 years using updated premium data, 
but would remain unchanged between the 5-year reviews.
    In CY 2017, we finalized the 8th GPCI update, which reflected 
updated MP premium data. We did not propose to use the updated MP 
premium data to propose updates for CY 2017 to the specialty risk 
factors used in the calculation of MP RVUs because it was inconsistent 
with the policy we previously finalized in the CY 2016 PFS final rule 
with comment period. That is, we indicated that the specialty-specific 
risk factors would continue to be updated through notice and comment 
rulemaking every 5 years using updated premium data, but would remain 
unchanged between the 5-year reviews. However, we solicited comment on 
whether we should consider doing so, perhaps as early as for CY 2018, 
prior to the fourth review and update of MP RVUs that must occur no 
later than CY 2020. After consideration of the comments received, we 
stated in the CY 2017 PFS final rule that we would consider the 
possibility of using the updated MP data to update the specialty risk 
factors used in the calculation of the MP RVUs prior to the next 5-year 
update in future rulemaking (81 FR 80191 through 80192).
    In the CY 2018 PFS proposed rule, we proposed to use the updated MP 
data to update the specialty risk factors used in calculation of the MP 
RVUs prior to the next 5-year update (CY 2020). However, in the CY 2018 
PFS final rule (82 FR 53000 through 53006), after consideration of the 
comments received and some differences we observed in the descriptions 
on the raw rate filings as compared to how those data were categorized 
to conform with the CMS specialties, we did not finalize our proposal 
to use the updated MP data. We are required to review, and if 
necessary, adjust the MP RVUs by CY 2020. We appreciate the feedback 
provided by commenters in response to the CY 2018 PFS proposed rule.
    In the CY 2019 PFS proposed rule, we solicited additional comment 
regarding the next MP RVU update which must occur by CY 2020. 
Specifically, we solicited comment on how we might improve the way that 
specialties in the state-level raw rate filings data are crosswalked 
for categorization into CMS specialty codes, which are used to develop 
the specialty-level risk factors and the MP RVUs.
    We received a few comments in response to the comment solicitation, 
and we appreciate the commenters' feedback and input. We will consider 
the suggestions and information received for future rulemaking, and in 
particular for the CY 2020 statutorily required update to MP RVUs.

D. Modernizing Medicare Physician Payment by Recognizing Communication 
Technology-Based Services

    The health care community uses the term ``telehealth'' broadly to 
refer to medical services furnished via communication technology. Under 
current PFS payment rules, Medicare routinely pays for many of these 
kinds of services. This includes some kinds of remote patient 
monitoring (either as separate services or as parts of bundled 
services), interpretations of diagnostic tests when furnished remotely 
and, under conditions specified in section 1834(m) of the Act, services 
that would otherwise be furnished in person but are instead furnished 
via real-time, interactive communication technology. Over the past 
several years, we have also established several PFS policies to 
explicitly pay for non-face-to-face services included as part of 
ongoing care management.
    Although all of the kinds of services stated above might be called 
``telehealth'' by patients, other payers and health care providers, we 
have generally used the term ``Medicare telehealth services'' to refer 
to the subset of services defined in section 1834(m) of the Act. 
Section 1834(m) of the Act defines Medicare telehealth services and 
specifies the payment amounts and circumstances under which Medicare 
makes payment for a discrete set of services, all of which must 
ordinarily be furnished in-person, when they are instead furnished 
using interactive, real-time telecommunication technology. Section 
1834(m)(4)(F)(i) of the Act enumerates certain Medicare telehealth 
services and section 1834(m)(4)(F)(ii) of the Act allows the Secretary 
to specify

[[Page 59483]]

additional Medicare telehealth services using an annual process to add 
or delete services from the Medicare telehealth list. Section 
1834(m)(4)(C) of the Act limits the scope of Medicare telehealth 
services for which payment may be made to those furnished to a 
beneficiary who is located in certain types of originating sites in 
certain, mostly rural, areas. Section 1834(m)(1) of the Act permits 
only physicians and certain other types of practitioners to furnish and 
be paid for Medicare telehealth services. Although section 
1834(m)(4)(F)(ii) of the Act grants the Secretary the authority to add 
services to, and delete services from, the list of telehealth services 
based on the established annual process, it does not provide any 
authority to change the limitations relating to geography, patient 
setting, or type of furnishing practitioner because these requirements 
are specified in statute. However, we note that sections 50302, 50324, 
and 50325 of the Bipartisan Budget Act of 2018 (BBA 18) (Pub. L. 115-
123) have modified or removed the limitations relating to geography and 
patient setting for certain telehealth services, including for certain 
home dialysis end-stage renal disease-related services, services 
furnished by practitioners in certain Accountable Care Organizations, 
and acute stroke-related services, respectively.
    In the CY 2018 PFS proposed rule (82 FR 53012), we solicited 
information from the public regarding ways that we might further expand 
access to telehealth services within the current statutory authority 
and pay appropriately for services that take full advantage of 
communication technologies. Commenters were very supportive of CMS 
expanding access to these kinds of services. Many commenters noted that 
Medicare payment for telehealth services is restricted by statute, but 
encouraged CMS to recognize and support technological developments in 
healthcare.
    We believe that the provisions in section 1834(m) of the Act apply 
particularly to the kinds of professional services explicitly 
enumerated in the statutory provisions, like professional 
consultations, office visits, and office psychiatry services. 
Generally, the services we have added to the telehealth list are 
similar to these kinds of services. As has long been the case, certain 
other kinds of services that are furnished remotely using 
communications technology are not considered ``Medicare telehealth 
services'' and are not subject to the restrictions articulated in 
section 1834(m) of the Act. This is true for services that were 
routinely paid separately prior to the enactment of the provisions in 
section 1834(m) of the Act and do not usually include patient 
interaction (such as remote interpretation of diagnostic imaging 
tests), and for services that were not discretely defined or separately 
paid for at the time of enactment and that do include patient 
interaction (such as chronic care management services).
    As we considered the concerns expressed by commenters about the 
statutory restrictions on Medicare telehealth services, we recognized 
that the concerns were not limited to the barriers to payment for 
remotely furnished services like those described by the office visit 
codes. The commenters also expressed concerns pertaining to the 
limitations on appropriate payment for evolving physicians' services 
that are inherently furnished via communication technology, especially 
as technology and its uses have evolved in the decades since the 
Medicare telehealth services statutory provision was enacted.
    In recent years, we have sought to recognize significant changes in 
health care practice, especially innovations in the active management 
and ongoing care of chronically ill patients, and have relied on the 
medical community to identify and define discrete physicians' services 
through the CPT Editorial Panel (82 FR 53163). In response to our 
comment solicitation on Medicare telehealth services in the CY 2018 PFS 
proposed rule (82 FR 53012), commenters provided many suggestions for 
how CMS could expand access to telehealth services within the current 
statutory authority and pay appropriately for services that take full 
advantage of communication technologies, such as waiving portions of 
the statutory restrictions using demonstration authority. After 
considering those comments we recognized that concerns regarding the 
provisions in section 1834(m) of the Act may have been limiting the 
degree to which the medical community developed coding for new kinds of 
services that inherently utilize communication technology. We have come 
to believe that section 1834(m) of the Act does not apply to all kinds 
of physicians' services whereby a medical professional interacts with a 
patient via remote communication technology. Instead, we believe that 
section 1834(m) of the Act applies to a discrete set of physicians' 
services that ordinarily involve, and are defined, coded, and paid for 
as if they were furnished during an in-person encounter between a 
patient and a health care professional.
    For CY 2019, we aimed to increase access for Medicare beneficiaries 
to physicians' services that are routinely furnished via communication 
technology by clearly recognizing a discrete set of services that are 
defined by and inherently involve the use of communication technology. 
Accordingly, we made several proposals for modernizing Medicare 
physician payment for communication technology-based services, 
described below. These services will not be subject to the limitations 
on Medicare telehealth services in section 1834(m) of the Act because, 
as we have explained, we do not consider them to be Medicare telehealth 
services; instead, they will be paid under the PFS like other 
physicians' services. Additionally, we note that in furnishing these 
services, practitioners need to comply with any applicable privacy and 
security laws, including the HIPAA Privacy Rule.
1. Brief Communication Technology-Based Service, e.g. Virtual Check-In 
(HCPCS Code G2012)
    The traditional office visit codes describe a broad range of 
physicians' services. Historically, we have considered any routine non-
face-to-face communication that takes place before or after an in-
person visit to be bundled into the payment for the visit itself. In 
recent years, we have recognized payment disparities that arise when 
the amount of non-face-to-face work for certain kinds of patients is 
disproportionately higher than for others, and created coding and 
separate payment to recognize care management services such as chronic 
care management and behavioral health integration services (81 FR 
80226). We now recognize that advances in communication technology have 
changed patients' and practitioners' expectations regarding the 
quantity and quality of information that can be conveyed via 
communication technology. From the ubiquity of synchronous, audio/video 
applications to the increased use of patient-facing health portals, a 
broader range of services can be furnished by health care professionals 
via communication technology as compared to 20 years ago.
    Among these services are the kinds of brief check-in services 
furnished using communication technology that are used to evaluate 
whether or not an office visit or other service is warranted. When 
these kinds of check-in services are furnished prior to an office 
visit, then we would currently consider them to be bundled into the 
payment for the resulting visit, such as through an evaluation and 
management (E/M) visit

[[Page 59484]]

code. However, in cases where the check-in service does not lead to an 
office visit, then there is no office visit with which the check-in 
service can be bundled. To the extent that these kinds of check-ins 
become more effective at addressing patient concerns and needs using 
evolving technology, we believe that the overall payment implications 
of considering the services to be broadly bundled becomes more 
problematic. This is especially true in a resource-based relative value 
payment system. Effectively, the better practitioners are in leveraging 
technology to furnish effective check-ins that mitigate the need for 
potentially unnecessary office visits, the fewer billable services they 
furnish. Given the evolving technological landscape, we believe this 
creates incentives that are inconsistent with current trends in medical 
practice and potentially undermines payment accuracy.
    Therefore, we proposed to pay separately, beginning January 1, 
2019, for a newly defined type of physicians' service furnished using 
communication technology. We stated this service would be billable when 
a physician or other qualified health care professional has a brief 
non-face-to-face check-in with a patient via communication technology, 
to assess whether the patient's condition necessitates an office visit. 
We understand that the kind of communication technology used to furnish 
these kinds of services has broadened over time and has enhanced the 
capacity for medical professionals to care for patients. We solicited 
comment on what types of communication technology are utilized by 
physicians or other qualified health care professionals in furnishing 
these services, including whether audio-only telephone interactions are 
sufficient compared to interactions that are enhanced with video or 
other kinds of data transmission.
    The following discussion summarizes particular definitions and 
billing rules for these services, as proposed, and more detailed 
comments we received regarding these aspects of the proposal. Our 
responses below include information regarding the service definitions 
and billing requirements applicable for CY 2019.
    Comment: Many commenters supported the proposal to pay for these 
kinds of services. Many commenters offered specific suggestions 
regarding the service definitions and associated billing rules, which 
we describe in detail below. Several commenters urged CMS to take a 
cautious approach in paying for these services, given concerns these 
commenters stated regarding potential overutilization, while some noted 
that potential overutilization would be mitigated by Medicare's 
requirements for the visit to be reasonable and medically necessary/
appropriate. Specific aspects of these comments are detailed below.
    Response: Based on the broad support for the proposal, we are 
creating coding and finalizing our proposal to make separate payment 
for this service. We note that in the proposed rule we referred to this 
service as HCPCS code GVCI1, which was a placeholder code. The code 
will be described as HCPCS code G2012 (Brief communication technology-
based service, e.g. virtual check-in, by a physician or other qualified 
health care professional who can report evaluation and management 
services, provided to an established patient, not originating from a 
related E/M service provided within the previous 7 days nor leading to 
an E/M service or procedure within the next 24 hours or soonest 
available appointment; 5-10 minutes of medical discussion).
    We appreciate commenters' concerns regarding the potential for 
overutilization of these services. We plan to monitor utilization with 
the intention of determining whether changes, such as a frequency 
limitation on the use of this code, are warranted. We would consider 
proposing such changes in future rulemaking. We note that, like all 
other physicians' services billed under the PFS, each of these services 
must be medically reasonable and necessary to be paid by Medicare.
    Comment: Many commenters suggested that we not be overly 
prescriptive regarding the types of communication technology that are 
utilized by physicians or other qualified health care professionals in 
furnishing these services. The commenters noted that technology is 
evolving at a rapid pace and would require us to have to update our 
policies frequently. Several commenters suggested that we permit the 
use of email and Electronic Health Record (EHR) patient portals to 
qualify. A few commenters stated that audio-visual communication is 
ideal. Others acknowledged that not all patients have the same level of 
connectivity and therefore recommended allowing audio-only 
communication.
    Response: We are persuaded by the comments advising us not to be 
overly prescriptive about the technology that is used, and are 
finalizing allowing audio-only real-time telephone interactions in 
addition to synchronous, two-way audio interactions that are enhanced 
with video or other kinds of data transmission. We note that telephone 
calls that involve only clinical staff could not be billed using HCPCS 
code G2012 since the code explicitly describes (and requires) direct 
interaction between the patient and the billing practitioner.
    We further proposed that in instances when the brief communication 
technology-based service originates from a related E/M service provided 
within the previous 7 days by the same physician or other qualified 
health care professional, that this service would be considered bundled 
into that previous E/M service and would not be separately billable, 
which is consistent with code descriptor language for CPT code 99441 
(Telephone evaluation and management service by a physician or other 
qualified health care professional who may report evaluation and 
management services provided to an established patient, parent, or 
guardian not originating from a related E/M service provided within the 
previous 7 days nor leading to an E/M service or procedure within the 
next 24 hours or soonest available appointment; 5-10 minutes of medical 
discussion), on which this service is partially modeled. We proposed 
that in instances when the brief communication technology-based service 
leads to an E/M service with the same physician or other qualified 
health care professional, this service would be considered bundled into 
the pre- or post-visit time of the associated E/M service, and 
therefore, would not be separately billable. We also noted that this 
service could be used as part of a treatment regimen for opioid use 
disorders and other substance use disorders to assess whether the 
patient's condition requires an office visit.
    We proposed pricing this distinct service at a rate lower than 
current E/M in-person visits to reflect the low work time and intensity 
and to account for the resource costs and efficiencies associated with 
the use of communication technology. We expect that these services will 
be initiated by the patient, especially since many beneficiaries would 
be financially liable for sharing in the cost of these services. For 
the same reason, we believe it is important for patients to consent to 
receiving these services. Therefore, we specifically solicited comment 
on whether we should require, for example, verbal consent that will be 
noted in the medical record for each service.
    Comment: Many commenters stated that it would be burdensome to 
obtain consent from the patient prior to each occurrence of this 
service. Some commenters suggested that the patient be informed through 
the use of a service agreement which could be signed once and kept on 
file. Several commenters

[[Page 59485]]

expressed concern about the cost to beneficiaries, especially since 
they may have previously received this service without financial 
liability, and therefore recommended requiring verbal consent that is 
documented in the medical record.
    Response: We understand the potential burden regarding obtaining 
consent for each occurrence of this service. However, we are persuaded 
by those commenters who suggest that unexpected cost to beneficiaries 
would be particularly problematic. We note that under our current 
policy for several types of care management services, verbal consent is 
required to be obtained and documented in the medical record. The 
consent policy was implemented, in part, based on feedback we received 
from practitioners reporting the care management services, to alleviate 
burdens of alternative approaches, such as requirements for written 
consent or completion of particular forms. Consequently, we believe the 
same requirement could be applied here, without imposition of 
significant burden. We are finalizing requiring verbal consent that is 
noted in the medical record for each billed service.
    We also proposed that this service can only be furnished for 
established patients because we believe that the practitioner needs to 
have an existing relationship with the patient, and therefore, basic 
knowledge of the patient's medical condition and needs, in order to 
perform this service.
    Comment: Many commenters were supportive of our proposal to limit 
this service to established patients, while several commenters noted 
that there would be instances when it would be appropriate to bill this 
service for new patients. MedPAC noted particular concern regarding 
potential increases in volume that are not related to ongoing, informed 
patient care. A few commenters requested that CMS clarify that 
established patients include those patients who have been seen by a 
practitioner within the same group practice.
    Response: After considering the comments, we are finalizing our 
proposal to limit this service to established patients, given the 
concern expressed by commenters regarding the degree to which these 
services can be furnished without familiarity and experience with 
individual patients, and in light of MedPAC's concerns regarding 
increases in utilization that are not related to ongoing, informed 
patient care. In response to the request for clarification about what 
constitutes an established patient, we defer to CPT's definition of 
this term. CPT defines an established patient as one who has received 
professional services from the physician or qualified health care 
professional or another physician or qualified health care professional 
of the exact same specialty and subspecialty who belongs to the same 
group practice, within the past 3 years. We also emphasize that payment 
for this service would not preclude a physician or other qualified 
health care professional from having communication via phone or other 
modalities with any patient, new or existing, for a variety of reasons. 
We believe that much of the pre- and post- work associated with, and 
included in the valuation of existing in-person services that are paid 
under the PFS can include some types of interactions with patients that 
are not in-person.
    We did not propose to apply a frequency limit on the use of this 
code by the same practitioner with the same patient, but we want to 
ensure that this code is appropriately utilized for circumstances when 
a patient needs a brief non-face-to-face check-in to assess whether an 
office visit is necessary. We solicited comment on whether it would be 
clinically appropriate to apply a frequency limitation on the use of 
this code by the same practitioner with the same patient, and on what 
would be a reasonable frequency limitation.
    Comment: Many commenters were opposed to creating a frequency 
limitation, suggesting we wait and monitor utilization. Others noted 
that it could be clinically appropriate to utilize this service 
multiple times in a week. A few commenters stated that this service 
could be utilized in behavioral health treatment, and cited an example 
of assessing suicidal risk, in which case they suggested the frequency 
should not be limited since routine virtual check-ins would be 
clinically warranted in some cases. Some commenters suggested a 
frequency limit of three times per week whereas others suggested a 
limit of once per week.
    Response: After considering these comments, we are not implementing 
a frequency limitation for CY 2019. However, we plan to monitor 
utilization with the intention of determining whether such a limitation 
is warranted. In that case, we would consider proposing a limitation in 
future rulemaking. We note that, like all other physicians' services 
billed under the PFS, each of these services must be medically 
reasonable and necessary to be paid by Medicare.
    We also solicited comment on the timeframes under which this 
service would be separately billable compared to when it would be 
bundled. We believe the general construct of bundling the services that 
lead directly to a billable visit is important, but we are concerned 
that establishing strict timeframes may create unintended consequences 
regarding scheduling of care. For example, we do not want to bundle 
only the services that occur within 24 hours of a visit only to see a 
significant number of visits occurring at 25 hours after the initial 
service. In order to mitigate these incentives, we solicited comment on 
whether we should consider broadening the window of time and/or 
circumstances in which this service should be bundled into the 
subsequent related visit. We noted that these services, like any other 
physicians' service, must be medically reasonable and necessary in 
order to be paid by Medicare.
    Comment: Several commenters suggested that we remove the language 
in the code descriptor that states ``or soonest available 
appointment.'' A few commenters suggested we extend the timeframe to 48 
hours following the virtual check-in, while others suggested it would 
be reasonable to expand the limit to 14 days before and 72 hours after 
the service. Several commenters stated concerns that it might be 
difficult to document that a subsequent visit was not the ``soonest 
available appointment.'' Several commenters expressed concern about the 
potential for overutilization of this code.
    Response: We agree with commenters that urged caution regarding 
overutilization of this service and believe that the language stating, 
`or soonest available appointment' in the code description may serve to 
reduce potential perverse payment incentives to delay seeing patients 
to ensure payment for this code. We appreciate the concerns regarding 
potential difficulty in proving that a particular visit was not the 
``soonest available.'' We agree that in each individual case, it might 
be challenging to prove whether or not other appointments were 
available prior to the visit, especially since beneficiary convenience 
is also presumably a factor for when appointments are scheduled. 
However, we believe that, as written, the code description could help 
to guard against the potential for abuse that would be present if we 
instead adopted a purely time-based window for bundling of this 
service. We also believe that ``soonest available appointment'' might 
allow for clinically appropriate flexibility. Therefore, after 
consideration of the public comments, we are finalizing the code 
descriptor for HCPCS code G2012 as proposed. However, we plan to 
monitor this service with the intention of determining whether changes 
are

[[Page 59486]]

necessary to the timeframes under which this service would be 
separately billable compared to when it would be bundled. We would 
consider any such changes in future rulemaking.
    We solicited comment on how clinicians could best document the 
medical necessity of this service, consistent with documentation 
requirements necessary to demonstrate the medical necessity of any 
service under the PFS.
    Comment: A few commenters stated that documentation for this 
service should be consistent with the requirements for an in-person 
encounter and requested appropriate documentation requirements to 
ensure that the check-in is fully incorporated into the individual's 
medical history. Other commenters urged us not to be overly 
prescriptive.
    Response: We appreciate the commenters' input. We do not want to 
impose undue administrative burden likely to discourage appropriate 
provision of these services, and are therefore not requiring any 
service-specific documentation requirements for this service. We note 
again that these services, like any other physicians' service, must be 
medically reasonable and necessary in order to be paid by Medicare.
    Comment: Several commenters stated that the proposed payment rate 
would be inadequate for modalities that are both audio- and visual-
capable, whereas others stated that the proposed valuation was 
appropriate. One commenter suggested we create a second code for a 
virtual check-in that only utilizes synchronous audio/video technology, 
with a higher reimbursement rate associated with the increased 
complexity of technology.
    Response: As discussed in section II.H of this final rule, we are 
finalizing the valuation for HCPCS code G2012 as proposed. We believe 
this valuation reflects the work time and intensity of the service 
relative to other PFS services and accounts for the resource costs and 
efficiencies associated with the use of communication technology. We 
recognize that the valuation of this service is relatively modest, 
especially compared to in-person services, however, we believe that the 
proposed valuation accurately reflects the resources involved in 
furnishing this service. We plan to monitor the utilization of this 
code and note that we routinely address recommended changes in values 
for codes paid under the PFS.
    Comment: A few commenters requested that CMS allow licensed 
physical therapists to furnish these services. Additionally, a few 
commenters requested that we allow other clinical staff, such as 
registered nurses, to furnish this service.
    Response: We are finalizing maintaining this code as part of the 
set of codes that is only reportable by those that can furnish E/M 
services. We believe this is appropriate since the service describes a 
check-in directly with the billing practitioner to assess whether an 
office visit is needed. We agree that similar check-ins provided by 
nurses and other clinical staff can be important aspects of coordinated 
patient care. We note that these kinds of non-face-to-face services by 
other medical professionals and clinical staff continue to be included 
in the RVUs for other codes, including those that describe E/M visits, 
and for procedures with global periods. We also note that non-face-to-
face services provided by clinical staff can be explicitly and 
separately paid for as part of several care management services, many 
of which we have introduced over the past several years. However, this 
service is meant to describe, and account for the resources involved, 
when the billing practitioner directly furnishes the virtual check-in.
    Comment: Several commenters requested that CMS waive the 
beneficiary co-payment for this service.
    Response: We appreciate the commenters' request; however, we do not 
have the statutory authority to make specific changes to the 
requirements regarding beneficiary cost sharing for this service.
    In summary, we are creating coding and finalizing our proposal to 
make separate payment for brief communication technology-based 
services. The code will be described as G2012 (Brief communication 
technology-based service, e.g. virtual check-in, by a physician or 
other qualified health care professional who can report evaluation and 
management services, provided to an established patient, not 
originating from a related E/M service provided within the previous 7 
days nor leading to an E/M service or procedure within the next 24 
hours or soonest available appointment; 5-10 minutes of medical 
discussion). We are finalizing allowing real-time audio-only telephone 
interactions in addition to synchronous, two-way audio interactions 
that are enhanced with video or other kinds of data transmission. We 
are finalizing our proposal to limit this service to established 
patients.
    We are finalizing that if the service originates from a related E/M 
service provided within the previous 7 days by the same physician or 
other qualified health care professional, that this service would be 
considered bundled into that previous E/M service and would not be 
separately billable. In instances when the service leads to an E/M 
service with the same physician or other qualified health care 
professional, we are finalizing that this service would be considered 
bundled into the pre- or post-visit time of the associated E/M service, 
and therefore, would not be separately billable. We plan to monitor 
this service with the intention of determining whether changes are 
necessary to the timeframes under which this service would be 
separately billable compared to when it would be bundled. We would 
consider any such changes in future rulemaking.
    We are finalizing requiring verbal consent from beneficiaries that 
is noted in the medical record for each service. We are not 
implementing a frequency limitation for CY 2019, however, we plan to 
monitor utilization with the intention of determining whether such a 
limitation is warranted. In that case, we would consider that for 
future rulemaking.
    We are finalizing the valuation for HCPCS code G2012 as proposed. 
We will monitor the utilization of this code and consider any potential 
adjustments to billing rules or valuation for this service through 
future rulemaking. We note that cost sharing for these services will 
apply.
    For details related to developing utilization estimates for this 
service, see section VII. of this final rule, Regulatory Impact 
Analysis. For additional details related to valuation of this service, 
see section II.H. of this final rule, Valuation of Specific Codes.
2. Remote Evaluation of Pre-Recorded Patient Information (HCPCS Code 
G2010)
    Stakeholders have requested that CMS make separate Medicare payment 
when a physician uses recorded video and/or images captured by a 
patient in order to evaluate a patient's condition. These services 
involve what is referred to under section 1834(m) of the Act as 
``store-and-forward'' communication technology that provides for the 
``asynchronous transmission of health care information.'' We noted in 
the proposed rule that we believe these services involve pre-recorded 
patient-generated still or video images. Other types of patient-
generated information, such as information from heart rate monitors or 
other devices that collect patient health marker data, could 
potentially be reported with CPT codes that describe remote patient 
monitoring (83 FR 35724). Under section 1834(m) of

[[Page 59487]]

the Act, payment for telehealth services furnished using such store-
and-forward technology is permitted only under federal telemedicine 
demonstration programs conducted in Alaska or Hawaii, and these 
telehealth services remain subject to the other statutory restrictions 
governing Medicare telehealth services. However, much like the brief 
communication technology-based service (``virtual check-in service'') 
that we are finalizing in this rule as described previously, this 
remote evaluation service would not be a substitute for an in-person 
service currently separately payable under the PFS. As such, this 
remote evaluation service is distinct from the telehealth services 
described under section 1834(m) of the Act. Effective January 1, 2019, 
we proposed to create specific coding that describes the remote 
professional evaluation of patient-transmitted information conducted 
via pre-recorded ``store and forward'' video or image technology. 
Because this service would not be considered a Medicare telehealth 
service, it would not be subject to the geographic and other 
restrictions on telehealth services under section 1834(m) of the Act; 
and the proposed valuation reflects the resource costs associated with 
furnishing services utilizing communication technology.
    Also like the virtual check-in service we are finalizing as 
described previously, this service would be used to determine whether 
or not an office visit or other service is warranted. When the remote 
evaluation of pre-recorded patient-submitted images and/or video 
results in an in-person E/M office visit with the same physician or 
qualified health care professional, we proposed that this remote 
service will be considered bundled into that office visit and therefore 
not be separately billable. We further proposed that in instances when 
the remote service originates from a related E/M service provided 
within the previous 7 days by the same physician or qualified health 
care professional that this service will be considered bundled into 
that previous E/M service and not be separately billable. In summary, 
we proposed this service to be a stand-alone service that could be 
separately billed to the extent that there is no resulting E/M office 
visit and there is no related E/M office visit within the previous 7 
days of the remote service being furnished. We believe the coding and 
separate payment for this service is consistent with the progression of 
technology and its impact on the practice of medicine in recent years, 
and would result in increased access to services for Medicare 
beneficiaries. We note that in the proposed rule we referred to this 
service as HCPCS code GRAS1, which was a placeholder code. The code for 
this service is G2010 (Remote evaluation of recorded video and/or 
images submitted by an established patient (e.g., store and forward), 
including interpretation with follow-up with the patient within 24 
business hours, not originating from a related E/M service provided 
within the previous 7 days nor leading to an E/M service or procedure 
within the next 24 hours or soonest available appointment). We 
solicited comment as to whether these services should be limited to 
established patients; or whether there are certain cases, like 
dermatological or ophthalmological services, where it might be 
appropriate for a new patient to receive these services. For example, 
when a patient seeks care for a specific skin condition from a 
dermatologist with whom she does not have a prior relationship, and 
part of the inquiry is an assessment of whether the patient needs an 
in-person visit, the patient could share, and the dermatologist could 
remotely evaluate, pre-recorded information. We also noted that this 
service is distinct from the virtual check-in service described 
previously in that this service involves the practitioner's evaluation 
of a patient-generated still or video image transmitted by the patient, 
and the subsequent communication of the practitioner's response to the 
patient; while the virtual check-in service describes a service that 
occurs in real time and does not involve the asynchronous transmission 
of any recorded image.
    The following discussion summarizes particular definitions and 
billing rules we proposed for this service and the more detailed 
comments we received regarding these aspects of the proposal. Our 
responses below include information regarding the service definitions 
and billing requirements applicable for 2019. We additionally address 
comments we received regarding whether these services should be limited 
to established patients; or whether there are certain cases, like 
dermatological or ophthalmological services, where it might be 
appropriate for a new patient to receive these services.
    Comment: Several commenters were supportive of the proposal to pay 
for these kinds of services. Several commenters urged CMS to take a 
cautious approach in paying for these services, given concerns these 
commenters expressed regarding potential overutilization.
    Response: We appreciate the many thoughtful comments regarding this 
proposal. Based on our review of the comments received, especially the 
broad support for the proposal, we are creating coding and finalizing 
our proposal to make separate payment for this service. The code will 
be described as G2010 (Remote evaluation of recorded video and/or 
images submitted by an established patient (e.g., store and forward), 
including interpretation with follow-up with the patient within 24 
business hours, not originating from a related E/M service provided 
within the previous 7 days nor leading to an E/M service or procedure 
within the next 24 hours or soonest available appointment).
    We appreciate commenters' concerns regarding the potential for 
overutilization of these services. We plan to monitor utilization. We 
note that, like all other physicians' services billed under the PFS, 
each of these services must be medically reasonable and necessary to be 
paid by Medicare.
    Comment: Many commenters supported allowing this service to be 
furnished to new patients, noting that an established relationship is 
not required for the practitioner to remotely evaluate an image or 
video to consider whether an office visit or other service is 
warranted, particularly in dermatology and ophthalmology. One commenter 
stated that allowing new patients to receive this service would also be 
of value in urology, as it would provide a way to assess patients with 
conditions such as hematuria (that is, blood in the urine) in a timely 
manner. The AMA and other commenters urged CMS to limit these services 
to established patients. The AMA also suggested that, at some point 
before a physician or practitioner furnishes a virtual service, the 
clinician (or another clinician with whom the furnishing clinician has 
a cross-coverage agreement in place) should conduct a face-to-face 
examination (either in-person or via telehealth) with the patient, 
noting that the existence of a valid patient-physician relationship 
ensures that the treating physician or qualified health professional 
meets a threshold standard of care, enhances care coordination/
continuity of care, and ensures that patients are afforded advance 
notice of when the relationship is being established and that such a 
patient-initiated service may result in out-of-pocket expenses 
including deductibles and co-insurance, and additionally serves to 
minimize the potential for program integrity concerns.
    Response: We are persuaded by comments urging us to permit separate

[[Page 59488]]

payment for these services only for established patients. Since this 
service is furnished directly by the billing practitioner, we believe 
it should be furnished in the context of an existing patient-clinician 
relationship. Therefore, we are finalizing the reporting and billing of 
HCPCS code G2010 only for established patients.
    Comment: Many commenters stated that it would be burdensome to 
obtain consent from the patient prior to each occurrence of this 
service. Some commenters suggested that the patient could be informed 
through the use of a service agreement which could be signed once and 
kept on file. Several commenters expressed concern about the cost to 
beneficiaries and therefore recommended requiring verbal consent that 
is documented in the medical record.
    Response: As noted previously regarding HCPCS code G2012, we 
believe it is important for patients to consent to receive these 
services, especially since many beneficiaries would be financially 
liable for sharing in the cost of these services. We understand the 
potential burden regarding obtaining consent for each occurrence of 
this service. However, we are persuaded by those commenters who suggest 
that unexpected cost to beneficiaries would be particularly 
problematic. We are finalizing requiring beneficiary consent that could 
be verbal or written, including electronic confirmation that is noted 
in the medical record for each billed service for HCPCS code G2010.
    We acknowledge that verbal consent could be obtained using more 
than one communication modality, especially since this service is 
initiated by the patient and involves submission of an image or video. 
Therefore, we do not intend to include the word ``verbal'' in the 
descriptor for the code that describes this services, since ``verbal'' 
could imply written or electronic consent.
    Comment: Several commenters stated that the proposed payment rate 
is too low, citing that it is below market compared to the rate many 
asynchronous telemedicine companies pay their contracted/employed 
physician staff, and noted that new patients in particular require more 
resources, whereas others stated that the proposed valuation was 
appropriate. One commenter suggested that CMS should encourage 
clinicians to recommend that patients have virtual or in-person visits 
if the clinician has concerns about the quality of the pre-recorded 
patient information, such as still or video images.
    Response: As discussed in section II.H. of this final rule, we are 
finalizing the valuation for HCPCS code G2010 as proposed. As stated 
previously regarding the valuation of the brief communication 
technology-based service code, HCPCS code G2012, we believe that the 
proposed valuation accurately reflects the resources involved in 
furnishing this service. We will monitor the utilization of this code 
and consider any potential adjustments to billing rules or valuation 
for this service through future rulemaking.
    Comment: A few commenters requested that CMS clarify that the 
``verbal follow-up'' that occurs after the billing practitioner 
evaluates the images or video submitted by the patient may take place 
via any mode of communication, including secure text messaging, phone 
call, or live/asynchronous video chat, so as not to restrict a 
clinician's interaction with patients. One commenter suggested that CMS 
should encourage clinicians to recommend that patients have a face-to-
face visit (in-person or via telehealth) if the clinician has concerns 
about the quality of the pre-recorded patient information, such as 
still or video images.
    Response: We are finalizing that the follow-up could take place via 
phone call, audio/video communication, secure text messaging, email, or 
patient portal communication and note that accordingly, we do not 
intend to include the word ``verbal'' in the code descriptor. We note 
that any such communications must be compliant with HIPAA and other 
relevant laws. Additionally, we agree that in instances in which the 
quality of the pre-recorded information submitted by a patient is 
insufficient for the clinician to assess whether an office visit or 
other medical service is warranted, the clinician could not fully 
furnish a remote evaluation service and, therefore, could not bill for 
the service. We anticipate that in such a circumstance, the clinician 
would attempt other methods of communication with the patient to either 
obtain sufficient images to enable a remote evaluation service or 
suggest other appropriate alternatives.
    Comment: Several commenters suggested that we remove the language 
in the code descriptor for this service that states ``or soonest 
available appointment,'' and stated that it might be difficult to 
document that a subsequent visit was not the ``soonest available 
appointment.''
    Response: As noted previously regarding similar comments on HCPCS 
code G2012, we appreciate the concerns regarding potential difficulty 
in proving that a particular visit was not the ``soonest available.'' 
We agree that in each individual case, it might be challenging to prove 
whether or not other appointments were available prior to the visit, 
especially since beneficiary convenience is also presumably a factor in 
when appointments are scheduled. However, we believe that, as written, 
the code description would guard against the potential for abuse that 
would be present if we instead adopted a purely time-based window for 
bundling of this service. Therefore, in response to the comments, we 
are finalizing retaining this language in the code descriptor for HCPCS 
code G2010 as proposed. However, we plan to monitor this service with 
the intention of determining if changes are necessary to the timeframes 
under which this service would be separately billable compared to when 
it would be bundled. We would consider any such changes in future 
rulemaking.
    Comment: A few commenters suggested that CMS consider inclusion of 
email/messaging or questionnaires/assessments that do not include an 
image or other visual item in the scope of this code.
    Response: The scope of this service is limited to the evaluation of 
pre-recorded video and/or images. We note that there is separate coding 
under the PFS for several types of formal assessments, such as CPT code 
96160 (Administration of patient-focused health risk assessment 
instrument (e.g., health hazard appraisal) with scoring and 
documentation, per standardized instrument), many of which can be 
reported when the form is completed by the patient and submitted using 
remote communication technology for subsequent evaluation by the 
clinician. Additionally, behavioral health assessments are included in 
coding and payment for the behavioral health integration services that 
were finalized for separate payment beginning in CY 2017.
    In summary, we are creating coding and finalizing our proposal to 
make separate payment for remote evaluation of recorded video and/or 
images submitted by the patient. The code will be described as G2010 
(Remote evaluation of recorded video and/or images submitted by an 
established patient (e.g., store and forward), including interpretation 
with follow-up with the patient within 24 business hours, not 
originating from a related E/M service provided within the previous 7 
days nor leading to an E/M service or procedure within the next 24 
hours or soonest available appointment). We are finalizing that

[[Page 59489]]

HCPCS code G2010 may be billed only for established patients. We are 
finalizing that the follow-up with the patient could take place via 
phone call, audio/video communication, secure text messaging, email, or 
patient portal communication.
    When the review of the patient-submitted image and/or video results 
in an in-person E/M office visit with the same physician or qualified 
health care professional, we are finalizing that this remote service 
will be considered bundled into that office visit and therefore will 
not be separately billable. We are further finalizing that in instances 
when the remote service originates from a related E/M service provided 
within the previous 7 days by the same physician or qualified health 
care professional that this service will be considered bundled into 
that previous E/M service and also will not be separately billable.
    We are finalizing requiring beneficiary consent that could be 
verbal or written, including electronic confirmation that is noted in 
the medical record for each billed service for HCPCS code G2010.
    We are finalizing the valuation for HCPCS code G2010 as proposed. 
We will monitor utilization of this code and consider any potential 
adjustments to billing rules or valuation of this service through 
future rulemaking. We note that cost sharing for these services will 
apply.
    For details related to our utilization estimates for this service, 
see section VII. of this final rule, Regulatory Impact Analysis. For 
further discussion related to valuation of this service, please see the 
section II.H. of this final rule, Valuation of Specific Codes.
3. Interprofessional Internet Consultation (CPT Codes 99451, 99452, 
99446, 99447, 99448, and 99449)
    As part of our standard rulemaking process, we received 
recommendations from the RUC to assist in establishing values for six 
CPT codes that describe interprofessional consultations. In 2013, CMS 
received recommendations from the RUC for CPT codes 99446 
(Interprofessional telephone/internet assessment and management service 
provided by a consultative physician including a verbal and written 
report to the patient's treating/requesting physician or other 
qualified health care professional; 5-10 minutes of medical 
consultative discussion and review), 99447 (Interprofessional 
telephone/internet assessment and management service provided by a 
consultative physician including a verbal and written report to the 
patient's treating/requesting physician or other qualified health care 
professional; 11-20 minutes of medical consultative discussion and 
review), 99448 (Interprofessional telephone/internet assessment and 
management service provided by a consultative physician including a 
verbal and written report to the patient's treating/requesting 
physician or other qualified health care professional; 21-30 minutes of 
medical consultative discussion and review), and 99449 
(Interprofessional telephone/internet assessment and management service 
provided by a consultative physician including a verbal and written 
report to the patient's treating/requesting physician or other 
qualified health care professional; 31 minutes or more of medical 
consultative discussion and review). CMS declined to adopt these codes 
for separate payment, stating in the CY 2014 PFS final rule with 
comment period that these kinds of services are considered bundled (78 
FR 74343). For CY 2019, the CPT Editorial Panel created two new codes 
to describe additional consultative services, including a code 
describing the work of the treating physician when initiating a 
consult, and the RUC recommended valuation for new codes, CPT codes 
99452 (Interprofessional telephone/internet/electronic health record 
referral service(s) provided by a treating/requesting physician or 
qualified health care professional, 30 minutes) and 99451 
(Interprofessional telephone/internet/electronic health record 
assessment and management service provided by a consultative physician 
including a written report to the patient's treating/requesting 
physician or other qualified health care professional, 5 or more 
minutes of medical consultative time). The RUC also reaffirmed their 
prior recommendations for the existing CPT codes. The six codes 
describe assessment and management services conducted through 
telephone, internet, or electronic health record consultations 
furnished when a patient's treating physician or other qualified 
healthcare professional requests the opinion and/or treatment advice of 
a consulting physician or qualified healthcare professional with 
specific specialty expertise to assist with the diagnosis and/or 
management of the patient's problem without the need for the patient's 
face-to-face contact with the consulting physician or qualified 
healthcare professional. Currently, the resource costs associated with 
seeking or providing such a consultation are considered bundled, which 
in practical terms means that specialist input is often sought through 
scheduling a separate visit for the patient when a phone or internet-
based interaction between the treating practitioner and the consulting 
practitioner would have been sufficient. We believe that proposing 
payment for these interprofessional consultations performed via 
communications technology such as telephone or internet is consistent 
with our ongoing efforts to recognize and reflect medical practice 
trends in primary care and patient-centered care management within the 
PFS.
    Beginning in the CY 2012 PFS proposed rule (76 FR 42793), we have 
recognized the changing focus in medical practice toward managing 
patients' chronic conditions, many of which particularly challenge the 
Medicare population, including heart disease, diabetes, respiratory 
disease, breast cancer, allergies, Alzheimer's disease, and factors 
associated with obesity. We have expressed concerns that the current E/
M coding does not adequately reflect the changes that have occurred in 
medical practice, and the activities and resource costs associated with 
the treatment of these complex patients in the primary care setting. In 
the years since 2012, we have acknowledged the shift in medical 
practice away from an episodic treatment-based approach to one that 
involves comprehensive patient-centered care management, and have taken 
steps through rulemaking to better reflect that approach in payment 
under the PFS. In CY 2013, we established new codes to pay separately 
for transitional care management (TCM) services. Next, we finalized new 
coding and separate payment beginning in CY 2015 for chronic care 
management (CCM) services provided by clinical staff (81 FR 80226). In 
the CY 2017 PFS final rule, we established separate payment for complex 
CCM services, an add-on code to the visit during which CCM is initiated 
to reflect the work of the billing practitioner in assessing the 
beneficiary and establishing the CCM care plan, and established 
separate payment for Behavioral Health Integration (BHI) services (81 
FR 80226 through 80227).
    As part of this shift in medical practice, and with the 
proliferation of team-based approaches to care that are often 
facilitated by electronic medical record technology, we believe that 
making separate payment for interprofessional consultations undertaken 
for the benefit of treating a patient will contribute to payment 
accuracy for primary care and care management services. We proposed

[[Page 59490]]

separate payment for these services, discussed in section II.H. of this 
final rule, Valuation of Specific Codes.
    Although we proposed to make separate payment for these services 
because we believe they describe resource costs directly associated 
with seeking a consultation for the benefit of the beneficiary, we do 
have concerns about how these services can be distinguished from 
activities undertaken for the benefit of the practitioner, such as 
information shared as a professional courtesy or as continuing 
education. We do not believe that those examples will constitute a 
service directly attributable to a single Medicare beneficiary, and 
therefore neither the Medicare program nor the beneficiary should be 
responsible for those costs. We therefore solicited comment on our 
assumption that these are separately identifiable services, and the 
extent to which they can be distinguished from similar services that 
are nonetheless primarily for the benefit of the practitioner. We noted 
that there are program integrity concerns around making separate 
payment for these interprofessional consultation services, including 
around CMS's or its contractors' ability to evaluate whether an 
interprofessional consultation is reasonable and necessary under the 
particular circumstances. As the beneficiary would be liable for any 
cost sharing associated with these services, we also sought comment on 
the necessity of requiring patient consent for these, and whether than 
consent should be written or verbal. We solicited comment on how best 
to minimize potential program integrity issues, and noted we were 
particularly interested in information on whether these types of 
services are paid separately by private payers and if so, what controls 
or limitations private payers have put in place to ensure these 
services are billed appropriately.
    The following is a summary of the comments we received regarding 
how best to minimize potential program integrity issues.
    Comment: Almost all commenters were very supportive of CMS 
proposing separate payment for these services. Commenters pointed out 
that these are discrete physician services undertaken for the benefit 
of the patient, and easily distinguished from consultations undertaken 
for the edification of the practitioner. One commenter stated as 
medical care moves toward more comprehensive patient-centered care 
management, frequent consultation with multiple specialists is 
necessary. Under the current model this means separate visits for the 
patients that are costly and inconvenient. Internet-based consultations 
between the treating practitioner and the consulting specialists 
provide appropriate, convenient and cost effective alternatives. 
Commenters were clear that, by not making separate payment for these 
services, CMS would not be accurately paying for the work of both the 
treating and consulting physicians in a consultative scenario.
    Many commenters provided helpful responses to CMS' request for 
information on how to minimize program integrity concerns for these 
services. A few commenters provided suggestions as to how CMS could 
verify the medical necessity of the consultation, including verifying 
that the treating and consulting physician were of different medical 
specialties, requiring patient identifiers and documentation of how the 
interaction improved patient care, defining a time period under which 
an E/M visit and an Interprofessional Consultation cannot both be 
billed for the same diagnosis, and creating frequency limitations on 
billing. Others suggested that the treating physician must document 
that they acted on the recommendation of the consulting physician prior 
to billing for CPT code 99452. Commenters had a number of suggestions 
for items that CMS should require, including that Interprofessional 
Consultations should consist of focused questions that are answerable 
solely from information in the EMR; that they be answered in 3 business 
days; and that the consulting physician should restate the question in 
their response, provide recommendations for evaluation, management, 
and/or ongoing monitoring, provide a rationale for recommendations, and 
provide recommendations for contingencies. Other commenters suggested 
that CMS could make separate payment contingent upon whether the 
underlying condition was urgent or related to critical care and that 
the consultation helped avoid transfer or interruption of care or that 
internal expertise was sought and was not available. Many commenters 
also encouraged CMS to avoid imposing overly restrictive documentation 
requirements. One commenter stated that, due to potential program 
integrity concerns, these services should be subject to the Medicare 
telehealth restrictions on beneficiary location and site of service. 
Another commenter recommended that CMS delay implementation until the 
program integrity concerns have been addressed. Other commenters 
encouraged CMS to monitor utilization for abuse.
    Response: We thank commenters for their support and additional 
information on the ways in which these services are distinct physician 
services. We note that because these services are inherently non face-
to-face (the patient need not be present in order for the service to be 
furnished in its entirety), they would not be considered as potential 
Medicare telehealth services under section 1834(m) of the Act. We 
appreciate the wealth of information and suggestions from commenters; 
however, we also agree with the many commenters who pointed out that 
adding many additional billing requirements may inhibit uptake for 
these services. As we note below, we are requiring documentation of 
verbal patient consent to receive these services, and are adopting 
existing CPT prefatory language. We plan to monitor utilization of 
these services and will consider making refinements to billing rules, 
documentation requirements or claims edits, including those suggested 
by commenters, through future rulemaking as necessary.
    Comment: Many commenters suggested that CMS limit or eliminate 
beneficiary cost sharing for these services to obviate the question of 
patient consent entirely.
    Response: Under current statute, we do not have the authority to 
change the requirements for the beneficiary cost sharing for these 
services.
    Additionally, since these codes describe services that are 
furnished without the beneficiary being present, we proposed to require 
the treating practitioner to obtain verbal beneficiary consent in 
advance of these services, which would be documented by the treating 
practitioner in the patient's medical record, similar to the conditions 
of payment associated with separately billable care management services 
under the PFS. Obtaining advance beneficiary consent includes ensuring 
that the patient is aware of applicable cost sharing.
    The following is a summary of the comments we received regarding 
whether to require the treating practitioner to obtain verbal 
beneficiary consent in advance of these services, which would be 
documented by the treating practitioner in the medical record similar 
to the conditions of payment associated with the care management 
services under the PFS, as well as comments on other aspects of this 
proposal.
    Comment: Many commenters stated that verbal patient consent was an 
appropriate safeguard against unnecessary utilization, while others 
disagreed, stating that the requirement

[[Page 59491]]

to obtain consent may cause unnecessary burden in cases where the 
patient is unresponsive or the need for the interprofessional 
consultation is urgent such as in a critical care or emergency setting. 
Other commenters stated that a single blanket patient consent to 
receive interprofessional consultation services would be preferable to 
minimize the need to obtain consent for each of what may be multiple 
consultations. One commenter questioned whether the consulting 
physician would need to verify that the beneficiary had consented, 
given that only the treating physician is in contact with the 
beneficiary.
    Response: We understand the potential burden regarding obtaining 
consent. However, we believe that it is important for beneficiaries to 
consent to the service and thus be notified of their cost-sharing 
obligations. We note that under our current policy for several care 
management services, consent is required to be documented in the 
medical record. That policy was implemented, in part, based on feedback 
we received from practitioners reporting the care management services, 
to alleviate burdens of alternative approaches. Consequently, we 
believe the same requirement could be applied here, without imposition 
of significant burden.
    We are finalizing that the patient's verbal consent is required, 
and that consent must be noted in the medical record for each service, 
consistent with the policy we are finalizing for the brief 
communication technology-based services (HCPCS code G2012) as noted 
above, as well as with the patient consent policies in place for care 
management services, under the PFS.
    Comment: Commenters requested that CMS clarify whether billing for 
these services is limited to physicians or if other healthcare 
practitioners, such as nurses or physical therapists, may bill for 
these services as well.
    Response: We appreciate commenters' request for clarification. We 
believe that billing of these services should be limited to those 
practitioners that can independently bill Medicare for E/M visits, as 
interprofessional consultations are primarily for the ongoing 
evaluation and management of the patient, including collaborative 
medical decision making among practitioners. We are therefore not 
finalizing any expansion of these services beyond their current scope.
    Comment: A few commenters requested that CMS adopt CPT prefatory 
language for these services as is CMS' longstanding practice when 
adopting most new CPT coding.
    Response: We agree with the commenters and confirm that we will be 
adopting existing CPT prefatory language regarding these services.
    In summary, we are finalizing separate payment for CPT codes 99451, 
99452, 99446, 99447, 99448, and 99449 describing Interprofessional 
consultations. We are finalizing a policy to require the patient's 
verbal consent that is noted in the medical record for each 
interprofessional consultation service. We note that cost sharing will 
apply for these services. These interprofessional services may be 
billed only by practitioners that can bill Medicare independently for 
E/M services.
    For further discussion related to the valuation of these services, 
please see section II.H. of this final rule, Valuation of Specific 
Codes.
4. Medicare Telehealth Services Under Section 1834(m) of the Act
a. Billing and Payment for Medicare Telehealth Services Under Section 
1834(m) of the Act
    As discussed in this rule and in prior rulemaking, several 
conditions must be met for Medicare to make payment for telehealth 
services under the PFS. For further details, see the full discussion of 
the scope of Medicare telehealth services in the CY 2018 PFS final rule 
(82 FR 53006).
b. Adding Services to the List of Medicare Telehealth Services
    In the CY 2003 PFS final rule with comment period (67 FR 79988), we 
established a process for adding services to or deleting services from 
the list of Medicare telehealth services in accordance with section 
1834(m)(4)(F)(ii) of the Act. This process provides the public with an 
ongoing opportunity to submit requests for adding services, which are 
then reviewed by us. Under this process, we assign any submitted 
request to add to the list of telehealth services to one of the 
following two categories:
     Category 1: Services that are similar to professional 
consultations, office visits, and office psychiatry services that are 
currently on the list of telehealth services. In reviewing these 
requests, we look for similarities between the requested and existing 
telehealth services for the roles of, and interactions among, the 
beneficiary, the physician (or other practitioner) at the distant site 
and, if necessary, the telepresenter, a practitioner who is present 
with the beneficiary in the originating site. We also look for 
similarities in the telecommunications system used to deliver the 
service; for example, the use of interactive audio and video equipment.
     Category 2: Services that are not similar to those on the 
current list of telehealth services. Our review of these requests 
includes an assessment of whether the service is accurately described 
by the corresponding code when furnished via telehealth and whether the 
use of a telecommunications system to furnish the service produces 
demonstrated clinical benefit to the patient. Submitted evidence should 
include both a description of relevant clinical studies that 
demonstrate the service furnished by telehealth to a Medicare 
beneficiary improves the diagnosis or treatment of an illness or injury 
or improves the functioning of a malformed body part, including dates 
and findings, and a list and copies of published peer reviewed articles 
relevant to the service when furnished via telehealth. Our evidentiary 
standard of clinical benefit does not include minor or incidental 
benefits.
    Some examples of clinical benefit include the following:
     Ability to diagnose a medical condition in a patient 
population without access to clinically appropriate in-person 
diagnostic services.
     Treatment option for a patient population without access 
to clinically appropriate in-person treatment options.
     Reduced rate of complications.
     Decreased rate of subsequent diagnostic or therapeutic 
interventions (for example, due to reduced rate of recurrence of the 
disease process).
     Decreased number of future hospitalizations or physician 
visits.
     More rapid beneficial resolution of the disease process 
treatment.
     Decreased pain, bleeding, or other quantifiable symptom.
     Reduced recovery time.
    The list of telehealth services, including the proposed additions 
described later in this section, is included in the Downloads section 
to this proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Historically, requests to add services to the list of Medicare 
telehealth services had to be submitted and received no later than 
December 31 of each calendar year to be considered for the next 
rulemaking cycle. However, for CY 2019 and onward, we intend to accept 
requests through February 10, consistent with the deadline for our 
receipt of code valuation recommendations from the RUC. To be

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considered during PFS rulemaking for CY 2020, requests to add services 
to the list of Medicare telehealth services must be submitted and 
received by February 10, 2019. Each request to add a service to the 
list of Medicare telehealth services must include any supporting 
documentation the requester wishes us to consider as we review the 
request. Because we use the annual PFS rulemaking process as the 
vehicle to make changes to the list of Medicare telehealth services, 
requesters should be advised that any information submitted as part of 
a request is subject to public disclosure for this purpose. For more 
information on submitting a request to add services to the list of 
Medicare telehealth services, including where to mail these requests, 
see our website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
c. Submitted Requests To Add Services to the List of Telehealth 
Services for CY 2019
    Under our current policy, we add services to the telehealth list on 
a Category 1 basis when we determine that they are similar to services 
on the existing telehealth list for the roles of, and interactions 
among, the beneficiary, physician (or other practitioner) at the 
distant site and, if necessary, the telepresenter. As we stated in the 
CY 2012 PFS final rule with comment period (76 FR 73098), we believe 
that the Category 1 criteria not only streamline our review process for 
publicly requested services that fall into this category, but also 
expedite our ability to identify codes for the telehealth list that 
resemble those services already on this list.
    We received several requests in CY 2017 to add various services as 
Medicare telehealth services effective for CY 2019. The following 
presents a discussion of these requests, and our proposals for 
additions to the CY 2019 telehealth list. Of the requests received, we 
found that two services were sufficiently similar to services currently 
on the telehealth list to be added on a Category 1 basis. Therefore, we 
proposed to add the following services to the telehealth list on a 
Category 1 basis for CY 2019:
     HCPCS codes G0513 and G0514 (Prolonged preventive 
service(s) (beyond the typical service time of the primary procedure), 
in the office or other outpatient setting requiring direct patient 
contact beyond the usual service; first 30 minutes (list separately in 
addition to code for preventive service) and (Prolonged preventive 
service(s) (beyond the typical service time of the primary procedure), 
in the office or other outpatient setting requiring direct patient 
contact beyond the usual service; each additional 30 minutes (list 
separately in addition to code G0513 for additional 30 minutes of 
preventive service).
    We found that the services described by HCPCS codes G0513 and G0514 
are sufficiently similar to office visits currently on the telehealth 
list. We believe that all the components of this service can be 
furnished via interactive telecommunications technology. Additionally, 
we believe that adding these services to the telehealth list will make 
it administratively easier for practitioners who report these services 
in connection with a preventive service that is furnished via 
telehealth, as both the base code and the add-on code would be reported 
with the telehealth place of service.
    We also received requests to add services to the telehealth list 
that do not meet our criteria for Medicare telehealth services. We did 
not propose to add to the Medicare telehealth services list the 
following procedures for chronic care remote physiologic monitoring, 
interprofessional internet consultation, and initial hospital care; or 
to change the requirements for subsequent hospital care or subsequent 
nursing facility care, for the reasons noted in the paragraphs that 
follow.
(1) Chronic Care Remote Physiologic Monitoring (CPT Codes 99453, 99454, 
and 99457)
     CPT code 99453 (Remote monitoring of physiologic 
parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory 
flow rate), initial; set-up and patient education on use of equipment).
     CPT code 99454 (Remote monitoring of physiologic 
parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory 
flow rate), initial; device(s) supply with daily recording(s) or 
programmed alert(s) transmission, each 30 days).
     CPT code 99457 (Remote physiologic monitoring treatment 
management services, 20 minutes or more of clinical staff/physician/
other qualified healthcare professional time in a calendar month 
requiring interactive communication with the patient/caregiver during 
the month).
    In the CY 2016 PFS final rule with comment period (80 FR 71064), we 
responded to a request to add CPT code 99490 (Chronic care management 
services, at least 20 minutes of clinical staff time directed by a 
physician or other qualified health care professional, per calendar 
month, with the following required elements: Multiple (two or more) 
chronic conditions expected to last at least 12 months, or until the 
death of the patient; chronic conditions place the patient at 
significant risk of death, acute exacerbation/decompensation, or 
functional decline; comprehensive care plan established, implemented, 
revised, or monitored) to the Medicare telehealth list. We discussed 
that the services described by CPT code 99490 can be furnished without 
the beneficiary's face-to-face presence and using any number of non-
face-to-face means of communication. We stated that it was therefore 
unnecessary to add that service to the list of Medicare telehealth 
services. Similarly, CPT codes 99453, 99454, and 99457 describe 
services that are inherently non face-to-face. As discussed in section 
II.H. of this final rule, Valuation of Specific Codes, we instead 
proposed to adopt CPT codes 99453, 99454, and 99457 for payment under 
the PFS. Because these codes describe services that are inherently non 
face-to-face, we do not consider them Medicare telehealth services 
under section 1834(m) of the Act; therefore, we did not propose to add 
them to the list of Medicare telehealth services.
(2) Interprofessional Internet Consultation (CPT Codes 99451and 99452)
     CPT code 99452 (Interprofessional telephone/internet/
electronic health record referral service(s) provided by a treating/
requesting physician or qualified health care professional, 30 
minutes).
     CPT code 99451 (Interprofessional telephone/internet/
electronic health record assessment and management service provided by 
a consultative physician including a written report to the patient's 
treating/requesting physician or other qualified health care 
professional, 5 or more minutes of medical consultative time).
    As discussed in section II.H. of this final rule, Valuation of 
Specific Codes, we proposed to adopt CPT codes 99452 and 99451 for 
payment under the PFS as these are distinct services furnished via 
communication technology. Because these codes describe services that 
are inherently non face-to-face, we do not consider them as Medicare 
telehealth services under section 1834(m) of the Act; therefore we did 
not propose to add them to the list of Medicare telehealth services for 
CY 2019.
(3) Initial Hospital Care Services (CPT Codes 99221-99223)
     CPT code 99221 (Initial hospital care, per day, for the 
evaluation and

[[Page 59493]]

management of a patient, which requires these 3 key components: A 
detailed or comprehensive history; A detailed or comprehensive 
examination; and Medical decision making that is straightforward or of 
low complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the problem(s) requiring admission are 
of low severity.)
     CPT code 99222 (Initial hospital care, per day, for the 
evaluation and management of a patient, which requires these 3 key 
components: A comprehensive history; A comprehensive examination; and 
Medical decision making of moderate complexity. Counseling and/or 
coordination of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
problem(s) requiring admission are of moderate severity.)
     CPT code 99223 (Initial hospital care, per day, for the 
evaluation and management of a patient, which requires these 3 key 
components: A comprehensive history; A comprehensive examination; and 
Medical decision making of high complexity. Counseling and/or 
coordination of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
problem(s) requiring admission are of high severity.)
    We have previously considered requests to add these codes to the 
telehealth list. As we stated in the CY 2011 PFS final rule with 
comment period (75 FR 73315), while initial inpatient consultation 
services are currently on the list of approved telehealth services, 
there are no services on the current list of telehealth services that 
resemble initial hospital care for an acutely ill patient by the 
admitting practitioner who has ongoing responsibility for the patient's 
treatment during the course of the hospital stay. Therefore, consistent 
with prior rulemaking, we did not propose that initial hospital care 
services be added to the Medicare telehealth services list on a 
category 1 basis.
    The initial hospital care codes describe the first visit of the 
hospitalized patient by the admitting practitioner who may or may not 
have seen the patient in the decision-making phase regarding 
hospitalization. Based on the description of the services for these 
codes, we believed it is critical that the initial hospital visit by 
the admitting practitioner be conducted in person to ensure that the 
practitioner with ongoing treatment responsibility comprehensively 
assesses the patient's condition upon admission to the hospital through 
a thorough in-person examination. Additionally, the requester submitted 
no additional research or evidence that the use of a telecommunications 
system to furnish the service produces demonstrated clinical benefit to 
the patient; therefore, we also did not propose adding initial hospital 
care services to the Medicare telehealth services list on a Category 2 
basis.
    We noted that Medicare beneficiaries who are being treated in the 
hospital setting can receive reasonable and necessary E/M services 
using other HCPCS codes that are currently on the Medicare telehealth 
list, including those for subsequent hospital care, initial and follow-
up telehealth inpatient and emergency department consultations, as well 
as initial and follow-up critical care telehealth consultations.
    Therefore, we did not propose to add the initial hospital care 
services to the list of Medicare telehealth services for CY 2019.
(4) Subsequent Hospital Care Services (CPT Codes 99231-99233)
     CPT code 99231 (Subsequent hospital care, per day, for the 
evaluation and management of a patient, which requires at least 2 of 
these 3 key components: A problem focused interval history; A problem 
focused examination; Medical decision making that is straightforward or 
of low complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the patient is stable, recovering or 
improving. Typically, 15 minutes are spent at the bedside and on the 
patient's hospital floor or unit.).
     CPT code 99232 (Subsequent hospital care, per day, for the 
evaluation and management of a patient, which requires at least 2 of 
these 3 key components: An expanded problem focused interval history; 
an expanded problem focused examination; medical decision making of 
moderate complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the patient is responding inadequately 
to therapy or has developed a minor complication. Typically, 25 minutes 
are spent at the bedside and on the patient's hospital floor or unit.).
     CPT code 99233 (Subsequent hospital care, per day, for the 
evaluation and management of a patient, which requires at least 2 of 
these 3 key components: A detailed interval history; a detailed 
examination; Medical decision making of high complexity. Counseling 
and/or coordination of care with other physicians, other qualified 
health care professionals, or agencies are provided consistent with the 
nature of the problem(s) and the patient's and/or family's needs. 
Usually, the patient is unstable or has developed a significant 
complication or a significant new problem. Typically, 35 minutes are 
spent at the bedside and on the patient's hospital floor or unit.).
    CPT codes 99231-99233 are currently on the list of Medicare 
telehealth services, but can only be billed via telehealth once every 3 
days. The requester requested that we remove the frequency limitation. 
We stated in the CY 2011 PFS final rule with comment period (75 FR 
73316) that, although we still believed the potential acuity of 
hospital inpatients is greater than those patients likely to receive 
Medicare telehealth services that were on the list at that time, we 
also believed that it would be appropriate to permit some subsequent 
hospital care services to be furnished through telehealth in order to 
ensure that hospitalized patients have frequent encounters with their 
admitting practitioner. We also noted that we continue to believe that 
the majority of these visits should be in-person to facilitate the 
comprehensive, coordinated, and personal care that medically volatile, 
acutely ill patients require on an ongoing basis. Because of our 
concerns regarding the potential acuity of hospital inpatients, we 
finalized the addition of CPT codes 99231-99233 to the list of Medicare 
telehealth services, but limited the provision of these subsequent 
hospital care services through telehealth to once every 3 days. We 
continue to believe that admitting practitioners should continue to 
make appropriate in-person visits to all patients who need such care 
during their hospitalization. Our concerns and position on the 
provision of subsequent hospital care services via telehealth have not 
changed. Therefore, we did not propose to remove the frequency 
limitation on these codes.

[[Page 59494]]

(5) Subsequent Nursing Facility Care Services (CPT Codes 99307-99310)
     CPT code 99307 (Subsequent nursing facility care, per day, 
for the evaluation and management of a patient, which requires at least 
2 of these 3 key components: A problem focused interval history; A 
problem focused examination; Straightforward medical decision making. 
Counseling and/or coordination of care with other physicians, other 
qualified health care professionals, or agencies are provided 
consistent with the nature of the problem(s) and the patient's and/or 
family's needs. Usually, the patient is stable, recovering, or 
improving. Typically, 10 minutes are spent at the bedside and on the 
patient's facility floor or unit.).
     CPT code 99308 (Subsequent nursing facility care, per day, 
for the evaluation and management of a patient, which requires at least 
2 of these 3 key components: An expanded problem focused interval 
history; an expanded problem focused examination; Medical decision 
making of low complexity. Counseling and/or coordination of care with 
other physicians, other qualified health care professionals, or 
agencies are provided consistent with the nature of the problem(s) and 
the patient's and/or family's needs. Usually, the patient is responding 
inadequately to therapy or has developed a minor complication. 
Typically, 15 minutes are spent at the bedside and on the patient's 
facility floor or unit.).
     CPT code 99309 (Subsequent nursing facility care, per day, 
for the evaluation and management of a patient, which requires at least 
2 of these 3 key components: A detailed interval history; a detailed 
examination; Medical decision making of moderate complexity. Counseling 
and/or coordination of care with other physicians, other qualified 
health care professionals, or agencies are provided consistent with the 
nature of the problem(s) and the patient's and/or family's needs. 
Usually, the patient has developed a significant complication or a 
significant new problem. Typically, 25 minutes are spent at the bedside 
and on the patient's facility floor or unit.).
     CPT code 99310 (Subsequent nursing facility care, per day, 
for the evaluation and management of a patient, which requires at least 
2 of these 3 key components: A comprehensive interval history; a 
comprehensive examination; Medical decision making of high complexity. 
Counseling and/or coordination of care with other physicians, other 
qualified health care professionals, or agencies are provided 
consistent with the nature of the problem(s) and the patient's and/or 
family's needs. The patient may be unstable or may have developed a 
significant new problem requiring immediate physician attention. 
Typically, 35 minutes are spent at the bedside and on the patient's 
facility floor or unit.).
    CPT codes 99307-99310 are currently on the list of Medicare 
telehealth services, but can only be billed via telehealth once every 
30 days. The requester requested that we remove the frequency 
limitation when these services are provided for psychiatric care. We 
stated in the CY 2011 PFS final rule with comment period (75 FR 73317) 
that we believed it would be appropriate to permit some subsequent 
nursing facility care services to be furnished through telehealth to 
ensure that complex nursing facility patients have frequent encounters 
with their admitting practitioner, but because of our concerns 
regarding the potential acuity and complexity of SNF inpatients, we 
limited the provision of subsequent nursing facility care services 
furnished through telehealth to once every 30 days. Since these codes 
are used to report care for patients with a variety of diagnoses, 
including psychiatric diagnoses, we do not think it would be 
appropriate to remove the frequency limitation only for certain 
diagnoses. The services described by these CPT codes are essentially 
the same service, regardless of the patient's diagnosis. We also 
continue to have concerns regarding the potential acuity and complexity 
of SNF inpatients, and therefore, we did not propose to remove the 
frequency limitation for subsequent nursing facility care services in 
CY 2019.
    In summary, we proposed to add the following codes to the list of 
Medicare telehealth services beginning in CY 2019 on a category 1 
basis:
     HCPCS code G0513 (Prolonged preventive service(s) (beyond 
the typical service time of the primary procedure), in the office or 
other outpatient setting requiring direct patient contact beyond the 
usual service; first 30 minutes (list separately in addition to code 
for preventive service).
     HCPCS code G0514 (Prolonged preventive service(s) (beyond 
the typical service time of the primary procedure), in the office or 
other outpatient setting requiring direct patient contact beyond the 
usual service; each additional 30 minutes (list separately in addition 
to code G0513 for additional 30 minutes of preventive service).
    Comment: Commenters were unanimously supportive of our proposal to 
add HCPCS codes G0513 and G0514 to the Medicare telehealth list. A few 
commenters noted they were disappointed that we did not propose to add 
the initial hospital care codes to the telehealth list and that we did 
not propose to lift the frequency limitation on the subsequent hospital 
care and subsequent nursing facility care codes.
    Response: We are finalizing adding HCPCS codes G0513 and G0514 to 
the Medicare telehealth list. We are not adding the initial hospital 
care codes to the telehealth list and we are not removing the frequency 
limitations on the subsequent hospital care and subsequent nursing 
facility care codes for the reasons noted above.
    Comment: Several commenters suggested that CMS conduct a pilot or 
demonstration program to evaluate the clinical benefit of physical 
therapists, occupational therapists, and speech-language pathologists 
furnishing telehealth services to Medicare beneficiaries in states that 
permit such services, noting that this would improve beneficiary access 
to therapy services, and help to inform policymakers as they consider 
whether to recognize such healthcare professionals as authorized 
providers of telehealth under the Social Security Act.
    Response: While we did not include any proposals on this topic in 
the proposed rule, we reiterate our commitment to expanding access to 
telehealth services consistent with statutory authority, and paying 
appropriately for services that maximize telecommunications technology. 
Regarding the possibility of a model or demonstration, we will consider 
the comments as we develop new models through the Center for Medicare 
and Medicaid Innovation. We note that we would need to determine 
whether such a model or demonstration would meet the statutory 
requirements, which generally require that the test be expected to 
reduce Medicare expenditures and preserve or enhance the quality of 
care for beneficiaries.
5. Expanding the Use of Telehealth Under the Bipartisan Budget Act of 
2018
a. Expanding Access to Home Dialysis Therapy Under the Bipartisan 
Budget Act of 2018
    Section 50302 of the BBA of 2018 amended sections 1881(b)(3) and 
1834(m) of the Act to allow an individual determined to have end-stage 
renal disease receiving home dialysis to choose to receive certain 
monthly end-stage renal disease-related (ESRD-related) clinical 
assessments via telehealth on or after January 1, 2019.

[[Page 59495]]

The new section 1881(b)(3)(B)(ii) of the Act requires that such an 
individual must receive a face-to-face visit, without the use of 
telehealth, at least monthly in the case of the initial 3 months of 
home dialysis and at least once every 3 consecutive months after the 
initial 3 months.
    As added by section 50302(b)(1) of the BBA of 2018, subclauses (IX) 
and (X) of section 1834(m)(4)(C)(ii) of the Act include a renal 
dialysis facility and the home of an individual as telehealth 
originating sites but only for the purposes of the monthly ESRD-related 
clinical assessments furnished through telehealth provided under 
section 1881(b)(3)(B) of the Act. Section 50302(b)(1) of the BBA of 
2018, also added a new section 1834(m)(5) of the Act which provides 
that the geographic requirements for telehealth services under section 
1834(m)(4)(C)(i) of the Act do not apply to telehealth services 
furnished on or after January 1, 2019 for purposes of the monthly ESRD-
related clinical assessments where the originating site is a hospital-
based or critical access hospital-based renal dialysis center, a renal 
dialysis facility, or the home of an individual. Section 50302(b)(2) of 
the BBA of 2018 amended section 1834(m)(2)(B)(ii) of the Act to require 
that no originating site facility fee is to be paid if the home of the 
individual is the originating site.
    Our current regulation at Sec.  410.78 specifies the conditions 
that must be met in order for Medicare Part B to pay for covered 
telehealth services included on the telehealth list when furnished by 
an interactive telecommunications system. In accordance with the new 
subclauses (IX) and (X) of section 1834(m)(4)(C)(ii) of the Act, we 
proposed to revise our regulation at Sec.  410.78(b)(3) to add a renal 
dialysis facility and the home of an individual as Medicare telehealth 
originating sites, but only for purposes of the home dialysis monthly 
ESRD-related clinical assessment in section 1881(b)(3)(B) of the Act. 
We proposed to amend Sec.  414.65(b)(3) to reflect the requirement in 
section 1834(m)(2)(B)(ii) of the Act that there is no originating site 
facility fee paid when the originating site for these services is the 
patient's home. Additionally, we proposed to add new Sec.  
410.78(b)(4)(iv)(A), to reflect the provision in section 1834(m)(5) of 
the Act, added by section 50302 of the BBA of 2018, specifying that the 
geographic requirements described in section 1834(m)(4)(C)(i) of the 
Act do not apply with respect to telehealth services furnished on or 
after January 1, 2019, in originating sites that are hospital-based or 
critical access hospital-based renal dialysis centers, renal dialysis 
facilities, or the patient's home, respectively under sections 
1834(m)(4)(C)(ii)(VI), (IX) and (X) of the Act, for purposes of section 
1881(b)(3)(B) of the Act.
    Commenters supported our proposals to revise the regulation text at 
Sec. Sec.  410.78 and 414.65 to implement the requirements of section 
50302 of the BBA of 2018 for expanding access to home dialysis therapy 
through telehealth. We are finalizing these regulation text changes as 
proposed.
b. Expanding the Use of Telehealth for Individuals With Stroke Under 
the Bipartisan Budget Act of 2018
    Section 50325 of the BBA of 2018 amended section 1834(m) of the Act 
by adding a new paragraph (6) that provides special rules for 
telehealth services furnished on or after January 1, 2019, for purposes 
of diagnosis, evaluation, or treatment of symptoms of an acute stroke 
(acute stroke telehealth services), as determined by the Secretary. 
Specifically, section 1834(m)(6)(A) of the Act removes the restrictions 
on the geographic locations and the types of originating sites where 
acute stroke telehealth services can be furnished. Section 
1834(m)(6)(B) of the Act specifies that acute stroke telehealth 
services can be furnished in any hospital, critical access hospital, 
mobile stroke units (as defined by the Secretary), or any other site 
determined appropriate by the Secretary, in addition to the current 
eligible telehealth originating sites. Section 1834(m)(6)(C) of the Act 
limits payment of an originating site facility fee to acute stroke 
telehealth services furnished in sites that meet the usual telehealth 
restrictions under section 1834(m)(4)(C) of the Act.
    To implement these requirements, we proposed to create a new 
modifier that would be used to identify acute stroke telehealth 
services. The practitioner and, as appropriate, the originating site, 
would append this modifier when clinically appropriate to the HCPCS 
code when billing for an acute stroke telehealth service or an 
originating site facility fee, respectively. We note that section 50325 
of the BBA of 2018 did not amend section 1834(m)(4)(F) of the Act, 
which limits the scope of telehealth services to those on the Medicare 
telehealth list. Practitioners would be responsible for assessing 
whether it would be clinically appropriate to use this modifier with 
codes from the Medicare telehealth list. By billing with this modifier, 
practitioners would be indicating that the codes billed were used to 
furnish telehealth services for diagnosis, evaluation, or treatment of 
symptoms of an acute stroke. We believe that the adoption of a service 
level modifier is the least administratively burdensome means of 
implementing this provision for practitioners, while also allowing CMS 
to easily track and analyze utilization of these services.
    In accordance with section 1834(m)(6)(B) of the Act, as added by 
section 50325 of the BBA of 2018, we also proposed to revise Sec.  
410.78(b)(3) to add mobile stroke unit as a permissible originating 
site for acute stroke telehealth services. We proposed to define a 
mobile stroke unit as a mobile unit that furnishes services to 
diagnose, evaluate, and/or treat symptoms of an acute stroke and 
solicited comment on this definition, as well as additional information 
on how these units are used in current medical practice. We therefore 
proposed that mobile stroke units and the current eligible telehealth 
originating sites, which include hospitals and critical access 
hospitals as specified in section 1834(m)(6)(B) of the Act, but 
excluding renal dialysis facilities and patient homes because they are 
only allowable originating sites for purposes of home dialysis monthly 
ESRD-related clinical assessments in section 1881(b)(3)(B) of the Act, 
would be permissible originating sites for acute stroke telehealth 
services.
    We also solicited comment on other possible appropriate originating 
sites for telehealth services furnished for the diagnosis, evaluation, 
or treatment of symptoms of an acute stroke. Any additional sites would 
be adopted through future rulemaking. As required under section 
1834(m)(6)(C) of the Act, the originating site facility fee would not 
apply in instances where the originating site does not meet the 
originating site type and geographic requirements under section 
1834(m)(4)(C) of the Act. Additionally, we proposed to add Sec.  410.78 
(b)(4)(iv)(B) to specify that the requirements in section 1834(m)(4)(C) 
of the Act do not apply with respect to telehealth services furnished 
on or after January 1, 2019, for purposes of diagnosis, evaluation, or 
treatment of symptoms of an acute stroke.
    Comment: Commenters supported the expansions to Medicare 
telehealth. The majority of commenters agreed with our proposed 
definition of a mobile stroke unit. However, the AMA suggested that CMS 
specify in the definition that a mobile stroke unit must include a 
computed tomographic (CT) scanner and a telehealth (audio and video) 
connection or an in-person physician who is able to interpret the CT 
scan and prescribe an intravenous thrombolysis and also have a 
qualified health

[[Page 59496]]

professional who is able to administer an intravenous thrombolysis if 
the physician interpreting the CT scan and prescribing the treatment 
does so via telehealth. The AMA also suggested that CMS add as an 
originating site Emergency Medical Service (EMS) transports equipped 
with a telehealth connection to stroke specialists in order to provide 
faster national access to patients who require an accurate stroke 
diagnosis and decision about eligibility for intravenous or 
endovascular therapy, and to determine where to take them (such as a 
primary stroke or comprehensive stroke center). One commenter urged CMS 
to distinguish between a mobile stroke unit and a standard ambulance 
that is equipped with telemedicine capability and to establish separate 
payment for each, noting that a telemedicine consult on a mobile stroke 
unit may involve much greater complexity and critical care treatment 
than on a standard ambulance that is equipped with telemedicine 
capability. Another commenter recommended that CMS require specially 
trained paramedics who can evaluate an acute ischemic stroke patient 
based on national standards.
    Response: We are finalizing the changes to the regulation text and 
the definition of a mobile stroke unit as proposed without 
modification. We believe that clinicians are in the best position to 
make decisions about what equipment and professional support are 
required in furnishing these services. We plan to monitor utilization 
of these services and will consider making refinements, including those 
suggested by commenters, through future rulemaking as necessary. We 
would welcome additional information to help us understand the merits 
of the commenters' suggestions, including those regarding specific 
equipment and staffing requirements for mobile stroke units.
    In summary, we are finalizing a new modifier that will be used to 
identify acute stroke telehealth services. The practitioner and, as 
appropriate, the originating site, will append this modifier to the 
HCPCS code as clinically appropriate when billing for an acute stroke 
telehealth service or an originating site facility fee, respectively. 
We are finalizing the regulation text changes at Sec. Sec.  410.78 and 
414.65 as proposed to implement the requirements of section 50325 of 
the BBA of 2018 for acute stroke telehealth services. Mobile stroke 
units, with the definition as proposed, and the current eligible 
telehealth originating sites, which include hospitals and critical 
access hospitals, but exclude renal dialysis facilities and patient 
homes because they are originating sites only for purposes of home 
dialysis monthly ESRD-related clinical assessments in section 
1881(b)(3)(B) of the Act, will be permissible originating sites for 
acute stroke telehealth services.
6. Requirements of the Substance Use-Disorder Prevention That Promotes 
Opioid Recovery and Treatment (SUPPORT) for Patients and Communities 
Act
a. Expanding Medicare Telehealth Services for the Treatment of Opioid 
Use Disorder and Other Substance Use Disorders--Interim Final Rule With 
Comment Period
    Section 2001(a) of the SUPPORT for Patients and Communities Act 
(Pub. L. 115-271, October 24, 2018) (the SUPPORT Act) makes several 
revisions to section 1834(m) of the Act. First, it removes the 
originating site geographic requirements under section 1834(m)(4)(C)(i) 
for telehealth services furnished on or after July 1, 2019 for the 
purpose of treating individuals diagnosed with a substance use disorder 
or a co-occurring mental health disorder, as determined by the 
Secretary, at an originating site described in section 
1834(m)(4)(C)(ii) of the Act, other than an originating site described 
in subclause (IX) of section 1834(m)(4)(C)(ii) of the Act. The site 
described in subclause (IX) of section 1834(m)(4)(C)(ii) of the Act is 
a renal dialysis facility, which is only an allowable originating site 
for purposes of home dialysis monthly ESRD-related clinical assessments 
in section 1881(b)(3)(B) of the Act. It also adds the home of an 
individual as a permissible originating site for these telehealth 
services. Section 2001(a) of the SUPPORT Act for Patients and 
Communities Act additionally amends section 1834(m) of the Act to 
require that no originating site facility fee will be paid in instances 
when the individual's home is the originating site. Section 2001(b) of 
the SUPPORT for Patients and Communities Act grants the Secretary 
specific authority to implement the amendments made by section 2001(a) 
through an interim final rule.
    Under the authority of section 2001(b) of the SUPPORT for Patients 
and Communities Act, we are issuing an interim final rule with comment 
period to implement the requirements of section 2001(a) of the SUPPORT 
for Patients and Communities Act. In accordance with section 
1834(m)(2)(B)(ii)(X) of the Act, as amended by section 2001(a) of the 
SUPPORT for Patients and Communities Act, we are revising Sec.  
410.78(b)(3) on an interim final basis, by adding Sec.  
410.78(b)(3)(xii), which adds the home of an individual as a 
permissible originating site for telehealth services furnished on or 
after July 1, 2019 to individuals with a substance use disorder 
diagnosis for purposes of treatment of a substance use disorder or a 
co-occurring mental health disorder. We are amending Sec.  414.65(b)(3) 
on an interim final basis to reflect the requirement in section 
1834(m)(2)(B)(ii) of the Act that there is no originating site facility 
fee paid when the originating site for these services is the 
individual's home. Additionally, we are adding Sec.  
410.78(b)(4)(iv)(C) on an interim final basis to specify that the 
geographic requirements in section 1834(m)(4)(C)(i) of the Act do not 
apply for telehealth services furnished on or after July 1, 2019, to 
individuals with a substance use disorder diagnosis for purposes of 
treatment of a substance use disorder or a co-occurring mental health 
disorder at an originating site other than a renal dialysis facility.
    We note that section 2001 of the SUPPORT for Patients and 
Communities Act did not amend section 1834(m)(4)(F) of the Act, which 
limits the scope of telehealth services to those on the Medicare 
telehealth list. Practitioners would be responsible for assessing 
whether individuals have a substance use disorder diagnosis and whether 
it would be clinically appropriate to furnish telehealth services for 
the treatment of the individual's substance use disorder or a co-
occurring mental health disorder. By billing codes on the Medicare 
telehealth list with the telehealth place of service code, 
practitioners would be indicating that the codes billed were used to 
furnish telehealth services to individuals with a substance use 
disorder diagnosis for the purpose of treating the substance use 
disorder or a co-occurring mental health disorder. We note that we may 
issue additional subregulatory guidance in the future for billing these 
telehealth services.
    We note that there is a 60-day period following publication of this 
interim final rule for the public to comment on these interim final 
amendments to our regulations. We invite public comment on our policies 
to implement section 2001 of the SUPPORT for Patients and Communities 
Act.

[[Page 59497]]

b. Medicare Payment for Certain Services Furnished by Opioid Treatment 
Programs (OTPs)--Request for Information
    Section 2005 of the SUPPORT Act establishes a new Medicare benefit 
category for opioid use disorder treatment services furnished by OTPs 
under Medicare Part B, beginning on or after January 1, 2020. This 
provision requires that opioid use disorder treatment services would 
include FDA-approved opioid agonist and antagonist treatment 
medications, the dispensing and administration of such medications (if 
applicable), substance use disorder counseling, individual and group 
therapy, toxicology testing, and other services determined appropriate 
(but in no event to include meals and transportation). The provision 
defines OTPs as those that enroll in Medicare and are certified by the 
Substance Abuse and Mental Health Services Administration (SAMHSA), 
accredited by a SAMHSA-approved entity, and meeting additional 
conditions as the Secretary finds necessary to ensure the health and 
safety of individuals being furnished services under these programs and 
the effective and efficient furnishing of such services.
    We note that there is a 60-day period for the public to comment on 
the provisions of the interim final rule described previously to 
implement section 2001 of the SUPPORT for Patients and Communities Act. 
During that same comment period, we are requesting information 
regarding services furnished by OTPs, payments for these services, and 
additional conditions for Medicare participation for OTPs that 
stakeholders believe may be useful for us to consider for future 
rulemaking to implement this new Medicare benefit category.
7. Modifying Sec.  414.65 Regarding List of Telehealth Services
    In the CY 2015 PFS final rule with comment period, we finalized a 
proposal to change our regulation at Sec.  410.78(b) by deleting the 
description of the individual services for which Medicare payment can 
be made when furnished via telehealth, noting that we revised Sec.  
410.78(f) to indicate that a list of Medicare telehealth codes and 
descriptors is available on the CMS website (79 FR 67602). In 
accordance with that change, we proposed a technical revision to also 
delete the description of individual services and exceptions for 
Medicare payment for telehealth services in Sec.  414.65, by amending 
Sec.  414.65(a) to note that Medicare payment for telehealth services 
is addressed in Sec.  410.78 and by deleting Sec.  414.65(a)(1).
    Comment: Commenters were supportive of CMS making a technical 
revision to delete the description of individual services and 
exceptions for Medicare payment for telehealth services in Sec.  
414.65.
    Response: We are finalizing the technical revision to Sec.  414.65 
as proposed.
8. Comment Solicitation on Creating a Bundled Episode of Care for 
Management and Counseling Treatment for Substance Use Disorders
    There is an evidence base that suggests that routine counseling, 
either associated with medication assisted treatment (MAT) or on its 
own, can increase the effectiveness of treatment for substance use 
disorders (SUDs). According to a study in the Journal of Substance 
Abuse Treatment,\1\ patients treated with a combination of web-based 
counseling as part of a substance abuse treatment program demonstrated 
increased treatment adherence and satisfaction. The federal guidelines 
for opioid treatment programs describe that MAT and wrap-around 
psychosocial and support services can include the following services: 
Physical exam and assessment; psychosocial assessment; treatment 
planning; counseling; medication management; drug administration; 
comprehensive care management and supportive services; care 
coordination; management of care transitions; individual and family 
support services; and health promotion (https://store.samhsa.gov/shin/content/PEP15-FEDGUIDEOTP/PEP15-FEDGUIDEOTP.pdf). Creating separate 
payment for a bundled episode of care for components of MAT such as 
management and counseling treatment for substance use disorders (SUD), 
including opioid use disorder, treatment planning, and medication 
management or observing drug dosing for treatment of SUDs under the PFS 
could provide opportunities to better leverage services furnished with 
communication technology while expanding access to treatment for SUDs.
---------------------------------------------------------------------------

    \1\ Van L. King, Robert K. Brooner, Jessica M. Peirce, Ken 
Kolodner, Michael S. Kidorf, ``A randomized trial of Web based 
videoconferencing for substance abuse counseling,'' Journal of 
Substance Abuse Treatment, Volume 46, Issue 1, 2014, Pages 36-42, 
http://www.sciencedirect.com/science/article/pii/S0740547213001876.
---------------------------------------------------------------------------

    We also believe making separate payment for a bundled episode of 
care for management and counseling for SUDs could be effective in 
preventing the need for more acute services. For example, according to 
the Healthcare Cost and Utilization Project,\2\ Medicare pays for one-
third of opioid-related hospital stays, and Medicare has seen the 
largest annual increase in the number of these stays over the past 2 
decades. We believe that separate payment for a bundled episode of care 
could help avoid such hospital admissions by supporting access to 
management and counseling services that could be important in 
preventing hospital admissions and other acute care events.
---------------------------------------------------------------------------

    \2\ Pamela L. Owens, Ph.D., Marguerite L. Barrett, M.S., Audrey 
J. Weiss, Ph.D., Raynard E. Washington, Ph.D., and Richard Kronick, 
Ph.D. ``Hospital Inpatient Utilization Related to Opioid Overuse 
Among Adults 1993-2012,'' Statistical Brief #177. Healthcare Cost 
and Utilization Project (HCUP). July 2014. Agency for Healthcare 
Research and Quality, Rockville, MD, https://www.hcup-us.ahrq.gov/reports/statbriefs/sb177-Hospitalizations-for-Opioid-Overuse.jsp.
---------------------------------------------------------------------------

    As indicated earlier, we considered whether it would be appropriate 
to develop a separate bundled payment for an episode of care for 
treatment of SUDs. We solicited public comment on whether such a 
bundled episode-based payment would be beneficial to improve access, 
quality and efficiency for SUD treatment. Further, we solicited public 
comment on developing coding and payment for a bundled episode of care 
for treatment for SUDs that could include overall treatment management, 
any necessary counseling, and components of a MAT program such as 
treatment planning, medication management, and observation of drug 
dosing. Specifically, we solicited public comments related to what 
assumptions we might make about the typical number of counseling 
sessions as well as the duration of the service period, which types of 
practitioners could furnish these services, and what components of MAT 
could be included in the bundled episode of care. We were interested in 
stakeholder feedback regarding how to define and value this bundle and 
what conditions of payment should be attached. Additionally, we 
solicited comment on whether the concept of a global period, similar to 
the currently existing global periods for surgical procedures, might be 
applicable to treatment for SUDs.
    We also solicited comment on whether the counseling portion and 
other MAT components could also be provided by qualified practitioners 
``incident to'' the services of the billing physician who will 
administer or prescribe any necessary medications and manage the 
overall care, as well as supervise any other counselors participating 
in the treatment, similar to the structure of the Behavioral Health 
Integration codes which include

[[Page 59498]]

services provided by other members of the care team under the direction 
of the billing practitioner on an ``incident to'' basis (81 FR 80231). 
We welcomed comments on potentially creating a bundled episode of care 
for management and counseling treatment for SUDs, which we will 
consider for future rulemaking.
    Comment: We received several comments with detailed information on 
this topic. Some commenters expressed concern that the format of a 
bundled episode of care may fail to take into account the wide 
variability in patient needs for treatment of SUDs, especially given 
the chronic nature of SUDs, which like other chronic diseases, 
typically involves ongoing treatment without a definitive end point. 
Some commenters additionally noted that a global period would not lend 
itself to treatment of SUDs, because the treatment is not an acute 
intervention like surgery; rather, patients with SUDs may require 
increasing and decreasing access to care, depending on their progress 
in treatment.
    Response: We thank the commenters for all of the information 
submitted and will consider this feedback for future rulemaking. We 
agree with commenters and understand that there is wide variability in 
patient needs for treatment of SUDs, and that unlike surgical global 
periods, ongoing treatment is often necessary in the treatment of SUDs. 
While we do not necessarily believe these characteristics preclude 
payment bundles and/or global periods, we do understand they would need 
to be taken into account. We reiterate that our intention as we 
consider these issues for future rulemaking is to increase access to 
necessary care, and that any potential bundled payment would be 
developed in consideration of these comments.
    We note that there is a 60-day period for the public to comment on 
the interim final telehealth policies and revisions to our regulations 
we are adopting to implement statutory amendments to section 1834(m) of 
the Act that expand access to telehealth services used to treat 
substance use disorders. During that same comment period, we are 
requesting additional information from stakeholders and the public that 
we might consider for future rulemaking regarding payment structure and 
amounts for SUD treatment that account for ongoing treatment and wide 
variability in patient needs for treatment of SUDs while improving 
access to necessary care.
    Additionally, we invited public comment and suggestions for 
regulatory and subregulatory changes to help prevent opioid use 
disorder and improve access to treatment under the Medicare program. We 
solicited comment on methods for identifying non-opioid alternatives 
for pain treatment and management, along with identifying barriers that 
may inhibit access to these non-opioid alternatives including barriers 
related to payment or coverage. Consistent with our ``Patients Over 
Paperwork'' Initiative, we were interested in suggestions to improve 
existing requirements to more effectively address the opioid epidemic.
    Comment: We received several comments with detailed information on 
this topic.
    Response: We thank the commenters for all of the information 
submitted and will consider this for future rulemaking.
9. Telehealth Originating Site Facility Fee Payment Amount Update
    Section 1834(m)(2)(B) of the Act established the Medicare 
telehealth originating site facility fee for telehealth services 
furnished from October 1, 2001 through December 31, 2002, at $20.00. 
For telehealth services furnished on or after January 1 of each 
subsequent calendar year, the telehealth originating site facility fee 
is increased by the percentage increase in the Medicare Economic Index 
(MEI) as defined in section 1842(i)(3) of the Act. The originating site 
facility fee for telehealth services furnished in CY 2018 is $25.76. 
The MEI increase for 2019 is 1.5 percent and is based on the most 
recent historical update of the MEI through 2018Q2 (2.0 percent), and 
the most recent historical multifactor productivity adjustment (MFP) 
through calendar year 2017 (0.5 percent). Therefore, for CY 2019, the 
payment amount for HCPCS code Q3014 (Telehealth originating site 
facility fee) is 80 percent of the lesser of the actual charge or 
$26.15. The Medicare telehealth originating site facility fee and the 
MEI increase by the applicable time period is shown in Table 10.

     Table 10--The Medicare Telehealth Originating Site Facility Fee
------------------------------------------------------------------------
                                                         MEI    Facility
                     Time period                      increase     fee
------------------------------------------------------------------------
10/01/2001-12/31/2002...............................       N/A    $20.00
01/01/2003-12/31/2003...............................       3.0     20.60
01/01/2004-12/31/2004...............................       2.9     21.20
01/01/2005-12/31/2005...............................       3.1     21.86
01/01/2006-12/31/2006...............................       2.8     22.47
01/01/2007-12/31/2007...............................       2.1     22.94
01/01/2008-12/31/2008...............................       1.8     23.35
01/01/2009-12/31/2009...............................       1.6     23.72
01/01/2010-12/31/2010...............................       1.2     24.00
01/01/2011-12/31/2011...............................       0.4     24.10
01/01/2012-12/31/2012...............................       0.6     24.24
01/01/2013-12/31/2013...............................       0.8     24.43
01/01/2014-12/31/2014...............................       0.8     24.63
01/01/2015-12/31/2015...............................       0.8     24.83
01/01/2016-12/31/2016...............................       1.1     25.10
01/01/2017-12/31/2017...............................       1.2     25.40
01/01/2018-12/31/2018...............................       1.4     25.76
01/01/2019-12/31/2019...............................       1.5     26.15
------------------------------------------------------------------------

E. Potentially Misvalued Services Under the PFS

1. Background
    Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a 
periodic review, not less often than every 5 years, of the RVUs 
established under the PFS. Section 1848(c)(2)(K) of the Act requires 
the Secretary to periodically identify potentially misvalued services 
using certain criteria and to review and make appropriate adjustments 
to the relative values for those services. Section 1848(c)(2)(L) of the 
Act also requires the Secretary to develop a process to validate the 
RVUs of certain potentially misvalued codes under the PFS, using the 
same criteria used to identify potentially misvalued codes, and to make 
appropriate adjustments.
    As discussed in section II.H. of this final rule, Valuation of 
Specific Codes, each year we develop appropriate adjustments to the 
RVUs taking into account recommendations provided by the RUC, MedPAC, 
and other stakeholders. For many years, the RUC has provided us with 
recommendations on the appropriate relative values for new, revised, 
and potentially misvalued PFS services. We review these recommendations 
on a code-by-code basis and consider these recommendations in 
conjunction with analyses of other data, such as claims data, to inform 
the decision-making process as authorized by law. We may also consider 
analyses of work time, work RVUs, or direct PE inputs using other data 
sources, such as Department of Veteran Affairs (VA), National Surgical 
Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons 
(STS), and the Merit-based Incentive Payment System (MIPS) data. In 
addition to considering the most recently available data, we assess the 
results of physician surveys and specialty recommendations submitted to 
us by the RUC for our review. We also consider information provided by 
other stakeholders. We conduct a review to assess the appropriate RVUs 
in the context of contemporary medical practice. We note that section

[[Page 59499]]

1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and 
other techniques to determine the RVUs for physicians' services for 
which specific data are not available and requires us to take into 
account the results of consultations with organizations representing 
physicians who provide the services. In accordance with section 1848(c) 
of the Act, we determine and make appropriate adjustments to the RVUs.
    In its March 2006 Report to the Congress (http://www.medpac.gov/docs/default-source/reports/Mar06_Ch03.pdf?sfvrsn=0), MedPAC discussed 
the importance of appropriately valuing physicians' services, noting 
that misvalued services can distort the market for physicians' 
services, as well as for other health care services that physicians 
order, such as hospital services. In that same report, MedPAC 
postulated that physicians' services under the PFS can become misvalued 
over time. MedPAC stated, ``When a new service is added to the 
physician fee schedule, it may be assigned a relatively high value 
because of the time, technical skill, and psychological stress that are 
often required to furnish that service. Over time, the work required 
for certain services would be expected to decline as physicians become 
more familiar with the service and more efficient in furnishing it.'' 
We believe services can also become overvalued when PE declines. This 
can happen when the costs of equipment and supplies fall, or when 
equipment is used more frequently than is estimated in the PE 
methodology, reducing its cost per use. Likewise, services can become 
undervalued when physician work increases or PE rises.
    As MedPAC noted in its March 2009 Report to Congress (http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since 
MedPAC made the initial recommendations, CMS and the RUC have taken 
several steps to improve the review process. Also, section 
1848(c)(2)(K)(ii) of the Act augments our efforts by directing the 
Secretary to specifically examine, as determined appropriate, 
potentially misvalued services in the following categories:
     Codes that have experienced the fastest growth.
     Codes that have experienced substantial changes in PE.
     Codes that describe new technologies or services within an 
appropriate time period (such as 3 years) after the relative values are 
initially established for such codes.
     Codes which are multiple codes that are frequently billed 
in conjunction with furnishing a single service.
     Codes with low relative values, particularly those that 
are often billed multiple times for a single treatment.
     Codes that have not been subject to review since 
implementation of the fee schedule.
     Codes that account for the majority of spending under the 
PFS.
     Codes for services that have experienced a substantial 
change in the hospital length of stay or procedure time.
     Codes for which there may be a change in the typical site 
of service since the code was last valued.
     Codes for which there is a significant difference in 
payment for the same service between different sites of service.
     Codes for which there may be anomalies in relative values 
within a family of codes.
     Codes for services where there may be efficiencies when a 
service is furnished at the same time as other services.
     Codes with high intraservice work per unit of time.
     Codes with high PE RVUs.
     Codes with high cost supplies.
     Codes as determined appropriate by the Secretary.
    Section 1848(c)(2)(K)(iii) of the Act also specifies that the 
Secretary may use existing processes to receive recommendations on the 
review and appropriate adjustment of potentially misvalued services. In 
addition, the Secretary may conduct surveys, other data collection 
activities, studies, or other analyses, as the Secretary determines to 
be appropriate, to facilitate the review and appropriate adjustment of 
potentially misvalued services. This section also authorizes the use of 
analytic contractors to identify and analyze potentially misvalued 
codes, conduct surveys or collect data, and make recommendations on the 
review and appropriate adjustment of potentially misvalued services. 
Additionally, this section provides that the Secretary may coordinate 
the review and adjustment of any RVU with the periodic review described 
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of 
the Act specifies that the Secretary may make appropriate coding 
revisions (including using existing processes for consideration of 
coding changes) that may include consolidation of individual services 
into bundled codes for payment under the PFS.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
    To fulfill our statutory mandate, we have identified and reviewed 
numerous potentially misvalued codes as specified in section 
1848(c)(2)(K)(ii) of the Act, and we intend to continue our work 
examining potentially misvalued codes in these areas over the upcoming 
years. As part of our current process, we identify potentially 
misvalued codes for review, and request recommendations from the RUC 
and other public commenters on revised work RVUs and direct PE inputs 
for those codes. The RUC, through its own processes, also identifies 
potentially misvalued codes for review. Through our public nomination 
process for potentially misvalued codes established in the CY 2012 PFS 
final rule with comment period, other individuals and stakeholder 
groups submit nominations for review of potentially misvalued codes as 
well.
    Since CY 2009, as a part of the annual potentially misvalued code 
review and Five-Year Review process, we have reviewed approximately 
1,700 potentially misvalued codes to refine work RVUs and direct PE 
inputs. We have assigned appropriate work RVUs and direct PE inputs for 
these services as a result of these reviews. A more detailed discussion 
of the extensive prior reviews of potentially misvalued codes is 
included in the CY 2012 PFS final rule with comment period (76 FR 73052 
through 73055). In the CY 2012 PFS final rule with comment period (76 
FR 73055 through 73958), we finalized our policy to consolidate the 
review of physician work and PE at the same time, and established a 
process for the annual public nomination of potentially misvalued 
services.
    In the CY 2013 PFS final rule with comment period, we built upon 
the work we began in CY 2009 to review potentially misvalued codes that 
have not been reviewed since the implementation of the PFS (so-called 
``Harvard-valued codes''). In CY 2009 (73 FR 38589), we requested 
recommendations from the RUC to aid in our review of Harvard-valued 
codes that had not yet been reviewed, focusing first on high-volume, 
low intensity codes. In the fourth Five-Year Review (76 FR 32410), we 
requested recommendations from the RUC to aid in our review of Harvard-
valued codes with annual utilization of greater than 30,000 services. 
In the CY 2013 PFS final rule with comment period, we identified 
specific Harvard-valued services with annual allowed charges that total 
at least $10,000,000 as

[[Page 59500]]

potentially misvalued. In addition to the Harvard-valued codes, in the 
CY 2013 PFS final rule with comment period we finalized for review a 
list of potentially misvalued codes that have stand-alone PE (codes 
with physician work and no listed work time and codes with no physician 
work that have listed work time).
    In the CY 2016 PFS final rule with comment period, we finalized for 
review a list of potentially misvalued services, which included eight 
codes in the neurostimulators analysis-programming family (CPT codes 
95970-95982). We also finalized as potentially misvalued 103 codes 
identified through our screen of high expenditure services across 
specialties.
    In the CY 2017 PFS final rule, we finalized for review a list of 
potentially misvalued services, which included eight codes in the end-
stage renal disease home dialysis family (CPT codes 90963-90970). We 
also finalized as potentially misvalued 19 codes identified through our 
screen for 0-day global services that are typically billed with an 
evaluation and management (E/M) service with modifier 25.
    In the CY 2018 PFS final rule, we finalized arthrodesis of 
sacroiliac joint (CPT code 27279) as potentially misvalued. Through the 
use of comment solicitations with regard to specific codes, we also 
examined the valuations of other services, in addition to, new 
potentially misvalued code screens (82 FR 53017 through 53018).
3. CY 2019 Identification and Review of Potentially Misvalued Services
    In the CY 2012 PFS final rule with comment period (76 FR 73058), we 
finalized a process for the public to nominate potentially misvalued 
codes. In the CY 2015 PFS final rule with comment period (79 FR 67606 
through 67608), we modified this process whereby the public and 
stakeholders may nominate potentially misvalued codes for review by 
submitting the code with supporting documentation by February 10th of 
each year. Supporting documentation for codes nominated for the annual 
review of potentially misvalued codes may include the following:
     Documentation in peer reviewed medical literature or other 
reliable data that there have been changes in physician work due to one 
or more of the following: Technique, knowledge and technology, patient 
population, site-of-service, length of hospital stay, and work time.
     An anomalous relationship between the code being proposed 
for review and other codes.
     Evidence that technology has changed physician work.
     Analysis of other data on time and effort measures, such 
as operating room logs or national and other representative databases.
     Evidence that incorrect assumptions were made in the 
previous valuation of the service, such as a misleading vignette, 
survey, or flawed crosswalk assumptions in a previous evaluation.
     Prices for certain high cost supplies or other direct PE 
inputs that are used to determine PE RVUs are inaccurate and do not 
reflect current information.
     Analyses of work time, work RVU, or direct PE inputs using 
other data sources (for example, VA, NSQIP, the STS National Database, 
and the MIPS data).
     National surveys of work time and intensity from 
professional and management societies and organizations, such as 
hospital associations.
    We evaluate the supporting documentation submitted with the 
nominated codes and assess whether the nominated codes appear to be 
potentially misvalued codes appropriate for review under the annual 
process. In the following year's PFS proposed rule, we publish the list 
of nominated codes and indicate for each nominated code whether we 
agree with its inclusion as a potentially misvalued code. The public 
has the opportunity to comment on these and all other proposed 
potentially misvalued codes. In that year's final rule, we finalize our 
list of potentially misvalued codes.
a. Public Nominations
    We received one submission that nominated several high-volume codes 
for review under the potentially misvalued code initiative. In its 
request, the submitter noted a systemic overvaluation of work RVUs in 
certain procedures and tests based ``on a number of Government 
Accountability Office (GAO) and the Medicare Payment Advisory 
Commission (MedPAC) reports, media reports regarding time inflation of 
specific services, and the January 19, 2017 Urban Institute report for 
CMS.'' The submitter suggested that the times CMS assumes in estimating 
work RVUs are inaccurate for procedures, especially due to substantial 
overestimates of preservice and postservice time, including follow-up 
inpatient and outpatient visits that do not take place. According to 
the submitter, the time estimates for tests and some other procedures 
are primarily overstated as part of the intraservice time. Furthermore, 
the submitter stated that previous RUC reviews of these services did 
not result in reductions in valuation that adequately reflected 
reductions in surveyed times.
    Based on these analyses, the submitter requested that the codes 
listed in Table 11 be prioritized for review under the potentially 
misvalued code initiative.

            Table 11--Public Nominations Due to Overvaluation
------------------------------------------------------------------------
             CPT code                         Short description
------------------------------------------------------------------------
27130.............................  Total hip arthroplasty.
27447.............................  Total knee arthroplasty.
43239.............................  Egd biopsy single/multiple.
45385.............................  Colonoscopy w/lesion removal.
70450.............................  CT head w/o contrast.
93000.............................  Electrocardiogram complete.
93306.............................  Tte w/doppler complete.
------------------------------------------------------------------------

    Another submitter requested that CPT codes 92992 (Atrial septectomy 
or septostomy; transvenous method, balloon (e.g., Rashkind type) 
(includes cardiac catheterization)) and 92993 (Atrial septectomy or 
septostomy; blade method (Park septostomy) (includes cardiac 
catheterization)) be reviewed under the potentially misvalued code 
initiative in order to establish national RVU values for these services 
under the MPFS. These codes are currently priced by the Medicare 
Administrative Contractors (MACs).
    We received several comments with regard to the nomination of 
several high-volume codes for review under the potentially misvalued 
code initiative.
    Comment: One commenter stated that specific details of the 
nomination of the seven high-volume codes were not provided in the CY 
2019 PFS proposed rule. Several other commenters, including the RUC, 
expressed concern that the source of the nomination of the seven high-
volume codes and its entire nomination letter was not made available. 
These commenters requested that CMS provide greater transparency and 
publicly provide all nomination requests identifying potentially 
misvalued codes.
    Response: We believe that we summarized the contents of the public 
nomination letter and provided the rationale in the CY 2019 PFS 
proposed rule with enough detail for commenters to comment 
substantively and provide supporting documentation or data to rebut the 
suggestion that these codes are potentially misvalued. We recognize the 
importance of transparency and note that under the public nomination 
process that was established in CY 2012 rulemaking, the first 
opportunity for the public to nominate codes was during the 60-day 
comment period for the CY

[[Page 59501]]

2012 final rule with comment period; therefore, public nominations were 
received via submission to www.regulations.gov. In the CY 2015 final 
rule with comment period (79 FR 67606 through 67608), we finalized a 
modified process for identifying potentially misvalued codes (fully 
effective in CY 2017), where we established a new deadline of February 
10th for receipt of public nominations for potentially misvalued codes 
to be considered for inclusion in the proposed rule. Although 
stakeholders often include public nominations of misvalued codes for 
consideration in a subsequent year's rulemaking as part of their 
comments on a current year's proposed rule, the public and stakeholders 
may nominate potentially misvalued codes for review by submitting the 
code with supporting documentation to CMS by February 10th of each 
year. In the future, public nominations that CMS receives by the 
February 10th deadline will be made available in the form of a public 
use file with the proposed rule, in the downloads section on the CMS 
website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/. We remind submitters that any information 
that might be considered proprietary or confidential should not be 
included. Additionally, we have included the submission that nominated 
these high-volume codes for review as potentially misvalued as a public 
use file for the CY 2019 PFS final rule.
    Comment: One commenter stated that because CMS did not include 
these publicly nominated codes in Table 13 of the proposed rule, it 
does not appear that CMS has agreed with the commenter on the need to 
revisit these codes. Another commenter stated that CMS did not provide 
guidance on whether these nominated codes would be considered for 
revaluation or retained at their current value.
    Response: We clarify that the codes for which we received public 
nominations as potentially misvalued were not included in Table 13 of 
the proposed rule because that table contains a list of codes for which 
we proposed work RVUs for CY 2019 (the list does not include codes for 
which we received nominations discussed in the proposed rule for 
consideration as potentially misvalued). As previously indicated, in 
the proposed rule we publish the list of codes nominated as potentially 
misvalued, which allows the public the opportunity to comment on these 
codes; then, in the final rule, we finalize our list of potentially 
misvalued codes. No new valuations were proposed for these codes in the 
CY 2019 PFS proposed rule. Any revaluation of these codes would be 
proposed in future rulemaking.
    Comment: One commenter stated that the codes in Table 8 in the 
proposed rule and their respective code families should be prioritized 
for review as potentially misvalued. The commenter suggested revisiting 
two recent efforts funded by CMS, reports by Urban Institute and RAND 
Corporation (https://www.urban.org/sites/default/files/publication/87771/2001123-collecting-empirical-physician-time-data-piloting-approach-for-validating-work-relative-value-units_1.pdf, and, https://www.rand.org/content/dam/rand/pubs/research_reports/RR600/RR662/RAND_RR662.pdf), for prioritization of codes for review to expand the 
misvalued codes initiative list. The commenter referenced a June 2018 
MedPAC report that stated that CMS' review of potentially misvalued 
codes has not addressed services that account for a substantial share 
of fee schedule spending and is hampered by the lack of current, 
accurate, and objective data on clinician work time and practice 
expenses. Consequently, according to the MedPAC report, work RVUs for 
procedures, imaging, and tests are systemically overvalued relative to 
other services, such as ambulatory evaluation and management (E/M) 
services.
    Response: We appreciate the commenters' recommendations for 
expanding the misvalued codes list. We will consider whether to address 
these suggestions in future rulemaking.
    Comment: One commenter recommended that additional research be 
conducted on the analytic products available that could be used to 
create transparency into the RUC process and allow for greater external 
participation in misvalued cost evaluation. The commenter also stated 
that CMS should reconsider reliance on the RUC altogether given the 
inherent conflicts of interest in the RUC-based process.
    Response: We acknowledge that the RUC provides critically important 
information that factors into our review process. However, our review 
of recommended work RVUs and time inputs is also informed by review of 
various alternate sources of information, in addition to the RUC. 
Examples of these alternate sources of information include information 
provided by other public commenters, Medicare claims data, comparative 
databases, medical literature, as well as consultation with other 
physicians and healthcare professionals within CMS and the federal 
government. We also reiterate that we continue to be open to reviewing 
additional and supplemental sources of data furnished by stakeholders, 
and providing such information to CMS is not limited to the public 
nomination process for potentially misvalued codes. We encourage 
stakeholders to continue to provide such information for our 
consideration in establishing work RVUs.
    Comment: One commenter stated concerns with CMS' use of a non-
relative measuring approach for the seven codes nominated for review 
when generally the RUC-valued and CMS-approved codes are based on the 
concept of relativity. The commenter stated that using such an 
inconsistent approach on select codes will potentially cause disruption 
and instability in code valuations. The commenter also stated that 
determining reimbursement in value-based care delivery models must rely 
on the carefully cultivated RUC process for fairness and 
accountability.
    Response: We are unclear about the commenter's claim that CMS is 
using a non-relative measuring approach for the seven high volume codes 
that have been nominated as potentially misvalued. We did not propose a 
valuation for the nominated codes, nor did we propose to use a non-
relative measuring approach. Rather, as part of our statutory 
obligation to identify and review potentially misvalued codes, we 
implemented an annual process whereby the public can nominate 
potentially misvalued codes with supporting documentation; we then 
publish the list of nominated codes and the public has the opportunity 
to comment on these nominations. We continue to maintain that 
adjustments to work RVUs should be based on the resources involved with 
each procedure or service, and reiterate that our review of work RVUs 
and time inputs utilizes information from various resources, including 
the RUC. We continue to seek information on the best sources of 
objective, routinely-updated, auditable, and robust data regarding the 
resource costs of furnishing PFS services.
    Comment: Several commenters stated that CPT codes 27130 and 27447 
should not be considered potentially misvalued and do not warrant any 
further action because the current valuation for the codes was 
established after review by the RUC and CMS in 2013, and since that 
time there are no new data to indicate a change in the work of 
performing the procedure or the number of post-operative follow up 
visits. Another commenter stated that CMS should not subject 
professions to code

[[Page 59502]]

valuations and analysis so frequently, and that doing so calls into 
question the validity of the RUC process in the first place.
    Response: We do not agree that recent review of a code should 
preclude it from being considered as potentially misvalued, nor that it 
calls into question the validity of the RUC process. We have a 
responsibility to identify and review potentially misvalued codes, and 
believe there is value in consistent and routine review of high-volume 
services, particularly considering that a minor adjustment to the work 
RVU of a high-volume code may have a significant dollar impact. We also 
note that review of high-volume services does not need to be predicated 
on the suspicion of overvaluation.
    Comment: One commenter stated that if CMS decides to reexamine 
these nominated codes in the future, then the agency should provide 
ample opportunity for public comments, and in the event of such review, 
CMS should consider supplemental sources of information, including 
hospital anesthesia time in addition to any RUC recommendations in 
order to support accurate valuations of these procedures.
    Response: Any revaluations of these codes would be undertaken 
through notice and comment rulemaking. Notice and comment rulemaking 
provides for an open process whereby we welcome input from all 
interested parties, and we encourage commenters to provide feedback 
including supplemental sources of information regarding potentially 
misvalued codes, as well as input on our annual proposed valuations.
    Comment: One commenter disagreed that CPT codes 43239 and 45385 are 
misvalued and stated that while the Urban Institute report provides 
insights into potential flaws in the RUC survey process, it should not 
be considered proof that these codes are overvalued. The commenter 
stated that these code valuations were recently revised, and the RUC 
survey responses from gastroenterologists informed revisions to the 
work RVUs for both services. The commenter stated that for CPT code 
43239, CMS finalized work RVUs that were less than the RUC's 
recommended work RVUs, and for CPT code 45385, CMS finalized the RUC-
recommended work RVUs, which were lower than the work RVUs prior to 
reevaluation. Therefore, the commenter stated that CMS should reject 
the nominations of these codes as potentially misvalued.
    Response: We note that the nomination referenced the Urban 
Institute report as only one of the sources regarding the issue of time 
inflation of specific services. Additionally, as previously indicated, 
we do not agree that recent review of a code should preclude it from 
being considered as potentially misvalued. We believe there is value in 
consistent and routine review of high-volume services, particularly 
considering that a minor adjustment to the work RVU of a high-volume 
code may have a significant dollar impact. Therefore, we do not agree 
that we should reject nominations of these codes as potentially 
misvalued because they were previously reviewed and refinements were 
made.
    Comment: A few commenters stated that the current work RVU 
valuation of 0.85 for CPT code 70450 is inadequate. The commenters 
stated that the level of effort associated with CPT code 70450 
increased between the time the code was originally valued and the 2012 
survey, and this increase continued through 2016. The commenters stated 
that over time, advances in technology led to many more images being 
created than existed historically. The commenters also stated that 
volume acquisitions, a CT scan technique that allows for multiple two-
dimensional images, has resulted in thinner reconstructions and 
effortless multiplanar reformats, and other technological advancements 
have increased the amount of professional work associated with 
interpreting a non-contrast head CT and should be considered in the 
work RVU. The commenters expressed concern that the nomination by a 
single entity threatens the integrity of how physician services are 
valued generally.
    Response: We disagree with the commenter that a nomination by a 
single entity threatens the integrity of how physician services are 
valued generally, and reiterate that a public nomination process was 
established through rulemaking as a way for the public and stakeholders 
to nominate potentially misvalued codes for consideration. Any future 
proposed valuations of specific codes are open for public comment, and 
we encourage stakeholders to submit data that would indicate that the 
current valuation is insufficient.
    Comment: One commenter stated that with regard to CPT code 70450, 
the times prior to survey were CMS/other times and were not subdivided 
into pre-service, intra-service, and post-service categories. 
Therefore, the commenter stated that drawing comparisons between prior 
RUC database times and the surveyed times is invalid because the source 
of the prior RUC database times are unknown and completely different 
from the surveyed times. The commenter also stated that selecting as 
potentially misvalued only certain CPT codes that have undergone the 
RUC process with validated surveys is not a rational approach because 
if the times assumed based on the RUC approved survey data are invalid 
for these codes, they should be invalid for the entire fee schedule so 
that consistent methodology is applied to all CPT codes.
    Response: We typically rely on RUC survey values because we believe 
they are the closest to accurate values, as they are the best data 
available in some cases. Although we do not agree that we should not 
consider comparisons of RUC database times to the newly surveyed times 
as described by the commenter, on a case-by-case basis we can consider 
the existence of previous inaccuracies. However, we also note that 
previous valuations established based on those inaccuracies would also 
indicate that the payments would have been inaccurate as well. The goal 
of the identification and review of potentially misvalued services is 
to facilitate accurate payment for PFS services. We also disagree with 
the commenter's characterization that selecting codes that have 
undergone the RUC process with validated surveys is not rational, and 
note that just because a code has been reviewed by the RUC does not 
preclude it from being identified and/or publically nominated as 
potentially misvalued.
    Comment: With regard to CPT codes 93000 and 93306, one commenter 
stated that while the Urban Institute report concludes that the 
intraservice time to interpret an electrocardiogram is 6 seconds, 
practitioners who furnish the service do not believe it is possible to 
completely interpret a study so quickly. The commenter expressed 
concern about the large emphasis placed on service time by CMS and some 
stakeholders when it comes to valuation. The commenter suggested that 
frequent reviews of long-established mature services like 
electrocardiography and echocardiography will produce two outcomes--the 
inputs will remain the same or circumstances at some point will align 
such that it appears they take less time, which will open the window 
for payers to try to reduce payment for services that have not actually 
changed, and eventually these reductive re-valuations produce 
underpayment. A few commenters stated that CPT code 93306 was recently 
reviewed and valued in CY 2018. One commenter stated that the current 
valuation is reflective of numerous accreditation body requirements 
that were implemented since the service was last valued in 2007, which 
increased the

[[Page 59503]]

work required per study. The commenter stated that the Urban Institute 
report should not be considered proof that the CPT code is overvalued, 
and given the recent RUC review of this service, CMS' acceptance of the 
RUC recommendation, and no change in the physician work of performing 
the service in the past year, this code should not be included in the 
potentially misvalued codes list.
    Response: We reiterate that it is our practice to consider all 
elements of the relative work when we are reviewing and determining 
work RVU valuations. Additionally, our review of recommended work RVUs 
and time inputs generally includes review of various sources such as 
information provided by the RUC, and other public commenters, medical 
literature, and comparative databases. As previously stated, we believe 
there is great value in consistent and routine review of high-volume 
services. Additionally, as previously indicated, we do not agree that 
recent review of a code should preclude it from being considered as 
potentially misvalued, and therefore, do not agree that CMS should not 
include a code in the list of potentially misvalued services because it 
was previously reviewed.
    Comment: One commenter disagreed that the time allocated to CPT 
code 93306 is overstated. The commenter stated that the Intersocietal 
Accreditation Commission for Echocardiography Guidelines regarding time 
standards indicated that more time is necessary from patient encounter 
to departure than is stipulated in the CMS time file. The commenter 
also stated there is more and more information being gathered with the 
introduction of technology that is labor and time intensive. The 
commenter suggested that if anything is revised, CMS times should be 
increased, not decreased.
    Response: We reiterate that we are interested in receiving 
resource-based data from stakeholders and not just the RUC and we 
encourage stakeholders to submit data that would indicate that the 
current valuations are insufficient.
    Although we appreciate the comments that were received regarding 
the seven high-volume codes, we believe that the nominator presented 
some concerns that have merit, such as the observation that in many 
cases time is reduced substantially but the work RVU only minimally, 
which results in an implied increase in the intensity of work that does 
not appear to be valid, and ultimately creates work intensity anomalies 
that are difficult to defend, and further review of these high-volume 
codes is the best way to determine the validity of the concerns 
articulated by the submitter. Therefore, we are adding CPT codes 27130, 
27447, 43239, 45385, 70450, 93000, and 93306 to the list of potentially 
misvalued codes and anticipate reviewing recommendations from the RUC 
and other stakeholders. We reiterate that we do not believe that the 
inclusion of a code on a potentially misvalued code list necessarily 
means that a particular code is misvalued. Instead, the list is 
intended to prioritize codes to be reviewed under the misvalued code 
initiative.
    In addition to comments on the nomination of the seven high-volume 
codes, we also received comments on the nomination of two contractor-
priced codes for review under the potentially misvalued code 
initiative.
    Comment: We received a few comments with regard to CPT codes 92992 
and 92993, which were requested for review under the potentially 
misvalued code initiative in order to establish national RVU values for 
these services under the PFS. One of the commenters, the RUC, stated 
that these contractor-priced services, which are typically performed on 
children, would be discussed at the October 2018 Relativity Assessment 
Workgroup meeting.
    Response: We appreciate the information from the RUC on their plans 
to discuss these codes. Given the plans by the RUC to consider CPT 
codes 92992 and 92993 we will wait for the RUC's review and will not 
add these codes to the list of potentially misvalued codes.
b. Update on the Global Surgery Data Collection
    Payment for postoperative care is currently bundled within 10 or 90 
days after many surgical procedures. Historically, we have not 
collected data on how many postoperative visits are actually performed 
during the global period. Section 523 of the MACRA added a new 
paragraph 1848(c)(8) to the Act, and section 1848(c)(8)(B) required CMS 
to use notice and comment rulemaking to implement a process to collect 
data on the number and level of postoperative visits and use these data 
to assess the accuracy of global surgical package valuation. In the CY 
2017 PFS final rule, we adopted a policy to collect postoperative visit 
data. Beginning July 1, 2017, we required practitioners in groups with 
10 or more practitioners in nine states (Florida, Kentucky, Louisiana, 
Nevada, New Jersey, North Dakota, Ohio, Oregon, and Rhode Island) to 
use the no-pay CPT code 99024 (Postoperative follow-up visit, normally 
included in the surgical package, to indicate that an E/M service was 
performed during a postoperative period for a reason(s) related to the 
original procedure) to report postoperative visits. Practitioners who 
only practice in groups with fewer than 10 practitioners are exempted 
from required reporting, but are encouraged to report if feasible. The 
293 procedures for which reporting is required are those furnished by 
more than 100 practitioners, and either are nationally furnished more 
than 10,000 times annually or have more than $10 million in annual 
allowed charges. A list of the procedures for which reporting is 
required is updated annually to reflect any coding changes and is 
posted on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-.html.
    In these nine states, from July 1, 2017 through December 31, 2017, 
there were 990,581 postoperative visits reported using CPT code 99024. 
Of the 32,573 practitioners who furnished at least one of the 293 
procedures during this period and who, based on Tax Identification 
Numbers in claims data, were likely to meet the practice size 
threshold, only 45 percent reported one or more visit using CPT code 
99024 during this 6-month period. The share of practitioners who 
reported any CPT code 99024 claims varied by specialty. Among surgical 
oncology, hand surgery, and orthopedic surgeons, reporting rates were 
92, 90, and 87 percent, respectively. In contrast, the reporting rate 
for emergency medicine physicians was 4 percent.
    Among 10-day global procedures performed from July 1, 2017 through 
December 31, 2017, where it is possible to clearly match postoperative 
visits to specific procedures, only 4 percent had one or more matched 
visit reported with CPT code 99024. The percentage of 10-day global 
procedures with a matched visit reported with CPT code 99024 varied by 
specialty. Among procedures with 10-day global periods performed by 
hand surgeons, critical care, and obstetrics/gynecology, 44, 36, and 23 
percent, respectively, of procedures had a matched visit reported using 
CPT code 99024. In contrast, less than 5 percent of 10-day global 
procedures performed by many other specialties had a matched visit 
reported using CPT code 99024. Among 90-day global procedures performed 
from July 1, 2017 through December 31, 2017, where it is possible to 
clearly match postoperative visits to specific procedures, 67 percent 
had one or more matched visits reported using CPT code 99024.
    In the CY 2019 PFS proposed rule, we suggested one potential 
explanation for

[[Page 59504]]

these findings is that many practitioners are not consistently 
reporting postoperative visits using CPT code 99024. We sought comment 
on how to encourage reporting to ensure the validity of the data 
without imposing undue burden. Specifically, we sought comment on 
whether we need to do more to make practitioners aware of their 
obligation and whether we should consider implementing an enforcement 
mechanism.
    We sought comment on several other issues. Given the very small 
number of postoperative visits reported using CPT code 99024 during 10-
day global periods, we sought comment on whether or not it might be 
reasonable to assume that many visits included in the valuation of 10-
day global packages are not being furnished, or whether there are 
alternative explanations for what could be a significant level of 
underreporting of postoperative visits. Alternatively, we sought 
comment on whether it is possible that some or all of the postoperative 
visits are occurring after the global period ends and are, therefore, 
reported and paid separately.
    We sought comment on whether we should consider requiring use of 
modifiers -54 and -55 in cases where the surgeon does not expect to 
perform the postoperative visits, regardless of whether or not the 
transfer of care is formalized. We also sought comment on the best 
approach to 10-day global codes for which the preliminary data suggest 
that postoperative visits are rarely performed by the practitioner 
reporting the global code and whether we should consider changing the 
global period and reviewing the code valuation.
    The following is a summary of the comments we received on 
collecting data on global surgery and reporting.
    Comment: The majority of commenters, including the RUC, noted that 
more time was needed for physicians to become aware of reporting and 
prepare for reporting. Moreover, they opposed implementing an 
enforcement mechanism, but supported more efforts by CMS to make 
physicians aware of the requirement. A few commenters objected to 
reporting and noted that CMS had complied with the statute. MedPAC, 
which supported converting all 10- and 90-day global codes to 0-day 
global codes and revaluing these codes as 0-day codes, suggested that 
these findings are consistent with the OIG's three studies that showed 
post-operative visits were not occurring at the rate that we estimated. 
MedPAC noted support for converting all codes with 10- and 90-day 
global periods to 0-day global codes and revaluing these codes as 0-day 
codes, most other commenters were opposed to creating 0-day global 
services out of 10-day global services. Of those who commented on 
reporting of post-operative visits, most suggested that improving 
reporting of these visits is essential if the data is to be used to 
improve the accuracy of the existing codes.
    Response: We will evaluate the public comments received and 
consider whether to propose action at a future date. For the comment 
calling for additional efforts to make physicians aware of the 
requirement, we sent a letter describing the requirement to 
practitioners who are required to report in the 9 affected states and 
we plan to send another such letter to these practitioners. We will 
also consider other actions to make sure affected practitioners are 
aware of the requirement.

F. Radiologist Assistants

    In accordance with Sec.  410.32(b)(3), except as otherwise 
provided, all diagnostic X-ray and other diagnostic tests covered under 
section 1861(s)(3) of the Act and payable under the PFS must be 
furnished under at least a general level of physician supervision as 
defined in paragraph (b)(3)(i) of that regulation. In addition, some of 
these tests require either direct or personal supervision as defined in 
paragraphs (b)(3)(ii) or (iii) of Sec.  410.32, respectively. We list 
the required minimum physician supervision level for each diagnostic X-
ray and other diagnostic test service along with the codes and relative 
values for these services in the PFS Relative Value File, which is 
posted on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Relative-Value-Files.html. 
For most diagnostic imaging procedures, this required physician 
supervision level applies only to the technical component (TC) of the 
procedure.
    In response to the Request for Information on CMS Flexibilities and 
Efficiencies (RFI) that was issued in the CY 2018 PFS proposed rule (82 
FR 34172 through 34173), many commenters recommended that we revise the 
physician supervision requirements at Sec.  410.32(b) for diagnostic 
tests with a focus on those that are typically furnished by a 
radiologist assistant (RA) under the supervision of a physician. 
Specifically, the commenters stated that all diagnostic tests, when 
performed by RAs, can be furnished under direct supervision rather than 
personal supervision of a physician, and that we should revise the 
Medicare supervision requirements so that when RAs conduct diagnostic 
imaging tests that would otherwise require personal supervision, they 
only need to do so under direct supervision. In addition to increasing 
efficiency, stakeholders suggested that the current supervision 
requirements for certain diagnostic imaging services unduly restrict 
RAs from conducting tests that they are permitted to do under current 
law in many states.
    After consideration of these comments on the RFI, as well as 
information provided by stakeholders, we proposed to revise our 
regulations to specify that all diagnostic imaging tests may be 
furnished under the direct supervision of a physician when performed by 
an RA in accordance with state law and state scope of practice rules. 
Stakeholders representing the radiology community have provided us with 
information showing that the RA designation includes registered 
radiologist assistants (RRAs) who are certified by The American 
Registry of Radiologic Technologists, and radiology practitioner 
assistants (RPAs) who are certified by the Certification Board for 
Radiology Practitioner Assistants. We proposed to revise our regulation 
at Sec.  410.32 to add a new paragraph (b)(4) to state that diagnostic 
tests performed by an RRA or an RPA require only a direct level of 
physician supervision, when permitted by state law and state scope of 
practice regulations. We noted that for diagnostic imaging tests 
requiring a general level of physician supervision, this proposal would 
not change the level of physician supervision to direct supervision. 
Otherwise, the diagnostic imaging tests must be performed as specified 
elsewhere under Sec.  410.32(b). We based this proposal on 
recommendations from the practitioner community that included specific 
recommendations on how to implement the change. Representatives of the 
practitioner community submitted information on the education and 
clinical experience of RAs, which we took into consideration in 
determining whether the proposal would pose a significant risk to 
patient safety, and we determined that it would not. In addition, we 
considered information provided by stakeholders that indicated that 28 
states have statutes or regulations that recognize RAs, and these 
states have general or direct supervision requirements for RAs.
    Comment: Many commenters supported our proposed changes to the 
regulations and stated that they agreed that diagnostic tests performed 
by RAs be performed under at most direct supervision rather than 
personal

[[Page 59505]]

supervision where permitted by state law and state scope of practice 
regulations. According to these commenters, the change would allow for 
greater efficiency, improved patient access, more dedicated time with 
patients, increased quality of care, and increased patient 
satisfaction.
    Response: We appreciate the comments received in support of this 
proposal. As discussed in the proposed rule, for diagnostic imaging 
tests requiring a general level of physician supervision, we are not 
changing the level of physician supervision to direct supervision. 
Otherwise, the diagnostic imaging tests must be performed as specified 
elsewhere under Sec.  410.32(b). In order to provide further clarity, 
we are modifying the regulation to clarify that diagnostic tests 
performed by an RRA who is certified and registered by the American 
Registry of Radiologic Technologists or an RPA who is certified by the 
Certification Board for Radiology Practitioner Assistants, and that 
would otherwise require a personal level of supervision as specified in 
Sec.  410.32(b)(3), may be furnished under a direct level of physician 
supervision to the extent permitted by state law and state scope of 
practice regulations.
    Comment: Many commenters requested that CMS ensure that the 
proposed policy be effective January 1, 2019 by providing any necessary 
administrative guidance. Many commenters requested that CMS clarify in 
its final regulation that all services within the RA scope of practice, 
including procedures, may be performed under direct supervision.
    Response: In implementing these changes to the regulation, we will 
be updating guidance contained in Pub. 100-04, Medicare Claims 
Processing Manual, Chapter 23 (available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/Pub100_23.html). Medicare supervision rules are only 
directly applicable to diagnostic tests, not procedures. We note that 
for procedures provided by auxiliary personnel (such as a radiologist 
assistant) incident to the services of the billing physician or 
practitioner, Medicare generally requires direct supervision in 
accordance with the regulation at Sec.  410.26(b)(5).
    Comment: One commenter suggested that CMS require verbal assurances 
to patients as to the credentials of the health care professional 
conducting the procedure, when the procedure is performed by an RA. The 
commenter stated that requiring this verbal assurance will minimize 
confusion about who the physician is when there are multiple 
individuals furnishing the procedure.
    Response: We believe such a requirement would be unwarranted and 
overly restrictive. We do not generally require practitioners to 
provide such assurances to Medicare beneficiaries, nor did we propose 
such a requirement in the proposed rule.
    Comment: Several commenters suggested that CMS should 
operationalize the proposal starting January 1, 2019 by using a 
radiologist supervision indicator to recognize the RA under direct 
supervision rather than personal supervision when they provide Medicare 
services under their state scope of practice. These commenters 
requested the creation of a new supervision indicator that would be 
applied to specific codes and would indicate that the procedure may be 
performed under the direct supervision of a radiologist when performed 
by an RRA who is certified by The American Registry of Radiologic 
Technologists, and an RPA who is certified by the Certification Board 
for Radiology Practitioner Assistants.
    Response: Our approach to effectuating this policy change was based 
on recommendations we received from the practitioner community. Under 
this approach, we allow for direct supervision for tests performed in 
part by an RA, which avoids the need to identify which CPT codes would 
be appropriate for inclusion under a new indicator. We believe our 
approach offers the most flexibility, ease of implementation, and 
subsequently reduces burden for billing practitioners and radiologist 
assistants.
    After consideration of the public comments received, we are 
finalizing, with refinements for further clarity, our proposed 
revisions to Sec.  410.32, by adding a new paragraph (b)(4) that states 
that diagnostic tests that are performed by a registered radiologist 
assistant (RRA) who is certified and registered by the American 
Registry of Radiologic Technologists or a radiology practitioner 
assistant (RPA) who is certified by the Certification Board for 
Radiology Practitioner Assistants, and that would otherwise require a 
personal level of supervision as specified in paragraph (3), may be 
furnished under a direct level of physician supervision to the extent 
permitted by state law and state scope of practice regulations.

G. Payment Rates Under the Medicare PFS for Nonexcepted Items and 
Services Furnished by Nonexcepted Off-Campus Provider-Based Departments 
of a Hospital

1. Background
    Sections 1833(t)(1)(B)(v) and (t)(21) of the Act require that 
certain items and services furnished by certain off-campus provider-
based departments (PBDs) (collectively referenced here as nonexcepted 
items and services furnished by nonexcepted off-campus PBDs) shall not 
be considered covered outpatient department (OPD) services for purposes 
of payment under the Hospital Outpatient Prospective Payment System 
(OPPS), and payment for those nonexcepted items and services furnished 
on or after January 1, 2017 shall be made under the applicable payment 
system under Medicare Part B if the requirements for such payment are 
otherwise met. These requirements were enacted in section 603 of the 
Bipartisan Budget Act of 2015 (Pub. L. 114-74, enacted November 2, 
2015).
    In the CY 2017 OPPS/Ambulatory Surgical Center (ASC) final rule 
with comment period (81 FR 79699 through 79719), we established several 
policies and provisions to define the scope of nonexcepted items and 
services in nonexcepted off-campus PBDs. We also finalized the PFS as 
the applicable payment system for most nonexcepted items and services 
furnished by nonexcepted off-campus PBDs. At the same time, we issued 
an interim final rule with comment period (81 FR 79720 through 79729) 
in which we established payment policies under the PFS for nonexcepted 
items and services furnished on or after January 1, 2017. In the 
following paragraphs, we summarize the policies that we adopted for CY 
2017 and CY 2018. We also summarize proposals for CY 2019, respond to 
public comments, and finalize payment policies for CY 2019. For issues 
related to the excepted status of off-campus PBDs or the excepted 
status of items and services, please see the CY 2019 OPPS/ASC final 
rule.
2. Payment Mechanism
    In establishing the PFS as the applicable payment system for most 
nonexcepted items and services in nonexcepted off-campus PBDs under 
sections 1833(t)(1)(B)(v) and (t)(21) of the Act, we recognized that 
there was no technological capability, at least in the near term, to 
allow off-campus PBDs to bill under the PFS for those nonexcepted items 
and services. Off-campus PBDs bill under the OPPS for their services on 
an institutional claim,

[[Page 59506]]

while physicians and other suppliers bill under the PFS on a 
practitioner claim. The two systems that process these different types 
of claims, the Fiscal Intermediary Standard System (FISS) and the 
Multi-Carrier System (MCS) system, respectively, were not designed to 
accept or process claims of a different type. To permit an off-campus 
PBD to bill directly under a different payment system than the OPPS 
would have required significant changes to these complex systems as 
well as other systems involved in the processing of Medicare Part B 
claims. Consequently, we proposed and finalized a policy for CY 2017 
and CY 2018 in which nonexcepted off-campus PBDs continue to bill for 
nonexcepted items and services on the institutional claim utilizing a 
new claim line modifier ``PN'' to indicate that an item or service is a 
nonexcepted item or service.
    We implemented requirements under section 1833(t)(1)(B) of the Act 
for CY 2017 and CY 2018 by applying an overall downward scaling factor, 
called the PFS Relativity Adjuster to payments for nonexcepted items 
and services furnished in nonexcepted off-campus PBDs. The PFS 
Relativity Adjuster generally reflects the average (weighted by claim 
line volume times rate) of the site-specific rate under the PFS 
compared to the rate under the OPPS (weighted by claim line volume 
times rate) for nonexcepted items and services furnished in nonexcepted 
off-campus PBDs. As we have discussed extensively in prior rulemaking 
(81 FR 97920 through 97929 and 82 FR 53021), we established a new set 
of site-specific payment rates under the PFS that reflect the relative 
resource cost of furnishing the technical component (TC) of services 
furnished in nonexcepted off-campus PBDs. For the majority of HCPCS 
codes, these rates are based on either (1) the difference between the 
PFS nonfacility payment rate and the PFS facility rate, (2) the TC, or 
(3) in instances where payment would have been made only to the 
facility or to the physician, the full nonfacility rate. The PFS 
Relativity Adjuster refers to the percentage of the OPPS payment amount 
paid under the PFS for a nonexcepted item or service to the nonexcepted 
off-campus PBD.
    To operationalize the PFS Relativity Adjuster as a mechanism to pay 
for nonexcepted items and services furnished by nonexcepted off-campus 
PBDs, we adopted the packaging payment rates and multiple procedure 
payment reduction (MPPR) percentage that applies under the OPPS. We 
also incorporated the claims processing logic that is used for payments 
under the OPPS for comprehensive Ambulatory Payment Classifications (C-
APCs), conditionally and unconditionally packaged items and services, 
and major procedures. As we noted in the CY 2017 PFS final rule (82 FR 
53024), we believe that this maintains the integrity of the cost-
specific relativity of current payments under the OPPS compared with 
those under the PFS.
    In CY 2017, we implemented a PFS Relativity Adjuster of 50 percent 
of the OPPS rate for nonexcepted items and services furnished in 
nonexcepted off-campus PBDs. For a detailed explanation of how we 
developed the PFS Relativity Adjuster of 50 percent for CY 2017, 
including assumptions and exclusions, we refer readers to the CY 2017 
OPPS/ASC interim final rule with comment period (81 FR 79720 through 
79729). Beginning for CY 2018, we adopted a PFS Relativity Adjuster of 
40 percent of the OPPS rate. For a detailed explanation of how we 
developed the PFS Relativity Adjuster of 40 percent, we refer readers 
to the CY 2018 PFS final rule (82 FR 53019 through 53042). A brief 
overview of the general approach we took for CY 2018 and how it differs 
from the proposal for CY 2019 appears in this section.
3. The PFS Relativity Adjuster
    The PFS Relativity Adjuster reflects the overall relativity of the 
applicable payment rate for nonexcepted items and services furnished in 
nonexcepted off-campus PBDs under the PFS compared with the rate under 
the OPPS. To develop the PFS Relativity Adjuster for CY 2017, we did 
not have all of the claims data needed to identify the mix of items and 
services that would be billed using the ``PN'' modifier. Instead, we 
analyzed hospital outpatient claims data from January 1 through August 
25, 2016, that contained the ``PO'' modifier, which was a new mandatory 
reporting requirement for CY 2016 for claims that were billed by an 
off-campus department of a hospital. We limited our analysis to those 
claims billed on the 13X Type of Bill because those claims were used 
for Medicare Part B billing under the OPPS. We then identified the 25 
most frequently billed major codes that were billed by claim line; that 
is, items and services that were separately payable or conditionally 
packaged. Specifically, we restricted our analysis to codes with OPPS 
status indicators (SI) ``J1'', ``J2'', ``Q1'', ``Q2'', ``Q3'', ``S'', 
``T'', or ``V''. The most frequently billed service with the ``PO'' 
modifier in CY 2016 was described by HCPCS code G0463 (Hospital 
outpatient clinic visit for the assessment and management of a 
patient), which, in CY 2016, was paid under APC 5012 at a rate of 
$102.12; the total number of claim lines for this service was 
approximately 6.7 million as of August 2016. Under the PFS, there are 
10 CPT codes describing different levels of office visits for new and 
established payments. We compared the payment rate under OPPS for HCPCS 
code G0463 ($102.12) to the average of the difference between the 
nonfacility and facility rates for CPT code 99213 (Level III office 
visit for an established patient) and CPT code 99214 (Level IV office 
visit for an established patient) in CY 2016 and found that the 
relative payment difference was approximately 22 percent. We did not 
include HCPCS code G0463 in our calculation of the PFS Relativity 
Adjuster for CY 2017 because we were concerned that there was no 
single, directly comparable code under the PFS. As we stated in the CY 
2017 PFS final rule (81 FR 79723), we wanted to mitigate the risk of 
underestimating the overall relativity between the PFS and OPPS rates. 
From the remaining top 24 most frequently billed codes, we excluded 
HCPCS code 36591 (Collection of blood specimen from a completely 
implantable venous access device) because, under PFS policies, the 
service was only separately payable under the PFS when no other code 
was on the claim. We also removed HCPCS code G0009 (Administration of 
Pneumococcal Vaccine) because there was no payment for this code under 
the PFS. For the remaining top 22 codes furnished with the ``PO'' 
modifier in CY 2016, the average (weighted by claim line volume times 
rate) of the nonfacility payment rate estimate for the PFS compared to 
the estimate for the OPPS was 45 percent. We indicated that, because of 
our inability to estimate the effect of the packaging difference 
between the OPPS and the PFS, we would assume a 5 percentage point 
adjustment upward from the calculated amount of 45 percent; therefore, 
we established the PFS Relativity Adjuster of 50 percent for CY 2017.
    In establishing the PFS Relativity Adjuster for CY 2018, we still 
did not have claims data for items and services furnished reported with 
a ``PN'' modifier. However, we updated the list of the 25 most 
frequently billed HCPCS codes using an entire year (CY 2016) of claims 
data for services submitted with a ``PO'' modifier and we updated the 
corresponding utilization weights for the codes used in the analysis. 
The order and composition of the top 25 separately payable HCPCS codes, 
based on the full year of claims from CY 2016

[[Page 59507]]

submitted with the ``PO'' modifier, changed minimally from the codes we 
used in our original analysis for the CY 2017 OPPS/ASC interim final 
rule with comment period. For a detailed list of the HCPCS codes we 
used in calculating the CY 2017 PFS Relativity Adjuster and the CY 2018 
PFS Relativity Adjuster, we refer readers to the CY 2018 PFS final rule 
(82 FR 53030 through 53031). As noted earlier, in establishing the PFS 
Relativity Adjuster of 50 percent for CY 2017, we did not include in 
the weighted average code comparison, the relative rate for the most 
frequently billed service furnished in off-campus PBDs, HCPCS code 
G0463 (Hospital outpatient clinic visit for assessment and management 
of a patient), in part to ensure that we were not underestimating the 
overall relativity between the PFS and the OPPS. In contrast, in the CY 
2018 PFS final rule, we stated that our objective for CY 2018 was to 
ensure that we did not overestimate the appropriate overall payment 
relativity, and that the payment made to nonexcepted off-campus PBDs 
better aligned with the services that are most frequently furnished in 
the setting. Therefore, in addition to using updated claims data, we 
revised the PFS Relativity Adjuster to incorporate the relative payment 
rate for HCPCS code G0463 into our analysis. We followed all other 
exclusions and assumptions that were made in calculating the CY 2017 
PFS Relativity Adjuster. Our analysis resulted in a 35 percent relative 
difference in payment rates. Similar to our stated rationale in the CY 
2017 PFS final rule, we increased the PFS Relativity Adjuster to 40 
percent, acknowledging the difficulty of estimating the effect of the 
packaging differences between the OPPS and the PFS.
4. Payment Policies for CY 2019
    In prior rulemaking, we stated our expectation that our general 
approach of adjusting OPPS payments using a single scaling factor, the 
PFS Relativity Adjuster, would continue to be an appropriate payment 
mechanism to implement provisions of section 603 of the Bipartisan 
Budget Act of 2015, and would remain in place until we are able to 
establish code-specific reductions that represent the TC of services 
furnished under the PFS or until we are able to implement system 
changes needed to enable nonexcepted off-campus PBDs to bill for 
nonexcepted items and services under the PFS directly (82 FR 53029). As 
we continue to explore alternative options related to requirements 
under section 1833(t)(21)(C) of the Act, we believed that this overall 
approach is still appropriate, and we are finalizing our proposal to 
continue to allow nonexcepted off-campus PBDs to bill for nonexcepted 
items and services on an institutional claim using a ``PN'' modifier 
until we identify a workable alternative mechanism to improve payment 
accuracy.
    We made several adjustments to our methodology for calculating the 
PFS Relativity Adjuster for CY 2019. Most importantly, we had access to 
a full year of claims data from CY 2017 for services submitted with the 
``PN'' modifier. Incorporating these data allows us to improve the 
accuracy of the PFS Relativity Adjuster by accounting for the specific 
mix of nonexcepted items and services furnished in nonexcepted off-
campus PBDs. In analyzing the CY 2017 claims data, we identified just 
under 2,000 unique OPPS HCPCS/OPPS status indicator (SI) code pairs 
reported in CY 2017 with status indicators ``J1'', ``J2'', ``Q1'', 
``Q2'', ``Q3'', ``S'', ``T'', or ``V''. The data reinforce our previous 
observation that the single most frequently reported service furnished 
in nonexcepted off-campus PBDs is HCPCS code G0463. Approximately half 
of all claim lines for separately payable or conditionally packaged 
services furnished by nonexcepted off-campus PBDs included HCPCS code 
G0463 in CY 2017, representing over 30 percent of total Medicare 
payments for separately payable or conditionally packaged services. The 
top 30 HCPCS/SI code combinations accounted for over 80 percent of all 
claim lines and approximately 70 percent of Medicare payments for 
services that are separately billable or conditionally packaged. In 
contrast with prior analyses, we also looked at claims units, which 
reflect HCPCS/SI code combinations that are billed more than once on a 
claim line. Certain HCPCS codes are much more frequently billed in 
multiple units than others. The largest differences between the number 
of claim lines and the number of claims units are for injections and 
immunizations, which are not typically separately payable or 
conditionally packaged under the OPPS. For instance, HCPCS code Q9967 
(Low osmolar contrast material, 300-399 mg/ml iodine concentration, per 
ml) was reported in 12,268 claim lines, but 1,168,393 times (claims 
units) in the aggregate. HCPCS code Q9967 has an OPPS status indicator 
of ``N'', meaning that there is no separate payment under OPPS (items 
and services are packaged into APC rates). To calculate the PFS 
Relativity Adjuster using the full range of claims data submitted with 
a ``PN'' modifier in CY 2017, we first established site-specific rates 
under the PFS that reflect the TC of items and services furnished by 
nonexcepted off-campus PBDs in CY 2017. These HCPCS-level rates reflect 
our best current estimate of the amount that would have been paid for 
the service in the office setting under the PFS for practice expenses 
(PEs) not associated with the professional component (PC) of the 
service. As discussed in prior rulemaking (81 FR 79720 through 79729), 
we believe the most appropriate code-level comparison would reflect the 
TC of each HCPCS code under the PFS. However, we do not currently 
calculate a separate TC rate for all HCPCS codes under the PFS--only 
for those for which the PC and TC of the service are distinct and can 
be separately billed by two different practitioners or other suppliers 
under the PFS. For most of the remainder of services that do not have a 
separately payable TC under the PFS, we estimated the site-specific 
rate as (1) the difference between the PFS nonfacility rate and the PFS 
facility rate, or (2) in instances where payment would have been made 
only to the facility or only to the physician, the full nonfacility 
rate. As with the PFS rates that we developed when calculating the PFS 
Relativity Adjuster for CY 2017 and CY 2018, there were large code-
level differences between the applicable PFS rate and the OPPS rate.
    In calculating the proposed PFS Relativity Adjuster for CY 2019, we 
employed the same fundamental methodology that we used to calculate the 
PFS Relativity Adjuster for CY 2017 and CY 2018. We began by limiting 
our analysis to the items and services billed in CY 2017 with a ``PN'' 
modifier that are separately payable or conditionally packaged under 
the OPPS (status indicator = ``J1'', ``J2'', ``Q1'', ``Q2'', ``Q3'', 
``S'', ``T'', or ``V'') and compared the rates for these codes under 
the OPPS with the site-specific rates under the PFS. Next, we imputed 
PFS rates for a limited number of items and services that are 
separately payable or conditionally packaged under the OPPS but are 
contractor priced under the PFS. We also imputed PFS rates for some 
HCPCS codes that are not separately payable under the OPPS (SI = 
``N''), but are separately payable under the PFS. This includes items 
and services with an indicator status of ``X'' under the PFS, which are 
statutorily excluded from payment under the PFS, but may be paid under 
a different fee schedule, such as the Clinical Lab Fee Schedule (CLFS). 
We summed the HCPCS-level

[[Page 59508]]

rates under the PFS across all nonexcepted items and services, weighted 
by the number of HCPCS code claims units for each service. Next, we 
calculated the sum of the HCPCS-level OPPS rate for items and services 
that are separately payable or conditionally packaged, also weighted by 
the number of HCPCS code claims units. We compared the weighted sum of 
the site-specific PFS rate with the weighted sum of the OPPS rate for 
items and services reported in CY 2017 and we found that our updated 
analysis supports maintaining a PFS Relativity Adjuster of 40 percent. 
In view of this analysis, we proposed to continue applying a PFS 
Relativity Adjuster of 40 percent for CY 2019. Moreover, we proposed to 
maintain this PFS Relativity Adjuster for future years until updated 
data or other considerations indicate that an alternative adjuster or a 
change to our approach is warranted, which we will then propose through 
notice and comment rulemaking. We discuss some of our ongoing data 
analyses and future plans regarding implementation of section 603 of 
the Bipartisan Budget Act of 2015 in this section.
    Comment: Several commenters were disappointed that CMS did not 
provide the same level of detail regarding the data and methodology 
used in calculating the PFS Relativity Adjuster for CY 2019 as we had 
in prior rulemaking (CY 2017 and CY 2018). In particular, these 
commenters noted that we had previously included specific HCPCS codes 
that comprised the top 25 reported, the number of claims lines for each 
HCPCS code, and the associated PFS payment rates we used to estimate 
the appropriate adjuster. Some commenters maintained that the lack of 
specific HCPCS codes and associated PFS payment rates prevented them 
from replicating our analysis and commenting on the merits of 
maintaining the 40 percent PFS Relativity Adjuster.
    Response: We understand and appreciate commenters' interest in 
replicating our analysis using the full set of claims data and PFS 
payment rates we used to conduct our analysis. However, we do not agree 
that commenters were not able to conduct their own analysis for 
purposes of evaluating our proposal. The principal data sources in the 
analysis are the OPPS CY 2017 rates, the CY 2017 PFS rates, and 
institutional claims data for items and services furnished in CY 2017 
that included the ``PN'' modifier, which are publicly available 
resources. We did not receive specific inquiries indicating that 
commenters tried to reproduce our results using these data sources (or 
other data sources), nor did we receive any specific alternatives for 
consideration. As we noted in the proposed rule, the methodological 
aspects of our proposed PFS Relativity Adjuster calculation for CY 2019 
differ from the calculation for CY 2017 and CY 2018 by the following 
two adjustments: (1) Development of site specific technical-equivalent 
rates under the PFS for all HCPCS codes reported on a claim with the 
``PN'' modifier in CY 2017; and (2) the addition of OPPS SI ``N'' 
claims data to the PFS component of the PFS Relativity Adjuster 
equation to reflect items and services that are packaged under OPPS but 
paid separately under the PFS. We imputed certain PFS rates, such as 
for codes that are contractor priced under the PFS, because those would 
be paid at the contractor price if the claim had been submitted in a 
freestanding office. We remind commenters that adding PFS rates to the 
analysis, where such rates would not have otherwise been included, has 
the effect of increasing the PFS Relativity Adjuster since the 
aggregate PFS payment amount increases relative to the aggregate OPPS 
payment amount. Nonetheless, we appreciate the commenters' interest in 
validating the results of our analysis. For the convenience of 
commenters wishing to conduct analysis of differences in payment rates 
between off-campus PBDs and freestanding offices for similar services, 
we are providing a public use file (PUF), available on the CMS website 
under the ``downloads'' section for this final rule containing the CY 
2017 PFS technical-equivalent payment rates for all HCPCS codes 
reported on an institutional claim with the ``PN'' modifier, as well as 
the OPPS payment rate and the number of claims units by OPPS SI (see 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched).
    Comment: Commenters posed specific questions about our PFS 
Relativity Adjuster calculations and requested that CMS provide 
additional detail about the calendar year we used for OPPS and PFS 
rates, the specific HCPCS codes for which we imputed PFS rates, our 
rationale for weighting the data using claims units instead of claims 
lines, and if our analysis accounted for the more extensive packaging 
that occurs under the OPPS compared with the PFS.
    Response: Although we addressed much, if not all, of the 
information requested by these commenters in the discussion of our 
methodology in the proposed rule, we provide the following summary, 
along with additional detail on specific aspects of our analysis to 
respond explicitly to commenters' questions. We began our analysis to 
identify the proposed CY 2019 PFS Relativity Adjuster by examining a 
full year of claims data for services furnished in CY 2017 that were 
reported on an institutional claim form and appended with the ``PN'' 
modifier. Because claims processed through the institutional setting 
are adjudicated based on the OPPS SI, our unit of analysis was the 
number of claims units at the HCPCS/SI code level. We used claim units 
instead of claim lines because this metric accounts for instances when 
a HCPCS code is reported multiple times on the same claim line. We made 
this methodological change in formulating our proposal for CY 2019 in 
large part to address commenters' concerns from prior years that our 
calculations may underrepresent PFS payment for HCPCS codes that would 
have been paid multiple times under the PFS if they were reported 
separately. For the majority of HCPCS/SI code combinations that were 
reported with the ``PN'' modifier, there is little difference between 
the number of claim lines and claim units. However, because more units 
are separately paid under the PFS than under the OPPS, using claims 
units rather than claims lines yielded a slightly higher PFS Relativity 
Adjuster.
    For CY 2019, our proposed PFS Relativity Adjuster was based on all 
HCPCS codes that were submitted on an institutional claim form in CY 
2017, appended with the ``PN'' modifier in order to improve the 
accuracy of the overall payment comparison using the best data 
available regarding the actual mix of services furnished in nonexcepted 
off-campus PBDs. In contrast, for CYs 2017 and 2018, we used only a 
subset of claims from CY 2016 because of known limitations regarding 
the data available at the time. In particular, the data from CY 2016 
were based on claims that were appended with the ``PO'' modifier, which 
was a new reporting requirement for CY 2016. Although the ``PO'' 
modifier allowed us to distinguish items and services furnished in off-
campus PBDs in CY 2016, it did not allow us to distinguish between 
excepted and nonexcepted off-campus PBDs. The ``PN'' modifier, which 
was a new reporting requirement for CY 2017, allows us to make the 
distinction between excepted and nonexcepted off-campus PBDs.
    In updating our analysis for calculating the proposed PFS 
Relativity Adjuster for CY 2019 to include all HCPCS codes that were 
reported on an institutional claim with the ``PN'' modifier, we also 
extended to all HCPCS

[[Page 59509]]

codes our earlier logic with regard to calculating the site specific 
rates that represent the technical-equivalent of the resource costs of 
furnishing a service under the PFS. This amount, as we discussed in the 
proposed rule, generally reflected: (1) The difference between the PFS 
nonfacility payment rate and the PFS facility rate; (2) the TC; or (3) 
in instances where payment would have been made only to the facility or 
only to the physician, the full nonfacility rate. Applying the same 
logic to the fuller range of HCPCS codes, we developed site specific 
rates for all HCPCS codes that are nationally priced under the PFS and 
we referred to them as the technical-equivalent rates.
    To continue with our analysis, we combined the CY 2017 OPPS rates 
at the HCPCS code level with the CY 2017 claims data representing 
nonexcepted items and services furnished in nonexcepted off-campus 
PBDs. Next, we added the technical-equivalent PFS rates for each HCPCS 
code, calculated using the approach described above. For both the OPPS 
and the PFS portions of the PFS Relativity Adjuster calculations, we 
weighted our analysis of HCPCS/SI code combinations by the number of 
claims units. For the OPPS component of the calculation, we restricted 
our analysis to HCPCS/SI code combinations that had OPPS SI indicators 
``J1'', ``J2'', ``Q1'', ``Q2'', ``Q3'', ``S'', ``T'', or ``V'', which 
are separately payable or conditionally packaged codes under the OPPS. 
We multiplied the number of claims units for each HCPCS/SI code 
combination by the OPPS rate for each HCPCS/SI code combination and 
summed across the weighted rates. To calculate the PFS component of the 
PFS Relativity Adjuster, we used the same OPPS/SI code combinations, 
but we also included claims for HCPCS codes with OPPS SI ``N'', which 
indicates that, under the OPPS, payment for these services is packaged 
into payment for other services. We multiplied the number of claims 
units for each HCPCS/SI code combination by the technical-equivalent 
PFS rate for each HCPCS code and summed across the HCPCS/SI code 
combinations. We believe that adding weighted rates for HCPCS codes 
with OPPS SI ``N'' to the PFS allows us to better adjust, although 
imprecisely, for the packaging under the OPPS of nonexcepted items and 
services for which separate payment would typically be made under the 
PFS in the office setting. Although we did not conduct code-level 
analysis to estimate packaging under the OPPS, we believe that the 
combination of using the full range of claims data for nonexcepted 
items and services furnished in nonexcepted off-campus PBDs, using 
claim units rather than claim lines to weight rates on both the OPPS 
and PFS, and adding PFS rates for HCPCS codes with OPPS status 
indicator ``N'' is an improved approach to the PFS Relativity Adjuster 
that better accounts for OPPS packaging policies.
    To increase the precision of our analysis, we imputed payment rates 
under the PFS for certain HCPCS codes for which payment is based on 
rates other than national PFS pricing. For services that are 
contractor-priced under the PFS, as indicated by a PFS status indicator 
of ``C'', we applied the national median allowed charge for these 
services in CY 2017. For a limited number of other services, where 
appropriate, we incorporated rates from the applicable fee schedule 
under which the service may have been paid if furnished in a 
freestanding office. For instance, HCPCS codes with a PFS status 
indicator of either ``X'' (service is statutorily excluded for payment 
under PFS) or ``E'' (service is excluded from payment under PFS by 
regulation), may be paid under the CLFS or the National Limitation 
Amount (NLA). The imputed values that we used, both from contractor 
priced codes and other fee schedules, are included in the data file 
that will be posted with this final rule, available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Although there remains a certain level of imprecision inherent in 
our analysis, we believe the margin of error is relatively small and 
would likely affect the PFS and OPPS amounts similarly. For instance, 
we did not take into account the several MPPRs that would reduce 
payment on the PFS side when multiple codes are billed together. In 
many cases, these codes are packaged under the OPPS, so not including 
the PFS MPPRs in our analysis has the effect of increasing the PFS 
component of the calculation by a marginal amount. Likewise, we 
recognize that because of existing packaging rules under the OPPS, 
there is likely to be underreporting of codes on institutional claims 
for which the hospital does not receive separate payment, but for which 
the practitioner might receive separate payment if furnished in a 
freestanding office and reported on a professional claim form. This 
would effectively reduce the PFS Relativity Adjuster, but only to the 
extent hospitals are not appropriately reporting furnished items and 
services.
    Comment: Many commenters expressed that the appropriate point of 
comparison for PFS technical-equivalent rates is the full nonfacility 
rate rather than the difference between the nonfacility rate and the 
facility rate. The commenters stated that since hospitals, like 
freestanding offices, incur both direct and indirect costs when 
services are furnished in nonexcepted off-campus PBDs, the difference 
between the nonfacility rate and the facility rate does not 
appropriately account for indirect costs incurred by the facility.
    Response: We believe the commenters misunderstood the methodology 
for allocating direct and indirect costs as part of the PFS ratesetting 
process. Under the PFS algorithm for allocating indirect costs, 
nonfacility PFS rates include indirect PE that is directly related to 
the resources associated with the professional portion of the service 
alone. In other words, this is the indirect PE that is also paid by 
Medicare to professionals like physicians when they report services in 
the hospital setting. In addition to these indirect PE RVUs, 
nonfacility PFS rates include indirect PE RVUs allocated based on the 
direct PE inputs. We believe these indirect costs, those associated 
with provision of the technical aspects of the service alone, are 
analogous to those incurred by facilities when professionals furnish 
services there. To be clear, even when the total nonfacility rates are 
reduced by the facility rates, there are remaining PE RVUs that result 
from both direct inputs and indirect allocations under the established 
PFS methodology. We agree with the commenters that nonexcepted off-
campus PBDs incur indirect costs, but we believe our calculation for 
the technical-equivalent PFS rates includes the relative resource costs 
of indirect expenses involved in furnishing the services. We also note 
that CMS makes corresponding payments under the PFS at the facility 
rate for nonexcepted items and services furnished in nonexcepted off-
campus PBD settings, meaning that CMS is already paying for some of the 
indirect expenses associated with the PCs of the service. If CMS were 
to use the full nonfacility PE RVUs as the basis for comparing PFS 
rates to OPPS rates, we would effectively be paying twice for a portion 
of indirect costs, once under the PFS for the PC of services and again 
through the PFS Relativity Adjusted payment under the OPPS to off-
campus PBDs for the facility part of the same service.
    We recognize that the process of allocating indirect costs under 
the PFS is built on assumptions about

[[Page 59510]]

organizational practices and healthcare payment structures that may not 
fully reflect the current health care delivery environment, especially 
where physicians and other professionals are paid under salaried 
arrangements by institutions such as hospitals. Under the current PFS 
payment methodology, we assume that indirect costs associated with 
professional services furnished in institutions like hospital PBDs are 
incurred by the individual practitioners and not by the institutions. 
We may consider this issue for future rulemaking.
    Comment: A commenter requested that CMS clarify how, in calculating 
the PFS Relativity Adjuster, CMS treated codes that are valued under 
the PFS only in a facility setting. Because these HCPCS codes do not 
have PE inputs reflecting the specific costs of furnishing a service in 
a freestanding office, the commenter stated concern that these codes 
may have been incorrectly incorporated in the analysis at a PFS payment 
rate of zero.
    Response: We appreciate the commenter's concern and the opportunity 
to clarify the way we treated services not priced in the nonfacility 
setting in calculating the PFS Relativity Adjuster. Because there are 
no PFS payment rates for these services in the nonfacility setting, we 
incorporated the OPPS rate as the technical equivalent rate under the 
PFS.
    Comment: Several commenters were opposed to our proposal to 
maintain the PFS Relativity Adjuster at 40 percent, citing both the 
lack of transparency in our methodology and prior analyses provided by 
the American Hospital Association (AHA) in earlier notice and comment 
rulemaking, suggesting that a 65 percent PFS Relativity Adjuster would 
appropriately incorporate into the Adjuster the additional packaging 
that occurs under the OPPS. Two commenters urged CMS to implement a 75 
percent PFS Relativity Adjuster for CY 2019, although no specific 
rationale was given.
    Response: We accounted for packaging under the OPPS by including 
PFS payment rates for HCPCS codes that were reported with OPPS SI 
``N''. Our analysis does not support a PFS Relativity Adjuster of 65 or 
75 percent, but rather indicates that a PFS Relativity Adjuster of 40 
percent appropriately accounts for packaging of services under the 
OPPS. For additional discussion of the challenges related to 
incorporating the effect of packaging into the PFS Relativity Adjuster, 
we refer readers to the CY 2018 PFS final rule (82 FR 53024 through 
53022).
    Comment: A commenter stated that CMS has not provided sufficient 
justification for continuation of a reduction in payment of 60 percent 
for nonexcepted items and services furnished in nonexcepted off campus 
PBDs. Commenters noted that the first 2017 claims from the initial 
period of implementation of this policy are only now being incorporated 
into CMS claims files. The commenter indicated that there is an 
insufficient volume of claims to determine the impact this policy is 
having on beneficiary access to services in the PBD setting, 
particularly at the 40 percent Relativity Adjuster. The commenter 
stated that CMS should, at minimum, restore the 50 percent PFS 
Relativity Adjuster that was in place for CY 2017.
    Response: We appreciate the commenter's suggestions, but we do not 
agree that there is insufficient data to support the PFS Relativity 
Adjuster of 40 percent. We have no reason to believe that the CY 2017 
claims data are not as robust as any other claims based analysis and, 
to the extent that we recognize, acknowledge, and try to account for 
difference in payment policies between the PFS and OPPS, we believe our 
analysis demonstrates that a PFS Relativity Adjuster of 40 percent is 
appropriate.
    Comment: Several commenters supported the 40 percent PFS Relativity 
Adjuster for CY 2019 and future years because this will provide 
stability for clinicians practicing in these settings and not disrupt 
patient access to care. One commenter cited the importance of making 
gradual changes to site neutrality policies to ensure alignment with 
other rapid changes in Medicare and the private sector regarding 
provider payment, including the movement to value-based purchasing and 
alternative payment systems.
    Response: We agree with the commenter that there is value in the 
stability of maintaining the PFS Relativity Adjuster at 40 percent, 
particularly to the extent that this enables continuity of care for 
beneficiaries. We appreciate the support from commenters.
    Comment: Some commenters, rather than opposing any particular PFS 
Relativity Adjuster, expressed disappointment that CMS did not propose 
to make broader changes to implement site-neutrality under section 603 
of the Bipartisan Budget Act of 2015. Commenters were displeased that 
CMS is continuing to implement the requirements of the legislation 
using a single scaling factor applied to payment rates under the OPPS. 
Instead, they stated CMS should revise the applicable payment rates to 
appropriately reimburse for services provided by off-campus PBDs. 
Commenters did not provide specific suggestions for implementing 
alternative policies, but several commenters noted that a single 
overall scaling factor was intended by CMS to be an interim, not a long 
term policy solution. A few commenters suggested that the PFS 
Relativity Adjuster as a mechanism for implementing section 603 of the 
Bipartisan Budget Act of 2015 is not consistent with the requirement 
under that section to pay for nonexcepted items and services under the 
applicable payment system because this approach is still fundamentally 
based on OPPS payment rates. Other commenters stated that nonexcepted 
off-campus PBDs differ from one another in the mix of services 
furnished and the beneficiary population and that CMS payment policies 
should reflect those variances.
    Despite concerns about the appropriateness of the PFS Relativity 
Adjuster for implementing requirements under section 603 of the 
Bipartisan Budget Act of 2015, several of the same commenters pointed 
out that there are significant advantages of continuing to allow 
hospitals to bill for items and services furnished in nonexcepted PBDs 
using the institutional claim form. In particular, they stated, this 
allows PBDs to properly use cost reporting procedures and to accurately 
reconcile the cost report to hospital ledgers for all services and 
departments and to correctly allow revenue for nonexcepted PBDs to flow 
through the Provider Statistical and Reimbursement (PS&R) report.
    Response: We previously expressed interest in exploring how 
hospitals might report and receive payment for nonexcepted items and 
services furnished in nonexcepted off-campus PBDs using the standard 
PFS payment rates based on HCPCS-specific RVUs. However, CMS does not 
currently develop as part of the PFS ratesetting process separate 
payment rates for the technical aspects of the full range of 
nonexcepted items and services furnished in nonexcepted off-campus PBDs 
specifically for services for which there are not separately valued PCs 
and TCs. As such, we do not have a consistent way for nonexcepted off-
campus PBDs and the professionals who furnish services in those 
settings to bill for the respective portions of the services for which 
they incurred costs. Additionally, while the statute was amended to 
change the nature and payment of nonexcepted items and services 
furnished in nonexcepted off-campus PBDs, the amendments did not

[[Page 59511]]

alter the status of non-excepted off-campus PBDs as parts of hospitals. 
Nonexcepted off-campus PBDs are still required to follow all reporting 
and regulatory policies consistent with hospital settings.
    We continue to explore options that would allow hospitals to report 
nonexcepted items and services on an institutional claim form but 
receive payments that more directly reflect the technical aspect of 
services under the PFS. In general, we believe there may be additional 
utility, especially in the context of improving price transparency for 
Medicare beneficiaries, in establishing and displaying a set of payment 
rates, recalculated annually as part of the annual PFS rulemaking 
cycle, that reflect the relative resource costs of the technical 
aspects of furnishing PFS services.
    Along with this final rule, we are including the technical-
equivalent rates that we developed specifically for calculating the PFS 
Relativity Adjuster for CY 2019, which is the current mechanism for 
implementing the PFS as the applicable payment system for nonexcepted 
items and services furnished in nonexcepted off-campus PBDs. This 
information is being made available under the downloads section for 
this final rule on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Comment: Several commenters supported our ongoing efforts to 
implement site neutral payments in the context of section 603 of the 
Bipartisan Budget Act of 2015. Several commenters indicated their 
support for additional policies that would equalize payment across 
freestanding offices and hospital PBDs, both on-campus and off-campus.
    Response: We recognize that this is a topic of great interest to 
many commenters and we welcome the range of perspectives and ideas 
posed by commenters.
    Comment: Some commenters disagreed with our view that the 
amendments under section 603 of the Bipartisan Budget Act of 2015 were 
intended to produce site neutral payments between freestanding offices 
and off-campus PBDs with the goal of removing incentives for hospitals 
to purchase physician offices. These commenters noted that hospital 
PBDs face higher costs than freestanding offices, such as those 
associated with regulatory requirements, and reducing payment to 
nonexcepted off-campus PBDs threatens the viability of hospitals that 
serve a vital role in providing services to rural and underserved 
communities in these off-campus settings. We received several comment 
letters from Medicare beneficiaries expressing concern about reduced 
payments to their community's major medical hospital offsite locations. 
The commenters stated that without the hospital's offsite locations 
community members would be forced to drive unreasonable distances to 
seek basic and immediate care.
    Response: We understand the commenters' concerns, especially with 
regard to maintaining access to appropriate care. CMS continues to 
evaluate data regarding beneficiary access to care to identify possible 
issues. We also agree that hospitals face additional regulatory and 
operational costs not generally incurred by physician offices, and that 
OPDs of a hospital function as an important and integral part of the 
Medicare care delivery infrastructure. However, many off-campus PBDs 
are similar to physician's offices and do not necessarily have the same 
operational costs as the main hospital. We believe that the amendments 
made to the statute by section 603 of the Bipartisan Budget Act of 2015 
were intended to reduce Medicare payment incentives for hospitals to 
purchase physician offices, convert them to off-campus PBDs, and bill 
under the OPPS for items and services furnished there.
    Comment: Several commenters opposed our inclusion of the proposal 
related to payment for nonexcepted off-campus PBDs under the CY 2019 
PFS rule instead of the CY 2019 OPPS/ASC rule. They suggested that 
proposals related to the payment rate for nonexcepted items and 
services furnished in nonexcepted off-campus PBDs are inseparable from 
proposals and comment solicitations in the OPPS/ASC rule related to 
service line expansions and other payment policies related to 
implementation of the amendments under section 603 of the Bipartisan 
Budget Act of 2015. Some commenters suggested that, for purposes of 
administrative simplification, the discussion of any changes to site-
of-service payments regarding PBDs of a hospital should be fully 
maintained within a single rule and recommended this be included in the 
OPPS rule. Some commenters expressed concern that the PFS and OPPS 
proposed rules were not released at the same time and that this 
presents challenges for them in reconciling and preparing their 
comments on each rule.
    Response: We appreciate commenters' concerns about responding to 
two separate rules for policies associated with payment for nonexcepted 
items and services furnished in nonexcepted off-campus PBDs. However, 
we note that in finalizing the PFS as the applicable payment system for 
most nonexcepted items and services, proposals related to the 
implementation of payment rates under the PFS fall reasonably under the 
purview of PFS rulemaking, while proposals related to the applicability 
of those rates are more appropriately addressed in OPPS/ASC rulemaking. 
We will consider these concerns for future rulemaking.
    We believe that our proposal to maintain the PFS Relativity 
Adjuster at 40 percent for CY 2019 and for future years reflects an 
analysis that accounts for many of the concerns expressed by commenters 
regarding the PFS Relativity Adjuster in prior rules. Therefore, we are 
finalizing the proposal to maintain the PFS Relativity Adjuster at 40 
percent for CY 2019 and beyond until there is an appropriate reason and 
process for implementing an alternative to our current policy, at which 
time we will make a proposal through notice and comment rulemaking.
5. Policies Related to Supervision, Beneficiary Cost-Sharing, and 
Geographic Adjustments
    In the CY 2018 PFS final rule (81FR 53019 through 53031), we 
finalized policies related to supervision rules, beneficiary cost 
sharing, and geographic adjustments. We finalized that supervision 
rules in nonexcepted off-campus PBDs that furnish nonexcepted items and 
services are the same as those that apply for hospitals, in general. We 
also finalized that all beneficiary cost sharing rules that apply under 
the PFS in accordance with sections 1848(g) and 1866(a)(2)(A) of the 
Act continue to apply when payment is made under the PFS for 
nonexcepted items and services furnished by nonexcepted off-campus 
PBDs, regardless of cost sharing obligations under the OPPS. Lastly, we 
finalized the policy to apply the same geographic adjustments used 
under the OPPS to nonexcepted items and services furnished in 
nonexcepted off-campus PBDs. We are maintaining these policies for CY 
2019, as finalized in the CY 2018 PFS final rule.
6. Partial Hospitalization
a. Partial Hospitalization Services
    Partial hospitalization programs (PHPs) are intensive outpatient 
psychiatric day treatment programs furnished to patients as an 
alternative to inpatient psychiatric hospitalization, or as a stepdown 
to shorten an inpatient stay and transition a patient to a less 
intensive level of care. Section

[[Page 59512]]

1861(ff)(3)(A) of the Act specifies that a PHP is a program furnished 
by a hospital, to its outpatients, or by a community mental health 
center (CMHC). In the CY 2017 OPPS/ASC proposed rule (81 FR 45690), in 
the discussion of the proposed implementation of section 603 of 
Bipartisan Budget Act of 2015, we noted that because CMHCs also furnish 
PHP services and are ineligible to be provider-based to a hospital, a 
nonexcepted off-campus PBD would be eligible for PHP payment if the 
entity enrolls and bills as a CMHC for payment under the OPPS. We 
further noted that a hospital may choose to enroll a nonexcepted off-
campus PBD as a CMHC, provided it meets all Medicare requirements and 
conditions of participation.
    In response to that rule, commenters expressed concern that without 
a clear payment mechanism for PHP services furnished by nonexcepted 
off-campus PBDs, access to partial hospitalization services would be 
limited, and pointed out the critical role PHPs play in the continuum 
of mental health care. Many commenters noted that the Congress did not 
intend for partial hospitalization services to no longer be paid for by 
Medicare when such services are furnished by nonexcepted off-campus 
PBDs. Several commenters disagreed with the notion of enrolling as a 
CMHC in order to receive payment for PHP services. The commenters 
stated that hospital-based PHPs and CMHCs are inherently different in 
structure, operation, and payment, and noted that the conditions of 
participation for hospital departments and CMHCs are different. Several 
commenters requested that CMS find a mechanism to pay hospital-based 
PHPs in nonexcepted off-campus PBDs.
    We agreed with the commenters' concerns and adopted payment for 
partial hospitalization items and services furnished by nonexcepted 
off-campus PBDs under the PFS in the CY 2017 OPPS/ASC final rule with 
comment period and interim final rule with comment period (81 FR 79715, 
79717, and 79727). When billed in accordance with the CY 2017 PFS final 
rule, these partial hospitalization services are paid at the CMHC per 
diem rate for APC 5853, for providing three or more partial 
hospitalization services per day (81 FR 79727).
    In the CY 2017 OPPS/ASC proposed rule (81 FR 45681), and the CY 
2017 OPPS/ASC final rule with comment period/interim final rule with 
comment period (81 FR 79717 and 79727), we noted that when a 
beneficiary receives outpatient services in an off-campus department of 
a hospital, the total Medicare payment for those services is generally 
higher than when those same services are provided in a physician's 
office. Similarly, when partial hospitalization services are provided 
in a hospital-based PHP, Medicare pays more than when those same 
services are provided by a CMHC. Our rationale for adopting the CMHC 
per diem rate for APC 5853 as the PFS payment amount for nonexcepted 
off-campus PBDs providing PHP services is because CMHCs are 
freestanding entities that are not part of a hospital, but they provide 
the same PHP services as hospital-based PHPs (81 FR 79727). This is 
similar to the differences between freestanding entities paid under the 
PFS that furnish other services also provided by hospital-based 
entities. Similar to other entities currently paid for their TC 
services under the PFS, we believe CMHCs would typically have lower 
cost structures than hospital-based PHPs, largely due to lower overhead 
costs and other indirect costs such as administration, personnel, and 
security. We believe that paying for nonexcepted hospital-based partial 
hospitalization services at the lower CMHC per diem rate aligns with 
section 603 of Bipartisan Budget Act of 2015, while also preserving 
access to PHP services. In addition, nonexcepted off-campus PBDs will 
not be required to enroll as CMHCs in order to bill and be paid for 
providing partial hospitalization services. However, a nonexcepted off-
campus PBD that wishes to provide PHP services may still enroll as a 
CMHC if it chooses to do so and meets the relevant requirements. 
Finally, we recognize that because hospital-based PHPs are providing 
partial hospitalization services in the hospital outpatient setting, 
they can offer benefits that CMHCs do not have, such as an easier 
patient transition to and from inpatient care, and easier sharing of 
health information between the PHP and the inpatient staff.
    In the CY 2018 PFS final rule, we did not require these PHPs to 
enroll as CMHCs but instead we continued to pay nonexcepted off-campus 
PBDs providing PHP items and services under the PFS. Further, in that 
CY 2018 PFS final rule (82 FR 53025 to 53026), we continued to adopt 
the CMHC per diem rate for APC 5853 as the PFS payment amount for 
nonexcepted off-campus PBDs providing three or more PHP services per 
day in CY 2018.
    For CY 2019, we proposed to continue to identify the PFS as the 
applicable payment system for PHP services furnished by nonexcepted 
off-campus PBDs, and proposed to continue to set the PFS payment rate 
for these PHP services as the per diem rate that will be paid to a CMHC 
in CY 2019. We further proposed to maintain these policies for future 
years until updated data or other considerations indicate that a change 
to our approach is warranted, which we will then propose through notice 
and comment rulemaking.
    We received no comments on our PHP proposals for CY 2019 and future 
years, and are finalizing our policies as proposed.
7. Future Years
    We continue to believe the amendments made by section 603 of the 
Bipartisan Budget Act of 2015 were intended to reduce the Medicare 
payment incentive for hospitals to purchase physician offices, convert 
them to off-campus PBDs, and bill under the OPPS for items and services 
they furnish there. Therefore, we continue to believe the payment 
policy under this provision should ultimately equalize payment rates 
between nonexcepted off-campus PBDs and physician offices to the 
greatest extent possible, while allowing nonexcepted off-campus PBDs to 
bill in a straight-forward way for services they furnish.
    In developing our proposal for CY 2019 as described previously, we 
incorporated all HCPCS codes that appeared in CY 2017 claims data from 
nonexcepted off-campus PBDs. We also expanded the number of site 
specific, technical-equivalent rates for nonexcepted items and services 
furnished in nonexcepted off-campus PBDs, in order to ensure that 
Medicare payment to hospitals billing for nonexcepted items and 
services furnished by nonexcepted off-campus PBDs reflects the relative 
resources involved in furnishing the items and services. We recognize 
that for certain specialties, service lines, and nonexcepted off-campus 
PBDs, total Medicare payments for the same services might be either 
higher or lower when furnished by a nonexcepted off-campus PBD rather 
than in a physician office.
    We intend to continue to examine the claims data in order to assess 
whether a different PFS Relativity Adjuster is warranted and also to 
consider whether additional adjustments to the methodology are 
appropriate. In particular, we are monitoring claims for shifts in the 
mix of services furnished in nonexcepted off-campus PBDs that may 
affect the relativity between the PFS and OPPS. An increase over time 
in the share of nonexcepted items and services with lower technical-
equivalent rates under the PFS compared with APC rates

[[Page 59513]]

under the OPPS might result in a lower PFS Relativity Adjuster, for 
example. We will also carefully assess annual payment policy updates to 
the PFS and OPPS, respectively, to identify changes in overall 
relativity resulting from any new or modified policies, such as 
expanded packaging under the OPPS or an increase in the number of HCPCS 
codes with global periods under the PFS. As part of these ongoing 
efforts, we are also analyzing PFS claims data to identify patterns of 
services furnished together on the same day. We anticipate that this 
will ultimately allow us to make refinements to the PFS Relativity 
Adjuster to better account for the more extensive packaging of services 
under the OPPS and the potential underreporting of services that are 
not separately payable under the OPPS but are paid separately under the 
PFS.
    Another dimension of our ongoing efforts to improve implementation 
of section 603 of the Bipartisan Budget Act of 2015 is the development 
and refinement of a new set of payment rates under the PFS that reflect 
the relative resource costs of furnishing the TC of items and services 
furnished in nonexcepted off-campus PBDs. Although we believe that our 
site-specific HCPCS code-level rates reflect the best available 
estimate of the amount that would have been paid for the service in the 
office setting under the PFS for practice expenses not associated with 
the PC of the service, for the majority of HCPCS codes there is no 
established methodology for separately valuing the resource costs 
incurred by a provider while furnishing a service from those incurred 
exclusively by the facility in which the service is furnished. We 
continue to explore alternatives to our current estimates that would 
better reflect the TC of services furnished in nonexcepted off-campus 
PBDs. We are broadly interested in stakeholder feedback and 
recommendations for ways in which CMS can improve pricing and 
transparency with regard to the differences in the payment rates across 
sites of service.
    We expect that our continued analyses of claims data and our 
ongoing exploration of systems changes that are needed to allow 
nonexcepted off-campus PBDs to bill directly for the TC portion of 
nonexcepted items and services may lead us to consider a different 
approach for implementing section 603 of the Bipartisan Budget Act of 
2015. On the whole, however, we believe that a PFS Relativity Adjuster 
for CY 2019 of 40 percent advances efforts to equalize payment rates in 
the aggregate between physician offices and nonexcepted off-campus 
PBDs. Maintaining our policy of applying an overall scaling factor to 
OPPS payments allows hospitals to continue billing through a facility 
claim form and permits continued use of the packaging rules and cost 
report-based relative payment rate determinations for nonexcepted 
services.

H. Valuation of Specific Codes

1. Background: Process for Valuing New, Revised, and Potentially 
Misvalued Codes
    Establishing valuations for newly created and revised CPT codes is 
a routine part of maintaining the PFS. Since the inception of the PFS, 
it has also been a priority to revalue services regularly to make sure 
that the payment rates reflect the changing trends in the practice of 
medicine and current prices for inputs used in the PE calculations. 
Initially, this was accomplished primarily through the 5-year review 
process, which resulted in revised work RVUs for CY 1997, CY 2002, CY 
2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY 
2011, and revised MP RVUs in CY 2010 and CY 2015. Under the 5-year 
review process, revisions in RVUs were proposed and finalized via 
rulemaking. In addition to the 5-year reviews, beginning with CY 2009, 
CMS and the RUC identified a number of potentially misvalued codes each 
year using various identification screens, as discussed in section 
II.E. of this final rule, Potentially Misvalued Services under the PFS. 
Historically, when we received RUC recommendations, our process had 
been to establish interim final RVUs for the potentially misvalued 
codes, new codes, and any other codes for which there were coding 
changes in the final rule with comment period for a year. Then, during 
the 60-day period following the publication of the final rule with 
comment period, we accepted public comment about those valuations. For 
services furnished during the calendar year following the publication 
of interim final rates, we paid for services based upon the interim 
final values established in the final rule. In the final rule with 
comment period for the subsequent year, we considered and responded to 
public comments received on the interim final values, and typically 
made any appropriate adjustments and finalized those values.
    In the CY 2015 PFS final rule with comment period, we finalized a 
new process for establishing values for new, revised and potentially 
misvalued codes. Under the new process, we include proposed values for 
these services in the proposed rule, rather than establishing them as 
interim final in the final rule with comment period. Beginning with the 
CY 2017 PFS proposed rule, the new process was applicable to all codes, 
except for new codes that describe truly new services. For CY 2017, we 
proposed new values in the CY 2017 PFS proposed rule for the vast 
majority of new, revised, and potentially misvalued codes for which we 
received complete RUC recommendations by February 10, 2016. To complete 
the transition to this new process, for codes for which we established 
interim final values in the CY 2016 PFS final rule with comment period, 
we reviewed the comments received during the 60-day public comment 
period following release of the CY 2016 PFS final rule with comment 
period, and re-proposed values for those codes in the CY 2017 PFS 
proposed rule.
    We considered public comments received during the 60-day public 
comment period for the proposed rule before establishing final values 
in the CY 2017 PFS final rule. As part of our established process, we 
will adopt interim final values only in the case of wholly new services 
for which there are no predecessor codes or values and for which we do 
not receive recommendations in time to propose values. For CY 2017, we 
did not identify any new codes that described such wholly new services. 
Therefore, we did not establish any code values on an interim final 
basis.
    For CY 2018, we generally proposed the RUC-recommended work RVUs 
for new, revised, and potentially misvalued codes. We proposed these 
values based on our understanding that the RUC generally considers the 
kinds of concerns we historically raised regarding appropriate 
valuation of work RVUs. However, during our review of these recommended 
values, we identified some concerns similar to those we recognized in 
prior years. Given the relative nature of the PFS and our obligation to 
ensure that the RVUs reflect relative resource use, we included 
descriptions of potential alternative approaches we might have taken in 
developing work RVUs that differed from the RUC-recommended values. We 
sought comment on both the RUC-recommended values, as well as the 
alternatives considered. Several commenters generally supported the 
proposed use of the RUC-recommended work RVUs, without refinement. 
Other commenters expressed concern about the effect of the misvalued 
code reviews on particular specialties and settings and disappointment 
with our proposed

[[Page 59514]]

approach for valuing codes for CY 2018. A detailed summary of the 
comments and our responses can be found in the CY 2018 PFS final rule 
(82 FR 53033-53035).
    We clarified in response to commenters that we are not 
relinquishing our obligation to independently establish appropriate 
RVUs for services paid under the PFS. We will continue to thoroughly 
review and consider information we receive from the RUC, the Health 
Care Professionals Advisory Committee (HCPAC), public commenters, 
medical literature, Medicare claims data, comparative databases, 
comparison with other codes within the PFS, as well as consultation 
with other physicians and healthcare professionals within CMS and the 
federal government as part of our process for establishing valuations. 
Although generally proposing the RUC-recommended work RVUs for new, 
revised, and potentially misvalued codes was our approach for CY 2018, 
we note that we also included alternative values where we believed 
there was a possible opportunity for increased precision. We also 
clarified that as part of our obligation to establish RVUs for the PFS, 
we annually make an independent assessment of the available 
recommendations, supporting documentation, and other available 
information from the RUC and other commenters to determine the 
appropriate valuations. Where we concur that the RUC's recommendations, 
or recommendations from other commenters, are reasonable and 
appropriate and are consistent with the time and intensity paradigm of 
physician work, we propose those values as recommended. Additionally, 
we will continue to engage with stakeholders, including the RUC, with 
regard to our approach for accurately valuing codes, and as we 
prioritize our obligation to value new, revised, and potentially 
misvalued codes. We continue to welcome feedback from all interested 
parties regarding valuation of services for consideration through our 
rulemaking process.
2. Methodology for Establishing Work RVUs
    For each code identified in this section, we conducted a review 
that included the current work RVU (if any), RUC-recommended work RVU, 
intensity, time to furnish the preservice, intraservice, and 
postservice activities, as well as other components of the service that 
contribute to the value. Our reviews of recommended work RVUs and time 
inputs generally included, but had not been limited to, a review of 
information provided by the RUC, the HCPAC, and other public 
commenters, medical literature, and comparative databases, as well as a 
comparison with other codes within the PFS, consultation with other 
physicians and health care professionals within CMS and the federal 
government, as well as Medicare claims data. We also assessed the 
methodology and data used to develop the recommendations submitted to 
us by the RUC and other public commenters and the rationale for the 
recommendations. In the CY 2011 PFS final rule with comment period (75 
FR 73328 through 73329), we discussed a variety of methodologies and 
approaches used to develop work RVUs, including survey data, building 
blocks, crosswalks to key reference or similar codes, and magnitude 
estimation (see the CY 2011 PFS final rule with comment period (75 FR 
73328 through 73329) for more information). When referring to a survey, 
unless otherwise noted, we mean the surveys conducted by specialty 
societies as part of the formal RUC process.
    Components that we used in the building block approach may have 
included preservice, intraservice, or postservice time and post-
procedure visits. When referring to a bundled CPT code, the building 
block components could include the CPT codes that make up the bundled 
code and the inputs associated with those codes. We used the building 
block methodology to construct, or deconstruct, the work RVU for a CPT 
code based on component pieces of the code. Magnitude estimation refers 
to a methodology for valuing work that determines the appropriate work 
RVU for a service by gauging the total amount of work for that service 
relative to the work for a similar service across the PFS without 
explicitly valuing the components of that work. In addition to these 
methodologies, we frequently utilized an incremental methodology in 
which we value a code based upon its incremental difference between 
another code and another family of codes. The statute specifically 
defines the work component as the resources in time and intensity 
required in furnishing the service. Also, the published literature on 
valuing work has recognized the key role of time in overall work. For 
particular codes, we refined the work RVUs in direct proportion to the 
changes in the best information regarding the time resources involved 
in furnishing particular services, either considering the total time or 
the intraservice time.
    Several years ago, to aid in the development of preservice time 
recommendations for new and revised CPT codes, the RUC created 
standardized preservice time packages. The packages include preservice 
evaluation time, preservice positioning time, and preservice scrub, 
dress and wait time. Currently, there are preservice time packages for 
services typically furnished in the facility setting (for example, 
preservice time packages reflecting the different combinations of 
straightforward or difficult procedure, and straightforward or 
difficult patient). Currently, there are three preservice time packages 
for services typically furnished in the nonfacility setting.
    We developed several standard building block methodologies to value 
services appropriately when they have common billing patterns. In cases 
where a service is typically furnished to a beneficiary on the same day 
as an evaluation and management (E/M) service, we believe that there is 
overlap between the two services in some of the activities furnished 
during the preservice evaluation and postservice time. Our longstanding 
adjustments have reflected a broad assumption that at least one-third 
of the work time in both the preservice evaluation and postservice 
period is duplicative of work furnished during the E/M visit.
    Accordingly, in cases where we believe that the RUC has not 
adequately accounted for the overlapping activities in the recommended 
work RVU and/or times, we adjusted the work RVU and/or times to account 
for the overlap. The work RVU for a service is the product of the time 
involved in furnishing the service multiplied by the intensity of the 
work. Preservice evaluation time and postservice time both have a long-
established intensity of work per unit of time (IWPUT) of 0.0224, which 
means that 1 minute of preservice evaluation or postservice time 
equates to 0.0224 of a work RVU.
    Therefore, in many cases when we removed 2 minutes of preservice 
time and 2 minutes of postservice time from a procedure to account for 
the overlap with the same day E/M service, we also removed a work RVU 
of 0.09 (4 minutes x 0.0224 IWPUT) if we did not believe the overlap in 
time had already been accounted for in the work RVU. The RUC has 
recognized this valuation policy and, in many cases, now addresses the 
overlap in time and work when a service is typically furnished on the 
same day as an E/M service.
    The following paragraphs contain a general discussion of our 
approach to reviewing RUC recommendations and developing proposed 
values for specific codes. When they exist we also include a summary of 
stakeholder reactions to

[[Page 59515]]

our approach. We note that many commenters and stakeholders have 
expressed concerns over the years with our ongoing adjustment of work 
RVUs based on changes in the best information we had regarding the time 
resources involved in furnishing individual services. We have been 
particularly concerned with the RUC's and various specialty societies' 
objections to our approach given the significance of their 
recommendations to our process for valuing services and since much of 
the information we used to make the adjustments is derived from their 
survey process. We are obligated under the statute to consider both 
time and intensity in establishing work RVUs for PFS services. As 
explained in the CY 2016 PFS final rule with comment period (80 FR 
70933), we recognize that adjusting work RVUs for changes in time is 
not always a straightforward process, so we have applied various 
methodologies to identify several potential work values for individual 
codes.
    We have observed that for many codes reviewed by the RUC, 
recommended work RVUs have appeared to be incongruous with recommended 
assumptions regarding the resource costs in time. This has been the 
case for a significant portion of codes for which we recently 
established or proposed work RVUs that are based on refinements to the 
RUC-recommended values. When we have adjusted work RVUs to account for 
significant changes in time, we have started by looking at the change 
in the time in the context of the RUC-recommended work RVU. When the 
recommended work RVUs do not appear to account for significant changes 
in time, we have employed the different approaches to identify 
potential values that reconcile the recommended work RVUs with the 
recommended time values. Many of these methodologies, such as survey 
data, building block, crosswalks to key reference or similar codes, and 
magnitude estimation have long been used in developing work RVUs under 
the PFS. In addition to these, we sometimes used the relationship 
between the old time values and the new time values for particular 
services to identify alternative work RVUs based on changes in time 
components.
    In so doing, rather than ignoring the RUC-recommended value, we 
have used the recommended values as a starting reference and then 
applied one of these several methodologies to account for the 
reductions in time that we believe were not otherwise reflected in the 
RUC-recommended value. If we believed that such changes in time were 
already accounted for in the RUC's recommendation, then we did not make 
such adjustments. Likewise, we did not arbitrarily apply time ratios to 
current work RVUs to calculate proposed work RVUs. We used the ratios 
to identify potential work RVUs and considered these work RVUs as 
potential options relative to the values developed through other 
options.
    We do not imply that the decrease in time as reflected in survey 
values should always equate to a one-to-one or linear decrease in newly 
valued work RVUs. Instead, we have believed that, since the two 
components of work are time and intensity, absent an obvious or 
explicitly stated rationale for why the relative intensity of a given 
procedure has increased, significant decreases in time should be 
reflected in decreases to work RVUs. If the RUC's recommendation has 
appeared to disregard or dismiss the changes in time, without a 
persuasive explanation of why such a change should not be accounted for 
in the overall work of the service, then we have generally used one of 
the aforementioned methodologies to identify potential work RVUs, 
including the methodologies intended to account for the changes in the 
resources involved in furnishing the procedure.
    Several stakeholders, including the RUC, have expressed general 
objections to our use of these methodologies and deemed our actions in 
adjusting the recommended work RVUs as inappropriate; other 
stakeholders have also expressed general concerns with CMS refinements 
to RUC recommended values in general. In the CY 2017 PFS final rule (81 
FR 80272 through 80277) we responded in detail to several comments that 
we received regarding this issue. In the CY 2017 PFS proposed rule, we 
requested comments regarding potential alternatives to making 
adjustments that would recognize overall estimates of work in the 
context of changes in the resource of time for particular services; 
however, we did not receive any specific potential alternatives. As 
described earlier in this section, crosswalks to key reference or 
similar codes is one of the many methodological approaches we have 
employed to identify potential values that reconcile the RUC-recommend 
work RVUs with the recommended time values when the RUC-recommended 
work RVUs did not appear to account for significant changes in time.
    Following the publication of the CY 2019 PFS proposed rule, we 
received several comments noting that there was some confusion in the 
terminology between ``reference services'' and ``crosswalks.'' 
Commenters stated that ``reference services'' are services indicated by 
the specialty society or the RUC as a good comparator that demonstrates 
relativity using magnitude estimation as requiring similar physician 
work, time, intensity and complexity. ``Key reference services'' are 
the top two services selected by the survey respondents as most similar 
to the code being surveyed. By contrast, ``crosswalks'' are services 
that have similar or exact intraservice time and require the same 
physician work (that is, have the same work RVU), and the term 
``crosswalk'' should only be used when making a comparison to a CPT 
code with the identical work RVU. The commenters noted that these terms 
were used interchangeably in the proposed rule when they have distinct 
and separate meanings.
    In response to the commenters, we would like to clarify that the 
terms ``reference services'', ``key reference services'', and 
``crosswalks'' as described by the commenters are part of the RUC's 
process for code valuation. These are not terms that we created, and we 
do not agree that we necessarily must employ them in the identical 
fashion for the purposes of discussing our valuation of individual 
services that come up for review. However, in the interest of 
minimizing confusion and providing clear language to facilitate 
stakeholder feedback, we will seek to limit the use of the term, 
``crosswalk,'' to those cases where we are making a comparison to a CPT 
code with the identical work RVU.
    We look forward to continuing to engage with stakeholders and 
commenters, including the RUC, as we prioritize our obligation to value 
new, revised, and potentially misvalued codes; and will continue to 
welcome feedback from all interested parties regarding valuation of 
services for consideration through our rulemaking process. We refer 
readers to the detailed discussion in this section of the final 
valuation considered for specific codes. Table 13 contains a list of 
codes for which we are finalizing work RVUs; this includes all codes 
for which we received RUC recommendations by February 10, 2018. The 
finalized work RVUs, work time and other payment information for all CY 
2019 payable codes are available on the CMS website under downloads for 
the CY 2019 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html). Table 13 also 
contains the CPT code descriptors for all new, revised, and potentially 
misvalued codes discussed in this section.

[[Page 59516]]

3. Methodology for the Direct PE Inputs To Develop PE RVUs
a. Background
    On an annual basis, the RUC provides us with recommendations 
regarding PE inputs for new, revised, and potentially misvalued codes. 
We review the RUC-recommended direct PE inputs on a code by code basis. 
Like our review of recommended work RVUs, our review of recommended 
direct PE inputs generally includes, but is not limited to, a review of 
information provided by the RUC, HCPAC, and other public commenters, 
medical literature, and comparative databases, as well as a comparison 
with other codes within the PFS, and consultation with physicians and 
health care professionals within CMS and the federal government, as 
well as Medicare claims data. We also assess the methodology and data 
used to develop the recommendations submitted to us by the RUC and 
other public commenters and the rationale for the recommendations. When 
we determine that the RUC's recommendations appropriately estimate the 
direct PE inputs (clinical labor, disposable supplies, and medical 
equipment) required for the typical service, are consistent with the 
principles of relativity, and reflect our payment policies, we use 
those direct PE inputs to value a service. If not, we refine the 
recommended PE inputs to better reflect our estimate of the PE 
resources required for the service. We also confirm whether CPT codes 
should have facility and/or nonfacility direct PE inputs and refine the 
inputs accordingly.
    Our review and refinement of RUC-recommended direct PE inputs 
includes many refinements that are common across codes, as well as 
refinements that are specific to particular services. Table 14 details 
our refinements of the RUC's direct PE recommendations at the code-
specific level. In this final rule, we address several refinements that 
are common across codes, and refinements to particular codes are 
addressed in the portions of this section that are dedicated to 
particular codes. We note that for each refinement, we indicate the 
impact on direct costs for that service. We note that, on average, in 
any case where the impact on the direct cost for a particular 
refinement is $0.30 or less, the refinement has no impact on the PE 
RVUs. This calculation considers both the impact on the direct portion 
of the PE RVU, as well as the impact on the indirect allocator for the 
average service. We also note that nearly half of the refinements 
listed in Table 14 result in changes under the $0.30 threshold and are 
unlikely to result in a change to the RVUs.
    We also note that the finalized direct PE inputs for CY 2019 are 
displayed in the CY 2019 direct PE input database, available on the CMS 
website under the downloads for the CY 2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs 
displayed there have been used in developing the final CY 2019 PE RVUs 
as displayed in Addendum B.
b. Common Refinements
(1) Changes in Work Time
    Some direct PE inputs are directly affected by revisions in work 
time. Specifically, changes in the intraservice portions of the work 
time and changes in the number or level of postoperative visits 
associated with the global periods result in corresponding changes to 
direct PE inputs. The direct PE input recommendations generally 
correspond to the work time values associated with services. We believe 
that inadvertent discrepancies between work time values and direct PE 
inputs should be refined or adjusted in the establishment of proposed 
direct PE inputs to resolve the discrepancies.
(2) Equipment Time
    Prior to CY 2010, the RUC did not generally provide CMS with 
recommendations regarding equipment time inputs. In CY 2010, in the 
interest of ensuring the greatest possible degree of accuracy in 
allocating equipment minutes, we requested that the RUC provide 
equipment times along with the other direct PE recommendations, and we 
provided the RUC with general guidelines regarding appropriate 
equipment time inputs. We appreciate the RUC's willingness to provide 
us with these additional inputs as part of its PE recommendations.
    In general, the equipment time inputs correspond to the service 
period portion of the clinical labor times. We clarified this principle 
over several years of rulemaking, indicating that we consider equipment 
time as the time within the intraservice period when a clinician is 
using the piece of equipment plus any additional time that the piece of 
equipment is not available for use for another patient due to its use 
during the designated procedure. For those services for which we 
allocate cleaning time to portable equipment items, because the 
portable equipment does not need to be cleaned in the room where the 
service is furnished, we do not include that cleaning time for the 
remaining equipment items, as those items and the room are both 
available for use for other patients during that time. In addition, 
when a piece of equipment is typically used during follow-up 
postoperative visits included in the global period for a service, the 
equipment time would also reflect that use.
    We believe that certain highly technical pieces of equipment and 
equipment rooms are less likely to be used during all of the preservice 
or postservice tasks performed by clinical labor staff on the day of 
the procedure (the clinical labor service period) and are typically 
available for other patients even when one member of the clinical staff 
may be occupied with a preservice or postservice task related to the 
procedure. We also note that we believe these same assumptions would 
apply to inexpensive equipment items that are used in conjunction with 
and located in a room with non-portable highly technical equipment 
items since any items in the room in question would be available if the 
room is not being occupied by a particular patient. For additional 
information, we refer readers to our discussion of these issues in the 
CY 2012 PFS final rule with comment period (76 FR 73182) and the CY 
2015 PFS final rule with comment period (79 FR 67639).
(3) Standard Tasks and Minutes for Clinical Labor Tasks
    In general, the preservice, intraservice, and postservice clinical 
labor minutes associated with clinical labor inputs in the direct PE 
input database reflect the sum of particular tasks described in the 
information that accompanies the RUC-recommended direct PE inputs, 
commonly called the ``PE worksheets.'' For most of these described 
tasks, there is a standardized number of minutes, depending on the type 
of procedure, its typical setting, its global period, and the other 
procedures with which it is typically reported. The RUC sometimes 
recommends a number of minutes either greater than or less than the 
time typically allotted for certain tasks. In those cases, we review 
the deviations from the standards and any rationale provided for the 
deviations. When we do not accept the RUC-recommended exceptions, we 
refine the proposed direct PE inputs to conform to the standard times 
for those tasks. In addition, in cases when a service is typically 
billed with an E/M service, we remove the preservice clinical labor 
tasks to avoid duplicative inputs and to reflect the resource costs of 
furnishing the typical service.
    We refer readers to section II.B. of this final rule, Determination 
of Practice

[[Page 59517]]

Expense Relative Value Units (PE RVUs), for more information regarding 
the collaborative work of CMS and the RUC in improvements in 
standardizing clinical labor tasks.
(4) Recommended Items That Are Not Direct PE Inputs
    In some cases, the PE worksheets included with the RUC's 
recommendations include items that are not clinical labor, disposable 
supplies, or medical equipment or that cannot be allocated to 
individual services or patients. We addressed these kinds of 
recommendations in previous rulemaking (78 FR 74242), and we do not use 
items included in these recommendations as direct PE inputs in the 
calculation of PE RVUs.
(5) New Supply and Equipment Items
    The RUC generally recommends the use of supply and equipment items 
that already exist in the direct PE input database for new, revised, 
and potentially misvalued codes. Some recommendations, however, include 
supply or equipment items that are not currently in the direct PE input 
database. In these cases, the RUC has historically recommended that a 
new item be created and has facilitated our pricing of that item by 
working with the specialty societies to provide us copies of sales 
invoices. For CY 2019, we received invoices for several new supply and 
equipment items. Tables 14 and 15 detail the invoices received for new 
and existing items in the direct PE database. As discussed in section 
II.B. of this final rule, we encouraged stakeholders to review the 
prices associated with these new and existing items to determine 
whether these prices appear to be accurate. Where prices appear 
inaccurate, we encouraged stakeholders to submit invoices or other 
information to improve the accuracy of pricing for these items in the 
direct PE database by February 10th of the following year for 
consideration in future rulemaking, similar to our process for 
consideration of RUC recommendations.
    We remind stakeholders that due to the relativity inherent in the 
development of RVUs, reductions in existing prices for any items in the 
direct PE database increase the pool of direct PE RVUs available to all 
other PFS services. Tables 14 and 15 also include the number of 
invoices received and the number of nonfacility allowed services for 
procedures that use these equipment items. We provide the nonfacility 
allowed services so that stakeholders will note the impact the 
particular price might have on PE relativity, as well as to identify 
items that are used frequently, since we believe that stakeholders are 
more likely to have better pricing information for items used more 
frequently. A single invoice may not be reflective of typical costs and 
we encourage stakeholders to provide additional invoices so that we 
might identify and use accurate prices in the development of PE RVUs.
    In some cases, we do not use the price listed on the invoice that 
accompanies the recommendation because we identify publicly available 
alternative prices or information that suggests a different price is 
more accurate. In these cases, we include this in the discussion of 
these codes. In other cases, we cannot adequately price a newly 
recommended item due to inadequate information. Sometimes, no 
supporting information regarding the price of the item has been 
included in the recommendation. In other cases, the supporting 
information does not demonstrate that the item has been purchased at 
the listed price (for example, vendor price quotes instead of paid 
invoices). In cases where the information provided on the item allows 
us to identify clinically appropriate proxy items, we might use 
existing items as proxies for the newly recommended items. In other 
cases, we included the item in the direct PE input database without any 
associated price. Although including the item without an associated 
price means that the item does not contribute to the calculation of the 
final PE RVU for particular services, it facilitates our ability to 
incorporate a price once we obtain information and are able to do so.
(6) Service Period Clinical Labor Time in the Facility Setting
    Generally speaking, our direct PE inputs do not include clinical 
labor minutes assigned to the service period because the cost of 
clinical labor during the service period for a procedure in the 
facility setting is not considered a resource cost to the practitioner 
since Medicare makes separate payment to the facility for these costs. 
We address proposed code-specific refinements to clinical labor in the 
individual code sections.
(7) Procedures Subject to the Multiple Procedure Payment Reduction 
(MPPR) and the OPPS Cap
    We note that the public use files for the PFS proposed and final 
rules for each year display the services subject to the MPPR lists on 
diagnostic cardiovascular services, diagnostic imaging services, 
diagnostic ophthalmology services, and therapy services. We also 
include a list of procedures that meet the definition of imaging under 
section 1848(b)(4)(B) of the Act, and therefore, are subject to the 
OPPS cap for the upcoming calendar year. The public use files for CY 
2019 are available on the CMS website under downloads for the CY 2019 
PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. For more 
information regarding the history of the MPPR policy, we refer readers 
to the CY 2014 PFS final rule with comment period (78 FR 74261-74263). 
For more information regarding the history of the OPPS cap, we refer 
readers to the CY 2007 PFS final rule with comment period (71 FR 69659-
69662).
4. Valuation of Specific Codes for CY 2019
(1) Fine Needle Aspiration (CPT Codes 10021, 10004, 10005, 10006, 
10007, 10008, 10009, 10010, 10011, 10012, 76492, 77002 and 77021)
    CPT code 10021 was identified as part of the OPPS cap payment 
proposal in CY 2014 (78 FR 74246-74248), and it was reviewed by the RUC 
for direct PE inputs only as part of the CY 2016 rule cycle. 
Afterwards, CPT codes 10021 and 10022 were referred to the CPT 
Editorial Panel to consider adding additional clarifying language to 
the code descriptors and to include bundled imaging guidance due to the 
fact that imaging had become typical with these services. In June 2017, 
the CPT Editorial Panel deleted CPT code 10022, revised CPT code 10021, 
and created nine new codes to describe fine needle aspiration 
procedures with and without imaging guidance. These ten codes were 
surveyed and reviewed for the October 2017 and January 2018 RUC 
meetings. Several imaging services were also reviewed along with the 
rest of the code family, although only CPT code 77021 was subject to a 
new survey.
    For CY 2019, we proposed the RUC-recommended work RVU for seven of 
the ten codes in this family. Specifically, we proposed a work RVU of 
0.80 for CPT code 10004 (Fine needle aspiration biopsy; without imaging 
guidance; each additional lesion), a work RVU of 1.00 for CPT code 
10006 (Fine needle aspiration biopsy, including ultrasound guidance; 
each additional lesion), a work RVU of 1.81 for CPT code 10007 (Fine 
needle aspiration biopsy, including fluoroscopic guidance; first 
lesion), a work RVU of 1.18 for CPT code 10008 (Fine needle aspiration 
biopsy, including fluoroscopic guidance; each additional lesion), and a 
work RVU of

[[Page 59518]]

1.65 for CPT code 10010 (Fine needle aspiration biopsy, including CT 
guidance; each additional lesion). We also proposed to assign the 
recommended contractor-priced status to CPT codes 10011 (Fine needle 
aspiration biopsy, including MR guidance; first lesion) and 10012 (Fine 
needle aspiration biopsy, including MR guidance; each additional 
lesion) due to low utilization until these services are more widely 
utilized. In addition, we proposed the recommended work RVU of 1.50 for 
CPT code 77021 (Magnetic resonance guidance for needle placement (e.g., 
for biopsy, fine needle aspiration biopsy, injection, or placement of 
localization device) radiological supervision and interpretation), as 
well as proposed to reaffirm the current work RVUs of 0.67 for CPT code 
76942 (Ultrasonic guidance for needle placement (e.g., biopsy, fine 
needle aspiration biopsy, injection, localization device), imaging 
supervision and interpretation) and 0.54 for 77002 (Fluoroscopic 
guidance for needle placement (e.g., biopsy, fine needle aspiration 
biopsy, injection, localization device)).
    We disagreed with the RUC-recommended work RVU of 1.20 for CPT code 
10021 (Fine needle aspiration biopsy; without imaging guidance; first 
lesion) and proposed a work RVU of 1.03 based on a direct crosswalk to 
CPT code 36440 (Push transfusion, blood, 2 years or younger). CPT code 
36440 is a recently reviewed code with the same intraservice time of 15 
minutes and 2 additional minutes of total time. In reviewing CPT code 
10021, we noted that the recommended intraservice time is decreasing 
from 17 minutes to 15 minutes (12 percent reduction), and the 
recommended total time is decreasing from 48 minutes to 33 minutes (32 
percent reduction); however, the RUC-recommended work RVU is only 
decreasing from 1.27 to 1.20, which is a reduction of just over 5 
percent. Although we did not imply that the decrease in time as 
reflected in survey values must equate to a one-to-one or linear 
decrease in the valuation of work RVUs, we believe that since the two 
components of work are time and intensity, significant decreases in 
time should be appropriately reflected in decreases to work RVUs. In 
the case of CPT code 10021, we believed that it was more accurate to 
propose a work RVU of 1.03 based on a crosswalk to CPT code 36440 to 
account for these decreases in the surveyed work time.
    We disagreed with the RUC-recommended work RVU of 1.63 for CPT code 
10005 (Fine needle aspiration biopsy, including ultrasound guidance; 
first lesion) and proposed a work RVU of 1.46. Although we disagreed 
with the RUC-recommended work RVU, we concurred that the relative 
difference in work between CPT codes 10021 and 10005 is equivalent to 
the recommended interval of 0.43 RVUs. Therefore, we proposed a work 
RVU of 1.46 for CPT code 10005, based on the recommended interval of 
0.43 additional RVUs above our proposed work RVU of 1.03 for CPT code 
10021. The proposed increment of 0.43 RVUs above CPT code 10021 was 
also based on the use of two crosswalk codes: CPT code 99225 
(Subsequent observation care, per day, for the evaluation and 
management of a patient, which requires at least 2 of 3 key 
components); and CPT code 99232 (Subsequent hospital care, per day, for 
the evaluation and management of a patient, which requires at least 2 
of 3 key components). Both of these codes have the same intraservice 
time and 1 additional minute of total time as compared with CPT code 
10005, and both crosswalk codes share a work RVU of 1.39.
    We disagreed with the RUC-recommended work RVU of 2.43 for CPT code 
10009 (Fine needle aspiration biopsy, including CT guidance; first 
lesion) and we proposed a work RVU of 2.26. Although we disagreed with 
the RUC-recommended work RVU, we concurred that the relative difference 
in work between CPT codes 10021 and 10009 is equivalent to the 
recommended interval of 1.23 RVUs. Therefore, we proposed a work RVU of 
2.26 for CPT code 10009, based on the recommended interval of 1.23 
additional RVUs above our proposed work RVU of 1.03 for CPT code 10021. 
The proposed use of the recommended increment from CPT code 10021 was 
also based on the use of a crosswalk to CPT code 74263 (Computed 
tomographic (CT) colonography, screening, including image 
postprocessing), another CT procedure with 38 minutes of intraservice 
time and 50 minutes of total time at a work RVU of 2.28.
    We noted that the recommended work pool is increasing by 
approximately 20 percent for the Fine Needle Aspiration family as a 
whole, while the recommended work time pool for the same codes is only 
increasing by about 2 percent. Since time is defined as one of the two 
components of work, we believed that this indicated a discrepancy in 
the recommended work values. We do not believe that the recoding of the 
services in this family has resulted in an increase in their intensity, 
only a change in the way in which they will be reported, and therefore, 
we do not believe that it would serve the interests of relativity to 
propose the recommended work values for all of the codes in this 
family. We believe that, generally speaking, the recoding of a family 
of services should maintain the same total work pool, as the services 
themselves are not changing, only the coding structure under which they 
are being reported. We also noted that through the bundling of some of 
these frequently reported services, it is reasonable to expect that the 
new coding system will achieve savings via elimination of duplicative 
assumptions of the resources involved in furnishing particular 
servicers. For example, a practitioner will not be carrying out the 
full preservice work twice for CPT codes 10022 and 76942, but 
preservice times were assigned to both of the codes under the old 
coding. We believe the new coding assigns more accurate work times and 
thus reflects efficiencies in resource costs that existed regardless of 
how the services were previously reported.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Prepare room, equipment and supplies'' (CA013) activity 
to 3 minutes and to refine the clinical labor time for the ``Confirm 
order, protocol exam'' (CA014) activity to 0 minutes for CPT code 
77021. This code did not previously have clinical labor time assigned 
for the ``Confirm order, protocol exam'' clinical labor task, and we do 
not have any reason to believe that the services being furnished by the 
clinical staff have changed, only the way in which this clinical labor 
time has been presented on the PE worksheets. We also noted that there 
is no effect on the total clinical labor direct costs in these 
situations, since the same 3 minutes of clinical labor time is still 
being furnished. We also proposed to refine the equipment times in 
accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the Fine Needle Aspiration family of codes.
    Comment: Several commenters disagreed with the CMS statement in the 
proposed rule that the RUC-recommended work pool was increasing by 
approximately 20 percent for this family of codes. Commenters stated 
that the work pool based on the RUC-recommended values would actually 
decrease by 15 percent and that the CMS work valuations were based on a 
flawed methodology that did not account for the associated savings with 
bundling the image guidance codes. One of the commenters supplied a 
table with data to support the claim that the work

[[Page 59519]]

pool based on the RUC-recommended values would decrease by 15 percent 
rather than increasing by 20 percent.
    Response: We disagree with the commenters that the work pool would 
decrease by 15 percent if we were to finalize the RUC recommendations. 
We investigated the data in the table submitted by the commenters, and 
we believe that there are several methodological flaws in the analysis 
it contains. First, there are a number of 0.00 work RVUs listed in the 
``RUC Recommended RVUs'' column for the new codes, which results in an 
incorrect amount of ``New/Rev Total RVUs'' when multiplied by the 
utilization for the new codes. As an example, CPT code 10005 has 
approximately 135,000 services that are counted as having a work RVU of 
0.00 in this table instead of the RUC-recommended work RVU of 1.63, 
which undercounts the total number of RVUs by a wide margin. Second, 
the values in the ``Total Source RVUs'' include the ratios from the 
utilization crosswalk (listed on the table as ``Percent''). We do not 
understand why these ratios would be used to calculate the total source 
RVUs, as this side of the work pool comparison is calculated from the 
utilization of the source codes times the work RVUs of the source 
codes. Third, the imaging guidance codes are not fully included in both 
sides of the comparison on this table, with their work RVUs included in 
the source RVU total but not in the new/revised RVU total. This uneven 
comparison results in an inaccurate tally of the work pools from before 
and after the coding revisions take place.
    In the interest of providing transparency, we are including Table 
12 with our work pool comparison for the Fine Needle Aspiration code 
family.

                                                  Table 12--Fine Needle Aspiration Work Pool Comparison
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                           Utilization   Utilization    Work RVU      Work pool     Work RVU      Work pool     Work pool    Work pool %
               HCPCS code                    source      destination     source        source      destination   destination   RVU change      change
--------------------------------------------------------------------------------------------------------------------------------------------------------
10021...................................        23,755        21,380          1.27        30,169          1.20        25,655        -4,513           -15
10004...................................             0         2,376          0.00             0          0.80         1,900         1,900  ............
10005...................................             0       270,753          0.00             0          1.63       441,327       441,327  ............
10006...................................             0        30,621          0.00             0          1.00        30,621        30,621  ............
10007...................................             0         6,857          0.00             0          1.81        12,411        12,411  ............
10008...................................             0           873          0.00             0          1.18         1,030         1,030  ............
10009...................................             0        60,665          0.00             0          2.43       147,416       147,416  ............
10010...................................             0         6,831          0.00             0          1.65        11,271        11,271  ............
10011...................................             0            83          0.00             0             C             0             0  ............
10012...................................             0             3          0.00             0             C             0             0  ............
10022...................................       186,455             0          1.27       236,798          0.00             0      -236,798          -100
76942...................................       558,081       488,321          0.67       373,914          0.67       327,175       -46,739           -13
7694226.................................       641,346       561,178          0.67       429,702          0.67       375,989       -53,713           -13
76942TC.................................         8,588         7,515          0.00             0          0.00             0             0  ............
77002...................................       311,280       308,790          0.54       168,091          0.54       166,746        -1,345            -1
7700226.................................       180,964       179,516          0.54        97,721          0.54        96,939          -782            -1
77002TC.................................         7,936         7,873          0.00             0          0.00             0             0  ............
77012...................................         9,343         7,792          1.16        10,838          1.50        11,688           850             8
7701226.................................       194,611       162,306          1.16       225,749          1.50       243,458        17,710             8
77012TC.................................           469           391          0.00             0          0.00             0             0  ............
77021...................................         1,481         1,432          1.50         2,222          1.50         2,148           -73            -3
7702126.................................         1,038         1,004          1.50         1,557          1.50         1,506           -51            -3
77021TC.................................            67            65          0.00             0          0.00             0             0  ............
                                         ---------------------------------------------------------------------------------------------------------------
    Totals..............................     2,125,414     2,126,622  ............     1,576,760  ............     1,897,282       320,523            20
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We continue to believe that the RUC-recommended work pool is 
increasing by approximately 20 percent for the Fine Needle Aspiration 
family as a whole, and that this percentage increase suggests that CPT 
codes 10021, 10005, and 10009 are more accurately valued at the CMS 
proposed work RVUs.
    Comment: Several commenters disagreed that this code family will 
achieve savings via elimination of duplicative assumptions of the 
resources involved in furnishing particular services. Commenters stated 
that there is no overlap between the current descriptions of work for 
the bundled codes, and that CPT code 10022 is never performed on the 
same patient without an image guidance code and the image guidance 
codes are never performed on the same patient without a corresponding 
procedure code. The commenters stated that any associated reduction in 
payment would be due to other factors, not due to the code bundling.
    Response: We disagree with the commenters that there would be no 
savings achieved via elimination of duplicative assumptions of the 
resources involved in furnishing particular services. As we stated in 
the proposed rule, a practitioner will not be carrying out the full 
preservice work twice for CPT codes 10022 and 76942, but preservice 
times were assigned to both of the codes under the old coding. In 
similar fashion, these codes both separately include immediate 
postservice work time for dictating a report in their clinical 
vignettes. This is an example of how savings are achieved via 
elimination of duplicative assumptions of resources, as the 
practitioner will only dictate a single report in the newly created CPT 
code 10005 that bundles these two services together. We continue to 
believe that the new coding assigns more accurate work times and thus 
reflects efficiencies in resource costs that existed regardless of how 
the services were previously reported.
    Comment: One commenter stated that while it may be true 
mathematically that the work pool for this family of codes was 
increasing by 20 percent, using this observation as the sole basis to 
implement work value relies on incorrect assumptions which do not 
adhere to current relativity-based RUC methodologies. The commenter 
stated that the rationale proposed by CMS incorrectly implies that the 
decrease in time as reflected in survey values must equate to a one to 
one or linear decrease in the valuation of work RVUs and fails to 
recognize changes in intensity that have taken place over time.
    Response: We disagree with the commenter that our analysis of 
changes in the work pool for this family of codes was the sole basis 
for the proposed refinements to the work RVUs. While

[[Page 59520]]

this was an important factor in our analysis of the work valuation of 
individual codes, we also detailed in the proposed rule our use of time 
ratios, increments, and crosswalk codes as part of our larger 
methodology to determine work RVUs. We specifically stated that we did 
not imply that the decrease in time as reflected in survey values must 
equate to a one-to-one or linear decrease in the valuation of work 
RVUs, but rather that we believe that since the two components of work 
are time and intensity, significant decreases in time should be 
appropriately reflected in decreases to work RVUs. We do consider 
changes in intensity that have taken place over time as part of our 
analysis of work valuation, as demonstrated by the fact that we 
proposed the RUC-recommended work RVUs for seven of the ten codes in 
this family.
    Comment: One commenter disagreed that the work pool for a family of 
revised codes should be similar before and after the valuation of the 
new codes. The commenter stated that by separating different modalities 
into their own codes, the appropriate time and intensity differences 
for these services were more accurately reflected in the recommended 
RVUs, and the work pool appropriately expanded to reflect these 
differences. The commenter cited the example of CPT code 10022 being 
unable to account for different patients receiving a biopsy using 
ultrasound or CT technology.
    Response: We agree with the commenter that the work pool for a 
revised code family does not always need to be similar before and after 
the valuation of the new codes. However, the commenter did not address 
our rationale for why we believe that an increase in the work pool 
would be inaccurate for this particular family of codes, which was 
based on the observation that the RUC-recommended work pool was 
increasing by approximately 20 percent while the RUC-recommended work 
time pool for the same codes was only increasing by about 2 percent. In 
a situation where prior coding was unable to account for newer and more 
complex forms of treatment, we would expect the work time pool to 
expand alongside the work pool, since these more complex and intensive 
procedures would take more time to furnish.
    Comment: A few commenters stated that since CMS changed the 
multiple procedure indicator from ``0'' to ``2'' for all Fine Needle 
Aspiration biopsy initial lesion codes for CY 2019, the commenter 
believes that using XXX global codes as references was incorrect. The 
commenter instead recommended that CMS review similar minor procedures 
that have a 0-day global designation, which suggested that a higher 
work RVU could have been supported.
    Response: We continue to believe that codes should generally be 
compared to codes with the same global period. Codes with a 0-day 
global period bundle other services that take place on the same day as 
the procedure into the valuation of the code, whereas such bundling is 
not included in codes with an XXX global period. We do not agree that 
it would have been more accurate to use codes with a 0-day global 
period as references for the codes in this family.
    Comment: Many commenters disagreed with the proposed work RVU of 
1.03 for CPT code 10021 and stated that CMS should finalize the RUC-
recommended work RVU of 1.20. Commenters stated that this service has a 
new coding structure as compared to the past, and that the prior review 
was last carried out in 1995 when physician work time was evaluated 
with much less rigor. Commenters stated that the old time values were 
also based on a crosswalk and not a survey, and that therefore the drop 
in work time did not warrant a proportional change in work RVU as the 
previous times were inaccurate.
    Response: We agree that it is important to use the most recent data 
available regarding time, and we note that when many years have passed 
between when time is measured, significant discrepancies can occur. 
However, we also believe that our operating assumption regarding the 
validity of the existing values as a point of comparison is critical to 
the integrity of the relative value system as currently constructed. 
The times currently associated with codes play a very important role in 
PFS ratesetting, both as points of comparison in establishing work RVUs 
and in the allocation of indirect PE RVUs by specialty. If we were to 
operate under the assumption that previously recommended work times had 
routinely been overestimated, this would undermine the relativity of 
the work RVUs on the PFS in general, given the process under which 
codes are often valued by comparisons to codes with similar times, and 
it also would undermine the validity of the allocation of indirect PE 
RVUs to physician specialties across the PFS. Instead, we believe that 
it is crucial that the code valuation process take place with the 
understanding that the existing work times used in the PFS ratesetting 
processes are accurate. We recognize that adjusting work RVUs for 
changes in time is not always a straightforward process and that the 
intensity associated with changes in time is not necessarily always 
linear, which is why we apply various methodologies to identify several 
potential work values for individual codes. However, we want to 
reiterate that we believe it would be irresponsible to ignore changes 
in time based on the best data available and that we are statutorily 
obligated to consider both time and intensity in establishing work RVUs 
for PFS services. For additional information regarding the use of prior 
work time values in our methodology, we refer readers to our discussion 
of the subject in the CY 2017 PFS final rule (81 FR 80273 through 
80274).
    Comment: Several commenters stated the CMS rationale for the 
proposed work RVU for CPT code 10021 incorrectly implies that the 
decreased time reflected in survey values should have a one-to-one 
decrease in value, or a linear decrease in the valuation of work RVUs. 
Commenters stated that CMS incorrectly assumed that there are no 
differences in how work was valued in 1995 and how it is valued now.
    Response: We do not agree with the commenters' characterization of 
our statements, and believe it misinterprets our view on this matter. 
We specifically stated in the CY 2019 PFS proposed rule that we were 
not implying that the decrease in time as reflected in survey values 
must necessarily equate to a one-to-one or linear decrease in the 
valuation of work RVUs, both generally speaking and with regards to 
this particular CPT code (83 FR 35747). We recognize that intensity for 
any given procedure may change over several years or within the 
intraservice period. Nevertheless, since the two components of work are 
time and intensity, we believe that absent an obvious or explicitly 
stated rationale for why the relative intensity of a given procedure 
has specifically increased or the reduction in time occurs 
disproportionally in the less-intensive portions of the procedure, 
significant decreases in time should generally be reflected as 
decreases to work RVUs.
    Comment: Several commenters disagreed with the use of CPT code 
36440 as a crosswalk for the work RVU of CPT code 10021. Commenters 
stated that there were differences in site of service, patient 
population, and utilization between these two codes, which made CPT 
code 36440 a poor choice to use for work valuation. One commenter 
stated that CPT code 36440 is used to report a push transfusion of 
blood through an already established

[[Page 59521]]

access in a vessel, and does not carry the same risk and intensity as 
CPT code 10021, which involves accessing a lesion in the neck multiple 
times to aspirate biopsy specimens. Commenters supplied a chart 
depicting several comparator codes for 10021 that they stated were more 
appropriate choices for a crosswalk.
    Response: We disagree with the commenters that CPT code 36440 is an 
inappropriate choice for a crosswalk code. While it is true that this 
code is typically performed on an inpatient basis and the patient 
population comprises neonates instead of adults, we note that these 
factors suggest that the patient population for CPT code 36440 is 
likely sicker and more complex than the patient population for CPT code 
10021. These differences would, if anything, be grounds for a lower 
work RVU for CPT code 10021, not a higher work RVU. We continue to 
believe that CPT code 36440 is an appropriate choice for a crosswalk 
due to the highly similar work times and intensity as compared to CPT 
code 10021. As for the other comparator codes provided by the 
commenters, we do not agree that they would be more appropriate choices 
for a crosswalk as we believe that they have a higher intensity than 
the service described by CPT code 10021. In more general terms, we 
continue to believe that the nature of the PFS relative value system 
necessarily involves comparisons of all services to one another. 
Although codes that describe clinically similar services are sometimes 
stronger comparator codes, we do not agree that codes must share the 
same site of service, patient population, or utilization level to serve 
as an appropriate crosswalk.
    Comment: Many commenters disagreed with the proposed work RVU of 
1.46 for CPT code 10005 and stated that CMS should finalize the RUC-
recommended work RVU of 1.63. Commenters stated that CMS should use 
valid methods of evaluating services, such as survey data and magnitude 
estimation, instead of relying on an incremental difference in work 
RVUs between CPT codes 10021 and 10005.
    Response: We believe the use of an incremental difference between 
codes is a valid methodology for setting values, especially in valuing 
services within a family of revised codes where it is important to 
maintain appropriate intra-family relativity. Historically, we have 
frequently utilized an incremental methodology in which we value a code 
based upon its incremental difference between another code or another 
family of codes. We note that the RUC has also used the same 
incremental methodology on occasion when it was unable to produce valid 
survey data for a service. We further note that we did not rely solely 
on an increment for our proposed work RVU for CPT code 10005, 
supporting our proposed valuation with the use of two reference codes: 
CPT codes 99225 and 99232. Both of these codes have the same 
intraservice time and 1 additional minute of total time as compared 
with CPT code 10005, and both reference codes share a work RVU of 1.39.
    Comment: One commenter stated that they did not object to the CMS 
designation of 0.43 RVUs as the increment over CPT code 10021 for 
adding ultrasound guidance; however, the commenter objected to the 
assumption that the work value for CPT code 36440 offers an acceptable 
baseline.
    Response: We continue to believe that a crosswalk to the work RVU 
of CPT code 36440 produces the most accurate valuation for baseline CPT 
code 10021.
    Comment: Commenters disagreed with the proposed work RVU of 2.26 
for CPT code 10009 and stated that CMS should finalize the RUC-
recommended work RVU of 2.43. Commenters provided similar comments for 
CPT code 10009 as they provided for CPT code 10005, suggesting that the 
use of an incremental methodology was inaccurate and that CMS should 
use more valid methods of evaluating services, such as survey data and 
magnitude estimation.
    Response: We continue to disagree with the commenters that the use 
of an increment is a less valid methodology for valuing services. As 
detailed in the response to the comment summary above for CPT code 
10005, we believe the use of an incremental difference is appropriate, 
especially in valuing services within a family of revised codes where 
it is important to maintain appropriate intra-family relativity. We 
further note that we did not rely solely on an increment for our 
proposed work RVU for CPT code 10009, supporting our proposed valuation 
with the use of a reference to CPT code 74263.
    Comment: A commenter stated that in the CMS refinements to the 
direct PE inputs for CPT codes 77012 and 77021, CMS proposed to remove 
1 minute from the CA014 activity code and proposed to add 1 minute to 
the CA013 activity code. The commenter stated that this refinement was 
inaccurate and encouraged CMS to modify this proposal by finalizing the 
RUC-recommended direct PE inputs for clinical labor.
    Response: We address this subject in detail in the PE section of 
this final rule under the Changes to Direct PE Inputs for Specific 
Services heading (section II.B.3. of this final rule). For CPT codes 
77012 and 77021, we are finalizing these clinical labor refinements as 
proposed.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for all of the codes in the Fine Needle 
Aspiration family as proposed.
(2) Biopsy of Nail (CPT Code 11755)
    CPT code 11755 (Biopsy of nail unit (e.g., plate, bed, matrix, 
hyponychium, proximal and lateral nail folds) (separate procedure)) was 
identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. For CY 2019, the HCPAC recommended a 
work RVU of 1.25 based on the survey median value.
    We disagreed with the recommended value and proposed a work RVU of 
1.08 for CPT code 11755 based on the survey 25th percentile value. We 
noted that the recommended intraservice time for CPT code 11755 is 
decreasing from 25 minutes to 15 minutes (40 percent reduction), and 
the recommended total time for CPT code 11755 is decreasing from 55 
minutes to 39 minutes (29 percent reduction); however, the recommended 
work RVU is only decreasing from 1.31 to 1.25, which is a reduction of 
less than 5 percent. Although we did not imply that the decrease in 
time as reflected in survey values must equate to a one-to-one or 
linear decrease in the valuation of work RVUs, we believe that since 
the two components of work are time and intensity, significant 
decreases in time should be reflected in decreases to work RVUs. In the 
case of CPT code 11755, we believed that it would be more accurate to 
propose the survey 25th percentile work RVU than the survey median to 
account for these decreases in the surveyed work time.
    The proposed work RVU of 1.08 is also based on a crosswalk to CPT 
code 11042 (Debridement, subcutaneous tissue (includes epidermis and 
dermis, if performed); first 20 sq cm or less), which has a work RVU of 
1.01, the same intraservice time of 15 minutes, and a similar total 
time of 36 minutes. We also noted that, generally speaking, working 
with extremities like nails tends to be less intensive in clinical 
terms than other services, especially as compared to surgical 
procedures. We believe that

[[Page 59522]]

this further supports our proposal of a work RVU of 1.08 for CPT code 
11755.
    We proposed to refine the equipment times in accordance with our 
standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 11755.
    Comment: A few commenters stated that section 1848(c)(7) of the 
Act, as amended by section 220(e) of the Protecting Access to Medicare 
Act of 2014 (PAMA), specifies that for services that are not described 
by new and revised codes, if the total RVU for a service would be 
decreased by 20 percent or more as compared to the total RVUs for the 
previous year, the applicable adjustments must be phased in over a 2-
year period. These commenters stated that, according to this 
requirement, CPT code 11755 should be subject to the phase-in for CY 
2019.
    Response: We agree that CPT code 11755 should be subject to the 
phase-in for CY 2019. Due to a technical error, we inadvertently 
neglected to apply the phase-in to the total RVU of this code in the 
facility setting for the proposed rule, and we are correcting this for 
the final rule.
    Comment: Many commenters disagreed with the proposed work RVU of 
1.08 for CPT code 11755 and stated that CMS should finalize the RUC-
recommended work RVU of 1.25. Commenters urged CMS to view the survey 
and the HCPAC's recommendation for the survey median work value of 1.25 
apart from the current work time and work RVU because the primary 
specialty that currently performs the service was not included in the 
prior survey conducted in 1993.
    Response: We disagree with the commenters that the current work 
time and work RVU for CPT code 11755 should be viewed separately from 
the new recommended values. We do not pay differentially for services 
on the basis of specialty, and a change in the dominant specialty since 
the time of the last survey is not a reason to disregard the current 
work time and work RVUs in developing proposed work RVUs.
    Comment: Commenters compared the proposed work RVU of CPT code 
11755 to the work valuation of the top key reference service, CPT code 
11730 (Avulsion of nail plate, partial or complete, simple; single). 
Commenters stated that the increment of work between CPT code 11730 of 
1.05 and the CMS proposed value for CPT code 11755 of 1.08 was only 
0.03 RVUs, which was not enough to account for the additional work 
involved in CPT code 11755 given that the latter code also had 50 
percent more intraservice time. Commenters also expressed concerns with 
the CMS reference to CPT code 11042 at a work RVU of 1.01, stating that 
it required less physician work time and a less refined technique. 
Commenters stated that the service described by CPT code 11755 was more 
intense to perform because the physician has to be extremely careful 
not to accidentally hit the patient's bone while taking the biopsy. 
Commenters stated that the nail plate is typically difficult to remove 
during the process of the biopsy performed in the service described by 
CPT code 11755, and that the biopsy must be performed with extreme care 
to avoid injury to the surgeon or extension of the incision to the 
underlying bone, which carries the potential for an osteomyelitis and 
significant post-operative pain. Commenters again urged CMS to finalize 
the RUC-recommended values for this code.
    Response: After reviewing the additional information about the 
risks inherent in the service provided by the commenters, we agree that 
it would be more accurate to finalize the RUC-recommended work RVU of 
1.25 for CPT code 11755 to reflect the intensity of the procedure.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was removed from the calculation of the 
equipment time, and that this made it difficult to determine the 
accuracy of the refinements. The commenter requested more information 
about this change.
    Response: For the basic instrument pack (EQ137) equipment, we 
removed the clinical labor for the CA024, CA027, CA029, and CA035 
clinical labor activities in accordance with our standard equipment 
time formula for surgical instrument packs. For the other three 
equipment items, we removed the clinical labor for the CA027 and CA035 
clinical labor activity codes in accordance with our standard equipment 
time formula for non-highly technical equipment.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVU of 1.25 for CPT code 11755. We are finalizing 
the direct PE inputs for this code as proposed.
(3) Skin Biopsy (CPT Codes 11102, 11103, 11104, 11105, 11106, and 
11107)
    In CY 2016, CPT codes 11100 (Biopsy of skin, subcutaneous tissue 
and/or mucous membrane (including simple closure), unless otherwise 
listed; single lesion) and 11101 (Biopsy of skin, subcutaneous tissue 
and/or mucous membrane (including simple closure), unless otherwise 
listed; each separate/additional lesion) were identified as potentially 
misvalued using a high expenditure services screen across specialties 
with Medicare allowed charges of $10 million or more. Prior to the 
January 2016 RUC meeting, the specialty society notified the RUC that 
its survey data displayed a bimodal distribution of responses with more 
outliers than usual. The RUC referred CPT codes 11100 and 11101 to the 
CPT Editorial Panel. In February 2017, the CPT Editorial Panel deleted 
these two codes and created six new codes for primary and additional 
biopsy based on the thickness of the sample and the technique utilized.
    For CY 2019, we proposed the RUC-recommended work RVUs for five of 
the six codes in the family. We proposed a work RVU of 0.66 for CPT 
code 11102 (Tangential biopsy of skin, (e.g., shave, scoop, saucerize, 
curette), single lesion), a work RVU of 0.83 for CPT code 11104 (Punch 
biopsy of skin, (including simple closure when performed), single 
lesion), a work RVU of 0.45 for CPT code 11105 (Punch biopsy of skin, 
(including simple closure when performed), each separate/additional 
lesion), a work RVU of 1.01 for CPT code 11106 (Incisional biopsy of 
skin (e.g., wedge), (including simple closure when performed), single 
lesion), and a work RVU of 0.54 for CPT code 11107 (Incisional biopsy 
of skin (e.g., wedge), (including simple closure when performed), each 
separate/additional lesion).
    For CPT code 11103 (Tangential biopsy of skin, (e.g., shave, scoop, 
saucerize, curette), each separate/additional lesion), we disagreed 
with the RUC-recommended work RVU of 0.38 and proposed a work RVU of 
0.29. When we compared the RUC-recommended work RVU of 0.38 to other 
add-on codes in the RUC database, we found that CPT code 11103 would 
have the second-highest work RVU for any code with 7 minutes or less of 
total time, with the recommended work RVU noticeably higher than other 
related add-on codes, and we did not agree that the tangential biopsy 
service being performed should have an anomalously high work value in 
comparison to other similar add-on codes. Our proposed work RVU of 0.29 
was based on a crosswalk to CPT code 11201 (Removal of skin tags, 
multiple fibrocutaneous tags, any area; each additional 10 lesions, or 
part thereof), a clinically related add-on procedure with 5 minutes of 
intraservice and total time as opposed to the surveyed 6 minutes for

[[Page 59523]]

CPT code 11103. We also noted that the intraservice time ratio between 
CPT code 11103 and the recommended reference code, CPT code 11732 
(Avulsion of nail plate, partial or complete, simple; each additional 
nail plate), was 75 percent (6 minutes divided by 8 minutes). This 75 
percent ratio when applied to the work RVU of CPT code 11732 also 
produced a work RVU of 0.29 (0.38 * 0.75 = 0.29). Finally, we also 
supported the proposed work RVU through a crosswalk to CPT code 33508 
(Endoscopy, surgical, including video-assisted harvest of vein(s) for 
coronary artery bypass procedure), which has a higher intraservice time 
of 10 minutes but a similar work RVU of 0.31. We believed that our 
proposed work RVU of 0.29 for CPT code 11103 better serves the 
interests of relativity, as well as better fitting with the other 
recommended work RVUs within this family of codes.
    For the direct PE inputs, we proposed to remove the 2 minutes of 
clinical labor time for the ``Review home care instructions, coordinate 
visits/prescriptions'' (CA035) activity for CPT codes 11102, 11104, and 
11106. These codes are typically billed with a same day E/M service, 
and we believe that it would be duplicative to assign clinical labor 
time for reviewing home care instructions given that this task would 
typically be done during the same day E/M service. We also proposed to 
refine the equipment times in accordance with our standard equipment 
time formulas.
    We proposed to refine the quantity of the ``gown, staff, 
impervious'' (SB024) and the ``mask, surgical, with face shield'' 
(SB034) supplies from 2 to 1 for CPT codes 11102, 11104, and 11106. We 
proposed to remove one gown and one surgical mask from these codes as 
duplicative since these supplies are also included within the surgical 
instrument cleaning pack (SA043). We also proposed to remove all of the 
supplies in the three add-on procedures (CPT codes 11103, 11105, and 
11107) that were not contained in the previous add-on procedure for 
this family, CPT code 11101. We do not believe that the use of these 
supplies would be typical for the ``each additional lesion'' add-on 
codes, as these supplies are all included in the base codes and are not 
currently utilized in CPT code 11101. We noted that the recommended 
direct PE costs for the three new add-on codes represent an increase of 
approximately 500 percent from the direct PE costs for CPT code 11101, 
and believe that this is largely due to the addition of these new 
supplies.
    The following is a summary of the public comments we received on 
our proposals involving the Skin Biopsy family of codes.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.29 for CPT code 11103 and stated that CMS should finalize the RUC-
recommended work RVU of 0.38. Commenters disagreed that CPT code 11103 
would have the second-highest work RVU for any code with 7 minutes or 
less of total time, stating that the total number of add-on codes with 
RUC total time of 7 minutes or less is 18. Commenters stated that only 
five of these services have total time of 6 or 7 minutes and the rest 
were lower, thus the majority of the work RVUs among these services 
were lower and not comparable. Commenters stressed that the RUC-
recommended work RVU of 0.38 for CPT code 11103 was appropriate since 
the service is performed on a separate site than the base code and 
there is additional physician work to transition to a different site. 
Commenters stated that the RUC's direct crosswalk to CPT code 11732 
(Avulsion of nail plate, partial or complete, simple; each additional 
nail plate), which describes procedures with significant physician 
effort in removing a nail plate with its anesthesia and hemostasis 
challenges, was a much better comparator to CPT code 11103 which 
involves the biopsy of a vascular tumor, typically on the face. 
Commenters stated that the proposed crosswalk to CPT code 11201 at a 
work RVU of 0.29 was too low to maintain relativity within the family 
of codes. One commenter stated that the type of skin biopsies performed 
in CPT code 11103 can result in the detection of carcinoma, melanoma, 
sarcoma/lymphoma, and other dangerous pathologies, and that making 
these diagnoses can save lives and ultimately decrease Medicare 
spending.
    Response: After reviewing the additional information provided by 
the commenters, we agree that it would be more accurate to finalize the 
RUC-recommended work RVU of 0.38 for CPT code 11103 as the proposed 
work RVU was too low to maintain relativity within the family of codes.
    Comment: Commenters disagreed with many of the refinements made by 
CMS to the direct PE inputs for this family of codes. Commenters stated 
that it was not appropriate to only include equipment and supply items 
in the new biopsy add-on codes that were included in the old add-on 
code (CPT code 11101) because the old codes were not specific enough to 
accurately distinguish between the three types of biopsies. Commenters 
cited as an example the fact that the predecessor CPT code 11101 did 
not include supply items that are necessary for the performance of the 
incisional biopsy.
    Response: We appreciate the feedback from the commenters clarifying 
some of the differences between the predecessor code and the newly 
created add-on codes. We evaluated these differences on an individual 
case-by-case basis when determining whether or not to finalize the 
proposed refinements to the direct PE inputs.
    Comment: Several commenters disagreed with the proposed refinements 
to the ``Review home care instructions, coordinate visits/
prescriptions'' (CA035) clinical labor time. Commenters stated that 
home care instructions furnished in an E/M visit do not typically 
include wound care instructions, and that this instruction would be 
above and beyond instructions proved during an E/M visit in which no 
procedure is performed.
    Response: We disagree with the commenters that wound care 
instructions would not be provided during the same day E/M visit. We 
continue to believe that it would be duplicative to assign clinical 
labor time for this task given the fact that a same day E/M visit is 
typical for these services. We believe that these instructions would be 
provided during the same day E/M visit.
    Comment: Several commenters disagreed with the CMS proposal to 
refine the quantity of the ``gown, staff, impervious'' (SB024) and the 
``mask, surgical, with face shield'' (SB034) supplies from 2 to 1 for 
CPT codes 11102, 11104, and 11106 since these supplies are also 
included within the surgical instrument cleaning pack (SA043). 
Commenters stated that the SA043 instrument cleaning pack is used in 
the dirty instrument room as part of the instrument cleaning and 
sterilization process and therefore cannot be used during a patient 
procedure as the instrument cleaning occurs after the procedure has 
been completed. Commenters stated that the personal protective 
equipment used during the patient procedure is considered contaminated 
after the procedure is concluded, and that personal protective 
equipment must be removed and disposed of prior to leaving the 
procedure room. As a result, these supplies were not duplicative and 
should not be removed.
    Response: We disagree with the commenter and we continue to believe 
that the impervious staff gown and the surgical mask with face shield 
would be duplicative supplies given that they are also contained within 
the instrument cleaning pack. We do not believe that it

[[Page 59524]]

would be typical to remove the staff gown and face shield used during a 
procedure and put on new items afterwards for the purposes of cleaning 
instruments.
    Comment: Commenters also disagreed with the CMS proposal to remove 
all of the supplies in the three add-on procedures (CPT codes 11103, 
11105, and 11107) that were not contained in the previous add-on 
procedure for this family, CPT code 11101. For the ``drape, sterile, 
fenestrated 16in x 29in'' (SB011) supply, commenters stated that 
draping the new body site with a new sterile disposable drape was 
clinically indicated and would be typically done rather than take a 
drape used on one body site and then reposition it to a new body site 
for a new procedure. Commenters made the same claim for the sterile 
gloves (SB024) supply. For the ``needle, OSHA compliant (SafetyGlide)'' 
(SC080) and the ``scalpel, safety, surgical, with blade (#10-20)'' 
(SF047) supplies, commenters stated that the add-on represented a 
completely new body site and completely new skin lesion which would not 
allow the needle or scalpel to be un-sheathed and then reused at a 
separate body site out of fear of contamination. For the ``dressing, 
12-7mm (Gelfoam)'' (SG033), ``dressing, 3in x 4in (Telfa, Release)'' 
(SG035), and ``gauze, sterile 4in x 4in (10 pack uou)'' (SG056) 
supplies, commenters stated that the add-on procedure is a second 
biopsy of a completely different body location and that these 
dressings/gauze pads would not be retained and then used on the second 
procedure out of fear of contamination. For the ``tape, surgical paper 
1in (Micropore)'' (SG079) supply, commenters stated that the quantity 
of this supply in the base code was sufficient for one lesion, but not 
more than one lesion due to the simple fact that two lesions required 
more surgical tape than one lesion. Finally, for the ``swab, patient 
prep, 1.5 ml (chloraprep)'' (SJ081) supply, commenters stated that the 
process of skin prep starts with the center of the lesion and moves 
outward in concentric circles to avoid bringing pathogens back into the 
field. Commenters stated that the prep sponge cannot be reused on a 
separate area of skin as it will contaminate that area by transporting 
pathogens from the last concentric circle of the prior area, and that 
the supply quantity in the base code contained an amount insufficient 
to prep more than one area. Commenters requested CMS not to finalize 
the proposal to remove these supplies from the add-on codes.
    Response: After considering the new information provided by the 
commenters regarding the clinical use of these supplies, we will not 
finalize our proposal to remove these supplies from the three add-on 
procedures (CPT codes 11103, 11105, and 11107). We will restore the 
RUC-recommended supplies for these three codes.
    Comment: Several commenters disagreed with the refinements to the 
equipment time in CPT codes 11102, 11104, and 11106. The commenters 
stated that the removal of 2 minutes of equipment time was not 
appropriate and that equipment time needs to match clinical staff time.
    Response: We agree with the commenter that changes in clinical 
labor time should be matched with corresponding changes in equipment 
time. However, since we continue to believe that the clinical labor to 
the ``Review home care instructions, coordinate visits/prescriptions'' 
(CA035) clinical labor time should be removed as duplicative with the 
same day E/M visit, we also continue to believe that the equipment 
times are accurate as proposed.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVUs for all of the codes in the Skin Biopsy 
family. We are finalizing the direct PE inputs as proposed, with the 
exception of the supplies from the three add-on procedures (CPT codes 
11103, 11105, and 11107) as detailed above.
(4) Injection Tendon Origin-Insertion (CPT Code 20551)
    CPT code 20551 (Injection(s); single tendon origin/insertion) was 
identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. For CY 2019, we proposed the RUC-
recommended work RVU of 0.75 for CPT code 20551.
    We proposed to maintain the current work RVU for many of the CPT 
codes identified as potentially misvalued on the screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more. We 
noted that regardless of the proposed work valuations for individual 
codes, which may or may not retain the same work RVU, we continue to 
have reservations about the valuation of 0-day global services that are 
typically billed with a separate E/M service with the use of Modifier 
25 (indicating that a significant and separately identifiable E/M 
service was provided on the same day). As we stated in the CY 2017 PFS 
final rule (81 FR 80204), we continue to believe that the routine 
billing of separate E/M services in conjunction with a particular code 
may indicate a possible problem with the valuation of the code bundle, 
which is intended to include all the routine care associated with the 
service. We will continue to consider additional ways to address the 
appropriate valuation for these services.
    For the direct PE inputs, we proposed to remove the clinical labor 
time for the ``Provide education/obtain consent'' (CA011) and the 
``Review home care instructions, coordinate visits/prescriptions'' 
(CA035) activities for CPT code 20551. This code is typically billed 
with a same day E/M service, and we believe that it will be duplicative 
to assign clinical labor time for obtaining consent or reviewing home 
care instructions given that these tasks will typically be done during 
the same day E/M service. We also proposed to refine the equipment 
times in accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 20551.
    Comment: A few commenters supported our proposal to maintain the 
current work RVU for this code, as recommended by the RUC.
    Response: We appreciate the support for our proposal from the 
commenters.
    Comment: Several commenters disagreed with the proposed direct PE 
refinements to CPT code 20551. Commenters stated that they did not 
agree that the clinical labor taking place in activity codes CA011 and 
CA035 were duplicative and that the RUC is careful to remove any 
duplication with E/M visits. Commenters stated that the home care 
instructions in activity code CA035 refer directly to the tendon 
injection and may include discussion of care for the affected area and 
home restrictions. Commenters stated that this injection is more 
involved and invasive than a vaccination such as the ones taking place 
in CPT codes 90470 and 90471, which were allowed 3 minutes for ``F/u on 
physician's discussion w/patient/parent & obtain actual consent 
signature'' and an additional 3 minutes for home care instructions and 
recording vaccine information.
    Response: For the CA011 clinical labor activity, we agree with the 
commenters that there would be a need for some additional time to 
obtain consent for the injection, but we do not agree that it would be 
typical to require the full 3 minutes because we believe there would be 
some overlap with the same day E/M visit. In similar fashion, we 
believe that there would also be some overlap with the same-day E/M

[[Page 59525]]

visit for the home care instructions described in activity code CA035. 
We also note that there is 1 minute of clinical labor time assigned to 
the ``Check dressings & wound/home care instructions/coordinate office 
visits/prescriptions'' clinical labor task for CPT code 90471 
referenced by the commenters. As a result, we are finalizing the 
assignment of 1 minute of clinical labor time to both of the CA011 and 
CA035 activities for CPT code 20551. We are also finalizing an increase 
of 1 minute in the equipment time for the exam table (EF023) to a total 
of 15 minutes, in accordance with our standard time formula for non-
highly technical equipment.
    After consideration of the public comments, we are finalizing our 
proposal to maintain the current work RVU for CPT code 20551. We are 
finalizing the direct PE inputs with the refinements detailed above.
(5) Structural Allograft (CPT Codes 20932, 20933, and 20934)
    In February 2017, the CPT Editorial Panel created three new codes 
to describe allografts. These codes were designated as add-on codes and 
revised to more accurately describe the structural allograft procedures 
they represent. For CY 2019, we proposed the RUC-recommended work RVUs 
for all three codes. We proposed a work RVU of 13.01 for CPT code 20932 
(Allograft, includes templating, cutting, placement and internal 
fixation when performed; osteoarticular, including articular surface 
and contiguous bone), a work RVU of 11.94 for CPT code 20933 
(Allograft, includes templating, cutting, placement and internal 
fixation when performed; hemicortical intercalary, partial (i.e., 
hemicylindrical)), and a work RVU of 13.00 for CPT code 20934 
(Allograft, includes templating, cutting, placement and internal 
fixation when performed; intercalary, complete (i.e., cylindrical)).
    These three new codes are all facility-only procedures with no 
recommended direct PE inputs.
    We did not receive any comments on our proposals involving the 
Structural Allograft family of codes. Therefore we are finalizing the 
work RVUs for the codes in this family as proposed.
(6) Knee Arthrography Injection (CPT Code 27369)
    CPT code 27370 (Injection of contrast for knee arthrography) 
repeatedly appeared on high volume growth screens between 2008 and 
2016, and the RUC expressed concern that the high volume growth for 
this procedure was likely due to its being reported incorrectly as 
arthrocentesis or aspiration. In June 2017, the CPT Editorial Panel 
deleted CPT code 27370 and replaced it with a new code, 27369, to 
report injection procedure for knee arthrography or enhanced CT/MRI 
knee arthrography.
    The RUC recommended a work RVU of 0.96 for CPT code 27369, which is 
identical to the work RVU for CPT code 27370 (Injection of contrast for 
knee arthrography). The RUC's recommendation is based on key reference 
service, CPT code 23350 (Injection procedure for shoulder arthrography 
or enhanced CT/MRI shoulder arthrography), with identical intraservice 
time (15 minutes) and total time (28 minutes) as the new CPT code and a 
work RVU of 1.00. The RUC notes that its recommendation is lower than 
the 25th percentile from the survey results, but that the work 
described by the service should be valued identically with the CPT code 
being replaced. We disagreed with the RUC's recommended work RVU for 
CPT code 27369. Both the total (28 minutes) and intraservice (15 
minutes) times for the new CPT code are considerably lower than the 
deleted CPT code 27370. Based on the reduced times and the projected 
work RVU from the reverse building block methodology (0.60 work RVUs), 
we believe this CPT code should be valued at 0.77 work RVUs, supported 
by a crosswalk to CPT code 29075 (Application, cast; elbow to finger 
(short arm)), with total time of 27 minutes and intraservice time of 15 
minutes. Therefore, we proposed a work RVU of 0.77 for CPT code 27369.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Prepare room, equipment and supplies'' (CA013) activity 
to 3 minutes and to refine the clinical labor time for the ``Confirm 
order, protocol exam'' (CA014) activity to 0 minutes. The predecessor 
code for 27369, CPT code 27370, did not have clinical labor time 
assigned for the ``Confirm order, protocol exam'' clinical labor task, 
and we do not have any reason to believe that the services being 
furnished by the clinical staff have changed, only the way in which 
this clinical labor time has been presented on the PE worksheets. We 
also noted that there is no effect on the total clinical labor direct 
costs in these situations, since the same 3 minutes of clinical labor 
time is still being furnished.
    We proposed to remove the clinical labor time for the ``Scan exam 
documents into PACS. Complete exam in RIS system to populate images 
into work queue'' (CA032) activity. CPT code 27369 does not include a 
PACS workstation among the recommended equipment, and the predecessor 
code 27370 did not previously include time for this clinical labor 
activity. We believe that data entry activities such as this task would 
be classified as indirect PE, as they are considered administrative 
activities and are not individually allocable to a particular patient 
for a particular service. We also proposed to refine the equipment 
times in accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 27369.
    Comment: We received one comment regarding our proposed work RVU 
for CPT code 27369 of 0.77 RVUs. The commenter disagreed with CMS's 
reference to CPT code 27370, which is being deleted, as a basis for 
evaluating whether the RUC's proposed work RVU for this CPT code (0.96) 
adequately accounts for the large reduction in time between the deleted 
code, CPT code 27370 and the new code, CPT code 27369. The commenter 
noted that it is particularly inappropriate for CMS to value codes on 
the basis of time differences when the comparison code had not been 
previously surveyed by the RUC. The commenter urged CMS to finalize the 
RUC-recommended work RVU for CPT code 27369 of 0.96.
    Response: We use several parameters to review the work RVU for 
codes including, where applicable, refining the work RVUs in direct 
proportion to either total time or intraservice time based on the best 
available information regarding the time resources involved in 
furnishing particular services. We note that the reason the CPT 
Editorial Panel was asked to review the code was to prevent incorrect 
reporting of the code, not to reflect a fundamentally different 
service. The work involved in furnishing the service described by CPT 
code 27369 is not fundamentally different from the work involved in 
furnishing the service described by the deleted code. In such cases we 
do not believe it is inappropriate to compare the survey times for the 
new code to the existing time for the code that it is intended to 
replace as one of several parameters we consider in our review. We are 
finalizing a work RVU for CPT code 27369 of 0.77 as proposed.
    Comment: A commenter stated that in the CMS refinements to the 
direct PE inputs for CPT code 27369, CMS proposed to remove 1 minute 
from the CA014 activity code and proposed to add 1 minute to the CA013 
activity code. The commenter stated that this refinement was inaccurate 
and encouraged CMS to modify this proposal by finalizing the RUC-

[[Page 59526]]

recommended direct PE inputs for clinical labor.
    Response: We addressed this subject in detail in the PE section of 
this final rule under the Changes to Direct PE Inputs for Specific 
Services heading (section II.B.3. of this final rule). For CPT code 
27369, we are finalizing these clinical labor refinements as proposed.
    Comment: One commenter agreed with the proposed CMS refinement to 
the CA032 clinical labor activity.
    Response: We appreciate the support for our proposal from the 
commenter.
    After consideration of the public comments, we are finalizing the 
direct PE inputs for CPT code 27369 as proposed.
(7) Application of Long Arm Splint (CPT Code 29105)
    CPT code 29105 (Application of long arm splint (shoulder to hand)) 
was identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. For CY 2019, we proposed the RUC-
recommended work RVU of 0.80 for CPT code 29105. For the direct PE 
inputs, we proposed to refine the equipment times in accordance with 
our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 29105.
    Comment: Some commenters expressed support for our proposal to 
accept the RUC-recommended work RVU for this code.
    Response: We appreciate the support for our proposal from the 
commenters.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was removed from the calculation of the 
equipment time, and that this made it difficult to determine the 
accuracy of the refinements. The commenter requested more information 
about this change.
    Response: For the five equipment items utilized in CPT code 29105, 
we removed the clinical labor for the CA035 clinical labor activity 
code in accordance with our standard equipment time formula for non-
highly technical equipment.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for CPT code 29105 as proposed.
(8) Strapping Lower Extremity (CPT Codes 29540 and 29550)
    CPT codes 29540 (Strapping; ankle and/or foot) and 29550 
(Strapping; toes) were identified as potentially misvalued on a screen 
of 0-day global services reported with an E/M visit 50 percent of the 
time or more, on the same day of service by the same patient and the 
same practitioner, that have not been reviewed in the last 5 years with 
Medicare utilization greater than 20,000. For CY 2019, we proposed the 
HCPAC-recommended work RVU of 0.39 for CPT code 29540 and the HCPAC-
recommended work RVU of 0.25 for CPT code 29550.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Provide education/obtain consent'' (CA011) activity from 
3 minutes to 2 minutes for both codes, as this is the standard clinical 
labor time assigned for patient education and consent. We also proposed 
to remove the 2 minutes of clinical labor time for the ``Review home 
care instructions, coordinate visits/prescriptions'' (CA035) activity 
for both codes. CPT codes 29540 and 29550 are both typically billed 
with a same day E/M service, and we believe that it would be 
duplicative to assign clinical labor time for reviewing home care 
instructions given that this task would typically be done during the 
same day E/M service. We also proposed to refine the equipment times in 
accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the Strapping Lower Extremity family of codes.
    Comment: A few commenters supported our proposal to accept the 
HCPAC-recommended work RVUs.
    Response: We appreciate the support for our proposal from the 
commenters.
    Comment: Several commenters disagreed with the proposed direct PE 
refinements to CPT codes 29540 and 29550. Commenters stated that CMS 
mistakenly cited a standard for this activity of 2 minutes, however 
there is no set standard for CA011, and that 3 minutes is needed for 
clinical staff to perform this clinical activity.
    Response: We disagree with the commenters that 3 minutes would be 
typically needed for the clinical staff to provide education and obtain 
consent in these procedures. We have typically assigned 2 minutes for 
this clinical labor activity unless we had a specific rationale for a 
higher amount of clinical labor time, and we continue to believe that 
this standard amount of clinical labor time would be the most accurate 
value for CPT codes 29540 and 29550.
    Comment: Several commenters disagreed that the clinical labor for 
home care instructions and coordinating visits/prescriptions would be 
duplicative with the same day E/M office visit in these services. 
Commenters stated that these home care instructions directly pertain to 
the strapping procedure and would not be provided during an evaluation 
of the patient. Commenters stated that the strappings do not work 
unless left alone and taken care of in a specific manner, and that this 
important information is included in the home care instructions that 
the patient receives from clinical staff.
    Response: We disagree with the commenters and we continue to 
believe that this clinical labor would be duplicative with the same day 
E/M visit. We believe that this clinical labor would take place during 
the same day E/M visit. Due to the way patients typically present in 
these procedures, we do not believe that the patients would typically 
need additional home care instructions above and beyond the E/M visit. 
We also note that these strapping procedures are frequently repeated 
for the same patient multiple times, and there would not be a need for 
repeated home care instructions for subsequent strapping procedures for 
the same patient. Any home care instructions taking place outside of 
the same day E/M visit would only be needed the first time that these 
procedures are performed on a patient, and as a result they would not 
be typical. As a result, we continue to believe that this clinical 
labor would not be typical.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was removed from the calculation of the 
equipment time, and that this made it difficult to determine the 
accuracy of the refinements. The commenter requested more information 
about this change.
    Response: For the two equipment items utilized in these CPT codes, 
we removed the clinical labor for the CA035 clinical labor activity 
code in accordance with our standard equipment time formula for non-
highly technical equipment.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for CPT codes 29540 and 29550 as 
proposed.
(9) Bronchoscopy (CPT Codes 31623 and 31624)
    CPT code 31623 (Bronchoscopy, rigid or flexible, including 
fluoroscopic guidance, when performed; with

[[Page 59527]]

brushing or protected brushings) was identified on a high growth screen 
of services with total Medicare utilization of 10,000 or more that have 
increased by at least 100 percent from 2009 through 2014. CPT code 
31624 (Bronchoscopy, rigid or flexible, including fluoroscopic 
guidance, when performed; with bronchial alveolar lavage) was also 
included for review as part of the same family of codes. For CY 2019, 
we proposed the RUC-recommended work RVU of 2.63 for CPT codes 31623 
and 31624.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Complete post-procedure diagnostic forms, lab and x-ray 
requisitions'' (CA027) activity from 4 minutes to 2 minutes for CPT 
codes 31623 and 31624. Two minutes is the standard time, as well as the 
current time for this clinical labor activity, and we have no reason to 
believe that the time to perform this task has increased since the 
codes were last reviewed. We did not receive any explanation in the 
recommendations as to why the time for this activity would be doubling 
over the current values. We also proposed to refine the equipment times 
in accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the Bronchoscopy family of codes.
    Comment: Several commenters disagreed with the proposal to refine 
the clinical labor time for the ``Complete post-procedure diagnostic 
forms, lab and x-ray requisitions'' (CA027) activity from 4 minutes to 
2 minutes for CPT codes 31623 and 31624. Commenters stated that there 
is no standard for the CA027 clinical labor activity and that the CMS 
logic to conform to such a standard lacks merit. Commenters also stated 
that these services require verification of samples, and completion of 
several lab forms and clearly requires more than the standard time for 
completing forms.
    Response: We disagree with the commenters. While it is true that we 
have not formalized 2 minutes as a standard through rulemaking for this 
clinical labor activity code, we have typically assigned 2 minutes for 
the CA027 activity across a wide variety of codes. Out of the 168 HCPCS 
codes that have clinical labor time for the CA027 clinical labor 
activity in our database, 64 codes have 2 minutes of assigned clinical 
labor time while only 9 codes have 4 minutes of assigned clinical labor 
time, which indicates that 2 minutes is far more typical for this 
activity. More importantly, commenters did not address our statement 
that 2 minutes is the current time for this clinical labor activity, 
and we had no reason to believe that the time to perform this task has 
increased since the codes were last reviewed. As a result, we are 
finalizing our refinement to 2 minutes of clinical labor time for the 
CA027 activity.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for CPT codes 31623 and 31624 as 
proposed.
(10) Pulmonary Wireless Pressure Sensor Services (CPT Codes 33289 and 
93264)
    In September 2017, the CPT Editorial Panel created a code to 
describe pulmonary wireless sensor implantation and another code for 
remote care management of patients with an implantable, wireless 
pulmonary artery pressure sensor monitor. For CY 2019, we proposed the 
RUC-recommended work RVU of 6.00 for CPT code 33289 (Transcatheter 
implantation of wireless pulmonary artery pressure sensor for long term 
hemodynamic monitoring, including deployment and calibration of the 
sensor, right heart catheterization, selective pulmonary 
catheterization, radiological supervision and interpretation, and 
pulmonary artery angiography, when performed), and the RUC-recommended 
work RVU of 0.70 for CPT code 93264 (Remote monitoring of a wireless 
pulmonary artery pressure sensor for up to 30 days including at least 
weekly downloads of pulmonary artery pressure recordings, 
interpretation(s), trend analysis, and report(s) by a physician or 
other qualified health care professional).
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving the Pulmonary Wireless Pressure Sensor Services 
family of codes.
    Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs.
    Response: We thank commenters for their support.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVUs for CPT codes 33289 and 93264 as proposed.
(11) Cardiac Event Recorder Procedures (CPT Codes 33285 and 33286)
    In February 2017, the CPT Editorial Panel created two new codes 
replacing cardiac event recorder codes to reflect new technology. For 
CY 2019, we proposed the RUC-recommended work RVU of 1.53 for CPT code 
33285 (Insertion, subcutaneous cardiac rhythm monitor, including 
programming) and the RUC-recommended work RVU of 1.50 for CPT code 
33286 (Removal, subcutaneous cardiac rhythm monitor).
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving the Cardiac Event Recorder Procedures family of 
codes.
    Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs.
    Response: We thank commenters for their support.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVUs and direct PE inputs for CPT codes 33285 and 
33286 as proposed.
(12) Aortoventriculoplasty With Pulmonary Autograft (CPT Code 33440)
    In September 2017, the CPT Editorial Panel created one new code to 
combine the efforts of aortic valve and root replacement with 
subvalvular left ventricular outflow tract enlargement to allow for an 
unobstructed left ventricular outflow tract.
    For CY 2019, we proposed the RUC-recommended work RVU of 64.00 for 
CPT code 33440 (Replacement, aortic valve; by translocation of 
autologous pulmonary valve and transventricular aortic annulus 
enlargement of the left ventricular outflow tract with valved conduit 
replacement of pulmonary valve (Ross-Konno procedure)). When this code 
is re-reviewed in a few years as part of the new technology screen, we 
look forward to receiving new recommendations on the whole family, 
including the related Ross and Konno procedures (CPT codes 33413 and 
33412 respectively) that were used as references for CPT code 33440.
    For the direct PE inputs, we proposed to refine the preservice 
clinical labor times to match our standards for 90-day global 
procedures. We proposed to refine the clinical labor time for the 
``Coordinate pre-surgery services (including test results)'' (CA002) 
activity from 25 minutes to 20 minutes, to refine the clinical labor 
time for the ``Schedule space and equipment in facility'' (CA003) 
activity from 12 minutes to 8 minutes, and to refine the clinical labor 
time for the ``Provide pre-service education/obtain consent'' (CA004) 
activity from 26 minutes to 20 minutes. We also proposed to add 15 
minutes of clinical labor time for the ``Perform regulatory mandated 
quality assurance activity (pre-service)'' (CA008) activity. We agreed 
with the recommendation that the total preservice clinical labor

[[Page 59528]]

time for CPT code 33440 is unchanged from the two reference codes at 75 
minutes. However, we believed that the clinical labor associated with 
additional coordination between multiple specialties prior to patient 
arrival is more accurately described through the use of the CA008 
activity code than by distributing this 15 minutes amongst the other 
preservice clinical labor activities. We previously established 
standard preservice times for 90-day global procedures, and did not 
want to propose clinical labor times above those standards for CPT code 
33440. We also noted that there is no effect on the total clinical 
labor direct costs in this situation, since the same 15 minutes of 
preservice clinical labor time is still being furnished.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 33440.
    Comment: A few commenters stated that they had no objections to the 
CMS proposal to refine the preservice clinical labor times for the 
direct PE inputs for code 33440 to match the 90-day global procedure 
standards and to add 15 minutes of clinical labor time to clinical 
labor activity code CA008. The commenters stated that they believed the 
RUC-recommended allocation of the preservice activities was 
appropriate, whereas activity code CA008 was not an accurate 
description of the additional work being done, and hoped that CMS would 
not use the allocation of time to CA008 as a way to reduce the 
preservice time in future rulemaking.
    Response: We appreciate the feedback on our proposed direct PE 
refinements from the commenters.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for CPT code 33440 as proposed.
(13) Hemi-Aortic Arch Replacement (CPT Code 33866)
    At the September 2017 CPT Editorial Panel meeting, the Panel 
created one new add-on code to report hemi-aortic arch graft 
replacement. For CY 2019, we proposed the RUC-recommended work RVU of 
19.74 for CPT code 33866 (Aortic hemiarch graft including isolation and 
control of the arch vessels, beveled open distal aortic anastomosis 
extending under one or more of the arch vessels, and total circulatory 
arrest or isolated cerebral perfusion). CPT code 33866 is a facility-
only procedure with no recommended direct PE inputs.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 33866.
    Comment: We received several comments, including comments from the 
RUC. The RUC noted in its comment letter that at the April 2018 RUC 
meeting, the specialty societies determined that the family of services 
encompassing CPT code 33866 should be submitted to the CPT Editorial 
Panel for the following revisions: (1) To develop distinct codes for 
ascending aortic report for dissection and ascending aortic repair for 
other ascending aortic disease such as aneurysms and congenital 
anomalies. The specialties noted that there is a difference in the work 
associated with these procedures and now there is sufficient volume to 
allow for more accurate capture of the work and outcomes data for these 
distinct patient populations, which was not the case when the code was 
first developed, (2) Revise the descriptor for transverse arch code, 
CPT code 33870, to further clarify the difference in work between the 
new add on code, CPT code 33866, and (3) Revise the guidelines to 
provide additional instructions on the appropriate use of these codes. 
The RUC further noted that the specialty societies had already 
submitted a new coding proposal for consideration at the May 2018 CPT 
Editorial Panel for CPT 2020, which the RUC supported. Following the 
April 2018 RUC meeting, the RUC rescinded its interim value 
recommendation (work RVU of 19.74) to us for CPT code 33866 for CY 
2019. One commenter noted, that although the RUC rescinded the interim 
work RVU of 19.74 due to a specialty societies' recommendation to 
submit the family of services to the CPT Editorial Panel, they 
encouraged CMS to consider using the work RVU of 19.74 as an interim 
value until the code can be re-surveyed and reviewed by the RUC. The 
commenter further noted that using the RUC-recommended value would 
allow physicians to be paid for the service in CY 2019, decreasing the 
burden of reporting a carrier-priced service to both the carriers and 
providers.
    Response: While we recognize that the RUC rescinded its work RVU 
recommendation, we note that we proposed the RUC-recommended work RVU 
for valuation in CY 2019. We also want to remind commenters that we no 
longer establish interim valuations on a routine basis, and we are not 
convinced that establishing an interim valuation for CPT code 33866 is 
necessary. We will review any new coding that the CPT Editorial Panel 
provides for 2020, and will review any recommendations we receive 
timely from the RUC or other stakeholders for valuation through CY 2020 
rulemaking.
    After consideration of the public comments received, we are 
finalizing the RUC-recommended work RVUs for CPT code 33866 as 
proposed.
(14) Leadless Pacemaker Procedures (CPT Codes 33274 and 33275)
    At the September 2017 CPT Editorial Panel meeting, the Panel 
replaced the five leadless pacemaker services, Category III codes, with 
the addition of two new CPT codes to report transcatheter leadless 
pacemaker procedures and revised five codes to include evaluation and 
interrogation services of leadless pacemaker systems.
    For CPT code 33274 (Transcatheter insertion or replacement of 
permanent leadless pacemaker, right ventricular, including imaging 
guidance (e.g., fluoroscopy, venous ultrasound, ventriculography, 
femoral venography) and device evaluation (e.g., interrogation or 
programming), when performed), we disagreed with the recommended work 
RVU of 8.77 and we proposed a work RVU of 7.80 based on a direct 
crosswalk to one of the top reference codes selected by the RUC survey 
participants, CPT code 33207 (Insertion of new or replacement of 
permanent pacemaker with transvenous electrode(s); ventricular). This 
code has the same 60 minutes of intraservice time as CPT code 33274 and 
an additional 61 minutes of total time at a work RVU of 7.80. In our 
review of CPT code 33274, we noted that this reference code had an 
additional inpatient hospital visit of CPT code 99232 (Subsequent 
hospital care, per day, for the evaluation and management of a patient, 
which requires at least 2 of 3 key components) and a full instead of a 
half discharge visit of CPT code 99238 (Hospital discharge day 
management; 30 minutes or less) included in its 90-day global period. 
The combined work RVU of these two visits would be equal to 2.03. 
However, the recommended work RVU for CPT code 33274 was 0.97 work RVUs 
higher than CPT code 33207, despite having fewer of these visits and 
significantly less surveyed total time. While we acknowledge that CPT 
code 33274 is a more intense procedure than CPT code 33207, we do not 
believe that it should be valued almost a full RVU higher than the 
reference code given the fewer visits in the global period and the 
lower surveyed work time.
    Therefore, we proposed to crosswalk CPT code 33274 to CPT code 
33207 at the same work RVU of 7.80. The proposed work RVU was also 
supported through a reference crosswalk to CPT code 38542 (Dissection, 
deep jugular node(s)), which has 60 minutes of intraservice time, 198 
minutes of total time, and a work RVU of 7.95. We believe that our 
proposed work RVU of

[[Page 59529]]

7.80 is a more accurate valuation for CPT code 33274, while still 
recognizing the greater intensity of this procedure in comparison to 
its reference code.
    For CPT code 33275 (Transcatheter removal of permanent leadless 
pacemaker, right ventricular), we disagreed with the RUC-recommended 
work RVU of 9.56 and we proposed a work RVU of 8.59. Although we 
disagreed with the RUC-recommended work RVU, we concurred that the 
relative difference in work between CPT codes 33274 and 33275 is 
equivalent to the recommended interval of 0.79 RVUs. Therefore, we 
proposed a work RVU of 8.59 for CPT code 33275, based on the 
recommended interval of 0.79 additional RVUs above our proposed work 
RVU of 7.80 for CPT code 33274. We also noted that our proposed work 
RVU for CPT code 33275 situates it approximately halfway between the 
two reference codes from the survey, with CPT code 33270 (Insertion or 
replacement of permanent subcutaneous implantable defibrillator system, 
with subcutaneous electrode, including defibrillation threshold 
evaluation, induction of arrhythmia, evaluation of sensing for 
arrhythmia termination, and programming or reprogramming of sensing or 
therapeutic parameters, when performed) having an intraservice time of 
90 minutes and a work RVU of 9.10, and CPT code 33207 having an 
intraservice time of 60 minutes and a work RVU of 7.80. CPT code 33275 
has a surveyed intraservice time of 75 minutes and nearly splits the 
difference between them at our proposed work RVU of 8.59.
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving the Leadless Pacemaker Procedures family of 
codes.
    Comment: One commenter recommended that CMS adopt the RUC-
recommended RVUs for both codes due to the newness of the procedures. 
The commenter stated that there might not be sufficient evidence or 
rationale for CMS to disagree with the RUC-recommended values, and 
again cited the newness of these procedures.
    Response: We disagree with the commenter that the newness of a 
procedure would provide a sufficient rationale for finalizing the RUC-
recommended work RVU for a new CPT code without any further 
consideration. Establishing valuations for newly created CPT codes is a 
routine part of maintaining the PFS, and we have historically valued 
new services since the inception of the resource-based relative value 
system. We also believe that RUC surveys are less likely to be 
representative of practitioners when evaluating new services, due to 
the fact that practitioners are not yet sufficiently experienced with 
the services to provide accurate evaluations, which is why we have been 
supportive of the RUC's policy to resurvey new services a few years 
after their creation when typical practice patterns have been more 
firmly established.
    Comment: Many commenters disagreed with the proposed work RVUs for 
CPT codes 33274 and 33275 and stated that CMS should instead finalize 
the RUC-recommended work RVUs for these services. Commenters stated 
that CMS provided no qualitative or quantitative rationale to support 
their assumption that the difference in time between CPT codes 33274 
and the top key reference from the survey (CPT code 33207) completely 
reflects the difference in intensity. Commenters stated that patients 
receiving leadless pacemakers are more complex and have more 
comorbidities and contraindications than transvenous patients, with 
more significant groin complications and more commonly present 
tamponade. Commenters stated that there were other issues that make CPT 
code 33274 more challenging, including: (1) Capture thresholds tend to 
change more than with transvenous devices; (2) There is a higher risk 
for complications including embolization and groin complications, which 
are not associated with tranvenous implants; and (3) Patients 
undergoing leadless pacemaker procedures are more likely to have 
chronic atrial fibrillation and poor venous access. Commenters 
emphasized that they believed the leadless pacemaker procedure 
described by CPT code 33274 was more intensive than the CMS crosswalk 
to CPT code 33207.
    Response: We disagree with the commenters' assertion that we 
provided no qualitative or quantitative rationale to support our choice 
of a crosswalk to CPT code 33207. We stated in the proposed rule that 
in our review of CPT code 33274, we noted that this reference code had 
an additional inpatient hospital visit of CPT code 99232 and a full, 
instead of a half, discharge visit of CPT code 99238 included in its 
90-day global period. We acknowledged that CPT code 33274 is a more 
intense procedure than CPT code 33207; however, we did not believe that 
it should be valued almost a full RVU higher than the reference code. 
We also supported the proposed work RVU through the use of a reference 
code, CPT code 38542, which was not addressed by the commenters.
    We also disagree with the commenters that CPT code 33274 has so 
much additional intensity and complexity as compared to key reference 
CPT code 33207 that they should be valued at the same work RVU of 8.77. 
We note that the RUC's research panel selected preservice package 3, 
``a straightforward patient and a difficult procedure'' for CPT code 
33274. We believe this indicates that the patient population for CPT 
code 33274 would not be unusually difficult or complex as suggested by 
the commenters. We further note that the summary of recommendations for 
CPT code 33274 states that these patients are typically sent home from 
the facility the next day. In contrast, reference CPT code 33207 
includes a full hospital inpatient day of post procedure care 
associated with CPT code 99322, as well as a full discharge visit 
instead of half of a discharge visit. We believe that this further 
suggests that the patient population for CPT code 33274 would not be 
more difficult or complex than the patient population for CPT code 
33207. As we stated in the proposed rule, we continue to acknowledge 
that CPT code 33274 is a more intense procedure than CPT code 33207, 
but we do not believe that it should be valued almost a full RVU higher 
than the reference code given the fewer visits in the global period and 
the lower surveyed work time.
    Comment: Commenters stated that CMS should use valid methods of 
evaluating services, such as survey data and magnitude estimation, 
instead of relying on an incremental difference in work RVUs between 
CPT codes 33274 and 33275.
    Response: We believe the use of an incremental difference between 
codes is a valid methodology for setting values, especially in valuing 
services within a family of revised codes where it is important to 
maintain appropriate intra-family relativity. Historically, we have 
frequently utilized an incremental methodology in which we value a code 
based upon its incremental difference between another code or another 
family of codes. We note that the RUC has also used the same 
incremental methodology on occasion when it was unable to produce valid 
survey data for a service. We further note that we did not rely solely 
on an increment for our proposed work RVU for CPT code 33275, 
supporting our proposed valuation by noting that the CMS work RVU of 
8.59 situated the code approximately halfway between the two reference 
codes from the survey, with CPT code 33270 having an intraservice time 
of 90 minutes and a work RVU of 9.10, and CPT code 33207 having an 
intraservice

[[Page 59530]]

time of 60 minutes and a work RVU of 7.80.
    Comment: Several commenters stated that while these procedures 
described in CPT code 33275 will be rare, these patients will still 
have the elevated risk factors mentioned in discussion of CPT code 
33274 and warranted the additional work indicated by survey respondents 
at the 25th percentile of the survey.
    Response: We continue to believe that the patients in CPT code 
33274 would not be more difficult or complex than the patients in CPT 
code 33207 for the reasons detailed above. We continue to believe that 
the relative difference in work between CPT codes 33274 and 33275 is 
equivalent to the recommended interval of 0.79 RVUs.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Leadless Pacemaker 
Procedures family as proposed.
(15) PICC Line Procedures (CPT Codes 36568, 36569, 36572, 36573, and 
36584)
    In CY 2016, CPT code 36569 (Insertion of peripherally inserted 
central venous catheter (PICC), without subcutaneous port or pump, 
without imaging guidance; age 5 years or older) was identified as 
potentially misvalued using a high expenditure services screen across 
specialties with Medicare allowed charges of $10 million or more. CPT 
code 36569 is typically reported with CPT codes 76937 (Ultrasound 
guidance for vascular access requiring ultrasound evaluation of 
potential access sites, documentation of selected vessel patency, 
concurrent real-time ultrasound visualization of vascular needle entry, 
with permanent recording and reporting) and 77001 (Fluoroscopic 
guidance for central venous access device placement, replacement 
(catheter only or complete), or removal) and was referred to the CPT 
Editorial Panel to have the two common imaging codes bundled into the 
code. In September 2017, the CPT Editorial Panel revised CPT codes 
36568 (Insertion of peripherally inserted central venous catheter 
(PICC), without subcutaneous port or pump; younger than 5 years of 
age), 36569 and 36584 (Replacement, complete, of a peripherally 
inserted central venous catheter (PICC), without subcutaneous port or 
pump, through same venous access, including all imaging guidance, image 
documentation, and all associated radiological supervision and 
interpretation required to perform the replacement) and created two new 
CPT codes to specify the insertion of peripherally inserted central 
venous catheter (PICC), without subcutaneous port or pump, including 
all imaging guidance, image documentation, and all associated 
radiological supervision and interpretation required to perform the 
insertion.
    For CY 2019, we proposed the RUC-recommended work RVU for two of 
the CPT codes in the family. We proposed the RUC-recommended work RVU 
of 2.11 for CPT code 36568 and the RUC-recommended work RVU of 1.90 for 
CPT code 36569.
    For CPT code 36572 (Insertion of peripherally inserted central 
venous catheter (PICC), without subcutaneous port or pump, including 
all imaging guidance, image documentation, and all associated 
radiological supervision and interpretation required to perform the 
insertion; younger than 5 years of age), we disagreed with the RUC-
recommended work RVU of 2.00 and proposed a work RVU of 1.82 based on a 
direct crosswalk to CPT code 50435 (Exchange nephrostomy catheter, 
percutaneous, including diagnostic nephrostogram and/or ureterogram 
when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy) 
and all associated radiological supervision and interpretation). CPT 
code 50435 is a recently reviewed code that also includes radiological 
supervision and interpretation with similar intraservice and total time 
values. In our review of CPT code 36572, we were concerned about the 
possibility that the recommended work RVU of 2.00 could create a rank 
order anomaly in terms of intensity with the other codes in the family. 
We noted that the recommended intraservice time for CPT code 36572 as 
compared to CPT code 36568, the most similar code in the family, is 
decreasing from 38 minutes to 22 minutes (42 percent), and the 
recommended total time is decreasing from 71 minutes to 51 minutes (38 
percent); however, the recommended work RVU is only decreasing from 
2.11 to 2.00, which is a reduction of just over 5 percent. We also 
noted that CPT code 36572 has a lower recommended intraservice time and 
total time as compared to CPT code 36569, yet has a higher recommended 
work RVU. Although we did not imply that the decreases in time as 
reflected in survey values must equate to a one-to-one or linear 
decrease in the valuation of work RVUs, we believe that since the two 
components of work are time and intensity, significant decreases in 
time should be reflected in decreases to work RVUs.
    In the case of CPT code 36572, we believed that it would be more 
accurate to propose a work RVU of 1.82 based on a crosswalk to CPT code 
50435 to better fit with the recommended work RVUs for CPT codes 36568 
and 36569. The proposed work valuation was also based on the use of 
three additional crosswalk codes: CPT code 32554 (Thoracentesis, needle 
or catheter, aspiration of the pleural space; without imaging 
guidance), CPT code 43198 (Esophagoscopy, flexible, transnasal; with 
biopsy, single or multiple), and CPT code 64644 (Chemodenervation of 
one extremity; 5 or more muscles). All of these codes were recently 
reviewed with similar intensity, intraservice time, and total time 
values, and all three of them share a work RVU of 1.82.
    For CPT code 36573 (Insertion of peripherally inserted central 
venous catheter (PICC), without subcutaneous port or pump, including 
all imaging guidance, image documentation, and all associated 
radiological supervision and interpretation required to perform the 
insertion; age 5 years or older), we disagreed with the RUC-recommended 
work RVU of 1.90 and proposed a work RVU of 1.70 based on maintaining 
the current work RVU of CPT code 36569. In our review of CPT code 
36573, we were again concerned about the possibility that the 
recommended work RVU of 1.90 could create a rank order anomaly in terms 
of intensity with the other codes in the family. We noted that the 
recommended intraservice time for CPT code 36573 as compared to CPT 
code 36569, the most similar code in the family, was decreasing from 27 
minutes to 15 minutes (45 percent), and the recommended total time was 
decreasing from 60 minutes to 40 minutes (33 percent); however, the 
RUC-recommended work RVU was exactly the same for these two codes at 
1.90. Although we did not imply that the decreases in time as reflected 
in survey values must equate to a one-to-one or linear decrease in the 
valuation of work RVUs, we believe that since the two components of 
work are time and intensity, significant decreases in time should be 
reflected in decreases to work RVUs.
    In the case of CPT code 36573, we believed that it would be more 
accurate to propose a work RVU of 1.70 based on maintaining the current 
work RVU of CPT code 36569. These two CPT codes describe the same 
procedure done with (CPT code 36573) and without (CPT code 35659) 
imaging guidance and radiological supervision and interpretation. 
Because the inclusion of the imaging described by CPT code 36573 has 
now become the typical case for this service, we believe that it is 
more accurate to maintain the current work RVU of 1.70 as opposed to

[[Page 59531]]

increasing the work RVU to 1.90, especially considering that the new 
surveyed work time for CPT code 36573 is lower than the current work 
time for CPT code 36569. The proposed work RVU of 1.70 was also based 
on a crosswalk to CPT code 36556 (Insertion of non-tunneled centrally 
inserted central venous catheter; age 5 years or older). This is a 
recently reviewed code with the same 15 minutes of intraservice time 
and the same 40 minutes of total time with a work RVU of 1.75.
    For CPT code 36584, we disagreed with the RUC-recommended work RVU 
of 1.47 and proposed a work RVU of 1.20 based on maintaining the 
current work RVU. We noted that the recommended intraservice time for 
CPT code 36584 was decreasing from 15 minutes to 12 minutes (20 percent 
reduction), and the recommended total time was decreasing from 45 
minutes to 34 minutes (25 percent reduction); however, the recommended 
work RVU was increasing from 1.20 to 1.47, an increase of approximately 
23 percent. Although we did not imply that the decreases in time as 
reflected in survey values must equate to a one-to-one or linear 
decrease in the valuation of work RVUs, we believed that since the two 
components of work are time and intensity, significant decreases in 
time should be reflected in decreases to work RVUs. We were especially 
concerned when the recommended work RVU is increasing despite survey 
results indicating that the work time is decreasing due to a 
combination of improving technology and greater efficiencies in 
practice patterns.
    In the case of CPT code 36584, we believed that it would be more 
accurate to propose a work RVU of 1.20 based on maintaining the current 
work RVU for the code. Because the inclusion of the imaging has now 
become the typical case for this service, we believed that it was more 
accurate to maintain the current work RVU of 1.20 as opposed to 
increasing the work RVU to 1.47, especially considering that the new 
surveyed work time for CPT code 36584 was decreasing from the current 
work time. The proposed work RVU of 1.20 was also based on a crosswalk 
to CPT code 40490 (Biopsy of lip), which has the same total time of 34 
minutes and slightly higher intraservice time at a work RVU of 1.22.
    We noted that the RUC-recommended work pool was increasing by 
approximately 68 percent for the PICC Line Procedures family as a 
whole, while the RUC-recommended work time pool for the same codes was 
only increasing by about 22 percent. Since time is defined as one of 
the two components of work, we believe that this indicated a 
discrepancy in the recommended work values. We do not believe that the 
recoding of the services in this family has resulted in an increase in 
their intensity, only a change in the way in which they will be 
reported, and therefore, we did not believe that it would serve the 
interests of relativity to propose the RUC-recommended work values for 
all of the codes in this family. We believe that, generally speaking, 
the recoding of a family of services should maintain the same total 
work pool, as the services themselves are not changing, only the coding 
structure under which they are being reported. We also noted that, 
through the bundling of some of these frequently reported services, it 
is reasonable to expect that the new coding system will achieve savings 
via elimination of duplicative assumptions of the resources involved in 
furnishing particular servicers. For example, a practitioner would not 
be carrying out the full preservice work three times for CPT codes 
36568, 76937, and 77001, but preservice times were assigned to all of 
the codes under the old coding. We believed the new coding assigns more 
accurate work times and thus reflects efficiencies in resource costs 
that existed but were not reflected in the services as they were 
previously reported.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Prepare, set-up and start IV, initial positioning and 
monitoring of patient'' (CA016) activity from 4 minutes to 2 minutes 
for CPT codes 36572 and 36573. We noted that the two reference codes 
for the two new codes, CPT codes 36568 and 36569, currently have 2 
minutes assigned for this activity, and CPT code 36584 also has a 
recommended 2 minutes assigned to this same activity. We did not agree 
that the patient positioning would take twice as long for CPT codes 
36572 and 36573 as compared to the rest of the family, and therefore 
proposed to refine both of them to the same 2 minutes of clinical labor 
time. We also proposed to refine the equipment times in accordance with 
our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the PICC Line Procedures family of codes.
    Comment: One commenter stated that CMS believes it is not accurate 
to ``increase'' work RVUs when survey results indicate that work time 
is ``decreasing'' due to improving technology and greater efficiencies 
in practice patterns. The commenter disagreed that the difference 
between the current codes (without imaging guidance) and the new 
bundled codes (with imaging guidance) could be characterized as an 
``increase'' or a ``decrease,'' as it was inappropriate simply to 
compare the RVUs of the bundled codes to the existing codes, because 
the bundled codes include imaging services that involve significantly 
more intense physician work than PICC line insertion without imaging 
guidance.
    Response: We disagree with the commenter that it is 
methodologically inappropriate to characterize changes in surveyed work 
time as ``increases'' or ``decreases''. As we stated in the proposed 
rule, we do not believe that the revised coding of the services in this 
family has changed the services themselves or resulted in an increase 
in their intensity, only changed in the way in which they will be 
reported under the new coding. CPT code 36572 is a new code resulting 
from the bundling together of CPT code 36568 with imaging guidance. The 
same services that were previously reported through a combination of 
CPT codes 36568 and 76397 will now be reported under CPT code 36572. We 
believe that it is highly relevant to note how the recommended work 
times for CPT code 36572 compare to the recommended work times for CPT 
code 36568, which includes noting that the intraservice time is 
decreasing from 38 minutes to 22 minutes (42 percent), and the 
recommended total time is decreasing from 71 minutes to 51 minutes (38 
percent). We also do not agree that it is inappropriate to compare the 
RVUs of the bundled codes to the existing codes, as all of these 
procedures describe clinically similar procedures that together 
comprise a family of codes. In more general terms, we continue to 
believe that the nature of the PFS relative value system is such that 
all services are appropriately subject to comparisons to one another. 
Although codes with clinically similar services are sometimes stronger 
comparator codes, we do not agree that codes must both include imaging 
guidance or not include imaging guidance to be used as a crosswalk.
    Comment: Several commenters disagreed that the recoding of the 
services in the PICC line code family had only resulted in a change in 
the way that services will be reported, and stated that that the 
imaging-related services now bundled into CPT codes 36572, 36573, and 
36584 are significantly more intense than PICC line insertion standing 
alone. One commenter stated that valuing a code using imaging guidance 
the same or less than the same code without imaging guidance is

[[Page 59532]]

specious and treats the use of imaging guidance as a negative work 
component when in fact there is additional work required in using 
imaging guidance. Commenters stated that the RUC-recommended values 
already reflect efficiencies in radiology work, and that the efficiency 
of radiologists should not diminish the RUC's recognition that their 
work is significantly more intense in these procedures.
    Response: We disagree with the commenters that the addition of 
imaging guidance has made CPT codes 36572, 36573, and 36584 
significantly more intense than the non-imaging guidance version of 
these procedures. While the incorporation of new technology can 
sometimes make services more complex and difficult to perform, it can 
also have the opposite effect by making services less reliant on manual 
skill and technique. We believe that if these procedures were 
significantly more intensive to perform, this would be reflected in the 
surveyed work times associated with these codes. However, the surveyed 
work times are instead decreasing in all three cases in comparison to 
the current non-imaging guidance version of the same services. As we 
stated in the proposed rule, we believe that the work times for these 
services are decreasing due to a combination of improving technology 
and greater efficiencies in practice patterns. Based on the RUC-
recommended utilization crosswalk for these services, which has 90 to 
95 percent of the utilization expected to be reported under the new 
codes that include imaging guidance, we believe that the use of imaging 
guidance has become typical for these services and does not represent a 
dramatic increase in intensity.
    Comment: Many commenters disagreed with the proposed work RVU of 
1.82 for CPT code 36572 and stated that CMS should finalize the RUC-
recommended work RVU of 2.00. Commenters stated that the CMS use of a 
crosswalk to CPT code 50435 was unsupported on a clinical basis, with 
significant differences in work intensity and patient population. 
Commenters stated that CPT code 36572 involves establishing new deep 
venous access on a pediatric patient while ensuring maximum sterile 
barrier technique so as to prevent a hospital acquired infection, 
whereas CPT code 50435 involves the exchange of an existing catheter in 
an adult who understands the procedure involved and has had previous 
catheter exchanges to maintain patency. One commenter stated that the 
RUC crosswalk to CPT code 19283 (Placement of breast localization 
device(s) (e.g., clip, metallic pellet, wire/needle, radioactive 
seeds)) was a more accurate choice because this service also uses 
imaging guidance to obtain de novo percutaneous access to a target and 
perform an intervention. Commenters stated that the crosswalk code 
would frequently be less intense than CPT code 36572.
    Response: We disagree with the commenters that the work involved in 
CPT code 50435 would be less clinically intense than the work in CPT 
code 36572. We believe that the exchange of a nephrostomy catheter 
taking place in CPT code 50435 is more difficult than the placement of 
a breast localization device as in the RUC crosswalk to CPT code 19283, 
percutaneous; first lesion, including stereotactic guidance). We also 
disagree with the commenters that the crosswalk we identified lacks 
clinical similarity to CPT code 36572. Both the reviewed code and the 
crosswalk to CPT code 50435 involve the percutaneous placement of a 
catheter in a deep structure; we believe that this crosswalk code is 
more clinically similar than the RUC's choice of a crosswalk to CPT 
code 19283, which does not involve catheter placement at all.
    Commenter: Several commenters disagreed that the RUC-recommended 
work RVU of 2.00 for CPT code 36572 would create a rank order anomaly 
within the family of codes. Commenters stated that since CPT code 36568 
requires more physician time to complete than CPT code 36572 (38 versus 
22 minutes intra-service time), the recommended work RVU of 2.00 for 
CPT code 36572 maintains the proper rank order within this family of 
services considering differences in patient population and differences 
in clinical intensity of work.
    Response: The commenters did not address the concerns we expressed 
regarding a potential rank order anomaly within the family. We noted in 
the proposed rule that CPT code 36572 had a lower recommended 
intraservice time and total time as compared to CPT code 36569 (not CPT 
code 36568), yet had a higher recommended work RVU. We continue to 
believe that this creates the potential for a rank order anomaly within 
the family, and we do not believe that this discrepancy can be 
justified by differences in patient population and differences in 
clinical intensity of work.
    Comment: Several commenters disagreed with the CMS statement that 
the reduced intraservice and total times in CPT code 36572 as compared 
to CPT code 36568 should result in a lower work value. Commenters 
stated that this was a simplistic comparison based on time, and that 
these were two technically different procedures, involving different 
patient populations and different service intensity. Commenters stated 
that each step in the non-image guided CPT code 36568 takes longer, 
though involves more periods of low intensity intraservice work as 
compared to CPT code 36572, where each procedural step is performed 
sequentially without the less intense intraservice work of the non-
image guided CPT code 36568.
    Response: We disagree with the commenters that the reductions in 
intraservice and total work time in CPT code 36572 as compared to CPT 
code 36568 should not result in a lower work value. Although we do not 
imply that the decreases in time as reflected in survey values must 
equate to a one-to-one or linear decrease in the valuation of work 
RVUs, we continue to believe that, since the two components of work are 
time and intensity, significant decreases in time should typically be 
reflected in decreases to work RVUs. We disagree that this is a 
simplistic comparison, and chose a crosswalk to CPT code 50435 to 
better fit with the recommended work RVUs for CPT codes 36568 and 
36569.
    We also do not agree that CPT codes 36568 and 36572 have 
significantly different patient populations and different service 
intensity. As we stated in the proposed rule, we do not believe that 
the revised coding of the services in this family has changed the 
services themselves or resulted in an increase in their intensity, only 
changed in the way in which they will be reported under the new coding. 
CPT code 36572 is a new code resulting from the bundling together of 
CPT code 36568 with imaging guidance. The same services that were 
previously reported through a combination of CPT codes 36568 and 76397 
will now be reported under CPT code 36572. Given that 90 percent of the 
services that were formerly reported using CPT code 36568 will now be 
reported using CPT code 36572, we do not agree that these codes 
represent significantly different patient populations.
    Comment: Many commenters disagreed with the proposed work RVU of 
1.70 for CPT code 36573 and stated that CMS should finalize the RUC-
recommended work RVU of 1.90. Commenters stated that CMS should not use 
a code value that is no longer in existence as the service (CPT code 
36569) itself has been revised and is currently under review in this 
family. Commenters stated that the reference was therefore not valid to 
the old work RVU.

[[Page 59533]]

    Response: We disagree with the commenters that it is somehow 
invalid to use a crosswalk to the current work RVU for CPT code 36569. 
It is not accurate to state that this code is no longer in existence, 
as it is being revised for CY 2019, not deleted. The RUC frequently 
recommends maintaining the current work RVU for reviewed codes rather 
than using a new work RVU from survey results when it believes that 
there is appropriate rationale to do so. Given that CPT code 36573 is a 
new code resulting from the bundling together of CPT code 36569 with 
imaging guidance, and that the use of imaging guidance has become 
typical in the performance of this service, we believe that it is 
appropriate to maintain the same work RVU for these services when they 
are reported under the new coding, especially in light of the fact that 
the surveyed intraservice work time for CPT code 36573 remains the same 
15 minutes as the current intraservice work time for CPT code 36569.
    Comment: Several commenters stated that CPT code 36573 involves a 
different patient population than CPT code 36569, as the patient 
population for CPT code 36573 does not have peripheral venous access 
present that can be used to obtain central venous access. Commenters 
stated that there is no evidence for a rank order anomaly within the 
codes in the family considering the differences in intensity and 
patient population.
    Response: As we stated previously with regard to CPT codes 36568 
and 36572, we also do not agree that CPT codes 36569 and 36573 have 
significantly different patient populations and different service 
intensity. As we stated in the proposed rule, we do not believe that 
the revised coding of the services in this family has changed the 
services themselves or resulted in an increase in their intensity, only 
changed in the way in which they will be reported under the new coding. 
CPT code 36573 is a new code resulting from the bundling together of 
CPT code 36569 with imaging guidance. The same services that were 
previously reported through a combination of CPT codes 36569 and 76397 
will now be reported under CPT code 36573. Given that 95 percent of the 
services that were formerly reported using CPT code 36569 are expected 
to be reported using CPT code 36573, we do not agree that these codes 
represent noticeably different patient populations.
    Comment: Several commenters disagreed with our use of CPT code 
36556 as a reference code. Commenters stated that CPT code 36556 
describes line placement in a larger and more central vein such as the 
internal jugular vein with known anatomical landmarks and a shorter 
distance between access and where the tip terminates centrally while 
CPT code 36573 describes access into a smaller vein without anatomic 
landmarks. Commenters stated that although imaging is inherent to CPT 
code 36573, the catheter is longer and there is a need to navigate the 
catheter through these peripheral and central veins for adequate 
placement, all of which would require more work.
    Response: We disagree with the commenters that CPT code 36556 would 
not be an accurate reference code for CPT code 36573. CPT code 36556 
describes the insertion of non-tunneled centrally inserted central 
venous catheter whereas CPT code 36573 describes the insertion of a 
peripherally inserted central venous catheter (PICC). We believe that 
these two codes, which both describe the insertion of central venous 
catheters, are highly similar to one another on a clinical basis and 
also from the perspective of work time, as they share the identical 
intraservice work time and total work time. Moreover, after further 
consideration, we are not able to identify any other more appropriate 
reference code for CPT code 36573 than CPT code 36556.
    Comment: Many commenters disagreed with the proposed work RVU of 
1.20 for CPT code 36584 and stated that CMS should finalize the RUC-
recommended work RVU of 1.47. Commenters stated that CMS was completely 
dismissing the additional work that was bundled in with CPT code 36584 
as part of the imaging guidance. Commenters stated that the RUC agreed 
that the recommended work RVU of 1.47 involves less time but involves a 
significant increase in intensity, and that the work RVU should not 
remain at the current work RVU of 1.20 as CPT code 36584 is now a 
bundled service.
    Response: We disagree with the commenters that the bundling of a 
service or the addition of imaging guidance must necessarily increase 
the intensity of the service or the work RVU. As we stated above, while 
the incorporation of new technology can sometimes make services more 
complex and difficult to perform, it can also have the opposite effect 
by making services less reliant on manual skill and technique. We 
believe that if CPT code 36584 had become significantly more intensive 
to perform, this would be reflected in the surveyed work times 
associated with the code. However, the surveyed intraservice work time 
and total work time for CPT code 36584 are both decreasing from their 
current values. As we stated in the proposed rule, we believe that 
these work times are decreasing due to a combination of improving 
technology and greater efficiencies in practice patterns, and we 
believe that the use of imaging guidance has become now typical for CPT 
code 36584 and does not represent a dramatic increase in intensity.
    Comment: Several commenters disagreed with the proposal to refine 
the clinical labor time for the ``Prepare, set-up and start IV, initial 
positioning and monitoring of patient'' (CA016) activity from 4 minutes 
to 2 minutes for CPT codes 36572 and 36573. Commenters stated that this 
additional clinical labor time would be typical since it included 
positioning of the patient as well as positioning the two forms of 
imaging equipment which are being bundled into the code (fluoroscopy 
and ultrasound). Commenters stated that the equipment needs to be 
positioned in a manner that is specific to the procedure and the chosen 
extremity, and that it takes approximately 2 additional minutes to 
position the patient and the equipment for those codes which are 
imaging-guided as opposed to those procedures which are not. Commenters 
stated that this difference applies to the two new placement codes (CPT 
code 36572 and 36573) but not to the replacement code (CPT code 36584) 
as the equipment is limited to fluoroscopy and the positioning is 
slightly simpler as the site already contains a PICC line.
    Response: After consideration of the new information provided by 
the commenters regarding the need for additional positioning time, we 
are not finalizing our proposed refinement to the CA016 clinical labor 
time. Due to this change in clinical labor time, we are also not 
finalizing any changes to the RUC-recommended equipment times.
    After consideration of the public comments, we are finalizing the 
work RVUs for the codes in the PICC Line Procedures family as proposed. 
After considering public comments, we are not finalizing our proposed 
direct PE refinements, and we are instead finalizing the RUC-
recommended direct PE inputs for all five codes.
(16) Biopsy or Excision of Inguinofemoral Node(s) (CPT Code 38531)
    In September 2017, the CPT Editorial Panel created a new code to 
describe biopsy or excision of inguinofemoral node(s). A parenthetical 
was added to CPT codes 56630 (Vulvectomy, radical, partial) and 56633 
(Vulvectomy, radical, complete) to instruct separate reporting of CPT 
code 38531 with radical

[[Page 59534]]

vulvectomy. This service was previously reported with unlisted codes.
    CPT code 38531 (Biopsy or excision of lymph node(s); open, 
inguinofemoral node(s)) is a new CPT code describing a lymph node 
biopsy without complete lymphadenectomy. The RUC recommended a work RVU 
of 6.74 for CPT code 38531, with 223 minutes of total time and 65 
minutes of intraservice time. We proposed the RUC-recommended work RVU 
of 6.74 for CPT code 38531. However, we were concerned that this CPT 
code is described as having a 10-day global period. The two CPT codes 
that are often reported together with this code, CPT codes 56630 and 
56633, are both 90-day global codes. In addition, CPT code 38531 has a 
discharge visit and two follow up visits in the global period. This is 
consistent with the number of postoperative visits typically associated 
with 90-day global codes. Therefore, we proposed to assign a 90-day 
global indicator for CPT code 38531 rather than the 10-day global time 
period reflected in the RUC recommendation.
    We did not propose any direct PE refinements for this code family.
    Comment: Several commenters thanked us for proposing the RUC-
recommended work RVU of 6.74 for CPT code 38531.
    Response: We appreciate the support from commenters.
    Comment: Several stakeholders disagreed with CMS's proposal to 
change the global status of this code from a 10-day global code to a 
90-day global code. They maintained that there are no claims data 
available to assess how often CPT code 38531 will be billed together 
with CPT codes 56630 or 56633. Commenters also noted that there is no 
necessary direct correlation between the two codes (CPT code 56630 and 
CPT code 56633) having a 90-day global period and the new code having a 
90-day global period.
    Response: We agree with commenters that when two or more closely 
related CPT codes are billed together, there is no requirement for them 
to share the same global period. However, the amount of post service 
time and the number of visits in CPT code 38531 are consistent with 
other 90-day global codes. We continue to believe that CPT code 38531 
should have a 90-day global period and we are finalizing that change as 
proposed.
    Comment: A few commenters pointed out that CMS has the opportunity 
to review the global periods for new codes directly after CPT Editorial 
Panel meetings, and that CMS should have provided input regarding the 
code's global period at that time.
    Response: While some of our staff have the opportunity to review 
global periods for new or modified CPT codes immediately after the CPT 
Editorial Panel meeting, the Agency does not systematically review or 
provide feedback on components of a CPT code, including global period, 
until we fully consider and address the code as part of the annual PFS 
notice-and-comment rulemaking process.
    After consideration of the public comments, we are finalizing a 
work RVU of 6.74 for CPT code 38531 as proposed.
(17) Radioactive Tracer (CPT Code 38792)
    CPT code 38792 (Injection procedure; radioactive tracer for 
identification of sentinel node) was identified as potentially 
misvalued on a screen of codes with a negative intraservice work per 
unit of time (IWPUT), with 2016 estimated Medicare utilization over 
10,000 for RUC reviewed codes and over 1,000 for Harvard valued and 
CMS/Other source codes. For CY 2019, we proposed the RUC-recommended 
work RVU of 0.65 for CPT code 38792.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Prepare room, equipment and supplies'' (CA013) activity 
to 3 minutes and to refine the clinical labor time for the ``Confirm 
order, protocol exam'' (CA014) activity to 0 minutes. CPT code 38792, 
as well as its alternate reference code, CPT code 78300 (Bone and/or 
joint imaging; limited area), did not previously have clinical labor 
time assigned for the ``Confirm order, protocol exam'' clinical labor 
task, and we do not have any reason to believe that the services being 
furnished by the clinical staff have changed, only the way in which 
this clinical labor time has been presented on the PE worksheets. We 
also note that there is no effect on the total clinical labor direct 
costs in these situations, since the same 3 minutes of clinical labor 
time is still being furnished. We also proposed to refine the equipment 
times in accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 38792.
    Comment: A commenter stated that they appreciated and supported our 
proposal to adopt the RUC-recommended work RVU of 0.65. The commenter 
also stated that they agreed with and supported the changes CMS 
proposed in clinical labor time and the standardized equipment time 
formulas.
    Response: We appreciate the support for our proposals from the 
commenter.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for CPT code 38792 as proposed.
(18) Percutaneous Change of G-Tube (CPT Code 43760)
    CPT code 43760 (Change of gastrostomy tube, percutaneous, without 
imaging or endoscopic guidance) was identified as potentially misvalued 
on a screen of 0-day global services reported with an E/M visit 50 
percent of the time or more, on the same day of service by the same 
patient and the same practitioner, that have not been reviewed in the 
last 5 years with Medicare utilization greater than 20,000. It was 
surveyed for the April 2017 RUC meeting and recommendations for work 
and direct PE inputs were submitted to CMS. However, the RUC also noted 
that because the data for CPT code 43760 were bimodal, it might be 
appropriate to consider changes in the CPT descriptors to better 
differentiate physician work. In September 2017, the CPT Editorial 
Panel deleted CPT code 43760 and will use two new CPT codes, CPT codes 
43762 and 43763, which describe replacement of gastrostomy tube, with 
and without revision of gastrostomy tract, respectively. (See 
discussion of these codes below.) Therefore, we did not propose work or 
direct PE values for CPT code 43760.
    Due to the impending deletion of CPT code 43760, we received no 
comments on this code.
(19) Gastrostomy Tube Replacement (CPT Codes 43762 and 43763)
    In September 2017, the CPT Editorial Panel created two new codes 
that describe replacement of gastrostomy tube, with and without 
revision of gastrostomy tract, respectively. These two new codes were 
surveyed for the January 2018 RUC meeting and recommendations for work 
and direct PE inputs were submitted to CMS.
    We proposed a work RVU of 0.75 for CPT code 43762 (Replacement of 
gastrostomy tube, percutaneous, includes removal, when performed, 
without imaging or endoscopic guidance; not requiring revision of 
gastrostomy tract.) and a work RVU of 1.41 for CPT code 43763 
(Replacement of gastrostomy tube, percutaneous, includes removal, when 
performed, without imaging or endoscopic guidance; requiring revision 
of gastrostomy tract.), consistent with the RUC's recommendations for 
these new CPT codes.

[[Page 59535]]

    For the direct PE inputs, we proposed to refine the equipment times 
in accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the codes in the Gastrostomy Tube Replacement 
code family.
    Comment: Several commenters stated that they appreciated CMS 
proposing the RUC-recommended work RVU for CPT codes 43762 and 43763.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was added to the calculation of the equipment 
time, and that this made it difficult to determine the accuracy of the 
refinements. The commenter requested more information about this 
change.
    Response: For the four equipment items where we made time 
refinements, we added the clinical labor for the CA029 clinical labor 
activity in accordance with our standard equipment time formula for 
non-highly technical equipment.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for the codes in the as Gastrostomy Tube 
Replacement code family as proposed.
(20) Diagnostic Proctosigmoidoscopy--Rigid (CPT Code 45300)
    CPT code 45300 (Proctosigmoidoscopy, rigid; diagnostic, with or 
without collection of specimen(s) by brushing or washing (separate 
procedure)) was identified as potentially misvalued on a screen of 0-
day global services reported with an E/M visit 50 percent of the time 
or more, on the same day of service by the same patient and the same 
practitioner, that have not been reviewed in the last 5 years, with 
Medicare utilization greater than 20,000. For CY 2019, we proposed the 
RUC-recommended work RVU of 0.80 for CPT code 45300.
    For the direct PE inputs, we proposed to refine the equipment times 
in accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 45300.
    Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs.
    Response: We thank commenters for their support.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was removed from the calculation of the 
equipment time, and that this made it difficult to determine the 
accuracy of the refinements. The commenter requested more information 
about this change.
    Response: For the four equipment items where we made time 
refinements, we removed the clinical labor for the CA035 clinical labor 
activity in accordance with our standard equipment time formula for 
non-highly technical equipment.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for CPT code 45300 as proposed.
(21) Hemorrhoid Injection (CPT Code 46500)
    CPT code 46500 (Injection of sclerosing solution, hemorrhoids) was 
identified as potentially misvalued on a screen of codes with a 
negative intraservice work per unit of time (IWPUT), with 2016 
estimated Medicare utilization over 10,000 for RUC reviewed codes and 
over 1,000 for Harvard valued and CMS/Other source codes.
    For CPT code 46500, we disagreed with the RUC-recommended work RVU 
of 2.00 and we proposed a work RVU of 1.74 based on a direct crosswalk 
to CPT code 68811 (Probing of nasolacrimal duct, with or without 
irrigation; requiring general anesthesia). This crosswalk code is 
another recently-reviewed 10-day global code with the same 10 minutes 
of intraservice time and slightly higher total time. When CPT code 
46500 was previously reviewed as described in the CY 2016 PFS final 
rule with comment period (80 FR 70963), we finalized a proposal to 
reduce the work RVU from 1.69 to 1.42, which reduced the work RVU by 
the same ratio as the reduction in the total work time. In light of the 
additional evidence provided by this new survey, we agree that the work 
RVU should be increased from the current value of 1.42. However, we 
believe that our proposed work RVU of 1.74 based on a crosswalk to CPT 
code 68811 is more accurate than the RUC-recommended work RVU of 2.00.
    In the most recent survey of CPT code 46500, the intraservice work 
time remained unchanged at 10 minutes while the total time increased by 
only 2 minutes, increasing from 59 minutes to 61 minutes (3 percent). 
However, the RUC-recommended work RVU is increasing from 1.42 to 2.00, 
an increase of 41 percent, and also an increase of 19 percent over the 
historic value of 1.69 for CPT code 46500. Although we did not imply 
that the increase in time as reflected in survey values must equate to 
a one-to-one or linear increase in the valuation of work RVUs, we 
believe that since the two components of work are time and intensity, 
minimal increases in surveyed work time typically should not be 
reflected in disproportionately large increases to work RVUs. In the 
case of CPT code 46500, we believe that our crosswalk to CPT code 68811 
at a work RVU of 1.74 more accurately maintains relativity with other 
10-day global codes on the PFS. We also noted that the 3 percent 
increase in surveyed work time for CPT code 46500 matches a 3 percent 
increase in the historic work RVU of the code, from 1.69 to 1.74. 
Therefore, we proposed a work RVU of 1.74 for CPT code 46500 based on 
the aforementioned crosswalk.
    For the direct PE inputs, we proposed to remove 10 minutes of 
clinical labor time for the ``Assist physician or other qualified 
healthcare professional--directly related to physician work time 
(100%)'' (CA018) activity. This clinical labor time is listed twice in 
the recommendations along with a statement that although the clinical 
labor has not changed from prior reviews, time for both clinical staff 
members was inadvertently not included in the previous spreadsheets. We 
appreciated this notification in the recommendations, and therefore, we 
requested more information about why the clinical labor associated with 
this additional staff member was left out for previous reviews. We were 
particularly interested in knowing what activities the additional staff 
member would be undertaking during the procedure. We proposed to remove 
the clinical labor associated with this additional clinical staff 
member pending the receipt of additional information. We also proposed 
to remove 1 impervious staff gown (SB027), 1 surgical mask with face 
shield (SB034), and 1 pair of shoe covers (SB039) pending more 
information about the additional clinical staff member.
    We proposed to remove the clinical labor time for the ``Review home 
care instructions, coordinate visits/prescriptions'' (CA035) activity. 
CPT code 46500 is typically billed with a same day E/M service, and we 
believe that it would be duplicative to assign clinical labor time for 
reviewing home care instructions given that this task would typically 
be done during the same day E/M service. We also proposed to refine the 
equipment times in accordance with our standard equipment time 
formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 46500.
    Comment: Many commenters disagreed with the proposed work RVU

[[Page 59536]]

of 1.74 for CPT code 46500 and stated that CMS should finalize the RUC-
recommended work RVU of 2.00. Commenters stated that they disagreed 
with CMS calculating intraservice time ratios to account for changes in 
work time, and that CPT code 46500 possesses a negative IWPUT, which 
makes the use of time ratios particularly inappropriate.
    Response: We disagree with the commenters and continue to believe 
that the use of time ratios is one of several reasonable methods for 
identifying potential work RVUs for particular PFS services, 
particularly when the alternative values do not account for information 
that suggests the amount of time involved in furnishing the service has 
changed significantly. We reiterate that, consistent with the statute, 
we are required to value the work RVU based on the relative resources 
involved in furnishing the service, which include time and intensity. 
When our review of recommended values reveals that changes in the 
resource of time have been unaccounted for in a recommended RVU, then 
we believe we have the obligation to account for that change in 
establishing work RVUs since the statute explicitly identifies time as 
one of the two elements of the work RVUs. We recognize that it would 
not be appropriate to develop work RVUs solely based on time given that 
intensity is also an element of work, but in applying the time ratios, 
we are using derived intensity measures based on current work RVUs for 
individual procedures. Were we to disregard intensity altogether, the 
work RVUs for all services would be developed based solely on time 
values and that is definitively not the case, as indicated by the many 
services that share the same time values but have different work RVUs. 
(As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all 
share identical CY 2019 work times with 15 minutes of preservice time, 
30 minutes of intraservice time, and 15 minutes of postservice time; 
however these codes have respective CY 2019 work RVUs of 1.44, 2.04, 
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time 
ratios to identify potentially appropriate work RVUs, and then use 
other methods (including estimates of work from CMS medical personnel 
and crosswalks to key reference or similar codes) to validate these 
RVUs. For more details on our methodology, we direct readers to the CY 
2017 PFS final rule (81 FR 80272 through 80277). We also note that in 
the case of CPT code 46500, we derived our proposed work RVU of 1.74 by 
using a direct crosswalk to CPT code 68811 and not a time ratio.
    Comment: Several commenters stated that the RUC compared CPT code 
46500 to the two key reference services: CPT code 46221 
(Hemorrhoidectomy, internal, by rubber band ligation(s)) and CPT code 
46930 (Destruction of internal hemorrhoid(s) by thermal energy (e.g., 
infrared coagulation, cautery, radiofrequency)). Commenters stated that 
the RUC-recommended work RVU of 2.00 places the value correctly between 
the key reference services and results in similar procedure intensity, 
whereas the CMS crosswalk to CPT code 68811 was not well aligned with 
the top two key reference services due to having a lower intensity.
    Response: We disagree with the commenters that our crosswalk to CPT 
code 68811 would be less accurate for work valuation than the two key 
references chosen by the survey respondents. We note, for example, that 
CPT code 46221 has 50 percent more intraservice time than CPT code 
46500, and CPT code 46930 has 50 percent less intraservice time than 
CPT code 46500, whereas the CMS crosswalk to CPT code 68811 shares the 
same 10 minutes of intraservice time as CPT code 46500. We believe that 
this closer match in the work time values makes CPT code 68811 a more 
appropriate choice for a crosswalk code. We also note that at the RUC 
meeting when CPT code 46500 was under review, the specialty presenters 
stated that the work RVU had not changed from the historical value of 
1.69 before the recommendation was changed to the final value of 2.00. 
As we stated in the proposed rule, the 3 percent increase in surveyed 
work time for CPT code 46500 matches a 3 percent increase in the 
historic work RVU of the code, from 1.69 to 1.74. We continue to 
believe that this is the most accurate value to finalize for CPT code 
46500.
    Comment: Several commenters compared CPT code 46500 to CPT code 
68810 (Probing of nasolacrimal duct, with or without irrigation) and 
noted that these codes have the same intraservice work time but the 
comparison code includes a lower level follow-up visit and therefore 
correctly has a lower work RVU. Commenters stated that CPT code 46500 
includes a follow-up office visit with an anoscopy to determine the 
effectiveness of the treatment and to monitor for infection or sepsis 
which adds work to the visit. Commenters stated that the proposed CMS 
crosswalk to CPT code 68811 includes an even lower level office visit 
(CPT code 99211) than the office visit in CPT code 68810, which 
indicated that it was an inappropriate choice for a crosswalk.
    Response: We continue to disagree with the commenters that the CMS 
crosswalk to CPT code 68811 would provide an inappropriate work 
valuation for CPT code 46500 based on the differences in postoperative 
work and work time. We would like to clarify again that we used CPT 
code 68811 as our crosswalk, not CPT code 68810, and we do not 
understand the comparisons to CPT code 68810 suggested by the 
commenters. Regarding our crosswalk code, while it is true that CPT 
code 68811 does not contain a level three (CPT code 99213) office visit 
in its global period like CPT code 46500, the code does include half of 
a discharge visit (CPT code 99238) in its global period, which is 
missing from the reviewed code. Under the building block methodology, 
the combined work RVU and the work time of a half discharge visit (CPT 
code 99238) and a level 1 office visit (CPT code 99211) would equal 
0.82 RVUs and 26 minutes. This is approximately equal to the level 3 
office visit (CPT code 99213 with 0.97 work RVUs and 23 minutes of work 
time) in the global period of CPT code 46500. As a result, we do not 
agree with the commenters that CPT code 46500 has a significantly 
greater amount of postservice work and postservice work time than our 
crosswalk code.
    Comment: Several commenters responded to our request for more 
information about why the clinical labor associated with the additional 
staff member was left out of previous reviews and what activities the 
additional staff member would be undertaking during the procedure. 
Commenters stated that two clinical staff are needed to assist the 
physician during the intraservice portion of the service: one staff 
person is handling suction and holding the retractor while the surgeon 
identifies and injects anesthetic and sclerosant into the poles of the 
hemorrhoids, and the second staff person is handing supplies (syringes, 
gauze) and taking soiled supplies away. The commenters stated that one 
staff person will assist with tasks such as irrigation, suction, etc. 
and one circulating staff person will hand syringes, sponges, etc. to 
the physician.
    Response: We appreciate the additional feedback from the commenters 
regarding what activities the additional staff member would be 
undertaking during the procedure, although we note that we did not 
receive a response regarding why the clinical labor associated with 
this additional staff member was left out of previous reviews. After 
reviewing the

[[Page 59537]]

additional information supplied by the commenters, we are not 
finalizing our proposal to remove the clinical labor time for the 
``Assist physician or other qualified healthcare professional'' (CA018) 
activity or the proposal to remove 1 impervious staff gown (SB027), 1 
surgical mask with face shield (SB034), and 1 pair of shoe covers 
(SB039). We are finalizing the RUC-recommended values for these direct 
PE inputs.
    Comment: Several commenters disagreed with the proposal to remove 
the clinical labor time for the ``Review home care instructions, 
coordinate visits/prescriptions'' (CA035) activity. Commenters stated 
that this clinical activity was not duplicative with the same day E/M 
office visit, as the home care instructions directly pertain to the 
procedure and would not be provided during an evaluation of the 
patient.
    Response: We disagree with the commenters that home care 
instructions would not be provided during the same day E/M visit. The 
commenters did not provide a rationale to explain why home care 
instructions would not be provided during the same day E/M visit, which 
also directly pertains to the procedure. We continue to believe that it 
would be duplicative to assign clinical labor time for this task, as we 
believe that the home care instructions would be furnished during the 
same day E/M visit.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was removed from the calculation of the 
equipment time, and that this made it difficult to determine the 
accuracy of the refinements. The commenter requested more information 
about this change.
    Response: For the anoscope with light source (ES002) equipment, we 
removed the clinical labor for the CA029 and CA035 clinical labor 
activities in accordance with our standard equipment time formula for 
scopes.
    After consideration of the public comments, we are finalizing the 
work RVU for CPT code 46500 as proposed. We are finalizing the RUC-
recommended direct PE inputs for this code, with the exception of our 
refinement to the CA035 clinical labor activity and standard equipment 
time refinements as detailed above.
(22) Removal of Intraperitoneal Catheter (CPT Code 49422)
    In October 2016, CPT code 49422 (Removal of tunneled 
intraperitoneal catheter) was identified as a site of service anomaly 
because Medicare data from 2012-2014 indicated that it was performed 
less than 50 percent of the time in the inpatient setting, yet it 
included inpatient hospital E/M services within the 10-day global 
period. The code was resurveyed using a 0-day global period for the 
April 2017 RUC meeting. For CY 2019, we proposed the RUC-recommended 
work RVU of 4.00 for CPT code 49422.
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 49422.
    Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs. Commenters also supported the change in global 
period to a 0-day global.
    Response: We thank commenters for their support.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVU and direct PE inputs for CPT code 49422 as 
proposed.
(23) Dilation of Urinary Tract (CPT Codes 50436, 50437, 52334, and 
74485)
    In October 2014, the CPT Editorial Panel deleted 6 codes and 
created 12 new codes to describe genitourinary catheter procedures and 
bundle inherent imaging services. In January 2015, the specialty 
societies indicated that CPT code 50395 (Introduction of guide into 
renal pelvis and/or ureter with dilation to establish nephrostomy 
tract, percutaneous), which was identified as part of the family, would 
be referred to the CPT Editorial Panel to clear up any confusion with 
overlap in physician work with CPT code 50432 (Placement of nephrostomy 
catheter, percutaneous, including diagnostic nephrostogram and/or 
ureterogram when performed, imaging guidance (e.g., ultrasound and/or 
fluoroscopy) and all associated radiological supervision and 
interpretation). In September 2017, the CPT Editorial Panel deleted CPT 
code 50395 and created 2 new codes to report dilation of existing 
tract, and establishment of new access to the collecting system, 
including percutaneous, for an endourologic procedure including imaging 
guidance (e.g., ultrasound and/or fluoroscopy), all associated 
radiological supervision and interpretation, as well as post procedure 
tube placement when performed.
    The specialty society surveyed the new CPT code 50436 (Dilation of 
existing tract, percutaneous, for an endourologic procedure including 
imaging guidance (e.g., ultrasound and/or fluoroscopy) and all 
associated radiological supervision and interpretation, as well as post 
procedure tube placement, when performed), and the RUC recommended a 
total time of 70 minutes, intraservice time of 30 minutes, and a work 
RVU of 3.37. The RUC indicated that its recommended work RVU for this 
CPT code is identical to the work RVU of the CPT code being deleted, 
even though imaging guidance CPT code 74485 has now been bundled into 
the valuation of the CPT code. The RUC provided two key reference CPT 
codes to support its recommendation: CPT code 50694 (Placement of 
ureteral stent, percutaneous, including diagnostic nephrostogram and/or 
ureterogram when performed, imaging guidance (e.g., ultrasound and/or 
fluoroscopy), and all associated radiological supervision and 
interpretation; new access, without separate nephrostomy catheter) with 
total time of 111 minutes, intraservice time of 62 minutes, and a work 
RVU of 5.25; and CPT code 50695 (Placement of ureteral stent, 
percutaneous, including diagnostic nephrostogram and/or ureterogram 
when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy), 
and all associated radiological supervision and interpretation; new 
access, with separate nephrostomy catheter), with total time of 124 
minutes and intraservice time of 75 minutes, and a work RVU of 6.80. To 
further support its recommendation, the RUC also referenced CPT code 
52287 (Cystourethroscopy, with injection(s) for chemodenervation of the 
bladder) with total time of 58 minutes, intraservice time of 21 
minutes, and a work RVU of 3.37.
    We disagreed with the RUC that the work RVU for this CPT code 
should be the same as the CPT code being deleted. Survey respondents 
indicated that the total time for completing the service described by 
the new CPT code is nearly 30 minutes less than the existing CPT code, 
even though imaging guidance was described as part of the procedure. We 
also noted that the reference CPT codes both have substantially higher 
total and intraservice times than CPT code 50436. We considered a 
number of parameters to arrive at our proposed work RVU of 2.78, 
supported by a crosswalk to CPT code 31646 (Bronchoscopy, rigid or 
flexible, including fluoroscopic guidance, when performed; with 
therapeutic aspiration of tracheobronchial tree, subsequent, same 
hospital stay). We examined the intraservice time ratio for the new CPT 
code in relation to the combination of CPT codes that the service 
represents and found that this would support a work RVU of 2.55. We 
also calculated the intraservice time ratio for the new CPT code in 
relation to each of the two

[[Page 59538]]

reference CPT codes. For the comparison with CPT code 50694, the 
intraservice time ratio is 2.54, while the comparison with the second 
reference CPT code 50695 yields an intraservice time ratio of 2.72. We 
took the highest of these three values, 2.72, and found a corresponding 
crosswalk that we believe appropriately values the service described by 
the new CPT code. Therefore, we proposed a work RVU of 2.78 for CPT 
code 50436.
    The specialty society also surveyed the new CPT code 50437 
(Dilation of existing tract, percutaneous, for an endourologic 
procedure including imaging guidance (e.g., ultrasound and/or 
fluoroscopy) and all associated radiological supervision and 
interpretation, as well as post procedure tube placement, when 
performed; including new access into the renal collecting system) and 
the RUC recommended a total time of 100 minutes, an intraservice time 
of 60 minutes, and a work RVU of 5.44. The recommended intraservice 
time of 60 minutes reflects the 75th percentile of survey results, 
rather than the median survey time, which is typically used for 
determining the intraservice time for new CPT codes. The RUC justified 
the use of the higher intraservice time because they believe the time 
better represents the additional time needed to introduce the guidewire 
into the renal pelvis and/or ureter, above and beyond the work involved 
in performing CPT code 50436. The RUC compared this CPT code to CPT 
code 52235 (Cystourethroscopy, with fulguration (including cryosurgery 
or laser surgery) and/or resection of; MEDIUM bladder tumor(s) (2.0 to 
5.0 cm)), with total time of 94 minutes, intraservice time of 45 
minutes, and a work RVU of 5.44. The RUC also cited as support the 
second key reference CPT code 50694 (Placement of ureteral stent, 
percutaneous, including diagnostic nephrostogram and/or ureterogram 
when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy), 
and all associated radiological supervision and interpretation; new 
access, without separate nephrostomy catheter) with total time 111 
minutes, intraservice time 62 minutes, and a work RVU of 5.25.
    We did not agree with the RUC's recommended work RVU because we 
believed that the intraservice time for this CPT code should reflect 
the survey median rather than the 75th percentile. There is no 
indication that the additional work of imaging guidance was 
systematically excluded by survey respondents when estimating the time 
needed to furnish the service. Therefore, we proposed to reduce the 
intraservice time for CPT code 50437 from the RUC- recommended 60 
minutes to the survey median time of 45 minutes. We noted that this is 
still 15 minutes more than the intraservice time for CPT code 50436, 
primarily for the provider to introduce the guidewire into the renal 
pelvis and/or ureter. We welcomed comments about the amount of time 
needed to furnish this procedure.
    With the revised intraservice time of 45 minutes and a total time 
of 85 minutes, we believed that the RUC-recommended work RVU for this 
CPT code is overstated. When we applied the increment between the RUC-
recommended values for between CPT codes 50436 and 50437 (2.07 work 
RVUs) in addition to our proposed work RVU for CPT code 50436, we 
estimated that this CPT code was more accurately represented by a work 
RVU of 4.83. This value is supported by a crosswalk to CPT code 36902 
(Introduction of needle(s) and/or catheter(s), dialysis circuit, with 
diagnostic angiography of the dialysis circuit, including all direct 
puncture(s) and catheter placement(s), injection(s) of contrast, all 
necessary imaging from the arterial anastomosis and adjacent artery 
through entire venous outflow including the inferior or superior vena 
cava, fluoroscopic guidance, radiological supervision and 
interpretation and image documentation and report; with transluminal 
balloon angioplasty, peripheral dialysis segment, including all imaging 
and radiological supervision and interpretation necessary to perform 
the angioplasty), which has an intraservice time of 40 minutes and a 
total time of 86 minutes. We believed that CPT code 36902 describes a 
service that is similar to the new CPT code 50437) and therefore 
provides a reasonable crosswalk. We proposed a work RVU of 4.83 for CPT 
code 50437.
    We proposed the RUC-recommended work RVU of 3.37 for CPT code 52334 
(Cystourethroscopy with insertion of ureteral guide wire through kidney 
to establish a percutaneous nephrostomy, retrograde) and the RUC-
recommended work RVU of 0.83 for CPT code 74485 (Dilation of ureter(s) 
or urethra, radiological supervision and interpretation).
    For the direct PE inputs, we proposed to remove the clinical labor 
time for the ``Confirm availability of prior images/studies'' (CA006) 
activity for CPT code 52334. This code does not currently include this 
clinical labor time, and unlike the two new codes in the family (CPT 
codes 50436 and 50437), CPT code 52334 does not include imaging 
guidance in its code descriptor. When CPT code 52334 is performed with 
imaging guidance, it would be billed together with a separate imaging 
code that already includes clinical labor time for confirming the 
availability of prior images. As a result, we believed that it would be 
duplicative to include this clinical labor time in CPT code 52334.
    The following is a summary of the public comments we received on 
our proposals involving the Dilation of Urinary Tract family of codes.
    Comment: Several commenters responded to our proposals regarding 
work RVUs for this family of codes. In general, commenters expressed 
support for our proposed work RVU of 3.37 for CPT code 52334 and 0.83 
for CPT code 74485.
    Response: We are finalizing the work RVUs for each of these codes 
as proposed.
    Comment: Several commenters did not support our proposals regarding 
the work RVU for CPT codes 50436 and 50437. The RUC and other 
commenters stated that CMS misunderstood the RUC's summary of results 
(SOR) and the purpose of the reference codes and the code comparisons 
as part of their review process. They suggested that our rejection of 
the RUC recommendation for CPT code 50436 was based on a mistake about 
the codes that the RUC cited as reference codes.
    Response: We consider a variety of documents and data during our 
review of the RUC's recommended work RVU for a code. The two reference 
codes cited in the excel summary work RVU spreadsheet for CPT code 
50436 were CPT codes 50694 and 50695, while the two reference codes 
cited in the SOR were CPT codes 52287 52214. In other words, there was 
an inconsistency in the documentation. We believe that any of the four 
reference codes cited in the documentation and/or data are valid points 
of comparison for evaluating whether the RUC's recommended work RVUs 
are appropriate.
    Comment: Some commenters did not agree with CMS's use of 
intraservice time ratios as a factor in determining whether a CPT code 
is appropriately valued. The commenters maintained that CMS's use of 
these parameters is inappropriate and demonstrates our prioritization 
of time-related factors above the intensity and complexity of the 
service.
    Response: We routinely use intraservice time ratios to determine 
whether a recommended work RVU for a new CPT code adequately reflects 
efficiencies gained when codes are bundled and/or providers become more 
efficient at furnishing services and we disagree with commenters that 
time

[[Page 59539]]

ratios are an inappropriate metric. We identify a crosswalk for the 
purpose of establishing the work RVU by comparing the survey code to 
other codes in the PFS with similar intraservice and total times and 
also by considering the intensity among codes with similar times. We 
disagree that this means we are prioritizing time parameters over other 
factors that are relevant in considering a code's value.
    Comment: Commenters disagreed with CMS's proposed work RVU of 2.78 
for CPT code 50436, citing CMS's inappropriate use of time parameters 
in comparing this code with the deleted CPT code 50395.
    Response: Even after taking into consideration the bundling of the 
deleted code, CPT 50395, with CPT code 74485, we believe that there are 
efficiencies in the work that are not adequately reflected in the RUC-
recommended work RVU for this new code, CPT 50436. We examined a number 
of parameters in seeking an appropriate crosswalk code for CPT 50436, 
including the intraservice time ratio for this new code in relation to 
the combination of CPT codes that the service represents and the 
intraservice time ratio for the new code in relation to each of the 
RUC's two reference codes. Our crosswalk, CPT code 31646, reflects the 
work RVU (2.78) corresponding to the most appropriate, and the highest, 
work RVU (2.72) associated with these calculations. Our identification 
of a crosswalk code is not dictated by the time parameter calculations 
alone, but rather is based on a combination of the time parameters and 
our understanding of the intensity involved in furnishing the service. 
If we had been looking only at time parameters, we might have chosen a 
CPT code with a work RVU closest to the lowest of the time parameter 
calculations (2.54). We continue to believe that the most appropriate 
crosswalk is CPT code 31646, and we are finalizing our proposed work 
RVU of 2.78 for CPT code 50436.
    Comment: As with CPT code 50436, commenters suggested that CMS 
mistook the codes included in the SOR as the codes that the RUC cited 
as reference codes.
    Response: As we indicated in our response to this comment for CPT 
code 50436, we consider all documentation and data provided by the RUC 
in our assessment of the work RVU for a code. The reference and 
comparison CPT codes cited in the SOR did not match those in the 
summary work RVU spreadsheet.
    Comment: Several commenters disagreed with our method of proposing 
a work RVU based on the incremental differences in the RUC-recommended 
work RVU between codes. Commenters stated that this erroneously 
considers all time components as having equal intensity.
    Response: We generally apply this methodology where we agree with, 
and seek to maintain the relativity between two codes reflected in the 
RUC recommendations, but we disagree with the RUC-recommended work RVU 
for one or both of the codes. We also considered, as an alternative, 
whether it would be more appropriate to use proportional increments 
rather than absolute differences between two RUC-recommended work RVUs. 
Under that scenario, we would have proposed a work RVU of 4.49 for CPT 
code 50437 [(2.78 * 5.44)/3.37 = 4.49]. However, since our general 
approach involves applying the absolute difference in work RVUs, our 
proposed value for CPT code 50437 was 4.83 work RVUs. We thank the 
commenter for pointing out our calculation error, due to which our 
proposed work RVU should have been 4.85 instead of 4.83. We continue to 
believe that relative difference in the RUC's recommendations for work 
RVUs between codes is a useful and appropriate tool for determining 
work RVUs for CPT codes, and we are finalizing a work RVU of 4.85 for 
CPT code 50437 based on a comparison with CPT code 36902, which has a 
work RVU of 4.83.
    Comment: Several commenters disagreed with the proposal to remove 
the clinical labor time for the ``Confirm availability of prior images/
studies'' (CA006) activity for CPT code 52334. Commenters stated that 
the equivalent of the CA006 clinical labor activity did not exist when 
this service was last reviewed by the Practice Expense subcommittee in 
2002, and that many surgical procedures and other types of services 
that do not have imaging bundled involve the physician reviewing images 
and studies before performing the service. Commenters stated that this 
review is not duplicative with image-guidance codes as it instead 
involves reviewing distinct previous studies.
    Response: We continue to believe that this clinical labor time 
should be removed because it is duplicative, as CPT code 52334 would be 
billed together with a separate imaging code that already includes 
clinical labor time for confirming the availability of prior images 
when it is performed with imaging guidance. We believe that the 
commenters may be conflating the absence of the CA006 clinical labor 
activity when CPT code 52334 was previously reviewed with the lack of 
any clinical labor for reviewing images that did not exist previously 
in this specific code. There were hundreds of procedures that included 
clinical labor for reviewing images prior to the creation of the CA006 
clinical labor code, and CPT code 52334 was not one of them. Similarly, 
while we agree that there are many services that do not have bundled 
imaging and nonetheless include the physician reviewing images and 
studies before performing the service, this does not explain why CPT 
code 52334 would require clinical labor time for confirming the 
availability of prior images and studies when the service did not 
include this clinical labor time previously. We continue to believe 
that the inclusion of this clinical labor time would be duplicative for 
this service.
    Comment: One commenter requested that CPT code 52334 be added to 
the phase-in list for codes with significant PE RVU reductions.
    Response: Section 1848(c)(7) of the Act, as added by section 220(e) 
of the PAMA, specifies that for services that are not new or revised 
codes, if the total RVUs for a service for a year would otherwise be 
decreased by an estimated 20 percent or more as compared to the total 
RVUs for the previous year, the applicable adjustments in work, PE, and 
MP RVUs shall be phased-in over a 2-year period. We proposed to exempt 
CPT code 52334 from the phase-in due to the fact that it is part of the 
same family of codes that included new CPT codes 50436 and 50437. We 
have previously finalized this policy through rulemaking, stating that 
significant coding revisions within a family of codes can change the 
relationships among codes to the extent that it changes the way that 
all services in the group are reported, even if some individual codes 
retain the same number or, in some cases, the same descriptor. 
Excluding codes from the phase-in when there are significant revisions 
to the code family also helps to maintain the appropriate rank order 
among codes in the family, avoiding years for which RVU changes for 
some codes in a family are in transition while others were fully 
implemented. For additional information regarding the phase-in of 
significant RVU reductions, we direct readers to the CY 2016 PFS final 
rule with comment period (80 FR 70927 through 70929).
(24) Transurethral Destruction of Prostate Tissue (CPT Codes 53850, 
53852, and 53854)
    In September 2017, the CPT Editorial Panel created a new code (CPT 
code

[[Page 59540]]

53854) to report transurethral destruction of prostate tissue by 
radiofrequency-generated water vapor thermotherapy. CPT codes 53850 
(Transurethral destruction of prostate tissue; by microwave 
thermotherapy) and 53852 (Transurethral destruction of prostate tissue; 
by radiofrequency thermotherapy) were also included for review as part 
of the same family of codes.
    For CPT code 53850 (Transurethral destruction of prostate tissue; 
by microwave thermotherapy), the RUC recommended a work RVU of 5.42, 
supported by a direct crosswalk to CPT code 33272 (Removal of 
subcutaneous implantable defibrillator electrode) with a total time of 
151 minutes, intraservice time of 45 minutes, and a work RVU of 5.42. 
The RUC indicated that a work RVU of 5.42 accurately reflects the 
lowest value of the three CPT codes in this family. We proposed the 
work RVU of 5.42 for CPT code 53850, as recommended by the RUC.
    The RUC recommended a work RVU of 5.93 for CPT code 53852 
(Transurethral destruction of prostate tissue; by radiofrequency 
thermotherapy) and for CPT code 53854 (Transurethral destruction of 
prostate tissue; by radiofrequency generated water vapor 
thermotherapy). We proposed the RUC-recommended work RVU of 5.93 for 
CPT code 53852.
    CPT code 53854 is a service reflecting the use of a new technology, 
``radiofrequency generated water vapor thermotherapy,'' as distinct 
from CPT code 53852, which describes destruction of tissue by 
``radiofrequency thermotherapy.'' The RUC indicated that this CPT code 
is the most intense of the three CPT codes in this family, thereby 
justifying a work RVU identical to that of CPT code 53852, despite 
lower intraservice and total times. The RUC stated that 15 minutes of 
post service time is appropriate due to greater occurrence of post-
procedure hematuria necessitating a longer monitoring time. However, 
the post-service monitoring time for this CPT code, 15 minutes, is 
identical to that for CPT code 53852. We did not agree with the 
explanation provided by the RUC for recommending a work RVU identical 
to that of CPT code 53852, given that the total time is 5 minutes 
lower, and the post service times are identical. Both the intraservice 
time ratio between this new CPT code and CPT code 53852 (4.94) and the 
total time ratio between the two CPT codes (5.72) suggest that the RUC-
recommended work RVU of 5.93 overestimates the work involved in 
furnishing this service. We reviewed other 90-day global CPT codes with 
similar times and identified CPT code 24071 (Excision, tumor, soft 
tissue of upper arm or elbow area, subcutaneous; 3 cm or greater) with 
a total time of 183 minutes, intraservice time of 45 minutes, and a 
work RVU of 5.70 as an appropriate crosswalk. We believed that this 
would be a better reflection of the work involved in furnishing CPT 
code 53854, and therefore, we proposed a work RVU of 5.70 for this CPT 
code. We welcomed comments about the time and intensity required to 
furnish this new service. Since this CPT code reflects the use of a new 
technology, it will be reviewed again in 3 years.
    For the direct PE inputs, we proposed to add a new supply (SA128: 
``kit, Rezum delivery device''), a new equipment item (EQ389: 
``generator, water thermotherapy procedure''), and proposed to update 
the price of two supplies (SA036: ``kit, transurethral microwave 
thermotherapy'' and SA037: ``kit, transurethral needle ablation 
(TUNA)'') after reviewing invoices that we received. We noted that 
these invoices were submitted along with additional information listing 
the vendor discount for these supplies and equipment. We appreciated 
the inclusion of the discounted prices on these invoices, and we 
encouraged other invoice submissions to provide the discounted price as 
well, where available. Based on market research on supply and equipment 
pricing carried out by our contractors, we believe that a vendor 
discount of 10-15 percent is common on many supplies and equipment. 
Since we are obligated by statute to establish RVUs for each service as 
required based on the resource inputs required to furnish the typical 
case of a service, we have concerns that relying on invoices for supply 
and equipment pricing absent these vendor discounts may overestimate 
the resource cost of some services. We encouraged the submission of 
additional invoices that include the discounted price of supplies and 
equipment to more accurately assess the market cost of these resources.
    The following is a summary of the public comments we received on 
our proposals involving the Transurethral Destruction of Prostate 
Tissue family of codes.
    Comment: Several commenters expressed support for our proposed work 
RVU of 5.42 for CPT code 53850 and 5.93 for CPT code 53852, which 
reflect the RUC's recommendations for these two codes.
    Response: We appreciate the commenters' support and we are 
finalizing a work RVU of 5.42 for CPT code 53850 and a work RVU of 5.93 
for CPT code 53852.
    Comment: A commenter pointed out that there is an error in our 
description of the RUC's time components for this code. We stated that 
there was less post service time for CPT code 53854 than for CPT code 
53852 when, in fact, both codes have a post service time of 15 minutes. 
The intraservice time between the two codes differs by 5 minutes, with 
CPT code 53854 having 5 fewer minutes than CPT code 53852.
    Response: We thank the commenter for informing us of the error. We 
note, however, that this does not affect our proposal which is based on 
a comparison of both intraservice and total time ratios.
    Comment: Several commenters, ranging from device manufacturers and 
professional associations, disagreed with our proposed value of 5.70 
for CPT code 53854 instead of the RUC-recommended work RVU of 5.93. 
Commenters stated that the work involved in furnishing the service 
described by CPT code 53854 is the most intense of the three CPT codes 
in this family because of the added risk of bleeding, urinary retention 
and damage to the external urinary sphincter with resultant 
incontinence of urine if not performed properly. Commenters also urged 
CMS to approach the time results from the survey for this code with 
caution, as few practitioners are likely to have had much experience 
with the new technology described by this service.
    Response: In our proposal, we requested additional information from 
stakeholders about the time and intensity required to furnish this 
service because we were not convinced that the work involved in 
furnishing the service described by CPT code 53854 is more intense than 
the work involved in furnishing CPT code 53852, which the RUC used as a 
reference code in developing their recommendation. We were convinced by 
commenters, however, that the additional risk in furnishing this 
service supports a higher work RVU than what we proposed. Therefore, we 
are finalizing a work RVU of 5.93 for this CPT code, as recommended by 
the RUC.
    Comment: One commenter stated that both CPT codes should be subject 
to the phase-in for CY 2019 because they will decrease more than 20 
percent and are not new or revised codes. The commenter urged CMS to 
add CPT codes 52380 and 52382 to the list of codes subject to the 
phase-in.
    Response: Section 1848(c)(7) of the Act, as added by section 220(e) 
of the PAMA, specifies that for services that

[[Page 59541]]

are not new or revised codes, if the total RVUs for a service for a 
year would otherwise be decreased by an estimated 20 percent or more as 
compared to the total RVUs for the previous year, the applicable 
adjustments in work, PE, and MP RVUs shall be phased-in over a 2-year 
period. We proposed to exempt CPT codes 52380 and 52382 from the phase-
in of significant RVU reductions required by section 1848(b)(11) of the 
Act because these codes are part of the same family of codes that 
included new CPT code 53854. We have previously finalized this policy 
through rulemaking, stating that significant coding revisions within a 
family of codes can change the relationships among codes to the extent 
that it changes the way that all services in the group are reported, 
even if some individual codes retain the same number or, in some cases, 
the same descriptor. Excluding codes from the phase-in when there are 
significant revisions to the code family also helps to maintain the 
appropriate rank order among codes in the family, avoiding years for 
which RVU changes for some codes in a family are in transition while 
others were fully implemented. For additional information regarding the 
phase-in of significant RVU reductions, we direct readers to the CY 
2016 PFS final rule with comment period (80 FR 70927 through 70929).
    Comment: One commenter stated that they were concerned about 
substantial reductions in billable staff time and supply costs 
associated with CPT codes 53850 and 53852. The commenter stated that 
reductions in billable staff time will require treating physicians to 
minimize non-procedural time which may include: Comfort control 
protocols; patient expectation management; patient post-procedure 
instructions; and recommended best practices for follow-up care. The 
commenter stated that they were concerned that the proposed supply 
costs are not in line with actual pricing or with actual cost increases 
for manufacturing of the product, and indicated that significant 
reductions in reimbursement will limit patient access to a therapy with 
demonstrated safety, effectiveness, and cost efficacy.
    Response: We appreciate the feedback from the commenter, and we are 
sensitive to the need for accurate payment under the PFS to ensure that 
beneficiaries maintain access to care. However, we note that we 
proposed the RUC-recommended direct PE inputs for this family of codes 
without refinement, and the decreases in clinical staff time for these 
procedures were almost entirely due to shorter surveyed intraservice 
work times and the removal of office visits in the postoperative 
portion of the global period as identified by the RUC. We agree with 
the RUC that fewer follow-up office visits and shorter intraservice 
times are now typical for these procedures, and we do not believe that 
the resulting decreases in clinical labor time will create barriers to 
accessing care. With regard to changes in the proposed supply costs, we 
direct readers to our discussion of the market-based supply and 
equipment pricing update in section II.B. of this final rule. We 
encourage stakeholders to continue to provide feedback concerning 
accurate supply and equipment pricing.
    After consideration of the comments, we are finalizing the RUC-
recommended work RVUs and direct PE inputs for the three codes in the 
Transurethral Destruction of Prostate Tissue family of codes.
(25) Vaginal Treatments (CPT Codes 57150 and 57160)
    CPT codes 57150 (Irrigation of vagina and/or application of 
medicament for treatment of bacterial, parasitic, or fungoid disease) 
and 57160 (Fitting and insertion of pessary or other intravaginal 
support device) were identified as potentially misvalued on a screen of 
0-day global services reported with an E/M visit 50 percent of the time 
or more, on the same day of service by the same patient and the same 
practitioner, that have not been reviewed in the last 5 years with 
Medicare utilization greater than 20,000. For CY 2019, we proposed the 
RUC-recommended work RVU of 0.50 for CPT code 57150 and the RUC-
recommended work RVU of 0.89 for CPT code 57160.
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving the Vaginal Treatments family of codes.
    Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs.
    Response: We thank commenters for their support.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVUs and direct PE inputs for CPT codes 57150 and 
57160 as proposed.
(26) Biopsy of Uterus Lining (CPT Codes 58100 and 58110)
    CPT code 58100 (Endometrial sampling (biopsy) with or without 
endocervical sampling (biopsy), without cervical dilation, any method) 
was identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. CPT code 58110 (Endometrial sampling 
(biopsy) performed in conjunction with colposcopy) was also included 
for review as part of the same family of codes. For CY 2019, we 
proposed the RUC-recommended work RVU of 1.21 for CPT code 58100 and 
the RUC-recommended work RVU of 0.77 for CPT code 58110.
    For the direct PE inputs, we proposed to remove the clinical labor 
time for the ``Review/read post-procedure x-ray, lab and pathology 
reports'' (CA028) activity for CPT code 58100. This code is typically 
billed with a same day E/M service, and we believe that it would be 
duplicative to assign clinical labor time for reviewing reports given 
that this task would typically be done during the same day E/M service. 
We also proposed to refine the equipment times in accordance with our 
standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the Biopsy of Uterus Lining family of codes.
    Comment: Several commenters stated that they appreciated that CMS 
proposed the RUC-recommended work RVU of 1.21 for CPT code 58100 and 
the RUC-recommended work RVU of 0.77 for CPT code 58110.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: Several commenters disagreed with the CMS proposal to 
remove the clinical labor time for the ``Review/read post-procedure x-
ray, lab and pathology reports'' (CA028) activity for CPT code 58100. 
Commenters stated that this clinical labor activity was not 
duplicative, as CA028 is designed specifically for post-procedure 
activity during the postservice of the service period which would not 
overlap with activities in the E/M office visit, which typically occur 
prior to the procedure and are listed as a preservice clinical labor 
activity. Commenters stated that the clinical description of the 
service for CPT code 58100 clearly notes that the E/M service is done 
the day before the service and that the patient returns for the biopsy.
    Response: We disagree with the commenters' statements about the 
timing of the E/M office visit. The same day billing data indicates 
that CPT code 58100 is typically billed with an E/M office visit on the 
same day (59 percent of the time), and it therefore seems clear that 
the E/M office visit typically takes place during the day of the 
procedure,

[[Page 59542]]

not the day before. We do not understand how the claims analysis fits 
with the statement from the commenters that the E/M service happens the 
day before the procedure, especially since CPT code 58100 has a 0-day 
global period that does not include preoperative care that takes place 
the day before the procedure. We continue to believe that it would be 
duplicative to assign clinical labor time for reviewing reports given 
that this task would typically be done during the same day E/M service. 
We believe that this clinical labor would be carried out during the 
same day E/M visit.
    After consideration of the public comments, we are finalizing the 
work RVUs and the direct PE inputs for the codes in the Biopsy of 
Uterus Lining family of codes as proposed.
(27) Injection Greater Occipital Nerve (CPT Code 64405)
    CPT code 64405 (Injection, anesthetic agent; greater occipital 
nerve) was identified as potentially misvalued on a screen of 0-day 
global services reported with an E/M visit 50 percent of the time or 
more, on the same day of service by the same patient and the same 
practitioner, that have not been reviewed in the last 5 years with 
Medicare utilization greater than 20,000. For CY 2019, we proposed the 
RUC-recommended work RVU of 0.94 for CPT code 64405.
    For the direct PE inputs, we proposed to refine the equipment time 
for the exam table (EF023) in accordance with our standard equipment 
time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 64405.
    Comment: Some commenters expressed support for our proposal to 
accept the RUC-recommended work RVU for this code.
    Response: We appreciate the support from the commenters for our 
proposals.
    After consideration of the public comments, we are finalizing the 
work RVU and the direct PE inputs for CPT code 64405 as proposed.
(28) Injection Digital Nerves (CPT Code 64455)
    CPT code 64455 (Injection(s), anesthetic agent and/or steroid, 
plantar common digital nerve(s) (e.g., Morton's neuroma)) was 
identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. For CY 2019, we proposed the RUC-
recommended work RVU of 0.75 for CPT code 64455.
    For the direct PE inputs, we proposed to refine the equipment time 
for the exam table (EF023) in accordance with our standard equipment 
time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 64455.
    Comment: Several commenters supported the CMS proposal of the RUC-
recommended work RVU of 0.75.
    Response: We appreciate the support for our proposals from the 
commenters.
    After consideration of the public comments, we are finalizing the 
work RVU and the direct PE inputs for CPT code 64455 as proposed.
(29) Removal of Foreign Body--Eye (CPT Codes 65205 and 65210)
    CPT codes 65205 (Removal of foreign body, external eye; 
conjunctival superficial) and 65210 (Removal of foreign body, external 
eye; conjunctival embedded (includes concretions), subconjunctival, or 
scleral nonperforating) were identified as potentially misvalued on a 
screen of 0-day global services reported with an E/M visit 50 percent 
of the time or more, on the same day of service by the same patient and 
the same practitioner, that have not been reviewed in the last 5 years 
with Medicare utilization greater than 20,000.
    For CY 2019, we proposed the RUC-recommended work RVU of 0.49 for 
CPT code 65205. We noted that the recommendations for this code 
included a statement that the work required to perform CPT code 65205 
and the procedure itself had not fundamentally changed since the time 
of the last review. However, due to the fact that the surveyed 
intraservice time had decreased from 5 minutes to 3 minutes, the work 
RVU was lowered from the current value of 0.71 to the recommended work 
RVU of 0.49, based on a direct crosswalk to CPT code 68200 
(Subconjunctival injection). We noted that this recommendation appears 
to have been developed under a methodology similar to our ongoing use 
of time ratios as one of several methods used to evaluate work. We used 
time ratios to identify potential work RVUs and considered these work 
RVUs as potential options relative to the values developed through 
other options. As we have stated in past rulemaking (such as 82 FR 
53032-53033), we did not imply that the decrease in time as reflected 
in survey values must equate to a one-to-one or linear decrease in 
newly valued work RVUs, as indeed it does not in the case of CPT code 
65205 here. Instead, we believed that, since the two components of work 
are time and intensity, significant decreases in time should be 
reflected in decreases to work RVUs. We appreciate that the RUC-
recommended work RVU for CPT code 65205 has taken these changes in work 
time into account, and we support the use of similar methodologies, 
where appropriate, in future work valuations.
    For CPT code 65210, we disagreed with the RUC-recommended work RVU 
of 0.75 and we proposed a work RVU of 0.61 based on a direct crosswalk 
to CPT code 92511 (Nasopharyngoscopy with endoscope). This crosswalk 
code has the same intraservice time of 5 minutes and 4 additional 
minutes of total time as compared to CPT code 65210. We noted that the 
recommended intraservice time for CPT code 65210 is decreasing from 13 
minutes to 5 minutes (62 percent reduction), and the recommended total 
time for CPT code 65210 is decreasing from 25 minutes to 13 minutes (48 
percent reduction); however, the RUC-recommended work RVU is only 
decreasing from 0.84 to 0.75, which is a reduction of about 11 percent. 
As we noted earlier, we do not believe that the decrease in time as 
reflected in survey values must equate to a one-to-one or linear 
decrease in the valuation of work RVUs, and we did not propose a linear 
decrease in the work valuation based on these time ratios. However, we 
believe that since the two components of work are time and intensity, 
significant decreases in time should be reflected in decreases to work 
RVUs, and we do not believe that the recommended work RVU of 0.75 
appropriately reflects these decreases in surveyed work time.
    Our proposed work RVU of 0.61 is also based on a crosswalk to CPT 
code 51700 (Bladder irrigation, simple, lavage and/or instillation), 
another recently reviewed code with higher time values and a work RVU 
of 0.60. We also noted that two injection codes (CPT codes 20551 and 
64455) were reviewed at the same RUC meeting as CPT code 65210, each of 
which shared the same intraservice time of 5 minutes and had a higher 
total time of 21 minutes. Both of these codes had a RUC-recommended 
work RVU of 0.75, which we proposed without refinement for CY 2019. Due 
to the fact that CPT code 65210 has a lower total time and a lower 
intensity than both of these injection procedures, we did not agree 
that CPT code 65210 should be valued at the same work RVU of 0.75. We 
believe that our proposed work RVU of 0.61 based on a crosswalk to CPT 
code 92511 is a more accurate value for this code.
    For the direct PE inputs, we noted that the RUC-recommended 
equipment time for the screening lane (EL006)

[[Page 59543]]

equipment in CPT codes 65205 and 65210 was equal to the total work time 
in addition to the clinical labor time needed to set up and clean the 
equipment. We disagreed that the screening lane would typically be in 
use for the total work time, given that this includes the preservice 
evaluation time and the immediate postservice time. Although we did not 
currently propose to refine the equipment time for the screening lane 
in these two codes, we solicited comments on whether the use of the 
intraservice work time would be more typical than the total work time 
for CPT codes 65205 and 65210.
    The following is a summary of the public comments we received on 
our proposals involving the Removal of Foreign Body--Eye family of 
codes.
    Comment: Commenters agreed with the CMS proposal of the RUC-
recommended work RVU for CPT code 65205.
    Response: We appreciate the support for our proposal from the 
commenters.
    Comment: Several commenters disagreed with our statement that the 
RUC-recommended work RVU for CPT code 65205 appeared to have been 
developed under a methodology similar to the use of time ratios. 
Commenters stated that time ratios were not used in arriving at the 
value of 0.49 for CPT code 65205, and that the recommended work RVU was 
based instead on a crosswalk to the second key reference code from the 
survey, CPT code 68200, which requires the same total time to perform 
and shares identical intensity and complexity.
    Response: We appreciate the additional information provided by the 
commenters regarding the methodology behind the recommended work RVU 
for CPT code 65205. As we noted in the proposed rule, this 
recommendation appeared to have been developed under a methodology 
similar to our ongoing use of time ratios; we did not state that the 
recommendation was explicitly based on the use of a time ratio.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.61 for CPT code 65210 and stated that CMS should finalize the RUC-
recommended work RVU of 0.75. Commenters stated that CMS should not use 
intraservice time ratios for work valuation as this methodology ignored 
the work estimates present in the survey data and the RUC review of 
those work estimates. Commenters stated that the RUC-recommended work 
values consider intensity and complexity of the work, while CMS 
substituted an arbitrary determination of work values based on time and 
a subjective estimate of intensity and complexity based on an unknown 
and clinically uninformed opinion.
    Response: We disagree with the commenters and continue to believe 
that the use of time ratios is one of several appropriate methods for 
identifying potential work RVUs for particular PFS services, 
particularly when the alternative values recommended by the RUC and 
other commenters do not account for information provided by surveys 
that suggests the amount of time involved in furnishing the service has 
changed significantly. We reiterate that, consistent with the statute, 
we are required to value the work RVU based on the relative resources 
involved in furnishing the service, which include time and intensity. 
When our review of recommended values reveals that changes in the 
resource of time have been unaccounted for in a recommended RVU, then 
we believe we have the obligation to account for that change in 
establishing work RVUs since the statute explicitly identifies time as 
one of the two elements of the work RVUs. We recognize that it would 
not be appropriate to develop work RVUs solely based on time given that 
intensity is also an element of work, but in applying the time ratios, 
we are using derived intensity measures based on current work RVUs for 
individual procedures. Were we to disregard intensity altogether, the 
work RVUs for all services would be developed based solely on time 
values and that is definitively not the case, as indicated by the many 
services that share the same time values but have different work RVUs. 
(As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all 
share identical CY 2019 work times with 15 minutes of preservice time, 
30 minutes of intraservice time, and 15 minutes of postservice time; 
however these codes have respective CY 2019 work RVUs of 1.44, 2.04, 
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time 
ratios to identify potentially appropriate work RVUs, and then use 
other methods (including estimates of work from CMS medical personnel 
and crosswalks to key reference or similar codes) to validate these 
RVUs. For more details on our methodology for developing work RVUs, we 
direct readers to the discussion in the CY 2017 PFS final rule (81 FR 
80272 through 80277). We also note that in the case of CPT code 65210, 
we derived our proposed work RVU of 0.61 by using a direct crosswalk to 
CPT code 92511 and not a time ratio.
    Comment: Several commenters noted that CPT code 65210 had never 
been surveyed and was based on Harvard time which contributed to the 
median survey intraservice time of 5 minutes being less than half of 
the current value of 13 minutes. Commenters stated that Harvard times 
should be not be used for any sort of time comparison, especially when 
the code was not originally surveyed by Harvard, and any comparisons 
with these work times were inappropriate.
    Response: We agree that it is important to use the most recent data 
available regarding time, and we note that when many years have passed 
between when time is measured, significant discrepancies can occur. 
However, we also believe that our operating assumption regarding the 
validity of the existing values as a point of comparison is critical to 
the integrity of the relative value system as currently constructed. 
The times currently associated with codes play a very important role in 
PFS ratesetting, both as points of comparison in establishing work RVUs 
and in the allocation of indirect PE RVUs by specialty. If we were to 
operate under the assumption that previously recommended work times had 
routinely been overestimated, this would undermine the relativity of 
the work RVUs on the PFS in general, given the process under which 
codes are often valued by comparisons to codes with similar times, and 
it also would undermine the validity of the allocation of indirect PE 
RVUs to physician specialties across the PFS. Instead, we believe that 
it is crucial that the code valuation process take place with the 
understanding that the existing work times used in the PFS ratesetting 
processes are accurate. We recognize that adjusting work RVUs for 
changes in time is not always a straightforward process and that the 
intensity associated with changes in time is not necessarily always 
linear, which is why we apply various methodologies to identify several 
potential work values for individual codes. However, we want to 
reiterate that we believe it would be irresponsible to ignore changes 
in time based on the best data available and that we are statutorily 
obligated to consider both time and intensity in establishing work RVUs 
for PFS services. For additional information regarding the use of 
current work time values in our methodology, we refer readers to our 
discussion of the subject in the CY 2017 final rule (81 FR 80273 
through 80274).
    Comment: Several commenters stated that the procedure described by 
CPT code 65210 has not fundamentally changed, and therefore the RUC had 
recommended a work RVU at the 25th percentile in accordance with the 
recent survey. One commenter stated that the

[[Page 59544]]

intensity of the procedure was also unchanged. Commenters stated that 
the crosswalk and reference codes chosen by CMS were clearly not as 
intense as the removal of an embedded foreign body described by CPT 
code 65210, in which an incision into ocular tissue is required.
    Response: We disagree with the commenters that CPT code 65210 has 
not fundamentally changed. We note for example that the surveyed work 
times have decreased drastically from the prior valuation, and 
similarly, the intensity of the service as measured by the survey more 
than doubled. These factors do not comport with the statement from the 
commenters that intensity of this service is unchanged. We also note 
that the RUC-recommended work RVU of 0.75 was a decrease from the 
current work RVU of 0.84, which also does not appear to reflect the 
idea that the intensity of the service has not changed. We similarly 
disagree with the commenters that our crosswalk and reference codes are 
not as intense as CPT code 65210. CPT code 92511 in particular 
describes a nasopharyngoscopy with endoscope that requires removing 
secretions and dried mucus blocking passage to the nasopharynx with 
suction and/or forceps. We disagree with the commenters that this 
procedure would be less intensive than the removal of a foreign body as 
described in CPT code 65210.
    Comment: Several commenters disagreed with the CMS comparison of 
CPT code 65210 to two injection codes (CPT codes 20551 and 64455) which 
were reviewed at the same RUC meeting as CPT code 65210. Commenters 
stated that the two referenced codes both have a lower intensity than 
CPT code 65210 and therefore they were not appropriate references for 
work valuation. Commenters stated that CPT code 65210 has a lower total 
time and a higher intensity than both of these injection procedures, 
justifying the recommended work RVU of 0.75.
    Response: We disagree with the commenters that CPT code 65210 would 
typically have a higher intensity than CPT codes 20551 and 64455. These 
codes both describe injection procedures, with CPT code 20551 
describing an injection into the tendon and CPT code 64455 describing 
an injection into the plantar common digital nerve. We do not agree 
that the removal of a foreign body from the eye as described in CPT 
code 65210 would have such greater intensity that it warrants a work 
RVU of 0.75 (to match CPT codes 20551 and 64455) despite having 
approximately 40 percent less total work time.
    Comment: Several commenters stated in response to the CMS comment 
solicitation that the screening lane (EL006) equipment would typically 
be in use for the total work time of CPT codes 65205 and 65210. 
Commenters stated that the screening lane is the ophthalmic equivalent 
of an exam room in the non-facility setting which would be needed for 
the total time of the procedure. Commenters stated that this equipment 
time represented the total time taken by the physician to perform the 
service in the screening lane (which would be not be available for use 
by another patient during the time of the procedure), plus the time 
inputs for the technician work as listed above.
    Response: We appreciate the additional information provided by the 
commenters regarding the use of the screening lane (EL006) equipment.
    After consideration of the public comments, we are finalizing the 
work RVUs and the direct PE inputs for the codes in the Removal of 
Foreign Body--Eye family of codes as proposed.
(30) Injection--Eye (CPT Codes 67500, 67505, and 67515)
    CPT code 67515 (Injection of medication or other substance into 
Tenon's capsule) was identified as potentially misvalued on a screen of 
0-day global services reported with an E/M visit 50 percent of the time 
or more, on the same day of service by the same patient and the same 
practitioner, that have not been reviewed in the last 5 years with 
Medicare utilization greater than 20,000. CPT codes 67500 (Retrobulbar 
injection; medication (separate procedure, does not include supply of 
medication)) and 67505 (Retrobulbar injection; alcohol) were also 
included for review as part of the same family of codes. For CY 2019, 
we proposed the RUC-recommended work RVU of 1.18 for CPT code 67500.
    For CPT code 67505, we disagreed with the RUC-recommended work RVU 
of 1.18 and we proposed a work RVU of 0.94 based on a direct crosswalk 
to CPT code 31575 (Laryngoscopy, flexible; diagnostic). This is a 
recently reviewed code with the same intraservice time of 5 minutes and 
2 fewer minutes of total time as compared to CPT code 67505. We 
disagreed with the recommendation to propose the same work RVU of 1.18 
for both CPT code 67500 and 67505 for several reasons. We noted that 
the current work RVU of 1.44 for CPT code 67500 is higher than the 
current work RVU of 1.27 for CPT code 67505, while the current work 
time of CPT code 67500 is less than the current work time for CPT code 
67505. This supported the view that CPT code 67500 should be valued 
higher than CPT code 67505 due to its greater intensity, which we also 
found to be supportable on clinical grounds. The typical patient for 
CPT code 67505 has already lost their sight, and there is less of a 
concern about accidental blindness as compared to CPT code 67500. At 
the recommended identical work RVUs, CPT code 67500 has almost triple 
the intensity of CPT code 67505. Similarly, the intensity does not 
match our clinical understanding of the complexity and difficulty of 
the two procedures.
    We also noted that the surveyed total time for CPT code 67505 was 7 
minutes less than the surveyed time for CPT code 67500, approximately 
21 percent lower. If we were to take the total time ratio between the 
two codes, it would produce a suggested work RVU of 0.93 (26 minutes 
divided by 33 minutes times a work RVU of 1.18). This time ratio 
suggested a work RVU almost identical to the 0.94 value that we 
determined via a crosswalk to CPT code 31575. Based on the preceding 
rationale, we proposed a work RVU of 0.94 for CPT code 67505.
    For CPT code 67515, we disagreed with the RUC-recommended work RVU 
of 0.84 and we proposed a work RVU of 0.75 based on a crosswalk to CPT 
code 64450 (Injection, anesthetic agent; other peripheral nerve or 
branch). The recommended work RVU is based on a direct crosswalk to CPT 
code 65222 (Removal of foreign body, external eye; corneal, with slit 
lamp) at a work RVU of 0.84. However, the recommended crosswalk code 
has more than double the intraservice time of CPT code 67515 at 7 
minutes, and we believe that it would be more accurate to use a 
crosswalk to a code with a more similar intraservice time such as CPT 
code 64450, which is another type of injection procedure. The proposed 
work RVU of 0.75 is also based on the use of the intraservice time 
ratio with the first code in the family, CPT code 67500. The 
intraservice time ratio between these codes is 0.60 (3 minutes divided 
by 5 minutes), which yields a suggested work RVU of 0.71 when 
multiplied by the recommended work RVU of 1.18 for CPT code 67500. We 
believe that this provides further rationale for our proposed work RVU 
of 0.75 for CPT code 67515.
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving the Injection--Eye family of codes.

[[Page 59545]]

    Comment: Commenters were supportive of the CMS proposal of the RUC-
recommended work RVU of 1.18 for CPT code 67500.
    Response: We appreciate the support for our proposal from the 
commenters.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.94 for CPT code 67505 and stated that CMS should finalize the RUC-
recommended work RVU of 1.18. Commenters were confused by the CMS 
statement that, at the recommended identical work RVUs, CPT code 67500 
has almost triple the intensity of CPT code 67505. Commenters stated 
that the RUC recommendation for CPT code 67505 has less total time and 
slightly higher intensity than CPT code 67500.
    Response: We agree with the commenters that this was an inaccurate 
statement; we intended to state that the current intensity of CPT code 
67500 prior to review is almost triple the current intensity of CPT 
code 67505. We regret any resulting confusion on this subject.
    Comment: Several commenters disagreed with the use of a time ratio 
analysis to support the CMS proposed work value. Commenters stated that 
time ratios do not adequately account for intensity and complexity of 
work, which can only be addressed through the survey and the RUC 
process.
    Response: We disagree with the commenters and continue to believe 
that the use of time ratios is one of several appropriate methods for 
identifying potential work RVUs for particular PFS services, 
particularly when the alternative values recommended by the RUC and 
other commenters do not account for information provided by surveys 
that suggests the amount of time involved in furnishing the service has 
changed significantly. We reiterate that, consistent with the statute, 
we are required to value the work RVU based on the relative resources 
involved in furnishing the service, which include time and intensity. 
When our review of recommended values reveals that changes in the 
resource of time have been unaccounted for in a recommended RVU, then 
we believe we have the obligation to account for that change in 
establishing work RVUs since the statute explicitly identifies time as 
one of the two elements of the work RVUs. We recognize that it would 
not be appropriate to develop work RVUs solely based on time given that 
intensity is also an element of work, but in applying the time ratios, 
we are using derived intensity measures based on current work RVUs for 
individual procedures. Were we to disregard intensity altogether, the 
work RVUs for all services would be developed based solely on time 
values and that is definitively not the case, as indicated by the many 
services that share the same time values but have different work RVUs. 
(As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all 
share identical CY 2019 work times with 15 minutes of preservice time, 
30 minutes of intraservice time, and 15 minutes of postservice time; 
however these codes have respective CY 2019 work RVUs of 1.44, 2.04, 
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time 
ratios to identify potentially appropriate work RVUs, and then use 
other methods (including estimates of work from CMS medical personnel 
and crosswalks to key reference or similar codes) to validate these 
RVUs. For more details on our methodology for developing work RVUs, we 
direct readers to the discussion CY 2017 PFS final rule (81 FR 80272 
through 80277). We also note that in the case of CPT code 65210, we 
derived our proposed work RVU of 0.61 by using a direct crosswalk to 
CPT code 31575 and not a time ratio.
    Comment: Several commenters stated that while it was true that the 
current work value for CPT code 67500 is higher than that of CPT code 
67505, the survey 25th percentiles indicated that the physician work of 
CPT code 67505 (work RVU = 1.30) is higher than that of CPT code 67500 
(work RVU = 1.18). Commenters stated that the reason for performing 
surveys is to adjust for changes in physician work that have occurred 
since the prior survey, and that it was inappropriate to put more 
weight on old data than on the most recent data. Commenters also 
disagreed with the proposed work RVU on clinical grounds, stating that 
CPT code 67505 has a higher intensity than CPT code 67500, not because 
of potential vision loss, but because of the risk of death if the 
absolute alcohol is injected accidentally into the optic nerve sheath. 
Commenters stated that the alcohol injection involved in CPT code 67505 
is typically very painful, even after a local anesthetic injection, and 
carries with it the risk of death which therefore makes it a high-
intensity procedure for both patient and physician.
    Response: We appreciate the additional clinical details involving 
CPT code 67505 from the commenters. After reviewing the information 
provided by the commenters, we are not finalizing our proposed work RVU 
of 0.94 for CPT code 67505, and we are finalizing the RUC-recommended 
work RVU of 1.18 instead due to the additional risks carried by the 
procedure.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.75 for CPT code 67515 and stated that CMS should finalize the RUC-
recommended work RVU of 0.84. Commenters disagreed with the CMS 
crosswalk to CPT code 64450 and stated that the intensity of an 
injection adjacent to the eye in which the physician is unable to see 
the needle tip is clearly greater than that of an injection into a 
peripheral nerve as in the code for the CMS proposed crosswalk. 
Commenters stated that the use of a time ratio methodology for CPT code 
67515 was particularly inappropriate due to changes in the RUC survey 
methodology since the last survey for this service was performed, and 
that increases in the intensity of CPT code 67515 should not be of 
concern due to the 0-day global period and short intraservice work 
time.
    Response: We continue to believe that the use of time ratios is one 
of several appropriate methods for identifying potential work RVUs, as 
described in more detail in our response to the comments for CPT code 
67505 above. We also disagree with the commenters on their objections 
on clinical grounds concerning our crosswalk to CPT code 64450. CPT 
code 64450 describes the injection of an anesthetic agent into a 
peripheral nerve or branch, and the practitioner performing this 
service also cannot see a needle tip when injecting into a peripheral 
nerve. In other words, this is the same situation as that described in 
CPT code 67515: The practitioner performing the service is unable to 
see the needle tip in both cases. We continue to note that the RUC-
recommended crosswalk code (CPT code 65222) has more than double the 
intraservice time of CPT code 67515 at 7 minutes, and we continue to 
believe that it would be more accurate to use a crosswalk to a code 
with a similar intraservice time such as CPT code 64450.
    After consideration of the public comments, we are finalizing the 
work RVUs for CPT codes 67500 and 67515 as proposed. We are finalizing 
the RUC-recommended work RVU of 1.18 for CPT code 67505. We are also 
finalizing the direct PE inputs for all three codes as proposed.
(31) X-Ray Spine (CPT Codes 72020, 72040, 72050, 72052, 72070, 72072, 
72074, 72080, 72100, 72110, 72114, and 72120)
    CPT codes 72020 (Radiologic examination, spine, single view, 
specify level) and 72072 (Radiologic examination, spine; thoracic, 3 
views) were identified on a screen of CMS or

[[Page 59546]]

Other source codes with Medicare utilization greater than 100,000 
services annually. The code family was expanded to include ten 
additional CPT codes to be reviewed together as a group: CPT codes 
72040 (Radiologic examination, spine, cervical; 2 or 3 views), 72050 
(Radiologic examination, spine, cervical; 4 or 5 views), 72052 
(Radiologic examination, spine, cervical; 6 or more views), 72070 
(Radiologic examination, spine; thoracic, 2 views), 72074 (Radiologic 
examination, spine; thoracic, minimum of 4 views), 72080 (Radiologic 
examination, spine; thoracolumbar junction, minimum of 2 views), 72100 
(Radiologic examination, spine, lumbosacral; 2 or 3 views), 72110 
(Radiologic examination, spine, lumbosacral; minimum of 4 views), 72114 
(Radiologic examination, spine, lumbosacral; complete, including 
bending views, minimum of 6 views), and 72120 (Radiologic examination, 
spine, lumbosacral; bending views only, 2 or 3 views).
    The radiologic examination procedures described by CPT codes 72020 
(Radiologic examination, spine, single view, specify level), 72040 
(Radiologic examination, spine, cervical; 2 or 3 views), 72050 
(Radiologic examination, spine, cervical; 4 or 5 views), 72052 
(Radiologic examination, spine, cervical; 6 or more views), 72070 
(Radiologic examination, spine; thoracic, 2 views), 72072 (Radiologic 
examination, spine; thoracic, 3 views), 72074 (Radiologic examination, 
spine; thoracic, minimum of 4 views), 72080 (Radiologic examination, 
spine; thoracolumbar junction, minimum of 2 views), 72100 (Radiologic 
examination, spine, lumbosacral; 2 or 3 views), 72110 (Radiologic 
examination, spine, lumbosacral; minimum of 4 views), 72114 (Radiologic 
examination, spine, lumbosacral; complete, including bending views, 
minimum of 6 views), 72120 (Radiologic examination, spine, lumbosacral; 
bending views only, 2 or 3 views), 72200 (Radiologic examination, 
sacroiliac joints; less than 3 views), 72202 (Radiologic examination, 
sacroiliac joints; 3 or more views), 72220 (Radiologic examination, 
sacrum and coccyx, minimum of 2 views), 73070 (Radiologic examination, 
elbow; 2 views), 73080 (Radiologic examination, elbow; complete, 
minimum of 3 views), 73090 (Radiologic examination; forearm, 2 views), 
73650 (Radiologic examination; calcaneus, minimum of 2 views), and 
73660 (Radiologic examination; toe(s), minimum of 2 views) were all 
identified as potentially misvalued through a screen for CPT codes with 
high utilization.
    With approval from the RUC Research Subcommittee, the specialty 
societies responsible for reviewing these CPT codes did not conduct 
surveys, but instead employed a ``crosswalk methodology,'' in which 
they derived physician work and time components for CPT codes by 
comparing them to similar CPT codes. We recognize that a substantial 
amount of time and effort is involved in conducting surveys of 
potentially misvalued CPT codes; however, we had concerns about the 
quality of the underlying data used to value these CPT codes. The 
descriptors and other information on which the recommendations are 
based have themselves not been surveyed, in several instances, since 
1995. Without the benefit of a survey or other external source of data 
about these CPT codes, there is no information that would allow us to 
detect any potential improvements in efficiency of furnishing the 
service or evaluate whether changes in practice patterns have affected 
time and intensity. We are not categorically opposed to changes in the 
RUC process or methodology that might reduce the burden of conducting 
surveys, but without the benefit of any additional data, through 
surveys or otherwise, we were not convinced that there was a basis for 
evaluating the RUC's recommendations for work RVUs for each of these 
CPT codes.
    Since all 20 of the CPT codes in this group have very similar 
intraservice (from 3-5 minutes) and total (ranging from 5-8 minutes) 
times, we proposed to use an alternative approach to the valuation of 
work RVUs for these CPT codes. We calculated the utilization-weighted 
average RUC-recommended work RVU for the 20 CPT codes. The result of 
this calculation was a work RVU of 0.23, which we proposed to apply 
uniformly to each CPT code: 72020, 72040, 72050, 72052, 72070, 72072, 
72074, 72080, 72100, 72110, 72114, 72120, 72200, 72202, 72220, 73070, 
73080, 73090, 73650, and 73660. We recognized that the proposed work 
RVU for some of these CPT codes might be somewhat lower at the code 
level than the RUC's recommendation, while the proposed work RVU for 
other CPT codes might be slightly higher than the RUC's recommended 
value. We nevertheless believe that the alternative, accepting the 
RUC's recommendation for each separate CPT code implied a level of 
precision about the time and intensity of the CPT codes that we had no 
way to validate.
    For the direct PE inputs, we proposed to add a patient gown (SB026) 
supply to CPT code 72120. We noted that all of the other codes in the 
family that included clinical labor time for the ``Greet patient, 
provide gowning, ensure appropriate medical records are available'' 
(CA009) task included a patient gown, and we proposed to add the 
patient gown to match the other codes in the family. We believed that 
the exclusion of the patient gown for CPT code 72120 was most likely 
due to a clerical error in the recommendations. We also proposed to 
refine the equipment time for the basic radiology room (EL012) in 
accordance with our standard equipment time formulas.
    In our review of the clinical labor time recommended for the 
``Perform procedure/service--NOT directly related to physician work 
time'' (CA021) task, we noted that the standard convention for this 
family of codes seemed to be 3 minutes of clinical labor time per view 
being conducted. For example, CPT code 72020 with a single view had 3 
minutes of recommended clinical labor time for this activity, while CPT 
code 72070 with two views had 6 minutes. However, we also noted that 
for the codes with 2-3 views such as CPT codes 72040 and 72100, the 
recommended clinical labor time of 9 minutes appears to assume that 3 
views would always be typical for the procedure. The same pattern 
occurred for codes with 4-5 views, which have a recommended clinical 
labor time of 15 minutes (assuming 5 views is typical), and for codes 
with 6 or more views, which have a recommended clinical labor time of 
21 minutes (assuming 7 views is typical).
    We did not propose to refine the clinical labor times for this task 
as we did not have data available to know how many views would be 
typical for these CPT codes. However, we noted that the intraservice 
clinical labor time has not changed in roughly 2 decades for these X-
ray services, including during this most recent review, and we believed 
that improving technology during this span of time may have resulted in 
greater efficiencies in the procedures. We continue to be interested in 
data sources regarding the intraservice clinical labor times for 
services such as these that do not match the physician intraservice 
time, and we welcomed any comments that may be able to provide 
additional details for the 12 codes under review in this family.
    The following is a summary of the public comments we received on 
our proposals involving the X-Ray Spine family of codes.

[[Page 59547]]

    Comment: A number of commenters disagreed with our proposal to 
apply an identical work RVU, calculated as the utilization-weighted 
average RUC-recommended work RVU for each of the 20 CPT codes, to each 
of the CPT codes in this group. Commenters defended the crosswalk 
methodology, stating that it is the best approach for valuing work RVUs 
for codes in which the service times are very low and therefore 
difficult to survey. The commenters noted that the specialty societies 
have tried to survey codes such as this in the past with results that 
yielded substantial inconsistencies.
    Response: We share the commenters' concerns about the validity of 
surveying services with very low intraservice and total time, but we 
have even more substantial concerns about a methodology that introduces 
no new information about the work involved in furnishing these CPT 
codes and then states their accuracy to the hundredth of a work RVU. 
Survey data from the specialty societies is often the only data source 
available to us that reflects the experiences of a cross-section of 
providers. We remind stakeholders that we welcome additional 
information or data from all sources to assist us in making proposals 
and finalizing values.
    Comment: In response to our proposal, the RUC offered to survey 
each code in the expanded family of X-ray codes to which CMS applied 
the weighted average methodology and provide survey based 
recommendations for CY 2020.
    Response: We appreciate the recognition on the part of the RUC of 
our serious concerns about the crosswalk methodology and the integrity 
of the resulting RUC recommended work RVUs. We welcome the submission 
of any additional data or information that would allow us to consider 
these codes for review at a future time. Commenters raised concerns 
that assigning a single weighted average work RVU across this broad 
family of x-ray codes inadequately reflects meaningful differences 
among the codes, including the number of views and the complexity of 
positioning for some x-ray services. In response to commenters' 
concerns, we are instead maintaining the CY 2018 work RVUs for each CPT 
code as follows: Work RVU of 0.15 for CPT code 72020, 0.22 for CPT 
72040, 0.31 for CPT code 72050, 0.36 for CPT code 72052, 0.22 for CPT 
code 72070, 0.22 for CPT code 72072, 0.22 for CPT code 72074, 0.22 for 
CPT code 72080, 0.22 for CPT code 72100, 0.31 for CPT code 72110, 0.32 
for CPT code 72114, and 0.22 for CPT code 72120.
    Comment: Several commenters indicated that it was inappropriate for 
CMS to value the practice expense portion of the 20 CPT codes 
identically because the resources required to furnish each of the 
services differ in accordance with the number of X-rays or views and 
other factors.
    Response: We did not propose to value the practice expense portion 
of these codes identically. The proposal regarding the weighted average 
for these codes refers to the work component of RVUs only.
    Comment: One commenter stated that they appreciated and agreed with 
adding a patient gown (SB026) supply to CPT code 72120.
    Response: We appreciate the support for our proposal from the 
commenter.
    Comment: Several commenters stated that they would like to provide 
clarity on the typical number of films obtained for the X-ray spine 
codes and the rationale for the number of minutes and assumed number of 
views that would be typical. Commenters stated that a minimum of 3 
views would be needed in order to adequately assess the cervical spine 
as described by CPT code 72040. Commenters stated that the open mouth 
odontoid view helps in the assessment of the atlanto-occipital joint, 
and that the AP and lateral views of the vertebral bodies are required 
to assess the alignment of the vertebral bodies in two planes, the disc 
spaces, the spinal canal, fractures, and widening of different joints. 
Commenters provided a similar level of clinical detail regarding the 
typical number of views required for CPT codes 72050 and 72052.
    Response: We appreciate the detailed information provided by the 
commenters in response to our request for data sources regarding the 
intraservice clinical labor times in those services that do not match 
the physician intraservice time.
    After consideration of the public comments, we are maintaining the 
CY 2018 work RVUs for the codes in the X-Ray Spine family of codes. We 
are finalizing the direct PE inputs for these codes as proposed.
(32) X-Ray Sacrum (CPT Codes 72200, 72202, and 72220)
    CPT code 72220 (Radiologic examination, sacrum and coccyx, minimum 
of 2 views) was identified on a screen of CMS or Other source codes 
with Medicare utilization greater than 100,000 services annually. CPT 
codes 72200 (Radiologic examination, sacroiliac joints; less than 3 
views) and 72202 (Radiologic examination, sacroiliac joints; 3 or more 
views) were also included for review as part of the same family of 
codes. See (31) X-Ray Spine (CPT codes 72020, 72040, 72050, 72052, 
72070, 72072, 72074, 72080, 72100, 72110, 72114, and 72120) for a 
discussion of proposed work RVUs for these codes.
    For the direct PE inputs, we proposed to refine the equipment time 
for the basic radiology room (EL012) in accordance with our standard 
equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the X-Ray Sacrum family of codes.
    Comment: Comments regarding our proposed work RVU for this family 
of codes were similar to those discussed in (31) X-Ray Spine (CPT codes 
72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 
72114, and 72120).
    Response: As discussed above, we are maintaining the CY 2018 work 
RVUs for each code in this family as follows: Work RVU of 0.17 for CPT 
code 72200, 0.19 for CPT Code 72202, and 0.17 for CPT code 72220.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was removed from the calculation of the 
equipment time, and that this made it difficult to determine the 
accuracy of the refinements. The commenter requested more information 
about this change.
    Response: For the basic radiology room (EQ137) equipment, we 
removed the clinical labor for the CA030 clinical labor activity in 
accordance with our standard equipment time formula for highly 
technical equipment.
    After consideration of the public comments, we are maintaining the 
CY 2018 work RVUs for the codes in the X-Ray Sacrum family of codes. We 
are finalizing the direct PE inputs for these codes as proposed.
(33) X-Ray Elbow-Forearm (CPT Codes 73070, 73080, and 73090)
    CPT codes 73070 (Radiologic examination, elbow; 2 views) and 73090 
(Radiologic examination; forearm, 2 views) were identified on a screen 
of CMS or Other source codes with Medicare utilization greater than 
100,000 services annually. CPT code 73080 (Radiologic examination, 
elbow; complete, minimum of 3 views) was also included for review as 
part of the same family of codes. See (31) X-Ray Spine (CPT codes 
72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 
72114, and 72120) above for a discussion of proposed work RVUs for 
these codes.
    For the direct PE inputs, we proposed to refine the equipment time 
for the

[[Page 59548]]

basic radiology room (EL012) in accordance with our standard equipment 
time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the X-Ray Elbow-Forearm family of codes.
    Comment: Comments regarding our proposed work RVU for this family 
of codes were similar to those discussed in (31) X-Ray Spine (CPT codes 
72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 
72114, and 72120).
    Response: As discussed above, we are maintaining the CY 2018 work 
RVUs for each code in this family as follows: Work RVU of 0.15 for CPT 
code 73070, 0.17 for CPT code 73080, 0.17 for CPT code 73090.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was removed from the calculation of the 
equipment time, and that this made it difficult to determine the 
accuracy of the refinements. The commenter requested more information 
about this change.
    Response: For the basic radiology room (EQ137) equipment, we 
removed the clinical labor for the CA030 clinical labor activity in 
accordance with our standard equipment time formula for highly 
technical equipment.
    After consideration of the public comments, we are maintaining the 
CY 2018 work RVUs for the codes in the X-Ray Elbow-Forearm family of 
codes. We are finalizing the direct PE inputs for these codes as 
proposed.
(34) X-Ray Heel (CPT Code 73650)
    CPT code 73650 (Radiologic examination; calcaneus, minimum of 2 
views) was identified on a screen of CMS or Other source codes with 
Medicare utilization greater than 100,000 services annually. See (31) 
X-Ray Spine above for a discussion of proposed work RVUs for these 
codes.
    For the direct PE inputs, we proposed to refine the equipment time 
for the basic radiology room (EL012) in accordance with our standard 
equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 73650.
    Comment: Comments regarding our proposed work RVU for this code 
were similar to those discussed in (31) X-Ray Spine (CPT codes 72020, 
72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 72114, 
and 72120).
    Response: As discussed above, we are maintaining the CY 2018 work 
RVU of 0.16 for CPT code 73650.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was removed from the calculation of the 
equipment time, and that this made it difficult to determine the 
accuracy of the refinements. The commenter requested more information 
about this change.
    Response: For the basic radiology room (EQ137) equipment, we 
removed the clinical labor for the CA030 clinical labor activity in 
accordance with our standard equipment time formula for highly 
technical equipment.
    After consideration of the public comments, we are maintaining the 
CY 2018 work RVUs for the codes in the X-Ray Heel family of codes. We 
are finalizing the direct PE inputs for these codes as proposed.
(35) X-Ray Toe (CPT Code 73660)
    CPT code 73660 (Radiologic examination; toe(s), minimum of 2 views) 
was identified on a screen of CMS or Other source codes with Medicare 
utilization greater than 100,000 services annually. See (31) X-Ray 
Spine above for a discussion of proposed work RVUs for these codes.
    For the direct PE inputs, we proposed to add a patient gown (SB026) 
supply to CPT code 73660. We noted that the other codes in related X-
ray code families that included clinical labor time for the ``Greet 
patient, provide gowning, ensure appropriate medical records are 
available'' (CA009) task included a patient gown, and we proposed to 
add the patient gown to match the other codes in these families. We 
also proposed to refine the equipment time for the basic radiology room 
(EL012) in accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 73660.
    Comment: Comments regarding our proposed work RVU for this code 
were similar to those discussed in (31) X-Ray Spine (CPT codes 72020, 
72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 72114, 
and 72120).
    Response: As discussed above, we are maintaining the CY 2018 work 
RVU of 0.13 for CPT code 73660.
    Comment: Several commenters stated that the typical patient for 
this service would not require a patient gown. Commenters stated that 
this was different than other codes in the family where the patient may 
need to be rotated lateral and prone for different views.
    Response: We appreciate the feedback from the commenters. In light 
of the information supplied by commenters, we will not finalize our 
proposal to add a patient gown (SB026) supply to CPT code 73660.
    Comment: One commenter stated that CMS did not indicate what amount 
of service period time was removed from the calculation of the 
equipment time, and that this made it difficult to determine the 
accuracy of the refinements. The commenter requested more information 
about this change.
    Response: For the basic radiology room (EQ137) equipment, we 
removed the clinical labor for the CA030 clinical labor activity in 
accordance with our standard equipment time formula for highly 
technical equipment.
    After consideration of the public comments, we are maintaining the 
CY 2018 work RVUs for the codes in the X-Ray Toe family of codes. We 
are finalizing the direct PE inputs as proposed with the exception of 
the patient gown (SB026) supply as detailed above.
(36) X-Ray Esophagus (CPT Codes 74210, 74220, and 74230)
    CPT code 74220 (Radiologic examination; esophagus) was identified 
on a screen of CMS or Other source codes with Medicare utilization 
greater than 100,000 services annually. CPT codes 74210 (Radiologic 
examination; pharynx and/or cervical esophagus) and 74230 (Swallowing 
function, with cineradiography/videoradiography) were also included for 
review as part of the same family of codes.
    We proposed the work RVUs recommended by the RUC for the CPT codes 
in this family as follows: A work RVU 0.59 for CPT code 74210 
(Radiologic examination; pharynx and/or cervical esophagus), a work RVU 
of 0.67 for CPT code 74220 (Radiologic examination; esophagus), and a 
work RVU of 0.53 for CPT code 74230 (Swallowing function, with 
cineradiography/videoradiography).
    For the direct PE inputs, we noted that the recommended quantity of 
the Polibar barium suspension (SH016) supply is increasing from 1 ml to 
150 ml for CPT code 74210 and 100 ml are being added to CPT code 74220, 
which did not previously include this supply. The RUC recommendation 
states that this supply quantity increase is due to clinical necessity, 
but does not go into further details about the typical use of the 
supply. Although we did not propose to refine the quantity of the 
Polibar barium suspension at this time, we solicited additional comment 
about the typical use of the supply in these procedures. We also 
proposed to refine the equipment times for all three codes in 
accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our

[[Page 59549]]

proposals involving the X-Ray Esophagus family of codes.
    Comment: We received no specific comments regarding our proposals 
for work RVUs in this family.
    Response: As a result, we are finalizing a work RVU of 0.59 for CPT 
code 74210, a work RVU of 0.67 for CPT code 74220, and a work RVU of 
0.53 for CPT code 74230 as proposed.
    Comment: Several commenters responded to the comment solicitation 
about the typical use of the Polibar barium suspension (SH016) supply 
in these procedures. Commenters stated that the barium suspension 
quantity listed for CPT code 74210 prior to review was only 1 ml which 
appeared to be a technical error in mistaking number of milliliters for 
number of items, as this was an insufficient quantity of barium for the 
procedure. Commenters stated that CPT code 74220 did not have barium 
suspension listed as a supply item, which appeared to be an oversight. 
The commenters described how the patient swallows a small quantity of 
high density barium to outline the esophagus, followed by multiple 
subsequent swallows of normal density barium that are assessed under 
fluoroscopy from different angles to evaluate the esophageal anatomy 
and mucosa.
    Response: We appreciate the additional details provided by the 
commenters regarding the use of the Polibar barium suspension (SH016) 
supply, and the clarification that the previous supply quantities in 
these procedures appear to have been in error.
    After consideration of the public comments, we are finalizing the 
work RVU and the direct PE inputs for the codes in the X-Ray Esophagus 
family of codes as proposed.
(37) X-Ray Urinary Tract (CPT Code 74420)
    CPT code 74420 (Urography, retrograde, with or without KUB) was 
identified on a screen of CMS or Other source codes with Medicare 
utilization greater than 100,000 services annually. We proposed the 
RUC-recommended work RVU of 0.52 for CPT code 74420 (Urography, 
retrograde, with or without KUB).
    For the direct PE inputs, we proposed to remove the 1 minute of 
clinical labor time for the ``Confirm order, protocol exam'' (CA014) 
activity. The clinical labor time recommended for this activity is not 
included in the reference code, nor is it included in any of the two 
dozen other X-ray codes that were reviewed at the same RUC meeting. 
There is also no explanation in the recommended materials as to why 
this clinical labor time would need to be added. We do not believe that 
this clinical labor would be typical for CPT code 74420, and we 
proposed to remove it to match the rest of the X-ray codes. We also 
proposed to refine the equipment times in accordance with our standard 
equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 74420.
    Comment: We received no specific comments regarding our proposal 
for the work RVU for CPT code 74420.
    Response: We are finalizing a work RVU of 0.52 for CPT code 74420.
    Comment: Several commenters disagreed with the proposal to remove 
the 1 minute of clinical labor time for the ``Confirm order, protocol 
exam'' (CA014) activity. The commenters stated that this service was 
distinct from the other X-ray services reviewed during this cycle and 
encouraged CMS to modify this proposal by finalizing the RUC-
recommended direct PE inputs for clinical labor.
    Response: We addressed this subject in detail in the PE section of 
this final rule under the Changes to Direct PE Inputs for Specific 
Services heading (section II.B.3. of this final rule). For CPT code 
74420, we are finalizing these clinical labor refinements as proposed 
as there is no clinical labor assigned to the ``Review patient clinical 
extant information and questionnaire'' (CA007) activity. We also note 
that commenters did not provide a rationale as to what made CPT code 
74420 distinct from the other X-ray services reviewed during this cycle 
and would justify this additional clinical labor time.
    After consideration of the public comments, we are finalizing the 
work RVU and the direct PE inputs for CPT code 74420 as proposed.
(38) Fluoroscopy (CPT Code 76000)
    CPT code 76000 (Fluoroscopy (separate procedure), up to 1 hour 
physician or other qualified health care professional time) was 
identified on a screen of CMS or Other source codes with Medicare 
utilization greater than 100,000 services annually. CPT code 76001 
(Fluoroscopy, physician or other qualified health care professional 
time more than 1 hour, assisting a nonradiologic physician or other 
qualified health care professional) was also included for review as 
part of the same family of codes. However, due to the fact that 
supervision and interpretation services have been increasingly bundled 
into the underlying procedure codes, the RUC concluded that this 
practice is rare, if not obsolete, and CPT code 76001 was recommended 
for deletion by the CPT Editorial Panel for CY 2019.
    We proposed the RUC-recommended work RVU of 0.30 for CPT code 76000 
(Fluoroscopy (separate procedure), up to 1 hour physician or other 
qualified health care professional time, other than 71023 or 71034 
(e.g., cardiac fluoroscopy)). For the direct PE inputs, we proposed to 
refine the equipment times in accordance with our standard equipment 
time formulas.
    We did not receive specific comments regarding our proposals for 
CPT code 76000. We are finalizing a work RVU of 0.30 and the direct PE 
inputs for CPT code 76000 as proposed.
(39) Echo Exam of Eye Thickness (CPT Code 76514)
    CPT code 76514 (Ophthalmic ultrasound, diagnostic; corneal 
pachymetry, unilateral or bilateral (determination of corneal 
thickness)) was identified as potentially misvalued on a screen of 
codes with a negative intraservice work per unit of time (IWPUT), with 
2016 estimated Medicare utilization over 10,000 for RUC reviewed codes 
and over 1,000 for Harvard-valued and CMS/Other source codes.
    For CPT code 76514, we disagreed with the RUC-recommended work RVU 
of 0.17 and we proposed a work RVU of 0.14. We noted that the 
recommended intraservice time for CPT code 76514 is decreasing from 5 
minutes to 3 minutes (40 percent reduction), and the recommended total 
time for CPT code 76514 is decreasing from 15 minutes to 5 minutes (67 
percent reduction); however, the RUC-recommended work RVU is not 
decreasing at all and remains at 0.17. Although we did not imply that 
the decrease in time as reflected in survey values must equate to a 
one-to-one or linear decrease in the valuation of work RVUs, we believe 
that since the two components of work are time and intensity, 
significant decreases in time should be reflected in decreases to work 
RVUs.
    We also noted that the RUC recommendations for CPT code 76514 
stated that, although the steps in the procedure are unchanged since it 
was first valued, the workflow has changed. With the advent of smaller 
and easier to use pachymeters, the technician now typically takes the 
measurements that used to be taken by the practitioner for CPT code 
76514, and the intraservice time was reduced by two minutes to account 
for the technician performing this service. We believe that this change 
in workflow indicates that the work RVU for the code should be reduced 
in some fashion, since some of the work

[[Page 59550]]

that was previously done by the practitioner is now typically performed 
by the technician. We have no reason to believe that there is more 
intensive cognitive work being performed by the practitioner after 
these measurements are taken since the recommendations indicated that 
the steps in the procedure are unchanged since this code was first 
valued.
    Therefore, we proposed a work RVU of 0.14 for CPT code 76514, which 
is based on taking half of the intraservice time ratio. We considered 
applying the intraservice time ratio to CPT code 76514, which would 
reduce the work RVU to 0.10 based on taking the change in intraservice 
time (from 5 minutes to 3 minutes) and multiplying this ratio of 0.60 
times the current work RVU of 0.17. However, we recognized that the 
minutes shifted to the clinical staff were less intense than the 
minutes that remained in CPT code 76514, and therefore, we applied half 
of the intraservice time ratio for a reduction of 0.03 RVUs to arrive 
at a proposed work RVU of 0.14. We believe that this proposed value 
more accurately takes into account the changes in workflow that have 
caused substantial reductions in the surveyed work time for the 
procedure.
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 76514.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.14 for CPT code 76514 and stated that CMS should finalize the RUC-
recommended work RVU of 0.17. Commenters stated that using an approach 
that takes a fraction of the intraservice time ratio in lieu of strong 
crosswalks and input from the RUC and physicians providing these 
services is unfounded. Commenters restated the key reference codes 
chosen by the survey participants and urged CMS to use survey data and 
supportive relative reference services when valuing services.
    Response: We disagree with the commenters and continue to believe 
that the use of time ratios is one of several appropriate methods for 
identifying potential work RVUs for particular PFS services, 
particularly when the alternative values recommended by the RUC and 
other commenters do not account for information provided by surveys 
that suggests the amount of time involved in furnishing the service has 
changed significantly. We reiterate that, consistent with the statute, 
we are required to value the work RVU based on the relative resources 
involved in furnishing the service, which include time and intensity. 
When our review of recommended values reveals that changes in the 
resource of time have been unaccounted for in a recommended RVU, then 
we believe we have the obligation to account for that change in 
establishing work RVUs since the statute explicitly identifies time as 
one of the two elements of the work RVUs. We recognize that it would 
not be appropriate to develop work RVUs solely based on time given that 
intensity is also an element of work, but in applying the time ratios, 
we are using derived intensity measures based on current work RVUs for 
individual procedures. Were we to disregard intensity altogether, the 
work RVUs for all services would be developed based solely on time 
values and that is definitively not the case, as indicated by the many 
services that share the same time values but have different work RVUs. 
(As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all 
share identical CY 2019 work times with 15 minutes of preservice time, 
30 minutes of intraservice time, and 15 minutes of postservice time; 
however these codes have respective CY 2019 work RVUs of 1.44, 2.04, 
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time 
ratios to identify potentially appropriate work RVUs, and then use 
other methods (including estimates of work from CMS medical personnel 
and crosswalks to key reference or similar codes) to validate these 
RVUs. For more details on our methodology for developing work RVUs, we 
direct readers to the discussion CY 2017 PFS final rule (81 FR 80272 
through 80277). We also note that in the case of CPT code 76514, we 
recognized that the minutes shifted to the clinical staff were less 
intense than the minutes that remained in CPT code 76514, and 
therefore, we applied only half of the intraservice time ratio instead 
of the full ratio.
    Comment: Several commenters stated that while it is true that 
changes in workflow as a result of smaller, portable, easier to use 
pachymeters now mean that the technician typically takes the 
measurements that used to be taken by the physician, the remaining 3 
minutes of intraservice work time reflect the more intense cognitive 
work performed by the physician after the measurements are taken. 
Commenters agreed that the procedure has not fundamentally changed and 
that maintaining a work RVU of 0.17 was warranted.
    Response: We disagree with the commenters and continue to believe 
that CPT code 76514 does not require more intensive cognitive work 
being performed by the practitioner after these measurements are taken, 
since the recommendations indicated that the steps in the procedure are 
unchanged since this code was first valued. While the incorporation of 
new technology can sometimes make services more complex and difficult 
to perform, it can also have the opposite effect by making services 
less reliant on manual skill and technique, and we believe that for CPT 
code 76514 the latter case is true since the same work previously 
carried out by the practitioner is now being carried out by the 
technician.
    After consideration of the public comments, we are finalizing the 
work RVU and the direct PE inputs for CPT code 76514 as proposed.
(40) Ultrasound Elastography (CPT Codes 76981, 76982, and 76983)
    In September 2017, the CPT Editorial Panel created three new codes 
describing the use of ultrasound elastography to assess organ 
parenchyma and focal lesions: CPT codes 76981 (Ultrasound, 
elastography; parenchyma), 76982 (Ultrasound, elastography; first 
target lesion) and 76983 (Ultrasound, elastography; each additional 
target lesion). The most common use of this code set will be for 
preparing patients with disease of solid organs, like the liver, or 
lesions within solid organs.
    The RUC recommended a work RVU of 0.59 for CPT code 76981 
(Ultrasound, elastography; parenchyma (e.g., organ)), a work RVU of 
0.59 for CPT code 76982 (Ultrasound, elastography; first target 
lesion), and a work RVU of 0.50 for add-on CPT code 76983 (Ultrasound, 
elastography; each additional target lesion). We are proposing the RUC- 
recommended work RVUs for each of these new CPT codes.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Prepare room, equipment and supplies'' (CA013) activity 
to 3 minutes and to refine the clinical labor time for the ``Confirm 
order, protocol exam'' (CA014) activity to 0 minutes for CPT codes 
76981 and 76982. CPT code 76700 (Ultrasound, abdominal, real time with 
image documentation; complete), the reference code for these two new 
codes, did not previously have clinical labor time assigned for the 
``Confirm order, protocol exam'' clinical labor task, and we do not 
have any reason to believe that these particular services being 
furnished by the clinical staff have changed in the new codes, only the 
way in which this clinical labor time has been presented on the PE

[[Page 59551]]

worksheets. We also noted that there is no effect on the total clinical 
labor direct costs in these situations, since the same 3 minutes of 
clinical labor time is still being furnished in CPT codes 76981 and 
76982. We also proposed to refine the equipment times in accordance 
with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the Ultrasound Elastography family of codes.
    Comment: Several commenters expressed support for our proposed work 
RVUs for each of the three CPT codes in this family.
    Response: We appreciate the support of commenters.
    Comment: A commenter stated that in the CMS refinements to the 
direct PE inputs for CPT codes 76981 and 76982, CMS proposed to remove 
1 minute from the CA014 activity code and proposed to add 1 minute to 
the CA013 activity code. The commenter stated that this refinement was 
inaccurate and encouraged CMS to modify this proposal by finalizing the 
RUC-recommended direct PE inputs for clinical labor.
    Response: We addressed this subject in detail in the PE section of 
this final rule under the Changes to Direct PE Inputs for Specific 
Services heading (section II.B.3. of this final rule). For CPT codes 
76981 and 76982, we are not finalizing these clinical labor refinements 
as proposed, as these codes have the ``Patient clinical information and 
questionnaire reviewed by technologist, order from physician confirmed 
and exam protocoled by radiologist'' task in predecessor CPT code 76700 
on the old PE worksheet as well as 1 minutes of CA007 clinical labor 
time. We are instead finalizing the RUC-recommended clinical labor 
times for CA013 and CA014 for CPT codes 76981 and 76982. We are also 
not finalizing our refinements to the corresponding equipment times as 
a result.
    After consideration of the public comments, we are finalizing the 
work RVUs for the codes in the Ultrasound Elastography family of codes 
as proposed: 0.59 work RVUs for CPT code 76981, 0.59 work RVUs for CPT 
code 76982, and 0.50 work RVUs for CPT code 76983. We are not 
finalizing our proposed direct PE inputs and are instead finalizing the 
RUC-recommended direct PE inputs for these three codes.
(41) Ultrasound Exam--Scrotum (CPT Code 76870)
    CPT code 76870 (Ultrasound, scrotum and contents) was identified on 
a screen of CMS or Other source codes with Medicare utilization greater 
than 100,000 services annually. We proposed a work RVU of 0.64 for CPT 
code 76870 (Ultrasound, scrotum and contents), as recommended by the 
RUC.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Prepare room, equipment and supplies'' (CA013) activity 
to 3 minutes and to refine the clinical labor time for the ``Confirm 
order, protocol exam'' (CA014) activity to 0 minutes. CPT code 76870 
did not previously have clinical labor time assigned for the ``Confirm 
order, protocol exam'' clinical labor task, and we did not have any 
reason to believe that the services being furnished by the clinical 
staff have changed, only the way in which this clinical labor time has 
been presented on the PE worksheets. We also noted that there was no 
effect on the total clinical labor direct costs in these situations 
since the same 3 minutes of clinical labor time is still being 
furnished under the CA013 room preparation activity. We also proposed 
to refine the equipment times in accordance with our standard equipment 
time formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 76870.
    Comment: We received general support from commenters for our 
proposed work RVU of 0.64 for CPT code 76870, as recommended by the 
RUC.
    Response: We thank commenters for their support.
    Comment: A commenter stated that in the CMS refinements to the 
direct PE inputs for CPT code 76870, CMS proposed to remove 1 minute 
from the CA014 activity code and proposed to add 1 minute to the CA013 
activity code. The commenter stated that this refinement was inaccurate 
and encouraged CMS to modify this proposal by finalizing the RUC-
recommended direct PE inputs for clinical labor.
    Response: We addressed this subject in detail in the PE section of 
this final rule under the Changes to Direct PE Inputs for Specific 
Services heading (section II.B.3. of this final rule). For CPT code 
76870, we are finalizing these clinical labor refinements as proposed.
    After consideration of the public comments, we are finalizing the 
work RVU of 0.64 and direct PE inputs for CPT code 76870 as proposed.
(42) Contrast-Enhanced Ultrasound (CPT Codes 76978 and 76979)
    In September 2017, the CPT Editorial Panel created two new CPT 
codes describing the use of intravenous microbubble agents to evaluate 
suspicious lesions by ultrasound. CPT code 76978 (Ultrasound, targeted 
dynamic microbubble sonographic contrast characterization (non-
cardiac); initial lesion) is a stand-alone procedure for the evaluation 
of a single target lesion. CPT code 76979 (Ultrasound, targeted dynamic 
microbubble sonographic contrast characterization (non-cardiac); each 
additional lesion with separate injection) is an add-on code for the 
evaluation of each additional lesion.
    The two new CPT codes in this family represent a new technology 
that involves the use of intravenous microbubble agents to evaluate 
suspicious lesions by ultrasound. The first new CPT code 76978 
(Ultrasound, targeted dynamic microbubble sonographic contrast 
characterization (non-cardiac); initial lesion), is the base code for 
the new add-on CPT code 76979 (Ultrasound, targeted dynamic microbubble 
sonographic contrast characterization (non-cardiac); each additional 
lesion with separate injection). The RUC reviewed the survey results 
for CPT code 76978 and recommended total time of 30 minutes and 
intraservice time of 20 minutes. Their recommendation for a work RVU of 
1.62 is based neither on the median of the survey results (1.82) nor 
the 25th percentile of the survey results (1.27). Instead, the RUC-
recommended work RVU is based on a crosswalk to CPT code 73719 
(Magnetic resonance (e.g., proton) imaging, lower extremity other than 
joint; with contrast material(s)), which has identical intraservice and 
total times as the survey CPT code. The RUC also identified a 
comparison CPT code (CPT code 73222 (Magnetic resonance (e.g., proton) 
imaging, any joint of upper extremity; with contrast material(s)) with 
work RVU 1.62 and similar times. For add-on CPT code 76979, the RUC 
recommended a work RVU of 0.85, which is the 25th percentile of survey 
results, with total and intraservice times of 15 minutes.
    Although we generally agree that, particularly in instances where a 
CPT code represents a new technology or procedure, there may be reason 
to deviate from survey metrics, we are confused by the logic behind the 
RUC's recommendation of a work RVU of 1.62 for CPT code 76978. When we 
considered the range of existing CPT codes with 30 minutes total time 
and 20 minutes intraservice time, we noted that a work RVU of 1.62 is 
among the highest potential crosswalks. We also noted that the RUC 
agreed with the 25th percentile of survey results for the new add-on 
CPT code, 76979, and we did not see

[[Page 59552]]

why the 25th percentile would not also be appropriate for the base CPT 
code, 76978. Therefore, we proposed a work RVU of 1.27 for CPT code 
76978. We identified two CPT codes with total time of 30 minutes and 
intraservice time of 20 minutes that bracket the proposed work RVU of 
1.27: CPT code 93975 (Duplex scan of arterial inflow and venous outflow 
of abdominal, pelvic, scrotal contents and/or retroperitoneal organs; 
complete study) has a work RVU of 1.16, and CPT code 72270 
(Myelography, 2 or more regions (e.g., lumbar/thoracic, cervical/
thoracic, lumbar/cervical, lumbar/thoracic/cervical), radiological 
supervision and interpretation) has a work RVU of 1.33. We proposed the 
RUC-recommended work RVU of 0.85 for add-on CPT code 76979.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Prepare room, equipment and supplies'' (CA013) activity 
to 3 minutes and to refine the clinical labor time for the ``Confirm 
order, protocol exam'' (CA014) activity to 0 minutes for CPT code 
76978. CPT codes 76700 (Ultrasound, abdominal, real time with image 
documentation; complete) and 76705 (Ultrasound, abdominal, real time 
with image documentation; limited), the reference codes for this new 
code, did not previously have clinical labor time assigned for the 
``Confirm order, protocol exam'' clinical labor task, and we did not 
have any reason to believe that these particular services being 
furnished by the clinical staff have changed in the new code, only the 
way in which this clinical labor time has been presented on the PE 
worksheets. We also noted that there is no effect on the total clinical 
labor direct costs in these situations, since the same 3 minutes of 
clinical labor time is still being furnished in CPT code 76978.
    We proposed to remove the 50 ml of the phosphate buffered saline 
(SL180) for CPT codes 76978 and 76979. When these codes were reviewed 
by the RUC, the conclusion that was reached was to remove this supply 
and replace it with normal saline. Since the phosphate buffered saline 
remained in the recommended direct PE inputs, we believe its inclusion 
may have been a clerical error. We proposed to remove the supply and 
solicited comments on the phosphate buffered saline or a replacement 
saline solution. We also proposed to refine the equipment times in 
accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the Contrast-Enhanced Ultrasound family of 
codes.
    Comment: Commenters were supportive of our proposed work RVU of 
0.85 for CPT code 76979, as recommended by the RUC.
    Response: We thank the commenters for their support of our proposal 
regarding the work RVU for this CPT code.
    Comment: A few commenters expressed opposition to our proposed work 
RVU of 1.27 for new CPT code 76978. Commenters acknowledged that the 
code is valued at the high end of the range of values for a given 
intraservice time. However, they stated, being on the high end of a 
range of comparison codes is not necessarily in itself a reason to 
reduce the work RVU. They cite this as an illustration of CMS's 
discounting the importance of intensity in valuing physician services 
in favor of considering only time. The same commenters also noted that 
the new technology used in furnishing the service, Contrast Enhanced 
Ultrasound (CEUS), requires more technical skill and time than other 
established ultrasound services.
    Response: Our observation that a survey code is on the high end of 
codes on the PFS with similar intraservice and total times is only one 
among several factors we consider when we perceive that the code is not 
properly valued in relation to other similar codes. We agree that there 
are instances in which valuing a code at the high range of work RVUs 
for codes with similar times is appropriate. However, on the whole, if 
a recommended work RVU places the code on the very high end of work 
RVUs with similar time parameters, we expect that the code would be of 
notably higher intensity than most other codes with those time 
parameters. We were not convinced that this was the case with CPT code 
76978.
    We were, however, persuaded by commenters that the higher technical 
skill and time involved in using the new technology, CEUS, compared 
with other established ultrasound services, is better reflected by the 
RUC's recommended work RVU than our proposed value. Consequently we are 
finalizing the RUC-recommended work RVU of 1.62 for CPT code 76978.
    Comment: A commenter stated that in the CMS refinements to the 
direct PE inputs for CPT code 76978, CMS proposed to remove 1 minute 
from the CA014 activity code and proposed to add 1 minute to the CA013 
activity code. The commenter stated that this refinement was inaccurate 
and encouraged CMS to modify this proposal by finalizing the RUC-
recommended direct PE inputs for clinical labor.
    Response: We addressed this subject in detail in the PE section of 
this final rule under the Changes to Direct PE Inputs for Specific 
Services heading (section II.B.3. of this final rule). For CPT code 
76978, we are not finalizing these clinical labor refinements as 
proposed, as this code has the ``Patient clinical information and 
questionnaire reviewed by technologist, order from physician confirmed 
and exam protocoled by radiologist'' task in predecessor CPT code 76700 
on the old PE worksheet as well as 1 minutes of CA007 clinical labor 
time. We are therefore finalizing the RUC-recommended clinical labor 
times for CA013 and CA014 for CPT code 76978. We are also not 
finalizing our refinements to the corresponding equipment times as a 
result.
    Comment: Several commenters disagreed with the proposal to remove 
the 50 ml of the phosphate buffered saline (SL180) for CPT codes 76978 
and 76979. Commenters stated that the SL180 supply can be replaced with 
``normal saline'', however the change was not made because an 
appropriate replacement could not be identified. Commenters stated that 
the SL180 phosphate buffered saline (PBS) had been removed but ``normal 
saline'' has not replaced it. Commenters agreed that this change was 
appropriate and urged CMS to add the correct supply item for the 
appropriate type of saline.
    Response: We disagree with the commenters that the ``normal 
saline'' was not added to these procedures. Both of these CPT codes 
include the ``sodium chloride 0.9% inj bacteriostatic (30ml uou)'' 
(SH068) supply which would function as a form of normal saline. We do 
not believe that it would be typical for these procedures to contain 50 
ml of the phosphate buffered saline (SL180) in addition to the ``normal 
saline'' described by the SH068 supply.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVUs for both codes in this family as follows: 
Work RVU of 0.85 for CPT code 76979 and a work RVU of 1.62 for CPT code 
76978. We are also finalizing the RUC-recommended direct PE inputs for 
these codes, with the exception of the refinement to the phosphate 
buffered saline (SL180) supply as detailed above.
(43) Magnetic Resonance Elastography (CPT Code 76391)
    The CPT Editorial Panel created new stand-alone CPT code 76391 
describing the use of magnetic resonance elastography for the 
evaluation of organ parenchymal pathology. This code will most often be 
used to evaluate patients

[[Page 59553]]

with disease of solid organs (for example, cirrhosis of the liver) or 
pathology within solid organs that manifest with increasing fibrosis or 
scarring. The goal with magnetic resonance elastography is to evaluate 
the degree of fibrosis/scarring (that is, stiffness) without having to 
perform more invasive procedures (for example, biopsy). This technique 
can be used to characterize the severity of parenchymal disease, follow 
disease progression, or response to therapy.
    The RUC recommended a work RVU for new CPT code 76391 (Magnetic 
resonance (e.g., vibration) elastography) of 1.29, with 15 minutes of 
intraservice time and 25 minutes of total time. The recommendation is 
based on a comparison with two reference CPT codes, CPT code 74183 
(Magnetic resonance (e.g., proton) imaging, abdomen; without contrast 
material(s), followed by with contrast material(s) and further 
sequences) with total time of 40 minutes, intraservice time of 30 
minutes, and a work RVU of 2.20; and CPT code 74181 (Magnetic resonance 
(e.g., proton) imaging, abdomen; without contrast material(s)), which 
has a total time of 30 minutes, intraservice time of 20 minutes, and a 
work RVU of 1.46. The RUC stated that both reference CPT codes have 
higher work values than the new CPT code, which is justified in both 
cases by higher intra-service times. They noted that, despite shorter 
intraservice and total time, CPT code 76391 is slightly more intense to 
perform due to the evaluation of wave propagation images and 
quantitative stiffness measures. We did not agree with the RUC's 
recommended work RVU for this CPT code. Using the RUC's two top 
reference CPT codes as a point of comparison, the intraservice time 
ratio in both instances suggests that a work RVU closer to 1.10 would 
be more appropriate. We recognize that the RUC believes the new CPT 
code is slightly more intense to furnish, but we are concerned about 
the relativity of this code in comparison with other imaging procedures 
that have similar intraservice and total times. Instead of the RUC-
recommended work RVU of 1.29 for CPT code 76391, we proposed a work RVU 
of 1.10, which is based on a direct crosswalk to CPT code 71250 
(Computed tomography, thorax; without contrast material). CPT code 
71250 has identical intraservice time (15 minutes) and total time (25 
minutes) compared to CPT code 76391, and we believe that the work 
involved in furnishing both services is similar. We note that CPT code 
76391 describes a new technology and will be reviewed again by the RUC 
in 3 years.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Prepare room, equipment and supplies'' (CA013) activity 
from 6 minutes to 5 minutes, and for the ``Prepare, set-up and start 
IV, initial positioning and monitoring of patient'' (CA016) activity 
from 4 minutes to 3 minutes. We disagreed that this additional clinical 
labor time would be typical for these activities, which are already 
above the standard times for these tasks. In both cases, we proposed to 
maintain the current time from the reference CPT code 72195 (Magnetic 
resonance (e.g., proton) imaging, pelvis; without contrast material(s)) 
for these clinical labor activities. We also proposed to refine the 
equipment times in accordance with our standard equipment time 
formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 76391.
    Comment: A commenter stated that CMS misunderstood the role of 
reference CPT codes in the RUC's valuation process, and therefore our 
proposed work RVU for CPT code 76391 is premised on a false time 
comparison and a methodology that is invalid.
    Response: In the materials provided to us, the RUC explicitly 
compared the two key reference services to CPT 76391 and stated that 
the higher work values for these codes are justified by higher 
intraservice times. The RUC did not provide a crosswalk code for CPT 
76391. Because of the RUC's justification of the higher work RVUs in 
the reference services in relation to the higher intraservice times for 
these codes, and because the RUC did not provide a crosswalk CPT code 
for us to review, we believe it is an entirely appropriate methodology 
to calculate the intraservice time ratios using those reference codes. 
We acknowledged that the survey code is slightly more intense to 
perform than the reference codes, according to the RUC's SOR, which is 
why our calculation of intraservice time ratios is only a starting 
point in our review of the code's recommended work RVU. We considered 
the intraservice time ratios for both reference codes, which were not 
identical, and compared these values to other CPT codes in the PFS with 
similar intraservice and total times. For this particular CPT code 
76391, we identified a crosswalk to CPT code 71250, which, as we 
stated, achieved an overall balance of similar times and similar 
intensity as the survey code and has a work RVU of 1.10.
    Comment: Some commenters stated that our proposed value of 1.10 
work RVUs for CPT code 76391 creates a rank order anomaly between an 
MRI code and CPT code, CPT code 74160.
    Response: We do not agree that our proposed work RVU of 1.10 for 
this code creates a rank order anomaly between an MRI code and CT code 
because this service is described as being unlike a routine magnetic 
resonance imaging. This service also involves use of a new technology, 
which makes it difficult to compare directly to services involving 
magnetic resonance imaging. We are finalizing a work RVU of 1.10 for 
CPT code 76391.
    Comment: One commenter agreed with the refinements to the direct PE 
inputs.
    Response: We appreciate the support for our proposals from the 
commenter.
    After consideration of the public comments, we are finalizing the 
work RVU of 1.10 and the direct PE inputs for CPT code 76391 as 
proposed.
(44) Computed Tomography (CT) Scan for Needle Biopsy (CPT Code 77012)
    CPT code 77012 (Computed tomography guidance for needle placement 
(e.g., biopsy, aspiration, injection, localization device), 
radiological supervision and interpretation) was identified on a screen 
of CMS or Other source codes with Medicare utilization greater than 
100,000 services annually.
    We proposed the RUC-recommended work RVU of 1.50 for CPT code 77012 
(Computed tomography guidance for needle placement (e.g., biopsy, 
aspiration, injection, localization device), radiological supervision 
and interpretation).
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Prepare room, equipment and supplies'' (CA013) activity 
to 3 minutes and to refine the clinical labor time for the ``Confirm 
order, protocol exam'' (CA014) activity to 0 minutes. CPT code 77012 
did not previously have clinical labor time assigned for the ``Confirm 
order, protocol exam'' clinical labor task, and we did not have any 
reason to believe that the services being furnished by the clinical 
staff have changed, only the way in which this clinical labor time has 
been presented on the PE worksheets. We also noted that there is no 
effect on the total clinical labor direct costs in these situations 
since the same 3 minutes of clinical labor time is still being 
furnished under the CA013 room preparation activity.
    We proposed to refine the equipment time for the CT room (EL007) to 
maintain the current time of 9 minutes. CPT code 77012 is a 
radiological supervision and interpretation

[[Page 59554]]

procedure and there has been a longstanding convention in the direct PE 
inputs, shared by 38 other codes, to assign an equipment time of 9 
minutes for the equipment room in these procedures. We do not believe 
that it would serve the interests of relativity to increase the 
equipment time for the CT room in CPT code 77012 without also 
addressing the equipment room time for the other radiological 
supervision and interpretation procedures. Therefore, we proposed to 
maintain the current equipment room time of 9 minutes until this group 
of procedures can be subject to a more comprehensive review. We also 
proposed to refine the equipment time for the Technologist PACS 
workstation (ED050) in accordance with our standard equipment time 
formulas.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 77012.
    Comment: We received support from a few commenters for our proposed 
work RVU for CPT code 77012, as recommended by the RUC.
    Response: We appreciate commenters' support. We are finalizing a 
work RVU of 1.50 for CPT code 77012.
    Comment: A commenter stated that in the CMS refinements to the 
direct PE inputs for CPT code 77012 CMS proposed to remove 1 minute 
from the CA014 activity code and proposed to add 1 minute to the CA013 
activity code. The commenter stated that this refinement was inaccurate 
and encouraged CMS to modify this proposal by finalizing the RUC-
recommended direct PE inputs for clinical labor.
    Response: We addressed this subject in detail in the PE section of 
this final rule under the Changes to Direct PE Inputs for Specific 
Services heading (section II.B.3. of this final rule). For CPT code 
77012, we are finalizing these clinical labor refinements as proposed.
    Comment: Several commenters disagreed with the proposal to refine 
the equipment time for the CT room (EL007) to maintain the current time 
of 9 minutes. Commenters stated that the room time is included in CT 
guidance, as it is in US guidance (such as in CPT code 76942) because 
that is the room the procedure is performed in. Commenters stated that 
they agreed with CMS that other RS&I codes use the 9 minutes for room 
time as a precedent, but this was specific to angiographic rooms and 
referred to language from 2013 regarding angiographic rooms.
    Response: We disagree with the commenters regarding the equipment 
time for the CT room (EL007) due to the longstanding convention in the 
direct PE inputs, shared by 38 other codes, to assign an equipment time 
of 9 minutes for the equipment room in radiological supervision and 
interpretation procedure. We agree with the commenters that at least 
some portion of the procedure is performed in the CT room, but we 
continue to believe that it would not serve the interests of relativity 
to increase the equipment time for the CT room in CPT code 77012 
without also addressing the equipment room time for the other 
radiological supervision and interpretation procedures in a more 
comprehensive fashion. We also disagree with the commenters that this 
policy is specific to angiography rooms, as CPT codes 75989 and 77012 
both employ CT rooms and currently utilize the standardized 9 minutes 
of equipment time for radiological supervision and interpretation 
procedures.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for CPT code 77012 as proposed.
(45) Dual-Energy X-Ray Absorptiometry (CPT Code 77081)
    CPT code 77081 (Dual-energy X-ray absorptiometry (DXA), bone 
density study, 1 or more sites; appendicular skeleton (peripheral) 
(e.g., radius, wrist, heel)) was identified as potentially misvalued on 
a screen of codes with a negative intraservice work per unit of time 
(IWPUT), with 2016 estimated Medicare utilization over 10,000 for RUC 
reviewed codes and over 1,000 for Harvard valued and CMS/Other source 
codes. For CY 2019, we proposed the RUC-recommended work RVU of 0.20 
for CPT code 77081.
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 77081.
    Comment: Commenters were supportive of our proposal regarding the 
work RVU for CPT code 77081.
    Response: We appreciate the support for our proposals from the 
commenters.
    After consideration of the public comments, we are finalizing the 
work RVU of 0.20 and direct PE inputs for CPT code 77081 as proposed.
(46) Breast MRI With Computer-Aided Detection (CPT Codes 77046, 77047, 
77048, and 77049)
    CPT codes 77058 (Magnetic resonance imaging, breast, without and/or 
with contrast material(s); unilateral) and 77059 (Magnetic resonance 
imaging, breast, without and/or with contrast material(s); bilateral) 
were identified in 2016 on a high expenditure services screen across 
specialties with Medicare allowed charges of $10 million or more. When 
preparing to survey these codes, the specialties noted that the 
clinical indications had changed for these exams. The technology had 
advanced to make computer-aided detection (CAD) typical and these codes 
did not parallel the structure of other magnetic resonance imaging 
(MRI) codes. In June 2017 the CPT Editorial Panel deleted CPT codes 
0159T, 77058, and 77059 and created four new CPT codes to report breast 
MRI with and without contrast (including computer-aided detection).
    The RUC recommended a work RVU of 1.45 for CPT code 77046 (Magnetic 
resonance imaging, breast, without contrast material; unilateral). This 
recommendation was based on a comparison with CPT codes 74176 (Computed 
tomography, abdomen and pelvis; without contrast material) and 74177 
(Computed tomography, abdomen and pelvis; with contrast material(s)), 
which both have similar intraservice and total times in relation to CPT 
code 77046. We disagreed with the RUC's recommended work RVU because we 
did not believe that the reduction in total time of 15 minutes between 
the new CPT code 77046 and the deleted CPT code 77058 was adequately 
reflected in its recommendation. Although total time has decreased by 
15 minutes, the only other difference between the two CPT codes is the 
change in the descriptor from the phrase `without and/or with contrast 
material(s)' to `without contrast material,' suggesting that there is 
less work involved in the new CPT code than in the deleted CPT code. 
Instead, we proposed a work RVU of 1.15 for CPT code 77046, which is 
similar to the total time ratio between the new CPT code and the 
deleted CPT code. It is also supported by a crosswalk to CPT code 77334 
(Treatment devices, design and construction; complex (irregular blocks, 
special shields, compensators, wedges, molds or casts)). CPT code 77334 
has total time of 35 minutes, intraservice time of 30 minutes, and a 
work RVU of 1.15.
    CPT code 77047 (Magnetic resonance imaging, breast, without 
contrast material; bilateral) describes the same work as CPT code 
77046, but reflects a bilateral rather than the unilateral procedure. 
The RUC recommended a work RVU of 1.60 for CPT code 77047. Since we 
proposed a different work RVU for the unilateral procedure than the 
value proposed by the RUC, we believe it is appropriate to recalibrate 
the work RVU for CPT code 77047 relative to the RUC's recommended 
difference in work between the two CPT codes. The RUC's recommendation 
for

[[Page 59555]]

the bilateral procedure is 0.15 work RVUs larger than for the 
unilateral procedure. Therefore, we proposed a work RVU of 1.30 for CPT 
code 77047.
    The RUC recommended a work RVU of 2.10 for CPT code 77048 (Magnetic 
resonance imaging, breast, without and with contrast material(s), 
including computer-aided detection (CAD-real time lesion detection, 
characterization and pharmacokinetic analysis) when performed; 
unilateral). CPT code 77048 is a new CPT code that bundles the deleted 
CPT code for unilateral breast MRI without and/or with contrast 
material(s) with CAD, which was previously reported, in addition to the 
primary procedure CPT code, as CPT code 0159T (computer aided 
detection, including computer algorithm analysis of MRI image data for 
lesion detection/characterization, pharmacokinetic analysis, with 
further physician review for interpretation, breast MRI). Consistent 
with our belief that the proposed value for the base CPT code in this 
series of new CPT codes (CPT code 77046) should be a work RVU of 1.15, 
we are proposing a work RVU for CPT code 77048 that adds the RUC-
recommended difference in RUC-recommended work RVUs between CPT codes 
77046 and 77048 (0.65 work RVUs) to the proposed work RVU for CPT code 
77046. Therefore, we proposed a work RVU of 1.80 for CPT code 77048.
    The last new CPT code in this series, CPT code 77049 (Magnetic 
resonance imaging, breast, without and with contrast material(s), 
including computer-aided detection (CAD-real time lesion detection, 
characterization and pharmoacokinetic analysis) when performed; 
bilateral) describes the same work as CPT code 77048, but reflects a 
bilateral rather than a unilateral procedure. The RUC recommended a 
work RVU of 2.30 for this CPT code. Similar to the process for valuing 
work RVUs for CPT code 77047 and CPT code 77048, we believe that a more 
appropriate work RVU is calculated by adding the difference in the RUC 
recommended work RVU for CPT codes 77046 and 77049, to the proposed 
value for CPT code 77046. Therefore, we proposed a work RVU of 2.00 for 
CPT code 77049.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Prepare, set-up and start IV, initial positioning and 
monitoring of patient'' (CA016) activity from 7 minutes to 3 minutes 
for CPT codes 77046 and 77047, and from 9 minutes to 5 minutes for CPT 
codes 77048 and 77049. We noted that when the MRI of Lower Extremity 
codes were reviewed during the previous rule cycle (CPT codes 73718-
73720), these codes contained either 3 minutes or 5 minutes of 
recommended time for this same clinical labor activity. We also noted 
that the current Breast MRI codes that are being deleted and replaced 
with these four new codes, CPT codes 77058 and 77059, contain 5 minutes 
of clinical labor time for this same activity. We had no reason to 
believe that the new codes would require additional clinical labor time 
for patient positioning, especially given that the recommended clinical 
labor times are decreasing in comparison to the reference codes for 
obtaining patient consent (CA011) and preparing the room (CA013). 
Therefore, we refined the clinical labor time for the CA016 activity as 
detailed earlier to maintain relativity with the current clinical labor 
times in the reference codes, as well as with other recently reviewed 
MRI procedures.
    Included in the recommendations for this code family were five new 
equipment items: CAD Server (ED057), CAD Software (ED058), CAD 
Software--Additional User License (ED059), Breast coil (EQ388), and CAD 
Workstation (CPU + Color Monitor) (ED056). We did not receive any 
invoices for these five equipment items, and as such we do not have any 
direct pricing information to use in their valuation. We proposed to 
use crosswalks to similar equipment items as proxies for three of these 
new types of equipment until we do have pricing information:
     CAD software (ED058) is crosswalked to flow cytometry 
analytics software (EQ380).
     Breast coil (EQ388) is crosswalked to Breast biopsy device 
(coil) (EQ371).
     CAD Workstation (CPU + Color Monitor) (ED056) is 
crosswalked to Professional PACS workstation (ED053).
    We welcomed the submission of invoices with pricing information for 
these three new equipment items for our consideration to replace the 
use of these proxies. For the other two equipment items (CAD Server 
(ED057) and CAD Software--Additional User License (ED059)), we did not 
propose to establish a price at this time as we believe both of them 
would constitute forms of indirect PE under our methodology. We do not 
believe that the CAD Server or Additional User License would be 
allocated to the use of an individual patient for an individual 
service, and can be better understood as forms of indirect costs 
similar to office rent or administrative expenses. We understand that 
as the PE data age, these issues involving the use of software and 
other forms of digital tools become more complex. However, the use of 
new technology does not change the statutory requirement under which 
indirect PE is assigned on the basis of direct costs that must be 
individually allocable to a particular patient for a particular 
service. We look forward to continuing to seek out new data sources to 
help in updating the PE methodology.
    We also proposed to refine the equipment times in accordance with 
our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving the Breast MRI with Computer-Aided Detection 
(CAD) family of codes.
    Comment: A commenter disagreed with our use of deleted CPT code 
77058 as a point of reference for considering whether the reduction in 
work RVU in the new code, CPT code 77046, is commensurate with the 
reduction in work time between the two codes. The commenter stated that 
CMS should not compare these new services with the old deleted 
services, as indicated by the specialty society having demonstrated 
compelling evidence that the work involved in the breast MRI code 
family has fundamentally changed.
    Response: We disagree that it is inappropriate to use time 
comparisons with a code that is being deleted as a guide for assessing 
whether the reduction in work RVU recommended by the RUC is 
commensurate with the reduction in time based on survey results. The 
description of the work involved in furnishing CPT code 77046 has not 
changed substantively from the code being deleted. The compelling 
evidence that the commenter cites is related to the two new codes, CPT 
code 77048 and 77049, which are newly bundled with CAD. The main 
distinction in the description of physician work for this CPT code is 
that the new code specifies `without contrast', while the deleted code 
described the service `without and/or with contrast.' The change in 
patient population, also cited by the commenter, actually suggests that 
the more complex patients will be screened using the advanced 
technologies, such as is described by CPT code 77048. We recognize that 
changes in technology and work flow for the work described by CPT code 
77046 have affected the work involved in furnishing these services. 
This is why we use the time ratios as a starting point for code 
comparisons rather than the end point.
    Comment: One commenter stated that our proposed crosswalk code for 
CPT 77046, CPT code 77334, is inappropriate because of different 
preservice and intraservice times between the two codes, and because 
there is more low-

[[Page 59556]]

intensity time in CPT code 77334 compared with CPT code 77046. The 
commenter also indicated that our proposed work RVU for CPT code 77046 
would create a rank order anomaly with other MRI codes.
    Response: As a matter of principle, we do not agree that a chosen 
crosswalk for a CPT code is required to be clinically similar or to 
have identical intraservice and/or total time as the code being valued. 
However, in this instance, after further consideration, we agree with 
the commenter that our crosswalk code, CPT 77334, is not a particularly 
good comparison, in terms of intensity, to CPT 77046. We also agree 
with the commenter that our proposed work RVU for CPT code 77046 would 
create an anomaly among other CPT codes involving MRI. We are 
finalizing a work RVU for CPT code 77046 of 1.45, as recommended by the 
RUC.
    Comment: A commenter disagreed with our use of increments in 
recalibrating work RVUs for codes that precede or follow a new or 
revalued CPT code, as was the process underlying our proposed work RVUs 
for CPT codes 77047, 77048, and 77049.
    Response: The recalibration of CPT codes based on incremental 
difference in the work RVUs recommended by the RUC is an established 
methodology used by CMS to value the work involved in furnishing a 
service. There are certain types of code groups, particularly those 
with clear stepwise changes in intensity, as described by the RUC, for 
which we believe this is entirely appropriate. We continue to believe 
that this is an appropriate approach. However, having agreed with the 
commenter that our proposed work RVU for CPT code 77046 should be 
finalized at the RUC recommended work RVU of 1.45, we also believe that 
it is unnecessary to recalibrate the RUC's recommended work RVUs for 
the remainder of the three codes in the series. Therefore, we are 
finalizing a work RVU of 1.60 for CPT code 77047, 2.10 for CPT code 
77048, and 2.30 for CPT code 77049.
    Comment: Several commenters disagreed with the CMS proposal to 
refine the clinical labor time for the ``Prepare, set-up and start IV, 
initial positioning and monitoring of patient'' (CA016) activity from 7 
minutes to 3 minutes for CPT codes 77046 and 77047, and from 9 minutes 
to 5 minutes for CPT codes 77048 and 77049. Commenters stated that the 
rationale for this change was likely derived from reference to the 
lower clinical labor times for this activity associated with lower 
extremity MRI codes, and that it was an error to treat the clinical 
labor time for this activity as akin to that for lower extremity MRI. 
Commenters requested that CMS consider the experience of an 80-year-old 
patient who needs assistance on and off the table, along with 
reassurance, added explanation, IV insertion into delicate skin, and 
other anxiety needs. Commenters stated that another major distinction 
between breast MRI and extremity MRI is that the patient lies prone on 
the coil, which requires an awkward process of positioning and causes 
the need for additional clinical labor time.
    Response: We continue to disagree with the commenters that the RUC-
recommended clinical labor time would be typical for these procedures. 
As part of our review, we compared the clinical labor times for the 
CA016 activity not only to the codes in the MRI of Lower Extremity 
family, but also to the current Breast MRI codes that are being deleted 
and replaced with these four new codes. CPT codes 77058 and 77059 
contain 5 minutes of clinical labor time for this same activity, and we 
do not agree that the clinical labor times would be increasing to 7 and 
9 minutes in the newly created CPT codes, especially given that 
commenters did not provide a rationale as to why time would be 
increasing. We also note that while some patients will have conditions 
that are more difficult than the typical case, such as the 80-year-old 
patient described by the commenters, other patients would have 
conditions that are less difficult than the typical case. We remind the 
reader that valuation of services under the PFS is based on the typical 
case and not the most difficult cases that may arise. We further note 
that the clinical vignette for CPT code 77047 describes a 53-year old 
female patient, not an 80-year old patient, and was stated to be 
typical by 96 percent of the survey respondents.
    Comment: A commenter stated that in the CMS refinements to the 
direct PE inputs for these four CPT codes, CMS proposed to remove 1 
minute from the CA014 activity code and proposed to add 1 minute to the 
CA013 activity code. The commenter stated that this refinement was 
inaccurate and encouraged CMS to modify this proposal by finalizing the 
RUC-recommended direct PE inputs for clinical labor.
    Response: We believe that the commenter may have been confused with 
several of the other code families that included these clinical labor 
refinements, which we described in the PE section of this final rule 
under the Changes to Direct PE Inputs for Specific Services heading 
(section II.B.3. of this final rule). We did not propose any 
refinements to the CA014 clinical labor for the codes in this family.
    Comment: Several commenters requested that CMS add 5 minutes to CPT 
codes 77048 and 77049 to account for the time required to obtain vital 
signs. Commenters stated that to maintain consistency within the codes 
for MRI with contrast, they requested that new codes for breast MRI 
with contrast receive an additional two minutes of time for MRI 
technologist (L047A) bringing the total time for obtain vital signs to 
5 minutes.
    Response: We proposed in CY 2018 to assign 5 minutes of clinical 
labor time for all codes that include the ``Obtain vital signs'' task, 
that included at least 1 minute previously assigned to this task 
regardless of the date of last review. After considering the comments, 
we did not finalize our proposal to establish 5 minutes as the new 
standard for the ``Obtain vital signs'' clinical labor task. As a 
result, we do not agree with the commenters that the clinical labor 
time for the CA010 activity should be increased to 5 minutes for CPT 
codes 77048 and 77049, especially given that we did not make a proposal 
to do so. We refer readers to the CY 2018 PFS final rule (82 FR 52990-
52991) for additional details about last year's proposal on this issue.
    Comment: One commenter requested that CMS assign additional 
clinical labor time for MRI procedures with contrast in order to 
account for time spent counseling patients. Commenters stated that 
because of the increased public awareness of the risk relating to 
gadolinium, additional time is required to explain the benefits and 
risks of the procedure.
    Response: We note that the MRI procedures in this family that are 
done with contrast (CPT codes 77048 and 77049) already contain more 
clinical labor than the MRI procedures that are done without contrast 
(CPT codes 77046 and 77047). Specifically, these procedures already 
contain two additional minutes for ``Provide education/obtain consent'' 
(CA011) clinical labor than the non-contrast versions of the 
procedures, which we believe indicates that the concerns of the 
commenters have been taken into account.
    Comment: Several commenters stated that the lack of invoices for 
the new equipment items may have been an oversight and enclosed new 
invoices with their comment letter. Commenters also stated that the CAD 
Software equipment (ED058) is actually synonymous with the ``breast 
biopsy software'' (EQ370) equipment, and recognized that in hindsight 
they should

[[Page 59557]]

have been consistent in identifying the equipment item between the 
breast biopsy codes and the MR breast codes. One commenter disagreed 
that the CAD Server or Additional User License equipment constituted 
forms of direct PE, and requested that CMS consider the cost of CAD 
service contracts and ``C-view'' costs in order to accurately access 
the calculation of indirect practice expenses.
    Response: We appreciate the submission of additional invoices from 
the commenters to assist in pricing these new equipment items. As we 
detailed in the Practice Expense portion of this final rule (section 
II.B. of this final rule), we are finalizing an update in the price of 
the CAD Software (ED058) equipment to $43,308.12 based on the new 
invoice submission and additional review by the StrategyGen contractor. 
We are also finalizing a price of $83,200 for the Breast coil (EQ388) 
equipment and a price of $12,031.52 for the CAD Workstation (CPU + 
Color Monitor) (ED056) based on the invoices submitted by the 
commenters. For the other two equipment items (CAD Server (ED057) and 
CAD Software--Additional User License (ED059)), we continue to believe 
that both of them would constitute forms of indirect PE under our 
methodology. The submitted invoices indicated that the CAD Server was a 
server type used in a data center while the user license was for a 
third license above and beyond the two licenses included in the price 
of the CAD software. As we stated in the proposed rule, we do not 
believe that these types of equipment would be allocated to the use of 
an individual patient for an individual service, and can be better 
understood as forms of indirect costs similar to office rent or 
administrative expenses.
    Comment: Several commenters stated that CMS had overstated the 
useful life of a breast coil. The commenters stated that a coil will 
start to display signs of wear, such as cracking of its case, flex 
spots, exposed wiring, or a degradation of its attenuated field causing 
a loss in image quality after about three to four years. Commenters 
stated that a useful life of 5 years would be more appropriate and 
consistent with the experience of their members.
    Response: We appreciate the additional information regarding the 
useful life of the breast coil equipment from the commenters. Our 
proposal to use 10 years as the useful life for this new equipment was 
based on our use of the breast biopsy device (EQ371) equipment as a 
proxy. We agree with the commenters that it would be more accurate to 
update the useful life to 5 years in light of this new information.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVUs for the codes in the Breast MRI with 
Computer-Aided Detection family of codes. We are finalizing the direct 
PE inputs as proposed, with the updates to the pricing of the new 
equipment as detailed above.
(47) Blood Smear Interpretation (CPT Code 85060)
    CPT code 85060 (Blood smear, peripheral, interpretation by 
physician with written report) was identified on a screen of CMS or 
Other source codes with Medicare utilization greater than 100,000 
services annually. For CY 2019, the RUC recommended a work RVU of 0.45 
based on maintaining the current work RVU.
    We disagreed with the recommended value and proposed a work RVU of 
0.36 for CPT code 85060 based on the total time ratio between the 
current time of 15 minutes and the recommended time established by the 
survey of 12 minutes. This ratio equals 80 percent, and 80 percent of 
the current work RVU of 0.45 equals a work RVU of 0.36. When we 
reviewed CPT code 85060, we found that the recommended work RVU was 
higher than nearly all of the other global XXX codes with similar time 
values, and we do not believe that this blood smear interpretation 
procedure would have an anomalously high intensity. Although we did not 
imply that the decrease in time as reflected in survey values must 
equate to a one-to-one or linear decrease in the valuation of work 
RVUs, we believe that since the two components of work are time and 
intensity, significant decreases in time should be reflected in 
decreases to work RVUs. In the case of CPT code 85060, we believe that 
it would be more accurate to propose the total time ratio at a work RVU 
of 0.36 to account for these decreases in the surveyed work time.
    The proposed work RVU was also based on the use of three crosswalk 
codes. We directly supported the proposed valuation through a crosswalk 
to CPT code 95930 (Visual evoked potential (VEP) checkerboard or flash 
testing, central nervous system except glaucoma, with interpretation 
and report), which has a work RVU of 0.35 along with 10 minutes of 
intraservice time and 14 minutes of total time. We also explained the 
proposed valuation by bracketing it between two other crosswalks, with 
CPT code 99152 (Moderate sedation services provided by the same 
physician or other qualified health care professional performing the 
diagnostic or therapeutic service that the sedation supports; initial 
15 minutes of intraservice time, patient age 5 years or older) on the 
lower end at a work RVU of 0.25 and CPT code 93923 (Complete bilateral 
noninvasive physiologic studies of upper or lower extremity arteries, 3 
or more levels, or single level study with provocative functional 
maneuvers) on the higher end at a work RVU of 0.45.
    The RUC recommended no direct PE inputs for CPT code 85060 and we 
proposed none.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 85060.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.36 for CPT code 85060 and stated that CMS should finalize the RUC-
recommended work RVU of 0.45. Commenters stated that a time ratio 
should not be used because any decrease will result in a large ratio 
and a corresponding but inappropriate decrease to the physician work 
RVU. Commenters stated that rather than using time ratios CMS should 
examine the magnitude estimation between the physician work, time, and 
intensity. Commenters also stated that the current time was not based 
on a survey and it was unclear how the time was determined.
    Response: We disagree with the commenters and continue to believe 
that the use of time ratios is one of several appropriate methods for 
identifying potential work RVUs for particular PFS services, 
particularly when the alternative values recommended by the RUC and 
other commenters do not account for information provided by surveys 
that suggests the amount of time involved in furnishing the service has 
changed significantly. We reiterate that, consistent with the statute, 
we are required to value the work RVU based on the relative resources 
involved in furnishing the service, which include time and intensity. 
When our review of recommended values reveals that changes in the 
resource of time have been unaccounted for in a recommended RVU, then 
we believe we have the obligation to account for that change in 
establishing work RVUs since the statute explicitly identifies time as 
one of the two elements of the work RVUs. We recognize that it would 
not be appropriate to develop work RVUs solely based on time given that 
intensity is also an element of work, but in applying the time ratios, 
we are using derived intensity measures based on current work RVUs for 
individual

[[Page 59558]]

procedures. Were we to disregard intensity altogether, the work RVUs 
for all services would be developed based solely on time values and 
that is definitively not the case, as indicated by the many services 
that share the same time values but have different work RVUs. (As an 
example, CPT codes 38222, 54231, 55870, 75573, and 78814 all share 
identical CY 2019 work times with 15 minutes of preservice time, 30 
minutes of intraservice time, and 15 minutes of postservice time; 
however these codes have respective CY 2019 work RVUs of 1.44, 2.04, 
2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time 
ratios to identify potentially appropriate work RVUs, and then use 
other methods (including estimates of work from CMS medical personnel 
and crosswalks to key reference or similar codes) to validate these 
RVUs. For more details on our methodology for developing work RVUs, we 
direct readers to the discussion CY 2017 PFS final rule (81 FR 80272 
through 80277).
    Comment: Several commenters disagreed with our statement that the 
recommended work value of 0.45 is higher than nearly all of the other 
global XXX codes with similar time values. Commenters stated that a 
search of the RUC database contradicted this finding, showing that 
eleven XXX codes with 12 minutes of intraservice time have values lower 
than 0.45 and thirteen XXX codes with 12 minutes of intraservice time 
have values the same or higher than 0.45 RVUs. Commenters stated that 
none of these services are pathology services and were not comparable, 
except for CPT code 88388 (Macroscopic examination, dissection, and 
preparation of tissue for non-microscopic analytical studies (e.g., 
nucleic acid-based molecular studies)) which has identical work value 
and intra-service time and was the reference code cited in the RUC 
recommendation. Commenters also disagreed with the CMS crosswalk to CPT 
code 95930 due to the fact that it is not a pathology service.
    Response: We disagree with the commenters' statement that pathology 
services are only comparable to other pathology services. Although we 
agree that the unique nature of pathology and laboratory services can 
make comparisons across codes more difficult than in other services, we 
believe the comparison of codes with similar work RVUs across different 
specialties is important to maintaining the relativity of the PFS. We 
disagree with the commenters that the crosswalk to CPT code 95930 would 
be methodologically inappropriate solely on the grounds that it is not 
a pathology service.
    Comment: Several commenters stated that there are a number of 
variables that must be considered in the evaluation of a blood smear 
when compared to others, including red blood cell count, size and 
morphology, platelet morphology and number, white blood cell morphology 
and the presence of white blood cell precursors. Commenters stated that 
other services with identical physician work include CPT code 88314 
(Special stain including interpretation and report; histochemical stain 
on frozen tissue block) and CPT code 93923 (Complete bilateral 
noninvasive physiologic studies of upper or lower extremity arteries, 3 
or more levels). Commenters stated the proposed work value would create 
significant rank order anomalies within the array of pathology 
services, as CPT code 85060 has nearly identical work time to CPT code 
88314 but would be valued lower at the proposed work RVU.
    Response: We appreciate the detailed information about CPT code 
85060 provided by the commenters regarding the clinical comparisons to 
CPT codes 88314 and 93923.
    After consideration of the public comments, we are not finalizing 
our proposed work RVU of 0.36 for CPT code 85060. We are finalizing the 
RUC-recommended work RVU of 0.45 instead.
(48) Bone Marrow Interpretation (CPT Code 85097)
    CPT code 85097 (Bone marrow, smear interpretation) was identified 
on a screen of CMS or Other source codes with Medicare utilization 
greater than 100,000 services annually. For CY 2019, the RUC 
recommended a work RVU of 1.00 based on a direct crosswalk to CPT code 
88121 (Cytopathology, in situ hybridization (e.g., FISH), urinary tract 
specimen with morphometric analysis, 3-5 molecular probes, each 
specimen; using computer-assisted technology).
    We disagreed with the RUC-recommended value and we proposed a work 
RVU of 0.94 for CPT code 85097 based on maintaining the current work 
valuation. We noted that the survey indicated that CPT code 85097 
typically takes 25 minutes of work time to perform, down from a 
previous work time of 30 minutes, and, generally speaking, since the 
two components of work are time and intensity, we believe that 
significant decreases in time should be reflected in decreases to work 
RVUs. For the specific case of CPT code 85097, we supported our 
proposed work RVU of 0.94 through a crosswalk to CPT code 88361 
(Morphometric analysis, tumor immunohistochemistry (e.g., Her-2/neu, 
estrogen receptor/progesterone receptor), quantitative or 
semiquantitative, per specimen, each single antibody stain procedure; 
using computer-assisted technology), a recently reviewed code from CY 
2018 with the identical time values and a work RVU of 0.95.
    We also considered a work RVU of 0.90 based on double the 
recommended work RVU of 0.45 for CPT code 85060 (Blood smear, 
peripheral, interpretation by physician with written report). When both 
of these CPT codes were under review, the explanation was offered that 
in a peripheral blood smear, typically, the practitioner does not have 
the approximately 12 precursor cells to review, whereas in an aspirate 
from the bone marrow, the practitioner is examining all the precursor 
cells. Additionally, for CPT code 85097, there are more cell types to 
look at as well as more slides, usually four, whereas with CPT code 
85060 the practitioner would typically only look at one slide. Although 
we did not propose to value CPT code 85097 at twice the work RVU of CPT 
code 85060, we believe this analysis also supports maintaining the 
current work RVU of 0.94 as opposed to raising it to 1.00.
    For the direct PE inputs, we proposed to remove the clinical labor 
time for the ``Accession and enter information'' (PA001) and ``File 
specimen, supplies, and other materials'' (PA008) activities. As we 
stated previously, information entry and specimen filing tasks are not 
individually allocable to a particular patient for a particular service 
and are considered to be forms of indirect PE. Although we agree that 
these are necessary tasks, under our established methodology we believe 
that they are more appropriately classified as indirect PE.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 85097.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.94 for CPT code 85097 and stated that CMS should finalize the RUC-
recommended work RVU of 1.00. Commenters stated that the CMS rationale 
about changes in work time was out of place in this context because the 
survey respondents indicate that the service requires 25 minutes to 
perform rather than the current time of 30 minutes, yet CMS proposed to 
maintain the current work value. The commenters suggested that 
maintaining the current work RVU of 0.94 was therefore inappropriate. 
Commenters also stated that the current work time for CPT code 85097 
was not based on a survey and that it was unknown how this time was

[[Page 59559]]

determined and what it actually represents.
    Response: We agree that it is important to use the most recent data 
available regarding time, and we note that when many years have passed 
between when time is measured, significant discrepancies can occur. 
However, we also believe that our operating assumption regarding the 
validity of the existing values as a point of comparison is critical to 
the integrity of the relative value system as currently constructed. 
The times currently associated with codes play a very important role in 
PFS ratesetting, both as points of comparison in establishing work RVUs 
and in the allocation of indirect PE RVUs by specialty. If we were to 
operate under the assumption that previously recommended work times had 
routinely been overestimated, this would undermine the relativity of 
the work RVUs on the PFS in general, given the process under which 
codes are often valued by comparisons to codes with similar times, and 
it also would undermine the validity of the allocation of indirect PE 
RVUs to physician specialties across the PFS. Instead, we believe that 
it is crucial that the code valuation process take place with the 
understanding that the existing work times used in the PFS ratesetting 
processes are accurate. We recognize that adjusting work RVUs for 
changes in time is not always a straightforward process and that the 
intensity associated with changes in time is not necessarily always 
linear, which is why we apply various methodologies to identify several 
potential work values for individual codes. However, we want to 
reiterate that we believe it would be irresponsible to ignore changes 
in time based on the best data available and that we are statutorily 
obligated to consider both time and intensity in establishing work RVUs 
for PFS services. For additional information regarding the use of old 
work time values in our methodology, we refer readers to our discussion 
of the subject in the CY 2017 final rule (81 FR 80273 through 80274). 
With regard to the specific case of CPT code 85097, we proposed to 
maintain the current work RVU rather than decreasing the work RVU due 
to some of the same concerns about the historical work times for this 
code raised by the commenters. We believe that the logic provided by 
the commenters suggests that the decreases in the work time of CPT code 
85097 should have been reflected in decreases to the work RVU (as 
opposed to maintaining the current value), which we do not believe was 
their intention.
    Comment: Several commenters stated that given the total work, time, 
intensity, and complexity of the patient case, the current work RVU of 
0.94 was too low for CPT code 85097. Commenters stated that the RUC 
chose a crosswalk to CPT code 88121 (Cytopathology, in situ 
hybridization (e.g., FISH), urinary tract specimen with morphometric 
analysis, 3-5 molecular probes, each specimen; using computer-assisted 
technology) specifically because it is a similar pathology code with a 
value between the current work value of 0.94 and the survey 25th 
percentile of 1.15. Commenters stated that the CMS reference code (CPT 
code 88361) was less intense and complex to perform as it involves 
evaluating a single antibody and determining the percentage of tumor 
cells that are positive for that antibody, as opposed to the work of 
CPT code 85097 which involves evaluating all blood cell precursors for 
quantitative and morphologic abnormalities, as well as evaluating for 
metastatic tumor cells, evidence of infection, or evidence of lymphoid 
neoplasms.
    Response: We disagree with the commenters that the current work RVU 
of 0.94 or the work RVU of our reference code of 88361 are too low in 
comparison to CPT code 85097. All three of the codes under discussion 
(CPT codes 85097, 88121, and 88361) are clinically similar procedures 
that involve the practitioner using their eyes to look at staining 
patterns. We do not agree with the commenters that the RUC's use of CPT 
code 88121 as a crosswalk would be any more accurate on clinical 
grounds that the reference code of 88361 that we chose in the proposed 
rule. Overall, we do not believe that there is a significant difference 
between these three procedures given their nearly identical work RVUs, 
intensities, and work times. However, given the decrease in surveyed 
work time, we continue to believe that it is more appropriate to 
maintain the current work RVU of 0.94 than to increase it to 1.00 due 
to our longstanding belief that decreases in work time should typically 
be not be reflected in increases to the work RVU. We note that we are 
not proposing to decrease the work RVU for CPT code 85097 despite this 
decrease in the surveyed work time, only to maintain the current 
valuation.
    Comment: Several commenters responded to the CMS consideration of a 
work RVU of 0.90 based on double the recommended work RVU of 0.45 for 
CPT code 85060. Commenters stated that they wished to clarify that this 
explanation was put forward to a RUC member whom was simply questioning 
why this service requires twice the time of CPT code 85060. Commenters 
stated that simply doubling the RUC-recommended work RVU of 0.45 for 
CPT code 85060 based on the amount of time does not account for the 
considerably greater intensity and complexity of CPT code 85097 over 
CPT code 85060 as described elsewhere in their comments.
    Response: We appreciate the clarification on this issue from the 
commenters.
    Comment: Several commenters disagreed with the CMS proposal remove 
the clinical labor time for the ``Accession and enter information'' 
(PA001) and ``File specimen, supplies, and other materials'' (PA008) 
activities. Commenters stated that although the descriptions for the 
PA001 and PA008 clinical labor activities appeared to describe data 
entry and filing activities, these tasks are very different in the 
pathology lab. Commenters stated that it is crucial for the performance 
of these tasks be executed accurately according to rigid patient 
laboratory protocols, standards, and legal processes associated with 
specimen/patient care and they should not be considered a form of 
indirect expense.
    Response: Although we agree that the unique nature of pathology and 
laboratory services can make comparisons across codes more difficult 
than for other services, we believe the comparison of similar clinical 
labor activities across different services is important to maintaining 
the relativity of the direct PE inputs. As we stated in the CY 2017 PFS 
final rule (81 FR 80324), we agree with the commenters that entering 
patient data into information systems and filing specimens are 
important tasks, and we agree that these would take more than zero 
minutes to perform. However, we continue to believe that these 
activities are correctly categorized as indirect PE as administrative 
functions, and therefore, we do not recognize the entry of patient data 
or the filing of specimens as direct PE inputs, and we do not consider 
this task as typically performed by clinical labor on a per-service 
basis.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for CPT code 85097 as proposed.
(49) Fibrinolysins Screen (CPT Code 85390)
    CPT code 85390 (Fibrinolysins or coagulopathy screen, 
interpretation and report) was identified as potentially misvalued on a 
screen of codes with a negative IWPUT, with 2016 estimated Medicare 
utilization over 10,000 for

[[Page 59560]]

RUC reviewed codes and over 1,000 for Harvard valued and CMS/Other 
source codes. For CY 2019, we are proposing the RUC-recommended work 
RVU of 0.75 for CPT code 85390. Because this is a work only code, the 
RUC did not recommend, and we did not propose any direct PE inputs for 
CPT code 85390.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 85390.
    Comment: A commenter expressed support for our proposal to accept 
the RUC-recommended work RVU for this code.
    Response: We appreciate the support for our proposals from the 
commenter.
    After consideration of the public comments, we are finalizing our 
proposal to accept the RUC-recommended work RVU for this code.
(50) Electroretinography (CPT Codes 92273, 92274, and 0509T)
    CPT code 92275 (Electroretinography with interpretation and report) 
was identified in 2016 on a high expenditure services screen across 
specialties with Medicare allowed charges of $10 million or more. In 
January 2016, the specialty society noted that they became aware of 
inappropriate use of CPT code 92275 for a less intensive version of 
this test for diagnosis and indications that are not clinically proven 
and for which less expensive and less intensive tests already exist. 
CPT changes were necessary to ensure that the service for which CPT 
code 92275 was intended was clearly described, as well as an accurate 
vignette and work descriptor were developed. In September 2017, the CPT 
Editorial Panel deleted CPT code 92275 and replaced it with two new 
codes to describe electroretinography full field and multi focal. A 
category III code was retained for pattern electroretinography.
    For CPT code 92273 (Electroretinography (ERG) with interpretation 
and report; full field (e.g., ffERG, flash ERG, Ganzfeld ERG)), we 
disagreed with the recommended work RVU of 0.80 and we instead proposed 
a work RVU of 0.69 based on a direct crosswalk to CPT code 88172 
(Cytopathology, evaluation of fine needle aspirate; immediate 
cytohistologic study to determine adequacy for diagnosis, first 
evaluation episode, each site). CPT code 88172 is another 
interpretation procedure with the same 20 minutes of intraservice time, 
which we believe is a more accurate comparison for CPT code 92273 than 
the two reference codes chosen by the survey participants due to their 
significantly higher and lower intraservice times. We noted that the 
recommended intraservice time for CPT code 92273 as compared to its 
predecessor CPT code 92275 is decreasing from 45 minutes to 20 minutes 
(56 percent reduction), and the recommended total time is decreasing 
from 71 minutes to 22 minutes (69 percent reduction); however, the work 
RVU is only decreasing from 1.01 to 0.80, which is a reduction of just 
over 20 percent. Although we did not imply that the decreases in time 
as reflected in survey values must equate to a one-to-one or linear 
decrease in the valuation of work RVUs, we believe that since the two 
components of work are time and intensity, significant decreases in 
time should be reflected in decreases to work RVUs. In the case of CPT 
code 92273, we have reason to believe that the significant drops in 
surveyed work time as compared to CPT code 92275 are a result of 
improvements in technology since the predecessor code was reviewed. The 
older machines used for electroretinography were slower and more 
cumbersome, and now the same work for the service can be performed in 
significantly less time. Therefore, we proposed a work RVU of 0.69 
based on the direct crosswalk to CPT code 88172, which we believe more 
accurately accounts for these decreases in surveyed work time.
    For CPT code 92274 (Electroretinography (ERG) with interpretation 
and report; multifocal (mfERG)), we disagreed with the RUC-recommended 
work RVU of 0.72 and proposed a work RVU of 0.61. We concurred that the 
relative difference in work between CPT code 92273 and 92274 is 
equivalent to the recommended interval of 0.08 RVUs. Therefore, we 
proposed a work RVU of 0.61 for CPT code 92274, based on the 
recommended interval of 0.08 fewer RVUs below our proposed work RVU of 
0.69 for CPT code 92273. The proposed work RVU is also based on the use 
of two crosswalk codes: CPT code 88387 (Macroscopic examination, 
dissection, and preparation of tissue for non-microscopic analytical 
studies; each tissue preparation); and CPT code 92100 (Serial tonometry 
(separate procedure) with multiple measurements of intraocular pressure 
over an extended time period with interpretation and report, same day). 
Both codes share the same 20 minutes of intraservice and 20 minutes of 
total time, with a work RVU of 0.62 for CPT code 88387 and a work RVU 
of 0.61 for CPT code 92100.
    The recommendations for this code family also include CPT Category 
III code 0509T (Electroretinography (ERG) with interpretation and 
report, pattern (PERG)). We typically assign contractor pricing for 
Category III codes since they are temporary codes assigned to emerging 
technology and services. However, in cases where there is an unusually 
high volume of services that will be performed under a Category III 
code, we have sometimes assigned an active status to the procedure and 
developed RVUs before a formal CPT code is created. In the case of CPT 
code 0509T, the recommendations indicate that approximately 80 percent 
of the services currently reported under CPT code 92275 will be 
reported under the new Category III code. Since this will involve an 
estimated 100,000 services for CY 2019, we believe that the interests 
of relativity would be better served by assigning an active status to 
CPT code 0509T and creating RVUs through the use of a proxy crosswalk 
to a similar existing service. Therefore, we proposed to assign an 
active status to CPT Category III code 0509T for CY 2019, with a work 
RVU and work time values crosswalked from CPT code 92250 (Fundus 
photography with interpretation and report). CPT code 92250 is a 
clinically similar procedure that was recently reviewed during the CY 
2017 rule cycle. We proposed a work RVU of 0.40 and work times of 10 
minutes of intraservice and 12 minutes of total time for CPT code 0509T 
based on this crosswalk to CPT code 92250.
    For the direct PE inputs, we proposed to remove the preservice 
clinical labor in the facility setting for CPT codes 92273 and 92274. 
Both of these codes are diagnostic tests under which the professional 
(26 modifier) and technical (TC modifier) components will be separately 
billable, and codes that have these professional and technical 
components typically will not have direct PE inputs in the facility 
setting since the technical component is only valued in the nonfacility 
setting. We also noted on this subject that the predecessor code, CPT 
code 92275, does not currently include any preservice clinical labor, 
nor any facility direct PE inputs.
    We proposed to remove the clinical labor time for the ``Greet 
patient, provide gowning, ensure appropriate medical records are 
available'' (CA009) and the ``Provide education/obtain consent'' 
(CA011) activities for CPT codes 92273 and 92274. Both of these CPT 
codes will typically be reported with a same day E/M service, and we 
believe that these clinical labor tasks will be carried out during the 
E/M service. We believe that their inclusion in CPT codes 92273 and 
92274 would be duplicative. We also proposed to refine the clinical 
labor time for the

[[Page 59561]]

``Prepare room, equipment and supplies'' (CA013) activity to 3 minutes 
and to refine the clinical labor time for the ``Confirm order, protocol 
exam'' (CA014) activity to 0 minutes for both codes. The predecessor 
CPT code 92275 did not previously have clinical labor time assigned for 
the ``Confirm order, protocol exam'' clinical labor task, and we did 
not have any reason to believe that the services being furnished by the 
clinical staff had changed in the new codes, only the way in which this 
clinical labor time has been presented on the PE worksheets. We also 
noted that there is no effect on the total clinical labor direct costs 
in these situations since the same 3 minutes of clinical labor time is 
still being furnished.
    We proposed to refine the clinical labor time for the ``Clean room/
equipment by clinical staff'' (CA024) activity from 12 minutes to 8 
minutes for CPT codes 92273 and 92274. The recommendations for these 
codes stated that cleaning is carried out in several steps: The patient 
is first cleaned for 2 minutes, followed by wires and electrodes being 
scrubbed carefully with detergent, soaked, and then rinsed with sterile 
water. We agree with the need for 2 minutes of patient cleaning time 
and for the cleaning of the wires and electrodes to take place in two 
different steps. However, our standard clinical labor time for room/
equipment cleaning is 3 minutes, and therefore, we proposed a total 
time of 8 minutes for these codes, based on 2 minutes for patient 
cleaning and then 3 minutes for each of the two steps of wire and 
electrode cleaning.
    We proposed to refine the clinical labor time for the 
``Technologist QC's images in PACS, checking for all images, reformats, 
and dose page'' (CA030) activity from 10 minutes to 3 minutes for CPT 
codes 92273 and 92274. We finalized in the CY 2017 PFS final rule (81 
FR 80184-80186) a range of appropriate standard minutes for this 
clinical labor activity, ranging from 2 minutes for simple services up 
to 5 minutes for highly complex services. We believe that the 
complexity of the imaging in CPT codes 92273 and 92274 is comparable to 
the CT and magnetic resonance (MR) codes that have been recently 
reviewed, such as CPT code 76391 (Magnetic resonance (e.g., vibration) 
elastography). Therefore, in order to maintain relativity, we proposed 
the same clinical labor time of 3 minutes for CPT codes 92273 and 92274 
that has been recommended for these CT and MR codes. We also proposed 
to refine the clinical labor time for the ``Review examination with 
interpreting MD/DO'' (CA031) activity from 5 minutes to 2 minutes for 
CPT codes 92273 and 92274. We also finalized in the CY 2017 PFS final 
rule a standard time of 2 minutes for reviewing examinations with the 
interpreting MD, and we have no reason to believe that these codes 
would typically require additional clinical labor at more than double 
the standard time.
    We noted that the new equipment item ``Contact lens electrode for 
mfERG and ffERG'' (EQ391) was listed twice for CPT code 92273 but only 
a single time for CPT code 92274. We solicited additional information 
about whether the recommendations intended this equipment item to be 
listed twice, with one contact intended for each eye, or whether this 
was a clerical mistake. We are also interested in additional 
information as to why the contact lens electrode was listed twice for 
CPT code 92273 but only a single time for CPT code 92274. Finally, we 
also proposed to refine the equipment times in accordance with our 
standard equipment time formulas.
    We proposed to use the direct PE inputs for CPT code 92274, 
including the refinements detailed above, as a proxy for CPT Category 
III code 0509T until it can be separately reviewed by the RUC.
    The following is a summary of the public comments we received on 
our proposals involving the Electroretinography family of codes.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.69 for CPT code 92273 and stated that CMS should finalize the RUC-
recommended work RVU of 0.80. Commenters stated that the RUC-
recommended work RVU was based on the survey 25th percentile and CMS 
should use survey data in establishing the work RVU. Commenters stated 
that the decrease in intraservice work time of deleted CPT code 92275 
from when it was last surveyed in 1995 was due to the fact that the 
physician no longer participates in the acquisition of the data or 
performing the test on the patient, which has become the technician's 
work. Commenters stated that the RUC determined that the physician work 
is not the same as it was with CPT code 92275 and the recommended 
decrease in work RVUs appropriately addresses the decrease in physician 
time to perform this service.
    Response: We disagree with the commenters that the RUC-recommended 
decrease in work RVUs appropriately addresses the decrease in physician 
time to perform this service. As we stated in the proposed rule, the 
recommended intraservice time for CPT code 92273 as compared to its 
predecessor CPT code 92275 is decreasing from 45 minutes to 20 minutes 
(56 percent reduction), and the recommended total time is decreasing 
from 71 minutes to 22 minutes (69 percent reduction); however, the RUC-
recommended work RVU is only decreasing from 1.01 to 0.80, which is a 
reduction of just over 20 percent. Although we did not imply that the 
decreases in time as reflected in survey values must equate to a one-
to-one or linear decrease in the valuation of work RVUs, we believe 
that since the two components of work are time and intensity, 
significant decreases in time should be reflected in decreases to work 
RVUs. As a result, we believe that our proposed work RVU of 0.69 more 
accurately captures the changes in work that have taken place since the 
previous survey.
    Comment: Several commenters stated that while the time required for 
CPT code 92273 is less than the time required for CPT code 92275, the 
code it replaced, the intensity and complexity of the work involved in 
interpreting the test has increased significantly. Commenters stated 
that the newer machines are easily programmed to produce more images 
and numbers for interpretation (double or more) than the machines in 
use in 1995 when the procedure was last valued and that advances in 
medical knowledge have identified more specific retinal dystrophy 
diagnoses with specific genotypes that the clinician must consider when 
interpreting the test. Commenters emphasized that while the machine may 
be more efficient as stated by CMS, the cognitive work required by the 
physician interpreting the test has increased significantly.
    Response: We disagree with the commenters that all of the 
efficiencies gained in work time via improved technology would be 
offset via higher intensity (that is, greater cognitive work on the 
part of the practitioner). While the incorporation of new technology 
can sometimes make services more complex and difficult to perform, it 
can also have the opposite effect by making services less reliant on 
manual skill and technique. At the RUC-recommended work RVU of 0.80, 
the intensity of CPT code 92273 would increase by nearly 300 percent, 
and we do not agree that the cognitive intensity of the procedure would 
have increased by this amount. We continue to believe that our proposed 
work RVU of 0.69 more accurately captures the changes in work taking 
place as a result of greater technological efficiencies in the service.

[[Page 59562]]

    Comment: Many commenters disagreed with the proposed work RVU of 
0.61 for CPT code 92274 and stated that CMS should finalize the RUC-
recommended work RVU of 0.72. Commenters stated that CMS should use 
valid methods of evaluating services, such as survey data and magnitude 
estimation, instead of relying on an incremental difference in work 
RVUs between codes 92273 and 92274.
    Response: We believe the use of an incremental difference between 
codes is a valid methodology for setting values, especially in valuing 
services within a family of revised codes where it is important to 
maintain appropriate intra-family relativity. Historically, we have 
frequently utilized an incremental methodology in which we value a code 
based upon its incremental difference between another code or another 
family of codes. We note that the RUC has also used the same 
incremental methodology on occasion when it was unable to produce valid 
survey data for a service. We further note that we did not rely solely 
on an increment for our proposed work RVU for CPT code 92274, as the 
proposed work RVU was also based on the use of a reference code (CPT 
code 88387) and a crosswalk code (CPT code 92100). Both codes share the 
same 20 minutes of intraservice and 20 minutes of total time, with a 
work RVU of 0.62 for CPT code 88387 and a work RVU of 0.61 for CPT code 
92100.
    Comment: Several commenters stated that while there was no 
predecessor code for direct comparison, the intensity and complexity of 
the work involved in interpreting the test has increased significantly 
compared to 1995, when CPT code 92275 was last valued. Commenters 
restated the same arguments they expressed for CPT code 92273: The new 
machines used in CPT code 92274 have become more efficient but the 
cognitive work required by the physician interpreting the test has 
increased significantly.
    Response: As we stated with regard to CPT code 92273, we continue 
to disagree with the commenters that all of the efficiencies gained in 
work time via improved technology would be offset via higher intensity 
(that is, greater cognitive work on the part of the practitioner). At 
the RUC-recommended work RVU of 0.72, the intensity of CPT code 92274 
would also increase by nearly 300 percent, and we do not agree that the 
cognitive intensity of the procedure would have increased by this 
amount. We continue to believe that our proposed work RVU of 0.61 more 
accurately captures the changes in work taking place as a result of 
greater technological efficiencies in the service.
    Comment: Several commenters stated that CPT code 92274 requires 
more physician work than the crosswalks we identified. Commenters 
stated that CPT code 88387 is a straightforward manual dissection that 
does not require interpretation of multiple images and numeric values 
to arrive at a diagnosis. Commenters stated that CPT code 92100 also 
requires less physician work, as CPT code 92274 requires interpretation 
of significantly more data and consideration of many more diagnostic 
possibilities.
    Response: We disagree with the commenters that our reference and 
crosswalk codes require less work than CPT code 92274. While it is true 
that CPT code 88387 does not require interpretation of multiple images 
and numeric values, this is because it is not an imaging service, and 
it is inappropriate to state that the work of CPT code 88387 is lower 
than CPT code 92274 based on this criteria. We do not agree that the 
macroscopic examination, dissection, and preparation of tissue taking 
place in CPT code 88387 would inherently constitute less work than CPT 
code 92274. Similarly, we do not agree that the serial tonometry with 
multiple measurements of intraocular pressure taking place in CPT code 
92100 would involve less work than CPT code 92274, especially due to 
the nearly identical intraservice and total work times shared by these 
procedures.
    Comment: One commenter disagreed with our proposal to assign active 
pricing to Category III code 0509T. The commenter stated that this code 
should go through the regular vetting process that other new technology 
typically follows, including development of appropriate clinical 
literature that would qualify it for elevation to a full Category I CPT 
code, and then a RUC survey in order to develop accurate valuation for 
work and practice expense. The commenter was concerned that CMS would 
single out and put forward a value for a technology that has not gone 
through the same scrutiny as other new technologies.
    Response: We understand the concerns expressed by the commenter. As 
we stated in the proposed rule, we typically assign contractor pricing 
for Category III codes since they are temporary codes assigned to 
emerging technology and services. However, in cases where there is an 
unusually high volume of services that will be performed under a 
Category III code, we have sometimes assigned an active status to the 
procedure, and in the case of Category III code 0509T the 
recommendations indicated that approximately 80 percent of the services 
currently reported under CPT code 92275 will be reported under the new 
Category III code. Since this will involve an estimated 100,000 
services for CY 2019, we continue to believe that the interests of 
relativity would be better served by assigning an active status to 
Category III code 0509T and creating RVUs through the use of a proxy 
crosswalk to a similar existing service. We agree with the commenter 
that this code should still go through the regular vetting process that 
other new technology typically follows, and we look forward to 
receiving recommendations for work and practice expense inputs in the 
future.
    Comment: One commenter stated that many of the proposed changes to 
the direct PE inputs were made with the intent to standardize inputs. 
The commenter stated that although the RUC has created many standards, 
they have always acknowledged that there are and will be exceptions to 
those standards. The commenter stated that these important diagnostic 
tests are unusual services that require significant amounts of 
preservice clinical labor time in whichever setting they are performed, 
and that the recommended direct PE inputs were carefully prepared based 
upon documented personal observation and time motion studies. The 
commenter stated that the predecessor CPT code 92275 had an over-
simplified PE spreadsheet with very few data inputs, each comprising 
substantial amounts of time that are now broken out into separate 
inputs, and as a result the work required had not changed substantially 
but there had been additional granularity in the direct PE inputs.
    Response: As we noted in the CY 2015 PFS final rule with comment 
period (79 FR 67640 through 67641), we continue to make improvements to 
the direct PE input database to provide the number of clinical labor 
minutes assigned for each task for every code in the database instead 
of only including the number of clinical labor minutes for the 
preservice, service, and postservice periods for each code. We have 
stated that we believe this additional level of detail helps to 
facilitate transparency, allows us to more easily compare clinical 
labor times across the PFS to maintain relativity, and helps in 
maintaining standard times for particular clinical labor tasks that can 
be applied consistently to many codes as they are valued over several 
years. However, we have always recognized that standards for clinical 
labor cannot be applied universally due to the differences between 
individual services, and we have frequently finalized

[[Page 59563]]

clinical labor times above the standard values where we believed that 
there was sufficient reason to establish these values as the typical 
case. In the case of CPT code 92273 and 92274, we detailed our 
rationale in the proposed rule for why we believed that some of the 
RUC-recommended direct PE inputs should be refined to a standard 
clinical labor time. We also note that we did not propose the standard 
clinical labor time for all activities, such as the ``Clean room/
equipment by clinical staff'' (CA024) activity.
    Comment: Several commenters disagreed with the proposal to remove 
the preservice clinical labor in the facility setting for CPT codes 
92273 and 92274. Commenters stated that these procedures, when done in 
a facility, must be scheduled in the operating room. Commenters stated 
that these procedures would typically be done in the facility only when 
it is not clinically appropriate for them to be performed in the 
clinic, such as for children or the cognitively impaired; and it takes 
substantial amounts of time for the staff to accomplish this 
coordination of care for these higher-needs patients.
    Response: We recognize that these procedures are rarely performed 
in the facility setting, with approximately 1 percent of the 
utilization of predecessor CPT code 92275 taking place in this setting. 
However, we disagree that these procedures would typically be performed 
in the operating room when furnished in the facility, and therefore, we 
do not agree that these procedures would typically require preservice 
clinical labor for coordination of care. We also noted on this subject 
that the predecessor code, CPT code 92275, does not currently include 
any preservice clinical labor, nor any facility direct PE inputs, and 
we did not receive an explanation from the commenters as to why this 
was the case. Furthermore, both of these codes are diagnostic tests 
under which the professional (26 modifier) and technical (TC modifier) 
components will be separately billable, and codes that have these 
professional and technical components typically will not have direct PE 
inputs in the facility setting since the technical component is only 
valued in the nonfacility setting.
    Comment: Several commenters disagreed with the proposal to remove 
the clinical labor time for the ``Greet patient, provide gowning, 
ensure appropriate medical records are available'' (CA009) and the 
``Provide education/obtain consent'' (CA011) activities for CPT codes 
92273 and 92274. Commenters stated that although slightly more than 50 
percent of these services are done on the same day as an office visit, 
the clinical staff time involved is completely divorced from the office 
visit and the staff performing the test are different from the staff 
assisting in the office visit. Commenters stated that the machine used 
for these procedures is housed in a different room, the patient needs 
to be transported from the ophthalmic exam lane to the ERG room and 
back, additional instructions are required that are never done during a 
typical office visit, and the nature of this test requires extra 
supplies and work in addition to those used for the office visit. 
Commenters emphasized that these clinical tasks are not duplicative 
with an E/M, as they represent separate actions by a different 
technician in a different room.
    Response: We disagree with the commenters and continue to believe 
that this clinical labor would be duplicative with the same day E/M 
office visit. While it is true that there is a different clinical labor 
staff type used by CPT codes 92273 and 92274, we are not suggesting 
that all clinical labor is duplicative with the same day E/M visit, 
only that clinical labor activities such as greeting and gowning the 
patient would only be done a single time. We also note that we do not 
include patient transportation as a form of direct PE, as it is not 
individually allocable to a single service and would instead be 
classified as an administrative task under indirect PE. However, we do 
agree with the commenters that additional instructions would be 
required for these electroretinography services, and as a result we 
will restore the 1 minute of clinical labor time for the ``Provide 
education/obtain consent'' (CA011) activity. We agree that this would 
not be duplicative with the same day E/M office visit.
    Comment: Several commenters stated that in our refinements to the 
direct PE inputs for CPT codes 92273 and 92274, CMS proposed to remove 
1 minute from the CA014 activity code and proposed to add 1 minute to 
the CA013 activity code. The commenter stated that this refinement was 
inaccurate and encouraged CMS to modify this proposal by finalizing the 
RUC-recommended direct PE inputs for clinical labor. One commenter 
stated that this work is done by a different technician in a different 
room typically in a busy clinical setting and this work was separate 
from that being done during the office visit.
    Response: We addressed this subject in detail in the PE section of 
this final rule under the Changes to Direct PE Inputs for Specific 
Services heading (section II.B.3. of this final rule). For CPT codes 
92273 and 92274, we are finalizing these clinical labor refinements as 
proposed. We also note in response to the one commenter that our 
refinements to the CA013 and CA014 clinical labor activities were not 
based on the premise on being duplicative with the same day E/M visit.
    Comment: Several commenters disagreed with the proposal to refine 
the clinical labor time for the ``Clean room/equipment by clinical 
staff'' (CA024) activity from 12 minutes to 8 minutes for CPT codes 
92273 and 92274. Commenters stated that this was the time that the 
specialty society found when directly shadowing the process to clean 
the patient and the equipment. Commenters stated that the technician 
needs to clean the patient's skin, rinse their eyes, and clean around 
the patient and escort them out. Commenters stated that the expensive 
and delicate eye electrodes require a significant amount of time to 
remove and clean the conductive paste and Goniosol without damaging the 
electrodes, which needs to be performed after each procedure so that 
the electrodes can be re-used for the next procedure. Commenters 
emphasized that the equipment cleaning process requires meticulous care 
and a significant amount of technician time.
    Response: We agree with the commenters that these procedures 
require more time for cleaning the room and equipment than the standard 
for the CA024 activity. This is the reason we proposed 8 minutes of 
clinical labor time instead of 3 minutes, almost triple the standard 
value for this activity code. As we stated in the proposed rule, we 
agreed with the need for 2 minutes of patient cleaning time and for the 
cleaning of the wires and electrodes to take place in two different 
steps. Since our standard clinical labor time for room/equipment 
cleaning is 3 minutes, we therefore proposed a total time of 8 minutes 
for these codes, based on 2 minutes for patient cleaning and then 3 
minutes for each of the two steps of wire and electrode cleaning. We 
continue to believe that 8 minutes would be the typical amount of 
clinical labor used for these procedures.
    Comment: Several commenters disagreed with the proposal to refine 
the clinical labor time for the ``Technologist QC's images in PACS, 
checking for all images, reformats, and dose page'' (CA030) activity 
from 10 minutes to 3 minutes for CPT codes 92273 and 92274. Commenters 
stated that the machine used for the ERG codes is not typically 
integrated into the clinic's electronic medical record. Commenters 
stated that this machine requires printing all images created by the 
testing

[[Page 59564]]

machine and uploading them into the EMR for subsequent review by the 
physician and that it is not unusual for re-printing using a different 
scale or limits to be necessary. Commenters stated that this clinical 
labor differed from a typical radiology scenario because the procedure 
is in fact different from a typical imaging study.
    Response: We disagree with the commenters that the full recommended 
time of 10 minutes would be typical for this clinical labor activity. 
We do not agree that it would be typical to physically print out all of 
the images produced by the machine, and note that we do not include 
additional direct PE inputs for inefficiencies in practice operations. 
We continue to believe that the complexity of the imaging in CPT codes 
92273 and 92274 is comparable to the CT and magnetic resonance (MR) 
codes, and that in order to maintain relativity, we proposed the same 
clinical labor time of 3 minutes.
    Comment: Several commenters disagreed with the proposal to refine 
the clinical labor time for the ``Review examination with interpreting 
MD/DO'' (CA031) activity from 5 minutes to 2 minutes for CPT codes 
92273 and 92274. Commenters stated that this input was calculated by 
direct observation of typical procedures with a stopwatch. Commenters 
stated that this test is performed in a different room than the office 
visit, and the technician needs to take time to find the ordering/
interpreting physician and review the quality of the gain and results.
    Response: We disagree with the commenters that the full recommended 
time of 5 minutes would be typical for this clinical labor activity. We 
note again that we do not include additional direct PE inputs for 
inefficiencies in practice operations, and that we would not increase 
the clinical labor to include time that the technician needs to find 
the ordering/interpreting physician. We finalized in the CY 2017 PFS 
final rule a standard time of 2 minutes for reviewing examinations with 
the interpreting MD, and we have no reason to believe that these codes 
would typically require additional clinical labor at more than double 
the standard time.
    Comment: Several commenters responded to the comment solicitation 
regarding additional information about whether the recommendations for 
the ``Contact lens electrode for mfERG and ffERG'' (EQ391) equipment 
intended this equipment item to be listed twice, with one contact 
intended for each eye, or whether this was a clerical mistake. 
Commenters stated that this was not an error but was intentional and 
reflects typical practice. Commenters stated that the test carried out 
in CPT code 92273 is performed with two contact lenses in place (one in 
each eye at the same time) in a simultaneous testing fashion. 
Commenters stated that the test carried out in CPT code 92274 is 
typically performed sequentially one eye at a time, re-using the same 
contact lens for each eye. Commenters stated that this discrepancy is 
primarily due to the dark and light-adaptation needs for the ffERG, 
which if done sequentially would double the amount of clinical time.
    Response: We appreciate the additional information supplied by the 
commenters in response to our comment solicitation.
    Comment: One commenter stated that the highly technical equipment 
formula should be used for the mfERG and ffERG electrodiagnostic unit 
(EQ390) equipment item.
    Response: We did not propose to classify the EQ390 equipment as 
highly technical. We note that if we were to use the highly technical 
equipment formula for the EQ390 equipment, the total equipment time for 
this item would decrease, and we do not believe that this was what the 
commenter intended.
    After consideration of the public comments, we are finalizing the 
work RVUs for the codes in the Electroretinography family of codes as 
proposed. We are also finalizing the direct PE inputs as proposed, with 
the exception of the CA011 clinical labor activity as described above.
(51) Cardiac Output Measurement (CPT Codes 93561 and 93562)
    CPT codes 93561 (Indicator dilution studies such as dye or 
thermodilution, including arterial and/or venous catheterization; with 
cardiac output measurement) and 93562 (Indicator dilution studies such 
as dye or thermodilution, including arterial and/or venous 
catheterization; subsequent measurement of cardiac output) were 
identified as potentially misvalued on a screen of codes with a 
negative IWPUT, with 2016 estimated Medicare utilization over 10,000 
for RUC reviewed codes and over 1,000 for Harvard valued and CMS/Other 
source codes. The specialty societies noted that CPT codes 93561 and 
93562 are primarily performed in the pediatric population, thus the 
Medicare utilization for these Harvard-source services is not over 
1,000. However, the specialty societies requested and the RUC agreed 
that these services should be reviewed under this negative IWPUT 
screen.
    For CPT code 93561, we disagreed with the RUC-recommended work RVU 
of 0.95 and we proposed a work RVU of 0.60 based on a crosswalk to CPT 
code 77003 (Fluoroscopic guidance and localization of needle or 
catheter tip for spine or paraspinous diagnostic or therapeutic 
injection procedures (epidural or subarachnoid)). CPT Code 77003 is 
another recently-reviewed add-on global code with the same 15 minutes 
of intraservice time and 2 additional minutes of preservice evaluation 
time. In our review of CPT code 93561, we found that there was a 
particularly unusual relationship between the surveyed work times and 
the RUC-recommended work RVU. We noted that the recommended 
intraservice time for CPT code 93561 was decreasing from 29 minutes to 
15 minutes (48 percent reduction), and the recommended total time for 
CPT code 93561 was decreasing from 78 minutes to 15 minutes (81 percent 
reduction); however, the recommended work RVU was instead increasing 
from 0.25 to 0.95, which is an increase of nearly 300 percent. Although 
we did not imply that the decrease in time as reflected in survey 
values must equate to a one-to-one or linear decrease in the valuation 
of work RVUs, we believe that since the two components of work are time 
and intensity, significant decreases in time should typically be 
reflected in decreases to work RVUs, not increases in valuation. We 
recognized that CPT code 93561 is an unusual case, as it is shifting 
from 0-day global status to add-on code status. However, when the work 
time for a code is going down and the unit of service is being reduced, 
we would not expect to see an increased work RVU under these 
circumstances, and especially not such a large work RVU increase. 
Therefore, we proposed instead to crosswalk CPT code 93561 to CPT code 
77003 at a work RVU of 0.60, which we believe is a more accurate 
valuation in relation to other recently-reviewed add-on codes on the 
PFS. We believe that this proposed work RVU of 0.60 better preserves 
relativity with other clinically similar codes with similar surveyed 
work times.
    For CPT code 93562, we disagreed with the recommended work RVU of 
0.77 and proposed a work RVU of 0.48 based on the intraservice time 
ratio with CPT code 93561. We observed a similar pattern taking place 
with CPT code 93562 as with the first code in the family, noting that 
the recommended intraservice time was decreasing from 16 minutes to 12 
minutes (25 percent reduction), and the recommended total time was 
decreasing from 44 minutes to

[[Page 59565]]

12 minutes (73 percent reduction); however, the RUC-recommended work 
RVU was instead increasing from 0.01 to 0.77. We recognized that CPT 
code 93562 is another unusual case, as it is also shifting from 0-day 
global status to add-on code status, and the current work RVU of 0.01 
is a decrease from the code's former valuation of 0.16 following the 
removal of moderate sedation in the CY 2017 rule cycle. However, when 
the work time for a code is going down and the unit of service is being 
reduced, we typically would not expect to see a work RVU increase under 
these circumstances, and especially not such a large work RVU increase. 
Therefore, we proposed instead to apply the intraservice time ratio 
from CPT code 93561, for a ratio of 0.80 (12 minutes divided by 15 
minutes) multiplied by the proposed work RVU of 0.60 for CPT code 
93561, which results in the proposed work RVU of 0.48 for CPT code 
93562. We noted that the RUC-recommended work values also line up 
according to the same intraservice time ratio, with the recommended 
work RVU of 0.77 for CPT code 93562 existing in a ratio of 0.81 with 
the recommended work RVU of 0.95 for CPT code 93561. We believe that 
this provides further rationale for our proposal to value the work RVU 
of CPT code 93562 at 80 percent of the work RVU of CPT code 93561.
    There are no recommended direct PE inputs for the codes in this 
family and we did not propose any direct PE inputs.
    The following is a summary of the public comments we received on 
our proposals involving the Cardiac Output Measurement family of codes.
    Comment: Commenters stated that there were three intertwined flawed 
assumptions that CMS considered when proposing values for CPT codes 
93561 and 93562, which if finalized would lead to continued 
misvaluation of these services. Commenters stated that the first of 
these flawed assumptions was a comparison of the survey data to Harvard 
data: The current time data for these codes came from the Harvard 
studies, has zero validity and should not be used to compare to current 
valid survey data. Commenters stated that the second of these flawed 
assumptions was a comparison of the recommended physician work RVUs to 
old work RVUs: The negative intensity of these codes confirmed that 
this previous methodology in which the current work RVU was derived 
from is flawed. Commenters stated that the third of these flawed 
assumptions was the use of an intraservice time ratio: This 
inaccurately treated all components of the physician time as having 
identical intensity and is incorrect. Other commenters identified 
changes in the global period from 0-day to add-on status and changes in 
the patient population from adult patients to pediatric patients as a 
rationale for why the increases in valuation were appropriate.
    Many commenters disagreed with the proposed work RVU of 0.60 for 
CPT code 93561 and stated that CMS should finalize the RUC-recommended 
work RVU of 0.95. Commenters disagreed with the CMS crosswalk to CPT 
code 77003, stating that it was not a good crosswalk despite having the 
same intraservice work time. Commenters stated that CPT code 77003 is 
the imaging guidance code for needle placement for the epidural 
injection, and that placing a catheter in the heart and lungs of a 
child is not merely an imaging procedure. Commenters stated that a more 
appropriate injection procedure comparison would be the actual epidural 
injection procedure code, CPT code 62320 (Injection(s), of diagnostic 
or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, 
steroid, other solution), not including neurolytic substances, 
including needle or catheter placement, interlaminar epidural or 
subarachnoid, cervical or thoracic; without imaging guidance) at a work 
RVU of 1.80 or to the top key reference CPT code 93567 (Injection 
procedure during cardiac catheterization including imaging supervision, 
interpretation, and report; for supravalvular aortography) at a work 
RVU of 0.97.
    Many commenters also disagreed with the proposed work RVU of 0.48 
for CPT code 93562 and stated that CMS should finalize the RUC-
recommended work RVU of 0.77. Commenters stated that using an 
incremental approach in lieu of strong crosswalks and input from the 
RUC and physicians providing these services was an unfounded 
methodology. Commenters stated that CMS should rely on the survey data 
instead of the use of an increment, and commenters listed the reference 
codes chosen by the RUC which they stated were more appropriate for 
valuation.
    Response: We appreciate the detailed feedback from the commenters 
regarding CPT Codes 93561 and 93562. We agree with the commenters that 
the proposed crosswalk to CPT code 77003 would result in an 
inappropriately low intensity for CPT code 93561.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVU of 0.95 for CPT code 93561 and the RUC-
recommended work RVU of 0.77 for CPT code 93562. We are also finalizing 
our proposal to have no direct PE inputs for these codes.
(52) Coronary Flow Reserve Measurement (CPT Codes 93571 and 93572)
    CPT code 93571 (Intravascular Doppler velocity and/or pressure 
derived coronary flow reserve measurement (coronary vessel or graft) 
during coronary angiography including pharmacologically induced stress; 
initial vessel) was identified on a list of all services with total 
Medicare utilization of 10,000 or more that have increased by at least 
100 percent from 2009 through 2014. CPT code 93572 (Intravascular 
Doppler velocity and/or pressure derived coronary flow reserve 
measurement (coronary vessel or graft) during coronary angiography 
including pharmacologically induced stress; each additional vessel) was 
also included for review as part of the same family of CPT codes. The 
RUC recommended a work RVU of 1.50 for CPT code 93571, which is lower 
than the current work RVU of 1.80. The total time for this service 
decreased by 5 minutes from 20 minutes to 15 minutes. The RUC's 
recommendation is based on a crosswalk to CPT code 15136 (Dermal 
autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, 
hands, feet, and/or multiple digits; each additional 100 sq cm, or each 
additional 1% of body area of infants and children, or part thereof), 
which has an identical intraservice and total time as CPT code 93571 of 
15 minutes.
    We disagreed with the recommended work RVU of 1.50 for this CPT 
code because we did not believe that a reduction in work RVU from 1.80 
to 1.50 was commensurate with the reduction in time for this service of 
5 minutes. Using the building block methodology, we believed the work 
RVU for CPT code 93571 should be 1.35. We believe that a crosswalk to 
CPT code 61517 (Implantation of brain intracavitary chemotherapy agent 
(List separately in addition to CPT code for primary procedure)) with a 
work RVU of 1.38 was more appropriate because it has an identical 
intraservice and total time (15 minutes) as CPT code 93571, described 
work that is similar, and was closer to the calculations for 
intraservice time ratio, total time ratio, and the building block 
method. Therefore, we proposed a work RVU of 1.38 for CPT code 93571.
    We proposed the RUC-recommended work RVU for CPT code 93572 
(Intravascular Doppler velocity and/or pressure derived coronary flow 
reserve measurement (coronary vessel or graft)

[[Page 59566]]

during coronary angiography including pharmacologically induced stress; 
each additional vessel) of 1.00.
    Both of these codes are facility-only procedures with no 
recommended direct PE inputs.
    The following is a summary of the public comments we received on 
our proposals involving the Coronary Flow Reserve Measurement family of 
codes.
    Comment: We received several comments regarding our proposed work 
RVU of 1.38 for CPT 93571. Commenters generally did not agree with the 
use of time based metrics in our assessment of the work RVU for this 
code. In particular, they opposed CMS's reduction of work RVUs in 
proportion to the total reduction in time for furnishing this service. 
This methodology, they maintain, ignores the fact that the time 
reduction of 5 minutes in furnishing this service is associated with 
the low intensity portion of the work.
    Response: We do not agree that a reduction in work RVU proportional 
to the total time decrease for this code, which has essentially only 
one time parameter since the intraservice time and total time are the 
same, is not appropriate. We continue to believe that this calculated 
value of 1.35 (a 75 percent reduction in both time and work RVU) 
accounts more appropriately for the reduction in time for a service in 
which the work to perform the service has not changed. We therefore 
continue to believe that our crosswalk to CPT code 61517 is similar in 
both work and time to CPT code 93571, and we are finalizing our 
proposed work RVU for CPT code 93571 of 1.38.
    Comment: We received support from commenters regarding our proposed 
work RVU of 1.00 for CPT code 93572.
    Response: We appreciate the support and are finalizing a work RVU 
of 1.00 for CPT code 93572 as proposed.
    After consideration of the public comments, we are finalizing the 
work RVUs for the codes in the Coronary Flow Reserve Measurement family 
of codes as proposed.
(53) Peripheral Artery Disease (PAD) Rehabilitation (CPT Code 93668)
    During 2017, we issued a national coverage determination (NCD) for 
Medicare coverage of supervised exercise therapy (SET) for the 
treatment of peripheral artery disease (PAD). Previously, the service 
had been assigned noncovered status under the PFS. CPT code 93668 
(Peripheral arterial disease (PAD) rehabilitation, per session) was 
payable before the end of CY 2017, retroactive to the effective date of 
the NCD (May 25, 2017), and for CY 2018, CMS made payment for Medicare-
covered SET for the treatment of PAD, consistent with the NCD, reported 
with CPT code 93668. We used the most recent RUC-recommended work and 
direct PE inputs and requested that the RUC review the service, which 
had not been reviewed since 2001, for direct PE inputs. The RUC did not 
recommend a work RVU for CPT code 93668 due to the belief that there is 
no physician work involved in this service. After reviewing this code, 
we proposed a work RVU of 0.00 for CPT code 93668 and proposed to 
continue valuing the code for PE only.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 93688.
    Comment: Commenters were supportive of our proposal of the RUC-
recommended work RVUs and PE inputs.
    Response: We thank commenters for their support.
    Comment: Several commenters noted that the proposed reductions in 
payment would impact their ability to perform the service in an office 
setting and that this would force them to perform the service in a 
hospital setting. They further noted that this would ultimately 
increase costs and impact patient satisfaction as well as impact their 
ability to provide the service to rural and under insured patients.
    Response: We appreciate the feedback these commenters provided. We 
note that we accepted the RUC-recommended work RVU of 0.00 and the RUC-
recommended direct PE inputs without refinements for CPT code 93668. We 
further note that the RUC has generally provided recommendations on 
work, work time, and direct PE inputs. We do not believe that the work 
or direct PE inputs assigned to these services are inaccurate. We 
further note that if commenters believe an additional RUC review would 
serve to address the issues they identified in our proposal, we would 
consider this information or recommendations from other interested 
stakeholders for future rulemaking.
    After consideration of the public comments received, we are 
finalizing the RUC-recommended work RVUs and direct PE inputs for CPT 
code 93668 as proposed.
(54) Home Sleep Apnea Testing (CPT Codes 95800, 95801, and 95806)
    CPT codes 95800 (Sleep study, unattended, simultaneous recording; 
heart rate, oxygen saturation, respiratory analysis (e.g., by airflow 
or peripheral arterial tone), and sleep time), 95801 (Sleep study, 
unattended, simultaneous recording; minimum of heart rate, oxygen 
saturation, and respiratory analysis (e.g., by airflow or peripheral 
arterial tone)), and 95806 (Sleep study, unattended, simultaneous 
recording of, heart rate, oxygen saturation, respiratory airflow, and 
respiratory effort (e.g., thoracoabdominal movement)) were flagged by 
the CPT Editorial Panel and reviewed at the October 2014 Relativity 
Assessment Workgroup meeting. Due to rapid growth in service volume, 
the RUC recommended that these services be reviewed after 2 more years 
of Medicare utilization data (2014 and 2015 data). These three codes 
were surveyed for the April 2017 RUC meeting and new recommendations 
for work and direct PE inputs were submitted to CMS.
    For CPT code 95800, the RUC recommended a work RVU of 1.00 based on 
the survey 25th percentile value. We disagreed with the recommended 
value and proposed a work RVU of 0.85 based on a pair of crosswalk 
codes: CPT code 93281 (Programming device evaluation (in person) with 
iterative adjustment of the implantable device to test the function of 
the device and select optimal permanent programmed values with 
analysis, review and report by a physician or other qualified health 
care professional; multiple lead pacemaker system) and CPT code 93260 
(Programming device evaluation (in person) with iterative adjustment of 
the implantable device to test the function of the device and select 
optimal permanent programmed values with analysis, review and report by 
a physician or other qualified health care professional; implantable 
subcutaneous lead defibrillator system). Both of these codes have a 
work RVU of 0.85, as well as having the same intraservice time of 15 
minutes, similar total times to CPT code 95800, and recent review dates 
within the last few years.
    In reviewing CPT code 95800, we noted that the recommended 
intraservice time is decreasing from 20 minutes to 15 minutes (25 
percent reduction), and the recommended total time is decreasing from 
50 minutes to 31 minutes (38 percent reduction); however, the RUC-
recommended work RVU is only decreasing from 1.05 to 1.00, which is a 
reduction of less than 5 percent. Although we did not imply that the 
decrease in time as reflected in survey values must equate to a one-to-
one or linear decrease in the valuation of work RVUs, we believe that 
since the two components of work are time and intensity, significant 
decreases in time should be reflected in decreases to work RVUs. In the 
case of CPT code 95800, we believe that it would be more accurate to 
propose a work RVU of 0.85

[[Page 59567]]

based on the aforementioned crosswalk codes to account for these 
decreases in the surveyed work time. We also noted that in this case 
where the surveyed times are decreasing and the utilization of CPT code 
95800 is increasingly significantly (quadrupling in the last 5 years), 
we had reason to believe that practitioners are becoming more efficient 
at performing the procedure, which, under the resource-based nature of 
the RVU system, lends further support for a reduction in the work RVU.
    For CPT code 95801, the RUC proposed a work RVU of 1.00 again based 
on the survey 25th percentile. We disagreed with the recommended value 
and we proposed a work RVU of 0.85 based on the same pair of crosswalk 
codes, CPT codes 93281 and 93260. We noted that CPT codes 95800 and 
95801 had identical recommended work RVUs and identical recommended 
survey work times. Given that these two codes also have extremely 
similar work descriptors, we interpreted this to mean that the two 
codes could have the same work RVU, and therefore, we proposed the same 
work RVU of 0.85 for both codes.
    For CPT code 95806, the RUC recommended a work RVU of 1.08 based on 
a crosswalk to CPT code 95819 (Electroencephalogram (EEG); including 
recording awake and asleep). Although we disagreed with the RUC-
recommended work RVU of 1.08, we concurred that the relative difference 
in work between CPT codes 95800 and 95801 and CPT code 95806 was 
equivalent to the recommended interval of 0.08 RVUs. Therefore, we 
proposed a work RVU of 0.93 for CPT code 95806, based on the 
recommended interval of 0.08 additional RVUs above our proposed work 
RVU of 0.85 for CPT codes 95800 and 95801. We also noted that CPT code 
95806 is experiencing a similar change in the recommended work and time 
values comparable to CPT code 95800. The recommended intraservice time 
for CPT code 95806 is decreasing from 25 minutes to 15 minutes (40 
percent), and the recommended total time is decreasing from 50 minutes 
to 31 minutes (38 percent); however, the recommended work RVU is only 
decreasing from 1.25 to 1.08, which is a reduction of only 14 percent. 
As we stated for CPT code 95800, we do not believe that decreases in 
work time must equate to a one-to-one or linear decrease in the 
valuation of work RVUs, but we do believe that these changes in 
surveyed work time suggest that practitioners are becoming more 
efficient at performing the procedure, and that it would be more 
accurate to maintain the recommended work interval with CPT codes 95800 
and 95801 by proposing a work RVU of 0.93 for CPT code 95806.
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving the Home Sleep Apnea Testing family of codes.
    Comment: One commenter stated that the obesity epidemic has 
contributed to the rising prevalence of obstructive sleep apnea, and 
sleep centers have already worked to reduce costs in diagnosis of 
obstructive sleep apnea by utilizing out-of-center, or home, sleep 
apnea testing. The commenter stated that further reduction in work 
RVUs, and hence payments for home sleep apnea testing services, may 
endanger the sustainability of sleep centers to provide this service to 
Medicare beneficiaries and may thus deny beneficiaries access to 
testing for obstructive sleep apnea. A different commenter stated that 
a reduction in work RVUs for home sleep apnea testing services will 
discourage vendors from producing technically better home sleep apnea 
testing devices and software.
    Response: We agree with the commenter regarding the importance of 
sleep centers in helping to diagnose and treat the occurrence of 
obstructive sleep apnea. However, we remind the commenter that we are 
obligated under the statute to consider both time and intensity in 
establishing work RVUs for PFS services. As explained in the CY 2017 
PFS final rule (81 FR 80272 through 80277), we recognize that adjusting 
work RVUs for changes in time is not always a straightforward process, 
so we have applied various methodologies to identify several potential 
work values for individual codes. When the recommended work RVUs do not 
appear to account for significant changes in time, we have employed the 
different approaches to identify potential values that reconcile the 
recommended work RVUs with the recommended time values. For the codes 
in the Home Sleep Apnea Testing family, we believe that the decreases 
in the surveyed work times should be reflected in decreases to the work 
RVUs.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.85 for CPT codes 95800 and 95801, and stated that CMS should finalize 
the RUC-recommended work RVU of 1.00 for these services. Commenters 
stated that it was unclear why CMS chose to employ the crosswalk to CPT 
codes 93281 and 93260, which the commenters stated were not at all 
similar to the home sleep apnea test codes and are cardiovascular 
implantable recording device codes, not diagnostic studies.
    Response: We continue to believe that the nature of the PFS 
relative value system is such that all services are appropriately 
subject to comparisons to one another. Although codes with clinically 
similar services are sometimes stronger comparator codes, we do not 
agree that codes must both constitute diagnostic studies to be used as 
a crosswalk. In the case of our specific crosswalk to CPT codes 93281 
and 93260, we noted in the proposed rule that both of these codes have 
a work RVU of 0.85, as well as having the same intraservice time of 15 
minutes and similar total times to CPT codes 95800 and 95801, and 
recent review dates within the last few years.
    Comment: Several commenters stated that the existing times for CPT 
codes 95800 and 95801 were likely an overestimate due to the lack of 
experience providing these services when they were first valued as new 
codes in April 2010. Commenters stated that physicians are now more 
familiar with home sleep apnea testing and the new survey times were 
more reflective of this family of services.
    Response: This information from the commenters appears to suggest 
that the current work RVUs for CPT codes 95800 and 95801 are also 
overestimates. If practitioners have become more familiar and efficient 
in the practice of home sleep apnea testing, we believe that the work 
RVUs should also be decreased to reflect the fact that the procedures 
can now be performed faster. We remind the commenters that we are 
obligated under the statute to consider both time and intensity in 
establishing work RVUs for PFS services, and we have no reason to 
believe that the intensity of these procedures has increased to the 
point of offsetting these gains in time efficiency.
    Comment: Several commenters stated that, despite the fact that we 
indicated we did not intend to imply that the decrease in time should 
equate to a linear decrease in the valuation of work RVUs, this seems 
to be the approach taken in the proposed rule. Commenters stated that 
modifications to work RVUs should be based on empirical evidence, 
gathered through the survey process, which takes into consideration the 
amount of time required to provide a service as well as the complexity 
and intensity of each service.
    Response: We disagree with the commenters, and we note that the 
proposed work RVUs for both CPT codes 95800 and 95801 were not based on 
pure time ratios on a one-to-one or linear basis. For CPT code 95800, 
use of

[[Page 59568]]

the intraservice time ratio alone would have yielded a work RVU of 0.79 
and the total time ratio would have yielded a work RVU of 0.65. For CPT 
code 95801, use of the intraservice time ratio would have yielded a 
work RVU of 1.00 and the total time ratio would have yielded a work RVU 
of 0.78. We did not propose these values and instead proposed a work 
RVU of 0.85 for both codes specifically because the consideration of 
time ratios is only one component of our review process. We believe 
that our proposed work RVU of 0.85 for these services based on a pair 
of crosswalk codes, CPT codes 93281 and 93260 is appropriate, and note 
that we recognized that the use of pure time ratios at a one-to-one or 
linear basis would not accurately capture the changes in work taking 
place in these codes since their last valuation.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.93 for CPT code 95806, and stated that CMS should finalize the RUC-
recommended work RVU of 1.08. Commenters stated that the survey process 
values a service compared to other similar services, and that using an 
incremental approach in lieu of strong crosswalks and input from the 
RUC and physicians providing these services was unfounded.
    Response: We believe the use of an incremental difference between 
codes is a valid methodology for setting values, especially in valuing 
services within a family of revised codes where it is important to 
maintain appropriate intra-family relativity. Historically, we have 
frequently utilized an incremental methodology in which we value a code 
based upon its incremental difference between another code or another 
family of codes. We note that the RUC has also used the same 
incremental methodology on occasion when it was unable to produce valid 
survey data for a service. We continue to believe that the proposed 
work RVU of 0.93 would be the most accurate valuation for CPT code 
95806.
    Comment: Several commenters stated that CPT code 95806 has become a 
more complex study and requires more time as well as greater levels of 
skill and training to perform the interpretation for this study. 
Commenters stated that more complex patients with a wider variety of 
sleep problems and more severe conditions are being studied with this 
modality, which means that the skills and continuing updates to 
education required to interpret these studies have dramatically 
increased.
    Response: We agree with the commenters that due to the decreasing 
surveyed work times and rapidly increasing utilization for these codes, 
we had reason to believe that practitioners are becoming more efficient 
at performing the procedure. While the incorporation of new technology 
can sometimes make services more complex and difficult to perform, it 
can also have the opposite effect by making services less reliant on 
manual skill and technique. We do not agree with the commenter that the 
need for additional training to use the equipment would necessarily be 
grounds for an increase in the work RVU, as improvements in technology 
are commonplace across many different services and are not specific to 
this procedure. As detailed above, we also have reason to believe that 
the improved technology has led to greater efficiencies in the 
procedure which, under the resource-based nature of the RVU system, 
lends further support for a reduction in the work RVU.
    After consideration of the public comments, we are finalizing the 
work RVUs and the direct PE inputs for the codes in the Home Sleep 
Apnea Testing family of codes as proposed.
(55) Neurostimulator Services (CPT Codes 95970, 95976, 95977, 95983, 
and 95984)
    In October 2013, CPT code 95971 (Electronic analysis of implanted 
neurostimulator pulse generator system; simple spinal cord, or 
peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular) 
neurostimulator pulse generator/transmitter, with intraoperative or 
subsequent programming) was identified in the second iteration of the 
High Volume Growth screen. In January 2014, the RUC recommended that 
CPT codes 95971, 95972 (Electronic analysis of implanted 
neurostimulator pulse generator system; complex spinal cord, or 
peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular) 
(except cranial nerve) neurostimulator pulse generator/transmitter, 
with intraoperative or subsequent programming) and 95974 (Electronic 
analysis of implanted neurostimulator pulse generator system; complex 
cranial nerve neurostimulator pulse generator/transmitter, with 
intraoperative or subsequent programming, with or without nerve 
interface testing, first hour) be referred to the CPT Editorial Panel 
to address the entire family regarding the time referenced in the CPT 
code descriptors. In June 2017, the CPT Editorial Panel revised CPT 
codes 95970, 95971, and 95972, deleted CPT codes 95974, 95975 
(Electronic analysis of implanted neurostimulator pulse generator 
system; complex cranial nerve neurostimulator pulse generator/
transmitter, with intraoperative or subsequent programming, each 
additional 30 minutes after first hour), 95978 (Electronic analysis of 
implanted neurostimulator pulse generator system, complex deep brain 
neurostimulator pulse generator/transmitter, with initial or subsequent 
programming; first hour), and 95979 (Electronic analysis of implanted 
neurostimulator pulse generator system, complex deep brain 
neurostimulator pulse generator/transmitter, with initial or subsequent 
programming; each additional 30 minutes after first hour) and created 
four new CPT codes for analysis and programming of implanted cranial 
nerve neurostimulator pulse generator, analysis, and programming of 
brain neurostimulator pulse generator systems and analysis of stored 
neurophysiology recording data.
    The RUC recommended a work RVU of 0.45 for CPT code 95970 
(Electronic analysis of implanted neurostimulator pulse generator/
transmitter (e.g., contact group(s),interleaving, amplitude, pulse 
width, frequency (Hz), on/off cycling, burst, magnet mode, dose 
lockout, patient selectable parameters, responsive neurostimulation, 
detection algorithms, closed loop parameters, and passive parameters by 
physician or other qualified health care professional; with brain, 
cranial nerve, spinal cord, peripheral nerve, or sacral nerve 
neurostimulator pulse generator/transmitter, without programming)), 
which is identical to the current work RVU for this CPT code. The 
descriptor for this CPT code has been modified slightly, but the 
specialty societies affirmed that the work itself has not changed. To 
justify its recommendation, the RUC provided two references: CPT code 
62368 (Electronic analysis of programmable, implanted pump for 
intrathecal or epidural drug infusion (includes evaluation of reservoir 
status, alarm status, drug prescription status); with reprogramming), 
with intraservice time of 15 minutes, total time of 27 minutes, and a 
work RVU of 0.67; and CPT code 99213 (Office or other outpatient visit 
for the evaluation and management of an established patient, which 
requires at least 2 of these 3 key components: An expanded problem 
focused history; An expanded problem focused examination; or Medical 
decision making of low complexity. Counseling and coordination of care 
with other physicians, other qualified health care professionals, or 
agencies are provided consistent with the nature of the problem(s) and 
the patient's and/or family's needs. Usually, the

[[Page 59569]]

presenting problem(s) are of low to moderate severity. Typically, 15 
minutes are spent face-to-face with the patient and/or family), with 
intraservice time of 15 minutes, total time of 23 minutes, and a work 
RVU of 0.97.
    We disagreed with the RUC's recommendation because we did not 
believe that maintaining the work RVU, given a decrease of four minutes 
in total time, was appropriate. In addition, we noted that the 
reference CPT codes chosen have much higher intraservice and total 
times than CPT code 95970, and also have higher work RVUs, making them 
poor comparisons. Instead, we identified a crosswalk to CPT code 95930 
(Visual evoked potential (VEP) checkerboard or flash testing, central 
nervous system except glaucoma, with interpretation and report) with 10 
minutes intraservice time, 14 minutes total time, and a work RVU of 
0.35. Therefore, we proposed a work RVU of 0.35 for CPT code 95970.
    CPT code 95976 (Electronic analysis of implanted neurostimulator 
pulse generator/transmitter (e.g., contact group(s), interleaving, 
amplitude, pulse width, frequency (Hz), on/off cycling, burst, magnet 
mode, dose lockout, patient selectable parameters, responsive 
neurostimulation, detection algorithms, closed loop parameters, and 
passive parameters) by physician or other qualified health care 
professional; with simple cranial nerve neurostimulator pulse 
generator/transmitter programming by physician or other qualified 
health care professional) is a new CPT code replacing CPT code 95974 
(Electronic analysis of implanted neurostimulator pulse generator 
system (e.g., rate, pulse amplitude, pulse duration, configuration of 
wave form, battery status, electrode selectability, output modulation, 
cycling, impedance and patient compliance measurements); complex 
cranial nerve neurostimulator pulse generator/transmitter, with 
intraoperative or subsequent programming, with or without nerve 
interface testing, first hour). The description of the work involved in 
furnishing CPT code 95976 differs from that of the deleted CPT code in 
a few important ways, notably that the time parameter has been removed 
so that the CPT code no longer describes the first hour of programming. 
In addition, the new CPT code refers to simple rather than complex 
programming. Accordingly, the intraservice and total times for this CPT 
code are substantively different from those of the deleted CPT code. 
CPT code 95976 has an intraservice time of 11 minutes and a total time 
of 24 minutes, while CPT code 95974 has an intraservice time of 60 
minutes and a total time of 110 minutes. The RUC recommended a work RVU 
of 0.95 for CPT code 95976. The RUC's top reference CPT code as chosen 
by the RUC survey participants was CPT code 95816 (Electroencephalogram 
(EEG); including recording awake and drowsy), with an intraservice time 
of 15 minutes, 26 minutes total time, and a work RVU of 1.08. The RUC 
indicated that the service is similar, but somewhat more complex than 
CPT code 95976.
    We disagreed with the RUC's recommended work RVU for this CPT code 
because we did not believe that the large difference in time between 
the new CPT code and CPT code 95974 was reflected in the slightly 
smaller proportional decrease in work RVUs. The reduction in total 
time, from 110 minutes to 24 minutes is nearly 80 percent. However, the 
RUC's recommended work RVU reflects a reduction of just under 70 
percent. We believe that a more appropriate crosswalk would be CPT code 
76641 (Ultrasound, breast, unilateral, real time with image 
documentation, including axilla when performed; complete) with 
intraservice time of 12 minutes, total time of 22 minutes, and a work 
RVU of 0.73. Therefore, we proposed a work RVU of 0.73 for CPT code 
95976.
    CPT code 95977 describes the same work as CPT code 95976, but with 
complex rather than simple programming. The CPT Editorial Panel refers 
to simple programming of a neurostimulator pulse generator/transmitter 
as the adjustment of one to three parameter(s), while complex 
programming includes adjustment of more than three parameters. For 
purposes of applying the building block methodology and calculating 
intraservice and total time ratios, the RUC compared CPT code 94X84 
with CPT code 95975 (Electronic analysis of implanted neurostimulator 
pulse generator system (e.g., rate, pulse amplitude, pulse duration, 
configuration of wave form, battery status, electrode selectability, 
output modulation, cycling, impedance and patient compliance 
measurements); complex cranial nerve neurostimulator pulse generator/
transmitter, with intraoperative or subsequent programming, each 
additional 30 minutes after first hour), which is being deleted by the 
CPT Editorial Panel. We believe that this was an inappropriate 
comparison since it is time based (first hour of programming) and is an 
add-on code. Instead we believe that the RUC intended to compare CPT 
code 95977 with CPT code 95974 (Electronic analysis of implanted 
neurostimulator pulse generator system (e.g., rate, pulse amplitude, 
pulse duration, configuration of wave form, battery status, electrode 
selectability, output modulation, cycling, impedance and patient 
compliance measurements); complex cranial nerve neurostimulator pulse 
generator/transmitter, with intraoperative or subsequent programming, 
with or without nerve interface testing, first hour), which has been 
recommended for deletion by the CPT Editorial Panel and is also the 
comparison for CPT code 95976. The RUC recommended a work RVU of 1.19 
for CPT code 95977. The RUC disagreed with the two top reference 
services CPT code 99215 (Office or other outpatient visit for the 
evaluation and management of an established patient, which requires at 
least 2 of these 3 key components: A comprehensive history; A 
comprehensive examination; or Medical decision making of high 
complexity. Counseling and/or coordination of care with other 
physicians, other qualified health care professionals, or agencies are 
provided consistent with the nature of the problem(s) and the patient's 
and/or family's needs. Usually, the presenting problem(s) are of 
moderate to high severity. Typically, 40 minutes are spent face-to-face 
with the patient and/or family) and CPT code 99202 (Office or other 
outpatient visit for the evaluation and management of a new patient, 
which requires these 3 key components: An expanded problem focused 
history; an expanded problem focused examination; or straightforward 
medical decision making. Counseling and/or coordination of care with 
other physicians, other qualified health care professionals, or 
agencies are provided consistent with the nature of the problem(s) and 
the patient's and/or family's needs. Usually, the presenting problem(s) 
are of low to moderate severity. Typically, 20 minutes are spent face-
to-face with the patient and/or family) and instead compared CPT code 
95977 to CPT code 99308 (Subsequent nursing facility care, per day, for 
the evaluation and management of a patient, which requires at least 2 
of these 3 key components: An expanded problem focused interval 
history; An expanded problem focused examination; or Medical decision 
making of low complexity. Counseling and/or coordination of care with 
other physicians, other qualified health care professionals, or 
agencies are provided consistent with the nature of the problem(s) and 
the patient's and/or family's needs. Usually, the patient is responding 
inadequately to therapy or has developed a minor complication.

[[Page 59570]]

Typically, 15 minutes are spent at the bedside and on the patient's 
facility floor or unit.) with total time of 31 minutes, intraservice 
time of 15 minutes, and a work RVU of 1.16; and CPT code 12013 (Simple 
repair of superficial wounds of face, ears, eyelids, nose, lips and/or 
mucous membranes; 2.6 cm to 5.0 cm), with total time of 27 minutes, 
intraservice time of 15 minutes, and a work RVU of 1.22.
    We disagreed with the RUC's recommended work RVU of 1.19 for CPT 
code 95977. Once the comparison CPT code is corrected to CPT code 
95974, the reverse building block calculation indicates that a lower 
work RVU (close to 0.82) would be a better reflection of the work 
involved in furnishing this service. As an alternative to the RUC's 
recommendation, we added the difference in RUC-recommended work RVUs 
between CPT codes 95976 and 95977 (0.24 RVUs) to the proposed work RVU 
of 0.73 for CPT code 95976. Therefore, we proposed a work RVU of 0.97 
for CPT code 95977.
    CPT code 95983 (Electronic analysis of implanted neurostimulator 
pulse generator/transmitter (e.g., contact group(s), interleaving, 
amplitude, pulse width, frequency (Hz), on/off cycling, burst, magnet 
mode, doe lockout, patient selectable parameters, responsive 
neurostimulation, detection algorithms, closed loop parameters, and 
passive parameters) by physician or other qualified health care 
professional; with brain neurostimulator pulse generator/transmitter 
programming, first 15 minutes face-to-face time with physician or other 
qualified health care professional) is the base code for add-on CPT 
code 95984 (Electronic analysis of implanted neurostimulator pulse 
generator/transmitter (e.g., contact group(s), interleaving, amplitude, 
pulse width, frequency (Hz), on/off cycling, burst, magnet mode, doe 
lockout, patient selectable parameters, responsive neurostimulation, 
detection algorithms, closed loop parameters, and passive parameters) 
by physician or other qualified health care professional; with brain 
neurostimulator pulse generator/transmitter programming, each 
additional 15 minutes face-to-face time with physician or other 
qualified health care professional), which is an add-on CPT code and 
can only be billed with CPT code 95983. The RUC compared CPT code 95983 
with CPT code 95978 (Electronic analysis of implanted neurostimulator 
pulse generator system (e.g., rate, pulse amplitude and duration, 
battery status, electrode selectability and polarity, impedance and 
patient compliance measurements), complex deep brain neurostimulator 
pulse generator/transmitter, with initial or subsequent programming; 
first hour), which the CPT Editorial Panel is recommending for 
deletion. The primary distinction between the new and old CPT codes is 
that the new CPT code describes the first 15 minutes of programming 
while the deleted CPT code describes up to one hour of programming. The 
RUC recommended a work RVU of 1.25 for CPT code 95983 and a work RVU of 
1.00 for CPT code 95984. For CPT code 95983, the RUC's recommendation 
is based on reference CPT codes 12013 (Simple repair of superficial 
wounds of face, ears, eyelids, nose, lips and/or mucous membranes; 2.6 
cm to 5.0 cm), with total time of 27 minutes, intraservice time of 15 
minutes, and a work RVU of 1.22; and CPT code 70470 (Computed 
tomography, head or brain; without contrast material, followed by 
contrast material(s) and further sections) with 25 minutes of total 
time, 15 minutes of intraservice time, and a work RVU of 1.27.
    We disagreed with the RUC's recommended work RVU for CPT code 95983 
because we did not believe that the reduction in work RVU reflected the 
change in time described by the CPT code. Using the reverse building 
block methodology, we estimated that a work RVU of nearer to 1.11 would 
be more appropriate. In addition, if we were to sum the RUC-recommended 
RVUs for a single hour of programming using one of the base CPT codes 
and three of the 15 minute follow-on CPT codes, 1 hour of programming 
would be valued at 4.25 work RVUs. This contrasts sharply from the work 
RVU of 3.50 for 1 hour of programming using the deleted CPT code 95978. 
We believe that a more appropriate valuation of the work involved in 
furnishing this service is reflected by a crosswalk to CPT code 93886 
(Transcranial Doppler study of the intracranial arteries; complete 
study), with total time 27 minutes, intraservice time of 17 minutes, 
and a work RVU of 0.91. Therefore, we proposed a work RVU of 0.91 for 
CPT code 95983.
    The RUC's recommended work RVU of 1.00 for CPT code 95984 is based 
on the key reference service CPT code 64645 (Chemodenervation of one 
extremity; each additional extremity, 5 or more muscles), which has 
total time of 26 minutes, intraservice time of 25 minutes, and a work 
RVU 1.39. This new CPT code is replacing CPT code 95978 (Electronic 
analysis of implanted neurostimulator pulse generator system (e.g., 
rate, pulse amplitude and duration, battery status, electrode 
selectability and polarity, impedance and patient compliance 
measurements), complex deep brain neurostimulator pulse generator/
transmitter, with initial or subsequent programming; first hour), which 
is being deleted by the CPT Editorial Panel. If we were to add the 
incremental difference between CPT codes 95983 and 95984 to the 
proposed value for the base CPT code (95983, work RVU = 0.91), we 
estimated that this add-on CPT code would have a work RVU of 0.75. The 
building block methodology results in a recommendation of a slightly 
higher work RVU of 0.82. We proposed a work RVU of 0.80 for CPT code 
95984, which falls between the calculated value using incremental 
differences and the calculation from the reverse building block, and is 
supported by a crosswalk to CPT code 51797 (Voiding pressure studies, 
intra-abdominal (ie, rectal, gastric, intraperitoneal)), which is an 
add-on CPT code with identical total and intraservice times (15 
minutes) as CPT code 95984.
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving the Neurostimulator Services family of codes.
    Comment: We received a number of comments regarding our proposed 
work RVUs for CPT codes 95970, 95976, 95977, 95983, and 95984. 
Commenters suggested that CMS misunderstood the role of reference codes 
in the RUC's process, and that CMS should not be comparing the times 
for the surveyed code to the reference codes because they are not 
specifically intended to match in time.
    Response: We appreciate the opportunity to clarify that we do not 
believe the reference codes provided by the RUC in the summary 
documents are being provided as a crosswalk. We did not state that we 
thought the two top reference codes, CPT code 62368 (total time of 27 
minutes) and CPT code 99213 (total time of 23 minutes) were being used 
by the RUC as crosswalk codes (as that term is used in the RUC 
process). Instead, we pointed out that the two reference codes are 
generally not a particularly good comparison for a survey code with 15 
minutes of total time. We understand that survey respondents, not the 
RUC, chose the reference codes, and that survey respondents do not have 
the physician times readily available when choosing from among services 
that they are familiar with. Nonetheless, we expect reference codes to 
generally have physician work times that are more similar to the survey 
code than an 80 percent difference (in the case of CPT

[[Page 59571]]

code 62368). When we make such an observation with regard to the times 
for reference codes in relation to a survey code, we are not 
disregarding parameters other than time. We also note that the RUC 
compares reference codes in terms of time or intensity relative to the 
survey code as a matter of common practice. We understand those 
comparisons to be intended by the RUC as one of several dimensions of a 
code's work RVU valuation.
    As we have stated in the past, we believe that practitioners become 
more efficient at furnishing some services over time, shortening the 
amount of clinical time required. We still believe this is the case 
with regard to CPT code 95970, which has decreased in time without a 
significant change in intensity. We maintain that our crosswalk to CPT 
code 95930 with a work RVU of 0.35 for this CPT code is appropriate.
    Comment: A commenter stated that, since CMS acknowledges that CPT 
code 95976 is different from CPT code 95974, which is being deleted, 
CMS should not compare the two codes for purpose of evaluating whether 
the decreased work time in the new code is appropriate in relation to 
the work involved in furnishing CPT code 95930. The commenter urged CMS 
to finalize the work RVU proposed by the RUC, which is 0.95.
    Response: The major difference in the description of work involved 
in furnishing CPT code 95974 and CPT code 95976 involves a change from 
`complex' to `simple' programming. We do not believe that this change, 
which indicates a lower level of intensity for new CPT code 95976 than 
for deleted CPT code 95974, precludes us from using the deleted CPT 
code as the basis for evaluating whether the comparatively lower time 
involved in furnishing CPT code 95976 is adequately reflected by the 
RUC-recommended work RVU for this new CPT code. We continue to believe 
that the lower time in furnishing the work described by CPT code 95976, 
compared with the time in furnishing the service described by deleted 
CPT code 95974, should result in a lower work RVU than the value 
recommended by the RUC. Therefore, we are finalizing the work RVU for 
CPT code 95976 of 0.73 based on a crosswalk to CPT code 76641.
    Comment: A commenter clarified that we incorrectly stated that the 
RUC compared the new CPT code 95977 with deleted CPT code 95975, which 
is an add-on code and would therefore not be an acceptable point of 
comparison.
    Response: We appreciate the commenter informing us of the error and 
we agree that the RUC did not compare CPT code 95977 with the deleted 
code, CPT code 95975. Instead, the RUC compared the new code with 
several other codes: CPT code 99308 (Subsequent nursing facility care, 
per day, for the evaluation and management of a patient) with a work 
RVU of 1.16, 15 minutes of intra-service time and 31 minutes total time 
and CPT code 12013 (Simple repair of superficial wounds of face, ears, 
eyelids, nose, lips and/or mucous membranes; 2.6 cm to 5.0 cm) with a 
work RVU of 1.22, 15 minutes of intra-service time and 27 minutes total 
time. The RUC also cited the following two CPT codes for support: CPT 
code 93975 (Duplex scan of arterial inflow and venous outflow of 
abdominal, pelvic, scrotal contents and/or retroperitoneal organs; 
complete study) with a work RVU of 1.16, 20 minutes of intra-service 
time and 30 minutes total time, and 67810 (Incisional biopsy of eyelid 
skin including lid margin), with a work RVU of 1.18, 13 minutes of 
intra-service time and 27 minutes total time. Despite having cited 
these numerous CPT codes as support for their recommended work RVU for 
CPT code 95977, we do not see why CPT code 95974 is not an entirely 
appropriate point of comparison for CPT code 95977 as we explained in 
making our proposal. The only difference between new CPT code 95977 and 
new CPT code 95976 is complex vs. simple programming and, since as we 
explained in response to comments above, we believe it is appropriate 
to use the deleted CPT code 95974 for a time comparison with CPT code 
95976, we believe that code is equally valid as the basis for 
comparison to CPT code 95977. The building block methodology between 
CPT code 95977 and CPT code 95974 suggests that a work RVU in the area 
of 0.82 would better reflect both the time and intensity of furnishing 
this service. In identifying a more appropriate work RVU, we looked at 
the difference in the RUC-recommended work RVU between CPT codes 95976 
and 95977, which differ by simple vs. complex programming, and added 
the increment to our proposed value for CPT code 95976. We continue to 
believe the use of an incremental difference between codes is a valid 
methodology for setting values, especially in valuing services within a 
family of revised codes where it is important to maintain appropriate 
intra-family relativity. Given that we are finalizing our proposed work 
RVU for CPT code 95976 of 0.73, we believe a work RVU of 0.97 for CPT 
code 95977 is appropriate. We are finalizing a work RVU of 0.97 for CPT 
code 95977 as proposed.
    Comment: A commenter expressed opposition to our use of the reverse 
building block methodology to evaluate the RUC-recommended work RVU for 
CPT code 95983 and to identify possible alternative crosswalk CPT 
codes. Consequently, the commenter stated that our crosswalk of CPT 
code 93886 is based on invalid reasoning about how the time parameter 
factors into the code valuation. The work involved in furnishing the 
service described by the crosswalk code, according to the commenter, is 
less intense than the work described by the survey code.
    Response: We disagree with the commenter that the reverse building 
block methodology not an appropriate approach to assessing whether the 
RUC-recommended work RVU for a code is appropriate. We employed a 
reverse building block methodology to assess the reasonableness of the 
RUC's recommendation, not to value the code in the first instance. As 
the commenter noted, the work described by new CPT code 95983 is 
difficult to value in relation to both the deleted code and other codes 
on the fee schedule because of the 15 minute time parameter. However, 
having looked carefully at the work involved in furnishing the service 
described by our crosswalk code, CPT code 93886, we do not believe it 
is less intense than the survey code. The service described by CPT code 
93886 is performed on patients with recent brain hemorrhage, which we 
believe is as complex to study as the work involved in programming 
adjustments to multiple parameters in real time. We continue to believe 
that CPT code 93886 is an appropriate crosswalk for CPT code 95983, and 
we are finalizing a work RVU for this code of 0.91.
    Comment: A commenter stated that our approach for valuing CPT code 
95984 ignored physician work intensity and complexity in favor of a 
random calculation involving code increments, which is a flawed 
methodology. CMS's choice of crosswalk code, according to the 
commenter, is invalid because it is based on this incorrect approach.
    Response: We disagree that the use of incremental differences in 
work RVU between codes that have an established pattern of intensity or 
time, is inappropriate. We remind the commenter that our calculation of 
increments is based on the RUC's recommended work RVUs for the relevant 
CPT codes. We continue to believe that this approach is necessary to 
maintain intra-family relativity of the PFS, and we maintain that CPT 
code 51797 is an appropriate crosswalk to the

[[Page 59572]]

add-on CPT code 95984. We are finalizing a work RVU for CPT 95984 of 
0.80.
    Comment: One commenter stated that CMS reduced the nonfacility 
service cost for clinical labor for CPT code 95970 to zero. The 
commenter stated that this may be a potential oversight, given that the 
RUC recommended nonfacility clinical labor time be reduced from 44 to 
15 minutes. The commenter stated that it was not consistent for CMS to 
recommend a nonfacility service cost of zero in light of the 
nonfacility exam table (EF023) equipment time of 15 minutes, and that 
this clinical labor should still be reflected in this service.
    Response: We disagree with the commenter and note that the RUC did 
not recommend any clinical labor time for CPT code 95970, as we 
proposed the RUC-recommended direct PE inputs without refinement. We 
believe that the equipment time assigned for the exam table (EF023) and 
the neurostimulator programmer (EQ209) indicate that these equipment 
items are in use by the practitioner and not the clinical staff.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Neurostimulator 
Services family of codes as proposed.
(56) Psychological and Neuropsychological Testing (CPT Codes 96105, 
96110, 96116, 96125, 96127, 96112, 96113, 96121, 96130, 96131, 96132, 
96133, 96136, 96137, 9613896138, 96139, 96X11, and 96146)
    In CY 2016, the Psychological and Neuropsychological Testing family 
of codes were identified as potentially misvalued using a high 
expenditure services screen across specialties with Medicare allowed 
charges of $10 million or more. The entire family of codes was referred 
to the CPT Editorial Panel to be revised, as the testing practices had 
been significantly altered by the growth and availability of 
technology, leading to confusion about how to report the codes. In June 
2017, the CPT Editorial Panel revised five existing codes, added 13 
codes to provide better description of psychological and 
neuropsychological testing, and deleted CPT codes 96101, 96102, 96103, 
96111, 96118, 96119, and 96120. The RUC and HCPAC submitted 
recommendations for the 13 new codes and for the existing CPT codes 
96105, 96110, 96116, 96125, and 96127.
    We proposed the RUC- and HCPAC-recommend work RVUs for several of 
the CPT codes in this family: A work RVU of 1.75 for CPT code 96105; a 
work RVU of 1.86 for CPT code 96116; a work RVU of 1.70 for CPT code 
96125; a work RVU of 1.71 for CPT code 96121; a work RVU of 0.55 for 
CPT code 96136; a work RVU of 0.46 for CPT code 96137; and a work RVU 
of 0.51 for CPT code 96X11. CPT codes 96110, 96127, 96138, 96139, and 
96146 were valued by the RUC for PE only.
    This code family contains a subset of codes that describe 
psychological and neuropsychological testing administration and 
evaluation, not including assessment of aphasia, developmental 
screening, or developmental testing. The CPT Editorial Panel's 
recommended coding for this subset of services consists of seven new 
codes: Two that describe either psychological or neuropsychological 
testing when administered by physicians or other qualified health 
professionals (CPT codes 96136 and 96137), and two for either type of 
testing when administered by technicians (CPT codes 96138 and 96139); 
and four new codes that describe testing evaluation by physicians or 
other qualified health care professionals (CPT codes 96130 through 
96133). This new coding effectively unbundles codes that currently 
report the full course of testing into separate codes for testing 
administration (CPT codes 96136, 96137, 96138, and 96139) and 
evaluation (CPT codes 96130, 96131, and 96132). According to a 
stakeholder that represents the psychologist and neuropsychologist 
community, this new coding will result in significant reductions in 
payment for these services due to the unbundling of the testing codes 
into codes for physician-administered tests and technician-administered 
tests. The stakeholder noted that because the new coding includes 
testing codes with zero work RVUs for the technician administered tests 
and the work RVUs are lower than they believe to be accurate, this new 
valuation would ignore the clinical evaluation and decision making 
performed by the physician or other qualified health professional 
during the course of testing administration and evaluation. 
Furthermore, the net result of the code valuations for these new codes 
is a reduction in the overall work RVUs for this family of codes. In 
other words, the stakeholder's analysis found that the RUC 
recommendations result in a reduction in total work RVUs, even though 
the actual physician work of a testing battery has not changed.
    In the interest of payment stability for these high-volume 
services, we proposed to implement work RVUs for this code family, 
which would eliminate the approximately 2 percent reduction in work 
spending. We proposed to achieve work neutrality for this code family 
by scaling the work RVUs upward from the RUC-recommended values so that 
the size of the pool of work RVUs would be essentially unchanged for 
this family of services. Therefore, we proposed: A work RVU of 2.56 for 
CPT code 96112, rather than the RUC-recommended work RVU of 2.50; a 
work RVU of 1.16 for CPT code 96113, rather than the RUC-recommended 
work RVU of 1.10; a work RVU of 2.56 for CPT code 96130, rather than 
the RUC-recommended work RVU of 2.50; a work RVU of 1.96 for CPT code 
96131, rather than the RUC-recommended work RVU of 1.90; a work RVU of 
2.56 for CPT code 96132, rather than the RUC-recommended work RVU of 
2.50; and a work RVU of 1.96 for CPT code 96133, rather than the RUC-
recommended work RVU of 1.90. We saw no evidence that the typical 
practice for these services has changed to merit a reduction in 
valuation of professional services.
    The RUC made several revisions to the recommended direct PE inputs 
for the administration codes from their respective predecessor codes, 
including revisions to quantities of testing forms. For the supply 
item, ``psych testing forms, average'' there is a quantity of 0.10 in 
the predecessor CPT code 96101, and a quantity of 0.33 in the 
predecessor CPT code 96102. For the supply item ``neurobehavioral 
status forms, average,'' there is a quantity of 1.0 in the predecessor 
CPT code 96118 and a quantity of 0.30 for predecessor CPT code 96119, 
and for the supply item ``aphasia assessment forms, average,'' there is 
a quantity of 1.0 in the predecessor CPT code 96118 and a quantity of 
0.30 in predecessor CPT code 96119. The RUC recommendation does not 
include any forms for CPT codes 96132 and 96133. The RUC has replaced 
the corresponding predecessor supply items with new items ``WAIS-IV 
Record Form,'' ``WAIS-IV Response Booklet #1,'' and ``WAIS-IV Response 
Booklet #2,'' and assigned quantities of 0.165 for each of these new 
supply items for CPT codes 96136 through 96139. In our analysis, we 
found that the RUC-recommended direct PE refinements contributed 
significantly to the reduction in the overall payment for this code 
family. We saw no compelling evidence that the quantities of testing 
forms used in a typical course of testing would have been reduced 
dramatically and, in the interest of payment stability, we proposed to 
refine the direct PE inputs for CPT codes 96132 through 96139 by 
including 1.0 quantity each of the supply items ``WAIS-IV Record

[[Page 59573]]

Form,'' ``WAIS-IV Response Booklet #1'', and ``WAIS-IV Response Booklet 
#2.'' We believe that a typical course of testing would involve use of 
one booklet for each of the relevant codes. In addition, these proposed 
refinements would largely mitigate potentially destabilizing payment 
reductions for these services. We solicited comments on our proposed 
work RVUs and proposed PE refinements for this family of services.
    We also proposed to remove the equipment time for the CANTAB Mobile 
(ED055) equipment item from CPT code 96146. This item was listed at 
different points in the recommendations as a supply item with a cost of 
$28 per assessment and as an equipment item for a software license with 
a cost of $2,800 that could be used for up to 100 assessments. We were 
unclear as to how the CANTAB Mobile would typically be used in this 
procedure, and we proposed to remove the equipment time pending the 
submission of more data about the item. We solicited additional 
information about the use of this item and how it should best be 
included into the PE methodology. We were also interested in 
information as to whether the submitted invoice refers to the cost of 
the mobile device itself, or the cost of user licenses for the mobile 
device, which was unclear from the information submitted with the 
recommendations.
    The following is a summary of the comments we received regarding 
our proposed work RVUs and proposed direct PE refinements for this 
family of services.
    Comment: Many commenters supported our proposal to increase payment 
from the RUC recommendations in the interest of payment stability. 
These commenters stated this proposal will help mitigate reductions in 
reimbursement rates for psychologists.
    According to some commenters, some psychologists will see slight 
decreases for neuropsychological testing services due to the new coding 
structure, which they say aligns psychological and neuropsychological 
testing services with other testing services in the program. Some 
commenters said that, due to the new coding structure, reimbursement 
will be lower for neuropsychological evaluation services that are 
provided by physicians than those provided by technicians. These 
commenters stated that physicians should not be reimbursed at a lesser 
rate than EEG or MRI technicians or other physician extenders.
    Response: We note that our proposed values for the evaluation CPT 
codes 96130 through 96133 and the administration and scoring CPT codes 
96136 through 96139 are generally higher for the physician-administered 
codes than for the analogous technician-administered codes. According 
to our proposed rates, however, the valuation of the add-on code for 
each additional 30 minutes of administration and scoring when performed 
by a technician reported with CPT code 96139 is, however, slightly 
higher than the valuation of the add-on code for each additional 30 
minutes of administration and scoring when performed by a physician or 
other qualified health care professional, reported with CPT code 96137. 
We thank commenters for bringing this potential rank-order anomaly to 
our attention. We believe that clinical staff will typically be 
providing some support when the physician or other qualified health 
care professional is performing testing administration as described by 
CPT codes 96136 and 96137. We are therefore refining the direct PE 
inputs for these services by adding 10 minutes of clinical labor time 
for the CA021 clinical labor activity, ``Perform procedure/service--NOT 
directly related to physician work time'' for these codes. We believe 
this will more accurately reflect the clinical staff support that is 
typical when a physician is performing test administration, and it will 
preserve appropriate rank-order among this subset of services, while 
mitigating reductions to payment rates for testing administration 
services.
    Comment: The RUC noted that in the February 5, 2018 RUC submission 
to CMS, the RUC rescinded its interim recommendation from October 2017, 
and stated that CPT code 96X11 is deleted and will not be a CPT code 
for CPT 2019. The RUC recommended that CMS delete this service and work 
RVU recommendation for the 2019 PFS.
    Response: As CPT code 96X11 will not be a CPT code for CY 2019, we 
are deleting this code. Based on the RUC-recommended utilization 
crosswalk, our proposed rates included utilization assumptions that for 
all services currently reported with CPT codes 96103 and 96120, half of 
these services will be reported with the new CPT code 96X11 and half 
will be reported with CPT code 96146. As we are not finalizing 96X11, 
for the purposes of ratesetting, our utilization for these service will 
include the assumption that half of the services currently reported 
with 96103 and 96120 will be reported with CPT code 96136 and half with 
CPT code 96146.
    Comment: A commenter requested clarification on how much time is 
considered typical for the neuropsychologist to perform record review 
and test selection in newly created CPT codes 96132 and 96133.
    Response: For CPT code 96132, we proposed the RUC-recommended 5 
minutes of pre-service work time which reflects activities such as 
preliminary selection of tests and record review. As CPT code 96133 is 
an add-on code for reporting each additional hour, it does not include 
additional pre-service work time, as the latter would be considered to 
be included in the corresponding base code.
    Comment: Several commenters disagreed with the proposal to remove 
the equipment time for the CANTAB Mobile (ED055) equipment item from 
CPT code 96146. Commenters stated that the PE Subcommittee determined 
that this was a software license and it would be more appropriately 
classified as equipment than as a supply. Commenters stated that they 
had submitted paid invoices for two additional software license-based 
automated instruments typically used when furnishing CPT code 96146, 
and that they were resubmitting these same invoices with their comment 
letter.
    Response: We appreciate the feedback from the commenter that the 
CANTAB Mobile (ED055) equipment item referred to a software license. We 
continue to believe that software licenses would typically be 
classified as a form of indirect PE under our methodology, and as a 
result we are finalizing our proposal to remove this equipment time 
from CPT code 96146.
    Comment: A commenter requested clarification on why new CPT codes 
96138, 96139, and 96146 do not include a facility fee, despite the fact 
that their respective source CPT codes 96102, 96119, 96103, and 96120 
do have RVUs in the facility setting.
    Response: The source codes mentioned by the commenter have 
associated work RVUs, while the new CPT codes do not, and they do not 
include physician work time. The new CPT coding effectively unbundles 
professional and technical services for some of these codes. Codes that 
do not have a physician work component would typically not be valued in 
the facility setting.
    After consideration of the public comments, we are finalizing the 
work RVUs for the codes in the Psychological and Neuropsychological 
Testing family of codes as proposed. We are also finalizing the direct 
PE inputs as proposed, with the exception of the refinement to the 
CA021 clinical labor for CPT codes 96136 and 96137 as detailed above.

[[Page 59574]]

(57) Electrocorticography (CPT Code 95836)
    CPT Code 95829 is used for Electrocorticogram performed at the time 
of surgery; however, a new code was needed to account for this non-
face-to-face service for the review of a month's worth or more of 
stored data. CPT code 95836 (Electrocorticogram from an implanted brain 
neurostimulator pulse generator/transmitter, including recording, with 
interpretation and written report, up to 30 days) is a new code 
approved at the September 2017 CPT Editorial Panel Meeting to describe 
this service.
    We disagreed with the RUC-recommended work RVU of 2.30 for CPT code 
95836 and proposed a work RVU of 1.98 based on a direct crosswalk to 
the top reference, CPT code 95957 (Digital analysis of 
electroencephalogram (EEG) (e.g., for epileptic spike analysis)). This 
is a recently-reviewed code with the same intraservice time of 30 
minutes and a total time only 2 minutes lower than CPT code 95836. We 
agreed with the survey respondents that CPT code 95957 was an accurate 
valuation for this new code, and due to the clinically similar nature 
of the two procedures and their near-identical time values, we proposed 
to value both of them at the same work RVU of 1.98.
    The RUC did not recommend, and we did not propose, any direct PE 
inputs for CPT code 95836.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 95836.
    Comment: Many commenters disagreed with the proposed work RVU of 
1.98 for CPT code 95836 and stated that CMS should finalize the RUC-
recommended work RVU of 2.30. Commenters stated that the survey 
respondents chose CPT code 95957 as a reference service and not as a 
direct crosswalk. Commenters stated that the survey respondents pick 
from a list of 10-20 services to use as a comparison and then recommend 
a work RVU based on the intensity, complexity and physician time 
required to perform the surveyed code. Commenters stated that the 
median survey work RVU was actually 2.97, much higher than the key 
reference service, and that the respondents specifically indicated that 
CPT code 95836 is more intense and complex than CPT code 95957 on all 
measures.
    Response: We disagree with the commenters that the key reference 
service of CPT code 95957 would be an inappropriate choice for a direct 
crosswalk, not least because the RUC commonly uses one of the key 
reference services in exactly this fashion. While it is true that the 
median survey work RVU was 2.97, we note that the RUC did not recommend 
this work valuation either, instead choosing to recommend a work RVU of 
2.30 in recognition that the survey median would be a value that is too 
high to maintain relativity. Similarly, while the survey respondents 
specifically indicated that CPT code 95836 is more intense and complex 
than CPT code 95957 on all measures, we note that the survey 
respondents also indicated that CPT code 95836 is more intense and 
complex than the second key reference code, CPT code 95810 
(Polysomnography; age 6 years or older, sleep staging with 4 or more 
additional parameters of sleep, attended by a technologist) which has a 
work RVU of 2.50. We proposed to use a crosswalk to CPT code 95957 not 
only because it was selected by the survey participants as the top key 
reference, but also because it is a recently-reviewed code with the 
same intraservice time of 30 minutes and a total time only 2 minutes 
lower than CPT code 95836. We continue to believe that this is the most 
accurate choice for work valuation.
    Comment: Several commenters stated that although the specialty 
society did not submit any direct PE inputs, it is not a facility only 
code. Commenters stated that CPT code 95836 can be performed in both 
the nonfacility and the facility setting, and that the nonfacility is 
actually the typical setting for this service. Commenters stated that 
they understood that there would be no direct staffing, equipment or 
supply costs associated with this service and that indirect costs would 
be similar regardless of the setting in which the service is performed, 
but there would still be indirect practice expense associated with 
providing the service in the nonfacility. Commenters apologized for the 
misunderstanding and requested that CPT code 95836 should be valued in 
the nonfacility setting.
    Response: We appreciate the additional information supplied by the 
commenters on this issue. We will remove the ``NA'' designation from 
the nonfacility setting for CPT code 95836. Due to the fact that there 
are no direct PE inputs for CPT code 95836, the PE RVU will be the same 
in both the nonfacility and facility settings because it is based 
solely on the indirect PE methodology.
    After consideration of the public comments, we are finalizing the 
work RVU for CPT code 95836 as proposed. We are not finalizing any 
direct PE inputs for this code, but we will value it in both the 
facility and nonfacility settings as noted above.
(58) Chronic Care Remote Physiologic Monitoring (CPT Codes 99453, 
99454, and 99457)
    In the CY 2018 PFS final rule, we finalized separate payment for 
CPT code 99091 (Collection and interpretation of physiologic data 
(e.g., ECG, blood pressure, glucose monitoring) digitally stored and/or 
transmitted by the patient and/or caregiver to the physician or other 
qualified health care professional, qualified by education, training, 
licensure/regulation (when applicable) requiring a minimum of 30 
minutes of time) (82 FR 53014). In that rule, we indicated that there 
would be new coding describing remote monitoring forthcoming from the 
CPT Editorial Panel and the RUC (82 FR 53014). In September 2017, the 
CPT Editorial Panel revised one code and created three new codes to 
describe remote physiologic monitoring and management, and the RUC 
provided valuation recommendations through our standard rulemaking 
process.
    CPT codes 99453 (Remote monitoring of physiologic parameter(s) 
(e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), 
initial; set-up and patient education on use of equipment) and 99454 
(Remote monitoring of physiologic parameter(s) (e.g., weight, blood 
pressure, pulse oximetry, respiratory flow rate), initial; device(s) 
supply with daily recording(s) or programmed alert(s) transmission, 
each 30 days) are both PE-only codes. We proposed the RUC-recommended 
work RVU of 0.61 for CPT code 99457 (Remote physiologic monitoring 
treatment management services, 20 minutes or more of clinical staff/
physician/other qualified healthcare professional time in a calendar 
month requiring interactive communication with the patient/caregiver 
during the month).
    For the direct PE inputs, we proposed to accept the RUC-recommended 
direct PE inputs for CPT code 99453 and to remove the ``Monthly 
cellular and licensing service fee'' supply from CPT code 99454. We do 
not believe that these licensing fees will be allocated to the use of 
an individual patient for an individual service, and instead believe 
they can be better understood as forms of indirect costs similar to 
office rent or administrative expenses. Therefore, we proposed to 
remove this supply input as a form of indirect PE. We proposed the 
direct PE inputs for CPT code 99457 without refinement.
    The following is a summary of the public comments we received on 
our

[[Page 59575]]

proposals involving the Chronic Care Remote Physiologic Monitoring 
family of codes.
    Comment: Commenters were very supportive of CMS making separate 
payment for these services. Several commenters supported the proposal 
of the RUC-recommended work RVU of 0.61 for CPT code 99457. A few 
commenters stated that the proposed rates for these services were too 
low, and that given industry standards, reimbursement should be 
increased.
    Response: We appreciate the support for our proposal from the 
commenters.
    Comment: Several commenters disagreed with the proposal to remove 
the ``Monthly cellular and licensing service fee'' supply from CPT code 
99454. Commenters stated that the monthly cellular and licensing 
service fee was a direct practice expense input as it is allocable to 
the patient for this service. Commenters stated that this fee is not a 
license for the entire practice; rather it is an individually allocable 
fee for the period that the patients is monitored and the physician 
would not incur such fees if the patient did have the wireless monitor. 
Commenters clarified that the fee is comprised of the monthly cost 
associated with encryption of data for safe HIPAA compliant transfer, 
programmed alerts, and the monthly cost of pre-loaded connectivity used 
to transmit patient generated physiological data from a specific 
patient to the provider's software. Commenters stated that reliance 
upon a patient's cellular connectivity or WIFI, which may or may not be 
operating based on patient technology capabilities, was not reliable 
for medical delivery purposes.
    Response: We disagree with the commenters and we continue to 
believe that the monthly cellular and licensing service fee constitutes 
a form of indirect PE. We believe that licensing and data costs are 
administrative costs that are not unique to individual procedures, in 
the same fashion that we do not assign separate direct PE for higher 
electricity costs to diagnostic imaging procedures as compared to 
cognitive evaluation procedures. We continue to believe that these data 
costs are appropriately captured via the indirect PE methodology as 
opposed to being included as a separate direct PE input. We also note 
that other services that require around-the-clock monitoring, such as 
the home PT/INR monitoring described in HCPCS code G0249 (Provision of 
test materials and equipment for home inr monitoring of patient with 
either mechanical heart valve(s), chronic atrial fibrillation, or 
venous thromboembolism who meets Medicare coverage criteria; includes: 
Provision of materials for use in the home and reporting of test 
results to physician; testing not occurring more frequently than once a 
week; testing materials, billing units of service include 4 tests), do 
not include additional direct PE inputs for data costs, and we do not 
believe it would be appropriate to include them for CPT code 99454.
    Comment: One commenter stated that CMS should add the cost of 
equipment sanitation and reprocessing as a one-time cost that is 
directly attributable to a patient. The commenter stated that FDA 
device guidelines require that a reusable medical device be 
reprocessed, which includes sanitation or sterilization and ensuring 
that all personal data is `wiped' or removed from the device. The 
commenter stated that this cost was not considered by the RUC, however, 
it is routinely part of the `set up' costs that are onetime costs 
directly attributable to a patient.
    Response: We disagree with the commenter that these expenses would 
constitute a separate form of direct PE. We agree with the RUC, which 
discussed the specialty society's recommended supply items, shipping 
costs and a device reprocessing fee, and determined that these expenses 
are not specifically allocable to the patient for this service, and 
would be considered indirect practice expenses.
    Comment: One commenter stated that there was direct time spent by 
pharmacists for each patient, and the commenter requested that CMS 
factor pharmacist time into the PE valuation for CPT codes 99453, 
99454, 99091, and 99457.
    Response: We typically do not consider time spent by a pharmacist 
to be a part of the clinical labor time for purposes of direct PE. For 
additional information, we direct readers to the Practice Expense 
portion of this final rule (section II.B. of this final rule).
    Comment: Many commenters pointed out that beneficiary cost sharing 
is a significant barrier to the use of non-face-to-face services, like 
remote patient monitoring. Commenters requested that CMS waive the cost 
sharing requirements for these codes.
    Response: We do not have the authority to make changes to the 
applicable beneficiary cost sharing for most physicians' services, 
including these.
    Comment: Many commenters requested that CMS clarify the kinds of 
technology covered under CPT codes 99453, 99454, and 99457. Commenters 
provided examples of the kinds of technology these codes should cover 
including software applications that could be integrated into a 
beneficiary's smart phone, Holter-Monitors, Fit-Bits, or artificial 
intelligence messaging. One commenter suggested that behavioral health 
data and data from wellness applications be included as well. Another 
commenter stated that the descriptor should include results of 
patients' self-care tasks. Many commenters stated that CMS should 
clarify certain elements in the scope of service and code descriptors 
and issue appropriate sub-regulatory guidance. Commenters inquired as 
to whether CPT code 99453 can be furnished via telecommunication 
technology, if it can be billed again if the number of parameters 
changed in the future. Commenters requested that CMS clarify the 
meaning of ``programmed alerts transmission'' in the descriptor for CPT 
code 99454, and whether it included transmissions that occurred other 
than daily. Commenters also encouraged CMS to allow flexibility in the 
time frame covered by these services.
    Response: We plan to issue guidance to help inform practitioners 
and stakeholders on these issues.
    Comment: Commenters requested that CMS clarify whether CPT code 
99457 can be billed incident to a practitioner's professional services 
and asked that CMS make an exception to the direct supervision 
requirements, stating that general supervision is sufficient for these 
services.
    Response: We note that CPT code 99457 describes professional time 
and therefore cannot be furnished by auxiliary personnel incident to a 
practitioner's professional services.
    Comment: A few commenters suggested that additional medical 
professionals, including pharmacists, paramedics, chiropractors, 
physical therapists, occupational therapists and dentists should be 
allowed to bill Medicare for these services. Other commenters requested 
that CMS clarify the practitioners referred to as ``other qualified 
healthcare professionals'' in the code descriptor.
    Response: We note that all practitioners must practice in 
accordance with applicable state law and scope of practice laws, and 
that some of the practitioners identified by the commenters are not 
authorized to bill Medicare independently for their services. We note 
that the term, ``other qualified healthcare professionals,'' used in 
the code descriptor is a defined by CPT, and that definition can be 
found in the CPT Codebook.
    Comment: A few commenters provided specific suggestions for 
revising the code descriptors, including

[[Page 59576]]

the addition of secure messaging platforms, revision of the time 
thresholds, specifying that the follow-up should be written in all 
instances, including ``for medical consultative discussion and review'' 
in the descriptor for CPT codes 99446 through 99449, and striking 
``referral services'' and rather, including language similar to the 
other codes regarding ``assessment and management'' services. Other 
commenters requested CMS clarify the definition of ``health record 
assessment'' in the descriptors for CPT codes 99451 and 99452. One 
commenter suggested that CMS add language about use of EHR to the 
existing CPT codes, rather than finalize separate payment for CPT codes 
99451 and 99452.
    Response: While we appreciate all of the specific suggestions 
regarding the code descriptions, we defer to the CPT to maintain code 
descriptors for CPT codes. Where additional clarification is needed, we 
may provide guidance in the future.
    Comment: A few commenters urged CMS not to be prescriptive 
regarding the technology that could be used to perform consultations, 
including real-time video, a store-and-forward visit, or simply a 
patient-provider message via a patient portal.
    Response: While we are sympathetic to the commenters' desire not to 
be overly prescriptive about the technology used to furnish these 
services, especially given the speed at which technology evolves, we 
note that we refer to the CPT code descriptors and guidance to 
ascertain the scope of technology that is used to furnish these 
services.
    Comment: One commenter asked whether there were geographic 
restrictions on these services.
    Response: There are no geographic restrictions, as these services 
are not Medicare telehealth services.
    After considering the public comments, we are finalizing the RUC-
recommended work RVU of 0.61 for CPT code 99457 and the direct PE 
inputs for all three codes as proposed.
(59) Interprofessional Internet Consultation (CPT Codes 99451, 99452, 
99446, 99447, 99448, and 99449)
    In September 2017, the CPT Editorial Panel revised four codes and 
created two codes to describe interprofessional telephone/internet/
electronic medical record consultation services. CPT codes 99446 
(Interprofessional telephone/internet assessment and management service 
provided by a consultative physician including a verbal and written 
report to the patient's treating/requesting physician or other 
qualified health care professional; 5-10 minutes of medical 
consultative discussion and review), 99447 (Interprofessional 
telephone/internet assessment and management service provided by a 
consultative physician including a verbal and written report to the 
patient's treating/requesting physician or other qualified health care 
professional; 11-20 minutes of medical consultative discussion and 
review), 99448 (Interprofessional telephone/internet assessment and 
management service provided by a consultative physician including a 
verbal and written report to the patient's treating/requesting 
physician or other qualified health care professional; 21-30 minutes of 
medical consultative discussion and review), and 99449 
(Interprofessional telephone/internet assessment and management service 
provided by a consultative physician including a verbal and written 
report to the patient's treating/requesting physician or other 
qualified health care professional; 31 minutes or more of medical 
consultative discussion and review) describe assessment and management 
services in which a patient's treating physician or other qualified 
healthcare professional requests the opinion and/or treatment advice of 
a physician with specific specialty expertise to assist with the 
diagnosis and/or management of the patient's problem without the need 
for the face-to-face interaction between the patient and the 
consultant. These CPT codes are currently assigned a procedure status 
of B (bundled) and are not separately payable under Medicare. The CPT 
Editorial Panel revised these codes to include electronic health record 
consultations, and the RUC reaffirmed the work RVUs it had previously 
submitted for these codes. We reevaluated the submitted recommendations 
and, in light of changes in medical practice and technology, we 
proposed to change the procedure status for CPT codes 99446, 99447, 
99448, and 99449 from B (bundled) to A (active). We also proposed the 
RUC re-affirmed work RVUs of 0.35 for CPT code 99446, 0.70 for CPT code 
99447, 1.05 for CPT code 99448, and 1.40 for CPT code 99449.
    The CPT Editorial Panel also created two new codes, CPT code 99452 
(Interprofessional telephone/internet/electronic health record referral 
service(s) provided by a treating/requesting physician or qualified 
health care professional, 30 minutes) and CPT code 99451 
(Interprofessional telephone/internet/electronic health record 
assessment and management service provided by a consultative physician 
including a written report to the patient's treating/requesting 
physician or other qualified health care professional, 5 or more 
minutes of medical consultative time). The RUC-recommended work RVUs 
are 0.50 for CPT code 99452 and 0.70 for 99451. Since the CPT code for 
the treating/requesting physician or qualified healthcare professional 
and the CPT code for the consultative physician have similar 
intraservice times, we believe that these CPT codes should have equal 
values for work. Therefore, we proposed a work RVU of 0.50 for both CPT 
codes 99452 and 99451.
    We welcomed comments on this proposal. We also direct readers to 
section II.D. of this final rule, Modernizing Medicare Physician 
Payment by Recognizing Communication Technology-Based Services, which 
includes additional detail regarding our policies for modernizing 
Medicare physician payment by recognizing communication technology-
based services.
    There are no recommended direct PE inputs for the codes in this 
family.
    The following is a summary of the public comments we received on 
our proposals involving the Interprofessional Internet Consultation 
family of codes.
    Comment: Almost all commenters were supportive of CMS' proposal to 
unbundle CPT codes 99446 through 99449 and make separate payment for 
CPT codes 99452 and 99451. Almost all commenters did not support 
lowering the RVU of CPT code 99451 to 0.50 as the work of the 
consulting physician in CPT code 99451 is more intense than the work of 
the treating physician in CPT code 99452. Commenters stated that the 
consulting practitioner exercises greater effort, both in judgment and 
technical skill to make a recommendation for the treatment of a 
previously unknown patient than the treating physician does in 
conveying the relevant information. A few commenters expressed concern 
that the proposed work RVU for CPT code 99452 is too low, and does not 
accurately reflect the resources associated with the work of the 
treating physician.
    Response: We agree with commenters that the work of the consulting 
physician is significant, and we are persuaded by the additional 
descriptions of that work provided by commenters. We also agree with 
the commenters who suggested that the proposed work RVU of 0.50 for CPT 
code 99452 undervalues the work associated with aggregating patient 
information, communicating with the consulting practitioner, and

[[Page 59577]]

implementing the results of the consultation. We continue, however, to 
have concerns regarding the valuation of these services. We note that 
there are instances where the patient would not be new to the 
consulting practitioner, and therefore the intensity of the work would 
be reduced. We are also concerned that, given the similarity of 
intraservice times, CPT code 99452 is undervalued relative to CPT code 
99451, especially since the code descriptor for CPT code 99452 
specifies that the consulting practitioner can spend a minimum of 5 
minutes providing the consultation. We believe that a work RVU of 0.50 
more accurately describes the work associated with both services. Given 
the similarity of intraservice times and the information indicating 
that both codes may be undervalued at 0.50 RVUs, we are finalizing a 
work RVU of 0.70 for CPT codes 99451 and 99452.
    Comment: A few commenters expressed concern that these codes were 
only payable in the facility setting.
    Response: These codes are payable in both facility and non-facility 
settings.
    Comment: One commenter requested that CMS include pharmacists as 
clinical staff in the direct PE.
    Response: We direct readers to the discussion of this issue in the 
PE section of the rule (Section II.B. of this final rule). We also note 
that these codes do not have direct PE inputs.
(60) Chronic Care Management Services (CPT Code 99491)
    In February 2017, the CPT Editorial Panel created a new code to 
describe at least 30 minutes of chronic care management services 
performed personally by the physician or qualified health care 
professional over one calendar month. CMS began making separate payment 
for CPT code 99490 (Chronic care management services, at least 20 
minutes of clinical staff time directed by a physician or other 
qualified health care professional, per calendar month, with the 
following required elements: Multiple (two or more) chronic conditions 
expected to last at least 12 months, or until the death of the patient; 
chronic conditions place the patient at significant risk of death, 
acute exacerbation/decompensation, or functional decline; comprehensive 
care plan established, implemented, revised, or monitored) in CY 2015 
(79 FR 67715). CPT code 99490 describes 20 minutes of clinical staff 
time spent on care management services for patients with 2 or more 
chronic conditions. CPT code 99490 also includes 15 minutes of 
physician time for supervision of clinical staff. For CY 2019, the CPT 
Editorial Panel created CPT code 99491 (Chronic care management 
services, provided personally by a physician or other qualified health 
care professional, at least 30 minutes of physician or other qualified 
health care professional time, per calendar month, with the following 
required elements: Multiple (two or more) chronic conditions expected 
to last at least 12 months, or until the death of the patient, chronic 
conditions place the patient at significant risk of death, acute 
exacerbation/decompensation, or functional decline; comprehensive care 
plan established, implemented, revised, or monitored) to describe 
situations when the billing practitioner is doing the care coordination 
work that is attributed to clinical staff in CPT code 99490. For CPT 
code 99491, the RUC recommended a work RVU of 1.45 for 30 minutes of 
physician time.
    We believe this work RVU overvalues the resource costs associated 
with the physician performing the same care coordination activities 
that are performed by clinical staff in the service described by CPT 
code 99490. Additionally, this valuation of the work is higher than 
that of CPT code 99487 (Complex chronic care management services, with 
the following required elements: Multiple (two or more) chronic 
conditions expected to last at least 12 months, or until the death of 
the patient, chronic conditions place the patient at significant risk 
of death, acute exacerbation/decompensation, or functional decline, 
establishment or substantial revision of a comprehensive care plan, 
moderate or high complexity medical decision making; 60 minutes of 
clinical staff time directed by a physician or other qualified health 
care professional, per calendar month), which includes 60 minutes of 
clinical staff time, creating a rank order anomaly within the family of 
codes if we were to accept the RUC-recommended value.
    CPT code 99490 has a work RVU of 0.61 for 15 minutes of physician 
time. Therefore, as CPT code 99491 describes 30 minutes of physician 
time, we proposed a work RVU of 1.22, which is double the work RVU of 
CPT code 99490.
    We did not propose any direct PE refinements for this code family.
    The following is a summary of the public comments we received on 
our proposals involving CPT code 99491.
    Comment: Almost all commenters recommended that CMS finalize the 
RUC-recommended work value of 1.45 for 99491. The RUC stated that CPT 
code 99491 is different from the existing chronic care management (CCM) 
services codes because those codes are performed by clinical staff 
under the supervision of a physician, while CPT code 99491 is performed 
by the physicians themselves. Commenters also stated that the typical 
patient requiring that the physician personally perform the care 
management services is of greater acuity than the typical patient for 
whom CCM may be performed by clinical staff. Additionally, CPT code 
99491 cannot be reported with CPT code 99490 or CPT code 99487, and 
must therefore account for all of the care management work in the 
month. Commenters also pointed out that there are multiple examples of 
CMS valuing the work of a physician more highly than clinical staff 
when they perform the same services, for example CPT codes 96101 
(Psychological testing (includes psychodiagnostic assessment of 
emotionality, intellectual abilities, personality and psychopathology, 
e.g., MMPI, Rorschach, WAIS), per hour of the psychologist's or 
physician's time, both face-to-face time administering tests to the 
patient and time interpreting these test results and preparing the 
report) and 96102 (Psychological testing (includes psychodiagnostic 
assessment of emotionality, intellectual abilities, personality and 
psychopathology, e.g., MMPI and WAIS), with qualified health care 
professional interpretation and report, administered by technician, per 
hour of technician time, face-to-face.)
    Response: We agree with commenters that a work RVU of 1.45 
accurately captures the resources associated when a physician furnishes 
CCM. We agree that in most cases, the physician would perform CCM on 
patients with higher acuity and therefore the care planning and medical 
decision making would be of greater intensity. We also agree with 
commenters that the work associated with personally performing CCM as 
opposed to supervising clinical staff is also of greater intensity. 
Therefore, we are finalizing that value based on our review of comments 
received.
    Comment: A few commenters requested that CMS clarify that CPT code 
99491 can be performed incident to a practitioner's professional 
services.
    Response: CPT code 99491 is specifically for use when the billing 
practitioner personally performs care management services, so this code 
cannot be furnished incident to a practitioner's professional services.
(61) Diabetes Management Training (HCPCS Codes G0108 and G0109)
    HCPCS codes G0108 (Diabetes outpatient self-management training 
services, individual, per 30 minutes) and G0109 (Diabetes outpatient 
self-

[[Page 59578]]

management training services, group session (2 or more), per 30 
minutes) were identified on a screen of CMS or Other source codes with 
Medicare utilization greater than 100,000 services annually. For CY 
2019, we proposed the HCPAC-recommended work RVU of 0.90 for HCPCS code 
G0108 and the HCPAC-recommended work RVU of 0.25 for HCPCS code G0109.
    For the direct PE inputs, we noted that there was a significant 
disparity between the specialty recommendation and the final 
recommendation submitted by the HCPAC. We were concerned about the 
significant decreases in direct PE inputs in the final recommendation 
when compared to the current makeup of the two codes. The final HCPAC 
recommendation removed a series of different syringes and the patient 
education booklet that currently accompanies the procedure. We believe 
that injection training is part of these services and that the supplies 
associated with that training would typically be included in the 
procedures. Due to these concerns, we proposed to maintain the current 
direct PE inputs for HCPCS codes G0108 and G0109. Therefore, we 
proposed not to add the new supply item ``20x30 inch self-stick easel 
pad, white, 30 sheets/pad'' (SK129) to HCPCS code G0109 that was 
included in the final HCPAC recommendation, as it was not a current 
supply for HCPCS code G0109; however, we proposed to accept the 
submitted invoice price and to add the supply to our direct PE 
database.
    The following is a summary of the public comments we received on 
our proposals involving the Diabetes Management Training family of 
codes.
    Comment: Several commenters supported the proposal of the HCPAC-
recommended work RVUs. Commenters also stated that they applauded CMS 
for recognizing and addressing the significant disparity in direct PE 
inputs between the specialty recommendations and the final 
recommendations submitted to CMS by the HCPAC.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: One commenter expressed disappointment that CMS did not 
address barriers in Medicare that impact beneficiary utilization of the 
diabetes self-management training (DSMT) benefit. The commenter stated 
that CMS solicited comments from stakeholders in the CY 2017 PFS 
proposed rule on this subject, and the commenter has been part of 
ongoing conversations with CMS about this issue, through in-person 
meetings and written communications, over the past two years. The 
commenter stated that they were hopeful CMS would use this opportunity 
to address barriers to DSMT given that utilization of the DSMT benefit 
stands at only 5 percent of eligible Medicare beneficiaries.
    Response: We appreciate the feedback from the commenter, and we 
will consider these issues for future rulemaking. However, we note that 
we did not specifically make any proposals associated with these 
subjects in the CY 2019 proposed rule.
    Comment: One commenter stated that the final HCPAC recommendations 
removed a series of different syringes and the patient education 
booklet that currently accompany these procedures. The commenter stated 
that several anti-glycemic medications other than insulin require 
injection with a syringe and a significant number of persons with both 
type 1 and type 2 diabetes are prescribed these medications, however 
the list of supplies in the current direct PE inputs does not include 
syringes. The commenter therefore recommended that CMS add a series of 
different syringes to the direct PE inputs for HCPCS codes G0108 and 
G0109.
    Response: We proposed to maintain the current direct PE inputs for 
HCPCS codes G0108 and G0109, which do not currently include the syringe 
supplies described by the commenter (supply codes SC051, SC052, and 
SC055). Although we are sensitive to the concerns raised by the 
commenter, we do not believe that adding these syringe supplies to the 
procedures would be consistent with our policy of maintaining the 
current direct PE inputs.
    After consideration of the public comments, we are finalizing the 
work RVUs and the direct PE inputs for the codes in the Diabetes 
Management Training family of codes as proposed.
(62) External Counterpulsation (HCPCS Code G0166)
    HCPCS code G0166 (External counterpulsation, per treatment session) 
was identified on a screen of CMS or Other source codes with Medicare 
utilization greater than 100,000 services annually. The RUC is not 
recommending a work RVU for HCPCS code G0166 because they found that 
there is no physician work involved in this service. After reviewing 
this code, we proposed a work RVU of 0.00 for HCPCS code G0166, and 
proposed to make the code valued for PE only. For the direct PE inputs, 
we proposed to refine the equipment times in accordance with our 
standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving HCPCS code G0166.
    Comment: A commenter agreed with the proposal that an individual 
treatment session would have no physician work and supported the 
proposed direct PE inputs. However, the commenter stated that future 
coding solutions may be necessary to recognize management of these 
services that is additional to that captured by E/M coding.
    Response: We appreciate the feedback from the commenter, and we 
will consider this information for future rulemaking.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for HCPCS code G0166 as proposed.
(63) Wound Closure by Adhesive (HCPCS Code G0168)
    HCPCS code G0168 (Wound closure utilizing tissue adhesive(s) only) 
was identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. For CY 2019, the RUC recommended a 
work RVU of 0.45 based on maintaining the current work RVU.
    We disagreed with the recommended value and we proposed a work RVU 
of 0.31 for HCPCS code G0168 based on a direct crosswalk to CPT code 
93293 (Transtelephonic rhythm strip pacemaker evaluation(s) single, 
dual, or multiple lead pacemaker system, includes recording with and 
without magnet application with analysis, review and report(s) by a 
physician or other qualified health care professional, up to 90 days). 
CPT code 93293 is a recently-reviewed code with the same 5 minutes of 
intraservice time and 1 fewer minute of total time. In reviewing HCPCS 
code G0168, the recommendations stated that the work involved in the 
service had not changed even though the surveyed intraservice time was 
decreasing by 50 percent, from 10 minutes to 5 minutes. Although we did 
not imply that the decrease in time as reflected in survey values must 
equate to a one-to-one or linear decrease in the valuation of work 
RVUs, we believe that since the two components of work are time and 
intensity, significant decreases in time should be reflected in 
decreases to work RVUs. In the case of HCPCS code G0168, we believe 
that it would be more accurate to propose a work RVU of 0.31 based on

[[Page 59579]]

the aforementioned crosswalk to CPT code 93293 to account for these 
decreases in the surveyed work time. Maintaining the current work RVU 
of 0.45 despite a 50 percent decrease in the surveyed intraservice time 
would result in a significant increase in the intensity of HCPCS code 
G0168, and we have no reason to believe that the procedure has 
increased in intensity since the last time that it was valued.
    For the direct PE inputs, we proposed to refine the equipment times 
in accordance with our standard equipment time formulas.
    The following is a summary of the public comments we received on 
our proposals involving HCPCS code G0168.
    Comment: Many commenters disagreed with the proposed work RVU of 
0.31 for HCPCS code G0168 and stated that CMS should finalize the 
HCPAC-recommended work RVU of 0.45. Commenters stated that CMS should 
not compare the valid survey time to the current work time because the 
initial CMS/Other source data is flawed and maintains zero validity for 
comparison. Commenters stated that surveyed time was never obtained 
from physicians who perform this service and should not be used as a 
comparison.
    Response: We agree that it is important to use the most recent data 
available regarding time, and we note that when many years have passed 
between when time is measured, significant discrepancies can occur. 
However, we also believe that our operating assumption regarding the 
validity of the existing values as a point of comparison is critical to 
the integrity of the relative value system as currently constructed. 
The times currently associated with codes play a very important element 
in PFS ratesetting, both as points of comparison in establishing work 
RVUs and in the allocation of indirect PE RVUs by specialty. If we were 
to operate under the assumption that previously recommended work times 
had routinely been overestimated, this would undermine the relativity 
of the work RVUs on the PFS in general, given the process under which 
codes are often valued by comparisons to codes with similar times and 
it undermine the validity of the allocation of indirect PE RVUs to 
physician specialties across the PFS. Instead, we believe that it is 
crucial that the code valuation process take place with the 
understanding that the existing work times, used in the PFS ratesetting 
processes, are accurate. We recognize that adjusting work RVUs for 
changes in time is not always a straightforward process and that the 
intensity associated with changes in time is not necessarily always 
linear, which is why we apply various methodologies to identify several 
potential work values for individual codes. However, we want to 
reiterate that we believe it would be irresponsible to ignore changes 
in time based on the best data available and that we are statutorily 
obligated to consider both time and intensity in establishing work RVUs 
for PFS services. For additional information regarding the use of old 
work time values in our methodology, we refer readers to our discussion 
of the subject in the CY 2017 final rule (81 FR 80273 through 80274).
    Comment: Several commenters stated that HCPCS code G0168 should not 
be crosswalked to CPT code 93293, as this is an evaluation of pacemaker 
strips over a 90 day period. Commenters stated that the skill of 
closing a facial laceration, typically near the eye, using a surgical 
tissue adhesive for HCPCS code G0168 is more intense and complex to 
perform than CPT code 93293 and thus should be valued higher. 
Commenters stated that CPT code 51702 (Insertion of temporary 
indwelling bladder catheter; simple (e.g., Foley)) would be a better 
reference service.
    Response: We disagree with the commenters that CPT code 93293 would 
be an inappropriate choice for a crosswalk. CPT code 93293 describes a 
transtelephonic rhythm strip pacemaker evaluation(s) for a single, 
dual, or multiple lead pacemaker system. We do not agree that this 
crosswalk code has lower intensity or complexity due to the cognitive 
work involved in evaluating the patient correctly. Both CPT code 93293 
and HCPCS code G0168 require skill on the part of the practitioner, 
only of different types. We also believe that our crosswalk to CPT code 
92393 is a more accurate choice because it has the same intraservice 
work time (5 minutes) closely matches the total work time (13 minutes 
as opposed to 14 minutes) of HCPCS code G0168. By contrast, CPT code 
51702 has nearly double the total work time at 25 minutes, which 
accounts for its higher work RVU of 0.50.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for HCPCS code G0168 as proposed.
(64) Removal of Impacted Cerumen (HCPCS Code G0268)
    HCPCS code G0268 (Removal of impacted cerumen (one or both ears) by 
physician on same date of service as audiologic function testing) was 
identified as potentially misvalued on a screen of 0-day global 
services reported with an E/M visit 50 percent of the time or more, on 
the same day of service by the same patient and the same practitioner, 
that have not been reviewed in the last 5 years with Medicare 
utilization greater than 20,000. For CY 2019, we proposed the RUC-
recommended work RVU of 0.61 for HCPCS code G0268.
    For the direct PE inputs, we proposed to remove the clinical labor 
time for the ``Clean surgical instrument package'' (CA026) activity. 
There is no surgical instrument pack included in the recommended 
equipment for HCPCS code G0268, and this code already includes the 
standard 3 minutes allocated for cleaning the room and equipment. In 
addition, all of the instruments used in the procedure appear to be 
disposable supplies that would not require cleaning since they would 
only be used a single time.
    The following is a summary of the public comments we received on 
our proposals involving HCPCS code G0268.
    Comment: Several commenters supported our proposal of the HCPAC-
recommended work RVU as well as the refinement to the direct PE inputs.
    Response: We appreciate the support for our proposals from the 
commenters.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for HCPCS code G0268 as proposed.
(65) Structured Assessment, Brief Intervention, and Referral to 
Treatment for Substance Use Disorders (HCPCS Codes G0396, G0397, and 
G2011)
    In response to the Request for Information in the CY 2018 PFS 
proposed rule (82 FR 34172), commenters requested that CMS pay 
separately for assessment and referral related to substance use 
disorders. In the CY 2008 PFS final rule (72 FR 66371), we created two 
G-codes to allow for appropriate Medicare reporting and payment for 
alcohol and substance abuse assessment and intervention services that 
are not provided as screening services, but that are performed in the 
context of the diagnosis or treatment of illness or injury. The codes 
are HCPCS code G0396 (Alcohol and/or substance (other than tobacco) 
abuse structured assessment (e.g., AUDIT, DAST) and brief intervention, 
15 to 30 minutes)) and HCPCS code G0397 (Alcohol and/or substance 
(other than tobacco) abuse structured assessment (e.g., AUDIT, DAST) 
and intervention greater than 30 minutes)). In 2008, we instructed 
Medicare contractors to pay for these codes only when the services were 
considered reasonable and necessary.

[[Page 59580]]

    Given the ongoing opioid epidemic and the current needs of the 
Medicare population, we expect that these services would often be 
reasonable and necessary. However, the utilization for these services 
is relatively low, which we believe is in part due to the service-
specific documentation requirements for these codes (the current 
requirements are available at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/SBIRT_Factsheet_ICN904084.pdf). We believe that removing the additional 
documentation requirements will also ease the administrative burden on 
providers. Therefore, for CY 2019, we proposed to eliminate the 
service-specific documentation requirements for HCPCS codes G0397 and 
G0398. We welcomed comments on our proposal to change the documentation 
requirements for these codes.
    The following is a summary of the comments we received regarding 
our proposal to change the documentation requirements for these codes.
    Comment: The majority of commenters were supportive of this 
proposal, some noting that this will ease administrative burden and 
some noting that this will incentivize providers to deliver SBIRT 
services, thereby increasing access to this service. One commenter 
stated they believe that practitioners are not utilizing SBIRT for 
illicit drug use due to the absence of conclusive evidence to support 
use of this service for illicit drug use and therefore, support 
removing the service documentation requirements for SBIRT when used to 
screen for unhealthy alcohol use, but not when used to screen for 
illicit drug use.
    Response: We thank the commenters for their feedback. We note that 
the services described by HCPCS codes G0397 and G0398 describe services 
for alcohol and/or substance abuse; we believe it would be 
administratively burdensome for practitioners were we to create varying 
rules for different diagnoses. Additionally, it is our intention to 
increase access to care for services that may be of use in addressing 
all substance use disorders, especially in light of the ongoing opioid 
epidemic. Therefore, we are finalizing our proposal to eliminate the 
service-specific documentation requirements for HCPCS codes G0397 and 
G0398.
    Additionally, we proposed to create a third HCPCS code G2011with a 
lower time threshold in order to accurately account for the resource 
costs when practitioners furnish these services, but do not meet the 
minimum time requirements of the existing codes. We note that in the 
proposed rule we referred to this service as HCPCS code GSBR1, which 
was a placeholder code. The code will be described as G2011: Alcohol 
and/or substance (other than tobacco) abuse structured assessment 
(e.g., AUDIT, DAST), and brief intervention, 5-14 minutes. We proposed 
a work RVU of 0.33, based on the intraservice time ratio between HCPCS 
codes G0396 and G0397. We welcomed comments on this code descriptor and 
proposed valuation for HCPCS code G2011.
    The following is a summary of the comments we received on this code 
descriptor and proposed valuation for HCPCS code G2011.
    Comment: Commenters were supportive of creating this code and the 
valuation proposed, and noted the lower time threshold will allow 
physicians the opportunity to provide brief counseling rather than 15 
or more minutes of discussion, which requires extended interest from a 
patient who may not yet be ready for prolonged discussion and/or is 
receptive to being referred to another health care provider for 
treatment. One commenter recommended finalizing guidance that allows 
the newly proposed SBIRT HCPCS code to be used for alcohol, but not 
illicit drug use.
    Response: We thank the commenters for their feedback. After 
considering these comments, we are finalizing the code descriptor and 
valuation for HCPCS code G2011 as proposed. We believe the code 
descriptor and guidance for this new SBIRT HCPCS code should be 
consistent with the existing SBIRT HCPCS codes. For future rulemaking 
we would consider recommendations on how to refine this family of codes 
under our standard process of reviewing codes.
(66) Prolonged Services (HCPCS Code GPRO1)
    CPT codes 99354 (Prolonged evaluation and management or 
psychotherapy service(s) (beyond the typical service time of the 
primary procedure) in the office or other outpatient setting requiring 
direct patient contact beyond the usual service; first hour (List 
separately in addition to code for office or other outpatient 
Evaluation and Management or psychotherapy service)) and 99355 
(Prolonged evaluation and management or psychotherapy service(s) 
(beyond the typical service time of the primary procedure) in the 
office or other outpatient setting requiring direct patient contact 
beyond the usual service; each additional 30 minutes (List separately 
in addition to code for prolonged service)) describe additional time 
spent face-to-face with a patient. Stakeholders have shared with us 
that the threshold of 60 minutes for CPT code 99354 is difficult to 
meet and is an impediment to billing these codes. In response to 
stakeholder feedback and as part of our proposal as discussed in 
section II.I. of this final rule, Evaluation and Management Services, 
to implement a single PFS rate for E/M visit levels 2-5 while 
maintaining payment stability across the specialties, we proposed HCPCS 
code GPRO1 (Prolonged evaluation and management or psychotherapy 
service(s) (beyond the typical service time of the primary procedure) 
in the office or other outpatient setting requiring direct patient 
contact beyond the usual service; 30 minutes (List separately in 
addition to code for office or other outpatient Evaluation and 
Management or psychotherapy service)), which could be billed with any 
level of E/M code. We noted that we did not propose to make any changes 
to CPT codes 99354 and 99355, which can still be billed, as needed, 
when their time thresholds and all other requirements are met. We 
proposed a work RVU of 1.17, which is equal to half of the work RVU 
assigned to CPT code 99354. Additionally, we proposed direct PE inputs 
for HCPCS code GPRO1 that are equal to one half of the values assigned 
to CPT code 99354, which can be found in the Direct PE Inputs public 
use file for this final rule.
    Comment: As almost all commenters did not support the overall E/M 
coding and payment proposals, we did not receive many comments with 
specific suggestions on valuation for HCPCS code GPRO1. Of the 
commenters that supported creation of the code, most supported the 
proposed valuation while others, while supporting the creation of a 30-
minute prolonged services code in principle, encouraged CMS to wait for 
recommendations from the CPT Editorial Panel and the RUC.
    Response: For CY 2021, we are finalizing the proposed add-on code 
for HCPCS code GPRO1 using the input values, as proposed. We note that 
prior to implementation for 2021, we could consider, through 
rulemaking, the code and its valuation in the context of any potential 
changes to CPT codes and/or recommendations offered by stakeholders, 
including the RUC, as part of our annual process for valuing PFS 
services. See section II.I. of this final rule for further discussion 
of the E/M policy.

[[Page 59581]]

(67) Remote Pre-Recorded Services (HCPCS Code G2010)
    For CY 2019, we proposed to make separate payment for remote 
evaluation services when a physician uses pre-recorded video and/or 
images submitted by a patient in order to evaluate a patient's 
condition through new HCPCS G-code G2010 (Remote evaluation of recorded 
video and/or images submitted by the patient (e.g., store and forward), 
including interpretation with verbal follow-up with the patient within 
24 business hours, not originating from a related E/M service provided 
within the previous 7 days nor leading to an E/M service or procedure 
within the next 24 hours or soonest available appointment). We proposed 
to value this service by a direct crosswalk to CPT code 93793 
(Anticoagulant management for a patient taking warfarin, must include 
review and interpretation of a new home, office, or lab international 
normalized ratio (INR) test result, patient instructions, dosage 
adjustment (as needed), and scheduling of additional test(s), when 
performed), as we believe the work described is similar in kind and 
intensity to the work performed as part of HCPCS code G2010. Therefore, 
we proposed a work RVU of 0.18, preservice time of 3 minutes, 
intraservice time of 4 minutes, and post service time of 2 minutes. We 
also proposed to add 6 minutes of clinical labor (L037D) in the service 
period. We solicited comment on the code descriptor and valuation for 
HCPCS code G2010. We direct readers to section II.D. of this final 
rule, which includes additional detail regarding our proposed policies 
for modernizing Medicare physician payment by recognizing communication 
technology-based services.
    The following is a summary of the comments we received on the code 
descriptor and valuation for HCPCS code G2010.
    Comment: Several commenters stated that the proposed payment rate 
is too low, citing that it is below market compared to the rate many 
asynchronous telemedicine companies pay their contracted/employed 
physician staff, and noted that new patients in particular require more 
resources, whereas others stated that the proposed valuation was 
appropriate.
    Response: We believe that the proposed valuation accurately 
reflects the resources involved in furnishing this service and note 
that we are finalizing limiting this service to established patients. 
We also note that we plan to monitor the utilization of this code and 
routinely address recommended changes in values for codes paid under 
the PFS.
    After considering the public comments, we are finalizing the work 
RVU and direct PE inputs for HCPCS code G2010 as proposed.
(68) Brief Communication Technology-Based Service, e.g. Virtual Check-
In (HCPCS Code G2012)
    We proposed to create a G-code, HCPCS code G2012 (Brief 
communication technology based service, e.g. virtual check-in, by a 
physician or other qualified health care professional who may report 
evaluation and management services provided to an established patient, 
not originating from a related E/M service provided within the previous 
7 days nor leading to an E/M service or procedure within the next 24 
hours or soonest available appointment; 5-10 minutes of medical 
discussion) to facilitate payment for these brief communication 
technology-based services. We proposed to base the code descriptor and 
valuation for HCPCS code G2012 on existing CPT code 99441 (Telephone 
evaluation and management service by a physician or other qualified 
health care professional who may report evaluation and management 
services provided to an established patient, parent, or guardian not 
originating from a related E/M service provided within the previous 7 
days nor leading to an E/M service or procedure within the next 24 
hours or soonest available appointment; 5-10 minutes of medical 
discussion), which is currently not separately payable under the PFS. 
As CPT code 99441 only describes telephone calls, we are proposing to 
create a new HCPCS code G2012 to encompass a broader array of 
communication modalities. We do, however, believe that the resource 
assumptions for CPT code 99441 would accurately account for the costs 
associated with providing the proposed virtual check-in service, 
regardless of the technology. We proposed a work RVU of 0.25, based on 
a direct crosswalk to CPT code 99441. For the direct PE inputs for 
HCPCS code G2012, we also proposed the direct PE inputs assigned to CPT 
code 99441. Given the breadth of technologies that could be described 
as telecommunications, we anticipated receiving public comments and 
working with the CPT Editorial Panel and the RUC to evaluate whether 
separate coding and payment is needed to account for differentiation 
between communication modalities. We solicited comment on the code 
descriptor, as well as the proposed valuation for HCPCS code G2012. We 
direct readers to section II.D. of this final rule, which includes 
additional detail regarding our proposed policies for modernizing 
Medicare physician payment by recognizing communication technology-
based services.
    The following is a summary of the comments we received on the code 
descriptor, as well as the proposed valuation for HCPCS code G2012.
    Comment: Several commenters stated that the proposed payment rate 
would be inadequate for modalities that are both audio and visual 
capable, whereas other commenters stated that the proposed valuation 
was appropriate.
    Response: We appreciate the input provided by the commenters. As 
noted in section II.D. of this final rule, we are finalizing the 
valuation for this service as proposed. We note that we are finalizing 
allowing audio-only real-time telephone interactions in addition to 
synchronous, two-way audio interactions that are enhanced with video or 
other kinds of data transmission. We believe the proposed valuation 
reflects the low work time and intensity and accounts for the resource 
costs and efficiencies associated with the use of communication 
technology. We recognize that the valuation of this service is 
relatively modest, especially compared to in-person services, however, 
we believe that the proposed valuation accurately reflects the 
resources involved in furnishing this service.
    We plan to monitor the utilization of this code and note that we 
routinely address recommended changes in values for codes paid under 
the PFS and would expect to do this in future rulemaking.
    After consideration of the public comments, we are finalizing the 
work RVU and direct PE inputs for HCPCS code G2012 as proposed.
(69) Visit Complexity Inherent to Certain Specialist Visits (HCPCS Code 
GCG0X)
    We proposed to create a HCPCS G-code to be reported with an E/M 
service to describe the additional resource costs for specialties for 
whom E/M visit codes make up a large percentage of their total allowed 
charges and who we believe primarily bill level 4 and level 5 visits. 
The treatment approaches for these specialties generally do not have 
separate coding and are generally reported using the E/M visit codes. 
We proposed to create HCPCS code, GCG0X (Visit complexity inherent to 
evaluation and management associated with endocrinology, rheumatology, 
hematology/oncology, urology, neurology, obstetrics/gynecology, 
allergy/immunology, otolaryngology, or

[[Page 59582]]

interventional pain management-centered care (Add-on code, list 
separately in addition to an evaluation and management visit)). We 
proposed a valuation for HCPCS code GCG0X based on a crosswalk to 75 
percent of the work RVU and time of CPT code 90785 (Interactive 
complexity), which would result in a proposed work RVU of 0.25 and a 
physician time of 8.25 minutes for HCPCS code GCG0X. CPT code 90785 has 
no direct PE inputs. Interactive complexity is an add-on code that may 
be billed when a psychotherapy or psychiatric service requires more 
work due to the complexity of the patient. We believe that this work 
RVU and physician time would be an accurate representation of the 
additional work associated with the higher level complex visits. For 
further discussion of proposals relating to this code, see section 
II.I. of this final rule. We solicited comment on the code descriptor, 
as well as the proposed valuation for HCPCS code GCG0X.
    The following is a summary of the comments we received on the code 
descriptor, as well as the proposed valuation for HCPCS code GCG0X.
    Comment: As almost all commenters did not support the overall E/M 
coding and payment proposals, we did not receive comments with specific 
suggestions on valuation for HCPCS code GCG0X.
    Response: For CY 2021, we are finalizing the proposed add-on code 
for visit complexity inherent to non-procedural specialty care using 
the input values, as proposed. We note that prior to implementation for 
CY 2021, we could consider, through rulemaking, the code and its 
valuation in the context of any potential changes to CPT codes and/or 
recommendations offered by stakeholders, including the RUC, as part of 
our annual process for valuing PFS services. See section II.I. of this 
final rule for further discussion of the E/M policy.
(70) Visit Complexity Inherent to Primary Care Services (HCPCS Code 
GPC1X)
    We proposed to create a HCPCS G-code for primary care services, 
GPC1X (Visit complexity inherent to evaluation and management 
associated with primary medical care services that serve as the 
continuing focal point for all needed health care services (Add-on 
code, list separately in addition to an evaluation and management 
visit)). This code describes furnishing a visit to a new or existing 
patient, and can include aspects of care management, counseling, or 
treatment of acute or chronic conditions not accounted for by other 
coding. HCPCS code GPC1X would be billed in addition to the E/M visit 
code when the visit involved primary care-focused services. We proposed 
a work RVU of 0.07, physician time of 1.75 minutes. This proposed 
valuation accounts for the additional work resource costs associated 
with furnishing primary care that distinguishes E/M primary care visits 
from other types of E/M visits and maintains work budget neutrality 
across the office/outpatient E/M code set. For further discussion of 
proposals relating to this code, see section II.I. of this final rule. 
We solicited comment on the code descriptor, as well as the proposed 
valuation for HCPCS code GPC1X.
    The following is a summary of the comments we received on the code 
descriptor, as well as the proposed valuation for HCPCS code GPC1X.
    Comment: We received a few comments suggesting that the primary 
care add-on was undervalued, particularly in comparison to the add-on 
code for specialty visit complexity. A few commenters suggested that, 
at the very least, we should equalize the value for these codes.
    Response: We agree that the proposed inputs do not reflect the 
resources associated with furnishing primary care visits. For CY 2021, 
we are finalizing the proposed add-on code for visit complexity 
inherent to primary care using the inputs associated with HCPCS code 
GCG1X: A work RVU of 0.25 and a physician time of 8.25 minutes. We note 
that prior to implementation for 2021, we could consider, through 
rulemaking, the code and its valuation in the context of any potential 
changes to CPT codes and/or recommendations offered by stakeholders, 
including the RUC, as part of our annual process for valuing PFS 
services. See section II.I. of this final rule for further discussion 
of the E/M policy.
(71) Podiatric Evaluation and Management Services (HCPCS Codes GPD0X 
and GPD1X)
    We proposed to create two HCPCS G-codes, HCPCS codes GPD0X 
(Podiatry services, medical examination and evaluation with initiation 
of diagnostic and treatment program, new patient) and GPD1X (Podiatry 
services, medical examination and evaluation with initiation of 
diagnostic and treatment program, established patient), to describe 
podiatric evaluation and management services. We proposed a work RVU of 
1.36, a physician time of 28.19 minutes, and direct costs summing to 
$21.29 for HCPCS code GPD0X, and a work RVU of 0.85, physician time of 
21.73 minutes, and direct costs summing to $15.87 for HCPCS code GPD1X. 
These values are based on the average rate for CPT codes 99201-99203 
and CPT codes 99211-99212 respectively, weighted by podiatric volume. 
For further discussion of proposals relating to these codes, see 
section II.I. of this final rule.
    Comment: As almost all commenters did not support the overall E/M 
coding and payment proposals and these codes specifically, we did not 
receive comments with specific suggestions on valuation.
    Response: In response to comments, we are not finalizing HCPCS 
codes GPD0X and GPD1X for CY 2019. See section X of this final rule for 
further discussion of the E/M policy.
(72) Comment Solicitation on Superficial Radiation Treatment Planning 
and Management
    In the CY 2015 PFS final rule with comment period (79 FR 67666 
through 67667), we noted that changes to the CPT prefatory language 
limited the codes that could be reported when describing services 
associated with superficial radiation treatment (SRT) delivery, 
described by CPT code 77401 (radiation treatment delivery, superficial 
and/or ortho voltage, per day). The changes effectively meant that many 
other related services were bundled with CPT code 77401, instead of 
being separately reported. For example, CPT guidance clarified that 
certain codes used to describe clinical treatment planning, treatment 
devices, isodose planning, physics consultation, and radiation 
treatment management cannot be reported when furnished in association 
with SRT. Stakeholders informed us that these changes to the CPT 
prefatory language prevented them from billing Medicare for codes that 
were previously frequently billed with CPT code 77401. We solicited 
comments as to whether the revised bundled coding for SRT allowed for 
accurate reporting of the associated services. In the CY 2016 PFS final 
rule with comment period (80 FR 70955), we noted that the RUC did not 
review the inputs for SRT procedures, and therefore, did not assess 
whether changes in valuation were appropriate in light of the bundling 
of associated services. In addition, we solicited recommendations from 
stakeholders regarding whether it would be appropriate to add physician 
work for this service, even though physician work is not included in 
other radiation treatment services. In the CY 2018 PFS proposed rule 
(82 FR 34012) and the CY 2018 PFS final rule (82 FR 53082), we noted 
that the 2016 National Correct

[[Page 59583]]

Coding Initiative (NCCI) Policy Manual for Medicare Services states 
that radiation oncology services may not be separately reported with E/
M codes. While this NCCI edit is no longer active stakeholders have 
stated that MACs have denied claims for E/M services associated with 
SRT based on the NCCI policy manual language. According to 
stakeholders, the bundling of SRT with associated services, as well as 
coding confusion regarding the appropriate use of E/M coding to report 
associated physician work, meant that practitioners were not being paid 
appropriately for planning and treatment management associated with 
furnishing SRT. Due to these concerns regarding reporting of services 
associated with SRT, in the CY 2018 PFS proposed rule (82 FR 34012 
through 34013), we proposed to make separate payment for the 
professional planning and management associated with SRT using HCPCS 
code GRRR1 (Superficial radiation treatment planning and management 
related services, including but not limited to, when performed, 
clinical treatment planning (for example, 77261, 77262, 77263), 
therapeutic radiology simulation-aided field setting (for example, 
77280, 77285, 77290, 77293), basic radiation dosimetry calculation (for 
example, 77300), treatment devices (for example, 77332, 77333, 77334), 
isodose planning (for example, 77306, 77307, 77316, 77317, 77318), 
radiation treatment management (for example, 77427, 77431, 77432, 
77435, 77469, 77470, 77499), and associated E/M per course of 
treatment). We proposed that this code would describe the range of 
professional services associated with a course of SRT, including 
services similar to those not otherwise separately reportable under CPT 
guidance. Furthermore, we proposed that this code would have included 
several inputs associated with related professional services such as 
treatment planning, treatment devices, and treatment management. Many 
commenters did not support our proposal to make separate payment for 
HCPCS code GRRR1 for CY 2018, stating that our proposed valuation of 
HCPCS code GRRR1 would represent a significant payment reduction for 
the associated services as compared with the list of services that they 
could previously bill in association with SRT. Commenters voiced 
concern that the proposed coding would inhibit access to care and 
discourage the use of SRT as a non-surgical alternative to Mohs 
surgery. We received comments recommending a variety of potential 
coding solutions but without a consistent preferred alternative. In the 
CY 2018 PFS final rule (82 FR 53081-53083), we solicited further 
comment, and stated that we would continue our dialogue with 
stakeholders to address appropriate coding and payment for professional 
services associated with SRT.
    Given stakeholder feedback that we have continued to receive 
following the publication of the CY 2018 PFS final rule, we continue to 
believe that there are potential coding gaps for SRT-related 
professional services. We generally rely on the CPT process to 
determine coding specificity, and we believe that deferring to this 
process in addressing potential coding gaps is generally preferable. As 
our previous attempt at designing a coding solution in the CY 2018 PFS 
proposed rule did not gain stakeholder consensus, and given that there 
were various, in some cases diverging, suggestions on a coding solution 
from stakeholders, we did not propose changes relating to SRT coding, 
SRT-related professional codes, or payment policies for CY 2019. 
However, we solicited comment on the possibility of creating multiple 
G-codes specific to services associated with SRT, as was suggested by 
one stakeholder following the CY 2018 PFS final rule. These codes would 
be used separately to report services including SRT planning, initial 
patient simulation visit, treatment device design and construction 
associated with SRT, SRT management, and medical physics consultation. 
We solicited comment on whether we should create such G-codes to 
separately report each of the services described previously, mirroring 
the coding of other types of radiation treatment delivery. For 
instance, HCPCS code G6003 (Radiation treatment delivery, single 
treatment area, single port or parallel opposed ports, simple blocks or 
no blocks: Up to 5 mev) is used to report radiation treatment delivery, 
while associated professional services are billed with codes such as 
CPT codes 77427 (Radiation treatment management, 5 treatments), 77261 
(Therapeutic radiology treatment planning; simple), 77332 (Treatment 
devices, design and construction; simple (simple block, simple bolus), 
and 77300 (Basic radiation dosimetry calculation, central axis depth 
dose calculation, TDF, NSD, gap calculation, off axis factor, tissue 
inhomogeneity factors, calculation of non-ionizing radiation surface 
and depth dose, as required during course of treatment, only when 
prescribed by the treating physician).
    We stated that we consider contractor pricing such codes for CY 
2019 because we believe that the preferable method to develop new 
coding is with multi-specialty input through the CPT and RUC process, 
and we prefer to defer nationally pricing such codes pending input from 
the CPT Editorial Panel and the RUC process to assist in determining 
the appropriate level of coding specificity for SRT-related 
professional services. Based on stakeholder feedback, we continue to 
believe there may be a coding gap for these services, and therefore, we 
solicited comment on whether we should create these G-codes and allow 
them to be contractor priced for CY 2019. This would be an interim 
approach for addressing the potential coding gap until the CPT 
Editorial Panel and the RUC can address coding for SRT and SRT-related 
professional services, giving the CPT Editorial Panel and the RUC an 
opportunity to develop a coding solution that could be addressed in 
future rulemaking.
    The following is a summary of the comments we received on the 
possibility of creating multiple G-codes specific to services 
associated with SRT, which could be used separately to report services 
including SRT planning, initial patient simulation visit, treatment 
device design and construction associated with SRT, SRT management, and 
medical physics consultation, which would be contractor priced for CY 
2019.
    Comment: Many commenters urged CMS to make appropriate payment for 
SRT-related services, stating that it is a vital non-surgical 
alternative treatment for skin cancer. Many commenters also said that 
coding should recognize newer generation, Image Guided Superficial 
Radiation (IGSRT), stating that IGSRT is the most advanced form of this 
technology, and has far better outcomes compared to those achieved with 
SRT.
    Some commenters recommended implementation of G-codes for SRT-
related professional services, and they submitted alternative G-code 
scenarios that they believe would be preferable to adopting contractor-
priced G-codes. These scenarios include one in which there would be one 
code for SRT-related treatment planning, with a value based on a 
crosswalk to CPT code 77261 (Therapeutic radiology treatment planning; 
simple), a code for SRT treatment device construction, with a value 
based on a crosswalk to CPT code 77332 (Treatment devices, design and 
construction; simple (simple block, simple bolus), and a code for SRT 
treatment management billed once per treatment, valued with a crosswalk 
to CPT code 99213 (Office or other outpatient visit for the evaluation 
and management of an established patient,

[[Page 59584]]

which requires at least 2 of these 3 key components: An expanded 
problem focused history; An expanded problem focused examination; 
Medical decision making of low complexity. Counseling and coordination 
of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
presenting problem(s) are of low to moderate severity. Typically, 15 
minutes are spent face-to-face with the patient and/or family.). 
According to this commenter, image guidance and tracking should not be 
billed with superficial treatments. Another commenter suggested a 
single code bundling SRT-related treatment management with SRT-related 
device construction as well as a code for SRT-related radiation 
treatment management, and a code representing treatment for multiple 
lesions. This commenter also urged us to either revalue CPT code 77401 
or to create an additional G-code billable with CPT code 77401 to 
represent professional services associated with SRT. Another commenter 
suggested a code for SRT-related radiology treatment planning, and an 
SRT management code including five treatments. A commenter suggested a 
coding structure that recognizes Image-Guided Superficial Radiation 
Therapy as a newer generation of SRT, and would consist of CPT code 
77401 for practitioners that utilize the SRT technologies; relying on 
human visualization for lesion(s) simulation, treatment and tracking, 
and a new G-code for providers who provide the newer generation 
technology relying on image-guided lesion simulation, treatment and 
tracking per fraction with Record and Verify precision tracking of 
treatment progress.
    A commenter stated that any codes utilized as part of superficial 
radiation treatment delivery that include medical physics time should 
require that a qualified medical physicist perform the physics work.
    A commenter stated that adopting contractor-priced G codes would be 
appropriate. Some other commenters, however, did not support our 
suggested adoption of contractor-priced codes. According to these 
commenters, we are correct in our belief that there are coding gaps in 
the current reimbursement structure, however a fuller evaluation that 
does not defer to Medicare contractors in determining reimbursement 
rates is appropriate. According to a commenter, contractor pricing 
creates unnecessary work for the Medicare Administrative Contractors 
and can also lead to wide variances in the valuing of codes across 
jurisdictions. Commenters expressed preference that coding for these 
services be developed through the CPT and RUC processes. Many 
commenters urged us not to change coding for CY 2019 for these 
services.
    Response: We expect to take these comments into consideration for 
future rulemaking and we hope to continue a dialogue with stakeholders 
on these important services. We reiterate that we believe multi-
specialty input through the CPT and RUC processes is the ideal way to 
develop coding specificity and evaluation, and we are not making any 
changes to payment policy based on this comment solicitation. In the 
interim, we refer readers to CPT guidance that states that CPT code 
77401, when performed, may be reported with appropriate E/M codes, and 
this is the appropriate way to currently report professional work 
associated with SRT. Going forward, we will attempt to determine 
whether MACs are inappropriately denying billing of E/M codes with CPT 
code 77401, and we will instruct MACs accordingly.
(73) Adaptive Behavior Analysis Services
    We note that we intended to assign a contractor price status in the 
Addendum B file of the proposed rule for the following CPT codes that 
describe adaptive behavior analysis services: CPT codes 97151, 97152, 
97153, 97154, 97155, 97156, 97157, and 97158. These codes are formerly 
contractor priced Category III CPT codes that were converted to 
Category I for CY 2019. We inadvertently excluded these codes in the 
Addendum B file of the proposed rule, and have updated the Addendum B 
file for this final rule.
BILLING CODE 4120-01-P

[[Page 59585]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.000


[[Page 59586]]


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[[Page 59587]]


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[[Page 59588]]


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[[Page 59590]]


[GRAPHIC] [TIFF OMITTED] TR23NO18.005


[[Page 59591]]


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[[Page 59593]]


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[[Page 59624]]



                                            Table 15--CY 2019 Invoices Received for Existing Direct PE Inputs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                              Estimated
                                                                                                                                                 non-
                                                                                                                                               facility
                                                                                                  Current    Updated    Percent   Number of    allowed
              CPT/HCPCS codes                        Item name                  CMS code           price      price      change    invoices    services
                                                                                                                                              for HCPCS
                                                                                                                                             codes using
                                                                                                                                              this item
--------------------------------------------------------------------------------------------------------------------------------------------------------
53850.....................................  kit, transurethral          SA036                     1,149.00   1,000.00        -13          1        5,608
                                             microwave thermotherapy.
53852.....................................  kit, transurethral needle   SA037                     1,050.00     900.00        -14          2        2,476
                                             ablation (TUNA).
85097.....................................  stain, Wright's Pack (per   SL140                         0.05       0.16        235          1       43,183
                                             slide).
96116, 96118, 96119, 96125................  neurobehavioral status      SK050                         5.77       4.00        -31          3      414,139
                                             forms, average.
258 codes.................................  scope video system          ES031                    33,391.00  36,306.00          9  .........    2,480,515
                                             (monitor, processor,
                                             digital capture, cart,
                                             printer, LED light).
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                             Table 16--CY 2019 New Invoices
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                             Number of      NF Allowed
             CPT/HCPCS codes                         Item name                       CMS code              Average price     invoices        services
--------------------------------------------------------------------------------------------------------------------------------------------------------
10011, 10012.............................  MREYE Chiba Biopsy Needle...  SC106                                     37.00               1               0
33285....................................  subcutaneous cardiac rhythm   SA127                                  5,032.50               4             280
                                            monitor system.
36572, 36573, 36584......................  Turbo-Ject PICC Line........  SD331                                    170.00               1          24,402
53854....................................  kit, Rezum delivery device..  SA128                                  1,150.00               1             121
53854....................................  generator, water              EQ389                                 27,538.00              10             121
                                            thermotherapy procedure.
58100....................................  Uterine Sound...............  SD329                                      3.17               1          59,152
58100....................................  Tenaculum...................  SD330                                      3.77               1          59,152
76391....................................  MR Elastography Package.....  EL050                                200,684.50               1             350
76978, 76979.............................  bubble contrast.............  SD332                                    126.59               1              89
76978, 76979.............................  Ultrasound Contrast Imaging   ER108                                  5,760.00               1              89
                                            Package.
76981, 76982, 76983......................  sheer wave elastography       ED060                                  9,600.00               1             493
                                            software.
77048, 77049.............................  CAD Software................  ED058                                 43,308.12               1          36,675
77046, 77047, 77048, 77049...............  Breast coil.................  EQ388                                 83,200.00               1          39,785
77048, 77049.............................  CAD Workstation (CPU + Color  ED056                                 12,031.52               1          36,675
                                            Monitor).
85097....................................  slide stainer, automated,     EP121                                  8,649.43               1          34,559
                                            hematology.
92273....................................  Sleep mask..................  SK133                                      9.95               1          10,266
92273, 92274.............................  mfERG and ffERG               EQ390                                102,400.00               1          25,602
                                            electrodiagnostic unit.
92273, 92274.............................  Contact lens electrode for    EQ391                                  1,440.00               1          25,602
                                            mfERG and ffERG.
96136, 96137, 96138, 96139...............  WAIS-IV Record Form.........  SK130                                      5.25               1         301,452
96136, 96137, 96138, 96139...............  WAIS-IV Response Booklet #1.  SK131                                      3.30               1         301,452
96136, 96137, 96138, 96139...............  WMS-IV Response Booklet #2..  SK132                                      2.00               1         301,452
96136, 96137, 96138, 96139...............  Wechsler Adult Intelligence   EQ387                                    971.30               1         301,452
                                            Scale--Fourth Edition (WAIS-
                                            IV) Kit (less forms).
99454....................................  heart failure patient         EQ392                                  1,000.00               1              58
                                            physiologic monitoring
                                            equipment package.
G0109....................................  20x30 inch self-stick easel   SK129                                      0.00               0          93,576
                                            pad, white, 30 sheets/pad.
none.....................................  needle holder, Mayo Hegar,    SC105                                      3.03               1               0
                                            6''.
--------------------------------------------------------------------------------------------------------------------------------------------------------


                   Table 17--CY 2019 No PE Refinements
------------------------------------------------------------------------
               HCPCS                             Description
------------------------------------------------------------------------
10004.............................  Fna bx w/o img gdn ea addl.
10006.............................  Fna bx w/us gdn ea addl.
10008.............................  Fna bx w/fluor gdn ea addl.
10010.............................  Fna bx w/ct gdn ea addl.
10011.............................  Fna bx w/mr gdn 1st les.
10012.............................  Fna bx w/mr gdn ea addl.
11103.............................  Tangntl bx skin ea sep/addl.
11105.............................  Punch bx skin ea sep/addl.
11107.............................  Incal bx skn ea sep/addl.
33274.............................  Tcat insj/rpl perm ldls pm.
33275.............................  Tcat rmvl perm ldls pm.
33285.............................  Insj subq car rhythm mntr.
33286.............................  Rmvl subq car rhythm mntr.
33289.............................  Tcat impl wrls p-art prs snr.
36568.............................  Insj picc <5 yr w/o imaging.
36569.............................  Insj picc 5 yr+ w/o imaging.
36572.............................  Insj picc rs&i <5 yr.
36573.............................  Insj picc rs&i 5 yr+.
36584.............................  Compl rplcmt picc rs&i.
38531.............................  Open bx/exc inguinofem nodes.
49422.............................  Remove tunneled ip cath.
50436.............................  Dilat xst trc ndurlgc px.
50437.............................  Dilat xst trc new access rcs.
53850.............................  Prostatic microwave thermotx.
53852.............................  Prostatic rf thermotx.
53854.............................  Trurl dstrj prst8 tiss rf wv.
57150.............................  Treat vagina infection.
57160.............................  Insert pessary/other device.
58110.............................  Bx done w/colposcopy add-on.
65205.............................  Remove foreign body from eye.
65210.............................  Remove foreign body from eye.
67500.............................  Inject/treat eye socket
67505.............................  Inject/treat eye socket.
67515.............................  Inject/treat eye socket.
74485.............................  Dilation urtr/urt rs&i.
76514.............................  Echo exam of eye thickness.

[[Page 59625]]

 
76942.............................  Echo guide for biopsy.
76981.............................  Use parenchyma.
76982.............................  Use 1st target lesion.
76983.............................  Use ea addl. target lesion.
77081.............................  Dxa bone density/peripheral.
93264.............................  Rem mntr wrls p-art prs snr.
93668.............................  Peripheral vascular rehab.
95800.............................  Slp stdy unattended.
95801.............................  Slp stdy unatnd w/anal.
95806.............................  Sleep study unatt&resp efft.
95836.............................  Ecog impltd brn npgt <30 d.
95970.............................  Alys npgt w/o prgrmg.
95976.............................  Alys smpl cn npgt prgrmg.
95977.............................  Alys cplx cn npgt prgrmg.
95983.............................  Alys brn npgt prgrmg 15 min.
95984.............................  Alys brn npgt prgrmg addl 15.
96105.............................  Assessment of aphasia.
96110.............................  Developmental screen w/score.
96112.............................  Devel tst phys/qhp 1st hr.
96113.............................  Devel tst phys/qhp ea addl.
96116.............................  Neurobehavioral status exam.
96121.............................  Nubhvl xm phy/qhp ea addl hr.
96125.............................  Cognitive test by hc pro.
96127.............................  Brief emotional/behav assmt.
96130.............................  Psycl tst eval phys/qhp 1st.
96131.............................  Psycl tst eval phys/qhp ea.
99453.............................  Rem mntr physiol param setup.
99457.............................  Rem physiol mntr 20 min mo.
99491.............................  Chrnc care mgmt svc 30 min.
G0166.............................  Extrnl counterpulse, per tx.
------------------------------------------------------------------------

I. Evaluation & Management (E/M) Visits

1. Background
a. E/M Visits Coding Structure
    Physicians and other practitioners paid under the PFS bill for 
common office visits for evaluation and management (E/M) services under 
a relatively generic set of CPT codes (Level I HCPCS codes) that 
distinguish visits based on the level of complexity, site of service, 
and whether the patient is new or established. The CPT codes have three 
key components:
     History of Present Illness (History),
     Physical Examination (Exam) and
     Medical Decision Making (MDM).
    These codes are broadly referred to as E/M visit codes. There are 
three to five E/M visit code levels, depending on site of service and 
the extent of the three components of history, exam and MDM. For 
example, there are three to four levels of E/M visit codes in the 
inpatient hospital and nursing facility settings, based on a relatively 
narrow degree of complexity in those settings. In contrast, there are 
five levels of E/M visit codes in the office or other outpatient 
setting based on a broader range of complexity in those settings.
    Current PFS payment rates for E/M visit codes increase with the 
level of visit billed. As for all services under the PFS, the rates are 
based on the resources in terms of work (time and intensity), PE and 
malpractice expense required to furnish the typical case of the 
service. The current payment rates reflect typical service times for 
each code that are based on RUC recommendations.
    In total, E/M visits comprise approximately 40 percent of allowed 
charges for PFS services, and office/outpatient E/M visits comprise 
approximately 20 percent of allowed charges for PFS services. Within 
these percentages, there is significant variation among specialties. 
According to Medicare claims data, E/M visits are furnished by nearly 
all specialties, but represent a greater share of total allowed 
services for physicians and other practitioners who do not routinely 
furnish procedural interventions or diagnostic tests. Generally, these 
practitioners include both primary care practitioners and specialists 
such as neurologists, endocrinologists and rheumatologists. Certain 
specialties, such as podiatry, tend to furnish lower level E/M visits 
more often than higher level E/M visits. Some specialties, such as 
dermatology and otolaryngology, tend to bill more E/M visits on the 
same day as they bill minor procedures.
    Potential misvaluation of E/M codes is an issue that we have been 
carefully considering for several years. We have discussed at length in 
our recent PFS proposed and final rules that the E/M visit code set is 
outdated and needs to be revised and revalued (for example: 81 FR 46200 
and 76 FR 42793). We have noted that this code set represents a high 
proportion of PFS expenditures, but has not been recently revalued to 
account for significant changes in the disease burden of the Medicare 
patient population and changes in health care practice that are 
underway to meet the Medicare population's health care needs (81 FR 
46200). In the CY 2012 PFS proposed rule, we proposed to refer all E/M 
codes to the RUC for review as potentially misvalued (76 FR 42793). 
Many commenters to that rule were concerned about the possible 
inadequacies of the current E/M coding and documentation structure to 
address evolving chronic care management and to support primary care 
(76 FR 73060 through 73064). We did not finalize our proposal to refer 
the E/M codes for RUC review at that time. Instead, we stated that we 
would allow time for consideration of the findings of certain 
demonstrations and other initiatives to provide improved information 
for the valuation of chronic care management, primary care, and care 
transitions. We stated that we would also continue to consider the 
numerous policy alternatives that commenters offered, such as separate 
E/M codes for established visits for patients with chronic disease 
versus a post-surgical follow-up office visit.
    Many stakeholders continue to similarly express to us through 
letters, meetings, public comments in past rulemaking cycles, and other 
avenues, that the E/M code set is outdated and needs to be revised. For 
example, some stakeholders recommend an extensive research effort to 
revise and revalue E/M services, especially physician work inputs (CY 
2017 PFS final rule, 81 FR 80227-80228). In recent years, we have 
continued to consider the best ways to recognize the significant 
changes in health care practice, especially innovations in the active 
management and ongoing care of chronically ill patients, under the PFS. 
We have been engaged in an ongoing, incremental effort to identify gaps 
in appropriate coding and payment.
b. E/M Documentation Guidelines
    For coding and billing E/M visits to Medicare, practitioners may 
use one of two versions of the E/M Documentation Guidelines for a 
patient encounter, commonly referenced based on the year of their 
release: the ``1995'' or ``1997'' E/M Documentation Guidelines. These 
guidelines are available on the CMS website.\3\ They specify the 
medical record information within each of the three key components 
(such as number of body systems reviewed) that serves as support for 
billing a given level of E/M visit. The 1995 and 1997 guidelines are 
very similar to the guidelines that reside within the AMA's CPT 
codebook for E/M visits. For example, the core structure of what 
comprises or defines the different levels of history, exam, and medical 
decision-making are the same. However, the 1995 and 1997 guidelines 
include extensive examples of clinical work that comprise different 
levels of medical decision-making and do not appear in the AMA's CPT 
codebook. Also, the 1995 and 1997 guidelines do not contain references 
to preventive care that appear in the AMA's CPT codebook. We provide an 
example of how the 1995 and 1997 guidelines distinguish between level 2 
and level 3 E/M visits in Table 18.
---------------------------------------------------------------------------

    \3\ See https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/95Docguidelines.pdf; 
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/97Docguidelines.pdf; and the 
Evaluation and Management Services guide at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/eval-mgmt-serv-guide-ICN006764.pdf.
---------------------------------------------------------------------------

BILLING CODE 4120-01-P

[[Page 59626]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.287

BILLING CODE 4120-01-C
    According to both Medicare claims processing manual instructions 
and CPT coding rules, when counseling and/or coordination of care 
accounts for more than 50 percent of the face-to-face physician/patient 
encounter (or, in the case of inpatient E/M services, the floor time) 
the duration of the visit can be used as an alternative basis to select 
the appropriate E/M visit level (Pub. L. 100-04, Medicare Claims 
Processing Manual, Chapter 12, Section 30.6.1.C available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf; see also 2017 CPT Codebook Evaluation and Management 
Services Guidelines, page 10). Public Law 100-04, Medicare Claims 
Processing Manual, Chapter 12, Section 30.6.1.B states, ``Instruct 
physicians to select the code for the service based upon the content of 
the service. The duration of the visit is an ancillary factor and does 
not control the level of the service to be billed unless more than 50 
percent of the face-to-face time (for non-inpatient services) or more 
than 50 percent of the floor time (for inpatient services) is spent 
providing counseling or coordination of care as described in subsection 
C.'' Subsection C states that ``the physician may document time spent 
with the patient in conjunction with the medical decision-making 
involved and a description of the coordination of care or counseling 
provided. Documentation must be in sufficient detail to support the 
claim.'' The example included in subsection C further states, ``The 
code selection is based on the total time of the face-to-face encounter 
or floor time, not just the counseling time. The medical record must be 
documented in sufficient detail

[[Page 59627]]

to justify the selection of the specific code if time is the basis for 
selection of the code.''
    Both the 1995 and 1997 E/M guidelines contain guidelines that 
address time, which state that ``In the case where counseling and/or 
coordination of care dominates (more than 50 percent of) the physician/
patient and/or family encounter (face-to-face time in the office or 
other outpatient setting or floor/unit time in the hospital or nursing 
facility), time is considered the key or controlling factor to qualify 
for a particular level of E/M services.'' The guidelines go on to state 
that ``If the physician elects to report the level of service based on 
counseling and/or coordination of care, the total length of time of the 
encounter (face-to-face or floor time, as appropriate) should be 
documented and the record should describe the counseling and/or 
activities to coordinate care.'' \4\
---------------------------------------------------------------------------

    \4\ Page 16 of the 1995 E/M guidelines and page 48 of the 1997 
guidelines.
---------------------------------------------------------------------------

    We note that other manual provisions regarding E/M visits that are 
cited in this final rule are housed separately within Medicare's 
Internet-Only Manuals, and are not contained within the 1995 or 1997 E/
M documentation guidelines.
    In accordance with section 1862(a)(1)(A) of the Act, which requires 
services paid under Medicare Part B to be reasonable and necessary for 
the diagnosis or treatment of illness or injury or to improve the 
functioning of a malformed body member, medical necessity is a 
prerequisite to Medicare payment for E/M visits. The Medicare Claims 
Processing Manual states, ``Medical necessity of a service is the 
overarching criterion for payment in addition to the individual 
requirements of a CPT code. It would not be medically necessary or 
appropriate to bill a higher level of evaluation and management service 
when a lower level of service is warranted. The volume of documentation 
should not be the primary influence upon which a specific level of 
service is billed. Documentation should support the level of service 
reported'' (Pub. L. 100-04, Medicare Claims Processing Manual, Chapter 
12, Section 30.6.1.A., available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf).
    Stakeholders have long maintained that all of the E/M documentation 
guidelines are administratively burdensome and outdated with respect to 
the practice of medicine. Stakeholders have provided CMS with examples 
of such outdated material (on history, exam and MDM) that can be found 
within all versions of the E/M guidelines (the AMA's CPT codebook, the 
1995 guidelines and the 1997 guidelines). Stakeholders have told CMS 
that they believe the guidelines are too complex, ambiguous, fail to 
meaningfully distinguish differences among code levels, and are not 
updated for changes in technology, especially electronic health record 
(EHR) use. Prior attempts to revise the E/M guidelines were 
unsuccessful or resulted in additional complexity due to lack of 
stakeholder consensus (with widely varying views among specialties), 
and differing perspectives on whether code revaluation would be 
necessary under the PFS as a result of revising the guidelines, which 
contributed another layer of complexity to the considerations. For 
example, an early attempt to revise the guidelines resulted in an 
additional version designed for use by certain specialties (the 1997 
version), and in CMS allowing the use of either the 1995 or 1997 
versions for purposes of documentation and billing to Medicare. Another 
complication in revising the guidelines is that they are also used by 
many other payers, which have their own payment rules and audit 
protocols. Moreover, stakeholders have suggested that there is 
sometimes variation in how Medicare's own contractors (Medicare 
Administrative Contractors (MACs)) interpret and apply the guidelines 
as part of their audit processes.
    As previously mentioned, in recent years, some clinicians and other 
stakeholders have requested a major CMS research initiative to overhaul 
not only the E/M documentation guidelines, but also the underlying 
coding structure and valuation. Stakeholders have reported to CMS that 
they believe the E/M visit codes themselves need substantial updating 
and revaluation to reflect changes in the practice of medicine, and 
that revising the documentation guidelines without addressing the codes 
themselves simply preserves an antiquated framework for payment of E/M 
services.
    Last year, CMS sought public comment on potential changes to the E/
M documentation rules, deferring making any changes to E/M coding 
itself in order to immediately focus on revision of the E/M guidelines 
to reduce unnecessary administrative burden (82 FR 34078 through 
34080). In the CY 2018 PFS final rule (82 FR 53163 through 53166), we 
summarized the public comments we received and stated that we would 
take that feedback into consideration for future rulemaking. In 
response to commenters' request that we provide additional venues for 
stakeholder input, we held a listening session this year on March 18, 
2018 (transcript and materials are available on the CMS website at 
https://www.cms.gov/Outreach-and-Education/Outreach/NPC/National-Provider-Calls-and-Events-Items/2018-03-21-Documentation-Guidelines-and-Burden-Reduction.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending). We 
also sought input by participating in several listening sessions 
recently hosted by the Office of the National Coordinator for Health 
Information Technology (ONC) in the course of implementing section 
4001(a) of the 21st Century Cures Act (Pub. L. 114-255). This provision 
requires the Department of Health and Human Services to establish a 
goal, develop a strategy, and make recommendations to reduce regulatory 
or administrative burdens relating to the use of EHRs. The ONC 
listening sessions sought public input on the E/M guidelines as one 
part of broader, related and unrelated burdens associated with EHRs.
    Several themes emerged from this recent stakeholder input. 
Stakeholders commended CMS for undertaking efforts to revise the E/M 
guidelines and recommended a multi-year process. Many commenters 
advised CMS to obtain further input across specialties. They 
recommended town halls, open door forums or a task force that would 
come up with replacement guidelines that would work for all specialties 
over the course of several years. They urged CMS to proceed cautiously 
given the magnitude of the undertaking; past failed reform attempts by 
the AMA, CMS, and other payers; and the wide-ranging impact of any 
changes (for example, how other payers approach the issue).
    We received substantially different recommendations by specialty. 
Based on this feedback, it is clear that any changes would have 
meaningful specialty-specific impacts, both clinical and financial. 
Based on this feedback, it also seems that the history and exam 
portions of the guidelines are most significantly outdated with respect 
to current clinical practice.
    A few stakeholders seemed to indicate that the documentation 
guidelines on history and exam should be kept in their current form. 
Many stakeholders believed they should be simplified or reduced, but 
not eliminated. Some stakeholders indicated that the documentation 
guidelines on history and exam could be eliminated altogether, and/or 
that documentation of these parts of an E/M visit could be left

[[Page 59628]]

to practitioner discretion. We also heard from stakeholders that the 
degree to which an extended history and exam enables a given 
practitioner to reach a certain level of coding (and payment) varies 
according to their specialty. Many commenters advised CMS to increase 
reliance on medical decision-making (MDM) and time in determining the 
appropriate level of E/M visit, or to use MDM by itself, but many of 
these commenters noted that the MDM portions of the guidelines would 
need to be altered before being used alone. Commenters were divided on 
the role of time in distinguishing among E/M visit levels, and 
expressed some concern about potential abuse or inequities among more- 
or less-efficient practitioners. Some commenters expressed support for 
simplifying E/M coding generally into three levels such as low, medium 
and high, and potentially distinguishing those levels on the basis of 
time.
2. CY 2019 Final Policies
a. Overview
    Having considered the public feedback to the CY 2018 PFS proposed 
rule (82 FR 53163 through 53166) and our other outreach efforts 
described above, in our CY 2019 proposed rule, we proposed several 
changes to E/M visit documentation and payment. We proposed that the 
changes would only apply to office/outpatient visit codes (CPT codes 
99201 through 99215), except where we specify otherwise. We agreed with 
commenters that we should take a step-wise approach to these issues, 
and therefore, we limited proposed changes to the office/outpatient E/M 
code set. We understood from commenters that there are more unique 
issues to consider for the E/M code sets used in other settings such as 
inpatient hospital or emergency department care, such as unique 
clinical and legal issues and the potential intersection with hospital 
Conditions of Participation (CoPs). We may consider expanding our 
efforts more broadly to address sections of the E/M code set beyond the 
office/outpatient codes in future years.
    We emphasized that, this year, we included our proposed E/M 
documentation changes in a proposed rule due to the longstanding nature 
of our instruction that practitioners may use either the 1995 or 1997 
versions of the E/M guidelines to document E/M visits billed to 
Medicare, the magnitude of the proposed changes, and the associated 
payment policy proposals that require notice and comment rulemaking. We 
believed our proposed documentation changes for E/M visits were 
intrinsically related to our proposal to alter PFS payment for E/M 
visits, and the PFS payment proposal for E/M visits required notice and 
comment rulemaking. We noted that we were proposing a relatively broad 
outline of changes, and anticipated that many details related to 
program integrity and ongoing refinement would need to be developed 
over time through subregulatory guidance. This would afford flexibility 
and enable us to more nimbly and quickly make ongoing clarifications, 
changes and refinements in response to continued practitioner 
experience moving forward.
    We put forth a key proposal that, at its core, strived to reduce 
the significant burden associated with documentation for payment 
purposes by eliminating the payment rules associated with the current 
primary means of varying payment among office/outpatient visits. 
Specifically, we proposed to develop single payment rates for the 
office/outpatient E/M visit levels 2 through 5 (one rate for 
established patients, and one rate for new patients), in order to 
mitigate the need for physicians and other practitioners to adhere to 
complex payment-specific documentation rules for each and every visit 
furnished to a Medicare beneficiary. If there were minimal payment 
variation based on the level of visit billed, then there would be 
minimal need to engage with the burdensome and outdated documentation 
guidelines and E/M visit coding to justify that the appropriate level 
visit was reported. Though we acknowledged a continued need to document 
information in the medical record for clinical and other purposes, our 
understanding based on extensive feedback from medical professionals 
was that the documentation specific to justifying the visit level 
reported to payers, including Medicare, was unduly and 
disproportionately burdensome among the many administrative burdens in 
current medical practice. To avoid the administrative burden and 
disruption of establishing a new G code to describe the level 2 through 
5 combined visit, under our proposal practitioners would continue to 
report on the claim the CPT code associated with the level of visit the 
practitioner believed they furnished.
    Along with eliminating payment variation for office/outpatient E/M 
visit levels 2 through 5, we proposed a series of corollary policies 
intended to vary payment for these visits based on a more meaningful 
set of attributes for visits. Our goal was that these payment 
variations, accomplished through new add-on and other coding changes, 
and multiple procedure payment reductions, would reflect the relative 
resource costs of furnishing E/M visits without requiring detailed 
documentation for purposes of justifying particular payment rates. We 
also expected these adjustments to offset some of the more significant 
potentially redistributive impacts of this proposal, especially among 
physicians and practitioners of different specialties. The potential 
redistributive impacts helped us to determine potential, initial values 
for the proposed add-on codes providing for the adjustments. Again, 
these proposals were intended to provide a more meaningful avenue for 
payment variation that would ease the documentation burdens currently 
faced by clinicians to justify the visit level that is reported for 
each and every visit with a beneficiary. These proposals reflected our 
longstanding beliefs that: There are certain complexities inherent in 
furnishing some kinds of E/M visits that are not currently accounted 
for in valuations for the current E/M code set, there are unaccounted-
for efficiencies when E/M visits are billed on the same day as global 
procedure codes that are already valued to include resources associated 
with E/M services, and the current E/M coding system does not fully 
account for the variety of legitimate circumstances when the needs of 
individual patients require more time with their physicians. We also 
proposed to establish unique E/M visit codes for podiatric care and 
make changes to the PE methodology in order to standardize the amount 
of PE RVUs allocated for this series of codes, regardless of which 
specialties were assumed to bill them.
    In conjunction with our proposal to effectively eliminate the 
variation in payment of choosing from among E/M visit levels 2 through 
5 for office/outpatient visits, we proposed a minimum level of 
associated documentation that would apply for payment purposes across 
all level 2 through 5 office/outpatient E/M visits. We also proposed to 
allow practitioners a choice regarding the basis for their 
documentation for these visits: Current documentation guidelines 
(history, exam and MDM); MDM alone; or time alone. We proposed that, 
when using current documentation guidelines or MDM, the current 
guidelines for level 2 visits would apply. When using time to document 
a visit, the practitioner would be required to demonstrate the medical 
necessity of the visit and report the total amount of face-to-face time 
they spent with the beneficiary. We solicited public comment on what 
the total time

[[Page 59629]]

requirement should be when using time to document a level 2 through 5 
visit. We presented several alternatives for determining the amount of 
time associated with each visit level: The new intra-service times 
associated with setting the payment rate for the visit codes, the 
midpoint of these new times, or the typical time for the CPT code 
reported on the claim (the time listed in the AMA/CPT codebook for that 
code) (83 FR 35837).
    We sought feedback in particular on the option to document using 
time when prolonged E/M services are billed. We proposed that when a 
practitioner uses time to document the visit and also reports prolonged 
E/M services, we would require the practitioner to document that the 
typical time required for the base or ``companion'' visit is exceeded 
by the amount required to report prolonged services (83 FR 35837). We 
did not propose any changes to CPT codes 99354 and 99355, and under our 
proposal these codes could still be billed, as needed, when their time 
thresholds and all other requirements are met (83 FR 35774).
    Since we proposed to create a single payment rate under the PFS 
that would be paid for services billed using the current CPT codes for 
level 2 through 5 visits, it would not be material to Medicare's 
payment decision which CPT code (of levels 2 through 5) would be 
reported on the claim, except to justify billing a level 2 or higher 
visit in comparison to a level 1 visit (providing the visit itself was 
reasonable and necessary) and when using certain potential approaches 
to documenting the visit using time (83 FR 35836 through 35837). 
However, we expected that for record keeping purposes or to meet 
requirements of other payers, practitioners would continue to choose 
and report the level of E/M visit they believed to be appropriate under 
the current CPT coding structure.
    We also proposed to remove an existing manual provision for home 
visits requiring documentation in the patient's medical record of the 
medical necessity of furnishing the visit in the home. For all office/
outpatient E/M visits, we also proposed several simplifications 
centered on reducing the need for duplicative, redundant data entry in 
the medical record.
    Several thousand commenters responded to this series of proposals. 
Generally, the commenters stated appreciation for CMS' goal of reducing 
administrative burden and reforming E/M coding and payment, but 
expressed concern about many impacts of the proposals. Commenters 
largely objected to our proposal to eliminate payment differences for 
office/outpatient E/M visit levels 2 through 5 based on the level of 
visit complexity. Many commenters stated that they would experience 
payment cuts relative to the current payment structure. Commenters 
generally stated that the implementation timeframe for the changes as 
proposed was too aggressive, especially since stakeholders were 
uncertain as to whether other payers would follow Medicare's proposed 
policies. Many commenters suggested that CMS could implement the 
proposed documentation reduction without the coding/payment policies, 
or that these policies could be adopted on separate timeframes.
    Many commenters suggested that the proposals did not specify the 
circumstances in which the proposed add-on codes for office/outpatient 
E/M visits could be used, and what documentation requirements might be 
adopted for them. Many commenters stated that it would be better if the 
physician community could consider a range of alternative coding and 
payment options to be modeled and thoroughly evaluated over several 
years instead of a single alternative during a 60-day public comment 
period.
    Many commenters opposed our proposal to establish that clinicians 
billing an office/outpatient E/M visit level 2 through 5 need only 
document medical necessity as specified for a level 2 visit (unless 
time is used as the basis for the visit level). Some commenters 
supported allowing a choice of documentation methodologies, while 
others opposed it. The vast majority of commenters did not support 
having only a single payment level to distinguish visit complexity 
(other than level 1), despite the associated minimum documentation that 
we proposed for these codes. Most commenters noted that CMS did not 
provide enough specificity in its proposals for how clinicians would 
document using time, and that because the definitions and billing rules 
regarding the add-on codes were ambiguous, they questioned whether the 
codes would have clinical validity. Regarding the valuation of these 
services, some commenters stated that the proposal did not follow the 
statutory requirement regarding using relative resources to set PFS 
rates. Others perceived that some of the newly proposed codes would be 
required or restricted based on physician specialty, and that such 
limitations would violate statutory provisions prohibiting varying 
payment for the same physicians' service by physician specialty.
    Many commenters recommended that CMS finalize the documentation 
proposals regarding home visits and redundant data recording for 2019, 
but defer other documentation reforms to future years after 
stakeholders provide additional input. Some commenters recommended that 
CMS finalize the proposed choice among documentation methodologies 
while stakeholders work with CMS to refine what the coding and payment 
changes should be.
    After considering the comments, for 2019 we are finalizing several 
of our documentation proposals that will provide some significant and 
immediate burden reduction, but are unrelated to changes to payment and 
coding. Specifically, we are finalizing the proposals regarding home 
visits and redundant data recording (discussed further in this 
section), as proposed, effective January 1, 2019.
    After considering the comments, especially those suggesting that 
implementation of significant payment and coding changes requires time 
for practitioners, vendors, health systems, and other stakeholders to 
prepare, we are finalizing modified changes in payment coding, and 
associated documentation rules for E/M office/outpatient visits for 
2021. These changes, detailed below, incorporate many significant 
changes from our proposals based on suggestions from the many comments 
we received. In brief summation, we are finalizing a significant 
reduction in the current payment variation in office/outpatient E/M 
visit levels by paying a single rate for E/M office/outpatient visit 
levels 2, 3, and 4 (one for established and another for new patients) 
beginning in 2021. However, we are not finalizing the inclusion of E/M 
office/outpatient level 5 visits in the single payment rate, to better 
account for the care and needs of particularly complex patients. Also, 
after consideration of public comments, we are not finalizing aspects 
of our proposal that would have: Reduced payment when E/M office/
outpatient visits are furnished on the same day as procedures, 
established separate podiatric E/M visit codes, or standardized the 
allocation of PE RVUs for the codes that describe these services. We 
are finalizing a policy for 2021 to adopt add-on codes that describe 
the additional resources inherent in visits for primary care and 
particular kinds of specialized medical care. As discussed further 
below, these codes will only be reportable with E/M office/outpatient 
level 2 through 4 visits, and their use generally will not impose new 
per-visit documentation requirements. These codes are neither required 
nor restricted by physician specialty, though we acknowledge that,

[[Page 59630]]

like many other physicians' services for which payment is made under 
the PFS, they are specifically intended to describe services that 
clinicians practicing in some specialties are more likely to perform 
than those in other specialties. We are also finalizing a policy for 
2021 to adopt a new ``extended visit'' add-on code for use only with E/
M office/outpatient level 2 through 4 visits to account for the 
additional resources required when practitioners need to spend extended 
time with the patient.
    For CY 2019 and 2020, we will continue the current coding and 
payment structure for E/M office/outpatient visits, and, therefore, 
practitioners should continue to use either the 1995 or 1997 versions 
of the E/M guidelines to document E/M office/outpatient visits billed 
to Medicare for 2019 and 2020 (with the exception of our final policy 
to eliminate redundant data recording).
    Beginning in 2021, for E/M office/outpatient levels 2 through 5 
visits, we will allow for flexibility in how visit levels are 
documented, specifically a choice to use the current framework, MDM or 
time. For E/M office/outpatient level 2 through 4 visits, beginning in 
2021 we will also apply a minimum supporting documentation standard 
associated with level 2 visits when practitioners use the current 
framework or MDM to document the visit.
    We intend to engage in further discussions with the public over the 
next several years to potentially further refine our policies, through 
future notice and comment rulemaking, for 2021. We discuss the public 
comments, our responses to the specific concerns and perspectives 
offered by commenters, and final policies in greater detail in this 
section.
b. Public Comments and Responses
(1) Lifting Restrictions Related to E/M Documentation
(a) Eliminating Extra Documentation Requirements for Home Visits
    Medicare pays for E/M visits furnished in the home (a private 
residence) under CPT codes 99341 through 99350. The payment rates for 
these codes are slightly more than for office visits (for example, 
approximately $30 more for a level 5 established patient, non-
facility). The beneficiary need not be confined to the home to be 
eligible for such a visit. However, there is a Medicare Claims 
Processing Manual provision requiring that the medical record must 
document the medical necessity of the home visit made in lieu of an 
office or outpatient visit (Pub. 100-04, Medicare Claims Processing 
Manual, Chapter 12, Section 30.6.14.1.B., available on the CMS website 
at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf). Stakeholders have suggested that whether a 
visit occurs in the home or the office is best determined by the 
practitioner and the patient without applying additional rules. We 
agreed, so we proposed to remove the requirement that the medical 
record must document the medical necessity of furnishing the visit in 
the home rather than in the office. We welcomed public comments on this 
proposal, including any potential, unintended consequences of 
eliminating this requirement.
    Comment: Commenters were generally supportive of our proposal to 
remove the requirement that the medical record must document the 
medical necessity of furnishing the visit in the home rather than in 
the office. Many commenters included this proposal in a list of 
appropriate changes CMS should make immediately regarding documentation 
of E/M visits, effective January 1, 2019.
    Response: We are finalizing this policy change to remove the 
requirement that the medical record must document the medical necessity 
of furnishing the visit in the home rather than in the office, as 
proposed, effective January 1, 2019.
(b) Public Comment Solicitation on Eliminating Prohibition on Billing 
Same-Day Visits by Practitioners of the Same Group and Specialty
    The Medicare Claims Processing Manual states, ``As for all other E/
M services except where specifically noted, the Medicare Administrative 
Contractors (MACs) may not pay two E/M office visits billed by a 
physician (or physician of the same specialty from the same group 
practice) for the same beneficiary on the same day unless the physician 
documents that the visits were for unrelated problems in the office, 
off campus-outpatient hospital, or on campus-outpatient hospital 
setting which could not be provided during the same encounter'' (Pub. 
100-04, Medicare Claims Processing Manual, Chapter 12, Section 
30.6.7.B., available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf).
    This instruction was intended to reflect the idea that multiple 
visits with the same practitioner, or by practitioners in the same or 
very similar specialties within a group practice, on the same day as 
another E/M service would not be medically necessary. However, 
stakeholders have provided a few examples where this policy does not 
make sense with respect to the current practice of medicine as the 
Medicare enrollment specialty does not always coincide with all areas 
of medical expertise possessed by a practitioner--for example, a 
practitioner with the Medicare enrollment specialty of geriatrics may 
also be an endocrinologist. If such a practitioner was one of many 
geriatricians in the same group practice, they would not be able to 
bill separately for an E/M visit focused on a patient's 
endocrinological issue if that patient had another more generalized E/M 
visit by another geriatrician on the same day. Stakeholders have 
pointed out that in these circumstances, practitioners often respond to 
this instruction by scheduling the E/M visits on two separate days, 
which could unnecessarily inconvenience the patient. Given that the 
number and granularity of practitioner specialties recognized for 
purposes of Medicare enrollment continue to increase over time 
(consistent with the medical community's requests), the value to the 
Medicare program of the prohibition on same-day E/M visits billed by 
physicians in the same group and medical specialty may be diminishing, 
especially as we believe it is becoming more common for practitioners 
to have multiple specialty affiliations, but would have only one 
primary Medicare enrollment specialty. We believe that eliminating this 
policy may better recognize the changing practice of medicine while 
reducing administrative burden. The impact of this proposal on program 
expenditures and beneficiary cost sharing is unclear. To the extent 
that many of these services are currently merely scheduled and 
furnished on different days in response to the instruction, eliminating 
this manual provision may not significantly increase utilization, 
Medicare spending and beneficiary cost sharing.
    We solicited public comment on whether we should eliminate the 
manual provision given the changes in the practice of medicine or 
whether there is concern that eliminating it might have unintended 
consequences for practitioners and beneficiaries.
    We recognize that this instruction may be appropriate only in 
certain clinical situations, so we also solicited public comments on 
whether and how we should consider creating exceptions to, or modify 
this manual provision rather than eliminating it entirely. We also 
requested that the public provide additional examples and situations in

[[Page 59631]]

which the current instruction is not clinically appropriate.
    Comment: We received many comments in response to this 
solicitation.
    Response: We thank the commenters for all of the information 
submitted, and will review the many public comments we received on this 
topic and consider this issue further for potential future rulemaking.
(2) Documentation Changes for Office or Other Outpatient E/M Visits and 
Home Visits
(a) Providing Choices in Documentation--Medical Decision-Making, Time 
or Current Framework
    Informed by comments and examples that we have received stating 
that the current E/M documentation guidelines are outdated with respect 
to the current practice of medicine, and in our efforts to simplify 
documentation for the purposes of coding E/M visit levels, we proposed 
to allow practitioners to choose, as an alternative to the current 
framework specified under the 1995 or 1997 guidelines, either MDM or 
time as a basis to determine the appropriate level of E/M visit. This 
would allow different practitioners in different specialties to choose 
to document the factor(s) that matter most given the nature of their 
clinical practice. It would also reduce the impact Medicare may have on 
the standardized recording of history, exam and MDM data in medical 
records, since practitioners could choose to no longer document many 
aspects of an E/M visit that they currently document under the 1995 or 
1997 guidelines for history, physical exam and MDM. Although we 
initially considered reducing the number of key components that 
practitioners needed to document in choosing the appropriate level of 
E/M service to bill, feedback from the stakeholder community led us to 
believe that offering practitioners a choice to either retain the 
current framework or choose among new options that involve a reduced 
level of documentation would be less burdensome for practitioners, and 
would allow more stability for practitioners who may need time to 
prepare for any potential new documentation framework.
    We sought to be clear that as part of this proposal, practitioners 
could use MDM, or time, or they could continue to use the current 
framework to document an E/M visit. In other words, we would be 
offering the practitioner the choice to continue to use the current 
framework by applying the 1995 or 1997 documentation guidelines for all 
three key components. However, our proposals on payment for office-
based/outpatient E/M visits described later in this section would apply 
to all practitioners, regardless of their selected documentation 
approach. Under our proposal, all practitioners, even those choosing to 
retain the current documentation framework, would be paid at the 
proposed new payment rate described in the CY 2019 PFS proposed rule 
(one rate for new patients and another for established patients), and 
could also report applicable G-codes as we proposed (83 FR 35839 
through 35843).
    We also sought to be clear that we proposed to retain the current 
CPT coding structure for E/M visits (along with our proposal to create 
new replacement codes for podiatry office/outpatient E/M visits). 
Practitioners would report on the professional claim whatever level of 
visit (1 through 5) they believe they furnished using CPT codes 99201-
99215. Because we believed the adoption of replacement G-codes to 
describe the visit levels 2 through 5 might result in unnecessary 
disruption to current billing systems and practices, we did not propose 
to modify the existing CPT coding structure for E/M visits. Since we 
proposed to create a single rate under the PFS that would be paid for 
services billed using the current CPT codes for level 2 through 5 E/M 
visits, under our proposal, it would not have been material to 
Medicare's payment decision which CPT code (of levels 2 through 5) is 
reported on the claim, except to justify billing a level 2 or higher 
visit in comparison to a level 1 visit (provided the visit itself was 
reasonable and necessary). We stated that we expected that, for record 
keeping purposes or to meet requirements of other payers, many 
practitioners would continue to choose and report the level of E/M 
visit they believed to be appropriate under the CPT coding structure.
    Even though under our proposal, there would have been no payment 
differential for E/M visits based on which of the codes describing 
visit levels 2 through 5 were reported, we believed we would still need 
to simplify and change our documentation requirements to better align 
with the current practice of medicine and eliminate unnecessary aspects 
of the current documentation framework. As a corollary to our proposal 
to adopt a single payment amount for office/outpatient E/M visit levels 
2 through 5 (83 FR 35839 through 35843), we proposed to apply a minimum 
documentation standard where, for the purposes of PFS payment for an 
office/outpatient E/M visit, practitioners would only need to meet 
documentation requirements currently associated with a level 2 visit 
for history, exam and/or MDM, except when using time to document the 
service. Practitioners could choose to document more information for 
clinical, legal, operational or other purposes, and we anticipated that 
for those reasons, practitioners would continue generally to seek to 
document medical record information that is consistent with the level 
of care furnished. For purposes of our medical review, however, for 
practitioners using the current documentation framework or, as we 
proposed, MDM, Medicare would only require documentation to support the 
medical necessity of the visit and the documentation that is associated 
with the current level 2 CPT visit code.
    For example, for a practitioner choosing to document using the 
current framework (1995 or 1997 guidelines), our proposed minimum 
documentation for any billed level of E/M visit from levels 2 through 5 
could include: (1) A problem-focused history that does not include a 
review of systems or a past, family, or social history; (2) a limited 
examination of the affected body area or organ system; and (3) 
straightforward medical decision making measured by minimal problems, 
data review, and risk (two of these three). If the practitioner was 
choosing to document based on MDM alone, Medicare would only require 
documentation supporting straightforward medical decision-making 
measured by minimal problems, data review, and risk (two of these 
three).
    Some commenters had suggested that the current framework of 
guidelines for the MDM component of visits would need to be changed 
before MDM could be relied upon by itself to distinguish visit levels. 
We proposed to allow practitioners to rely on MDM in its current form 
to document their visit, and solicited public comment on whether and 
how guidelines for MDM might be changed in subsequent years.
    As described earlier, we currently allow time or duration of visit 
to be used as the governing factor in selecting the appropriate E/M 
visit level only when counseling and/or coordination of care accounts 
for more than 50 percent of the face-to-face physician/patient 
encounter (or, in the case of inpatient E/M services, the floor time). 
Our proposal to allow practitioners the choice of using time to 
document office/outpatient E/M visits would have meant that this time-
based standard is not limited to E/M visits in which counseling and/or 
care coordination

[[Page 59632]]

accounts for more than 50 percent of the face-to-face practitioner/
patient encounter. Rather, the amount of time personally spent by the 
billing practitioner face-to-face with the patient could be used to 
document the E/M visit regardless of the amount of counseling and/or 
care coordination furnished as part of the face-to-face encounter.
    Some commenters had raised concerns with reliance on time to 
distinguish visit levels, for example the potential for abuse, 
inequities among more- or less-efficient practitioners, and specialties 
for which time is less of a factor in determining visit complexity. We 
noted in the proposed rule that relying on time as the basis for 
identifying the E/M visit level would also raise the issue of what 
would be required by way of supporting documentation; for example, what 
amount of time should be documented, and whether the specific 
activities comprising the time need to be documented and to what 
degree. However, a number of stakeholders had suggested that, within 
their specialties, time is a good indicator of the complexity of the 
visit or patient, and requested that we allow practitioners to use time 
as the single factor in all E/M visits, not just when counseling or 
care coordination dominate a visit. We agreed that for some 
practitioners and patients, time may be a good indicator of complexity 
of the visit, and proposed to allow practitioners the option to use 
time as the single factor in selecting visit level and documenting the 
E/M visit, regardless of whether counseling or care coordination 
dominate the visit. We stated that if finalized, we would monitor the 
results of this policy for any program integrity issues, administrative 
burden or other issues.
    For practitioners choosing to support their coding and payment for 
an E/M visit by documenting the amount of time spent with the patient, 
we proposed to require the practitioner to document the medical 
necessity of the visit and show the total amount of time spent by the 
billing practitioner face-to-face with the patient. We solicited public 
comment on what that total time should be for payment of the single, 
new rate for E/M visits levels 2 through 5. We presented the typical 
time for our proposed new single payment for E/M visit levels 2 through 
5 (the weighted average of the intra-service times across the current 
E/M visit utilization) and suggested we could use this time. We noted 
that currently the PFS does not require the practitioner to spend or 
document a specified amount of time with a given patient in order to 
receive payment for an E/M visit, unless the visit is dominated by 
counseling/care coordination and, on that account, the practitioner is 
using time as the basis for code selection. The times for E/M visits 
and most other PFS services in the physician time files, which are used 
to set PFS rates, are typical times rather than requirements, and were 
recommended by the AMA RUC and then reviewed and either adopted or 
adjusted for Medicare through our usual ratesetting process as 
``typical,'' but not strictly required.
    We presented a potential alternative to apply the AMA's CPT 
codebook provision that, for timed services, a unit of time is attained 
when the mid-point is passed,\5\ such that we would require 
documentation that at least 16 minutes for an established patient (more 
than half of 31 minutes) and at least 20 minutes for a new patient 
(more than half of 38 minutes) were spent face-to-face by the billing 
practitioner with the patient, to support making payment at the 
proposed single rate for visit levels 2 through 5 when the practitioner 
chose to document the visit using time.
---------------------------------------------------------------------------

    \5\ 2017 CPT Codebook Introduction, p.xv.
---------------------------------------------------------------------------

    We presented another potential alternative to require documentation 
that the typical time for the CPT code that is reported (which is also 
the typical time listed in the AMA's CPT codebook for that code) was 
spent face-to-face by the billing practitioner with the patient. For 
example, a practitioner reporting CPT code 99212 (a level 2 established 
patient visit) would be required to document having spent a minimum of 
10 minutes, and a practitioner reporting CPT code 99214 (a level 4 
established patient visit) would be required to document having spent a 
minimum of 25 minutes. Under this approach, the total amount of time 
spent by the billing practitioner face-to-face with the patient would 
inform the level of E/M visit (of levels 2 through 5) coded by the 
billing practitioner. We noted that in contrast to other proposed 
documentation approaches discussed above, this approach of requiring 
documentation of the typical time associated with the CPT visit code 
reported on the claim would introduce unique payment implications for 
reporting that code, especially when the time associated with the 
billed E/M code is the basis for reporting prolonged E/M services.
    We solicited public comments on the use of time as a framework for 
documentation of office/outpatient E/M visits, and whether we should 
adopt any of these approaches or specify other requirements with 
respect to the proposed option for documentation using time.
    In providing us with feedback, we requested that commenters take 
into consideration ways in which the time associated with, or required 
for, the billing of any add-on codes (especially the proposed prolonged 
E/M visit add-on code(s) described in the CY 2019 PFS proposed rule (83 
FR 35844)) would intersect with the time spent for the base E/M visit, 
when the practitioner is documenting the E/M visit using only time. 
Currently, when reporting prolonged E/M services, we expect the 
practitioner to exceed the typical time assigned for the base E/M visit 
code (also commonly referred to as the companion code). For example, in 
the CY 2017 PFS final rule (81 FR 80229), we expressed appreciation for 
the commenters' suggestion to display the typical times associated with 
relevant services. We also discussed, and in response to those 
comments, decided to post a file annually that notes the times assumed 
to be typical for purposes of PFS ratesetting for practitioners to use 
as a reference in deciding whether time requirements for reporting 
prolonged E/M services are met. We stated that although these typical 
times are not required for a practitioner to bill the displayed base 
codes, we expect that only time spent in excess of these times will be 
reported using a non-face-to-face prolonged service code. We proposed 
to formalize this policy in the case where a practitioner uses time to 
document a visit, since there would be a stricter time requirement 
associated with the base E/M code. Specifically, we proposed that, when 
a practitioner chooses to document using time and also reports 
prolonged E/M services, we would require the practitioner to document 
that the typical time required for the base or ``companion'' visit is 
exceeded by the amount required to report prolonged services. Further 
discussion of our proposal regarding reporting prolonged E/M services 
is available in the CY 2019 PFS proposed rule (83 FR 35844).
    We believed that allowing practitioners to choose the most 
appropriate basis for distinguishing among the levels of E/M visits and 
applying a minimum documentation requirement, together with reducing 
the payment variation among E/M visit levels, would significantly 
reduce administrative burden for practitioners, and would avoid the 
current need to make coding and documentation decisions based on codes 
and documentation guidelines that are not a good fit with current 
medical practice. The practitioner could choose to use

[[Page 59633]]

MDM, time or the current documentation framework, and could also apply 
the proposed policies discussed below regarding redundancy and who can 
document information in the medical record.
    We solicited public comment on these proposals to provide 
practitioners choice in the basis for documenting E/M visits in an 
effort to allow for documentation alternatives that better reflect the 
current practice of medicine and to alleviate documentation burden. We 
stated our interest in receiving public comments on practitioners' 
ability to avail themselves of these choices for how they would impact 
clinical workflows, EHR templates, and other aspects of practitioner 
work.
    Stakeholders had requested that CMS not merely shift burden by 
implementing another framework that might avoid issues caused by the 
current guidelines, but that would be equally complex and burdensome. 
Our primary goal was to reduce administrative burden so that the 
practitioner can focus on the patient, and we were interested in 
commenters' opinions as to whether our E/M visit proposals would, in 
fact, support and further this goal. We believed our proposals would 
allow practitioners to exercise greater clinical judgment and 
discretion in what they document, focusing on what is clinically 
relevant and medically necessary for the patient rather than what will 
illustrate that the appropriate visit level was reported. Although we 
proposed to no longer apply much of the E/M documentation guidelines 
involving history, physical exam and, for those choosing to document 
based on time, documentation of medical decision-making, we stated our 
expectation that practitioners would continue to perform as medically 
necessary for the patient and document E/M visits to ensure quality and 
continuity of care. For example, we believed that it remains an 
important part of care for the practitioner to understand the patient's 
social history, even though certain documentation options we proposed 
would no longer require that history to be re-documented to bill 
Medicare for the visit.
    Comment: Many commenters supported the proposal to allow choice in 
documentation between the current framework, medical decision making or 
time. However, some commenters stated that such a policy would 
introduce too much variation in medical record format and content, or 
too many potential frameworks against which an auditor might review a 
claim. Commenters were unsure whether CMS envisioned the choice being 
made on a case-by-case basis or with some regularity. Other commenters 
noted that time alone is not an accurate measure of visit complexity or 
would be subject to gaming, or that CMS did not provide enough detail 
regarding time thresholds and documentation requirements to allow them 
to assess potential impact.
    Many of the commenters did not support the proposal, as a corollary 
to our proposal to adopt a single payment amount for office-outpatient 
E/M visit levels 2 through 5, to apply a minimum level 2 documentation 
standard. These commenters were concerned that this standard would 
result in inadequate documentation for patient care, legal and other 
purposes. They noted that CMS overestimated the associated reduction in 
burden that would result from this proposal, and instead believe the 
level 2 documentation standard would reduce burden to a lesser degree 
than we estimated, or potentially increase burden. They indicated that 
there would be costs in terms of time and resources to update EHRs and 
train staff, and that they expected there would be the need to continue 
documenting many elements included in the current code definitions for 
patient care and other purposes, including other payers. Many 
commenters expressed concern that the documentation could potentially 
increase due to misalignment in documentation rules between payers, as 
they presume that Medicaid, commercial payers and secondary payers 
would not likely adopt Medicare's payment changes, at least not 
immediately. Several commercial payers or their associations expressed 
similar concerns and recommended implementing a more limited set of 
documentation changes and ongoing monitoring.
    MedPAC and a few other commenters recommended paying for visits on 
the basis of time alone. MedPAC recommended requiring the time spent to 
be reported on the claim so CMS can collect data on current times 
actually spent and use it to more accurately set rates in the future.
    A few commenters indicated what the time requirement should be when 
using time to document. Most of these commenters noted that CMS should 
require the typical time associated with the CPT code reported on the 
claim. One commenter who opposed the single payment rate stated that if 
CMS did finalize a single payment rate, then CMS should require only 
the time associated with the level 2 CPT codes (10 minutes for an 
established patient and 20 minutes for a new patient). Some commenters 
expressed support for requiring that this time be spent by the billing 
practitioner face-to-face with the patient, and a few commenters 
expressed support for allowing time spent by individuals other than the 
billing practitioner and/or time spent furnishing non-face-to-face care 
to count.
    Response: For CY 2019 and 2020, we will continue the current coding 
and payment structure for E/M office/outpatient visits, and, therefore, 
practitioners should continue to use either the 1995 or 1997 versions 
of the E/M guidelines to document E/M office/outpatient visits billed 
to Medicare for 2019 and 2020 (with the exception of our final policy 
to eliminate redundant data recording).
    We appreciate the issues raised by commenters but continue to 
believe our proposals allowing for flexibility in how E/M office/
outpatient visit levels are documented and the applying of a minimum 
documentation standard as a corollary to establishing single payment 
rates for E/M office/outpatient visits will significantly reduce burden 
for clinicians and support them in making coding and documentation 
decisions that better align with current medical practice. Beginning in 
2021, for E/M office/outpatient levels 2 through 5 visits, we will 
allow for flexibility in how visit levels are documented, allowing 
billing practitioners the choice to use the current framework, MDM or 
time. Specifically, for level 5 visits, for PFS payment purposes a 
practitioner can use the current framework with the documentation 
requirements applicable to a level 5 visit or the current definition of 
level 5 MDM. As an another alternative, the practitioner can document 
using time, which will require documentation of the medical necessity 
of the visit and that the billing practitioner personally spent at 
least the typical time associated with the level 5 CPT code that is 
reported face-to-face with the patient (40 minutes for an established 
patient and 60 minutes for a new patient). Since there will be no new 
intra-service time associated with the level 5 visit codes, we are 
finalizing our proposed alternative to use the typical time associated 
with the CPT code reported on the claim, consistent with current policy 
when counseling and/or coordination of care accounts for more than 50 
percent of the face-to-face physician/patient encounter.
    For E/M office/outpatient level 2 through 4 visits, in 2021 we will 
also allow choice of documentation methodology (current framework, MDM 
or time). For practitioners using the current documentation framework 
or

[[Page 59634]]

MDM, for PFS payment purposes, we will apply a minimum supporting 
documentation standard associated with E/M office/outpatient level 2 
visits such that we only require documentation that is associated with 
the current level 2 CPT visit code (new or established patient, as 
applicable). For example, if the practitioner is choosing to document 
based on MDM alone, for PFS payment purposes we will only require 
documentation supporting straight forward medical decision-making 
measured by minimal problems, data review, and risk (two of these 
three). If choosing to document using time, for PFS payment purposes we 
will require the billing practitioner to document that the visit was 
medically reasonable and necessary and that the billing practitioner 
personally spent the current typical time for the CPT code reported 
(for example, 15 minutes when reporting CPT code 99213 (a level 3 
established patient visit)). For administrative simplicity, it may be 
most straight forward to track to the typical time for the CPT code.
    We address the public comments on our burden reduction estimate and 
changes to our estimate based on our final policies further below (see 
section VII. of this final rule, Regulatory Impact Analysis). We intend 
to engage in further discussions with the public over the next several 
years to potentially further refine our policies for 2021.
    As we noted in the CY 2019 PFS proposed rule, we heard from a few 
commenters on the CY 2018 PFS proposed rule that some practitioners 
rely on unofficial Marshfield clinic or other criteria to help them 
document E/M visit levels. These commenters conveyed that the 
Marshfield ``point system'' is commonly used to supplement the E/M 
documentation guidelines, because of a lack of concrete criteria for 
certain elements of medical decision making in the 1995 and 1997 
guidelines or in CPT guidance. Accordingly, in the CY 2019 PFS proposed 
rule, we solicited public comment on whether Medicare should use or 
adopt any aspects of other E/M documentation systems that may be in use 
among practitioners, such as the Marshfield tool. We were interested in 
feedback as to whether the 1995 and 1997 guidelines contain adequate 
information for practitioners to use in documenting visits under our 
proposals, or whether these versions of the guidelines would need to be 
supplemented in any way.
    The following is a summary of the comments we received on whether 
Medicare should use or adopt any aspects of other E/M documentation 
systems that may be in use among practitioners, such as the Marshfield 
tool, and also whether the 1995 and 1997 guidelines contain adequate 
information for practitioners to use in documenting visits under our 
proposals, or whether these versions of the guidelines would need to be 
supplemented in any way.
    Comment: We received a few comments clarifying how the Marshfield 
tool is currently used, but the commenters provided reasons not to use 
it as a replacement standard for current measures of visit complexity 
specified in the 1995 and 1997 documentation guidelines. A few 
commenters suggested new methods that could be used to support the 
level of E/M visit reported, such as risk adjustment with CMS's 
Hierarchical Condition Category scores used in Medicare Advantage; and 
some commenters recommended that CMS use medical decision making alone 
or in combination with time to distinguish visit/patient complexity. A 
few commenters recommended ways in which medical decision making could 
be relied upon, and ways that it should be changed, suggesting that 
history and physical exam might be incorporated with medical decision 
making. Many commenters recommended that CMS should continue to work 
with the AMA/CPT, specialty associations and other stakeholders to come 
up with revised measures of visit complexity, recommending between 
three to five levels.
    Response: We appreciate commenters' feedback on this solicitation, 
and we considered it in the context of making a final decision. As 
stated previously, we are finalizing a significant reduction in the 
current payment variation in office/outpatient E/M visit levels by 
paying a single rate for E/M office/outpatient visit levels 2, 3, and 4 
(one for established and another for new patients). However, we are not 
finalizing the inclusion of E/M office/outpatient level 5 visits in the 
single payment rate, in order to better account for the care and needs 
of particularly complex patients. Beginning in 2021, for E/M office/
outpatient levels 2 through 5 visits, we will allow for flexibility in 
how visit levels are documented, specifically a choice to use the 
current framework, MDM or time, discussed previously. For E/M office/
outpatient level 2 through 4 visits, in 2021 we will also apply a 
minimum supporting documentation standard associated with level 2 
visits, also discussed previously. We intend to engage in further 
discussions with the public over the next several years to potentially 
further refine our policies for 2021.
(b) Removing Redundancy in E/M Visit Documentation
    Stakeholders have recently expressed that CMS should not require 
documentation of information in the billing practitioner's note that is 
already present in the medical record, particularly with regard to 
history and exam. Currently, both the 1995 and 1997 guidelines provide 
such flexibility for certain parts of the history for established 
patients, stating, ``A Review of Systems ``ROS'' and/or a pertinent 
past, family, and/or social history (PFSH) obtained during an earlier 
encounter does not need to be re-recorded if there is evidence that the 
physician reviewed and updated the previous information. This may occur 
when a physician updates his/her own record or in an institutional 
setting or group practice where many physicians use a common record. 
The review and update may be documented by:
     Describing any new ROS and/or PFSH information or noting 
there has been no change in the information; and
     Noting the date and location of the earlier ROS and/or 
PFSH.
    Documentation Guidelines ``DG'': The ROS and/or PFSH may be 
recorded by ancillary staff or on a form completed by the patient. To 
document that the physician reviewed the information, there must be a 
notation supplementing or confirming the information recorded by others 
(https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/95Docguidelines.pdf; https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/97Docguidelines.pdf).
    We proposed to expand this policy to further simplify the 
documentation of history and exam for established patients such that, 
for both of these key components, when relevant information is already 
contained in the medical record, practitioners would only be required 
to focus their documentation on what has changed since the last visit 
or on pertinent items that have not changed, rather than re-documenting 
a defined list of required elements such as review of a specified 
number of systems and family/social history. Practitioners would still 
review prior data, update as necessary, and indicate in the medical 
record that they had done so. Practitioners would conduct clinically 
relevant and medically necessary elements of history and physical exam, 
and conform to the general principles of medical record documentation 
in the 1995 and 1997 guidelines. However,

[[Page 59635]]

practitioners would not need to re-record these elements (or parts 
thereof) if there is evidence that the practitioner reviewed and 
updated the previous information.
    Comment: Commenters were very supportive of this proposal. Many 
commenters included this proposal in a list of appropriate changes CMS 
should make immediately regarding documentation of E/M visits, 
effective January 1, 2019.
    Response: We are finalizing this policy to simplify the 
documentation of history and exam for established patients for E/M 
office/outpatient visits as proposed, effective January 1, 2019. 
Accordingly, when relevant information is already contained in the 
medical record, practitioners may choose to focus their documentation 
on what has changed since the last visit, or on pertinent items that 
have not changed, and need not re-record the defined list of required 
elements if there is evidence that the practitioner reviewed the 
previous information and updated it as needed. Practitioners should 
still review prior data, update as necessary, and indicate in the 
medical record that they have done so. We note that this policy to 
simplify and reduce redundancy in documentation is optional for 
practitioners, and they may choose to continue the current process of 
entering, re-entering and bringing forward information (83 FR 35838). 
The option to continue current documentation processes may be 
particularly important for practitioners who lack time to adjust 
workflows, templates and other aspects of their work by January 1, 
2019.
    We solicited comment on whether there may be ways to implement a 
similar provision for any aspects of medical decision-making, or for 
new patients, such as when prior data is available to the billing 
practitioner through an interoperable EHR or other data exchange. We 
stated our belief that there would be special challenges in realizing 
documentation efficiencies with new patients, since they may not have 
received exams or histories that were complete or relevant to the 
current complaint(s), and the information in the transferred record 
could be more likely to be incomplete, outdated or inaccurate.
    Comment: A few commenters indicated that there might be ways to 
recognize some documentation efficiencies for referred new patients or 
situations where data are available through an interoperable EHR, but 
did not provide detail about what kinds of data are commonly available 
and how they might be relevant to the receiving practitioner for 
purposes of visit documentation.
    Response: We appreciate the commenters' feedback in this area and 
will continue to consider this issue.
    We similarly proposed that for both new and established patients, 
practitioners would no longer be required to re-enter information in 
the medical record regarding the chief complaint and history that are 
already entered by ancillary staff or the beneficiary. The practitioner 
could simply indicate in the medical record that they reviewed and 
verified this information. Our goal was to allow practitioners more 
flexibility to exercise greater clinical judgment and discretion in 
what they document, focusing on what is clinically relevant and 
medically necessary for the patient.
    Comment: Commenters were very supportive of this proposal. Many 
commenters included this proposal in a list of appropriate changes CMS 
should make immediately regarding documentation of E/M visits, 
effective January 1, 2019.
    Response: We are finalizing our proposal that, effective January 1, 
2019, for new and established patients for E/M office/outpatient 
visits, practitioners need not re-enter in the medical record 
information on the patient's chief complaint and history that has 
already been entered by ancillary staff or the beneficiary. The 
practitioner may simply indicate in the medical record that he or she 
reviewed and verified this information. We note that this policy to 
simplify and reduce redundancy in documentation is optional for 
practitioners, and they may choose to continue the current process of 
entering, re-entering and bringing forward information (83 FR 35838). 
The option to continue current documentation processes may be 
particularly important for practitioners who lack time to adjust 
workflows, templates and other aspects of their work by January 1, 
2019.
(c) Podiatry Visits
    As described in the CY 2019 PFS proposed rule (83 FR 35843), as 
part of our proposal to improve payment accuracy by creating a single 
PFS payment rate for E/M visit levels 2 through 5 (with one proposed 
rate for new patients and one proposed rate for established patients), 
we proposed to create separate coding for podiatry visits that are 
currently reported as E/M office/outpatient visits. We proposed that, 
rather than reporting visits under the general E/M office/outpatient 
visit code set, podiatrists would instead report visits under new G-
codes that more specifically identify and value their services. We 
proposed to apply substantially the same documentation standards for 
these proposed new podiatry-specific codes as we proposed for other 
office/outpatient E/M visits.
    If a practitioner chose to use time to document a podiatry office/
outpatient E/M visit, we proposed to apply substantially the same rules 
as those we proposed for documenting on the basis of time for other 
office/outpatient E/M visits. For practitioners choosing to use time to 
provide supporting documentation for the podiatry visit, we would 
require documentation supporting the medical necessity of the visit and 
showing the total amount of time spent by the billing practitioner 
face-to-face with the patient. We solicited public comment on what that 
total time would be for payment of the proposed new podiatry G-codes. 
The typical times for these proposed codes were 22 minutes for an 
established patient and 28 minutes for a new patient, and we noted we 
could use these times. Alternatively, we noted we could apply the AMA's 
CPT codebook provision that, for timed services, a unit of time is 
attained when the mid-point is passed,\6\ such that we would require 
documentation that at least 12 minutes for an established patient (more 
than half of 22 minutes) or at least 15 minutes for a new patient (more 
than half of 28 minutes) were spent face-to-face by the billing 
practitioner with the patient, to support making payment for these 
codes when the practitioner chose to document the visit using time. We 
solicited comment on the use of time as a basis for documentation of 
our proposed podiatric E/M visit codes, and whether we should adopt any 
of these approaches or further specify other requirements with respect 
to this proposed option for podiatric practitioners to document their 
visits using time.
---------------------------------------------------------------------------

    \6\ 2017 CPT Codebook Introduction, p.xv.
---------------------------------------------------------------------------

    Comment: We did not receive any comments on how the proposed 
podiatric codes should be documented. A few commenters noted that our 
proposal to apply the same documentation rules to the proposed new 
podiatric codes as for all other office/outpatient E/M visits 
demonstrated that these visits were essentially the same, and that 
podiatry should not be singled out for the creation of separate codes.
    Response: We believe the absence of comments on our proposals for 
documentation of the proposed podiatric codes is due to a lack of 
general support for creation of the new

[[Page 59636]]

codes to describe podiatric E/M visits, as noted below in the comment 
summary on that topic. As discussed below, we are not finalizing our 
proposal to create new codes to describe podiatric E/M visits, and 
accordingly, we are not finalizing any rules regarding documentation of 
those codes.
(3) Minimizing Documentation Requirements by Simplifying Payment 
Amounts
    As we have explained above, and in prior rulemaking, we believe 
that the coding, payment, and documentation requirements for E/M visits 
are overly burdensome and no longer aligned with the current practice 
of medicine. We believe the current set of 10 CPT codes for new and 
established office-based and outpatient E/M visits and their respective 
payment rates no longer appropriately reflect the complete range of 
services and resource costs associated with furnishing E/M services to 
all patients across the different physician specialties, and that 
documenting these services using the current guidelines has become 
burdensome and out of step with the current practice of medicine. To 
alleviate the effects and mitigate the burden associated with continued 
use of the outdated CPT code set, we proposed to simplify the office-
based and outpatient E/M payment rates and documentation requirements, 
and create new add-on codes to better capture the differential 
resources involved in furnishing certain types of E/M visits.
    In conjunction with our proposal to reduce the documentation 
requirements for E/M visit levels 2 through 5, we proposed to simplify 
the payment for those services by paying a single rate for the level 2 
through 5 E/M visits. The visit level of the E/M service is tied to the 
documentation requirements in the 1995 and 1997 Documentation 
Guidelines for E/M Services, which may not be reflective of changes in 
technology or, in particular, the ways that electronic medical records 
have changed documentation and the patient's medical record. 
Additionally, current documentation requirements may not account for 
changes in care delivery, such as a growing emphasis on team based 
care, increases in the number of recognized chronic conditions, or 
increased emphasis on access to behavioral health care. However, based 
on the feedback we have received from stakeholders, it was clear to us 
that the burdens associated with documenting the selection of the level 
of E/M service arise from not only the documentation guidelines, but 
also from the coding structure itself. Like the documentation 
guidelines, the distinctions between visit levels reflect a reasonable 
assessment of variations in care, effort, and resource costs as 
identified and articulated several decades ago. We believed that the 
most important distinctions between the kinds of visits furnished to 
Medicare beneficiaries are not well reflected by the current E/M visit 
coding. Most significantly, we have understood from stakeholders that 
current E/M coding does not reflect important distinctions in services 
and differences in resources. At present, we believed the current 
payment for E/M visit levels, generally distinguished by common 
elements of patient history, physical exam, and MDM, that may have been 
good approximations for important distinctions in resource costs 
between kinds of visits in the 1990s, when the CPT developed the E/M 
code set, are increasingly outdated in the context of changing models 
of care and information technologies.
    As described earlier in this section, we proposed to change the 
documentation requirements for E/M levels such that practitioners have 
the choice to use the 1995 guidelines, 1997 guidelines, time, or MDM to 
determine the E/M level. We believed that these proposed changes would 
better reflect the current practice of medicine and represent 
significant reductions in burdens associated with documenting visits 
using the current set of E/M codes.
    In alignment with our proposed documentation changes, we proposed 
to develop a single set of RVUs under the PFS for E/M office-based and 
outpatient visit levels 2 through 5 for new patients (CPT codes 99202 
through 99205) and a single set of RVUs for visit levels 2 through 5 
for established patients (CPT codes 99212 through 99215). Although we 
considered creating new HCPCS G-codes that would describe the services 
associated with these proposed payment rates, given the wide and 
longstanding use of these visit codes by both Medicare and private 
payers, we believed it would have created unnecessary administrative 
burden to propose new coding. Therefore, we instead proposed to 
maintain the current code set. Of the five levels of office-based and 
outpatient E/M visits, the vast majority of visits are reported as 
levels 3 and 4. In CY 2016, CPT codes 99203 and 99204 (or E/M visit 
level 3 and level 4 for new patients) made up around 32 percent and 44 
percent, respectively, of the total allowed charges for CPT codes 
99201-99205. In the same year, CPT codes 99213 and 99214 (or E/M visit 
level 3 and 4 for established patients) made up around 39 percent and 
50 percent, respectively, of the allowed charges for CPT codes 99211-
99215. If our proposals to simplify the documentation requirements and 
to pay a single PFS rate for new patient E/M visit levels 2 through 5 
and a single rate for established patient E/M visit levels 2 through 5 
were finalized, practitioners would still bill the CPT code for 
whichever level of E/M service they furnished and they would be paid at 
the single PFS rate. However, we believed that eliminating the 
distinction in payment between visit levels 2 through 5 would eliminate 
the need to audit against the visit levels, and therefore, would 
provide immediate relief from the burden of documentation. A single 
payment rate would also eliminate the increasingly outdated distinction 
between the kinds of visits that are reflected in the current CPT code 
levels in both the coding and the associated documentation rules.
    In order to set RVUs for the proposed single payment rate for new 
and established patient office/outpatient E/M visit codes, we proposed 
to develop resource inputs based on the current inputs for the 
individual E/M codes, generally weighted by the frequency at which they 
are currently billed, based on the 5 most recent years of Medicare 
claims data (CY 2012 through CY 2017). Specifically, we proposed a work 
RVU of 1.90 for CPT codes 99202 through 99205, a physician time of 
37.79 minutes, and direct PE inputs that sum to $24.98, each based on 
an average of the current inputs for the individual codes weighted by 5 
years of accumulated utilization data. Similarly, we proposed a work 
RVU of 1.22 for CPT codes 99212 through 99215, with a physician time of 
31.31 minutes and direct PE inputs that sum to $20.70. These inputs 
were based on an average of the inputs for the individual codes, 
weighted by volume based on utilization data from the past 5 years (CY 
2012 through CY 2017). Tables 19 and 20 reflect the payment rates in 
dollars that would result from the approach described above were it to 
have been implemented for CY 2018. In other words, the dollar amounts 
in the charts below reflect how the changes we proposed for CY 2019 
would have impacted payment rates for CY 2018.

[[Page 59637]]



   Table 19--Preliminary Comparison of Payment Rates for Office Visits
                             [New patients]
------------------------------------------------------------------------
                                                            CY 2018 non-
                                                  CY 2018     facility
                                                   non-     payment rate
                  HCPCS code                     facility     under the
                                                  payment     proposed
                                                   rate      methodology
------------------------------------------------------------------------
99201.........................................         $45           $44
99202.........................................          76           135
99203.........................................         110
99204.........................................         167
99205.........................................         211
------------------------------------------------------------------------


   Table 20--Preliminary Comparison of Payment Rates for Office Visits
                         [Established patients]
------------------------------------------------------------------------
                                                  Current
                                                   non-     Proposed non-
                  HCPCS code                     facility     facility
                                                  payment   payment rate
                                                   rate
------------------------------------------------------------------------
99211.........................................         $22           $24
99212.........................................          45            93
99213.........................................          74
99214.........................................         109
99215.........................................         148
------------------------------------------------------------------------

    Although we believed that the proposed rates for E/M visit levels 2 
through 5 represent the valuation of a typical E/M service, we also 
recognized that the current E/M code set itself does not appropriately 
reflect differences in resource costs between certain types of E/M 
visits. As a result, we believed that the way we currently value the 
resource costs for E/M services through the existing HCPCS CPT code set 
for office-based and outpatient E/M visits does not appropriately 
reflect the resources used in furnishing the range of E/M services that 
are provided through the current the practice of medicine. Based on 
stakeholder comments and examples and our review of the literature on 
E/M services, we identified three types of E/M visits that differ from 
the typical E/M visit and are not appropriately reflected in the 
current office/outpatient E/M code set and valuation. Rather, these 
three types of E/M visits can be distinguished by the mode of care 
provided and, as a result, have different resource costs. The three 
types of E/M visits that differ from the typical E/M service are (1) 
separately identifiable E/M visits furnished in conjunction with a 
global procedure, (2) primary care E/M visits for continuous patient 
care, and (3) certain types of specialist E/M visits, including those 
with inherent visit complexity. We addressed each of these 
distinguishable visit types in the proposed rule.
    The following is a summary of the comments we received on the 
proposed blended payment rate for new and established office/outpatient 
E/M visit levels 2 through 5.
    Comment: While many commenters agreed that the current E/M coding 
for office/outpatient visits is flawed and some agreed that the current 
coding and valuation systematically undervalues primary care visits and 
visits furnished in the context of non-procedural specialty care, most 
commenters opposed this proposal. Many commenters stated that using a 
single payment rate for new and established office/outpatient E/M visit 
levels 2 through 5 could have highly variable negative repercussions at 
the specialty, practice, and practitioner level. Some commenters 
suggested that the proposed single payment rate for these visits was 
inherently not resource-based. Many commenters stated that the proposed 
single payment rate that did not vary based on patient complexity from 
levels 2 through 5 was insufficient to account for the resource 
differential associated with treating complex patients, and that, 
without accurate payment, physicians would be likely to either schedule 
multiple visits or stop taking on complex patients all together.
    The few commenters who supported the proposal stated that the 
negative payment implications of the single proposed payment rate are 
outweighed by the reduction in documentation burden. While 
acknowledging that the initial years following adoption of a single 
payment rate for the level 2 through 5 E/M visit codes would be 
challenging, these commenters noted that over time, potential 
reductions in payment would be offset by the time saved from 
unnecessary documentation. Other commenters, while urging CMS not to 
finalize the proposed single payment rate for these codes, did provide 
suggested alternative coding structures. Of these comments, there was a 
consensus that three levels of coding for office and outpatient E/M 
services is preferable to two, whether that be accomplished through 
blended payment rates for levels 2 through 3 and 4 through 5, or 
through a blended rate for levels 2 through 4. Most commenters pointed 
to the joint CPT/AMA E/M workgroup formed in response to CMS' proposal, 
and urged CMS to wait for forthcoming coding and documentation 
definitions generated by that group and recommendations regarding 
valuation developed through the RUC process.
    Response: We appreciate the number and broad range of interested 
commenters who responded to our proposal. After reviewing all of the 
comments received, we understand the broad consensus regarding the 
potential negative implications of the proposal for patients with the 
most complex needs and the clinicians who serve them. In attempting to 
eliminate the reliance on the current outmoded E/M coding structure as 
it is used for purposes of payment, we recognize that the alternative 
coding and payment structure we proposed lacked an element that we 
agree is critical in making accurate payment: Namely, accounting for 
resource costs for the most complex patients. While we believe that our 
proposal to address the inherent complexity involved in furnishing 
certain kinds of care combined with our proposed payment for visits 
that take additional time might have accounted for a significant 
portion of the resource costs associated with particularly complex 
patients, we recognize the concerns expressed by commenters that these 
payment adjustments might be insufficient in some cases. We also 
recognize the potential negative consequences to clinicians and access 
to care that could result if we do not ensure that coding and payment 
appropriately account for patients with the most complex needs.
    We do not believe, however, that appropriate care for complex 
patients currently requiring visit levels 2 through 4 are nearly as 
dependent on the current payment variations for these services. Given 
that the significant majority of the volume is concentrated in the 
level 3 and 4 new and established patient visits, we believe the 
concerns expressed by commenters about potential shifts in practitioner 
behavior would be likely to occur. We believe it would simply not be 
practical for clinicians to prioritize seeing the relatively few 
potential patients requiring level 2 visits in order to maximize their 
revenue relative to per patient costs. Likewise, because the level 4 
established patient E/M visit is the most commonly reported code among 
the 5 levels for both new and established patients, any effort to avoid 
treating patients requiring care that is currently reported as a level 
4 visit would likely result in significantly reduced volume and overall 
revenue for physician practices. We will, however, monitor utilization 
of these services and make any necessary adjustments through future 
rulemaking. Additionally, we recognize that because level 5 visits 
represent a very small proportion of visits reported under current E/M 
coding, maintaining

[[Page 59638]]

differential payment rates and documentation for these visits will 
strike an appropriate balance, simplifying and reducing the burden in 
distinguishing among CPT codes for the vast majority of E/M visits, 
while retaining a separate payment rate for the level of care furnished 
to the most complex patients.
    On that basis, we are finalizing for 2021, a single payment rate 
for levels 2 through 4 E/M office/outpatient visits (one rate for new, 
and one for established patients) and maintaining separate payment 
rates for new and established patients for level 5 E/M office/
outpatient visits to account for the most complex patients and visits. 
We are finalizing a policy, modified from our proposal, to develop a 
set of single payment rates for visit levels 2 through 4 (one each for 
new and established patients), instead of levels 2 through 5, as 
proposed. We are finalizing development of payment rates for levels 2 
through 4 visits using the weighted average of the current inputs (work 
RVUs, direct PE inputs, time and specialty mix) assigned to the 
individual codes, based on the most recent 5 years of utilization for 
each of the constituent codes. For the level 1 and level 5 office/
outpatient E/M visits we are finalizing payment rates that rely on 
current inputs. The inputs we will use (in the absence of intervening 
changes to CPT coding or the development of other considerations) to 
develop proposed values for these services for 2021 appear in the Table 
21.

                       Table 21--Finalized Inputs for E/M Office/Outpatient Codes for 2021
----------------------------------------------------------------------------------------------------------------
                                                     Physician                      Malpractice   Sum of  direct
                      HCPCS                            time          Work RVU           RVU          PE inputs
----------------------------------------------------------------------------------------------------------------
99201...........................................           17.00            0.48            0.05          $13.97
99202...........................................           34.43            1.76            0.17           24.37
99203...........................................           34.43            1.76            0.17           24.37
99204...........................................           34.43            1.76            0.17           24.37
99205...........................................           67.00            3.17            0.28           30.92
99211...........................................            7.00            0.18            0.01           11.31
99212...........................................           30.26            1.18            0.08           20.41
99213...........................................           30.26            1.18            0.08           20.41
99214...........................................           30.26            1.18            0.08           20.41
99215...........................................           55.00            2.11            0.14           27.83
----------------------------------------------------------------------------------------------------------------

    We are also finalizing separate, add-on payments for visit 
complexity inherently associated with primary care and non-procedural 
specialty care, as well as separate payment for extended visits via 
HCPCS G-codes. These codes and the associated policies will be 
discussed in greater detail in the discussion below. We recognize that 
many commenters, including the AMA, the RUC, and specialties that 
participate as members in those committees, have stated intentions of 
the AMA and the CPT Editorial Panel to revisit coding for E/M office/
outpatient services in the immediate future. We note that the 2-year 
delay in implementation will provide the opportunity for us to respond 
to the work done by the AMA and the CPT Editorial Panel, as well as 
other stakeholders. We will consider any changes that are made to CPT 
coding for E/M services, and recommendations regarding appropriate 
valuation of new or revised codes, through our annual rulemaking 
process.
(4) Recognizing the Resource Costs for Different Types of E/M Visits
    As a corollary to our proposal to adopt a single payment rate for 
office and outpatient E/M services for level 2 through 5 E/M visits, we 
stated that we could better capture differential resource costs and 
minimize reporting and documentation burden by proposing several 
additional payment policies and ratesetting adjustments. These 
additional proposals were intended to reflect the important 
distinctions between the kinds of visits furnished to Medicare 
beneficiaries, and to reduce the burden of billing and documentation 
rules to effectuate payment.
    In response to the CY 2018 comment solicitation on burden reduction 
for E/M visits (82 FR 53163 through 53166), we received several 
comments that highlighted the inadequacy of the E/M code set to 
accurately pay for the resources associated with furnishing visits, 
particularly for primary care visits, and visits associated with 
treating patients with particular conditions for which there is not 
additional procedural coding. One commenter stated that the current 
structure and valuation of the E/M code set inadequately describes the 
range of services provided by different specialties, and in particular 
primary care services. This commenter noted that although the 10 
office/outpatient E/M codes make up the bulk of the services reported 
by primary care practitioners, the valuation does not reflect their 
particular resource costs. Another commenter pointed out that for 
specialties that principally rely on E/M visit codes to bill for their 
professional services, the complex medical decision making and the 
intensity of their visits is not reflected in the E/M code set or 
documentation guidelines.
    In view of the comments we received, we proposed the following 
adjustments to better capture the variety of resource costs associated 
with different types of care provided in E/M visits: (1) An E/M 
multiple procedure payment adjustment to account for duplicative 
resource costs when E/M visits and procedures with global periods are 
furnished together; (2) HCPCS G-code add-ons to recognize additional 
relative resources for primary care visits and inherent visit 
complexity that require additional work beyond that which is accounted 
for in the single payment rates for new and established patient levels 
2 through level 5 visits; (3) HCPCS G-codes to describe podiatric E/M 
visits; (4) an additional prolonged face-to-face services add-on HCPCS 
G-code; and (5) a technical modification to the PE methodology to 
stabilize the allocation of indirect PE for visit services.
(a) Accounting for E/M Resource Overlap Between Stand-Alone Visits and 
Global Periods
    Under the PFS, E/M services are generally paid in one of two ways: 
As standalone visits using E/M visit codes, or included in global 
procedural codes. In both cases, RVUs are allocated to the services to 
account for the estimated relative resources involved in furnishing 
professional E/M services. In the case of procedural codes with global 
periods,

[[Page 59639]]

the overall resource inputs reflect the costs of the E/M work 
considered to be typically furnished with the procedure. Therefore, the 
standalone E/M visit codes are not billable on the same day as the 
procedure codes unless the billing professional specifically indicates 
that the visit is separately identifiable from the procedure.
    In cases where a physician furnishes a separately identifiable E/M 
visit to a beneficiary on the same day as a procedure, payment for the 
procedure and the E/M visit is based on rates generally developed under 
the assumption that these services are typically furnished 
independently. In CY 2017 PFS rulemaking, we noted that the current 
valuation for services with global periods may not accurately reflect 
much of the overlap in resource costs (81 FR 80209). We were 
particularly concerned that when a standalone E/M visit occurs on the 
same day as a 0-day global procedure, there are significant overlapping 
resource costs that are not accounted for. We believe that separately 
identifiable visits occurring on the same day as 0-day global 
procedures have resources that are sufficiently distinct from the costs 
associated with furnishing one of the 10 office/outpatient E/M visits 
to warrant payment adjustment. There are other existing policies under 
the PFS where we reduce payments if multiple procedures are furnished 
on the same day to the same patient. Medicare has a longstanding policy 
to reduce payment by 50 percent for the second and subsequent surgical 
procedures furnished to the same patient by the same physician on the 
same day, largely based on the presence of efficiencies in PE and pre- 
and post-surgical physician work. Effective January 1, 1995, the MPPR 
policy, with the same percentage reduction, was extended to nuclear 
medicine diagnostic procedures (CPT codes 78306, 78320, 78802, 78803, 
78806, and 78807). In the CY 1995 PFS final rule with comment period 
(59 FR 63410), we indicated that we would consider applying the policy 
to other diagnostic tests in the future. In the CYs 2009 and 2010 PFS 
proposed rules (73 FR 38586 and 74 FR 33554, respectively), we stated 
that we planned to analyze nonsurgical services commonly furnished 
together (for example, 60 to 75 percent of the time) to assess whether 
an expansion of the MPPR policy could be warranted. MedPAC encouraged 
us to consider duplicative physician work, as well as PE, in any 
expansion of the MPPR policy. Finally, in the CY 2011 PFS final rule 
with comment period, CMS finalized the application of the MPPR to 
always-therapy services on the justification that there was significant 
overlap in the PE portion of these services (75 FR 73233).
    Using the surgical MPPR as a template, we proposed that, as part of 
our proposal to make payment for the E/M levels 2 through 5 at a single 
PFS rate, we would reduce payment by 50 percent for the least expensive 
global procedure or visit that the same physician (or a physician in 
the same group practice) furnishes on the same day as a separately 
identifiable E/M visit, currently identified on the claim by an 
appended modifier -25. We believed that the efficiencies associated 
with furnishing an E/M visit in combination with a same-day global 
procedure were similar enough to those accounted for by the surgical 
MPPR to merit a reduction in the relative resources of 50 percent. We 
estimated that, based on CY 2017 Medicare claims data, applying a 50 
percent MPPR to E/M visits furnished as separately identifiable 
services on the same day as a global procedure would reduce 
expenditures under the PFS by approximately 6.7 million RVUs. To 
accurately reflect resource costs of the different types of E/M visits 
that we previously identified while maintaining work budget neutrality 
within this proposal, we proposed to allocate those RVUs toward the 
values of the add-on codes that reflect the additional resources 
associated with E/M visits for primary care and inherent visit 
complexity, similar to existing policies. As we articulated in the CY 
2012 PFS final rule with comment period, where the aggregate work RVUs 
within a code family change but the overall actual physician work 
associated with those services does not change, we make work budget 
neutrality adjustments to hold the aggregate work RVUs constant within 
the code family, while maintaining the relativity of values for the 
individual codes within that set (76 FR 73105).
    Comment: Many commenters opposed this proposal. Commenters 
generally objected to the underlying principle of the application of an 
MPPR to office/outpatient E/M codes billed on the same day as a minor 
procedure. Many of these commenters stated that the current billing 
rules allow these services to be billed only when modifier -25 is used, 
and that modifier makes it clear that the visits are significant and 
separately identifiable. Consequently, these commenters stated that no 
payment adjustment should apply. Many commenters pointed to the RUC 
review process wherein procedures that are typically furnished with a 
same day visit are subject to adjustments to account for any resource 
costs that the RUC considers to be typically duplicative. Commenters 
stated that by applying an MPPR adjustment to these services, CMS was 
making an unwarranted second adjustment to account for efficiencies the 
RUC already considers to be addressed. A few commenters stated that CMS 
provided insufficient rationale for the choice to propose a 50 percent 
payment reduction instead of other potential adjustments. Several 
commenters also pointed out that there are a number of 0-day global 
procedure codes that are valued not to include any evaluation and 
management, such as CPT codes 98925-98929 (Osteopathic manipulative 
treatment (OMT)). Commenters urged CMS to exempt these codes from the 
MPPR adjustment.
    Many commenters, including both physician specialty organizations 
and patient advocacy groups, expressed concerns about how physicians 
would respond to the financial incentives resulting from the 
application of an MPPR adjustment in the context of patient care. 
Commenters noted that it is often convenient for both the beneficiary 
and the practitioner to address multiple concerns in a single visit. 
Many commenters stated that there would be a strong financial incentive 
to bring patients back for necessary visits on a different day so as to 
avoid triggering the payment reduction. This would result in 
inconvenience to the beneficiary, as they would experience treatment 
delays and be forced to return for a visit. Some commenters suggested 
this approach would result in additional cost sharing for patients.
    Several commenters also highlighted programmatic concerns, stating 
that an MPPR adjustment would incentivize fractured care and undermine 
the goals of patient-centered and value-based care. Commenters also 
requested that CMS clarify whether certain other visits, such as the 
annual wellness visit, would also be subject to the MPPR adjustment. 
Others stated that inconsistent guidance, differing policies, and 
varying edits among the MACs would result in confusion and 
administrative burden in the implementation of this proposal.
    A few commenters, including MedPAC, supported the proposal. MedPAC 
stated that when a standalone E/M visit occurs on the same day as a 
procedure, there are efficiencies (for example, in pre-service and 
post-service clinician work and practice expense) that are not 
accounted for in the current payment system. MedPAC concluded

[[Page 59640]]

that applying an MPPR to the procedure or visit would account for these 
efficiencies. Additional commenters suggested alternative percentages 
for the reduction, such as 5 percent or 25 percent. A few commenters 
stated that, if the MPPR were to be implemented, services performed by 
primary care specialties such as internal medicine, family practice, 
geriatrics, and pediatrics should be exempt.
    Response: We appreciate commenters' feedback on this aspect of the 
proposal, particularly the comments regarding the potentially 
troublesome incentives and undesirable consequences associated with the 
financial incentives.
    We continue to have significant concerns about the appropriate 
payment when codes with global periods, especially 0 and 10-day global 
periods, are billed on the same day as an E/M visit. Generally, we 
understand that the global codes are valued to include the typical 
amount of evaluation and management furnished to patients as part of 
the service. We understand that when these codes are reported, the -25 
modifier is used with an E/M code to report a significant, separately 
identifiable E/M visit that is furnished on the same day. We also note 
that the CPT descriptor of the -25 modifier includes language 
suggesting that the modifier can be used whenever care beyond the usual 
preoperative and postoperative care associated with the procedure is 
performed. We note further that the values for global codes are 
intended to incorporate the typical amount of pre- and post-operative 
care. However, given the CPT description of the -25 modifier, a 
separately reportable visit could be billed in any case where the pre- 
or post-operative care exceeds the typical amount. In contrast, there 
does not appear to be a way to similarly account for cases where the 
needs of a particular patient require less than the typical amount of 
preoperative and postoperative work.
    Although many commenters suggested that the overlapping resource 
costs between global codes and E/M visits billed on the same day have 
already been accounted for, we are not persuaded by the statements that 
the RUC process has achieved this goal, and we agree with MedPAC's 
assessment of the significant problem with valuation of codes that 
describe global services. We acknowledge and appreciate the efforts of 
the RUC to address overlaps when they recognize that a code is usually 
reported with a same day E/M visit. However, as observers to the RUC 
process, we have noted a general tendency for the RUC to recommend only 
minor adjustments in physician time and direct PE inputs to account for 
overlap. We also often make adjustments to the RUC recommended 
valuation in cases where the agency believes there is overlap between 
services frequently billed together that has not been adequately 
addressed through the RUC process. More importantly, even if the RUC 
valuation process better accounted for the overlapping resource costs, 
those adjustments would be made to national valuation of particular 
codes based on snapshot, national claims data for a given year, and 
would apply to all physicians reporting the services regardless of 
whether or not these particular physicians were achieving the 
efficiencies that occur when visits are reported on the same day as 
codes with global periods. Because this dynamic is an inherent part of 
valuation based on the typical case for discrete services, we routinely 
prioritize review of high-volume services. However, we believe the 
application of this methodology in valuing global services is 
particularly problematic because there are several thousand codes with 
global periods and it is impractical to conduct these kinds of code-
level reviews as frequently as would be necessary to improve the 
accuracy of accounting for these efficiencies.
    We agree with commenters that if practitioners began deliberately 
scheduling visits on separate days, when they could be furnished 
together on the same day, in order to avoid the payment adjustment that 
could create a significant undue burden for beneficiaries. We have 
heard this concern before regarding other MPPRs. We note that we have 
major concerns about this kind of manipulation of patient scheduling, 
especially as it relates to the fundamental requirement that Medicare 
payment may be made only for reasonable and necessary medical care, and 
intend to consider this concern more broadly for future rulemaking. 
Because we are obligated to develop PFS payments based on the relative 
resources involved in furnishing services, we believe the total of 
payments to practitioners for physicians' services from both Medicare 
and beneficiaries should reflect efficiencies inherent in furnishing 
two services that can be furnished together without prompting 
manipulative scheduling practices that result in inconvenience and 
potential medical risks to Medicare beneficiaries.
    After consideration of the public comments, we recognize that we 
must balance concerns about appropriate valuation with the potential 
disruptions to patient care suggested by commenters. Though we find the 
possible practice of scheduling medical services to maximize payment 
without regard to patient needs or costs to be highly problematic, we 
take these concerns seriously given the broad-based consensus within 
the medical and stakeholder community regarding likely behavioral 
changes in response to the proposal. After weighing these concerns, we 
are not finalizing the proposal to apply an MPPR to a separately 
identifiable office/outpatient E/M visit furnished on the same day as a 
global procedure. We intend to consider ways to address the practice of 
scheduling patients to avoid payment adjustments in future rulemaking.
    Given the variety of comments we received regarding the valuation 
of specific codes, especially codes with global periods that are 
perceived to include no resource costs associated with evaluation and 
management, we intend to reconsider the appropriate global period 
assigned to certain services. We welcome stakeholder input regarding 
appropriate global period assignment through our routine valuation 
processes. We will also continue to consider how to address what we 
believe to be a significant problem of accurately accounting for 
duplicative resource costs in ways that will protect Medicare 
beneficiaries' access to appropriate care.
(b) HCPCS G-Code Add-Ons To Recognize Additional Relative Resources for 
Certain Kinds of Visits
    The distribution of E/M visits is not uniform across medical 
specialties. We have found that certain specialists, like neurologists 
and endocrinologists, for example, bill higher level E/M codes more 
frequently than procedural specialists, such as dermatologists. We 
believed this tendency reflects a significant and important distinction 
between the kinds of E/M visits furnished by professionals whose 
treatment approaches are primarily reported using visit codes versus 
those professionals whose treatment approaches are primarily reported 
using available procedural or testing codes. However, based on feedback 
we received from the medical professionals who furnish primary care and 
have visits with greater complexity, we did not believe the current 
visit definitions and the associated documentation burdens are the most 
accurate descriptions of the variation in work. Instead, we believed 
these professionals have been particularly burdened by the 
documentation requirements, given that so much of their medical 
treatment is

[[Page 59641]]

described imperfectly by relatively generic visit codes.
    Similarly, stakeholders such as the commenters responding to the CY 
2018 PFS proposed rule have articulated persuasively that visits 
furnished for the purpose of primary care also involve distinct 
resource costs. In developing this proposal, we consulted a variety of 
resources, including the American Academy of Family Physicians (AAFP) 
definition of primary care that states that the resource costs 
associated with furnishing primary care services particularly include 
time spent coordinating patient care, collaborating with other 
physicians, and communicating with patients (see https://www.aafp.org/about/policies/all/primary-care.html). Despite our efforts in recent 
years to pay separately for certain aspects of primary care services, 
such as through the chronic care management or the transitional care 
management services, the currently available coding still does not 
adequately reflect the full range of primary care services, nor does it 
allow payment to fully capture the resource costs involved in 
furnishing a face-to-face primary care E/M visit. We recognized that 
primary care services frequently involve substantial non-face-to-face 
work, and noted that there is currently coding available to account for 
many of those resources, such as chronic care management (CCM), 
behavioral health integration (BHI), and prolonged non-face-to-face 
services. In light of the existing coding, our proposal only addressed 
the additional resources involved in furnishing the face-to-face 
portion of a primary care service. As the point of entry for many 
patients into the healthcare system, primary care visits frequently 
require additional time for communicating with the patient, patient 
education, consideration and review of the patient's medical needs. We 
believed the proposed value for the single payment rate for the E/M 
levels 2 through 5 new and established patient visit codes does not 
reflect these additional resources inherent to primary care visits, as 
evidenced by the fact that primary care visits are generally reported 
using level 4 E/M codes. Therefore, to more accurately account for the 
type and intensity of E/M work performed in primary care-focused 
visits, we proposed to create a HCPCS add-on G-code that could be 
billed with the generic E/M code set to adjust payment to account for 
additional costs beyond the typical resources accounted for in the 
single payment rate for the levels 2 through 5 visits.
    We proposed to create a HCPCS G-code for primary care services, 
HCPCS code GPC1X (Visit complexity inherent to evaluation and 
management associated with primary medical care services that serve as 
the continuing focal point for all needed health care services (Add-on 
code, list separately in addition to an established patient evaluation 
and management visit)). As we believe a primary care visit is partially 
defined by an ongoing relationship with the patient, this code would 
describe furnishing a visit to an established patient. HCPCS code GPC1X 
could also be reported for other forms of face-to-face care management, 
counseling, or treatment of acute or chronic conditions not accounted 
for by other coding. We noted that we believed the additional resources 
to address inherent complexity in E/M visits associated with primary 
care services are associated only with stand-alone E/M visits as 
opposed to separately identifiable visits furnished within the global 
period of a procedure. Separately identifiable visits furnished within 
a global period are identified on the claim using modifier -25, and 
would be subject to the MPPR. We noted that we created separate coding 
that describes non-face-to-face care management and coordination, such 
as CCM and BHI; however, these services describe non-face-to-face care 
and can be provided by any specialty as long as they meet the 
requirements for those codes. HCPCS code GPC1X was intended to capture 
the additional resource costs, beyond those involved in the base E/M 
codes, of providing face-to-face primary care services for established 
patients. HCPCS code GPC1X would be billed in addition to the E/M visit 
for an established patient when the visit includes primary care 
services. For HCPCS code GPC1X, we proposed a work RVU of 0.07, 
physician time of 1.75 minutes, no direct PE inputs, and an MP RVU of 
0.01. This proposed valuation accounted for the additional resource 
costs associated with furnishing primary care that distinguishes E/M 
primary care visits from other types of E/M visits, and would maintain 
work budget neutrality across the office/outpatient E/M code set. 
Furthermore, the proposed add-on G-code for primary care-focused E/M 
services would help to mitigate potential payment instability that 
could result from our adoption of single payment rates that apply for 
E/M code levels 2 through 5. As this add-on G-code would account for 
the inherent resource costs associated with furnishing primary care E/M 
services, we anticipated that it would be billed with every primary 
care-focused E/M visit for an established patient. Although we expected 
that this code would mostly be utilized by the primary care 
specialties, such as family practice or pediatrics, we were also aware 
that, in some instances, certain specialists function as primary care 
practitioners--for example, an OB/GYN or a cardiologist. Although the 
definition of primary care is widely agreed upon by the medical 
community and we intended for this G-code to account for the resource 
costs of performing those types of visits, regardless of Medicare 
enrollment specialty, we also solicited comment on how best to identify 
whether or not a primary care visit was furnished, particularly in 
cases where a specialist is providing those services. For especially 
complex patients, we also expected that this G-code would be billed 
alongside the new code we proposed for prolonged E/M services described 
later in this section.
    We also solicited comment on whether this policy adequately 
addresses the deficiencies in CPT coding for E/M services in describing 
current medical practice, and concerns about the impact on payment for 
primary care and other services under the PFS.
    We also proposed to create a HCPCS G-code to be reported with an E/
M service to describe the additional resource costs for specialty 
professionals for whom E/M visit codes make up a large percentage of 
their overall allowed charges and whose treatment approaches we 
believed are generally reported using the level 4 and level 5 E/M visit 
codes rather than procedural coding. Due to these factors, the proposed 
single payment rate for E/M levels 2 through 5 visit codes would not 
necessarily reflect the resource costs of those types of visits. 
Therefore, we proposed to create a new HCPCS code GCG0X (Visit 
complexity inherent to evaluation and management associated with 
endocrinology, rheumatology, hematology/oncology, urology, neurology, 
obstetrics/gynecology, allergy/immunology, otolaryngology, cardiology, 
or interventional pain management-centered care (Add-on code, list 
separately in addition to an evaluation and management visit)). Given 
their billing patterns, we believed that these are specialties that 
apply predominantly non-procedural approaches to complex conditions 
that are intrinsically diffuse to multi-organ or neurologic diseases. 
Although some of these specialties are surgical in nature, we believed 
these surgical specialties are providing increased non-procedural care 
of high complexity in the Medicare population. The high complexity of 
these services is reflected

[[Page 59642]]

in the large proportion of level 4 and level 5 visits that we believed 
are reported by these specialties, and the extent to which E/M visits 
are a high proportion of these specialties' total allowed charges. 
Consequently, these are specialties for which the resource costs of the 
visits they typically perform are not fully captured in the proposed 
single payment rate for the levels 2 through level 5 office/outpatient 
visit codes. When billed in conjunction with standalone office/
outpatient E/M visits for new and established patients, the combined 
valuation more accurately accounts for the intensity associated with 
higher level E/M visits. To establish a value for this add-on service 
to be applied with a standalone E/M visit, we proposed a crosswalk to 
75 percent of the work and time of CPT code 90785 (Interactive 
complexity), which would result in a work RVU of 0.25, no direct PE 
inputs, and an MP RVU of 0.01, as well as 8.25 minutes of physician 
time based on the CY 2018 valuation for CPT code 90785. Interactive 
complexity is an add-on code that may be billed when a psychotherapy or 
psychiatric service requires more resources due to the complexity of 
the patient. We believed that the proposed valuation for CPT code 90785 
would be an accurate representation of the additional work associated 
with the higher level complex visits. We noted that we believed the 
additional resources to address inherent complexity in E/M visits are 
associated with stand-alone E/M visits. Additionally, we acknowledged 
that resource costs for primary care are reflected with the proposed 
HCPCS code GPC1X, as opposed to the proposed HCPCS code GCG0X. We note 
that there are additional codes available that include face-to-face and 
non-face-to-face work, depending on the code, that previously would 
have been considered part of an E/M visit, such as the codes for CCM, 
BHI, and CPT code 99483 (Assessment of and care planning for a patient 
with cognitive impairment, requiring an independent historian, in the 
office or other outpatient, home or domiciliary or rest home, with all 
of the following required elements: Cognition-focused evaluation 
including a pertinent history and examination; Medical decision making 
of moderate or high complexity; Functional assessment (e.g., basic and 
instrumental activities of daily living), including decision-making 
capacity; Use of standardized instruments for staging of dementia 
(e.g., functional assessment staging test [FAST], clinical dementia 
rating [CDR]); Medication reconciliation and review for high-risk 
medications; Evaluation for neuropsychiatric and behavioral symptoms, 
including depression, including use of standardized screening 
instrument(s); Evaluation of safety (e.g., home), including motor 
vehicle operation; Identification of caregiver(s), caregiver knowledge, 
caregiver needs, social supports, and the willingness of caregiver to 
take on caregiving tasks; Development, updating or revision, or review 
of an Advance Care Plan; Creation of a written care plan, including 
initial plans to address any neuropsychiatric symptoms, neuro-cognitive 
symptoms, functional limitations, and referral to community resources 
as needed (e.g., rehabilitation services, adult day programs, support 
groups) shared with the patient and/or caregiver with initial education 
and support. Typically, 50 minutes are spent face-to-face with the 
patient and/or family or caregiver), which were developed to reflect 
the additional work of those practitioners furnishing primary care 
visits. Likewise, we proposed that practitioners in the specialty of 
psychiatry would not use either add-on code because psychiatrists may 
utilize CPT code 90785 to describe work that might otherwise be 
reported with a level 4 or level 5 E/M visit.
    Given the broad scope of our proposals related to E/M services, we 
solicited feedback on any unintended consequences of those proposals. 
We also solicited comment on any other concerns related to primary care 
that we might consider for future rulemaking.
    Comment: Many commenters stated that CMS needed to clarify the 
definition of primary care services that would fall under the scope of 
the primary care complexity add-on.
    Some commenters suggested that ambiguity around the definition of 
the primary care add-on would create additional documentation burden 
and concern regarding audit risk. For example, many commenters 
presented examples of physicians of many different specialties 
furnishing particular services that might be considered to be primary 
care, such as when a dermatologist prescribes an anti-hypertensive 
medication, and what documentation would be required to justify billing 
of the add-on code.
    In response to CMS' solicitation for accepted definitions of 
primary care, the AAFP stated that primary care services are performed 
by practitioners ``specifically trained for and skilled in 
comprehensive first contact and continuing care for persons with any 
undiagnosed sign, symptom, or health concern.'' The primary care 
physician ``provides definitive care to the undifferentiated patient at 
the point of first contact and takes continuing responsibility for 
providing the patient's comprehensive care.'' Because the definition of 
a primary care service hinges on the ongoing relationship with the 
patient, the AAFP recommended that the add-on code not be limited to 
established patients, but expanded to new patients when the physician 
has an expectation that an ongoing relationship will develop.
    In response to CMS' request for comment on the circumstances when 
it would be appropriate for a specialist to bill for primary care 
services, the AAFP stated that while physicians who are not trained in 
the core primary care specialties can provide services focused on 
``specific patient care needs related to prevention, health 
maintenance, acute care, chronic care, or rehabilitation'' but not 
within the context of ``comprehensive, first contact, and continuing 
care.'' Therefore, the AAFP stated that these practitioners were not 
providing primary care.
    Response: We are appreciative of the concerns commenters shared 
regarding the potential risks of ambiguity in knowing when the code, as 
proposed, would be appropriately reported, and how the documentation 
would need to justify its appropriateness. The proposal to use an add-
on code to account for the inherent complexity associated with primary 
care visits was intended to account for appropriate resource variation 
between primary care and other kinds of visits without imposing 
additional documentation to justify its being reported for each and 
every visit with a beneficiary. We note that this proposal was in 
keeping with our longstanding assessment that there are certain 
complexities inherent in furnishing some kinds of E/M visits that the 
current E/M coding and visit levels do not fully recognize. We also 
believe that in almost all cases where physicians and other 
professionals are furnishing primary care, information already in the 
medical record or on the claim, such as physician specialty, diagnosis 
codes, other service codes billed (chronic care or transitional care 
management services), or patient relationship codes would serve as 
sufficient documentation that the furnished visit met the primary care 
description. For example, we would expect that most practitioners 
enrolled in such specialties as family medicine, internal medicine, 
pediatrics, and geriatrics would be billing the primary care visit 
complexity add-on with every office/outpatient E/M visit. The visits 
themselves would still need to be

[[Page 59643]]

medically reasonable and necessary in order for the practitioner to 
report the service, and the documentation would need to illustrate 
medical necessity of the visit, but we believe the appropriateness of 
using the primary care add-on to the visit would not necessitate 
additional documentation. We also agree with the AAFP that billing this 
code should not be limited to established patients, as a primary care 
visit may also be a new patient visit where the expectation of an 
ongoing relationship is present.
    For example, a 68-year-old woman with progressive congestive heart 
failure (CHF), diabetes and gout on multiple medications transfers care 
to a new primary care clinician. During a visit to establish care, the 
clinician discusses the patient's current health issues that includes 
confirmation that her CHF symptoms have remained stable over the past 3 
months. She also denies symptoms to suggest hyper or hypoglycemia, but 
does note pain in her right wrist and knee. Based on the patient's 
history, physical exam findings and discussion, the clinician adjusts 
the dosage of some of the patient's medications, instructs the patient 
to take acetaminophen for her joint pain, request copies of prior 
diagnostic studies from his former providers, and orders laboratory 
tests to assess glycemic control, metabolic status and kidney function. 
The practitioner also discusses age appropriate prevention with the 
patient and orders a pneumonia vaccination and screening colonoscopy.
    In this case, since the practitioner is furnishing care for 
conditions across a spectrum of diagnoses and organ systems and 
coordinating the patient's care among multiple health care providers, 
the practitioner would report the primary care resource add-on with the 
appropriate E/M code. We anticipate that the issues addressed by a 
physician will often track with the physician's specialty training. 
Therefore, it would not be unexpected for this physician to be 
reporting the primary care resource add-on code for almost all E/M 
visits, provided they are furnishing primary care during those visits. 
We would expect that claims records would include the billing 
physician's specialty and that the medical record would include the 
diagnoses for the patient, and the clinician's assessment and plan for 
that visit. This information would serve as sufficient documentation 
that the furnished visit met the primary care complexity description 
and so there would be no need to provide additional documentation.
    We agree with AAFP that the vast majority of visits billed with the 
primary care complexity add-on would be performed by the previously 
mentioned specialties; however, we also recognize that there is not 
consensus among medical specialties on this definition. We also believe 
that there are clinical scenarios when a specialist may perform primary 
care. For example:
    A cardiologist serving beneficiaries in a rural location provides 
care for complex cardiac conditions as well as primary care in her 
clinical practice. This practitioner sees a 75-year-old female with 
hypertension, coronary artery disease, and osteoarthritis for routine 
follow up care. During the visit, the patient describes a worsening 
pain in her hip and dizziness for the past month. The clinician notes 
gait instability and painful motion of her hip, and significant 
orthostasis upon standing. The clinician observes that the patient has 
made errors in filling her pill box, and has a new counter anti-
histamine that the patient obtained from her friend to help with sleep. 
The clinician conducts a brief cognitive test, ascertains that the 
patient had not fallen, and recommends stopping the anti-cholinergic 
medication, and adjustment of her blood pressure medications with close 
follow-up monitoring. In addition to reviewing the patients' cardiac 
status, initiating imaging to evaluate the hip, the clinician also 
recommends a home safety evaluation and schedules a follow-up visit to 
include her adult daughter who lives nearby. In this case, since the 
clinician is furnishing primary care services as well as specialty 
cardiology services, the physician would appropriately be reporting the 
primary care complexity add-on in addition to the appropriate E/M visit 
code. We would expect that the claims record would include the billing 
physician's specialty. The medical record would also include the 
diagnoses for the patient and clinician's assessment and plan for that 
visit.
    This information would serve as sufficient documentation that the 
furnished visit met the primary care and non-procedural specialty care 
complexity adjustment descriptions and so there would be no need to 
provide additional documentation.
    Comment: Some commenters supported the creation of an add-on code 
for primary care visit complexity, but pointed out that, as proposed, 
the primary care add-on code was significantly undervalued, 
particularly in comparison to the add-on code for visit complexity 
associated with specialty care. Commenters were critical of the 
approach CMS used to value the proposed primary care add-on code. A few 
commenters suggested that CMS should equalize the values between the 
two add-on codes.
    The AAFP did not support the add-on code, and instead suggested 
that CMS provide a 15 percent increase in payment to physicians who 
list their primary practice designation as family medicine, internal 
medicine, pediatrics, or geriatrics.
    Response: The proposed valuation for the primary care complexity 
add-on code was based on the application of family budget neutrality to 
the proposed changes in other codes and payment policies--most notably 
applying an MPPR to E/M office/outpatient visit codes furnished in the 
same day as a procedure. While we continue to believe that budget 
neutrality within the code family can be an appropriate approach to 
assess relative resources under the PFS, we appreciate and agree with 
commenters' concerns regarding the asymmetry between the proposed 
values for the add-on codes for non-procedural specialty care 
complexity and primary care complexity. We also note that we are not 
finalizing the proposed multiple procedure payment adjustment for these 
E/M office/outpatient visit codes.
    Comment: Many commenters did not support separate payment for an 
add-on code to account for the resource costs for the inherent 
complexity associated with furnishing non-procedural specialty visits. 
Commenters assumed that billing the visit complexity add-on code was 
limited to the specialties included in the code descriptor, 
constituting specialty-specific payment prohibited by statute. 
Commenters also stated that CMS was unclear about the rationale for 
which specialties were included in the code descriptor, and that the 
explanation provided was ambiguous and not clinically derived. Several 
commenters expressed concern that CMS did not include the work of a 
number of specialties that routinely furnish non-procedural specialist 
care and that primarily report that care through the office/outpatient 
E/M code set. Many commenters representing these specialties requested 
that CMS include them in the code descriptor. These include: 
Nephrology, infectious disease, gastroenterology, psychiatry, 
ophthalmology, pediatric ophthalmology, orthopedic surgery, sports 
medicine, neuro-ophthalmology, hepatology, interventional radiology, 
pulmonology, dermatology, medical oncology, Hematopoietic Cell 
Transplantation and Cellular Therapy (HCTCT), hospice, and palliative 
medicine. Some commenters also noted

[[Page 59644]]

that nurse practitioners are frequently specialized and recommended 
that they be eligible to bill for the specialty complexity add-on. A 
few commenters stated that Medicare enrollment specialty was a poor 
proxy for patient complexity, and that instead, CMS should rely on the 
patient's diagnosis. Several commenters did not agree with the proposed 
values for the add-on code, but none provided alternatives for CMS to 
consider.
    Many commenters were also concerned about the documentation 
requirements that would be associated with the new coding, stating that 
CMS was replacing the burden of documenting the level of E/M visit with 
the burden of documenting proper use of the visit complexity add-ons. A 
few commenters did support the add-on codes in concept as a useful way 
of adjusting payment for different types of visits, although several 
commenters pointed out that the add-on codes were not valued 
sufficiently to overcome any reduction in payment due to the proposed 
single payment rate for visit levels. Commenters requested that CMS 
clarify whether the add-on codes could be billed concurrently for the 
same visit.
    Response: We are appreciative of the concerns commenters shared 
regarding the potential risks of ambiguity in knowing when the code, as 
proposed, would be appropriately reported, and how the documentation 
would need to justify its appropriateness. The proposal to use an add-
on code to account for the inherent complexity associated with non-
procedural specialty care visits was intended to account for 
appropriate resource variation between non-procedural specialty care 
and other kinds of visits without imposing additional documentation to 
justify its being reported for each and every visit with a beneficiary. 
We noted that this proposal was in keeping with our longstanding 
assessment that there are certain complexities inherent in furnishing 
some kinds of E/M visits that the visit levels do not fully recognize. 
We also believed that in almost all cases where physicians and other 
professionals are furnishing specialty care that is centered around 
separately reportable office/outpatient visit codes (as opposed to 
procedural codes with global periods, for example), information already 
in the medical record or in the claims history for that practitioner, 
such as physician specialty, diagnosis codes, and/or other service 
codes billed (chemotherapy administration) would serve as sufficient 
documentation that the furnished visit met the description of non-
procedural specialty care. For example, we would expect that most 
practitioners enrolled in the specialties used as descriptive examples 
in the proposed descriptor would report the complexity add-on with 
every office/outpatient E/M visit. The visits themselves would still 
need to be medically reasonable and necessary in order for the 
practitioner to report the service, and the documentation would need to 
illustrate medical necessity of the visit, but we believe the 
appropriateness of routinely using the add-on to the visit would not 
necessitate additional documentation for each and every visit.
    A clinical scenario for the use of this proposed add-on code would 
be a 72-year-old female with colon cancer who sees her oncologist to 
discuss her treatment plan, including surgical and chemotherapeutic 
options. Since this E/M visit focuses on oncologic care, the physician 
would report the specialty care add-on in addition to the appropriate 
E/M visit code. It would not be unexpected for this physician to be 
reporting the non-procedural specialty care complexity add-on code for 
almost all E/M visits, provided they are providing oncologic care 
during those visits. We would expect that the claims record would 
include the billing physician's specialty. The medical record would 
also include the diagnoses for the patient and clinician's assessment 
and plan for that visit. This information would serve as sufficient 
documentation that the furnished visit met the description of non-
procedural specialty care complexity and so there would be no need to 
provide additional documentation.
    We also agree with commenters that the code descriptor omitted 
several specialties that provide this type of visit, such as 
nephrology, psychiatry, pulmonology, infectious disease, and hospice 
and palliative care medicine. We also believe that there are 
circumstances where specialties not included in the code descriptor 
would appropriately bill this add-on code for inherent visit 
complexity. As discussed previously, appropriate reporting of the 
specialty care resource add-on code should be apparent based on the 
nature of the clinical issues addressed at the E/M visit, and not 
limited by the practitioner's specialty.
    In cases where appropriate reporting of the add-on code is not as 
apparent, we understand that some degree of visit-specific 
documentation might be necessary for purposes of demonstrating that the 
add-on code was reported appropriately. For example, a physician 
enrolled in Medicare as a pathologist may serve a broader role in a 
rural community, including furnishing primary care. In this instance, 
we expect that there would be documentation in the medical record to 
illustrate that it was appropriate for this physician to bill using the 
primary care complexity add-on. However, we do not believe that such 
scenarios would represent the majority of instances of appropriate use 
of the code. Additionally, we note that information usually included in 
medical documentation, combined with diagnosis coding, would likely 
suffice for purposes of documentation.
    After consideration of the comments, we are finalizing for 2021 the 
proposal to introduce add-on codes that would adjust payment for new 
and established E/M office/outpatient visits to account for inherent 
complexity in primary care and non-procedural specialty care. We are 
finalizing the code descriptor for the add-on code for inherent 
complexity of E/M furnished primary care (HCPCS code GPC1X) as 
described in Table 22. We are also finalizing the code descriptor for 
the add-on code for inherent complexity of E/M furnished with non-
procedural specialty care (HCPCS code GCG0X) in Table 22, and we note 
that we have included refinements to refer to additional kinds of non-
procedural specialty care as suggested by commenters and clarifying 
that it could be reported for both new and established patients. We 
note that we are not including in the descriptor references to 
specialty care that routinely involves significant procedural 
interventions, such as interventional radiology and dermatology, since 
we do not agree with commenters that these kinds of specialty care are 
routinely considered to be ``non-procedural specialist care.'' However, 
we note that when clinical circumstances support it, practitioners not 
enrolled among the specialties expressly listed within the code 
descriptor may bill the inherent visit complexity add-on codes. We are 
also finalizing as proposed the code descriptor for inherent complexity 
of E/M furnished with primary care (HCPCS code GPC1X) with the 
refinement of including that it could be reported for both new and 
established patients. The add-on codes to account for inherent 
complexity in primary care and non-procedural specialty care could only 
be reported with E/M office/outpatient levels 2 through 4 visits. We 
note that for this and the other HCPCS G-codes we are finalizing for CY 
2021, we are retaining the placeholder HCPCS code numbers until they 
are replaced through our standard process.

[[Page 59645]]



    Table 22--Finalized Code Descriptors for Visit Complexity Add-Ons
------------------------------------------------------------------------
            HCPCS                              Descriptor
------------------------------------------------------------------------
GPC1X........................  Visit complexity inherent to evaluation
                                and management associated with primary
                                medical care services that serve as the
                                continuing focal point for all needed
                                health care services (Add-on code, list
                                separately in addition to level 2
                                through 4 office/outpatient evaluation
                                and management visit, new or
                                established).
GCG0X........................  Visit complexity inherent to evaluation
                                and management associated with non-
                                procedural specialty care including
                                endocrinology, rheumatology, hematology/
                                oncology, urology, neurology, obstetrics/
                                gynecology, allergy/immunology,
                                otolaryngology, interventional pain
                                management, cardiology, nephrology,
                                infectious disease, psychiatry, and
                                pulmonology (Add-on code, list
                                separately in addition to level 2
                                through 4 office/outpatient evaluation
                                and management visit, new or
                                established).
------------------------------------------------------------------------

    We again note that we are finalizing the add-on codes for primary 
care and non-procedural specialized care complexity adjustment, as well 
as other payment and coding changes to be implemented for E/M office/
outpatient visits for CY 2021. We are specifying the later date, in 
great part, so that we have an opportunity to fully consider public 
comments and other important input from stakeholders on potential 
refinements in code and service definitions that can be used with ease, 
when appropriate, and by practitioners whom we currently believe are 
disproportionately burdened under the current coding and documentation 
requirements and, more generally, other important information involving 
coding and payment for E/M services.
    After considering the public comments, we agree that the complexity 
associated with furnishing a primary care visit is equivalent to that 
associated with furnishing a non-procedural specialty care visit, and 
therefore, the two codes should be valued equally. We are finalizing, 
for 2021, the input values for these two codes as reflected in Table 
23.
    We note that these inputs reflect our proposed valuation of the 
non-procedural specialty complexity code, based on a modified crosswalk 
from CPT code 90785 as discussed in the CY 2019 PFS proposed rule (83 
FR 35842).

   Table 23--Inputs for HCPCS Codes GCG0X and GPC1X Finalized for 2021
------------------------------------------------------------------------
                                    Physician
              HCPCS                    time       Work RVU      MP RVU
------------------------------------------------------------------------
GCG0X............................         8.25         0.25         0.02
GPC1X............................         8.25         0.25         0.02
------------------------------------------------------------------------

    We also note that, while our policy will result in our inclusion of 
these input values in developing proposed rates for CY 2021, we also 
recognize that we routinely accept recommendations from the RUC and 
other stakeholders regarding appropriate valuation for PFS services, 
and would consider such recommendations regarding appropriate valuation 
for these services under our usual, annual process for receiving 
recommendations for PFS services.
    In response to the commenters' concerns regarding the interactions 
between this code and the other codes that describe more complex E/M 
visits, we are clarifying that these add-on codes are intended to serve 
as a corollary to the single payment rate for E/M office/outpatient 
visit codes defined as levels 2 through 4 to provide for more 
appropriate recognition of the variations in resources involved in 
furnishing those services, and not to be used in association with E/M 
office/outpatient level 1 or level 5 visits.
    While we believe that in most cases practitioners would only be 
reporting either the primary care complexity code or non-procedural 
specialty care complexity code, we believe there are some very rare 
circumstances where use of both codes might be appropriate. We return 
to our example of the cardiologist serving beneficiaries in a rural 
location who provides care for complex cardiac conditions as well as 
primary care in her clinical practice. Since the needs of the community 
prompt this physician to provide primary care services as well as 
specialty cardiology services, we would expect that she would report 
the primary care complexity add-on code and non-procedural specialty 
care complexity add-on code in addition to the appropriate E/M visit 
code when both primary care and non-procedural specialty care are 
furnished in connection with E/M visits.
(c) HCPCS G-Coded To Describe Podiatric E/M Visits
    As described earlier, the vast majority of podiatric visits are 
reported using lower level E/M codes, with most E/M visits billed at a 
level 2 or 3, reflecting the type of work done by podiatrists as part 
of an E/M visit. Therefore, while the proposed consolidation of 
documentation and payment for E/M code levels 2 through 5 was intended 
to better reflect the universal elements of E/M visits across 
specialties and patients, we believed that podiatric E/M visits were 
not accurately represented by the consolidated E/M structure. In order 
for payment to reflect the resource costs of podiatric visits, we 
proposed to create two HCPCS G codes, HCPCS codes GPD0X (Podiatry 
services, medical examination and evaluation with initiation of 
diagnostic and treatment program, new patient) and GPD1X (Podiatry 
services, medical examination and evaluation with initiation of 
diagnostic and treatment program, established patient), to describe 
podiatric E/M services. Under this proposal, podiatric E/M services 
would be billed using these G-codes instead of the generic office/
outpatient E/M visit codes (CPT codes 99201 through 99205 and 99211 
through 99215). We proposed to create these separate G-codes for 
podiatric E/M services to differentiate the resources associated with 
podiatric E/M visits rather than propose a negative add-on adjustment 
relative to the proposed single payment rates for the generic E/M 
levels 2 through 5 codes. Therefore, we proposed to create separate 
coding to describe these services, taking into account that most 
podiatric visits are billed as level 2 or 3 E/M codes. We based the 
coding structure and code descriptor on CPT codes 92004 
(Ophthalmological services: Medical examination and evaluation with 
initiation of diagnostic and treatment program; comprehensive, new 
patient, 1 or more visits) and 92012

[[Page 59646]]

(Ophthalmological services: Medical examination and evaluation, with 
initiation or continuation of diagnostic and treatment program; 
intermediate, established patient), which describe visits specific to 
ophthalmology. To accurately reflect payment for the resource costs 
associated with podiatric E/M visits, we proposed a work RVU of 1.35, a 
physician time of 28.11 minutes, and direct PE inputs totaling $22.53 
for HCPCS code GPD0X, and a work RVU of 0.85, physician time of 21.60 
minutes, and direct PE inputs totaling $17.07 for HCPCS code GPD1X. 
These values were based on the average rate for the level 2 and 3 E/M 
codes (CPT codes 99201-99203 and CPT codes 99211-99212, respectively), 
weighted by podiatric volume.
    Comment: Commenters opposed making separate payment for podiatric 
E/M visits using distinct coding. Commenters stated that, by creating 
separate coding and payment to describe these types of visits, CMS was 
singling out podiatrists and devaluing podiatric physicians' status 
among their peer physicians. Some commenters questioned the legality of 
our proposal since it would effectively pay physicians of different 
specialties different amounts for services that CPT considers to be the 
same. Furthermore, commenters stated that the proposed rates for 
podiatric E/M visits did not reflect the resource costs associated with 
providing podiatric care. Commenters also objected to the use of the 
ophthalmology visit codes as a precedent, stating that the significant 
practice expense associated with ophthalmologic visits was the impetus 
for separate coding for those services.
    Response: Based on our consideration of the information presented 
by commenters, we are persuaded that there could be a perceived 
devaluation of the breadth and value of care associated with podiatric 
visits by use of separate coding for these visits. Given these 
potential negative consequences, we are not finalizing the proposal to 
adopt separate coding for podiatric E/M visits. However, as our 
discussion in the preceding sections reflects, we do not agree with the 
commenters that all office/outpatient visits furnished by physicians 
are only distinguishable by visit levels under the current CPT 
definitions. Instead, we believe that, like procedural services, visit 
services and their associated relative resource costs can vary greatly 
by the kind of care that is provided by particular physicians. We also 
believe that physician specialties can often reflect different 
approaches to medical care, and that the nomenclature used to describe 
and define various clinical specialties is useful for purposes of 
distinguishing among the types of services, including visits, furnished 
by physicians using these different approaches.
    We also acknowledge that our proposal should have clearly 
articulated that we were not proposing to prohibit podiatrists from 
reporting the E/M office/outpatient visit codes under circumstances 
where those codes more accurately described visits with particular 
patients or, more broadly, visits generally furnished by particular 
podiatrists.
    We also would like to note that our analysis of claims data 
indicates that the vast majority of podiatric visits are reported as 
level 2 and 3 visits. We believe that these claims data are an 
important piece of evidence regarding the relative resource costs of 
office/outpatient visits that are podiatric in nature. Therefore, we do 
not agree with the commenters that stated that our proposal did not 
reflect resource-based valuation, since we consider Medicare claims 
data to be one of the best sources of data regarding the resources 
involved in furnishing PFS services.
    After considering the comments regarding this proposal, we are not 
finalizing our proposal to create separate coding for podiatric E/M 
services and establish payment rates for podiatric E/M visits based on 
historical billing patterns. We acknowledge the commenters' concerns 
that creating specific coding as we proposed could suggest a 
devaluation of services furnished by podiatrists. Therefore, we are not 
finalizing creation of specific coding and payment values for podiatric 
E/M visits. For CY 2021, podiatric E/M visits would be reported and 
paid using the E/M coding and payment structure applicable to other E/M 
office/outpatient visits.
(d) Adjustment to the PE/HR Calculation
    As we explain in section II.B. of this final rule, Determination of 
Practice Expense (PE) Relative Value Units (RVUs), we generally 
allocate indirect costs for each code on the basis of the direct costs 
specifically associated with a code and the greater of either the 
clinical labor costs or the work RVUs. Indirect expenses include 
administrative labor, office expense, and all other PEs that are not 
directly attributable to a particular service for a particular patient. 
Generally, the proportion of indirect PE allocated to a service is 
determined by calculating a PE/HR based upon the mix of specialties 
that bill for a service.
    As described earlier, E/M visits comprise a significant portion of 
allowable charges under the PFS and are used broadly across specialties 
such that our proposed changes can greatly impact the change in payment 
at the specialty level and at the practitioner level. Our proposals 
sought to simplify payment for E/M visit levels 2 through 5, and to 
additionally take into consideration that there are inherent 
differences in primary care-focused E/M services and in more complex E/
M services such that those visits involve greater relative resources, 
while seeking to maintain overall payment stability across specialties. 
However, establishing a single PFS rate for new and established patient 
E/M levels 2 through 5 would have a large and unintended effect on many 
specialties due to the way that indirect PE is allocated based on the 
mixture of specialties that furnish a service. The single payment rates 
proposed for E/M levels 2 through 5 could not reflect the indirect PE 
previously allocated differentially across those 8 codes. Historically, 
a broad blend of specialties and associated PE/HR has been used in the 
allocation of indirect PE and MP RVUs to E/M services to determine 
payment rates for these services. As this proposal would have 
significantly altered the PE/HR allocation for the office/outpatient E/
M codes and any previous opportunities for the public to comment on the 
data would not have applied to these kinds of E/M services, we did not 
believe it was in the public interest to allow the allocation of 
indirect PE to have such an outsized impact on the payment rates for 
this proposal. Due to the magnitude of the proposed coding and payment 
changes for E/M visits, it was unclear how the distribution of 
specialties across E/M services would change. We were concerned that 
such changes could produce anomalous results for indirect PE 
allocations since we did not yet know the extent to which specialties 
would utilize the proposed simplified E/M codes and proposed G-codes. 
In the past, when utilization data are not available or do not 
accurately reflect the expected specialty mix of a new service, we have 
proposed to crosswalk the PE/HR value from another specialty (76 FR 
73036). As such, we proposed to create a single PE/HR value for E/M 
visits (including all of the proposed HCPCS G-codes discussed above) of 
approximately $136, based on an average of the PE/HR across all 
specialties that bill these E/M codes, weighted by the volume of those 
specialties' allowed E/M services. We believed that this was consistent 
with

[[Page 59647]]

the methodology used to develop the inputs for the proposed simplified 
E/M payment for the levels 2 through 5 E/M visit codes, and that, for 
purposes of consistency, the new PE/HR should be applied across the 
additional E/M codes. We believed a new PE/HR value would more 
accurately reflect the mix of specialties billing both the generic E/M 
code set and the add-on codes. If we finalized this proposal, we would 
have considered revisiting the PE/HR after several years of claims data 
become available.
    The following is a summary of the comments we received on this 
proposal.
    Comment: Many commenters noted that the application of a single PE/
HR value to E/M visit codes had significant, if unintended, 
consequences for the allocation of indirect PE across the PFS. 
Commenters also stated that CMS did not provide enough information as 
to how we arrived at the PE/HR value, which resulted in difficulty 
among external stakeholders in modeling the proposal.
    Response: We appreciate commenters highlighting the broad 
ramifications of this proposal.
    After consideration of these comments, we will not be finalizing a 
separate PE/HR for office/outpatient E/M visits.
(e) HCPCS G-Code for Extended Visit Services
    Time is often an important determining factor in the level of care, 
which we consider in our proposal described earlier that physicians and 
other practitioners can use time as the basis for documenting and 
billing the appropriate level of E/M visit for purposes of Medicare 
payment. Currently there is inadequate coding to describe services 
where the primary resource of a service is physician time. CPT codes 
99354 (Prolonged evaluation and management or psychotherapy service(s) 
(beyond the typical service time of the primary procedure) in the 
office or other outpatient setting requiring direct patient contact 
beyond the usual service; first hour (List separately in addition to 
code for office or other outpatient Evaluation and Management or 
psychotherapy service)) and 99355 (Prolonged evaluation and management 
or psychotherapy service(s) (beyond the typical service time of the 
primary procedure) in the office or other outpatient setting requiring 
direct patient contact beyond the usual service; each additional 30 
minutes (List separately in addition to code for prolonged service)) 
describe additional time spent face-to-face with a patient and may be 
billed when the applicable amount of time exceeds the typical service 
time of the primary procedure.
    Stakeholders have informed CMS that the ``first hour'' time 
threshold in the descriptor for CPT code 99354 is difficult to meet and 
is an impediment to billing these codes (81 FR 80228). In response to 
stakeholder feedback and as part of our proposal to implement a single 
payment rate for E/M visit levels 2 through 5 while maintaining payment 
accuracy across the specialties, we proposed to create a new HCPCS code 
GPRO1 (Prolonged evaluation and management or psychotherapy service(s) 
(beyond the typical service time of the primary procedure) in the 
office or other outpatient setting requiring direct patient contact 
beyond the usual service; 30 minutes (List separately in addition to 
code for office or other outpatient Evaluation and Management or 
psychotherapy service)). Given that the physician time of HCPCS code 
GPRO1 is half of the physician time assigned to CPT code 99354, we 
proposed a work RVU of 1.17, which is half the work RVU of CPT code 
99354.
    Comment: Many commenters, including the AMA, were supportive of the 
creation of this code in isolation from the rest of the E/M coding and 
payment proposals. Other commenters stated that the code was 
unnecessary, that current coding was sufficient to account for 
additional time spent with patients, and that it was unrealistic to 
expect that most physicians would be able to meet the time threshold in 
enough volume to offset the negative impacts of the single payment rate 
for E/M office/outpatient new and established patient visit levels 2 
through 5. Some commenters suggested more documentation would be 
necessary to bill this new code. Many commenters also stated that 
referring to this code as ``prolonged services'' was inconsistent with 
coding conventions and CPT definitions, as the CPT Editorial Panel 
defined prolonged services as an unusual amount of time spent beyond 
the typical time and these commenters understood from the proposal that 
the code was intended to be reported more frequently. Many commenters 
stated that it would be difficult to assess how the code might be used 
without more specific guidelines regarding how time would be counted, 
particularly with regard to how many minutes would be assumed to be 
associated with the companion visit code and whether or not we adopt 
the usual CPT coding convention for appropriate reporting of the time-
based code when over half the number of minutes (16 in this case) have 
been spent. Several commenters suggested that 16 minutes beyond the 
time associated with the proposed single payment rate (31 minutes as 
described by many of these commenters) would mean that the code could 
only be reported after 47 minutes spent with an established patient. 
These commenters suggested that that threshold would likely result in 
the code being used rarely.
    Response: We agree with commenters that current coding describing 
prolonged services is not sufficient to capture additional time spent 
with patients, especially in the context of creating a single payment 
rate for office/outpatient E/M levels 2 through 4. We believe that time 
is a critical resource cost for physicians and other practitioners, and 
the time spent with patients is a great benefit to Medicare 
beneficiaries. We also note that we are required by statute to consider 
time, along with intensity, in establishing the work relative value 
units that determine PFS payments. We are therefore finalizing for 2021 
separate payment for HCPCS code GPRO1, and are finalizing the input 
values as proposed.
    We appreciate commenters' concerns regarding the current 
definitions and use of ``prolonged'' as applying to unusually long 
visits. We believe that time spent with patients ought to vary based on 
the particular needs of the patient and that variations in time spent 
face-to-face with the patient can be critical in defining differences 
between the services being furnished. Consequently, we agree that for 
many practitioners, times that extend beyond what we, or the CPT 
Editorial Panel, consider to be typical under the current visit code 
descriptors and definitions, might, in actual practice, be routine. We 
also note that many services, such as psychotherapy, are currently 
defined and paid based on the duration of the service.
    However, since commenters have suggested that the term 
``prolonged'' has been established in coding convention as applying 
only to unusually long visits as opposed to use in describing routine 
variations in the amount of time spent during visits with patients, we 
believe using an alternative term, like ``extended visit'' may serve to 
underscore our expectation that the length of some visits might exceed 
the typical length, but would not be unusual for certain practices or 
patients.
    We also note that, for audit purposes, we would expect the medical 
record to reflect that the billing practitioner actually spent the 
amount of time with the patient described by the code and that the 
visit itself, in its entirety, was medically necessary; but we would 
not

[[Page 59648]]

expect additional documentation to demonstrate that the difference in 
time between the visit code and the extended visit code was, in 
isolation of the visit, medically necessary.
    For CY 2021, we are finalizing a coding and payment policy to 
account for the additional resources required when practitioners need 
to spend extended time with their patients during particular E/M 
office/outpatient level 2 through 4 visits, regardless of the kind of 
care the practitioner is furnishing or whether or not the medical 
complexity of the visit is the determining factor for the length of 
visit. After considering the comments, we believe that 30 additional 
minutes (which, in accordance with CPT coding conventions for timed 
codes, can be reported after 15 additional minutes is spent with the 
patient) is an appropriate interval of time after which to reflect the 
additional resource costs associated with patient visits that require 
more time than is typical for the visit. After considering the 
questions and concerns expressed by commenters about how the new add-on 
code would be used, and in particular, the number of minutes that would 
serve as the basis for counting time toward an extended visit (for 
example, whether we would look to the typical time for the companion E/
M code level and use the CPT coding convention for time-based codes), 
we acknowledge that it would not be workable to use the same 
conventions as are used for the prolonged service codes.
    Under the current conventions used in reporting the existing 
prolonged service codes, the prolonged codes are defined by a set 
number of additional minutes beyond time associated with individual 
companion visit codes. For example, the initial prolonged services code 
describes 60 minutes of prolonged time beyond the time associated with 
the individual companion visit code. The current level 5 existing 
patient code is described by CPT as typically requiring 40 minutes with 
the patient, so that when reporting 99215 with the prolonged service 
code, the time being described is a total of 100 minutes (40 minutes 
for the level 5 code and 60 minutes for the initial prolonged code). 
Under applicable coding conventions, the code is reportable, when at 
least half the number of described minutes for the prolonged code is 
spent. This means that the initial prolonged service code can be 
reported with a level 5 existing patient code after 70 minutes (40 
minutes for the full time associated with the level 5 visit and 30 
minutes for half the number of minutes described by the initial 
prolonged service code).
    We recognize that to implement use of either new or even the 
existing prolonged services code in the context of using a single 
payment rate for codes of varying levels, we would need to be clear 
about what time should be used for the companion visit codes. 
Currently, practitioners rely on the CPT ``typical'' times to determine 
the time for the visit codes of varying levels. This means that the 
thresholds for visit time required before the prolonged services can be 
reported are higher when higher level visits are reported in comparison 
to lower level visits. Under current payment rates, this situation is 
offset to some degree by the higher overall payment in circumstances 
where the higher level visit code is reported.
    Because we are finalizing a single payment rate for levels 2-4, 
however, use of the ``typical'' CPT times as the basis for reporting 
add-on codes that describe additional time would mean that lower level 
visits that take more time would be paid at higher rates than higher 
visit rates that take the same amount of time. We believe that because 
we are paying a single rate for these services (as each of the codes 
describe a single ``typical'' for purposes of payment), we should also 
use a single number of minutes for purposes of reporting time-based 
add-on codes: The weighted average of the ``typical'' times associated 
with each of the codes that comprise the single payment rate.
    One approach to implementing this would be to revise our billing 
rules to instruct practitioners to use the weighted average of the 
``typical'' times associated with each of the codes that comprise the 
single payment rate, instead of the ``typical'' CPT times associated 
with the individual billed codes. We could apply this definition 
broadly to specify use of the weighted average typical times for level 
2-4 codes regardless of whether or not they are being reported with 
time-based add-on codes, but we do not want to prevent practitioners 
from appropriately reporting visits based on the time defined as 
typical under the CPT code descriptors for office/outpatient E/M 
visits, especially since we are adopting a policy to allow clinicians 
to use time as the basis for documentation and code selection. 
Alternatively, we could require practitioners to use the weighted 
average of the ``typical'' times associated with each of the codes that 
comprise the single payment rate only in cases where time-based add-on 
codes are also being reported. However, we believe using two separate 
rules, especially one that deviates from the typical times established 
for the different visit levels that will continue to be routinely 
reported by a wide range of practitioners, would be likely to cause 
confusion.
    After consideration of these issues and considering the 
alternatives, we are finalizing a code descriptor for the extended 
visit code that describes a single range of minutes that applies to the 
overall duration of face-to-face time during the visit, without regard 
to which level 2, 3, or 4 E/M office/outpatient visit was reported. 
This range is 34 to 69 minutes, so that the add-on code for extended 
visits would be appropriately reported in any case where a medically 
necessary E/M office/outpatient visit, reported using levels 2 through 
4, required between 34 and 69 minutes (for established patients) and 
between 38 and 89 minutes (for new patients) of face-to-face time with 
the billing practitioner. We calculated the lower end of the range by 
summing the weighted average of intraservice times for the component 
codes that make up the single payment rate for level 2 through 4 visits 
(23 minutes for new and 19 minutes for established) and the additional 
amount of time required to bill the proposed add-on code (15 minutes 
under coding convention for prolonged services). The upper range of the 
use of the extended visit code is 69 minutes for established patients 
and 89 minutes for new patients.
    We note that to report the current prolonged codes or the new 
extended services code, practitioners need to note that the requisite 
number of minutes were spent with the patient. We also note that we are 
finalizing the policy to allow practitioners the choice to use time as 
the basis for code selection for level 2 through 5 all office/
outpatient E/M codes beginning in 2021 regardless of whether or not 
counseling and/or coordination of care accounts for more than 50 
percent of the face-to-face physician/patient encounter. Under the new 
policy, then, any visits that exceed the length of the time ranges of 
the level 2 through 4 visit codes plus the extended visit code, could 
be reported using the level 5 visit code and the existing prolonged 
services code. Table 24A illustrates these rules:

[[Page 59649]]



                             Table 24A--Minutes Spent on Extended Outpatient Visits
                                         [Established and new patients]
----------------------------------------------------------------------------------------------------------------
                  Established patient                                          New patient
----------------------------------------------------------------------------------------------------------------
      Level         Minutes spent     Codes reported           Level         Minutes spent     Codes reported
----------------------------------------------------------------------------------------------------------------
1................                   N/A                  1................                   N/A
                  --------------------------------------                   -------------------------------------
2................           34-69  99212/3/4+extended    2................           38-89  99203/4/5+extended
                                    services G-code.                                         services G-code.
3................                                        3................
4................                                        4................
                  --------------------------------------                   -------------------------------------
5................             70+  99215+99354.........  5................             90+  99205+99354.
----------------------------------------------------------------------------------------------------------------

    The new extended services code will be described as GPRO1 (Extended 
time for evaluation and management service(s) in the office or other 
outpatient setting, when the visit requires direct patient contact of 
34-69 total face-to-face minutes overall for an existing patient or 38-
89 minutes for a new patient (List separately in addition to code for 
level 2 through 4 office or other outpatient Evaluation and Management 
service)). We again note that we are finalizing payment and coding 
changes to be implemented for E/M office/outpatient visits for CY 2021. 
We will consider any changes that are made to CPT coding, including for 
prolonged services, and recommendations regarding appropriate valuation 
of new or revised codes, through our annual rulemaking process.
    In order to estimate the potential impact of the proposed changes 
in the proposed rule, we modeled the results of several options and 
examined the estimated resulting impacts in overall Medicare allowed 
charges by physician specialty. Because we are not finalizing many of 
the changes for CY 2019 as proposed, we believe the inclusion of those 
same discussions in this final rule is unnecessary and could 
potentially be confusing. We point readers to the CY 2019 PFS proposed 
rule, (83 FR 35844 through 35847) for discussion of the analyses 
relevant to the proposals. For analysis regarding the potential impacts 
of the alternatives considered in development of this final rule, we 
direct readers to the section VII. of this final rule, Regulatory 
Impact Analysis, in addition to the discussion that follows.
    To compare the overall payment impact for the changes in payment 
for visit services between the current policy as of 2018 and the 
policies we are finalizing starting in 2021, we provide a narrative 
example in the paragraph below and Table 24B. In CY 2018, a physician 
would bill a level 4 E/M visit and document using the existing 
documentation framework for a level 4 E/M visit. The payment rate would 
be approximately $109 in the office setting. In CY 2021, the physician 
would bill the same visit code for a level 4 E/M visit, with the option 
to document the visit according to the minimum documentation 
requirements for a level 2 E/M visit if they choose to document based 
on MDM, or the 1995 or 1997 guidelines, or to document on the basis of 
time. The physician might also bill either of the proposed add-on codes 
(HCPCS codes GPC1X or GCG0X) depending on the type of patient care 
furnished, and could bill the extended services code if she met the 
time threshold for this code. The combined payment rate for the E/M 
visit code, plus the extended services code, and either HCPCS code 
GPC1X or GCG0X would be approximately $170.
[GRAPHIC] [TIFF OMITTED] TR23NO18.039


[[Page 59650]]


(f) Alternatives Considered
    We considered a number of other options for simplifying coding and 
payment for E/M services to align with the proposed reduction in 
documentation requirements and to better account for the resources 
associated with inherent complexity, visit complexity, and visits 
furnished on the same day as a 0-day global procedure. As we are 
finalizing a policy very similar to one of the alternatives we 
considered for the proposed rule, we believe it would be confusing to 
include a detailed discussion of that policy as an alternative 
considered. We therefore direct interested readers to the CY 2019 PFS 
proposed rule (83 FR 35847).
    Section 101(f) of the MACRA added a new subsection (r) under 
section 1848 of the Act entitled Collaborating with the Physician, 
Practitioner, and Other Stakeholder Communities to Improve Resource Use 
Measurement. Section 1848(r) of the Act requires the establishment and 
use of classification code sets: Care episode and patient condition 
groups and codes; and patient relationship categories and codes. As 
described in the CY 2018 PFS final rule, we finalized use of Level II 
HCPCS Modifiers as the patient relationship codes and finalized that 
Medicare claims submitted for items and services furnished by a 
physician or applicable practitioner on or after January 1, 2018, 
should include the applicable patient relationship codes, as well as 
the NPI of the ordering physician or applicable practitioner (if 
different from the billing physician or applicable practitioner). We 
noted that for CY 2018, reporting of the patient relationship modifiers 
would be voluntary and the use and selection of the modifiers would not 
be a condition of payment (82 FR 53234). The patient relationship codes 
are as follows: X1: Continuous/broad; X2: Continuous/focused; X3: 
Episodic/focused; X4: Episodic/broad; and X5: Only as ordered by 
another physician. These codes are to be used to help define and 
distinguish the relationship and responsibility of a clinician with a 
patient at the time of furnishing an item or service, facilitate the 
attribution of patients and episodes to one or more clinicians, and to 
allow clinicians to self-identify their patient relationships.
    We considered proposing the use of the care episode and patient 
relationship codes to adjust payment for E/M visits to the extent that 
these codes are indicative of differentiated resources provided in E/M 
visits, and we considered using these codes as an alternative to the 
proposed use of G-codes to reflect visit complexity inherent to 
evaluation and management in primary care and certain other specialist 
services, as a way to more accurately reflect the resource costs 
associated with furnishing different kinds of E/M visits. We solicited 
comment on this alternative. We were particularly interested in whether 
the modifiers would accurately reflect the differences between 
resources for E/M visits across specialties and would therefore be 
useful to adjust payment differentially for the different types of E/M 
visits that we previously identified. The following is a summary of the 
comments we received on these items.
    Comment: AAFP urged CMS not to use the patient relationship codes 
for the purposes of making differential payment, stating that these 
modifiers were never intended to adjust payment or reflect visit 
complexity, only to denote the relationship of the beneficiary and 
practitioner at any given encounter. One commenter stated that using 
patient relationship codes to adjust payment was an intriguing idea 
that should be researched further.
    Response: We thank commenters for their input and will consider 
whether to adopt these codes for use to adjust payment at a later date 
through notice and comment rulemaking. We note, however, that we 
believe the use of the continuous care patient relationship codes 
stands as a good example of evidence in the claims record to support 
use of the primary care inherent complexity add-on code, as discussed 
previously.
    In Table 24C, we estimate the specialty level impacts of the E/M 
payment and coding policies we are finalizing for 2021, calculated as 
if they were implemented for CY 2019.

  Table 24C--Estimated Specialty Level Impacts of Final E/M Payment and Coding Policies if Implemented for 2019
----------------------------------------------------------------------------------------------------------------
               (A)                      (B)             (C)             (D)             (E)             (F)
Specialty                                Allowed  Impact of work    Impact of PE    Impact of MP        Combined
                                         charges     RVU changes     RVU changes     RVU changes          impact
                                           (mil)             (%)             (%)             (%)             (%)
----------------------------------------------------------------------------------------------------------------
Allergy/Immunology..............            $239               0               0               0               0
Anesthesiology..................           1,981              -1               0               0              -2
Audiologist.....................              68              -1               1               0               0
Cardiac Surgery.................             294              -1              -1               0              -2
Cardiology......................           6,618              -1              -1               0              -2
Chiropractor....................             754              -1               0               0              -1
Clinical Psychologist...........             776              -1               1               0               0
Clinical Social Worker..........             728              -2               2               0               0
Colon And Rectal Surgery........             166               0               1               0               0
Critical Care...................             342              -2              -1               0              -3
Dermatology.....................           3,486               1               3               0               4
Diagnostic Testing Facility.....             733               0              -5               0              -5
Emergency Medicine..............           3,121              -2              -1               0              -2
Endocrinology...................             482              -1              -1               0              -2
Family Practice.................           6,208               1               1               0               2
Gastroenterology................           1,757              -2              -1               0              -3
General Practice................             429               2               1               0               3
General Surgery.................           2,093               0               0               0              -1
Geriatrics......................             197              -1              -1               0              -1
Hand Surgery....................             214               1               1               0               3
Hematology/Oncology.............           1,741               0              -1               0               0
Independent Laboratory..........             646              -1               3               0               3
Infectious Disease..............             649              -1              -1               0              -1
Internal Medicine...............          10,767               0               0               0               0

[[Page 59651]]

 
Interventional Pain Mgmt........             868               1               2               0               3
Interventional Radiology........             386               0              -2               0              -2
Multispecialty Clinic/Other Phys             149              -1              -1               0              -2
Nephrology......................           2,190              -1              -1               0              -2
Neurology.......................           1,529              -1               0               0              -1
Neurosurgery....................             804              -1              -1               0              -1
Nuclear Medicine................              50              -1              -1               0              -3
Nurse Anes/Anes Asst............           1,242              -2               0               0              -2
Nurse Practitioner..............           4,065               2               1               0               3
Obstetrics/Gynecology...........             638               2               2               0               5
Ophthalmology...................           5,448              -1              -2               0              -3
Optometry.......................           1,309               0              -1               0              -1
Oral/Maxillofacial Surgery......              68               0               0               0               1
Orthopedic Surgery..............           3,743               0               1               0               1
Other...........................              31              -1               3               0               2
Otolarngology...................           1,210               3               3               0               5
Pathology.......................           1,165              -1              -1               0              -2
Pediatrics......................              61               1               0               0               1
Physical Medicine...............           1,107              -1               0               0              -2
Physical/Occupational Therapy...           3,950              -1              -2               0              -3
Physician Assistant.............           2,457               2               1               0               4
Plastic Surgery.................             377               0               0               0               1
Podiatry........................           1,974               4               6               0              10
Portable X-Ray Supplier.........              99               0               0               0               0
Psychiatry......................           1,187               3               2               0               5
Pulmonary Disease...............           1,715              -1              -1               0              -2
Radiation Oncology And Radiation           1,766              -1              -1               0              -1
 Therapy Centers................
Radiology.......................           4,911              -1              -1               0              -2
Rheumatology....................             541               0              -1               0              -1
Thoracic Surgery................             358              -1              -1               0              -2
Urology.........................           1,738               2               3               0               4
Vascular Surgery................           1,148               0              -2               0              -2
                                 -------------------------------------------------------------------------------
    Total.......................          92,771               0               0               0               0
----------------------------------------------------------------------------------------------------------------

    Table 24C illustrates the estimated specialty level impacts 
associated with implementing our finalized policies for E/M coding and 
payment in CY 2019, rather than delaying until CY 2021. Table 24C shows 
the estimated impacts of adopting single payment rates for new and 
established patient E/M office/outpatient visit levels 2 through 4 
(with the rates determined using input values that reflect the 5 year 
weighted average of current inputs for codes describing those visit 
levels), keeping separate rates for new and established patient E/M 
visit level 5 (with the rates determined using the current input values 
for level 5 visits), and adopting add-on codes with equal rates to 
adjust for the inherent visit complexity of primary care and non-
procedural specialty care (with the rates determined using the input 
values from the proposed rule for the non-procedural specialty care 
complexity code). Under our finalized policies, specialties who 
disproportionately report lower level visits, such as podiatry, and 
specialties that report office/outpatient visits in conjunction with 
minor procedures, such as dermatology, would see the significant 
increases. Specialties that predominantly furnish higher level visits 
would have their payment decreases significantly mitigated by the 
maintenance of the level 5 visit and the add-on codes for inherent 
visit complexity for primary and non-procedural specialty care. 
Specialties that do not furnish office/outpatient visits generally 
would see modest reductions in overall payment.
    We note that because our original proposal was developed more 
generally to maintain overall RVUs within the range of codes describing 
office/outpatient E/M visits, but, in response to public comment, we 
are not finalizing several elements of those proposals including, and 
especially, the multiple procedure payment reduction relating to global 
services billed with same day E/M services, the overall number of RVUs 
allocated to office/outpatient services would be increased relative to 
other PFS services. Under our established methodology and consistent 
with the governing statute, we usually apply a budget neutrality 
adjustment in the PFS conversion factor to account for the changes in 
overall RVUs. This adjustment would apply to all PFS services, and we 
are not finalizing any deviation from that approach for 2021. However, 
we also note that in some cases, we have proposed and finalized inputs 
for particular services that are designed to maintain the overall RVUs 
for those services despite changes in coding. For more detailed 
information on this approach to addressing valuation for families of 
services, we direct readers to the CY 2012 PFS final rule with comment 
period (76 FR 73105). We also note that while it has been our standard 
practice to avoid scaling the full set of work RVUs to maintain budget 
neutrality, we could also consider that alternative given the 
significance of office/outpatient visit codes in PFS relativity. Were 
we to consider either of these alternative

[[Page 59652]]

approaches for 2021, we would address them through future rulemaking.
g. Emergency Department and Other E/M Visit Settings
    As we mentioned above, the E/M visit code set is comprised of 
individual subsets of codes that are specific to various clinical 
settings including office/outpatient, observation, hospital inpatient, 
emergency department, critical care, nursing facility, domiciliary or 
rest home, and home services. Some of these code subsets have three E/M 
levels of care, while others have five. Some of these E/M code subsets 
distinguish among levels based heavily on time, while others do not. 
Recent public comments have noted that some E/M code subsets intersect 
more heavily than others with hospital conditions of participation 
(CoP). For example, the American Psychiatric Association (APA) 
submitted a letter to CMS indicating that Medicare requires specific 
documentation in the medical record as part of the CoPs for inpatient 
psychiatric facilities. The APA believed that the required initial 
psychiatric evaluation for inpatients currently closely follows the E/M 
criteria for CPT codes 99221-99223, which are the codes that would be 
used to bill for these services. The APA stated that any changes in 
these E/M codes, without corresponding changes in the CoPs, could lead 
to the unintended consequence of adding to the burden of documentation 
by essentially requiring two different sets of data or areas of focus 
to be included, or two different documentation formats being required.
    Regarding emergency department visits (CPT codes 99281-99285), we 
received more recent feedback through our coordinated efforts with ONC 
this year, emphasizing that these codes may benefit from a coding or 
payment compression into fewer levels of codes, or that documentation 
rules may need to be reduced or altered. However, in public comments to 
the CY 2018 PFS proposed rule, commenters noted several issues unique 
to the emergency department setting that we believe require further 
consideration. For example, commenters stated that intensity, and not 
time, is the main determinant of code level in emergency departments. 
They requested that CMS use caution in changing required elements for 
documentation so that medical information used for legal purposes (for 
example, meeting the prudent layperson standard) is not lost. They 
urged caution and requested that CMS not immediately implement any 
major changes. They recommended refocusing documentation on presenting 
conditions and medical decision-making. Some commenters were supportive 
of leaving it largely to the discretion of individual practitioners to 
determine the degree to which they should perform and document the 
history and physical exam in the emergency department setting. Other 
commenters suggested that CMS encourage use of standardized guidelines 
and minimum documentation requirements to facilitate post-treatment 
evaluation, as well as analysis of records for various clinical, legal, 
operational and other purposes. The commenters discussed the importance 
of extensive histories and exams in emergency departments, where 
usually there is no established relationship with the patient and 
differential diagnosis is critical to rule out many life-threatening 
conditions. They were cognizant of the need for a clear record of 
services rendered and the medical necessity for each service, 
procedure, diagnostic test, and MDM performed for every patient 
encounter.
    In addition, although the RUC is in the process of revaluing this 
code set, some commenters stated that the main issue is not that the 
emergency department visit codes themselves are undervalued. Rather, 
these commenters noted that a greater percentage of emergency 
department visits are at a higher acuity level, yet payers often do not 
pay at a higher level of care and the visit is often inappropriately 
down-coded based on retrospective review. These commenters noted that 
the documentation needed to support a higher level of care is too 
burdensome or subjective. In addition, it seems that policy proposals 
regarding emergency department visits billed by physicians might best 
be coordinated with parallel changes to payment policy for facility 
billing of these codes, which would require more time and analyses.
    Accordingly, we did not propose any changes to the emergency 
department E/M code set or to the E/M code sets for settings of care 
other than office-based and outpatient settings at this time. However, 
we solicited public comment on whether we should make any changes to it 
in future years, whether by way of documentation, coding, and/or 
payment and, if so, what the changes should be.
    Consistent with public feedback to date, we are taking a step-wise 
approach and limiting our policy proposals this year to the office/
outpatient E/M code set (and the limited proposal above regarding 
documentation of medical necessity for home visits in lieu of office 
visits). We may consider expanding our efforts more broadly to 
additional sections of the E/M visit code set in future years, and 
solicited public comment broadly on how we might proceed in this 
regard.
    We received a few comments on this solicitation. We thank the 
commenters for their feedback and will take it into account for future 
rulemaking.
(h) Implementation Date
    We proposed that our proposed E/M visit policies would be effective 
January 1, 2019. However, we were sensitive to commenters' suggestions 
that we should consider a multi-year process and proceed cautiously, 
allowing adequate time to educate practitioners and their staff; and to 
transition clinical workflows, EHR templates, institutional processes 
and policies (such as those for provider-based practitioners), and 
other aspects of practitioner work that would be impacted by these 
policy changes. We emphasized that our proposed documentation changes 
for office/outpatient E/M visits would be optional, and practitioners 
could choose to continue to document these visits using the current 
framework and rules, which may reduce the need for a delayed 
implementation. Nevertheless, practitioners who choose a new 
documentation framework may need time to deploy it. A delayed 
implementation date for our documentation proposals would also allow 
the AMA time to develop changes to the CPT coding definitions and 
guidance prior to our implementation, such as changes to MDM or code 
definitions that we could then consider for adoption. It would also 
allow other payers time to react and potentially adjust their policies. 
Accordingly, we solicited comment on whether a delayed implementation 
date, such as January 1, 2020, would be appropriate for our proposals.
    Comment: With the exception of several documentation proposals, 
most of the commenters urged us not to finalize the E/M visit 
proposals, or to delay their implementation by at least one year. With 
the exception of our proposals regarding home E/M visits and reducing 
redundant recording of data, most commenters recommended that CMS 
engage in further work with the AMA and other stakeholders in the 
coming months to develop alternative approaches. Many commenters noted 
that our proposals regarding home E/M visits and reducing redundant 
recording of data would not impact payment or require extensive 
training or other extended preparatory time. The commenters largely 
recommended that CMS finalize these proposals for 2019,

[[Page 59653]]

but defer other documentation, coding and payment reforms to future 
years after obtaining additional stakeholder input. Some commenters did 
recommend that CMS finalize the proposed policy to allow choice among 
documentation methodologies while working with stakeholders to refine 
any coding and payment changes. A few commenters were supportive of a 
minimum level 2 documentation standard and intimated that this could be 
accomplished without changes to coding or payment, but other commenters 
opposed this approach.
    Many stakeholders, including some commercial insurers and EHR-
related associations, commented that if CMS were to finalize its 
proposals, the industry would need more time to prepare and CMS should 
delay implementation a year or more. Some commenters noted that CMS 
should consider not setting a date for implementation until the 
necessary structure is in place. Most commenters, including some 
insurers, urged CMS to work with the AMA or other stakeholders on 
alternative policies. For example, some insurers were concerned that 
the proposals would not allow them to understand the true complexity of 
care being delivered and recommended that documentation requirements 
should continue to be linked to complexity and, if the proposal were 
finalized, CMS would need to monitor various program integrity issues. 
They were concerned that the collapsed payment rate for level 2 through 
5 E/M visits would disincentivize treatment of complex patients. Some 
health plans expressed concern that medical record data used to inform 
their payments and risk adjustment and HEDIS scores might be impacted. 
In response to our proposed rule, several organizations stated they are 
forming workgroups to conduct data analysis and develop policy 
alternatives, including the AMA and the Cognitive Care Alliance. The 
American Health Insurance Plans believed documentation requirements 
should continue to be linked to complexity.
    Commenters were concerned there would not be enough time for 
developers and clinicians to make changes, leading to confusion in the 
market and disparate systems with other payers, in addition to other 
concerns about the coding and payment proposals discussed further 
below. The commenters were concerned about not having enough time to 
develop differing documentation based on payer status, and said that 
the burden on the clinician to determine which payer and which 
documentation method should not be underestimated.
    Response: After consideration of public comments, we are not 
finalizing aspects of our proposal that would have reduced payment when 
E/M office/outpatient visits are furnished on the same day as certain 
procedures, established separate podiatric E/M visit codes, or 
standardized the allocation of PE RVUs for E/M visit codes. After 
considering the comments, for 2019 we are finalizing several of our 
documentation proposals that will provide some significant and 
immediate burden reduction but are unrelated to changes to payment and 
coding. Specifically, we are finalizing the proposals regarding home 
visits and redundant data recording (discussed above), as proposed and 
effective January 1, 2019. We are delaying implementation of our other 
final policies relating to payment for E/M visits to January 1, 2021.

J. Teaching Physician Documentation Requirements for Evaluation and 
Management Services

1. Background
    Per 42 CFR part 415, subpart D, Medicare Part B makes payment under 
the PFS for teaching physician services when certain conditions are 
met, including that medical record documentation must reflect the 
teaching physician's participation in the review and direction of 
services performed by residents in teaching settings. Under Sec.  
415.172(b), for certain procedural services, the participation of the 
teaching physician may be demonstrated by the notes in the medical 
records made by a physician, resident, or nurse; and for E/M visits, 
the teaching physician is required to personally document their 
participation in the medical record. We received stakeholder feedback 
suggesting that documentation requirements for E/M services furnished 
by teaching physicians are burdensome and duplicative of notations that 
may have previously been included in the medical records by residents 
or other members of the medical team.
2. Implementation
    We proposed to revise our regulations to eliminate potentially 
duplicative requirements for notations that may have previously been 
included in the medical records by residents or other members of the 
medical team. These modifications are intended to align and simplify 
teaching physician E/M service documentation requirements. We believed 
these changes would reduce burden and duplication of effort for 
teaching physicians. We proposed to amend Sec.  415.172(b) to provide 
that, except for services furnished as set forth in Sec. Sec.  415.174 
(concerning an exception for services furnished in hospital outpatient 
and certain other ambulatory settings), 415.176 (concerning renal 
dialysis services), and 415.184 (concerning psychiatric services), the 
medical records must document that the teaching physician was present 
at the time the service is furnished. Additionally, the revised 
paragraph would specify that the presence of the teaching physician 
during procedures and E/M services may be demonstrated by the notes in 
the medical records made by a physician, resident, or nurse. We also 
proposed to amend Sec.  415.174, by deleting paragraph (a)(3)(v) which 
requires the teaching physician to document the extent of their 
participation in the review and direction of the services furnished to 
each beneficiary. We proposed to add new paragraph (a)(6) to Sec.  
415.174 to provide that the medical record must document the extent of 
the teaching physician's participation in the review and direction of 
services furnished to each beneficiary, and that the extent of the 
teaching physician's participation may be demonstrated by the notes in 
the medical records made by a physician, resident, or nurse.
    Comment: Many commenters supported the proposed regulatory changes 
without modifications.
    Response: We appreciate the commenters' support of our proposals.
    Comment: Some commenters disagreed with the proposed changes and 
indicated teaching physicians should continue to be personally 
responsible for documenting their physical presence and for 
verification with patients of all medical team members' documentation 
as it relates to the patient encounters. The commenters were concerned 
that the proposed changes would shift the documentation burden and 
responsibility from the teaching physician to the resident or nurse who 
has a limited number of hours of work. One commenter stated that the 
nurse would not be an inherent party to the teaching physician's or 
resident's involvement in an E/M service.
    Response: While we appreciate the commenters' concerns, the purpose 
of these revisions to the regulations is to eliminate potentially 
duplicative requirements for notations that may have previously been 
included in the medical records by residents or other members of the 
medical team. The teaching physician continues to be

[[Page 59654]]

responsible for reviewing and verifying the accuracy of notations 
previously included by residents and members of the medical team, along 
with further documenting the medical record if the notations previously 
provided did not accurately demonstrate the teaching physician's 
involvement in an E/M service. After consideration of the comments 
received, we are finalizing the proposed changes to Sec. Sec.  
415.172(b) and 415.174 without modification.

K. GPCI Comment Solicitation

    Section 1848(e)(1)(C) of the Act requires us to review and, if 
necessary, adjust the GPCIs at least every 3 years. Section 
1848(e)(1)(D) of the Act requires us to establish the GPCIs using the 
most recent data available. The last GPCI update was implemented in CY 
2017; therefore, we are required to review and make any necessary 
revisions to the GPCIs for CY 2020. Please refer to the CY 2017 PFS 
final rule with comment period for a discussion of the last GPCI update 
(81 FR 80261 through 80270). Some commenters have continued to express 
concerns regarding some of the data sources used in developing the 
indices for PFS geographic adjustment purposes, specifically that we 
use residential rent data as a proxy for commercial rent in the rent 
index component of the PE GPCI--that is, the data that are used to 
develop the office rent component of the PE GPCI. We will continue our 
efforts to identify a nationally representative commercial rent data 
source that could be made available to CMS. In support of that effort, 
we were particularly interested in, and solicited comments regarding 
potential sources of commercial rent data for potential use in the next 
GPCI update for CY 2020.
    We received a few comments in response to the comment solicitation, 
and we appreciate the commenters' feedback and input. We will consider 
the suggestions and information received for future rulemaking, and in 
particular for the CY 2020 statutorily required update to the GPCIs.

L. Therapy Services

1. Repeal of the Therapy Caps and Limitation To Ensure Appropriate 
Therapy
    Section 50202 of the Bipartisan Budget Act of 2018 amended section 
1833(g) of the Act, effective January 1, 2018, to repeal the 
application of the Medicare outpatient therapy caps and the therapy cap 
exceptions process while retaining and adding limitations to ensure 
therapy services are furnished when appropriate. Section 50202 also 
adds section 1833(g)(7)(A) of the Act which requires that after 
expenses incurred for the beneficiary's outpatient therapy services for 
the year have exceeded one or both of the previous therapy cap amounts, 
all therapy suppliers and providers must continue to use an appropriate 
modifier such as the KX modifier on claims for subsequent services in 
order for Medicare to pay for the services. We implemented this 
provision by continuing to use the existing KX modifier. By applying 
the KX modifier to the claim, the therapist or therapy provider is 
confirming that the services are medically necessary as justified by 
appropriate documentation in the medical record. Just as with the 
incurred expenses for the prior therapy cap amounts, there is one 
amount for physical therapy (PT) and speech language pathology (SLP) 
services combined and a separate amount for occupational therapy (OT) 
services. These KX modifier threshold amounts are indexed annually by 
the Medicare Economic Index (MEI). For CY 2018, the KX modifier 
threshold amount was $2,010 for PT and SLP services combined, and 
$2,010 for OT. After the beneficiary's incurred expenditures for 
outpatient therapy services exceed the KX modifier threshold amount for 
the year, claims for outpatient therapy services without the KX 
modifier are denied.
    Along with the KX modifier thresholds, section 50202 also adds 
section 1833(g)(7)(B) of the Act that retains the targeted medical 
review (MR) process (first established through section 202 of the 
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)), but at a 
lower threshold amount of $3,000. For CY 2018 (and each successive 
calendar year until 2028, at which time it is indexed annually by the 
MEI), the MR threshold is $3,000 for PT and SLP services and $3,000 for 
OT services. The targeted MR process means that not all claims 
exceeding the MR threshold amount are subject to review as they once 
were.
    Section 1833(g)(8) of the Act, as re-designated by section 50202 of 
the Bipartisan Budget Act of 2018, retains the provider liability 
procedures which first became effective January 1, 2013, extending 
limitation of liability protections to beneficiaries who receive 
outpatient therapy services, when services are denied for certain 
reasons, including failure to include a necessary KX modifier.
2. Payment for Outpatient PT and OT Services Furnished by Therapy 
Assistants
    Section 53107 of the Bipartisan Budget Act of 2018 (BBA of 2018) 
amended the Act to add a new subsection 1834(v) that addresses payment 
for outpatient therapy services for which payment is made under section 
1848 or section 1834(k) of the Act that are furnished on or after 
January 1, 2022, in whole or in part by a therapy assistant (as defined 
by the Secretary). The new section 1834(v)(1) of the Act provides for 
payment of those services at 85 percent of the otherwise applicable 
Part B payment amount for the service. In accordance with section 
1834(v)(1) of the Act, the reduced payment amount for such outpatient 
therapy services is applicable when payment is made directly under the 
PFS as specified in section 1848 of the Act, for example when payment 
is made to therapists in private practice (TPPs); and when payment is 
made based on the PFS as specified in section 1834(k)(3) of the Act, 
for example, when payment is made for outpatient therapy services 
identified in sections 1833(a)(8) and (9) of the Act, including payment 
to providers that submit institutional claims for therapy services such 
as outpatient hospitals, rehabilitation agencies, skilled nursing 
facilities, home health agencies and comprehensive outpatient 
rehabilitation facilities (CORFs). The reduced payment rate under 
section 1834(v)(1) of the Act for outpatient therapy services when 
furnished in whole or in part by a therapy assistant is not applicable 
to outpatient therapy services furnished by critical access hospitals 
for which payment is made as specified in section 1834(g) of the Act.
    To implement this payment reduction, section 1834(v)(2)(A) of the 
Act requires us to establish a new modifier, in a form and manner 
specified by the Secretary, by January 1, 2019 to indicate, in the case 
of an outpatient therapy service furnished in whole or in part by a 
therapy assistant, that the service was furnished by a therapy 
assistant. Although we generally consider all genres of outpatient 
therapy services together (PT/OT/SLP), we did not believe there are 
therapy assistants in the case of SLP services, so we proposed to apply 
the new modifier only to services furnished in whole or in part by a 
physical therapist assistant (PTA) or an occupational therapy assistant 
(OTA). Section 1834(v)(2)(B) of the Act requires that each request for 
payment or bill submitted for an outpatient PT or OT

[[Page 59655]]

service furnished in whole or in part by a therapy assistant on or 
after January 1, 2020, must include the established modifier. As such, 
the modifier will be required to be reported on claims for outpatient 
PT and OT services with dates of service on and after January 1, 2020, 
when the service is furnished in whole or in part by a therapy 
assistant, regardless of whether the reduced payment under section 
1834(v)(1) of the Act is applicable. However, the required payment 
reductions do not apply for these services until January 1, 2022, as 
required by section 1834(v)(1) of the Act.
    To implement this provision, we proposed to establish two new 
modifiers to separately identify PT and OT services that are furnished 
in whole or in part by PTAs and OTAs, respectively. We proposed to 
establish two modifiers because the incurred expenses for PT and OT 
services are tracked and accrued separately in order to apply the two 
different KX modifier threshold amounts as specified by section 
1833(g)(2) of the Act; and the use of the two proposed modifiers would 
facilitate appropriate tracking and accrual of services furnished in 
whole or in part by PTAs and OTAs. We additionally proposed that these 
two new therapy modifiers would be added to the existing three therapy 
modifiers--GP, GO, and GN--that are currently used to identify all 
therapy services delivered under a PT, OT or SLP plan of care, 
respectively. The addition of the two new modifiers as therapy 
modifiers would bring the total to five therapy modifiers, with four 
therapy modifiers used to report and track PT and OT services, instead 
of two. The GP, GO, and GN modifiers have existed since 1998 to track 
outpatient therapy services that were subject to the therapy caps. 
Although the therapy caps were repealed through amendments made to 
section 1833(g) of the Act by section 50202 of the Bipartisan Budget 
Act of 2018, as discussed in the above section, the statute continues 
to require that we track and accrue incurred expenses for all PT, OT, 
and SLP services, including those above the specified per beneficiary 
amounts for medically necessary therapy services for each calendar 
year; one amount for PT and SLP services combined, and another for OT 
services.
    For purposes of implementing section 1834(v) of the Act through 
rulemaking as required under section 1834(v)(2)(C) of the Act, we 
proposed to define therapy assistant as an individual who meets the 
personnel qualifications set forth at Sec.  484.4 of our regulations 
for a PTA and OTA. We proposed that the two new therapy modifiers would 
be used to identify services furnished in whole or in part by a PTA or 
an OTA; and, that these new therapy modifiers would be used instead of 
the GP and GO modifiers that are currently used to report PT and OT 
services delivered under the respective plan of care whenever the 
service is furnished in whole or in part by a PTA or OTA.
    Effective for dates of service on and after January 1, 2020, the 
new therapy modifiers that identify services furnished in whole or in 
part by a PTA or OTA would be required to be used on all therapy claims 
instead of the existing modifiers GP and GO, respectively. As a result, 
in order to implement the provisions of the new subsection 1834(v) of 
the Act and carry out the continuing provisions of section 1833(g) of 
the Act as amended, we proposed that, beginning in CY 2020, five 
therapy modifiers be used to track outpatient therapy services instead 
of the current three. These five therapy modifiers would include two 
new therapy modifiers to identify PT and OT services furnished by PTAs 
and OTAs, respectively, and three existing therapy modifiers--GP, GO 
and GN--that will be used when PT, OT, and SLP services, respectively, 
are fully furnished by therapists or when fully furnished by or 
incident to physicians and NPPs.
    The creation of therapy modifiers specific to PT or OT services 
delivered under a plan of care and furnished in whole or in part by a 
PTA or OTA would necessitate that we make changes to the descriptors of 
the existing GP and GO modifiers to clarify which qualified 
professionals, for example, therapist, physician, or NPP, can furnish 
the PT and OT services identified by these modifiers, and to 
differentiate them from the therapy modifiers specific to the services 
of PTAs and OTAs. We also proposed to revise the GN modifier descriptor 
to conform to the changes to the GP and GO modifiers by clarifying the 
qualified professionals that furnish SLP therapy services.
    We proposed to define the two new therapy modifiers for services 
furnished in whole or in part by therapy assistants and to revise the 
existing therapy modifier descriptors as follows:
     New PT Assistant services modifier (to be used instead of 
the GP modifier currently reported when a PTA furnishes services in 
whole or in part): Services furnished in whole or in part by a physical 
therapist assistant under an outpatient physical therapy plan of care;
     New OT Assistant services modifier (to be used instead of 
the GO modifier currently reported when an OTA furnishes services in 
whole or in part): Services furnished in whole or in part by 
occupational therapy assistant under an outpatient occupational therapy 
plan of care.
    We proposed that the existing GP modifier, ``Services delivered 
under an outpatient physical therapy plan of care'' would be revised to 
read as follows:
     Revised GP modifier: Services fully furnished by a 
physical therapist or by or incident to the services of another 
qualified clinician--that is, physician, nurse practitioner, certified 
clinical nurse specialist, or physician assistant--under an outpatient 
physical therapy plan of care.
    We proposed that the existing GO modifier, ``Services delivered 
under an outpatient occupational therapy plan of care'' would be 
revised to read as follows:
     Revised GO modifier: Services fully furnished by an 
occupational therapist or by or incident to the services of another 
qualified clinician--that is, physician, nurse practitioner, certified 
clinical nurse specialist, or physician assistant--under an outpatient 
occupational therapy plan of care.
    We proposed that the existing GN modifier, ``Services delivered 
under an outpatient speech-language pathology plan of care'' would be 
revised to be consistent with the revisions to the GP and GO modifiers 
to read as follows:
     Revised GN modifier: Services fully furnished by a speech-
language pathologist or by or incident to the services of another 
qualified clinician--that is, physician, nurse practitioner, certified 
clinical nurse specialist, or physician assistant--under an outpatient 
speech-language pathology plan of care.
    As finalized in CY 2005 PFS final rule with comment period (69 FR 
66351 through 66354), and as required as a condition of payment under 
our regulations at Sec. Sec.  410.59(a)(3)(iii), 410.60(a)(3)(iii), and 
410.62(a)(3)(iii), the person furnishing outpatient therapy services 
incident to the physician, PA, NP or CNS service must meet the 
therapist personnel qualification and standards at Sec.  484.4, except 
for licensure per section 1862(a)(20) of the Act. As such, we noted 
that only a therapist, not a therapy assistant, can furnish outpatient 
therapy services incident to the services of a physician or a non-
physician practitioner (NPP), so the new PT- and OT-Assistant therapy 
modifiers cannot be used on the line of service when the rendering 
practitioner identified on the claim is a physician or an NPP. For 
therapy services billed by physicians or NPPs, whether furnished

[[Page 59656]]

personally or incident to their professional services, the GP or GO 
modifier is required for those PT or OT services furnished under an 
outpatient therapy plan.
    We proposed that all services that are furnished in whole or in 
part by a PTA or OTA are subject to the use of the new therapy 
modifiers. A new therapy modifier would be required to be used whenever 
a PTA or OTA furnishes all or part of any covered outpatient therapy 
service. However, we did not believe the provisions of section 1834(v) 
of the Act were intended to apply when a PTA or OTA performs portions 
of the service such as administrative tasks that are not related to 
their qualifications as a PTA or OTA. Rather, we believed the 
provisions of section 1834(v) of the Act were meant to apply when a PTA 
or OTA is involved in providing some or all of the therapeutic portions 
of an outpatient therapy service. We proposed to define ``in part,'' 
for purposes of the proposed new modifiers, to mean any minute of the 
outpatient therapy service that is therapeutic in nature, and that is 
provided by the PTA or OTA when acting as an extension of the 
therapist. Therefore, a service furnished in part by a therapy 
assistant would not include a service for which the PTA or OTA 
furnished only non-therapeutic services that others without the PTA's 
or OTA's training can do, such as scheduling the next appointment, 
greeting and gowning the patient, and preparing or cleaning the room. 
We remind therapists and therapy providers that we do not recognize 
PTAs and OTAs to wholly furnish PT and OT evaluations and 
reevaluations, that is, CPT codes 97161 through 97164 for PT and CPT 
codes 97165 through 97168 for OT, but to the extent that they do 
furnish part of an evaluative service, the appropriate therapy modifier 
must be used on the claim to signal that the service was furnished in 
part by the PTA or OTA, and the payment reduction should be applied 
once it goes into effect. We continue to believe that the clinical 
judgment and decision making involved in furnishing an evaluation or 
re-evaluation is similar to that involved with establishing the therapy 
plan that can only be established by a therapist, physician, or NPP 
(NP, CNS, or PA) as specified in Sec.  410.61 of our regulations. In 
addition, PTAs and OTAs are not recognized separately in the statute to 
enroll as practitioners for purposes of independently billing for their 
services under the Medicare program. For these reasons, Pub. 100-02, 
Medicare Benefits Policy Manual, Chapter 15, sections 230.1 and 230.2 
state that PTAs and OTAs may not provide evaluative or assessment 
services, make clinical judgments or decisions; develop, manage, or 
furnish skilled maintenance program services; or take responsibility 
for the service. Although we expect that the therapist will continue to 
furnish the majority of an evaluative procedure service, section 
1834(v)(1) of the Act requires that the adjusted payment amount (85 
percent of the otherwise applicable Part B payment amount) be applied 
when a therapy assistant furnishes a therapy service in part, including 
part of an evaluative service.
    Additionally, we would like to clarify that the requirements for 
evaluations, including those for documentation, are separate and 
distinct from those for plans of care (plans). The plan is a statutory 
requirement under section 1861(p) of the Act for outpatient PT services 
(and through sections 1861(g) and 1861(ll)(2) of the Act for outpatient 
OT and SLP services, respectively) and may only be established by a 
therapist or physician. Through Sec.  410.61(b)(5), NPs, CNSs, and PAs 
are also permitted to establish the plan. This means that if the 
evaluative procedure is furnished in part by an assistant, the new 
therapy modifiers that distinguish services furnished by PTAs or OTAs 
must be applied to the claim; however, the plan, which is not 
separately reported or paid, must be established by the supervising 
therapist who furnished part of the evaluation services as specified at 
Sec.  410.61(b). When an evaluative therapy service is billed by a 
physician or an NPP as the rendering provider, either the physician/NPP 
or the therapist furnishing the service incident to the services of the 
physician or NPP, may establish the therapy plan in accordance with 
Sec.  410.61(b). All regulatory and subregulatory plan requirements 
continue to apply.
    To implement the new statutory provision at section 1834(v)(2)(A) 
of the Act, we proposed to establish two new therapy modifiers to 
identify the services furnished in whole or in part by PTAs and OTAs. 
As required under section 1834(v)(2)(B) of the Act, claims from all 
providers of PT and OT services furnished on and after January 1, 2020, 
will be required to include these new PT- and OT-Assistant therapy 
modifiers for services furnished in whole or in part by a PTA or OTA. 
We proposed that these therapy modifiers would be required, when 
applicable, in place of the GP and GO modifiers currently used to 
identify all PT and OT services furnished under an outpatient plan of 
care, including the services furnished by PTAs and OTAs. To test our 
systems ahead of the required implementation date of January 1, 2020, 
we anticipated allowing voluntary reporting of the new modifiers at 
some point during CY 2019, which we would announce to our contractors, 
therapists and therapy providers through a Change Request, as part of 
our usual change management process.
    We solicited comments on these proposals.
    The following is a summary of the comments we received on these 
proposals.
    Comment: Some commenters opposed paying differently for the 
services furnished in whole or in part by OTAs and PTAs while other 
commenters supported the payment differential, with a few comparing it 
to the 85 percent payment rate for certain NPPs.
    Response: While we appreciate hearing various commenters' views, 
the new statutory provision at section 1834(v) of the Act added by 
section 53107 of the Bipartisan Budget Act of 2018 (Pub. L. 115-123, 
enacted February 9, 2018) requires CMS to implement through notice and 
comment rulemaking a reduced rate for the services furnished on or 
after January 1, 2022, in whole or in part by therapy assistants at 85 
percent of the otherwise applicable Part B payment amount for the 
service. Section 1834(v) of the Act further requires that we establish 
a modifier to identify services furnished in whole or in part by a 
therapy assistant by January 1, 2019, and that claims for outpatient 
therapy services furnished in whole or in part by therapy assistant on 
or after January 1, 2020, must include the modifier. As such, we are 
following statutory directives to implement section 1834(v) of the Act.
    Comment: Some commenters supported our proposal to establish two 
modifiers, instead of one, to separately identify PT and OT services 
that are furnished in whole or in part by PTAs and OTAs, respectively. 
Several commenters expressed support for our proposal defining therapy 
assistant as an individual who meets the personnel qualifications set 
forth in Sec.  484.4 of our regulations for PTAs and OTAs.
    Response: We thank the many commenters who supported our proposals 
to (a) establish two new modifiers instead of one to separately define 
therapy assistant services furnished by PTAs and OTAs, and (b) to 
define the PTA and OTA as individuals who meet the personnel 
qualifications set forth in regulations at 42 CFR part 484. Although we 
stated that these personnel qualifications were located at Sec.  484.4, 
we note that, effective January 13, 2018, the personnel qualifications 
for PTAs and OTAs were moved from

[[Page 59657]]

Sec.  484.4 and redesignated without changes at Sec. Sec.  484.115(g) 
and (i), respectively (82 FR 4504, January 13, 2017).
    Comment: Most commenters did not choose to comment specifically 
about our proposal to establish the two new modifiers as therapy 
modifiers for services furnished by PTAs and OTAs that are to be used 
instead of the current GP and GO modifiers used to capture the these 
services. However, several commenters opposed the structure we proposed 
for the modifiers that would be required on therapy claims when 
services are furnished by PTAs and OTAs which would change from the 
current two therapy modifiers, GP and GO, to identify all therapy 
services delivered under an outpatient PT or OT plan of care, to four 
therapy modifiers. Instead, they urged us to adopt new modifiers that 
would be used in tandem with, rather than replace, the respective 
existing GP and GO therapy modifiers on the same claim line of service 
to identify services delivered in whole or in part by PTAs and OTAs. 
The commenters stated that their suggested approach would mitigate 
administrative burden for all PT and OT professionals, as well as 
therapy assistants. Specifically, commenters stated that their 
therapists and therapy assistants use the same chargemasters, and their 
charge systems are hardcoded to default to either the PT or OT therapy 
modifier (GP or GO) that are now required on these claims, which saves 
both the therapists and therapy assistants from having to add the GP or 
GO therapy modifier to each claim line for the services they furnish. 
According to the commenters, under our proposal, both therapists and 
assistants would have to add one of the four modifiers for PT and OT 
services to the claim line and they would no longer be able to default 
their charge systems to report the GP or GO modifiers. This would mean 
that new PTA- and OTA-specific systems would need to be duplicated, 
creating undue chargemaster confusion and adding training and education 
burden to both therapists and therapy assistants for reporting one the 
four therapy modifiers. The commenters stated that adopting their 
proposal to add the new therapy assistant modifiers to the same claim 
line of service alongside the existing GP and GO modifiers eliminates 
the administrative burden on therapists since only therapy assistants 
would be required to use the new modifiers, and charge systems could 
remain hardcoded to default to the GP or GO modifiers as they are now 
to include all PT and OT services.
    Response: We appreciate the commenters' concerns and agree that 
their suggested approach to use the new modifiers for services 
furnished in whole or in part by PTAs and OTAs on the same line of 
service as the existing GP and GO therapy modifiers, instead of 
replacing them, has merit, since it preserves the current use of the GP 
and GO therapy modifiers to identify outpatient therapy services 
furnished by both therapists and therapy assistants under a PT or OT 
plan of care. We also agree that adding the new therapy assistant 
modifiers to the same claim line of service alongside the existing GP 
and GO modifiers will prevent undue burden for physical therapists and 
occupational therapists, as only PTAs and OTAs will add the new 
modifiers to the claim line of service.
    After considering the comments on the establishment and use of the 
new modifiers, the statutory changes, and our other payment policies 
for therapy services, we are not finalizing the new modifiers for 
therapy assistant services as therapy modifiers as proposed. Instead, 
we will use the two new modifiers for therapy assistant services as a 
type of payment modifier that will be used alongside of, instead of 
replacing, the GP and GO therapy modifiers, to identify the services 
furnished in whole or in part by PTAs or OTAs that will be tied to the 
reduced payment for the respective PT or OT discipline in CY 2022. By 
using the new modifiers for therapy assistants as payment modifiers, 
rather than therapy modifiers, services furnished by PTAs and OTAs will 
continue to be captured by the GP and GO therapy modifiers, as they are 
now, when delivered under the an outpatient PT or OT plan of care, 
respectively. We considered the commenters' requests not to use the two 
new modifiers for services furnished by PTAs and OTAs as therapy 
modifiers in addition to the current two therapy modifiers, GP and GO, 
respectively. We took into account their concerns about the reporting 
burden for both therapists and therapy assistants that would result if 
we were to double the number of therapy modifiers used to report the 
services delivered under PT and OT plans of care. We also considered 
the unintended consequences that could result from changing the long-
standing nature of our three existing discipline-specific therapy 
modifiers used to report all services delivered under an outpatient 
plan of care for PT, OT, and SLP services. These consequences could be 
significant, especially since the existing modifiers are used by many 
other government payers and private insurers. Additionally, our claims 
processing systems have numerous edits tied to the therapy modifiers 
because these modifiers are used to track and accrue incurred costs of 
therapy services furnished under the outpatient therapy benefit by 
therapists and their assistants, as well as those services that 
physicians and NPPs furnish and bill as therapy services. Consequently, 
we agree with commenters that it is preferable to use the two new 
modifiers as payment modifiers to identify the services furnished in 
whole or in part by therapy assistants, instead of changing the overall 
configuration of our therapy modifiers established through CY 1998 
rulemaking and designed to track services to the then therapy cap 
amounts for outpatient therapy services furnished under PT, OT, and SLP 
plans of care.
    This approach--using payment modifiers rather than therapy 
modifiers--necessitates revisions to the descriptors we proposed for 
the new therapy assistant modifiers. As therapy modifiers, the new 
modifiers were proposed to define the PTA or OTA services delivered 
under an outpatient PT or OT plan of care, respectively. Modifying our 
proposal to instead use the two new modifiers as payment modifiers, we 
are removing references to the services being delivered under an 
outpatient PT or OT plan of care because the plan is specific to the GP 
and GO therapy modifiers. We also retained the terminology of ``in 
whole or in part'' as part of the definition of these therapy assistant 
payment modifiers, as specified at section 1834(v) of the Act, and 
clarified the therapy assistants' services are included as part of the 
corresponding PT or OT discipline. As a result, we are finalizing the 
two new payment modifiers to identify services furnished in whole or in 
part by a PTA and OTA, modifiers CQ and CO (C, capital letter O), 
respectively as follows.
     PTA Modifier CQ: Outpatient physical therapy services 
furnished in whole or in part by a physical therapist assistant.
     OTA Modifier CO: Outpatient occupational therapy services 
furnished in whole or in part by an occupational therapy assistant.
    Because we are establishing the two new modifiers for the services 
furnished in whole or in part by a PTA or OTA as payment modifiers 
instead of as therapy modifiers, it is no longer necessary to revise 
the existing GP, GO, and GN therapy modifiers as we initially proposed 
to differentiate which professionals may furnish services using the GP, 
GO, and GN therapy modifiers in the absence of therapy modifiers used

[[Page 59658]]

specifically to identify services furnished in whole or in part by PTAs 
and OTAs. As a result, we are not finalizing our proposal to change the 
descriptors for the current therapy modifiers: GP, GO and GN--their 
descriptors and their use remains unchanged, as follows:
     GP--services delivered under an outpatient physical 
therapy plan of care.
     GO--services delivered under an outpatient occupational 
therapy plan of care.
     GN--services delivered under an outpatient speech-language 
pathology plan of care.
    As part of the proposed rule, we noted that therapy assistants are 
precluded from furnishing outpatient therapy services incident to the 
services of a physician or NPP, and as such, the new PTA and OTA 
modifiers cannot be used on the line of service of the professional 
claim when the rendering NPI identified on the claim is a physician or 
an NPP. This is because PTAs and OTAs don't meet the qualifications of 
a physical or occupational therapist that is set forth as conditions of 
payment in the regulatory provisions at Sec. Sec.  410.59(a)(3)(iii) 
and 410.60(a)(3)(iii). We are clarifying that this payment policy 
applies similarly when the CQ and CO modifiers are used as payment 
modifiers. We plan to revise our manual provisions at Pub. 100-02, 
Medicare Benefit Policy Manual, Chapter 15, section 230, as 
appropriate, to reference the new CQ and CO modifiers that will be used 
to identify services furnished in whole or in part by a PTA or OTA 
starting in CY 2020.
    Comment: Several commenters referenced therapist and therapy 
assistant shortages, and stated that this discounted payment rate for 
services furnished in whole or in part by therapy assistants will 
increase financial hardships to retain therapists and therapy 
assistants. Commenters requested that CMS exempt therapy services 
furnished in rural areas, health professional shortage areas (HPSAs), 
and medically underserved areas (MUAs) from application of the reduced 
payment rate when a therapy assistant is involved.
    Response: We understand the commenters' concerns. Given the 
parameters of the statute at section 1834(v) of the Act, we do not have 
authority to exempt services furnished in whole or in part by therapy 
assistants from application of the reduced payment rate when furnished 
in rural areas, HPSAs, and MUAs. As we do for other services, we will 
monitor for potential access issues and consider how to address them 
should they arise. We do not currently have information on the 
geographic distribution or quantity of services furnished in whole or 
in part by PTAs and OTAs, and look forward to reviewing this 
information as it becomes available after January 1, 2020, when the new 
therapy assistant modifiers are required to be reported on claims.
    Comment: Many commenters expressed concerns about different aspects 
of our proposed interpretation of the statutory reference to services 
furnished ``in whole or in part'' by PTAs and OTAs. Commenters also 
expressed concern about our proposal to define ``in part'' to mean any 
minute of therapeutic services delivered by a PTA or OTA. Several 
commenters raised concerns about the reduced payment associated with 
the future use of the new modifiers to describe services furnished in 
whole or in part by PTAs and OTAs, and asked us to consider the 
practical day-to-day implications of using these modifiers. These 
commenters stated that requiring the new modifiers to be applied when 
any minute of outpatient therapy is delivered by the PTA or OTA has 
serious implications for beneficiary access to care.
    Some commenters stated that documenting in the medical record the 
therapy services that are delivered in part by a therapy assistant will 
be burdensome for those services not fully or wholly furnished by an 
OTA or PTA, and some suggested that the reduced payment rates should 
only apply when the PTA or OTA furnishes the entire service.
    Many commenters objected to our definition of ``in part'' and 
offered several alternatives. Some commenters suggested that we should 
not define when a PTA or OTA furnishes a service in whole or in part, 
but instead consider whether a therapist furnishes a service in whole 
or in part, stating that the PTA/OTA modifiers should not apply in 
cases where the therapist, not the assistant, furnishes the majority of 
the service.
    Several commenters were concerned that applying the modifier when 
any minute of outpatient therapy is delivered by a therapy assistant 
has serious implications for beneficiary access to care and asked us to 
not finalize the definition of ``in part'' until CY 2020 rulemaking, 
when the new modifiers for services of therapy assistants are required 
on claims. The commenters stated that this delay would allow CMS 
additional time to engage in an extensive discussion with various 
external stakeholders in order to consider their input before CY 2020 
rulemaking. Instead of waiting to define ``in part'' during CY 2020 
rulemaking, one commenter suggested that we adopt a blended fee 
schedule rate for services furnished for more than 50 percent of the 
time by a therapist, including the services of both the 15-minute timed 
codes or untimed service-based codes, meaning that the rate paid would 
be 92.5 percent, halfway between 85 and 100 percent. Other commenters 
stated that the modifiers to identify services of PTAs and OTAs should 
not apply when the therapist fully furnished the services and the 
assistant merely lent a second pair of hands during the treatment for 
example, for safety reasons, such as where the patient is morbidly 
obese or has flaccid limb(s) and the completion of such services 
require more than one therapy professional.
    Many commenters raised concerns about the application of our 
definition of ``in part'' when therapists and therapy assistants work 
together collaboratively. Some commenters raised concerns about 
applying the modifier for therapy assistant services when therapists 
and their assistants work interchangeably without a clear line between 
when the physical therapist might stop delivering treatment and the 
therapy assistant resumes treatment, and when the assistant acts as a 
second pair of hands to the therapist. Some commenters stated that when 
a therapist and assistant work together in a team-based approach, 
regardless of the amount of time the PTA or OTA contributes, that the 
new modifiers identifying services for application of the discounted 
payment rate should not apply. Some of these commenters requested that 
we exclude the use of new modifiers for therapy evaluations and re-
evaluations because a therapy assistant is not permitted to fully 
furnish these services and these services require the therapist's 
clinical skill, judgment, and decision-making throughout. Others 
commenters requested that the modifiers should not apply for group 
therapy services, which are often provided collaboratively between the 
assistant and therapist because it is not fair to affix the discounted 
payment modifier to every patient in the group when a PTA or OTA 
furnishes one minute of the group service. Some commenters suggested we 
apply an 8-minute rule to the codes defined by 15-minute increments, 
stating that the modifiers should apply only when the PTA/OTA furnishes 
at least 8 minutes of the service, while other commenters asked us not 
to apply the assistant modifiers when these intervention services are 
furnished collaboratively by the therapist and

[[Page 59659]]

assistant. Several commenters recommended that CMS allow for reporting 
of the same code on the same day for the same beneficiary on two 
different claim lines to distinguish between those code units furnished 
by a therapist and those furnished by a therapy assistant in reference 
to the 15-minute timed intervention codes and the group therapy code 
(CPT code 97150).
    Response: We acknowledge the views of the many commenters regarding 
our proposed interpretation of the statutory reference to therapy 
services furnished in whole or ``in part'' by PTAs and OTAs as part of 
the requirement that we establish a modifier to identify such services 
on claims beginning January 1, 2020, and apply a discounted payment 
rate to those services beginning January 1, 2022. We offer 
clarification on some of the commenters' concerns and alternatives, as 
follows. We do not agree that the statutory provision at section 
1834(v) of the Act, which specifies a discounted payment rate for 
services furnished ``in whole or in part'' by a therapy assistant, 
could be interpreted to apply only when the therapy assistant furnishes 
the entire service. We also clarify that the modifiers would not apply 
to those services that are exclusively furnished by therapists without 
the assistance of PTAs or OTAs. However, the extent to which the 
modifiers apply to clinical scenarios in which the therapist and 
therapy assistant work together to furnish services collaboratively may 
be dependent on whether the therapy assistant's services are furnished 
in the absence of the therapist, whose time could then no longer be 
attributed to that patient. We do not agree that services in which the 
therapist and therapy assistant work collaboratively or in tandem are 
necessarily services that are not furnished ``in part'' by a therapy 
assistant. Rather, when a therapist and therapy assistant work together 
in furnishing a therapy service, we would generally view that service 
as being furnished in part by a therapy assistant, especially when the 
therapist is absent for a portion of the service, as explained above. 
We recognize there are other clinical scenarios and types of services 
where it is less obvious whether the service should be considered 
furnished ``in part'' by a therapy assistant when a therapist and 
therapy assistant work collaboratively together to treat one patient, 
and we anticipate addressing applicability of the modifiers in 
additional clinical scenarios through further rulemaking for CY 2020. 
We also clarify that the statutory provision at section 1834(v) of the 
Act requiring the reduced payment at 85 percent for services furnished 
in whole or in part by a therapy assistant beginning in CY 2022, does 
not permit us to make payment at 92.5 percent, as suggested by some 
commenters. We also note the concerns of the few commenters requesting 
that we allow the same procedure code for the same patient on the same 
day to appear on multiple claim lines, some of which might include the 
new modifier for therapy assistant services and others of which would 
not. CMS claims processing systems already allow, when not constrained 
by other policies such as Medically Unlikely Edits (MUEs), the same 
procedure code to be reported on two different claim lines as long as 
there is a different modifier used to uniquely identify the service and 
prevent the service from being considered a duplicate. For example, if 
a therapy assistant furnished one unit (15 minutes) and the therapist 
furnished 2 units (30 minutes) of the same procedure code that is 
defined to be billable in 15-minute increments, one unit of the 
procedure code would be billed on the claim line with the modifier for 
the therapy assistant's services and two units of the procedure code 
would be billed on another claim line without the assistant modifier.
    We do not agree with the commenters' suggestion that we define ``in 
part'' to mean a therapy service for which a PTA or OTA furnishes 50 
percent or a majority of the service, or an otherwise substantial part 
of the service. The discounted payment rate specified under section 
1834(v)(1) of the Act is required to be applied for services furnished 
``in whole or in part'' by a therapy assistant. We do not believe ``in 
whole or in part'' means that the discounted payment rate would apply 
only to services for which 50 percent or more of the service was 
furnished by a therapy assistant.
    In our review of section 1834(v)(1) of the Act, we believe that the 
phrase ``in part'' could be read to mean that if a therapy assistant 
participates only in a very small (so insubstantial as to not be 
meaningful) portion of the service, the discounted payment rate would 
not apply. In the proposed rule, we proposed that ``in part'' would not 
include the non-therapeutic portions of a service that could be 
performed by others without the training of PTAs or OTAs. Along those 
same lines, after further consideration of the public comments 
explaining the fluid nature of clinical practice between therapists and 
therapy assistants and the complexity of identifying and documenting 
when a service is furnished in part by a therapy assistant, we believe 
it would be appropriate to define a therapy assistant's participation 
in furnishing a therapy service ``in part'' to mean that the therapy 
assistant furnished more than a de minimis portion of the therapy 
service. Specifically, we believe it would be appropriate to specify 
that a therapy assistant is considered to furnish a therapy service 
``in part'' when they perform more than 10 percent of the service. If, 
instead of specifying as we proposed that the modifiers are applicable 
when any minute of a therapeutic service is furnished by a PTA or OTA, 
we specified that the modifiers apply when more than 10 percent of a 
service is furnished by the therapy assistant, 1.5 minutes of a 15-
minute unit could be furnished by the PTA or OTA without being subject 
to the discounted payment rate. If this 10 percent de minimis standard 
is applied to an untimed service, for example to a therapy evaluation 
for which the typical time is 45 minutes, the PTA or OTA could furnish 
up to 4.5 minutes of the service before the modifier and discounted 
payment rate would apply. We anticipate addressing applicability of the 
ten percent de minimis standard for other clinical scenarios in further 
rulemaking for CY 2020.
    After consideration of the public comments, the following reflects 
a full summary of our finalized policies.
    We are finalizing the establishment of two modifiers, one to 
identify services furnished in whole or in part by PTAs and the other 
to identify services furnished in whole or in part by OTAs. We are also 
finalizing our proposal to define PTAs and OTAs as those individuals 
meeting the personnel qualifications set forth in part 484.
    Instead of finalizing the new modifiers to identify services 
furnished by PTAs and OTAs as therapy modifiers, we are adopting a 
final policy to use these new modifiers as a payment modifier that will 
be appended on the same line of service with the respective PT or OT 
therapy modifier. This modified approach necessitates revisions to the 
proposed descriptors of the new CQ and CO modifiers, and allows us to 
proceed without making the proposed revisions to the current 
descriptors for the three therapy modifiers--GP, GO and GN. We are 
finalizing the new payment modifiers as follows.
     CQ Modifier: Outpatient physical therapy services 
furnished in whole or in part by a physical therapist assistant.
     CO Modifier: Outpatient occupational therapy services 
furnished

[[Page 59660]]

in whole or in part by an occupational therapy assistant.
    We are not revising the three therapy modifiers as we had proposed. 
Instead, they will continue in effect, unmodified, as follows:
     GP--services delivered under an outpatient physical 
therapy plan of care.
     GO--services delivered under an outpatient occupational 
therapy plan of care.
     GN--services delivered under an outpatient speech-language 
pathology plan of care.
    Instead of finalizing our proposed definition of a service that is 
furnished in whole or in part by a PTA or OTA as a service for which 
any minute of a therapeutic service is furnished by a PTA or OTA, we 
are finalizing a de minimis standard under which a service is furnished 
in whole or in part by a PTA or OTA when more than 10 percent of the 
service is furnished by the PTA or OTA. We anticipate addressing 
application of the therapy assistant modifiers and the 10 percent 
standard more specifically, including their application for different 
scenarios and types of services, in rulemaking for CY 2020.
3. Functional Reporting Modifications
    Since January 1, 2013, all providers of outpatient therapy 
services, including PT, OT, and SLP services, have been required to 
include functional status information on claims for therapy services. 
In response to the Request for Information (RFI) on CMS Flexibilities 
and Efficiencies that was issued in the CY 2018 PFS proposed rule (82 
FR 34172 through 34173), we received comments requesting burden 
reduction related to the functional reporting requirements that were 
adopted to implement section 3005(g) of the Middle Class Tax Relief and 
Jobs Creation Act (MCTRJCA) of 2012 (Pub. L. 112-96, January 1, 2013). 
More information about these requirements can be found in the CY 2019 
PFS proposed rule (83 FR 35852).
    We proposed to discontinue the functional reporting requirements 
for services furnished on or after January 1, 2019. Specifically, we 
proposed to amend our regulations by removing the following: (1) 
Conditions of payment at Sec. Sec.  410.59(a)(4), 410.60(a)(4), 
410.62(a)(4), and 410.105(d) that require claims for OT, PT, SLP, and 
Comprehensive Outpatient Rehabilitation Facility (CORF) PT, OT, and SLP 
services, respectively, to contain prescribed information on patient 
functional limitations; and, (2) the functional reporting-related 
phrase that requires the plan's goals to be consistent with functional 
information on the claim at Sec.  410.61(c) for outpatient PT, OT, and 
SLP services and at Sec.  410.105(c)(1)(ii) for the PT, OT, and SLP 
services in CORFs. In addition, we would (1) remove the functional 
reporting subregulatory requirements implemented primarily through 
Change Request 8005 last issued on December 21, 2012, via Transmittal 
2622, (2) eliminate the functional reporting standard systems edits we 
have applied to claims, and (3) remove the functional reporting 
requirement provisions in our internet Only Manual (IOM) provisions 
including the Medicare Claims Processing Manual, Chapter 5 and the 
functional reporting requirements in Chapters 12 and 15 of the Medicare 
Benefits Policy Manual.
    Our proposal would end the requirements for the reporting and 
documentation of functional limitation G-codes (HCPCS codes G8978 
through G8999 and G9158 through G9186) and severity modifiers (in the 
range CH through CN) for outpatient therapy claims with dates of 
service on and after January 1, 2019. Accordingly, with the conclusion 
of our functional reporting system for dates of service after December 
31, 2018, we proposed to delete the applicable non-payable HCPCS G-
codes specifically developed to implement that system through the CY 
2013 PFS final rule with comment period (77 FR 68598 through 68978).
    We sought comment on these proposals. The following is a summary of 
the comments we received on these proposals.
    Comment: Many commenters supported the proposal to eliminate the 
functional reporting requirements for outpatient therapy services and 
urged us to end these requirements for reporting and documenting the G-
codes and severity modifiers on claims for PT, OT, and SLP services 
beginning January 1, 2019. Many commenters agreed that these 
requirements are overly complex and burdensome for therapy providers.
    Response: We appreciate the commenters' support of our proposal to 
end the reporting and documentation requirements effective January 1, 
2019.
    Comment: Some commenters disagreed with our proposal to end the 
functional reporting and documentation requirements beginning in CY 
2019. One commenter who liked our functional reporting system suggested 
that we retain a reduced version of it. Two other commenters supported 
our requirement for assessment tools or outcome measures to be used to 
quantify the severity of dysfunction or disability. One commenter 
representing a software developer supported the flexibility in our 
rules permitting professional judgment of therapists to select from a 
composite outcome measure a single functional measure that reflects a 
more accurate disability rating. Another commenter representing a large 
private payer asked us to retain our functional reporting requirements 
because they believe that information about functional status of 
therapy patients remains an essential source of information for health 
plan care management activities such as health plan care coordination 
programs and to accurately complete risk adjustment requirements. This 
commenter also noted that the end of Medicare functional reporting 
requirements may cause therapists to stop documenting information about 
their patients' functional status, and this, along with the repeal of 
the therapy caps, could instead prompt therapists to furnish non-
covered long-term custodial care services that are not medically 
necessary.
    Response: We appreciate the commenters' support for the claims-
based functional reporting system requirements currently in place 
including the use by the private payer of the functional status 
information reported on claims for health plan care management 
activities. While we acknowledge that functional status will no longer 
be required to be reported on Medicare claims and, thus, will not be 
available for use on claims for health plan care management activities, 
we do not share the commenter's concern though that the lack of a 
functional reporting requirement to document the non-payable HCPCS 
codes and related severity modifiers or the repeal of the therapy caps 
will cause therapists to begin furnishing therapy services that do not 
meet the statutory requirement for reasonable and necessary services or 
keep them from documenting other information required about patients' 
physical status in medical records. The documentation requirements 
specified in Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, 
section 220.3 titled Documentation Requirements for Therapy Services, 
in subsection C. for Evaluation/Re-Evaluation and Plan of Care, which 
were established prior to the MCTRJCA provisions' mandate, would remain 
in place. These documentation instructions continue to require that 
therapists document in the beneficiary's medical record, either in the 
evaluation or in the plan of care containing the evaluation, objective, 
measurable beneficiary physical function. In order to meet these 
requirements, therapists may use one of

[[Page 59661]]

four measurement instruments, including National Outcomes Measurement 
System (NOMS) by the American Speech-Language Hearing Association, 
Activity Measure--Post Acute Care (AM-PAC), Patient Inquiry by Focus On 
Therapeutic Outcomes, Inc. (FOTO), or OPTIMAL by Cedaron through the 
American Physical Therapy Association; or, when one of these tools is 
not used, they may use (a) functional assessment individual item and 
summary scores from commercially available therapy outcomes 
instruments, (b) functional assessment scores from tests and 
measurements validated in the professional literature that are 
appropriate for the condition/function being measured; or (c) other 
measurable progress towards identified goals for functioning in the 
home environment at the conclusion of the therapy episode of care. For 
these reasons, we believe therapists will continue to use the 
measurement tools they have used in the past to identify measureable 
physical functional status even after we discontinue the claims-based 
functional reporting requirements.
    After consideration of the public comments, we are finalizing our 
proposed changes to discontinue the functional reporting requirements 
for outpatient therapy services furnished on or after January 1, 2019. 
Specifically, we are removing the following regulatory requirements: 
(1) Conditions of payment at Sec. Sec.  410.59(a)(4), 410.60(a)(4), 
410.62(a)(4), and 410.105(d) that require claims for OT, PT, SLP, and 
Comprehensive Outpatient Rehabilitation Facility (CORF) PT, OT, and SLP 
services, respectively, to contain prescribed information on patient 
functional limitations; and, (2) the functional reporting-related 
phrase that requires the plan's goals to be consistent with functional 
information on the claim at Sec.  410.61(c) for outpatient PT, OT, and 
SLP services and at Sec.  410.105(c)(1)(ii) for the PT, OT, and SLP 
services in CORFs.
    In addition to amending these regulations, we are ending the 
requirements for the reporting and documentation of functional 
limitation G-codes (HCPCS codes G8978 through G8999 and G9158 through 
G9186) and severity modifiers (in the range CH through CN) for 
outpatient therapy claims with dates of service on and after January 1, 
2019.
    Instead of deleting the HCPCS G-codes effective for CY 2019 as 
proposed, we are finalizing a modification of that proposal to retain 
the set of 42 non-payable HCPCS G-codes until CY 2020 as this will 
allow time for therapy providers and other private insurers who 
currently use these HCPCS G-codes for purposes of functional reporting 
to update their billing systems and policies. This will avoid a 
situation where claims that inadvertently contain any of these G-codes 
during CY 2019 can be processed, and are not unnecessarily returned or 
rejected. The retention of HCPCS G-codes through CY 2019 will also 
allow physical and occupational therapists to report six of these non-
payable HCPCS G-codes and the measures developed from them for purposes 
of meeting the MIPS program requirements which are found in section 
III.I.3. of this final rule.
    We also intend to revise our manuals regarding the application of 
the functional reporting requirements in our IOM, Pub. 100-02, Medicare 
Benefits Policy Manual, Chapters 12 and 15, and Pub. 100-04, Medicare 
Claims Processing Manual, Chapter 5.
4. Therapy KX Threshold Amounts
    As noted above in this section, the KX modifier thresholds were 
established through section 50202 of the Bipartisan Budget Act of 2018. 
These KX modifier thresholds were formerly referred to as therapy caps 
and are a permanent provision of the law, meaning that the statute does 
not specify an end date. These per-beneficiary amounts under section 
1833(g) of the Act (as amended by section 4541 of the Balanced Budget 
Act of 1997) (Pub. L. 105-33, August 5, 1997) are updated each year 
based on the MEI. Specifically, these amounts are calculated by 
updating the previous year's amount by the MEI for the upcoming 
calendar year and rounding to the nearest $10.00. Increasing the CY 
2018 KX modifier threshold amount of $2,010 by the CY 2019 MEI of 1.5 
percent and rounding to the nearest $10.00 results in a CY 2019 KX 
threshold amount of $2,040 for PT and SLP services combined and $2,040 
for OT services.
    Along with the KX modifier thresholds, section 50202 of the 
Bipartisan Budget Act of 2018 also added section 1833(g)(7)(B) of the 
Act which retains the targeted medical review process, but at a lower 
threshold amount of $3,000 (until CY 2028) as detailed previously in 
this section. For CY 2018, the MR threshold is $3,000 for PT and SLP 
services combined and $3,000 for OT services. Under the established 
targeted review process, some, but not all claims exceeding the MR 
threshold amount are subject to review. For information on the targeted 
manual medical review process, go to https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/TherapyCap.html.
    CMS tracks each beneficiary's incurred expenses for therapy 
services annually and counts them toward the KX modifier and MR 
thresholds by applying the PFS rate for each service less any 
applicable multiple procedure payment reduction (MPPR) amount for 
services of CMS-designated ``always therapy'' services.
    As required by section 1833(g)(6)(B) of the Act, added by section 
603(b) of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-
240, January 2, 2013) and extended by subsequent legislation, including 
section 50202 of the Bipartisan Budget Act of 2018, the PFS-rate 
accrual process is applied to outpatient therapy services furnished by 
critical access hospitals (CAHs) even though they may be paid on a cost 
basis (effective January 1, 2014).
    For Maryland hospitals paid under the Maryland All-Payer Model, 
currently being tested under the authority of section 1115A of the Act 
(effective January 1, 2016), we use the submitted charge amounts to 
accrue to the KX modifier and MR thresholds.
    After expenses incurred for the beneficiary's outpatient therapy 
services for the year have exceeded one or both of the KX modifier 
thresholds, therapy suppliers and providers use the KX modifier on 
claims for subsequent medically necessary services. By using the KX 
modifier, the therapist is attesting that the services above the KX 
modifier thresholds are reasonable and necessary and that there is 
documentation of medical necessity for the services in the 
beneficiary's medical record. Claims for outpatient therapy services 
that exceed the KX modifier thresholds but do not include the KX 
modifier are denied.

M. Part B Drugs: Application of an Add-On Percentage for Certain 
Wholesale Acquisition Cost (WAC)-Based Payments

    Consistent with statutory provisions in section 1847A of the Act, 
many current Medicare Fee-For-Service (FFS) payments for separately 
payable drugs and biologicals furnished by providers and suppliers 
include an add-on set at 6 percent of the volume-weighted average sales 
price (ASP) or wholesale acquisition cost (WAC) for the drug or 
biological (the ``6 percent add-on''). Although section 1847A of the 
Act does not specifically state what the 6 percent add-on represents, 
it is widely believed to include services associated with drug 
acquisition that are not separately paid for, such as handling, 
storage, other overhead, as well as additional mark-

[[Page 59662]]

ups in drug distribution channels. The 6 percent add-on described in 
section 1847A of the Act has raised concerns because more revenue can 
be generated from percentage-based add-on payments for expensive drugs, 
and an opportunity to generate more revenue may create an incentive for 
the use of more expensive drugs (MedPAC Report to the Congress: 
Medicare and the Health Care Delivery System June 2015, http://medpac.gov/docs/default-source/reports/june-2015-report-to-the-congress-medicare-and-the-health-care-delivery-system.pdf, pages 65 
through 72). Also, the Office of the Assistant Secretary for Planning 
and Evaluation (ASPE) March 8, 2016, Issue Briefing pointed out that 
administrative complexity and overhead costs are not exactly 
proportional to the price of a drug (https://aspe.hhs.gov/pdf-report/medicare-part-b-drugs-pricing-and-incentives). Thus, the suitability of 
using a percentage of the volume-weighted ASP or WAC of the drug or 
biological for an add-on payment may vary depending on the price of the 
drug or how the payment rate has been determined.
    Although the add-on percentage for drug payments made under section 
1847A of the Act is typically applied to the ASP, a 6 percent add-on is 
also applied to the WAC to determine the Part B drug payment allowances 
in the following situations. First, for single source drugs, as 
authorized in section 1847A(b)(4) of the Act, payment is made using the 
lesser of ASP or WAC; and section 1847A(b)(1) of the Act requires that 
a 6 percent add-on be applied regardless of whether WAC or ASP is less. 
Second, for drugs and biologicals where the ASP during first quarter of 
sales is unavailable, section 1847A(c)(4) of the Act allows the 
Secretary to determine the payment amount for the drug or biological 
based on the WAC or payment methodologies in effect on November 1, 
2003. We note that this provision does not specify that an add-on 
percentage be applied if WAC-based payment is used, nor is an add-on 
percentage specified in the implementing regulations at Sec.  
414.904(e)(4). The application of the add-on percentage to WAC-based 
payments during a period where partial quarter ASP data was available 
was discussed in the 2011 PFS final rule with comment (75 FR 73465 
through 73466). Third, in situations where Medicare Administrative 
Contractors (MACs) determine pricing for drugs that do not appear on 
the ASP pricing files and for new drugs, WAC-based payment amounts may 
also be used, as discussed in Chapter 17, Section 20.1.3 of the 
Medicare Claims Processing Manual. This section of the manual describes 
the use of a 6 percent add-on.
    The incorporation of discounts in the determination of payment 
amounts made for Part B drug varies. Most Part B drug payments are 
based on the drug's or biological's ASP; as provided in section 
1847A(c)(3) of the Act, the ASP is net of many discounts such as volume 
discounts, prompt pay discounts, cash discounts, free goods that are 
contingent on any purchase, chargebacks, and rebates (other than 
rebates under Medicaid drug rebate program). In contrast, the WAC of a 
drug or biological is defined in section 1847A(c)(6)(B) of the Act as 
the manufacturer's list price for the drug or biological to wholesalers 
or direct purchasers in the United States, not including prompt pay or 
other discounts, rebates or reductions in price, for the most recent 
month for which the information is available, as reported in wholesale 
price guides or other publications of drug or biological pricing data. 
Because the WAC does not include discounts, it typically exceeds ASP, 
and the use of a WAC-based payment amount for the same drug results in 
higher dollar payments than the use of an ASP-based payment amount.
    Although discussions about the add-on tend to focus on ASP-based 
payments (because ASP-based payments are more common than WAC-based 
payments), the add-on for WAC-based payments has also been raised in 
the June 2017 MedPAC Report to the Congress (http://www.medpac.gov/docs/default-source/reports/jun17_reporttocongress_sec.pdf, pages 42 
through 44). The MedPAC report focused on how the 2 quarter lag in 
payments determined under section 1847A of the Act led to a situation 
where undiscounted WAC-based payment amounts determined using 
information from 2 quarters earlier were used to pay for drugs that 
providers purchased at a discount. To determine the extent of the 
discounts, MedPAC sampled new, high-expenditure Part B drugs and found 
that these drugs' ASPs were generally lower than their WACs. Seven out 
of the 8 drugs showed pricing declines from initial WAC to ASP one year 
after being listed in the ASP pricing files with the remaining product 
showing no change, which suggests purchasers received discounts that 
WAC did not reflect. MedPAC further cited a 2014 OIG report (OIG, 
Limitations in Manufacturer Reporting of Average Sales Price Data for 
Part B Drugs, (OEI-12-13-00040), July 2014) to illustrate that there 
may be differences between WAC and ASP in other instances in which CMS 
utilizes WAC instead of ASP and noted that OIG found that ``WACs often 
do not reflect actual market prices for drugs.'' MedPAC also 
characterized Part B payments based on undiscounted list prices for 
products that were available at a discount as excessive. The report 
suggested that greater parity between ASP-based acquisition costs and 
WAC-based payments for Part B drugs could be achieved and recommended 
changing the 6 percent add-on for WAC-based payments to 3 percent. A 3 
percent change was recommended based on statements made by industry, 
MedPAC's analysis of new drug pricing, and OIG data. The report also 
mentioned that discounts on WAC, such as prompt pay discounts, were 
available soon after the drug went on the market.
    In the case of a drug or biological during an initial sales period 
in which data on the prices for sales for the drug or biological is not 
sufficiently available from the manufacturer, section 1847A(c)(4) of 
the Act permits the Secretary to make payments that are based on WAC. 
In other words, although payments under this section may be based on 
WAC, unlike section 1847A(b) of the Act (which specifies that certain 
payments must be made with a 6 percent add-on), section 1847A(c)(4) of 
the Act does not require that a particular add-on amount or percentage 
be applied to partial quarter WAC-based pricing. Consistent with 
section 1847A(c)(4) of the Act, we proposed that effective January 1, 
2019, WAC based payments for Part B drugs made under section 
1847A(c)(4) of the Act, utilize a 3 percent add-on in place of the 6 
percent add-on that is currently being used. We proposed a 3 percent 
add-on because this percentage is consistent with MedPAC's analysis and 
recommendations discussed in the paragraph above and cited in its June 
2017 Report to the Congress. Although other approaches for modifying 
the add-on amount, such as a flat fee, or percentages that vary with 
the cost of a drug, are possible, we proposed a fixed percentage in 
order to be consistent with other provisions in section 1847A of the 
Act that specify fixed add-on percentages of 6 percent (section 
1847A(b) of the Act) or 3 percent (section 1847A(d)(3)(C) of the Act). 
A fixed percentage is also administratively simple to implement and 
administer, predictable, and easy for manufacturers, providers and the 
public to understand.
    We have also reviewed corresponding regulation text at Sec.  
414.904(e)(4). To conform the regulation text more closely to the 
statutory language at section

[[Page 59663]]

1847A(c)(4) of the Act, we also proposed to strike the word 
``applicable'' from paragraph (e)(4) of Sec.  414.904. Section 
1847A(c)(4) of the Act does not use the term ``applicable'' to describe 
the payment methodologies in effect on November 1, 2003.
    We also discussed changing the policy articulated in the Medicare 
Claims Processing Manual that describes the application of the 6 
percent add-on to payment determinations made by MACs for new drugs and 
biologicals. Chapter 17 section 20.1.3 of the Claims Processing Manual 
(https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdf) states that WAC-based payment limits for drugs 
and biologicals that are produced or distributed under a new drug 
application (or other new application) approved by the Food and Drug 
Administration, and that are not included in the ASP Medicare Part B 
Drug Pricing File or Not Otherwise Classified (NOC) Pricing File, are 
based on 106 percent of WAC. Invoice-based pricing is used if the WAC 
is not published. In the Hospital Outpatient Prospective Payment System 
(OPPS) program, the payment allowance limit is 95 percent of the 
published Average Wholesale Price (AWP). We discussed permitting MACs 
to use an add-on percentage of up to 3 percent for WAC-based payments 
for new drugs. MACs have longstanding authority to make payment 
determinations when we do not publish a payment limit in our national 
Part B drug pricing files and when a new drug becomes available. This 
proposal intended to preserve consistency with our proposed national 
pricing policy and would apply when MACs perform pricing 
determinations, for example during the period when ASPs have not been 
reported. The proposed policy would not alter OPPS payment limits; 
however, the CY 2019 OPPS proposed rule (83 FR 37046) includes a 
discussion about proposed changes to certain WAC-based drug payments 
under the OPPS.
    We note that the PFS rule proposals do not include WAC-based 
payments for single source drugs under section 1847A(b) of the Act, 
that is, where the statute specifies that the payment limit is 106 
percent of the lesser of ASP or WAC.
    We have stated in previous rulemaking (80 FR 71101) that it is 
desirable to have fair reimbursement in a healthy marketplace that 
encourages product development. We have also stated that we seek to 
promote innovation to provide more options to patients and physicians, 
and competition to drive prices down (82 FR 53183). These positions 
have not changed. However, since 2011, concern about the impact of drug 
pricing and spending on Part B drugs has continued to grow. From 2011 
to 2016, Medicare Part B drug spending increased from $17.6 billion to 
$28.0 billion, representing a compound annual growth rate of 9.8 
percent, with per capita spending increasing 54 percent, from $532 to 
$818 (Based on Spending and Enrollment Data from the CMS Office of 
Enterprise Data and Analytics). These increases affect the spending by 
Medicare and beneficiary out-of-pocket costs. In the context of these 
concerns, we believe that implementation of these proposals would 
improve Medicare payment rates by better aligning payments with drug 
acquisition costs, especially for the growing number of drugs with high 
annual spending and high launch prices where single doses can cost tens 
or even hundreds of thousands of dollars. The proposals would also 
decrease beneficiary cost sharing. A 3 percentage point reduction in 
the total payment allowance will reduce a patient's 20 percent Medicare 
Part B copayment--for a drug that costs many thousands of dollars per 
dose, this can result in significant savings to an individual. The 
proposed approach would help Medicare beneficiaries afford to pay for 
new drugs by reducing out of pocket expenses and would help counteract 
the effects of increasing launch prices for newly approved drugs and 
biologicals. Finally, the proposals are consistent with recent MedPAC 
recommendations.
    The following is a summary of the comments we received on these 
proposals.
    Comment: Many commenters expressed concerns about the proposed add-
on reduction and its effect on providers. Many of these commenters 
focused on the percentage portion of the add-on, stating that the 
proposed lower add-on would result in payment at ASP + 1.35 percent 
because of the sequester reduction.
    Response: The Budget Control Act of 2011 (Pub. L. 112-25, enacted 
August 2, 2011) requires mandatory across-the-board reductions in 
Federal spending, also known as sequestration. The application of 
sequestration (after the American Taxpayer Relief Act of 2012 (Pub. L. 
112-240, enacted January 2, 2013) postponed sequestration for 2 months) 
requires the reduction of Medicare payments by 2 percent for many 
Medicare FFS claims with dates-of-service on or after April 1, 2013. 
The proposed change to the add-on percentage does not include 
reductions applied to Medicare payments under sequestration, as 
sequestration is independent of Medicare payment policy. However, we 
understand the concerns about the reduction to the add-on and the 
effects of the sequester resulting in a situation where payment amounts 
could be potentially insufficient to cover acquisition costs for 
expensive drugs, such as for specialties like rheumatology, which 
utilize a narrow range of drugs with similar prices, and for providers 
who may not be able to acquire drugs below the ASP. The policy we 
proposed would reduce the add-on for WAC-based payment to 3 percent; it 
would be limited to new drugs and would not apply to the add-on to ASP-
based payment amounts. The 3 percent reduction is discussed in further 
detail in the comment responses below.
    Comment: A number of commenters stated that the 6 percent markup is 
intended to account for specific costs, such as handling, storage and 
other administrative expenses.
    Response: Section 1847A of the Act does not specifically state what 
the 6 percent add-on represents, and the accompanying Conference Report 
to the Medicare Prescription Drug, Improvement, and Modernization Act 
of 2003, which added section 1847A to the Act, similarly does not 
discuss the purpose of the 6 percent add-on (see Conference Report on 
H.R. 1, November 20, 2003). Although section 1847A of the Act does not 
specifically state what the add-on represents, it is believed by many 
that the 6 percent add on includes various activities associated with 
drug acquisition that are not separately paid for, such as handling, 
and storage, as well as additional costs, such as overhead and mark-ups 
in drug distribution channels; however, there is no consensus on the 
intent of the add-on (MedPAC Report to the Congress: Medicare and the 
Health Care Delivery System June 2016, http://www.medpac.gov/docs/default-source/reports/june-2016-report-to-the-congress-medicare-and-the-health-care-delivery-system.pdf?sfvrsn=0, page 127).
    Comment: Commenters expressed concerns that a payment reduction of 
3 percent would affect physicians and limit their utilization of new 
drugs, particularly in practices where margins are small, such as rural 
practices and small practices. Commenters were concerned that payments 
for drugs under the proposed reduction would not cover overhead (such 
as costs to order and store drugs, and rising costs for compliance with 
standards for the preparation of sterile drugs for administration to a 
patient), and other

[[Page 59664]]

costs (such as taxes and markups from intermediaries like wholesalers). 
Commenters stated that such payment reductions would require physicians 
to take a loss on new drugs or would prevent physicians from providing 
new drugs in the office. Several commenters disagreed that the markup 
incentivizes the use of more expensive drugs, while others agreed that 
financial incentives to use Part B drugs exist, particularly in the 
case of expensive drugs. One commenter noted that Part B includes some 
of the most expensive drugs available in the United States. Several 
commenters also noted that MedPAC data suggested that WAC-based 
payments with a 3 percent add-on could sometimes be less than ASP based 
payments with a 6 percent add-on.
    Response: The payment methodology in section 1847A of the Act was 
authorized by the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (Pub. L. 108-173, enacted on December 8, 
2003). Since then, drug prices have increased significantly, sometimes 
reaching into the tens and even hundreds of thousands of dollars for a 
single dose of a drug. We agree with commenters that Part B includes 
payments for very expensive drugs, and at least one GAO study has 
pointed out that the most new Part B drugs are costly and tend to be 
biologicals (Medicare Part B: Expenditures for New Drugs Concentrated 
among a Few Drugs, and Most Were Costly for Beneficiaries. (GAO 
Publication No. GAO-16-12; https://www.gao.gov/assets/680/673304.pdf)). 
As stated in the previous comment response, the purpose of the 6 
percent add-on is not clear, however, we are interested in striking a 
balance between concerns about providers' overhead costs and concerns 
about addressing financial incentives that may lead to excessive drug 
use.
    If the add-on is intended to account for administrative complexity, 
handling, storage and other overhead costs, these factors are not 
considered to be exactly proportional to current drug prices (https://aspe.hhs.gov/pdf-report/medicare-part-b-drugs-pricing-and-incentives). 
The application of the 6 percent add-on results in large dollar value 
payments for new drugs that are proportional only to the price of the 
drug. Further, the application of a 6 percent add-on to an undiscounted 
price like WAC, rather than a market-based price, can result in 
additional differences between acquisition cost and payment. This 
difference can become significant, particularly for higher cost drugs 
where the 6 percent add-on can be hundreds or even thousands of 
dollars, and can become even more substantial when WAC exceeds ASP or 
acquisition cost. We are concerned that as drug prices continue to 
increase, the add-on is continuing to evolve into a financial incentive 
that is not consistent with the appropriate use of new Part B drugs.
    Many new drugs are expensive; single doses may cost thousands of 
dollars. Six percent add-ons for expensive drugs may be excessive 
relative to factors such as the cost to acquire a drug, handling and 
storage, and other overhead costs. We believe that overhead costs for 
most new drugs and biologicals are generally comparable to the overhead 
costs for most other injectable Part B drugs. For example, many heavily 
utilized injectable Part B drugs and biologicals, including new 
products, appear to be readily available since they are listed in drug 
wholesalers' catalogues. With certain exceptions, such as biologicals 
made from autologous cells, prescribing information indicates that many 
injectable Part B drugs and biologicals are stable under refrigeration 
or room temperature and do not require highly specialized storage or 
shipping conditions. We also note that many newer injectable drugs are 
also produced in ready to use liquid form, thus additional 
reconstitution and complicated dose preparation steps are not 
necessary. For many newer injectable products that were added to the 
ASP drug files in 2018, prescribing information indicates that dose 
preparation is comparable to many other sterile injectables and 
consists of drawing up the drug into a syringe using aseptic technique, 
and sometimes diluting the dose in a small volume bag of intravenous 
fluid. Some of the newer products are available in ready to use 
syringes which are administered directly to the patient with no special 
preparation steps.
    We believe that the 3 percent reduction will help encourage the 
appropriate utilization of new drugs by lessening the financial 
incentive to overutilize drugs during their initial period of sales. We 
will discuss the percentage in more detail in the next comment 
response, but in general we believe that this reduction will not reduce 
margins for Part B drugs to an extent that would significantly and 
negatively affect providers, for several reasons. First, the overhead 
for many new drugs and biologicals is not likely to be significantly 
higher than the overhead for existing Part B injectable drugs (as 
discussed in the paragraph above). Second, the add-on is based on an 
undiscounted list price that is usually higher than market prices, and 
many new drugs and biologicals are costly. When the add-on is based on 
an undiscounted list price, this may contribute to potentially 
excessive add-on payments, particularly for expensive new drugs. As the 
WAC of a drug increases, so does the dollar value of the add-on, and 
this increase is not tied to any other factors, such actual market 
cost, administrative complexity of ordering the drug, or additional 
overhead costs, for example. The add-on for a costly drug can add 
significantly to the payment for a drug; a 6 percent add-on for a 
$5,000 dose of a drug is $300, while the 6 percent add-on for a $10,000 
dose is $600. Third, the duration of the reduction to WAC-based 
payments for new drugs would be brief, applying only during an initial 
period as stipulated in section 1847A(c)(4) of the Act, where ASP data 
for drugs or biologicals (including biosimilars) is not sufficiently 
available to determine an ASP-based payment. Fourth, based on recent 
additions to the ASP drug pricing files, the change would affect only a 
small number of drugs each year. Typically, several drugs are added to 
the ASP Drug Pricing files each quarter, and not all of those drugs are 
priced based on WAC; some are added to the pricing files after the 
initial period of sales and are paid based on ASP. For these reasons, 
we are not persuaded that the reduction of the add-on for new drugs 
would have significant impact on margins for most physicians or other 
providers, including small and rural practices.
    While some WAC based payments for new drugs could be less than ASP-
based payments, the WAC exceeds the ASP for most new drugs entering the 
market. Our approach using a percentage of the WAC-based amount 
provides an administratively simple and straightforward solution for 
new Part B drugs.
    We reiterate that our proposal did not include payments for single 
source drugs under section 1847A(b)(4) of the Act, where payment is 
made using the lesser of ASP or WAC. (This methodology applies after 
CMS receives ASP data for the drug.) Section 1847A(b)(1) of the Act 
requires that a 6 percent add-on be applied regardless of whether WAC 
or ASP is less; legislation would be required to change the percentage 
of the add-on that is specified in this provision.
    Comment: Several commenters stated that the MedPAC analysis was too 
limited and did not support a 3 percent add-on. Some suggested that 
delaying the add-on reduction and conducting more research was a 
reasonable alternative. Several commenters noted that manufacturers 
could increase WAC in response to CMS' change in policy.

[[Page 59665]]

    Response: The MedPAC analysis encompassed drugs with ASP data after 
2005 that were in the top 20 highest expenditures in 2014. The analysis 
indicated that ASP was lower than WAC soon after a drug is marketed; a 
range of percentages from 0.0 to -2.7 percent was reported. We believe 
that the 0.0 to -2.7 percent range may underestimate the average 
difference between WAC and ASP because the MedPAC's group of 8 drugs 
did not encompass codes where WAC substantially exceeded ASP, such as 
certain biosimilars. We also note that this analysis of drugs was not 
the only factor for MedPAC's recommendation of a 3 percent add-on. The 
report stated that the recommendation for 3 percent change was also 
based on industry statements regarding prompt-pay discounts, and 
previous OIG research (http://www.medpac.gov/docs/default-source/reports/jun17_reporttocongress_sec.pdf, pages 43, 44, 52, and 68). For 
these reasons, we disagree with commenters that the MedPAC analysis was 
too limited.
    Although the number of new drugs that appear on the ASP Drug 
Pricing Files with a WAC-based payment amount is limited, we stated in 
the proposed rule (83 FR 36047) that the average difference between WAC 
and ASP-based payment limits for a group of 3 recently approved drugs 
and biologicals that appeared on the ASP Drug Pricing Files (including 
one biosimilar biological product) was 9.0 percent. Excluding the 
biosimilar biological product results in a difference of 3.5 percent. 
These findings agree with the MedPAC's analysis and support the use of 
a 3 percent reduction to WAC-based payments for new drugs. Given the 
limited application of this policy change, the sources used by the 
MedPAC (which include industry statements), and our internal review, we 
do not believe that additional study or delay is necessary.
    We are aware that ASP-based payments may exceed payments based on 
WAC if the percentage for the WAC add-on is smaller than the ASP add-
on. The proposal for this policy change was limited to payments under 
section 1847A(c)(4) of the Act. We do not have authority to change the 
add-on for WAC based payments made under section 1847A(b)(4) of the Act 
or payments based on the ASP, and we have not addressed such payments 
in this rule. We believe that implementation of this relatively minor 
change without further delay is a positive step toward addressing high 
drug prices, including list prices. We acknowledge that manufacturers 
may increase Part B drug prices and that price increases could apply to 
both list prices like WAC and market-based prices, such as ASP. Section 
1847A of the Act does not provide us with authority to addresses most 
increases for Part B drug prices (we have limited authority to 
substitute AMP-based prices for ASP, and authority to use alternative 
prices in response to certain public health emergencies). Price 
increases from manufacturers and other sources that add to high drug 
costs will be considered as we continue our work to address concerns 
about high drug prices.
    Comment: Several commenters pointed out that the proposal does not 
address prices after the initial period of drug marketing, and that the 
MedPAC's recommendations about reducing the WAC payment add-on 
percentage were part of several proposals about Part B drug pricing. 
Several commenters also stated that the proposal to decrease WAC 
payments is not consistent with the President's goal to decrease list 
prices for drugs.
    Response: This proposal encompassed a change in policy that could 
be implemented in a relatively short time period and without additional 
legislation. The proposal is also consistent with the 2019 President's 
Budget's proposal. Language in the Major Savings and Reforms document 
states that if discounts are available for new Part B drugs, the use of 
WAC-based payments results in Medicare paying more than under ASP-based 
pricing (https://www.whitehouse.gov/wp-content/uploads/2018/02/msar-fy2019.pdf, page 150). The Budget proposal also contained other agenda 
items that are similar to the MedPAC's 2017 recommendations and would 
require legislation to implement. Such legislative changes, including 
authority to limit or to otherwise regulate WAC or other list prices 
for drugs are outside the scope of this rule; however, other 
information pertaining to drug pricing will be made public as it is 
developed. We also note that the use of list prices to determine the 
payment for Part B drugs is limited and the number of drugs paid using 
list prices is small. As we continue to work on other approaches to 
address high drug prices, we plan to monitor Part B drug prices and 
changes to drug costs that may be related to this policy.
    Comment: Many commenters focused on potential negative effects on 
patients, and expressed concerns that a negative impact on physicians 
would lead to fewer offices providing new drugs, leading to shifts to 
higher cost care settings like hospital outpatient departments, and 
ultimately leading to higher cost sharing payments. A few commenters 
stated that direct reductions in cost sharing (that is, the amount of 
money paid by a patient) would be minimal because secondary insurance 
(like Medigap) or alternative sources of payment are typically 
available and pay for much of Part B drug cost sharing.
    In contrast, several commenters agreed that cost sharing could 
drop, though the effect would be transient (limited to the early phase 
of a drug's marketing). However, these commenters generally agree that 
the CMS proposal was a step in the right direction for addressing the 
high cost of drugs.
    Response: Overall, as discussed in an earlier comment response, we 
believe that the scope of these changes is modest, will affect few 
drugs, and will exert a brief effect on Part B drug payment, applying 
only during the initial quarters when a new drug enters the market. As 
stated earlier in this section, the overhead for many new drugs and 
biologicals is not likely to be significantly higher than the overhead 
for existing Part B injectable drugs, the add-on is based on an 
undiscounted list price that tends to be higher than market prices, and 
many new drugs and biologicals are expensive, thus we do not expect a 
significant effect on providers' margins. Because we do not anticipate 
a significant or prolonged effect on providers' margins, we also 
disagree with the position that physicians' offices will be reluctant 
to administer new drugs and that this reduction to the add-on will 
negatively affect beneficiaries access to drugs at offices resulting in 
shifting patients to more expensive settings. As we stated in the 
proposed rule (83 FR 36047), we believe that the reduction in the WAC-
based payment add-on can positively impact individual beneficiaries in 
situations where they encounter out of pocket cost sharing payments for 
new and expensive drugs entering the market. We acknowledge that many 
beneficiaries that receive Part B drugs have supplementary insurance, 
but for beneficiaries that do not have supplementary insurance, this 
policy will help reduce out of pocket costs. We would like to reiterate 
that single doses of new drugs may costs thousands of dollars or more 
and a 3 percent reduction in the add-on percentage can result in 
meaningful savings to individual patients. We agree with commenters 
that a change to the add-on for new drugs is a step in the right 
direction for addressing the high cost of drugs. Overall, this policy 
will also provide a modest reduction in spending

[[Page 59666]]

for drugs by lowering the total payment for new Part B drugs.
    After considering the comments submitted in response to our 
proposal, consistent with section 1847A(c)(4) of the Act, we are 
finalizing our proposal to reduce the add-on percentage for WAC based 
payments for new drugs. Effective January 1, 2019, WAC based payments 
for new Part B drugs made under section 1847A(c)(4) of the Act, will 
utilize a 3 percent add-on in place of the 6 percent add-on that is 
currently being used. Our final policy is consistent with the 
President's Budget and affects an area where we have flexibility to 
make a change through regulation. The percentage reduction is also 
consistent with the MedPAC's analysis and recommendations discussed in 
this section and cited in its June 2017 Report to the Congress. A fixed 
percentage is also administratively simple to implement and administer, 
is predictable, and is easy for manufacturers, providers and the public 
to understand. We believe that the 3 percent reduction to the add-on 
for WAC-based payments will create greater parity overall between WAC 
and ASP for new drugs, biologicals and biosimilars and continue to 
encourage appropriate utilization of drugs. We are not persuaded that 
this modest and brief reduction in payments will impair access to new 
drugs or shift patient care to other settings.
    This change does not apply to single source drugs or biologicals 
paid under section 1847A(b)(4) of the Act where payment is made using 
the lesser of ASP or WAC; section 1847A(b)(1) of the Act requires that 
a 6 percent add-on be applied regardless of whether WAC or ASP is less.
    Comment: We received no specific comments on the proposal to 
conform the regulation text more closely to the statutory language at 
section 1847A(c)(4) of the Act. We proposed striking ``applicable'' 
from regulation text at Sec.  414.904(e)(4).
    Response: We are finalizing this change as proposed and revising 
regulation text at Sec.  414.904(e)(4) so that the language is more 
consistent with the statute.
    Comment: Several commenters opposed our intent to change the policy 
articulated in Chapter 17 of the Medicare Claims Processing Manual that 
describes the application of the 6 percent add-on to payment 
determinations made by MACs for new drugs and biologicals to reflect 
our proposal, if finalized. Commenters opposed the Manual changes for 
the same general reasons that they opposed the proposal to change the 
WAC-based add-on percentage under section 1847A(c)(4) of the Act. 
Commenters were also concerned about whether the use of an add-on that 
could be less than 3 percent would create additional financial stress 
for providers and whether the manual changes would apply to any WAC-
based payment. The commenters also questioned whether CMS has authority 
to make these changes.
    Response: The discussion about changes to Chapter 17 of the 
Medicare Claims Processing Manual was intended to provide notice of a 
potential corresponding subregulatory change to align with our 
regulatory policy if the provision to change the add-on percentage was 
finalized. Because we finalized the proposal to reduce the WAC-based 
payment add-on for payments made under the authority in section 
1847A(c)(4) of the Act, in the near future we plan to issue Manual 
instructions that will address contractor pricing for new Part B drugs.
    We are clarifying that changes to payments for WAC based drugs 
discussed in this rule apply only to new drugs and only during the time 
period while an ASP-based payment limit is not available. This time 
period begins when a drug is marketed and no ASP data is available for 
the manufacturer to report to us and ends at the end of the partial 
quarter pricing period when partial quarter ASP data becomes available 
to us. We will provide additional guidance or program instructions as 
appropriate.
    The variable percentage that we plan to utilize in the manual, that 
is, the use of an add-on that is up to 3 percent, addresses the wide 
range of Part B drug prices. As discussed earlier in this section, the 
6 percent add-on payment amount for very expensive drugs can result in 
very high add-on payments. For example, 6 percent of a $30,000 drug is 
$1800, while 6 percent of $300,000 is $18,000. We are aware of recently 
approved Part B drugs that have per dose price points up to several 
hundred thousand dollars. Our intent is to address the add-on payment 
that is associated with new drugs before national pricing and 
potentially other related policies, such as coverage, are developed. 
Our approach is consistent with provisions in section 1847A(c)(4) of 
the Act, which does not set a specific percentage for the add-on for 
drugs where ASP is not available. We also note that section 1847A(c)(5) 
of the Act provides authority to issue program instructions to 
implement section 1847A of the Act.
    Comment: One commenter expressed concern about the lack of lead 
time for the changes in drug payment policy.
    Response: Notice and comment rulemaking associated with Part B drug 
payments made under the methodology in section 1847A of the Act 
typically appears in the annual PFS Rule. Finalized changes to the add-
on percentage will not be implemented until January 1, 2019. We believe 
that using the established process for notice and comment rulemaking is 
acceptable and provides sufficient notice for the public. As stated 
earlier in this section, we believe that this change is modest, and its 
effects on payment for individual drugs will be brief. Further, this 
change does not require any billing or claims processing changes.
    In addition to the comments on the Part B drug add-on percentage 
for certain drugs discussed previously in this section, we received 
comments that suggested other alterations to the payment methodology 
under section 1847A of the Act. These suggestions include replacing a 
percentage add-on with a flat fee, changes to WAC-based pricing for 
drugs that are not new, changing payments for drugs that are not paid 
for under section 1847A of the Act (such as radiopharmaceuticals used 
in the office), the use of competitive acquisition or value-based 
payment for Part B drugs, making direct pricing interventions with 
manufacturers, requiring greater transparency for drug pricing, and 
educating (or otherwise influencing) providers about Part B drug 
prescribing. We also received comments pertaining to ASP reporting by 
manufacturers. Several commenters also questioned the authority for 
Part B drug payment reductions associated with the sequester. Comments 
on these issues are also outside the scope of this rule. Therefore, 
these comments are not addressed in this final rule.

N. Potential Model for Radiation Therapy

    Section 3(a) of the Patient Access and Medicare Protection Act 
(PAMPA) (Pub. L. 114-115, enacted December 28, 2015) revised section 
1848 of the Act so that, for the fee schedule established under section 
1848(b) of the Act in 2017 and 2018, we must apply the same code 
definitions and work RVUs under section 1848(c)(2)(C)(ii) of the Act, 
and the same direct inputs for the PE RVUs for radiation treatment 
delivery and related imaging services under section 1848(c)(2)(C)(ii) 
of the Act as those definitions, units, and inputs for such services 
for the fee schedule established for services furnished in 2016. 
Section 51009 of the Bipartisan Budget Act of

[[Page 59667]]

2018 extended these policies through 2019. Furthermore, section 3(b) of 
the PAMPA requires the Secretary of Health and Human Services to submit 
to Congress a report on the development of an episodic APM for payment 
under the Medicare program under title XVIII of the Act for radiation 
therapy (RT) services furnished in non-facility settings (``Report to 
Congress''). In the Report to Congress \7\ delivered in November 2017, 
we discussed the current status of RT services and payment, and 
reviewed model design considerations for a potential APM for RT 
services.
---------------------------------------------------------------------------

    \7\ Report to Congress: Episodic Alternative Payment Model for 
Radiation Therapy Services. https://innovation.cms.gov/Files/reports/radiationtherapy-apm-rtc.pdf.
---------------------------------------------------------------------------

    For the Report to Congress, the CMS Center for Medicare and 
Medicaid Innovation (Innovation Center) conducted an environmental scan 
of current evidence, as well as held a public listening session 
followed by an opportunity for RT stakeholders to submit written 
comments about a potential APM. A review of the applicable evidence in 
the Report to Congress demonstrated that episode payment models can be 
a tool for improving care and reducing expenditures. We believe that 
radiation oncology is a promising area of health care for bundled 
payments, in part, based on the findings in the Report to Congress. The 
CMS Innovation Center has and will continue to use public information 
regarding commercial initiatives, as well as stakeholder feedback to 
help inform the development, implementation, and refinement of design 
and testing of a potential model that tests payment for RT services 
under the authority of section 1115A of the Act.

III. Other Provisions of the Proposed Rule

A. Clinical Laboratory Fee Schedule

1. Background
    Prior to January 1, 2018, Medicare paid for clinical diagnostic 
laboratory tests (CDLTs) on the Clinical Laboratory Fee Schedule (CLFS) 
under sections 1832, 1833(a), (b), and (h), and 1861 of the Social 
Security Act (the Act). Under the previous methodology, CDLTs were paid 
based on the lesser of: (1) The amount billed; (2) the local fee 
schedule amount established by the Medicare Administrative Contractor 
(MAC); or (3) a national limitation amount (NLA), which is a percentage 
of the median of all the local fee schedule amounts (or 100 percent of 
the median for new tests furnished on or after January 1, 2001). In 
practice, most tests were paid at the NLA. Under the previous system, 
the CLFS amounts were updated for inflation based on the percentage 
change in the Consumer Price Index for All Urban Consumers (CPI-U), and 
reduced by a multi-factor productivity adjustment and other statutory 
adjustments, but were not otherwise updated or changed.
    Section 1834A of the Act, as established by section 216(a) of the 
Protecting Access to Medicare Act of 2014 (PAMA), required significant 
changes to how Medicare pays for CDLTs under the CLFS. The CLFS final 
rule, entitled Medicare Clinical Diagnostic Laboratory Tests Payment 
System (CLFS final rule), published in the Federal Register on June 23, 
2016, implemented section 1834A of the Act. Under the CLFS final rule, 
``reporting entities'' must report to CMS during a ``data reporting 
period'' ``applicable information'' collected during a ``data 
collection period'' for their component ``applicable laboratories.'' 
Applicable information is defined at Sec.  414.502 as, with respect to 
each CDLT for a data collection period: Each private payor rate for 
which final payment has been made during the data collection period; 
the associated volume of tests performed corresponding to each private 
payor rate; and the specific Healthcare Common Procedure Coding System 
(HCPCS) code associated with the test. Applicable information does not 
include information about a test for which payment is made on a 
capitated basis. An applicable laboratory is defined at Sec.  414.502, 
in part, as an entity that is a laboratory (as defined under the 
Clinical Laboratory Improvement Amendments (CLIA) definition at Sec.  
493.2) that bills Medicare Part B under its own National Provider 
Identifier (NPI). In addition, an applicable laboratory is an entity 
that receives more than 50 percent of its Medicare revenues during a 
data collection period from the CLFS and/or the Physician Fee Schedule 
(PFS). We refer to this component of the applicable laboratory 
definition as the ``majority of Medicare revenues threshold.'' The 
definition of applicable laboratory also includes a ``low expenditure 
threshold'' component which requires an entity to receive at least 
$12,500 of its Medicare revenues from the CLFS for its CDLTs that are 
not advanced diagnostic laboratory tests (ADLTs).
    The first data collection period, for which applicable information 
was collected, occurred from January 1, 2016 through June 30, 2016. The 
first data reporting period, during which reporting entities reported 
applicable information to CMS, occurred January 1, 2017 through March 
31, 2017. On March 30, 2017, we announced a 60-day enforcement 
discretion period of the assessment of civil monetary penalties (CMPs) 
for reporting entities that failed to report applicable information. 
Additional information about the 60-day enforcement discretion period 
is available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-March-Announcement.pdf.
    In general, the payment amount for each CDLT on the CLFS furnished 
beginning January 1, 2018, is based on the applicable information 
collected during the data collection period and reported to us during 
the data reporting period, and is equal to the weighted median of the 
private payor rates for the test. The weighted median is calculated by 
arraying the distribution of all private payor rates, weighted by the 
volume for each payor and each laboratory. The payment amounts 
established under the CLFS are not subject to any other adjustment, 
such as geographic, budget neutrality, or annual update, as required by 
section 1834A(b)(4)(B) of the Act. Additionally, section 1834A(b)(3) of 
the Act, implemented at Sec.  414.507(d), provides a phase-in of 
payment reductions, limiting the amounts the CLFS rates for each CDLT 
(that is not a new ADLT or new CDLT) can be reduced as compared to the 
payment rates for the preceding year. For the first 3 years after 
implementation (CY 2018 through CY 2020), the reduction cannot be more 
than 10 percent per year, and for the next 3 years (CY 2021 through CY 
2023), the reduction cannot be more than 15 percent per year. For most 
CDLTs, the data collection period, data reporting period, and payment 
rate update occur every 3 years. As such, the next data collection 
period for most CDLTs will be January 1, 2019 through June 30, 2019, 
and the next data reporting period will be January 1, 2020 through 
March 31, 2020, with the next update to CLFS occurring on January 1, 
2021. Additional information on the private payor rate-based CLFS is 
detailed in the CLFS final rule (81 FR 41036 through 41101).
2. Recent Stakeholder Feedback
    As we discussed in the CY 2019 PFS proposed rule (83 FR 35856), 
after the initial data collection and data reporting periods, we 
received feedback on a range of topics related to the private payor 
rate-based CLFS. Some commenters expressed concern that the

[[Page 59668]]

CY 2018 CLFS payments rates are based on applicable information from 
only a relatively small number of laboratories. Some commenters stated 
that, because most hospital-based laboratories were not applicable 
laboratories, and therefore, did not report applicable information 
during the initial data reporting period, the CY 2018 CLFS payment 
rates do not reflect their information and are inaccurate. Other 
commenters were concerned that the low expenditure threshold excluded 
most physician office laboratories and many small independent 
laboratories from reporting applicable information.
    We noted in the proposed rule that, in determining payment rates 
under the private payor rate-based CLFS, one of our objectives is to 
obtain as much applicable information as possible from the broadest 
possible representation of the national laboratory market on which to 
base CLFS payment amounts, for example, from independent laboratories, 
hospital outreach laboratories, and physician office laboratories, 
without imposing undue burden on those entities. As we noted throughout 
the CLFS final rule, we believe it is important to achieve a balance 
between collecting sufficient data to calculate a weighted median that 
appropriately reflects the private market rate for a CDLT, and 
minimizing the reporting burden for entities. In response to this 
feedback and in the interest of facilitating our goal, we proposed a 
change to the Medicare CLFS for CY 2019 in section III.A. of the CY 
2019 PFS proposed rule. We stated that we believe this proposal may 
result in more data being used on which to base CLFS payment rates.
    In addition to this proposal, we solicited public comments on other 
approaches that have been requested by some stakeholders who suggested 
that such approaches would result in CMS receiving even more applicable 
information to use in establishing CLFS payment rates. The approaches 
include revising the definition of applicable laboratory and changing 
the low expenditure threshold. These topics are discussed in this 
section.
3. Change to the Majority of Medicare Revenues Threshold in Definition 
of Applicable Laboratory
    In order for a laboratory to meet the majority of Medicare revenues 
threshold, section 1834A(a)(2) of the Act requires that, ``with respect 
to its revenues under this title, a majority of such revenues are 
from'' the CLFS and the PFS in a data collection period. In the CLFS 
final rule, we stated that ``revenues under this title'' are payments 
received from the Medicare program, which includes fee-for-service 
payments under Medicare Parts A and B, as well as Medicare Advantage 
(MA) payments under Medicare Part C, and prescription drug payments 
under Medicare Part D, and any associated Medicare beneficiary 
deductible or coinsurance amounts for Medicare services furnished 
during the data collection period (81 FR 41043). This total Medicare 
revenues amount (the denominator in the majority of Medicare revenues 
threshold calculation) is compared to the total of Medicare revenues 
received from the CLFS and/or PFS (the numerator in the majority of 
Medicare revenues threshold calculation). If the numerator is greater 
than 50 percent of the denominator for a data collection period, the 
entity has met the majority of Medicare revenues threshold criterion. 
We reflected that requirement in Sec.  414.502 in the third paragraph 
of the definition of applicable laboratory.
    As we explained in the CY 2019 PFS proposed rule, we have 
considered that our current interpretation of total Medicare revenues 
may have the effect of excluding laboratories that furnish Medicare 
services to a significant number of beneficiaries enrolled in MA plans 
under Medicare Part C from meeting the majority of Medicare revenues 
threshold criterion, and therefore, from qualifying as applicable 
laboratories. For instance, if a laboratory has a significant enough 
Part C component so that it is receiving greater than 50 percent of its 
total Medicare revenues from MA payments under Part C, it would not 
meet the majority of Medicare revenues threshold because its revenues 
derived from the CLFS and/or PFS would not constitute a majority of its 
total Medicare revenues. We stated that we believe if we were to 
exclude MA plan revenues from total Medicare revenues, more 
laboratories of all types may meet the majority of Medicare revenues 
threshold, and therefore, the definition of applicable laboratory, 
because it would have the effect of decreasing the amount of total 
Medicare revenues and increase the likelihood that a laboratory's CLFS 
and PFS revenues would constitute a majority of its Medicare revenues.
    We stated in the proposed rule that we believe section 1834A of the 
Act permits an interpretation that MA plan payments to laboratories not 
be included in the total Medicare revenues component of the majority of 
Medicare revenues threshold calculation. Rather, MA plan payments to 
laboratories can be considered to only be private payor payments under 
the CLFS. We emphasized in the CY 2019 PFS proposed rule that this 
characterization of MA plan payments is limited to only the CLFS for 
purposes of defining applicable laboratory. Whether MA plan payments to 
laboratories or other entities are considered Medicare ``revenues'' or 
``private payor payments'' in other contexts in the Medicare program is 
not relevant to our proposal, and our characterization of MA plan 
payments as private payor payments for purposes of the CLFS has no 
bearing on any aspect of the Medicare program other than the CLFS.
    As noted above, we defined total Medicare revenues for purposes of 
the majority of Medicare revenues threshold calculation to include fee-
for-service payments under Medicare Parts A and B, as well as MA 
payments under Medicare Part C, prescription drug payments under 
Medicare Part D, and any associated Medicare beneficiary deductible or 
coinsurance amounts for Medicare services furnished during the data 
collection period. However, section 1834A(a)(8) of the Act, which 
defines the term ``private payor,'' identifies at section 
1834A(a)(8)(B) a ``Medicare Advantage plan under Part C'' as a type of 
private payor. Under the private payor rate-based CLFS, CLFS payment 
amounts are based on private payor rates that are reported to CMS. 
Accordingly, an applicable laboratory that receives MA plan payments is 
to consider those MA plan payments in identifying its applicable 
information, which must be reported to CMS. We explained in the 
proposed rule that we believe it is more logical to not consider MA 
plan payments under Part C to be both Medicare revenues for determining 
applicable laboratory status and private payor rates for purposes of 
reporting applicable information. Congress contemplated that applicable 
laboratories would furnish MA services, as reflected in the requirement 
that private payor rates must be reported for MA services. However, 
under our current definition of applicable laboratory, laboratories 
that furnish MA services, particularly those that furnish a significant 
amount, are less likely to meet the majority of Medicare revenues 
threshold, which means they would be less likely to qualify as 
applicable laboratories, and as a result, to report private payor rates 
for MA services.
    Therefore, we stated in the proposed rule that after further review 
and consideration of the new private payor rate-based CLFS, we believe 
it is appropriate to include MA plan revenues as only private payor 
payments rather than both Medicare revenues, for the purpose of

[[Page 59669]]

determining applicable laboratory status, and private payor payments, 
for the purpose of specifying what is applicable information. Such a 
change would have the effect of eliminating the laboratory revenue 
generated from a laboratory's Part C-enrolled patient population as a 
factor in determining whether a majority of the laboratory's Medicare 
revenues are comprised of services paid under the CLFS or PFS. We noted 
that we believe this change would permit a laboratory with a 
significant Medicare Part C revenue component to be more likely to meet 
the majority of Medicare revenues threshold and qualify as an 
applicable laboratory. In other words, MA payments are currently 
included as total Medicare revenues (the denominator). In order to meet 
the majority of Medicare revenues threshold, the statute requires a 
laboratory to receive the majority of its Medicare revenues from the 
CLFS and or PFS. If MA plan payments were excluded from the total 
Medicare revenues calculation, the denominator amount would decrease. 
If the denominator amount decreases, the likelihood increases that a 
laboratory would qualify as an applicable laboratory. Therefore, we 
stated that we believe this proposal responds directly to stakeholders' 
concerns regarding the number of laboratories for which applicable 
information must be reported because a broader representation of the 
laboratory industry may qualify as applicable laboratories, which means 
we would receive more applicable information to use in setting CLFS 
payment rates.
    For these reasons, we proposed that MA plan payments under Part C 
would not be considered Medicare revenues for purposes of the 
applicable laboratory definition. We noted in the CY 2019 PFS proposed 
rule that if finalized, we would revise paragraph (3) of the definition 
of applicable laboratory at Sec.  414.502 accordingly. We reiterated 
that not characterizing MA plan payments under Medicare Part C as 
Medicare revenues would be limited to the definition of applicable 
laboratory under the CLFS, and would not affect, reflect on, or 
otherwise have any bearing on any other aspect of the Medicare program.
    In an effort to provide stakeholders a better understanding of the 
potential reporting burden that may result from this proposal, we 
provided a summary of the distribution of data reporting that occurred 
for the first data reporting period. We explained that if we were to 
finalize the proposed change to the majority of Medicare revenues 
threshold component of the definition of applicable laboratory, 
additional laboratories of all types serving a significant population 
of beneficiaries enrolled in Medicare Part C could potentially qualify 
as applicable laboratories, in which case their data would be reported 
to us. As discussed in the proposed rule, we received over 4.9 million 
records from 1,942 applicable laboratories for the initial data 
reporting period, which we used to set CY 2018 CLFS rates. Additional 
analysis shows that the average number of records reported for an 
applicable laboratory was 2,573. The largest number of records reported 
for an applicable laboratory was 457,585 while the smallest amount was 
1 record. A summary of the distribution of reported records from the 
first data collection period is illustrated in the Table 25.

                                          Table 25--Summary of Records Reported for First Data Reporting Period
                                                               [By applicable laboratory]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                               Percentile distribution of records
                        Total records                            Average     Min records   Max records -------------------------------------------------
                                                                 records                                  10th      25th      50th      75th      90th
--------------------------------------------------------------------------------------------------------------------------------------------------------
4,995,877...................................................        2,573             1       457,585        23        79       294     1,345     4,884
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Assuming a similar distribution of data reporting for the next data 
reporting period, the mid-point of reported records for an applicable 
laboratory would be approximately 300 (50th percentile for the first 
data reporting period was 294). However, as illustrated in Table 25, 
the number of records reported varies greatly, depending on the volume 
of services performed by a given laboratory. Laboratories with larger 
test volumes, for instance at the 90th percentile, should expect to 
report more records as compared to the midpoint used for this analysis. 
Likewise, laboratories with smaller test volume, for instance at the 
10th percentile, should expect to report fewer records as compared to 
the midpoint.
    The following is a summary of the comments we received and our 
responses to the comments regarding our proposal to modify the 
definition of applicable laboratory to exclude MA plan payments under 
Part C as Medicare revenues.
    Comment: Many commenters supported CMS' proposal to exclude MA plan 
payments under Part C from total Medicare revenues and agreed it would 
help achieve CMS' goal of increasing the number of laboratories 
reporting applicable information. They stated that by excluding MA plan 
payments from total Medicare revenues, the denominator of the majority 
of Medicare revenues threshold, more laboratories of all types with a 
significant share of revenues from Medicare Part C would be more likely 
to qualify as an applicable laboratory and report applicable 
information to CMS. They also agreed that removal of MA plan payments 
from total Medicare revenues is consistent with the statute, which 
defines MA plans as a private payor, and therefore will help enable 
more laboratories to qualify as applicable laboratories. The commenters 
that supported excluding MA plan payments under Part C from total 
Medicare revenues urged CMS to finalize the proposal. However, some 
stakeholders objected to CMS' proposal because it would result in 
administrative reporting burden for additional laboratories without 
having a perceptible impact on CLFS rates (because the largest 
laboratories with the highest test volumes will continue to dominate 
the weighted median of private payor rates). They stated that 
increasing the number of laboratories qualifying for applicable 
laboratory status and imposing additional data reporting burden, with 
no perceptible impact expected on the CLFS rates, is in direct conflict 
with the Administration's goal of reducing regulatory burden.
    Response: As discussed in the proposed rule, including MA plan 
payments as total Medicare revenues in the majority of Medicare 
revenues threshold (as we currently do) dilutes the percentage of total 
Medicare revenues attributed to CLFS and PFS revenues. As a result, 
laboratories performing tests for a significant Medicare Part C 
population are less likely to qualify as an applicable

[[Page 59670]]

laboratory and, therefore, to report applicable information to us.
    For the additional data reporting burden, as discussed in the 
Regulatory Impact Analysis in section VII. of the proposed rule (83 FR 
36048), we estimated that excluding MA plan payments from total 
Medicare revenues (the denominator) of the majority of Medicare 
revenues threshold, and keeping the numerator constant (that is, 
revenues from only the CLFS and or PFS) yielded an increase of 49 
percent in the number of laboratories meeting the majority of Medicare 
revenues threshold.
    We also noted in the proposed rule that there would only be an 
associated impact to the Medicare rates to the extent the additional 
applicable laboratories are paid at a higher (or lower) private payor 
rate, as compared to other laboratories that reported previously and to 
the extent the volume of services performed by these additional 
applicable laboratories is significant enough to make an impact on the 
weighted median of private payor rates. Given that the largest 
laboratories with the highest test volumes dominate the weighted median 
of private payor rates, and the largest laboratories reported data for 
the determination of CY 2018 CLFS rates and are expected to report 
again, we stated that we do not expect the additional reported data 
resulting from our proposed change to the majority of Medicare revenues 
threshold to have a predictable, direct impact on CLFS rates. By this 
we mean that we cannot predict whether the additional applicable 
laboratories reporting applicable information are paid at a higher (or 
lower) private payor rate, as compared to other laboratories that 
reported previously and whether the private payor rate volume of 
services performed by these additional applicable laboratories is 
significant enough to make an impact on the weighted median of private 
payor rates.
    However, as we noted in the proposed rule, our proposal to exclude 
MA plan payments from total Medicare revenues responded directly to 
stakeholder concerns regarding the number of applicable laboratories 
reporting applicable information for the initial data reporting period. 
We believe that enabling more laboratories of all types that furnish 
testing to a significant Medicare Part C population to qualify as 
applicable laboratories and report data to CMS directly supports our 
goal of collecting as much applicable information as possible from the 
broadest representation of the national laboratory market on which to 
base CLFS payment amounts. Therefore, we believe receiving additional 
applicable information from more laboratories of all laboratory types 
outweighs the additional reporting burden on laboratories.
    Comment: One commenter disagreed with CMS' proposal to define MA 
plan payments as private payor payments and not Medicare revenues for 
the purpose of determining applicable laboratory status. The commenter 
stated that MA plans are Medicare plans that rarely negotiate a rate 
that varies from the Medicare payment rate and that using MA plan 
payments to develop Medicare rates is simply a circular reference. The 
commenter also stated that Medicaid managed care plans should not be 
considered as a private payor because state Medicaid programs may set 
laboratory test rates at a percentage of the Medicare CLFS, for 
example, 80 percent of the Medicare CLFS rate. As such, the commenter 
stated that the use of Medicaid managed care plan data will create a 
``downward spiral'' of CLFS rates.
    Response: Sections 1834A(a)(8)(B) and (C) of the Act define a 
private payor to include a Medicare Advantage plan under Part C, and a 
Medicaid managed care organization (as defined in section 1903(m) of 
the Act), respectively. Therefore, the statute would not permit us to 
exclude a Medicare Advantage plan under Part C or a Medicaid managed 
care organization from the definition of private payor for the purposes 
of determining the applicable information reported to us from which to 
set CLFS rates. We understand the commenter's concern regarding the 
potential circularity of using Medicaid managed care and MA plan data 
to set Medicare CLFS rates to the extent that Medicaid managed care and 
MA plan rates are established based on Medicare rates. However, we note 
that section 1834A(a) of the Act explicitly directs us to use such data 
in setting the CLFS rates. For the suggestion that including Medicaid 
managed care plan data will result in a ``downward spiral,'' we note 
that the statute anticipates that rates will decrease under the new 
private payor rate-based CLFS and provides a phase-in of payment 
reductions. Section 1834A(b)(3) of the Act, implemented at Sec.  
414.507(d), limits the amounts the CLFS rates for each CDLT (that is 
not a new ADLT or new CDLT) can be reduced as compared to the payment 
rates for the preceding year. For the first 3 years after 
implementation (CY 2018 through CY 2020), the reduction cannot be more 
than 10 percent per year, and for the next 3 years (CY 2021 through CY 
2023), the reduction cannot be more than 15 percent per year. We also 
note that the Medicaid managed care plans may or may not be obligated 
to continue to use Medicare rates (or a reduction thereof) as a basis 
for their rates were such a ``downward spiral'' to occur.
    Comment: One commenter urged CMS to conduct a more robust and 
transparent analysis of this proposal to identify the types of 
laboratories to which this policy would apply and the relative impact 
on payment rates. The commenter also requested that CMS release the 
number of clinical laboratories that previously reported applicable 
information, based on market segment and geographic locations. The 
commenter asserted that without such information, it would be premature 
to implement a proposal that will only increase administrative burden 
on hospitals and other organizations which will be forced to re-
determine their applicable laboratory status.
    Response: As discussed previously, our proposal to exclude MA plan 
payments from the total Medicare revenues for purposes of applying the 
majority of Medicare revenues threshold would affect laboratories of 
all types, that is hospital laboratories, large and small independent 
laboratories, and physician office laboratories that furnish services 
to a significant Medicare Part C enrollment population. We also 
explained that since the largest laboratories with the highest test 
volumes dominate the weighted median of private payor rates, and the 
largest laboratories reported data for the determination of CY 2018 
CLFS rates and are expected to report again, we did not expect the 
additional reported data resulting from our proposed change to the 
majority of Medicare revenues threshold to have a predictable, direct 
impact on CLFS rates. As we noted previously, this means that we cannot 
predict whether the additional applicable laboratories reporting 
applicable information are paid at a higher (or lower) private payor 
rate, as compared to other laboratories that reported previously and 
whether the private payor rate volume of services performed by these 
``additional'' applicable laboratories is significant enough to make an 
impact on the weighted median of private payor rates. However, we noted 
that we believe this proposal responded directly to stakeholder 
concerns regarding the number of applicable laboratories reporting 
applicable information for the initial data reporting period (83 FR 
36049). We also noted that in the previous data reporting period we 
received applicable information from 1,942 applicable laboratories from 
every state, the District of Columbia, and

[[Page 59671]]

Puerto Rico, and that additional summary information regarding data 
reporting for the Medicare CLFS from the first data reporting period is 
available on the CLFS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/CY2018-CLFS-Payment-System-Summary-Data.pdf.
    Given that section 1834A(a)(8)(B) of the Act specifically defines 
MA plans under Part C as private payors, and an applicable laboratory 
that receives MA plan payments must consider those MA plan payments in 
identifying its applicable information for reporting, we believe that 
it is more logical to consider MA plan payments only as private payor 
rates for purposes of reporting applicable information, rather than 
both private payor rates and Medicare revenues. We believe this is 
consistent with the statute and will help to increase laboratory 
participation from all types of laboratories. At the same time, we 
recognize the administrative concerns raised by some commenters 
regarding the data reporting requirements for laboratories with a 
significant Medicare Part C revenue component, particularly as some of 
these laboratories may be small physician offices or independent 
laboratories, which we have previously discussed as having a 
significant burden in reporting applicable information. However, as 
discussed previously in response to comments, we believe that modifying 
our definition of applicable laboratory so that we may receive 
applicable information from more laboratories that furnish tests to a 
significant Medicare Part C population, which are less likely to 
qualify for applicable laboratory status under the current policy, 
outweighs the additional reporting burden placed on these laboratories 
as well as directly supports our goal of collecting as much applicable 
information as possible from the broadest representation of the 
national laboratory market on which to base CLFS payment amounts. For 
these reasons we are finalizing our proposal to modify the definition 
of applicable laboratory to exclude MA plan revenues from total 
Medicare revenues (the denominator of the majority of Medicare revenues 
threshold). We are revising paragraph (3) of the definition of 
applicable laboratory at Sec.  414.502 accordingly.
    Comment: In addition to CMS' proposal to exclude MA plan payments 
from total Medicare revenues, one commenter recommended that CMS also 
remove prescription drug payments under Medicare Part D from the 
description of total Medicare revenues in the applicable laboratory 
definition. The commenter stated that including Part D payments is 
illogical because there is no circumstance under which such payments 
would be related to laboratory testing.
    Response: As discussed previously, we are finalizing our proposal 
to modify the definition of applicable laboratory to exclude MA plan 
payments from total Medicare revenues, the denominator of the majority 
of Medicare revenues threshold, so that more types of laboratories may 
qualify as an applicable laboratory. While the agency did not propose 
or solicit comments on the possibility of excluding Medicare Part D 
revenues from total Medicare revenues, we will take the commenter's 
suggestion into consideration for future refinements to the CLFS. 
However, we note that if the commenter is correct that there is no 
circumstance under which such payments would be related to laboratory 
testing, then whether Part D payments are included or excluded from the 
denominator would have no effect on the calculation.
4. Solicitation of Public Comments on Other Approaches To Defining 
Applicable Laboratory
    As discussed in the CY 2019 PFS proposed rule (83 FR 35858), and as 
noted previously, we define applicable laboratory at the NPI level, 
which means the laboratory's own billing NPI is used to identify a 
laboratory's revenues for purposes of determining whether it meets the 
majority of Medicare revenues threshold and the low expenditure 
threshold components of the applicable laboratory definition. For 
background purposes, the following summarizes some of the 
considerations we made in establishing this policy.
    In the CLFS proposed rule, entitled Medicare Clinical Diagnostic 
Laboratory Tests Payment System, published in the October 1, 2015 
Federal Register, we proposed to define applicable laboratory at the 
TIN level so that an applicable laboratory would be an entity that 
reports tax-related information to the IRS under a TIN with which all 
of the NPIs in the entity are associated, and was itself a laboratory 
or had at least one component that was a laboratory, as defined in 
Sec.  493.2. In the CLFS proposed rule, we discussed that we considered 
proposing to define applicable laboratory at the NPI level. However, we 
did not propose that approach because we believed private payor rates 
for CDLTs are negotiated at the TIN level and not by individual 
laboratory locations at the NPI level. Numerous stakeholders had 
indicated that the TIN-level entity is the entity negotiating pricing, 
and therefore, is the entity in the best position to compile and report 
applicable information across its multiple NPIs when there are multiple 
NPIs associated with a TIN-level entity. We stated that we believed 
defining applicable laboratory by TIN rather than NPI would result in 
the same applicable information being reported, and would require 
reporting by fewer entities, and therefore, would be less burdensome to 
applicable laboratories. In addition, we stated that we did not believe 
reporting at the TIN level would affect or diminish the quality of the 
applicable information reported. To the extent the information is 
accurately reported, we expected reporting at a higher organizational 
level to produce exactly the same applicable information as reporting 
at a lower level (80 FR 59391 through 59393).
    Commenters who objected to our proposal to define applicable 
laboratory at the TIN level stated that our definition would exclude 
hospital laboratories because, in calculating the applicable 
laboratory's majority of Medicare revenues amount, which looks at the 
percentage of Medicare revenues from the PFS and CLFS across the entire 
TIN-level entity, virtually all hospital laboratories would not be 
considered an applicable laboratory. Many commenters expressed 
particular concern that our proposed definition would exclude hospital 
outreach laboratories, stating that hospital outreach laboratories, 
which do not provide laboratory services to hospital patients, are 
direct competitors of the broader independent laboratory market, and 
therefore, excluding them from the definition of applicable laboratory 
would result in incomplete and inappropriate applicable information, 
which would skew CLFS payment rates. Commenters maintained that CMS 
needed to ensure reporting by a broad scope of the laboratory market to 
meet what they viewed as the intent of the statute that all sectors of 
the laboratory market be included to establish accurate market-based 
rates (81 FR 41045).
    In issuing the CLFS final rule, we found particularly compelling 
the comments that urged us to adopt a policy that would better enable 
hospital outreach laboratories to be applicable laboratories because we 
agreed hospital outreach laboratories should be included in determining 
the new CLFS payment rates. We believed it was important to facilitate 
reporting of private payor rates for hospital outreach laboratories to 
ensure a broader representation of the national laboratory

[[Page 59672]]

market to use in setting CLFS payment amounts (81 FR 41045).
    We also stated in the CLFS final rule that we believed the intent 
of the statute was to effectively exclude hospital laboratories as 
applicable laboratories, based on the statutory language, in 
particular, regarding the majority of Medicare revenues threshold 
criterion in section 1834A(a)(2) of the Act. Section 1834A(a)(2) of the 
Act provides that, to qualify as an applicable laboratory, an entity's 
revenues from the CLFS and the PFS need to constitute a majority of its 
total Medicare payments received from the Medicare program for a data 
collection period. What we found significant was that most hospital 
laboratories would not meet that majority of Medicare revenues 
threshold because their revenues under the Inpatient Prospective 
Payment System (IPPS) and Outpatient Prospective Payment System (OPPS) 
alone would likely far exceed the revenues they received under the CLFS 
and PFS. Therefore, we stated that we believe the statute intended to 
limit reporting primarily to independent laboratories and physician 
offices (81 FR 41045 through 41047). For a full discussion of the 
definition of applicable laboratory, see the CLFS final rule (81 FR 
41041 through 41051).
a. Stakeholder Continuing Comments and Stakeholder-Suggested 
Alternative Approaches
    As noted above, in response to public comments, we had previously 
finalized that an applicable laboratory is the NPI-level entity so that 
a hospital outreach laboratory assigned a unique NPI, separate from the 
hospital of which it is a part, is able to meet the definition of 
applicable laboratory and its applicable information can be used for 
CLFS rate-setting. We stated in the CY 2019 PFS proposed rule that we 
continue to believe that the NPI is the most effective mechanism for 
identifying Medicare revenues for purposes of determining applicable 
laboratory status and identifying private payor rates for purposes of 
reporting applicable information. Once a hospital outreach laboratory 
obtains its own unique billing NPI and bills for services using its own 
unique NPI, Medicare and private payor revenues are directly 
attributable to the hospital outreach laboratory. By defining 
applicable laboratory using the NPI, Medicare payments (for purposes of 
determining applicable laboratory status) and private payor rates and 
the associated volume of CDLTs can be more easily identified and 
reported to us. We also noted that we believe that finalizing our 
proposal to exclude MA plan payments under Medicare Part C from total 
Medicare revenues in the definition of applicable laboratory may 
increase the number of entities meeting the majority of Medicare 
revenues threshold, and therefore, allow them to qualify for applicable 
laboratory status. We stated that we believe that finalizing the change 
to the total Medicare revenues component of the applicable laboratory 
definition and our current policy that requires an entity to bill 
Medicare Part B under its own NPI, may increase the number of hospital 
outreach laboratories qualifying as applicable laboratories.
    In addition, we noted that we are confident that our current policy 
supports our collecting sufficient applicable information in the next 
data reporting period, and that we received sufficient and reliable 
applicable information with which we set CY 2018 CLFS rates, and that 
those rates are accurate. We noted that we received applicable 
information from laboratories in every state, the District of Columbia, 
and Puerto Rico. This data included private payor rates for almost 248 
million laboratory tests conducted by 1,942 applicable laboratories, 
with over 4 million records of applicable information. As we have 
noted, the largest laboratories dominate the market, and therefore, 
most significantly affect the payment weights (81 FR 41049). We stated 
that given that the largest laboratories reported their applicable 
information to CMS in the initial data reporting period, along with 
many smaller laboratories, we believe the data we used to calculate the 
CY 2018 CLFS rates was sufficient and resulted in accurate weighted 
medians of private payor rates.
    However, we noted that we continue to consider refinements to our 
policies that could lead to including even more applicable information 
for the next data reporting period. Therefore, the comments and 
alternative approaches suggested by commenters, even though some were 
first raised prior to the CLFS final rule, were presented and offered 
for comment as part of the proposed rule.
(1) Using Form CMS-1450 UB 04 (and Electronic Equivalent, 837I) 14X 
Type of Bill (TOB) To Determine Majority of Medicare Revenues and Low 
Expenditure Thresholds
    Although an NPI-based definition of applicable laboratories 
includes more hospital outreach laboratories than a TIN-based 
definition, some commenters expressed concern that the NPI-based 
definition of applicable laboratory may not be sufficient to capture 
all of the hospital outreach laboratories. These commenters suggested 
we revise the definition specifically for the purpose of including more 
hospital outreach laboratories. Under a suggested approach, a 
laboratory could determine whether it meets the majority of Medicare 
revenues threshold and low expenditure threshold using only the 
revenues from services reported on the Form CMS-1450 (approved Office 
of Management and Budget number 0938-0997) 14x Type of Bill (TOB), 
which is used only by hospital outreach laboratories. The CMS-1450 14X 
TOB is the uniform bill (also known as the UB-04) for institutional 
providers that was approved by the National Uniform Billing Committee 
(NUBC) \8\ at its February 2005 meeting.
---------------------------------------------------------------------------

    \8\ Copyright (copyright) 2012 the American Hospital 
Association, Chicago, Illinois. Reproduced with permission. No 
portion of this publication may be copied without the express 
written consent of the AHA.
---------------------------------------------------------------------------

    The data elements referenced in the UB-04 manual are also used in 
the electronic claim standard as required by the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191, 
enacted August 21, 1996) as per of sections 1171 and 1172 of the Act. 
Consequently, there was additional emphasis placed on aligning the 
reporting instructions to closely mirror the HIPAA claim standard for 
institutional providers for both paper and electronic claims. The TOB 
is a required element on both the UB 04 and electronic equivalent of 
the 837I transaction of the HIPAA compliant 005010 standard 
transaction. The NUBC defines the 14X TOB as an outpatient hospital 
TOB, and it is used by hospitals to bill a payor for outreach 
laboratory services for non-patients. As discussed in Transmittal 3425, 
a non-patient is defined as a beneficiary who is neither an inpatient 
nor an outpatient of a hospital, but who has a specimen that is 
submitted for analysis to a hospital and the beneficiary is not 
physically present at the hospital for purposes of the laboratory 
service. All hospitals (including Critical Access Hospitals) bill non-
patient laboratory tests on a TOB 14X. They are paid under the CLFS, 
and the Part B deductible and coinsurance do not apply. We believe that 
laboratory services billed on the CMS 1450 14X encompass all of the 
laboratory testing services.
    To address this stakeholder's concern of including hospital 
outreach laboratories, we solicited public comments in the CY 2019 PFS 
on revising the definition of applicable laboratory to permit the 
revenues identified on the Form CMS-1450 14x

[[Page 59673]]

TOB to be used instead of the revenues associated with the NPI that the 
laboratory uses in order to determine whether it meets the majority of 
Medicare revenues threshold (and the low expenditure threshold). Under 
this approach, the applicable revenues would be based on the bills used 
for hospital laboratory services provided to non-patients, which are 
paid under Medicare Part B (that is, the 14x TOB). If we pursued this 
approach, we explained that we would have to modify the definition of 
applicable laboratory in Sec.  414.502 by indicating that an applicable 
laboratory may include an entity that bills Medicare Part B on the Form 
CMS-1450 14x TOB.
    Although using the 14x TOB could alleviate some initial, albeit 
limited, administrative burden on hospital outreach laboratories to 
obtain a unique billing NPI, we explained that we would have 
operational and statutory authority concerns about defining applicable 
laboratory by the Form CMS-1450 14x TOB, as indicated below.
    First, we explained that defining an applicable laboratory using 
the Form CMS-1450 14x TOB does not identify an entity the same way an 
NPI does. Whereas an NPI is associated with a provider or supplier to 
determine specific Medicare revenues, the 14x TOB is merely a billing 
mechanism that is currently used only for a limited set of services. 
Under an approach that permits laboratories to meet the majority of 
Medicare revenues threshold using the 14x TOB, private payor rates (and 
the volume of tests paid at those rates) would have to be identified 
that are associated with only the outreach laboratory services of a 
hospital's laboratory business. However, some private payors, such as 
MA plans, may not require hospital outreach laboratories to use the 14x 
TOB for their outreach laboratory services. To the extent a private 
payor does not require hospital outreach laboratory services to be 
billed on a 14x TOB (which specifically identifies outreach services), 
hospitals may need to develop their own mechanism for identifying and 
reporting only the applicable information associated with its hospital 
outreach laboratory services. In light of this possible scenario, we 
requested public comments about the utility of using the 14x TOB in the 
way we have described and on the level of administrative burden created 
if we defined applicable laboratory using the Form CMS-1450 14x TOB.
    Second, we questioned whether hospitals would have sufficient time 
after publication of a new final rule that included using the Form CMS-
1450 14x TOB, and any related subregulatory guidance, to develop and 
implement the information systems necessary to collect private payor 
rate data before the start of the next data collection period, that is, 
January 1, 2019. Therefore, we solicited public comments as to whether 
revising the definition of applicable laboratory to use the Form CMS-
1450 14x TOB would allow laboratories sufficient time to make the 
necessary systems changes to identify applicable information before the 
start of the next data collection period.
    Third, we noted that we believe defining applicable laboratory at 
the NPI level, as we currently do, provides flexibility for hospital 
outreach laboratories to not obtain a unique billing NPI, which may be 
burdensome, particularly where a hospital outreach laboratory performs 
relatively few outreach services under Medicare Part B. For example, 
under the current definition of applicable laboratory, if a hospital 
outreach laboratory's CLFS revenues in a data collection period are 
typically less than the low expenditure threshold, the hospital of 
which it is a part could choose not to obtain a separate NPI for its 
outreach laboratory and could thus avoid determining applicable 
laboratory status for its outreach laboratory component. In contrast, 
if laboratories were permitted to use the Form CMS-1450 14x TOB, 
revenues attributed to the hospital outreach laboratory would have to 
be calculated in every instance where those services exceeded the low 
expenditure threshold. This would be true even for a hospital outreach 
laboratory that performs relatively few outreach services under 
Medicare Part B. Therefore, we also solicited comments concerning this 
aspect of using the 14x TOB definition.
    Fourth, and significantly, we stated that we believe that if we 
were to utilize such an approach in defining applicable laboratory, all 
hospital outreach laboratories would meet the majority of Medicare 
revenues threshold. We noted, at that time, we believed this approach 
would be inconsistent with the statute. By virtue of the majority of 
Medicare revenues threshold, the statute defines applicable laboratory 
in such a way that not all laboratories qualify as applicable 
laboratories. However, if we were to use the CMS-1450 14x TOB to define 
an applicable laboratory, all hospital outreach laboratories that use 
the 14x TOB would meet the majority of Medicare revenues threshold. 
Accordingly, we requested public comments regarding whether this 
definition would indeed be inconsistent with the statute, as well as 
comments that could identify circumstances under this definition 
whereby a hospital outreach laboratory would not meet the majority of 
Medicare revenues threshold.
    The following is a summary of the comments we received and our 
responses to the comments regarding the use of the CMS-1450 14x TOB to 
define an applicable laboratory.
    Comment: We received conflicting comments on this potential 
refinement to the definition of an applicable laboratory. Some 
commenters supported using the CMS-1450 14x TOB as a mechanism to 
define an applicable laboratory, and others were opposed to this 
approach. The commenters who supported this believe that it provides an 
opportunity for hospital outreach laboratories that have not obtained 
an NPI separate from the hospital to qualify as an applicable 
laboratory and report applicable information. These commenters opined 
that since the 14X TOB is used only to submit claims by hospital 
outreach laboratories for non-patient claims, this approach would 
include hospital laboratories without their own NPI who compete in the 
marketplace with independent clinical laboratories. These commenters 
also noted that, in their view, this approach would effectuate 
Congress' intent to determine whether a majority of Medicare revenues 
attributable to the laboratory part of the hospital--as opposed to the 
entire hospital--was from the CLFS and/or PFS.
    Another commenter stated their view that considerable burden is 
associated with requiring a hospital outreach laboratory to obtain its 
own NPI. According to this commenter, a hospital would need to re-
credential under a new NPI with each of their payors in order to submit 
claims and receive payment from each of their payors for their hospital 
outreach laboratory services. This commenter stated that this process 
could take more than a year to complete. Accordingly, this commenter 
concluded that hospital outreach laboratories rarely obtain their own 
unique NPI (separate from the hospital) and it would not be practical 
to do so for the single purpose of reporting applicable information to 
CMS.
    Additional commenters in support of refinements to the definition 
responded to CMS' concern that revenues attributed to the hospital 
outreach laboratory would have to be calculated in every instance where 
those services exceeded the low expenditure threshold, even for a 
hospital outreach laboratory that performs relatively few outreach 
services under Medicare Part

[[Page 59674]]

B. In response to this concern, commenters noted that this refinement 
to the definition would require hospital outreach laboratories to have 
the same obligations as other laboratories that exceed the low 
expenditure threshold and that serve non-hospital patients. 
Furthermore, commenters suggested that if CMS is concerned that 
refinements to the definition would result in all hospital outreach 
laboratories meeting the majority of Medicare revenues threshold, that 
is the case for almost all independent laboratories, as well, where 
hospital outreach laboratories compete with independent laboratories in 
the marketplace. Furthermore, they stated it is reasonable that a 
laboratory whose revenues are derived primarily from the CLFS and/or 
PFS and that meets the low expenditure threshold be included in data 
reporting, regardless if it is a hospital outreach laboratory.
    In contrast, several commenters strongly opposed the use of Form 
CMS-1450 14x TOB to define an applicable laboratory because of their 
views of the additional administrative burden for hospitals relative to 
the effect on CLFS rates. These commenters stated that even if every 
hospital outreach laboratory were to report private payor data, it is 
unlikely that it would result in a significant change to the weighted 
median of private payor rates due to the massive amount of data that 
would be reported by the large independent laboratories. They also 
agreed with the potential operational feasibility concerns we raised in 
the proposed rule.
    Response: We appreciate the comments raised about the 
administrative aspects of obtaining an NPI for a hospital outreach 
laboratory for the sole purpose of reporting data to CMS and the 
associated administrative burden. We agree that one advantage of using 
the Form CMS-1450 14x TOB to define an applicable laboratory is that it 
provides an opportunity for more hospital outreach laboratories to 
report data for calculating CLFS rates. However, we also recognize that 
this will result in additional administrative burden on the hospital 
industry, such as changes to collect and report applicable information. 
We discuss specific operational concerns in more detail in the sections 
below. However, we generally believe that this advantage outweighs the 
potential burden for hospital outreach laboratories, the data collected 
from hospital outreach laboratories will create a dataset that is a 
more robust representation of the laboratory testing market, and that 
this outweighs the potential burden to hospital outreach laboratories. 
Accordingly, we are finalizing the use of the Form CMS-1450 14x TOB to 
define applicable laboratories for the next data collection period 
(January 1, 2019, through June 30, 2019) and the next data reporting 
period (January 1, 2020, and ends March 31, 2020), subject to other 
regulatory and subregulatory requirements, such as the regulatory low 
expenditure threshold.
    We also considered the comments regarding the limited impact of 
this additional data to the weighted median of private payor rates. We 
believe that we will only know the impact of the data on CLFS rates by 
collecting data from hospital outreach laboratories. We believe 
inclusion of this information so that the CLFS rates better reflect the 
market outweighs the potential added burden on one segment of the 
market. However, if it becomes apparent that data from hospital 
outreach laboratories do not result in a significant change in the 
weighted median of private payor rates, we will revisit the use of the 
CMS-1450 14x TOB through future rulemaking.
    Comment: A few commenters stated that CMS should not be concerned 
that hospitals will need to develop additional mechanisms to identify 
applicable information if private payors do not require hospital 
outreach laboratories to use the CMS-1450 14x TOB. They noted that this 
point is not relevant to reporting private payor rates because once 
applicable laboratory status is determined, the hospital outreach 
laboratory ``can simply report its private payor data for all of its 
fee for service work that is not part of a capitated plan.'' The 
commenters stated that the reporting entities for all other laboratory 
types would have the same burden as hospital outreach laboratories, 
that is, of identifying and reporting accurate applicable information.
    In contrast, several stakeholders raised concerns about the 
implications this alternative approach would have on identifying 
applicable information for purposes of reporting that data to us. They 
stated that the Form CMS-1450 14x TOB will only capture Medicare Part B 
revenues, while private payor data would not be captured. In other 
words, the 14x TOB will correctly identify Medicare Part B revenues for 
purposes of determining applicable laboratory status, but that the 
hospital would be responsible for correctly identifying and collecting 
applicable information associated solely with the hospital outreach 
laboratory. Several commenters stated that billing systems for hospital 
outreach laboratories are not set up in a manner that allows this type 
of information to be easily extracted, and therefore, this approach to 
defining an applicable laboratory would pose a significant operational 
burden on hospitals.
    Response: We note that hospital outreach laboratories who meet the 
definition of an applicable laboratory would have the same burden of 
identifying and reporting accurate applicable information as all other 
laboratory types that meet the definition of an applicable laboratory.
    Comment: Some commenters stated that they believe hospitals would 
have sufficient time to develop and implement the information systems 
necessary to collect private payor rate data before the start of the 
next data collection period, and noted that even though the CLFS final 
rule was published less than 2 weeks prior to the end of the first data 
collection period, applicable laboratories were able to develop and 
implement the information systems necessary to collect private payor 
rate data and report it to CMS. However, several commenters expressed 
serious concerns about developing the systems to collect applicable 
information before the next data reporting period. They indicated that 
finalizing this alternative approach for defining an applicable 
laboratory would not allow hospital outreach laboratories sufficient 
time to make the necessary systems changes prior to the start of the 
next data collection, and as a result, there would be a risk that 
inaccurate data would be reported.
    Response: As discussed previously in this section, the next data 
collection period is January 1, 2019, through June 30, 2019. A 6-month 
window follows the data collection period from July 1, 2019, through 
December 31, 2019 and the next data reporting period begins January 1, 
2020, and ends March 31, 2020. While several commenters raised concerns 
about the operational changes needed for reporting before the next data 
collection period, we believe that, similar to the retroactive data 
collection that occurred under the initial private payor rate-based 
CLFS, hospitals, including the part of the hospital represented by 
their hospital outreach laboratories, could develop these operational 
changes in time. For example, hospitals, including the part of the 
hospital represented by their hospital outreach laboratories, could use 
the time before and during the next data collection period to develop 
processes to collect applicable information, the 6-month window between 
the collection and reporting periods to determine applicable laboratory 
status and retroactively collect applicable

[[Page 59675]]

information to report it before the close of the next data reporting 
period (March 31, 2020).
    Comment: Many commenters noted the concern that hospital outreach 
laboratories would lose the flexibility to not obtain an NPI for low 
volume hospital outreach laboratories. For instance, they stated all 
hospitals would be required to go through the exercise of determining 
applicable laboratory status for their hospital outreach laboratory 
components. However, a few commenters indicated that hospital outreach 
laboratories would have the same obligations as every other laboratory 
to determine whether it is an applicable laboratory. Therefore, in 
their view, the loss of flexibility for hospital outreach laboratories 
to not obtain an NPI should not be a concern.
    Response: We agree that the use of Form CMS-1450 14x TOB to define 
an applicable laboratory will require hospitals to assess applicable 
laboratory status for all outreach laboratory components, similar to 
the obligations of other laboratory types. For instance, all 
independent and physician office laboratories billing Medicare Part B 
under their own NPI must assess whether they qualify as an applicable 
laboratory, and if so, report applicable information to us. 
Consequently, independent and physician office laboratories do not have 
the flexibility of not reporting private payor data that is currently 
afforded to hospital outpatient laboratories. Use of the 14x TOB to 
define an applicable laboratory would equalize the obligations across 
laboratories, regardless of their affiliation with a hospital, to 
determine whether they qualify for applicable laboratory status. We 
note that, insofar as commenters expressed concern about low volume 
hospital outreach laboratories, our policy regarding laboratories 
receiving less than a minimum in CLFS revenues remains unchanged. 
Specifically, hospital outreach laboratories that do not receive at 
least $12,500 in CLFS revenues on the 14X TOB during a data collection 
period would be exempt from the reporting requirements.
    Comment: Several commenters noted that by using the 14x TOB to 
define an applicable laboratory, all hospital outreach laboratories 
would meet the majority of Medicare revenues threshold. They, 
therefore, raised concerns about the legality of this approach. For 
instance, some commenters stated their view that Congress did not 
intend for all hospital outreach laboratories to qualify as applicable 
laboratories. In contrast, some commenters stated their view that 
Congress clearly intended for the CLFS to reflect a market-based system 
that includes hospital outreach laboratories and that it is reasonable 
for a laboratory with revenues derived primarily from the CLFS and/or 
PFS that also meets the low expenditure threshold to be an applicable 
laboratory, regardless of whether it is a hospital outreach laboratory 
or not.
    Response: After further review of this issue, we believe that using 
Form CMS-1450 14x TOB provides a means of distinguishing services 
furnished by a hospital outreach laboratory from other services 
furnished and billed by a hospital using the same NPI. The statute 
specifically directs us to identify applicable ``laboratories'' and not 
``providers'' or ``suppliers.'' We believe that hospital outreach 
laboratories without unique NPIs furnish clinical laboratory tests paid 
under the CLFS and PFS, albeit to Medicare beneficiaries who are not 
hospital patients. Accordingly, we believe such laboratories, should 
not be exempt from reporting the applicable data merely due to their 
shared use of a billing entity with a hospital.
    Using the laboratory's own billing NPI as the basis for defining 
applicable laboratory, as we currently do, results in all independent 
laboratories meeting the statutory ``majority of Medicare revenues'' 
requirement because most, if not all, of an independent laboratory's 
Medicare revenues are received from the PFS and or CLFS. Similar to how 
the use of the NPI results in all independent laboratories meeting the 
majority of Medicare revenues threshold, using the Form CMS-1450 14x 
TOB as the basis for defining applicable laboratory would identify all 
hospital outreach laboratories that meet the statutorily required 
``majority of Medicare revenues'' component of applicable laboratory.
    We believe that the use of Form CMS-1450 14x TOB as a mechanism for 
applying the majority of Medicare revenues threshold identifies 
hospital outreach laboratories that meet this threshold, consistent 
with the statutory requirement for applicable laboratory status. We 
further believe that, absent having an NPI separate from the hospital, 
these hospital outreach laboratories otherwise would be excluded. We do 
not believe that the statute excludes laboratories that meet the 
majority of Medicare revenues threshold from potentially qualifying as 
an applicable laboratory. Therefore, using the 14x TOB to define 
applicable laboratory is consistent with the statute.
    As stated above, accordingly, we are finalizing the use of the Form 
CMS-1450 14x TOB to define applicable laboratories, subject to other 
regulatory and subregulatory requirements, such as the regulatory low 
expenditure threshold.
    Comment: Two commenters stated that it is unclear whether the 
burden associated with considering every hospital outreach laboratory 
to meet the majority of Medicare revenues threshold and an applicable 
laboratory (if the low expenditure threshold is also met) would 
outweigh the additional applicable information that would be reported. 
Therefore, they requested that we continue evaluating this approach 
before implementing any changes.
    Response: As we stated previously, we generally believe that the 
advantage of including private payor data from hospital outreach 
laboratories in setting CLFS rates outweighs the potential burden for 
hospital outreach laboratories; data collected from hospital outreach 
laboratories will create a dataset that is a more robust representation 
of the laboratory testing market. We also note that the timing of the 
data collection and reporting periods, and the 6 month window in 
between provide time for laboratories to implement needed operational 
changes.
    Comment: One commenter suggested that an alternative approach to 
identifying applicable laboratories would be for the hospital to 
develop an ``adjustment factor'' based on its payment-to-charges ratio 
to estimate laboratory revenues received from the IPPS and OPPS. The 
same commenter suggested that we remove the requirement that an 
applicable laboratory is an entity that bills Medicare Part B under its 
own NPI and that we amend the majority of Medicare revenues threshold 
so that ``Medicare revenues'' means payment for claims submitted on a 
CMS 1500, a CMS 1450 using a 14x TOB, or their electronic equivalents.
    Response: We appreciate this suggested approach and we may consider 
it in future rulemaking.
    In conclusion, as stated previously and for the reasons described 
previously, we are finalizing the use of the Form CMS-1450 14x TOB to 
define applicable laboratories, subject to other regulatory and 
subregulatory requirements, such as the regulatory low expenditure 
threshold.
    We note that because of the low expenditure threshold, not all 
hospital outreach laboratories would meet the definition of an 
applicable laboratory and therefore not all hospital outreach 
laboratories would be required to report applicable information to us. 
In other words, hospital outreach laboratories

[[Page 59676]]

that do not receive at least $12,500 in CLFS revenues on the 14X TOB 
during a data collection period would be exempt from the reporting 
requirements.
    We believe that defining applicable laboratory by the NPI may be 
preferable to using the CMS-1450 14x TOB for some hospitals and so 
expect that some hospital outreach laboratories may still want to 
obtain their own billing NPI separate from the hospital. As such, they 
may do so and may qualify as an applicable laboratory in this manner. 
If so, they would report applicable information during the next data 
reporting period beginning January 1, 2020, through March 31, 2020.
    We note that we utilize ongoing subregulatory guidance and provider 
education materials to provide more details regarding how applicable 
laboratories, both those identified through NPIs and hospital outreach 
laboratories identified through the combination of NPI and services 
reported using the 14x TOBs, are to report the applicable data to CMS. 
We also note that for hospitals which have an applicable laboratory, 
whether via its own NPI for its outreach laboratory or by identifying 
its status with the 14X TOB, the applicable laboratory would be 
required to report applicable information by March 31, 2020, for 
services reimbursed for the period between January 1, 2019, and June 
30, 2019.
    In conclusion, as stated previously, we are finalizing the use of 
the Form CMS-1450 14x TOB to define applicable laboratories. In other 
words, we are finalizing modification of the definition of applicable 
laboratory to also include 14X TOB revenues. We will also revise 
paragraph (2) of the definition of applicable laboratory at Sec.  
414.502 accordingly.
(2) Using CLIA Certificate To Define Applicable Laboratories
    Some commenters requested that we use the CLIA certificate rather 
than the NPI to identify a laboratory that would be considered an 
applicable laboratory. We discussed in the CLFS proposed rule (80 FR 
59392) why not all entities that meet the CLIA regulatory definition at 
Sec.  493.2 would be applicable laboratories, and therefore, we did not 
propose to use the CLIA certificate as the mechanism for defining 
applicable laboratory. However, some commenters to the CLFS proposed 
rule suggested we use the CLIA certificate to identify the 
organizational entity that would be considered an applicable laboratory 
so that each entity that had a CLIA certificate would be an applicable 
laboratory (81 FR 41045). We considered those comments in the CLFS 
final rule and discussed why we chose not to adopt that approach.
    Among other reasons, we explained in the CLFS final rule that we 
believed a CLIA certificate-based definition of applicable laboratory 
would be overly inclusive by including all hospital laboratories, as 
opposed to just hospital outreach laboratories. In addition, the CLIA 
certificate is used to certify that a laboratory meets applicable 
health and safety regulations in order to furnish laboratory services. 
Unlike, for example, the NPI, with which revenues for specific services 
can easily be identified, the CLIA certificate is not associated with 
Medicare billing and cannot be used to identify revenues for specific 
services. We also indicated that we did not know how a hospital would 
determine whether its laboratories would meet the majority of Medicare 
revenues threshold (and the low expenditure threshold) using the CLIA 
certificate as the basis for defining an applicable laboratory. In 
addition, we stated that, given the difficulties many hospitals would 
likely have in determining whether their laboratories are applicable 
laboratories, we also believed hospitals may object to using the CLIA 
certificate (81 FR 41045).
    However, in light of stakeholders' suggestions to use the CLIA 
certificate to include hospital outreach laboratories in the definition 
of applicable laboratories, we solicited public comments on that 
approach. Under such an approach, the majority of Medicare revenues 
threshold and low expenditure threshold components of the definition of 
applicable laboratory would be determined at the CLIA certificate level 
instead of the NPI level. We explained that if we pursued such an 
approach, we would have to modify the definition of applicable 
laboratory in Sec.  414.502 to indicate that an applicable laboratory 
is one that holds a CLIA certificate under Sec.  493.2 of the chapter. 
We noted in the CY 2019 PFS proposed rule that we would have concerns, 
however, about defining applicable laboratory by the CLIA certificate.
    First, we explained that as we discussed in the CLFS final rule, 
given that information regarding the CLIA certificate is not required 
on the Form CMS-1450 14x TOB, which is the billing form used by 
hospitals for their laboratory outreach services, it is not clear how a 
hospital would identify and distinguish revenues generated by its 
separately CLIA-certified laboratories for their outreach services. 
Therefore, we solicited public comments regarding the mechanisms a 
hospital would need to develop to identify revenues if we used the CLIA 
certificate for purposes of determining applicable laboratory status, 
as well as comments about the administrative burden associated with 
developing such mechanisms.
    In addition, we understood there could be a scenario where one CLIA 
certificate is assigned to a hospital's entire laboratory business, 
which would include laboratory tests performed for hospital patients as 
well as non-patients (that is, patients who are not admitted inpatients 
or registered outpatients of the hospital). For example, hospital 
laboratories with an outreach laboratory component would be assigned a 
single CLIA certificate if the hospital outreach laboratory has the 
same mailing address or location as the hospital laboratory. We noted 
that in this scenario, the majority of Medicare revenues threshold 
would be applied to the entire hospital laboratory, not just its 
outreach laboratory component. If a single CLIA certificate is assigned 
to the hospital's entire laboratory business, the hospital laboratory 
would be unlikely to meet the majority of Medicare revenues threshold 
because its laboratory revenues under the IPPS and OPPS alone would 
likely far exceed the revenues it receives under the CLFS and PFS. As a 
result, a hospital outreach laboratory that could otherwise meet the 
definition of applicable laboratory, as currently defined at the NPI 
level, would not be an applicable laboratory if we were to require the 
CLIA certificate to define applicable laboratory. Given that this 
approach could have the effect of decreasing as opposed to increasing 
the number of applicable laboratories, we requested public comments on 
this potential drawback of defining applicable laboratory at the CLIA 
certificate level. We stated in the comment solicitation that feedback 
on this topic could help inform us regarding potential refinements to 
the definition of applicable laboratory, and that depending on the 
comments we receive, it is possible we would consider approaches 
described in that section. The following is a summary of the comments 
we received and our responses to the comments regarding the use of the 
CLIA certificate to define an applicable laboratory.
    Comment: Many commenters did not support using the CLIA certificate 
to define applicable laboratory because of the administrative 
complexity associated with this approach. Commenters stated that the 
CLIA certificate has no relationship to actual laboratory revenues, 
like the NPI does, and therefore, laboratories would need to develop 
their own mechanisms to attribute Medicare revenues to the CLIA

[[Page 59677]]

certificate. Commenters stated that any ``workaround'' to resolve these 
issues would be extremely burdensome to develop and implement. These 
same commenters also noted that when one CLIA certificate is assigned 
to a hospital's entire laboratory business, which would include 
laboratory tests performed for hospital patients as well as non-
patients, the total Medicare revenues component of the majority of 
Medicare revenues threshold equation would be ``overly inclusive.'' 
Therefore, they agreed with CMS' concern that hospital outreach 
laboratories would be unlikely to meet the majority of Medicare 
revenues threshold under those circumstances because revenues from the 
IPPS and OPPS alone would likely far exceed the revenues those 
laboratories receive under the CLFS and PFS. For these reasons, they 
encouraged CMS to reject the use of the CLIA certificate for defining 
an applicable laboratory.
    Response: We agree that defining applicable laboratory by the CLIA 
certificate would result in substantial administrative burden for the 
laboratory industry. From an administrative perspective, we believe the 
using the CLIA certificate unworkable for the purpose of determining 
applicable laboratory status because the CLIA certificate is not 
required on the CMS 1450 14x TOB which is the billing form used by 
hospital outreach laboratories. Therefore, no revenues can be readily 
identified by the CLIA certificate. Even if the hospital developed its 
own mechanism to identify revenues by the CLIA certificate, the CLIA 
certificate could be assigned to the hospital's entire laboratory 
business, which includes laboratory tests performed for hospital 
patients, as well as non-patients. For example, we understand hospital-
based laboratories with an outreach component would be assigned a 
single CLIA certificate if the hospital outreach laboratory has the 
same mailing address or location as the main laboratory. In this 
scenario, the applicable laboratory criteria would be applied to the 
CLIA certificate of the entire hospital laboratory not just its 
outreach laboratory component. When a single CLIA certificate is 
assigned to the hospital's entire laboratory business, we believe it 
would result in the hospital laboratory not meeting the majority of 
Medicare revenues threshold because its laboratory revenues under the 
IPPS and OPPS alone will far exceed the revenues it receives under the 
CLFS and PFS. We also understand that a hospital could have multiple 
outreach laboratories each with its own CLIA certificate. Therefore, we 
believe those hospitals would also have difficulties separating 
Medicare revenues and applicable information among their various CLIA 
certificates as described below.
    Comment: One commenter stated that it is unlikely that a single 
CLIA certificate would be assigned to both its outreach laboratory 
(non-patients) and its laboratory that that provides testing for its 
hospital inpatients and hospital outpatients. The commenter stated that 
it would be more likely that the outreach laboratory would be at a 
different location than the hospital and therefore, be assigned its own 
CLIA certificate even though the outreach laboratory is enrolled in the 
Medicare program under the hospital's NPI. As such, the commenter 
stated that an outreach laboratory operates as a distinct laboratory 
entity by virtue of having its own CLIA certificate and billing on the 
Form CMS-1450 14x TOB. The commenter suggested that the 14x TOB could 
be used in combination with each individual CLIA certificate to define 
applicable laboratory.
    Response: We understand that the assignment of CLIA certificates 
for hospital outreach laboratories could vary depending on the location 
of the outreach laboratory. As discussed previously, Medicare revenues 
are not attributed to the CLIA certificate and information regarding 
the CLIA certificate is not required on the Form CMS-1450 14x TOB. As 
such, we believe the commenter's suggestion would result in defining 
applicable laboratory by the Form CMS-1450 14x TOB. We note that in 
cases in which a hospital owns and operates multiple outreach 
laboratories at different locations, we believe the administrative 
burden of attributing Medicare revenues to the CLIA certificate would 
be even more substantial as there could be several CLIA certificates 
assigned under the same NPI. In such cases, the hospital would need to 
attribute laboratory revenues among multiple CLIA certificates under 
the same billing entity. In other words, if the 14x TOB is used by a 
hospital to bill for laboratory tests furnished by more than one CLIA 
certificate under the same NPI, the hospital would need to devise a 
mechanism to attribute Medicare revenues to each individual CLIA 
certificate.
5. Solicitation of Public Comments on the Low Expenditure Threshold in 
the Definition of Applicable Laboratory
a. Decreasing the Low Expenditure Threshold
    In the CLFS final rule, we established a low expenditure threshold 
component in the definition of applicable laboratory at Sec.  414.502, 
which is reflected in paragraph (4). To be an applicable laboratory, at 
least $12,500 of an entity's Medicare revenues in a data collection 
period must be CLFS revenues (with the exception that there is no low 
expenditure threshold for an entity with respect to the ADLTs it 
furnishes). We established $12,500 as the low expenditure threshold 
because we believed it achieved a balance between collecting sufficient 
data to calculate a weighted median that appropriately reflects the 
private market rate for a test, and minimizing the reporting burden for 
laboratories that receive a relatively small amount of revenues under 
the CLFS. We indicated in the CLFS final rule (81 FR 41049) that once 
we obtained applicable information under the new payment system, we may 
decide to reevaluate the low expenditure threshold in future years and 
propose a different threshold amount through notice and comment 
rulemaking.
    We explained in the CY 2019 PFS proposed rule that we recently 
heard from some laboratory stakeholders that the low expenditure 
threshold excludes most physician office laboratories and many small 
independent laboratories from reporting applicable information, and 
that by excluding so many laboratories, the payment rates under the new 
private payor rate-based CLFS reflect incomplete data, and therefore, 
inaccurate CLFS pricing.
    As noted previously, we discussed in the CLFS final rule that we 
believed a $12,500 low expenditure threshold would reduce the reporting 
burden on small laboratories. In the CLFS final rule (81 FR 41051), we 
estimated that 95 percent of physician office laboratories and 55 
percent of independent laboratories would not be required to report 
applicable information under our low expenditure criterion. Although we 
substantially reduced the number of laboratories qualifying as 
applicable laboratories (that is, approximately 5 percent of physician 
office laboratories and approximately 45 percent of independent 
laboratories), we estimated that the percentage of Medicare utilization 
would remain high. That is, approximately 5 percent of physician office 
laboratories would account for approximately 92 percent of CLFS

[[Page 59678]]

spending on physician office laboratories and approximately 45 percent 
of independent laboratories would account for approximately 99 percent 
of CLFS spending on independent laboratories (81 FR 41051).
    We stated that it is our understanding that physician offices are 
generally not prepared to identify, collect, and report each unique 
private payor rate from each private payor for each laboratory test 
code subject to the data collection and reporting requirements, and the 
volume associated with each unique private payor rate. As such, we 
explained that we believe revising the low expenditure threshold so 
that more physician office laboratories are required to report 
applicable information would likely impose significant administrative 
burdens on physician offices. We stated that we also believe that 
increasing participation from physician office laboratories would have 
minimal overall impact on payment rates given that the weighted median 
of private payor rates is dominated by the laboratories with the 
largest test volume. We noted that our participation simulations from 
the first data reporting period show that increasing the volume of 
physician office laboratories reporting applicable information has 
minimal overall impact on the weighted median of private payor rates. 
For more information on our participation simulations, please visit the 
CLFS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/CY2018-CLFS-Payment-System-Summary-Data.pdf.
    We stated in the proposed rule that we continue to believe the 
current low expenditure threshold strikes an appropriate balance 
between collecting enough private payor rate data to accurately 
represent the weighted median of private payor rates while limiting the 
administrative burden on small laboratories. In addition, as discussed 
previously in this section, we are finalizing excluding MA plan 
revenues under Part C from total Medicare revenues in the definition of 
applicable laboratory, and we noted that we expect more laboratories of 
all types, including physician office laboratories, may meet the 
majority of Medicare revenues threshold.
    However, we recognized from stakeholders that some physician office 
laboratories and small independent laboratories that are not applicable 
laboratories because they do not meet the current low expenditure 
threshold may still want to report applicable information despite the 
administrative burden associated with qualifying as an applicable 
laboratory. Therefore, we sought public comment on revising the low 
expenditure threshold to increase the level of participation among 
physician office laboratories and small independent laboratories.
    In the proposed rule we explained that one approach could be for us 
to decrease the low expenditure threshold by 50 percent, from $12,500 
to $6,250, in CLFS revenues during a data collection period. Under such 
an approach, a laboratory would need to receive at least $6,250 in CLFS 
revenues in a data collection period. We stated that if we were to 
adopt such an approach, we would need to revise paragraph (4) of the 
definition of applicable laboratory at Sec.  414.502 to replace $12,500 
with $6,250. We solicited public comments on this approach.
    We noted that we were particularly interested in comments from the 
physician community and small independent laboratories as to the 
administrative burden associated with such a revision to the low 
expenditure threshold. Specifically, we requested comments on the 
following issues: (1) Whether physician offices and small independent 
laboratories currently have adequate staff levels to meet the data 
collection and data reporting requirements; (2) whether data systems 
are currently in place to identify, collect, and report each unique 
private payor rate from each private payor for each CLFS test code and 
the volume of tests associated with each unique private payor rate; (3) 
if physician offices and small independent laboratories are generally 
not prepared to conduct the data collection and data reporting 
requirements, what is the anticipated timeframe needed for physician 
office and small independent laboratories to be able to meet the data 
collection and data reporting requirements; and (4) any other 
administrative concerns that decreasing the low expenditure threshold 
may impose on offices and small independent laboratories.
    The following is a summary of the comments we received and our 
responses to the comments regarding the approach of decreasing the low 
expenditure threshold by 50 percent, from $12,500 to $6,250, in CLFS 
revenues during a data collection period.
    Comment: Many commenters were opposed to reducing the low 
expenditure threshold because of the administrative burden it would 
place on physician office laboratories and small independent 
laboratories. Commenters noted that they experienced difficulties 
during the initial data collection and data reporting period with 
determining whether they met the definition of applicable laboratory 
and therefore if they were required to report applicable information. 
Some commenters that did report applicable information stated that they 
experienced significant administrative burden in collecting and 
compiling information, especially for test codes that involved numerous 
different sources of payment (such as the beneficiary's primary private 
payor, the beneficiary's secondary insurance, and coinsurance 
requirements). Some commenters reported having to remove staff from 
regular duties to work full time on preparing to report applicable 
information to CMS. A few commenters noted that physician office 
laboratories and small independent laboratories do not have the 
staffing or resources currently available, nor do they anticipate 
having them available in the future, to identify, collect and report 
each unique private payor rate for each CLFS test code and the volume 
of tests associated with each unique private payor rate. As such, 
commenters encouraged CMS not to decrease the low expenditure threshold 
component of the definition of applicable laboratory.
    Response: We appreciate the comments regarding the administrative 
burden imposed by the data collection and reporting requirements on 
physician office laboratories and small independent laboratories and 
understand that reducing the low expenditure threshold by 50 percent 
would add more burden on this segment of the laboratory industry. We 
will consider the commenters' input regarding the low expenditure 
threshold as we continue to evaluate and refine Medicare CLFS payment 
policy in the future.
    Comment: A few commenters suggested alternative approaches to 
lowering the low expenditure threshold that involve collecting data for 
physician office dependent tests and allowing laboratories to 
voluntarily report applicable information. For example, two commenters 
suggested that CMS identify laboratory tests predominantly performed by 
physician office laboratories and collect a statistically 
representative sample of data from physician office laboratories for 
the range of tests commonly performed in this setting. Under the 
commenters' approach, physician office laboratories would be required 
to report those tests. The commenters stated that this would ensure 
that the private payor rates for tests mostly performed by physician 
office laboratories are

[[Page 59679]]

represented in the weighted median of private payor rates used to 
determine CLFS rates. Moreover, a few other commenters suggested that 
CMS permit voluntary reporting so that laboratories that do not meet 
the current low expenditure threshold may report applicable information 
if they choose to.
    Response: The suggestions to identify physician office laboratory 
dependent tests and to permit voluntary reporting have already been 
addressed in previous rulemaking and we chose not to adopt them (81 FR 
41048). We noted that statute is clear about the particular information 
that is to be reported and on which we must base the new CLFS payment 
rates. Only applicable information of applicable laboratories is to be 
reported, and section 1834A(a)(3) of the Act indicates that applicable 
information is private payor rate information. We also explained that 
the statute imposes parameters on the collection and reporting of 
private payor rate information, and section 1834A(b) of the Act 
specifies that the payment amounts for CDLTs are to be based on the 
median of the private payor rate information. As such, we stated that 
we believe the statute supports our policy to prohibit information 
other than statutorily specified private payor rate information of 
applicable laboratories from being reported and used to set CLFS 
payment amounts under the revised CLFS. We also noted that we did not 
agree with the commenters' recommendation to allow voluntary reporting 
and at Sec.  414.504(g), we finalized that an entity that does not meet 
the definition of an applicable laboratory may not report applicable 
information. We continue to believe that our policy to not allow 
voluntary reporting is the most appropriate interpretation of the 
statute, and that applicable information may not be reported for an 
entity that does not meet the definition of an applicable laboratory.
b. Increasing the Low Expenditure Threshold
    We also discussed in the CY 2019 PFS proposed rule that we 
recognize many small laboratories may not want the additional 
administrative burden of data collection and reporting and, because 
their test volume is relatively low, their data is unlikely to have a 
meaningful impact on the weighted median of private payor rates for 
CDLTs under the CLFS. In response to comments from smaller laboratories 
that they prefer to not be applicable laboratories because of the 
burden of collecting and reporting applicable information, we stated 
that we could increase the low expenditure threshold in the definition 
of applicable laboratory by 50 percent, from $12,500 to $18,750, in 
CLFS revenues during a data collection period. Because physician office 
laboratories would be less likely to meet a higher threshold, such an 
approach would decrease the number of physician office laboratories and 
small independent laboratories required to collect and report 
applicable information. We noted that we expected decreasing the number 
of physician office laboratories and small independent laboratories 
reporting applicable information would have minimal impact on 
determining CLFS rates because the largest laboratories with the 
highest test volumes dominate the weighted median of private payor 
rates.
    We stated that if we were to adopt such an approach, we would need 
to revise paragraph (4) of the definition of applicable laboratory at 
Sec.  414.502 to replace $12,500 with $18,750. We explained in the 
proposed rule that we were particularly interested in comments from the 
physician community and small independent laboratories on the 
administrative burden and relief of increasing the low expenditure 
threshold and noted that we believe that feedback on the topics 
discussed in this section would help inform us regarding potential 
refinements to the low expenditure threshold. We noted that depending 
on the comments we received, we would consider approaches described in 
this section.
    The following is a summary of the comments we received and our 
responses to the comments regarding the approach of increasing the low 
expenditure threshold by 50 percent, from $12,500 to $18,750, in CLFS 
revenues during a data collection period.
    Comment: Several commenters did not support raising the low 
expenditure threshold because it would further reduce the amount of 
applicable information reported from small laboratories. However, one 
commenter encouraged CMS to increase the low expenditure threshold to 
exclude even more small laboratories from the administrative burden of 
collecting and reporting applicable information. A few commenters 
suggested that CMS not make any changes to the low expenditure 
threshold at this time and encouraged CMS to allow the program to 
mature and to only make changes after a careful and transparent review 
of the data with additional opportunities for public comment.
    Response: We appreciate the comments from stakeholders on raising 
the low expenditure threshold and understand that increasing the low 
expenditure threshold by 50 percent would lead to fewer physician 
office laboratories and small independent laboratories from reporting 
applicable information for purposes of calculating CLFS rates. We will 
consider the commenters input on increasing the low expenditure 
threshold as we continue to evaluate and refine Medicare CLFS payment 
policy in the future, but make no changes to this policy at this time.
c. Additional Comments Received
    Comment: Many commenters stated that CMS' implementation of the new 
private payor rate-based CLFS does not reflect the cost or the value of 
performing clinical laboratory services and that without meaningful 
changes to how data is collected from laboratories, Medicare 
beneficiaries will lose access to the vital laboratory services they 
rely on to monitor their health and prevent and treat many diseases and 
conditions. The commenters stated that CMS' regulations, which 
implemented the private payor rate-based CLFS required under PAMA, 
prohibit most independent laboratories and physician office 
laboratories, and virtually all hospital laboratories, from providing 
data to set Medicare rates, and therefore, results in ``skewed data'' 
that does not represent true market rates. The commenters stated that 
Congress directed CMS to implement a market-based payment system in 
which private market data from all segments of the laboratory industry, 
including independent laboratories, hospital laboratories, and 
physician office laboratories, would be collected in order to determine 
Medicare reimbursement for laboratory tests. To implement a true market 
based payment system the commenters encouraged CMS to develop payment 
rates through a statistically valid process to ensure that the private 
payer data collected accurately represents all sectors of the 
laboratory market.
    Response: In general, section 1834A of the Act requires the payment 
amount for each CDLT on the CLFS to be based on the applicable 
information collected from applicable laboratories during a data 
collection period and reported to CMS during a data reporting period. 
For most tests on the CLFS, the statute requires the payment amount to 
be equal to the weighted median of the private payor rates for each 
test and specifies that the weighted median is calculated by arraying 
the distribution of all private payor rates, weighted by the volume for 
each payor and each laboratory. Given that the largest

[[Page 59680]]

laboratories reported their applicable information to CMS in the 
initial data reporting period, as well as many smaller laboratories, we 
believe the data we used to calculate the CY 2018 CLFS rates was 
sufficient and resulted in accurate weighted medians of private payor 
rates per test as required by the statute. As discussed previously in 
this section, we are finalizing our proposal to exclude MA plan 
payments under Part C from total Medicare revenues for purposes of the 
applicable laboratory definition. We believe this change will permit 
laboratories of all types with a significant Medicare Part C revenue 
component to be more likely to meet the majority of Medicare revenues 
threshold and qualify as an applicable laboratory. As a result of this 
change, we believe that applicable information from a broader segment 
of the laboratory industry will be reported for purposes of calculating 
the CLFS rates. As stated previously, we are finalizing the use of the 
Form CMS-1450 14x TOB to define applicable laboratories, subject to 
other regulatory and subregulatory requirements, such as the regulatory 
low expenditure threshold.
    Comment: One commenter stated that the reductions in Medicare 
payment rates for laboratory tests result directly from CMS' regulatory 
decisions to relieve most laboratories of reporting burdens. According 
to the commenter, excluding so many laboratories from the data 
reporting requirements results in median prices that are not 
representative across the clinical laboratory industry. As such, the 
commenter noted that the market data upon which Medicare reimbursement 
is based does not reflect the market composition of the clinical 
laboratory industry. In other words, exempting low-volume and many 
hospital laboratories from reporting does not allow for Medicare prices 
to reflect the full range of payment amounts paid to varying entities. 
The commenter encouraged CMS to collect data from a broader segment of 
the laboratory industry and suggested that we weight private payor 
rates by market share (that is, prices typically paid per reporting 
entity), instead of based on overall volume per test.
    Response: As discussed in response to the previous comment, section 
1834A of the Act generally requires the payment amount for each CDLT on 
the CLFS to be based on the applicable information collected from 
applicable laboratories during a data collection period and reported to 
CMS during a data reporting period. Because for most tests, the payment 
amount is equal to the median of the private payor rates weighted by 
volume, the largest laboratories with the highest test volumes will 
most significantly affect the payment rates. Because of this, we 
established and implemented a low expenditure threshold to alleviate 
administrative burden on small laboratories. We believe that our 
current method of calculating the weighted median of private payor 
rates is appropriate and consistent with the statute. Given that the 
largest laboratories reported their applicable information to us in the 
initial data reporting period, along with many smaller laboratories, we 
believe the data we used to calculate the CY 2018 CLFS rates was 
sufficient and resulted in accurate weighted medians of private payor 
rates as required by statute. As noted above, we are finalizing changes 
to the definition of an applicable laboratory, which we believe will 
lead to an even more robust data collection from which to calculate 
payment rates for the next CLFS update.
    Comment: Many commenters stated that the administrative burden for 
the first data reporting period was overwhelming and they offered 
suggestions on how to reduce the reporting burden on applicable 
laboratories. Many commenters suggested that CMS implement a ``data 
aggregation system'' consistent with statutory authority. In addition, 
a few commenters requested that CMS allow flexibility to exclude manual 
remittances from the definition of applicable information and therefore 
from data reporting. One commenter requested an ``across the board 
waiver'' from the reporting requirement for all small medical 
practices.
    Response: We addressed the comment requesting exclusion of manual 
remittances from the definition of applicable information in the CLFS 
final rule (81 FR 41053 through 41054). We explained that the statute 
is clear that applicable information, which is used to set CLFS payment 
amounts, must be reported for applicable laboratories for a data 
collection period, and it defines applicable information, in part, as 
the payment rate that was paid by each private payor for the test 
during a data collection period and the volume of such tests for each 
such payor for the data collection period. As such, we stated that we 
believe the statute does not support selective reporting of applicable 
information for applicable laboratories. If the laboratory meets the 
definition of applicable laboratory, the applicable information for 
that laboratory must be reported. In addition, given that the statute 
requires applicable information to be reported for applicable 
laboratories, we do not believe granting an ``across the board waiver'' 
from the reporting requirements for all small laboratories would be 
consistent with statute. We believe that the low expenditure threshold 
would continue to exclude the majority of small laboratories from the 
applicable laboratory definition and, therefore, from data reporting.
    With regard to the commenters suggesting that we implement 
aggregate reporting, we note that section 1834A(a)(6) of the Act 
permits the Secretary, beginning with January 1, 2019, to establish 
rules to aggregate reporting in situations where an applicable 
laboratory has more than one payment rate for the same payor for the 
same test or more than one payment rate for different payors for the 
same test. While the agency did not propose or solicit comments on 
implementing aggregate data reporting, we will take the commenters' 
suggestion into consideration for future refinements to the CLFS. 
However, to help reduce administrative burden for the next data 
reporting period, we will allow reporting entities the option to 
condense certain applicable information at the TIN-level, instead of 
reporting for each applicable laboratory individually at the NPI level. 
We will provide more information regarding the condensed reporting 
option through subregulatory guidance during the next data collection 
period.
    Comment: One commenter suggested that CMS adopt a 90-day data 
collection period instead of the current 6-month data collection period 
to alleviate some of the burden associated with collecting applicable 
information.
    Response: While we did not propose or solicit comments on changing 
the data collection period, we will take the commenter's suggestion 
into consideration for future refinements to the CLFS.
    Comment: One commenter raised concerns about the integrity of the 
data reported during the first data reporting period. The commenter 
mentioned that the CLFS final rule was released just prior to the end 
of the first data collection period and as a result, laboratories 
struggled to collect information and submit the required data 
accurately. The commenter noted that many laboratories still do not 
have the systems in place to determine the private payor payment rates 
for each test and the associated volume paid at each rate, therefore 
exacerbating the potential for inaccurate reporting in the next data 
reporting period. The commenter was particularly concerned about how 
inaccurate data affects newer tests in which the volume of services has

[[Page 59681]]

remained relatively low as compared to well established laboratory 
procedures. For instance, because of the low volume of applicable 
information being reported for Tier 1 and Tier 2 molecular pathology 
procedures, the commenter stated that any inaccurate data reported has 
a greater impact on these test codes. The commenter noted that 
expanding the definition of an applicable laboratory would likely 
result in additional reporting errors and therefore, did not support 
any revisions to the definition of an applicable laboratory. Instead, 
the commenter urged CMS to refine the reporting process and implement 
measures to safeguard data integrity in future reporting periods. 
Specifically, the commenter requested that CMS consider implementing a 
data aggregation system for future data reporting periods, consistent 
with statutory authority. The commenter noted that a data aggregation 
system may guarantee more complete reporting and expand the ability of 
laboratories to report accurate data.
    Response: We share the commenter's interest in collecting accurate 
data. As discussed previously, we are finalizing changes to the 
definition of applicable laboratory in Sec.  414.502. We did not 
propose changes to the CLFS data reporting requirements or solicit 
comments on how to safeguard against inaccurate data. We will consider 
the issues raised by the commenter for future rulemaking. As noted in 
response to another comment, for the next data reporting period we will 
permit the reporting entity to condense applicable information for its 
applicable laboratories at the TIN level, instead of reporting for each 
of its applicable laboratories individually, and will issue 
subregulatory guidance on this topic.
    Comment: One commenter stated that in general ``our market based 
system is flawed'' because it allows companies to profit on people's 
health. The commenter stated that the CLFS should be based on 
recovering costs only and not profit. The commenter noted that such 
approach will lead to a decrease in cost for laboratory testing and a 
standardization of fees across the industry.
    Response: As previously noted, section 1834A of the Act generally 
requires the payment amount for each CDLT on the CLFS to be based on 
the applicable information collected from applicable laboratories 
during a data collection period and reported to us during a data 
reporting period. Basing CLFS rates on laboratory costs would not be 
permissible under the statute.
    Comment: One commenter stated that uncertainty regarding the 
definition of an ADLT has discouraged some laboratories from applying 
for ADLT status, and suggested that we should implement the regulatory 
requirements in a manner that ``recognizes the uniqueness of the 
results generated by each precision diagnostic test due to its use of a 
proprietary algorithm validated in a unique patient cohort.''
    Response: We did not propose or solicit any comments regarding 
changes to the definition of an ADLT, therefore, this comment is not 
within the scope of this rulemaking.

B. Changes to the Regulations Associated With the Ambulance Fee 
Schedule

1. Overview of Ambulance Services
a. Ambulance Services
    Under the ambulance fee schedule, the Medicare program pays for 
ambulance transportation services for Medicare beneficiaries under 
Medicare Part B when other means of transportation are contraindicated 
by the beneficiary's medical condition and all other coverage 
requirements are met. Ambulance services are classified into different 
levels of ground (including water) and air ambulance services based on 
the medically necessary treatment provided during transport.
    These services include the following levels of service:
     For Ground--

    ++ Basic Life Support (BLS) (emergency and non-emergency).
    ++ Advanced Life Support, Level 1 (ALS1) (emergency and non-
emergency).
    ++ Advanced Life Support, Level 2 (ALS2).
    ++ Paramedic ALS Intercept (PI).
    ++ Specialty Care Transport (SCT).

     For Air--

    ++ Fixed Wing Air Ambulance (FW).
    ++ Rotary Wing Air Ambulance (RW).
b. Statutory Coverage of Ambulance Services
    Under sections 1834(l) and 1861(s)(7) of the Act, Medicare Part B 
(Supplemental Medical Insurance) covers and pays for ambulance 
services, to the extent prescribed in regulations, when the use of 
other methods of transportation would be contraindicated by the 
beneficiary's medical condition.
    The House Ways and Means Committee and Senate Finance Committee 
Reports that accompanied the 1965 Social Security Amendments suggest 
that the Congress intended that--
     The ambulance benefit cover transportation services only 
if other means of transportation are contraindicated by the 
beneficiary's medical condition; and
     Only ambulance service to local facilities be covered 
unless necessary services are not available locally, in which case, 
transportation to the nearest facility furnishing those services is 
covered (H.R. Rep. No. 213, 89th Cong., 1st Sess. 37 and Rep. No. 404, 
89th Cong., 1st Sess. Pt 1, 43 (1965)).
    The reports indicate that transportation may also be provided from 
one hospital to another, to the beneficiary's home, or to an extended 
care facility.
c. Medicare Regulations for Ambulance Services
    The regulations relating to ambulance services are set forth at 42 
CFR part 410, subpart B, and 42 CFR part 414, subpart H. Section 
410.10(i) lists ambulance services as one of the covered medical and 
other health services under Medicare Part B. Therefore, ambulance 
services are subject to basic conditions and limitations set forth at 
Sec.  410.12 and to specific conditions and limitations included at 
Sec. Sec.  410.40 and 410.41. Subpart H of part 414 describes how 
payment is made for ambulance services covered by Medicare Part B.
2. Ambulance Extender Provisions
a. Amendment to Section 1834(l)(13) of the Act
    Section 146(a) of the Medicare Improvements for Patients and 
Providers Act of 2008 (MIPPA), (Pub. L. 110-275, enacted July 15, 2008) 
amended section 1834(l)(13)(A) of the Act to specify that, effective 
for ground ambulance services furnished on or after July 1, 2008, and 
before January 1, 2010, the ambulance fee schedule amounts for ground 
ambulance services shall be increased as follows:
     For covered ground ambulance transports that originate in 
a rural area or in a rural census tract of a metropolitan statistical 
area, the fee schedule amounts shall be increased by 3 percent.
     For covered ground ambulance transports that do not 
originate in a rural area or in a rural census tract of a metropolitan 
statistical area, the fee schedule amounts shall be increased by 2 
percent.
    The payment add-ons under section 1834(l)(13)(A) of the Act have 
been extended several times. Most recently, section 50203(a)(1) of the 
Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123, enacted February 
9, 2018) amended section 1834(l)(13)(A) of the Act to extend the 
payment add-ons through

[[Page 59682]]

December 31, 2022. Thus, these payment add-ons apply to covered ground 
ambulance transports furnished before January 1, 2023. We proposed to 
revise Sec.  414.610(c)(1)(ii) to conform the regulations to this 
statutory requirement. (For further information regarding the 
implementation of this provision for claims processing, please see CR 
10531. For a discussion of past legislation extending section 
1834(l)(13) of the Act, please see the CY 2014 PFS final rule with 
comment period (78 FR 74438 through 74439), the CY 2015 PFS final rule 
with comment period (79 FR 67743) and the CY 2016 PFS final rule with 
comment period (80 FR 71071 through 71072)).
    This statutory requirement is self-implementing. A plain reading of 
the statute requires only a ministerial application of the mandated 
rate increase, and does not require any substantive exercise of 
discretion on the part of the Secretary.
    We received two comments on this proposal. The following is a 
summary of those comments along with our response.
    Comment: One commenter supported the 5-year extension of the add-on 
payments and appreciates CMS' implementation of the statutory 
requirement, and stated these provisions are critical to ensuring the 
delivery of ambulance services. Another commenter stated that due to 
the staffing and distances that might be involved in the use of 
ambulance services in varying areas (for example, urban, rural and 
super rural), these add-ons payments will assist in appropriate 
reimbursements for these services.
    Response: We appreciate the commenters' support.
    After consideration of the comments received, we are finalizing our 
proposal, without modification, to revise Sec.  414.610(c)(1)(ii) to 
conform the regulations to this statutory requirement.
b. Amendment to Section 1834(l)(12) of the Act
    Section 414(c) of the Medicare Prescription Drug, Improvement and 
Modernization Act of 2003 (Pub. L. 108-173, enacted December 8, 2003) 
(MMA) added section 1834(l)(12) to the Act, which specified that, in 
the case of ground ambulance services furnished on or after July 1, 
2004, and before January 1, 2010, for which transportation originates 
in a qualified rural area (as described in the statute), the Secretary 
shall provide for a percent increase in the base rate of the fee 
schedule for such transports. The statute requires this percent 
increase to be based on the Secretary's estimate of the average cost 
per trip for such services (not taking into account mileage) in the 
lowest quartile of all rural county populations as compared to the 
average cost per trip for such services (not taking into account 
mileage) in the highest quartile of rural county populations. Using the 
methodology specified in the July 1, 2004 interim final rule (69 FR 
40288), we determined that this percent increase was equal to 22.6 
percent. As required by the MMA, this payment increase was applied to 
ground ambulance transports that originated in a ``qualified rural 
area,'' that is, to transports that originated in a rural area included 
in those areas comprising the lowest 25th percentile of all rural 
populations arrayed by population density. For this purpose, rural 
areas included Goldsmith areas (a type of rural census tract). This 
rural bonus is sometimes referred to as the ``Super Rural Bonus'' and 
the qualified rural areas (also known as ``super rural'' areas) are 
identified during the claims adjudicative process via the use of a data 
field included in the CMS-supplied ZIP code file.
    The Super Rural Bonus under section 1834(l)(12) of the Act has been 
extended several times. Most recently, section 50203(a)(2) of the BBA 
amended section 1834(l)(12)(A) of the Act to extend this rural bonus 
through December 31, 2022. Therefore, we are continuing to apply the 
22.6 percent rural bonus described in this section (in the same manner 
as in previous years) to ground ambulance services with dates of 
service before January 1, 2023 where transportation originates in a 
qualified rural area. Accordingly, we proposed to revise Sec.  
414.610(c)(5)(ii) to conform the regulations to this statutory 
requirement. (For further information regarding the implementation of 
this provision for claims processing, please see CR 10531. For a 
discussion of past legislation extending section 1834(l)(12) of the 
Act, please see the CY 2014 PFS final rule with comment period (78 FR 
74439 through 74440), CY 2015 PFS final rule with comment period (79 FR 
67743 through 67744) and the CY 2016 PFS final rule with comment period 
(80 FR 71072)).
    This statutory provision is self-implementing. It requires an 
extension of this rural bonus (which was previously established by the 
Secretary) through December 31, 2022, and does not require any 
substantive exercise of discretion on the part of the Secretary.
    We received two comments on this proposal. The following is a 
summary of those comments along with our response.
    Comment: One commenter supported the 5-year extension of this 
provision and appreciates CMS' implementation of the statutory 
requirement and noted this provision is critical to ensuring the 
delivery of ambulance services. Another commenter stated that due to 
the staffing and distances that might be involved in the use of 
ambulance services in varying areas (for example, urban, rural and 
super rural), these add-ons payments will assist in appropriate 
reimbursements for these services.
    Response: We appreciate the commenters' support.
    After consideration of the comments received, we are finalizing our 
proposal, without modification, to revise Sec.  414.610(c)(5)(ii) to 
conform the regulations to this statutory requirement.
3. Amendment to Section 1834(l)(15) of the Act
    Section 637 of the American Taxpayer Relief Act of 2012 (ATRA) 
(Pub. L. 112-240, enacted January 2, 2013) added section 1834(l)(15) of 
the Act to specify that the fee schedule amount otherwise applicable 
under the preceding provisions of section 1834(l) of the Act shall be 
reduced by 10 percent for ambulance services furnished on or after 
October 1, 2013, consisting of non-emergency BLS services involving 
transport of an individual with end-stage renal disease for renal 
dialysis services (as described in section 1881(b)(14)(B) of the Act) 
furnished other than on an emergency basis by a provider of services or 
a renal dialysis facility. In the CY 2014 PFS final rule with comment 
period (78 FR 74440), we revised Sec.  414.610 by adding paragraph 
(c)(8) to conform the regulations to this statutory requirement.
    Section 53108 of the BBA amended section 1834(l)(15) of the Act to 
increase the reduction from 10 percent to 23 percent effective for 
ambulance services (as described in section 1834(l)(15) of the Act) 
furnished on or after October 1, 2018. The 10 percent reduction applies 
for ambulance services (as described in section 1834(l)(15) of the Act) 
furnished during the period beginning on October 1, 2013 and ending on 
September 30, 2018. Accordingly, we proposed to revise Sec.  
414.610(c)(8) to conform the regulations to this statutory requirement.
    This statutory requirement is self-implementing. A plain reading of 
the statute requires only a ministerial application of the mandated 
rate decrease, and does not require any substantive exercise of 
discretion on the part of the Secretary. Accordingly, for ambulance 
services described in section

[[Page 59683]]

1834(l)(15) of the Act furnished during the period beginning on October 
1, 2013 and ending on September 30, 2018, the fee schedule amount 
otherwise applicable (both base rate and mileage) is reduced by 10 
percent, and for ambulance services described in section 1834(l)(15) of 
the Act furnished on or after October 1, 2018, the fee schedule amount 
otherwise applicable (both base rate and mileage) is reduced by 23 
percent. (For further information regarding application of this 
mandated rate decrease, please see CR 10549.)
    We received two comments on this proposal. The following is a 
summary of those comments along with our response.
    Comment: One commenter supported the reduction of payment for these 
ambulance services and stated that the payment adjustment for non-
emergency, BLS transports for ESRD beneficiaries is at an appropriate 
level. Another commenter stated that for accountable care 
organizations, transportation for dialysis services constitutes the 
largest portion of ambulance spending. According to the commenter, 
because patients often do not receive medical care during the 
transportation, they supported the reduction to the ambulance fee 
schedule for the transportation of patients with ESRD for renal 
dialysis services.
    Response: We appreciate the commenters' support.
    After consideration of the comments received, we are finalizing our 
proposal, without modification, to revise Sec.  414.610(c)(8) to 
conform the regulations to the statutory requirement described above.

C. Rural Health Clinics (RHCs) and Federally Qualified Health Centers 
(FQHCs)

1. Payment for Care Management Services
    In the CY 2018 PFS final rule, we revised the payment methodology 
for Chronic Care Management (CCM) services furnished by RHCs and FQHCs, 
and established requirements and payment for general Behavioral Health 
Integration (BHI) and psychiatric Collaborative Care Management (CoCM) 
services furnished in RHCs and FQHCs, beginning on January 1, 2018.
    For CCM services furnished by RHCs or FQHCs between January 1, 
2016, and December 31, 2017, payment is at the PFS national average 
payment rate for CPT 99490. For CCM, general BHI, and psychiatric CoCM 
services furnished by RHCs or FQHCs on or after January 1, 2018, we 
established 2 new HCPCS codes. The first HCPCS code, G0511, is a 
General Care Management code for use by RHCs or FQHCs when at least 20 
minutes of qualified CCM or general BHI services are furnished to a 
patient in a calendar month. The second HCPCS code, G0512, is a 
psychiatric CoCM code for use by RHCs or FQHCs when at least 70 minutes 
of initial psychiatric CoCM services or 60 minutes of subsequent 
psychiatric CoCM services are furnished to a patient in a calendar 
month.
    The payment amount for HCPCS code G0511 is set at the average of 
the 3 national non-facility PFS payment rates for the CCM and general 
BHI codes and updated annually based on the PFS amounts. The 3 codes 
are CPT 99490 (20 minutes or more of CCM services), CPT 99487 (60 
minutes or more of complex CCM services), and CPT 99484 (20 minutes or 
more of BHI services).
    The payment amount for HCPCS code G0512 is set at the average of 
the 2 national non-facility PFS payment rates for CoCM codes and 
updated annually based on the PFS amounts. The 2 codes are CPT 99492 
(70 minutes or more of initial psychiatric CoCM services) and CPT 99493 
(60 minutes or more of subsequent psychiatric CoCM services).
    For practitioners billing under the PFS, we proposed for CY 2019 a 
new CPT code, 994X7, which would correspond to 30 minutes or more of 
CCM furnished by a physician or other qualified health care 
professional and is similar to CPT codes 99490 and 99487. For RHCs and 
FQHCs, we proposed to add CPT code 994X7 as a general care management 
service and to include it in the calculation of HCPCS code G0511. That 
is, we proposed that starting on January 1, 2019, RHCs and FQHCs would 
be paid for HCPCS code G0511 based on the average of the national non-
facility PFS payment rates for CPT codes 99490, 99487, 99484, and 
994X7. We note that CPT code 994X7 was a placeholder code, and the 
final code is CPT code 99491.
    We proposed to revise Sec.  405.2464 to reflect the current payment 
methodology that was finalized in the CY 2018 PFS and incorporate the 
addition of the new CPT code to HCPCS code G0511.
2. Communication Technology-Based and Remote Evaluation Services
    RHC and FQHC visits are face-to-face (in-person) encounters between 
a patient and an RHC or FQHC practitioner during which time one or more 
RHC or FQHC qualifying services are furnished. RHC and FQHC 
practitioners are physicians, nurse practitioners, physician 
assistants, certified nurse midwives, clinical psychologists, and 
clinical social workers, and under certain conditions, a registered 
nurse or licensed practical nurse furnishing care to a homebound RHC or 
FQHC patient. A Transitional Care Management service can also be an RHC 
or FQHC visit. A Diabetes Self-Management Training (DSMT) service or a 
Medical Nutrition Therapy (MNT) service furnished by a certified DSMT 
or MNT provider may also be an FQHC visit.
    RHCs are paid an all-inclusive rate (AIR) for medically-necessary, 
face-to-face visits with an RHC practitioner. The rate is subject to a 
payment limit, except for those RHCs that have an exception to the 
payment limit for being ``provider-based'' (see Sec.  413.65). FQHCs 
are paid the lesser of their charges or the FQHC Prospective Payment 
System (PPS) rate for medically-necessary, face-to-face visits with an 
FQHC practitioner. Only medically-necessary medical, mental health, or 
qualified preventive health services that require the skill level of an 
RHC or FQHC practitioner can be RHC or FQHC billable visits.
    The RHC and FQHC payment rates reflect the cost of all services and 
supplies that an RHC or FQHC furnishes to a patient in a single day, 
and are not adjusted for the complexity of the patient health care 
needs, the length of the visit, or the number or type of practitioners 
involved in the patient's care.
    Services furnished by auxiliary personnel (such as nurses, medical 
assistants, or other clinical personnel acting under the supervision of 
the RHC or FQHC practitioner) are considered incident to the visit and 
are included in the per-visit payment. This may include services 
furnished prior to or after the billable visit that occur within a 
medically appropriate time period, which is usually 30 days or less.
    RHCS and FQHCs are also paid for care management services, 
including chronic care management services, general behavioral health 
integration services, and psychiatric Collaborative Care Model 
services. These are typically non-face-to-face services that do not 
require the skill level of an RHC or FQHC practitioner and are not 
included in the RHC or FQHC payment methodologies.
    For practitioners billing under the PFS, we proposed for CY 2019 
separate payment for certain communication technology-based services. 
This includes what is referred to as ``Brief Communication Technology-
Based Services'' for a ``virtual check-in'' and separate payment for 
remote evaluation of recorded video and/or images. The ``virtual check-
in'' visit would be

[[Page 59684]]

billable when a physician or non-physician practitioner has a brief (5 
to 10 minutes), non-face-to-face check in with a patient via 
communication technology to assess whether the patient's condition 
necessitates an office visit. This service could be billed only in 
situations where the medical discussion was for a condition not related 
to an E/M service provided within the previous 7 days, and does not 
lead to an E/M service or procedure within the next 24 hours or at the 
soonest available appointment. We also proposed payment for 
practitioners billing under the PFS for remote evaluation services. 
This payment would be for the remote evaluation of patient-transmitted 
information conducted via pre-recorded ``store and forward'' video or 
image technology, including interpretation with verbal follow-up with 
the patient within 24 business hours, not originating from a related E/
M service provided within the previous 7 days nor leading to an E/M 
service or procedure within the next 24 hours or soonest available 
appointment. We stated that both of these services would be priced 
under the PFS at a rate that reflects the resource costs of these non-
face-to-face services relative to other PFS services, including face-
to-face and in-person visits.
    The RHC and FQHC payment models are distinct from the PFS model in 
that the payment is for a comprehensive set of services and supplies 
associated with an RHC or FQHC visit. A direct comparison between the 
payment for a specific service furnished in an RHC or FQHC and the same 
service furnished in a physician's office is not possible, because the 
payment for RHCs and FQHCs is a per diem payment that includes the cost 
for all services and supplies rendered during an encounter, and payment 
for a service furnished in a physician's office and billed under the 
PFS is only for that service.
    We recognize that there are occasions when it may be beneficial to 
both the patient and the RHC or FQHC to utilize communication 
technology-based services to determine the course of action for a 
health issue. Currently under the RHC and FQHC payment systems, if the 
communication results in a face-to-face billable visit with an RHC or 
FQHC practitioner, the cost of the prior communication would be 
included in the RHC AIR or the FQHC PPS. However, if as a result of the 
communication it is determined that a visit is not necessary, there 
would not be a billable visit and there would be no payment.
    RHCs and FQHCs furnish services in rural and urban areas that have 
been determined to be medically underserved areas or health 
professional shortage areas. They are an integral component of the 
Nation's health care safety net, and we want to ensure that Medicare 
patients who are served by RHCs and FQHCs are able to communicate with 
their RHC or FQHC practitioner in a manner that enhances access to 
care, consistent with evolving medical care. Particularly in rural 
areas where transportation is limited and distances may be far, we 
believe the use of communication technology-based services may help 
some patients to determine if they need to schedule a visit at the RHC 
or FQHC. If it is determined that a visit is not necessary, the RHC or 
FQHC practitioner would be available for other patients who need their 
care.
    When communication technology-based services are furnished in 
association with an RHC or FQHC billable visit, the costs of these 
services are included in the RHC AIR or the FQHC PPS and are not 
separately billable. However, if there is no RHC or FQHC billable 
visit, these costs are not paid as part of an RHC AIR or FQHC PPS 
payment. We therefore proposed that, effective January 1, 2019, RHCs 
and FQHCs receive an additional payment for the costs of communication 
technology-based services or remote evaluation services that are not 
already captured in the RHC AIR or the FQHC PPS payment when the 
requirements for these services are met.
    We proposed that RHCs and FQHCs receive payment for communication 
technology-based or remote evaluation services when at least 5 minutes 
of communication technology-based or remote evaluation services are 
furnished by an RHC or FQHC practitioner to a patient who has been seen 
in the RHC or FQHC within the previous year. These services may only be 
billed when the medical discussion or remote evaluation is for a 
condition not related to an RHC or FQHC service provided within the 
previous 7 days, and does not lead to an RHC or FQHC service within the 
next 24 hours or at the soonest available appointment, since in those 
situations the services are already paid as part of the RHC or FQHC 
per-visit payment.
    We proposed to create a new virtual communication G-code for use by 
RHCs and FQHCs only, with a payment rate set at the average of the PFS 
national non-facility payment rates for HCPCS code GVCI1 for 
communication technology-based services, and HCPCS code GRAS1 for 
remote evaluation services. RHCs and FQHCs would be able to bill the 
virtual communication G-code either alone or with other payable 
services. The payment rate for the virtual communication G-code would 
be updated annually based on the PFS amounts. We note that HCPCS codes 
GCVI1 and GRAS1 were placeholder codes, and the final HCPCS codes are 
G2012 and G2010, respectively.
    We also proposed to waive the RHC and FQHC face-to-face 
requirements when these services are furnished to an RHC or FQHC 
patient. Coinsurance would be applied to FQHC claims, and coinsurance 
and deductibles would apply to RHC claims for these services. Services 
that are currently being furnished and paid under the RHC AIR or FQHC 
PPS payment methodology will not be affected by the ability of the RHC 
or FQHC to receive payment for additional services that are not 
included in the RHC AIR or FQHC PPS.
3. Other Options Considered
    We considered other options for payment for these services. First, 
we considered adding communication technology-based and remote 
evaluation services as an RHC or FQHC stand-alone service. Under this 
option, payment for RHCs would be at the AIR, and payment for FQHCs 
would be the lesser of total charges or the PPS rate. We did not 
propose this payment option because these services do not meet the 
requirements for an RHC or FQHC billable visit and payment at the RHC 
AIR or FQHC PPS would result in a payment rate incongruent with 
efficiencies inherent in the provision of the technology-based 
services.
    The second option we considered was to allow RHCs and FQHCs to bill 
HCPCS codes G2012 or G2010 separately on an RHC or FQHC claim. We did 
not propose this payment option because we believe that a combined G-
code is less burdensome and will allow expansion of these services 
without adding additional codes on an RHC or FQHC claim.
4. Comments and Responses
    We invited comments on this proposal. In particular, we were 
interested in comments regarding the appropriateness of payment for 
communication technology-based and remote evaluation services in the 
absence of an RHC or FQHC visit, the burden associated with 
documentation for billing these codes (RHC or FQHC practitioner's time, 
medical records, etc.), and any potential impact on the per diem nature 
of RHC and FQHC billing and payment structure as a result of payment 
for these services.

[[Page 59685]]

    The following is a summary of the comments we received regarding 
the addition of CPT code 99491 to the codes used to determine the 
payment for HCPCS code G0511 in RHCs and FQHCs, and the proposed 
requirements and payment for a new G-code for virtual communication for 
payment for communication technology-based and remote evaluation 
services. The majority of the commenters were very supportive of both 
proposals, and some requested clarification on issues related to 
billing, cost reporting, and payment for care management and virtual 
communication services in RHCs and FQHCs.
    Comment: Several commenters requested clarification of how the 
inclusion of the new chronic care management code, CPT code 99491 
(previously referred to as CPT code 994X7), would impact the payment of 
HCPCS code G0511 (the RHC and FQHC General Care Management code), and 
requested assurance that adding this code to the codes used to 
determine the payment for HCPCS code G0511 would not result in a lower 
payment rate.
    Response: In the CY 2018 PFS final rule, we stated that if a new 
care management code is proposed and subsequently finalized for 
practitioners billing under the PFS, we would review the new code to 
determine if it should be included in the calculation of the RHC and 
FQHC General Care Management Code. The determination of whether a new 
care management code should be added to the codes used to determine the 
payment rate is based on the applicability of the service in RHCs and 
FQHCs, and may result in either an increase or decrease in the payment 
amount for HCPCS code G0511.
    CPT code 99491 is for 30 minutes or more of CCM furnished by a 
physician or other qualified health care professional. Since this is 
similar to CPT codes 99490 and 99487, we determined that it should be 
included in the RHC and FQHC General Care Management code, which is 
paid using HCPCS code G0511. The CY 2019 payment rate for this code is 
expected to be $74.26, and the payment rate for CY 2019 payment rate 
for HCPCS code G0511 is expected to be approximately $67, which will 
result in a higher payment for HCPCS code G0511 than it would have been 
if CPT code 99491 was not added to the codes used to determine the 
rate. The rate is adjusted annually based on the PFS payment rates for 
these codes.
    Comment: A commenter stated that the care management services 
included in the PFS are already contemplated and included in the RHC 
AIR and the FQHC PPS payments, which are designed to cover all 
activities related to a comprehensive primary care visit, even if they 
do not occur on the same day. The commenter did not support separate 
payment to RHCs and FQHCs for care management services, and stated that 
paying separately for these services results in duplicative payment. 
The commenter also noted that because the care management payment is 
made through the RHC and FQHC payment systems, it does not trigger a 
budget-neutrality adjustment and therefore represents additional 
spending for the Medicare program and its beneficiaries.
    Response: Comprehensive, high quality, and coordinated primary care 
has always been an integral part of RHC and FQHC services in their 
communities, We respectfully disagree with the suggestion that the type 
of structured chronic care management and behavioral health integration 
services that are now separately paid as care management are already 
included in the RHC AIR or the FQHC PPS payment methodologies. These 
services have specific requirements which have not typically or 
routinely been provided by RHCs or FQHCs, and therefore have not been 
factored into either the RHC AIR or the FQHC PPS rate. RHC and FQHC 
payments are not subject to the budget neutrality provisions of the 
PFS, and we believe that the cost-saving potential of these services is 
likely to offset any additional Medicare spending.
    Comment: A commenter encouraged CMS to evaluate the additional 
costs of providing CCM services for people with limited English 
proficiency and to adjust payment accordingly in future rulemaking.
    Response: We are aware that some RHCs and FQHCs have a higher than 
average rate of patients with limited English proficiency, which may 
sometimes require additional time or resources. However, once the 
minimum requirements for care management are met, the RHC or FQHC can 
bill for the service, and the rate is based on the average cost of 
furnishing the services.
    Comment: Several commenters noted their support for a new G-code 
for payment for communication technology[hyphen]based and remote 
evaluation services and requested that CMS investigate its authority to 
allow FQHCs to serve as distant site providers for telehealth services 
to Medicare beneficiaries.
    Response: Although both telehealth and virtual communication 
services use technology to communicate, these are separate and distinct 
services. Telehealth services are considered a substitute for an in-
person visit, and are therefore paid at the same rate as it would have 
been had it been furnished in person. With some exceptions, telehealth 
services require the use of interactive audio and digital 
telecommunication systems that permit real-time communication between 
the practitioner at the distant site and the beneficiary at the 
originating site. The communication technology-based and remote 
evaluation services that we proposed are not a substitute for a visit, 
but are instead brief discussions with the RHC or FQHC practitioner to 
determine if a visit is necessary. If the discussion between the RHC or 
FQHC practitioner and the Medicare beneficiary results in a billable 
visit, then the usual RHC or FQHC billing would occur. The virtual 
communication G-code would only be separately payable if the discussion 
between the RHC or FQHC practitioner does not result from or lead to an 
RHC or FQHC billable visit. The payment rate for communication 
technology-based services are valued based on the shorter duration of 
time and the efficiencies associated with the use of communication 
technology.
    Section 1834(m)(4)(C)(ii) of the Act authorizes RHCs and FQHCs to 
serve as telehealth ``originating sites'' (that is, where the patient 
is located) for qualified telehealth services. Section 1834(m)(1) of 
the Act, which describes distant site telehealth services (where the 
practitioner is located), does not include RHCs and FQHCs. We do not 
have the authority to allow RHCs and FQHCs to furnish distant site 
telehealth services, and RHCs and FQHCs may not bill for distant site 
telehealth services under the PFS.
    Comment: Some commenters supported a separate payment for 
communication technology-based and remote evaluation services using a 
virtual communication G-code because these new services were not 
included in the calculation of the Medicare FQHC PPS rate, but 
requested that CMS reconsider the payment amount for these services. 
The commenters suggested that because an FQHC practitioner is required 
and the face-to-face requirements for these services are waived, the 
payment should be on par with a traditional FQHC visit.
    Response: We disagree with the suggestion that the payment be on 
par with a regular FQHC visit. If the communication technology-based or 
remote evaluation service results in a face-to-face visit with an RHC 
or FQHC practitioner, the cost of the brief communication with the RHC 
or FQHC practitioner would already be included in the RHC AIR or the 
FQHC PPS payment. If the communication

[[Page 59686]]

technology-based or remote evaluation service does not originate from 
or result in a face-to-face visit with an RHC or FQHC practitioner, the 
RHC or FQHC may bill using the new virtual communication G-code. The 
payment rate for these services under the PFS reflects the resource 
costs of these non-face-to-face services relative to other PFS 
services, including face-to-face and in-person visits. We did not 
propose payment for these services as an RHC or FQHC visit or at the 
same payment rate as an RHC or FQHC visit because these services do not 
meet the requirements for an RHC or FQHC billable visit, and payment at 
the RHC AIR or FQHC PPS would result in a payment rate incongruent with 
efficiencies inherent in the provision of these communication services.
    Comment: Commenters recommended not implementing any type of 
frequency limitation, especially as RHCs and FQHCs learn to utilize 
these services for their patients. Commenters stated that any frequency 
limitation would be arbitrary, may have the opposite effect of the 
provision's intended purpose to encourage innovative ways to provide 
comprehensive care to Medicare beneficiaries, that the reimbursement 
rate does not provide a financial incentive for overuse of this 
service, and that the cost of virtual visits, even if unlimited, would 
more than offset the cost of even one emergency room visit.
    Response: We agree that frequency limitations should not be 
implemented at this time.
    Comment: Some commenters questioned the feasibility of billing for 
virtual communication services because they noted that the coinsurance 
requirement will discourage individuals from utilizing virtual 
communication services to assess whether or not they need to come in 
for an E/M visit, and will create patient confusion and dissatisfaction 
if they receive a bill for these services.
    Response: We are aware that coinsurance can be a barrier for some 
beneficiaries, but we do not have the statutory authority to waive the 
coinsurance requirement. RHCs and FQHCs should inform their patients 
that coinsurance applies, and provide information on the availability 
of assistance to qualified patients in meeting their cost sharing 
obligations, or any other programs to provide financial assistance, if 
applicable.
    Comment: A few commenters expressed concern about how care 
management is currently reported and how virtual communication services 
will be reported on the RHC cost report. The commenters stated that 
although care management services are considered RHC services, they are 
reported separately on line 80 in the non-reimbursable section of the 
cost report, and as a result, they are not considered allowable costs 
on the RHC cost report. The commenters stated that this process is 
administratively cumbersome, exposes the RHC to an audit risk, and 
represents a significant barrier for RHCs in offering care management 
services. The commenters suggested that the costs included on line 80 
should only be the direct costs associated with care management 
services, which would allow RHCs to more easily identify those costs 
and assure them that they are completing this form correctly. The 
commenters noted similar concerns for the reporting of virtual 
communication services, and recommended that CMS allow the costs 
associated with virtual communication to be reported in the 
reimbursable section of the RHC cost report.
    Response: Reducing administrative burden and encouraging the 
appropriate use of services is a high priority for CMS, and we 
appreciate the detailed comments and suggested changes regarding the 
reporting of care management and virtual communication services on the 
RHC cost report. Cost reporting information in typically provided in 
subregulatory guidance, and we will carefully consider these comments.
    Comment: A commenter questioned how virtual communication that 
occurs during non-RHC hours would be billed and calculated on the cost 
report.
    Response: Services such as care management and virtual 
communication services are not billable visits in RHCs and FQHCs and 
may occur outside of the RHC's or FQHC's posted hours. As stated 
previously, information on cost reporting will be provided in 
subregulatory guidance.
    Comment: Some commenters recommended removing the timeframe 
restrictions for billing virtual communication services, stating that 
they are vague, arbitrary, administratively burdensome, or that 
allowing daily check in would improve health and reduce costs. Other 
commenters suggested modifying the timeframe limitations with a clear 
cut-off that RHCs and FQHCs can track and calculate, such as within the 
previous 3 days or subsequent 24 hours, or the previous and subsequent 
24 hours. One commenter stated that the timeframe restrictions would 
require RHCs and FQHCs to review prior patient clinical activity, 
assess the diagnostic category of any recent activity, and then delay 
for 24 hours to ascertain whether the service is followed by a clinical 
visit, rather than billing immediately for the services. This commenter 
also stated that most computer billing systems are not set up for this 
type of review, and a supplemental billing process would be costly, and 
noted that there are no restrictions on face-to-face visits in RHCs or 
FQHCs.
    Response: PFS payments for HCPCS code G2012 (communication 
technology-based services), and HCPCS code G2010 (remote evaluation 
services) are based on the descriptor for CPT code 99441 (Telephone 
evaluation and management service by a physician or other qualified 
health care professional who may report evaluation and management 
services provided to an established patient, parent, or guardian not 
originating from a related E/M service provided within the previous 7 
days nor leading to an E/M service or procedure within the next 24 
hours or soonest available appointment; 5-10 minutes of medical 
discussion). HCPCS code G0071, the new virtual communication G-code for 
RHCs and FQHCs, is set at the average of the PFS national non-facility 
payment rates for HCPCS codes G2012 and G2010, and would be billed by 
the RHC or FQHC when the minimum requirements for either of these codes 
are met.
    Except for the Initial Preventive Physical Exam and the Annual 
Wellness Visit, RHC and FQHC visits do not have frequency limitations, 
and a patient could have more than one RHC or FQHC billable visit in 
the same week if it is a medically-necessary, face-to-face visit with 
an RHC or FQHC practitioner. If a service is not medically-necessary, 
or is not furnished by an RHC or FQHC practitioner, or does not require 
the skill level of an RHC or FQHC practitioner, it would not be a 
billable visit. Since the RHC AIR and FQHC PPS payment methodologies 
are designed to include all services and supplies incident to a visit, 
the absence of time restrictions could result in duplicate payment to 
the RHC or FQHC. Since the virtual communication payment is designed to 
provide payment to the RHC or FQHC when there is no billable visit, the 
time restrictions are necessary to avoid any duplicate payment.
    Communication technology-based and remote evaluation services are 
initiated by a patient who has been seen in the past year by the RHC or 
FQHC practitioner, and in many cases, a review of prior patient 
clinical activity and diagnoses would be necessary as part of the 
virtual communication with the patient. Since most RHCs and FQHCs are 
utilizing electronic health records, we expect that RHCs and

[[Page 59687]]

FQHCs will be able to comply with the time restrictions without any 
additional burden. It is also our understanding that most RHCs and 
FQHCs (like other providers and supplies) may not always submit a claim 
immediately upon furnishing a service. As with any new service, we 
expect that there would be a period of adjustment, and we will monitor 
implementation to determine if changes are necessary.
    Comment: Commenters questioned if an RHC could bill for virtual 
communication services if the discussion results in the patient going 
to an emergency room, an urgent care center, or a specialist not 
affiliated with the RHC or FQHC, or if it leads to an ``incident-to'' 
service at the RHC (such as an injection) that is not a billable visit.
    Response: If the discussion with the RHC or FQHC practitioner does 
not occur within 7 days of an RHC or FQHC visit, and does not result in 
an RHC or FQHC visit with 24 hours or the soonest available appointment 
with an RHC or FQHC practitioner, and all other requirements are met, 
the RHC or FQHC could bill for virtual communication services. This 
would apply even if the patient is subsequently seen in an emergency 
room, urgent care center, or by a non-RHC or FQHC practitioner, or has 
a subsequent non-billable service in the RHC or FQHC such as an 
injection.
    Comment: A commenter questioned if communication technology-based 
and remote evaluation services could be used by RHC and FQHC 
practitioners to help beneficiaries determine whether they should visit 
an RHC or FQHC for DSMT services, and states that this would allow RHC 
and FQHC practitioners to reach beneficiaries in both rural and urban 
underserved area and improve the lives of beneficiaries with diabetes. 
Another commenter questioned if the new virtual communication codes for 
RHCs and FQHCs would impact payment for DSMT in FQHCs.
    Response: We agree that outreach and education to communities on 
diabetes prevention services are important, especially in rural and 
urban underserved areas. However, communication technology-based and 
remote evaluation services would be billable by RHCs and FQHCs only 
when the discussion requires the skill level of the RHC or FQHC 
practitioner. If the discussion could be conducted by a nurse, health 
educator, or other clinical personnel, it would not be billable as a 
virtual communication service. Payment for DSMT in FQHCs would not be 
impacted by the new virtual communication codes.
    Comment: A commenter agreed that virtual communication services 
should be limited to established patients (seen by an RHC or FQHC 
practitioner within the previous year), and recommends that audio-only 
technology (that is, telephone) should be allowed for virtual check-ins 
because many RHC or FQHC patients may not have access to technology 
capabilities beyond audio-only communication.
    Response: We note that while other technology can be used, 
telephone discussions are acceptable for billing the virtual 
communication G-code.
    Comment: A commenter suggested that CMS should consider redefining 
what constitutes a billable RHC visit and develop a new and expansive 
definition so that new healthcare services such as care management and 
virtual communication services can be incorporated in the RHC cost-
based model in the same manner as face-to-face billable visits.
    Response: We welcome suggestions on modifying program requirements, 
but redefining RHC and FQHC billable visits is outside the scope of 
this regulation.
    Comment: A commenter stated that the proposed PFS change for CPT 
code 99213 will result in independent RHCs and provider-based RHCs with 
more than 50 beds being paid $10 less per visit than practitioners 
billing under the PFS. The commenter stated that this will cause some 
RHCs to leave the RHC program, resulting in higher costs to Medicare, 
and questioned what can be done to raise the RHC capped encounter 
payment.
    Response: RHCs are paid based on their costs, subject to a payment 
limit set out at section 1833(f) of the Act, except for those RHCs that 
have an exception to the payment limit, and is adjusted annually based 
on the Medicare Economic Index. We do not have the authority to make 
changes in the RHC payment rate.
    Comment: A commenter questioned if this proposed change will impact 
the FQHC payment rate.
    Response: The RHC AIR and the FQHC PPS would not be impacted by 
these changes.
    Comment: A commenter questioned if the new virtual communication G-
code would be accepted by Medicare Advantage Plans.
    Response: HCPCS code G0071 is part of the HCPCS code set and must 
be accepted by all payers as a HIPAA standard (45 CFR 162.1002). RHCs 
and FQHCs should consult their associated MA plans for billing 
information.
    Comment: A commenter questioned whether the two new add-on codes 
proposed for inherent visit complexity would apply to RHCs and FQHCs 
and be eligible for separate payment in addition to their standard all 
inclusive rate, and several commenters requested that RHCs and FQHCs be 
allowed to bill separately for interprofessional internet 
consultations.
    Response: The two new add-on codes proposed for inherent visit 
complexity are for practitioners billing under the PFS, and do not 
apply to RHCs and FQHCs. The RHC AIR and the FQHC PPS includes all 
costs associated with a billable visit, and therefore consultations 
with other practitioners are not separately billable.
    Comment: We received comments on allowing RNs to provide billable 
visits in RHCs, allowing FQHCs to bill for assessment and care planning 
for patients with cognitive impairment, reducing the requirements for 
psychiatric collaborative care management services in RHCs and FQHCs, 
providing separate payment to RHCs and FQHCs for medications to treat 
alcohol and substance use disorders, revising payment for pneumococcal 
vaccines, and reducing the requirements for patient consent for care 
management services.
    Response: These comments are beyond the scope of this rule.
5. Finalized Provisions
    As a result of the comments, we are finalizing the following 
provisions:
     Effective January 1, 2019, the payment rate for HCPCS code 
G0511 (General Care Management Services) is set at the average of the 
national non-facility PFS payment rates for CPT codes 99490, 99487, 
99484, and 99491.
     Effective January 1, 2019, RHCs and FQHCs are paid for 
HCPCS code G0071 (Virtual Communication Services), when HCPCS code 
G0071 is on an RHC or FQHC claim, either alone or with other payable 
services, and at least 5 minutes of communication technology-based or 
remote evaluation services are furnished by an RHC or FQHC practitioner 
to a patient who has had an RHC or FQHC billable visit within the 
previous year, and the medical discussion or remote evaluation is for a 
condition not related to an RHC or FQHC service provided within the 
previous 7 days, and does not lead to an RHC or FQHC visit within the 
next 24 hours or at the soonest available appointment. We are adding a 
new paragraph (e) to Sec.  405.2464 to reflect this payment and making 
additional minor conforming changes to this section.
     HCPCS code G0071 is set at the average of the national 
non-facility PFS payment rates for HCPCS code G2012

[[Page 59688]]

(communication technology-based services) and HCPCS code G2010 (remote 
evaluation services) and is updated annually based on the PFS national 
non-facility payment rate for these codes.
     RHC and FQHC face-to-face requirements are waived when 
these services are furnished to an RHC or FQHC patient. Coinsurance and 
deductibles apply to RHC claims for G0071 and coinsurance applies to 
FQHC claims for G0071.
6. Other Regulatory Updates
    In addition to the regulatory change described in this section of 
the rule, we are finalizing the following technical corrections for 
accuracy:
     Removal of the extra section mark in the definition of 
``Federally qualified health center (FQHC)'' in Sec.  405.2401.
     Replacing the word ``his'' with ``his or her'' in the 
definition of ``Secretary'' in Sec.  405.2401.
     Reordering the occurrence of RHC and FQHC in Sec.  
405.2462(g).
7. Substance Use-Disorder Prevention That Promotes Opioid Recovery and 
Treatment (SUPPORT) for Patients and Communities Act
    Section 6083 of the SUPPORT for Patients and Communities Act (Pub. 
L. 115-271, enacted on October 24, 2018) provides additional payments 
to RHCs and FQHCs for services furnished for the treatment of opioid 
use disorders by practitioners meeting certain requirements. We 
anticipate guidance from the Department of Health and Human Services on 
the implementation of this provision will be forthcoming.

D. Appropriate Use Criteria for Advanced Diagnostic Imaging Services

    Section 218(b) of the Protecting Access to Medicare Act (PAMA) 
(Pub. L. 113-93, enacted April 1, 2014) amended Title XVIII of the Act 
to add section 1834(q) of the Act directing us to establish a program 
to promote the use of appropriate use criteria (AUC) for advanced 
diagnostic imaging services. The CY 2016 PFS final rule with comment 
period addressed the initial component of the new Medicare AUC program, 
specifying applicable AUC. In that rule (80 FR 70886), we established 
an evidence-based process and transparency requirements for the 
development of AUC, defined provider-led entities (PLEs) and 
established the process by which PLEs may become qualified to develop, 
modify or endorse AUC. The first list of qualified PLEs was posted on 
the CMS website at the end of June 2016 at which time their AUC 
libraries became specified applicable AUC for purposes of section 
1834(q)(2)(A) of the Act. The CY 2017 PFS final rule addressed the 
second component of this program, specification of qualified clinical 
decision support mechanisms (CDSMs). In the CY 2017 PFS final rule (81 
FR 80170), we defined CDSM, identified the requirements CDSMs must meet 
for qualification, including preliminary qualification for mechanisms 
documenting how and when each requirement is reasonably expected to be 
met, and established a process by which CDSMs may become qualified. We 
also defined applicable payment systems under this program, specified 
the first list of priority clinical areas, and identified exceptions to 
the requirement that ordering professionals consult specified 
applicable AUC when ordering applicable imaging services. The first 
list of qualified CDSMs was posted on the CMS website in July 2017.
    The CY 2018 PFS final rule addressed the third component of this 
program, the consultation and reporting requirements. In the CY 2018 
PFS final rule (82 FR 53190), we established the start date of January 
1, 2020 for the Medicare AUC program for advanced diagnostic imaging 
services. It is for services ordered on and after this date that 
ordering professionals must consult specified applicable AUC using a 
qualified CDSM when ordering applicable imaging services, and 
furnishing professionals must report AUC consultation information on 
the Medicare claim. We further specified that the AUC program will 
begin on January 1, 2020 with a year-long educational and operations 
testing period during which time AUC consultation information is 
expected to be reported on claims, but claims will not be denied for 
failure to include proper AUC consultation information. We also 
established a voluntary period from July 2018 through the end of 2019 
during which ordering professionals who are ready to participate in the 
AUC program may consult specified applicable AUC through qualified 
CDSMs and communicate the results to furnishing professionals, and 
furnishing professionals who are ready to do so may report AUC 
consultation information on the claim (https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10481.pdf). Additionally, to incentivize early use of 
qualified CDSMs to consult AUC, we established in the CY 2018 Updates 
to the Quality Payment Program; and Quality Payment Program: Extreme 
and Uncontrollable Circumstances Policy for the Transition Year final 
rule with comment period and interim final rule (hereinafter ``CY 2018 
Quality Payment Program final rule'') a high-weight improvement 
activity for ordering professionals who consult specified AUC using a 
qualified CDSM for the Merit-based Incentive Payment System (MIPS) 
performance period that began January 1, 2018 (82 FR 54193).
    In the CY 2019 PFS proposed rule, we proposed additions to the 
definition of applicable setting, clarification around who may perform 
the required AUC consultation using a qualified CDSM under this 
program, clarification that reporting is required across claim types 
and by both the furnishing professional and furnishing facility, 
changes to the policy for significant hardship exceptions for ordering 
professionals under this program, mechanisms for claims-based 
reporting, and a solicitation of feedback regarding the methodology to 
identify outlier ordering professionals.
1. Background
    AUC present information in a manner that links: A specific clinical 
condition or presentation; one or more services; and an assessment of 
the appropriateness of the service(s). Evidence-based AUC for imaging 
can assist clinicians in selecting the imaging study that is most 
likely to improve health outcomes for patients based on their 
individual clinical presentation. For purposes of this program, AUC is 
a set or library of individual appropriate use criteria. Each 
individual criterion is an evidence-based guideline for a particular 
clinical scenario based on a patient's presenting symptoms or 
condition.
    AUC need to be integrated as seamlessly as possible into the 
clinical workflow. CDSMs are the electronic portals through which 
clinicians access the AUC during the patient workup. They can be 
standalone applications that require direct entry of patient 
information, but may be more effective when they are integrated into 
electronic health records (EHRs). Ideally, practitioners would interact 
directly with the CDSM through their primary user interface, thus 
minimizing interruption to the clinical workflow.
2. Statutory Authority
    Section 218(b) of the PAMA added a new section 1834(q) of the Act 
entitled, ``Recognizing Appropriate Use Criteria for Certain Imaging 
Services,'' which directs the Secretary to establish a new program to 
promote the use of AUC. Section 1834(q)(4) of the Act requires

[[Page 59689]]

ordering professionals to consult with specified applicable AUC through 
a qualified CDSM for applicable imaging services furnished in an 
applicable setting and paid for under an applicable payment system; and 
payment for such service may only be made if the claim for the service 
includes information about the ordering professional's consultation of 
specified applicable AUC through a qualified CDSM.
3. Discussion of Statutory Requirements
    There are four major components of the AUC program under section 
1834(q) of the Act, and each component has its own implementation date: 
(1) Establishment of AUC by November 15, 2015 (section 1834(q)(2) of 
the Act); (2) identification of mechanisms for consultation with AUC by 
April 1, 2016 (section 1834(q)(3) of the Act); (3) AUC consultation by 
ordering professionals, and reporting on AUC consultation by January 1, 
2017 (section 1834(q)(4) of the Act); and (4) annual identification of 
outlier ordering professionals for services furnished after January 1, 
2017 (section 1834(q)(5) of the Act). We did not identify mechanisms 
for consultation by April 1, 2016. Therefore, we did not require 
ordering professionals to consult CDSMs or furnishing professionals to 
report information on the consultation by the January 1, 2017 date.
a. Establishment of AUC
    In the CY 2016 PFS final rule with comment period, we addressed the 
first component of the Medicare AUC program under section 1834(q)(2) of 
the Act--the requirements and process for establishment and 
specification of applicable AUC, along with relevant aspects of the 
definitions under section 1834(q)(1) of the Act. This included defining 
the term ``provider-led entity'' and finalizing requirements for the 
rigorous, evidence-based process by which a PLE would develop AUC, upon 
which qualification is based, as provided in section 1834(q)(2)(B) of 
the Act and in the CY 2016 PFS final rule with comment period. Using 
this process, once a PLE is qualified by us, the AUC that are 
developed, modified or endorsed by the qualified PLE are considered to 
be specified applicable AUC under section 1834(q)(2)(A) of the Act. We 
defined PLE to include national professional medical societies, health 
systems, hospitals, clinical practices and collaborations of such 
entities such as the High Value Healthcare Collaborative or the 
National Comprehensive Cancer Network. Qualified PLEs may collaborate 
with third parties that they believe add value to their development of 
AUC, provided such collaboration is transparent. We expect qualified 
PLEs to have sufficient infrastructure, resources, and the relevant 
experience to develop and maintain AUC according to the rigorous, 
transparent, and evidence-based processes detailed in the CY 2016 PFS 
final rule with comment period.
    In the same rule we established a timeline and process under Sec.  
414.94(c)(2) for PLEs to apply to become qualified. Consistent with 
this timeline the first list of qualified PLEs was published at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/PLE.html in June 2016 (OMB 
Control Number 0938-1288).
b. Mechanism for AUC Consultation
    In the CY 2017 PFS final rule, we addressed the second major 
component of the Medicare AUC program--the specification of qualified 
CDSMs for use by ordering professionals for consultation with specified 
applicable AUC under section 1834(q)(3) of the Act, along with relevant 
aspects of the definitions under section 1834(q)(1) of the Act. This 
included defining the term CDSM and finalizing functionality 
requirements of mechanisms, upon which qualification is based, as 
provided in section 1834(q)(3)(B) of the Act and in the CY 2017 PFS 
final rule. CDSMs may receive full qualification or preliminary 
qualification if most, but not all, of the requirements are met at the 
time of application. The preliminary qualification period began June 
30, 2017 and ends when the AUC consulting and reporting requirements 
become effective on January 1, 2020. The preliminarily qualified CDSMs 
must meet all requirements by that date. We defined CDSM as an 
interactive, electronic tool for use by clinicians that communicates 
AUC information to the user and assists them in making the most 
appropriate treatment decision for a patient's specific clinical 
condition. Tools may be modules within or available through certified 
EHR technology (as defined in section 1848(o)(4) of the Act) or private 
sector mechanisms independent from certified EHR technology or a 
mechanism established by the Secretary.
    In the CY 2017 PFS final rule, we established a timeline and 
process in Sec.  414.94(g)(2) for CDSM developers to apply to have 
their CDSMs qualified. Consistent with this timeline, the first list of 
qualified CDSMs was published at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM.html in July 2017 (OMB Control Number 0938-1315).
c. AUC Consultation and Reporting
    In the CY 2018 PFS final rule, we addressed the third major 
component of the Medicare AUC program--consultation with applicable AUC 
by the ordering professional and reporting of such consultations under 
section 1834(q)(4) of the Act. We established a January 1, 2020 
effective date for the AUC consultation and reporting requirements for 
this program. We also established a voluntary period during which early 
adopters can begin reporting limited consultation information on 
Medicare claims from July 2018 through December 2019. During the 
voluntary period there is no requirement for ordering professionals to 
consult AUC or furnishing professionals to report information related 
to the consultation. On January 1, 2020, the program will begin with an 
educational and operations testing period and during this time we will 
continue to pay claims whether or not they correctly include AUC 
consultation information. Ordering professionals must consult specified 
applicable AUC through qualified CDSMs for applicable imaging services 
furnished in an applicable setting, paid for under an applicable 
payment system and ordered on or after January 1, 2020; and furnishing 
professionals must report the AUC consultation information on the 
Medicare claim for these services ordered on or after January 1, 2020.
    Consistent with section 1834(q)(4)(B) of the Act, we also 
established that furnishing professionals must report the following 
information on Medicare claims for advanced diagnostic imaging services 
as specified in section 1834(q)(1)(C) of the Act and defined in Sec.  
414.94(b), furnished in an applicable setting as defined in section 
1834(q)(1)(D) of the Act, paid for under an applicable payment system 
as defined in section 1834(q)(4)(D) of the Act, and ordered on or after 
January 1, 2020: (1) The qualified CDSM consulted by the ordering 
professional; (2) whether the service ordered would or would not adhere 
to specified applicable AUC, or whether the specified applicable AUC 
consulted was not applicable to the service ordered; and (3) the NPI of 
the ordering professional (if different from the furnishing 
professional). Clarifying revisions to the reporting requirement are 
discussed later in this preamble.
    Section 1834(q)(4)(C) of the Act provides for exceptions to the AUC 
consultation and reporting requirements in the case of: A service 
ordered for an

[[Page 59690]]

individual with an emergency medical condition, a service ordered for 
an inpatient and for which payment is made under Medicare Part A, and a 
service ordered by an ordering professional for whom the Secretary 
determines that consultation with applicable AUC would result in a 
significant hardship. In the CY 2017 PFS final rule, we adopted a 
regulation at Sec.  414.94(h)(1)(i) to specify the circumstances under 
which AUC consultation and reporting requirements are not applicable. 
These include applicable imaging services ordered: (1) For an 
individual with an emergency medical condition (as defined in section 
1867(e)(1) of the Act); (2) for an inpatient and for which payment is 
made under Medicare Part A; and (3) by an ordering professional who is 
granted a significant hardship exception to the Medicare EHR Incentive 
Program payment adjustment for that year under Sec.  495.102(d)(4), 
except for those granted under Sec.  495.102(d)(4)(iv)(C). In the CY 
2019 PFS proposed rule, we proposed changes to the conditions for 
significant hardship exceptions, and we summarize and respond to public 
comments on our proposals later in this preamble. We remind readers 
that, consistent with section 1834(q)(4)(A) of the Act, ordering 
professionals must consult AUC for every applicable imaging service 
furnished in an applicable setting and paid under an applicable payment 
system unless a statutory exception applies.
    Section 1834(q)(4)(D) of the Act specifies the applicable payment 
systems for which AUC consultation and reporting requirements apply 
and, in the CY 2017 PFS final rule, consistent with the statute, we 
defined applicable payment system in our regulation at Sec.  414.94(b) 
as: (1) The PFS established under section 1848(b) of the Act; (2) the 
prospective payment system for hospital outpatient department services 
under section 1833(t) of the Act; and (3) the ambulatory surgical 
center payment system under section 1833(i) of the Act.
    Section 1834(q)(1)(D) of the Act specifies the applicable settings 
in which AUC consultation and reporting requirements apply: A 
physician's office, a hospital outpatient department (including an 
emergency department), an ambulatory surgical center, and any other 
``provider-led outpatient setting determined appropriate by the 
Secretary.'' In the CY 2017 PFS final rule, we added this definition to 
our regulation at Sec.  414.94(b). Proposed additional applicable 
settings are discussed later in this preamble.
d. Identification of Outliers
    The fourth component of the Medicare AUC program is specified in 
section 1834(q)(5) of the Act, Identification of Outlier Ordering 
Professionals. The identification of outlier ordering professionals 
under this paragraph facilitates a prior authorization requirement that 
applies for outlier professionals beginning January 1, 2020, as 
specified under section 1834(q)(6) of the Act. Because we established a 
start date of January 1, 2020 for AUC consultation and reporting 
requirements, we will not have identified any outlier ordering 
professionals by that date. As such, implementation of the prior 
authorization component is delayed. However, we did finalize in the CY 
2017 PFS final rule the first list of priority clinical areas to guide 
identification of outlier ordering professionals as follows:
     Coronary artery disease (suspected or diagnosed).
     Suspected pulmonary embolism.
     Headache (traumatic and non-traumatic).
     Hip pain.
     Low back pain.
     Shoulder pain (to include suspected rotator cuff injury).
     Cancer of the lung (primary or metastatic, suspected or 
diagnosed).
     Cervical or neck pain.
    We did not include proposals to expand or modify the list of 
priority clinical areas in this final rule.
4. Proposals for Continuing Implementation
    In the CY 2019 PFS proposed rule, we proposed to amend Sec.  414.94 
of our regulations, ``Appropriate Use Criteria for Certain Imaging 
Services,'' to reflect the following policies.
a. Expanding Applicable Settings
    Section 1834(q)(1)(D) of the Act specifies that the AUC 
consultation and reporting requirements apply only in an applicable 
setting, which means a physician's office, a hospital outpatient 
department (including an emergency department), an ambulatory surgical 
center, and any other provider-led outpatient setting determined 
appropriate by the Secretary. In the CY 2017 PFS final rule, we 
codified this definition in Sec.  414.94(b). We proposed to revise the 
definition of applicable setting to add an independent diagnostic 
testing facility (IDTF).
    We believe the addition of IDTFs to the definition of applicable 
setting will ensure that the AUC program is in place across outpatient 
settings in which outpatient advanced diagnostic imaging services are 
furnished. IDTFs furnish services for a large number of Medicare 
beneficiaries; nearly $1 billion in claims for 2.4 million 
beneficiaries in 2010 (OEI-05-09-00560). An IDTF is independent of a 
hospital or physician's office and diagnostic tests furnished by an 
IDTF are performed by licensed, certified non-physician personnel under 
appropriate physician supervision (Sec.  410.33). Like other applicable 
settings, IDTFs must meet the requirements specified in Sec.  410.33 of 
our regulations to be enrolled to furnish and bill for advanced 
diagnostic imaging and other IDTF services. Services that may be 
provided by an IDTF include, but are not limited to, magnetic resonance 
imaging (MRI), ultrasound, x-rays, and sleep studies. An IDTF may be a 
fixed location, a mobile entity, or an individual non-physician 
practitioner, and diagnostic procedures performed by an IDTF are paid 
under the PFS. IDTF services must be furnished under the appropriate 
level of physician supervision as specified in Sec.  410.33(b); and all 
procedures furnished by the IDTF must be ordered in writing by the 
patient's treating physician or non-physician practitioner. As such, we 
believe the IDTF setting is a provider-led outpatient setting 
appropriate for addition to the list of applicable settings under 
section 1834(q)(1)(D), and we proposed to add IDTF to our definition of 
applicable setting under Sec.  414.94(b) of the regulations.
    We note that under the PFS, payment for many diagnostic tests 
including the advanced diagnostic imaging services to which the AUC 
program applies can be made either ``globally'' when the entire service 
is furnished and billed by the same entity; or payment can be made 
separately for the technical component (TC) of the service and the 
professional component (PC) when those portions of the service are 
furnished and billed by different entities. In general, the TC for an 
advanced diagnostic imaging service is the portion of the test during 
which the patient is present and the image is captured. The PC is the 
portion of the test that involves a physician's interpretation and 
report on the captured image. For example, when a CT scan is ordered by 
a patient's treating physician, the entire test (TC and PC) could be 
furnished by a radiologist in their office and billed as a ``global'' 
service. Alternatively, the TC could be furnished and billed by an 
IDTF, and the PC could be furnished and billed by a radiologist in 
private practice. By adding IDTFs as an

[[Page 59691]]

applicable setting, we believe we would appropriately and consistently 
apply the AUC program across the range of outpatient settings where 
applicable imaging services are furnished.
    We proposed to revise the definition of applicable setting under 
Sec.  414.94(b) to include an IDTF. We invited comments on this 
proposal and on the possible inclusion of any other applicable setting. 
We reminded commenters that application of the AUC program is not only 
limited to applicable settings, but also to services for which payment 
is made under applicable payment systems (the PFS, the OPPS, and the 
ASC payment system).
    The following is a summary of the comments we received on revising 
the definition of applicable setting under Sec.  414.94(b) to include 
an IDTF and on the possible inclusion of any other applicable setting.
    Comment: The majority of commenters supported adding IDTF to the 
definition of applicable setting. These commenters agreed that this 
addition would apply the AUC program appropriately and consistently 
across outpatient settings where applicable advanced diagnostic imaging 
services are furnished and reported. In contrast, a few commenters were 
concerned with expanding the definition of applicable setting until CMS 
and other impacted stakeholders have a better understanding of the 
program and 3 to 5 years of experience with it. These commenters 
suggested that any expanded definition will add complexity and make 
implementation even more difficult by the 2020 required start date as 
the addition of another applicable setting would require broader 
reporting of AUC consultation information. To this end, these 
commenters requested modification to the proposal to allow some 
flexibility on the timeline to add IDTFs as an applicable setting. 
Finally, a few commenters requested that the definition of applicable 
setting be further expanded to include any office-based service, 
including for example, situations in which physicians have an MRI in 
their own office.
    Response: We appreciate these perspectives by the commenters. We 
continue to believe that the IDTF setting is a provider-led outpatient 
setting appropriate for addition to the list of applicable settings 
under section 1834(q)(1)(D) of the Act, and are finalizing this 
definition as proposed. We disagree that the definition will add 
complexity as we seek consistency in applying our regulations across 
outpatient settings in which outpatient advanced diagnostic imaging 
services are furnished, and would be concerned with applying these 
requirements in different settings along different timelines. Because 
we did not propose adding other settings to this definition we will not 
expand it further in this final rule, but will continue to monitor 
claims for advanced diagnostic imaging services across the Medicare 
program. We remind readers that the physician's office (including one 
where advanced imaging equipment is located), hospital outpatient 
department (including an emergency department), and an ambulatory 
surgical center are already included in the definition of applicable 
setting.
    After considering the comments, we are finalizing the proposal 
revising the definition of applicable setting under Sec.  414.94(b) to 
include an IDTF.
b. Consultations by Ordering Professionals
    Section 1834(q)(1)(E) of the Act defines the term ``ordering 
professional'' as a physician (as defined in section 1861(r)) or a 
practitioner described in section 1842(b)(18)(C) who orders an 
applicable imaging service. The AUC consultation requirement applies to 
these ordering professionals. We proposed that the consultation with 
AUC through a qualified CDSM may be performed by auxiliary personnel 
under the direction of the ordering professional and incident to the 
ordering professional's services, when the consultation is not 
performed personally by the ordering professional whose NPI will be 
listed on the order for an advanced imaging service.
    In response to the CY 2018 PFS proposed rule, we received several 
public comments requesting clarification regarding who is required to 
perform the consultation of AUC through a qualified CDSM. Commenters 
not only sought clarification, but also provided recommendations for 
requirements around this topic. Some commenters recommended that CMS 
strictly interpret the statutory language and only allow the clinician 
placing the order to perform the consultation and others recommended 
that CMS allow others to perform the AUC consultation on behalf of the 
clinician.
    Section 1834(q)(4)(A)(i) of the Act requires an ordering 
professional to consult with a qualified CDSM, and this was codified in 
our regulations at Sec.  414.94(j). The statute does not explicitly 
provide for consultations under the AUC program to be fulfilled by 
other professionals, individuals or organizations on behalf of the 
ordering professional; however, we continue to seek ways to minimize 
the burden of this new Medicare program and understand that many 
practices currently use clinical staff, working under the direction of 
the ordering professional, to interact with the CDSM for AUC 
consultation and subsequent ordering of advanced diagnostic imaging. 
Therefore, we proposed to modify paragraph Sec.  414.94(j) to specify 
that additional individuals may perform the required AUC consultation.
    When the AUC consultation is not performed personally by the 
ordering professional, we proposed the consultation may be performed by 
auxiliary personnel incident to the ordering physician or non-physician 
practitioner's professional service. We believed this approach was 
appropriate under this program and still accomplishes the goal of 
promoting the use of AUC. This proposed policy would allow the ordering 
professional to exercise their discretion to delegate the performance 
of this consultation. It is important to note that the ordering 
professional is ultimately responsible for the consultation as their 
NPI is reported by the furnishing professional on the claim for the 
applicable imaging service; and that it is the ordering professional 
who could be identified as an outlier ordering professional and become 
subject to prior authorization based on their ordering pattern.
    We proposed to revise the AUC consultation requirement specified at 
Sec.  414.94(j) to specify that the AUC consultation may be performed 
by auxiliary personnel under the direction of the ordering professional 
and incident to the ordering professional's services.
    The following is a summary of the comments we received on this 
proposal. Overall commenters either agreed or disagreed with the 
proposal to expand who can perform the consultation with a qualified 
CDSM, and the commenters that agreed with the concept of the proposal 
either requested clarification around the term auxiliary personnel or 
recommended that we use more specific language to describe eligible 
personnel.
    Comment: Some commenters were completely against the concept of 
this proposal and did not support allowing anyone beyond the ordering 
professional to perform the AUC consultation stating that allowing 
anyone other than the ordering professional to perform the consultation 
would undermine the intent of the AUC program and increase 
administrative burden. A few of those commenters suggested that 
expanding the scope of individuals who can perform the consultation 
would actually increase

[[Page 59692]]

burden and confusion for ordering professionals. Others opposed the 
proposal on the basis that the educational goals of the program would 
be undermined or auxiliary personnel would manipulate the information 
to achieve adherent responses. These commenters wanted ordering 
professionals to be directly exposed to AUC. Some of the commenters 
that agreed with the proposal specifically stated that the intent of 
the AUC program would not be diminished by expanding AUC consultation 
beyond the ordering professional. However, the vast majority of 
commenters agreed that expanding beyond the ordering professional 
allows flexibility and the opportunity for the AUC consultation 
requirement to be less burdensome on the ordering professional.
    Response: We agree that the AUC program should be a learning 
program for ordering professionals. However, to balance the burden put 
upon ordering professionals and their offices to comply with this 
program as well as focus on the educational component of this program, 
we maintain that expanding AUC consultations to individuals beyond the 
ordering professional is an important step. We envision that the 
ordering professionals will, even when they do not personally perform 
the AUC consultation, remain closely involved and will engage with the 
individual to whom they delegate the task of performing the 
consultation. For many ordering professionals, this delegation may save 
time when they routinely order tests that are consistently considered 
to adhere to AUC. In those cases, the back-and-forth between the 
ordering professional and the individual who conducts the consultation 
may be minimal. We anticipate that, when an AUC consultation is 
performed by someone other than the ordering professional and the 
result is that the imaging service does not adhere to the consulted 
AUC, that information will be provided back to the ordering 
professional to allow them to consider whether a different test (or no 
test) should be ordered, or if the original order is still appropriate 
for the patient. Additionally, ordering professionals may still choose 
to personally perform the consultation. This may be ideal for ordering 
professionals with CDSMs that allow for seamless interaction, such as 
the case of a CDSM integrated within an EHR.
    Regardless of who performs the AUC consultation, the ordering 
professional is ultimately responsible for the order and may become 
subject to prior authorization if they demonstrate a pattern of non-
adherent orders. Therefore, the ordering professional not only has a 
vested interest in terms of providing the right test for their patient, 
but also to monitor the frequency with which they order tests that do 
not adhere to AUC.
    Comment: While the majority of commenters agreed with expanding 
who, beyond the ordering professional, can personally perform the 
consultation with a qualified CDSM, they expressed either confusion 
with the term ``auxiliary personnel'' or recommended additional 
regulatory language to more specifically identify the scope of 
individuals who could perform the AUC consultation. Other commenters 
questioned the applicability of ``incident to'' provisions since 
consulting AUC through a CDSM is not a billable service.
    Some commenters suggested additional language that would identify 
specific licensed professionals, lay out training requirements, allow 
for medical assistants or credentialed clinical staff, cite state scope 
of practice laws, or require that the individual be present in the 
office of the ordering professional. These commenters stated that the 
AUC consultation should not be an administrative task that can be 
performed by any staff member, such as a receptionist or data entry 
clerk. The underlying concern of commenters that wanted to explicitly 
allow only clinical personnel to consult AUC was that the individual 
performing an AUC consultation would need to understand the patient's 
medical information, the advanced imaging service being recommended and 
the clinical information that is returned by the CDSM. Commenters 
stated that this understanding on the part of the individual who 
performs the AUC consultation was particularly important when a CDSM 
indicates that the order is not adherent to AUC.
    Some commenters specifically addressed our proposal that the 
individual who consults AUC must be under the direction of the ordering 
professional. At least one commenter noted the need for direct 
supervision while another said the individual should be physically 
located in the office of the ordering professional as opposed to off-
site. Other commenters suggested that we use language that allows for 
maximum flexibility.
    One commenter gave an example that drew parallels between CDSMs and 
Computerized Provider Order Entry (CPOE) systems, and suggested the 
same requirements should apply to individuals consulting CDSMs. The 
commenter stated that for CPOE entries to count toward meeting Medicaid 
Meaningful Use thresholds, the entry must be made by a licensed 
healthcare professional or credentialed medical assistant. Similarly, 
the commenter suggested the consultation should be performed consistent 
with state scope of practice laws since the use of CPOE is limited to 
those individuals referenced above, as it is within their state scope 
of practice to enter orders into medical records.
    Response: We agree with comments suggesting that the language we 
proposed could potentially cause confusion, and we understand the 
disagreement among commenters regarding precisely who, beyond the 
ordering professional, should be eligible to perform the AUC 
consultation. We further agree that the concept of services incident to 
a physician's professional services may not be directly relevant to the 
action of consulting AUC using a CDSM. We proposed using ``incident 
to'' as a description of the relationship between the ordering 
professional and the auxiliary personnel consulting the AUC.
    We also agree that there are similarities between CPOE systems and 
CDSMs, and that individuals using these systems should have some level 
of knowledge of the clinical information they are inputting and, 
importantly, the information they receive back from the system. 
However, we also agree with the view of most commenters that ordering 
professionals should have flexibility to delegate the AUC consultation 
task. We also agree that the learning and educational aspects of AUC 
are more likely to be realized when there is real communication between 
the ordering professional and the person performing the consultation. 
While we proposed the consultation could be performed incident to the 
ordering professional's service, we agree with commenters that the 
``incident to'' concept is difficult to apply to a service that is not 
billable and does not require the patient to be present. We further 
agree with comments recommending that there be good communication and a 
close relationship between the ordering professional and individual 
consulting the AUC. In the case of consulting AUC, we believe it is 
important that the individual who uses the CDSM is working under the 
ordering professional, and that the individual is available to the 
ordering professional to discuss the results of the consultation and 
any responsive adjustments to planned orders.
    Comment: A few commenters suggested allowing the furnishing 
professional to occasionally consult AUC using a CDSM. Another

[[Page 59693]]

commenter questioned whether auxiliary personnel would be permitted to 
change the order based on the AUC consultation and an additional 
commenter questioned whether physical therapists could write orders.
    Response: While a furnishing professional may consult AUC as they 
wish for other purposes, such a consultation would not suffice for 
purposes of the AUC consultation required under this program. The AUC 
consultation must be performed by the ordering professional or an 
individual to whom the ordering professional has delegated it; and the 
ordering professional may only delegate the required AUC consultation 
to an individual as specified in our final policy. The furnishing 
professional may perform their own AUC consultation to verify 
information; however, that would not replace the consultation that is 
required to be performed by the ordering professional or their 
appropriately designated surrogate. The AUC program does not change the 
scope of professionals permitted under law to write or change orders 
for advanced diagnostic imaging services.
    Comment: Some commenters questioned whether there was statutory 
authority to allow anyone other than the ordering professional to 
personally perform the AUC consultation with a CDSM.
    Response: We do not believe it is inconsistent with the statute to 
allow an individual other than the ordering professional to perform the 
AUC consultation with a qualified CDSM. Moreover, regardless of who 
performs the act of consulting with a qualified CDSM, it is important 
to understand that the ordering professional remains ultimately 
responsible for the AUC consultation and communication of the 
consultation information to the furnishing professional.
    Comment: A commenter who disagreed with our proposal to permit 
certain individuals other than the ordering professional to perform the 
AUC consultation suggested that the proposal is counter to the intent 
of the existing regulation at Sec.  414.94(k) finalized in the CY 2018 
PFS final rule. The commenter suggested that educating ordering 
professionals regarding the optimal use of advanced imaging services 
can only be accomplished when ordering professionals are directly 
exposed to AUC.
    Response: We believe the intent of the statutory provisions 
requiring the AUC program is to increase appropriate ordering of 
advanced imaging services through a learning system, and that can still 
be achieved even if we allow delegation of the consultation when the 
individual performing it has the proper training and is working under 
the appropriate direction of the ordering professional.
    Comment: One commenter requested a specific set of standards or 
training requirements for such auxiliary personnel to ensure that 
diagnostic imaging services comply with AUC requirements.
    Response: At this time, we are not in a position to establish 
training requirements or standards tailored to the AUC program for 
individuals that may be delegated the AUC consultation.
    Based on the public comments received, we do not believe it would 
be appropriate to move forward with the proposal to specify the scope 
of individuals who can perform the AUC consultation as auxiliary 
personnel. We are modifying our proposal in response to comments, and 
conforming the regulation at Sec.  414.94(j)(2), to clarify that, in 
the event of a significant hardship, the requirement to consult AUC 
does not apply and specify that, when not personally performed by the 
ordering professional, the consultation with a qualified CDSM may be 
performed by clinical staff under the direction of the ordering 
professional. We have used the term clinical staff elsewhere in the 
Medicare program to identify the individuals that may perform care 
management services including chronic care management (CCM), behavioral 
health integration (BHI) and transitional care management (TCM) 
services. These services involve some non-face-to-face services along 
with clinical activities around the care plan and communication and 
coordination with the patient's other healthcare professionals. For 
care management, the clinical staff requirement ensures that the 
individual performing the service must have the level of clinical 
knowledge necessary to effectively coordinate and communicate with the 
treating clinician. Similarly, in the case of the AUC program, the 
individual performing the AUC consultation must have sufficient 
clinical knowledge to interact with the CDSM and communicate with the 
ordering professional. After considering public comments on our 
proposal, we have concluded that allowing clinical staff to perform the 
AUC consultation under the direction of the ordering professional is a 
better fit with the AUC program than our proposal, and is responsive to 
public comments asserting that the concept of ``incident to'' is not 
relevant in the context of the AUC program. We believe the policy we 
are finalizing, to allow the AUC consultation to be performed by 
clinical staff under the direction of the ordering professional, 
further reflects a balance between those commenters who wanted only the 
ordering professional to perform the consultation and those who 
suggested we should allow the consultation to be delegated. Clinical 
staff will have a level of knowledge that allows for effective 
communication of advanced diagnostic imaging orders, interaction with 
AUC, and engagement with the ordering professional, while they remain 
under the direction of the ordering professional.
c. Reporting AUC Consultation Information
    Section 1834(q)(4)(B) of the Act requires that payment for an 
applicable imaging service furnished in an applicable setting and paid 
for under an applicable payment system may only be made if the claim 
for the service includes certain information about the AUC 
consultation. As such, the statute requires that AUC consultation 
information be included on any claim for an outpatient advanced 
diagnostic imaging service, including those billed and paid under any 
applicable payment system (the PFS, OPPS or ASC payment system). When 
we initially codified the AUC consultation reporting requirement in 
Sec.  414.94(k) through rulemaking in the CY 2018 PFS final rule, we 
specified only that ``furnishing professionals'' must report AUC 
consultation information on claims for applicable imaging services. 
This led some stakeholders to believe that AUC consultation information 
would be required only on practitioner claims. To better reflect the 
statutory requirements of section 1834(q)(4)(B) of the Act, we proposed 
to revise our regulations to clarify that AUC consultation information 
must be reported on all claims for an applicable imaging service 
furnished in an applicable setting and paid for under an applicable 
payment system. The revised regulation would more clearly express the 
scope of advanced diagnostic imaging services that are subject to the 
AUC program, that is, those furnished in an applicable setting and paid 
under an applicable payment system.
    The language codified in Sec.  414.94(k) uses the term furnishing 
professional to describe who must report the information on the 
Medicare claims. We recognize that section 1834(q)(1)(F) of the Act 
specifies that a ``furnishing professional'' is a physician (as defined 
in section 1861(r)) or a practitioner described in section 
1842(b)(18)(C) who furnishes an applicable imaging service.

[[Page 59694]]

However, because section 1834(q)(4)(B) of the Act, as described above, 
clearly includes all claims paid under applicable payment systems 
without exclusion, we believe that the claims from both furnishing 
professionals and facilities must include AUC consultation information. 
In other words, we would expect this information to be included on the 
practitioner's claim for the PC of the applicable advanced diagnostic 
imaging service and on the provider's or supplier's claim for the 
facility portion or TC of the imaging service.
    As such, we proposed to revise Sec.  414.94(k) to clearly reflect 
the scope of claims for which AUC consultation information must be 
reported, and to clarify that the requirement to report AUC 
consultation information is not limited to the furnishing professional. 
The following is a summary of the comments we received.
    Comment: Some commenters stated that they appreciate the 
clarification that the requirement to report AUC consultation 
information is not limited to the furnishing professional. These 
commenters thanked CMS for addressing the increasingly common instances 
in which the TC and PC of an advanced diagnostic imaging service are 
performed at separate locations. Additionally, these commenters 
acknowledged that the clarification recognizes situations when payment 
can be made globally, to include both the TC and PC furnished and 
billed by the same entity, and situations of Method II billing by 
critical access hospitals. In contrast, other commenters opposed the 
reporting of AUC consultation information on all claims, specifically 
the facility claims, for an applicable imaging service furnished in an 
applicable setting and paid under an applicable payment system. These 
commenters noted that requiring the reporting of AUC consultation 
information does not appropriately target the ordering professionals 
for whom the AUC program is intended, and creates a duplicative effort 
when CMS receives AUC consultation information from both facilities and 
furnishing professionals for different parts of the same exam. A few 
other commenters expressed concern that requiring two sources of AUC 
consultation information that relates to the same test for the same 
patient could result in situations where one source was inaccurate or 
provides conflicting information.
    Response: The statutory requirement under section 1834(q)(4)(B) of 
the Act specifies that payment for an applicable imaging service 
furnished in an applicable setting and paid for under an applicable 
payment system may only be made if the claim for the service includes 
certain information about the AUC consultation. We recognize that this 
requirement to report AUC consultation information is not placed on the 
ordering professional, but rather on those submitting claims for the 
advanced diagnostic imaging service that the ordering professional 
orders. We also recognize that the TC or facility portion of an 
applicable imaging service is frequently furnished and billed by a 
different entity than the PC portion of the service. We do not 
currently do any matching or comparison of separate claims for the PC 
and TC or facility portion of an advanced diagnostic imaging service. 
Rather, we process these separate claims individually, and have no 
immediate plans to begin doing otherwise for purposes of the AUC 
program. We hope to learn more about the implementation of this 
program, including issues such as these commenters have raised, during 
the educational and operations testing period.
    After considering the comments, we are finalizing without 
modification the proposal to revise Sec.  414.94(k) to clearly reflect 
the scope of claims for which AUC consultation information must be 
reported, and to make this requirement consistent with section 
1834(q)(4)(B) of the Act.
d. Claims-Based Reporting
    In the CY 2018 PFS proposed rule (82 FR 34094) we discussed using a 
combination of G-codes and modifiers to report the AUC consultation 
information on the Medicare claim. We received numerous public comments 
objecting to this potential solution. In the 2018 PFS final rule, we 
agreed with many of the commenters that additional approaches to 
reporting AUC consultation information on Medicare claims should be 
considered, and we learned from many commenters that reporting a unique 
consultation identifier (UCI) would be a less burdensome and preferred 
approach. The UCI would include all the information required under 
section 1834(q)(4)(B) of the Act including an indication of AUC 
adherence, non-adherence and not applicable responses. Commenters noted 
that capturing a truly distinguishing UCI on the claim will allow for 
direct mapping from a single AUC consultation to embedded information 
within a CDSM. We indicated that we would work with stakeholders to 
further explore the concept of using a UCI to satisfy the requirements 
of section 1834(q)(4)(B) of the Act, which will be used for Medicare 
claims processing and, ultimately, for the identification of outlier 
ordering professionals, and consider developing a taxonomy for a UCI.
    We had the opportunity to engage with some stakeholders over the 
last 6 months and we understand that some commenters from the previous 
rule continue to be in favor of a UCI, while some may have changed 
their position upon further consideration.
    We provide the following information to summarize alternatives we 
considered. We had originally considered assigning a G-code for every 
qualified CDSM with a code descriptor containing the name of the 
qualified CDSM. The challenge to this approach arises when there is 
more than one advanced imaging service on a single claim. We could 
attribute a single G-code to all of the applicable imaging services for 
the patient's clinical condition on the claim, which might be 
appropriate if each AUC consultation for each service was through the 
same CDSM. If a different CDSM was used for each service (for example, 
when services on a single claim were ordered by more than one ordering 
professional and each ordering professional used a different CDSM) then 
multiple G-codes could be needed on the claim. Each G-code would appear 
on the claim individually as its own line item. As a potential 
solution, we considered the use of modifiers, which are appealing 
because they would appear on the same line as the CPT code that 
identifies the specific billed service. Therefore, information entered 
onto a claim would arrive into the claims processing system paired with 
the relevant AUC consultation information.
    When reporting the required AUC consultation information based on 
the response from a CDSM: (1) The imaging service would adhere to the 
applicable AUC; (2) the imaging service would not adhere to such 
criteria; or (3) such criteria were not applicable to the imaging 
service ordered, three modifiers could be developed. These modifiers, 
when placed on the same line with the CPT code for the advanced imaging 
service would allow this information to be easily accessed in the 
Medicare claims data and matched with the imaging service.
    Stakeholders have made various suggestions for a taxonomy that 
could be used to develop a UCI to report the required information. 
Stakeholders have also considered where to place the UCI on the claim. 
We understand the majority of solutions suggested by stakeholders 
involving a UCI are claim-

[[Page 59695]]

level solutions and would not allow us to attribute the CDSM used or 
the AUC adherence status (adherent or not adherent, or not applicable) 
to a specific imaging service. As such, the approach of using a UCI 
would not identify whether an AUC consultation was performed for each 
applicable imaging service reported on a claim form, or be useful for 
purposes of identifying outlier ordering professionals in accordance 
with section 1834(q)(5) of the Act.
    We have received ideas from stakeholders that are both for and 
against the two approaches we have identified; and we appreciate the 
stakeholders that have provided additional information or engaged us in 
this discussion. Internally, we have explored the possibility of using, 
and feasibility of developing, a UCI; and concluded that, although we 
initiated this approach during the CY 2018 PFS final rule, it is not 
feasible to create a uniform UCI taxonomy, determine a location of the 
UCI on the claims forms, obtain the support and permission by national 
bodies to use claim fields for this purpose, and solve the underlying 
issue that the UCI seems limited to claim-level reporting. Using coding 
structures that are already in place (such as G-codes and modifiers) 
would allow us to establish reporting requirements prior to the start 
of the program (January 1, 2020).
    Since we did not finalize a proposal in the CY 2018 PFS final rule, 
we proposed in this rule to use established coding methods, to include 
G-codes and modifiers, to report the required AUC information on 
Medicare claims. This would allow the program to be implemented by 
January 1, 2020. We will consider future opportunities to use a UCI and 
look forward to continued engagement with and feedback from 
stakeholders.
    The following is a summary of comments we received on this 
proposal.
    Comment: The majority of commenters agreed with our proposed 
approach of using G-codes and modifiers to append AUC information on 
claims. Of those commenters, most stated that the approach is not 
without flaws, including increased workflow challenges and complexity, 
time needed for staff to learn and incorporate these changes into 
billing practices, and the limited information modifiers may convey for 
outlier identification purposes. We summarize and respond to comments 
on these issues below. However, they acknowledged that there is a lack 
of better alternatives. Other commenters disagreed with the proposal, 
and recommended CMS not require claims-based reporting until a UCI can 
be reported on claims. In addition to those recommending a delay in 
reporting, others suggested that CMS not require claims-based reporting 
at all and instead allow information to be transmitted directly from 
qualified CDSMs to CMS.
    Response: We agree with commenters that G-codes and modifiers may 
not be the ideal solution. However, it is important that we make 
strides to implement this program and prepare stakeholders for the 
method of reporting in the immediate years of the program. We will 
continue to discuss with stakeholders the potential of using a UCI in 
the future. There are hurdles to overcome with respect to the use of a 
UCI that are discussed in the comment summaries and responses below. 
Some of these include understanding how UCI information would be used 
in the development of the eventual outlier ordering professional 
methodology, and where it would be appended to the claim. In addition, 
there is disagreement among stakeholders regarding whether the UCI 
would contain a taxonomy and embed meaningful information. 
Additionally, as we have consulted with stakeholders responsible for 
updating the claims forms, which would be necessary to establish a 
field to report a UCI on claims, we understand that it would be a 
matter of years before the forms could be updated. As such, the 
prospect of developing and using a UCI is not a realistic immediate 
solution.
    Comment: There were disagreements and concerns among commenters 
that support the use of G-codes to identify which qualified CDSM was 
consulted. Some were concerned that CMS could not develop G-codes 
quickly enough to keep pace with newly qualified CDSMs and that the 
total number of G-codes would be unwieldy. Others supported the use of 
a single generic G-code to describe that a qualified CDSM was consulted 
but would not identify a particular CDSM. Another commenter pointed out 
that a G-code would not be necessary on claims when a CDSM was not 
consulted, rather, only a modifier (placed on the same line as the CPT 
code for the imaging service) would be used in these circumstances.
    Commenters pointed out that claims for both the furnishing facility 
and furnishing professional are capable of reporting G-codes and 
modifiers, but identified an issue related to resorting of information 
on claims as they are processed through the system. In other words, the 
codes billed on separate claim lines can come through the system and 
end up in a different order than how they originally appeared when the 
claim was submitted. This means CMS cannot presume to pair an imaging 
service reported on a specific claim line with a specific G-code when 
more than one imaging service appears on the claim. A commenter 
suggested that furnishing professionals could split their claims so 
only one imaging service and one G-code would appear on each claim. 
Commenters pointed out that while this is possible on the furnishing 
professional claim, it is not possible on the furnishing facility claim 
due to other rules involving facility billing and same-day procedures.
    Response: We are optimistic that we can issue G-codes in a timely 
manner upon qualifying new CDSMs. There are a number of CDSMs already 
qualified and G-codes could be issued for those prior to the start of 
the educational and operations testing period set to begin in 2020. We 
could secure additional G-codes with general descriptors to describe 
``newly qualified CDSM A,'' ``newly qualified CDSM B,'' etc. to be 
ready for assignment to a specific CDSM upon qualification. That would 
allow some time for the descriptor to be changed to reflect the name of 
the CDSM, but also enable immediate use of the appropriate G-code for 
reporting purposes. This information will be contained in standard 
coding information issued by the agency as well as on the AUC website 
that lists all qualified CDSMs.
    Regarding the use of one generic G-code to describe that a 
qualified CDSM was consulted, we are not confident that this would 
satisfy the statutory requirement under section 1834(q)(4)(B) of the 
Act to report which qualified CDSM was consulted. However, we may find 
that generic codes are needed as a temporary measure as we move forward 
with implementation.
    If a CDSM is not consulted, for example due to the ordering 
professional attesting to a significant hardship, then we agree that a 
distinct G-code for that purpose is not necessary. Rather the modifier 
describing that hardship could be placed on the same claim line as the 
CPT code for the imaging service.
    We agree with commenters that the issue of claims processing system 
resorting of claims information is problematic. When multiple imaging 
services are reported on a single claim, it will not be possible to 
pair the G-code describing which CDSM was consulted with the imaging 
service for which it was consulted. While we could require the 
furnishing professional to split the claim, we are not committing to 
that solution at this point but will explore that option as we move 
forward with implementation. Another possible

[[Page 59696]]

solution, though still imperfect, could be to list the G-code on a line 
and place the modifiers describing AUC adherence on the line with the 
CPT code describing the imaging service. This model could work when the 
same ordering professional has ordered all of the furnished imaging 
services on the claim, and if we presume that an ordering professional 
will consistently use only one qualified CDSM. We appreciate commenters 
raising these issues and we will continue to explore options to address 
them.
    Comment: One commenter suggested that, instead of G-codes, CPT 
codes should be developed to identify the qualified CDSM consulted.
    Response: Initially we do not believe it will be possible for AMA-
CPT to issue CPT codes identifying qualified CDSMs in time for the 
program to begin. We do, however, understand that there may be benefits 
to making these codes Level 1 HCPCS codes that are issued by AMA-CPT as 
opposed to HCPCS Level 3 codes (G-codes). We will look into the 
benefits and potential problems of using CPT codes to describe which 
qualified CDSM was consulted. An initial concern we have, in addition 
to timing to accommodate the start of the AUC program, is whether CPT 
code descriptors could be changed quickly enough to accommodate newly 
qualified CDSMs and whether CPT codes would be set aside for future 
use.
    Comment: Many commenters observed that, under this AUC program, 
qualified CDSMs must generate and provide a certification or 
documentation at the time of order that documents which qualified CDSM 
was consulted, the name and NPI of the ordering professional that 
consulted the CDSM, and whether the service ordered would or would not 
adhere to specified applicable AUC or whether the specified applicable 
AUC consulted was not applicable to the service ordered. As a result, 
these commenters assumed that the CDSM would also communicate the 
relevant G-codes and modifiers, and requested that CMS clarify that 
qualified CDSMs are required to explicitly communicate their assigned 
G-code and the adherence modifier to the ordering professional. The 
commenters stated that absent this clarification, some CDSMs may simply 
convey their name and an indication (other than the relevant modifier) 
as to whether the ordered service ``adhered,'' or ``didn't adhere,'' or 
the AUC ``didn't apply'' to the imaging test. The commenters were 
concerned that if CDSMs provide AUC consultation results in this way, 
it would create additional burden for ordering professionals to 
manually assign coding information to be transmitted for billing 
purposes.
    A few of these commenters stated that they requested this 
clarification because they noted: (1) Each qualified CDSM will know its 
G-code and can readily convert their adherence rating system into 
modifiers, (2) the required data could be transmitted between EHR and 
CDSM vendors and communicated between professionals in a standardized 
manner, and (3) accuracy of consultation reporting would improve.
    Response: Commenters accurately described what information must be 
included in the certification or documentation generated by a qualified 
CDSM at the time of order, and this is specified in our regulation at 
Sec.  414.94(g)(1)(vi). As we move forward in finalizing our approach 
for claims-based reporting where CDSMs will be represented through G-
codes, and AUC adherence represented through modifiers, we agree with 
commenters that CDSMs should include the G-codes and modifiers in their 
certification or documentation. We would like to see CDSMs begin to do 
this as the specific G-codes and modifiers become available. And as the 
commenters noted, this would seem to be a simple thing for CDSMs to do. 
If we do not see CDSMs making such adjustments to their certification 
or documentation, we will consider imposing a requirement in 
regulation.
    Comment: Commenters had varying views of using a UCI to report 
consultation information on claims. Some commenters were interested in 
moving forward with the UCI requirement when the claims forms are 
adjusted to accommodate this new information. Others disagreed on 
whether or not a taxonomy with embedded meaning was necessary. Some of 
these commenters supported a UCI issued by the qualified CDSM that was 
unique to that CDSM. A G-code would also appear on the claim that would 
identify which qualified CDSM was consulted and then the UCI would be 
used to pair the information with the data in the CDSM specific to that 
consultation. Others supported a UCI with a taxonomy with embedded 
meaning so one could look at the UCI and know, without accessing 
additional information, which CDSM was consulted and the outcome of 
that consultation. We also heard from commenters that the UCI could be 
lengthy and therefore prone to transcription errors when entering 
information on the order or the claim form.
    Response: We will continue to consult with stakeholders about the 
future possibility of using the UCI.
    Comment: Numerous commenters were concerned about the requirements 
for claims-based reporting of AUC consultation information when the 
claims are not yet able to accommodate new types of information. Most 
of these commenters expressed concern about the placement of the UCI 
and other commenters pointed out that the furnishing facility claim 
does not contain a designated location for the ordering professional's 
NPI.
    Response: We agree with these concerns and will work with the 
appropriate stakeholders to identify a possible future location for a 
UCI to be appended to claims. We are not committing to using the UCI at 
this time but will be open to exploring the possibility of developing a 
UCI that could be appended to claims in the future. We will also work 
to better understand and identify a potentially appropriate place on 
the furnishing facility claim to include the ordering professional's 
NPI, and to understand whether changes to that claim form may be 
needed. In the short term we will consider other implementation options 
so that fields on the claims are not used improperly.
    Comment: Several commenters sought clarification on how, absent a 
UCI, AUC claims-based information as reported by the furnishing 
professional and facility would be reconciled with the AUC consultation 
performed by the ordering professional as there is interest in 
establishing best practices for retaining this information. These 
commenters requested clarification on who bears responsibility if such 
data are not available during an audit, considering that the ordering 
professional interacts with the CDSM and provides the information that 
the furnishing provider submits on the claim.
    Response: It is the responsibility of the ordering professional to 
consult AUC and to provide that consultation information to the 
furnishing professional; and it is the responsibility of the furnishing 
professional and facility to accurately report that information on 
claims for applicable imaging services. We will take into account the 
specific roles of ordering and furnishing professionals and facilities 
as the program develops and we begin to engage in program monitoring 
activities.
    Comment: Many commenters noted the practice of ``exam 
substitution'' permitted by Sections 80.6.2-80.6.4 of Chapter 15 of the 
Medicare Benefit Policy Manual when the furnishing

[[Page 59697]]

professional determines a different diagnostic imaging service should 
be ordered in certain circumstances and the ordering practitioner is 
not available to provide a new order. To this end, commenters 
recommended additional proposals to modify the reporting method using 
G-codes and modifiers by creating additional modifiers for those orders 
that (1) are initiated in one location and furnished at a different 
point of service, (2) furnished after a second consultation has 
occurred, or (3) are the result of interpretation-only services.
    Response: We thank these commenters for their suggestions on 
additional modifiers and will consider these recommendations during 
implementation.
    Based on the public comments we are finalizing the proposal to use 
G-codes and modifiers to report consultation information on claims. We 
appreciate that commenters pointed out concerns and technical issues 
regarding this approach and we will work to address them during 
implementation.
e. Significant Hardship Exception
    We proposed to revise Sec.  414.94(i)(3) of our regulations to 
adjust the significant hardship exception requirements under the AUC 
program. We proposed criteria specific to the AUC program and 
independent of other programs. An ordering professional experiencing 
any of the following when ordering an advanced diagnostic imaging 
service would not be required to consult AUC using a qualified CDSM, 
and the claim for the applicable imaging service would not be required 
to include AUC consultation information. The proposed criteria include:
     Insufficient internet access;
     EHR or CDSM vendor issues; or
     Extreme and uncontrollable circumstances.
    Insufficient internet access is specific to the location where an 
advanced diagnostic imaging service is ordered by the ordering 
professional. EHR or CDSM vendor issues may include situations where 
ordering professionals experience temporary technical problems, 
installation or upgrades that temporarily impede access to the CDSM, 
vendors cease operations, or we de-qualify a CDSM. We expect these 
situations to generally be irregular and unusual. Extreme and 
uncontrollable circumstances include disasters, natural or man-made, 
that have a significant negative impact on healthcare operations, area 
infrastructure or communication systems. These could include areas 
where events occur that have been designated a federal Emergency 
Management Agency (FEMA) major disaster or a public health emergency 
declared by the Secretary. Based on 2016 data from the Medicare EHR 
Incentive Program and the 2019 payment year MIPS eligibility and 
special status file, we estimate that 6,699 eligible clinicians could 
submit such a request due to extreme and uncontrollable circumstances 
or as a result of a decertification of an EHR, which represents less 
than 1 percent of available ordering professionals.
    In the CY 2017 PFS final rule, for purposes of the AUC program 
significant hardship exceptions, we provided that those who received 
significant hardship exceptions in the following categories from Sec.  
495.102(d)(4) would also qualify for significant hardship exceptions 
for the AUC program:
     Insufficient internet Connectivity (as specified in Sec.  
495.102(d)(4)(i)).
     Practicing for less than 2 years (as specified in Sec.  
495.102(d)(4)(ii)).
     Extreme and Uncontrollable Circumstances (as specified in 
Sec.  495.102(d)(4)(iii)).
     Lack of Control over the Availability of CEHRT (as 
specified in Sec.  495.102(d)(4)(iv)(A)).
     Lack of Face-to-Face Patient Interaction (as specified in 
Sec.  495.102(d)(4)(iv)(B)).
    In the CY 2018 PFS proposed rule, we proposed to amend the AUC 
significant hardship exception regulation to specify that ordering 
professionals who are granted reweighting of the Advancing Care 
Information (ACI) performance category to zero percent of the final 
score for the year under MIPS per Sec.  414.1380(c)(2) due to 
circumstances that include the criteria listed in Sec.  
495.102(d)(4)(i), (d)(4)(iii), and (d)(4)(iv)(A) and (B) (as outlined 
in the bulleted list above) would be excepted from the AUC consultation 
requirement during the same year that the re-weighting applies for 
purposes of the MIPS payment adjustment. This proposal removed Sec.  
495.102(d)(4)(ii), practicing for less than 2 years, as a criterion 
since these clinicians are not MIPS eligible clinicians and thus would 
never meet the criteria for reweighting of their MIPS ACI performance 
category for the year.
    In response to public comments, we did not finalize the proposed 
changes to the significant hardship exceptions in the CY 2018 PFS final 
rule and instead decided further evaluation was needed before moving 
forward with any modifications. Our original intention was to design 
the AUC significant hardship exception process in alignment with the 
process for the Medicare EHR Incentive Program for eligible 
professionals, and then for the MIPS ACI (now Promoting 
Interoperability) performance category. Under section 1848(a)(7)(A) of 
the Act, the downward payment adjustment for eligible professionals 
under the Medicare EHR Incentive Program will end in 2018, and we are 
unable to continue making reference to a regulation relating to a 
program that is no longer in effect. As we have continued to evaluate 
both policy options and operational considerations for the AUC 
significant hardship exception, we have concluded that the most 
appropriate approach, which we consider to be more straightforward and 
less burdensome than the current approach, involves establishing 
significant hardship criteria and a process that is independent from 
other Medicare programs. We also note as we have in the past that the 
AUC program is a real-time program with a need for real-time 
significant hardship exceptions. This is in contrast to the way 
significant hardship exceptions are handled under MIPS where the 
hardship might impact some or all of a performance period, or might 
impact reporting, both of which occur well before the MIPS payment 
adjustment is applied in a subsequent year. We recognize that when a 
significant hardship arises, an application process to qualify for an 
exception becomes a time consuming hurdle for health care providers to 
navigate, and we believe that it is important to minimize the burden 
involved in seeking significant hardship exceptions. As such, we 
proposed that ordering professionals would self-attest if they are 
experiencing a significant hardship at the time of placing an advanced 
diagnostic imaging order and such attestation would be supported with 
documentation of significant hardship. Ordering professionals attesting 
to a significant hardship would communicate that information to the 
furnishing professional with the order and it would be reflected on the 
furnishing professional's and furnishing facility's claim by appending 
a HCPCS modifier. The modifier would indicate that the ordering 
professional has self-attested to experiencing a significant hardship 
and communicated this to the furnishing professional with the order. 
Claims for advanced diagnostic imaging services that include a 
significant hardship exception modifier would not be required to 
include AUC consultation information.
    In addition to the proposals above, we invited the public to 
comment on any

[[Page 59698]]

additional circumstances that would cause the act of consulting AUC to 
be particularly difficult or challenging for the ordering professional, 
and for which it may be appropriate for an ordering professional to be 
granted a significant hardship exception under the AUC program. 
Although we understand the desire by some for significant hardship 
categories unrelated to difficulty in consulting AUC through a CDSM, we 
remind readers that circumstances that are not specific to AUC 
consultation, such as the ordering professional being in clinical 
practice for a short period of time or having limited numbers of 
Medicare patients, would not impede clinicians from consulting AUC 
through a CDSM as required to meet the requirements of this program.
    The following is a summary of the comments we received on the 
modifications to the significant hardship exceptions and additional 
circumstances for consideration as needing significant hardship 
exceptions.
    Comment: Some commenters requested that clinicians in the Quality 
Payment Program be excepted from or considered automatically in 
compliance with the AUC program requirements. Some of these commenters 
specified that an exception should apply to all primary care 
practitioners, others suggested an exception should apply to all 
clinicians in the Quality Payment Program, and several commenters 
requested that hospitals and health systems be exempt from reporting 
AUC consultation information. One commenter requested that facility and 
institutional providers be exempt. Acknowledging that the statutory 
language in section 218(b) of the PAMA does not include such an 
exception, some of these commenters clarified that CMS should seek 
legislative authority to add such an exception.
    Response: As added by section 218(b) of the PAMA, section 
1834(q)(4)(B) of the Act specifies that AUC consultation information 
must be included on all claims for applicable imaging services when 
furnished in an applicable setting and paid under an applicable payment 
system, which includes the physician fee schedule, prospective payment 
system for hospital outpatient department services and the ambulatory 
surgical center payment system. Section 1834(q)(4)(C) of the Act also 
set forth specific exceptions, including for a service ordered for an 
individual with an emergency medical condition, a service ordered for 
an inpatient for which payment is made under Medicare Part A, or for a 
service ordered by an ordering professional for whom AUC consultation 
would result in a significant hardship. In the case of significant 
hardship, section 1834(q)(4)(C)(iii) of the Act provides for such 
exceptions in situations when the Secretary determines, on a case-by-
case basis, that an ordering professional is exempt because 
``consultation with applicable appropriate use criteria would result in 
a significant hardship, such as in the case of a professional who 
practices in a rural area without sufficient internet access.'' Given 
these statutory provisions, blanket exceptions, considered significant 
hardships or otherwise, for clinicians in the Quality Payment Program, 
for facility or institutional providers, or for hospitals and health 
systems, would not be consistent with the statutory requirements. While 
we understand that stakeholders may view the AUC program as duplicative 
of the Quality Payment Program, we also note that there are specific 
and distinct differences between the programs. The AUC program was 
established to promote appropriate use of advanced diagnostic imaging 
and improve ordering patterns for these services through the 
consultation of AUC with real time reporting requirements and payment 
implications. While some components of the Quality Payment Program can 
involve using AUC and clinical decision support, their use is not 
mandatory, and the Quality Payment Program provides numerous options 
for participation across all MIPS performance categories. In contrast, 
consultation with AUC using a CDSM is required for each order for an 
applicable imaging service furnished in an applicable setting and paid 
under an applicable payment system under the AUC program. If amendments 
are made to the AUC statutory provisions, we will adjust our 
regulations throughout Sec.  414.94 accordingly. However, at this time, 
we do not have the authority to include exceptions to the AUC program 
beyond the scope of those specified in section 1834(q)(4)(C) of the 
Act.
    Comment: Some commenters requested an additional significant 
hardship category based on a low-volume threshold for practices with 
low patient volumes, low number of covered services or a low number of 
Medicare charges. Some commenters supported this request by noting the 
increased cost and burden a small practice would be required to 
undertake to meet the requirements of the AUC program.
    Response: As noted above, we believe that significant hardships are 
reflective of situations that would impede clinicians from consulting 
AUC through a CDSM. As the program is structured and given the 
availability of qualified CDSMs that are free of charge, we do not 
agree that ordering professionals in practices with low patient 
volumes, low number of covered services or a low number of Medicare 
charges would be impeded from consulting AUC. While we do understand 
that participation in the AUC program may result in increased cost and 
burden, which could arguably be disproportionate for these types of low 
volume practices, we do not have the authority to include exceptions to 
the AUC program beyond the scope of those specified in section 
1834(q)(4)(C) of the Act.
    Comment: Several commenters provided recommendations for other 
categories of significant hardship exceptions. One commenter requested 
an exception for professionals when the PLE they rely upon becomes 
unavailable, and another commenter requested a significant hardship 
exception when there is a lack of AUC for the service(s) requiring 
consultation or AUC are outdated. Another commenter suggested that new 
physicians be excepted from the AUC program and another identified 
imaging services ordered as the result of a clinical research protocol 
as a potential significant hardship.
    Response: We disagree with adding these scenarios to the 
significant hardship exceptions under this program. For unavailable 
PLEs and AUC, we established specific requirements for both qualified 
PLEs and CDSMs that address the two situations included above. First, 
qualified CDSMs are required to make available, at a minimum, specified 
applicable AUC that reasonably address common and important clinical 
scenarios within all priority clinical areas and be able to incorporate 
specified applicable AUC from more than one qualified PLE. Should a 
qualified PLE cease to exist or otherwise become unavailable, then the 
qualified CDSM through which the AUC for that qualified PLE is 
consulted would no longer meet the requirements to be a qualified CDSM 
(assuming it does not incorporate AUC from another qualified PLE), and 
as such, would be de-qualified as a CDSM under this program. As noted 
above, de-qualification of a CDSM would be an allowable circumstance 
for an ordering professional to attest to a significant hardship due to 
EHR or CDSM vendor issues. Second, when an ordering professional 
consults a qualified CDSM and there are no AUC applicable to the 
service ordered, that information would be reported on the claim as 
such. In these situations, the qualified CDSM is required under Sec.  
414.94(g)(1)(vi) to

[[Page 59699]]

generate and provide a certification or documentation at the time of 
order that documents whether the specified applicable AUC consulted was 
not applicable to the service ordered. The ordering professional is 
then required to provide that information to the furnishing 
professional and facility so that it can be reported as specified under 
Sec.  414.94(k). The absence of applicable AUC does not constitute an 
exception from the requirement to consult AUC using the qualified CDSM 
in an effort to find specified applicable AUC for the order. Third, 
qualified PLEs are required to review their AUC regularly and update 
them at least annually when appropriate; and qualified CDSMs are 
required to make any updated AUC content available within 12 months of 
the qualified PLE's update(s). Finally, we do not believe that being a 
new physician or conducting clinical research would cause the act of 
consulting AUC to be particularly difficult or challenging for the 
ordering professional.
    Comment: Several commenters revisited previously expressed concerns 
about the emergency services exception. The commenters requested 
clarification around what constitutes an emergency medical condition. 
One commenter suggested that CMS revise the regulatory language to 
allow exceptions when an emergency medical condition is suspected for 
cases in which clinicians, in their best judgment, believe a patient 
may be experiencing a medical emergency at the time of order. This 
commenter noted that this approach was the intent of section 218(b) of 
the PAMA as explained by a member of Congress who was involved in 
drafting the statutory language, and that the reference to section 
1867(e) of the Act instead of section 1867(a) of the Act was an 
inadvertent drafting error. One commenter requested that CMS delay 
requiring AUC consultations in the emergency department until the 
ambiguity over what services are considered emergency services is 
resolved.
    Response: Section 1834(q)(4)(C)(i) of the Act provides for an 
exception to the AUC consultation and reporting requirements in the 
case of a service ordered for an individual with an emergency medical 
condition as defined in section 1867(e)(1) of the Act, not section 
1867(a) of the Act as the commenter suggests. The regulation reflects 
the current statutory language and we will not amend our regulation in 
response to these comments. As stated in our response to comments in 
the CY 2017 PFS final rule with comment, we agree that exceptions 
granted for an individual with an emergency medical condition include 
instances where an emergency medical condition is suspected, but not 
yet confirmed. This may include, for example, instances of severe pain 
or severe allergic reactions. In these instances, the exception is 
applicable even if it is determined later that the patient did not in 
fact have an emergency medical condition.
    Comment: Many commenters generally supported the proposed 
significant hardship categories and self-attestation approach, with one 
commenter specifically encouraging oversight of AUC and the use of 
significant hardship exceptions. However, many other commenters 
challenged the proposed approach to annotating the significant hardship 
self-attestation on every Medicare claim. Specifically, they requested 
that a blanket exception or single attestation be applied over a period 
of time to avoid increased burden of communicating and reporting a 
significant hardship attestation on every advanced diagnostic imaging 
order, and suggested using a significant hardship exception modifier on 
the subsequent claim(s) after the single attestation. One commenter 
noted that the approach as proposed by CMS is more burdensome than 
requiring the use of an applications process.
    Response: Because the AUC program requires real time reporting on 
Medicare claims, we believe the best way to ensure clinicians have the 
ability and flexibility to use the significant hardships allowable 
under this program is to establish a mechanism for real time 
application of significant hardship attestations. To accomplish this, 
inclusion of the relevant significant hardship modifier on each 
Medicare claim offers the most straightforward approach, enabling 
ordering professionals to use a significant hardship exception as 
needed and without more complicated, time consuming steps that could 
result in a delay in the transmission, acceptance and processing of the 
imaging order for the ordering and furnishing professionals, as well as 
a delay in care for the patient. We note that applying a blanket 
exception for a specific period of time for ordering professionals 
based on a single significant hardship attestation would introduce a 
level of complexity and burden to the process that was not identified 
by requestors. Following such a single attestation, furnishing 
professionals (as well as CMS) would need to keep track of which 
ordering professionals had attested to a significant hardship as well 
as the period of time applicable to each attestation every time an 
order is received and a claim is prepared, submitted and processed. We 
disagree with commenters that inclusion of significant hardship 
information on each imaging order and subsequent claim imposes 
extensive burden, or that other approaches would be less burdensome and 
achieve the same goal of allowing for a real time significant hardship 
exception process under the real time AUC program.
    Comment: Many commenters posed specific requests for clarification 
around the proposed significant hardship exception categories. One 
commenter requested further clarity and a broader application of 
insufficient internet access and extreme and uncontrollable 
circumstances to include, respectively, situations out of the control 
of the ordering professional like slow internet and no physical access 
to the CDSM, lost CDSM usernames and passwords and other situations 
preventing an ordering professional from consulting at the time of the 
patient encounter. Other commenters requested clarification around how 
orders would be made during downtime and how and when to document the 
significant hardship and by whom. A few commenters did not understand 
how de-certification of an EHR would qualify as a significant hardship 
since there are no certification requirements related to the AUC 
program. Others requested further information on how hardship 
information must be reported on the claim, specific information on 
coding a significant hardship, how to handle emergency situations and 
what to report when orders are changed.
    Response: We appreciate the comments submitted requesting further 
clarification around exactly how significant hardship exceptions will 
be operationalized. We note that many of the questions posed are 
specific to claims reporting details. We expect to provide further 
details and clarification in the claims processing instructions that we 
expect to release following the final rule.
    We describe insufficient internet access as specific to the 
location where an advanced diagnostic imaging service is ordered by the 
ordering professional. To further clarify, we note that in addition to 
ordering imaging services in an area without sufficient internet 
access, a significant hardship may apply when ordering professionals 
would face insurmountable barriers to obtaining infrastructure to have 
internet access (that is, lack of broadband). We do not believe that 
occasions of slow internet constitute a significant hardship.

[[Page 59700]]

    We describe EHR or CDSM vendor issues as situations where ordering 
professionals experience temporary technical problems, installation or 
upgrades that temporarily impede access to the CDSM, vendors cease 
operations, or we de-qualify a CDSM and note that we expect these 
situations to be irregular and unusual. De-certification of an EHR 
would qualify as a significant hardship when the ordering 
professionals' qualified CDSM is integrated into their EHR, and the 
ordering professional's access to the CDSM is temporarily impeded due 
to installation issues associated with switching to a new vendor. We do 
not agree that losing CDSM usernames and passwords constitutes a 
significant hardship under the AUC program. Self-attestation for this 
significant hardship should be used as needed when the situations 
described above occur. We have not established limitations around using 
the EHR or CDSM vendor issues or the other significant hardship 
exceptions, but may monitor the use of these exceptions to ensure 
misuse or overuse does not become a problem.
    We describe extreme and uncontrollable circumstances to include 
disasters, natural or man-made, that have a significant negative impact 
on healthcare operations, area infrastructure or communication systems. 
We also explain these may include areas where events occur that have 
been designated by FEMA as a major disaster or a public health 
emergency declared by the Secretary. To further clarify, these 
circumstances are events that are entirely outside the control of the 
ordering professional that prevent the ordering professional from 
consulting AUC through a qualified CDSM. We believe the hardship 
criteria under this program are similar to other programs such as MIPS 
and Promoting Interoperability, particularly the flexibility that is 
given to clinicians to identify extreme and uncontrollable 
circumstances.
    Comment: Several commenters submitted a variety of additional 
comments and questions about the proposed significant hardship 
exceptions. One commenter questioned why the AUC hardships are not 
completely aligned with Quality Payment Program hardships. One stated 
that interpretation-only services do not need to include documentation 
of AUC consultation because professionals with no face-to-face 
encounters are excepted. One commenter questioned why an ordering 
professional with a significant hardship exception would need to 
communicate AUC consultation information, and suggested that they 
should only need to communicate the exception information to the 
furnishing professional and facility. A few commenters recommended that 
furnishing professionals should be held harmless when ordering 
professionals self-attest to experiencing a significant hardship.
    Response: As explained above, the AUC program requires real time 
reporting of information on the Medicare claims for payment purposes. 
The Quality Payment Program is not a real time program but instead uses 
data from prior performance years to determine status and potential 
payment adjustments in future years. This distinct and significant 
difference, along with statutory differences between the programs, 
necessitates a separate significant hardship exception approach and 
process for the AUC program. As discussed throughout this section, we 
have made efforts to align significant hardship exception concepts with 
the Quality Payment Program as closely as possible; however, we are 
unable to achieve full alignment due to the innate programmatic 
differences. For ordering professionals without face-to-face patient 
interactions, we did not include this circumstance in our proposals and 
do not provide for such an exception in this final rule. The degree of 
patient interaction does not create in itself a significant hardship to 
consultation with applicable AUC. For communicating consultation 
information on the imaging order when a significant hardship is 
experienced, the commenter is correct. No AUC consultation information 
is to be communicated when an ordering professional self-attests to 
experiencing a significant hardship and communicates that on the order. 
This confusion likely arose from language that we inadvertently 
included in the preamble and have corrected for the final rule. Section 
1834(q)(4)(B) of the Act requires certain information to be included on 
the claim for applicable imaging services under this program. As long 
as the furnishing professional and facilities correctly include the 
required information or append the appropriate hardship modifier, the 
claims will not be denied for failing to include AUC consultation 
information, and the furnishing professionals and facilities are not 
held responsible for the self-attestation made by the ordering 
professional. As noted above, we may monitor the use of these 
exceptions to ensure misuse or overuse does not become a problem, with 
the understanding that they reflect the ordering professional's self-
attestation, not a representation made by the furnishing professional 
or facility. It is not appropriate for furnishing professionals or 
facilities to append significant hardship modifiers at their 
discretion; and we note that support for the use of such a modifier 
should be included by the ordering professional in the patient's 
medical record.
    After considering the public comments, we are finalizing the 
significant hardship categories of insufficient internet access, EHR or 
CDSM vendor issues, and extreme and uncontrollable circumstances and 
updating this language in Sec.  414.94(i)(3) of our regulations. We are 
also finalizing our proposal to allow ordering professionals 
experiencing a significant hardship to self-attest and include that 
information on the order for the advanced diagnostic imaging service, 
which the furnishing professional or facility would then communicate on 
the Medicare claim for the service by appending a HCPCS modifier 
identifying the ordering professional's self-attested significant 
hardship category.
f. Identification of Outliers
    As previously mentioned, the fourth component of the AUC program 
specified in section 1834(q)(5) of the Act, is the identification of 
outlier ordering professionals. In our efforts to start a dialogue with 
stakeholders, we invited the public to submit their ideas on a possible 
methodology for the identification of outlier ordering professionals 
who would eventually be subject to a prior authorization process when 
ordering advanced diagnostic imaging services. Specifically, we 
solicited comments on the data elements and thresholds that we should 
consider when identifying outliers. We also intend to perform and use 
analysis to assist us in developing the outlier methodology for the AUC 
program. Our existing prior authorization programs generally do not 
specifically focus on outliers. We are interested in hearing ideas from 
the public on how outliers could be determined for the AUC program. 
Because we would be concerned about data integrity and reliability, we 
do not intend to include data from the educational and operations 
testing period in CY 2020 in the analysis used to develop our outlier 
methodology. Since we intend to evaluate claims data to inform our 
methodology we expect to address outlier identification and prior 
authorization more fully in CY 2022 or 2023 rulemaking. We appreciate 
the feedback received from public commenters and as noted above, we

[[Page 59701]]

expect to solicit additional public comment to inform our methodology 
through rulemaking before finalizing our approach.
5. Summary
    We appreciate the commenters that continue to provide their 
perspective and feedback on this program. Based on those comments we 
will finalize the following:
    We will finalize as proposed to add IDTFs to the definition of 
applicable settings under Sec.  414.94(b) of this program. We will also 
finalize as proposed that furnishing professionals and all furnishing 
entities are required to report AUC consultation information on the 
claim as specified under Sec.  414.94(k). In addition we will finalize 
as proposed the significant hardship exception criteria and process 
under Sec.  414.94(i)(3) to be specific to the AUC program and 
independent of other Medicare programs.
    We will not finalize as proposed the proposal to allow the AUC 
consultation, when not personally performed by the ordering 
professional, to be performed by auxiliary personnel incident to the 
ordering professional's services. Rather we are finalizing under Sec.  
414.94(j)(2) that when delegated by the ordering professional, clinical 
staff under the direction of the ordering professional may perform the 
AUC consultation with a qualified CDSM.
    Additionally, we will move forward with plans to use G-codes and 
modifiers to report AUC consultation information on the Medicare 
claims.
    We will continue to post information on our website for this 
program, accessible at www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/index.html.

E. Medicaid Promoting Interoperability Program Requirements for 
Eligible Professionals (EPs)

1. Background
    Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory 
basis for the incentive payments made to Medicaid EPs and eligible 
hospitals for the adoption, implementation, upgrade, and meaningful use 
of CEHRT. We have implemented these statutory provisions in prior 
rulemakings to establish the Medicaid Promoting Interoperability 
Program.
    Under sections 1848(o)(2)(A)(iii) and 1903(t)(6)(C)(i)(II) of the 
Act, and the definition of ``meaningful EHR user'' in regulations at 
Sec.  495.4, one of the requirements of being a meaningful EHR user is 
to successfully report the clinical quality measures selected by CMS to 
CMS or a state, as applicable, in the form and manner specified by CMS 
or the state, as applicable. Section 1848(o)(2)(B)(iii) of the Act 
requires that in selecting electronic clinical quality measures (eCQMs) 
for EPs to report under the Promoting Interoperability Program, and in 
establishing the form and manner of reporting, the Secretary shall seek 
to avoid redundant or duplicative reporting otherwise required. We have 
taken steps to align various quality reporting and payment programs 
that include the submission of eCQMs.
    In the ``Medicare Program; Hospital Inpatient Prospective Payment 
Systems for Acute Care Hospitals and the Long-Term Care Hospital 
Prospective Payment System and Policy Changes and Fiscal Year 2018 
Rates; Quality Reporting Requirements for Specific Providers; Medicare 
and Medicaid Electronic Health Record (EHR) Incentive Program 
Requirements for Eligible Hospitals, Critical Access Hospitals, and 
Eligible Professionals; Provider-Based Status of Indian Health Service 
and Tribal Facilities and Organizations; Costs Reporting and Provider 
Requirements; Agreement Termination Notices'' final rule (82 FR 37990, 
38487) (hereafter referred to as the ``FY 2018 IPPS/LTCH PPS final 
rule''), we established that, for 2017, Medicaid EPs would be required 
to report on any six eCQMs that are relevant to the EP's scope of 
practice. In proposing and finalizing that change, we indicated that it 
is our intention to align eCQM requirements for Medicaid EPs with the 
requirements of Medicare quality improvement programs, to the extent 
practicable.
2. eCQM Reporting Requirements for EPs Under the Medicaid Promoting 
Interoperability Program for 2019
    CMS annually reviews and revises the list of eCQMs for each MIPS 
performance year to reflect updated clinical standards and guidelines. 
In section III.I.3.h.(2)(b)(i) of this final rule, we amend the list of 
available eCQMs for the CY 2019 performance period. To keep eCQM 
specifications current and minimize complexity, we proposed to align 
the eCQMs available for Medicaid EPs in 2019 with those available for 
MIPS eligible clinicians for the CY 2019 performance period (83 FR 
35871). Specifically, we proposed that the eCQMs available for Medicaid 
EPs in 2019 would consist of the list of quality measures available 
under the eCQM collection type on the final list of quality measures 
established under MIPS for the CY 2019 performance period.
    We explained that we believed that this proposal would be 
responsive to stakeholder feedback supporting quality measure alignment 
between MIPS and the Medicaid Promoting Interoperability Program for 
EPs, and that it would encourage EP participation in the Medicaid 
Promoting Interoperability Program by allowing those that are also MIPS 
eligible clinicians the ability to report the same eCQMs as they report 
for MIPS in 2019. In addition, we explained that we believed that 
aligning the eCQMs available in each program would ensure the most 
uniform application of up-to-date clinical standards and guidelines 
possible.
    We explained that we anticipated that this proposal would reduce 
burden for Medicaid EPs by aligning the requirements for multiple 
reporting programs, and that the system changes required for EPs to 
implement this change would not be significant, particularly in light 
of our belief that many EPs will report eCQMs to meet the quality 
performance category of MIPS and therefore should be prepared to report 
on the available eCQMs for 2019. We explained that we expected that 
this proposal would have only a minimal impact on states, by requiring 
minor adjustments to state systems for 2019 to maintain current eCQM 
lists and specifications.
    We also requested comments on whether in future years of the 
Medicaid Promoting Interoperability Program beyond 2019, we should 
include all e-specified measures from the core set of quality measures 
for Medicaid and the Children's Health Insurance Program (CHIP) (the 
Child Core Set) and the core set of health care quality measures for 
adults enrolled in Medicaid (Adult Core Set) (hereinafter together 
referred to as ``Core Sets'') as additional options for Medicaid EPs.
    Sections 1139A and 1139B of the Act require the Secretary to 
identify and publish core sets of health care quality measures for 
child Medicaid and CHIP beneficiaries and adult Medicaid beneficiaries. 
These measure sets are required by statute to be updated annually and 
are voluntarily reported by states to CMS. These core sets comprise 
measures that specifically focus on populations served by the Medicaid 
and CHIP programs and are of particular importance to their care. 
Several of these Core Set measures are included in the MIPS eCQM list, 
but some are not. We explained that we believe that including, as eCQM 
reporting options for Medicaid EPs, the e-specified measures from the 
Core Sets that are not

[[Page 59702]]

also on the MIPS eCQM list would increase EP utilization of these 
measures and provide states with better data to report. At this time, 
the only measure within the Core Sets that would not be available as an 
option for Medicaid EPs in 2019 (because it is not on the MIPS eCQM 
list for Performance Year 2019) is NQF-1360, ``Audiological Diagnosis 
No Later Than 3 Months of Age.'' However, as these Core Sets are 
updated annually, in future years there may be other eCQMs that would 
not be on the MIPS eCQM list, and that could be included.
    For 2019, we proposed that Medicaid EPs would report on any six 
eCQMs that are relevant to their scope of practice, regardless of 
whether they report via attestation or electronically. After we removed 
the NQS domain requirements for Medicaid EPs' 2017 eCQM submissions in 
the FY 2018 IPPS/LTCH PPS final rule, we have found that allowing EPs 
to report on any six quality measures that are relevant to their 
practice has increased EPs' flexibility to report pertinent data. In 
addition, this policy of allowing Medicaid EPs to report on any six 
measures relevant to their scope of practice would generally align with 
the MIPS data submission requirement for eligible clinicians using the 
eCQM collection type for the quality performance category, which is 
established at Sec.  414.1335(a)(1). MIPS eligible clinicians who elect 
to submit eCQMs must generally submit data on at least six quality 
measures, including at least one outcome measure (or, if an applicable 
outcome measure is not available, one other high priority measure). We 
refer readers to Sec.  414.1335(a) for the data submission criteria 
that apply to individual MIPS eligible clinicians and groups that elect 
to submit data with other collection types.
    We proposed that for 2019 the Medicaid Promoting Interoperability 
Program would adopt the MIPS requirement that EPs report on at least 
one outcome measure (or, if an outcome measure is not available or 
relevant, one other high priority measure).
    We also requested comments on how high priority measures should be 
identified for Medicaid EPs. We proposed (83 FR 35872) to use all three 
of the following methods to identify which of the available measures 
are high priority measures, but invited comments on other 
possibilities.
    1. We proposed to use the same set of high priority measures for 
EPs participating in the Medicaid Promoting Interoperability Program 
that the MIPS program has identified for eligible clinicians. As 
discussed in section III.I.3.h.(2)(b)(i) of this final rule, we 
proposed to amend Sec.  414.1305 to revise the definition of high 
priority measure for purposes of MIPS to mean an outcome (including 
intermediate-outcome and patient-reported outcome), appropriate use, 
patient safety, efficiency, patient experience, care coordination, or 
opioid-related quality measure, beginning with the 2021 MIPS payment 
year.
    2. For 2019, we also proposed to identify as high priority measures 
the available eCQMs that are included in the previous year's Core Sets 
and that are also included on the MIPS list of eCQMs. We explained that 
because the Core Sets are released at the beginning of each year, it 
would not be possible to update the list of high-priority eCQMs with 
those added to the current year's Core Sets. We also explained that CMS 
has already identified the measures included in the Core Sets as ones 
that specifically focus on populations served by the Medicaid and CHIP 
programs and are particularly important to their care. The eCQMs that 
would be available for Medicaid EPs to report in 2019, that are both 
part of the Core Sets and on the MIPS list of eCQMs, and that would be 
considered high priority measures under our proposal are: CMS2, 
``Preventive Care and Screening: Screening for Depression and Follow-Up 
Plan''; CMS4, ``Initiation and Engagement of Alcohol and Other Drug 
Dependence Treatment''; CMS122, ``Diabetes: Hemoglobin A1c (HbA1c) Poor 
Control (>9%)''; CMS125, ``Breast Cancer Screening''; CMS128, ``Anti-
depressant Medication Management''; CMS136, ``Follow-Up Care for 
Children Prescribed ADHD Medication (ADD)''; CMS153, ``Chlamydia 
Screening for Women''; CMS155, ``Weight Assessment and Counseling for 
Nutrition and Physical Activity for Children and Adolescents''; and 
CMS165, ``Controlling High Blood Pressure.''
    3. We also proposed to give each state the flexibility to identify 
which of the available eCQMs selected by CMS are high priority measures 
for Medicaid EPs in that state, with review and approval from CMS, 
through their State Medicaid HIT Plans (SMHP), similar to the 
flexibility granted states to modify the definition of Meaningful Use 
at Sec.  495.332(f). We explained that we believe this proposal would 
give states the ability to identify as high priority those measures 
that align with their state health goals or other programs within the 
state. We proposed to amend Sec.  495.332(f) to provide for this state 
flexibility to identify high priority measures.
    We proposed that any eCQMs identified via any of these mechanisms 
be considered to be high priority measures for EPs participating in the 
Medicaid Promoting Interoperability Program for 2019.
    We also proposed that the eCQM reporting period for EPs in the 
Medicaid Promoting Interoperability Program would be a full CY in 2019 
for EPs who have demonstrated meaningful use in a prior year, in order 
to align with the corresponding performance period in MIPS for the 
quality performance category. We explained that we continue to align 
Medicaid Promoting Interoperability Program requirements with 
requirements for other CMS quality programs, such as MIPS, to the 
extent practicable, to reduce the burden of reporting different data 
for separate programs. In addition, we explained that we have found 
that clinical quality data from an entire year reporting period is 
significantly more useful than partial year data for quality 
measurement and improvement because it gives states a fuller picture of 
a health care provider's care and patient outcomes. We proposed that 
the eCQM reporting period for Medicaid EPs demonstrating meaningful use 
for the first time, which was established in the final rule entitled 
``Medicare and Medicaid Programs; Electronic Health Record Incentive 
Program-Stage 3 and Modifications to Meaningful Use in 2015 Through 
2017'' (80 FR 62762) (hereafter referred to as ``Stage 3 final rule''), 
would remain any continuous 90-day period (80 FR 62892).
    We explained that we will adjust future years' requirements for 
reporting eCQMs in the Medicaid Promoting Interoperability Program 
through rulemaking, and will continue to align the quality reporting 
requirements, as logical and feasible, to minimize EP burden.
    Comment: Many commenters stated that they support the alignment of 
the eCQMs available for Medicaid EPs in 2019 with those available for 
MIPS eligible clinicians for the CY 2019 performance period. These 
commenters stated that alignment between the two programs helps reduce 
health care provider reporting burden. In addition, several commenters 
noted that the MIPS eCQM list is geared toward adults and that 
including measures from the Child Core Set in future years, after 2019, 
would add measures that are more applicable to certain specialties that 
serve Medicaid and CHIP beneficiaries, such as pediatricians and 
pediatric dentists.
    Response: We appreciate these comments, and we continue to look for

[[Page 59703]]

opportunities to align programs, make measures more relevant to 
Medicaid EPs, and reduce reporting burden when possible.
    Comment: Several commenters supported the proposal to include any 
e-specified measures from the Adult Core Set and Child Core Set that 
are not also on the MIPS eCQM list, in order to align with other CMS 
programs, as well as to provide a wider variety of measures that are 
specifically applicable to Medicaid EPs.
    Response: We agree that the measures included in the Adult Core Set 
and the Child Core Set are targeted toward Medicaid patients and 
Medicaid health care providers. These Core Sets are tools states can 
use to monitor and improve the quality of health care provided to 
Medicaid and CHIP enrollees. Although under statute, state reporting on 
these measure sets is voluntary, we aim to increase the number of 
states reporting on a uniform set of measures and to support states in 
using these measures to drive quality improvement for the beneficiaries 
they serve.
    Comment: One commenter stated that the e-specified Adult Core Set 
and Child Core Set measures that are not also on the MIPS eCQM list 
should not be included in future years of the Medicaid Promoting 
Interoperability Program beyond 2019 because the Medicaid Promoting 
Interoperability Program is approaching the final years of 
participation and Medicaid EPs are already aware of the requirements 
they need to meet to be a meaningful EHR user. In addition, the same 
commenter stated that adding additional measures from the Core Sets 
would create a large burden on all states to update their attestation 
systems for the one or two remaining participation years.
    Response: We appreciate this comment, but point out that the burden 
to states would be no greater than including any additional measures 
that may be added to the MIPS eCQM set in future years, if CMS 
continues to align the MIPS and Medicaid Promoting Interoperability 
Program eCQM requirements. We also point out that many of the positive 
comments regarding this proposal came from states that appreciated the 
proposal to align with other CMS reporting requirements. Those 
commenters did not indicate that such a requirement would impose a 
significant burden on states.
    After careful consideration of the comments, we are finalizing 
without change our proposal to amend the list of available eCQMs for 
the CY 2019 performance period. To keep eCQM specifications current and 
minimize complexity, we are aligning the eCQMs available for Medicaid 
EPs in 2019 with those available for MIPS eligible clinicians for the 
CY 2019 performance period. Specifically, the eCQMs available for 
Medicaid EPs in 2019 will consist of the list of quality measures 
available under the eCQM collection type on the final list of quality 
measures established under MIPS for the CY 2019 performance period.
    We did not propose to include the e-specified measures within the 
Adult Core Set and Child Core Set that are not also on the MIPS eCQM 
list for eCQM reporting in the Medicaid Promoting Interoperability 
Program in 2019, due to timing and logistical feasibility. However, we 
intend to reevaluate whether to add these measures when proposing eCQM 
reporting requirements for the Medicaid Promoting Interoperability 
Program for 2020 and beyond.
    Comment: Many commenters stated their support for aligning the 
Medicaid Promoting Interoperability Program with the MIPS requirement 
that eligible clinicians who elect to submit eCQMs must generally 
submit data on at least six quality measures, including at least one 
outcome measure (or, if an applicable outcome measure is not available, 
one other high priority measure).
    Response: We thank these commenters and we will continue to look 
for opportunities to align the programs and reduce reporting burden 
when possible.
    Comment: One commenter stated that there are relatively few 
pediatric-appropriate measures in the Medicaid Promoting 
Interoperability Program and MIPS, and therefore recommended that CMS 
provide specific clarification that pediatric providers would not be 
held responsible for adult measures that are not necessarily applicable 
to pediatrics.
    Response: We acknowledge that not all Medicaid EPs may find six 
measures applicable to their scope of practice. Therefore, we note that 
our policy continues to allow Medicaid EPs to report eCQMs with zero in 
the denominator, which indicates that they have no data on that eCQM in 
their EHR from the reporting period. If fewer than six measures are 
relevant to a Medicaid EP's scope of practice, he or she may submit 
``zero denominator'' eCQMs that his or her CEHRT is able to calculate 
to meet the requirement to report six measures. If an EP's CEHRT 
contains no data on a specific eCQM, when states are auditing EP's 
submissions, it may create a rebuttable presumption that that measure 
falls outside of the EP's scope of practice. However, unless they 
cannot otherwise report on six measures, we encourage EPs to report on 
eCQMs that contain data, which are more likely to be within their scope 
of practice, instead of reporting eCQMs with a zero denominator.
    Comment: One commenter stated that some specialists may have 
difficulty finding an outcome or high priority measure applicable to 
their scope of practice. The commenter also noted that this difficulty 
is alleviated under MIPS with the group reporting option, which is not 
available under the Medicaid Promoting Interoperability Program.
    Response: In light of this concern, we now explain that if no 
outcome or high priority measures apply to a Medicaid EP's scope of 
practice and there is no data for any of the outcome or high priority 
measures reportable by his or her CEHRT, he or she may report on six 
non-outcome and non-high priority measures that are applicable to his 
or her scope of practice.
    Comment: One commenter inquired as to a state's responsibility for 
auditing the eCQMs a Medicaid EP submits, how a state would ensure that 
the reported eCQMs are within the EP's scope of practice, and how a 
state would know whether there was an unselected relevant outcome or 
high priority measure.
    Response: Under Sec.  495.368, states are required to combat fraud 
and abuse and ensure that incentive payments are made properly per the 
requirements of the program, including the eCQM reporting requirements. 
In regard to this particular requirement, we believe that Medicaid EPs 
are in the best position to determine which measures are applicable to 
their scope of practice, not the state. Therefore, when verifying EPs' 
submissions, either at prepayment or during a post-payment audit, 
states should give Medicaid EPs the widest reasonable latitude to 
determine which eCQMs are relevant to their scope of practice. For 
instance, an EP should be able to meet the eCQM reporting requirements 
by submitting non-zero data for six relevant eCQMs, including one 
outcome or high-priority measure, regardless of whether there may be an 
unselected eCQM more relevant to his or her practice. That is, as we 
noted above, we do not think EPs should be reporting on eCQMs with a 
zero denominator unless that is the only way the EP can report on six 
measures. We encourage states to provide technical assistance to 
Medicaid EPs and to design their attestation systems in such a way that 
will assist EPs to meet this program requirement, and that will help 
avoid recouping incentive payments.
    After careful consideration of the comments, we are finalizing our

[[Page 59704]]

proposal that for 2019, Medicaid EPs will report on any six eCQMs that 
are relevant to the EP's scope of practice, regardless of whether they 
report via attestation or electronically. We are also finalizing the 
proposal that for 2019 the Medicaid Promoting Interoperability Program 
will adopt the MIPS requirement that EPs report on at least one outcome 
measure (or, if an applicable outcome measure is not available or 
relevant, one other high priority measure). Additionally, in response 
to comments summarized above, we now explain that if no outcome or high 
priority measure is relevant to a Medicaid EP's scope of practice, he 
or she may report on any six eCQMs that are relevant.
    Comment: Some commenters approved of our proposal to allow states 
to indicate which eCQMs are high priority measures for that state's 
Medicaid agency.
    Response: We thank these commenters for their comments.
    Comment: A few commenters opposed offering states the flexibility 
to identify high priority eCQMs because it can cause additional cost to 
states for technology updates, and additional burden for vendors to 
customize and make software updates in a short timeframe. They also 
commented that having differences among states can cause burden on 
Medicaid EPs.
    Response: We do not believe that this flexibility and variation 
between states will cause any additional burden for states, vendors or 
Medicaid EPs. Allowing states to identify their own high priority 
measures is entirely optional. If a state chooses not to identify 
additional high priority measures, the state would need to take no 
additional action. Furthermore, we expect that providing this option 
for states will reduce Medicaid EP burden, as it will give EPs a wider 
range of options to meet the requirement that they report on at least 
one outcome measure, or on at least one high priority measure if an 
outcome measure is not available or relevant. Additionally, as we 
explain above, if no outcome or priority measure is relevant to a 
Medicaid EP's scope of practice, he or she may instead report on any 
six measures that are relevant.
    Finally, this proposal should not increase burden on CEHRT vendors. 
States may select high priority measures only from the list of eCQMs 
that are already available for Medicaid EPs to meet the requirements of 
the program. Medicaid EPs are not required to select any of their 
state-specific high priority measures. Therefore, the CEHRT need not 
vary between states, but must be able to calculate and report on at 
least one outcome measure (or, if an applicable outcome measure is not 
available or relevant, one other high priority measure) relevant to the 
provider's scope of practice, whether or not that is a state-specific 
high priority measure.
    We received no comments on the first and second methods of 
identifying high priority measures for the Medicaid Promoting 
Interoperability Program. After careful consideration of the comments 
on our proposed approach to how high priority measures would be 
identified, we are finalizing it without modification.
    Comment: Several commenters stated their support for aligning the 
eCQM reporting period for EPs in the Medicaid Promoting 
Interoperability Program with the corresponding performance period in 
MIPS, because they agreed this proposal would reduce EP burden. In 
addition, commenters noted that consistency with previous years will 
reduce confusion among EPs.
    Response: We appreciate these comments and will continue to align 
when possible.
    Comment: Several commenters urged CMS to adopt a 90-day eCQM 
reporting period within CY 2019 for all Medicaid EPs. A couple 
commenters indicated that the transition between 2014 Edition and 2015 
Edition CEHRT during the year may create difficulty for Medicaid EPs to 
report a full year of data.
    Response: We acknowledge that many Medicaid EPs might be upgrading 
or implementing new CEHRT in 2019. However, Medicaid EPs frequently 
upgrade or implement new CEHRT, regardless of the reporting year. 
Regardless of what CEHRT the EP used during the eCQM reporting period, 
the data that Medicaid EPs are required to report for eCQMs is a 
snapshot based on the data within the CEHRT, taken at the time of 
attestation, for the reporting period. Medicaid EPs are only 
responsible for reporting exactly the data that their CEHRT produces. 
As certified, 2015 Edition CEHRT should accurately calculate and report 
the eCQM data for the full reporting period, in accordance with the 
relevant certification requirements at 45 CFR 170.315(c), even if that 
2015 Edition CEHRT was not implemented for the entire reporting period. 
Vendors should ensure that their CEHRT is performing in accordance with 
relevant 2015 Edition Certification requirements as defined by the 
Office of the National Coordinator for Health IT. The reporting process 
for EPs should be no different regardless of the length of the 
reporting period.
    After careful consideration of the comments, we are finalizing 
without change our proposal that the eCQM reporting period for EPs in 
the Medicaid Promoting Interoperability Program will be a full CY in 
2019 for EPs who have demonstrated meaningful use in a prior year, in 
order to align with the corresponding performance period in MIPS for 
the quality performance category. The eCQM reporting period for 
Medicaid EPs demonstrating meaningful use for the first time, which was 
established in the Stage 3 final rule, will remain any continuous 90-
day period (80 FR 62892).
3. Proposed Revisions to the EHR Reporting Period and eCQM Reporting 
Period in 2021 for EPs Participating in the Medicaid Promoting 
Interoperability Program
    In the July 28, 2010 final rule titled ``Medicare and Medicaid 
Programs; Electronic Health Record Incentive Program'' at 75 FR 44319, 
we established that, in accordance with section 1903(t)(4)(A)(iii) of 
the Act, in no case may any Medicaid EP receive an incentive after 2021 
(see Sec.  495.310(a)(2)(v)). Therefore, December 31, 2021 is the last 
date that states could make Medicaid Promoting Interoperability Program 
payments to Medicaid EPs (other than pursuant to a successful appeal 
related to 2021 or a prior year).
    For states to make payments by that deadline, there must be 
sufficient time after EHR and eCQM reporting periods end for Medicaid 
EPs to attest to states, for states to conduct their prepayment 
processes, and for states to issue payments. Therefore, we proposed to 
amend Sec.  495.4 to provide that the EHR reporting period in 2021 for 
all EPs in the Medicaid Promoting Interoperability Program would be a 
minimum of any continuous 90-day period within CY 2021, provided that 
the end date for this period falls before October 31, 2021, to help 
ensure that the state can issue all Medicaid Promoting Interoperability 
Program payments on or before December 31, 2021. Similarly, we proposed 
to change the eCQM reporting period in 2021 for EPs in the Medicaid 
Promoting Interoperability Program to a minimum of any continuous 90-
day period within CY 2021, provided that the end date for this period 
falls before October 31, 2021, to help ensure that the state can issue 
all Medicaid Promoting Interoperability Program payments on or before 
December 31, 2021.
    We explained that we understand that the October 31, 2021 date 
might not provide some states with sufficient time to process payments 
by December 31,

[[Page 59705]]

2021. We also explained that we believe that states are best positioned 
to determine the last possible date in CY 2021 by which the EHR or eCQM 
reporting periods for Medicaid EPs must end, and the deadline for 
receiving EP attestations, so that the state is able to issue all 
payments by December 31, 2021. Therefore, we proposed to allow states 
the flexibility to set alternative, earlier final deadlines for EHR or 
eCQM reporting periods for Medicaid EPs in CY 2021, with prior approval 
from us, through their State Medicaid HIT Plans (SMHP). If a state 
establishes an alternative, earlier date within CY 2021 by which all 
EHR or eCQM reporting periods in CY 2021 must end, Medicaid EPs in that 
state would continue to have a reporting period of a minimum of any 
continuous 90-day period within CY 2021. The end date for the reporting 
period would have to occur before the day of attestation, which must 
occur prior to the final deadline for attestations established by their 
state. We proposed to amend Sec.  495.332(f) to provide for this state 
flexibility to identify an alternative date by which all EHR reporting 
periods or eCQM reporting periods for Medicaid EPs in CY 2021 must end.
    We believe there is no reason why a state would need to set a date 
by which EHR reporting periods and eCQM reporting periods must end for 
Medicaid EPs that is earlier than the day before that state's 
attestation deadline for EPs. Doing so would restrict Medicaid EPs' 
ability to select EHR and eCQM reporting periods. Therefore, we 
proposed that any alternative deadline for CY 2021 EHR and eCQM 
reporting periods set by a state may not be any earlier than the day 
prior to the attestation deadline for Medicaid EPs attesting to that 
state.
    The following is a summary of the comments we received regarding 
these proposals.
    Comment: Multiple commenters stated their support for the proposal 
that the EHR reporting period in 2021 for all EPs in the Medicaid 
Promoting Interoperability Program would be a minimum of any continuous 
90-day period within CY 2021, provided that the end date for this 
period falls before October 31, 2021. They agreed that this would help 
ensure that states can issue all Medicaid Promoting Interoperability 
Program payments on or before December 31, 2021. They also stated their 
support of the 90-day period for eCQM reporting, and for state 
flexibility to set earlier final deadlines for EHR or eCQM reporting 
periods for Medicaid EPs in CY 2021.
    Response: We appreciate these comments and thank the commenters for 
their input.
    Comment: A commenter pointed out that the earlier in the year a 
state sets the reporting period and attestation deadline, the more 
burden is put on Medicaid EPs to attest after a 90 day EHR and eCQM 
reporting period in 2021. They requested that we balance the burden 
between states and Medicaid EPs by setting a regulatory date before 
which a state could not set an attestation deadline.
    Response: The commenters raise important questions about whether 
burden should be reduced on state staff and systems to the disadvantage 
of Medicaid EPs. Therefore, while we are finalizing the proposed 
policies without change, we are considering whether to propose in 
future rulemaking that no state may set a reporting period deadline for 
CY 2021 that is earlier than June 30, 2021 or an attestation deadline 
that is earlier than July 1, 2021. In the meanwhile, we welcome input 
from states and other interested parties on whether any state would 
need more than 6 months to process Medicaid EPs' attestations, perform 
the required prepayment validations, and disburse incentive payments.
    Comment: One commenter requested that CMS provide outreach and 
educational materials to providers about the 2021 deadline, as they 
anticipate confusion.
    Response: We will work with State Medicaid Agencies and provider 
communities to ensure that outreach and education are provided about 
the final attestation deadline and the end of the program.
    Comment: Some commenters requested that CMS consider making the 
eCQM reporting period any 90 days within CY 2020 as well. They note 
that a full year reporting period may create significant backlogs of 
2020 and 2021 attestations in 2021 that may create difficulty for 
states to issue payments by the statutory deadline.
    Response: We understand that this is a concern. We will continue to 
monitor this issue as we develop proposed rules for the Medicaid 
Promoting Interoperability Program in 2020.
    After careful consideration of the comments, we are finalizing our 
proposal to amend Sec.  495.4 to provide that the EHR reporting period 
in 2021 for all EPs in the Medicaid Promoting Interoperability Program 
will be a minimum of any continuous 90-day period within CY 2021, 
provided that the end date for this period falls before October 31, 
2021, to help ensure that states can issue all Medicaid Promoting 
Interoperability Program payments on or before December 31, 2021. We 
are also finalizing our proposal to change the eCQM reporting period in 
2021 for EPs in the Medicaid Promoting Interoperability Program to a 
minimum of any continuous 90-day period within CY 2021, provided that 
the end date for this period falls before October 31, 2021, to help 
ensure that states can issue all Medicaid Promoting Interoperability 
Program payments on or before December 31, 2021.
    In addition, we are finalizing our proposal to allow states the 
flexibility to set alternative, earlier final deadlines for EHR or eCQM 
reporting periods for Medicaid EPs in CY 2021, with prior approval from 
us, through their State Medicaid HIT Plan (SMHP). Any alternative 
deadline for CY 2021 EHR and eCQM reporting periods set by a state may 
not be any earlier than the day prior to the attestation deadline for 
Medicaid EPs attesting to that state.
    Although we did not address reporting periods in 2021 for eligible 
hospitals in the proposed rule, we acknowledge that there will be a 
similar issue if there are still hospitals eligible to receive Medicaid 
Promoting Interoperability Program payments in 2021, including 
Medicaid-only eligible hospitals as well as ``dually-eligible'' 
eligible hospitals and critical access hospitals (CAHs) (those that are 
eligible for an incentive payment under Medicare for meaningful use of 
CEHRT and/or subject to the Medicare payment reduction for failing to 
demonstrate meaningful use of CEHRT, and are also eligible to earn a 
Medicaid incentive payment for meaningful use of CEHRT). However, based 
on attestation data and information from states' SMHPs regarding the 
number of years states disburse Medicaid Promoting Interoperability 
Program payments to hospitals, we believe that there will be no 
hospitals eligible to receive Medicaid Promoting Interoperability 
Program payments in 2021 due to the requirement that, after 2016, 
eligible hospitals cannot receive a Medicaid Promoting Interoperability 
Program payment unless they have received such a payment in the prior 
fiscal year. At this time, we believe that there are no hospitals that 
will be able to receive incentive payments in 2020 or 2021. We invited 
comments and suggestions on whether this belief is accurate, and if 
not, how we could address the issue in a manner that limits the burden 
on hospitals and states. The following is a summary of the comments we 
received on this issue.
    Comment: One commenter stated that CMS's belief is accurate, and 
that they

[[Page 59706]]

do not anticipate any hospitals to participate in program years 2020 or 
2021. However, the commenter requested that CMS take into consideration 
the audit and appeals process, which may result in payments made during 
those years.
    Response: We acknowledge that Medicaid Promoting Interoperability 
Program incentive payments might still be made to hospitals after 
hospitals' participation years, or even after December 31, 2021, in the 
limited circumstance of a successful hospital appeal related to 
participation in the Medicaid Promoting Interoperability Program in a 
prior year.
    We did not propose any specific policy regarding eligible hospital 
reporting periods for 2021 in this rule and thus are not finalizing any 
policy in this area now, but we expect to solicit additional comment on 
the issue in a future proposed rule that is more specifically related 
to hospital payment.
4. Revisions to Stage 3 Meaningful Use Measures for Medicaid EPs
a. Change to Objective 6 (Coordination of Care Through Patient 
Engagement)
    In the Stage 3 final rule, we adopted a phased approach under Stage 
3 for EP Objective 6 (Coordination of care through patient engagement), 
Measure 1 (View, Download, or Transmit) and Measure 2 (Secure 
Electronic Messaging). This phased approach established a 5 percent 
threshold for both measures 1 and 2 of this objective for an EHR 
reporting period in 2017. (80 FR 62848 through 62849) In the same rule, 
we established that the threshold for Measure 1 would rise to 10 
percent, beginning with the EHR reporting period in 2018, and that the 
threshold for Measure 2 would rise to 25 percent, beginning with the 
EHR reporting period in 2018. We stated that we would continue to 
monitor performance on these measures to determine if any further 
adjustment was needed. In the FY 2018 IPPS/LTCH PPS final rule (82 FR 
38493), we established a policy allowing EPs, eligible hospitals, and 
CAHs to use either 2014 Edition or 2015 Edition CEHRT, or a combination 
of 2014 Edition and 2015 Edition CEHRT, for an EHR reporting period in 
CY 2018, and depending on which Edition(s) they use, to attest to the 
Modified Stage 2 objectives and measures or the Stage 3 objectives and 
measures. In doing so, we also delayed the rise of the Objective 6 
Measure 1 and Measure 2 thresholds until 2019.
    We explained that based on feedback we have received, we understand 
that these two measures are the largest barrier to successfully 
demonstrating meaningful use, especially in rural areas and at safety 
net clinics. Stakeholders have reported a variety of causes that have 
resulted in lower patient participation than was anticipated when the 
Stage 3 final rule was issued. The data that we have collected via 
states for Medicaid EPs and at CMS from Medicare EPs for previous 
program years support this feedback. The primary issue is that the 
view, download, transmit measure requires a positive action by 
patients, which cannot be controlled by an EP. Medicaid populations 
that are at the greatest risk have lower levels of internet access, 
internet literacy and health literacy than the general population. 
Although the Secure Electronic Messaging measure does not require 
patient action, only that the EP send a secure message, we have 
received feedback that this functionality is not highly utilized by 
patients. Although we encourage Medicaid EPs to continue to reach out 
to patients via secure messaging to engage them in their health care 
between office visits, it is not productive for EPs to send messages to 
patients who are unlikely to see them or take action. Retaining the 
current threshold of 5 percent for both measures would continue to 
incentivize Medicaid EPs to engage patients in their own care without 
raising the requirements to unattainable thresholds for EPs who serve 
vulnerable Medicaid patients. Therefore, we proposed to amend Sec.  
495.24(d)(6)(i) such that the thresholds for Measure 1 (View, Download, 
or Transmit) and Measure 2 (Secure Electronic Messaging) of Meaningful 
Use Stage 3 EP Objective 6 (Coordination of care through patient 
engagement) would remain 5 percent for 2019 and subsequent years.
    The following is a summary of the comments we received on this 
proposal.
    Comment: The majority of commenters stated that they support CMS's 
proposal for the Objective 6 threshold to remain at 5 percent for the 
remainder of the Medicaid Promoting Interoperability Program, and that 
raising the thresholds would place undue burden on EPs.
    Response: We thank the many commenters who stated their support.
    Comment: One commenter stated that certain populations, 
specifically older adults, may struggle to engage with technology, 
which created challenges for health care providers and recommended 
giving special consideration to health care providers who struggle to 
meet this objective.
    Response: We understand that some Medicaid EPs struggle to meet the 
objective due to factors outside of their control. However, this 
comment further supports our decision to keep the Objective 6 threshold 
at 5 percent rather than increasing it, as would happen without this 
rule change.
    Comment: Several commenters noted that the Medicaid Promoting 
Interoperability Program and the Medicare Promoting Interoperability 
category of MIPS are still not fully aligned, and that this creates 
reporting burdens for providers. These commenters requested further 
alignment, between these two Objective 6 measures, which were proposed 
for removal under MIPS, as well as more broadly between the two 
programs.
    Response: We agree that alignment of MIPS and the Medicaid 
Promoting Interoperability Program, to the degree practicable, is 
advantageous. The greater the discrepancy between the program 
requirements, the greater the reporting burden on health care providers 
who participate in both programs. We are finalizing our proposed 
changes to the Objective 6 measures without change, because we 
anticipate that doing so will reduce Medicaid EP burden. However, 
especially in light of these comments, we will also consider proposing 
further changes to the Medicaid Promoting Interoperability Program in 
future rulemaking, to improve alignment with the objectives and 
measures under the MIPS program. In the meanwhile, we welcome input 
from the public on this topic, and on additional ways that CMS can 
improve alignment between the two programs.
    In addition, we note that the change from the Modified Stage 2 
objectives and measures will make this objective easier for Medicaid 
EPs to meet. There are three measures under ``Objective 6: Coordination 
of Care through Patient Engagement.'' To be a meaningful EHR user, an 
EP must attest to all three measures, but only meet the thresholds for 
two of those three. Under Modified Stage 2, both Measure 1 (View, 
Download, or Transmit) and Measure 2 (Secure Electronic Messaging) were 
required (but not under the same objective) and Measure 3 was not an 
option. Both Measure 2 and Measure 3 do not rely on any patient action, 
but only require Medicaid EPs' action.
    After reviewing the comments, we are finalizing without change the 
proposal to amend Sec.  495.24(d)(6)(i) so that the thresholds for 
Measure 1 (View, Download, or Transmit) and Measure 2 (Secure 
Electronic Messaging) of Meaningful Use Stage 3 EP Objective 6 
(Coordination of care through patient engagement) will remain 5 percent 
for 2019 and subsequent years.

[[Page 59707]]

b. Change to the Syndromic Surveillance Reporting Measure
    In the proposed rule, we explained that in the Stage 3 final rule, 
we established that the syndromic surveillance reporting measure for 
EPs was limited to those who practice in urgent care settings (80 FR 
62866 through 62870). Since then, we have received feedback from states 
and public health agencies that while many are unable to accept non-
emergency or non-urgent care ambulatory syndromic surveillance data 
electronically, some public health agencies can and do want to receive 
data from health care providers in non-urgent care settings. We also 
explained that we believe that public health agencies that set the 
requirements for data submission to public health registries are in a 
better position to judge which health care providers can contribute 
useful data.
    Therefore, we proposed to amend Sec.  495.24(d)(8)(i)(B)(2), EP 
Objective 8 (Public health and clinical data registry reporting), 
Measure 2 (Syndromic surveillance reporting measure), to amend the 
language restricting the use of syndromic surveillance reporting for 
meaningful use only to EPs practicing in an urgent care setting. We 
proposed to include any EP defined by the state or local public health 
agency as a provider who can submit syndromic surveillance data. This 
change would not alter the exclusion for this measure at Sec.  
495.24(d)(8)(i)(C)(2)(i), for EPs who are not in a category of health 
care providers from which ambulatory syndromic surveillance data is 
collected by their jurisdiction's syndromic surveillance system, as 
defined by the state or local public health agency. Furthermore, we did 
not propose to create any requirements for syndromic surveillance 
registries to include all EPs. Additionally, we noted that under the 
specifications for the 2015 Edition of CEHRT for syndromic 
surveillance, it is possible that an EP could own CEHRT and submit 
syndromic surveillance in a format that is not accepted by the local 
jurisdiction. In this case, the EP may take an exclusion for syndromic 
surveillance.
    The following is a summary of the comments we received on this 
proposal.
    Comment: Several commenters stated their support of our proposal to 
include any EP defined by the state or local public health agency as a 
provider who can submit syndromic surveillance data.
    Response: We thank the commenters for their support.
    After careful consideration of the comments, we are finalizing 
without change our proposal to amend Sec.  495.24(d)(8)(i)(B)(2), EP 
Objective 8 (Public health and clinical data registry reporting), 
Measure 2 (Syndromic surveillance reporting measure), to amend the 
language restricting the use of syndromic surveillance reporting for 
meaningful use only to EPs practicing in an urgent care setting. The 
new objective will also include any other setting from which ambulatory 
syndromic surveillance data are collected by the state or local public 
health agency. This change does not alter the exclusion for this 
measure at Sec.  495.24(d)(8)(i)(C)(2)(i), for EPs who are not in a 
category of health care providers from which ambulatory syndromic 
surveillance data is collected by their jurisdiction's syndromic 
surveillance system, as defined by the state or local public health 
agency. Furthermore, this does not create any requirements for 
syndromic surveillance registries to include all EPs. Additionally, 
under the specifications for the 2015 Edition of CEHRT for syndromic 
surveillance, it is possible that an EP could own CEHRT and submit 
syndromic surveillance in a format that is not accepted by the local 
jurisdiction. In this case, the EP may take an exclusion for syndromic 
surveillance.

F. Medicare Shared Savings Program

    As required under section 1899 of the Act, we established the 
Medicare Shared Savings Program (Shared Savings Program) to facilitate 
coordination and cooperation among health care providers to improve the 
quality of care for Medicare fee-for-service (FFS) beneficiaries and 
reduce the rate of growth in expenditures under Medicare Parts A and B. 
Eligible groups of providers and suppliers, including physicians, 
hospitals, and other health care providers, may participate in the 
Shared Savings Program by forming or participating in an Accountable 
Care Organization (ACO). The final rule establishing the Shared Savings 
Program appeared in the November 2, 2011 Federal Register (Medicare 
Program; Medicare Shared Savings Program: Accountable Care 
Organizations; Final Rule (76 FR 67802) (hereinafter referred to as the 
``November 2011 final rule'')). A subsequent major update to the 
program rules appeared in the June 9, 2015 Federal Register (Medicare 
Program; Medicare Shared Savings Program: Accountable Care 
Organizations; Final Rule (80 FR 32692) (hereinafter referred to as the 
``June 2015 final rule'')). The final rule entitled, ``Medicare 
Program; Medicare Shared Savings Program; Accountable Care 
Organizations--Revised Benchmark Rebasing Methodology, Facilitating 
Transition to Performance-Based Risk, and Administrative Finality of 
Financial Calculations,'' which addressed changes related to the 
program's financial benchmark methodology, appeared in the June 10, 
2016 Federal Register (81 FR 37950) (hereinafter referred to as the 
``June 2016 final rule'')).
    In August 2018, we issued the ``Medicare Program: Medicare Shared 
Savings Program; Accountable Care Organizations--Pathways to Success'' 
proposed rule (hereinafter referred to as the ``August 2018 proposed 
rule'') which addressed a number of proposed policy changes including 
redesign of the participation options available under the program to 
encourage ACOs to transition to two-sided models; new tools to support 
coordination of care across settings and strengthen beneficiary 
engagement; revisions to ensure rigorous benchmarking; and policies 
promoting use of interoperable electronic health record technology 
among ACO providers/suppliers (83 FR 41786). In section V. of this 
final rule, we are finalizing the following proposals from the August 
2018 proposed rule:
     A voluntary 6-month extension for existing ACOs whose 
participation agreements expire on December 31, 2018 and the 
methodology for determining financial and quality performance for this 
6-month performance year from January 1, 2019, through June 30, 2019;
     Policies implementing the Bipartisan Budget Act of 2018 
provisions on voluntary alignment;
     Modifications to the definition of primary care services 
used in assigning beneficiaries to ACOs to reflect recent code changes;
     Extension of policies providing relief for ACOs and their 
clinicians impacted by extreme and uncontrollable circumstances during 
2017 to performance year 2018 and subsequent years; and
     Policies to promote interoperability among ACO providers/
suppliers, including establishing a new program eligibility requirement 
regarding CEHRT use and retiring the CEHRT quality measure (ACO-11).
    We expect to address the remaining proposals in the August 2018 
proposed rule in a forthcoming final rule.
    We have also made use of the annual calendar year (CY) PFS rules to 
address quality reporting for the Shared Savings Program and certain 
other issues. In the CY 2018 PFS final rule (82 FR 53209 through 
53226), we finalized revisions to several different policies under the

[[Page 59708]]

Shared Savings Program, including the assignment methodology, quality 
measure validation audit process, use of the skilled nursing facility 
(SNF) 3-day waiver, and handling of demonstration payments for purposes 
financial reconciliation and establishing historical benchmarks. In 
addition, in the CY 2017 and CY 2018 Quality Payment Program final 
rules (81 FR 77255 through 77260, and 82 FR 53688 through 53706, 
respectively), we finalized policies related to the Alternative Payment 
Model (APM) scoring standard under the Merit-Based Incentive Payment 
System (MIPS), which reduces the reporting burden for MIPS eligible 
clinicians who participate in MIPS APMs, such as the Shared Savings 
Program, by: (1) Using the CAHPS for ACOs survey and the ACO reported 
CMS Web Interface quality data for purposes of assessing quality 
performance in the Shared Savings Program and to score the MIPS quality 
performance category for these eligible clinicians; (2) automatically 
awarding MIPS eligible clinicians participating in Shared Savings 
Program ACOs a minimum of one-half of the total points in the MIPS 
improvement activities performance category; (3) requiring ACO 
participants to report Advancing Care Information (ACI) data at the 
group practice level or solo practitioner level; and (4) not assessing 
MIPS eligible clinicians on the MIPS cost performance category because, 
through their participation in the ACO, they are already being assessed 
on cost and utilization under the Shared Savings Program.
    As a general summary, in the CY 2019 PFS proposed rule, we proposed 
the following changes to the quality performance measures that will be 
used to assess quality performance under the Shared Savings Program for 
performance year 2019 and subsequent years:
     Changes to Patient Experience of Care Survey measures.
     Changes to CMS Web Interface and Claims-Based measures.
    In addition, in the August 2018 proposed rule, we proposed another 
change to the Shared Savings Program quality measure set, which we are 
finalizing in section V.B.2.f. of this final rule. We proposed to 
remove the ACO-11--Use of Certified EHR Technology measure (83 FR 41908 
through 41911). We refer readers to section V.B.2.f. of this final rule 
for a description of that proposal and a discussion of related public 
comments.
1. Quality Measurement
a. Background
    Section 1899(b)(3)(C) of the Act states that the Secretary shall 
establish quality performance standards to assess the quality of care 
furnished by ACOs and seek to improve the quality of care furnished by 
ACOs over time by specifying higher standards, new measures, or both. 
In the November 2011 final rule, we established a quality measure set 
spanning four domains: Patient experience of care, care coordination/
patient safety, preventive health, and at-risk population (76 FR 67872 
through 67891). Since the Shared Savings Program was established, we 
have updated the measures that comprise the quality performance measure 
set for the Shared Savings Program through the annual rulemaking in the 
CY 2015, 2016, and 2017 PFS final rules (79 FR 67907 through 67920, 80 
FR 71263 through 71268, and 81 FR 80484 through 80489, respectively).
    As we stated in the November 2011 final rule establishing the 
Shared Savings Program (76 FR 67872), our principal goal in selecting 
quality measures for ACOs has been to identify measures of success in 
the delivery of high-quality health care at the individual and 
population levels, with a focus on outcomes. For performance year 2018, 
31 quality measures will be used to determine ACO quality performance 
(81 FR 80488 and 80489). The information used to determine ACO 
performance on these quality measures will be submitted by the ACO 
through the CMS Web Interface, submitted by ACO participant TINs to 
MIPS for the Promoting Interoperability (PI) performance category 
(formerly Advancing Care Information), calculated by CMS from 
administrative claims data, and collected via a patient experience of 
care survey referred to as the Consumer Assessment of Healthcare 
Provider and Systems (CAHPS) for ACOs Survey. The CAHPS for ACOs survey 
is based on the Clinician and Group Consumer Assessment of Healthcare 
Providers and Systems (CG-CAHPS) Survey and includes additional, 
program specific questions that are not part of the CG-CAHPS. The CG-
CAHPS survey is maintained, and periodically updated, by the Agency for 
Healthcare Research and Quality (AHRQ) in HHS.
    The quality measures collected through the CMS Web Interface in 
2015 and 2016 were used to determine whether eligible professionals 
participating in an ACO would avoid the PQRS and automatic Physician 
Value-Based Payment Modifier (Value Modifier) downward payment 
adjustments for 2017 and 2018 and to determine if ACO participants were 
eligible for upward, neutral or downward adjustments based on quality 
measure performance under the Value Modifier. Beginning with the 2017 
performance period, which impacts payments in 2019, PQRS and the Value 
Modifier were replaced by the MIPS. Eligible clinicians who are 
participating in an ACO and who are subject to MIPS (MIPS eligible 
clinicians) will be scored under the APM scoring standard under MIPS 
(81 FR 77260). These MIPS eligible clinicians include any eligible 
clinicians who are participating in an ACO in a track of the Shared 
Savings Program that is not an Advanced APM, as well as those 
participating in an ACO in a track that is an Advanced APM, but who do 
not become Qualifying APM Participants (QPs) as specified in Sec.  
414.1425, and are not otherwise excluded from MIPS. Beginning with the 
2017 reporting period, measures collected through the CMS Web Interface 
will be used to determine the MIPS quality performance category score 
for MIPS eligible clinicians participating in a Shared Savings Program 
ACO. Starting with the 2018 performance period, the quality performance 
category under the MIPS APM Scoring Standard for MIPS eligible 
clinicians participating in a Shared Savings Program ACO will include 
measures collected through the CMS Web Interface and the CAHPS for ACOs 
survey measures.
    The CAHPS for ACOs Survey includes the core questions contained in 
the CG-CAHPS, plus additional questions to measure access to and use of 
specialist care, experience with care coordination, patient involvement 
in decision-making, experiences with a health care team, health 
promotion and patient education, patient functional status, and general 
health. The 2018 CAHPS for ACOs Survey 3.0 incorporates updates made by 
AHRQ to the CG-CAHPS survey based on feedback from survey users and 
stakeholders, as well as analyses of multiple data sets. For a summary 
of the history of changes to the CAHPS for ACOs survey, please refer to 
the CY 2019 PFS proposed rule (83 FR 35875). Additional information on 
the CG-CAHPS survey update is available on the AHRQ website at https://www.ahrq.gov/sites/default/files/wysiwyg/cahps/surveys-guidance/cg/about/proposed-changes-cahps-c&g-survey2015.pdf.
    In addition to incorporating changes based on the AHRQ survey 
update, CMS removed all items included in the

[[Page 59709]]

Summary Survey Measures (SSMs), Helping You to Take Medications as 
Directed and Between Visit Communication from the 2018 survey. These 
optional SSMs were not part of the scored measures. The update resulted 
in a reduction in the number of survey questions from 80 to 58. The 
CAHPS for ACOs SSMs that contribute to the ACO performance score for 
performance year 2018, as finalized in the CY 2017 PFS final rule (81 
FR 80488) are as follows: Getting Timely Care, Appointments & 
Information; How Well Your Providers Communicate; Patients' Rating of 
Provider; Access to Specialists; Health Promotion and Education; Shared 
Decision Making; Health Status & Functional Status; and Stewardship of 
Patient Resources. In addition, the core survey includes SSMs on Care 
Coordination and Courteous & Helpful Office Staff. However, because 
these measures are not included in the Shared Savings Program quality 
measure set for 2018, scores for these measures will be provided to 
ACOs for informational purposes only and will not be used in 
determining the ACOs' quality scores.
b. Proposals for Changes to the CAHPS Measure Set
    To enhance the Patient/Caregiver Experience domain and align with 
MIPS (82 FR 54163), we proposed to begin scoring the 2 SSMs that are 
currently collected with the administration of the CAHPS for ACOs 
survey and shared with the ACOs for informational purposes only. Under 
this proposal, we would add the following CAHPS for ACOs SSMs that are 
already collected and provided to ACOs for informational purposes to 
the quality measure set for the Shared Savings Program as ACO-45, 
CAHPS: Courteous and Helpful Office Staff, and ACO-46: CAHPS: Care 
Coordination. These measures would be scored and included in the ACO 
quality determination starting in 2019. Both of these SSMs are 
currently designated by AHRQ as CG CAHPS core measures.
    The Courteous and Helpful Office Staff SSM, which we proposed to 
add as ACO-45, asks about the helpfulness, courtesy and respectfulness 
of office staff. This SSM has been a CG-CAHPS core measure in the 
previous two versions of the CG-CAHPS survey, but was previously 
provided for informational purposes only and not included in the ACO 
quality score determination. We also proposed to add the SSM, CAHPS: 
Care Coordination to the CAHPS for ACOs measures used in ACO quality 
score determination as ACO-46. The Care Coordination SSM asks questions 
about provider access to beneficiary information and provider follow-
up. This SSM was designated a core measure in the most recent version 
of the CG-CAHPS survey.
    Including these measures in the quality measure set that is used to 
assess the quality performance of ACOs under the Shared Savings Program 
would place greater emphasis on outcome measures and the voice of the 
patient and provide ACOs with an additional incentive to act upon 
opportunities for improved care coordination and communication, and 
would align with the MIPS measure set finalized in the CY 2018 Quality 
Payment Program final rule (82 FR 54163). Care Coordination and patient 
and caregiver engagement are goals of the Shared Savings Program. The 
Care Coordination SSM emphasizes the care coordination goal, while the 
Courteous and Helpful Office Staff SSM supports patient engagement as 
it addresses a topic that has been identified as important to 
beneficiaries in testing. For performance year 2016, the mean 
performance rates across all ACOs for these two measures, which were 
not included in the ACO quality score determination, were 87.18 for the 
Care Coordination SSM and 92.12 for Courteous and Helpful Office Staff 
SSM.
    Consistent with Sec.  425.502(a)(4), regarding the scoring of newly 
introduced quality measures, we proposed that these additional SSMs 
would be pay-for-reporting for all ACOs for 2 years (performance years 
2019 and 2020). The measures would then phase into pay-for-performance 
in the program, according to the schedule in Table 26 beginning in 
performance year 2021. We solicited comment on this proposed change to 
the quality measure set.
    The following is a summary of the comments we received on this 
proposed change to the CAHPS measures included in the Shared Savings 
Program quality measure set.
    Comment: The majority of commenters supported our proposal. Several 
commenters noted that ACOs have had experience with these measures for 
some time now and that patient experience measures help to keep 
providers accountable for patient-centered care. A few commenters 
indicated support for the proposal but noted reservations, including 
the potentially limited ability of ACOs that include independent 
physician groups and hospitals as ACO participants to impact 
performance on ACO-45, a concern that the subjectivity of the CAHPS for 
ACOs measures (especially ACO-45) may put too much emphasis on aspects 
of care that have little effect on quality outcomes, and a 
recommendation to consider expanding ACO-45 (Courteous and Helpful 
Office Staff) to include medical assistants and nurses. Some commenters 
recommended delaying implementation of the proposal. A commenter 
suggested that we work with the Core Quality Measures Collaborative 
(CQMC) to re-evaluate the ACO quality measures, before implementing 
this proposed change. Another commenter recommended that we streamline 
the Shared Savings Program quality measure set. In addition, one 
commenter noted its support in principle for adding a quality measure 
to assess patients' experience with office staff, but indicated that 
adding a measure with a high average performance rate seems unnecessary 
for improving care.
    Response: We believe that adding ACO-45 CAHPS: Courteous and 
Helpful Office Staff puts greater emphasis on the voice of the patient 
and provides ACOs with an additional incentive to act upon 
opportunities for improved communication. With regard to the comment 
that ACOs that include independent physician groups and hospitals as 
ACO participants may not be able to influence the outcomes of ACO-45 
CAHPS: Courteous and Helpful Office Staff, we note that this SSM has 
been provided for informational purposes as part of the CAHPS for ACO 
survey for several years. Therefore, we believe ACOs have had 
sufficient experience with the SSM and have had the opportunity to 
monitor the survey results and make improvements, as needed. Scoring 
this measure would also provide ACOs with a stronger incentive to 
improve performance on this measure that has been identified as 
important by the beneficiaries they serve. We would also re-emphasize 
that measures newly added to the scored measures set will be pay-for-
reporting for the first 2 years after inclusion, giving ACOs additional 
time to work toward improvement. With regard to the concern that the 
proposed new CAHPS measures do not impact quality outcomes, we 
disagree. We consider the patient's experience of care to be a quality 
outcome. We also note that the Courteous and Helpful Office Staff 
measure focuses on an issue that has been identified as important to 
beneficiaries in testing and that the Care Coordination SSM addresses a 
primary objective of the Shared Savings Program. With regard to 
commenters' suggestions that we delay implementation of the proposal to 
score these measures, including the suggestion that we work with the 
CQMC

[[Page 59710]]

to re-evaluate the ACO quality measures first, we disagree with 
delaying the scoring of these important SSMs. These measures assess 
performance in areas that the beneficiaries served by ACOs have 
identified as valuable and that are central to the fundamental purpose 
of the Shared Savings Program to promote care coordination and improve 
quality of care. Again, we note that the newly-scored measures would be 
pay-for-reporting for the first 2 years after their addition, giving 
ACOs additional time to become familiar with them before the 
performance rates are considered in scoring. In response to the 
commenter's suggestion that we streamline the Shared Savings Program 
quality measure set, we do not have plans at this time to reduce the 
number of CAHPS measures for which ACOs are held accountable. The two 
CAHPs measures we proposed to add to the quality measure set for 
scoring purposes are already being collected and reported to ACOs for 
informational purposes; thus, the addition of these measures should not 
result in significant additional burden on ACOs. Moreover, we note that 
overall, we are reducing the total number of quality measures in the 
ACO quality measure set, as detailed below and summarized in Table 26 
of this final rule.
    With regard to the comment supporting the intent of our proposal to 
start scoring performance on the Courteous and Helpful Office Staff 
measure, but stating that it is unnecessary to add a measure with a 
high average performance rate, we believe that this is an important 
area for continued measurement as beneficiaries have expressed its 
importance to them in testing, as noted previously. In addition, we 
believe it is important to continue monitoring this measure because it 
is an important factor in patient experience of care. By scoring this 
measure, we acknowledge its continued importance as a patient 
experience measure. With regard to the comment that we consider 
expanding ACO-45 to include medical assistants and nurses, we will take 
this comment under consideration for further analysis as part of any 
potential future measure refinement.
    After considering the comments, we are finalizing our proposal to 
begin scoring ACO-45 and ACO-46 as part of the CAHPS for ACO survey 
beginning with quality reporting for performance years during 2019. 
Consistent with our existing policy regarding the scoring of newly 
introduced quality measures, these additional SSMs will be pay-for-
reporting for all ACOs for 2 years (performance years during 2019 and 
performance year 2020). The measures would then phase into pay-for-
performance beginning in performance year 2021 (Sec.  425.502(a)(4)). 
The phase-in schedule for the 2019 ACO quality measures set that we are 
finalizing in this rule is presented in Table 26.
    Additionally, we solicited comment on potentially converting the 
Health and Functional Status SSM (ACO-7) to pay-for-performance in the 
future. The Health and Functional Status SSM is currently pay-for-
reporting for all years. We have not scored this measure because the 
scores on the Health and Functional Status SSM may reflect the 
underlying health of beneficiaries seen by ACO providers/suppliers as 
opposed to the quality of the care provided by the ACO. We also sought 
stakeholder feedback on possible options for enhancing the collection 
of health and functional status data, including potentially changing 
our data collection procedures to collect data from the same ACO's 
assigned beneficiaries over time. We noted that such a change could 
allow for measurement of functional status changes that occurred while 
beneficiaries were receiving care from ACO providers/suppliers. We also 
solicited other recommendations regarding the potential inclusion of a 
functional status measure in the assessment of ACO quality performance 
in the future.
    The following is a summary of the comments we received regarding 
potentially converting the Health and Functional Status SSM (ACO-7) to 
pay-for-performance in the future.
    Comment: The majority of commenters opposed including ACO-7--Health 
and Functional Status as a pay-for-performance measure in future years, 
noting that the measure is largely outside of the physician's control. 
Some commenters were supportive of including a Health and Functional 
Status measure as pay-for-performance, but expressed concerns with 
inclusion of the measure as it is currently structured. For example, 
one commenter stated that the current structure of the SSM captures 
patient health and functional status at a single point in time but not 
as a change in status over time. A number of commenters emphasized this 
point, noting that a lack of baseline data for this measure for the 
ACO-assigned beneficiary population means the results cannot be 
attributed to ACOs. One commenter acknowledged the potential for 
collecting longitudinal data, but questioned the effectiveness of this 
approach given that ACOs may not have the same beneficiaries assigned 
over multiple years. Another commenter expressed concern regarding the 
lack of benchmark information against which ACOs might measure their 
performance to date. A commenter encouraged CMS to conduct analyses 
using existing CAHPS data to identify models that allow for a fair 
comparison across ACOs. Another commenter suggested an approach to 
scoring health and functional status using another survey instrument 
(such as Patient Reported Outcomes Measurement Information System), or 
collecting baseline data for an ACO and implementing adjustments to 
account for differences in patient mix across ACOs.
    Response: We appreciate the comments. We agree that additional 
analytic work would be needed in order to assess the potential 
implications of adding a scored health and functional status measure to 
the ACO quality measure set in the future. As we plan for future 
updates and changes to the Shared Savings Program measure set, we will 
consider this feedback from commenters further before making any 
proposal to begin scoring ACO-7--Health and Functional Status or to 
include a different scored heath and functional status measure.
    Comment: We also received a few general comments on the 
applicability of the CAHPS for ACOs SSM to institutional providers, 
including a comment that raised concerns about low response rates and 
low reliability of the results.
    Response: We made no proposals to adjust the application of the 
CAHPS for ACOs survey for any specific provider types under the Shared 
Savings Program. The CAHPS for ACO survey is focused on beneficiaries' 
experience of care received from clinicians in ambulatory care 
settings. Consequently, we note that CMS currently excludes 
beneficiaries from CAHPS sampling if 100 percent of their primary care 
service visits were performed in an institutional setting (as 
determined using HCPCS codes). However, after reviewing our current 
CAHPS sampling process, starting with the CAHPS sample for performance 
year 2018, we will also begin excluding beneficiaries if their last 
primary care service visit (as determined using HCPCS codes) during the 
sampling timeframe was performed in an institutional setting. We 
believe this change will help to ensure that beneficiaries who are 
residing in institutional settings are appropriately excluded from 
CAHPS sampling. Patient experience is a key component of quality 
measurement under the Shared Savings Program, and at this time we do 
not have plans to provide exemptions from patient experience measures 
for

[[Page 59711]]

specific ACOs. We will monitor this issue, and may in the future 
consider whether additional changes to measures of patient experience 
would be appropriate moving forward, based on the goals and priorities 
of the Shared Savings Program.
c. Proposed Changes to the CMS Web Interface and Claims-Based Quality 
Measure Sets
    In developing the proposals we made in the CY 2019 PFS proposed 
rule, we considered the agency's efforts to streamline quality 
measures, reduce regulatory burden and promote innovation as part of 
the agency's Meaningful Measures initiative (see CMS Press Release, CMS 
Administrator Verma Announces New Meaningful Measures Initiative and 
Addresses Regulatory Reform; Promotes Innovation at LAN Summit, October 
30, 2017, available at https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2017-Press-releases-items/2017-10-30.html). As noted in the proposed rule, under the Meaningful Measures 
initiative, we have committed to assessing only those core issues that 
are most vital to providing high-quality care and improving patient 
outcomes, with the aim of focusing on outcome-based measures, reducing 
unnecessary burden on providers, and putting patients first. In 
considering the quality reporting requirements under the Shared Savings 
Program, we also considered the quality reporting requirements under 
other initiatives, such as the MIPS and Million Hearts Initiative, and 
consulted with the measures community to ensure that the specifications 
for the measures used under the Shared Savings Program are up-to-date 
with current clinical guidelines, focus on outcomes over process, 
reflect agency and program priorities, and reduce reporting burden.
    Since the Shared Savings Program was first established in 2012, we 
have updated the quality measure set to reduce reporting burden and 
focus on more meaningful, outcome-based measures. The most recent 
updates to the Shared Savings Program quality measure set were made in 
the CY 2017 PFS final rule (81 FR 80484 through 80489) to adopt the ACO 
measure recommendations made by the Core Quality Measures 
Collaborative, a multi-stakeholder group with the goal of aligning 
quality measures for reporting across public and private initiatives to 
reduce provider reporting burden. Currently, more than half of the 31 
Shared Savings Program quality measures are outcome-based, including:
     Patient-reported outcome measures collected through the 
CAHPS for ACOs Survey that strengthen patient and caregiver experience.
     Outcome measures supporting effective communication and 
care coordination, such as unplanned admission and readmission 
measures.
     Intermediate outcome measures that address the effective 
treatment of chronic disease, such as hemoglobin A1c control for 
patients with diabetes.
    In the CY 2019 PFS proposed rule, we proposed to reduce the total 
number of measures in the Shared Savings Program quality measure set. 
The proposals were intended to reduce the burden on ACOs and their 
participating providers and suppliers by lowering the number of 
measures they are required to report through the CMS Web Interface and 
on which they are assessed using claims data. Reducing the number of 
measures on which ACOs are assessed would reduce the number of 
performance metrics that they are required to track and eliminate 
redundancies between measures that target similar populations. The 
proposed reduction in the number of measures would enable ACOs to 
better utilize their resources toward improving patient care. The 
proposed reduction in the number of measures would further reduce 
burden by aligning with the proposed changes to the CMS Web Interface 
measures that are reported under MIPS as discussed in Tables A, C, and 
D of Appendix 1: Proposed MIPS Quality Measures of the proposed rule. 
We recognize that ACOs and their participating providers and suppliers 
dedicate resources to performing well on our quality metrics, and we 
believe that reducing the number of metrics and aligning them across 
programs would allow them to more effectively target those resources 
toward improving patient care. We proposed to reduce the number of 
measures by minimizing measure overlap and eliminating several process 
measures. The proposal to remove process measures also aligns with our 
proposal to reduce the number of process measures within the MIPS 
measure set as discussed in section III.H.b.iii of this final rule and 
would support the CMS goal of moving toward outcome-based measurement.
    We proposed to retire the following claims-based quality measures, 
which have a high degree of overlap with other measures that would 
remain in the measure set:
     ACO-35--Skilled Nursing Facility 30-Day All-Cause 
Readmission Measure (SNFRM).
     ACO-36--All-Cause Unplanned Admissions for Patients with 
Diabetes.
     ACO-37--All-Cause Unplanned Admission for Patients with 
Heart Failure.
    Within the claims-based quality measures, a high degree of overlap 
exists between measures with respect to the population being measured 
(the denominator), because a single admission may be counted in 
multiple measures. For example, ACO-35 addresses unplanned readmissions 
from a SNF, and the vast majority of these SNF readmissions are also 
captured in the numerator of ACO-8 Risk-Standardized All Condition 
Readmission. Similarly, ACO-36 and ACO-37 address unplanned admissions 
for patients with diabetes and heart failure and most of these 
admissions are captured in the numerator of ACO-38 Risk-Standardized 
Acute Admission Rates for Patients with Multiple Chronic Conditions 
(please note that the measure name has been updated to align with 
changes made by the measure steward). Therefore, to reduce redundancies 
within the Shared Savings Program measure set, we proposed to remove 
ACO-35, ACO-36, and ACO-37 from the measure set. However, because these 
measures are claims-based measures and therefore do not impose any 
reporting burden on ACOs, we intend to continue to provide information 
to ACOs on their performance on these measures for use in their quality 
improvement activities through a new quarterly claims-based quality 
outcome report that ACOs began receiving in August 2018.
    We also proposed to retire claims-based measure ACO-44--Use of 
Imaging Studies for Low Back Pain, as this measure is restricted to 
individuals 18-50 years of age, which results in low denominator rates 
under the Shared Savings Program, meaning that the measure is not a 
meaningful reflection of the beneficiaries cared for by Shared Savings 
Program ACOs. Although this measure was originally added to the Shared 
Savings Program quality measure set in order to align with the Core 
Quality Measures Collaborative, we proposed to remove this measure as a 
result of low denominators for many ACOs. We also indicated that 
removing this measure would align ACO quality measurement with the MIPS 
requirements as this measure was removed for purposes of reporting 
under the MIPS program in the CY 2018 Quality Payment Program final 
rule (82 FR 54159). However, in recognition of the value in providing 
feedback to providers on potential overuse of diagnostic procedures, we 
noted that we intended to continue to provide ACOs feedback on 
performance on this

[[Page 59712]]

measure as part of the new quarterly claims based quality report.
    We welcomed public comment on our proposal to retire these 4 
claims-based measures from the quality measure set.
    The following is a summary of the comments we received on our 
proposal to retire ACO-35--Skilled Nursing Facility 30-Day All-Cause 
Readmission Measure (SNFRM), ACO-36--All-Cause Unplanned Admissions for 
Patients with Diabetes, and ACO-37--All-Cause Unplanned Admission for 
Patients with Heart Failure from the quality measure set.
    Comment: The majority of commenters supported our proposal to 
remove these measures stating that they appreciated our efforts to 
modernize the quality measurement requirements and reduce measure 
overlap. However, a commenter who supported our proposal cautioned, 
``that there may be a tipping point at which the choice of measures 
becomes too narrowed. . . .'' Another commenter expressed concern that 
diabetes is not included as one of the multiple chronic conditions for 
purposes of ACO-38--All-Cause Unplanned Admissions for Patients with 
Multiple Chronic Conditions (MCC). The commenter noted that the 
retirement of ACO-36--All-Cause Unplanned Admissions for Patients with 
Diabetes, without an adequate alternative to measure performance in 
this area could cause a potential decline in provider performance and 
care quality. This commenter emphasized that reducing admission rates 
of diabetic patients should be a shared goal and priority of CMS and 
ACOs. Another commenter asked if we considered adding diabetes as a 
qualifying condition for ACO-38.
    Response: We acknowledge the concerns raised by commenters with 
respect to the proposed removal of ACO-36 All-Cause Unplanned 
Admissions for Patients with Diabetes. However, we disagree with the 
commenter who stated that without a comparable diabetes measure to 
replace ACO-36 there would be a decline in provider performance and 
care quality. An analysis of ACO data from the 2015 performance year 
found that, as a result of the other comorbidities included for 
purposes of ACO-38, 48 percent of assigned ACO beneficiaries included 
in the diabetes measure were also included in the MCC measure. Measure 
overlap was even higher when considering the number of unplanned 
admissions shared by the two measures. Almost three-fourths (73 
percent) of the unplanned admissions for assigned ACO beneficiaries 
under ACO-36 were also unplanned admissions for purposes of ACO-38, and 
thus were counted in both measures. In addition, we note that the 
Shared Savings Program measure set still includes a diabetes measure 
that monitors Hemoglobin A1c control (ACO-27: Diabetes Hemoglobin A1c 
(HbA1c) Poor Control (9%)) which is reported via the CMS Web 
Interface. Consequently, we believe that removing ACO-36 will not 
negatively impact patients with diabetes as the majority of 
readmissions for these patients are captured by ACO-38. In addition, we 
note that we plan to continue providing metrics on ACO-36 and ACO-37 in 
the quarterly claims-based measure reports for informational purposes 
only, which will allow ACOs to continue to monitor their results for 
these metrics. We are not considering revisions to add diabetes as a 
qualifying condition for ACO-38 at this time, but we will consider any 
changes to the ACO-38 cohort during the annual measure update. In 
response to the comment that there may be a point at which the measure 
set becomes too narrow, we understand the concern and will continue to 
carefully consider the balance between burden reduction and meaningful 
measurement in order to retain a sufficiently robust measure set 
against which ACO performance can be measured.
    After considering the comments, we are finalizing our proposal to 
remove ACO-35--Skilled Nursing Facility 30-Day All-Cause Readmission 
Measure (SNFRM), ACO-36--All-Cause Unplanned Admissions for Patients 
with Diabetes, and ACO-37--All-Cause Unplanned Admission for Patients 
with Heart Failure from the Shared Savings Program quality measure set 
effective for quality reporting for performance years during 2019.
    The following is a summary of the comments we received on our 
proposal to retire ACO-44--Use of Imaging Studies for Low Back Pain 
from the quality measure set.
    Comment: A majority of commenters supported our proposal stating 
that they agreed the measure should be removed due to low denominators 
in the Medicare population and because the measure was retired from 
MIPS. MedPAC opposed the removal of this measure stating, ``According 
to our analysis, imaging for patients with nonspecific low back pain 
affects between 3.1 to 8.9 percent of Medicare beneficiaries.'' MedPAC 
encouraged CMS to consider respecifying the measure to include 
beneficiaries over the age of 50 and retaining the measure in the ACO 
quality measure set.
    Response: We appreciate the recommendation to respecify the ACO 
imaging for low-back pain measure to include beneficiaries over age 50 
and recognize the value of including over-utilization of care measures 
in the ACO quality measure set. However, we note that CMS is not the 
measure steward for this measure. We have raised the issue with the 
measure steward and will continue to coordinate with the measure owner. 
Additionally, we note that we proposed to remove this measure to align 
ACO quality measurement with the MIPS reporting requirements as this 
measure was removed from the quality measure set under the MIPS program 
in the CY 2018 Quality Payment Program final rule (82 FR 54159).
    After considering the comments, we are finalizing our proposal to 
remove ACO-44 from the Shared Savings Program quality measure set 
effective for quality reporting for performance years during 2019.
    Although we proposed to retire ACO-35 Skilled Nursing Facility 30-
Day All-Cause Readmission Measure (SNFRM) from the set of quality 
measures that are scored for the Shared Savings Program, we recognize 
the value of measuring the quality of care furnished to Medicare 
beneficiaries in SNFs. Therefore, we solicited comment on the 
possibility of adding the Skilled Nursing Facility Quality Reporting 
Program (SNFQRP) measure ``Potentially Preventable 30-Day Post-
Discharge Readmission Measure for Skilled Nursing Facilities'' to the 
Shared Savings Program quality measure set through future rulemaking. 
This measure differs from ACO-35--SNFRM, which we are removing from the 
quality measure set as discussed above, as the SNFQRP measure looks 
only at unplanned, potentially preventable readmissions for Medicare 
FFS beneficiaries within 30 days of discharge to a lower level of care 
from a SNF, while ACO-35 assesses hospital readmissions from a SNF, 
that occur within 30 days following discharge from a hospital for 
beneficiaries admitted to a SNF after hospital discharge. As a result, 
the SNFQRP measure would have less overlap with ACO-8 (Risk-
Standardized All Cause Readmission measure) because the readmission 
windows for the two measures are different. Specifically, the 
readmission window for the SNFQRP measure is 30 days following 
discharge from a SNF, while the readmission window for ACO-8 is 30 days 
following discharge from a hospital.
    The following is a summary of the comments we received on the 
possibility of adding the SNFQRP measure ``Potentially Preventable 30-
Day Post-Discharge Readmission Measure for Skilled Nursing Facilities''

[[Page 59713]]

to the Shared Savings Program quality measure set through future 
rulemaking.
    Comment: A few commenters supported the potential inclusion of the 
SNFQRP measure to the Shared Savings Program quality measure set 
through future rulemaking stating that the SNFQRP measure would 
potentially add more value to the Shared Savings Program measure set 
than ACO-35 as it is more targeted. Additionally, a few commenters 
suggested that we should test the measure in the ACO population and 
consider risk-adjusting the measure for sociodemographic factors prior 
to proposing the measure for inclusion into the Shared Savings Program 
quality measure set. However, the majority of commenters were opposed 
to potentially adding this measure to the Shared Savings Program 
quality measure set. One commenter stated that the SNFQRP measure 
assumes that the ACO has input into the care processes at the SNF and 
has the ability to direct patients to higher quality facilities, which 
is not always the case. Another commenter stated that as the measure is 
already used in the SNFQRP, they would not support inclusion in the 
Shared Savings Program quality measure set because they support 
avoiding the use of duplicative measures across CMS programs. Some of 
the commenters further stated that they believed this measure would 
still overlap with ACO-8 Risk-Standardized All Condition Readmission 
measure.
    Response: As we plan for future updates and changes to the Shared 
Savings Program quality measure set, we will consider this feedback 
prior to making any proposals regarding the SNFQRP measure.
    Further, as we stated in the CY 2019 PFS proposed rule (83 FR 
35877), we seek to align with changes made to the CMS Web Interface 
measures under the Quality Payment Program. In the 2017 PFS final rule, 
we stated that we do not believe it is beneficial to propose CMS Web 
interface measures for ACO quality reporting separately (81 FR 80499). 
Therefore, in order to avoid confusion and duplicative rulemaking, we 
adopted a policy that any future changes to the CMS Web interface 
measures would be proposed and finalized through rulemaking for the 
Quality Payment Program, and that such changes would be applicable to 
ACO quality reporting under the Shared Savings Program. In accordance 
with the policy adopted in the CY 2017 PFS final rule (81 FR 80501), we 
did not make any specific proposals related to changes in CMS Web 
Interface measures reported under the Shared Savings Program. Rather, 
we referred readers to Tables A, C, and D of Appendix 1: Proposed MIPS 
Quality Measures in the proposed rule for a complete discussion of the 
proposed changes to the CMS Web Interface measures. Based on the 
changes being finalized in Tables A, C and D of Appendix 1: Finalized 
MIPS Quality Measures of this final rule, ACOs will no longer be 
responsible for reporting the following measures for purposes of the 
Shared Savings Program starting with reporting for performance years 
during 2019:
     ACO-12 (NQF #0097) Medication Reconciliation Post-
Discharge.
     ACO-15 (NQF #0043) Pneumonia Vaccination Status for Older 
Adults.
     ACO-16 (NQF #0421) Preventive Care and Screening: Body 
Mass Index (BMI) Screening and Follow Up.
     ACO-41 (NQF #0055) Diabetes: Eye Exam.
     ACO-30 (NQF #0068) Ischemic Vascular Disease (IVD): Use of 
Aspirin or another Antithrombotic.
    We note that ACO-41 is one measure within a two-component diabetes 
composite that is currently scored as one measure. The removal of ACO-
41 means that ACO-27 Diabetes Hemoglobin A1c (HbA1c) Poor Control 
(>9%)) will now be assessed as an individual measure. As discussed in 
section III.I.2.B.i of this final rule, lists of the measures being 
finalized for purposes of MIPS are in Tables A, C and D of Appendix 1: 
Finalized MIPS Quality Measures.
    Additionally, we proposed to add the following measure to the CMS 
Web Interface for purposes of the Quality Payment Program:
     ACO-47 (NQF #0101) Falls: Screening, Risk-Assessment, and 
Plan of Care to Prevent Future Falls.
    Based on the policies being finalized for purposes of MIPS in Table 
A of Appendix 1: Finalized MIPS Quality Measures, Shared Savings 
Program ACOs will not be responsible for reporting this measure 
starting with quality reporting for performance years during 2019.
    Table 26 shows the Shared Savings Program quality measure set for 
performance years during 2019 and subsequent performance years.
BILLING CODE 4120-01-P

[[Page 59714]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.040


[[Page 59715]]


[GRAPHIC] [TIFF OMITTED] TR23NO18.041

BILLING CODE 4120-01-C
    In this section of this final rule, we are finalizing proposals to 
eliminate 9 measures and to add 2 measures to the Shared Savings 
Program quality measure set. Separately, in August 2018 proposed rule, 
we also proposed to remove ACO-11--Percent of Primary Care Physicians 
Who Successfully Meet Meaningful Use Requirements (83 FR 41910 and 
41911). We are finalizing the removal of ACO-11 in section V.B.2.f. of 
this final rule and refer readers to that section for a summary of that 
proposal and a discussion of public comments related to it. The net 
result of the final policies included in this final rule is a set of 23 
measures on which ACOs' quality performance will be assessed for 
performance years during 2019 and subsequent performance years. The 4 
domains will include the following numbers of quality measures (See 
Table 27):
     Patient/Caregiver Experience of Care--10 measures.
     Care Coordination/Patient Safety--4 measures.
     Preventive Health--6 measures.
     At Risk Populations--3 measures.
    Table 27 provides a summary of the number of measures by domain and 
the total points and domain weights that will be used for scoring 
purposes under the changes to the quality measure set finalized in this 
rule.
[GRAPHIC] [TIFF OMITTED] TR23NO18.042

G. Physician Self-Referral Law

1. Background
    Section 1877 of the Act, also known as the physician self-referral 
law: (1) Prohibits a physician from making referrals for certain 
designated health services (DHS) payable by Medicare to an entity with 
which he or she (or an immediate family member) has a financial 
relationship (ownership or compensation), unless an exception applies; 
and (2) prohibits the entity from filing claims with Medicare (or 
billing another individual, entity, or third party payer) for those 
referred services. The statute establishes a number of specific 
exceptions, and grants the Secretary the authority to create regulatory 
exceptions for financial relationships that pose no risk of program or 
patient abuse. Additionally, the statute mandates refunding any amount 
collected under a bill for an item or service furnished under a 
prohibited referral. Finally, the statute imposes reporting 
requirements and provides for sanctions, including civil monetary 
penalty provisions.
    Section 50404 of the Bipartisan Budget Act of 2018 (Pub. L. 115-
123, enacted February 9, 2018) added provisions to section 1877(h)(1) 
of the Act pertaining to the writing and

[[Page 59716]]

signature requirements in certain compensation arrangement exceptions 
to the statute's referral and billing prohibitions. Although we believe 
that the newly enacted provisions in section 1877(h)(1) of the Act are 
principally intended merely to codify in statute existing CMS policy 
and regulations with respect to compliance with the writing and 
signature requirements, we proposed revisions to our regulations to 
address any actual or perceived difference between the statutory and 
regulatory language, to codify in regulation our longstanding policy 
regarding satisfaction of the writing requirement found in many of the 
exceptions to the physician self-referral law, and to make the 
Bipartisan Budget Act of 2018 policies applicable to compensation 
arrangement exceptions issued using the Secretary's authority in 
section 1877(b)(4) of the Act.
    In the CY 2016 PFS final rule with comment period (80 FR 70885), we 
revised Sec.  411.357(a)(7), (b)(6), and (d)(1)(vii) to permit a lease 
arrangement or personal service arrangement to continue indefinitely 
beyond the stated expiration of the written documentation describing 
the arrangement under certain circumstances. Section 50404 of the 
Bipartisan Budget Act of 2018 added substantively identical holdover 
provisions to section 1877(e) of the Act. Because the new statutory 
holdover provisions effectively mirror the existing regulatory 
provisions, we do not believe it is necessary to revise Sec.  
411.357(a)(7), (b)(6), and (d)(1)(vii) as a result of these statutory 
revisions. Therefore, we made no proposals to these provisions.
2. Special Rules on Compensation Arrangements (Section 1877(h)(1)(D) & 
(E) of the Act)
    Many of the exceptions for compensation arrangements in Sec.  
411.357 require that the arrangements are set out in writing and signed 
by the parties. (See Sec.  411.357(a)(1), (b)(1), (d)(1)(i), (e)(1)(i), 
(e)(4)(i), (l)(1), (p)(2), (q) (incorporating the requirement contained 
in Sec.  1001.952(f)(4)), (r)(2)(ii), (t)(1)(ii) or (t)(2)(iii) (both 
incorporating the requirements contained in Sec.  411.357(e)(1)(i)), 
(v)(7), (w)(7), (x)(1)(i), and (y)(1).) \9\ As described above, section 
50404 of the Bipartisan Budget Act of 2018 amended section 1877 of the 
Act with respect to the writing and signature requirements in the 
statutory compensation arrangement exceptions. As detailed in this 
section, we proposed a new special rule on compensation arrangements at 
Sec.  411.354(e) and proposed to amend existing Sec.  411.353(g) to 
codify the statutory provisions in our regulations.
---------------------------------------------------------------------------

    \9\ We note that, where the writing requirement appears in the 
statutory and regulatory exceptions, we interpret it uniformly, 
regardless of any minor differences in the language of the 
requirement. See 80 FR 71315. Similarly, we interpret the signature 
requirement uniformly where it appears, regardless of any minor 
differences in the language of the statutory and regulatory 
exceptions.
---------------------------------------------------------------------------

a. Writing Requirement (Sec.  411.354(e))
    In the CY 2016 PFS final rule with comment period, we stated CMS' 
longstanding policy that the writing requirement in various 
compensation arrangement exceptions in Sec.  411.357 can be satisfied 
by ``a collection of documents, including contemporaneous documents 
evidencing the course of conduct between the parties'' (80 FR 71315). 
Our guidance on the writing requirement appeared in the preamble of the 
CY 2016 PFS final rule with comment period but was not codified in 
regulations. Section 50404 of the Bipartisan Budget Act of 2018 added 
subparagraph D, ``Written Requirement Clarified,'' to section 
1877(h)(1) of the Act. Section 1877(h)(1)(D) of the Act provides that, 
in the case of any requirement in section 1877 of the Act for a 
compensation arrangement to be in writing, such requirement shall be 
satisfied by such means as determined by the Secretary, including by a 
collection of documents, including contemporaneous documents evidencing 
the course of conduct between the parties involved.
    In light of the recently added statutory provision at section 
1877(h)(1)(D) of the Act, we proposed to add a special rule on 
compensation arrangements at Sec.  411.354(e). Proposed Sec.  
411.354(e) provides that, in the case of any requirement in 42 CFR part 
411, subpart J, for a compensation arrangement to be in writing, the 
writing requirement may be satisfied by a collection of documents, 
including contemporaneous documents evidencing the course of conduct 
between the parties. The proposed special rule at Sec.  411.354(e) 
codifies our existing policy on the writing requirement, as previously 
articulated in the CY 2016 PFS final rule with comment period. (See 80 
FR 71314 et seq.)
b. Special Rule for Certain Arrangements Involving Temporary 
Noncompliance With Signature Requirements (Sec.  411.353(g))
    Many of the exceptions for compensation arrangements in Sec.  
411.357 require that the arrangement (that is, the written 
documentation evidencing the arrangement) is signed by the parties to 
the arrangement. Under our existing special rule for certain 
arrangements involving temporary noncompliance with signature 
requirements at Sec.  411.353(g)(1), an entity that has a compensation 
arrangement with a physician that satisfies all the requirements of an 
applicable exception in Sec.  411.355, Sec.  411.356 or Sec.  411.357 
except the signature requirement may submit a claim and receive payment 
for a designated health service referred by the physician, provided 
that: (1) The parties obtain the required signature(s) within 90 
consecutive calendar days immediately following the date on which the 
compensation arrangement became noncompliant (without regard to whether 
any referrals occur or compensation is paid during such 90-day period); 
and (2) the compensation arrangement otherwise complies with all 
criteria of the applicable exception. Existing Sec.  411.353(g)(1) 
specifies the paragraphs where the applicable signature requirements 
are found and existing Sec.  411.353(g)(2) limits an entity's use of 
the special rule at Sec.  411.353(g)(1) to only once every 3 years with 
respect to the same referring physician.
    Section 50404 of the Bipartisan Budget Act of 2018 added 
subparagraph E, ``Signature Requirement,'' to section 1877(h)(1) of the 
Act. Section 1877(h)(1)(E) of the Act provides that, in the case of any 
requirement in section 1877 of the Act for a compensation arrangement 
to be in writing and signed by the parties, the signature requirement 
is satisfied if: (1) Not later than 90 consecutive calendar days 
immediately following the date on which the compensation arrangement 
became noncompliant, the parties obtain the required signatures; and 
(2) the compensation arrangement otherwise complies with all criteria 
of the applicable exception. Notably, under the newly added section 
1877(h)(1)(E) of the Act, an applicable signature requirement is not 
limited to specific exceptions and entities are not limited in their 
use of the rule to only once every 3 years with respect to the same 
referring physician. In addition, section 1877(h)(1)(E) of the Act does 
not include a reference to the occurrence of referrals or the payment 
of compensation during the 90-day period when the signature requirement 
is not met.
    To conform the regulations with the recently added statutory 
provision at section 1877(h)(1)(E) of the Act, we proposed to amend 
existing Sec.  411.353(g) by: (1) Revising the reference at Sec.  
411.353(g)(1) to specific exceptions and signature requirements; (2) 
deleting the reference at Sec.  411.353(g)(1) to the

[[Page 59717]]

occurrence of referrals or the payment of compensation during the 90-
day period when the signature requirement is not met; and (3) deleting 
the limitation at Sec.  411.353(g)(2). In the alternative, we proposed 
to delete Sec.  411.353(g) in its entirety and codify in proposed Sec.  
411.354(e) the special rule for signature requirements in section 
1877(h)(1)(E) of the Act. We solicited comments regarding the best 
approach for codifying in regulation this provision of the Bipartisan 
Budget Act of 2018.
    The following is a summary of the comments we received regarding 
the best approach for codifying in regulation sections 1877(h)(1)(D) & 
(E) of the Act.
    Comment: We received a few comments in support of our proposal to 
codify our existing policy on the writing requirement in a special rule 
on compensation arrangements at Sec.  411.354(e). No commenters opposed 
the proposal or suggested revisions or additions to the proposed 
regulatory text in Sec.  411.354(e).
    Response: We are finalizing proposed Sec.  411.354(e) without 
modification. We remind readers that Sec.  411.354(e) codifies our 
longstanding policy on the writing requirement in various compensation 
exceptions, as explained in detail in the CY 2016 PFS final rule with 
comment period. (See 80 FR 71314 et seq.)
    Comment: We received a few comments expressing general support for 
the special rule on temporary noncompliance with signature 
requirements. Commenters appreciated the flexibility that the special 
rule affords. We received no comments in opposition to our proposal. 
Commenters approved of our efforts to align our regulations pertaining 
to temporary noncompliance with signature requirements with the 
statutory provision at section 1877(h)(1)(E) of the Act. Most 
commenters did not note if it would be better to codify section 
1877(h)(1)(E) of the Act at Sec.  411.353(g) or to delete Sec.  
411.353(g) in its entirety and codify section 1877(h)(1)(E) of the Act 
in the special rules on compensation arrangements at Sec.  411.354(e). 
A couple of commenters acknowledged that both proposals provide 
clarification but expressed a preference that we delete Sec.  
411.353(g) in its entirety and codify section 1877(h)(1)(E) of the Act 
in proposed Sec.  411.354(e), asserting that such a change would 
provide a ``clear reflection of the statute.''
    Response: We believe it would be less disruptive to provider and 
supplier compliance efforts to amend Sec.  411.353(g), a regulation 
that has been in place for over 10 years. Therefore, we are finalizing 
our proposal to revise the special rule for temporary noncompliance 
with signature requirements at Sec.  411.353(g), thus aligning Sec.  
411.353(g) with the newly added section 1877(h)(1)(E) of the Act.
    Comment: We received a few comments seeking physician self-referral 
law regulatory changes that were not proposed.
    Response: These comments are beyond the scope of this rulemaking 
and are not addressed in this final rule.
    Finally, we note that the effective date of section 50404 of the 
Bipartisan Budget Act was February 9, 2018. Thus, beginning February 9, 
2018, parties who meet the requirements of section 1877(h)(1)(E) of the 
Act, including parties who otherwise would have been barred from 
relying on the special rule for certain arrangements involving 
temporary noncompliance with signature requirements at Sec.  
411.353(g)(1) because of the 3-year limitation at Sec.  411.353(g)(2), 
may avail themselves of the new statutory provision at section 
1877(h)(1)(E) of the Act.
    After reviewing the comments, we are finalizing the special rule on 
compensation arrangements at Sec.  411.354(e) as proposed, and we are 
finalizing the modifications to Sec.  411.353(g) as proposed.

N. Physician Self-Referral Law: Annual Update to the List of CPT/HCPCS 
Codes

1. General
    Section 1877 of the Act prohibits a physician from referring a 
Medicare beneficiary for certain designated health services (DHS) to an 
entity with which the physician (or a member of the physician's 
immediate family) has a financial relationship, unless an exception 
applies. Section 1877 of the Act also prohibits the DHS entity from 
submitting claims to Medicare or billing the beneficiary or any other 
entity for Medicare DHS that are furnished as a result of a prohibited 
referral.
    Section 1877(h)(6) of the Act and Sec.  411.351 of our regulations 
specify that the following services are DHS:
     Clinical laboratory services.
     Physical therapy services.
     Occupational therapy services.
     Outpatient speech-language pathology services.
     Radiology services.
     Radiation therapy services and supplies.
     Durable medical equipment and supplies.
     Parenteral and enteral nutrients, equipment, and supplies.
     Prosthetics, orthotics, and prosthetic devices and 
supplies.
     Home health services.
     Outpatient prescription drugs.
     Inpatient and outpatient hospital services.
2. Annual Update to the Code List
a. Background
    In Sec.  411.351, we specify that the entire scope of four DHS 
categories is defined in a list of CPT/HCPCS codes (the Code List), 
which is updated annually to account for changes in the most recent CPT 
and HCPCS Level II publications. The DHS categories defined and updated 
in this manner are:
     Clinical laboratory services.
     Physical therapy, occupational therapy, and outpatient 
speech-language pathology services.
     Radiology and certain other imaging services.
     Radiation therapy services and supplies.
    The Code List also identifies those items and services that may 
qualify for either of the following two exceptions to the physician 
self-referral prohibition:
     EPO and other dialysis-related drugs furnished in or by an 
ESRD facility (Sec.  411.355(g)).
     Preventive screening tests, immunizations, or vaccines 
(Sec.  411.355(h)).
    The definition of DHS at Sec.  411.351 excludes services for which 
payment is made by Medicare as part of a composite rate (unless the 
services are specifically identified as DHS and are themselves payable 
through a composite rate, such as home health and inpatient and 
outpatient hospital services). Effective January 1, 2011, EPO and 
dialysis-related drugs furnished in or by an ESRD facility (except 
drugs for which there are no injectable equivalents or other forms of 
administration), have been reimbursed under a composite rate known as 
the ESRD prospective payment system (ESRD PPS) (75 FR 49030). 
Accordingly, EPO and any dialysis-related drugs that are paid for under 
ESRD PPS are not DHS and are not listed among the drugs that could 
qualify for the exception at Sec.  [thinsp]411.355(g) for EPO and other 
dialysis-related drugs furnished by an ESRD facility.
    ESRD-related oral-only drugs, which are drugs or biologicals with 
no injectable equivalents or other forms of administration other than 
an oral form, were scheduled to be paid under ESRD PPS beginning 
January 1, 2014 (75 FR 49044). However, there have been several delays 
of the implementation of payment of these drugs under ESRD PPS. On 
December 19, 2014, section 204 of the Stephen Beck, Jr., Achieving a 
Better Life Experience Act of 2014

[[Page 59718]]

(ABLE) (Pub. L. 113-295) was enacted and delayed the inclusion of these 
oral-only drugs under the ESRD PPS until 2025. Until that time, such 
drugs furnished in or by an ESRD facility are not paid as part of a 
composite rate and thus, are DHS.
    The Code List was last updated in Tables 44 and 45 of the CY 2018 
PFS final rule (82 FR 53339).
b. Response to Comments
    We received no comments relating to the Code List that became 
effective January 1, 2018.
c. Revisions Effective for CY 2019
    The updated, comprehensive Code List effective January 1, 2019, is 
available on our website at http://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/List_of_Codes.html.
    Additions and deletions to the Code List conform it to the most 
recent publications of CPT and HCPCS Level II and to changes in 
Medicare coverage policy and payment status.
    Tables 28 and 29 identify the additions and deletions, 
respectively, to the comprehensive Code List that become effective 
January 1, 2019. Tables 28 and 29 also identify the additions and 
deletions to the list of codes used to identify the items and services 
that may qualify for the exception in Sec.  411.355(g) (regarding 
dialysis-related outpatient prescription drugs furnished in or by an 
ESRD facility) and in Sec.  411.355(h) (regarding preventive screening 
tests, immunizations, and vaccines).

Table 28--Additions to the Physician Self-Referral List of CPT \1\ HCPCS
                                  Codes
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Clinical Laboratory Services:
  0018U Onc thyr 10 microrna seq alg.
  0019U Onc rna tiss predict alg.
  0020U Rx test prsmv ur w/def conf.
  0021U Onc prst8 detcj 8 autoantb.
  0022U Trgt gen seq dna&rna 23 gene.
  0023U Onc aml dna detcj/nondetcj.
  0024U Glyca nuc mr spectrsc quan.
  0025U Tenofovir liq chrom ur quan.
  0026U Onc thyr dna&mrna 112 genes.
  0027U Jak2 gene trgt seq alys.
  0028U Cyp2d6 gene cpy nmr cmn vrnt.
  0029U Rx metab advrs trgt seq alys.
  0030U Rx metab warf trgt seq alys.
  0031U Cypia2 gene.
  0032U Comt gene.
  0033U Htr2a htr2c genes.
  0034U Tpmt nudt15 genes.
  0035U Neuro csf prion prtn qual.
  0036U Xome tum & nml spec seq alys.
  0037U Trgt gen seq rgt gen seq dna 324 genes.
  0038U Vitamin d srm microsamp quan.
  0039U Dna antb 2strand hi avidity.
  0040U Bcr/abl1 gene major bp quan.
  0041U B brgdrferi antb 5 prtn igm.
  0042U B brgdrferi antb 12 prtn igg.
  0043U Tbrg b grp antb 4 prtn igm.
  0044U Tbrf b grp antb 4 prtn igg.
  0045U Onc brst dux carc is 12 gene.
  0046U Flt3 genie itd variants quan.
  0047U Onc prst8 mrna 17 gene alg.
  0048U Onc sld org neo dna 468 gene.
  0049U Npm1 gene analysis quan.
  0050U Trgt gen seq dna 194 genes.
  0051U Rx mntr lc-ms/ms ur 31 pnl.
  0052U Lpoprtn bld w/5 maj classes.
  0053U Onc prst8 ca fish alys 4 gen.
  0054U Rx mntr 14+ drugs & sbsts.
  0055U Card hrt trnspl 96 dna seq.
  0056U Hem aml dna gene reargmt.
  0057U Onc sld org neo mrna 51 gene.
  0058U Onc merkel cll carc srm quan.
  0059U Onc merkel cll carc srm+/-.
  0060U Twn zyg gen seq alys chrms2.
  0061U Tc meas 5 bmrk sfdi m-s alys.
  0011M Onc prst8 ca mrna 12 gen alg.
  0012M Onc mrna 5 gen rsk urthl ca.
  0013M Onc mrna 5 gen recr urthl ca.
Physical Therapy, Occupational Therapy, and Outpatient Speech-Language
 Pathology Services:
  {No additions.{time}
Radiology and Certain Other Imaging Services:
  0508T Pls echo us b1 dns meas tib.
  76391 Mr elastography.
  76978 Us trgt dyn mbubb 1st les.
  76979 Us trgt dyn mbubb ea addl.
  76981 Use parenchyma.
  76982 Use 1st target lesion.
  76983 Use ea addl target lesion.
  77046 Mri breast c-unilateral.
  77047 Mri breast c-bilateral.
  77048 Mri breast c-+ w/cad uni.
  77049 Mri breast c-+ w/cad bi.
  C8937 Cad breast Mri.
  C9407 Iodine i-131 iobenguane, dx.
  Q9950 Inj sulf hexa lipid microsph.
Radiation Therapy Services and Supplies:
  A9513 Lutetium Lu 177 dotatat ther.
  C9408 Iodine i-131 iobenguane, tx.
Drugs Used by Patients Undergoing Dialysis:
  {No additions.{time}
Preventive Screening Tests, Immunizations and Vaccines:
  81528 Oncology colorectal scr.
  90689 Vacc IIv4 no prsrv 0.25ml im.
------------------------------------------------------------------------
\1\ CPT codes and descriptions only are copyright 2018 AMA. All rights
  are reserved and applicable FARS/DFARS clauses apply.


  Table 29--Deletions From the Physician Self-Referral List of CPT \1\
                               HCPCS Codes
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Clinical Laboratory Services:
  78270 Vit B-12 absorption exam.
  78271 Vit B-12 absrp exam int fac.
  78272 Vit B-12 absorp combined.
Physical Therapy, Occupational Therapy, and Outpatient Speech-Language
 Pathology Services:
  64550 Appl surface neurostimulator.
  96111 Developmental testing.
Radiology and Certain Other Imaging Services:
  0159T Cad breast mri.
  0346T Ultrasound elastography.
  C9744 Abd us w/contrast.
  77058 Mri one breast.
  77059 Mri both breasts.
  77776 Apply interstit radiat simpl.
  77785 HDR brachytx 1 channel.
  77786 HDR brachytx 2-12 channel.
  C9457 Lumason contrast agent.
  C9461 Choline C 11, diagnostic.
  G0173 Linear acc stereo radsur com.
  G0251 Linear acc based stero radio.
Radiation Therapy Services and Supplies:
  0190T Place intraoc radiation src.
Drugs Used by Patients Undergoing Dialysis:
  {No deletions{time} .
Preventive Screening Tests, Immunizations and Vaccines:
  G0389 Ultrasound exam AAA screen.
  G0464 Colorec CA scr, sto bas DNA.
------------------------------------------------------------------------
\1\ CPT codes and descriptions only are copyright 2018 AMA. All rights
  are reserved and applicable FARS/DFARS clauses apply.

I. CY 2019 Updates to the Quality Payment Program

1. Executive Summary
a. Overview
    This final rule will make payment and policy changes to the Quality 
Payment Program starting January 1, 2019, except as noted for specific 
provisions elsewhere in this final rule. The Medicare Access and CHIP 
Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 
2015) amended title XVIII of the Act to repeal the Medicare sustainable 
growth rate (SGR) formula, to reauthorize the Children's Health 
Insurance Program, and to strengthen Medicare access by improving 
physician and other clinician payments and making other improvements. 
The MACRA advances a forward-looking, coordinated framework for 
clinicians to successfully participate in the Quality Payment Program, 
which rewards value in one of two ways:
     The Merit-based Incentive Payment System (MIPS).
     Advanced Alternative Payment Models (Advanced APMs).
    As we move into the third year of the Quality Payment Program, we 
have taken all stakeholder input into consideration, including 
recommendations made by the Medicare Payment Advisory Commission 
(MedPAC), an independent congressional agency established by the 
Balanced Budget Act of 1997 (Pub. L. 105-33, enacted on August 5, 1997) 
to advise the U.S. Congress on issues

[[Page 59719]]

affecting the Medicare program, such as payment policies under 
Medicare, the factors affecting expenditures for the efficient 
provision of services, and the relationship of payment policies to 
access and quality of care for Medicare beneficiaries. We will continue 
to implement the Quality Payment Program as required, smoothing the 
transition where possible and offering targeted educational resources 
for program participants. A few examples of how we are working to 
address stakeholder input are evident in our work around burden 
reduction and reshaping our focus of interoperability. We have heard 
the concern about process-based measures, and we are continuing to move 
towards the development and use of more outcome measures by way of 
removing process measures that are topped out and funding new quality 
measure development, as required by section 102 of MACRA. We have also 
developed new episode-based cost measures, with stakeholder feedback, 
for inclusion in the cost performance category beginning in 2019, with 
additional measure development occurring for potential inclusion in 
future years.
    Additionally, we have also received feedback from stakeholders 
regarding the added value of the Quality Payment Program. To that 
point, CMS has begun a series of strategic planning sessions to (1) 
assess the current value of the program for clinicians and 
beneficiaries alike and (2) implement the program in a way that is 
understandable to beneficiaries, as they are the core of the Medicare 
program.
    As a priority for the Quality Payment Program Year 3, we are 
committed to continue using the framework established by the Patients 
over Paperwork initiative to assist in reducing clinician burden, 
implementing the Meaningful Measures Initiative, promoting 
interoperability, continuing our support of small and rural practices, 
empowering patients, and promoting price transparency.
Reducing Clinician Burden
    We are committed to reducing clinician burden by simplifying and 
streamlining the program for participating clinicians. Examples 
include:
     Implementing the Meaningful Measures Initiative, which is 
a framework that applies a series of cross-cutting criteria to identify 
and utilize the most meaningful measures with the least amount of 
burden and greatest impact on patient outcomes;
     Promoting advances in interoperability; and
     Establishing an automatic extreme and uncontrollable 
circumstances policy for MIPS eligible clinicians.
Improving Patient Outcomes and Reducing Burden Through Meaningful 
Measures
    Regulatory reform and reducing regulatory burden are high 
priorities for CMS. To reduce the regulatory burden on the healthcare 
industry, lower health care costs, and enhance patient care, we 
launched the Meaningful Measures Initiative in October 2017.\10\ This 
initiative is one component of our agency-wide Patients Over Paperwork 
Initiative,\11\ which is aimed at evaluating and streamlining 
regulations with a goal to reduce unnecessary cost and burden, increase 
efficiencies, and improve beneficiary experience. The Meaningful 
Measures Initiative is aimed at identifying the highest priority areas 
for quality measurement and quality improvement to assess the core 
quality of care issues that are most vital to advancing our work to 
improve patient outcomes. The Meaningful Measures Initiative represents 
a new approach to quality measures that fosters operational 
efficiencies, and reduces cost associated with collection and reporting 
burden, while producing quality measurement that is more focused on 
meaningful outcomes.
---------------------------------------------------------------------------

    \10\ Meaningful Measures web page: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
    \11\ See Remarks by Administrator Seema Verma at the Health Care 
Payment Learning and Action Network (LAN) Fall Summit, as prepared 
for delivery on October 30, 2017, https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-10-30.html.
---------------------------------------------------------------------------

    The Meaningful Measures Framework has the following principles for 
identifying measures that:
     Address high-impact measure areas that safeguard public 
health;
     Patient-centered and meaningful to patients;
     Outcome-based where possible;
     Fulfill each program's statutory requirements;
     Minimize the level of burden for health care providers 
(for example, through a preference for EHR-based measures where 
possible, such as electronic clinical quality measures);
     Significant opportunity for improvement;
     Address measure needs for population based payment through 
alternative payment models; and
     Align across programs and/or with other payers.
    To achieve these objectives, we have identified 19 Meaningful 
Measures areas and mapped them to six overarching quality priorities as 
shown in Table 30.

    Table 30--Meaningful Measures Framework Domains and Measure Areas
------------------------------------------------------------------------
            Quality priority                 Meaningful measure area
------------------------------------------------------------------------
Making Care Safer by Reducing Harm       Healthcare-Associated
 Caused in the Delivery of Care.          Infections.
                                         Preventable Healthcare Harm.
Strengthen Person and Family Engagement  Care is Personalized and
 as Partners in Their Care.               Aligned with Patient's Goals.
                                         End of Life Care according to
                                          Preferences.
                                         Patient's Experience of Care.
                                         Patient Reported Functional
                                          Outcomes.
Promote Effective Communication and      Medication Management.
 Coordination of Care.                   Admissions and Readmissions to
                                          Hospitals.
                                         Transfer of Health Information
                                          and Interoperability.
Promote Effective Prevention and         Preventive Care.
 Treatment of Chronic Disease.           Management of Chronic
                                          Conditions.
                                         Prevention, Treatment, and
                                          Management of Mental Health.
                                         Prevention and Treatment of
                                          Opioid and Substance Use
                                          Disorders.
                                         Risk Adjusted Mortality.
Work with Communities to Promote Best    Equity of Care.
 Practices of Healthy Living.            Community Engagement.

[[Page 59720]]

 
Make Care Affordable...................  Appropriate Use of Healthcare.
                                         Patient-focused Episode of
                                          Care.
                                         Risk Adjusted Total Cost of
                                          Care.
------------------------------------------------------------------------

    By including Meaningful Measures in our programs, we believe that 
we can also address the following cross-cutting measure criteria:
     Eliminating disparities;
     Tracking measurable outcomes and impact;
     Safeguarding public health;
     Achieving cost savings;
     Improving access for rural communities; and
     Reducing burden.
    We believe that the Meaningful Measures Initiative will improve 
outcomes for patients, their families, and health care providers while 
reducing burden and costs for clinicians and providers and promoting 
operational efficiencies.
    In the quality performance category under MIPS, clinicians have the 
flexibility to select and report the measures that matter most to their 
practice and patients. However, we have received feedback that some 
clinicians find the performance requirements confusing, and the program 
makes it difficult for them to choose measures that are meaningful to 
their practices and have more direct benefit to beneficiaries. For the 
2019 MIPS performance period, we are finalizing the following updates: 
(1) Adding 8 new MIPS quality measures that include 4 patient reported 
outcome measures, 6 high priority measures, and 2 measures on important 
clinical topics in the Meaningful Measures framework; and (2) removing 
26 quality measures.
    In addition to having the right measures, we want to ensure that 
the collection of information is valuable to clinicians and worth the 
cost and resources of collecting the information.
Promoting Interoperability Performance Category
    As required by MACRA, the Quality Payment Program includes a MIPS 
performance category that focuses on meaningful use of certified EHR 
technology, referred to in the CY 2017 and CY 2018 Quality Payment 
Program final rules as the ``advancing care information'' performance 
category. As part of our approach to promoting and prioritizing 
interoperability of healthcare data, in Quality Payment Program Year 2, 
we changed the name of the performance category to the Promoting 
Interoperability performance category.
    We have prioritized interoperability, which we define as health 
information technology, that enables the secure exchange of electronic 
health information with, and use of electronic health information from, 
other health information technology without special effort on the part 
of the user; allows for complete access, exchange, and use of all 
electronically accessible health information for authorized use under 
applicable law; and does not constitute information blocking as defined 
by the 21st Century Cures Act (Pub. L. 114-255, enacted December 13, 
2016). We are committed to working with the Office of the National 
Coordinator for Health IT (ONC) on implementation of the 
interoperability provisions of the 21st Century Cures Act to have 
seamless but secure exchange of health information for clinicians and 
patients, ultimately enabling Medicare beneficiaries to get their 
claims information electronically. In addition, we are prioritizing 
quality measures and improvement activities that support 
interoperability.
    To further CMS' commitment to implementing interoperability, at the 
2018 Healthcare Information and Management Systems Society (HIMSS) 
conference, CMS Administrator Seema Verma announced the launching of 
the MyHealthEData initiative.\12\ This initiative aims to empower 
patients by ensuring that they control their healthcare data and can 
decide how their data is going to be used, all while keeping that 
information safe and secure. The overall government-wide initiative is 
led by the White House Office of American Innovation with participation 
from HHS--including its CMS, ONC, and the National Institutes of Health 
(NIH)--as well as the U.S. Department of Veterans Affairs (VA). 
MyHealthEData aims to break down the barriers that prevent patients 
from having electronic access and true control of their own health 
records from the device or application of their choice. This effort 
will approach the issue of healthcare data from the patient's 
perspective.
---------------------------------------------------------------------------

    \12\ https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2018-Fact-sheets-items/2018-03-06.html.
---------------------------------------------------------------------------

    For the Promoting Interoperability performance category, we require 
MIPS eligible clinicians to use 2015 Edition certified EHR technology 
beginning with the 2019 MIPS performance period to make it easier for:
     Patients to access their data.
     Patient information to be shared between doctors and other 
health care providers.
Continuing To Support Small and Rural Practices
    We understand that the Quality Payment Program is a big change for 
clinicians, especially for those in small and rural practices. We 
intend to continue to offer tailored flexibilities to help these 
clinicians to participate in the program. For example, in this rule we 
are finalizing our proposal to retain a small practice bonus under MIPS 
by moving it to the quality performance category. We will also continue 
to support small and rural practices by offering free and customized 
resources available within local communities, including direct, one-on-
one support from the Small, Underserved, and Rural Support Initiative 
along with our other no-cost technical assistance.
    Further, we note that we are finalizing our proposal to amend our 
regulatory text to allow small practices to continue using the Medicare 
Part B claims collection type. We are also finalizing our proposal to 
revise the regulatory text to allow a small practice to submit quality 
data for covered professional services through the Medicare Part B 
claims submission type for the quality performance category, as 
discussed further in section III.I.3.h. of this final rule. Finally, in 
the CY 2018 Quality Payment Program final rule, we finalized a policy 
to allow small practices to continue to choose to participate in MIPS 
as a virtual group (82 FR 53598).
Empowering Patients Through the Patients Over Paperwork Initiative
    Our Patients Over Paperwork initiative establishes an internal 
process to evaluate and streamline regulations with a goal to reduce 
unnecessary burden, to increase efficiencies, and to

[[Page 59721]]

improve the beneficiary experience.\13\ This administration is 
dedicated to putting patients first, empowering consumers of healthcare 
to have the information they need to be engaged and active decision-
makers in their care. As a result of this consumer empowerment, 
clinicians will gain competitive advantage by delivering coordinated, 
high-value quality care.
---------------------------------------------------------------------------

    \13\ Patients Over Paperwork web page available at https://www.cms.gov/Outreach-and-Education/Outreach/Partnerships/PatientsOverPaperwork.html.
---------------------------------------------------------------------------

    The policies for the Quality Payment Program in this final rule 
promote competition and empower patients. We are consistently 
listening, and we are committed to using data-driven insights, 
increasingly aligned and meaningful quality measures, and technology 
that empowers patients and clinicians to make decisions about their 
healthcare.
    In conjunction with development of the Patients Over Paperwork 
initiative, we are making progress toward developing a patient-centered 
portfolio of measures for the Quality Payment Program, including 7 new 
outcome measures included on the 2017 CMS Measures Under Consideration 
List,\14\ 5 of which are directly applicable to the prioritized 
specialties of general medicine/crosscutting and orthopedic surgery. 
Finally, on September 21, 2018, CMS awarded seven organizations new 
cooperative agreements to partner with the agency in developing, 
improving, updating, or expanding quality measures for Medicare's 
Quality Payment Program. Awardees will work to establish more 
appropriate measures for clinical specialties underrepresented in the 
current measure set with the goal of improving patient care, and focus 
on outcome measures, including patient-reported and functional-status 
measures, to better reflect what matters most to patients.\15\
---------------------------------------------------------------------------

    \14\ Centers for Medicare & Medicaid Services. List of Measures 
Under Consideration for December 1, 2017. Baltimore, MD: US 
Department of Health and Human Services; 2017. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Downloads/Measures-under-Consideration-Listfor2017.pdf. Accessed May 4, 2018.
    \15\ CMS Awards Funding for Quality Measure Development, https://www.cms.gov/newsroom/press-releases/cms-awards-funding-quality-measure-development.
---------------------------------------------------------------------------

b. Summary of the Major Provisions
    In May 2018, CMS announced that 91 percent of MIPS eligible 
clinicians participated in the 2017 transition year. (See https://www.cms.gov/blog/quality-payment-program-exceeds-year-1-participation-goal.) This CY 2017 performance period data were incorporated for this 
final rule when estimating eligibility and payment adjustment for the 
CY 2019 MIPS performance period. One important finding is that many 
more clinicians than reported in the CY 2019 PFS proposed rule are 
expected to participate in MIPS using the group reporting option. This 
increase means more clinicians are covered in MIPS and are measured on 
their performance.
(1) Quality Payment Program Year 3
    During the first 2 years of the program, we have heard concerns 
from clinicians that were not eligible to participate. Under MIPS, for 
year 3, we are expanding in this final rule the opportunities to 
participate, while still understanding the burden required to 
participate, to include physical therapists, occupational therapists, 
qualified speech-language pathologists, qualified audiologists, 
clinical psychologists, and registered dietitians or nutrition 
professionals in the list of MIPS eligible clinicians. We also are 
finalizing an opt-in policy that allows some clinicians, who otherwise 
would have been excluded under the low-volume threshold, the option to 
participate in MIPS.
    We believe the third year of the Quality Payment Program should 
build upon the foundation that has been established in the first 2 
years, which provides a trajectory for clinicians moving to a 
performance-based payment system. This trajectory provides clinicians 
the ability to participate in the program through two pathways: MIPS 
and Advanced APMs.
(2) Payment Adjustments
    As discussed in section VII.F.8. of this final rule, for the 2021 
payment year and based on Advanced APM participation during the 2019 
MIPS performance period, we estimate that between 165,000 and 220,000 
clinicians will become Qualifying APM Participants (QP). As a QP, an 
eligible clinician is not subject to the MIPS reporting requirements 
and payment adjustment, and qualifies for a lump sum APM incentive 
payment equal to 5 percent of their aggregate payment amounts for 
covered professional services for the year prior to the payment year. 
We estimate that the total lump sum APM incentive payments will be 
approximately $600-800 million for the 2021 Quality Payment Program 
payment year.
    Again, we estimate that approximately 798,000 clinicians would be 
MIPS eligible clinicians in the 2019 MIPS performance period, an 
increase of almost 148,000 from the estimate we provided in the CY 2019 
PFS proposed rule, which reflects growth in group reporting and our 
ability to better capture group reporting. The final number will depend 
on several factors, including the number of eligible clinicians 
excluded from MIPS based on their status as QPs or Partial QPs, the 
number that report as groups, and the number that elect to opt-in to 
MIPS. In the 2021 MIPS payment year, MIPS payment adjustments, which 
only apply to covered professional services, will be applied based on 
MIPS eligible clinicians' performance on specified measures and 
activities within four integrated performance categories. We estimate 
that MIPS payment adjustments will be approximately equally distributed 
between negative MIPS payment adjustments ($390 million) and positive 
MIPS payment adjustments ($390 million) to MIPS eligible clinicians, as 
required by the statute to ensure budget neutrality. Positive MIPS 
payment adjustments will also include up to an additional $500 million 
for exceptional performance to MIPS eligible clinicians whose final 
score meets or exceeds the additional performance threshold of 75 
points that we are establishing in this final rule. However, the 
distribution will change based on the final population of MIPS eligible 
clinicians for the 2021 MIPS payment year and the distribution of final 
scores under the program.
2. Definitions
    At Sec.  414.1305, subpart O--
     We are revising in this final rule the regulation to 
define the following terms:
    ++ Ambulatory Surgical Center (ASC)-based MIPS eligible clinician.
    ++ Collection type.
    ++ Health IT vendor.
    ++ MIPS determination period.
    ++ Submission type.
    ++ Submitter type.
    ++ Third party intermediary.
     We are revising in this final rule the definitions of the 
following terms:
    ++ High priority measure.
    ++ Hospital-based MIPS eligible clinician
    ++ Low-volume threshold.
    ++ MIPS eligible clinician.
    ++ Non-patient facing MIPS eligible clinician.
    ++ Qualified clinical data registry (QCDR).
    ++ Qualifying APM Participant (QP).
    ++ Small practice.

These terms and definitions are discussed in detail in relevant 
sections of this final rule.

[[Page 59722]]

3. MIPS Program Details
a. MIPS Eligible Clinicians
    Under Sec.  414.1305, a MIPS eligible clinician, as identified by a 
unique billing TIN and NPI combination used to assess performance, is 
defined as any of the following (excluding those identified at Sec.  
414.1310(b)): A physician (as defined in section 1861(r) of the Act); a 
physician assistant, nurse practitioner, and clinical nurse specialist 
(as such terms are defined in section 1861(aa)(5) of the Act); a 
certified registered nurse anesthetist (as defined in section 
1861(bb)(2) of the Act); and a group that includes such clinicians. 
Section 1848(q)(1)(C)(II) of the Act provides the Secretary with 
discretion, beginning with the 2021 MIPS payment year, to specify 
additional eligible clinicians (as defined in section 1848(k)(3)(B) of 
the Act) as MIPS eligible clinicians. Such clinicians may include 
physical therapists, occupational therapists, or qualified speech-
language pathologists; qualified audiologists (as defined in section 
1861(ll)(3)(B) of the Act); certified nurse-midwives (as defined in 
section 1861(gg)(2) of the Act); clinical social workers (as defined in 
section 1861(hh)(1) of the Act); clinical psychologists (as defined by 
the Secretary for purposes of section 1861(ii) of the Act); and 
registered dietitians or nutrition professionals.
    As discussed in the CY 2019 PFS proposed rule (83 FR 35883 through 
35884), we received feedback from non-physician associations 
representing each type of additional eligible clinician through 
listening sessions and meetings with various stakeholder entities and 
through public comments discussed in the CY 2017 Quality Payment 
Program final rule (81 FR 77038). Commenters generally supported the 
specification of such clinicians as MIPS eligible clinicians beginning 
with the 2021 MIPS payment year. In order to assess whether these 
additional eligible clinicians could successfully participate in MIPS, 
we evaluated whether there would be sufficient measures and activities 
applicable and available for each of the additional eligible clinician 
types. We finalized in the CY 2018 Quality Payment Program final rule 
(82 FR 53780), that having sufficient measures for the quality 
performance category, means having sufficient measures applicable and 
available means that we can calculate a quality performance category 
percent score for the MIPS eligible clinician because at least one 
quality measure is applicable and available to the clinician. For the 
improvement activities performance category, we stated the belief that 
all MIPS eligible clinicians will have sufficient activities applicable 
and available. We focused our analysis on the quality and improvement 
activities performance categories because these performance categories 
require submission of data. We did not focus on the Promoting 
Interoperability performance category because there is extensive 
analysis regarding who can participate in the Promoting 
Interoperability performance category under the current exclusion 
criteria. In addition, in section III.I.3.h.(5) of this final rule, we 
are finalizing a policy to automatically assign a zero percent 
weighting for the Promoting Interoperability performance category for 
these new types of MIPS eligible clinicians. We did not focus as part 
of our analysis on the cost performance category because we are only 
able to assess cost performance for a subset of eligible clinicians--
specifically, those who are currently eligible as a result of not 
meeting any of the current exclusion criteria. So the impact of the 
cost performance category for these additional eligible clinicians will 
continue to be considered but is currently not a decisive factor for 
successful participation in MIPS. From our analysis, we found that 
improvement activities would generally be applicable and available for 
each of the additional eligible clinician types. However, for the 
quality performance category, we found that not all of the additional 
eligible clinician types would have sufficient MIPS quality measures 
applicable and available. As discussed in section III.I.3.h.(2)(b)(iii) 
of this final rule, for the quality performance category, we are 
finalizing our proposals to remove several MIPS quality measures. In 
the CY 2019 PFS proposed rule (83 FR 35883 through 35884), we explained 
that if those measures were finalized for removal, we anticipated that 
qualified speech-language pathologists, qualified audiologists, 
certified nurse-midwives, and registered dietitians or nutrition 
professionals would each have less than 6 MIPS quality measures 
applicable and available to them. However, if the quality measures were 
not finalized for removal, we would reassess whether these eligible 
clinicians would have an adequate amount of MIPS quality measures 
available to them. We proposed to include these additional clinicians 
in the MIPS eligible clinician definition if we found that they do have 
at least 6 MIPS quality measures available to them. As discussed in 
``Appendix 1: Finalized MIPS Quality Measures'', TABLE Group C. of this 
final rule, we are retaining one of the MIPS quality measures that was 
proposed for removal: ``Colonoscopy Interval for Patients with a 
History of Adenomatous Polyps--Avoidance of Inappropriate Use'' 
(Quality #185). We do not believe that this measure is applicable to 
any of the proposed additional eligible clinicians. Therefore, it does 
not affect the number of available measures for these clinicians. We 
refer readers to section III.I.3.h.(2) of this final rule for more 
information regarding quality measures.
    We focused on the quality performance category because the quality 
and improvement activities performance categories require submission of 
data. We believed there would generally be applicable and available 
improvement activities for each of the additional eligible clinician 
types, but that not all of the additional eligible clinician types 
would have sufficient MIPS quality measures applicable and available if 
the proposed MIPS quality measures were removed from the program. In 
our analysis, we did find QCDR measures approved for the CY 2018 
performance period that are either high priority and/or outcome 
measures that, if approved for the CY 2019 performance period, may be 
applicable to these additional eligible clinicians. However, this would 
necessitate that the clinician utilize a QCDR in order to be successful 
in MIPS. Further, we have heard some concerns from the non-physician 
associations, through written correspondence, that since their 
clinicians would be joining the program 2 years after its inception, we 
should consider several ramp-up policies in order to facilitate an 
efficient integration of these clinicians into MIPS. We note that the 
MIPS program is still ramping up, and we will continue to increase the 
performance threshold to ensure a gradual and incremental transition to 
the performance threshold that will be used in the Quality Payment 
Program Year 6. Therefore, if specified as MIPS eligible clinicians 
beginning with the 2021 MIPS payment year, the additional eligible 
clinicians would have 4 years in the program in order to ramp up. 
Conversely, if specified as MIPS eligible clinicians beginning in a 
future year, they would be afforded less time to ramp up the closer the 
program gets to Quality Payment Program Year 6.
    We requested comments on our proposal to amend Sec.  414.1305 to 
modify the definition of a MIPS eligible clinician, as identified by a 
unique billing TIN and NPI combination used to assess performance, to 
mean any of

[[Page 59723]]

the following (excluding those identified at Sec.  414.1310(b)): A 
physician (as defined in section 1861(r) of the Act); a physician 
assistant, nurse practitioner, and clinical nurse specialist (as such 
terms are defined in section 1861(aa)(5) of the Act); a certified 
registered nurse anesthetist (as defined in section 1861(bb)(2) of the 
Act); beginning with the 2021 MIPS payment year, a physical therapist, 
occupational therapist, a clinical social worker (as defined in section 
1861(hh)(1) of the Act), a clinical psychologist (as defined by the 
Secretary for purposes of section 1861(ii) of the Act); and a group 
that includes such clinicians. Alternatively, we proposed that if the 
quality measures proposed for removal were not finalized, then we would 
include additional eligible clinician types in the definition of a MIPS 
eligible clinician beginning with the 2021 MIPS payment year 
(specifically, qualified speech-language pathologists, qualified 
audiologists, certified nurse-midwives, and registered dietitians or 
nutrition professionals), provided that we determine that each 
applicable eligible clinician type would have at least 6 MIPS quality 
measures available to them. In addition, we requested comments on: (1) 
Specifying qualified speech-language pathologists, qualified 
audiologists, certified nurse-midwives, and registered dietitians or 
nutrition professionals as MIPS eligible clinicians beginning with the 
2021 MIPS payment year; and (2) delaying the specification of one or 
more additional eligible clinician types as MIPS eligible clinicians 
until a future MIPS payment year.
    The following is a summary of the public comments received on our 
proposals and our responses:
    Comment: Many commenters supported our proposal to expand the 
definition of MIPS eligible clinicians to physical therapists, 
occupational therapists, clinical social workers, and clinical 
psychologists. A few commenters encouraged us to ensure that a 
reasonable number of measures are maintained for these newly eligible 
clinicians. Other commenters specifically discussed adding qualified 
audiologist and qualified speech-language pathologists as MIPS eligible 
clinicians, stating that there are enough discipline-specific measures 
for these clinicians to be included in the program. One commenter 
specifically stated that registered dietitians have seven quality 
measures on which to report, and, therefore should be included in the 
program. A few commenters requested that we include the following 
additional clinicians as MIPS eligible clinicians: Nurse navigators, 
oncology staff nurses, and clinical pharmacists, stating that adding 
more clinicians would enable better understanding of healthcare data 
across other specialties.
    Response: We appreciate the additional information provided 
regarding the quality measures available to the additional eligible 
clinicians. After review of the additional information regarding 
quality measures we revisited our findings and found support for the 
comments. We were persuaded by the arguments of the specialties who 
requested to be included in the program including: Physical therapists, 
occupational therapists, speech-language pathologists, audiologists, 
clinical psychologists, and dieticians or nutrition professionals. 
However, we believe that clinical social workers may not have six 
applicable quality measures to report. For example, some measures may 
contain CPT codes utilized by clinical social workers, but may not be 
applicable to their practice. We do believe that there is at least one 
quality measure that clinical social workers could report for MIPS. We 
encourage the clinicians within the specialty provide feedback during 
the specialty measure set solicitation process to create a measure set 
applicable to clinical social workers for implementation in future 
rulemaking. This will ensure proper scoring based on applicable 
measures and will not hold clinical social workers accountable for 
measures that are outside their scope. Therefore, we are modifying our 
proposal by removing clinical social workers from our proposed list and 
including qualified speech-language pathologists, qualified 
audiologists, and registered dieticians who were not in our proposed 
list but have requested inclusion as MIPS eligible clinicians. We are 
finalizing to modify Sec.  414.1305 the definition of a MIPS eligible 
clinician to include: Beginning with the 2021 MIPS payment year, a 
physical therapist, occupational therapist, qualified speech-language 
pathologist; a qualified audiologist (as defined in section 
1861(ll)(3)(B) of the Act); clinical psychologist (as defined by the 
Secretary for purposes of section 1861(ii) of the Act); and registered 
dietician or nutrition professional; and a group that includes such 
clinicians. We note that we do not have discretion under the statute to 
include clinicians other than those specified in section 
1848(q)(1)(C)(II) of the Act. Thus, nurses and pharmacists would not be 
able to participate in MIPS.
    Comment: A few commenters requested that clinical social workers 
not be included in MIPS. They stated several reasons why they believe 
that clinical social workers should not be included in MIPS: (1) Many 
of their clinicians are solo or small group practices and do not have 
the technology infrastructure in place to effectively meet expectations 
in the Promoting Interoperability performance category; (2) many are in 
private practice and have limited ability to influence the overall care 
of patients limiting their ability to manage the overall cost of the 
beneficiary; (3) while there are more than six measures available in 
the mental/behavioral health measure set there are only four claims 
measures appropriate for use by clinical social workers as determined 
by eligible CPT codes and scope of practice; and (4) some of the 
available MIPS CQM measures are limited by patient diagnosis, such as 
dementia, which may further limit a clinical social workers ability to 
effectively report on six quality measures, as there are only two 
outcome measures in the Mental/Behavioral health measure set for 
clinical social workers and they require the utilization of the PHQ-9 
measure which is only reportable via EHR. When a clinical social worker 
does not utilize EHR technology there may be further limitations to 
reporting adequate measures.
    Response: After review of the additional information regarding 
quality measures, we revisited our findings and found support for the 
comments. We were persuaded by the arguments of the specialties who 
requested to be included in the program including: Physical therapists; 
occupational therapists; speech-language pathologists; audiologists; 
clinical psychologists; and dieticians or nutrition professionals. We 
understand the issues that have been highlighted by the commenters and 
believe that some clinical social workers may have a difficult time 
successfully participating in MIPS. Therefore, we agree that clinical 
social workers should not be added as a MIPS eligible clinician at this 
time. However, we do believe that they may be able to participate at 
some point in the future. From our analysis, clinical social workers 
may not have six applicable quality measures to report at this time. 
For example, some measures may contain CPT codes utilized by clinical 
social workers, but may not be applicable to their practice. We do 
believe that there is at least one quality measure that clinical social 
workers

[[Page 59724]]

could report for MIPS. Therefore, we are modifying our proposal by 
removing clinical social workers and certified nurse-midwives from our 
proposed list and including qualified speech-language pathologists, 
qualified audiologists, and registered dieticians who were not in our 
proposed list but have requested inclusion as MIPS eligible clinicians. 
We are finalizing to modify Sec.  414.1305 the definition of a MIPS 
eligible clinician to include, beginning with the 2021 MIPS payment 
year, a physical therapist, occupational therapist, qualified speech-
language pathologist; a qualified audiologist (as defined in section 
1861(ll)(3)(B) of the Act); clinical psychologist (as defined by the 
Secretary for purposes of section 1861(ii) of the Act); and registered 
dietician or nutrition professional; and a group that includes such 
clinicians. We encourage clinicians who are not eligible to participate 
in MIPS to voluntarily report on applicable measures and activities for 
MIPS. The data received will not be used to assess performance for the 
purpose of the MIPS payment adjustment; however, these clinicians will 
have the opportunity to access feedback on their submitted MIPS data. 
We agree that the two outcome measures within the mental/behavioral 
health specialty measure set do require the utilization of the PHQ-9 to 
measure the depression outcome; however, we disagree with the commenter 
as this is not restricted to EHR and available by MIPS CQMs 
Specification.
    Comment: One commenter recommended that we adopt a standard 
definition of a Quality Payment Program eligible provider, eligible 
clinician and/or an eligible professional as it continues to expand the 
list of eligible clinicians. The commenter recommended the word 
``physician'' be replaced with provider and/or clinician, stating that 
this terminology better reflects the collaboration of the current 
inter-professional healthcare team.
    Response: We understand the commenter to be suggesting that we 
unify the definitions of eligible clinician and MIPS eligible 
clinician. While we agree that a unified definition might have certain 
benefits, we believe that two separate definitions are necessary as the 
two tracks of the Quality Payment Program (MIPS and APM) have 
distinctly different requirements for participation and the term 
eligible clinicians reflects, a broader set of clinician types than the 
term MIPS eligible clinicians. We note that both terms already refer to 
clinicians.
    Comment: Some commenters stated that inclusion of these additional 
eligible clinicians in the program with just two months' notice is 
overly burdensome and would ultimately prove counterproductive. One 
commenter stated that because of the limited scope of MIPS reporting 
that is applicable to these specialties, we should carefully evaluate 
whether the expense and added burden of reporting for these specialties 
is commensurate with the benefits. Another commenter noted that these 
clinicians tend to have a high patient turnover rate, which could make 
certain measures challenging. Several commenters opposed expanding the 
definition of eligible clinician to the proposed clinician types, 
stating that the clinician types do not, as a general rule, encompass 
the same types of workflows as current MIPS eligible clinicians, and, 
therefore, adding these clinicians could increase the cost, time, and 
effort for reporting and documentation. Many commenters requested we 
create ramp-up policies for the additional eligible clinicians, such as 
a pick-your-pace approach or a 1-year delayed effective date. Likewise, 
a few commenters requested that we allow the additional clinicians to 
opt-in for the first year in which they are eligible to participate. A 
few commenters requested that we consider a one-time bonus payment for 
voluntary reporting, and requested modified quality benchmarks, 
performance thresholds, reporting requirements, and data completeness 
requirements.
    Response: We acknowledge that adding these additional clinicians 
will require some adaptation to the current systems and processes and 
will take careful consideration by measure stewards to determine the 
appropriateness of adding clinician encounters to align with measure 
intent. However, we believe the benefits outweigh the costs as these 
clinicians are an integral part of the health care delivery team. We 
believe that all eligible clinicians benefit from participation in 
quality reporting under MIPS and help reach one of our strategic 
objectives to improve beneficiary outcomes and engage and empower 
consumers by providing healthcare information useful for driving value 
and making healthcare decisions. Regarding measures that are considered 
challenging, the additional clinicians should choose measures and 
activities that are applicable and meaningful to them. As noted in the 
proposed rule (83 FR 35884), the MIPS program is still ramping up, and 
we will continue to increase the performance threshold to ensure a 
gradual and incremental transition to the performance threshold that 
will be used in the Quality Payment Program Year 6. Therefore, if 
specified as MIPS eligible clinicians beginning with the 2021 MIPS 
payment year, the additional eligible clinicians would have 4 years in 
the program in order to ramp up. Conversely, if specified as MIPS 
eligible clinicians beginning in a future year, they would be afforded 
less time to ramp up the closer the program gets to Quality Payment 
Program Year 6. In addition, for the first 2 years of MIPS, clinicians 
who are not MIPS eligible had the opportunity to voluntarily report to 
become familiar with MIPS measures and reporting. For these reasons, we 
do not believe we should adopt policies such as those suggested by the 
commenters. We note that additional eligible clinicians that exceed at 
least one, but not all, of the low-volume threshold criteria will have 
the opportunity to opt-in to participate in MIPS as discussed in 
section III.I.3.c.(5) of this final rule. We do not agree with offering 
a one-time bonus payment for voluntary reporting as section 
1848(q)(1)(C)(vi) of the Act precludes the application of a MIPS 
adjustment factor (or additional MIPS adjustment factor) to an 
individual who is not a MIPS eligible clinician. Finally, as these 
additional clinicians will be defined as MIPS eligible clinicians, they 
will be subject to the same requirements as other MIPS eligible 
clinicians, including quality benchmarks, performance thresholds, 
reporting requirements, and data completeness requirements.
    Comment: Several commenters requested that we provide targeted 
education on program requirements to additional eligible clinicians. 
Specifically, the commenters urged us to provide compliance support to 
small practices, by creating an industry pathway to EHR reporting. A 
few commenters requested that we convene a Technical Expert Panel (TEP) 
comprised of individuals representing the additional eligible clinician 
types to inform adaptation of the Quality Payment Program to meet their 
needs.
    Response: We have consistently provided targeted education on 
program requirements in the past and intend to continue doing so 
through various means including: Webinars, national provider calls, 
virtual office hours, speaking engagements, and tailored educational 
resources for the additional clinicians. No cost technical assistance 
is also available by contacting the Quality Payment Program Service 
Center by phone at 1-866-288-8292, (TTY) 1-877-715-6222 or by email at 
[email protected]. We will also continue to support small and rural

[[Page 59725]]

practices by offering free and customized resources available within 
local communities, including direct, one-on-one support from the Small, 
Underserved, and Rural Support Initiative along with our other no-cost 
technical assistance. We appreciate the suggestion to convene a TEP 
comprised of the additional clinicians. We will continue to explore 
additional opportunities for this type of engagement in the future.
    Comment: Many commenters noted their concern regarding whether the 
Quality Payment Program could be utilized for these new clinician 
types, asking us to consider if these clinicians are able to meet MIPS 
reporting requirements across all performance categories before 
expanding the list of MIPS-eligible clinicians. Specifically, some 
commenters stated that the Promoting Interoperability performance 
category would be difficult to meet without a change in meaningful use 
guidelines, noting that because these clinicians rarely bill the 
clinician group directly and may not be integrated with the clinician 
group's EHR, interoperability remains a material issue. These 
commenters requested that we weight the Promoting Interoperability 
performance category at zero percent or allow new eligible clinicians 
to opt-in to this performance category. Another commenter requested 
clarification on whether the proposal to automatically assign a zero 
percent weighting for the Promoting Interoperability performance 
category for these new types of MIPS eligible clinicians applies to 
both individual clinicians and groups. Another commenter asked for 
clarification regarding if they could continue to report as a group. 
One commenter questioned whether the additional clinicians would be 
removed from the denominator for these measures. Other commenters asked 
for clarification on how quality measures will be captured as most of 
these clinicians may not have electronic medical records (EMRs).
    Response: In the CY 2019 PFS proposed rule (83 FR 35883 through 
35884) to assess whether these additional eligible clinicians could 
successfully participate in MIPS, we evaluated whether there would be 
sufficient measures and activities applicable and available for each of 
the additional eligible clinician types. We did not focus on the 
Promoting Interoperability performance category because for CY 2019 we 
are finalizing to automatically assign a zero percent weighting for the 
Promoting Interoperability performance category which will be 
reweighted to the quality performance category for these new types of 
MIPS eligible clinicians. In response to the comment, the proposal to 
automatically assign a zero percent weighting for the Promoting 
Interoperability performance category does apply to both individual 
clinicians and groups. Clinicians may choose to report for MIPS as an 
individual or as part of a group. If the clinician chooses to report as 
part of a group, then under the policy we established previously (82 FR 
53687), all of the MIPS eligible clinicians in the group must qualify 
for a zero percent weighting in order for the Promoting 
Interoperability performance category to be reweighted in the final 
score. We refer readers to section III.I.3.h.(5)(h)(ii) of this final 
rule for further details on the policy that we are finalizing in this 
rule to automatically assign a zero percent weighting for the Promoting 
Interoperability performance category. Regarding data submission 
requirements for quality measures, the additional eligible clinicians 
may submit their quality data through the same data collection types 
available to all MIPS eligible clinicians including eCQMs, MIPS 
Clinical Quality Measures (MIPS CQMs), QCDR measures, Medicare Part B 
claims measures, CMS Web Interface measures, the CAHPS for MIPS survey, 
and administrative claims measures which may be submitted via one of 
the submission types including: Direct; log in and upload; log in and 
attest; Medicare Part B claims; and the CMS Web Interface. We refer 
readers to section III.I.3.h.(1) in this final rule for further 
information regarding performance category measures and reporting.
    Comment: A few commenters requested that we be certain that we are 
operationally prepared to support reporting and scoring for the 
additional eligible clinician types, as clinicians have experienced 
operational data submissions issues in the past.
    Response: We intend to have our Quality Payment Program portal 
ready to accept and process data for all MIPS eligible clinicians for 
2021 MIPS payment year.
    Comment: Several commenters requested clarification on how our 
proposal would apply to eligible clinicians billing under a hospital- 
or facility-based TIN. A few commenters stated that the rule does not 
indicate whether hospitals should report the NPI of these clinicians on 
the UB-04 claims used by hospitals and cautioned that adding these 
clinician types to UB-04 claims would entail significant administrative 
burden to hospitals. One commenter also stated that the majority of 
facility-based outpatient therapy claims do not contain the rendering 
NPI and usually contain just a facility NPI; therefore, most facility-
based outpatient therapy claims will not be eligible for MIPS. A few 
commenters said that due to a technicality in how facility-based claims 
(such as those submitted by inpatient rehabilitation facilities) are 
submitted, only independently rendered, private practice outpatient 
therapy services will be included in MIPS, and facility-based 
outpatient therapy will generally not be included. One commenter 
recommended that we operationalize the inclusion of facility-based 
clinicians in MIPS by treating the facility NPI as a MIPS-participating 
NPI and allow the facility to report measures under MIPS like a group. 
Another commenter argued that facility-based outpatient therapy 
clinicians should be included in the program. A few commenters sought 
clarification of how clinicians of therapy services in skilled-nursing 
facilities will be treated, stating that assessing individual 
clinicians for quality and adjusting payment poses unique challenges in 
this setting.
    Response: These additional clinicians will be defined as MIPS 
eligible clinicians and will be subject to the same requirements as 
other MIPS eligible clinicians billing under a hospital- or facility-
based TIN. MIPS eligible clinician may report as an individual or as 
part of a group. We finalized at Sec.  414.1380(e)(2)(i) and (ii) the 
determination of a facility-based individual and facility-based group. 
A facility-based individual is a MIPS eligible clinician that furnishes 
75 percent or more of his or her covered professional services in sites 
of service identified by the place of service codes used in the HIPAA 
standard transaction as an inpatient hospital or emergency room setting 
based on claims for a period prior to the performance period as 
specified by CMS. A facility-based group is a group in which 75 percent 
or more of its eligible clinician NPIs billing under the group's TIN 
meet the facility-based individual determination. Therefore, if a MIPS 
eligible clinician is submitting their data as part of a facility-based 
group their NPI number would need to be annotated on the claim which is 
part of normal billing practices. We refer readers to section 
III.I.3.h.(2)(a)(iv) of this final rule for further details regarding 
the application of facility-based measures. The definition of a 
hospital-based clinician finalized at Sec.  414.1410 is primarily 
applicable to the Promoting Interoperability performance category. We 
refer readers to the CY 2018 Quality Payment Program final rule (82 FR

[[Page 59726]]

53684) for details on a hospital-based clinician. We are aware that 
facility-based outpatient therapy and skilled nursing facility claims 
do not contain the rendering NPI and usually contain just a facility 
NPI; therefore, facility-based outpatient therapy and skilled nursing 
facility claims will not be eligible for MIPS. For those billed 
Medicare Part B allowed charges we are able to associate with a MIPS 
eligible clinician at an NPI level, such covered professional services 
furnished by such clinicians would be included for purposes of applying 
any MIPS payment adjustment. It is our intention to provide clinicians 
with their eligibility status prior to the performance period through 
the Quality Payment Program portal eligibility determination tool. This 
should allow clinicians to know ahead of time whether they are included 
in MIPS or not. We will take these comments into consideration in 
future rulemaking.
    Comment: A few commenters noted that adding physical and 
occupational therapists would affect the determination of practice 
size. One commenter expressed concern that groups may lose their small 
group status even though the composition of the practice did not 
change.
    Response: We do not anticipate that the small practice size 
determination will be affected by adding additional clinicians to the 
definition of MIPS eligible clinician. Small practice is defined at 
Sec.  414.1305 to mean a practice consisting of 15 or fewer eligible 
clinicians. Thus, the definition of small practice already accounts for 
all eligible clinicians in the practice, including those that we are 
adding to the definition of MIPS eligible clinician.
    Comment: One commenter requested clarification regarding how the 
additional MIPS eligible clinicians would be subject to payment 
reductions if they do not meet the performance requirements under MIPS.
    Response: The additional eligible clinicians, who are not otherwise 
excluded, will be included in the performance requirements for a MIPS 
eligible clinician for CY 2021 payment year. In addition, MIPS eligible 
clinicians are subject to the MIPS payment adjustment factor. 
Clinicians who are considered MIPS eligible and who do not report under 
MIPS may receive a final score of zero and an associated negative 
payment adjustment of 7 percent during the CY 2021 payment year.
    Comment: Some commenters stated that the additional clinician types 
could water down the performance pool, and increasing the number of 
participants will create increased competition for an additional 
performance threshold, making it more difficult for disadvantaged 
clinicians to meaningfully participate in MIPS.
    Response: Although the number of MIPS eligible clinicians will 
increase, we do not anticipate that the additional clinicians will 
substantially change the total number of MIPS eligible clinicians or 
make it more difficult for other clinicians to meaningfully participate 
in MIPS. Regarding the additional performance threshold, we note that 
the eligible clinician must first qualify for the additional 
performance threshold for exceptional performance. We do not believe 
that the addition of new clinician types to be MIPS eligible implies 
they are going to perform at a level that qualifies for the additional 
performance threshold. We refer readers to Table 98 in section VII 
(Regulatory Impact Analysis) of this final rule for information 
regarding the impact of expanding the definition of MIPS eligible 
clinicians on the total number of MIPS eligible clinicians and the 
total estimated PFS amount paid.
    Comment: One commenter believed it was unnecessary to include the 
proposed additional eligible clinicians as they would more than likely 
be ineligible because they would fall below the low-volume threshold.
    Response: We understand that some of the additional eligible 
clinicians may not exceed the low-volume threshold. However, as 
discussed in section III.I.3.c.(5) of this final rule, we are also 
finalizing an opt-in option that will allow eligible clinicians to opt-
in to MIPS if the eligible clinician or group meets or exceeds at least 
one, but not all, of the low-volume threshold criteria. In addition, 
MIPS eligible clinicians may participate in MIPS as part of a group or 
virtual group which should improve their ability to exceed the low-
volume threshold. We believe this option would allow the additional 
eligible clinicians the opportunity to participate in MIPS if they 
desired to do so.
    Comment: Several commenters suggested that there is misalignment 
between the proposed expanded list of eligible clinician types for the 
MIPS and the scope of clinician types for the Advanced Alternative 
Payment Model path under the Quality Payment Program. Specifically, a 
few commenters noted that, currently, a number of clinician types (for 
example, clinical psychologists and certified nurse midwives) could be 
in an Advanced APM, but that we are proposing to include clinician 
types for MIPS that may not be eligible for the Advanced APM path under 
the Quality Payment Program. Thus, commenters suggested that we 
standardize the included clinician types across the Quality Payment 
Program unless there are appropriate clinical reasons for differences. 
One commenter requested clarification as to whether physical, 
occupational, and speech therapists, as eligible clinicians, can 
participate in the Advanced APMs path under the Quality Payment 
Program. Another commenter requested that we provide guidance on how 
APM entities, ACOs, and other health care organizations should identify 
these clinician types on their clinician participation lists.
    Response: We note that the proposed expanded list of eligible 
clinician types for the MIPS is not misaligned with the scope of 
eligible clinicians for the Advanced APMs path under the Quality 
Payment Program. In accordance with section 1848(q)(1)(C)(i)(I) of the 
Act, we defined MIPS eligible clinician for the 2019 and 2020 MIPS 
payment years to include only physicians (as defined under section 
1861(r) of the Act), physician assistants, nurse practitioners, 
clinician nurse specialists, and certified registered nurse 
anesthetists (and groups that include these clinicians). In contrast, 
we explained in the CY 2017 Quality Payment Program final rule (81 FR 
77405 through 77406), for the Advanced APM path under the Quality 
Payment Program, the term ``eligible clinician'' is defined in section 
1833(z)(3)(B) of the Act (by cross-reference to the definition of 
``eligible professional'' in section 1848(k)(3)(B) of the Act), and 
includes: Physicians, physician assistants, nurse practitioners, 
clinical nurse specialists, certified registered nurse anesthetists, 
certified nurse-midwives, clinical social workers, clinical 
psychologists, registered dietitians or nutrition professionals, 
physical or occupational therapists, qualified speech-language 
pathologists, and qualified audiologists, and a group that includes 
these professionals. Our proposed expansion of the list of MIPS 
eligible clinician types would actually align with the current scope of 
eligible clinicians under the Advanced APM path of the Quality Payment 
Program. Currently, any of those eligible clinicians who participate 
sufficiently in Advanced APMs can become QPs for a year and receive the 
associated APM Incentive Payment. We note that each APM has its own 
focus, and many offer participation opportunities for a broad scope of 
eligible clinicians. Although the design of existing or future APMs is 
beyond the scope of this final rule, we welcome ideas on how to further 
engage

[[Page 59727]]

the full scope of eligible clinicians as we work hard to develop more 
APM opportunities. Additionally, we finalized in the CY 2017 Quality 
Payment Program final rule (81 FR 77442) that the eligible clinicians 
for whom we would make QP determinations would be all the eligible 
clinicians participating in an APM Entity in an Advanced APM, as 
identified at each of three snapshot dates, during a QP Performance 
Period. The eligible clinicians for whom we make QP determinations are 
those identified on an Advanced APM's Participation List or Affiliated 
Practitioner List on one of those three dates. Lastly, we note that 
decisions about the eligible clinicians that are included on the 
Participation List or Affiliated Practitioner List for any particular 
Advanced APM are made based on the specific terms and conditions of the 
Advanced APM, which can vary based on the model test, entities 
involved, payment arrangements, and other factors.
    After consideration of the public comments received, we are 
finalizing a modification of our proposal to amend Sec.  414.1305 to 
revise the definition of a MIPS eligible clinician, as identified by a 
unique billing TIN and NPI combination used to assess performance, to 
mean any of the following (excluding those identified at Sec.  
414.1310(b)): A physician (as defined in section 1861(r) of the Act); a 
physician assistant, nurse practitioner, and clinical nurse specialist 
(as such terms are defined in section 1861(aa)(5) of the Act); a 
certified registered nurse anesthetist (as defined in section 
1861(bb)(2) of the Act); beginning with the 2021 MIPS payment year, a 
physical therapist, occupational therapist, qualified speech-language 
pathologist; qualified audiologist (as defined in section 
1861(ll)(3)(B) of the Act); clinical psychologist (as defined by the 
Secretary for purposes of section 1861(ii) of the Act); and registered 
dietician or nutrition professional; and a group that includes such 
clinicians.
b. MIPS Determination Period
    As discussed in the proposed rule (83 FR 35884 through 35886), 
currently MIPS uses various determination periods to identify certain 
MIPS eligible clinicians for consideration for certain applicable 
policies. For example, the low-volume threshold, non-patient facing, 
small practice, hospital-based, and ambulatory surgical center (ASC)-
based determinations are on the same timeline with slight differences 
in the claims run-out policies, whereas the facility-based 
determinations has a slightly different determination period. The 
virtual group eligibility determination requires a separate election 
process. We proposed to add a virtual group eligibility determination 
period beginning in CY 2020 as discussed in section III.I.3.f.(2)(a) of 
this final rule. In addition, the rural and HPSA determinations do not 
utilize a determination period.
    Under Sec.  414.1305, the low-volume threshold determination period 
is described as a 24[dash]month assessment period consisting of an 
initial 12[dash]month segment that spans from the last 4 months of the 
calendar year 2 years prior to the performance period through the first 
8 months of the calendar year preceding the performance period, and a 
second 12[dash]month segment that spans from the last 4 months of the 
calendar year 1 year prior to the performance period through the first 
8 months of the calendar year performance period. An individual 
eligible clinician or group that is identified as not exceeding the 
low-volume threshold during the initial 12[dash]month segment will 
continue to be excluded under Sec.  414.1310(b)(1)(iii) for the 
applicable year regardless of the results of the second 12-month 
segment analysis. For the 2020 MIPS payment year and future years, each 
segment of the low-volume threshold determination period includes a 30-
day claims run out.
    Under Sec.  414.1305, the non-patient facing determination period 
is described as a 24[dash]month assessment period consisting of an 
initial 12[dash]month segment that spans from the last 4 months of the 
calendar year 2 years prior to the performance period through the first 
8 months of the calendar year preceding the performance period and a 
second 12[dash]month segment that spans from the last 4 months of the 
calendar year 1 year prior to the performance period through the first 
8 months of the calendar year performance period. An individual 
eligible MIPS clinician, group, or virtual group that is identified as 
non-patient facing during the initial 12-month segment will continue to 
be considered non-patient facing for the applicable year regardless of 
the results of the second 12[dash]month segment analysis. For the 2020 
MIPS payment year and future years, each segment of the non-patient 
facing determination period includes a 30[dash]day claims run out.
    In the CY 2018 Quality Payment Program final rule (82 FR 53581), we 
finalized that for the small practice size determination period, we 
would utilize a 12-month assessment period, which consists of an 
analysis of claims data that spans from the last 4 months of a calendar 
year 2 years prior to the performance period followed by the first 8 
months of the next calendar year and includes a 30-day claims run out.
    In the CY 2017 Quality Payment Program final rule (81 FR 77238 
through 77240), we finalized that to identify a MIPS eligible clinician 
as hospital-based we would use claims with dates of service between 
September 1 of the calendar year 2 years preceding the performance 
period through August 31 of the calendar year preceding the performance 
period, but in the event it is not operationally feasible to use claims 
from this time period, we would use a 12-month period as close as 
practicable to this time period.
    In the CY 2018 Quality Payment Program final rule (82 FR 53684 
through 53685), we finalized that to identify a MIPS eligible clinician 
as ASC-based, we would use claims with dates of service between 
September 1 of the calendar year 2 years preceding the performance 
period through August 31 of the calendar year preceding the performance 
period, but in the event it is not operationally feasible to use claims 
from this time period, we would use a 12-month period as close as 
practicable to this time period.
    In the CY 2018 Quality Payment Program final rule (82 FR 53760), we 
discussed, but did not finalize, our proposal or the alternative option 
for how an individual clinician or group would elect to use and be 
identified as using facility-based measurement for the MIPS program. 
Because we were not offering facility-based measurement until the 2019 
MIPS performance period, we did not need to finalize either of these 
for the 2018 MIPS performance period. However, as discussed in section 
III.I.3.i.(1)(d) of this final rule, we proposed to amend Sec.  
414.1380(e)(2)(i)(A) to specify a criterion for a clinician to be 
eligible for facility-based measurement. Specifically, that is, the 
clinician furnishes 75 percent or more of his or her covered 
professional services in sites of service identified by the place of 
service codes used in the HIPAA standard transaction as an inpatient 
hospital, on-campus outpatient hospital, or emergency room setting 
based on claims for a 12-month segment beginning on October 1 of the 
calendar year 2 years prior to the applicable performance period and 
ending on September 30 of the calendar year preceding the applicable 
performance period with a 30-days claims run out. We did not propose to 
utilize the MIPS determination period for purposes of the facility-
based determination because for the facility-based determination, we 
are only using the first segment of the MIPS determination period. We 
are using the

[[Page 59728]]

first segment because the performance period for measures in the 
hospital value-based purchasing program overlapped in part with that 
determination period. If we were to use the second segment, we could 
not be assured that the clinician actually worked in the hospital on 
which their MIPS score would be based during that time. We believe this 
approach provides clarity and is a cleaner than providing a special 
exception for the facility-based determination in the MIPS 
determination period for the second segment. We refer readers to 
section III.I.3.i.(1)(d) for further details on the facility-based 
determinations and the time periods that are applicable to those 
determinations.
    In the CY 2018 Quality Payment Program final rule (82 FR 53602 
through 53604), we finalized that for the virtual group eligibility 
determination period, we would utilize an analysis of claims data 
during an assessment period of up to 5 months that would begin on July 
1 and end as late as November 30 of the calendar year prior to the 
applicable performance period and include a 30-day claims run out. To 
capture a real-time representation of TIN size, we finalized that we 
would analyze up to 5 months of claims data on a rolling basis, in 
which virtual group eligibility determinations for each TIN would be 
updated and made available monthly. We noted that an eligibility 
determination regarding TIN size is based on a relative point in time 
within the 5-month virtual group eligibility determination period, and 
not made at the end of such 5-month determination period. Beginning 
with the 2019 performance period, we proposed to amend Sec.  
414.1315(c)(1) to establish a virtual group eligibility determination 
period to align with the first segment of the MIPS determination 
period, which includes an analysis of claims data during a 12-month 
assessment period (fiscal year) that would begin on October 1 of the 
calendar year 2 years prior to the applicable performance period and 
end on September 30 of the calendar year preceding the applicable 
performance period and include a 30-day claims run out. We refer 
readers to section III.I.3.f.(2)(a) of this final rule for further 
details on this proposal.
    In addition, we have established other special status 
determinations, including rural area and HPSA. Rural area is defined at 
Sec.  414.1305 as a ZIP code designated as rural, using the most recent 
Health Resources and Services Administration (HRSA) Area Health 
Resource File data set available. HPSAs are defined at Sec.  414.1305 
as areas designated under section 332(a)(1)(A) of the Public Health 
Service Act.
    We understand that the current use of various MIPS determination 
periods is complex and causes confusion. Therefore, beginning with the 
2021 MIPS payment year, we proposed to consolidate several of these 
policies into a single MIPS determination period that would be used for 
purposes of the low-volume threshold and to identify MIPS eligible 
clinicians as non-patient facing, a small practice, hospital-based, and 
ASC-based, as applicable. We did not propose to include the facility-
based or virtual group eligibility determination periods or the rural 
and HPSA determinations in the MIPS determination period, as they each 
require a different process or timeline that does not align with the 
other determination periods, or do not utilize determination periods. 
We invited public comments on the possibility of incorporating these 
determinations into the MIPS determination period in the future.
    There are several reasons we believe a single MIPS determination 
period for most of the eligibility criteria is the most appropriate. 
First, it would simplify the program by aligning most of the MIPS 
eligibility determination periods. Second, it would continue to allow 
us to provide eligibility determinations as close to the beginning of 
the performance period as feasible. Third, we believe a timeframe that 
aligns with the fiscal year is easier to communicate and more 
straightforward to understand compared to the current determination 
periods. Finally, it would allow us to extend our data analysis an 
additional 30 days.
    It is important to note that during the final 3 months of the 
calendar year in which the performance period occurs, in general, we do 
not believe it would be feasible for many MIPS eligible clinicians who 
join an existing practice (existing TIN) or join a newly formed 
practice (new TIN) to participate in MIPS as individuals. We refer 
readers to section III.I.3.i.(2)(b) of this final rule for more 
information on the proposed reweighting policies for MIPS eligible 
clinicians who join an existing practice or who join a newly formed 
practice during this timeframe.
    We requested comments on our proposal that beginning with the 2021 
MIPS payment year, the MIPS determination period would be a 24-month 
assessment period including a two-segment analysis of claims data 
consisting of: (1) An initial 12-month segment beginning on October 1 
of the calendar year 2 years prior to the applicable performance period 
and ending on September 30 of the calendar year preceding the 
applicable performance period; and (2) a second 12-month segment 
beginning on October 1 of the calendar year preceding the applicable 
performance period and ending on September 30 of the calendar year in 
which the applicable performance period occurs. The first segment would 
include a 30[dash]day claims run out. The second segment would not 
include a claims run out, but would include quarterly snapshots for 
informational use only, if technically feasible. For example, a 
clinician could use the quarterly snapshots to understand their 
eligibility status between segments. Specifically, we believe the 
quarterly snapshots would be helpful for new TIN/NPIs and TINs created 
between the first segment and the second segment allowing them to see 
their preliminary eligibility status sooner. Without the quarterly 
snapshots, these clinicians would not have any indication of their 
eligibility status until just before the submission period. An 
individual eligible clinician or group that is identified as not 
exceeding the low-volume threshold, or a MIPS eligible clinician that 
is identified as non-patient facing, a small practice, hospital-based, 
or ASC-based, as applicable, during the first segment would continue to 
be identified as such for the applicable MIPS payment year regardless 
of the second segment. For example, for the 2021 MIPS payment year, the 
first segment would be October 1, 2017 through September 30, 2018, and 
the second segment would be October 1, 2018 through September 30, 2019. 
However, based on our experience with the Quality Payment Program, we 
believe that some eligible clinicians, whose TIN or TIN/NPIs are 
identified as eligible during the first segment and do not exist in the 
second segment, are no longer utilizing these same TIN or TIN/NPI 
combinations. Therefore, because those TIN or TIN/NPIs would not exceed 
the low-volume threshold in the second segment, they would no longer be 
eligible for MIPS. For example, in the 2019 performance period a 
clinician exceeded the low-volume threshold during the first segment of 
the determination period (data from the end of CY 2017 to early 2018) 
under one TIN; then in CY 2019 the clinician switches practices under a 
new TIN and during segment two of the determination period. Therefore, 
it is determined that the clinician is not eligible (based on CY 2019 
data) under either TIN. This clinician would not be eligible to 
participate in MIPS based on either segment of the determination

[[Page 59729]]

period because the TIN that was assessed for the first segment of the 
determination period no longer exists. So there are no charges or 
services that would be available to assess in the second segment for 
that TIN and the new TIN assessed during the second segment was not 
eligible. In this scenario, though the clinician exceeded the low-
volume threshold criteria initially, the clinician is not required to 
submit any data based on TIN eligibility determinations. However, it is 
important to note that if a TIN or TIN/NPI did not exist in the first 
segment but does exist in the second segment, these eligible clinicians 
could be eligible for MIPS. For example, the eligible clinician may not 
find their TIN or TIN/NPI in the Quality Payment Program lookup tool 
but may still be eligible if they exceed the low-volume threshold in 
the second segment. We proposed to incorporate this policy into our 
proposed definition of MIPS determination period at Sec.  414.1305. We 
also requested comments on our proposals to define MIPS determination 
period at Sec.  414.1305 and modify the definitions of low-volume 
threshold, non-patient facing, a small practice, hospital-based, and 
ASC-based at Sec.  414.1305 to incorporate references to the MIPS 
determination period.
    The following is a summary of the public comments received on our 
proposals and our responses:
    Comment: Several commenters supported our proposal, noting that the 
varying determination periods add unnecessary confusion and this policy 
would reduce complexity. One commenter recommended we continue our 
efforts to align the determination period with facility-based, virtual 
groups, and rural and HPSA eligibility determinations.
    Response: We appreciate the commenters' support.
    Comment: Some commenters stated that in order for clinicians to 
successfully perform over a 12-month period for the cost and quality 
performance categories, the clinician must know before the start of the 
performance period their full eligibility status for MIPS.
    Response: We understand that it is important for clinicians to know 
their eligibility status prior to the performance period. It is our 
intention to provide eligibility determinations as close to the 
beginning of the performance period as feasible. We would like to 
assure commenters that we are working diligently to provide clinicians 
with this information at the earliest time possible.
    Comment: A few commenters supported using quarterly snapshots for 
the second segment of the MIPS determination period to show preliminary 
eligibility status. One commenter recommended that the first quarterly 
snapshot for the second segment be mandated to be available in the 
look-up tool no later than January 1, 2019, the first day of the CY 
2019 performance period. One commenter recommended that if a clinician 
does not exceed the low-volume threshold during the quarterly 
snapshots, then they should be automatically excluded from MIPS unless 
further snapshots allow for an opt-in similar to the proposed low-
volume threshold opt-in policy.
    Response: While the statute does not require the use of quarterly 
snapshots, we believe the snapshots may provide useful information for 
eligible clinicians. Therefore, we are working to provide the quarterly 
snapshots, if feasible. In addition, it is important to note that the 
quarterly snapshots are being provided for informational use only and 
are not final until after the second segment of the MIPS determination 
period closes and a reconciliation between the segments occurs. Since 
the quarterly snapshots are not final this information is subject to 
change and should not be considered the final eligibility 
determination. The eligibility determination will be made after a 
reconciliation of the first and second segment of the MIPS 
determination period.
    Comment: Several commenters did not support the proposed 24-month 
MIPS determination period, with most arguing for a single determination 
period. These commenters recommended that the MIPS determination period 
be a single, 12-month segment beginning on October 1 of the calendar 
year preceding the applicable performance period and ending on 
September 30 of the calendar year in which the applicable performance 
period occurs. Another commenter stated that a preliminary assessment 
for the exclusions would be useful, but the final decision should be 
made only based on performance period data. One commenter stated that 
the two segments lead to confusion and uncertainty about participation 
status and requested that the second segment have an end date and 
notification date prior to the start of the performance year. Another 
commenter opposed the shift in determination period dates unless the 
eligibility tool on the Quality Payment Program website is updated in a 
timely fashion prior to the performance year.
    Response: If we had a singular eligibility determination period we 
would not be able to identify eligible clinicians who switch practices 
between the first and second segments of the MIPS determination period. 
We estimate that this would affect approximately 13 percent of MIPS 
eligible clinicians who may switch practices between the first and 
second determination periods. If we did not conduct the first segment 
analyses then there would be no way to inform clinicians of their 
eligibility status prior to the performance period. The second segment 
accounts for the identification of additional, previously unidentified 
individual eligible clinicians and groups who do not exceed the low-
volume threshold or meet other special circumstances. It is our 
intention that the eligibility tool on the Quality Payment Program 
website will be updated to provide eligibility determinations prior to 
the start of the performance period.
    Comment: A few commenters noted the challenge for clinicians who 
exceeded the low-volume threshold during the first segment of the MIPS 
determination period and then discovered late in the performance 
period, after the second segment of the MIPS determination period that 
they are no longer eligible. One commenter suggested that if a 
clinician exceeds the low-volume threshold during the second segment of 
MIPS eligibility determination period, the clinician should remain 
excluded unless the clinician opts-in. One commenter noted that these 
issues may be less of a problem if the opt-in proposal is finalized. 
Another commenter requested the definition of the MIPS determination 
period be expanded to account for scenarios when an eligible clinician 
or group exceeded the low-volume threshold during the first segment but 
falls below the low-volume threshold during the second segment or when 
a eligible clinician or group is not categorized as a special status 
(such as non-patient facing) during the first segment but gains special 
status during the second segment.
    Response: We agree that the issues identified by the commenters may 
be alleviated with the opt-in policy. If an eligible clinician finds 
out following the second segment of the MIPS determination period that 
they are no longer eligible to participate in MIPS and they meet the 
requirements of the opt-in policy they may choose to participate in 
MIPS by opting-in to MIPS. Regarding changing statuses between the two 
segments of the MIPS determination period, we are finalizing

[[Page 59730]]

the definition of the MIPS determination period at Sec.  414.1305(2) 
that subject to Sec.  414.1310(b)(1)(iii), an individual eligible 
clinician or group that is identified as not exceeding the low-volume 
threshold or as having special status during the first segment of the 
MIPS determination period will continue to be identified as such for 
the applicable MIPS payment year regardless of the results of the 
second segment of the MIPS determination period. An individual eligible 
clinician or group for which the unique billing TIN and NPI combination 
is established during the second segment of the MIPS determination 
period will be assessed based solely on the results of that segment. 
While we would like to ensure that there is as much flexibility as 
possible within the MIPS program, we believe it is important that MIPS 
eligible clinicians choose how they will participate in MIPS as a 
whole, either as an individual or as a group. Whether MIPS eligible 
clinicians participate in MIPS as an individual or group, it is 
critical for us to assess the performance of individual MIPS eligible 
clinicians or groups across the four performance categories 
collectively as either an individual or group in order for the final 
score to reflect performance at a true individual or group level and to 
ensure the comparability of data.
    After consideration of the public comments received, we are 
finalizing our proposal to define MIPS determination period at Sec.  
414.1305 beginning with the 2021 MIPS payment year, as a 24-month 
assessment period including a two-segment analysis of claims data 
consisting of: (1) An initial 12-month segment beginning on October 1 
of the calendar year 2 years prior to the applicable performance period 
and ending on September 30 of the calendar year preceding the 
applicable performance period; and (2) a second 12-month segment 
beginning on October 1 of the calendar year preceding the applicable 
performance period and ending on September 30 of the calendar year in 
which the applicable performance period occurs. The first segment would 
include a 30-day claims run out. The second segment would not include a 
claims run out, but would include quarterly snapshots for informational 
use only, if technically feasible. In addition, we are finalizing that 
subject to Sec.  414.1310(b)(1)(iii), an individual eligible clinician 
or group that is identified as not exceeding the low-volume threshold 
or as having special status during the first segment of the MIPS 
determination period will continue to be identified as such for the 
applicable MIPS payment year regardless of the results of the second 
segment of the MIPS determination period. An individual eligible 
clinician or group for which the unique billing TIN and NPI combination 
is established during the second segment of the MIPS determination 
period will be assessed based solely on the results of that segment. 
Finally, at Sec.  414.1305 we are finalizing our proposal to modify the 
definitions of low-volume threshold, non-patient facing MIPS eligible 
clinician, a small practice, hospital-based MIPS eligible clinician, 
and ASC-based MIPS eligible clinician at Sec.  414.1305 to incorporate 
references to the MIPS determination period.
c. Low-Volume Threshold
(1) Overview
    As discussed in the CY 2019 PFS proposed rule (83 FR 35886), 
section 1848(q)(1)(C)(iv) of the Act, as amended by section 
51003(a)(1)(A)(ii) of the Bipartisan Budget Act of 2018, provides that, 
for performance periods beginning on or after January 1, 2018, the low-
volume threshold selected by the Secretary may include one or more or a 
combination of the following (as determined by the Secretary): (1) The 
minimum number of part B-enrolled individuals who are furnished covered 
professional services (as defined in section 1848(k)(3)(A) of the Act) 
by the eligible clinician for the performance period involved; (2) the 
minimum number of covered professional services furnished to part B-
enrolled individuals by such clinician for such performance period; and 
(3) the minimum amount of allowed charges for covered professional 
services billed by such clinician for such performance period.
    Under Sec.  414.1310(b)(1)(iii), for a year, eligible clinicians 
who do not exceed the low-volume threshold for the performance period 
with respect to a year are excluded from MIPS. Under Sec.  414.1305, 
the low-volume threshold is defined as, for the 2019 MIPS payment year, 
the low-volume threshold that applies to an individual eligible 
clinician or group that, during the low-volume threshold determination 
period, has Medicare Part B allowed charges less than or equal to 
$30,000 or provides care for 100 or fewer Part B-enrolled Medicare 
beneficiaries. In addition, for the 2020 MIPS payment year and future 
years, the low-volume threshold is defined as the low-volume threshold 
that applies to an individual eligible clinician or group that, during 
the low-volume threshold determination period, has Medicare Part B 
allowed charges less than or equal to $90,000 or provides care for 200 
or fewer Part B-enrolled Medicare beneficiaries. The low-volume 
threshold determination period is a 24-month assessment period 
consisting of: (1) An initial 12-month segment that spans from the last 
4 months of the calendar year 2 years prior to the performance period 
through the first 8 months of the calendar year preceding the 
performance period; and (2) a second 12-month segment that spans from 
the last 4 months of the calendar year 1 year prior to the performance 
period through the first 8 months of the calendar year performance 
period. An individual eligible clinician or group that is identified as 
not exceeding the low-volume threshold during the initial 12-month 
segment will continue to be excluded under Sec.  414.1310(b)(1)(iii) 
for the applicable year regardless of the results of the second 12-
month segment analysis. For the 2019 MIPS payment year, each segment of 
the low-volume threshold determination period includes a 60-day claims 
run out. For the 2020 MIPS payment year, each segment of the low-volume 
threshold determination period includes a 30-day claims run out.
(2) Amendments To Comply With the Bipartisan Budget Act of 2018
    In the CY 2019 PFS proposed rule (83 FR 35887), we proposed to 
amend Sec.  414.1305 to modify the definition of low-volume threshold 
in accordance with section 1848(q)(1)(C)(iv) of the Act, as amended by 
section 51003(a)(1)(A)(ii) of the Bipartisan Budget Act of 2018. 
Specifically, we requested comments on our proposals that for the 2020 
MIPS payment year, we will utilize the minimum number (200 patients) of 
Part B-enrolled individuals who are furnished covered professional 
services by the eligible clinician or group during the low-volume 
threshold determination period or the minimum amount ($90,000) of 
allowed charges for covered professional services to Part B-enrolled 
individuals by the eligible clinician or group during the low-volume 
threshold determination period.
    The following is a summary of the public comments received on our 
proposals and our responses:
    Comment: A few commenters supported the technical amendments passed 
by Congress in the Bipartisan Budget Act of 2018, specifically noting 
support for the proposal to not use Part B drugs for the low-volume 
threshold determinations, and to rely instead on covered professional 
services (instead of all Medicare Part B items and services) to 
determine MIPS eligibility. Other commenters supported that items or 
services beyond the PFS, especially Part B drugs, would not be subject 
to the

[[Page 59731]]

MIPS payment adjustment factor or the MIPS additional payment 
adjustment factor.
    Response: We appreciate the commenters' support.
    Comment: One commenter expressed concern about using covered 
professional services for low-volume threshold determinations because 
it could make it difficult for eligible clinicians and groups to 
predict whether they are subject or excluded from MIPS. Additionally, 
the commenter recommended that we provide timely notification based on 
the results of the first determination period.
    Response: We understand that utilizing covered professional 
services rather than all Medicare Part B items and services is a 
different approach to calculating the low-volume threshold. For the CY 
2018 and CY 2019 MIPS payment years, we have utilized two calculations 
in order to make low-volume threshold determinations: The number of 
patients and the amount of allowed charges for each eligible clinician 
or group. These calculations were based on the patients who were 
furnished any Part B item or service, and on the allowed charges for 
all Part B items and services. Beginning for the 2020 MIPS payment 
year, the calculations will instead be based only on covered 
professional services. A clinician may identify and monitor a claim to 
distinguish covered professional services from Part B items and 
services by calculating one professional claim line with positive 
allowed charges to be considered one covered professional service. In 
addition, we believe the quarterly snapshots will be helpful for new 
TIN/NPIs and TINs created between the first segment and the second 
segment allowing them to see their preliminary eligibility status 
sooner. In addition, we believe these policies will allow clinicians to 
understand their eligibility determination as close to the beginning of 
the performance period as feasible.
    After consideration of the public comments received, we are 
finalizing our proposal to amend Sec.  414.1305 to modify the 
definition of low-volume threshold to mean for the 2020 MIPS payment 
year, we will utilize the minimum number (200 patients) of Part B-
enrolled individuals who are furnished covered professional services by 
the eligible clinician or group during the low-volume threshold 
determination period or the minimum amount ($90,000) of allowed charges 
for covered professional services to Part B-enrolled individuals by the 
eligible clinician or group during the low-volume threshold 
determination period.
(3) MIPS Program Details
    In the CY 2019 PFS proposed rule (83 FR 35887), we requested 
comments on our proposal to modify Sec.  414.1310 to specify in 
paragraph (a), Program Implementation, that except as specified in 
paragraph (b), MIPS applies to payments for covered professional 
services furnished by MIPS eligible clinicians on or after January 1, 
2019. We also requested comments on our proposal to revise Sec.  
414.1310(b)(1)(ii) to specify that for a year, a MIPS eligible 
clinician does not include an eligible clinician that is a Partial 
Qualifying APM Participant (as defined in Sec.  414.1305) and does not 
elect, as discussed in section III.I.4.e. of this final rule, to report 
on applicable measures and activities under MIPS. Finally, we requested 
comments on our proposal to revise Sec.  414.1310(d) to specify that, 
in no case will a MIPS payment adjustment factor (or additional MIPS 
payment adjustment factor) apply to payments for covered professional 
services furnished during a year by eligible clinicians (including 
those described in paragraphs (b) and (c) of this section) who are not 
MIPS eligible clinicians, including those who voluntarily report on 
applicable measures and activities under MIPS.
    We did not receive any comments regarding these proposals.
    We are finalizing our proposal to modify Sec.  414.1310 to specify 
in paragraph (a), Program Implementation, that except as specified in 
paragraph (b), MIPS applies to payments for covered professional 
services furnished by MIPS eligible clinicians on or after January 1, 
2019. We are also finalizing our proposal to revise Sec.  
414.1310(b)(1)(ii) to specify that for a year, a MIPS eligible 
clinician does not include an eligible clinician that is a Partial 
Qualifying APM Participant (as defined in Sec.  414.1305) and does not 
elect, as discussed in section III.I.4.e. of this final rule, to report 
on applicable measures and activities under MIPS. Finally, we are 
finalizing our proposal to revise Sec.  414.1310(d) to specify that, in 
no case will a MIPS payment adjustment factor (or additional MIPS 
payment adjustment factor) apply to payments for covered professional 
services furnished during a year by eligible clinicians (including 
those described in paragraphs (b) and (c) of this section) who are not 
MIPS eligible clinicians, including those who voluntarily report on 
applicable measures and activities under MIPS.
(4) Addition of Low-Volume Threshold Criterion Based on Number of 
Covered Professional Services
    In the CY 2018 Quality Payment Program final rule (82 FR 53591), we 
received several comments in response to the proposed rule regarding 
adding a third criterion of items and services for defining the low-
volume threshold. We refer readers to that rule for further details.
    As discussed in the CY 2019 PFS proposed rule (83 FR 35887) for the 
2021 MIPS payment year and future years, we proposed to add one 
additional criterion to the low-volume threshold determination--the 
minimum number of covered professional services furnished to Part B-
enrolled individuals by the clinician. Specifically, we requested 
comments on our proposal, for the 2021 MIPS payment year and future 
years, that eligible clinicians or groups who meet at least one of the 
following three criteria during the MIPS determination period will not 
exceed the low-volume threshold: (1) Those who have allowed charges for 
covered professional services less than or equal to $90,000; (2) those 
who provide covered professional services to 200 or fewer Part B-
enrolled individuals; or (3) those who provide 200 or fewer covered 
professional services to Part B-enrolled individuals.
    For the third criterion, we proposed to set the threshold at 200 or 
fewer covered professional services furnished to Part B-enrolled 
individuals for several reasons. First, in the CY 2018 Quality Payment 
Program final rule (82 FR 53589 through 53590), although we received 
positive feedback from stakeholders on the increased low-volume 
threshold, we also heard from some stakeholders that they would like to 
participate in the program. Second, setting the third criterion at 200 
or fewer covered professional services, combined with our proposed 
policy with respect to opting in to MIPS, allows us to ensure that a 
significant number of eligible clinicians have the ability to opt-in if 
they wish to participate in MIPS. Finally, when we considered where to 
set the low-volume threshold for covered professional services, we 
examined two options: 100 or 200 covered professional services. For 100 
covered professional services, there is some historical precedent. In 
the CY 2017 Quality Payment Program final rule (81 FR 77062), we 
finalized a low-volume threshold that excluded individual eligible 
clinicians or groups that have Medicare Part B allowed charges less 
than $30,000 or that provide care for 100 or fewer Part B-

[[Page 59732]]

enrolled Medicare beneficiaries; we believe the latter criterion is 
comparable to 100 covered professional services. Conversely for 200 
covered professional services, in the CY 2018 Quality Payment Program 
final rule with comment period (82 FR 53588), we discussed that based 
on our data analysis, excluding individual eligible clinicians or 
groups that have Medicare Part B allowed charges less than or equal to 
$90,000 or that provide care for 200 or fewer Part B-enrolled Medicare 
beneficiaries decreased the percentage of MIPS eligible clinicians that 
come from small practices. In addition, in the CY 2018 Quality Payment 
final rule (82 FR 53955), we codified at Sec.  414.1380(b)(1)(iv) that 
the minimum case requirements for quality measures are 20 cases, which 
both services thresholds being considered (100 or 200) exceed. We also 
codified at Sec.  414.1380(b)(1)(v) that the minimum case requirement 
for the all-cause hospital readmission measure is 200 cases, which only 
the 200 services threshold consideration exceeds. We believe that 
setting a threshold of 200 services for the third criterion, combined 
with our proposed policy for opting in to MIPS, strikes the appropriate 
balance between allowing a significant number of eligible clinicians 
the ability to opt-in (as described in this section) to MIPS and 
consistency with the previously established low-volume threshold 
criteria. In section VII.F.8.b. of this final rule, we estimated no 
additional clinicians would be excluded if we add the third criterion 
because a clinician that cares for at least 200 beneficiaries would 
have at least 100 or 200 services; however, we estimate 27,903 
clinicians would opt-in with the low-volume threshold at 200 services, 
as compared to 12,242 clinicians if we did not add the third criterion. 
If we set the third criterion at 100 services, then we estimate 32,828 
clinicians would opt-in.
    The following is a summary of the public comments received on our 
proposals and our responses:
    Comment: Many commenters supported the low-volume threshold 
criteria and the newly proposed criterion based on number of covered 
professional services. Many commenters noted this policy will reduce 
burden, will help mitigate adverse effects on solo and small or rural 
practices, and combined with the opt-in policy, allow practices to 
transition into MIPS. Commenters specifically noted that the addition 
of the third criteria and the proposed opt-in policy will permit 
clinicians who are ready to participate if they had been previously 
excluded. Several commenters also mentioned the newly proposed 
criterion would increase the number of eligible clinicians that are 
able to participate in MIPS.
    Response: We appreciate the commenters' support.
    Comment: One commenter noted concern that MIPS reporting 
requirements may place significant financial, administrative, and 
operational burdens on clinicians treating a low volume of Medicare 
patients.
    Response: It is important to note that clinicians who treat a low-
volume of Part B Medicare beneficiaries may be excluded from MIPS if 
they fall below the low-volume threshold.
    Comment: Many commenters opposed the low-volume threshold criteria 
because they noted the thresholds for the individual criteria are too 
high and excluded too many clinicians and added complexity. Many of 
these commenters stated that the proposed low-volume threshold limits 
the number of clinicians in the budget neutral pool and effectively 
precludes MIPS eligible clinicians with good performance from earning 
more than a nominal payment adjustment. Several commenters expressed 
concern that eligible clinicians who make large financial commitments 
and organizational infrastructure modifications to obtain designation 
as exceptional performers would be adversely affected. A few commenters 
noted that practices with these types of clinicians do not have large 
compliance staff and other resources that larger groups have, and 
therefore, it may be difficult for these clinicians to report and 
navigate the program with short notice. Many commenters also stated the 
proposed low-volume threshold would not move the Quality Payment 
Program toward value and could jeopardize clinicians, particularly 
those in small or rural practices, by leaving them unprepared should 
they become MIPS eligible. One commenter expressed concerned that the 
threshold could make it difficult to benchmark data because fewer 
practices would be expected to participate in the program. One 
commenter requested lowering the performance threshold to the $30,000 
in Part B claims or 100 Part B patients threshold that we utilized for 
2017 MIPS performance period or lowering the criteria for the opt-in 
policy. A few commenters recommended that we consider revisiting the 
low-volume thresholds to increase the percentage of clinicians that are 
eligible.
    Response: We believe that the proposed low-volume threshold strikes 
the correct balance by including a sufficient number of clinicians, 
while excluding those who are not quite ready to participate and need 
additional time to prepare, such as clinicians in small and rural 
practices. The addition of the third criterion for covered professional 
services, in conjunction with the opt-in policy, creates a highly-
desired opportunity to join MIPS and provides new flexibility for 
clinicians otherwise excluded to drive value and improve patient 
outcomes when they are prepared to meaningfully participate. We have 
heard feedback from many clinicians indicating the desire to 
participate in MIPS. This feedback was especially prominent from 
clinicians in small practices who were initially included in the 2017 
performance year, but excluded in 2018 due to the increase in the low-
volume threshold. The addition of the third criterion for covered 
professional services, in conjunction with the opt-in policy, provides 
new flexibilities to participate in MIPS, which creates opportunities 
for clinicians to drive value and improve patient outcomes. While we 
understand that the inclusion of any new element may add complexity, we 
believe that this enhancement will benefit both clinicians and 
beneficiaries. We will work closely with the clinician and stakeholder 
community to develop educational resources to help clarify the 
requirements and reduce any potential confusion. Further, we do not 
believe that the addition of the third criterion for covered 
professional services will exclude more clinicians, as clinicians who 
are currently treating over 200 beneficiaries would likely also be 
furnishing over 200 covered professional services. As discussed, in 
section III.I.3.j. of this final rule, we are finalizing our proposal 
to increase the MIPS performance threshold to 30 points and the 
exceptional performance bonus to 75 points in 2019. We believe that 
this will likely result in an evolving distribution of payment 
adjustments for high performing clinicians who have made the 
investments to advance quality improvement, enhance clinical practice, 
and improve outcomes for beneficiaries.
    We understand that some MIPS eligible clinicians may work in small 
group practices and may not have the same resources as a large group. 
As discussed in the proposed rule (83 FR 35882) we intend to continue 
to offer tailored flexibilities to help these clinicians to participate 
in the program. For example, we are finalizing to retain a small 
practice bonus under MIPS by moving it to the quality performance 
category. We will also continue to

[[Page 59733]]

support small and rural practices by offering free and customized 
resources available within local communities, including direct, one-on-
one support from the Small, Underserved, and Rural Support Initiative 
along with our other no-cost technical assistance. Further, we note 
that we are finalizing to amend our regulatory text to allow small 
practices to continue using the Medicare Part B claims collection type 
and submission types, either as an individual or as a group. Finally, 
small practices may continue to choose to participate in MIPS as a 
virtual group. In addition, we will continue offering the voluntary 
reporting option, and encourage clinicians to pursue this pathway so 
that they can familiarize themselves with the program requirements and 
prepare to participate in future years. We clarify that for the first 
several years of MIPS, which we view as transitional, we anticipate 
that the distribution of MIPS payment adjustments will be spread across 
many more clinicians and groups due to the moderate performance 
thresholds and not necessarily because clinicians are excluded by the 
low-volume threshold. For example, in 2017, the performance threshold 
was set at 3 points, which resulted in an estimated participation rate 
of 91 percent of MIPS eligible clinicians. As discussed in section 
III.I.3.j. of this final rule, we are finalizing our proposal to 
increase the MIPS performance threshold to 30 points and the 
exceptional performance bonus to 75 points in 2019, which we anticipate 
will likely result in an evolving distribution of payment adjustments 
for high performing clinicians who have made the investments to advance 
quality improvement, enhance clinical practice, and improve outcomes 
for beneficiaries.
    We do not believe that the total amount of dollars available for 
the payment adjustments is low because too many clinicians are excluded 
from the program. After incorporating the data submitted for the 2017 
MIPS performance period (which we refer to as Quality Payment Program 
Year 1 data) to estimate the CY 2021 MIPS payment year, an estimated 
three-quarters (approximately $66.6B) of all PFS dollars will be 
included in the CY 2021 MIPS payment year. Of the remaining one-quarter 
(approximately $23.2B), only 2 percent (or less than 1 percent of total 
PFS dollars) were associated with clinicians who did not meet the low-
volume threshold. The remaining clinicians excluded from the budget 
neutral payment adjustments were Qualifying APM Participants, 
clinicians with ineligible specialties, and newly enrolled clinicians 
(11 percent of total PFS dollars). We considered the impact of lowering 
the low-volume threshold to $30,000/100 beneficiaries/100 covered 
professional services from the finalized low-volume threshold of this 
final rule based on the budget neutrality distributions and the size of 
the total payments. As seen in Figure 1, reducing the low-volume 
threshold to $30,000/100 beneficiaries/100 covered professional 
services) \16\ leads to an increase in the number of MIPS eligible 
clinicians (by approximately 73,000 clinicians) and on the dollars 
available in the budget neutral pool ($131M), but has minimal impact on 
the maximum possible positive payment adjustment. The majority of 
clinicians excluded from MIPS with the higher low-volume threshold are 
clinicians in small practices with fewer than 15 clinicians. We 
understand the importance of ensuring meaningful participation in the 
program. We will continue to strike a balance between ensuring 
sufficient participation in MIPS while also addressing the needs of 
small practices that may find it difficult to meet the program 
requirements.
---------------------------------------------------------------------------

    \16\ The estimated values when the threshold is set to $30,000/
100 beneficiaries/100 covered professional services are not 
reflective of actual MIPS results for the 2019 MIPS payment year. 
There are slight differences in data sources and methods compared to 
the 2019 MIPS payment year such as the low-volume threshold in this 
model is based on covered PFS services and the model assumes a 33 
percent opt-in assumption and uses the QP thresholds for the 2019 QP 
performance period.

---------------------------------------------------------------------------

[[Page 59734]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.043

    Comment: One commenter encouraged us to continue reviewing the low-
volume threshold annually to ensure that the low-volume threshold 
serves the purpose of excluding those for which the work of MIPS 
reporting would outweigh the number of Medicare beneficiaries impacted. 
A few commenters stated that the burden and cost of reporting for those 
who do not exceed the low-volume threshold far exceeds any possible 
benefit.
    Response: We are committed to continuing program simplification and 
burden reduction as we move into future years, including identifying 
additional opportunities to help clinicians successfully participate. 
We will continue to assess the low-volume threshold, as needed, to help 
reduce burden for clinicians, especially those in small and rural 
practices, who still find participation challenging. We believe that it 
is important to implement the low-volume threshold in a way that 
provides more time for clinicians to familiarize themselves with the 
performance requirements under MIPS and, most importantly, prepare to 
drive clinical quality improvement and improved outcomes for all 
Medicare beneficiaries. We refer readers to the regulatory impact 
analysis in section VII.F.8.b. of this final rule for further details 
on the burden and cost of reporting.
    Comment: A few commenters requested that we clarify how a covered 
professional service would count when calculating the low-volume 
threshold. Other commenters supported defining the concept of a covered 
professional service as a single billing of a CPT code. One commenter 
suggested 15-minute increments as the defining characteristic of a 
professional service.
    Response: For the CY 2018 and CY 2019 MIPS payment years, we have 
utilized two calculations in order to make low-volume threshold 
determinations: The number of patients and the amount of allowed 
charges for each eligible clinician or group. These calculations were 
based on the patients who were furnished any Part B item or service, 
and on the allowed charges for all Part B items and services. Beginning 
for the 2020 MIPS payment year, the calculations will instead be based 
on covered professional services rather than all Part B items and 
services.
    Comment: One commenter requested clarification on the definition of 
allowed charges for the low-volume threshold. The commenter asked if 
allowed charges is equivalent to the full PFS amount or the PFS amount 
minus the 20 percent co-pay. The commenter also asked about the 
applicable Multiple Procedure Payment Reduction for a given session. 
The commenter noted that each option would result in a different dollar 
amount.
    Response: In general, allowed charges refers to the maximum amount 
Medicare will pay for a covered professional service under the PFS, 
which is the PFS fee schedule amount reduced by the applicable 
beneficiary co-payment. For purposes of MIPS low-volume threshold 
determinations, allowed charges are calculated before any Multiple 
Procedure Payment Reduction is applied. We refer readers to the CY 2018 
Quality Payment Program final rule with comment period (82 FR 53578 
through 53579) where we discuss the items and services to which the 
MIPS payment adjustment could be applied under Part B.
    Comment: A few commenters requested we outline a plan for the low-
volume threshold, such as a roadmap approach in which we propose and 
adopt lower thresholds for several performance years at a time.

[[Page 59735]]

Additionally, the commenters requested that we describe if CMS has 
plans to include currently excluded clinicians in the MIPS program in 
the future. A few commenters asked for a report on the number of low-
volume clinicians that elect to be eligible and for us to use this 
experience to modify the low-volume threshold criteria in future years 
to move more clinicians into value-based programs.
    Response: We agree that providing more clarity and stability into 
the future of MIPS would be helpful and are interested in working with 
stakeholders on what such future changes should look like. We are 
working to provide as much consistency as possible for the low-volume 
threshold while being flexible and considering changing needs. We note 
that we are finalizing the low-volume threshold for the 2021 MIPS 
payment year and future years, as well. Regarding a report on the 
number of clinicians who are excluded due to the low-volume threshold 
but elect to opt-in to MIPS, we will consider this suggestion for our 
MIPS Experience Report.
    After consideration of the public comments received, we are 
finalizing our proposal to modify the definition of low-volume 
threshold at Sec.  414.1305, to mean that for the 2021 MIPS payment 
year and future years, that eligible clinicians or groups who meet at 
least one of the following three criteria during the MIPS determination 
period will not exceed the low-volume threshold: (1) Those who have 
allowed charges for covered professional services less than or equal to 
$90,000; (2) those who provide covered professional services to 200 or 
fewer Part B-enrolled individuals; or (3) those who provide 200 or 
fewer covered professional services to Part B-enrolled individuals.
(5) Low-Volume Threshold Opt-In
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30026), 
we proposed the option to opt-in to MIPS participation if clinicians 
might otherwise be excluded under the low-volume threshold. We received 
general support from comments received on that final rule (82 FR 
53589). However, we did not finalize the proposal for the 2019 MIPS 
performance period at that time. We were concerned that we would not be 
able to operationalize this policy in a low-burden manner to MIPS 
eligible clinicians as it was proposed.
    After consideration of operational and user experience implications 
of an opt-in policy, we proposed an approach we believed could be 
implemented in a way that provides the least burden to clinicians. As 
discussed in the CY 2019 PFS proposed rule (83 FR 35887 through 35890), 
we proposed to modify Sec.  414.1310(b)(1)(iii) to provide that 
beginning with the 2021 MIPS payment year, if an eligible clinician or 
group meets or exceeds at least one, but not all, of the low-volume 
threshold determinations, including as defined by dollar amount (less 
than or equal to $90,000) or number of beneficiaries (200 or fewer), or 
number of covered professional services (200 or fewer), then such 
eligible individual or group may choose to opt-in to MIPS.
    This policy would apply to individual eligible clinicians and 
groups who exceed at least one, but not all, of the low-volume 
threshold criteria and would otherwise be excluded from MIPS 
participation as a result of the low-volume threshold. We believed that 
it would be beneficial to provide, to the extent feasible, such 
individual eligible clinicians and groups with the ability to opt-in to 
MIPS. Conversely, this policy would not apply to individual eligible 
clinicians and groups who exceed all of the low-volume threshold 
criteria, who unless otherwise excluded, are required to participate in 
MIPS. In addition, this policy would not apply to individual eligible 
clinicians and groups who do not exceed any of the low-volume threshold 
criteria, who would be excluded from MIPS participation without the 
ability to opt-in to MIPS. Although we believe we proposed the 
appropriate balance for the low-volume threshold elements and the opt-
in policy, we requested comments on other low-volume threshold criteria 
and supporting justification for the recommended criteria.
    Under the proposed policies, we estimated clinician eligibility 
based on the following (we refer readers to the regulatory impact 
analysis in section VII.F.8.b. of this final rule for further details 
on our assumptions): (1) Eligible because they exceed all three 
criteria of the low-volume threshold and are not otherwise excluded 
(estimated 770,000 based on our assumptions of who did individual and 
group reporting); (2) eligible because they exceed at least one, but 
not all, of the low-volume threshold criteria and elect to opt-in 
(estimated 28,000 for a total MIPS eligible clinician population of 
approximately 798,000); (3) potentially eligible if they either did 
group reporting or elected to opt-in \17\ (estimated 390,000); (4) 
excluded because they do not exceed any of the low-volume threshold 
criteria (estimated 78,000); and (5) excluded due to non-eligible 
specialty, newly enrolled, or QP status (estimated 209,000).
---------------------------------------------------------------------------

    \17\ A clinician may be in a group that we estimated would not 
elect group reporting, however, the group would exceed the low-
volume threshold on all three criteria if the group elected group 
reporting. Similarly, an individual or group may exceed at least one 
but not all of the low-volume threshold criteria, but we estimated 
the clinician or group would not elect to opt-in to MIPS. In both 
cases, these clinicians could be eligible for MIPS if the group or 
individual makes choices that differ from our assumptions.
---------------------------------------------------------------------------

    We proposed that applicable eligible clinicians who meet one or 
two, but not all, of the criteria to opt-in and are interested in 
participating in MIPS would be required to make a definitive choice to 
either opt-in to participate in MIPS or choose to voluntarily report 
before data submission (83 FR 35888). If they do not want to 
participate in MIPS, they will not be required to do anything and will 
be excluded from MIPS under the low-volume threshold. For those who do 
want to participate in MIPS, we considered the option of allowing the 
submission of data to signal that the clinician is choosing to 
participate in MIPS. However, we anticipated that some clinicians who 
utilize the quality data code (QDC) claims submission type may have 
their systems coded to automatically append QDCs on claims for eligible 
patients. We were concerned that they could submit a QDC code and 
inadvertently opt-in when that was not their intention.
    For individual eligible clinicians and groups to make an election 
to opt-in or voluntarily report to MIPS, they will make an election via 
the Quality Payment Program portal by logging into their account and 
simply selecting either the option to opt-in (positive, neutral, or 
negative MIPS adjustment) or to remain excluded and voluntarily report 
(no MIPS adjustment). Once the eligible clinician has elected to 
participate in MIPS, the decision to opt-in to MIPS will be irrevocable 
and cannot be changed for the applicable performance period. Clinicians 
who opt-in will be subject to the MIPS payment adjustment during the 
applicable MIPS payment year. Clinicians who do not decide to opt-in to 
MIPS will remain excluded and may choose to voluntarily report. Such 
clinicians will not receive a MIPS payment adjustment factor. To assist 
commenters in providing pertinent comments, we developed a website that 
provided design examples of the different approaches to MIPS 
participation in CY 2019. The website utilized wireframe (schematic) 
drawings to illustrate the three different approaches to MIPS 
participation: Voluntary reporting to MIPS, opt-in reporting to MIPS, 
and required to

[[Page 59736]]

participate in MIPS. The website provided specific matrices 
illustrating potential stakeholder experiences when opting-in or 
voluntarily reporting.
    The option to opt-in to participate in the MIPS as a result of an 
individual eligible clinician or group exceeding at least one, but not 
all, of the low-volume threshold elements differs from the option to 
voluntarily report to the MIPS as established at Sec.  414.1310(b)(2) 
and (d). Individual eligible clinicians and groups opting-in to 
participate in MIPS will be considered MIPS eligible clinicians, and 
therefore subject to the MIPS payment adjustment factor; whereas, 
individual eligible clinicians and groups voluntarily reporting 
measures and activities for the MIPS are not considered MIPS eligible 
clinicians, and therefore not subject to the MIPS payment adjustment 
factor. MIPS eligible clinicians and groups that made an election to 
opt-in will be able to participate in MIPS at the individual, group, or 
virtual group level for that performance period. Eligible clinicians 
and groups that are excluded from MIPS, but voluntarily report, are 
able to report measures and activities at the individual or group 
level; however, such eligible clinicians and groups are not able to 
voluntarily report for MIPS at the virtual group level.
    In Table 31, we provided possible scenarios regarding which 
eligible clinicians may be able to opt-in to MIPS depending upon their 
beneficiary count, dollars, and covered professional services if the 
proposed opt-in policy was finalized.

                          Table 31--Low-Volume Threshold Determination Opt-In Scenarios
----------------------------------------------------------------------------------------------------------------
                                                                    Covered
                 Beneficiaries                      Dollars      professional          Eligible for opt-in
                                                                   services
----------------------------------------------------------------------------------------------------------------
<=200.........................................           <=90K           <=200  Excluded not eligible to Opt-in.
<=200.........................................           <=90K            >200  Eligible to Opt-in, Voluntarily
                                                                                 Report, or Not Participate.
<=200.........................................            >90K           <=200  Eligible to Opt-in, Voluntarily
                                                                                 Report, or Not Participate.
>200..........................................           <=90K            >200  Eligible to Opt-in, Voluntarily
                                                                                 Report, or Not Participate.
>200..........................................            >90K            >200  Not eligible to Opt-in, Required
                                                                                 to Participate.
----------------------------------------------------------------------------------------------------------------

    We recognize that the low-volume threshold opt-in option may expand 
MIPS participation at the individual, group, and virtual group levels. 
For solo practitioners and groups with 10 or fewer eligible clinicians 
(including at least one MIPS eligible clinician) that exceed at least 
one, but not all, of the elements of the low-volume threshold and are 
interested in participating in MIPS via the opt-in and doing so as part 
of a virtual group, such solo practitioners and groups will need to 
make an election to opt-in to participate in the MIPS. Therefore, 
beginning with the 2021 MIPS payment year, we proposed that a virtual 
group election would constitute a low-volume threshold opt-in for any 
prospective member of the virtual group (solo practitioner or group) 
that exceeds at least one, but not all, of the low-volume threshold 
criteria. As a result of the virtual group election, any such solo 
practitioner or group will be treated as a MIPS eligible clinician for 
the applicable MIPS payment year.
    During the virtual group election process, the official virtual 
group representative of a virtual group submits an election to 
participate in the MIPS as a virtual group to CMS prior to the start of 
a performance period (82 FR 53601 through 53604). The submission of a 
virtual group election includes TIN and NPI information, which is the 
identification of TINs composing the virtual group and each member of 
the virtual group. As part of a virtual group election, the virtual 
group representative is required to confirm through acknowledgement 
that a formal written agreement is in place between each member of the 
virtual group (82 FR 53604). A virtual group may not include a solo 
practitioner or group as part of a virtual group unless an authorized 
person of the TIN has executed a formal written agreement.
    For a solo practitioner or group that exceeds only one or two 
elements of the low-volume threshold, an election to opt-in to 
participate in the MIPS as part of a virtual group would be represented 
by being identified as a TIN that is included in the submission of a 
virtual group election. Such solo practitioners and groups opting-in to 
participate in the MIPS as part of a virtual group would not need to 
independently make a separate election to opt-in to participate in the 
MIPS. We note that being identified as a TIN in a submitted virtual 
group election, any such TIN (represented as a solo practitioner or 
group) that exceeds at least one, but not all, of the low-volume 
threshold elements during the MIPS determination period is signifying 
an election to opt-in to participate in MIPS as part of a virtual group 
and recognizing that a MIPS payment adjustment factor would be applied 
to any such TIN based on the final score of the virtual group. For a 
virtual group election that includes a TIN determined to exceed at 
least one, but not all, of the low-volume threshold elements during the 
MIPS determination period, such election would have a precedence over 
the eligibility determination made during the MIPS determination period 
pertaining to the low-volume threshold and as a result, any such TIN 
would be considered MIPS eligible and subject to a MIPS payment 
adjustment factor due the virtual group election. Furthermore, we note 
that a virtual group election would constitute an election to opt-in to 
participate in MIPS and any low-volume threshold determinations that 
result from segment 2 data analysis of the MIPS determination period 
would not have any bearing on the virtual group election. Thus, a TIN 
included as part of a virtual group election that submitted prior to 
the start of the applicable performance period and does not exceed at 
least one element of the low-volume threshold during segment 2 of the 
MIPS determination period, such TIN would be considered MIPS eligible 
and a virtual group participant by virtue of the virtual group's 
election to participate in MIPS as a virtual group that was made prior 
to the applicable performance period. For virtual groups with a 
composition that may only consist of solo practitioners and groups that 
exceed at least one, but not all of the low-volume threshold elements, 
such virtual groups are encouraged to form a virtual group that would 
include a sufficient number of TINs to ensure that such virtual groups 
are able to meet program requirements such as case minimum criteria 
that would allow measures to be scored. For example, if a virtual group 
does not have a sufficient number of cases to report for quality 
measures (minimum of 20 cases per measures), a virtual group would

[[Page 59737]]

not be scored on such measures (81 FR 77175).
    We further noted that APM Entities in MIPS APMs, which meet one or 
two, but not all, of the low-volume threshold elements to opt-in and 
are interested in participating in MIPS under the APM scoring standard, 
would be required to make a definitive choice at the APM Entity level 
to opt-in to participate in MIPS. For such APM Entities to make an 
election to opt-in to MIPS, they would make an election via a similar 
process that individual eligible clinicians and groups will use to make 
an election to opt-in. Once the APM Entity has elected to participate 
in MIPS, the decision to opt-in to MIPS is irrevocable and cannot be 
changed for the performance period in which the data was submitted. 
Eligible clinicians in APM Entities in MIPS APMs that opt-in would be 
subject to the MIPS payment adjustment factor. APM Entities in MIPS 
APMs that do not decided to opt-in to MIPS cannot voluntarily report.
    Additionally, we proposed for applicable eligible clinicians 
participating in a MIPS APM, whose APM Entity meets one or two, but not 
all, of the low-volume threshold elements rendering the option to opt-
in and does not decide to opt-in to MIPS, that if their TIN or virtual 
group does elect to opt-in, it does not mean that the eligible 
clinician is opting-in on his/her own behalf, or on behalf of the APM 
Entity, but that the eligible clinician is still excluded from MIPS 
participation as part of the APM Entity even though such eligible 
clinician is part of a TIN or virtual group. This is necessary because 
low-volume threshold determinations are currently conducted at the APM 
Entity level for all applicable eligible clinicians in MIPS APMs, and 
therefore, the low-volume threshold opt-in option should similarly be 
executed at the APM Entity level rather than at the individual eligible 
clinician, TIN, or virtual group level. Thus, in order for an APM 
Entity to opt-in to participate in MIPS at the APM Entity level and for 
eligible clinicians within such APM Entity to be subject to the MIPS 
payment adjustment factor, an election would need to be made at the APM 
Entity level in a similar process that individual eligible clinicians 
and groups would use to make an election to opt-in to participate in 
MIPS.
    We requested comments on our proposals: (1) To modify Sec.  
414.1305 for the low-volume threshold definition at paragraph (3) to 
specify that, beginning with the 2021 MIPS payment year, the low-volume 
threshold that applies to an individual eligible clinician or group 
that, during the MIPS determination period, has allowed charges for 
covered professional services less than or equal to $90,000, furnishes 
covered professional services to 200 or fewer Medicare Part B-enrolled 
individuals, or furnishes 200 or fewer covered professional services to 
Medicare Part B-enrolled individuals; (2) that a clinician who is 
eligible to opt-in would be required to make an affirmative election to 
opt-in to participate in MIPS, elect to be a voluntary reporter, or by 
not submitting any data the clinician is choosing to not report; and 
(3) to modify Sec.  414.1310(b)(1)(iii) under Applicability to specify 
exclusions as follows: Beginning with the 2021 MIPS payment year, if an 
individual eligible clinician, group, or APM Entity group in a MIPS APM 
exceeds at least one, but not all, of the low-volume threshold criteria 
and elects to report on applicable measures and activities under MIPS, 
the individual eligible clinician, group, or APM Entity group is 
treated as a MIPS eligible clinician for the applicable MIPS payment 
year. For APM Entity groups in MIPS APMs, only the APM Entity group 
election can result in the APM Entity group being treated as MIPS 
eligible clinicians for the applicable payment year.
    The following is a summary of the public comments received on our 
proposals and our responses:
    Comment: Many commenters supported the opt-in policy as proposed. 
Many commenters supported that clinicians electing to opt-in may have 
either a negative or positive payment adjustment. One commenter stated 
the opportunity for clinicians to opt-in to MIPS will help to offset 
the additional exclusions resulting from the addition of a third low-
volume criterion. A few commenters noted the opt-in provides a 
participation opportunity for clinicians who bill low-cost services and 
would not otherwise exceed the low-volume threshold based on allowed 
charges. Other commenters noted that MIPS is the only way for MIPS 
eligible clinicians to earn a meaningful MIPS payment adjustment factor 
and opt-in is the only way for eligible clinicians who do not exceed 
the low-volume threshold to participate. Many commenters noted the 
policy provides flexibility and may encourage those clinicians who are 
not ready to have their payment affected by MIPS performance to test 
their ability to gather and submit performance data and gain experience 
with MIPS.
    Response: We appreciate the commenters' support. We note that if an 
eligible clinician chooses to opt-in to MIPS then they will be subject 
to the MIPS payment adjustment during the applicable MIPS payment year. 
If a clinician is eligible to opt-in but does not want to participate 
in MIPS, and be subject to the MIPS payment adjustment, then we would 
encourage clinicians to voluntarily report.
    Comment: Many commenters opposed the opt-in policy. A few 
commenters noted concern that the opt-in will reduce incentives to 
participate in MIPS, with one specifically stating it does not align 
with the agency's stated goal for MIPS to be a pathway to eventual 
participation in APMs. Some commenters also noted concern with how the 
opt-in may affect the overall scores, stating that (1) the additional 
clinicians who voluntarily opt-in are likely to be above the MIPS 
threshold, and therefore may reduce the amount of positive MIPS payment 
adjustment factors for clinicians who are required to participate, (2) 
the opt-in will likely continue to flatten the clinician's final score, 
lowering the overall aggregate increase, and (3) if too many eligible 
clinicians are excluded, positive payment adjustments would be 
insufficient to help offset the investments practices health systems 
must make to succeed under MIPS. Another commenter stated that CMS 
should identify a core set of data on MIPS and its various exclusions 
to be updated annually in conjunction with the proposed rule to allow 
stakeholders to follow the impacts of those exclusions longitudinally.
    Response: While we encourage clinicians who are excluded to opt-in 
to the program once they are prepared to meaningfully participate as a 
means of driving value and improving outcomes for more Medicare 
beneficiaries, we believe that the opt-in policy does not undermine APM 
participation or the transition of clinicians from MIPS to APMs because 
the opt-in policy is applied at the APM Entity level for clinicians and 
groups participating in APMs. For this final rule, we analyzed the 
impact of the opt-in policy by running models which incorporate the 
Quality Payment Program Year 1 submissions data. The models include 
eligibility without opt-in, opt-in based on a random sample of 33 
percent of clinicians who can elect to opt-in, and opt-in where only 
high performers (that is, clinicians who can anticipate a positive 
adjustment) elect to opt-in. To model the situation where only high 
performers would opt-in to MIPS, we assumed 100 percent of clinicians 
with final scores above the additional performance threshold would opt-
in and 50 percent of clinicians above the performance threshold but 
below the additional performance threshold would

[[Page 59738]]

opt-in. We observed a very modest impact to the payment adjustment 
irrespective of the opt-in assumption used. Please see Figure 2 for the 
model by opt-in assumption. Lastly, we appreciate the request for 
additional core data to be made available, we will continue to work 
with stakeholders to identify the information that is valuable and 
release it accordingly.
    Comment: Many commenters supported an opt-in policy, but believed 
the policy should be available to more clinicians. Of these commenters, 
most believed that the opt-in should be available even if the clinician 
did not exceed any of the low-volume criteria. A few commenters 
indicated that MIPS should be voluntary for all clinicians. One 
commenter requested that we make the opt-in policy retroactive to the 
MIPS 2018 performance period for year-to-year consistency, 
simplification, and to improve overall participation. Another commenter 
stated that the clinicians who switch practices in the last three 
months of MIPS performance period should be able to opt-in.
    Response: We do not believe that we have the flexibility to allow 
any clinician who wishes to participate in MIPS to opt-in nor to 
retroactively apply the opt-in policy to the 2018 MIPS performance 
period. Finally, as discussed in the section III.I.3.b. of this final 
rule, during the final 3 months of the calendar year in which the 
performance period occurs, in general, we do not believe it would be 
feasible for many MIPS eligible clinicians who join an existing 
practice (existing TIN) or join a newly formed practice (new TIN) to 
participate in MIPS as individuals. To clarify if an eligible clinician 
switches to an existing TIN or a new TIN they may be able to 
participate in MIPS as a group. However, they would not be able to 
participate as an individual.
    Comment: Several commenters supported the proposal that eligible 
clinicians who are eligible to opt-in would be required to make an 
affirmative election to opt-in to participate in MIPS. One commenter 
agreed that an affirmative election to report is necessary to avoid 
confusion and possible inadvertent claims submissions that might 
involuntarily opt-in a clinician to MIPS.
    Response: We agree that even eligible clinicians submitting MIPS 
data via claims must make an affirmative election.
    Comment: Several commenters sought clarification on the deadline to 
opt-in. A few commenters wondered if clinicians can choose to wait 
until the data submission deadline for a performance year, or whether 
they must elect to opt-in sooner than that. One commenter recommended 
that clinicians should have a deadline of no later than the last day in 
the month of February, or perhaps the 15th of March, for the 
performance period in which they intend to participate. This commenter 
stated that allowing the choice to opt-in at any point during the 
performance period will only increase participatory rates among 
clinicians or groups who have knowledge of favorable outcomes and will 
excuse those whose outcomes were undesirable. One commenter encouraged 
us to allow clinicians to opt-in at the time of data submission, as 
this would create the least amount of burden on clinicians who wish to 
opt-into the program. Another commenter urged us to allow an opt-in 
decision at any point during the data submission window and to provide 
confirmation of the decision to opt-in. Another commenter stated that 
we should not make the opt-in decision irrevocable.
    Response: We would like to create a process for eligible clinicians 
who wish to opt-in to MIPS that is the least burdensome but also 
provides the clinician with the most flexibility. We are exploring if 
we can operationally allow clinicians to opt-in at any time prior to 
the submission period and will provide further guidance via 
subregulatory guidance if this becomes available. We are finalizing at 
Sec.  414.1310(b)(1)(iii) under Applicability to specify exclusions as 
follows: Beginning with the 2021 MIPS payment year, if an individual 
eligible clinician, group, or APM Entity group in a MIPS APM exceeds at 
least one, but not all, of the low-volume threshold criteria and elects 
to report on applicable measures and activities under MIPS, the 
individual eligible clinician, group, or APM Entity group is treated as 
a MIPS eligible clinician for the applicable MIPS payment year. We 
agree that allowing clinicians the choice to opt-in at any point during 
the performance period may increase the potential that only high 
performers will opt-in, but we believe that this policy accounts for 
clinicians who identified in the second segment of the MIPS 
determination period. Also, we plan to monitor this issue and will 
address it through future rulemaking if necessary. Finally, regarding 
the opt-in decision being irrevocable, we believe it is necessary for 
the clinician to make a definitive decision regarding their 
participation in MIPS. If the decision to opt-in was not definitive 
then we believe the potential for a clinician to have an unfair 
advantage is increased by their ability to review their final feedback 
and scoring information available at submissions and subsequently alter 
their participation decision.
    Comment: One commenter noted that with the manual election to 
indicate opt-in, the need for a low-volume threshold criterion based on 
professional services should not make a difference in a clinician's 
ability to opt-in. Other commenters opposed the requirement for the 
eligible clinician to manually opt-in, noting that it would add 
administrative burden. Another commenter stated that it is unnecessary 
to create a MIPS opt-in policy for some low-volume clinicians as they 
may not meet the case minimums for measures.
    Response: We do not believe that the manual election to opt-in has 
relevance to the clinician's covered professional services. We are 
providing the third criterion of covered professional services to 
expand the number of clinicians eligible to opt-in to the program. 
Regarding the manual election to opt-in, we believe this is the least 
burdensome approach to ensuring that clinicians are making an informed 
decision regarding their MIPS participation. We believe that most MIPS 
eligible clinicians that provide at least 200 covered professional 
service will be able to meet the case minimums for measures.
    Comment: A few commenters requested additional clarification on the 
implication of the opt-in policy on the MIPS payment adjustment and on 
how we estimated the number of opt-in clinicians.
    Response: We described our approach to estimating the opt-in policy 
in the regulatory impact analysis of the CY 2019 PFS proposed rule (83 
FR 36057 through 36068). We sought comment on this approach and refer 
readers to the Regulatory Impact Analysis (RIA) in section VII. of this 
final rule for additional information. The RIA for this final rule 
examined the impact of the opt-in policy on payment adjustments by 
using two alternate opt-in assumptions: (1) If only clinicians with 
scores above the performance threshold opt-in (the actual opt-in is 
likely to be lower than this estimated number of clinicians opting-in); 
and (2) if none of the clinicians elected to opt-in. See Figure 2 for a 
summary of the results. As shown in Figure 2, the opt-in policy was 
found to have a small impact on the budget neutral pool when we assumed 
a random 33 percent of clinicians would opt-in irrespective of their 
performance and a minimal impact on payment adjustments regardless of 
the opt-in assumption used. Given these findings, we chose to use the 
33 percent opt-in

[[Page 59739]]

assumption for all CY 2019 performance period estimates.
[GRAPHIC] [TIFF OMITTED] TR23NO18.044

    Comment: A few commenters supported the proposal to only allow APM 
entities to opt-in as a group. One commenter urged us to explain in-
depth the application of the low-volume threshold opt-in option for 
MIPS APM TINs.
    Response: We explained the application of the low-volume threshold 
for APM Entities in MIPS APMs in detail in the CY 2019 PFS proposed 
rule (83 FR 35889) and refer readers to that discussion.
    Comment: One commenter did not agree that performance category data 
submitted by a third party intermediary needed a separate opt-in 
election. The commenter stated that in these instances, the clinician 
or group has chosen to engage a third party intermediary for MIPS 
reporting which the commenter believed is an affirmative event 
demonstrating intent to participate in the MIPS program. The commenter 
also noted that for clinicians or small-groups submitting quality data 
via QDC codes on claims, if those clinicians and/or small groups also 
submit any category data via a third-party intermediary, the Quality 
Payment Program portal, or the CMS Web Interface, that should be 
considered as an opt-in decision. One commenter requested that we 
provide a technical interface/API which allows clinicians and groups to 
opt-in through the service of third party intermediaries.
    Response: We want to ensure that clinicians are making an informed 
decision regarding opting-in to participate in MIPS. It is imperative 
that they make a definitive decision since clinicians who opt-in will 
be subject to the MIPS payment adjustment during the applicable MIPS 
payment year. We believe that an election to opt-in to MIPS must be 
made by the clinician or group through a definitive opt-in decision to 
participate in MIPS regardless of the way in which the data is 
submitted. In addition, in response to public comments, in instances 
where a third party intermediary is representing a MIPS eligible 
clinician, the third party intermediary must be able to transmit the 
clinician's opt-in decision to CMS. We refer readers to section 
III.I.3.k. of this final rule for more information regarding third 
party intermediary requirements.
    Comment: A few commenters requested information for clinicians and 
groups to make an informed choice about the opt-in. One commenter urged 
us to make it clear as to whether a clinician and group is eligible to 
opt-in to MIPS, what this decision could mean in terms of reducing or 
increasing their Medicare payments, and when the decision would be 
final. A few commenters requested the eligibility information prior to 
the start of the performance period, so that MIPS eligible clinicians 
and groups who want to opt-in to MIPS have the information necessary to 
make an informed choice about their participation options. Other 
commenters requested information on how the two MIPS determination 
periods work with the opt-in policy.
    Response: We understand that it is important for clinicians to know 
their eligibility status prior to the performance period. We are 
working to provide quarterly snapshots, if feasible. We believe these 
quarterly snapshots will provide important information to clinicians so 
that they may make informed decisions regarding whether they should 
opt-in to participate in MIPS. It is important to note that the 
quarterly snapshots are being provided for informational use only and 
not final until after the second segment of the MIPS determination 
period closes (which is September 30 of the calendar year in which the 
applicable performance period occurs) and a reconciliation occurs. 
Since the quarterly snapshots are not final this information is subject 
to change and should not be considered the final eligibility 
determination. The eligibility determination will be made after a 
reconciliation of the first and second segment of the MIPS 
determination period. We are finalizing at Sec.  414.1310(b)(1)(iii) 
under Applicability to specify exclusions that include, beginning with 
the 2021 MIPS payment year, if an individual eligible clinician, group, 
or APM Entity group in a MIPS APM exceeds at least one, but not all,

[[Page 59740]]

of the low-volume threshold criteria and elects to report on applicable 
measures and activities under MIPS, the individual eligible clinician, 
group, or APM Entity group is treated as a MIPS eligible clinician for 
the applicable MIPS payment year.
    Comment: One commenter recommended that we change the name of the 
voluntary participation option to ensure that clinicians do not confuse 
that option with opt-in participation. Since a voluntary participant is 
only reporting data, they suggested changing that category to Voluntary 
Reporting to ensure this is not confused with opt-in Participation.
    Response: We agree and are modifying the participation terms on the 
Quality Payment Program website to provide clear directions. Therefore, 
we note that when clinicians are reporting for MIPS they may enter the 
Quality Payment Program portal to choose the appropriate MIPS 
participation. For those eligible clinicians or groups who exceed all 
three criteria of the low-volume threshold their participation will be 
automatically selected as they are required to participate. For 
individual eligible clinicians and groups who are qualified they may 
make an election to by choosing to either: Agree to opt-in 
participation or to voluntarily report to MIPS, the clinician would 
make an election via the Quality Payment Program portal by logging into 
their account and simply selecting either the option to opt-in 
participation (positive, neutral, or negative MIPS adjustment) or to 
remain excluded and voluntarily report (no MIPS adjustment). So the 
three options when reporting data through the Quality Payment Program 
portal are: Voluntary reporting, opt-in participation, and required to 
participate in MIPS. We referred readers to the Quality Payment Program 
at qpp.cms.gov/design-examples to review the finalized wireframe 
drawings.
    After consideration of the public comments received, we are 
finalizing our proposals: (1) To modify Sec.  414.1305 for the low-
volume threshold definition at paragraph (3) to specify that, beginning 
with the 2021 MIPS payment year, the low-volume threshold that applies 
to an individual eligible clinician, group, or APM Entity group that, 
during the MIPS determination period, has allowed charges for covered 
professional services less than or equal to $90,000, furnishes covered 
professional services to 200 or fewer Medicare Part B-enrolled 
individuals, or furnishes 200 or fewer covered professional services to 
Medicare Part B-enrolled individuals; (2) that a clinician who is 
eligible to opt-in would be required to make an affirmative election to 
opt-in to participate in MIPS, elect to be a voluntary reporter, or by 
not submitting any data the clinician is choosing to not report; and 
(3) to modify Sec.  414.1310(b)(1)(iii) under Applicability to specify 
exclusions as follows: Beginning with the 2021 MIPS payment year, if an 
individual eligible clinician, group, or APM Entity group in a MIPS APM 
exceeds at least one, but not all, of the low-volume threshold criteria 
and elects to report on applicable measures and activities under MIPS, 
the individual eligible clinician, group, or APM Entity group is 
treated as a MIPS eligible clinician for the applicable MIPS payment 
year. For such solo practitioners and groups that elect to participate 
in MIPS as a virtual group (except for APM Entity groups in MIPS APMs), 
the virtual group election under Sec.  414.1315 constitutes an election 
under this paragraph and results in the solo practitioners and groups 
being treated as MIPS eligible clinicians for the applicable MIPS 
payment year. For such APM Entity groups in MIPS APMs, only the APM 
Entity group election can constitute an election under this paragraph 
and result in the APM Entity group being treated as MIPS eligible 
clinicians for the applicable MIPS payment year. We note that a virtual 
group election does not constitute a Partial QP election under revised 
Sec.  414.1310(b)(1)(ii). In order for an individual eligible clinician 
or APM Entity with a Partial QP status to explicitly elect to 
participate in MIPS and be subject to the MIPS payment adjustment 
factor, such individual eligible clinician or APM Entity would make 
such election during the applicable performance period as a Partial QP 
status becomes applicable and such option for election is warranted.
(6) Part B Services Subject to MIPS Payment Adjustment
    Section 1848(q)(6)(E) of the Act, as amended by section 
51003(a)(1)(E) of the Bipartisan Budget Act of 2018, provides that the 
MIPS adjustment factor and, as applicable, the additional MIPS 
adjustment factor, apply to the amount otherwise paid under Part B with 
respect to covered professional services (as defined in subsection 
(k)(3)(A) of the Act) furnished by a MIPS eligible clinician during a 
year (beginning with 2019) and with respect to the MIPS eligible 
clinician for such year.
    In the CY 2019 PFS proposed rule (83 FR 35890), we requested 
comments on our proposal to amend Sec.  414.1405(e) to modify the 
application of both the MIPS adjustment factor and, if applicable, the 
additional MIPS adjustment factor so that beginning with the 2019 MIPS 
payment year, these adjustment factors will apply to Part B payments 
for covered professional services (as defined in section 1848(k)(3)(A) 
of the Act) furnished by the MIPS eligible clinician during the year. 
We are making this change beginning with the first MIPS payment year 
and note that these adjustment factors will not apply to Part B drugs 
and other items furnished by a MIPS eligible clinician, but will apply 
to covered professional services furnished by a MIPS eligible 
clinician. We refer readers to section III.I.3.j. of this final rule 
for further details on this modification.
    The following is a summary of the public comments received on our 
proposals and our responses:
    Comment: One commenter stated that they support the technical 
amendment made by Congress in the Bipartisan Budget Act of 2018 to 
clarify that items or services beyond the PFS, especially Part B drugs, 
should not be included when determining MIPS eligibility and applying 
the MIPS payment adjustment.
    Response: We appreciate the commenters' support.
    After consideration of the public comments received, we are 
finalizing our proposal to amend Sec.  414.1405(e) to modify the 
application of both the MIPS adjustment factor and, if applicable, the 
additional MIPS adjustment factor so that beginning with the 2019 MIPS 
payment year, these adjustment factors will apply to Part B payments 
for covered professional services (as defined in section 1848(k)(3)(A) 
of the Act) furnished by the MIPS eligible clinician during the year. 
We are making this change beginning with the first MIPS payment year 
and note that these adjustment factors will not apply to Part B drugs 
and other items furnished by a MIPS eligible clinician, but will apply 
to covered professional services furnished by a MIPS eligible 
clinician.
d. Partial QPs
(1) Partial QP Elections Within Virtual Groups
    In the CY 2017 Quality Payment Program final rule, we finalized 
that following a determination that eligible clinicians in an APM 
Entity group in an Advanced APM are Partial QPs for a year, the APM 
Entity will make an election whether to report on applicable measures 
and activities as required under MIPS. If the APM Entity elects to 
report to MIPS, all eligible clinicians in

[[Page 59741]]

the APM Entity would be subject to the MIPS reporting requirements and 
payment adjustments for the relevant year. If the APM Entity elects not 
to report, all eligible clinicians in the APM Entity group will be 
excluded from the MIPS reporting requirements and payment adjustments 
for the relevant year (81 FR 77449).
    We also finalized that in cases where the Partial QP determination 
is made at the individual eligible clinician level, if the individual 
eligible clinician is determined to be a Partial QP, the eligible 
clinician will make the election whether to report on applicable 
measures and activities as required under MIPS and, as a result, be 
subject to the MIPS reporting requirements and payment adjustments (81 
FR 77449). If the individual eligible clinician elects to report to 
MIPS, he or she would be subject to the MIPS reporting requirements and 
payment adjustments for the relevant year. If the individual eligible 
elects not to report to MIPS, he or she will be excluded from the MIPS 
reporting requirements and payment adjustments for the relevant year.
    We also clarified how we consider the absence of an explicit 
election to report to MIPS or to be excluded from MIPS. We finalized 
that for situations in which the APM Entity is responsible for making 
the decision on behalf of all eligible clinicians in the APM Entity 
group, the group of Partial QPs will not be considered MIPS eligible 
clinicians unless the APM Entity opts the group into MIPS 
participation, so that no actions other than the APM Entity's election 
for the group to participate in MIPS would result in MIPS participation 
(81 FR 77449). For eligible clinicians who are determined to be Partial 
QPs individually, we finalized that we will use the eligible 
clinician's actual MIPS reporting activity to determine whether to 
exclude the Partial QP from MIPS in the absence of an explicit 
election. Therefore, if an eligible clinician who is individually 
determined to be a Partial QP submits information to MIPS (not 
including information automatically populated or calculated by CMS on 
the Partial QP's behalf), we will consider the Partial QP to have 
reported, and thus to be participating in MIPS. Likewise, if such an 
individual does not take any action to submit information to MIPS, we 
will consider the Partial QP to have elected to be excluded from MIPS 
(81 FR 77449).
    In the CY 2018 Quality Payment Program final rule, we clarified 
that in the case of an eligible clinician participating in both a 
virtual group and an Advanced APM who has achieved Partial QP status, 
that the eligible clinician would be excluded from the MIPS payment 
adjustment unless the eligible clinician elects to report under MIPS 
(82 FR 53615). As discussed in the CY 2019 PFS proposed rule (83 FR 
35890 through 35891), we incorrectly stated that affirmatively agreeing 
to participate in MIPS as part of a virtual group prior to the start of 
the applicable performance period would constitute an explicit election 
to report under MIPS for all Partial QPs. As such, we also incorrectly 
stated that all eligible clinicians who participate in a virtual group 
and achieve Partial QP status would remain subject to the MIPS payment 
adjustment due to their virtual group election to report under MIPS, 
regardless of their Partial QP election. We note that an election made 
prior to the start of an applicable performance period to participate 
in MIPS as part of a virtual group is separate from an election made 
during the performance period that is warranted as a result of an 
individual eligible clinician or APM Entity achieving Partial QP status 
during the applicable performance period. A virtual group election does 
not equate to an individual eligible clinician or APM Entity with a 
Partial QP status explicitly electing to participate in MIPS. In order 
for an individual eligible clinician or APM Entity with a Partial QP 
status to explicitly elect to participate in MIPS and be subject to the 
MIPS payment adjustment factor, such individual eligible clinician or 
APM Entity would make such election during the applicable performance 
period as a Partial QP status becomes applicable and such option for 
election is warranted. Thus, we are restating that affirmatively 
agreeing to participate in MIPS as part of a virtual group prior to the 
start of the applicable performance period does not constitute an 
explicit election to report under MIPS as it pertains to making an 
explicit election to either report to MIPS or be excluded from MIPS for 
individual eligible clinicians or APM Entities that have Partial QP 
status.
    Related to this clarification, we are finalizing in section 
III.I.4.e.(3) of this final rule to clarify that beginning with the 
2021 MIPS payment year, when an eligible clinician is determined to be 
a Partial QP for a year at the individual eligible clinician level, the 
individual eligible clinician has the option to make an election 
whether to report to MIPS. If the eligible clinician elects to report 
to MIPS, he or she will be subject to MIPS reporting requirements and 
payment adjustments. If the eligible clinician elects to not report to 
MIPS, he or she will not be subject to MIPS reporting requirements and 
payment adjustments. If the eligible clinician does not make any 
affirmatively election to report to MIPS, he or she will not be subject 
to MIPS reporting requirements and payment adjustments. As a result, 
beginning with the 2021 MIPS payment year, for eligible clinicians who 
are determined to be Partial QPs individually, we will not use the 
eligible clinician's actual MIPS reporting activity to determine 
whether to exclude the Partial QP from MIPS in the absence of an 
explicit election.
    Therefore, the finalized policy in section III.I.4.e.(3) of this 
final rule eliminates the scenario in which affirmatively agreeing to 
participate in MIPS as part of a virtual group prior to the start of 
the applicable performance period will constitute an explicit election 
to report under MIPS for eligible clinicians who are determined to be 
Partial QPs individually and make no explicit election to either report 
to MIPS or be excluded from MIPS. We believe this change is necessary 
because QP status and Partial QP status, achieved at the APM Entity 
level or eligible clinician level, is applied to an individual and all 
of his or her TIN/NPI combinations, whereas virtual group participation 
is determined at the TIN level. Therefore, we do not believe that it is 
appropriate that the actions of the TIN in joining the virtual group 
should deprive the eligible clinician who is a Partial QP, whether that 
status was achieved at APM Entity level or eligible clinician level, of 
the opportunity to elect whether or not to opt-in to MIPS.
e. Group Reporting
    We refer readers to Sec.  414.1310(e) and the CY 2018 Quality 
Payment Program final rule (82 FR 53592 through 53593) for a 
description of our previously established policies regarding group 
reporting.
    In the CY 2018 Quality Payment Program final rule (82 FR 53593), we 
clarified that we consider a group to be either an entire single TIN or 
portion of a TIN that: (1) Is participating in MIPS according to the 
generally applicable scoring criteria while the remaining portion of 
the TIN is participating in a MIPS APM or an Advanced APM according to 
the MIPS APM scoring standard; and (2) chooses to participate in MIPS 
at the group level. We further clarify that we consider a group to be 
an entire single TIN that chooses to participate in MIPS at the group 
level. However, individual eligible clinicians (TIN/NPIs) within that 
group may receive a MIPS payment adjustment

[[Page 59742]]

based on the APM scoring standard if they are on the participant list 
of a MIPS APM. We proposed to amend Sec. Sec.  414.1310(e) and 
414.1370(f)(2) to codify this policy and more fully reflect the scoring 
hierarchy as discussed in section III.I.3.h.(6) of this final rule.
    As discussed in the CY 2018 Quality Payment Program final rule (82 
FR 53593), one of the overarching themes we have heard from 
stakeholders is that we make an option available to groups that would 
allow a portion of a group to report as a separate sub-group on 
measures and activities that are more applicable to the sub-group and 
be assessed and scored accordingly based on the performance of the sub-
group. We stated that in future rulemaking, we intend to explore the 
feasibility of establishing group-related policies that would permit 
participation in MIPS at a sub-group level and create such 
functionality through a new identifier. In the CY 2018 Quality Payment 
Program proposed rule (82 FR 30027), we solicited public comments on 
the ways in which participation in MIPS at the sub-group level could be 
established. In addition, in the CY 2018 Quality Payment Program final 
rule (82 FR 53593), we sought comment on additional ways to define a 
group, not solely based on a TIN. Because there are several operational 
challenges with implementing a sub-group option, we did not propose any 
such changes to our established reporting policies in this final rule. 
Rather, we are considering facilitating the use of a sub-group 
identifier in the Quality Payment Program Year 4 through future 
rulemaking, as necessary. In addition, it has come to our attention 
that providing a sub-group option may provide potential gaming 
opportunities. For example, a group could manipulate scoring by 
creating sub-groups that are comprised of only the high performing 
clinicians in the group. Therefore, we requested comment on 
implementing sub-group level reporting through a separate sub-group 
sub-identifier in the Quality Payment Program Year 4 and possibly 
future years of the program.
    In the CY 2019 PFS proposed rule (83 FR 35891) we requested 
comments on the following: (1) Whether and how a sub-group should be 
treated as a separate group from the primary group: For example, if 
there is 1 sub-group within a group, how would we assess eligibility, 
performance, scoring, and application of the MIPS payment adjustment at 
the sub-group level; (2) whether all of the sub-group's MIPS 
performance data should be aggregated with that of the primary group or 
should be treated as a distinct entity for determining the sub-group's 
final score, MIPS payment adjustments, and public reporting, and 
eligibility be determined at the whole group level; (3) possible low 
burden solutions for identification of sub-groups: For example, whether 
we should require registration similar to the CMS Web Interface or a 
similar mechanism to the low-volume threshold opt-in that we proposed 
and is discussed in section III.I.3.c.(5) of this final rule; and (4) 
potential issues or solutions needed for sub-groups utilizing 
submission mechanisms, measures, or activities, such as APM 
participation, that are different than the primary group. We also 
welcomed comments on other approaches for sub-group reporting that we 
should consider. We received many comments on group reporting and will 
take them into consideration for future rulemaking.
f. Virtual Groups
(1) Background
    We refer readers to Sec.  414.1315 and the CY 2018 Quality Payment 
Program final rule (82 FR 53593 through 53617) for our previously 
established policies regarding virtual groups.
(2) Virtual Group Election Process
    We refer readers to Sec.  414.1315(c) and the CY 2018 Quality 
Payment Program final rule (82 FR 53601 through 53604) for our 
previously established policies regarding the virtual group election 
process.
    We proposed to amend Sec.  414.1315(c) to continue to apply the 
previously established policies regarding the virtual group election 
process for the 2022 MIPS payment year and future years, with the 
exception of the proposed policy modification discussed below (83 FR 
35891 through 35892).
    Under Sec.  414.1315(c)(2)(ii), an official designated virtual 
group representative must submit an election on behalf of the virtual 
group by December 31 of the calendar year prior to the start of the 
applicable performance period. In the CY 2018 Quality Payment Program 
final rule (82 FR 53603), we stated that such election will occur via 
email to the Quality Payment Program Service Center using the following 
email address for the 2018 and 2019 performance periods: 
[email protected]. Beginning with the 2022 MIPS payment 
year, we proposed to amend Sec.  414.1315(c)(2)(ii) to provide that the 
election would occur in a manner specified by CMS. We anticipate that a 
virtual group representative would make an election on behalf of a 
virtual group by registering to participate in MIPS as a virtual group 
via a web-based system developed by CMS. We believe that a web-based 
system would be less burdensome for virtual groups given that the 
interactions stakeholders would have with the Quality Payment Program 
are already conducted via the Quality Payment Program portal, and would 
provide stakeholders with a seamless user experience. Stakeholders 
would be able to make a virtual group election in a similar manner to 
all other interactions with the Quality Payment Program portal and 
would no longer need to separately identify the appropriate email 
address to submit such an election and email an election outside of the 
Quality Payment Program portal. The Quality Payment Program portal is 
the gateway and source for interaction with MIPS that contains a range 
of information on topics including eligibility, data submission, and 
performance reports. We believe that using the same web-based platform 
to make a virtual group election would enhance the one-stop MIPS 
interactive experience and eliminate the potential for stakeholders to 
be unable to identify or erroneously enter the email address.
    We solicited public comment on this proposal, which would provide 
for an election to occur in a manner specified by CMS such as a web-
based system developed by CMS.
    The following is a summary of the public comments received 
regarding the proposal to continue to apply the previously established 
policies regarding the virtual group election process for the 2022 MIPS 
payment year and future years, with the exception of providing for an 
election to occur in a manner specified by CMS, such as a web-based 
system developed by CMS, and our responses.
    Comment: Several commenters supported the proposal to facilitate 
virtual group elections through the Quality Payment Program portal, as 
opposed to email, and indicated that the use of portal would be less 
burdensome for virtual groups and facilitate a more seamless user 
experience. A few commenters noted that the web-based system linked to 
the existing portal could give interested participants an easier means 
of connecting with other possible virtual group members. The commenters 
recommended that CMS explore the inclusion/development of a platform 
within the portal that would facilitate interactions and connections 
between parties interested in forming or joining a virtual group. 
Additionally, the commenters requested that CMS clearly outline and 
provide additional guidance on the election process via the

[[Page 59743]]

Quality Payment Program website. Another commenter recommended that CMS 
devise, as part of the portal, a direct way for clinicians to confirm 
their virtual group[hyphen]eligibility status with 100 percent 
reliability, and eliminate potential human errors when using a Quality 
Payment Program representative as an intermediary.
    Response: We will consider various means for providing information 
and guidance to virtual groups regarding the election process, and 
explore options for facilitating and supporting virtual group formation 
and providing virtual group eligibility via the Quality Payment Program 
portal in future years. It should be noted that all necessary 
information pertaining to virtual groups will be published on the CMS 
website prior to the virtual group election period, which occurs during 
the calendar before the start of the applicable performance period.
    After consideration of the public comments, we are finalizing our 
proposal at Sec.  414.1315(c) to continue to apply the previously 
established policies regarding the virtual group election process for 
the 2022 MIPS payment year and future years, with the exception of 
providing for an election to occur in a manner specified by CMS, such 
as a web-based system developed by CMS.
(a) Virtual Group Eligibility Determinations
    For purposes of determining TIN size for virtual group 
participation eligibility for the CY 2018 and 2019 performance periods, 
we coined the term ``virtual group eligibility determination period'' 
and defined it to mean an analysis of claims data during an assessment 
period of up to 5 months that would begin on July 1 and end as late as 
November 30 of the calendar year prior to the applicable performance 
period and includes a 30-day claims run out (82 FR 53602). We proposed 
to modify the virtual group eligibility determination period beginning 
with the 2019 performance period (83 FR 35892 through 35893). We 
proposed to amend Sec.  414.1315(c)(1) to establish a virtual group 
eligibility determination period to mean an analysis of claims data 
during a 12-month assessment period (fiscal year) that would begin on 
October 1 of the calendar year 2 years prior to the applicable 
performance period and end on September 30 of the calendar year 
preceding the applicable performance period and include a 30-day claims 
run out. The virtual group eligibility determination period aligns with 
the first segment of data analysis under the MIPS eligibility 
determination period. As part of the virtual group eligibility 
determination period, TINs would be able to inquire about their TIN 
size prior to making an election during a 5-month timeframe, which 
would begin on August 1 and end on December 31 of a calendar year prior 
to the applicable performance period. TIN size inquiries would be made 
through the Quality Payment Program Service Center. For TINs that 
inquire about their TIN size during such 5-month timeframe, it should 
be noted that any TIN size information provided is only for 
informational purposes and may be subject to change; official 
eligibility regarding TIN size and all other eligibility pertaining to 
virtual groups would be determined in accordance with the MIPS 
determination period and other applicable special status eligibility 
determination periods. The proposed modification would provide 
stakeholders with real-time information regarding TIN size for 
informational purposes instead of TIN size eligibility determinations 
on an ongoing basis (between July 1 and November 30 of the calendar 
year prior to the applicable performance period) due to technical 
limitations.
    For the 2018 and 2019 performance periods, TINs could determine 
their status by contacting their designated TA representative as 
provided at Sec.  414.1315(c)(1); otherwise, the TIN's status would be 
determined at the time that the TIN's virtual group election is 
submitted. We proposed to amend Sec.  414.1315(c)(1) to remove this 
provision since the inquiry about TIN size would be for informational 
purposes only and may be subject to change.
    We believe that the utilization of the Quality Payment Program 
Service Center, versus the utilization of designated TA 
representatives, as the means for stakeholders to obtain information 
regarding TIN size provides continuity and a seamless experience for 
stakeholders. We note that the TA resources already available to 
stakeholders would continue to be available. The following describes 
the experience a stakeholder would encounter when interacting with the 
Quality Payment Program Service Center to obtain information pertaining 
to TIN size. For example, the applicable performance period for the 
2022 MIPS payment year would be CY 2020. If a group contacted the 
Quality Payment Program Service Center on September 20, 2019, the 
claims data analysis would include the months of October of 2018 
through August of 2019. If another group contacted the Quality Payment 
Program Service Center on November 20, 2019, the claims data analysis 
would include the months of October of 2018 through September of 2019 
with a 30-day claims run out.
    We believe this virtual group eligibility determination period 
provides a real-time representation of TIN size for purposes of 
determining virtual group eligibility and allows solo practitioners and 
groups to know their real-time virtual group eligibility status and 
plan accordingly for virtual group implementation. Beginning with the 
2022 MIPS payment year, it is anticipated that starting in August of 
each calendar year prior to the applicable performance period, solo 
practitioners and groups would be able to contact the Quality Payment 
Program Service Center and inquire about their TIN size. TIN size 
determinations would be based on the number of NPIs associated with a 
TIN, which may include clinicians (NPIs) who do not meet the definition 
of a MIPS eligible clinician at Sec.  414.1305 or who are excluded from 
MIPS under Sec.  414.1310(b) or (c).
    We proposed to continue to apply the aforementioned previously 
established virtual group policies for the 2022 MIPS payment year and 
future years, with the exception of the following policy modifications:
     The virtual group eligibility determination period would 
align with the first segment of the MIPS determination period, which 
includes an analysis of claims data during a 12-month assessment period 
(fiscal year) that would begin on October 1 of the calendar year 2 
years prior to the applicable performance period and end on September 
30 of the calendar year preceding the applicable performance period and 
include a 30-day claims run out. As part of the virtual group 
eligibility determination period, TINs would be able to inquire about 
their TIN size prior to making an election during a 5-month timeframe, 
which would begin on August 1 and end on December 31 of a calendar year 
prior to the applicable performance period.
     MIPS eligible clinicians would be able to contact their 
designated technical assistance representative or, beginning with the 
2022 MIPS payment year, the Quality Payment Program Service Center, as 
applicable, to inquire about their TIN size for informational purposes 
in order to assist MIPS eligible clinicians in determining whether or 
not to participate in MIPS as part of a virtual group. We anticipate 
that starting in August of each calendar year prior to the applicable 
performance period, solo practitioners and groups would be able to 
contact the Quality Payment Program

[[Page 59744]]

Service Center and inquire about virtual group participation 
eligibility.
     A virtual group representative would make an election on 
behalf of a virtual group by registering to participate in MIPS as a 
virtual group in a form and manner specified by CMS. We anticipate that 
a virtual group representative would make the election via a web-based 
system developed by CMS.
    We also proposed updates to Sec.  414.1315 in an effort to more 
clearly and concisely capture previously established policies. These 
proposed updates are not intended to be substantive in nature, but 
rather to bring more clarity to the regulatory text.
    The following is a summary of the public comments received on these 
proposals and our responses.
    Comment: One commenter requested that CMS revisit the virtual group 
definition's current limit of ten clinicians because the definition of 
eligible clinician will be expanded. The commenter recommended revising 
the definition and measure virtual groups by setting an attributed 
membership floor to improve reporting validity.
    Response: In regard to determining TIN size for purposes of virtual 
group eligibility, we count each NPI associated with a TIN in order to 
determine whether or not a TIN exceeds the threshold of 10 NPIs, which 
includes clinicians who are eligible and not eligible for MIPS. We 
believe that such an approach provides continuity over time if the 
definition of a MIPS eligible clinician is expanded in future years 
under section 1848(q)(1)(C)(i)(II) of the Act to include other eligible 
clinicians (82 FR 53596). As discussed in the 2018 Quality Payment 
Program final rule (82 FR 53596 through 53597), we considered an 
alternative approach for determining TIN size, which would determine 
TIN size for virtual group eligibility based on NPIs who are MIPS 
eligible clinicians. However, as we conducted a comparative assessment 
of the application of such alternative approach with the current 
definition of a MIPS eligible clinician (as defined at Sec.  414.1305) 
and a potential expanded definition of a MIPS eligible clinician, we 
found that such an approach could create confusion as to which factors 
determine virtual group eligibility and cause the pool of virtual group 
eligible TINs to significantly be reduced once the definition of a MIPS 
eligible clinician would be expanded, which may impact a larger portion 
of virtual groups that intend to participate in MIPS as a virtual group 
for consecutive performance periods. Such impact would be the result of 
the current definition of a MIPS eligible clinician being narrower than 
the potential expanded definition of a MIPS eligible clinician. We did 
not pursue such an approach given that it did not align with our 
objective of establishing virtual group eligibility policies that are 
simplistic in understanding and provide continuity.
    Furthermore, we note that given that the TIN size is already based 
on the total number of NPIs within a TIN, the expanded definition of a 
MIPS eligible clinician will not impact the population of TINs eligible 
to form or join a virtual group. In regard to increasing the TIN size 
threshold of 10, section 1848(q)(5)(I)(ii) of the Act establishes a 
threshold of 10 and as a result, we do not have discretion to expand 
virtual group participation to TINs with more than 10 NPIs.
    Comment: A few commenters supported our proposal to align the 
virtual group eligibility determination period with the first segment 
of the MIPS determination period for consistency. The commenters also 
supported the availability of TIN size information that can be 
considered by groups prior to submitting a virtual group election. One 
commenter requested that CMS provide notification regarding the 
timeframe for the virtual group election process each year.
    Response: In regard to the virtual group election period, we 
publish the timeframe for virtual groups to make an election in 
subregulatory guidance (that is, materials published and posted on the 
CMS website and information disseminated via a listserv) each year on 
the CMS website in advance of the start of the election period. Each 
year, the virtual group election period will occur prior to the start 
of an applicable performance period and have an end date of December 
31.
    Comment: One commenter requested clarification as to why a virtual 
group election must be made prior to the performance period and 
recommended that CMS postpone the deadline to the third quarter of the 
performance year.
    Response: Section 1848(q)(5)(I)(iii)(I) of the Act provides that 
the virtual group election process must include the following 
requirement: An individual MIPS eligible clinician or group electing to 
be in a virtual group must make their election prior to the start of 
the performance period and cannot change their election during the 
performance period.
    After consideration of the public comments, we are finalizing our 
proposals to continue to apply the aforementioned previously 
established virtual group policies for the 2022 MIPS payment year and 
future years, with the exception of the following:
     The virtual group eligibility determination period is the 
first segment of the MIPS determination period (proposal finalized at 
Sec.  414.1315(c)(1)(ii)), which consists of an analysis of claims data 
during a 12-month assessment period (fiscal year) that begins on 
October 1 of the calendar year 2 years prior to the applicable 
performance period and ends on September 30 of the calendar year 
preceding the applicable performance period and includes a 30-day 
claims run out. As part of the virtual group eligibility determination 
period, TINs will be able to inquire about their TIN size prior to 
making an election during a 5-month timeframe, which will begin on 
August 1 and end on December 31 of a calendar year prior to the 
applicable performance period. We refer readers to section III.I.3.b. 
of this final rule for more information regarding the MIPS 
determination period.
     MIPS eligible clinicians will be able to contact their 
designated technical assistance representative or, beginning with the 
2022 MIPS payment year, the Quality Payment Program Service Center, as 
applicable, to inquire about their TIN size for informational purposes 
in order to assist MIPS eligible clinicians in determining whether or 
not to participate in MIPS as part of a virtual group. We anticipate 
that starting in August of each calendar year prior to the applicable 
performance period, solo practitioners and groups would be able to 
contact the Quality Payment Program Service Center and inquire about 
virtual group participation eligibility.
     A designated virtual group representative must submit an 
election, on behalf of the solo practitioners and groups that compose a 
virtual group, to participate in MIPS as a virtual group for a 
performance period in a form and manner specified by CMS by the 
election deadline specified at Sec.  414.1315(b) (proposal finalized at 
Sec.  414.1315(c)(2)(ii)) We anticipate that a virtual group 
representative will make the election via a web-based system developed 
by CMS.
    Also, we are finalizing updates to Sec.  414.1315 in an effort to 
more clearly and concisely capture previously established policies. The 
updates are not intended to be substantive in nature, but rather to 
bring more clarity to the regulatory text.
    We note that we are further revising Sec.  414.1315 to consolidate 
paragraphs (c)(2)(ii) and (iii) and redesignate paragraph (c)(2)(iv) as 
paragraph (c)(2)(iii) for clarity. Additionally, we are revising 
redesignated paragraph

[[Page 59745]]

(c)(2)(iii) to refer to ``the start of data submission'' rather than 
``the start of an applicable submission period'' because ``submission 
period'' is not an expressly defined term.
g. MIPS Performance Period
    In the CY 2018 Quality Payment Program final rule (82 FR 53617 
through 53619), we finalized at Sec.  414.1320(c)(1) that for purposes 
of the 2021 MIPS payment year, the performance period for the quality 
and cost performance categories is CY 2019 (January 1, 2019 through 
December 31, 2019). We did not finalize the performance period for the 
quality and cost performance categories for purposes of the 2022 MIPS 
payment year or future years. We also redesignated Sec.  414.1320(d)(1) 
and finalized at Sec.  414.1320(c)(2) that for purposes of the 2021 
MIPS payment year, the performance period for the Promoting 
Interoperability and improvement activities performance categories is a 
minimum of a continuous 90-day period within CY 2019, up to and 
including the full CY 2019 (January 1, 2019 through December 31, 2019).
    As noted in the CY 2018 Quality Payment Program final rule, we 
received comments that were not supportive of a full calendar year 
performance period for the quality and cost performance categories. 
However, we continue to believe that a full calendar year performance 
period for the quality and cost performance categories will be less 
confusing for MIPS eligible clinicians. As discussed in the CY 2019 PFS 
proposed rule (83 FR 35893), we believe that a longer performance 
period for the quality and cost performance categories will likely 
include more patient encounters, which will increase the denominator of 
the quality and cost measures. Statistically, larger sample sizes 
provide more accurate and actionable information. Additionally, a full 
calendar year performance period is consistent with how many of the 
measures used in our program were designed to be performed and 
reported. We also noted that the Bipartisan Budget Act of 2018 (Pub. L. 
115-119, enacted February 9, 2018) has provided further flexibility to 
the 3rd, 4th, and 5th years of MIPS to help continue the gradual 
transition to MIPS.
    Regarding the Promoting Interoperability performance category, we 
have heard from stakeholders through public comments, letters, and 
listening sessions that they oppose a full year performance period, 
indicating that it is very challenging and may add administrative 
burdens (83 FR 35893). Some stated that a 90-day performance period is 
necessary in order to enable clinicians to have a greater focus on the 
objectives and measures that promote patient safety, support clinical 
effectiveness, and drive toward advanced use of health IT. They also 
noted that as this performance category requires the use of CEHRT, a 
90-day performance period will help relieve pressure on clinicians to 
quickly implement changes and updates from their CEHRT vendors and 
developers so that patient care is not compromised. Others cited the 
challenges associated with reporting on a full calendar year for 
clinicians newly employed by a health system or practice during the 
course of a program year, switching CEHRT, vendor issues, system 
downtime, cyber-attacks, difficulty getting data from old places of 
employment, and office relocation. Most stakeholders stated that the 
performance period should be 90 days in perpetuity, as this would 
greatly reduce the reporting burden (83 FR 35893).
    In the CY 2019 PFS proposed rule (83 FR 35893), in an effort to 
provide as much transparency as possible so that MIPS eligible 
clinicians and groups may plan for participation in the program, we 
requested comments on our proposals at Sec.  414.1320(d)(1) that for 
purposes of the 2022 MIPS payment year and future years, the 
performance period for the quality and cost performance categories 
would be the full calendar year (January 1 through December 31) that 
occurs 2 years prior to the applicable MIPS payment year. For example, 
for the 2022 MIPS payment year, the performance period would be 2020 
(January 1, 2020 through December 31, 2020), and for the 2023 MIPS 
payment year, the performance period would be CY 2021 (January 1, 2021 
through December 31, 2021).
    In addition, we requested comments on our proposal at Sec.  
414.1320(d)(2) that for purposes of the 2022 MIPS payment year and 
future years, the performance period for the improvement activities 
performance category would be a minimum of a continuous 90-day period 
within the calendar year that occurs 2 years prior to the applicable 
MIPS payment year, up to and including the full calendar year. For 
example, for the 2022 MIPS payment year, the performance period for the 
improvement activities performance category would be a minimum of a 
continuous 90-day period within CY 2020, up to and including the full 
CY 2020 (January 1, 2020 through December 31, 2020). For the 2023 MIPS 
payment year, the performance period for the improvement activities 
performance category would be a minimum of a continuous 90-day period 
within CY 2021, up to and including the full CY 2021 (January 1, 2021 
through December 31, 2021) that occurs 2 years before the MIPS payment 
year (83 FR 35893).
    Finally, we requested comments on our proposal to add Sec.  
414.1320(e)(1) that for purposes of the 2022 MIPS payment year, the 
performance period for the Promoting Interoperability performance 
category would be a minimum of a continuous 90-day period within the 
calendar year that occurs 2 years prior to the applicable MIPS payment 
year, up to and including the full calendar year. Thus, for the 2022 
MIPS payment year, the performance period for the Promoting 
Interoperability performance category would be a minimum of a 
continuous 90-day period within CY 2020, up to and including the full 
CY 2020 (January 1, 2020 through December 31, 2020) (83 FR 35893).
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Several commenters agreed with our proposal to maintain 
the quality and cost performance periods as a full calendar year that 
occurs 2 years prior to the applicable MIPS payment year, noting that 
this proposal provides some of the stability needed for MIPS. One 
commenter supported a full calendar year for the cost performance 
category as this allows for a greater number of cases to be included in 
each measure, which will give a more reliable performance result. 
Another commenter supported a full calendar year for the quality and 
cost performance categories because they stated that it is in the best 
interest of patients encouraging clinicians to evolve in their approach 
to delivering care.
    Response: We appreciate the commenters' support.
    Comment: Several commenters opposed a full calendar-year 
performance period for the quality and cost performance categories and 
urged CMS to establish a minimum 90-day performance period, consistent 
with the other performance categories. Commenters noted that a minimum 
of 90-day performance period would reduce the administrative burden in 
MIPS, align the performance period across MIPS performance categories 
and allow the agency to shorten the 2-year lag between performance and 
payment. Other commenters requested that clinicians be allowed to 
choose between 90 days up to a full year of reporting. Another 
commenter urged CMS to consider adopting a 90-day performance period to 
capture eligible clinicians who may join a group in the middle of a 
performance year. One commenter agreed with the challenges CMS

[[Page 59746]]

outlined in the proposed rule (83 FR 35893) regarding the Promoting 
Interoperability performance category and stated that these various 
challenges create obstacles outside the control of the clinician, which 
inhibits their ability to collect and report 12 months of MIPS data for 
the quality performance category as well.
    Response: We do not believe that it would be in the best interest 
of MIPS eligible clinicians to have less than a full calendar year 
performance period for the quality and cost performance categories for 
the 2022 MIPS payment year and future years, as we are maintaining 
consistency with the performance period established for the first 3 
MIPS payment years. We believe this will be less burdensome and 
confusing for MIPS eligible clinicians. As discussed in the CY 2018 
Quality Payment Program final rule (82 FR 53618), statistically, larger 
sample sizes provide more accurate and actionable information. 
Additionally, a full calendar year performance period is consistent 
with how many of the measures used in our program were designed to be 
reported and performed; some of the measures do not allow for a 90-day 
performance period. We believe these issues make the quality 
performance category inherently different for reporting requirements 
and measures than the Promoting Interoperability and improvement 
activities performance categories. We do not believe reducing the 
performance period for the quality and cost performance categories will 
alleviate any issues with clinicians switching practices. Regarding 
reducing the 2-year lag between performance and payment, as noted in 
the CY 2017 Quality Payment Final Rule (81 FR 77077), the data 
submission activities and claims for services furnished during the 1 
year performance period (which could be used for claims- or 
administrative claims-based quality or cost measures) may not be fully 
processed until the following year. These circumstances require 
adequate lead time to collect performance data, assess performance, and 
compute the MIPS adjustment so the applicable MIPS adjustment can be 
made available to each MIPS eligible clinician at least 30 days prior 
to when the MIPS payment adjustment is applied each year. Finally, in 
regard to the challenges we outlined in the proposed rule (83 FR 
35893), these were specifically referring to the Promoting 
Interoperability performance category. We do not believe that these 
challenges affect the quality performance category, as well.
    Comment: A few commenters noted that establishing a 90-day 
performance period would give CMS an opportunity to set benchmarks 
based on more current data, rather than from 4 years prior to the 
applicable MIPS payment year.
    Response: We believe that benchmarks based on data from a 90-day 
performance period would be less reliable than those based on a full 
calendar year because fewer reported instances would meet the case 
minimum needed to be included in the benchmarks. This would also cause 
some measures to not have an available benchmark that could be used for 
scoring. In addition, using a 90-day performance period would not allow 
the creation of benchmarks from more current data. This is because we 
would still need to wait until the end of the data submission period 
before we could create the benchmarks based on data submitted by all 
MIPS eligible clinicians, and to publish historical benchmarks prior to 
the beginning of the performance period, we would still need to use 
data from 2 years prior to the performance period (4 years prior to the 
MIPS payment year).
    Comment: Several commenters supported the proposal to keep the 
minimum performance period for the improvement activities performance 
category at 90 days, noting the proposal maintains stability and 
simplifies the program. One commenter stated that practices should be 
able to complete improvement activities lasting 90 days even if the 
performance spans over two performance periods. The commenter stated 
that CMS should require practices to complete at least 45 consecutive 
days during each of two consecutive performance periods to equal a 
total of at least 90 days, noting that this lowers the burden on 
clinicians and further encourages participation in this performance 
category.
    Response: We appreciate the support for our proposal. However, we 
do not agree that an improvement activity should be split into two, 45-
day periods. As discussed in the CY 2017 Quality Payment Program final 
rule (81 FR 77186), after researching several organizations, we believe 
a minimum of 90 days is a reasonable amount of time required for 
performing an activity. We do not believe that performance periods as 
short as 45 days are sufficient for many of the available improvement 
activities to ensure that the activities being performed result in 
actual practice improvements.
    Comment: One commenter opposed our proposal to keep the minimum 
performance period for the improvement activities performance category 
at 90-days and urged CMS to adopt a 12-month performance period. The 
commenter noted that a 12-month performance period may be in the best 
interest of patients and may evolve clinicians' approach to delivering 
care.
    Response: We appreciate the commenters' recommendation. However, we 
believe that a minimum of a continuous 90-day performance period is 
appropriate for MIPS eligible clinicians to perform improvement 
activities that would improve clinical practice and provides more 
flexibility as some improvement activities may be ongoing, while others 
may be appropriately episodic.
    Comment: Many commenters supported our proposal to keep the minimum 
performance period for the Promoting Interoperability performance 
category at 90 days, noting that this proposal maintains stability, 
helps reduce administrative burden, provides clinicians with the time 
needed to manage changes and updates from their CEHRT vendors and 
developers, allows for effective measurement, and allows clinicians the 
flexibility to address scheduled or unanticipated events such as 
switching EHR vendors, system downtime, and cyber-attacks without 
jeopardizing patient care. Several commenters requested that CMS 
consider extending this performance period beyond the CY 2020 MIPS 
performance period.
    Response: We appreciate the commenters' support. We believe it is 
premature to establish policy beyond CY 2020 at this time appreciating 
the continued work in this area across HHS. We are finalizing the 
Promoting Interoperability performance period specific to CY 2019. We 
will take the comment into consideration for future rulemaking.
    Comment: One commenter requested that CMS investigate ways to 
shorten the time between performance periods and for future MIPS 
payment years in the Quality Payment Program. This commenter noted 
concern that 2 years is too long to impact practice patterns and lead 
to meaningful changes in behavior.
    Response: We understand the commenter's concern. However, as 
discussed in the CY 2017 Quality Payment Program final rule (81 FR 
77083), there is a ``2-year lag'' at this time, in order to account for 
the post-submission processes of calculating the MIPS eligible 
clinician's final score, establishing budget neutrality and issuing the 
MIPS payment adjustment factors, and allowing for a targeted review 
period to occur prior to the application of the MIPS payment

[[Page 59747]]

adjustment. We will continue working to shorten the ``2-year lag'' that 
the commenter describes.
    Comment: Several commenters urged CMS to consider the timing of 
previous year MIPS feedback reports, which are released in July after 
the close of the performance period, noting that this timeline does not 
allow for clinicians to make necessary changes before the beginning of 
the next performance period. Several commenters noted that, if the 
performance period was reduced to a 90-day minimum with the option to 
submit additional data, individuals and groups would have greater 
flexibility to incorporate previous MIPS feedback into their 
performance during the remaining portion of 2019, thereby increasing 
quality and patient safety, and to focus more of their attention on 
improving patient care.
    Response: Regarding the release of the feedback reports for the 1st 
year of MIPS, we provided 3 rounds of feedback including: (1) Round 1--
at the point of submission feedback; (2) round 2--pre-performance 
feedback; and (3) round 3--performance feedback. First, in round 1, at 
the point of submission we provided real time feedback that was 
available from the opening to the close of the submission period. 
Second, in round 2, we provided pre-performance feedback, which was 
available at the beginning of the close of the submission period and 
updated the round 2 feedback as new data became available such as CAHPS 
for MIPS survey, all-cause readmission measure, and cost measures data. 
Third, in round 3, we provided performance feedback that while it looks 
similar to round 2 is different in that the data is final with no new 
data being added and the payment adjustment(s) is included. This is the 
data that can be used to determine if a targeted review is to be filed. 
Considering there are opportunities for a clinician to gain insight 
into their possible performance prior to the release of the performance 
feedback in July, we encourage MIPS eligible clinicians to review the 
preliminary feedback and make necessary process and performance 
improvements, as needed. While we agree that there is some benefit to a 
90-day performance period, we believe that more continuous feedback is 
more beneficial. We also note that operationally our goal is to provide 
as much continuous submission opportunity as we can support in the 
future, including allowing clinicians to submit data during the 
performance period, as feasible. The ability to receive more frequent 
and continuous submissions will further our ability to provide more 
frequent feedback to MIPS eligible clinicians.
    Comment: A few commenters did not support the 90-day performance 
period for the Promoting Interoperability performance category and 
urged CMS to move to full calendar year reporting as soon as possible 
to achieve value-based care, stating that patients and families should 
be able to experience the benefits of health IT any day of the year, 
rather than a particular 3-month period. One commenter noted that a 12-
month performance period would more effectively achieve the objectives 
of MACRA. One commenter also noted that requiring full-year reporting 
would be less burdensome because it aligns with performance period for 
the quality performance category. Finally, one commenter also noted 
that requiring full-year reporting is more likely to prompt changes to 
clinician workflows.
    Response: Although the performance period for the Promoting 
Interoperability performance category is a minimum of a continuous 90-
day period during the calendar year, clinicians may report for a period 
up to and including the full calendar year. In addition, we do not 
believe that the duration of the performance period is indicative of 
the availability of the EHR to patients. We believe it is likely that a 
clinician who uses an EHR for a period of 90 days will continue to use 
it year round.
    Comment: One commenter urged us to consider the practical 
implications of a 90-day performance period for Promoting 
Interoperability measure reporting, emphasizing the need to ensure MIPS 
eligible clinicians and groups maintain interoperability capabilities 
in months that are not in the Promoting Interoperability performance 
period. This commenter noted the reporting periods may vary across 
eligible clinicians and groups and that a 90-day performance period 
could reduce the MIPS program's incentives for interoperability and may 
delay roll-out of enhanced interoperability functionality.
    Response: While MIPS eligible clinicians are required to report for 
a minimum of 90 days, they have the flexibility to report for a longer 
performance if they choose. Further we believe that once CEHRT is being 
utilized by the MIPS eligible clinician, it will be used on an ongoing 
basis and not just during a 90-day performance period.
    After consideration of the public comments received, we are 
finalizing our proposal at Sec.  414.1320(d)(1) that for purposes of 
the 2022 MIPS payment year and future years, the performance period for 
the quality and cost performance categories would be the full calendar 
year (January 1 through December 31) that occurs 2 years prior to the 
applicable MIPS payment year. In addition, we are finalizing our 
proposal at Sec.  414.1320(d)(2) that for purposes of the 2022 MIPS 
payment year and future years, the performance period for the 
improvement activities performance category would be a minimum of a 
continuous 90-day period within the calendar year that occurs 2 years 
prior to the applicable MIPS payment year, up to and including the full 
calendar year. We are also finalizing our proposal to add at Sec.  
414.1320(e)(1) that for purposes of the 2022 MIPS payment year, the 
performance period for the Promoting Interoperability performance 
category would be a minimum of a continuous 90-day period within the 
calendar year that occurs 2 years prior to the applicable MIPS payment 
year, up to and including the full calendar year. Finally, we are 
finalizing revisions to Sec.  414.1320(b)(2) and (c)(2) to refer to the 
new name of the Promoting Interoperability performance category.
h. MIPS Performance Category Measures and Activities
(1) Data Submission Requirements
(a) Background
    We refer readers to Sec.  414.1325 and the CY 2017 and CY 2018 
Quality Payment Program final rules (81 FR 77087 through 77095, and 82 
FR 53619 through 53626, respectively) for our previously established 
policies regarding data submission requirements.
(b) Collection Types, Submission Types and Submitter Types
    It has come to our attention that the way we have previously 
described data submission by MIPS eligible clinicians, groups and third 
party intermediaries does not precisely reflect the experience users 
have when submitting data to us. To clarify, we have previously used 
the term ``submission mechanisms'' to refer not only to the mechanism 
by which data is submitted, but also to certain types of measures and 
activities on which data are submitted (for example, electronic 
clinical quality measures (eCQMs) reported via EHR) and to the entities 
submitting such data (for example, third party intermediaries on behalf 
of MIPS eligible clinicians and groups). To ensure clarity and 
precision for all users, we are proposing to revise existing and define 
additional terminology to more precisely reflect the experience users 
have when submitting data to the Quality Payment Program.

[[Page 59748]]

    In the CY 2019 PFS proposed rule (83 FR 35894), we requested 
comments on our proposal to define the following terms at Sec.  
414.1305:
     Collection type as a set of quality measures with 
comparable specifications and data completeness criteria, including, as 
applicable: eCQMs; MIPS Clinical Quality Measures (MIPS CQMs); QCDR 
measures; Medicare Part B claims measures; CMS Web Interface measures; 
the CAHPS for MIPS survey; and administrative claims measures. The term 
MIPS CQMs would replace what was formerly referred to as registry 
measures since entities other than registries may submit data on these 
measures. These new terms are referenced in the collection type field 
for the following measure tables of the appendices in the CY 2019 PFS 
proposed rule (83 FR 36092 through 36358): Table Group A: Proposed New 
Quality Measures for Inclusion in MIPS for the 2021 MIPS Payment Year 
and Future Years; Table Group B: Proposed New and Modified MIPS 
Specialty Measure Sets for the 2021 MIPS Payment Year and Future Years; 
Table C: Quality Measures Proposed for Removal from the Merit-Based 
Incentive Payment System Program for the 2019 Performance Period and 
Future Years; and Table Group D: Measures with Substantive Changes 
Proposed for the 2021 MIPS Payment Year and Future Years.
     Submitter type as the MIPS eligible clinician, group, or 
third party intermediary acting on behalf of a MIPS eligible clinician 
or group, as applicable, that submits data on measures and activities 
under MIPS.
     Submission type as the mechanism by which a submitter type 
submits data to CMS, including, as applicable: Direct, log in and 
upload, log in and attest, Medicare Part B claims and the CMS Web 
Interface. The direct submission type allows users to transmit data 
through a computer-to-computer interaction, such as an API. The log in 
and upload submission type allows users to upload and submit data in 
the form and manner specified by CMS with a set of authenticated 
credentials. The log in and attest submission type allows users to 
manually attest that certain measures and activities were performed in 
the form and manner specified by CMS with a set of authenticated 
credentials. We note that there is no submission type for the 
administrative claims collection type because we calculate measures for 
this collection type based on administrative claims data available to 
us.
    In the CY 2019 PFS proposed rule (83 FR 35894), we solicited 
additional feedback and alternative suggestions on terminology that 
appropriately reflects the concepts described in the proposed 
definitions of collection type, submitter type and submission type, as 
well as the term MIPS CQMs to replace the formerly used term of 
registry measures.
    The following is a summary of the comments we received on 
``Collection Types, Submission Types and Submitter Types''.
    Comment: A few commenters supported the clarification of submission 
terms, stating that the new definitions recognize the complexity of 
measure types and submission options and reduce the potential for 
confusion. Commenters asked whether, if we finalize these terminology 
updates, educational information will be made available on the Quality 
Payment Program website so that clinicians will understand and 
appropriately apply these terms. One commenter also emphasized the 
importance of ensuring that submitting and attesting to measures is 
flexible and easy for clinicians to do.
    Response: We intend to update the Quality Payment Program website 
appropriately and provide any relevant educational materials.
    Comment: One commenter recommended that, if the ``collection type'' 
definition only refers to quality measures, CMS change ``collection 
type'' to ``quality measure type'' and requested that CMS provide a 
definition for data collection recognizing that all performance 
categories collect data. Another commenter also recommended that we 
recommend that we change ``collection type'' to ``measure type'' or 
``measure category'' to more intuitively and accurately reflect the 
meaning of the term.
    Response: The proposed definition of collection type states that it 
is specific to a set of quality measures. Therefore, we do not agree 
the suggested term of ``quality measure type'' would be the most 
beneficial in clarifying the actual submission experience for the user, 
in comparison to how submission mechanisms were discussed in our 
previous policies. We also note that the usage of the term ``quality 
measure type'' is commonly used to refer to mean a specific type of 
measure such as process or outcome measure. While we agree that all 
performance categories do in fact collect data, for purposes of 
clarifying the user experience for data submission, it is most 
beneficial to only refer to data collection in regards to the quality 
performance category. The suggested terms ``measure type'' or ``measure 
category'' could create further misunderstanding of the intent of the 
definition. As far as ``measure type'', there are other measures 
available in the program than just those available for reporting on in 
the quality performance category. For the term ``measure category'', we 
disagree as this could give the implication that this is another 
performance category within the Quality Payment Program.
    Comment: One commenter recommended that we change the term 
``submission type'' to ``submission method'' and to define the 
mechanisms by which CMS means by ``direct,'' ``log in,'' ``upload,'' 
and ``attest.''
    Response: We agree that the term ``submission method'' is an 
appropriate term for the proposed definition. However, the term did not 
gain support during user testing that surpassed the proposed terms. 
According to feedback from user testing, the proposed terms of 
collection, submitter and submission type, were found to be intuitive 
and to match the user experience when submitting data to the Quality 
Payment Program. The direct, log in and upload, log in and attest modes 
of data submission will be discussed in further detail in forthcoming 
educational resources. We also encourage review of the terms and 
wireframes for the submission types on qpp.cms.gov/design-examples.
    Comment: One commenter recommended that we change ``submitter 
type'' to ``submitting entity'' and define this as the entity who will 
be submitting the eligible clinician's data.
    Response: We believe that consistent terminology would be most 
beneficial in providing clarity for users submitting data to the 
Quality Payment Program. We also note that the term submitter type 
includes both entities that would submit on a clinician's behalf, as 
well as actions made directly by clinicians or their practice.
    After consideration of the public comments received, we are 
finalizing our proposal at Sec.  414.1305 to define the following 
terms:
     Collection type as a set of quality measures with 
comparable specifications and data completeness criteria, including, as 
applicable: eCQMs; MIPS Clinical Quality Measures (MIPS CQMs); QCDR 
measures; Medicare Part B claims measures; CMS Web Interface measures; 
the CAHPS for MIPS survey; and administrative claims measures. The term 
MIPS CQMs would replace what was formerly referred to as registry 
measures since entities other than registries may submit data on these 
measures. These new terms are referenced in the collection type field 
for the following measure tables of ``Appendix 1: Finalized MIPS 
Quality

[[Page 59749]]

Measures'' in this final rule: Table Group A: Finalized New Quality 
Measures for Inclusion in MIPS for the 2021 MIPS Payment Year and 
Future Years; Table Group B: Finalized New and Modified MIPS Specialty 
Measure Sets for the 2021 MIPS Payment Year and Future Years; Table 
Group C: Quality Measures Finalized for Removal in the 2021 MIPS 
Payment Year and Future Years; and Table Group D: Measures with 
Substantive Changes Finalized for the 2021 MIPS Payment Year and Future 
Years.
     Submitter type as the MIPS eligible clinician, group, or 
third party intermediary acting on behalf of a MIPS eligible clinician 
or group, as applicable, that submits data on measures and activities 
under MIPS.
     Submission type as the mechanism by which a submitter type 
submits data to CMS, including, as applicable: Direct, log in and 
upload, log in and attest, Medicare Part B claims and the CMS Web 
Interface. The direct submission type allows users to transmit data 
through a computer-to-computer interaction, such as an API. The log in 
and upload submission type allows users to upload and submit data in 
the form and manner specified by CMS with a set of authenticated 
credentials. The log in and attest submission type allows users to 
manually attest that certain measures and activities were performed in 
the form and manner specified by CMS with a set of authenticated 
credentials. We note that there is no submission type for the 
administrative claims collection type because we calculate measures for 
this collection type based on administrative claims data available to 
us.
(c) Performance Category Measures and Reporting
    We previously finalized at Sec.  414.1325(a) and (e), respectively, 
that MIPS eligible clinicians and groups must submit measures, 
objectives, and activities for the quality, improvement activities, and 
advancing care information performance categories and that there are no 
data submission requirements for the cost performance category and for 
certain quality measures used to assess performance in the quality 
performance category; CMS will calculate performance on these measures 
using administrative claims data. In the CY 2019 PFS proposed rule (83 
FR 35894), we proposed to amend Sec.  414.1325(a) to incorporate Sec.  
414.1325(e), as they both address which performance categories require 
data submission; Sec.  414.1325(f) would be redesignated as Sec.  
414.1325(e). We also proposed in the CY 2019 PFS proposed rule (83 FR 
35894) at Sec.  414.1325(a)(2)(ii) that there is no data submission 
requirement for the quality or cost performance category, as 
applicable, for MIPS eligible clinicians and groups that are scored 
under the facility-based measurement scoring methodology described in 
Sec.  414.1380(e). We also recognized the need to clarify to users how 
they submit data to us. In the CY 2019 PFS proposed rule (83 FR 35894), 
there are five basic submission types that we proposed to define in 
MIPS: Direct; log in and upload; login and attest; Medicare Part B 
claims; and the CMS Web Interface. We proposed to reorganize Sec.  
414.1325(b) and (c) by performance category in the CY 2019 PFS proposed 
rule (83 FR 35894). We proposed in the CY 2019 PFS proposed rule (83 FR 
35894) to also clarify at Sec.  414.1325(b)(1) that an individual MIPS 
eligible clinician may submit their MIPS data for the quality 
performance category using the direct, login and upload, and Medicare 
Part B claims submission types. In the CY 2019 PFS proposed rule (83 FR 
35894), similarly, we proposed to clarify at Sec.  414.1325(b)(2) that 
an individual MIPS eligible clinician may submit their MIPS data for 
the improvement activities or Promoting Interoperability performance 
categories using the direct, login and upload, or login and attest 
submission types. As for groups, we proposed in the CY 2019 PFS 
proposed rule (83 FR 35894) to clarify at Sec.  414.1325(c)(1) that 
groups may submit their MIPS data for the quality performance category 
using the direct, login and upload, and CMS Web Interface (for groups 
consisting of 25 or more eligible clinicians) submission types. Lastly, 
we proposed to clarify at Sec.  414.1325(c)(2) that groups may submit 
their MIPS data for the improvement activities or Promoting 
Interoperability performance categories using the direct, login and 
upload, or login and attest submission types in the CY 2019 PFS 
proposed rule (83 FR 35894). We believe that these clarifications will 
enhance the submission experience for clinicians and other 
stakeholders. As technology continues to evolve, we will continue to 
look for new ways that we can offer further technical flexibilities on 
submitting data to the Quality Payment Program. In the CY 2019 PFS 
proposed rule (83 FR 35894), we requested comment on these proposals. 
To assist commenters in providing pertinent comments, we developed a 
website that uses wireframe (schematic) drawings to illustrate a subset 
of the different submission types available for MIPS participation. 
Specifically, the wireframe drawings describe the direct, login and 
attest, and login and upload submission types. We refer readers to the 
Quality Payment Program at qpp.cms.gov/design-examples to review these 
wireframe drawings. The website will provide specific matrices 
illustrating potential stakeholder experiences when choosing to submit 
data under MIPS.
    As previously expressed in the 2017 Quality Payment Program final 
rule (81 FR 77090), we want to move away from claims reporting, since 
approximately 69 percent of the Medicare Part B claims measures are 
topped out. Although we would like to move towards the utilization of 
electronic reporting by all clinicians and groups, we realize that 
small practices face additional challenges, and this requirement may 
limit their ability to participate. For this reason, we believe that 
Medicare Part B claims measures should be available to small practices, 
regardless of whether they are reporting as individual MIPS eligible 
clinicians or as groups. Therefore, we proposed amending Sec.  
414.1325(c)(1) to make the Medicare Part B claims collection type 
available to MIPS eligible clinicians in small practices beginning with 
the 2021 MIPS payment year in the CY 2019 PFS proposed rule (83 FR 
35894). Although this will limit the current availability of Medicare 
Part B claims measures for individual MIPS eligible clinicians that do 
not meet the definition of a small practice, it will expand the 
availability of such measures for small practices who choose to 
participate in MIPS as a group, which currently does not have a claims-
based reporting option as a group.
    Under Sec.  414.1325(c)(4), we previously finalized that groups may 
submit their MIPS data using the CMS Web Interface (for groups 
consisting of 25 or more eligible clinicians) for the quality, 
improvement activities, and promoting interoperability performance 
categories. In the CY 2019 PFS proposed rule (83 FR 35894 through 
35895), we proposed that the CMS Web Interface submission type would no 
longer be available for groups to use to submit data for the 
improvement activities and Promoting Interoperability performance 
categories at Sec.  414.1325(c)(2). The CMS Web Interface has been 
designed based on user feedback as a method for quality submissions 
only; however, groups that elect to utilize the CMS Web Interface can 
still submit improvement activities or promoting interoperability data 
via direct, log in and attest or log in and upload submission types. We 
also recognized that certain groups that have elected to use the CMS 
Web Interface

[[Page 59750]]

may prefer to have their data submitted on their behalf by a third 
party intermediary described at Sec.  414.1400(a). We recognized the 
benefit and burden reduction in such a flexibility and therefore 
proposed to allow third party intermediaries to submit data to the CMS 
Web Interface in addition to groups in the CY 2019 PFS proposed rule 
(83 FR 35895). Specifically, we proposed in the CY 2019 PFS proposed 
rule (83 FR 35895) to redesignate Sec.  414.1325(c)(4) as Sec.  
414.1325(c)(1) and amend Sec.  414.1325(c)(1) to allow third party 
intermediaries to submit data using the CMS Web Interface on behalf of 
groups. To further our efforts to provide flexibility in reporting to 
the Quality Payment Program, we solicited comment in the CY 2019 PFS 
proposed rule (83 FR 35895) on expanding the CMS Web Interface 
submission type to groups consisting of 16 or more eligible clinicians 
to inform our future rulemaking.
    We previously finalized at Sec.  414.1325(e) that there are no data 
submission requirements for the cost performance category and for 
certain quality measures used to assess performance in the quality 
performance category and that CMS will calculate performance on these 
measures using administrative claims data. We also finalized at Sec.  
414.1325(f)(2), (which, as noted, we proposed to redesignate as Sec.  
414.1325(e)(2)) that for Medicare Part B claims, data must be submitted 
on claims with dates of service during the performance period that must 
be processed no later than 60 days following the close of the 
performance period. We neglected to codify this requirement at Sec.  
414.1325(e) (which, as noted, we proposed to consolidate with Sec.  
414.1325(a)) for administrative claims data used to assess performance 
in the cost performance category and for administrative claims-based 
quality measures. Therefore, in the CY 2019 PFS proposed rule (83 FR 
35895), we proposed to amend Sec.  414.1325(a)(2)(i) to reflect that 
claims included in the measures are those submitted with dates of 
service during the performance period that are processed no later than 
60 days following the close of the performance period.
    In the CY 2019 PFS proposed rule (83 FR 35895), a summary of these 
proposed changes is included in Tables 32 and 33. For reference, Table 
32 summarizes the data submission types for individual MIPS eligible 
clinicians that we proposed at Sec.  414.1325(b) and (e) in the CY 2019 
PFS proposed rule (83 FR 35895). Table 33 summarizes the data 
submission types for groups that we proposed at Sec.  414.1325(c) and 
(e) in the CY 2019 PFS proposed rule (83 FR 35895 through 35896). We 
requested comment on these proposals.
    The following is a summary of the comments we received on 
``Performance Category Measures and Reporting''.
    Comment: Many commenters supported our proposal to allow small 
practices to use the Medicare Part B claims-based reporting option for 
group reporting, with some noting that this option specifically 
relieves the burden on rural providers. However, several of these 
commenters opposed limiting the Medicare Part B claims reporting to 
only clinicians in small practices, stating that many clinicians are 
excluded from the special small practice policies despite operating as 
small practices in all other respects, and there may be circumstances 
where reporting via Medicare Part B claims as individuals is the best 
option for clinicians in larger multispecialty practices to allow each 
clinician to focus on quality measures most relevant to his/her 
specialty and scope of practice. A few commenters stated that this 
policy would result in a negative impact on clinicians who are part of 
specialties that do not have relevant eCQMs available to them, but have 
nonetheless implemented workflows to support reporting data using 
Medicare Part B claims; requiring them to change these workflows based 
solely on practice size would cause unnecessary clinician burden 
without an offsetting benefit to the clinician already participating in 
the program. Therefore, these commenters recommended that CMS retain 
the Medicare Part B claims-based reporting option in the quality 
performance category for all clinicians regardless of practice size. 
One commenter also requested that we provide a definition for a small 
practice in the final rule.
    Response: We likewise acknowledge that many clinicians that are not 
in a small practice currently report via Medicare Part B claims. 
However, as we previously expressed in the CY 2017 Quality Payment 
Program final rule (81 FR 77090), we want to move away from claims 
reporting, as more measures are available through health IT mechanisms 
such as registries, QCDRs, and health IT vendors. We believe it is 
important to move away from manual methods of reporting and instead 
utilize more electronic methods such as using EHRs, registries, QCDRs. 
Also, as we have described above with our revised terms, clinicians 
that are part of a practice that opts not to work with a third party 
intermediary can submit data directly to us, which is a flexibility we 
have under MIPS that was not available under the legacy programs. We 
note that this change does not require the use of eCQMs by MIPS 
eligible clinicians that are not considered to be part of a small 
practice. Rather, MIPS eligible clinicians that do not meet the 
definition of a small practice will have the ability to select from all 
other collection types. We refer readers to Sec.  414.1305 for the 
definition of small practice.
    Comment: A few commenters did not support the proposal to make the 
Medicare Part B claims collection type available to clinicians in small 
practices, stating that it does not align with the objectives of 
electronic reporting and Promoting Interoperability. Commenters 
specifically stated that the small administrative burden to implement 
CEHRT exceeds the cost of the various benefits of utilizing technology 
to improve the quality of care and that CEHRT is the only method that 
is completely accurate based upon the patient record and prevents 
organizations from ``cherry-picking'' patients to meet the 60 percent 
reporting threshold. One commenter also noted that registries are 
available at very affordable costs for clinicians and groups. Another 
commenter stated concern about how small and rural practices that have 
made the financial investment into CEHRT would react to this proposed 
update, stating that the proposal sends an inconsistent message to 
those small and rural psychiatric practices that made the financial 
investment to adopt CEHRT.
    Response: To clarify, our policy is to make the Medicare Part B 
claims collection type only available to small practices. We agree that 
there are many benefits to CEHRT adoption and also agree that many 
registries are available at low cost. We do not agree that this sends 
an inconsistent message with the objectives of electronic reporting and 
Promoting Interoperability as we still encourage all clinicians (small 
practices and non-small practices) to submit electronically. However, 
we recognize that small practices have additional challenges and 
believe that continuing to allow the Medicare Part B claims collection 
type only to small practices is beneficial. To further highlight 
alignment in policy regarding small practices across performance 
categories in MIPS, as discussed in section III.I.3.h.(5) of this final 
rule for the Promoting Interoperability performance category, small 
practices can apply for a significant hardship exception if they have 
issues acquiring an EHR.
    Comment: Several commenters opposed the proposed removal of 
Medicare Part B claims-based reporting

[[Page 59751]]

as an option for clinicians. One commenter noted concern because the 
proposal to expand the definition of a MIPS eligible clinician stated 
it would also coincide with a decrease in the number of group practices 
that will be considered a small practice. Commenters requested that CMS 
finalize a future timeframe for retiring the Medicare Part B claims 
based submission type for eligible clinicians, stating that: Medicare 
Part B claims based submission of quality data is still an extremely 
popular submission method in certain specialties; eliminating this 
reporting option may reduce the number of clinicians who participate in 
MIPS reporting; clinicians in many specialties, most notably those that 
are hospital based, will have to transition to use of a qualified 
registry or QCDR for quality measure reporting once claims based 
reporting is no longer an option, and this will require new and 
unplanned costs and further burden. Commenters also noted that 
clinicians who elect to report via Medicare Part B claims-based 
reporting, and choose to report topped out measures, are penalized in 
their quality score under current methods by receiving a maximum of 7 
of 10 points for each topped out measure; therefore there is not an 
inappropriate incentive for continued use of this method. Another 
commenter stated that the removal of Medicare Part B claims reporting 
contradicts the provisions in the Bipartisan Budget Act of 2018 that 
moves the Agency toward accepting more claims data. Another commenter 
recommended waiting to see if the number of clinicians reporting 
through Medicare Part B claims increases over the next years and then 
determine if a future proposal is appropriate.
    Response: We acknowledge that many clinicians that are not in a 
small practice currently report via Medicare Part B claims. However, we 
disagree that only allowing the reporting of this collection type to 
small practices forces non-small practices to transition to the use of 
a qualified registry or QCDR for quality measure reporting, as there 
are other collection types and submitter types available in which non-
small practices can report (that is, eCQMs, MIPS CQMs, CMS Web 
Interface measures, the CMS approved survey vendor measure and 
Administrative claims measures). For example, a non-small practice that 
does not wish to enter into an arrangement with a third party 
intermediary can use the MIPS CQM collection type and either login and 
upload their data or use the direct submission type for the quality 
performance category. These submission types do not require the usage 
of a third party intermediary, but we note that there are certain 
technical capabilities that a practice must have to submit data in this 
manner. Additional details on the form and manner requirements of these 
submission types is available at qpp.cms.gov/design-examples.
    We agree that choosing to report topped out measures is not 
incentivized. As discussed in the CY 2019 PFS proposed rule (83 FR 
35894), we want to move away from claims reporting, since approximately 
69 percent of the Medicare Part B claims measures are topped out. This 
is a contributing factor as to why we are looking to decrease the usage 
of this option over time, as we have been signaling we would do for 
many years. We will continue to work with stakeholders on providing 
further transparency of the future of this collection type. It is 
unclear to what reference the commenter is discussing where the removal 
of claims reporting is a contradiction to provisions made in the 
Bipartisan Budget Act of 2018. We do not believe that this proposal is 
inconsistent with the Bipartisan Budget Act of 2018.
    We do not believe further delay is warranted but will continue to 
work with stakeholders to provide further clarity on the future of this 
collection type. Lastly, we disagree that the expansion of the MIPS 
eligible clinician type as discussed in section III.I.3.c. will 
decrease the number of small practices. As defined at Sec.  414.1305, a 
small practice is a TIN consisting of 15 or fewer eligible clinicians 
during the MIPS determination period. We note that this definition 
currently includes both eligible clinicians and MIPS eligible 
clinicians, and therefore, the expansion of the MIPS eligible clinician 
definition should not negatively impact a practice's ability to be 
considered a small practice.
    Comment: One commenter asked us to acknowledge that, from their 
experiences participating in MIPS for the CY 2017 transition period, 
when a group attests for promoting interoperability but uses Medicare 
Part B claims to submit for the quality performance category as 
individuals, every clinician must have quality data and this data does 
not roll-up to the group.
    Response: In the CY 2017 Quality Payment Program final rule (81 FR 
77087 through 77088), Tables 1 and 2 summarized allowable individual 
and group submission types. In the 2017 MIPS performance period, 
Medicare Part B claims submissions for the quality performance category 
could only be used by individuals, and no group score was calculated 
for this collection type. In this final rule, we are finalizing our 
proposal to allow small practices the option to report as individuals 
or a group using Medicare Part B claims data so that a group 
performance score can be calculated for quality and combined with other 
group scores from other performance categories.
    Comment: One commenter urged CMS to provide greater detail about 
whether there is value in the data submitted through the Medicare Part 
B claims measure collection type, given the reduced number of 
clinically appropriate and applicable claims measures under Medicare 
Part B, particularly considering data that is collected from claims 
forms contains minimal clinical information.
    Response: Medicare Part B Claims Measure Specifications do provide 
value in the data submitted. Denominator eligibility can be determined 
by billing already included within a Medicare Part B Claim. The 
eligible clinician can submit a quality data code to attest to the 
quality action defined by the measure specification. The Medicare Part 
B Measure Specifications address a number of clinical outcomes on 
prevalent health conditions (for example, diabetes, hypertension). In 
addition to the outcomes, the Medicare Part B Claims Measure 
Specifications provide eligible clinicians who provide services in a 
small practice to participate within MIPS without incurring additional 
costs in data abstraction by third party intermediaries.
    Comment: One commenter urged CMS to provide greater detail about 
whether small and rural practices who report their performance solely 
through Medicare Part B claims measures would be afforded the 
opportunity to submit fewer than 6 measures (including one outcome or 
high priority measure) as currently required. This commenter also urged 
CMS to provide greater detail about whether new Medicare Part B claims 
quality measures would be accepted for inclusion in the rulemaking 
process, or if only the current Medicare Part B claims quality measures 
would be continued for use by small and rural practices.
    Response: We did not propose any changes to the quality performance 
submission criteria for the Medicare Part B claims collection type. We 
validate the availability and applicability of quality measures for 
clinicians who collect data via claims with fewer than six measures. 
Clinicians would only need to report the measures that are applicable. 
We refer readers to

[[Page 59752]]

section III.I.3.i.(1)(b)(vii) of this final rule for more discussion on 
our data validation process. Any updates to the measures list would go 
through future rulemaking. We want to clarify, that while reference was 
made to both small and rural practices by the commenter, this policy is 
limited to those that are small practices. We note that a practice that 
is small and rural would be eligible to use the Medicare Part B claims 
collection type, but only with meeting the special status designation 
of being a small practice.
    Comment: One commenter requested clarification on how CMS would 
determine that a claims submission is intended for group reporting if 
the group is only submitting data for the quality performance category 
of MIPS.
    Response: In the scenarios where we only receive Medicare Part B 
claims submissions for a practice for the quality performance category 
of MIPS, we intend on calculating the quality performance category for 
the practice as both a group and as individuals and will apply the 
quality performance category score that is the greater of the two. We 
considered requiring an election for assessment as a group but believe 
this would be unduly burdensome on small practices.
    Comment: One commenter disagreed with our proposal to eliminate Web 
Interface reporting for the improvement activities and Promoting 
Interoperability performance categories, stating this reduces 
flexibility for groups and adds unnecessary complexity.
    Response: We clarify that the CMS Web Interface has been designed 
as a method for quality submissions only, based on user feedback. As we 
developed the CMS Web Interface for usage under the Quality Payment 
Program, we engaged in user testing with stakeholders and the inclusion 
of the improvement activities and promoting interoperability 
performance categories within the CMS Web Interface tool negatively 
impacted the design. Instead, what users experienced for submissions in 
the first year of the program was a seamless interaction between the 
CMS Web Interface and the ability to attest for these two performance 
categories. With the finalization of this policy, users will have the 
exact same experiences of reporting data for the promoting 
interoperability and improvement activities performance categories 
while still using the CMS Web Interface for the quality performance 
category. We reiterate that we are simply updating our policy to 
reflect the existing user experience that stakeholders encounter. We 
would also like to highlight that groups that elect to utilize the CMS 
Web Interface can still submit improvement activities or promoting 
interoperability data via direct and log in and upload, if they choose 
not to utilize the login and attest submission type.
    Comment: One commenter supported our proposal to eliminate Web 
Interface reporting for the improvement activities and Promoting 
Interoperability performance categories.
    Response: We appreciate the commenter's support.
    Comment: One commenter appreciated that we clarified that groups 
may submit their MIPS data for the improvement activities or Promoting 
Interoperability performance categories using the direct, login and 
upload, or login and attest submission types.
    Response: Our intent was to provide clarity with the submission 
experience for clinicians and other stakeholders.
    Comment: A few commenters supported our proposal to allow third 
party intermediaries to submit data using the CMS Web Interface on 
behalf of groups, which alleviates burden on group practices to report 
the data themselves.
    Response: We appreciate the commenters' support.
    After consideration of the public comments received, we are 
finalizing our proposal to amend Sec.  414.1325(a) to incorporate Sec.  
414.1325(e), as they both address which performance categories require 
data submission; Sec.  414.1325(f) will be redesignated as Sec.  
414.1325(e). We are finalizing our proposal at Sec.  414.1325(a)(2)(ii) 
that there is no data submission requirement for the quality or cost 
performance category, as applicable, for MIPS eligible clinicians and 
groups that are scored under the facility-based measurement scoring 
methodology described in Sec.  414.1380(e). We are finalizing our 
proposals to reorganize Sec.  414.1325(b) and (c) by performance 
category and to clarify at Sec.  414.1325(b)(1) that an individual MIPS 
eligible clinician may submit their MIPS data for the quality 
performance category using the direct, login and upload, and Medicare 
Part B claims submission types. We are finalizing our proposal to 
clarify at Sec.  414.1325(b)(2) that an individual MIPS eligible 
clinician may submit their MIPS data for the improvement activities or 
Promoting Interoperability performance categories using the direct, 
login and upload, or login and attest submission types. We are 
finalizing our proposal to clarify at Sec.  414.1325(c)(1) that groups 
may submit their MIPS data for the quality performance category using 
the direct, login and upload, and CMS Web Interface (for groups 
consisting of 25 or more eligible clinicians) submission types. We are 
also finalizing our proposal to clarify at Sec.  414.1325(c)(2) that 
groups may submit their MIPS data for the improvement activities or 
Promoting Interoperability performance categories using the direct, 
login and upload, or login and attest submission types. We are 
finalizing our proposal to amend Sec.  414.1325(c)(1) to make the 
Medicare Part B claims collection type available to MIPS eligible 
clinicians in small practices beginning with the 2021 MIPS payment 
year. We are finalizing our proposal at Sec.  414.1325(c)(2) to state 
that the CMS Web Interface submission type will no longer be available 
for groups to use to submit data for the improvement activities and 
Promoting Interoperability performance categories. We are finalizing 
our proposal to redesignate Sec.  414.1325(c)(4) as Sec.  
414.1325(c)(1) and amend Sec.  414.1325(c)(1) to allow third party 
intermediaries to submit data using the CMS Web Interface on behalf of 
groups. We are finalizing our proposal to redesignate Sec.  
414.1325(f)(2) as Sec.  414.1325(e)(2) that for Medicare Part B claims, 
data must be submitted on claims with dates of service during the 
performance period that must be processed no later than 60 days 
following the close of the performance period. Lastly, we are also 
finalizing our proposal to amend Sec.  414.1325(a)(2)(i) to reflect 
that claims included in the measures are those submitted with dates of 
service during the performance period that are processed no later than 
60 days following the close of the performance period. We received many 
comments on our comment solicitation to expand the scope of practices 
that can utilize the Web Interface and will take them into 
consideration for future rulemaking.

[[Page 59753]]



              Table 32--Data Submission Types for MIPS Eligible Clinicians Reporting as Individuals
----------------------------------------------------------------------------------------------------------------
   Performance category/submission
        combinations accepted              Submission type           Submitter type          Collection type
----------------------------------------------------------------------------------------------------------------
Quality..............................  Direct.................  Individual or Third      eCQMs.
                                       Log in and upload......   Party Intermediary \2\. MIPS CQMs.
                                       Medicare Part B claims   Individual.............  QCDR measures.
                                        (small practices) \1\..                          Medicare Part B claims
                                                                                          measures (small
                                                                                          practices).
Cost.................................  No data submission       Individual               .......................
                                        required \2\.
Promoting Interoperability...........  Direct.................  Individual or Third      .......................
                                       Log in and upload......   Party Intermediary.
                                       Log in and attest......
Improvement Activities...............  Direct.................  Individual or Third      .......................
                                       Log in and upload......   Party Intermediary.
                                       Log in and attest......
----------------------------------------------------------------------------------------------------------------
\1\ Third party intermediary does not apply to Medicare Part B claims submission type.
\2\ Requires no separate data submission to CMS: Measures are calculated based on data available from MIPS
  eligible clinicians' billings on Medicare claims. Note: As used in this rule, the term ``Medicare Part B
  claims'' differs from ``administrative claims'' in that ``Medicare Part B claims'' require MIPS eligible
  clinicians to append certain billing codes to denominator-eligible claims to indicate the required quality
  action or exclusion occurred.


                Table 33--Data Submission Types for MIPS Eligible Clinicians Reporting as Groups
----------------------------------------------------------------------------------------------------------------
   Performance category/submission
        combinations accepted              Submission types          Submitter type          Collection type
----------------------------------------------------------------------------------------------------------------
Quality..............................  Direct.................  Group or Third Party     eCQMs.
                                       Log in and upload......   Intermediary.           MIPS CQMs.
                                       CMS Web Interface                                 QCDR measures.
                                        (groups of 25 or more                            CMS Web Interface
                                        eligible clinicians)..                            measures.
                                       Medicare Part B claims                            Medicare Part B claims
                                        (small practices) \1\..                           measures (small
                                                                                          practices).
                                                                                         CMS approved survey
                                                                                          vendor measure.
                                                                                         Administrative claims
                                                                                          measures.
Cost.................................  No data submission       Group                    .......................
                                        required 1 2.
Promoting Interoperability...........  Direct.................  Group or Third Party     .......................
                                       Log in and upload......   Intermediary
                                       Log in and attest......
Improvement Activities...............  Direct.................  Group or Third Party     .......................
                                       Log in and upload......   Intermediary
                                       Log in and attest......
----------------------------------------------------------------------------------------------------------------
\1\ Third party intermediary does not apply to Medicare Part B claims submission type.
\2\ Requires no separate data submission to CMS: Measures are calculated based on data available from MIPS
  eligible clinicians' billings on Medicare claims. Note: As used in this rule, the term ``Medicare Part B
  claims'' differs from ``administrative claims'' in that ``Medicare Part B claims'' require MIPS eligible
  clinicians to append certain billing codes to denominator-eligible claims to indicate the required quality
  action or exclusion occurred.

(d) Submission Deadlines
    We previously finalized data submission deadlines in the CY 2017 
Quality Payment Program final rule (81 FR 77095 through 77097) at Sec.  
414.1325(f), which outlined data submission deadlines for all 
submission mechanisms for individual eligible clinicians and groups for 
all performance categories. As discussed in section III.I.3.h.(1) of 
this final rule, the term submission mechanism, that includes 
submission via the qualified registry, QCDR, EHR, Medicare Part B 
claims, the CMS Web Interface and attestation, does not align with the 
existing process of data submission to the Quality Payment Program. In 
the CY 2019 PFS proposed rule (83 FR 35896), we proposed to revise 
regulatory text language at Sec.  414.1325(f), which, as noted, we 
proposed to redesignate as Sec.  414.1325(e), to outline data 
submission deadlines for all submission types for individual eligible 
clinicians and groups for all performance categories. In the CY 2019 
PFS proposed rule (83 FR 35896), we also proposed to revise Sec.  
414.1325(e)(1) to allow flexibility for CMS to alter submission 
deadlines for the direct, login and upload, the CMS Web Interface, and 
login and attest submission types. We anticipate that in scenarios 
where the March 31st deadline falls on a weekend or holiday, we will 
extend the submission period to the next business day (that is, 
Monday). There also may be instances where due to unforeseen technical 
issues, the submission system may be inaccessible for a period of time. 
If this scenario were to occur, we anticipate that we will extend the 
submission period to account for this lost time, to the extent 
feasible. We note that this revision would also revise the previously 
finalized policy at Sec.  414.1325(e)(3) stating that data must be 
submitted during an 8-week period following the close of the 
performance period, and that the period must begin no earlier than 
January 2 and end no later than March 31 for the CMS Web Interface. In 
the CY 2019 PFS proposed rule (83 FR 35896), we proposed to align the 
deadline for the CMS Web Interface submission type with all other 
submission type deadlines at Sec.  414.1325(e)(1), while we also 
proposed to remove the previously finalized policy at Sec.  
414.1325(e)(3) because it is no longer needed to mandate a different 
submission

[[Page 59754]]

deadline for the CMS Web Interface submission type. In the CY 2019 PFS 
proposed rule (83 FR 35896), we also proposed a number of other 
technical revisions to Sec.  414.1325 to more clearly and concisely 
reflect previously established policies.
    The following is a summary of the comments we received on 
``Submission Deadlines''.
    Comment: Several commenters supported our proposal to align the 
deadline for the CMS Web Interface submission type with all other 
submission type deadlines and appreciated further aligning deadlines 
within the program, stating that predictable and achievable deadlines 
are preferred for planning and education purposes. Another commenter 
urged us to make this new deadline clear to physicians by emphasizing 
the different deadlines at the start of the performance year.
    Response: We will take all feedback into consideration for future 
educational materials.
    Comment: One commenter opposed our proposal to align the deadline 
for the CMS Web Interface submission type with all other submission 
type deadlines, stating that this flexibility is being used to shorten 
the deadline, and that the earliest deadline should be set at March 31.
    Response: We disagree that this flexibility is being used to 
shorten the deadline. We clarify that it is no longer necessary to 
mandate a different submission deadline for the CMS Web Interface 
submission type and this proposal will bring further alignment amongst 
submission types. Furthermore, this policy extends the CMS Web 
Interface submission deadline by approximately 4 additional weeks.
    After consideration of the public comments received, we are 
finalizing our proposal to redesignate Sec.  414.1325(f) as Sec.  
414.1325(e), to outline data submission deadlines for all submission 
types for individual eligible clinicians and groups for all performance 
categories. We are finalizing our proposal to revise Sec.  
414.1325(e)(1) to allow flexibility for CMS to alter submission 
deadlines for the direct, login and upload, the CMS Web Interface, and 
login and attest submission types. We are also finalizing our proposals 
to align the deadline for the CMS Web Interface submission type with 
all other submission type deadlines at Sec.  414.1325(e)(1), and to 
remove the previously finalized policy at Sec.  414.1325(e)(3) because 
it is no longer needed to mandate a different submission deadline for 
the CMS Web Interface submission type.
(2) Quality Performance Category
(a) Background
    We refer readers to Sec. Sec.  414.1330 through 414.1340 and the CY 
2018 Quality Payment Program final rule (82 FR 53626 through 53641) for 
our previously established policies regarding the quality performance 
category.
(i) Assessing Performance on the Quality Performance Category
    As discussed in the CY 2019 PFS proposed rule (83 FR 35896), under 
Sec.  414.1330(a), for purposes of assessing performance of MIPS 
eligible clinicians on the quality performance category, we will use: 
Quality measures included in the MIPS final list of quality measures; 
and quality measures used by QCDRs. We proposed to amend Sec.  
414.1330(a) to account for facility-based measurement and the APM 
scoring standard. For that reason, we proposed at Sec.  414.1330(a) to 
specify, for a MIPS payment year, that we use the following quality 
measures, as applicable to assess performance in the quality 
performance category: Measures included in the MIPS final list of 
quality measures established by CMS through rulemaking; QCDR measures 
approved by CMS under Sec.  414.1440; facility-based measures as 
described under Sec.  414.1380; and MIPS APM measures as described at 
Sec.  414.1370.
    We did not receive any comments on the proposal of how we will 
assess performance in the quality performance category. Therefore, we 
are finalizing our proposal to amend Sec.  414.1330(a) to state that 
for a MIPS payment year, we use the following quality measures, as 
applicable, to assess performance in the quality performance category: 
Measures included in the MIPS final list of quality measures 
established by CMS through rulemaking; QCDR measures approved by CMS 
under Sec.  414.1440; facility-based measures as described in Sec.  
414.1380; and MIPS APM measures as described in Sec.  414.1370.
(ii) Contribution to Final Score
    In the CY 2019 PFS proposed rule (83 FR 35896) under Sec.  
414.1330(b)(2) and (3), we state that performance in the quality 
performance category will comprise 50 percent of a MIPS eligible 
clinician's final score for the 2020 MIPS payment year and 30 percent 
of a MIPS eligible clinician's final score for each MIPS payment year 
thereafter. Section 1848(q)(5)(E)(i)(I) of the Act, as amended by 
section 51003(a)(1)(C)(i) of the Bipartisan Budget Act of 2018, 
provides that 30 percent of the final score shall be based on 
performance with respect to the quality performance category, but that 
for each of the 1st through 5th years for which MIPS applies to 
payments, the quality performance category performance percentage shall 
be increased so that the total percentage points of the increase equals 
the total number of percentage points that is based on the cost 
performance category performance is less than 30 percent for the 
respective year. As discussed in section III.I.3.i.(c) of this final 
rule, we proposed to weight the cost performance category at 15 percent 
for the 2021 MIPS payment year. Accordingly, we proposed to amend Sec.  
414.1330(b)(2) to provide that performance in the quality performance 
category will comprise 50 percent of a MIPS eligible clinician's final 
score for the 2020 MIPS payment year, and proposed at Sec.  
414.1330(b)(3) that the quality performance category comprises 45 
percent of a MIPS eligible clinician's final score for the 2021 MIPS 
payment year.
    We received the following comments on our proposals regarding the 
quality performance category's contribution to the final score 
proposal:
    Comment: A few commenters supported our proposals.
    Response: We thank the commenters for their support.
    Comment: Several commenters did not support the proposed reduction 
of the quality performance category weight to 45 percent from 50 
percent for the 2021 MIPS payment year, suggesting that CMS maintain 
the weight at 50 percent. The commenters indicated that adjusting the 
weight downward sends the wrong message to physicians regarding quality 
of care and that de-emphasizing quality runs contrary to the aim of 
reforming toward a value-based system. Further, commenters stated that 
altering the weight prematurely leads to less stability with the 
program and adds complexity. A few commenters recommended that we 
transfer the weight from the improvement activity category as needed to 
preserve the weight of the quality category.
    Response: As discussed in section III.I.3.h.(3) of this final rule, 
we are finalizing the proposal to weight the cost performance category 
at 15 percent for the 2021 MIPS payment year. Accordingly, section 
1848(q)(5)(E)(i)(1) of the Act requires that the quality performance 
category weight to be 45 percent. While we understand that the quality 
performance category requires additional resources to report, we 
believe that we are measuring value by rewarding performance in quality 
while keeping down costs and that clinicians can influence the cost of 
services that they do not personally perform by

[[Page 59755]]

improving care management with other clinicians and avoiding 
unnecessary services. Regarding the commenters' recommendation that we 
reduce the weight of the improvement activities performance category to 
preserve the weight of the quality performance category, we note that 
we do not have discretion to reduce the weight of the improvement 
activities performance category except for scenarios where reweighting 
can occur due to measures and activities and not being available and 
applicable. Please refer to section III.I.3.i.(1)(e) for information on 
our reweighting policies.
    As discussed in section III.I.3.h.(3) of this final rule, we are 
finalizing our proposal to weight the cost performance category at 15 
percent for the 2021 MIPS payment year. After consideration of the 
public comments received, we are finalizing our proposal to amend Sec.  
414.1330(b)(2) to provide that performance in the quality performance 
category comprises 50 percent of a MIPS eligible clinician's final 
score for the 2020 MIPS payment year, and our proposal to amend Sec.  
414.1330(b)(3) to provide that the quality performance category 
comprises 45 percent of a MIPS eligible clinician's final score for the 
2021 MIPS payment year.
(iii) Quality Data Submission Criteria
(A) Submission Criteria
(aa) Submission Criteria for Groups Reporting Quality Measures, 
Excluding CMS Web Interface Measures and the CAHPS for MIPS Survey 
Measure
    In the CY 2019 Quality Payment Program proposed rule (83 FR 35896 
through 35897), we referred readers to Sec.  414.1335(a)(1) for our 
previously established submission criteria for quality measures 
submitted via claims, registry, QCDR, or EHR. As discussed in section 
III.I.3.h. of this final rule, we proposed revisions to existing and 
additional terminology to clarify the data submission processes 
available for MIPS eligible clinicians, groups and third party 
intermediaries, to align with the way users actually submit data to the 
Quality Payment Program. For that reason, we proposed to revise Sec.  
414.1335(a)(1) to state that data would be collected for the following 
collection types: Medicare Part B claims measures; MIPS CQMs; eCQMs; or 
QCDR measures. Codified at Sec.  414.1335(a)(1)(i), MIPS eligible 
clinicians and groups must submit data on at least six measures 
including at least one outcome measure. If an applicable outcome 
measure is not available, eligible clinicians and groups must report 
one other high priority measure. If fewer than six measures apply to 
the MIPS eligible clinician or group, they must report on each measure 
that is applicable. Furthermore, we proposed beginning with the 2021 
MIPS payment year to revise Sec.  414.1335(a)(1)(ii) to indicate that 
MIPS eligible clinicians and groups that report on a specialty or 
subspecialty measure set, must submit data on at least six measures 
within that set, provided the set contain at least six measures. If the 
set contains fewer than six measures or if fewer than six measures 
apply to the MIPS eligible clinician or group, they must report on each 
measure that is applicable.
    As previously expressed in the 2017 Quality Payment Program final 
rule (81 FR 77090), we want to move away from claims reporting, since 
approximately 69 percent of the Medicare Part B claims measures are 
topped out. As discussed in section III.I.3.h. of this final rule, we 
proposed to limit the Medicare Part B claims submission type, and 
therefore, the Medicare Part B claims measures, to MIPS eligible 
clinicians in small practices. We refer readers to section III.I.3.h of 
this final rule for discussion of this proposal.
    The following is a summary of the public comments on these 
proposals and our responses:
    Comment: A few commenters did not support the proposed specialty or 
subspecialty measure set submission criteria, citing the potential 
difficulty in reporting measures within the set that are not 
applicable. One commenter requested that, if the proposal is finalized, 
CMS should clarify how the requirement applies when clinicians submit 
both MIPS CQMs and QCDR measures to meet the quality performance 
category requirements, recognizing that some eligible clinicians may 
not be able to meet the requirement to report on all measures within a 
specialty or subspecialty set. Another commenter recommended that CMS 
revise its data submission criteria pertaining to specialty and 
subspecialty measure sets and require clinicians to report at least one 
outcome or high priority measure.
    Response: To clarify, should a MIPS eligible clinician choose to 
report on a specialty or a subspecialty measure set, they are only 
required to submit data on six measures within that set, provided the 
set contain at least six measures. If the set contains fewer than six 
measures or if fewer than six measures apply to the MIPS eligible 
clinician or group, they are required to report on each measure that is 
applicable. If a MIPS eligible clinician chooses to report only on a 
specialty or subspecialty measure set and reports on less than 6 
quality measures through either the MIPS CQM or Medicare Part B claims 
collection types, they will be subjected to the measure validation 
process that will validate whether the clinician actually had less than 
6 measures available or applicable to their scope of practice. If a 
MIPS eligible clinician chooses to report via the QCDR measure 
collection type, they will be required to meet the reporting 
requirement of 6 quality measures. If a MIPS eligible clinician reports 
fewer than 6 quality measures through a QCDR, they will receive zero 
points for each unreported quality measure. As stated at revised Sec.  
414.1335(a)(1)(ii), MIPS eligible clinicians are required to report at 
least one outcome measure, or if no outcome measures are available or 
applicable, report another high priority measure in lieu of an outcome 
measure.
    Comment: One commenter sought clarification on the proposed 
specialty or subspecialty measure set submission criteria. 
Specifically, the commenter questioned what a MIPS eligible clinician 
or group is required to do if fewer than 6 measures apply to the MIPS 
eligible clinician within their specialty or sub-specialty domain. 
Additionally, the commenter requested clarification on whether outcome 
measures or high-priority measures for specialty sets were required.
    Response: The clinician is required to report at least one outcome 
measure or, if an applicable outcome measure is not available, one 
other high priority measure. If a MIPS eligible clinician chooses to 
report on a specialty or subspecialty measure set, the set contains at 
least 6 quality measures, and the clinician reports on fewer than 6 
measures through the MIPS CQM or Medicare Part B claims collection 
type, the clinician will be subjected to the measure validation 
process, which will validate whether fewer than 6 measures were 
actually available and applicable to their scope of practice. If the 
measure validation process determines that at least 6 measures were 
available and applicable to the clinician's scope of practice, they 
will receive zero points for each unreported measure. We refer readers 
to Appendix 1: Finalized MIPS Quality Measures in this final rule, 
where the specialty sets are finalized in Table Group B. There are high 
priority measures available in all the specialty sets, and therefore a 
MIPS eligible clinician should be able to select a specialty set that 
reflects their scope of practice, and be able to report on the measures 
within that set, including the high-priority measures.

[[Page 59756]]

    After consideration of the public comments received, we are 
finalizing our proposal to amend Sec.  414.1335(a)(1) to state that 
data would be collected for the following collection types: Medicare 
Part B claims measures; MIPS CQMs; eCQMs; or QCDR measures. Codified at 
Sec.  414.1335(a)(1)(i), MIPS eligible clinicians and groups must 
submit data on at least six measures including at least one outcome 
measure. If an applicable outcome measure is not available, they must 
report one other high priority measure. If fewer than six measures 
apply to the MIPS eligible clinician or group, report on each measure 
that is applicable. We are also finalizing our proposal to amend Sec.  
414.1335(a)(1)(ii) to state that MIPS eligible clinicians and groups 
that report on a specialty or subspecialty measure set, must submit 
data on at least six measures within that set, provided the set 
contains at least six measures. If the set contains fewer than six 
measures or if fewer than six measures apply to the MIPS eligible 
clinician or group, they must report on each measure that is 
applicable.
(bb) Submission Criteria for Groups Reporting CMS Web Interface 
Measures
    As noted in the CY 2019 PFS proposed rule (83 FR 35897), we did not 
propose any changes to the established submission criteria for CMS Web 
Interface measures. For purposes of clarity and organization, we are 
finalizing a technical change by moving the regulation text on the 
sampling requirements for reporting CMS Web Interface measures from 
Sec.  414.1335(a)(2) to Sec.  414.1340(c)(1). However, beginning with 
the 2021 MIPS payment year, we proposed to revise the terminology with 
which CMS Web Interface measures are referenced-to align with the 
updated submission terminology as discussed in section III.I.3.h. of 
this final rule. Therefore, we proposed to revise Sec.  414.1335(a)(2) 
from ``via the CMS Web Interface-for groups consisting of 25 or more 
eligible clinicians only'', to ``for CMS Web Interface measures''.
    In order to ensure that the collection of information is valuable 
to clinicians and worth the cost and burden of collecting information, 
and address the challenge of fragmented reporting for multiple measures 
and submission options, we solicited comment on expanding the CMS Web 
Interface option to groups with 16 or more eligible clinicians. 
Preliminary analysis has indicated that expanding the CMS Web Interface 
option to groups of 16 or more eligible clinicians would likely result 
in many of these new groups not being able to fully satisfy measure 
case minimums on multiple CMS Web Interface measures. However, we could 
possibly mitigate this issue if we require smaller groups (with 16-24 
eligible clinicians) to report on only a subset of the CMS Web 
Interface measures, such as the preventive care measures. We solicited 
stakeholder feedback on the issue of expanding the CMS Web interface to 
groups of 16 or more, as well as other factors we should consider with 
such expansion. We received comments from stakeholders regarding 
expanding the CMS Web Interface option to groups with 16 or more 
eligible clinicians. We thank commenters for their input and may take 
this input into consideration in future years.
    As discussed in section III.F.1.c. of this final rule, changes 
proposed and finalized through rulemaking to the CMS Web Interface 
measures for MIPS would be applicable to ACO quality reporting under 
the Shared Savings Program. As discussed in Table Group D: Measures 
with Substantive Changes Proposed for the 2021 MIPS Payment Year and 
Future Years of the measures appendix of this final rule, we proposed 
to remove 6 measures from the CMS Web Interface in MIPS. If finalized, 
groups reporting CMS Web Interface measures for MIPS would not be 
responsible for reporting those removed measures. We refer readers to 
the quality measure appendix for additional details on the proposals 
related to changes in CMS Web Interface measures.
    As discussed in the CY 2017 Quality Payment Program final rule (81 
FR 77116), the CMS Web Interface has a two-step attribution process 
that associates beneficiaries with TINs during the period in which 
performance is assessed (adopted from the Physician Value-based Payment 
Modifier (VM) program). The CAHPS for MIPS survey utilizes the same 
two-step attribution process as the CMS Web Interface. The CY 2017 
Quality Payment Program final rule (81 FR 77116) noted that attribution 
would be conducted using the different identifiers in MIPS. For 
purposes of the CMS Web Interface and the CAHPS for MIPS survey, we 
clarified that attribution would be conducted at the TIN level (83 FR 
35897).
    We did not receive comments on the proposal to revise Sec.  
414.1335(a)(2) from ``via the CMS Web Interface-for groups consisting 
of 25 or more eligible clinicians only'', to ``for CMS Web Interface 
measures''.
    We are finalizing revisions to Sec.  414.1335(a)(2) to state that 
via the CMS Web Interface measures- for groups consisting of 25 or more 
eligible clinicians only, groups must report on all measure included in 
the CMS Web Interface. The group must report on the first 248 
consecutively ranked beneficiaries in the sample for each module.
(cc) Submission Criteria for Groups Electing to Report Consumer 
Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Survey
    As noted in the CY 2019 PFS proposed rule (83 FR 35897), we did not 
propose any changes to the established submission criteria for the 
CAHPS for MIPS Survey at Sec.  414.1335(a)(3). However, beginning with 
the 2021 MIPS payment year, we proposed to revise Sec.  414.1335(a)(3) 
to clarify for the CAHPS for MIPS survey, for the 12-month performance 
period, a group that wishes to voluntarily elect to participate in the 
CAHPS for MIPS survey measure must use a survey vendor that is approved 
by CMS for the applicable performance period to transmit survey measure 
data to us.
    We did not receive comments on the proposal to clarify the 
requirement to use a CMS approved CAHPS for MIPS survey vendor.
    We are finalizing our proposal to amend Sec.  414.1335(a)(3) to 
clarify for the CAHPS for MIPS survey that beginning with the 2021 MIPS 
payment year, for the 12-month performance period, a group that wishes 
to voluntarily elect to participate in the CAHPS for MIPS survey 
measure must use a survey vendor that is approved by CMS for the 
applicable performance period to transmit survey measure data to us.
(B) Summary of Data Submission Criteria
    In the CY 2019 PFS proposed rule (83 FR 35897), we did not propose 
any changes to the quality data submission criteria for the 2021 MIPS 
payment year; however, as discussed in section III.I.3.h. of this final 
rule, we proposed changes to existing and additional submission related 
terminology. Similarly, although we did not propose changes to the data 
completeness criteria at Sec.  414.1340, we proposed changes to 
existing and additional submission related terminology. For that 
reason, we proposed to revise Sec.  414.1340 to specify that MIPS 
eligible clinicians and groups submitting quality measures data on QCDR 
measures, MIPS CQMs, or eCQMs must submit data on at least 60 percent 
of the MIPS eligible clinician or group's patients that meet the 
measure's denominator criteria, regardless of payer for MIPS payment 
year 2021; MIPS eligible clinicians and groups submitting quality 
measure data

[[Page 59757]]

on the Medicare Part B claims measures must submit data on at least 60 
percent of the applicable Medicare Part B patients seen during the 
performance period to which the measure applies for the 2021 MIPS 
payment year; and groups submitting quality measures data on CMS Web 
Interface measures or the CAHPS for MIPS survey measure, must meet the 
data submission requirement on the sample of the Medicare Part B 
patients CMS provides. Tables 34 and 35 clearly capture the data 
completeness requirements and submission criteria by collection type 
for individual clinicians and groups.

   Table 34--Summary of Data Completeness Requirements and Performance
   Period by Collection Type for the 2020 and 2021 MIPS Payment Years
------------------------------------------------------------------------
                                   Performance
        Collection type               period         Data completeness
------------------------------------------------------------------------
Medicare Part B claims          Jan 1-Dec 31.....  60 percent of
 measures.                                          individual MIPS
                                                    eligible
                                                    clinician's, or
                                                    group's Medicare
                                                    Part B patients for
                                                    the performance
                                                    period.
Administrative claims measures  Jan 1-Dec 31.....  100 percent of
                                                    individual MIPS
                                                    eligible clinician's
                                                    Medicare Part B
                                                    patients for the
                                                    performance period.
QCDR measures, MIPS CQMs, and   Jan 1-Dec 31.....  60 percent of
 eCQMs.                                             individual MIPS
                                                    eligible
                                                    clinician's, or
                                                    group's patients
                                                    across all payers
                                                    for the performance
                                                    period.
CMS Web Interface measures....  Jan 1-Dec 31.....  Sampling requirements
                                                    for the group's
                                                    Medicare Part B
                                                    patients: Populate
                                                    data fields for the
                                                    first 248
                                                    consecutively ranked
                                                    and assigned
                                                    Medicare
                                                    beneficiaries in the
                                                    order in which they
                                                    appear in the
                                                    group's sample for
                                                    each module/measure.
                                                    If the pool of
                                                    eligible assigned
                                                    beneficiaries is
                                                    less than 248, then
                                                    the group would
                                                    report on 100
                                                    percent of assigned
                                                    beneficiaries.
CAHPS for MIPS survey measure.  Jan 1-Dec 31.....  Sampling requirements
                                                    for the group's
                                                    Medicare Part B
                                                    patients.
------------------------------------------------------------------------


 Table 35--Summary of Quality Data Submission Criteria for MIPS Payment
         Year 2020 and 2021 for Individual Clinicians and Groups
------------------------------------------------------------------------
                                                     Measure collection
       Clinician type          Submission criteria   types  (or measure
                                                       sets) available
------------------------------------------------------------------------
Individual Clinicians.......  Report at least six   Individual MIPS
                               measures including    eligible clinicians
                               one outcome           select their
                               measure, or if an     measures from the
                               outcome measure is    following
                               not available         collection types:
                               report another high   Medicare Part B
                               priority measure;     claims measures
                               if less than six      (individual
                               measures apply then   clinicians in small
                               report on each        practices only),
                               measure that is       MIPS CQMs, QCDR
                               applicable.           measures, eCQMs, or
                               Clinicians would      reports on one of
                               need to meet the      the specialty
                               applicable data       measure sets if
                               completeness          applicable.
                               standard for the
                               applicable
                               performance period
                               for each collection
                               type.
Groups (non-CMS Web           Report at least six   Groups select their
 Interface).                   measures including    measures from the
                               one outcome           following
                               measure, or if an     collection types:
                               outcome measure is    Medicare Part B
                               not available         claims measures
                               report another high   (small practices
                               priority measure;     only), MIPS CQMs,
                               if less than six      QCDR measures,
                               measures apply then   eCQMs, or the CAHPS
                               report on each        for MIPS survey--or
                               measure that is       reports on one of
                               applicable.           the specialty
                               Clinicians would      measure sets if
                               need to meet the      applicable.
                               applicable data      Groups of 16 or more
                               completeness          clinicians who meet
                               standard for the      the case minimum of
                               applicable            200 will also be
                               performance period    automatically
                               for each collection   scored on the
                               type.                 administrative
                                                     claims based all-
                                                     cause hospital
                                                     readmission
                                                     measure.
Groups (CMS Web Interface     Report on all         Groups report on all
 for group of at least 25      measures includes     measures included
 clinicians).                  in the CMS Web        in the CMS Web
                               Interface             Interface measures
                               collection type and   collection type and
                               optionally the        optionally the
                               CAHPS for MIPS        CAHPS for MIPS
                               survey. Clinicians    survey.
                               would need to meet   Groups of 16 or more
                               the applicable data   clinicians who meet
                               completeness          the case minimum of
                               standard for the      200 will also be
                               applicable            automatically
                               performance period    scored on the
                               for each collection   administrative
                               type.                 claims based all-
                                                     cause hospital
                                                     readmission
                                                     measure.
------------------------------------------------------------------------

    We received comments on the proposal to revise Sec.  414.1340 to 
specify that MIPS eligible clinicians and groups submitting quality 
measures data must submit data on at least 60 percent of the MIPS 
eligible clinician or group's patients that meet the measure's 
denominator criteria, regardless of payer for MIPS payment year 2021:
    Comment: One commenter requested that CMS clarify the 90-day 
performance period mentioned in Table 31 of the proposed rule. This 
commenter requested more information concerning to which measures the 
performance period would apply and expressed concerns about the 
differing performance period for measures.
    Response: We clarify that in the CY 2019 PFS proposed rule (83 FR 
35898), the reference in Table 31 to a 90-day performance period for 
certain measures was an inadvertent error. To clarify, there is no 90-
day performance period for any MIPS quality measure. For the 2020 and 
2021 MIPS payment years, the performance period is 12 months. Table 34 
Summary of Data Completeness Requirements and Performance Period by 
Collection Type for the 2020 and 2021 MIPS Payment Years has been 
updated to reflect this correction.
    Comment: One commenter opposed a full calendar-year performance 
period given the proposed 60 percent data completion requirement for 
the quality performance category and the potential burden in developing 
and implementing new applicable measures.
    Response: While the data completeness requirement will remain at 60 
percent for the 2019 performance

[[Page 59758]]

period, we have previously noted our interest in incorporating higher 
data completeness thresholds in future years to ensure a more accurate 
assessment of a MIPS eligible clinician's performance on quality 
measures and to avoid measure selection bias as much as possible, but 
believe it should be done so in a gradual manner. In the CY 2019 PFS 
proposed rule (83 FR 35893), we noted our belief that a full calendar 
year performance period for the quality and cost performance categories 
will be less confusing for MIPS eligible clinicians. A longer 
performance period for quality will likely include more patient 
encounters, which will increase the denominator of the quality measures 
reported. Statistically, a larger sample size provides more accurate 
and actionable information. Furthermore, a full calendar year 
performance period is consistent with how many of the measures used in 
our program were designed to be performed and reported.
    Comment: A few commenters supported the fact that our proposal to 
maintain the 60 percent data completeness threshold and encouraged CMS 
to retain this policy for future program years.
    Response: We thank the commenters for their support.
    Comment: One commenter recommended that CMS increase the data 
completeness threshold to 100 percent. Other commenters noted that 
because calculating and submitting an accurate reporting rate requires 
an analysis of a full set of data and is often a manual and error-prone 
process, they do not believe it significantly reduces provider burden 
to have a 60 percent data completeness threshold as compared to 100 
percent.
    Response: As discussed in the CY 2018 Quality Payment Program final 
rule (82 FR 53632), we noted concerns about the unintended consequences 
of accelerating the data completeness threshold so dramatically, which 
may jeopardize a MIPS eligible clinician's ability to participate and 
perform well in MIPS, particularly with those clinicians who are not as 
experienced with MIPS quality measure submission. While we do continue 
to monitor the data completeness threshold with future intentions of 
raising the threshold for data completeness, we want to ensure that the 
data completeness requirement is achievable by all MIPS eligible 
clinicians. We do agree that it is important to incorporate higher data 
completeness thresholds in future years to ensure a more accurate 
assessment of a MIPS eligible clinician's performance on quality 
measures and to avoid measure selection bias as much as possible, but 
believe it should be done so in a gradual manner.
    Comment: One commenter requested clarification on whether the data 
completeness criteria is 60 percent of the performance year, regardless 
of time, or if MIPS eligible clinicians are mandated to include 60 
percent of their patient data from the calendar year.
    Response: As stated at Sec.  414.1340(b)(2), MIPS eligible 
clinicians are required to submit data on at least 60 percent of the 
applicable Medicare Part B patients seen during the performance period, 
as illustrated in Table 34.
    Comment: One commenter expressed support for updating the 
terminology of the data completeness criteria, stating that it does not 
change the data completeness criteria from the previous years.
    Response: We thank the commenter for their support. We clarify that 
we did not make any proposals or changes to the data completeness 
criteria, and only made changes to existing and additional submission 
related terminology, as explained in the CY 2019 PFS proposed rule (83 
FR 35897).
    After consideration of the public comments received, we are 
finalizing revisions to Sec.  414.1340 to specify that MIPS eligible 
clinicians and groups submitting quality measures data on QCDR 
measures, MIPS CQMs, or the eCQMs must submit data on at least 60 
percent of the MIPS eligible clinician or group's patients that meet 
the measure's denominator criteria, regardless of payer for MIPS 
payment year 2021; MIPS eligible clinicians and groups submitting 
quality measure data on the Medicare Part B claims measures must submit 
data on at least 60 percent of the applicable Medicare Part B patients 
seen during the performance period to which the measure applies for the 
2021 MIPS payment year; and groups submitting quality measures data on 
CMS Web Interface measures or the CAHPS for MIPS survey measure, must 
meet the data submission requirement on the sample of the Medicare Part 
B patients CMS provides, as applicable.
(iv) Application of Facility-Based Measures
    Under section 1848(q)(2)(C)(ii) of the Act, the Secretary may use 
measures for payment systems other than for physicians, such as 
measures used for inpatient hospitals, for purposes of the quality and 
cost performance categories. However, the Secretary may not use 
measures for hospital outpatient departments, except in the case of 
items and services furnished by emergency physicians, radiologists, and 
anesthesiologists. We refer readers to section III.I.3.i.(1)(d) of this 
final rule for a full discussion of facility-based measures and scoring 
for the 2021 MIPS payment year.
(b) Selection of MIPS Quality Measures for Individual MIPS Eligible 
Clinicians and Groups Under the Annual List of Quality Measures 
Available for MIPS Assessment
(i) Background and Policies for the Call for Measures and Measure 
Selection Process
    In the CY 2019 PFS proposed rule (83 FR 35898 through 35899), we 
noted that developed and announced our Meaningful Measures 
Initiative.\18\ By identifying the highest priority areas for quality 
measurement and quality improvement, the Meaning Measures Initiative 
identifies the core quality of care issues that advances our work to 
improve patient outcomes. Through subregulatory guidance, we will 
categorize quality measures by the 19 Meaningful Measure areas as 
identified on the Meaningful Measures Initiative website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html. 
The categorization of quality measures by Meaningful Measure area would 
provide MIPS eligible clinicians and groups with guidance as to how 
each measure fits into the framework of the Meaningful Measure 
Initiative.
---------------------------------------------------------------------------

    \18\ Link to Meaningful Measures web page on CMS site to be 
provided at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.
---------------------------------------------------------------------------

    Furthermore, under Sec.  414.1305, a high priority measure is 
defined as an outcome, appropriate use, patient safety, efficiency, 
patient experience or care coordination quality measure. Due to the 
immense impact of the opioid epidemic across the United States, we 
believe it is imperative to promote the measurement of opioid use and 
overuse, risks, monitoring, and education through quality reporting. 
For that reason, beginning with the 2019 performance period, we 
proposed at Sec.  414.1305 to amend the definition of a high priority 
measure to include quality measures that relate to opioids and to 
further clarify the types of outcome measures that are considered high 
priority. Beginning with the 2021 MIPS payment year, we proposed to 
define at Sec.  414.1305 a high priority measure to mean an outcome, 
appropriate use, patient safety, efficiency, patient experience, care 
coordination, or

[[Page 59759]]

opioid-related quality measure. Outcome measures would include 
intermediate-outcome and patient-reported outcome measures. We 
requested comment on this proposal, specifically if stakeholders have 
suggestions on what aspects of opioids should be measured--for example, 
whether we should focus solely on opioid overuse. We summarize and 
respond to the comments received on this proposal below.
    Previously finalized MIPS quality measures can be found in the CY 
2018 Quality Payment Program final rule (82 FR 53966 through 54174) and 
in the CY 2017 Quality Payment Program final rule (81 FR 77558 through 
77816). The new MIPS quality measures finalized for inclusion in MIPS 
for the 2019 performance period and future years are found in Table 
Group A of the ``Appendix 1: Finalized MIPS Quality Measures'' of this 
final rule. The current specialty measure sets can be found in the CY 
2018 Quality Payment Program final rule (82 FR 53976 through 54146). 
The finalized new and modified quality measure specialty sets can be 
found in Table Group B of the ``Appendix 1: Finalized MIPS Quality 
Measures'' of this final rule and include new measures, previously 
finalized measures with modifications, and previously finalized 
measures with no modifications.
    We note that modifications made to the specialty sets may include 
the removal of certain previously finalized quality measures. Certain 
MIPS specialty sets have further defined subspecialty sets, each of 
which constitutes a separate specialty set. In instances where an 
individual MIPS eligible clinician or group reports on a specialty or 
subspecialty set, if the set has less than six measures, that is all 
the clinician is required to report. MIPS eligible clinicians are not 
required to report on the specialty measure sets, but they are 
suggested measures for specific specialties. Please note that the 
finalized specialty and subspecialty sets are not inclusive of every 
specialty or subspecialty.
    On January 9, 2018,\19\ we announced that we would be accepting 
recommendations for potential new specialty measure sets for Year 3 of 
MIPS under the Quality Payment Program. These recommendations were 
based on the MIPS quality measures finalized in the CY 2018 Quality 
Payment Program final rule, and includes recommendations to add or 
remove the current MIPS quality measures from the specialty measure 
sets. All specialty measure set recommendations submitted for 
consideration were assessed to ensure that they meet the needs of the 
Quality Payment Program.
---------------------------------------------------------------------------

    \19\ Listserv messaging was distributed through the Quality 
Payment Program listserv on January 9th, 2018, titled: ``CMS is 
Soliciting Stakeholder Recommendations for Potential Consideration 
of New Specialty Measure Sets and/or Revisions to the Existing 
Specialty Measure Sets for the 2019 Program Year of Merit-based 
Incentive Payment System (MIPS).''
---------------------------------------------------------------------------

    In the CY 2017 Quality Payment Program final rule (81 FR 77137), we 
finalized that substantive changes to MIPS quality measures, to include 
but are not limited to, measures that have had measure specification 
changes, measure title changes, or domain changes. MIPS quality 
measures with finalized substantive changes can be found in Table Group 
D of the ``Appendix 1: Finalized MIPS Quality Measures'' of this final 
rule.
    As referenced in the CY 2017 Quality Payment Program final rule (81 
FR 77291), with regards to eCQMs, in the 2015 EHR Incentive Program 
final rule, CMS required eligible clinicians, eligible hospitals, and 
critical access hospitals (CAHs) to use the most recent version of an 
eCQM for electronic reporting beginning in 2017 (80 FR 62893). We 
proposed this policy for the end-to-end electronic reporting bonus 
under MIPS and encourage MIPS eligible clinicians to work with their 
EHR vendors to ensure they have the most recent version of the eCQM. We 
will not accept an older version of an eCQM as a submission for the 
MIPS program for the quality performance category or the end-to-end 
electronic reporting bonus within that category. MIPS eligible 
clinicians and groups reporting on the quality performance category are 
required to use the most recent version of the eCQM specifications. The 
annual updates to the eCQM specifications and any applicable addenda 
are available on the electronic quality improvement (eCQI) Resource 
Center website at https://ecqi.healthit.gov for the applicable 
performance period. Furthermore, as discussed in section III.E. of this 
final rule, the Medicaid Promoting Interoperability Program generally 
intends to utilize eCQM measures as they are available in MIPS. We 
refer readers to section III.E. of this final rule for additional 
details and criteria on the Medicaid Promoting Interoperability 
Program.
    In MIPS, there are a limited number of CMS Web Interface measures. 
We solicited comment on building upon the CMS Web Interface submission 
type by expanding the core set of measures available for that 
submission type to include other specialty specific measures (such as 
surgery). We thank stakeholders for their comments, and will consider 
it for future rulemaking.
    To provide clinicians with a more cohesive reporting experience, 
where they may focus on activities and measures that are meaningful to 
their scope of practice, we discuss the development of public health 
priority measurement sets that would include measures and activities 
across the quality, Promoting Interoperability, and improvement 
activities performance categories, focused on public health priorities 
such as fighting the opioid epidemic, in section III.I.3.h.(5), of this 
final rule. We refer readers to section III.I.3.h.(5) of this final 
rule for additional details on this concept.
    We received comments on the proposal to revise the definition of a 
high priority measure, to include quality measures that relate to 
opioids and to further clarify the types of outcome measures that are 
considered high priority; and the policy that MIPS eligible clinicians 
must use the most recent specification of MIPS eCQMs while reporting 
for MIPS:
    Comment: A few commenters expressed concern with the proposals to 
revise the definition of high-priority measures to include opioid 
related quality measures and to add several new measures to the MIPS 
program specifically focused on opioid use. The commenters urged CMS to 
consider the unintended consequences that could result if seriously ill 
patients experience barriers to receiving appropriate pain management. 
Specifically, commenters stated that, if the proposed policies are 
finalized, they could create incentives to reduce opioid prescriptions, 
even for patients with debilitating pain resulting from advanced 
disease progression who would respond to opioid treatment with more 
potential benefit than risk. The commenters also asked CMS to consider 
protections that could be incorporated into opioid-focused measures, 
such as exceptions for patients receiving hospice and palliative care 
and other patients with advanced stage serious illness. Further, 
commenters suggested that CMS rely on clinical evidence regarding the 
reliability and validity of measures or activities to address public 
health and safety concerns with opioids. One commenter also expressed 
concerns that measures may not take into account numerous factors that 
play a role in the opioid crisis, including habits outside of 
clinicians' control such as combining opioids with other medicines, 
using opioid for something other than pain, and failure to adhere to 
medicines as prescribed. One commenter

[[Page 59760]]

recommended including quality measures that address the application of 
non-addictive alternatives to pain management, whether in the form of 
pharmacotherapeutics, medication-assisted treatment, or non-
pharmacological options.
    Response: To clarify, our intention is not to create barriers for 
seriously ill patients receiving appropriate pain management, we 
encourage appropriate treatment, but also encourage proper monitoring, 
management, follow-up, and education of patients. We believe it is 
important to consider patients such as those receiving hospice and 
palliative care, and will discuss with measure stewards of opioid-
related measures whether exceptions for such patients may be 
appropriate. Furthermore, we have considered the reliability and 
validity of measures, as we require that measures have completed 
reliability and validity testing prior to them being considered as 
quality measures in MIPS. We agree with commenters that the application 
of non-addictive alternatives to pain management is an important area 
to include in quality measurement, and encourage stakeholders to reach 
out to the measure stewards for the consideration of their suggestions. 
Based on the comments and concerns expressed by commenters, we are 
clarifying that the finalized definition of a high priority measure is 
broad enough to include all aspects of opioid-related measurement 
rather than focus on a specific aspect of opioid measurement. We 
believe there are multiple areas within opioid measurement that are 
important; for example (but not limited to): Medication management, 
patient education, patient outcomes, monitoring, pain management, and 
follow-up.
    Comment: Several commenters agreed that opioid-related measures 
should be categorized as high-priority measures due to national 
interest. The commenters encouraged CMS to evaluate the inclusion of 
any opioid-related measures, especially eCQMs that measure developers 
bring to the table. Commenters stated that any opioid-related quality 
measures, especially if designated as high-priority measures, need to 
recognize that numerous factors play a role in opioid use, including 
factors such as pain control, patient use of other medicines combined 
with opioids, patient use of opioids for something other than pain, and 
patient failure to adhere to medicines as prescribed. One commenter 
cautioned against focusing solely on overuse, but rather focus on a 
combination of how well patient's pain is controlled, if functional 
improvement goals have been met, and opioid use. A few commenters 
indicated that identifying patients by daily use and daily dosage may 
not, on its own, be a good indication of quality patient care. 
Commenters also encouraged CMS to include patient-reported outcomes 
measures that look at symptom management and pain interference.
    Response: We will consider opioid-related quality measures as they 
are submitted through the call for measures process or as QCDR 
measures, and also encourage the development of fully tested eCQMs. We 
agree with the commenters that factors such as pain control, use of 
other medications, and adherence are all important factors and that 
overuse should not be the only focus of measurement. We encourage 
stakeholders to submit patient-reported outcomes measures that also 
relate to opioids during the call for measures process or as QCDR 
measures during the self-nomination process.
    Comment: A few commenters expressed support of the policy to 
require the reporting of the most current version of the eCQM. One 
commenter recommended that to improve electronic capture, calculation, 
and reporting of quality measures, CMS should incent the use of 
standardized semantic content from recognized developers. Further, the 
commenter encouraged CMS to incorporate this work into its 
implementation guides to ensure eCQM calculations and benchmarks are 
accurate and that EHRs are accurately capturing eCQMs. In addition, a 
commenter noted that to continue to encourage eCQM reporting, CMS 
should not remove the 8 eCQMs from the measure list in 2019 as 
proposed.
    Response: We will take these recommendations into consideration for 
future years of MIPS. We note that eCQM calculation standards are also 
included as a part of ONC's Health IT Certification Program to ensure 
accuracy and consistency. We refer readers to the 2015 Edition Health 
IT Certification Criterion at 45 CFR 170.315(c)(1) (Clinical quality 
measures) for additional information on the criteria. Furthermore, we 
have identified those 8 eCQMs for removal for reasons including the 
measure having high, unvarying performance rates, or the measure is 
being replaced by a more robust measure that has a more meaningful 
quality action. Quality actions include steps taken to advance the 
patient care provided, moving beyond documenting in the medical record 
or conducting a standard of care process. For example, was a follow-up 
examination conducted on the patient monitor changes in medical 
condition or did the specialist follow-up with the primary care 
physician to close the referral loop. We believe that it is important 
to have measures in the program that provide meaningful quality 
measurement, by demonstrating a performance gap and having a robust 
quality action.
    Comment: A few commenters did not support the timeline for removing 
eCQMs from the measure set because of the time required for EHR vendors 
to modify systems. One commenter recommended supporting the last two 
versions of eCQMs to allow sufficient time for vendors and health care 
organizations to develop and deploy the latest eCQM versions.
    Response: As described in the CY 2017 Quality Payment Program final 
rule (81 FR 77291), in the 2015 EHR Incentive Programs final rule, CMS 
required EPs, eligible hospitals, and CAHs to use the most recent 
version of an eCQM for electronic reporting beginning in 2017 (80 FR 
62893). Furthermore, we update specifications annually in order to stay 
relevant with the clinical guidelines, updates to terminology, and to 
correct any identified issues. We will take this recommendation into 
further consideration, as we plan for our annual update process 
improvements.
    Comment: A few commenters requested clarification on whether or not 
practices will be required to use 2015 Edition CEHRT for the entire 
performance year for quality and the latest version of eCQM to earn the 
end-to-end bonus.
    Response: As described at Sec.  414.1305, the definition of CEHRT 
for 2019 and subsequent years is EHR technology (which could include 
multiple technologies) certified under the ONC Health IT Certification 
Program that meets the 2015 Edition Base EHR definition (as defined at 
45 CFR 170.102), and has been certified to the 2015 Edition health IT 
certification criteria. In the CY 2017 Quality Payment Program final 
rule (81 FR 77297), we finalized that the CEHRT bonus would be 
available to MIPS eligible clinicians who report via qualified 
registries, QCDRs, EHRs, or the CMS Web Interface for the Quality 
Payment Program, in a manner that meets the end-to-end reporting 
requirements. Thus, in order for practices to earn the end-to-end bonus 
for reporting eCQMs for the 2019 performance period, they will need to 
be reporting using the latest version of the eCQM and will need to use 
CEHRT that has been certified to the 2015 Edition.

[[Page 59761]]

    Comment: A few commenters noted concern with the timeline for the 
approval and communication of updated quality measures with the 12-
month performance period, noting that clinicians and groups relying on 
this information for measure selection are unable to easily access a 
measure list until months after the performance period begins. 
Commenters also noted that QCDR measures have traditionally not been 
approved until the end of December preceding the performance year, 
leaving registries with limited time to update their dashboards in time 
for the January 1 start of the new performance year. Commenters stated 
that clinicians need additional time to work with their EHRs to ensure 
that they are capturing the elements necessary to report on a measure. 
Therefore, commenters urged CMS to approve and communicate updates 
earlier.
    Response: With regard to MIPS quality measures, the final 
specifications of the measures can only be posted once the final rule 
is published. For Year 2 of the program there was a delay in posting 
the measures within the Quality Payment Program Explore Measures Tool 
due to technical difficulties. However, the measure specifications were 
made available on the Quality Payment Program resource library (http://qpp.cms.gov) prior to the beginning of the performance period. We will 
continue to post the year 3 measure specifications on the Quality 
Payment Program resource library prior to the beginning of the 
performance period and will make every effort to update the Quality 
Payment Program Explore Measures Tool with the year 3 measures prior to 
the performance period, or as close to the beginning of the performance 
period as technically feasible. We also note that we do not incorporate 
the QCDR measures into the Quality Payment Program Explore Measures 
Tool, rather these will be available on the Quality Payment Program 
resource library. During the limited timeframe available between 
November 1st and January 1st, we have reviewed over a thousand QCDR 
measure submissions for consideration in the upcoming MIPS performance 
period, communicated those decisions to the QCDRs, and posted the 
qualified postings by January 1 of the performance period. QCDRs and 
registries are notified prior to January 1 regarding which measures 
will be approved for the upcoming performance period. In section 
III.I.3.k.(3) of this final rule, we describe the finalized policy to 
move the self-nomination period up to begin in July 1 and end on 
September 1, thereby giving us an earlier start to evaluate and make 
decisions on QCDR measures.
    Comment: Many commenters stated that the current timeline for 
release of measure specifications in December is overly burdensome and 
hinders the consistency of measure data in terms of comparability of 
results over time as it does not allow adequate time to build and test 
systems prior to QCDRs reporting measures on January 1.
    Response: We understand the commenters' concerns, and interpret 
their reference to measures to mean the MIPS quality measure 
specifications not the QCDR measure specifications. We clarify that it 
is not technically feasible to release the MIPS quality measure 
specifications until the final rule is published. We will take the 
commenters suggestion in to consideration as we consider the 
operational feasibility of releasing the MIPS quality measure 
specifications earlier than December. As stated in the CY 2017 Quality 
Payment Program final rule (81 FR 77368), in order for a QCDR to be 
approved for a given performance period, they must support the minimum 
of 6 quality measures to be approved. Similar to previous performance 
periods, we plan to provide QCDRs and qualified registries with time to 
select additional MIPS quality measures to support for the upcoming 
performance period based upon their review of the measure 
specifications. Furthermore, we note that we expect that QCDRs and 
qualified registries would be up and running by January 1 of the 
performance period to accept and retain data, to allow clinicians to 
begin their data collection on January 1 of the performance period. 
However, the data will not be submitted to us until the start of data 
submission for the 2019 performance period.
    After consideration of the public comments received, we are 
finalizing our proposal, beginning with the 2021 MIPS payment year, to 
define a high priority measure at Sec.  414.1305 as an outcome, 
appropriate use, patient safety, efficiency, patient experience, care 
coordination, or opioid-related quality measure. Outcome measures 
include intermediate-outcome and patient-reported outcome measures.
    In the CY 2017 Quality Payment Program final rule (81 FR 77090), we 
indicated that we intend to reduce the number of claims-based measures 
in future program years as more measures become available through 
electronic collection types such as eCQMs or MIPS CQMs. In section 
III.I.3.h of this final rule, we are finalizing our proposal to limit 
the Medicare Part B claims collection type to small practices, which 
furthers our goal of moving away from Medicare Part B claims measures. 
We strongly encourage measure stewards to keep this in mind as they 
develop and submit measures for consideration, during the call for 
measures process (specifically for the MIPS quality performance 
category).
(ii) Topped Out Measures
    In the CY 2018 Quality Payment Program final rule (82 FR 53637 
through 53640), we finalized the 4-year timeline to identify topped out 
measures, after which we may propose to remove the measures through 
future rulemaking. After a measure has been identified as topped out 
for 3 consecutive years through the benchmarks, we may propose to 
remove the measure through notice and comment rulemaking. Therefore, in 
the 4th year, if finalized through rulemaking, the measure would be 
removed and would no longer be available for reporting during the 
performance period. We refer readers to the 2018 MIPS Quality 
Benchmarks' file, that is located on the Quality Payment Program 
resource library (https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/Resource-library.html) to determine which measure 
benchmarks are topped out for 2018 and would be subject to the cap if 
they are also topped out in the 2019 MIPS Quality Benchmarks' file. It 
should be noted that the final determination of which measure 
benchmarks are subject to the topped out cap would not be available 
until the 2019 MIPS Quality Benchmarks' file is released in late 2018.
    In the CY 2019 PFS proposed rule (83 FR 35899 through 35900), we 
proposed that once a measure has reached an extremely topped out status 
(for example, a measure with an average mean performance within the 
98th to 100th percentile range), we may propose the measure for removal 
in the next rulemaking cycle, regardless of whether or not it is in the 
midst of the topped out measure lifecycle, due to the extremely high 
and unvarying performance where meaningful distinctions and improvement 
in performance can no longer be made, after taking into account any 
other relevant factors. We are concerned that topped out non-high 
priority process measures require data collection burden without added 
value for eligible clinicians and groups participating in MIPS. It is 
important to remove these types of measures, so that available measures 
provide meaningful value to

[[Page 59762]]

clinicians collecting data, beneficiaries, and the program. However, we 
would also consider retaining the measure if there are compelling 
reasons as to why it should not be removed (for example, if the removal 
would impact the number of measures available to a specialist type or 
if the measure addressed an area of importance to the Agency).
    Since QCDR measures are not approved or removed from MIPS through 
the rulemaking timeline or cycle, we proposed to exclude QCDR measures 
from the topped out timeline that was finalized in the CY 2018 Quality 
Payment Program final rule (82 FR 53640). When a QCDR measure reaches 
topped out status, as determined during the QCDR measure approval 
process, it may not be approved as a QCDR measure for the applicable 
performance period. Because QCDRs have more flexibility to develop 
innovative measures, we believe there is limited value in maintaining 
topped out QCDR measures in MIPS.
    We received comments on the following proposals: (1) Once a measure 
has reached an extremely topped out status (for example, a measure with 
an average mean performance within the 98th to 100th percentile range), 
we may propose the measure for removal in the next rulemaking cycle, 
regardless of whether or not it is in the midst of the topped out 
measure lifecycle; and (2) to exclude QCDR measures from the topped out 
timeline that was finalized in the CY 2018 Quality Payment Program 
final rule:
    Comment: Several commenters supported the topped out proposal, 
stating that it would reduce clinician burden, discontinue measures 
that have limited value to the Quality Payment Program, and continue to 
focus on measures that are clinically meaningful to patients. One 
commenter noted that this proposal will allow CMS to differentiate 
between exceptional, high performing, and other clinicians. Several 
commenters recommended that topped out measures be removed regardless 
of the collection type.
    Response: We disagree that topped out measures should be removed 
regardless of the collection type. There have been instances where 
measures have been specified through multiple collection types, but 
have only become topped out in one or two of the collection types. If 
there is an opportunity to collect more robust data on a measure, while 
the measure is not topped out for that particular collection type, we 
believe we should continue to do so.
    Comment: Several commenters did not support the proposal to exclude 
QCDR measures from the topped out timeline, indicating that review 
processes for QCDR and MIPS measures should be standardized and provide 
clinicians, groups, and measure stewards sufficient notice to review 
and potentially replace topped out measures. One commenter indicated 
that applying the topped out policy to QCDR measures will also ensure 
consistency across the program and minimize complexity. A few 
commenters indicated that maintaining QCDR measures in the program for 
a minimum number of years will also limit measures with sufficient 
historical data to set a benchmark that permits the evaluation of 
performance. Several commenters noted that removal of topped out QCDR 
measures would limit the number of specialty-specific measures 
available and stated that and the proposal does not allow sufficient 
time and volume of cases to determine if QCDR measures have a valid 
benchmark. One commenter recommended a two-year retention policy for 
extremely topped out QCDR measures to reduce burden and confusion for 
clinicians.
    Response: We note that the process and timeline in which MIPS 
quality measures and QCDR measures are approved for a given MIPS 
performance period is different, as is the criteria for consideration. 
QCDRs are expected to be nimble and innovative enough to develop QCDR 
measures that are robust in their quality action and demonstrate a 
performance gap. We believe topped out measures do not add value in the 
realm of quality measurement, and believe they should be removed from 
the program as appropriate. We do not agree that removing topped out 
QCDR measures would create complexity, since it is a well-established 
process that QCDR measures are reviewed for approval on an annual 
basis, and is something that stakeholders should be aware of. We also 
do not believe that topped out QCDR measures should be retained in the 
program for 2 years; this may inadvertently impact a high performing 
clinician who may not receive a high score when compared to other 
clinicians reporting on the same measure. For example, a clinician 
whose performance rate is at 96 percent on a topped out measure may 
receive fewer points than another clinician whose reporting rate is at 
98 percent on the same measure, when both performance rates would be 
considered high performing. We do not agree that the removal of topped 
out QCDR measures would impact the number of available specialty-
specific measures available, since QCDR measures are reviewed and 
approved on a more accelerated timeline in comparison to the MIPS 
quality measures. Furthermore, MIPS eligible clinicians who wish to use 
QCDRs, are not limited to reporting on QCDR measures.
    Comment: Many commenters did not support the proposal to allow the 
identification and removal of extremely topped out measures. Several 
commenters noted that removal of measures will have a large impact on 
small practices and specialists who have limited options regarding 
relevant quality measures. Several commenters stated that more time is 
needed to determine if measures are truly topped out because benchmarks 
may reflect the performance of only top-performing clinicians rather 
than performance across all clinicians. They stated that additional 
time would allow for the collection of more robust data. Many 
commenters stated that topped out measures should all have the same 4-
year timeline because the process to develop a measure that could 
replace a topped out measure is lengthy and recommended close 
communication with measure stewards. A few commenters recommended a 2-
year timeline for the removal of extremely topped out measures. A few 
commenters encouraged CMS to defer to measure developers and national 
endorsement organizations to define which measures are topped out. One 
commenter noted that additional factors should be taken into 
consideration prior to removing an extremely topped out measure, 
including the type of measure, the length of time the measure is 
reported, measure steward and specialist input, performance results, 
reporting options, data sources, small sample size, public health 
issues covered, and whether measures are used in other programs. One 
commenter recommended that prior to removing a topped out measure, CMS 
be transparent about the data used to determine topped out status, so 
the public has an understanding of how many clinicians reported the 
measure and the performance rate.
    Response: We note that in addition to the quality measures 
available in the MIPS quality measure set, QCDR measures are also 
available. We review measure benchmarks as a part of our process for 
identifying topped out and extremely topped out measures and believe 
that extremely topped out measures, such as those with an average mean 
performance within the 98th to 100th percentile, leave no room for 
further quality improvement, thereby providing clinicians little value. 
We

[[Page 59763]]

utilized the 2018 quality measure benchmarks as a part of the criteria 
used to identify those measures for removal. The benchmarks are 
reflective of the performance of those clinicians who have reported on 
the measure and will continue to do so should the measure be available 
in the program which is why we do not believe there will be variances 
in the high performing data submitted if the measure is retained. We do 
not believe that we should retain the extremely topped out measures 
within a 4 year timeline because the measures take a lengthy time to 
replace. While the timeline to add MIPS quality measures does typically 
take about 2 years, we note there are additional measures (QCDR 
measures) available for reporting through QCDRs. We appreciate the 
commenters' feedback suggesting we defer to measure developers and 
national endorsement organizations to define which measures are topped 
out; we can take this suggestion in to future consideration. In the CY 
2019 PFS proposed rule (83 FR 35900), we stated we would also consider 
retaining the measure if there are compelling reasons as to why it 
should not be removed (for example, if the removal would impact the 
number of measures available to a specialist type or if the measure 
addressed an area of importance to the Agency). We encourage 
stakeholders to continue to submit quality measures that address 
measurement gaps as we incrementally remove quality measures that are 
extremely topped out, merely reflect the standard of care without a 
quality action, or are duplicative of other more robust quality 
measures, as we believe they no longer provide meaningful measurement 
to clinicians.
    After consideration of the public comments received, we are 
finalizing our proposal that once the measure has reached an extremely 
topped out status (for example, a measure with an average mean 
performance within the 98th to 100th percentile range), we may propose 
the measure for removal in the next rulemaking cycle, regardless of 
whether or not it is in the midst of the topped out measure lifecycle, 
due to the extremely high and unvarying performance where meaningful 
distinctions and improvement in performance can no longer be made, 
after taking into account any other relevant factors. However, we will 
also consider retaining the measure if there are compelling reasons as 
to why it should not be removed (for example, if the removal would 
impact the number of measures available to a specialist type or if the 
measure addressed an area of importance to CMS).
    We are also finalizing our proposal to exclude QCDR measures from 
the topped out timeline that was finalized in the CY 2018 Quality 
Payment Program final rule (82 FR 53640). When a QCDR measure reaches 
topped out status, as determined during the QCDR measure approval 
process, it may not be approved as a QCDR measure for the applicable 
performance period.
(iii) Removal of Quality Measures
    In the CY 2017 Quality Payment Program final rule (81 FR 77136 
through 77137), we discussed removal criteria for quality measures, 
including that a quality measure may be considered for removal if the 
Secretary determines that the measure is no longer meaningful, such as 
measures that are topped out. Furthermore, if a measure steward is no 
longer able to maintain the quality measure, it would also be 
considered for removal.
    We have previously communicated to stakeholders our desire to 
reduce the number of process measures within the MIPS quality measure 
set. In the CY 2017 Quality Payment Program final rule (81 FR 77101), 
we explained that we believe that outcome measures are more valuable 
than clinical process measures and are instrumental to improving the 
quality of care patients receive. In the CY 2018 Quality Payment 
Program quality measure set, 102 of the 275 quality measures are 
process measures that are not considered high priority. As discussed 
above, beginning with the 2021 MIPS payment year, we proposed to define 
at Sec.  414.1305 a high priority measure to mean an outcome, 
appropriate use, patient safety, efficiency, patient experience, care 
coordination, or opioid-related quality measure. Because the removal of 
all non-high priority process measures would impact most specialty 
sets, nearly 94 percent, we believe incrementally removing non-high 
priority process measures through notice and comment rulemaking is 
appropriate.
    As described in the CY 2019 PFS proposed rule (83 FR 35900), 
beginning with the 2019 performance period, we proposed to implement an 
approach to incrementally remove process measures where prior to 
removal, consideration will be given to, but is not limited to:
     Whether the removal of the process measure impacts the 
number of measures available for a specific specialty.
     Whether the measure addresses a priority area highlighted 
in the Measure Development Plan at https://www.cms.gov/Medicare/Quality-Payment-Program/Measure-Development/Measure-development.html.
     Whether the measure promotes positive outcomes in 
patients.
     Considerations and evaluation of the measure's performance 
data.
     Whether the measure is designated as high priority or not.
     Whether the measure has reached an extremely topped out 
status within the 98th to 100th percentile range, due to the extremely 
high and unvarying performance where meaningful distinctions and 
improvement in performance can no longer be made, as described in 
section III.I.3.(b)(ii) of this final rule.
    We received the following comments on the proposal to implement a 
process to incrementally remove process measures:
    Comment: While some commenters supported the inclusion of 
population measures, several commenters recommended the removal of 
population health measures, which it believed are often incorrectly 
attributed, especially for specialty clinicians and rural clinicians, 
and often have a very low statistical reliability at the individual 
clinician and group practice levels.
    Response: We believe that population measures may reduce burden on 
clinicians and allow for assessment of public health issues on a larger 
scale. Reliability is one of the many important and scientific issues 
that CMS addresses and tests during our measure development process 
regardless of measure type (that is, whether the measures are 
population-based or provider-specific measures). We recognize that 
specialty clinicians and rural clinicians may be more likely to have a 
smaller sample size, and that this may result in lower reliability. At 
the same time, we also recognize that many clinicians or groups may 
have sufficient volume depending on the measures under development, and 
because measure reliability also depends on the particular cohort and 
outcome of the specific measures under development. As part of the CMS 
standardized measure development process, we will address the 
reliability issue in several ways. We will consult national experts and 
stakeholders including health care providers and patients in 
conceptualizing and selecting measures for development and conduct 
rigorous testing of the measure reliability and volume threshold for 
use.
    Comment: Many commenters supported the removal of 34 MIPS measures 
to align with CMS's Meaningful Measures framework and allow eligible 
clinicians to reduce and

[[Page 59764]]

prioritize other measures, providing a focus on improving patient care 
and outcomes. A few commenters encouraged CMS to continue to review its 
quality measure sets to identify the most meaningful measures and 
further align hospital and clinician reporting requirements.
    Response: We agree that alignment across quality programs is 
important in an effort to reduce clinician burden, and will seek to 
continue to look for ways to align with other programs while 
maintaining the objective and goals of MIPS through future rulemaking.
    Comment: Many commenters did not support the proposal to remove 
measures, stating that many specialists will not have enough relevant 
measures to meet reporting requirements, clinicians may still be 
required to report removed measures to other payers, and process 
measures are under the control of the clinician and often important 
when coupled with other measures including cost measures. A few 
commenters indicated that important quality of care aspects may only be 
captured by a process measure, even those that are topped out. One 
commenter disagreed with the removal of topped out measures generally 
until the vast majority of peer reviewed literature demonstrates a 
significant change in practice patterns. One commenter recommended 
delaying the removal of measures, to allow time for clinicians to 
comply with program requirements.
    Response: We note that prior to proposing to remove quality 
measures from the program, we take into consideration the impacts the 
removal would have on the number of measures available to clinicians in 
the program. We do not agree that we should delay the removal of 
measures. We continue to believe that non-high priority process 
measures impose data collection burden without adding value for 
eligible clinicians and groups participating in MIPS. Typically, 
process measures merely reflect the standard of care and do not have a 
robust quality action. In many instances, process measures have high, 
unvarying performance leaving no room for improvement. We understand 
that there are some process measures that are valuable, but believe 
that it is important that they address one of the high priority areas 
and demonstrate a performance gap in order to be meaningful. 
Furthermore, we do understand that important quality of care aspects 
may only be captured by some topped out process measures, and encourage 
clinicians to continue to measure and monitor their progress in these 
areas; however, we do not believe that these measures provide value or 
should be tied to a pay for performance program such as MIPS. If a MIPS 
quality measure is removed from the program, it is because the measure 
no longer has value in the performance payment program; however, we 
believe that clinicians can still collect and evaluate data on these 
metrics for their own internal quality improvement goals or areas of 
improvement as outlined in peer reviewed literature. We are aware that 
there are certain process measures that may be required to be reported 
to other payers; however, note that this difference may reflect 
different underlying goals of their program. Another consideration is 
that these process measures with high, unvarying performance, may also 
impact a MIPS eligible clinician's ability to receive a high score in 
the quality performance category. While we agree that process measures 
are under the control of the clinician and often important when coupled 
with other measures including cost measures, we do not believe that 
this justifies retaining extremely topped out measures in MIPS.
    Comment: Several commenters expressed concern about the timeline 
for removing measures. A few commenters requested that CMS maintain the 
4-year measure removal policy since it would give clinicians, 
professional societies, and third party vendors (for example, 
registries) some time to prepare and develop an alternative reporting 
strategy. One commenter recommended an incremental phased approach 
according to a specified timeline, similar to the 4-year timeline 
currently in place for removing topped out measures from the program in 
order to ensure that the removal of the measures is truly warranted and 
to allow clinicians time to begin implementing other measures for 
reporting purposes. One commenter recommend that CMS only propose 
removal of measures during the official measure process to assist with 
predictability.
    Response: To clarify, similar to how MIPS quality measures are 
proposed and finalized into the MIPS program through notice-and-comment 
rulemaking, we utilize a similar approach for removing measures from 
the program. We do not believe that a 4-year timeline to remove all 
measures is appropriate. A topped out measure timeline that is 4 years 
long is appropriate for measures with high performance where special 
scoring caps are applied as a response to the high unvarying 
performance; however, we are still finalizing the policy to remove 
extremely topped out measures (within the 98-100 percent range) through 
the following rulemaking cycle after the measure is identified as 
extremely topped out. This is to note that there are exceptions to the 
4 year timeline, and in instances where there are more robust measures 
being proposed and finalized, we believe it is appropriate to remove 
duplicative measures through notice-and-comment rulemaking without 
consideration to a longer timeline. In addition, measures that are not 
maintained or updated to reflect current clinical guidelines are not 
reflective of a clinician's scope of practice, should also be proposed 
for removal in the next rulemaking cycle. Furthermore, the removal of 
low-bar, standard of care process measures aligns with our goals to 
have more outcomes based measures in the program. Furthermore, a 4-year 
timeline does not take into consideration that we may propose new 
quality measures that are more robust in their quality action that 
would deem the existing process measure to be duplicative. Also, as 
process measures top out, they will inadvertently impact a clinician's 
ability to achieve a high score for that specific measure. As stated 
earlier above, we will only propose the removal of MIPS quality 
measures through formal notice-and-comment rulemaking, and we believe 
that this annual process will provide stakeholders with sufficient 
notice and opportunity to voice their concerns on specific measure 
removals through the public comment process.
    Comment: One commenter also requested that CMS evaluate measures 
for removal based on the collection type. They stated that the 
differences in collection types can be enough of a workflow and cost 
consideration in alterations that it should be a factor in the 
consideration of measures removal. For example, there are several eCQMs 
proposed for removal due to a duplicative measure being available; 
however, in most instances, that duplicative measure is not available 
as an eCQM. This would potentially force practices to maintain 
relationships and pay for reporting through multiple vendors to 
maintain their list of measures.
    Response: Initially, we proposed to remove specific MIPS quality 
measures that were duplicative of new, robust measures. We have taken 
the comments into consideration and in instances where the new measure 
does not have eCQM available as a collection type, we have decided not 
to remove the existing (duplicative) measure for the eCQM collection 
type only. We refer readers to Appendix 1: Finalized Quality Measures 
of this final rule for additional detail on

[[Page 59765]]

these eCQMs. We clarify that we do look at the availability of measures 
through the different collection types as we review measures for 
possible inclusion or removal, and will continue to monitor and 
consider the availability through the collection types as criteria when 
removing quality measures from MIPS.
    After consideration of the public comments received, we are 
finalizing our proposal, beginning with the 2021 MIPS payment year, to 
implement an approach to incrementally remove process measures where 
prior to removal, consideration will be given to, but will not be 
limited to:
     Whether the removal of the process measure impacts the 
number of measures available for a specific specialty.
     Whether the measure addresses a priority area highlighted 
in the Measure Development Plan: https://www.cms.gov/Medicare/Quality-Payment-Program/Measure-Development/Measure-development.html.
     Whether the measure promotes positive outcomes in 
patients.
     Considerations and evaluation of the measure's performance 
data.
     Whether the measure is designated as high priority or not.
     Whether the measure has reached an extremely topped out 
status within the 98th to 100th percentile range, due to the extremely 
high and unvarying performance where meaningful distinctions and 
improvement in performance can no longer be made.
(iv) Categorizing Measures by Value
    In the CY 2019 PFS proposed rule (83 FR 35900), we outlined the 
various types of MIPS quality and QCDR measures available for reporting 
in the quality performance category, such as outcome, high-priority, 
composite, and process measures, we acknowledge that not all measures 
are created equal. For example, the value or information gained by 
reporting on certain process measures does not equate that which is 
collected on outcome measures. We seek to ensure that the collection 
and submission of data is valuable to clinicians and worth the cost and 
burden of collecting the information.
    Based on this, we solicited comment on implementing a system where 
measures are classified as a particular value (gold, silver or bronze) 
and points are awarded based on the value of the measure. For example, 
higher value measures that are considered ``gold'' standard, which 
could include outcome measures, composite measures, or measures that 
address agency priorities (such as opioids). The CAHPS for MIPS survey, 
which collects patient experience data, may also be considered a high 
value measure. Measures that are considered second tier, or at a 
``silver'' standard would be measures that are considered process 
measures that are directly related to outcomes and have a good gap in 
performance (there is no high, unwavering performance) and demonstrate 
room for improvement; or topped out outcome measures. Lower value 
measures, such as standard of care process measures or topped out 
process measures would be considered ``bronze'' measures. We refer 
readers to section III.I.3.i.(1)(b)(xi) of this final rule for 
discussion on the assignment of value and scoring based on measure 
value.
    We have received comments from stakeholders regarding categorizing 
measure by value. We thank commenters for their input and may take this 
input into consideration in future years.
(3) Cost Performance Category
    For a description of the statutory basis and our existing policies 
for the cost performance category, we refer readers to the CY 2017 and 
CY 2018 Quality Payment Program final rules (81 FR 77162 through 77177, 
and 82 FR 53641 through 53648, respectively).
(a) Weight in the Final Score
    In the CY 2018 Quality Payment Program final rule, we established 
that the weight of the cost performance category would be 10 percent of 
the final score for the 2020 MIPS payment year (82 FR 53643). We had 
previously finalized in the CY 2017 Quality Payment Program final rule 
at Sec.  414.1350(b)(3) that beginning with the 2021 MIPS payment year, 
the cost performance category would be 30 percent of the final score, 
as required by section 1848(q)(5)(E)(i)(II)(aa) of the Act (81 FR 
77166). Section 51003(a)(1)(C) of the Bipartisan Budget Act of 2018, 
enacted on February 9, 2018, amended section 1848(q)(5)(E)(i)(II)(bb) 
of the Act such that for each of the second, third, fourth, and fifth 
years for which the MIPS applies to payments, not less than 10 percent 
and not more than 30 percent of the MIPS final score shall be based on 
the cost performance category score. Additionally, this provision shall 
not be construed as preventing the Secretary from adopting a 30 percent 
weight if the Secretary determines, based on information posted under 
section 1848(r)(2)(I) of the Act, that sufficient cost measures are 
ready for adoption for use under the cost performance category for the 
relevant performance period. Section 51003(a)(2) of the Bipartisan 
Budget Act of 2018 amended section 1848(r)(2) of the Act to add a new 
paragraph (I), which we discuss in section III.I.3.h.(3)(b)(i) of this 
final rule.
    In light of these amendments, in the proposed rule (83 FR 35900 
through 35901), we proposed at Sec.  414.1350(d)(3) that the cost 
performance category would make up 15 percent of a MIPS eligible 
clinician's final score for the 2021 MIPS payment year. As discussed in 
section III.I.3.h.(3)(b)(iv) of this final rule, Sec.  414.1350(b) will 
be redesignated as Sec.  414.1350(d). We proposed to delete the 
existing text under Sec.  414.1350(b)(3) and address the weight of the 
cost performance category for the MIPS payment years following 2021 in 
future rulemaking. We also proposed a technical change to the text at 
Sec.  414.1350(b) (redesignated as Sec.  414.1350(d)) to state that the 
cost performance category weight will be as specified under 
redesignated Sec.  414.1350(d), unless a different scoring weight is 
assigned by CMS under section 1848(q)(5)(F) of the Act (83 FR 35901).
    We believe that measuring cost is an integral part of measuring 
value, and we believe that clinicians have a significant impact on the 
costs of patient care. However, we proposed to only modestly increase 
the weight of the cost performance category for the 2021 MIPS payment 
year from the 2020 MIPS payment year because we recognize that cost 
measures are still relatively early in the process of development and 
that clinicians do not have the level of familiarity or understanding 
of cost measures that they do of comparable quality measures (83 FR 
35900 through 35901). As described in section III.I.3.h.(3)(b)(ii) of 
this final rule, we are finalizing the addition of 8 episode-based 
measures to the cost performance category beginning with the 2019 MIPS 
performance period. This is a first step in developing a more robust 
and clinician-focused measurement of cost performance. We will continue 
to work on developing additional episode-based measures that we may 
consider proposing for the cost performance category in future years. 
Introducing more measures over time would allow for more clinicians to 
be measured in this performance category. It would also allow time for 
more outreach to clinicians to better educate them on the cost 
measures. We considered maintaining the weight of the cost performance 
category at 10 percent for the 2021 MIPS payment year as we recognize 
that clinicians are still learning about the cost performance category 
and being introduced to new measures. We invited comment on

[[Page 59766]]

whether we should consider an alternative weight for the 2021 MIPS 
payment year.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Several commenters supported our proposal to increase the 
weight of the cost performance category to 15 percent for the 2021 MIPS 
payment year, noting the importance of managing cost in measuring the 
value of a clinician as well as the opportunity to gradually increase 
the weight of the performance category.
    Response: We thank the commenters for their support for this 
proposal.
    Comment: Several commenters opposed our proposal to increase the 
weight of the cost performance category to 15 percent for MIPS payment 
year 2021. They believed that the increased flexibility provided by the 
Bipartisan Budget Act of 2018 should be used to maintain the weight at 
10 percent for MIPS payment year 2021 and in future years. Some 
commenters requested that the weight of the cost performance category 
not be increased until CMS can address issues of social and complexity 
risk factors and of clinical risk adjustment for measures in areas such 
as oncology. Some commenters suggested maintaining the weight of the 
cost performance category at 10 percent until CMS is able to provide 
more detailed and actionable performance data and develop more reliable 
and valid measures.
    Additionally, several commenters opposed our proposal to increase 
the weight of the cost performance category because we proposed to add 
new episode-based measures (as detailed in section III.I.3.h.(3)(b)(ii) 
of this rule) and clinicians should have time to learn about these 
measures before the category weight is increased. Additionally, several 
commenters suggested CMS wait to increase the cost performance category 
weight until sufficient episode groups exist for additional 
specialties.
    Response: We continue to investigate ways to best accommodate the 
issue of clinical and social risk adjustment in measures contained in 
the cost performance category. All measures included in the cost 
performance category are adjusted for clinical risk. We have adopted a 
complex patient bonus at the final score level that adjusts again for 
patient clinical complexity as well as some elements of social 
complexity. We also continue to consider ways to offer actionable 
feedback on cost measures to clinicians in the future.
    In regards to the episode-based measures, we do not believe the 
introduction of these new measures should mean that the weight of the 
performance category should be maintained, especially since 
stakeholders had the opportunity to gain experience with the new 
measures through field testing in the fall of 2017. The performance 
category also still includes two measures that were used in the first 2 
years of MIPS. The Bipartisan Budget Act of 2018 gave CMS increased 
flexibility to establish the weight of the cost performance category 
for the first 5 years of MIPS, but the weight is still required to be 
30 percent beginning with the 2024 MIPS payment year. Therefore, we 
believe it is necessary to begin adjusting the weight gradually, 
including increasing the weight to 15 percent for the 2021 MIPS payment 
year. We will concurrently look to increase the number of clinicians 
who are measured in the cost performance category by developing and 
considering for inclusion in the Quality Payment Program more episode-
based measures that cover additional types of clinicians and 
specialties.
    After consideration of the public comments, we are finalizing our 
proposal at Sec.  414.1350(d)(3) to weight the cost performance 
category at 15 percent for the 2021 MIPS payment year as proposed. 
Additionally, we are also finalizing our proposal to delete the 
existing text under Sec.  414.1350(b)(3) and address the weight of the 
cost performance category for the MIPS payment years following 2021 in 
future rulemaking as proposed. Finally, we are finalizing our proposed 
technical change to the text at Sec.  414.1350(b) (redesignated as 
Sec.  414.1350(d)) to state that the cost performance category weight 
will be as specified under redesignated Sec.  414.1350(d), unless a 
different scoring weight is assigned by CMS under section 1848(q)(5)(F) 
of the Act, as proposed.
    In accordance with section 1848(q)(5)(E)(i)(II)(bb) of the Act, we 
will continue to evaluate whether sufficient cost measures are ready 
for adoption under the cost performance category and move towards the 
goal of increasing the weight to 30 percent of the final score. To 
provide for a smooth transition, we anticipate that we would increase 
the weight of the cost performance category by 5 percentage points each 
year until we reach the required 30 percent weight for the 2024 MIPS 
payment year. We invited comments on this approach to weighting the 
cost performance category for the 2022 and 2023 MIPS payment years, 
considering our flexibility in setting the weight between 10 percent 
and 30 percent of the final score, the availability of cost measures, 
and our desire to ensure a smooth transition to a 30 percent weight for 
the cost performance category. We appreciate the comments we received 
and will consider them as we develop proposals for future rulemaking.
(b) Cost Criteria
(i) Background
    Under Sec.  414.1350(a), we specify cost measures for a performance 
period to assess the performance of MIPS eligible clinicians on the 
cost performance category. In the CY 2018 Quality Payment Program final 
rule, we established two cost measures (total per capita cost measure 
and Medicare spending per beneficiary (MSPB) measure) for the 2018 MIPS 
performance period and future performance periods (82 FR 53644). These 
measures were previously established for the 2017 MIPS performance 
period (81 FR 77168). We will continue to evaluate cost measures that 
are included in MIPS on a regular basis and anticipate that measures 
could be added or removed through rulemaking as measure development 
continues. In general, we expect to evaluate cost measures according to 
the measure reevaluation and maintenance processes outlined in the 
``Blueprint for the CMS Measures Management System'' (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/BlueprintVer14.pdf). As described in section 
2 of the Blueprint for the CMS Measures Management System Version 14.0, 
we will conduct annual evaluations to review the continued accuracy of 
the measure specifications. Annual updates ensure that the procedure, 
diagnostic, and other codes used in the measure account for updates to 
coding systems over time. To the extent that these updates would 
constitute a substantive change to a measure, we would ensure the 
changes are proposed for adoption through rulemaking. We will also 
comprehensively reevaluate the measures every 3 years to ensure that 
they continue to meet measure priorities. As a part of this 
comprehensive reevaluation, we will gather information through 
environmental scans and literature reviews of recent studies and new 
clinical guidelines that may inform potential refinements. We will also 
analyze measure performance rates and re-assess the reliability and 
validity of the measures. Throughout these

[[Page 59767]]

reevaluation efforts, we will summarize and consider all stakeholder 
feedback received on the measure specifications during the 
implementation process, and may seek input through public comment 
periods. In addition, the measure development contractor may acquire 
individual input on measures by convening Technical Expert Panels 
(TEPs) and clinical subcommittees. Aside from these regular measure 
reevaluations, there may be ad-hoc reviews of the measures if new 
evidence comes to light which indicates that significant revisions may 
be required.
    We will also continue to update the specifications to address 
changes in coding, risk adjustment, and other factors. The process for 
updating measure specifications will take place through ongoing 
maintenance and evaluation, during which we expect to continue seeking 
stakeholder input. As we noted above, any substantive changes to a 
measure would be proposed for adoption in future years through notice 
and comment rulemaking. We appreciate the feedback that we have 
received so far throughout the measure development process and believe 
that stakeholders will continue to provide feedback to the measure 
development contractor on episode-based cost measures by submitting 
written comments during public comment opportunities, by participating 
in the clinical subcommittees convened by the measure development 
contractor, or by attending education and outreach events. We will take 
all comments and feedback into consideration as part of the ongoing 
measure evaluation process.
    As we noted in the CY 2017 Quality Payment Program final rule (81 
FR 77137) regarding quality measures, which we believe would also apply 
for cost measures, some updates may incorporate changes that would not 
substantively change the intent of the measure. Examples of such 
changes may include updated diagnosis or procedure codes or changes to 
exclusions to the patient population or definitions. While we address 
such changes on a case-by-case basis, we generally believe these types 
of maintenance changes are distinct from substantive changes to 
measures that result in what are considered new or different measures. 
As described in section 3 of the Blueprint for the CMS Measures 
Management System Version 14.0, if substantive changes to these 
measures become necessary, we expect to follow the pre-rulemaking 
process for new measures, including resubmission to the Measures Under 
Consideration (MUC) list and consideration by the Measure Applications 
Partnership (MAP). The MAP provides an additional opportunity for an 
interdisciplinary group of stakeholders to provide feedback on whether 
they believe the measures under consideration are attributable and 
applicable to clinicians. The MAP also reviews measures for clinician 
level feasibility, reliability, and validity. They also consider 
whether the measures are scientifically acceptable and reflect current 
clinical guidelines.
    Section 51003(a)(2) of the Bipartisan Budget Act of 2018 amended 
section 1848(r)(2) of the Act to add a new paragraph (I) requiring the 
Secretary to post on the CMS website information on cost measures in 
use under MIPS, cost measures under development and the time-frame for 
such development, potential future cost measure topics, a description 
of stakeholder engagement, and the percent of expenditures under 
Medicare Part A and Part B that are covered by cost measures. This 
information shall be posted no later than December 31 of each year 
beginning with 2018. We expect this posting will provide a list of the 
cost measures established for the cost performance category for the 
current performance period (for example, the posting in 2018 would 
include a list of the measures for the 2018 MIPS performance period), 
as well as a list of any cost measures that may be proposed for a 
future performance period through rulemaking. We will provide 
hyperlinks to the measure specifications documents and include the 
percent of Medicare Part A and Part B expenditures that are covered by 
these cost measures. The posting will also include a list and 
description of the measures under development at that time. We intend 
to summarize the timeline for measure development, including the 
stakeholder engagement activities undertaken, which may include a TEP, 
clinical subcommittees, field testing, and education and outreach 
activities, such as national provider calls and listening sessions. 
Finally, the posting will provide an overview of potential future 
topics in cost measure development, such as any clinical areas in which 
measures may be developed in the future (83 FR 35901 through 35902).
(ii) Episode-Based Measures for the 2019 and Future Performance Periods
    Episode-based measures differ from the total per capita cost 
measure and MSPB measure because episode-based measure specifications 
only include items and services that are related to the episode of care 
for a clinical condition or procedure (as defined by procedure and 
diagnosis codes), as opposed to including all services that are 
provided to a patient over a given timeframe.
    We discussed our progress in the development of episode-based 
measures in the CY 2018 Quality Payment Program proposed rule (82 FR 
30049 through 30050) and received significant positive feedback on the 
process used to develop the measures as well as the measures' clinical 
focus that was informed by expert opinion (82 FR 53644 through 53646). 
The specific measures selected for the initial round of field testing 
were included based on the volume of beneficiaries impacted by the 
condition or procedure, the share of cost to Medicare impacted by the 
condition or procedure, the number of clinicians/clinician groups 
attributed, and the potential for alignment with existing quality 
measures.
    We have developed episode-based measures to represent the cost to 
Medicare for the items and services furnished to a patient during an 
episode of care (``episode''). Episode-based measures are developed to 
let attributed clinicians know the cost of the care clinically related 
to their initial treatment of a patient and provided during the 
episode's timeframe. Specifically, we define cost based on the allowed 
amounts on Medicare claims, which include both Medicare payments and 
beneficiary deductible and coinsurance amounts. Episode-based measures 
are calculated using Medicare Parts A and B fee-for-service claims data 
and are based on episode groups. Episode groups:
     Represent a clinically cohesive set of medical services 
rendered to treat a given medical condition.
     Aggregate all items and services provided for a defined 
patient cohort to assess the total cost of care.
     Are defined around treatment for a condition (acute or 
chronic) or performance of a procedure.
    Items and services in the episode group could be treatment 
services, diagnostic services, and ancillary items and services 
directly related to treatment (such as anesthesia for a surgical 
procedure). They could also be items and services that occur after the 
initial treatment period that may be furnished to patients as follow-up 
care or to treat complications resulting from the treatment. An episode 
is a specific instance of an episode group for a specific patient and 
clinician. For example, in a given year, a clinician might be 
attributed 20 episodes (instances of the episode group) from the 
episode group for heart failure. In section III.I.3.h.(3)(b)(iv) of 
this final rule, we discuss the attribution rules for cost measures.

[[Page 59768]]

    After episodes are attributed to one or more clinicians, items and 
services may be included in the episode costs if they are furnished 
within a patient's episode window. Items and services will be included 
if they are the trigger event for the episode or if a service 
assignment rule identifies them as a clinically related item or service 
during the episode. The detailed specifications for these measures, 
which include information about the service assignment rules, can be 
reviewed at qpp.cms.gov.
    To ensure a more accurate comparison of cost across clinicians, 
episode costs are payment standardized and risk adjusted. Payment 
standardization adjusts the allowed amount for an item or service to 
facilitate cost comparisons and limit observed differences in costs to 
those that may result from health care delivery choices. Payment 
standardized costs remove any Medicare payment differences due to 
adjustments for geographic differences in wage levels or policy-driven 
payment adjustments such as those for teaching hospitals. Risk 
adjustment accounts for patient characteristics that can influence 
spending and are outside of clinician control. For example, for the 
elective outpatient PCI episode-based measure, the risk adjustment 
model may account for a patient's history of heart failure.
    The measure development contractor has continued to seek extensive 
stakeholder feedback on the development of episode-based measures, 
building on the processes outlined in the CY 2018 Quality Payment 
Program final rule (82 FR 53644). These processes included convening a 
TEP and clinical subcommittees to solicit expert and clinical input for 
measure development, conducting national field testing on the episode-
based cost measures developed, and seeking input from clinicians and 
stakeholders through engagement activities. Seven clinical 
subcommittees were convened through an open call for nominations 
between March 17, 2017 and April 24, 2017, composed of nearly 150 
clinicians affiliated with almost 100 specialty societies. These 
subcommittees met at an in-person meeting and through webinars from May 
2017 to January 2018 to select an episode group or groups to develop 
and provide detailed clinical input on each component of episode-based 
cost measures. These components included episode triggers and windows, 
item and service assignment, exclusions, attribution methodology, and 
risk adjustment variables.
    As described in the CY 2018 Quality Payment Program final rule (82 
FR 53645), we provided an initial opportunity for clinicians to review 
their performance based on the new episode-based measures developed by 
the clinical subcommittees in the fall of 2017 through national field 
testing.
    During field testing, we sought feedback from stakeholders on the 
draft measure specifications, feedback report format, and supplemental 
documentation through an online form. We received over 200 responses, 
including 53 comment letters, during the field test feedback period. We 
shared the feedback on the draft measure specifications with the 
clinical subcommittees who considered it in providing input on measure 
refinements after the end of field testing. A field testing feedback 
summary report is publicly available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/2018-field-testing-feedback-summary-report.pdf.
    To engage clinicians and stakeholders, we conducted extensive 
outreach activities including hosting National Provider Calls (NPCs) to 
provide information about the measure development process and field 
test reports, and to give stakeholders the opportunity to ask 
questions.
    The new episode-based measures developed by the clinical 
subcommittees were considered by the NQF-convened MAP, and were all 
conditionally supported by the MAP, with the recommendation of 
obtaining NQF endorsement. We intend to submit these episode-based 
measures to NQF for endorsement in the future. The MAP provides an 
opportunity for an interdisciplinary group of stakeholders to provide 
input on whether the measures under consideration are attributable and 
applicable to clinicians. The MAP also reviews measures for clinician 
level feasibility, reliability, and validity. Following the successful 
field testing and review through the MAP process, we proposed to add 8 
episode-based measures listed in Table 36 as cost measures for the 2019 
MIPS performance period and future performance periods (83 FR 35902).
    The attribution methodology for these measures is discussed in 
section III.I.3.h.(3)(b)(iv)(B) of this final rule. The detailed 
specifications for these measures can be reviewed at qpp.cms.gov. These 
specifications documents consist of (i) a methods document that 
outlines the methodology for constructing the measures, and (ii) a 
measure codes list file that contains the medical codes used in that 
methodology. First, the methods document provides a high-level overview 
of the measure development process, including discussion of the 
detailed clinical input obtained at each step, and details about the 
components of episode-based cost measures: Defining an episode group; 
assigning costs to the episode group; attributing the episode group; 
risk adjusting episode group costs; and aligning cost with quality. The 
methods document also contains the detailed measure methodology that 
describes each logic step involved in constructing the episode groups 
and calculating the cost measure. Second, the measure codes list file 
contains the codes used in the specifications, including the episode 
triggers, exclusions, episode sub-groups, assigned items and services, 
and risk adjustors.

 Table 36--Episode-Based Measures Proposed for the 2019 MIPS Performance
                  Period and Future Performance Periods
------------------------------------------------------------------------
        Measure topic                         Measure type
------------------------------------------------------------------------
Elective Outpatient            Procedural.
 Percutaneous Coronary
 Intervention (PCI).
Knee Arthroplasty............  Procedural.
Revascularization for Lower    Procedural.
 Extremity Chronic Critical
 Limb Ischemia.
Routine Cataract Removal with  Procedural.
 Intraocular Lens (IOL)
 Implantation.
Screening/Surveillance         Procedural.
 Colonoscopy.
Intracranial Hemorrhage or     Acute inpatient medical condition.
 Cerebral Infarction.
Simple Pneumonia with          Acute inpatient medical condition.
 Hospitalization.
ST-Elevation Myocardial        Acute inpatient medical condition.
 Infarction (STEMI) with
 Percutaneous Coronary
 Intervention (PCI).
------------------------------------------------------------------------


[[Page 59769]]

    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Several commenters supported our proposed adoption of the 
8 episode-based measures under the cost performance category for the 
2021 MIPS payment year. These commenters noted their support for the 
significant clinician input into the measures.
    Response: We thank the commenters for their support.
    Comment: Several commenters supported the development of episode-
based measures but expressed concern about including them in the MIPS 
cost performance category for the 2019 MIPS performance period. They 
recommended that there be additional time for clinicians to understand 
and address their performance on the measures. One commenter indicated 
that although the measures had been made available as part of field 
testing in the fall of 2017, the feedback that was made available did 
not facilitate action to improve on the part of the clinician. Another 
commenter suggested that CMS use 2019 as a pilot year to better test 
these new episode-based measures.
    Response: We will continue to work to make clinicians more familiar 
with the measures through education and outreach activities. For 
example, we have held cost performance category webinars to help 
clinicians understand the cost measures in use for the MIPS 2018 
performance period, and expect to hold similar webinars in the future. 
We believe that the extensive field testing activities conducted in the 
fall of 2017 in combination with future education and outreach will 
help to ensure clinicians will understand these episode-based measures 
and what actions they could take to improve their performance in the 
measures. We do not believe that an additional year of pilot testing is 
necessary at this time given the field testing and extensive 
involvement of clinicians in the development of these measures.
    Comment: Many commenters requested more detailed feedback on cost 
measures in order to improve their performance, stating that it is 
difficult to manage costs without receiving data on the patients 
attributed to them for purposes of the cost measures. Some commenters 
requested that CMS provide information on attributed patients on a 
regular basis, such as quarterly. Some commenters expressed concern 
that in contrast with the Value Modifier program, CMS has not provided 
detailed feedback on cost measures, such as identifying beneficiaries 
and the services they received for the 2017 MIPS performance period. 
One commenter also suggested the use of an alternative metric, such as 
the average ratio of the observed cost compared to the expected cost, 
as a final comparison for the episode-based measures, as they believe 
this to be more informative and actionable for clinicians.
    Response: We have conducted user research on the feedback provided 
for the first year of MIPS. In addition to that feedback, we are also 
reviewing the QRURs from the legacy VM program and conducting user 
research about what is valuable within the information provided 
historically. We are committed to maturing the feedback experience for 
year 2 and may consider providing beneficiary-level data on cost 
measures in the future. Additionally, while we are unsure whether or 
not the average ratio of the observed cost to expected cost would be 
more informative than our current feedback reports, we will continue to 
monitor the information provided, and explore ways to provide 
actionable information to clinicians as we develop the measures for the 
cost performance category.
    Comment: A few commenters supported the development and inclusion 
of episode-based measures but expressed concern that measures for their 
particular specialty or focus area, such as urology, chiropractic 
medicine, and medical oncology, were not yet included. A few commenters 
suggested that CMS continue to engage with stakeholders and provide a 
transparent process as CMS continues to develop additional episode-
based measures. One commenter recommended that CMS develop or include 
quality measures in tandem with cost measures to prevent unintended 
consequences of attempts to reduce cost which could adversely affect 
quality of care.
    Response: We continue to work to develop new episode-based measures 
that could be considered for inclusion in the cost performance category 
in future years. We expect that future measures may apply to a greater 
range of specialties and clinical areas, such as urology and the other 
focus areas suggested by commenters. Section 1848(r)(2)(D)(i)(I) of the 
Act requires us to establish care episode groups and patient condition 
groups, which account for a target of an estimated one half of 
expenditures under parts A and B with such target increasing over time 
as appropriate. While we have developed some episode-based measures to 
target that goal as required, we shall continue our work to develop 
additional measures focusing on both additional specialty types as well 
as consider the important issue of measuring both cost and quality. By 
continuing to gather detailed clinician and expert input on episode-
based measures, such as through clinical subcommittees and technical 
expert panels, we hope to identify and mitigate potential unintended 
consequences at each stage of measure development and testing.
    Comment: A few commenters expressed concern with the overall 
process for adding episode-based measures to the MIPS program on an 
annual basis. They indicated that while clinician input is valuable in 
defining the measures, it is also of particular importance to have an 
underlying structure for episode-based measures that defines 
responsibility for patients as they cross between multiple episodes. 
They opposed inclusion of episode-based measures until these issues are 
addressed. Additionally, several commenters offered alternative 
frameworks to consider in the future development of episode-based 
measures, including moving towards a tool that offers a multi-payer 
perspective. One commenter urged CMS to develop episode-based measures 
that are specific to discrete episodes of care. A few commenters 
encouraged CMS to consider other factors when developing episode-based 
measures including Activities of Daily Living (ADLs), counter quality 
measures, patient specific pricing, and medical innovations.
    Response: We rely on a comprehensive framework and systematic 
process for creating episode-based measures that account for the roles 
and responsibilities of individual clinicians in the care of individual 
patients experiencing specific health conditions. This framework has 
been applied in constructing all of the new cost measures for use in 
MIPS, and in revising episode groups that had been developed under 
section 1848(n)(9)(A) of the Act. Our current process includes: (1) A 
transparent conceptual framework for creating episodes of care that 
assigns costs for patients to those clinicians with the ability to 
influence those costs; (2) a mechanism for incentivizing high quality 
treatment that lowers preventable high cost future adverse health 
events; and (3) a data-driven stakeholder input process for acquiring 
and implementing clinical input that ensures clinical face validity and 
actionability of constructed episode-based cost measures. This 
framework was developed in part based on stakeholder comments on 
measures in the Value Modifier program and overcomes the fundamental 
shortcomings of earlier episode grouping approaches previously studied

[[Page 59770]]

by CMS. Shortcomings of previously studied episode grouping approaches 
included lack of actionability arising from the unpredictable and 
clinically inappropriate assignment of costs, limited relevance as 
episode constructions did not focus on the role of attributed 
clinicians in providing patient care, and limited transparency arising 
from the use of complicated software algorithms.
    Our conceptual framework provides a comprehensive foundation for 
episode-based measures that can be used to incentivize high-value care 
by attributed clinicians at each stage of the patient care continuum, 
and allows for progressively adding new episode-based measures in a 
logically cohesive and consistent manner. The framework involves three 
distinct types of episode groups: Procedural, acute inpatient medical 
condition, and chronic. Procedural episode groups are triggered by 
performance of a major procedure, acute inpatient medical condition 
episode groups are triggered by evaluation and management claims during 
hospitalizations with specific DRGs, and chronic condition episode 
groups are triggered by evaluation and management claims with 
particular diagnoses. Attribution is determined by the clinician(s) 
involved in the triggering claims, with consistent rules within each 
type of episode group. Services, and their associated costs, are 
assigned to an episode based on a clinical determination of whether a 
service is under the influence of the attributed clinician (for 
example, routine follow-up care or adverse health outcomes such as a 
readmission). Clinical determinations of service assignment are made 
using common criteria and methods across episode groups, to encourage 
distinctions in service assignment and reflect differences in clinical 
influence across episode groups. Risk adjustment employs a common 
starting point of the CMS-HCC model across episode groups, but risk 
adjustment models can be enhanced by the use of risk factors 
specifically adapted for each episode group. This allows, for instance, 
for adjustments to be made for an acute condition episode group based 
on whether the condition is a stand-alone presentation of the condition 
versus the exacerbation of an ongoing chronic condition. The framework 
also allows for complete stratification in risk adjustment through the 
use of episode sub-groups, with the definition of sub-groups (such as 
unilateral vs. bilateral) being based on common principles across 
episode groups. Episodes from distinct episode groups can overlap with 
one another to ensure that each clinician treating a patient with 
multiple health issues has incentives for providing high value care. 
When a given service is clinically related to only one overlapping 
episode, it is assigned only to that one. When a service is clinically 
related to two overlapping episodes, it is assigned to both to ensure 
joint accountability. Since each episode's cost is compared to a risk-
adjusted expected cost only for other episodes from the same episode 
group, there is no issue of double counting. This approach allows for 
development of distinct episode groups that cover a patient's care 
continuum, including an underlying chronic condition as well as a 
procedure or treatment for an exacerbation. As an example, a patient 
receiving chronic care for coronary artery disease (CAD) (a chronic 
episode) could have an acute incidence of STEMI requiring PCI for 
stabilization (an acute inpatient medical condition episode), and due 
to having severe CAD could later receive a coronary artery bypass graft 
(CABG) procedure (a procedural episode). This logically, cohesive 
framework for episode group development avoids a series of challenges 
raised by previously studied episode grouping approaches that assign 
services to only a single episode, including lack of transparency and 
predictability in what an attributed clinician will be held accountable 
for at the beginning of an episode. For information on how this 
framework has been operationalized, refer to the measure specifications 
available at https://qpp.cms.gov.
    Using this conceptual framework, we have created a concrete process 
for developing new measures over time. To prioritize the areas for 
development of the new cost measures, our measure development 
contractor convened a clinical committee, comprised of over 70 
clinicians affiliated with over 50 specialty societies that provided 
input necessary to develop a public posting of 117 episode groups for 
development in December 2016. We then used criteria vetted by a 
standing technical expert panel--comprised of 19 clinicians, health 
researchers, and representatives of patient advocacy organizations--to 
divide these 117 episode groups into 18 clinical areas. The 
prioritization criteria focused on identifying areas where potential 
episode-based measures could affect the highest number of beneficiaries 
and clinicians, address particularly high cost procedures and 
conditions, provide an opportunity for improvement, and best align with 
quality measures.
    Our measure development contractor has and is continuing to convene 
clinical subcommittees for each of the priority clinical areas. The 
composition of a subcommittee for an area principally consists of 
practicing clinicians who are candidates for attribution of episode-
based measures developed for that area. Each clinical subcommittee 
prioritizes specific episode measures for development within its area 
based on the criteria above. The structure for developing specific cost 
measures relies on a systematic data-based conceptual framework for 
triggering logic, cohort definition, attribution, and cost assignment. 
For the 8 episode-based measures discussed in this rule, nearly 150 
clinicians affiliated with 98 specialty societies participated in the 
clinical subcommittees in the creation of these measures. After 
positive reception of the initial development process, 267 clinicians 
affiliated with more than 120 specialty societies are now participating 
in the clinical subcommittees and workgroups developing 11 additional 
episode-based cost measures. The structure of episode-based cost 
measure development provides a vehicle for continued stakeholder 
engagement as additional measures are developed in the future.
    Comment: A few commenters recommended that episode-based measures 
not be included in the MIPS cost performance category if the measures 
have not been endorsed by the NQF or supported by the MAP. They stated 
that the NQF process gives important insights into the reliability, 
validity, and usability of measures.
    Response: The episode-based measures were reviewed by the MAP and 
received the recommendation of ``conditional support for rulemaking,'' 
with the MAP recommending that the measures be submitted for NQF 
endorsement. This review provided stakeholders with additional public 
comment opportunities, which the MAP considered along with submission 
materials regarding the scientific acceptability, reliability, 
validity, and usability of the measures. We intend to submit the 
episode-based measures for NQF endorsement in an upcoming review cycle.
    Comment: One commenter expressed concern that particular episode-
based measures did not properly account for risk because of the nature 
of their construction and lack of clinical data. Specifically, this 
commenter stated that a combined measure of intracranial hemorrhage and 
cerebral infraction

[[Page 59771]]

would produce distortions in results. This commenter also stated that 
risk adjustment for this measure did not include a measure of stroke 
severity. Another commenter expressed uncertainty about the risk 
adjustment methodology and also suggested the use of both inpatient and 
outpatient claims data to obtain a complete understanding of the 
patient's risk factors. One commenter suggested excluding Implantable 
Cardioverter Defibrillator (ICD) implantation MS-DRGs (222-227) from 
the Elective Outpatient PCI and STEMI with PCI measures to ensure there 
are no adverse incentives to providing a service that is both covered 
and clinically indicated. One commenter expressed concern that the 
episode-based measure for Revascularization for Lower Extremity Chronic 
Critical Limb Ischemia should have a longer measurement period. One 
commenter requested that post-discharge events unrelated to the initial 
pneumonia hospitalization and any hospice costs be excluded for the 
Simple Pneumonia episode-based measure. The same commenter also stated 
that new episodes for the same measure should not be started for a 
patient if they already have an ongoing episode.
    Response: We understand the interest in risk adjustment and other 
aspects of measure construction. To summarize, the risk adjustment for 
the eight episode-based measures includes risk adjustors from the CMS-
HCC model and additional measure-specific risk adjustors recommended by 
the Clinical Subcommittee for the measure. Risk adjustors are defined 
using the beneficiary's Medicare claims history (including inpatient, 
outpatient, and Part B Physician/Supplier claims) during the period 
prior to the start of the episode. Claims from the triggering 
hospitalization or on the triggering Part B Physician/Supplier claim 
are typically not included, as we understand it may be difficult to 
discern which claims are due to complications and which were already 
present at the initiation of the episode. We believe that utilizing the 
claims from the look back window adequately identifies patient 
comorbidities. To address the specific comments, we believe that the 
Intracranial Hemorrhage and Cerebral Infarction measure accurately 
assesses clinician cost performance as there are separate sub-groups 
for Intracerebral Hemorrhage and Cerebral Infarction such that patients 
within each sub-group are compared only with each other (that is, a 
patient being treated for Cerebral Infarction would only be compared to 
other patients being treated for Cerebral Infarction). The risk 
adjustors for this measure were developed with significant input from a 
Neuropsychiatric Disease Management Clinical Subcommittee, which 
recommended specific risk adjustors that include MS-DRG severity for 
Intracranial Hemorrhage or Cerebral Infarction and Nonspecific 
Cerebrovascular Disorders. Additional risk adjustors were included to 
account for comorbidities that could lead to worse outcomes such as 
aphasia and dysphagia. However, measures of stroke severity such as the 
NIH stroke scale were not included in the risk adjustment model to 
avoid possible unintended consequences (for example, coding of higher 
severity for improvement of individual episode risk adjustment) and to 
avoid penalizing clinicians who do not code for severity, especially 
since ICD-10-CM codes for NIH Stroke Scale have only been operational 
since October 2017. The Revascularization for Lower Extremity Chronic 
Critical Limb Ischemia measure has a 30-day pre-trigger period and a 
90-day post-trigger period. This episode window was determined through 
extensive input from a Peripheral Vascular Disease Management Clinical 
Subcommittee, which we believe to be an appropriate length of time for 
which the attributed clinician can reasonably influence services. The 
measure specifications, including the post-discharge assigned services, 
for the Simple Pneumonia with Hospitalization measure were developed 
with significant clinical input from the Pulmonary Disease Management 
Clinical Subcommittee, which only assigned services they believed the 
attributed clinician could reasonably influence. For this reason, the 
costs associated with the hospice setting are not assigned to Simple 
Pneumonia with Hospitalization episodes. We will conduct annual 
evaluations to review the continued accuracy of the measure 
specifications. Finally, we do not exclude episodes if a patient 
already qualifies for another episode since we believe that allowing 
for overlapping episodes incentivizes communication and care 
coordination as a patient progresses through the care continuum. For 
example, if a patient is re-hospitalized for pneumonia after an initial 
pneumonia episode, this triggers two separate episodes of care for 
pneumonia. The risk adjustment model adjusts for differences in 
clinical complexity at the time each episode begins. This ensures that 
the attributed clinicians managing each hospitalization face analogous 
incentives to provide the patient high value care. The assigned 
services for the STEMI with PCI and Elective Outpatient PCI measures 
were developed with input from the Cardiovascular Disease Management 
Clinical Subcommittee, with the goal of capturing complications of 
Myocardial Infarction (MI) or Heart Failure (HF) admissions. Given this 
clinical intent of the measure, we believe that MS-DRGs with MI or HF 
in the measure (MS-DRGs 222-223: Defib with Cath with MI/HF) are 
appropriate to include as assigned services. We agree, however, with 
the comment about removing assignments of the MS-DRGs without MI or HF 
(MS-DRGs 224-225: Defib with Cath without MI/HF and MS-DRGs 226-227: 
Defib without Cath without MI/HF), as these are more likely to be 
elective ICD placements. Given the scope of the measure, we believe it 
is appropriate to assign services that are part of an admission for MI 
or HF, while excluding services that are elective. To maintain a 
consistent framework across all measures, we are implementing this 
revision where relevant in STEMI with PCI, Elective Outpatient PCI, and 
Revascularization for Lower Extremity Chronic Critical Limb Ischemia.
    Comment: One commenter expressed concern with the possibility of 
high cost variation for some episode-based measures depending on the 
codes that trigger the episodes or the place of service in which an 
episode is triggered. To account for this variation, the commenter 
suggested incorporating a sub-group based on the triggering DRG code 
for the Intracranial Hemorrhage or Cerebral Infarction measure and the 
STEMI with PCI measure, a sub-group based on triggering procedure code 
for the Elective Outpatient PCI measure, and a place of service sub-
group for the Revascularization for Lower Extremity Chronic Critical 
Limb Ischemia measure and Screening/Surveillance Colonoscopy measure.
    Response: The measure specifications, including the episode 
triggers and the sub-groups for each measure, were determined with 
significant clinical input from the Clinical Subcommittees that 
developed each episode-based measure. To adjust for patient differences 
outside attributed clinicians' influence, the Clinical Subcommittees 
could choose to risk adjust for a specific patient factor or sub-group 
by that factor. Risk adjustment ensures that a measure accounts for 
average cost differences associated with the specific factor, while 
sub-grouping involves estimating an entirely separate risk adjustment 
model for patients with that factor. Sub-grouping is only appropriate

[[Page 59772]]

in cases where a sufficient number of episodes are present in the sub-
population to ensure a statistically meaningful model and where a 
separate model for the sub-population is necessary. Balancing these 
considerations, the Clinical Subcommittees addressed concerns raised by 
the commenter by: Including indicators for MS-DRG in risk adjustment 
models for the Intracranial Hemorrhage or Cerebral Infarction measure 
and the STEMI with PCI measure to reflect the presence of Complication 
or Comorbidity (CC) or Major Complication or Comorbidity (MCC); and 
including place of service factors in risk adjustment models for the 
Revascularization for Lower Extremity Chronic Critical Limb Ischemia 
measure and the Screening/Surveillance Colonoscopy measure. For the 
Elective Outpatient PCI measure, the current inclusion of other risk 
adjustment factors is designed to control for factors outside of the 
clinician's influence that may dictate the particular triggering 
procedure used.
    Comment: Several commenters expressed support for the episode-based 
measure development process implemented by CMS that incorporates 
significant stakeholder input as well as support for the measures. One 
commenter commended CMS for convening the Clinical Subcommittees, 
specifically noting that they believed members of the subcommittee that 
developed the Screening/Surveillance Colonoscopy measure were part of a 
successful and deliberative process. Two commenters also supported the 
Routine Cataract with IOL Implantation measure, stating the measure 
accurately reflected the costs of the procedure and will provide 
actionable data to clinicians. Another commenter expressed appreciation 
for the pace of the development process and urged CMS to continue this 
level of engagement with stakeholders in other areas of the Quality 
Payment Program.
    Response: We recognize the importance of clinician input in 
developing episode-based measures that provide actionable data and aim 
to continue this level of engagement in the development of future 
episode-based measures for MIPS.
    Comment: One commenter supported the total per capita cost measure 
and stated it is the best initial metric for assessing the cost-
effectiveness of primary care providers while fulfilling MACRA's 
mandate to evaluate a primary care provider's cost performance.
    Response: We agree that this measure is important as a measure of 
the overall cost of care, even as we develop episode-based measures 
which are also important measures of the cost of care.
    Comment: Several commenters opposed the continued inclusion of the 
total per capita cost measure and the MSPB measure in the cost 
performance category. They stated that the measures included all 
services provided to a patient, even those for which the attributed 
clinician could not control. One commenter requested that these 
measures only be applied to primary care clinicians and not to 
specialists. Finally, one commenter expressed concerns with how total 
per capita cost measure has not yet been endorsed by NQF, and MSPB 
measure has only been endorsed at the facility-level.
    Response: While we appreciate the interest in the total per capita 
cost and MSPB measures' NQF endorsement status, we continue to believe 
that these measures are tested and reliable for Medicare populations 
and provide an important measurement of clinician cost performance (82 
FR 53644) while we continue to develop episode-based measures that 
precisely identify services that are part of an episode that could be 
considered directly under the control of a clinician. Versions of the 
total per capita cost and MSPB measures were included in the QRURs and 
used in the VM for many years before the implementation in MIPS. These 
measures have an important place in cost measurement given that the 
episode-based measures will only apply to a subset of clinicians at 
this time.
    The total per capita cost measure uses a primary care attribution 
method in which a specialist would not be attributed a patient unless 
that patient did not see a primary care clinician (based on the 
Medicare specialty) during the year. For some patients who do not see a 
primary care clinician in a year, a specialist may serve as a primary 
care clinician due to an underlying disease or condition which the 
specialist focuses on. For the MSPB measure, we do not believe it is 
appropriate to limit attribution to primary care clinicians as 
specialists may perform procedures or manage patients in the hospital 
and can have a significant influence on the overall spending during the 
hospitalization.
    Both the total per capita cost and MSPB measures are being refined 
as part of the measure maintenance and re-evaluation process, 
incorporating substantial stakeholder input. We are completing an 
extensive outreach initiative in the fall of 2018 to share performance 
information with clinicians as part of field testing, a part of measure 
re-evaluation. After considering the stakeholder feedback on these 
refinements, we may propose the re-evaluated measures for use in MIPS 
to replace the current versions of the measures in the program.
    Comment: Several commenters expressed concern about the risk and 
specialty adjustment methods used in the measures that are part of the 
cost performance category. In particular, several commenters stated 
that measures do not appropriately account for sociodemographic status, 
which can drive differences in average episode costs. Additionally, 
commenters noted that measures did not take into account the risks 
associated with complex or dual-eligible patients or patients seen by 
certain specialists. Another noted the lack of risk-adjustment for 
cancer treatment. One commenter also expressed concern about the 
differences in case-mix across specialties for a given measure, 
specifically STEMI with PCI. The commenter stated that under this 
measure, hospitalists may be attributed episodes that include more 
medically complex patients who require post-ICU care on a general 
medicine floor, making these hospitalists appear to be costlier than 
other clinicians.
    Response: We understand stakeholders' concerns regarding risk 
adjustment for social risk factors and dual eligible status. As we have 
previously stated, we are concerned about holding clinicians to 
different standards for the outcomes of their patients with social risk 
factors, because we do not want to mask potential disparities. We 
believe that the path forward should incentivize improvements in health 
outcomes for disadvantaged populations while ensuring that 
beneficiaries have adequate access to excellent care. We thank 
commenters for this important feedback and will continue to consider 
options to account for social risk factors that would allow us to view 
disparities and potentially incentivize improvement in care for 
patients and beneficiaries. We recognize the concern regarding risk 
adjusting for complex patients, including those with cancer treatment, 
and regarding the variation in case-mix across specialties for a given 
episode. Our risk adjustment methodology, which employs a common 
starting point of the CMS-HCC model across episode groups and can 
include the use of risk factors specifically adapted for each episode 
group is designed to account for patient comorbidities that predict a 
complex hospitalization and lead to higher costs that are outside the 
influence of attributed clinicians, regardless of

[[Page 59773]]

which specialty designations those clinicians choose to identify.
    Comment: Several commenters requested that certain clinicians be 
excluded or included in the cost performance category on the basis of 
their type of practice, particularly non-patient facing clinicians.
    Response: We have established a policy to assign a zero percent 
weight to the cost performance category if there are not sufficient 
measures applicable and available to a MIPS eligible clinician (see, 
for example, 81 FR 77322 through 77325). We believe it is possible that 
a clinician may not have sufficient cost measures applicable or 
available to them based on their specialty or type of practice, 
including clinicians who are non-patient facing. We continue to work to 
expand the reach of the cost performance category to as many clinicians 
as possible, including non-patient facing clinicians in accordance with 
section 1848(q)(2)(C)(iv) of the Act.
    After consideration of the public comments, we are finalizing our 
proposal to include the 8 episode-based measures listed in Table 36 in 
the cost performance category beginning with the 2019 MIPS performance 
period with a modification to the STEMI with PCI, Elective Outpatient 
PCI, and Revascularization for Lower Extremity Chronic Critical Limb 
Ischemia episode-based measures to remove assignments of the MS-DRGs 
without MI or HF (MS-DRGs 224-225: Defib with Cath without MI/HF and 
MS-DRGs 226-227: Defib without Cath without MI/HF).
(iii) Reliability
    In the CY 2017 Quality Payment Program final rule (81 FR 77169 
through 77170), we finalized a reliability threshold of 0.4 for 
measures in the cost performance category. We seek to ensure that MIPS 
eligible clinicians are measured reliably. In the CY 2017 Quality 
Payment Program final rule, we finalized a case minimum of 20 for the 
episode-based measures specified for the 2017 MIPS performance period 
(81 FR 77175). We examined the reliability of the proposed 8 episode-
based measures listed in Table 36 at various case minimums and found 
that all of these measures meet the reliability threshold of 0.4 for 
the majority of clinicians and groups at a case minimum of 10 episodes 
for procedural episode-based measures and 20 episodes for acute 
inpatient medical condition episode-based measures. Furthermore, these 
case minimums would balance the goal of increased reliability with the 
goal of adopting cost measures that are applicable to a larger set of 
clinicians and clinician groups. Our analysis indicated that the case 
minimum for procedural episode-based measures could be lower than that 
of acute inpatient medical condition episode-based measures while still 
ensuring reliable measures.
    Table 37 presents the percentage of TINs and TIN/NPIs with 0.4 or 
higher reliability, as well as the mean reliability for the subset of 
TINs and TIN/NPIs who met the proposed case minimums of 10 episodes for 
procedural episode-based measures and 20 episodes for acute inpatient 
medical condition episode-based measures for each of the proposed 
episode-based measures. Each row in Table 37 provides the percentage of 
TINs and TIN/NPIs who had reliability of 0.4 or higher among all the 
TINs and TIN/NPIs who met the case minimum for that measure during the 
study period (6/1/2016 to 5/31/2017).

  Table 37--Percentage of TINs and TIN/NPIs With 0.4 or Higher Reliability From June 1, 2016 to May 31, 2017 at
                                             Proposed Case Minimums
----------------------------------------------------------------------------------------------------------------
                                                    Percentage                    Percentage TIN/
                                                   TINs with 0.4       Mean        NPIs with 0.4       Mean
                  Measure name                       or higher      reliability      or higher      reliability
                                                    reliability      for TINs       reliability    for TIN/NPIs
                                                        (%)                             (%)
----------------------------------------------------------------------------------------------------------------
Elective Outpatient Percutaneous Coronary                  100.0            0.73            84.1            0.53
 Intervention (PCI).............................
Knee Arthroplasty...............................           100.0            0.87           100.0            0.81
Revascularization for Lower Extremity Chronic              100.0            0.74           100.0            0.64
 Critical Limb Ischemia.........................
Routine Cataract Removal with Intraocular Lens             100.0            0.95           100.0            0.94
 (IOL) Implantation.............................
Screening/Surveillance Colonoscopy..............           100.0            0.96           100.0            0.93
Intracranial Hemorrhage or Cerebral Infarction..           100.0            0.70            74.9            0.48
Simple Pneumonia with Hospitalization...........           100.0            0.64            31.8            0.40
ST-Elevation Myocardial Infarction (STEMI) with            100.0            0.59           100.0            0.59
 PCI............................................
----------------------------------------------------------------------------------------------------------------

    Based on this analysis, we proposed at Sec.  414.1350(c)(4) and (5) 
a case minimum of 10 episodes for the procedural episode-based measures 
and 20 episodes for the acute inpatient medical condition episode-based 
measures beginning with the 2019 MIPS performance period (83 FR 35904). 
We stated that these case minimums would ensure that the measures meet 
the reliability threshold for groups and individual clinicians. We 
stated that we believe that the proposed case minimums for these 
procedural and acute inpatient medical condition episode-based measures 
would achieve a balance between several important considerations. In 
order to help clinicians become familiar with the episode-based 
measures as a robust and clinician-focused form of cost measurement, we 
want to provide as many clinicians as possible the opportunity to 
receive information about their performance on reliable measures. This 
is consistent with the stakeholder feedback that we have received 
throughout the measure development process. We stated that we believe 
that calculating episode-based measures with these case minimums would 
accurately and reliably measure the performance of a large number of 
clinicians and clinician group practices.
    We stated that we recognize that the percentage of TIN/NPIs with 
0.4 or greater reliability for the Simple Pneumonia with 
Hospitalization measure, while still meeting our reliability threshold, 
is somewhat lower than that of the other proposed acute inpatient 
medical condition episode-based measures, as well as all of the 
proposed procedural episode-based measures. For this reason, we 
considered an alternative case minimum of 30 for both TIN/NPIs and TINs 
for this measure. At this case minimum, 100 percent of TIN/NPIs would 
have 0.4 or greater reliability and the mean reliability would increase 
to 0.49 for TIN/NPIs and 0.70 for TINs. However, the number of TINs and 
TIN/NPIs that would meet the case minimum for this important measure 
would decrease by 29 percent for TINs and by 84 percent for TIN/NPIs. 
We invited comments on

[[Page 59774]]

this alternative case minimum for TIN/NPIs and TINs for the Simple 
Pneumonia with Hospitalization episode-based measure.
    We previously finalized a case minimum of 35 for the MSPB measure 
(81 FR 77171), 20 for the total per capita cost measure (81 FR 77170), 
and 20 for the episode-based measures specified for the 2017 MIPS 
performance period (81 FR 77175). We proposed to codify these final 
policies under Sec.  414.1350(c) (83 FR 35904).
    In general, higher case minimums increase reliability, but also 
decrease the number of clinicians who are measured. We aim to measure 
as many clinicians as possible in the cost performance category. Some 
clinicians or smaller groups may never see enough patients in a single 
year to meet the case minimum for a specific episode-based measure. For 
this reason, we solicited comment on whether we should consider 
expanding the performance period for the cost performance category 
measures from a single year to 2 or more years in future rulemaking. We 
believe this would allow us to more reliably measure a larger number of 
clinicians. However, we are also concerned that expanding the 
performance period would increase the time between the measurement of 
performance and the application of the MIPS payment adjustment. In 
addition, it would take a longer period of time for us to introduce new 
cost measures as we would expect to adopt them through rulemaking prior 
to the beginning of the performance period.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Many commenters expressed concern with the reliability 
thresholds that we use to inform the determination of case minimums in 
the cost performance category. Several of these commenters suggested 
that measures should have case minimums that would reflect 0.8 
reliability for all TINs and TIN/NPI combinations. One commenter stated 
that using a low reliability threshold would result in measuring the 
acuity of patients as opposed to the performance of a clinician. 
Another commenter suggested that we consider whether a standard case 
minimum for all episode group should continue to be set or case 
minimums should be set accordingly for each individual measure. One 
commenter also suggested increasing to a 20 episode case minimum for 
procedural episode-based measures.
    Response: Because we aim to balance the need for consistent program 
standards with ensuring that measures are reliable, we proposed to set 
a different case minimum for the procedural and acute inpatient medical 
condition episode-based measures. We aim to measure cost for as many 
clinicians as possible, and limiting measures to reliability of 0.7 or 
0.8 would result in few individual clinicians with attributed cost 
measures. In addition, a 0.4 reliability threshold ensures moderate 
reliability for most MIPS eligible clinicians and group practices that 
are being measured on cost. Under the proposed case minimum of 10 
episodes for the procedural episode-based measures, the reliability of 
the measures already exceeds the 0.4 reliability threshold we have 
previously established, with most having higher than 0.7 reliability. 
Using a 20 episode case minimum, while having a slight increase in 
reliability, will reduce clinician coverage. Therefore, retaining the 
proposed case minimum of 10 episodes for the procedural measures allows 
us to maximize the number of clinicians covered by these measures, 
while still exceeding the 0.4 moderate reliability threshold. We will 
continue to evaluate reliability as we develop new measures and propose 
them for inclusion in MIPS in future rulemaking.
    Comment: Several commenters supported our alternative proposal for 
a case minimum of 30 for the Simple Pneumonia with Hospitalization 
measure. The commenters stated that using a more reliable measure would 
be preferred over measuring more clinicians.
    Response: We agree that our proposed alternative case minimum of 30 
episodes for the Simple Pneumonia with Hospitalization measure would 
have slightly higher reliability, but we also believe that maintaining 
a consistent case minimum across all acute inpatient medical condition 
episode-based measures would accurately and reliably assess cost 
measure performance for a large number of clinicians and clinician 
groups. We believe it is in the interests of MIPS participants, 
particularly specialists who treat patients for this condition, to have 
this new episode-based measure available to them. A consistent case 
minimum for acute inpatient medical condition episode-based measures 
would also make it easier for clinicians to understand because it 
establishes cohesiveness across the different measures as stakeholders 
are still becoming familiar with these new measures. The mean 
reliability of the Simple Pneumonia with Hospitalization measure at 20 
episodes exceeds the 0.4 reliability threshold (indicating moderate 
reliability) for TINs and meets that threshold for TIN/NPIs.
    Comment: One commenter stated that small practices are less 
reliably measured by cost measures and that it will be difficult for 
small practices to analyze cost data in order to improve.
    Response: While we have not examined the issue of practice size in 
relation to the reliability of the cost measures, we have examined the 
issue of case size in relation to the reliability of cost measures. The 
results of the analysis of episode-based cost measures can be found in 
our National Summary Data Report on Eight Wave 1 Episode-Based Cost 
Measures at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Updated-2017-National-Summary-Data-Report.pdf. To some degree, the size 
of a practice correlates with the case size for cost measures, as an 
individual clinician can only see so many patients. We believe that 
establishing case minimums that are based on moderate reliability allow 
us to measure all clinicians and groups that meet those case minimums. 
We note that the scores on the measures in the cost performance 
category are only a component of the MIPS final score, which also 
includes a small practice bonus available within the quality 
performance category to accommodate the issues that may be faced by 
small practices.
    After consideration of the public comments, we are finalizing our 
proposed case minimum of 10 episodes for the procedural episode-based 
measures and 20 episodes for the acute inpatient medical condition 
episode-based measures beginning with the 2019 MIPS performance period 
at Sec.  414.1350(c)(4) and (5) as proposed. We are also finalizing our 
proposal to codify our previously finalized case minimum of 35 for the 
MSPB measure, 20 for the total per capita cost measure, and 20 for the 
episode-based measures specified for the 2017 MIPS performance period 
at Sec.  414.1350(c) as proposed. We will take the comments we received 
on expanding the performance period for measures in the cost 
performance category into account for future rulemaking.
(iv) Attribution
(A) Attribution Methodology for Cost Measures
    In the CY 2017 Quality Payment Program final rule (81 FR 77168 
through 77169; 77174 through 77176), we adopted final policies 
concerning the attribution methodologies for the total

[[Page 59775]]

per capita cost measure, the MSPB measure, and the episode-based 
measures specified for the 2017 MIPS performance period in addition to 
an attribution methodology for individual clinicians and groups. We 
proposed to codify these final policies under Sec.  414.1350(b).
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Several commenters expressed concern with the attribution 
methods finalized in the 2017 Quality Payment Program final rule (81 FR 
77168 through 77169), which we proposed to codify. These commenters 
stated that it was unclear to clinicians which patients would be 
attributed to them. They recommended a number of methods to improve 
this process, such as offering feedback on the patients that may be 
attributed to a clinician at some time during the performance period or 
allowing clinicians to define attribution with the use of patient 
relationship codes.
    Response: We will continue to look at ways to facilitate the 
engagement of clinicians in the measures in the cost performance 
category and will look into offering as much information as is feasible 
to clinicians.
    Comment: Several commenters expressed concern with the attribution 
methodology for the total per capita cost measure that we finalized in 
the CY 2017 Quality Payment Program final rule (81 FR 77168 through 
77169), which we proposed to codify. In particular, they expressed 
concerns with the identification of clinicians such as nurse 
practitioners and physician assistants as primary care clinicians under 
this methodology, because many of them work in specialist practices.
    Response: We believe that attribution methods that include nurse 
practitioners (NP) and physician assistants (PA) as primary care 
clinicians best represents the role they play in clinical care. Under 
the attribution methodology for the total per capita cost measure, a 
patient who saw a primary care physician more often than an NP or PA in 
a specialty practice would be attributed to that primary care 
physician. As we have observed in rulemaking for the Value Modifier (79 
FR 67961), including NPs and PAs in the first step of attribution in 
the total per capita care cost measure did not significantly affect the 
attribution of patients.
    Comment: Several commenters expressed concern with the attribution 
methods used for the MSPB measure for which we finalized policy in the 
CY 2017 Quality Payment Program final rule (81 FR 77168 through 77169) 
and which we proposed to add to regulatory text. Many of the commenters 
expressed concern that the method of attribution was assigning patients 
to non-patient facing specialists such as pathologists and radiologists 
because they may provide expensive services, but do not provide overall 
care management for the patient. A few commenters requested that non-
patient facing clinicians not be attributed this measure.
    Response: We believe that the MSPB measure continues to be an 
important measure of the overall cost of care for a patient and the 
clinician who provides the plurality of care. We believe that a 
clinician who provides the plurality of care in a hospital has 
opportunities to affect the cost of care for that patient. In some 
cases that may be a non-patient facing clinician, who in order to 
provide the plurality of care, would have provided a significant amount 
of service to a hospitalized patient.
    After consideration of the public comments, we are finalizing our 
proposal to codify the previously adopted final policies at Sec.  
414.1350(b) as proposed.
(B) Attribution Rules for the Episode-Based Measures
    In section III.I.3.h.(3)(b)(ii) of this final rule, we finalized 8 
episode-based measures for the cost performance category for the 2019 
MIPS performance period and future performance periods, which can be 
categorized into two types of episode groups: Acute inpatient medical 
condition episode groups, and procedural episode groups. These measures 
only include items and services that are related to the episode of care 
for a clinical condition or procedure (as defined by procedure and 
diagnosis codes), as opposed to including all services that are 
provided to a patient over a given period of time. The attribution 
methodology will be the same for all of the measures within each type 
of episode groups--acute inpatient medical condition episode groups and 
procedural episode groups. Our approach to attribution will ensure that 
the episode-based measures reflect the roles of the individuals and 
groups in providing care to patients.
    For acute inpatient medical condition episode groups specified 
beginning in the 2019 performance period, we proposed at Sec.  
414.1350(b)(6) to attribute episodes to each MIPS eligible clinician 
who bills inpatient evaluation and management (E&M) claim lines during 
a trigger inpatient hospitalization under a TIN that renders at least 
30 percent of the inpatient E&M claim lines in that hospitalization (83 
FR 35905). We stated that a trigger inpatient hospitalization is a 
hospitalization with a particular MS-DRG identifying the episode group. 
These MS-DRGs, and any supplementary trigger rules, are identified in 
the measure specifications posted at qpp.cms.gov. The measure score for 
an individual clinician (TIN/NPI) is based on all of the episodes 
attributed to the individual. The measure score for a group (TIN) is 
based on all of the episodes attributed to a TIN/NPI in the given TIN. 
If a single episode is attributed to multiple TIN/NPIs in a single TIN, 
the episode is only counted once in the TIN's measure score. We stated 
that we believe that establishing a 30 percent threshold for the TIN 
would ensure that the clinician group is collectively measured across 
all of its clinicians who are likely responsible for the oversight of 
care for the patient during the trigger hospitalization.
    This proposed attribution approach differs from the attribution 
approach previously established for episode-based measures for acute 
inpatient medical conditions specified for the 2017 performance period 
in the CY 2017 Quality Payment Program final rule (81 FR 77174 through 
77175). The previous approach attributed episodes to TIN/NPIs who 
individually exceed the 30 percent E&M threshold, while excluding all 
episodes where no TIN/NPI exceeds the 30 percent threshold. Throughout 
the measure development process, stakeholders have discussed the team-
based nature of acute care, in which multiple clinicians share 
management of a patient during a hospital stay. The previous approach 
outlined in the CY 2017 Quality Payment Program final rule (81 FR 77174 
through 77175) does not capture patients' episodes when a group 
collaborates to manage a patient but no individual clinician exceeds 
the 30 percent threshold. Based upon stakeholder feedback, our proposed 
approach emphasizes team-based care and expands the measures' coverage 
of clinicians, patients, and cost.
    We provided an example to illustrate the proposed attribution rules 
for acute inpatient medical condition episode groups in the proposed 
rule (83 FR 35905).
    For procedural episode groups specified beginning in the 2019 MIPS 
performance period, we proposed at Sec.  414.1350(b)(7) to attribute 
episodes to each MIPS eligible clinician who renders a trigger service 
as identified by HCPCS/CPT procedure codes (83 FR 35905). These trigger 
services are identified in the measure specifications posted at 
qpp.cms.gov. We stated that the measure score for an individual

[[Page 59776]]

clinician (TIN/NPI) is based on all of the episodes attributed to the 
individual. The measure score for a group (TIN) is based on all of the 
episodes attributed to a TIN/NPI in the given TIN. If a single episode 
is attributed to multiple TIN/NPIs in a single TIN, the episode is only 
counted once in the TIN's measure score. We stated that we believe this 
approach best identifies the clinician(s) responsible for the patient's 
care. This attribution method is similar to that used for procedural 
episode-based measures in the 2017 MIPS performance period but more 
clearly defines that the services must be provided during the episode 
and how we would address instances in which two NPIs in the same TIN 
provided a trigger service.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: One commenter supported our proposed attribution methods 
for the procedural and acute inpatient medical condition episode-based 
measures.
    Response: We appreciate the support of the commenter.
    Comment: A few commenters agreed with the importance of shared 
accountability in attribution, with one commenter noting that they 
believed the proposed methodology represented a novel approach to this 
shared accountability. However, a few commenters opposed our proposed 
attribution methodology for acute inpatient medical condition episode-
based measures. A few commenters recommended that the required 
percentage be increased. A few commenters expressed concern that a 
single patient could be attributed to many clinicians in a practice if 
they participated in MIPS as individuals under this proposed 
attribution method. This commenter stated that a clinician billing for 
a single service during a hospitalization could not be expected to have 
a significant effect on costs. A few commenters stated that this change 
in attribution methodology had been made following the episode-based 
measure field testing and could undercut the viability of measures 
established with clinical input.
    Response: We appreciate the support for the emphasis on team-based 
care and shared accountability in the attribution methodology. We also 
appreciate the interest in increasing the E&M threshold percentage as 
part of the attribution methodology for the acute inpatient medical 
condition episode-based measures. While there is interest in increasing 
the E&M threshold and concern about the impact of the proposed 
attribution methodology on clinicians participating in MIPS as 
individuals, we believe that the methodology as proposed appropriately 
balances the interest in team-based care and enabling as many 
clinicians as possible to be attributed to these new acute inpatient 
medical condition episode-based measures. Specifically, we believe that 
an E&M threshold requirement of 30 percent reflects stakeholder input 
throughout the measure development process to reasonably reflect the 
nature of care in an inpatient setting, and it is in the interests of a 
large number of clinicians and clinician groups to be able to access 
these episode-based measures. We disagree that the proposed methodology 
undercuts the viability of the episode-based measures. Each component 
of the measures reflects feedback that the measure development 
contractor has gathered from clinical subcommittees, a technical expert 
panel, and public comments, including during field testing in 2017. We 
believe that the changes made to the attribution methodology after 
field testing reflect the purpose of such testing--which we believe 
goes beyond the typical testing associated with many performance 
measures--to reveal issues and to gather stakeholder feedback to inform 
potential measure refinements. This included feedback on the importance 
of incorporating considerations of care coordination into the 
attribution methodology. We believe that a clinician participating as 
an individual who bills one E&M claim within a TIN that has 30 percent 
of the total E&Ms for that trigger inpatient stay does not necessarily 
have limited influence on episode costs due to the nature of inpatient 
care involving teams. In addition, we seek to incentivize clinicians to 
engage in greater care coordination throughout a patient's trajectory. 
The case minimum of 20 for acute inpatient medical condition episode-
based measures as finalized above ensures that clinicians are reliably 
measured in providing care to beneficiaries with those specific 
conditions. We note that the mean reliability for the measures meets or 
exceeds the established 0.4 reliability threshold under this 
attribution methodology for TINs and TIN/NPIs.
    Comment: Some commenters expressed concern with our procedural 
episode groups proposal to attribute episodes to each MIPS eligible 
clinician who renders a trigger service as identified by HCPCS/CPT 
procedure codes. One commenter suggested that a clinician should be 
required to bill at least two service codes in order to be attributed a 
procedural episode in order to increase the reliability of the measure. 
One commenter recommended that a single clinician should not be solely 
attributed the costs for a patient based on the provision of a trigger 
service, but that the responsibility should be shared among all 
clinicians who treated the patient during the episode. One commenter 
stated that the same patient would be attributed twice if a two-stage 
procedure were performed.
    Response: We believe that in the case of a procedural episode, the 
clinician who performs the service has a significant influence on the 
costs of care that are part of the episode that follows the provision 
of that service. These clinicians perform significant therapeutic and 
diagnostic services, and the episode-based measures are intended to 
limit costs to those which the clinician can affect, such as by 
avoiding complications or better managing the patient during the 
episode. In many cases, it would not be practical to require more than 
a single service, such as in cases of surgical services which may 
encompass much of the period of the episode.
    After consideration of the public comments, we are finalizing as 
proposed our proposal at Sec.  414.1350(b)(6) for acute inpatient 
medical condition episode groups specified beginning in the 2019 
performance period, to attribute episodes to each MIPS eligible 
clinician who bills inpatient evaluation and management (E&M) claim 
lines during a trigger inpatient hospitalization under a TIN that 
renders at least 30 percent of the inpatient E&M claim lines in that 
hospitalization. Additionally, we also finalizing as proposed our 
proposal at Sec.  414.1350(b)(7) for procedural episode groups 
specified beginning in the 2019 MIPS performance period, to attribute 
episodes to each MIPS eligible clinician who renders a trigger service 
as identified by HCPCS/CPT procedure codes.
(4) Improvement Activities Performance Category
(a) Background
    In CY 2017 Quality Payment Program final rule (81 FR 77179 through 
77180), we codified at Sec.  414.1355 that the improvement activities 
performance category would account for 15 percent of the final score. 
We refer readers to section III.I.3.i.(1)(e) of this final rule where 
we proposed to modify Sec.  414.1355 to provide further technical 
clarifications. In addition, in the CY 2018 Quality Payment Program 
final

[[Page 59777]]

rule (82 FR 53649), we codified at Sec.  414.1380(b)(3)(iv) that the 
term recognized be accepted as equivalent to the term certified when 
referring to the requirements for a patient-centered medical home to 
receive full credit for the improvement activities performance category 
for MIPS. We also finalized at Sec.  414.1380(b)(3)(x) that for the 
2020 MIPS payment year and future years, to receive full credit as a 
certified or recognized patient-centered medical home or comparable 
specialty practice, at least 50 percent of the practice sites within 
the TIN must be recognized as a patient-centered medical home or 
comparable specialty practice (82 FR 53655). We refer readers to 
section III.I.3.i.(1)(e)(i)(D) of this final rule for details on our 
proposals regarding patient-centered medical homes.
    In the CY 2017 Quality Payment Program final rule (81 FR 77539), we 
codified the definition of improvement activities at Sec.  414.1305 to 
mean an activity that relevant MIPS eligible clinicians, organizations, 
and other relevant stakeholders identify as improving clinical practice 
or care delivery and that the Secretary determines, when effectively 
executed, is likely to result in improved outcomes. Further, in that 
final rule (81 FR 77190), we codified at Sec.  414.1365 that the 
improvement activities performance category would include the 
subcategories of activities provided at section 1848(q)(2)(B)(iii) of 
the Act. We also codified subcategories for improvement activities at 
Sec.  414.1365 (81 FR 77190).
    We also previously codified in the CY 2017 and CY 2018 Quality 
Payment Program final rules (81 FR 77180 and 82 FR 53651, respectively) 
data submission criteria for the improvement activities performance 
category at Sec.  414.1360(a)(1). In addition, we established 
exceptions for: Small practices; practices located in rural areas; 
practices located in geographic HPSAs; non-patient facing individual 
MIPS eligible clinicians or groups; and individual MIPS eligible 
clinicians and groups that participate in a MIPS APM or a patient-
centered medical home submitting in MIPS (81 FR 77185, 77188). 
Specifically, we codified at Sec.  414.1380(b)(3)(vii) that non-patient 
facing MIPS eligible clinicians and groups, small practices, and 
practices located in rural areas and geographic HPSAs receive full 
credit for the improvement activities performance category by selecting 
one high-weighted improvement activity or two medium-weighted 
improvement activities; such practices receive half credit for the 
improvement activities performance category by selecting one medium-
weighted improvement activity (81 FR 77185). We refer readers to 
section III.I.3.i.(1)(e)(i)(B) of this final rule for our proposals 
related to that provision. In addition, we specified at Sec.  414.1305 
that rural areas refers to ZIP codes designated as rural, using the 
most recent HRSA Area Health Resource File data set available (81 FR 
77188, 82 FR 53582). Lastly, we finalized the meaning of Health 
Professional Shortage Areas (HPSA) at Sec.  414.1305 to mean areas as 
designated under section 332(a)(1)(A) of the Public Health Service Act 
(81 FR 77188). In the CY 2018 Quality Payment Program final rule (82 FR 
53581), we modified the definition of small practices at Sec.  414.1305 
to mean practices consisting of 15 or fewer eligible clinicians.
    In the CY 2019 PFS proposed rule (83 FR 35906 through 35912), we 
requested comments on our proposals to: (1) Revise Sec.  414.1360(a)(1) 
to more accurately describe the data submission criteria; (2) delete 
Sec.  414.1365 and move improvement activities subcategories to Sec.  
414.1355(c); (3) update the criteria considered for nominating new 
improvement activities; (4) modify the Annual Call for Activities 
timeline for the CY 2019 performance period and future years; (5) add 6 
new improvement activities for the CY 2019 performance period and 
future years; (6) modify 5 existing improvement activities for the CY 
2019 performance period and future years; and (7) remove 1 existing 
improvement activity for the CY 2019 performance period and future 
years. In addition, we also requested comments on our proposals with 
respect to the CMS Study on Factors Associated with Reporting Quality 
Measures for the CY 2019 performance period and future years the 
following proposals: (1) Change the title of the study to CMS Study on 
Factors Associated with Reporting Quality Measures; (2) increase the 
sample size to a minimum of 200 participants; (3) limit the focus group 
requirement to a subset of the 200 participants; and (4) require that 
at least one of the minimum of three required measures be a high 
priority measure. We are also making clarifications to: (1) 
Considerations for selecting improvement activities for the CY 2019 
performance period and future years; and (2) the weighting of 
improvement activities.
    These topics are discussed in more detail below.
(b) Submission Criteria
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77181) for submission mechanism policies we finalized and 
codified for the transition year of MIPS. In the CY 2018 Quality 
Payment Program final rule (82 FR 53651), we continued these policies 
for future years. Specifically, we finalized that for MIPS Year 2 and 
future years, MIPS eligible clinicians or groups must submit data on 
MIPS improvement activities in one of the following manners: Qualified 
registries; EHR submission mechanisms; QCDR; CMS Web Interface; or 
attestation. Additionally, we finalized that for activities that are 
performed for at least a continuous 90-days during the performance 
period, MIPS eligible clinicians must submit a yes response for 
activities within the improvement activities inventory. In addition, in 
the case where an individual MIPS eligible clinician or group is using 
a health IT vendor, QCDR, or qualified registry for their data 
submission, we finalized that the MIPS eligible clinician or group must 
certify all improvement activities were performed and the health IT 
vendor, QCDR, or qualified registry would submit on their behalf (82 FR 
53650 through 53651). We also updated Sec.  414.1360 to reflect those 
changes (82 FR 53651). We refer readers to section III.I.3.h.(1) of 
this final rule, MIPS Performance Category Measures and Activities, 
where we discuss our finalized policies to update the data submission 
process for MIPS eligible clinicians, groups and third party 
intermediaries, by updating our terminology. We also refer readers to 
changes to Sec.  414.1325 for data submission requirements. In the CY 
2019 PFS proposed rule (83 FR 35906), we proposed those changes to more 
closely align with the actual submission experience users have.
    In alignment with those proposals, we also proposed to revise Sec.  
414.1360(a)(1) to more accurately reflect the data submission process 
for the improvement activities performance category. In particular, in 
the CY 2019 PFS proposed rule (83 FR 35906), we proposed that instead 
of ``via qualified registries; EHR submission mechanisms; QCDR, CMS Web 
Interface; or attestation,'' as currently stated, we revised the first 
sentence to state that data would be submitted ``via direct, login and 
upload, and login and attest'' as discussed in section III.I.3.h.(1)(b) 
of this final rule. In addition, we proposed to add further additions 
to Sec.  414.1360(a)(1) to specify, submit a yes response for each 
improvement activity that is performed for at least a continuous 90-day 
period during the applicable performance period.
    We did not receive any comments on these proposals. Therefore, we 
are

[[Page 59778]]

finalizing our proposals, as proposed, to revise the first sentence of 
Sec.  414.1360(a)(1) to state that data must be submitted via direct, 
login and upload, and login and attest. In addition, we are finalizing 
our proposal, as proposed, to update Sec.  414.1360(a)(1) to specify: 
Submit a yes response for each improvement activity that is performed 
for at least a continuous 90-day period during the applicable 
performance period.
(c) Subcategories
    In the CY 2017 Quality Payment Program final rule (81 FR 77190), we 
finalized at Sec.  414.1365 that the improvement activities performance 
category includes the subcategories of activities provided at section 
1848(q)(2)(B)(iii) of the Act. It has since come to our attention that 
it is unnecessary to have a separate regulation text included under 
Sec.  414.1365 since the subcategories are not a component of the 
scoring calculations. Therefore, in the CY 2019 PFS proposed rule (83 
FR 35906 through 35907), we proposed to delete Sec.  414.1365 and move 
the same improvement activities subcategories to Sec.  414.1355(c). We 
reiterate that we did not propose any changes to the subcategories 
themselves. These subcategories are:
     Expanded practice access, such as same day appointments 
for urgent needs and after-hours access to clinician advice.
     Population management, such as monitoring health 
conditions of individuals to provide timely health care interventions 
or participation in a QCDR.
     Care coordination, such as timely communication of test 
results, timely exchange of clinical information to patients or other 
clinicians, and use of remote monitoring or telehealth.
     Beneficiary engagement, such as the establishment of care 
plans for individuals with complex care needs, beneficiary self-
management assessment and training, and using shared decision making 
mechanisms.
     Patient safety and practice assessment, such as through 
the use of clinical or surgical checklists and practice assessments 
related to maintaining certification.
     Participation in an APM.
     Achieving health equity, such as for MIPS eligible 
clinicians that achieve high quality for underserved populations, 
including persons with behavioral health conditions, racial and ethnic 
minorities, sexual and gender minorities, people with disabilities, 
people living in rural areas, and people in geographic HPSAs.
     Emergency preparedness and response, such as measuring 
MIPS eligible clinician participation in the Medical Reserve Corps, 
measuring registration in the Emergency System for Advance Registration 
of Volunteer Health Professionals, measuring relevant reserve and 
active duty uniformed services MIPS eligible clinician activities, and 
measuring MIPS eligible clinician volunteer participation in domestic 
or international humanitarian medical relief work.
     Integrated behavioral and mental health, such as measuring 
or evaluating such practices as: Co-location of behavioral health and 
primary care services; shared/integrated behavioral health and primary 
care records; cross training of MIPS eligible clinicians, and 
integrating behavioral health with primary care to address substance 
use disorders or other behavioral health conditions, as well as 
integrating mental health with primary care.
    The following is a summary of the public comments received on our 
proposals and our responses:
    Comment: One commenter supported the definition of achieving health 
equity and underserved populations. The commenter recommended that we 
explicitly include people with limited English in those groups.
    Response: We will take this suggestion into consideration for the 
future.
    After consideration of the public comments received, we are 
finalizing our proposal, as proposed, to delete Sec.  414.1365 and move 
the same improvement activities subcategories to Sec.  414.1355(c).
(d) Improvement Activities Inventory
    In the CY 2019 PFS proposed rule (83 FR 35907 through 35910), we 
proposed to: (1) Adopt one new criterion and remove one existing 
criterion for nominating new improvement activities beginning with the 
CY 2019 performance period and future years; (2) modify the timeframe 
for the Annual Call for Activities; (3) add 6 new improvement 
activities for the CY 2019 performance period and future years; (4) 
modify 5 existing improvement activities for the CY 2019 performance 
period and future years; and (5) remove 1 existing improvement activity 
for the CY 2019 performance period and future years. We are also making 
clarifications to: (1) Considerations for selecting improvement 
activities for the CY 2019 performance period and future years; and (2) 
the weighting of improvement activities.
(i) Annual Call for Activities
    In the CY 2017 Quality Payment Program final rule (81 FR 77190), 
for the transition year of MIPS, we implemented the initial Improvement 
Activities Inventory and took several steps to ensure it was inclusive 
of activities in line with statutory and program requirements. For Year 
2, we provided an informal process for submitting new improvement 
activities or modifications for potential inclusion in the 
comprehensive Improvement Activities Inventory for the Quality Payment 
Program Year 2 and future years through subregulatory guidance (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Annual-Call-for-Measures-and-Activities-for-MIPS_Overview-Factsheet.pdf). In the CY 2018 Quality Payment Program 
final rule (82 FR 53656 through 53659), for Year 3 and future years, we 
finalized a formal Annual Call for Activities process for adding 
possible new activities or providing modifications to the current 
activities in the Improvement Activities Inventory, including 
information required to submit a nomination form similar to the one we 
utilized for Year 2 (82 FR 53656 through 53659). It is important to 
note that in order to submit a request for a new activity or a 
modification to an existing improvement activity the stakeholder must 
submit a nomination form available at www.qpp.cms.gov during the Annual 
Call for Activities.
(A) Criteria for Nominating New Improvement Activities
    In the CY 2019 PFS proposed rule (83 FR 35907 through 35908), we 
proposed to add one new criterion and remove a previously adopted 
criterion from the improvement activities nomination criteria. We also 
clarified our considerations in selecting improvement activities.
(aa) Currently Adopted Criteria
    In the CY 2017 Quality Payment Program final rule (81 FR 77190 
through 77195), we discussed guidelines for the selection of 
improvement activities. In the CY 2018 Quality Payment Program final 
rule, we formalized the Annual Call for Activities process for Year 3 
and future years and added additional criteria; stakeholders would 
apply one or more of the below criteria when submitting nominations for 
improvement activities (82 FR 53660):
     Relevance to an existing improvement activities 
subcategory (or a proposed new subcategory);

[[Page 59779]]

     Importance of an activity toward achieving improved 
beneficiary health outcome;
     Importance of an activity that could lead to improvement 
in practice to reduce health care disparities;
     Aligned with patient-centered medical homes;
     Focus on meaningful actions from the person and family's 
point of view;
     Support the patient's family or personal caregiver;
     Activities that may be considered for an advancing care 
information bonus;
     Representative of activities that multiple individual MIPS 
eligible clinicians or groups could perform (for example, primary care, 
specialty care);
     Feasible to implement, recognizing importance in 
minimizing burden, especially for small practices, practices in rural 
areas, or in areas designated as geographic HPSAs by HRSA;
     Evidence supports that an activity has a high probability 
of contributing to improved beneficiary health outcomes; or
     CMS is able to validate the activity.
(bb) New Criteria
    We believe it is important to place attention on public health 
emergencies, such as the opioid epidemic, when considering improvement 
activities for inclusion in the Inventory, because their inclusion 
raises awareness for clinicians about the urgency of the situation and 
to promote clinician adoption of best practices to combat those public 
health emergencies. A list of the public health emergency declarations 
is available at https://www.phe.gov/Preparedness/legal/Pages/phedeclaration.aspx. Therefore, in the CY 2019 PFS proposed rule (83 FR 
35907 through 35908), we proposed to adopt an additional criterion 
entitled ``Include a public health emergency as determined by the 
Secretary'' to the criteria for nominating new improvement activities 
beginning with the CY 2019 performance period and future years. We 
invited public comment on our proposal.
    The following is a summary of the public comments received on our 
proposals and our responses:
    Comment: Many commenters supported the additional criterion for 
nominating improvement activities to include public health emergencies, 
noting that such activities are important for patient care and will 
help raise clinician awareness and promote best practices related to 
the medically appropriate, evidence-based, and safe use of opioids in 
treating chronic and acute pain and the use of non-opioid pain 
management treatment alternatives. One commenter stated this criteria 
could help ensure patients receive the most appropriate pain and 
substance use disorder treatments. Another commenter stated this 
criteria could support efforts to mobilize health care resources to 
assist those in need and aid providers in relief efforts.
    Response: We appreciate the commenters' support.
    Comment: One commenter requested clarification regarding whether a 
public health emergency is required to be listed for an improvement 
activity to be considered and whether the improvement activities will 
be removed once the public health emergency has been resolved.
    Response: A list of federal public health emergency declarations is 
available at https://www.phe.gov/Preparedness/legal/Pages/phedeclaration.aspx. Modifications to existing improvement activities 
in the Improvement Activities Inventory, including whether an 
improvement activity should be removed due to a change in a public 
health emergency status, will be considered through the formal Annual 
Call for Activities on a case-by-case basis.
    Comment: A few commenters did not support the proposed addition of 
the public health emergency criteria. One commenter stated there is a 
need for adequate notice and tracking mechanisms and recommended that 
improvement activities should progress through the formal review 
process. Another commenter recommended a process outside the Annual 
Call for Activities that enables clinicians to propose an activity for 
immediate implementation during a public health emergency declaration 
and that such activities remain optional and be granted full credit 
even if the duration does not span at least 90 continuous days.
    Response: We agree that there is a need for adequate notice in 
order to allow clinicians time to prepare. To be clear, Improvement 
Activities will continue to be proposed and adopted via rulemaking; we 
are merely adding a new criteria such that public health emergencies 
are considered when stakeholders nominate improvement activities and 
while we select improvement activities for proposal and adoption into 
the Inventory. We do not agree that we should create a separate process 
outside of the Annual Call for Activities or that such activities 
should remain optional and be granted full credit even if the duration 
does not span at least 90 continuous days. In the CY 2017 Quality 
Payment Program final rule (81 FR 77186), we specified at Sec.  
414.1360 that MIPS eligible clinicians or groups must perform 
improvement activities for at least 90 consecutive days during the 
performance period for improvement activities performance category 
credit.
    Comment: One commenter suggested that there should be a bonus 
associated with the submission of an improvement activity regarding a 
public health emergency.
    Response: We disagree as we do not believe the submission of an 
improvement activity should get bonus points. We are not able to 
provide bonus points for improvement activities at this time.
    After consideration of the public comments received, we are 
finalizing our proposal, as proposed to adopt an additional criterion 
entitled ``Include a public health emergency as determined by the 
Secretary'' to the criteria for nominating new improvement activities 
beginning with the CY 2019 performance period and future years.
(cc) Removal of One Criteria
    In the CY 2017 Quality Payment Program final rule (81 FR 77202 
through 77209), we adopted a policy to award a bonus to the Promoting 
Interoperability performance category score for MIPS eligible 
clinicians who use CEHRT to complete certain activities in the 
improvement activities performance category. We included a designation 
column in the Improvement Activities Inventory at Table H in the 
Appendix of the CY 2017 Quality Payment Program final rule (81 FR 
77817) that indicated which activities qualified for the Promoting 
Interoperability (formerly Advancing Care Information) bonus codified 
at Sec.  414.1380(b)(4)(i)(D).
    In the CY 2019 PFS proposed rule (83 FR 35982), under the Promoting 
Interoperability performance category, we proposed a new approach for 
scoring that moves away from the base, performance, and bonus score 
methodology currently established. This new approach removes the 
availability of a bonus score for attesting to completing one or more 
specified improvement activities using CEHRT beginning with the CY 2019 
performance period and future years. As a result, we do not believe the 
criterion for selecting improvement activities for inclusion in the 
program entitled ``Activities that may be considered for an advancing 
care information bonus'' remains relevant. Therefore, we proposed to 
remove the criterion for selecting improvement activities for inclusion 
in the program entitled ``Activities that may be considered for an 
advancing care information bonus''

[[Page 59780]]

beginning with the CY 2019 performance period and future years (83 FR 
35908).
    If our proposals to add one criterion and remove one criterion are 
adopted as proposed, the new list of criteria for nominating new 
improvement activities for the CY 2019 performance period and future 
years would be as follows:
     Relevance to an existing improvement activities 
subcategory (or a proposed new subcategory);
     Importance of an activity toward achieving improved 
beneficiary health outcome;
     Importance of an activity that could lead to improvement 
in practice to reduce health care disparities;
     Aligned with patient-centered medical homes;
     Focus on meaningful actions from the person and family's 
point of view;
     Support the patient's family or personal caregiver;
     Representative of activities that multiple individual MIPS 
eligible clinicians or groups could perform (for example, primary care, 
specialty care);
     Feasible to implement, recognizing importance in 
minimizing burden, especially for small practices, practices in rural 
areas, or in areas designated as geographic HPSAs by HRSA;
     Evidence supports that an activity has a high probability 
of contributing to improved beneficiary health outcomes;
     Include a public health emergency as determined by the 
Secretary; or
     CMS is able to validate the activity.
    We did not receive any comments on our proposal. Therefore, we are 
finalizing our proposal, as proposed, to remove the criterion entitled 
``Activities that may be considered for an advancing care information 
bonus'' beginning with the CY 2019 performance period and future years. 
We note that this policy is being finalized in alignment with those in 
section III.I.3.h.(5)(d)(ii) of this final rule.
(B) Considerations in Selecting Improvement Activities
    As noted in the CY 2017 Quality Payment Program final rule, we 
intend to use the criteria for nominating new improvement activities in 
selecting improvement activities for inclusion in the program (82 FR 
53659). However, we clarify here that those criteria are but one factor 
in determining which improvement activities we ultimately propose. For 
example, we also generally take into consideration other factors, such 
as whether the nominated improvement activity uses publically available 
products or techniques (that is, does not contain proprietary products 
or information limiting an activity) or whether the nominated 
improvement activity duplicates any currently adopted activity (83 FR 
35908).
(C) Weighting of Improvement Activities
    Given stakeholder feedback requesting additional transparency 
regarding the weighting of improvement activities (82 FR 53657), in the 
CY 2019 PFS proposed rule (83 FR 35908 through 35909), we summarized 
considerations we have previously used to assign weights to improvement 
activities included in the Improvement Activities Inventory (see 
Appendix 2: Improvement Activities, Tables A and B). We also made a few 
clarifications and solicited comment for future weighting 
considerations. These topics are discussed in more detail below.
(aa) Summary of Past Considerations
    In the CY 2017 Quality Payment Program final rule (81 FR 77191), we 
explained that to define the criteria and establish weighting for each 
activity, we engaged multiple stakeholder groups, including the Centers 
for Disease Control and Prevention, Health Resources and Services 
Administration, Office of the National Coordinator for Health 
Information Technology, SAMHSA, Agency for Healthcare Research and 
Quality, Food and Drug Administration, the Department of Veterans 
Affairs, and several clinical specialty groups, small and rural 
practices and non-patient facing clinicians. Activities were proposed 
to be weighted as high based on the extent to which they align with 
activities that support the patient-centered medical home, since that 
is the standard under section 1848(q)(5)(C)(i) of the Act for achieving 
the highest potential score for the improvement activities performance 
category, as well as with our priorities for transforming clinical 
practice (81 FR 77191). Activities that require performance of multiple 
actions, such as participation in the Transforming Clinical Practice 
Initiative (TCPI), participation in a MIPS eligible clinician's state 
Medicaid program, or an activity identified as a public health priority 
(such as emphasis on anticoagulation management or utilization of 
prescription drug monitoring programs) were also proposed to be 
weighted as high (81 FR 77191). We also stated that we believe that 
high-weighting should be used for activities that directly address 
areas with the greatest impact on beneficiary care, safety, health, and 
well-being (81 FR 77194). In the past, we have given certain 
improvement activities high-weighting due to the intensity of the 
activity; for example, one improvement activity was changed to high-
weighting because it often involves travel and work under challenging 
physical and clinical circumstances (81 FR 77194). Also, we note that 
successful participation in the CMS Study on Factors Associated with 
Reporting Quality Measures as discussed in section III.I.3.h.(4)(e) of 
this final rule would result in full credit for the improvement 
activities performance category of 40 points; if participants do not 
meet the study guidelines, they will need to follow the current 
improvement activities guidelines (81 FR 77197).
(bb) Clarifications
    In this final rule, we are clarifying: (a) Our consideration of 
giving high-weighting due to activity intensity; and (b) differences 
between high- and medium-weighting.
(AA) High-Weighting Due to Activity Intensity
    As stated previously, we have given certain improvement activities 
high-weighting due to the intensity of the activity (81 FR 77194). To 
elaborate, we believe that an activity that requires significant 
investment of time and resources should be high-weighted. For example, 
we finalized the CAHPS for MIPS survey as high-weighted (81 FR 77827), 
because it requires a significant investment of time and resources. As 
part of the requirements of this activity, MIPS eligible clinicians: 
(1) Must register for the CAHPS for MIPS survey; (2) must select and 
authorize a CMS-approved survey vendor to collect and report survey 
data using the survey and specifications provided by us; and (3) are 
responsible for vendor's costs to collect and report the survey (ranges 
from approximately $4,000 to $7,000 depending on services requested).
    In contrast, we believe medium-weighted improvement activities are 
simpler to complete and require less time and resources as compared to 
high-weighted improvement activities. For example, we finalized the 
Cost Display for Laboratory and Radiographic Orders improvement 
activity as medium-weighted (82 FR 54188), because the information 
required to be used is readily available (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html) at no 
cost through the Medicare clinical laboratory fee schedule and can be 
distributed in a variety of manners with very little investment (for 
example, it may be displayed in the clinic, provided to patients 
through hardcopies, or incorporated in the electronic health record).

[[Page 59781]]

(BB) High- Versus Medium-Weighting
    We recognize that we did not previously explicitly state separate 
considerations for medium-weighted activities. This is because an 
improvement activity is only either high or medium-weighted. In this 
final rule, we are clarifying that an improvement activity is by 
default medium-weight unless it meets considerations for high-weighting 
as discussed previously (83 FR 35909).
(cc) Request for Comments
    We intend to more thoroughly revisit our improvement activity 
weighting policies in next year's rulemaking. We invited public comment 
on the need for additional transparency and guidance on the weighting 
of improvement activities as we work to refine the Annual Call for 
Activities process for future years. Furthermore, in light of the 
finalized policy to remove bonus points for improvement activities that 
may be applicable to the Promoting Interoperability performance 
category as discussed in sections III.I.3.h.(4)(d)(i)(A)(cc) and 
III.I.3.h.(5)(d)(ii), we recognize the need to continue incentives for 
CEHRT. Therefore, for future consideration, we solicited comment on 
potentially applying high-weighting for any improvement activity 
employing CEHRT. We also invited public comment on any other additional 
considerations for high- or medium-weighting.
    Comment: One commenter supported more transparency regarding the 
differences between high-weight and medium-weight activities and 
encouraged continued education related to the improvement activities 
performance category as new activities are added. Another commenter 
recommended that improvement activities related to Continuing Medical 
Education (CME) be weighted in a bifurcated manner with more 
substantial CME's potentially counting as high-weighted.
    Response: We will take these comments into consideration as we 
develop future policy.
(D) Timeframe for the Annual Call for Activities
    In the CY 2018 Quality Payment Program final rule (82 FR 53660), we 
finalized that we would accept submissions for prospective improvement 
activities and modifications to existing improvement activities at any 
time during the performance period to be added to the Improvement 
Activities Under Review (IAUR) list, for the applicable performance 
period, which would be displayed on a CMS website following the close 
of the Annual Call for Activities. In addition, we finalized that for 
the Annual Call for Activities, only nominations and modifications 
submitted by March 1st would be considered for inclusion in the IAUR 
list and Improvement Activities Inventory for the performance period 
occurring in the following calendar year (82 FR 53660). For example, 
for the CY 2018 Annual Call for Activities, we received nominations for 
new and modified improvement activities from February 1st through March 
1st. Currently, an improvement activity nomination submitted during the 
CY 2018 Annual Call for Activities would be vetted in CY 2018, and 
after review, if accepted by CMS, would be proposed during the CY 2018 
rulemaking cycle for possible implementation in the CY 2019 performance 
period and future years.
    However, the previously established timeline, which includes 
prospective new and modified improvement activities submission period, 
review, and publication of proposed improvement activities for 
implementation in the next performance period, has become operationally 
challenging. Based on our experience over the past 2 years, we have 
found that processing and reviewing the volume of improvement 
activities nominations requires more time than originally thought. In 
addition, preparations and drafting for annual rulemaking begin around 
the time of the close date for the current Annual Call for Activities 
(that is, March 1st), leaving incorporation into the proposed rule 
challenging. Therefore, in the CY 2019 PFS proposed rule, beginning 
with the CY 2019 performance period, we proposed to: (1) Delay the year 
for which nominations of prospective new and modified improvement 
activities would apply; and (2) expand the submission timeframe/due 
date for nominations (83 FR 35909).
    Beginning with the CY 2019 performance period, we proposed to 
change the performance year for which the nominations of prospective 
new and modified improvement activities would apply, such that 
improvement activities nominations received in a particular year will 
be vetted and considered for the next year's rulemaking cycle for 
possible implementation in a future year. This timeframe parallels the 
Promoting Interoperability performance category Annual Call for EHR 
Measures timeframe available at https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/CallForMeasures.html. For 
example, an improvement activity nomination submitted during the CY 
2020 Annual Call for Activities would be vetted, and if accepted by 
CMS, would be proposed during the CY 2021 rulemaking cycle for possible 
implementation starting in CY 2022. We believe this change would give 
us adequate time to thoroughly vet improvement activity nominations 
prior to rulemaking (83 FR 35909).
    Second, beginning with the CY 2019 performance period, we proposed 
to change the submission timeframe for the Annual Call for Activities 
from February 1st through March 1st to February 1st through June 30th, 
providing approximately 4 additional months for stakeholders to submit 
nominations. We believe this change would assist stakeholders by 
providing additional time to submit improvement activities nominations. 
Consistent with previous policy, nominations for prospective new and 
modified improvement activities would be accepted during the Annual 
Call for Activities time period only and would be included in the IAUR 
displayed on a CMS website following the close of the Annual Call for 
Activities (83 FR 35909).
    The following is a summary of the public comments received on our 
proposals and our responses:
    Comment: Several commenters supported the proposed change to the 
Annual Call for Activities timeframe citing that the modified timeline 
provides a longer window during which to propose new improvement 
activities, allows for more advance notice to implement new activities 
that have been finalized, aligns the Annual Call for Activities with 
the Annual Call for Measures, and reduces overall program complexity. 
One commenter noted the new timeframe would ensure that the inventory 
includes an appropriate number of measures that are meaningful to each 
specialty, including non-physician Medicare clinicians, and that are 
appropriate for the patient-centered health care team and have a 
positive impact on patient care.
    Response: We appreciate the commenters' support.
    Comment: Several commenters did not support the proposed extension 
of the timeframe for the Annual Call for Activities and recommended 
that we maintain the current schedule because this would ensure the 
improvement activities inventory include activities that are timely, 
important, relevant, and meaningful to the evolving practice of 
medicine and to public health. One commenter noted extending the 
timeframe from submission to

[[Page 59782]]

implementation is a barrier to previously stated goals in aligning 
improvement activities with the quality improvement cycle. Another 
commenter noted the benefit of being able to modify or add measures 
each year outweighs the need for additional submission time and that 
improvement activities do not require the same reliability and validity 
testing necessary for successful quality measures and that improvement 
activities be considered annually informed by the quality improvement 
cycle. One commenter stated the proposal would impede the ability of 
groups to create activities that raise awareness of novel or pressing 
issues and promote best practices in a timely manner. Another commenter 
urged us to take a modified approach to its proposal in which the 
timeframe to modify existing measures would be shorter than that for 
new measures. One commenter stated that delaying consideration of 
improvement activities until the following year's rule making does not 
appropriately reward early adopters of activities and suggested that 
early adopters of an improvement activity could be given credit.
    Response: Although improvement activities do not have the same 
testing requirements as quality measures, we believe that improvement 
activities are equally important in facilitating clinical practice 
improvement. As such, sufficient time is needed to thoroughly review 
all submissions to ensure we maintain an inventory that is both 
meaningful and robust. In addition, we cannot increase the submission 
period without increasing our review period. It would not be 
operationally feasible to do otherwise. We also do not believe that 
there is a benefit to providing for a review period that does not allow 
for an adequate time to thoroughly vet improvement activity nominations 
prior to rulemaking. However, we will continue to monitor the timeline 
to assess if there are any future improvements that can be made to more 
quickly incorporate new improvement activities into the program when 
feasibly possible. We disagree that the timeframe would impede the 
promotion of best practices or awareness of improvement-related 
activities or issues because stakeholders are not precluded from 
referencing that a particular activity has been submitted for 
consideration as part of the Annual Call for Activities to raise 
awareness and promote best practices. We recognize that the proposed 
extended timeframe does not align with the submission, review, and 
implementation of quality measures as part of the Annual Call for 
Measures; however, we note our proposal parallels our timeframe with 
the Promoting Interoperability performance category Annual Call for EHR 
Measures timeframe (we refer readers to section III.I.3.h.(5)(f) of 
this final rule for more information) and achieves alignment between 
those performance categories.
    After consideration of the public comments received on our 
proposal, we are finalizing our proposal, as proposed, to change the 
performance year for which the nominations of prospective new and 
modified improvement activities would apply, such that beginning with 
the CY 2019 performance period, improvement activities nominations 
received in a particular year will be vetted and considered for the 
next year's rulemaking cycle for possible implementation in a future 
year. In addition, we are finalizing our proposal, as proposed, to 
change the submission timeframe for the Annual Call for Activities from 
February 1st through March 1st to February 1st through June 30th, 
providing approximately 4 additional months for stakeholders to submit 
nominations beginning with the CY 2019 performance period.
(ii) New Improvement Activities and Modifications to and Removal of 
Existing Improvement Activities
    In the CY 2018 Quality Payment Program final rule (82 FR 53660), we 
finalized that we would add new improvement activities to the 
Improvement Activities Inventory through notice-and-comment rulemaking. 
We referred readers to Table H in the Appendix of the CY 2017 Quality 
Payment Program final rule (81 FR 77177 through 77199) and Table F and 
G in the Appendix of the CY 2018 Quality Payment Program final rule (82 
FR 54175 through 54229) for our previously finalized Improvement 
Activities Inventory. In the CY 2019 PFS proposed rule (83 FR 36359 
through 36368), for CY 2019 performance period and future years, we 
proposed 6 new improvement activities; we also proposed to: (1) Modify 
5 existing activities; and (2) remove 1 existing activity. We also 
proposed changes to our CMS Study on Factors Associated with Reporting 
Quality Measures in section III.I.3.h.(4)(e) of this final rule.
    Comment: A few commenters supported the overall approach for the 
improvement activities performance category because of its goal-
oriented and technology-neutral approach to compliance, stating that 
this provides the flexibility needed for clinicians to select the most 
effective approaches for their patients that could include connected 
health technology innovations. One commenter supported the stability in 
the improvement activities performance category and the transparent 
process for adding improvement activities to the inventory.
    Response: We appreciate the commenters' support.
    A summary of the public comments received on specific improvement 
activities proposals and our responses may be found in Tables A and B 
of Appendix 2: Improvement Activities in this final rule.
(e) CMS Study on Factors Associated With Reporting Quality Measures
(i) Background
    In the CY 2017 Quality Payment Program final rule (81 FR 77195), we 
created the Study on Improvement Activities and Measurement. In CMS' 
quest to create a culture of improvement using evidence based medicine 
on a consistent basis, fully understanding the strengths and 
limitations of the current processes is crucial to better understand 
and improve these current processes. We proposed to conduct a study on 
clinical improvement activities and measurement to examine clinical 
quality workflows and data capture using a simpler approach to quality 
measures (81 FR 77196). The lessons learned in this study on practice 
improvement and measurement may influence changes to future MIPS data 
submission requirements. The goals of the study are to see whether 
there will be improved outcomes, reduced burden in reporting, and 
enhancements in clinical care by selected MIPS eligible clinicians (81 
FR 77196). This study shall inform us on the root causes of clinicians' 
performance measure data collection and submission burdens, as well as 
challenges that hinder accurate and timely quality measurement 
activities. Our goals are to use high quality, low cost measures that 
are meaningful, easy to understand, operable, reliable, and valid. As 
discussed in the CY 2017 Quality Payment Program final rule (81 FR 
77195) the CMS Study on Burden Associated with Quality Reporting goals 
are to see whether there will be improved outcomes, reduced burden in 
reporting, and enhancements in clinical care by selected MIPS eligible 
clinicians desiring:
     A more data driven approach to quality measurement.
     Measure selection unconstrained by a CEHRT program or 
system.
     Improving data quality submitted to CMS.

[[Page 59783]]

     Enabling CMS to get data more frequently and provide 
feedback more often.
    This study evolved into ``CMS Study on Burdens Associated with 
Reporting Quality Measures'' in the CY 2018 Quality Payment Program 
final rule (82 FR 53662).
    This study is ongoing, participants are recruited on a yearly basis 
for a minimum period of 3 years, and current participants can opt-in or 
out when the study year ends (81 FR 77195). Successful participation in 
the study would result in full credit for the improvement activities 
performance category of 40 points; if participants do not meet the 
study guidelines, they will need to follow the current improvement 
activities requirements (81 FR 77197). To meet the study requirements, 
study participants must partake in two web-based survey questionnaires, 
submit data for at least three MIPS clinician quality measures to CMS 
during the CY 2019 performance period, and be available for selection 
and participation in at least one focus group meeting (82 FR 53662).
    Although we did not propose any changes to the study purpose, aim, 
eligibility, or credit, in the CY 2019 PFS proposed rule (83 FR 35910 
through 35911), we proposed, for the CY 2019 performance period and 
future years, changes to the: (1) Title of the study; (2) sample size 
to allow enough statistical power for rigorous analysis within some 
categories, (3) focus group and survey requirements; and (4) measure 
requirements. These proposals are discussed in more detail below.
(ii) Title
    In the CY 2019 PFS proposed rule (83 FR 35910), beginning with the 
CY 2019 performance period, we proposed to change the title of the 
study from ``CMS Study on Burdens Associated with Reporting Quality 
Measures'' to ``CMS Study on Factors Associated with Reporting Quality 
Measures'' to more accurately reflect the study's intent and purpose. 
To assess the root causes of clinician burden associated with the 
collection and submission of clinician quality measures for MIPS, as 
depicted in CY 2017 Quality Payment Program final rule (81 FR 77195), 
replacing ``Burden'' with ``Factors'' in the title will eliminate 
possible response or recall bias that may occur with data collection. 
Having ``burden'' in the study title may elicit the tendency of survey 
participants reporting more on their perception of burden and 
challenges, and/or suppressing other factors that are associated with 
their quality measure data collection and submission, that may be 
relevant to examining the root cause of burden.
    The following is a summary of the public comments related to our 
proposal and our response:
    Comment: One commenter supported the title change stating that the 
terminology changes will attract a more diverse group of study 
participants and encourage clinician participants in the study who will 
work to simplify measures and ensure that that measures bring maximum 
value to CMS, clinicians, and beneficiaries.
    Response: We appreciate the commenters' support.
    After consideration of the comments, we are finalizing our 
proposal, as proposed, to change the title of the study from ``CMS 
Study on Burdens Associated with Reporting Quality Measures'' to ``CMS 
Study on Factors Associated with Reporting Quality Measures'' beginning 
with the CY 2019 performance period.
(iii) Sample Size
(A) Current Policy
    In the CY 2017 Quality Payment Program final rule (81 FR 77196), we 
initially finalized a sample size of 42 participants (comprising of 
groups and individual MIPS eligible facilities). In the CY 2018 Quality 
Payment Program final rule (82 FR 53661), we increased that number and 
finalized a sample size of a minimum of 102 individual and group 
participants for performance periods occurring in CY 2018 for the 
following categories:
     20 urban individuals or groups of <3 eligible clinicians--
(broken down into 10 individuals & 10 groups).
     20 rural individuals or groups of <3 eligible clinicians--
(broken down into 10 individuals & 10 groups).
     10 groups of 3-8 eligible clinicians.
     10 groups of 8-20 eligible clinicians.
     10 groups of 20-100 eligible clinicians.
     10 groups of 100 or greater eligible clinicians.
     6 groups of >20 eligible clinicians reporting as 
individuals--(broken down into 3 urban & 3 rural).
     6 specialty groups--(broken down into 3 reporting 
individually & 3 reporting as a group).
     Up to 10 non-MIPS eligible clinicians reporting as a group 
or individual (any number of individuals and any group size).
(B) New Sample Size
    In the CY 2019 PFS proposed rule (83 FR 35910 through 35911), we 
proposed to again increase the sample size for the CY 2019 performance 
period and future years from a minimum of 102 to a minimum of 200 MIPS 
eligible clinicians, which will enable us to more rigorously analyze 
the statistical difference between the burden and factors associated 
within the categories listed above. This proposed increase in sample 
size would provide the minimum sample needed to get a significant 
result with adequate statistical power to determine whether there are 
any statistically significant differences in quality measurement data 
submission associated with: (1) The size of practice or facility; (2) 
clinician specialty of practice; (3) region of practice; (4) individual 
or group reporting; and (5) clinician quality measure type. This 
rigorous statistical analysis is important, because it facilitates 
tracing the root causes of measurement burdens and data submission 
errors that may be associated with various sub-groups of clinician 
practices using quantitative analytical methods. We believe that a 
larger sample size would also account for any attrition (drop out of 
study participants before the study ends). Therefore, we proposed that 
the new sample size distribution would be:
     40 urban individuals or groups of <3 eligible clinicians--
(broken down into 20 individuals & 20 groups).
     40 rural individuals or groups of <3 eligible clinicians--
(broken down into 20 individuals & 20 groups).
     20 groups of 3-8 eligible clinicians.
     20 groups of 8-20 eligible clinicians.
     20 groups of 20-100 eligible clinicians.
     20 groups of 100 or greater eligible clinicians.
     Up to 6 groups of >20 eligible clinicians reporting as 
individuals--(broken down into 3 urban & 3 rural).
     Up to 6 specialty groups--(broken down into 3 reporting 
individually & 3 reporting as a group).
     Up to 10 non-MIPS eligible clinicians reporting as a group 
or individual (any number of individuals and any group size).
    The following is a summary of the public comments related to our 
proposals and our responses:
    Comment: One commenter supported the continuation of the study to 
gather data on clinical improvement activities and measurement to 
examine clinical quality workflows and data and the proposal to 
increase the sample size of the study, stating that this would be a 
simpler approach and allow more clinicians to participate and increase 
the ability to conduct rigorous statistical analysis with sufficient 
power.

[[Page 59784]]

    Response: We appreciate the commenter's support.
    Comment: One commenter recommended that clinicians located in both 
urban and rural health practitioner shortage areas and clinicians who 
serve a high proportion of low-income patients and patients of color be 
included as study participants.
    Response: We have been recruiting participants from health 
practitioner shortage areas, as well as areas with high proportion of 
patients of color and minority groups.
    Comment: One commenter requested that CMS assure the quality 
reporting burden study includes a sample of clinicians with multiple 
special status categories, such as Certified Registered Nurse 
Anesthetists, citing there is likely a sufficient number of clinicians 
that meet the CMS special status requirements in the six specialty 
groups. The commenter also requested CMS ascertain the burden placed on 
special status clinicians in outpatient and ASC facilities.
    Response: We appreciate the commenter's recommendation. The study 
welcomes all MIPS eligible clinicians, including Certified Registered 
Nurse Anesthetists, and non-MIPS clinicians to apply. We hope to 
further expand the scope of the study in the future.
    After consideration of the comments received, we are finalizing our 
proposal, as proposed, to increase the sample size for the CY 2019 
performance period and future years from a minimum of 102 to a minimum 
of 200 MIPS eligible clinicians.
(iv) Focus Group
(A) Current Policies
    We previously finalized in the CY 2017 Quality Payment Program 
final rule (81 FR 77195) that for the transition year of MIPS, study 
participants were required to attend a monthly focus group to share 
lessons learned in submitting quality data along with providing survey 
feedback to monitor effectiveness. The focus group includes providing 
visual displays of data, workflows, and best practices to share amongst 
the participants to obtain feedback and make further improvements (81 
FR 77196). The focus groups are used to learn from the practices about 
how to be more agile as we test new ways of measure recording and 
workflow (81 FR 77196). In the CY 2018 Quality Payment Program final 
rule (82 FR 53662), for Year 2 and future years, we reduced that 
requirement and finalized that study participants would be required to 
complete at least two web-based survey questionnaire and attend up to 4 
focus group sessions throughout the year, but certain study 
participants would be able to attend less frequently. Each study 
participant is required to complete a survey prior to submitting MIPS 
data and another survey after submitting MIPS data (82 FR 53662). The 
purpose of reducing focus group attendance and survey participation was 
to ease requirements for MIPS eligible clinicians or group of 
clinicians who may have nothing new to contribute, without compromising 
the minimum sample needed for focus groups. For example, if a MIPS 
eligible clinician submitted all 6 measures after collecting 90 days of 
data and attended the first available focus group and/or survey, the 
clinician may have nothing new or relevant to discuss with the research 
team on subsequent focus groups and/or surveys.
(B) New Requirements for Focus Group and Survey Participation
    Although we proposed in the section previously to increase the 
sample size of the study to a minimum of 200 MIPS eligible clinicians, 
we do not believe we need focus groups for the entirety of that 
population. We believe that requiring focus groups for all proposed 
minimum of 200 MIPS eligible clinicians would only result in bringing 
the data to a saturation point, a situation whereby the same themes and 
information are recurring, and no new insights are given by additional 
sources of data from focus groups.
    Instead, we believe that selecting a subset of clinicians, 
purposively, to participate in focus groups would be a more appropriate 
approach because that would allow us to understand the experience of 
select clinicians without imposing undue burden on all. This study is 
voluntary as clinicians nominate themselves to participate and we 
select a cohort from among these volunteers. Therefore, in the CY 2019 
PFS proposed rule (83 FR 35911), we proposed to make the focus group 
participation a requirement only for a selected subset of the study 
participants, using purposive sampling and random sampling methods, 
beginning with the CY 2019 performance period and future years. Those 
selected would be required to participate in at least one focus group 
meeting and complete survey requirement, in addition to all the other 
study requirements. As previously established, each study participant 
is required to complete a survey prior to submitting MIPS data and 
another survey after submitting MIPS data. This requirement would 
continue to apply for each selected subset participating in a focus 
group.
    We did not receive any comments on our proposal. Therefore, we are 
finalizing our proposals, as proposed, to make the focus group 
participation a requirement only for a selected subset of the study 
participants, using purposive sampling and random sampling methods, 
beginning with the CY 2019 performance period and future years. Those 
selected would be required to participate in at least one focus group 
meeting and complete the survey requirements, in addition to all the 
other study requirements (81 FR 77195).
(v) Measure Requirements
(A) Current Requirements
    In the CY 2017 Quality Payment Program final rule (81 FR 77196), we 
finalized that for CY 2017, MIPS eligible clinicians or groups 
participating in the CMS Study would submit their data and workflows 
for a minimum of three MIPS clinician quality measures that are 
relevant and prioritized by their practice. One of the measures must be 
an outcome measure, and one must be a patient experience measure (81 FR 
77196). We also finalized that for future years, participating MIPS 
eligible clinicians or groups would select three of the measures for 
which they have baseline data from the 2017 performance period to 
compare against later performance years. We note that participating 
MIPS eligible clinicians could elect to report on more measures 
originally as this would provide more options from which to select in 
subsequent years for purposes of measuring improvement. In the CY 2018 
Quality Payment Program final rule, we finalized for the Quality 
Payment Program Year 2 and future years, that study participants could 
submit all their quality measures data at once, as it is done in the 
MIPS program, (qpp.cms.gov) (82 FR 53662).
(B) Measure Requirements
    In the CY 2019 PFS proposed rule (83 FR 35911), we proposed to 
continue the previously required minimum number of measures. That is, 
for the CY 2019 performance period and future years: participants must 
submit data and workflows for a minimum of three MIPS quality measures 
for which they have baseline data. However, instead of requiring one 
outcome measure and one patient experience measure as previously 
finalized, we proposed that, for the CY 2019 performance period and 
future years, at least one of the minimum of three measures must be a 
high priority measure as defined at

[[Page 59785]]

Sec.  414.1305. As defined there and discussed in section III.I.3.h.(2) 
of this final rule, a high priority measure means an outcome, 
appropriate use, patient safety, efficiency, patient experience, care 
coordination, or opioid-related quality measure. Outcome measures 
includes intermediate-outcome and patient-reported outcome measures. We 
believe that focusing on high priority measures, rather than patient 
experience measures, is important at this time, because it better 
aligns with the MIPS quality measures data submission criteria. We 
invited public comment on our proposal.
    We did not receive any comments on our proposal. Therefore, we are 
finalizing our proposal, as proposed, that for the CY 2019 performance 
period and future years, at least one of the minimum of three measures 
must be a high priority measure as defined at Sec.  414.1305.
    We note that although the aforementioned activities (that is, the 
CMS Study on Factors Associated with Reporting Quality Measures) 
constitute an information collection request as defined in the 
implementing regulations of the Paperwork Reduction Act of 1995 (5 CFR 
part 1320), the associated burden is exempt from application of the 
Paperwork Reduction Act. Specifically, section 1848(s)(7) of the Act, 
as added by section 102 of MACRA (Pub. L. 114-10) states that Chapter 
35 of title 44, United States Code, shall not apply to the collection 
of information for the development of quality measures.
(5) Promoting Interoperability (PI) (Previously Known as the Advancing 
Care Information Performance Category)
(a) Background
    Section 1848(q)(2)(A) of the Act includes the meaningful use of 
CEHRT as a performance category under the MIPS. In prior rulemaking, we 
referred to this performance category as the advancing care information 
performance category, and it is reported by MIPS eligible clinicians as 
part of the overall MIPS program. As required by sections 1848(q)(2) 
and (5) of the Act, the four performance categories of the MIPS shall 
be used in determining the MIPS final score for each MIPS eligible 
clinician. In general, MIPS eligible clinicians will be evaluated under 
all four of the MIPS performance categories, including the advancing 
care information performance category.
(b) Renaming the Advancing Care Information Performance Category
    In this final rule, we are adopting several scoring and measurement 
policies that will bring the performance category to a new phase of EHR 
measurement with an increased focus on interoperability and improving 
patient access to health information. To better reflect this focus, we 
renamed the advancing care information performance category to the 
Promoting Interoperability (PI) performance category. We believe this 
change will help highlight the enhanced goals of this performance 
category. We are finalizing revisions to the regulation text under 42 
CFR part 414, subpart O, to reflect the new name.
(c) Certification Requirements Beginning in 2019
    Under the definition of CEHRT under Sec.  414.1305, for the 
performance periods in 2017 and 2018, MIPS eligible clinicians had 
flexibility to use EHR technology certified to either the 2014 or 2015 
Edition certification criteria, or a combination of the two Editions, 
to meet the objectives and measures specified for the Promoting 
Interoperability performance category (82 FR 53671 through 53672). As 
we finalized previously (82 FR 53671-53672) beginning with the 
performance period in 2019, MIPS eligible clinicians must use EHR 
technology certified to the 2015 Edition certification criteria as 
specified at Sec.  414.1305. We believe it is appropriate to require 
the use of 2015 Edition CEHRT beginning in CY 2019. In reviewing the 
state of health information technology, it is clear the 2014 Edition 
certification criterion are out of date and insufficient for clinician 
needs in the evolving health information technology (IT) industry. It 
will be beneficial to health IT developers and health care providers to 
move to more up-to-date standards and functions that better support 
interoperable exchange of health information and improve clinical 
workflows.
    We received many comments regarding the requirement to use the 2015 
Edition of CEHRT beginning in 2019. As we stated in the CY 2019 PFS 
proposed rule (83 FR 35912 through 35913), we did not propose to change 
the requirement. Because the requirement was not a subject of this 
rulemaking, we are not responding to the comments we received, although 
we may consider them to inform our future policy making in this subject 
area.
(d) Scoring Methodology
(i) Scoring Methodology for 2017 and 2018 Performance Periods
    Section 1848(q)(5)(E)(i)(IV) of the Act states that 25 percent of 
the MIPS final score shall be based on performance for the Promoting 
Interoperability performance category. Accordingly, under Sec.  
414.1375(a), the Promoting Interoperability performance category 
comprises 25 percent of a MIPS eligible clinician's final score for the 
2019 MIPS payment year and each MIPS payment year thereafter, unless we 
assign a different scoring weight. We proposed to revise Sec.  
414.1375(a) (83 FR 35913) to specify the various sections of the 
statute (sections 1848(o)(2)(D), 1848(q)(5)(E)(ii), and 1848(q)(5)(F) 
of the Act) under which a different scoring weight may be assigned for 
the Promoting Interoperability performance category. We established the 
reporting criteria to earn a performance category score for the 
Promoting Interoperability performance category under Sec.  
414.1375(b). We proposed to revise Sec.  414.1375(b)(2)(i) to replace 
the reference to ``each required measure'' with ``each base score 
measure'' to improve the precision of the text. Under Sec.  
414.1380(b)(4), the Promoting Interoperability performance category 
score is comprised of a score for participation and reporting, known as 
the ``base score,'' and a score for performance at varying levels above 
the base score requirements, known as the ``performance score,'' as 
well as any applicable bonus scores. We proposed several editorial 
changes to Sec.  414.1380(b)(4) in an effort to more clearly and 
concisely capture the previously established policies. For further 
explanation of our scoring policies for performance periods in 2017 and 
2018 for the Promoting Interoperability performance category, we refer 
readers to 81 FR 77216 through 77227 and 82 FR 53663 through 53664.
    A general summary overview of the scoring methodology for the 
performance period in 2018 is provided in the Table 38.

BILLING CODE 4120-01-P

[[Page 59786]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.045

BILLING CODE 4120-01-C
    We did not receive any comments on the proposed revisions to the 
regulation text at Sec. Sec.  414.1375(a) and (b)(2)(i), and Sec.  
414.1380(b)(4). We are finalizing these revisions as proposed.
    We heard from many stakeholders that the current scoring 
methodology is complicated and difficult to understand. By providing 
flexibility and offering clinicians multiple measures to choose from 
within the performance score, it appears some clinicians may have been 
confused by the options. Other MIPS eligible clinicians have indicated 
that they dislike the base score because it is a required set of 
measures and provides no flexibility because the scoring is all or 
nothing. If a MIPS eligible clinician cannot fulfill the base score, 
they cannot

[[Page 59787]]

earn a performance and/or bonus score. We have also received feedback 
from clinicians and specialty societies that the current requirements 
detract from their ability to provide care to their patients. In 
addition, stakeholders have indicated that the requirements of the 
Promoting Interoperability performance category for clinicians do not 
align with the requirements of the Medicare Promoting Interoperability 
Program for eligible hospitals and critical access hospitals (CAHs) and 
that this creates a burden for the medical staff who are tasked with 
overseeing the participation of both clinicians and hospitals in these 
programs.
    Based on the concerns expressed by stakeholders, we proposed a new 
scoring methodology (83 FR 35913-395918) and moved away from the base, 
performance and bonus score methodology that we currently use. We 
stated our belief that this change would provide a simpler, more 
flexible, less burdensome structure, allowing MIPS eligible clinicians 
to put their focus back on patients. The introduction of this new 
scoring methodology would continue to encourage MIPS eligible 
clinicians to push themselves on measures that are most applicable to 
how they deliver care to patients, instead of focusing on measures that 
may not be as applicable to them. Our goal was to provide increased 
flexibility to MIPS eligible clinicians and enable them to focus more 
on patient care and health data exchange through interoperability. 
Additionally, we wanted to align the requirements of the Promoting 
Interoperability performance category with the requirements of the 
Medicare Promoting Interoperability Program for eligible hospitals and 
CAHs as we had proposed in the FY 2019 IPPS/LTCH PPS proposed rule (83 
FR 20515 through 20537). As the distinction between ambulatory and 
inpatient CEHRT has diminished and more clinicians are sharing 
hospitals' CEHRT, we stated our belief that aligning the requirements 
between programs would lessen the burden on health care providers and 
facilitate their participation in both programs.
(ii) Proposed Scoring Methodology Beginning With the MIPS Performance 
Period in 2019
    In the CY 2019 PFS proposed rule (83 FR 35914 through 35918), we 
proposed a new scoring methodology, beginning with the performance 
period in 2019, to include a combination of new measures, as well as 
the existing Promoting Interoperability performance category measures, 
broken into a smaller set of four objectives and scored based on 
performance. We stated our belief that this would be an overhaul of the 
existing program requirements as it would eliminate the concept of base 
and performance scores. We proposed a smaller set of objectives that 
consisted of e-Prescribing, Health Information Exchange, Provider to 
Patient Exchange, and Public Health and Clinical Data Exchange. We 
proposed these objectives to promote specific HHS priorities and 
satisfy the requirements of section 1848(o)(2) of the Act. We included 
the e-Prescribing and Health Information Exchange objectives in part to 
capture what we believe are core goals for the 2015 Edition of CEHRT 
and also to satisfy the statutory requirements. These core goals 
promote interoperability between health care providers and health IT 
systems to support safer, more coordinated care. The Provider to 
Patient Exchange objective promotes patient awareness and involvement 
in their health care through the use of APIs, and ensures patients have 
access to their medical data. Finally, the Public Health and Clinical 
Data Exchange objective supports the ongoing systematic collection, 
analysis, and interpretation of data that may be used in the prevention 
and controlling of disease through the estimation of health status and 
behavior. The integration of health IT systems into the national 
network of health data tracking and promotion improves the efficiency, 
timeliness, and effectiveness of public health surveillance. We stated 
our belief that it is important to keep these core goals, primarily 
because these objectives promote interoperability between health care 
providers and health IT systems to support safer, more coordinated care 
while ensuring patients have access to their medical data.
    Under the proposed scoring methodology, MIPS eligible clinicians 
would be required to report certain measures from each of the four 
objectives, with performance-based scoring occurring at the individual 
measure-level. Each measure would be scored based on the MIPS eligible 
clinician's performance for that measure, based on the submission of a 
numerator and denominator, except for the measures associated with the 
Public Health and Clinical Data Exchange objective, which require ``yes 
or no'' submissions. Each measure would contribute to the MIPS eligible 
clinician's total Promoting Interoperability performance category 
score. The scores for each of the individual measures would be added 
together to calculate the Promoting Interoperability performance 
category score of up to 100 possible points for each MIPS eligible 
clinician. In general, the Promoting Interoperability performance 
category score makes up 25 percent of the MIPS final score. If a MIPS 
eligible clinician fails to report on a required measure or claim an 
exclusion for a required measure if applicable, the clinician would 
receive a total score of zero for the Promoting Interoperability 
performance category.
    We also considered an alternative approach in which scoring would 
occur at the objective level, instead of the individual measure level, 
and MIPS eligible clinicians would be required to report on only one 
measure from each objective to earn a score for that objective. Under 
this scoring methodology, instead of six required measures, the MIPS 
eligible clinician total Promoting Interoperability performance 
category score would be based on only four measures, one measure from 
each objective. Each objective would be weighted similarly to how the 
objectives are weighted in our proposed methodology, and bonus points 
would be awarded for reporting any additional measures beyond the 
required four. We solicited public comment on this alternative 
approach, and whether additional flexibilities should be considered, 
such as allowing MIPS eligible clinicians to select which measures to 
report on within an objective and how those objectives should be 
weighted, as well as whether additional scoring approaches or 
methodologies should be considered.
    In our proposed scoring methodology, the e-Prescribing objective 
would contain three measures each weighted differently to reflect their 
potential availability and applicability to the clinician community. In 
addition to the existing e-Prescribing measure, we proposed to add two 
new measures to the e-Prescribing objective: Query of Prescription Drug 
Monitoring Program (PDMP); and Verify Opioid Treatment Agreement. For 
more information about these two proposed measures, we refer readers to 
section III.H.3.h.(5)(f) of the proposed rule (83 FR 35922 through 
35925). The e-Prescribing measure would be required for reporting and 
weighted at 10 points because we believed it would be applicable to 
most MIPS eligible clinicians. In the event that a MIPS eligible 
clinician meets the criteria and claims the exclusion for the e-
Prescribing measure in 2019, the 10 points available for that measure 
would be redistributed equally among the two measures under the Health 
Information Exchange objective:

[[Page 59788]]

     Support Electronic Referral Loops By Sending Health 
Information Measure (25 points).
     Support Electronic Referral Loops By Receiving and 
Incorporating Health Information (25 points).
    We solicited public comment on whether this redistribution is 
appropriate for 2019, or whether the points should be distributed 
differently.
    The Query of PDMP and Verify Opioid Treatment Agreement measures 
would be optional for the MIPS performance period in 2019. These new 
measures may not be available to all MIPS eligible clinicians for the 
MIPS performance period in 2019 as they may not have been fully 
developed by their health IT vendor, or not fully implemented in time 
for data capture and reporting. Therefore, we did not propose to 
require these two new measures in 2019, although MIPS eligible 
clinicians may choose to report them and earn up to 5 bonus points for 
each measure. We proposed to require these measures beginning with the 
MIPS performance period in 2020, and we solicited public comment on 
this proposal.
    Due to varying state requirements, not all MIPS eligible clinicians 
would be able to e-prescribe controlled substances, and thus, these 
measures would not be available to them. For these reasons, in the CY 
2019 PFS proposed rule (83 FR 35915 through 35916) we proposed an 
exclusion for these two measures beginning with the MIPS performance 
period in 2020. The exclusion would provide that any MIPS eligible 
clinician who is unable to report the measure in accordance with 
applicable law would be excluded from reporting the measure, and the 5 
points assigned to that measure would be redistributed to the e-
Prescribing measure.
    As the two new opioid measures become more broadly available in 
CEHRT, we proposed each of the three measures within the e-Prescribing 
objective would be worth 5 points beginning with the MIPS performance 
period in 2020. Requiring these two measures would add 10 points to the 
maximum total score for the Promoting Interoperability performance 
category as these measures would no longer be eligible for optional 
bonus points. To maintain a maximum total score of 100 points, 
beginning with the MIPS performance period in 2020, we proposed to 
reweight the e-Prescribing measure from 10 points down to 5 points, and 
reweight the Provide Patients Electronic Access to Their Health 
Information measure from 40 points down to 35 points as illustrated in 
Table 38. We proposed that if the MIPS eligible clinician qualifies for 
the e-Prescribing exclusion and is excluded from reporting all three of 
the measures associated with the e-Prescribing objective as described 
in section III.H.3.h.(5)(f) of the proposed rule, (83 FR 35921) the 15 
points for the e-Prescribing objective would be redistributed evenly 
among the two measures associated with the Health Information Exchange 
objective and the Provide Patients Electronic Access to their Health 
Information measure by adding 5 points to each measure.
    We refer readers to section III.I.3.h.(5)(f) of this final rule, 
where we discuss the Promoting Interoperability performance category 
measures, for a discussion of the comments we received regarding the 
above-referenced proposed scoring methodology for the e-Prescribing 
objective and associated measures. After consideration of the public 
comments we received, we are finalizing our proposed scoring for the E-
Prescribing objective as proposed but with the modifications discussed 
at the end of this section III.I.3.h.(5)(f) of the preamble of this 
final rule. The e-Prescribing measure is finalized with modification, 
the Query of PDMP measure is finalized with modification, and the 
Verify Opioid Treatment Agreement measure is finalized with 
modification. In addition, we refer readers to section 
III.I.3.h.(5)(f)(ii) of the preamble of this final rule where we 
discuss our reasons for adopting the Query of PDMP measure with 
modification and the Verify Opioid Treatment Agreement measure with 
modification.
    For the Health Information Exchange objective, we proposed to 
change the name of the existing Send a Summary of Care measure to 
Support Electronic Referral Loops by Sending Health Information 
measure, and proposed a new measure which combines the functionality of 
the existing Request/Accept Summary of Care and Clinical Information 
Reconciliation measures into a new measure, Support Electronic Referral 
Loops by Receiving and Incorporating Health Information measure. For 
more information about the proposed measure and measure changes, we 
refer readers to section III.I.3.h.(5)(f) of the proposed final rule 
(83 FR 35925 through 35928). MIPS eligible clinicians would be required 
to report both of these measures, each worth 20 points toward their 
total Promoting Interoperability performance category score. These 
measures are weighted heavily to emphasize the importance of sharing 
health information through interoperable exchange in an effort to 
promote care coordination and better patient outcomes. Similar to the 
two new measures in the e-Prescribing objective, the new Support 
Electronic Referral Loops by Receiving and Incorporating Health 
Information measure may not be available to all MIPS eligible 
clinicians as it may not have been fully developed by their health IT 
vendor, or not fully implemented in time for a MIPS performance period 
in 2019. For these reasons, we proposed two exclusions for the Support 
Electronic Referral Loops by Receiving and Incorporating Health 
Information measure:
    1. Any MIPS eligible clinician who is unable to implement the 
measure for a MIPS performance period in 2019 would be excluded from 
this measure.
    2. Any MIPS eligible clinician who receives fewer than 100 
transitions of care or referrals or has fewer than 100 encounters with 
patients never before encountered during the performance period would 
be excluded from this measure.
    We note that these two exclusions for the measure were proposed in 
different sections of the proposed rule (83 FR 35916, 35927).
    In the event that a MIPS eligible clinician claims an exclusion for 
the Support Electronic Referral Loops by Receiving and Incorporating 
Health Information measure, the 20 points would be redistributed to the 
Support Electronic Referral Loops by Sending Health Information 
measure, and that measure would then be worth 40 points. We solicited 
public comment on whether this redistribution is appropriate, or 
whether the points should be redistributed to other measures instead.
    We refer readers to section III.I.3.h.(5)(f) of this final rule, 
where we discuss the Promoting Interoperability performance category 
measures, for a discussion of the comments we received regarding the 
above-referenced proposed scoring methodology for the Health 
Information Exchange objective and associated measures. We did not 
receive any comments regarding the redistribution of points if an 
exclusion is claimed for the Support Electronic Referral Loops by 
Receiving and Incorporating Health Information measure. After 
consideration of the comments that we received, we are finalizing our 
proposals for the Health Information Exchange objective as proposed. In 
addition, measure specification details can be found in section 
III.I.3.h.(5)(f) of the preamble of this final rule.
    In the CY 2019 PFS proposed rule (83 FR 359186), we proposed to 
weight the

[[Page 59789]]

one measure in the Provider to Patient Exchange objective, Provide 
Patients Electronic Access to Their Health Information, at 40 points 
toward the total Promoting Interoperability performance category score 
in 2019 and 35 points beginning in 2020. We proposed that this measure 
would be weighted at 35 points beginning in 2020 to account for the two 
new opioid measures, which would be worth 5 points each beginning in 
2020 as proposed. We stated our belief that this objective and its 
associated measure get to the core of improved access and exchange of 
patient data in Promoting Interoperability and are the crux of the 
Promoting Interoperability performance category. This exchange of data 
between health care provider and patient is imperative in order to 
continue to improve interoperability, data exchange and improved health 
outcomes. We stated that it is important for patients to have control 
over their own health information, and through this highly weighted 
objective we are aiming to show our dedication to this effort.
    We solicited comment on these proposals and our summary and 
response are below.
    Comment: A few commenters supported CMS' proposed weighting of the 
Provide Patients Electronic Access to Their Health Information measure.
    Response: We appreciate the support regarding the proposed weight 
of this measure. We believe that it is important to give patients 
access to their data and therefore the measure deserves to be highly 
weighted.
    Comment: A few commenters stated that an allocation of 40 points to 
a single measure (Provide Patient Electronic Access to Their Health 
Information) is too high. Commenters stated that if the points are 
redistributed to other measures because exclusions are claimed, 
especially if an exclusion is claimed on more than one measure, the 
emphasis on the remaining measures will increase.
    Response: We believe that it is essential for patients to have 
access to their health information and the assignment of 40 points to 
this measure reflects the importance we place on patient's access to 
their health information.
    After consideration of the comments, we are finalizing with 
modification the proposals for the Provider to Patient Exchange 
objective. The Provide Patients Electronic Access to Their Health 
Information measure will be worth up to 40 points beginning in CY 2019. 
We had proposed that the measure would be worth up to 35 points 
beginning in CY 2020, but we are not finalizing that proposal because 
we are not requiring the Verify Opioid Treatment Agreement measure 
beginning in CY 2020 as proposed, which would have been worth up to 5 
points. For additional measure information, we refer readers to section 
III.I.3.h.(5)(f) of the preamble of this final rule.
    The measures under the Public Health and Clinical Data Exchange 
objective are reported using ``yes or no'' responses and thus we 
proposed to score those measures on a pass/fail basis in which the MIPS 
eligible clinician would receive the full 10 points for reporting two 
``yes'' responses, or for submitting a ``yes'' for one measure and 
claiming an exclusion for another. If there are no ``yes'' responses 
and two exclusions are claimed, the 10 points would be redistributed to 
the Provide Patients Electronic Access to Their Health Information 
measure. A MIPS eligible clinician would receive zero points for 
reporting ``no'' responses for the measures in this objective if they 
do not submit a ``yes'' or claim an exclusion for at least two measures 
under this objective. We proposed that for this objective, the MIPS 
eligible clinician would be required to report on two measures of their 
choice from the following list of measures: Immunization Registry 
Reporting, Electronic Case Reporting, Public Health Registry Reporting, 
Clinical Data Registry Reporting, and Syndromic Surveillance Reporting. 
To account for the possibility that not all of the measures under the 
Public Health and Clinical Data Exchange objective may be applicable to 
all MIPS eligible clinicians, we proposed to establish exclusions for 
these measures as described in section III.H.3.h.(5)(f) of the proposed 
rule (83 FR 35929 through 35930). If a MIPS eligible clinician claims 
two exclusions, the 10 points for this objective would be redistributed 
to the Provide Patients Electronic Access to their Health Information 
measure under the Provider to Patient Exchange objective, making that 
measure worth 50 points in 2019 and 45 points beginning in 2020. 
Reporting more than two measures for this objective would not earn the 
MIPS eligible clinician any additional points. We refer readers to 
section III.H.3.h.(5)(f) of the proposed rule (83 FR 35929 through 
35930) in regard to the proposals for the Public Health and Clinical 
Data Exchange objective and its associated measures.
    We solicited comment on these proposals and our summary and 
response are below.
    Comment: A commenter suggested that MIPS eligible clinicians should 
be eligible to earn more points for reporting on more than two public 
health and clinical data exchange measures.
    Response: We appreciate the suggestion but decline to implement it 
at this time. We are limiting bonus point opportunities to brand new 
measures, such as those associated with the e-Prescribing objective, in 
an effort to maintain simplicity and avoid confusion in our scoring 
methodology.
    Comment: Some commenters questioned whether they could receive 
credit for reporting to more than one registry for a measure.
    Response: We believe that a clinician who is in active engagement 
with two different public health agencies or clinical data registries 
for purposes of the same measure would accomplish the same policy goal 
as our proposal to report on two measures. It is also consistent with 
the policy we established in the CY 2018 Quality Payment Program final 
rule for reporting on the measures associated with the Public Health 
and Clinical Data Registry Reporting Objective for the performance 
score and bonus score (82 FR 53663-53664). In addition, allowing MIPS 
eligible clinicians to report to two different public health agencies 
or clinical data registries of their choice promotes flexibility in 
reporting and allows them to focus on the public health measures that 
are most relevant to them and their patient populations. Therefore, we 
will be adopting our proposal with modification to allow clinicians the 
flexibility to report to two different public health agencies or 
clinical data registries for purposes of the same measure.
    After consideration of the public comments we received, we are 
finalizing our proposals for the Public Health and Clinical Data 
Exchange objective with modifications. MIPS eligible clinicians must 
report to two different public health agencies or clinical data 
registries for any of the following measures: Syndromic Surveillance 
Reporting, Immunization Registry Reporting, Electronic Case Reporting, 
Public Health Registry Reporting, and Clinical Data Registry Reporting. 
MIPS eligible clinicians may report to two different public health 
agencies or clinical data registries for purposes of the same measure 
if they choose. For additional measure information, we refer readers to 
section III.I.3.h.(5)(f) of this final rule.
    In the CY 2019 PFS proposed rule (83 FR 359186), we proposed that 
the Protect Patient Health Information objective and its associated 
measure, Security Risk Analysis, would remain part of the requirements 
for the

[[Page 59790]]

Promoting Interoperability performance category, but would no longer be 
scored as a measure and would not contribute to the MIPS eligible 
clinician's Promoting Interoperability performance category score. To 
earn any score in the Promoting Interoperability performance category, 
we proposed a MIPS eligible clinician would have to report that they 
completed the actions included in the Security Risk Analysis measure at 
some point during the calendar year in which the performance period 
occurs. We stated our belief that the Security Risk Analysis measure 
involves critical tasks and noted that the HIPAA Security Rule requires 
covered entities to conduct a risk assessment of their health care 
organization. This risk assessment will help MIPS eligible clinicians 
comply with HIPAA's administrative, physical, and technical safeguards. 
Therefore, we stated that every MIPS eligible clinician should already 
be meeting the requirements for this objective and measure as it is a 
requirement of HIPAA. We indicated that we still believe this objective 
and its associated measure are imperative in ensuring the safe delivery 
of patient health data. As a result, we would maintain the Security 
Risk Analysis measure as part of the Promoting Interoperability 
performance category, but we would not score the measure.
    The following is a summary of the public comments received on the 
proposals for the Protect Patient Health Information objective and its 
associated measure, Security Risk Analysis and our responses.
    Comment: A commenter stated that the Security Risk Analysis measure 
has historically been challenging for physicians. The commenter did not 
support the annual reporting of this measure to be required to achieve 
any score in the Promoting Interoperability category. To overcome what 
the commenter described as the burdensome nature of this measure, the 
commenter indicated that MIPS eligible clinicians need additional 
support and resources to aid in their understanding of how to conduct a 
security risk analysis that is compliant with CMS's standards.
    Response: The Security Risk Analysis measure has been a required 
measure since the beginning of the EHR Incentive programs in 2011 
through the transition to MIPS starting in 2017. The requirement 
remains that the actions included in the measure must be performed once 
during the calendar year in which the performance period occurs. We 
appreciate the commenter's interest in additional educational materials 
for clinicians on how they can improve the privacy and security of 
their health information. We refer them to https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Downloads/2016_SecurityRiskAnalysis.pdf. HHS Office for Civil Rights (OCR) has 
issued guidance on conducting a security risk analysis in accordance 
with the HIPAA Security Rule (http://www.hhs.gov/hipaa/forprofessionals/security/guidance/guidance-risk-analysis/index.html). 
Additional free tools and resources available to assist MIPS eligible 
clinicians include a Security Risk Assessment (SRA) Tool developed by 
the Office of National Coordinator for Health Information Technology 
(ONC) and OCR at http://www.healthit.gov/providersprofessionals/security-risk-assessment-tool. We believe that performing an annual 
security risk assessment will help identify security weaknesses and may 
provide opportunities to improve the security of the MIPS eligible 
clinician's electronic systems.
    Comment: Several commenters stated that if the Security Risk 
Analysis measure is required, then MIPS eligible clinicians should 
receive credit for doing it. The commenters recommended that the 
technological, encryption, and other cybersecurity components of the 
security risk analysis should be shifted to the health IT vendor and 
should not be a burden placed on MIPS eligible clinicians.
    Response: As we discussed in the proposed rule (83 FR 35916), we do 
not believe that the Security Risk Analysis measure should be scored 
because it includes actions already required under HIPAA and will help 
MIPS eligible clinicians comply with HIPAA's administrative, physical, 
and technical safeguards. We do not believe points should be awarded 
because MIPS eligible clinicians should have already been performing 
these actions. In addition, while a health IT vendor's products must 
possess the relevant privacy and security capabilities be certified, we 
believe that MIPS eligible clinicians must also conduct security risk 
assessments to make sure that vulnerabilities are identified and 
remediated. In addition, successful completion of a security risk 
analysis is required to earn a score in the Promoting Interoperability 
performance category.
    Comment: The majority of commenters supported CMS' proposal to 
require MIPS eligible clinicians to attest to the completion of the 
actions of the Security Risk Analysis measure with no associated score 
in order to be eligible to receive an overall score in the Promoting 
Interoperability performance category. They stated that this measure is 
essential to safely transmitting their patient data and successfully 
participating in the Promoting Interoperability performance category.
    Response: As discussed in the preceding response, we agree that 
this measure should not be scored.
    After consideration of the public comments, we are finalizing our 
proposal to require MIPS eligible clinicians to attest that they 
completed the actions included in the Security Risk Analysis measure at 
some point during the calendar year in which the MIPS performance 
period occurs. MIPS eligible clinicians who fail to complete these 
actions or fail to attest will not earn any score for the Promoting 
Interoperability performance category, regardless of whether they 
report on other measures for this category.
    As we proposed at 83 FR 35916, similar to how MIPS eligible 
clinicians currently submit data, the MIPS eligible clinician would 
submit their numerator and denominator data for each measure, and a 
``yes or no'' response for each of the two reported measures under the 
Public Health and Clinical Data Exchange objective. The numerator and 
denominator for each measure would then translate to a performance rate 
for that measure and would be applied to the total possible points for 
that measure. For example, the e-Prescribing measure was proposed to be 
worth 10 points. A numerator of 200 and denominator of 250 would yield 
a performance rate of (200/250) = 80 percent. This 80 percent would be 
applied to the 10 total points available for the e-Prescribing measure 
to determine the measure score. A performance rate of 80 percent for 
the e-Prescribing measure would equate to a measure score of 8 points 
(performance rate * total possible measure points = points awarded 
toward the total Promoting Interoperability performance category score; 
80 percent * 10 = 8 points). To calculate the Promoting 
Interoperability performance category score, the measure scores would 
be added together, and the total sum would be divided by the total 
possible points (100). The total sum cannot exceed the total possible 
points. This calculation results in a fraction from zero to 1, which 
can be formatted as a percent. For further clarification we refer 
readers to the scoring example that we included in the proposed rule 
(83 FR 35917).
    When calculating the performance rates, measure and objective 
scores, and the Promoting Interoperability performance category score, 
we would generally round to the nearest whole

[[Page 59791]]

number. For example if a MIPS eligible clinician received a score of 
8.53 the nearest whole number would be 9. Similarly, if the MIPS 
eligible clinician received a score of 8.33 the nearest whole number 
would be 8. In the event that the MIPS eligible clinician receives a 
performance rate or measure score of less than 0.5, as long as the MIPS 
eligible clinician reported on at least one patient for a given 
measure, a score of 1 would be awarded for that measure. We stated that 
we believed this is the best method for the issues that might arise 
with the decimal points and is the easiest for computations.
    In order to meet statutory requirements and HHS priorities, the 
MIPS eligible clinician would need to report on all of the required 
measures across all objectives in order to earn any score at all for 
the Promoting Interoperability performance category. Failure to report 
any required measure, or reporting a ``no'' response on a ``yes or no'' 
response measure, unless an exclusion applies would result in a score 
of zero. We solicited public comment on the proposed requirement to 
report on all required measures, or whether reporting on a smaller 
subset of optional measures would be appropriate.

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BILLING CODE 4120-01-C
    In the proposed rule (83 FR 35917), we sought public comment on 
whether these measures are weighted appropriately, or whether a 
different weighting distribution, such as equal distribution across all 
measures would be better suited to this program and this proposed 
scoring methodology. We also sought public comment on other scoring 
methodologies such as the alternative we considered and described 
earlier in this section.
    We solicited comment on these proposals and our summary of these 
comments and responses are below.
    Comment: Some commenters expressed concern that CMS has gone back 
to an ``all or nothing'' approach, which existed in the original 
meaningful use program. Commenters indicated that under CMS' proposal, 
clinicians would be required to report on all required measures within 
each of the four objectives. Failure to report on one measure without 
claiming an exclusion would result in a score of zero. Other commenters 
stated that the proposed new structure is still essentially an ``all or 
nothing'' approach, which they do not support. Instead, they suggested 
that MIPS eligible clinicians who do not or cannot attest to a measure 
should not receive points for that particular measure, but they should 
still earn points for all of the other measures that they are able to 
submit data for.
    Response: We tried to reduce confusion and clinician burden by 
proposing to reduce the number of measures that MIPS eligible 
clinicians are required to report and provide an opportunity for MIPS 
eligible clinicians to earn points by redistributing the points to 
other measures when an exclusion is claimed. We do not agree that this 
scoring structure is an all or nothing approach due to the reduction of 
measures, the requirement of a one in the numerator for numerator/
denominator measures or a ``yes'' for yes/no measures, and the 
redistribution of points when an exclusion is claimed. We do not agree 
with the suggestion that MIPS eligible clinicians that do not or cannot 
attest to measures should not receive points since the measures have 
been reduced to six required measures which will reduce administrative 
burden and allow MIPS eligible clinicians to focus more on their 
patients. We believe it would disadvantage clinicians if we did not 
redistribute the points for measures when an exclusion is claimed. We 
believe the proposed scoring methodology promotes the goals of the 
performance category to focus on interoperability, improving patient 
access to health information and aligning the performance category with 
the Medicare Promoting Interoperability Program for eligible hospitals 
and CAHs.
    Comment: One commenter agreed with the CMS proposal to give a MIPS 
eligible clinician a Promoting Interoperability performance category 
score of ``zero'' for failure to report on any one required measure, 
but recommended that CMS create an exclusion process with identified 
circumstances where partial credit for the measure may be applied, but 
such partial credit should be the exception and not the norm and should 
be evaluated on a case-by-case basis.
    Response: We appreciate the suggestion but believe it would further 
complicate scoring when we are trying to simplify it to the greatest 
extent possible. Our intention with our proposals for the scoring 
methodology was to reduce clinician burden. We do not believe that a 
process to address individual scenarios is feasible for us to implement 
at this time, but will take this comment into consideration for future 
rulemaking.
    Comment: One commenter requested clarification of our proposal to 
require MIPS eligible clinicians to report on all of the required 
measures across all objectives in order to earn any score at all for 
the Promoting Interoperability performance category. The commenter 
questioned if failure to report any required measure would result in a 
zero for that measure or a zero for the Promoting Interoperability 
performance category.
    Response: The clinician would earn a score of zero for the entire 
Promoting Interoperability performance category.
    Comment: Some commenters expressed concern with the time required 
to incorporate new measures into CEHRT (an average of 1,000 hours per 
measure per product) and requested that measures changes be done 
judiciously to minimize the burden to developers and to MIPS eligible 
clinicians who must implement the new measures.
    Response: The proposed scoring methodology primarily would 
eliminate or revise existing measures, which should only require 
consolidation of existing workflows and actions. In addition, the 
certification criteria and standards for EHR technology would remain 
the same as finalized in the October 16, 2015 final rule titled ``2015 
Edition Health Information Technology (Health IT) Certification 
Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, 
and ONC Health IT Certification Program Modifications'' (80 FR 62602 
through 62759).
    Comment: One commenter stated that we should not require a minimum 
numerator of 1 for any of the performance measures, but instead we 
should require all program participants to report on all of the 
performance measures, with an exclusion available for each measure in 
case their CEHRT does not support the measure. If the exclusion is 
claimed, the participant would receive a 0 on that measure, and the 
exclusion status would be published on Physician Compare.
    Response: We disagree with the commenter's suggested approach. 
CEHRT presently has the capability to support all of the proposed 
measures with the exception of the Query of Prescription Drug 
Monitoring measure and the Verify Opioid Treatment Agreement measure, 
which would be optional in the 2019 MIPS performance period. For more 
information on what will be posted on Physician Compare, see section 
III.I.3.l. of this final rule.
    Comment: One commenter suggested an alternative intermediate 
solution where each measure would be worth up to 10 points for a total 
of 110 points (90 for the existing performance measures plus e-
Prescribing plus a second registry measure).
    Response: We appreciate this suggestion, but we believe that 
removing several of the existing performance score measures will help 
to reduce burden for MIPS eligible clinicians.
    Comment: Many commenters supported CMS' proposal to reduce the 
number of measures to be reported as part of the Promoting 
Interoperability performance category.
    Response: We believe the reduction in reporting will relieve health 
care provider burden through a more flexible, performance-based 
approach.
    Comment: Some commenters supported the CMS effort to reduce the 
complexity of the scoring methodology. Some commenters stated that the 
proposed scoring methodology reduces clinician burden by eliminating 
confusing base and performance scores in favor of scoring at the 
individual measure level, with relevant measure exclusions. Some 
commenters supported the overall reduction of measures in this category 
through the elimination of burdensome measures. Another commenter 
indicated that the proposed scoring methodology and measure set is a 
huge improvement and does a lot to streamline the requirements of the 
Promoting Interoperability performance category. Commenters supported 
the move to a

[[Page 59793]]

single set of measures because it will help alleviate confusion by MIPS 
eligible clinicians. Many commenters supported CMS' proposed scoring 
methodology in which MIPS eligible clinicians would be required to 
report certain measures from each of the four objectives, with 
performance-based scoring occurring at the individual measure-level.
    Response: We appreciate the many commenters who supported the 
proposed scoring methodology and agree it will reduce burden.
    Comment: A few commenters stated they favored a system that 
provides the flexibility for MIPS eligible clinicians to select the 
measures most relevant to their practice and patient population and are 
the least burdensome to implement.
    Response: We believe the proposed scoring methodology approach, 
including the reduction of measures to reduce reporting burden and our 
goal to provide patients with access to their health information 
promotes the goals of the Promoting Interoperability performance 
category. Providing flexibility to choose measures that do not promote 
increased focus on interoperability or improving patient access to 
health information will deemphasize the goals of the Promoting 
Interoperability performance category. We received many comments 
indicating that there were too many measures so to address that we have 
reduced and combined measures to reduce MIPS eligible clinician burden.
    Comment: One commenter supported this specific proposal to 
streamline and simplify the Promoting Interoperability performance 
category, but cautioned CMS against further implementation of major 
category overhauls. Significant changes, even those intended to reduce 
physician reporting burden, can increase burden when they require yet 
another round of health care provider and staff education to understand 
how to maximize performance under a redesigned category scoring 
methodology. Solo practitioners and small group practices in particular 
have indicated that substantial category changes are significant 
burdens for their practices.
    Response: We appreciate the commenter's support for our proposal 
and will take the recommendation against further implementation of 
major category overhaul into consideration in future rulemaking. We 
note that in the CY 2018 Quality Payment Program final rule (82 FR 
53682-53683), we finalized a significant hardship exception for the 
Promoting Interoperability performance category for MIPS eligible 
clinicians who are in small practices.
    Comment: A few commenters disagreed with our proposal to combine 
the Request/Accept Summary of Care measure with the Clinical 
Information Reconciliation measure and they proposed that each measure 
remain separate and be worth 10 points, rather than having them 
combined and worth 20 points.
    Response: We thank commenters for their suggestion but we decline 
to adopt it. For the reasons discussed in section III.I.3.h.(5)(f) of 
this final rule, we believe it is appropriate to combine these measures 
and have the point value reflect the combination.
    Comment: Many commenters recommended that we establish a threshold 
of 50 points to align with the Medicare Promoting Interoperability 
Program for eligible hospitals and CAHs.
    Response: Although our proposed scoring methodology did not include 
a point threshold, we appreciate this comment and will take it into 
consideration as we develop future proposals.
    Comment: A commenter supported the proposed weighting of the 
measures but recommended that CMS consider adding additional measures 
that would promote the integration of clinical and administrative data 
toward the goal of creating substantive longitudinal patient records.
    Response: We appreciate the support and appreciate the suggestion. 
In the proposed rule we did request comments (83 FR 35931 through 
35932) on potential new measures as well as ways to link the quality, 
improvement activities, and the Promoting Interoperability performance 
categories. We plan to use the comments we received to inform future 
proposals that focus on integration.
    Comment: Some commenters thanked CMS for aligning the measures in 
the inpatient and outpatient settings because it will reduce burden.
    Response: We appreciate commenter's support of our proposal to 
align the MIPS Promoting Interoperability performance category measures 
with the Medicare Promoting Interoperability Program measures for 
eligible hospitals and CAHs.
    Comment: Some commenters stated that CMS should not implement the 
alternative scoring approach that was considered and discussed in the 
proposed rule because it would allow MIPS eligible clinicians to report 
on fewer measures and still earn the same credit which is a lowering of 
the bar for achieving interoperability. Many commenters suggested that 
the Public Health and Clinical Data Exchange objective would be 
deemphasized by reducing the reporting requirement to only one measure.
    Response: We agree and will not be implementing the alternative 
that we considered. Our primary proposal focuses on interoperability 
and improving patient access to health information and we believe that 
the objectives and measures we have chosen will help to fulfill these 
goals. We agree that reporting to two different public health agencies 
or clinical data registries for any of the measures from the Public 
Health and Clinical Data Exchange objective will help to build bi-
directional data exchange between clinicians and public health agencies 
and clinical data registries. We believe that our proposal will enable 
MIPS eligible clinicians to push themselves on measures that are the 
most applicable to how they deliver care to patients.
    Comment: Many commenters supported CMS' alternative approach to 
scoring in which scoring would occur at the objective level, instead of 
the individual measure level, and MIPS eligible clinicians would be 
required to report on only one measure from each objective to earn a 
score for that objective.
    Some commenters stated that requiring MIPS eligible clinicians to 
report on every single measure or claim an exclusion creates an unfair 
burden. Other commenters supported the alternative approach because 
they believe it is less rigid and provides MIPS eligible clinicians 
with more flexibility to report measures that are part of their 
workflow.
    Response: We have taken commenters' feedback into consideration as 
we have constructed our final policy as outlined in section 
III.I.3.h.(5)(d) of this final rule. We decline to finalize the 
alternative approach to scoring. In addition, the other objectives 
containing more than one measure are the Electronic Prescribing 
objective and the Health Information Exchange objective. For the 
Electronic Prescribing objective, we note that both the Query of PDMP 
and Verify Opioid Treatment Agreement measures are optional for 
reporting for CY 2019; therefore we believe this objective could 
require reporting on only one measure as opposed to multiple measures. 
We continue to believe that the objective and measure set that we 
selected will enable MIPS eligible clinicians to focus on 
interoperability and improving patient access to health information.

[[Page 59794]]

    Comment: A commenter recommended that CMS only require that MIPS 
eligible clinicians attest to satisfying each measure for a least 1 
patient instead of using a performance rate.
    Response: We disagree. We believe that a performance-based scoring 
mechanism will enable MIPS eligible clinicians who perform well on 
measures to differentiate themselves from other MIPS eligible 
clinicians who submitted data with lower results for the Promoting 
Interoperability performance category.
    Comment: One commenter suggested that if a MIPS eligible clinician 
cannot fulfill a measure that an exclusion process be created where 
partial credit can be earned. They recommended that partial credit be 
granted on a case-by-case basis.
    Response: We do not believe that finalizing a process to address 
individual scenarios is feasible for us to implement at this time. We 
may take this comment into consideration in our development of future 
rulemaking.
    Comment: One commenter supported all of the proposed measures as 
long as there is no minimum threshold requirement and no performance 
measurement.
    Response: The Promoting Interoperability performance category sets 
a very low minimum threshold requirement for measures. We believe that 
the minimum reporting requirements we set (a one in the numerator for 
numerator/denominator measures, a ``yes'' for yes/no measures, unless 
an exclusion is claimed) are appropriate. We believe that a performance 
based scoring system as we are implementing for the Promoting 
Interoperability performance category will enable high performing MIPS 
eligible clinicians to distinguish themselves from others and 
potentially earn a higher upward adjustment.
    Comment: One commenter urged CMS to allow MIPS eligible clinicians 
to ``pick and choose'' measures from a ``menu'' of objectives and 
measures. Other commenters recommended that the Promoting 
Interoperability performance category not be limited to a small set of 
measures. The commenters recommended more flexibility by allowing MIPS 
eligible clinicians to select from a larger list of measures.
    Response: We disagree because we allowed considerable choice for 
years one and two and received significant feedback about how 
complicated it was for clinicians to understand the requirements for 
the base and performance scores. We continue to believe that a reduced 
set of measures will reduce burden for clinicians and will enable them 
to focus more on patient care. As we have received significant 
commenters support on our proposal to align the Promoting 
Interoperability requirements and measures with the Medicare Promoting 
Interoperability Program measures for eligible hospitals and CAHs, we 
decline to retain measures so that MIPS eligible clinicians have 
flexibility in selecting measures.
    Comment: A commenter stated that if CMS does not remove the ``all 
or nothing'' scoring requirement, we recommend that the proposals 
related to re-weighting measures when a MIPS eligible clinician claims 
an exclusion be modified because they are confusing.
    Response: While we understand that concern, we believe that if a 
MIPS eligible clinician meets the requirements of an exclusion, then 
the points for the excluded measure should be redistributed to another 
measure. We will develop educational tools to assist MIPS eligible 
clinicians to understand our redistribution policy.
    Comment: A commenter stated that MIPS eligible clinicians rely on 
their EHR systems to help them with program participation. They warned 
that if these proposed changes are finalized in November 2018 for the 
2019 performance period, the systems will not be updated until mid-2019 
at the earliest. They requested a full calendar year's notice before 
any changes would become applicable.
    Response: We disagree that a full calendar year's notice is 
necessary. The proposed new measure, Support Electronic Referral Loops 
by Receiving and Incorporating Health Information, includes two 
exclusions in CY 2019, as described in section III.I.3.h.(5)(f) of the 
preamble of this final rule. For the Electronic Prescribing objective, 
we note that both the Query of PDMP and Verify Opioid Treatment 
Agreement measures are optional for reporting for CY 2019.The criteria 
for all of the remaining measures (numerator/denominator or yes/no 
measures) would remain the same and are supported by 2015 Edition 
CEHRT.
    Summary of Final Scoring Methodology: As discussed above, after 
consideration of the comments we received, we are finalizing our 
proposed performance-based scoring methodology for the Promoting 
Interoperability performance category beginning with the performance 
period in CY 2019, with modifications, as described below.
    For additional measure-specific information, we refer readers to 
section III.I.3.h.(5)(f) the preamble of this final rule.
    Promoting Interoperability Score: We are finalizing that MIPS 
eligible clinicians are required to report certain measures from each 
of the four objectives, with performance-based scoring occurring at the 
individual measure-level. Each measure is scored based on the MIPS 
eligible clinician's performance for that measure, except for the 
measures associated with the Public Health and Clinical Data Exchange 
objective, which require a yes/no attestation. Each measure will 
contribute to the MIPS eligible clinician's total Promoting 
Interoperability performance category score. The scores for each of the 
individual measures are added together to calculate the total Promoting 
Interoperability performance category score of up to 100 possible 
points for each MIPS eligible clinician. To calculate the Promoting 
Interoperability performance category score, the measure scores are 
added together, and the total sum is divided by the total possible 
points (100). The total sum cannot exceed the total possible points. 
This calculation results in a fraction from zero to 1, which can be 
formatted as a percent. For a MIPS eligible clinician to earn a score 
greater than zero for the Promoting Interoperability performance 
category, in addition to completing the actions included in the 
Security Risk Analysis measure, the MIPS eligible clinician must submit 
their complete numerator and denominator or yes/no data for all 
required measures. The numerator and denominator for each performance 
measure will translate to a performance rate for that measure and will 
be applied to the total possible points for that measure. The MIPS 
eligible clinician must report on all of the required measures across 
all of the objectives in order to earn any score at all. Failure to 
report any required measure, or reporting a ``no'' response on a yes/no 
response measure, unless an exclusion is claimed will result in a 
Promoting Interoperability performance category score of zero.
    Security Risk Analysis Measure: We are finalizing our proposal that 
MIPS eligible clinicians must attest to having completed the actions 
included in the Security Risk Analysis measure at some point during the 
calendar year in which the MIPS performance period occurs. The Security 
Risk Analysis measure is not scored and does not contribute any points 
to the MIPS eligible clinician's total score for the objectives and 
measures.
    Electronic Prescribing Objective Scoring: We are finalizing the 
Electronic

[[Page 59795]]

Prescribing objective as proposed with the following modifications. The 
e-Prescribing measure is worth up to 10 points in CYs 2019 and 2020. We 
are modifying the points for CY 2020 to reflect the modification to our 
proposal for the Query of Prescription Drug Monitoring Program (PDMP) 
measure in CY 2020. The Query of PDMP measure is optional in CY 2019 
and worth 5 bonus points. We are not establishing a policy for the 
Query of PDMP measure for CY 2020 in this final rule and intend to 
address this measure in future rulemaking. The Verify Opioid Treatment 
Agreement measure is optional in CY 2019 and 2020, and worth five bonus 
points. We intend to reevaluate the status of the Verify Opioid 
Treatment Agreement measure for subsequent years in future rulemaking. 
An exclusion is available for the e-Prescribing measure as described in 
section III.I.3.h.(5)(f) of the preamble of this final rule. If an 
exclusion is claimed for the e-Prescribing measure for CY 2019, the 10 
points for the e-Prescribing measure will be redistributed equally 
among the measures associated with the Health Information Exchange 
objective. Since the Query of PDMP and Verify Opioid Treatment 
Agreement measures are optional and eligible for bonus points, no 
exclusions are available.
    Health Information Exchange Objective Scoring: We are finalizing 
the Health Information Exchange objective as proposed. The Support 
Electronic Referral Loops by Sending Health Information measure is 
worth up to 20 points. An exclusion is available for this measure, as 
described in section III.I.3.h.(5)(f) of the preamble of this final 
rule, although we did not address in the proposed rule how the points 
would be redistributed in the event the exclusion is claimed. We intend 
to propose in next year's rulemaking how the points will be 
redistributed if an exclusion is claimed. The new measure, Support 
Electronic Referral Loops by Receiving and Incorporating Health 
Information, is worth up to 20 points. Exclusions are available for 
this measure, as described in section III.I.3.h.(5)(f) of this final 
rule. If an exclusion is claimed, the 20 points would be redistributed 
to the other measure within this objective, the Support Electronic 
Referral Loops by Sending Health Information measure, which would be 
worth up to 40 points. We will address in future rulemaking how the 
points will be redistributed if exclusions are claimed for both the 
Support Electronic Referral Loops by Sending Health Information measure 
and the Support Electronic Referral Loops by Receiving and 
Incorporating Health Information measure.
    Provider to Patient Exchange Objective Scoring: We are finalizing 
the Provider to Patient Exchange objective with modifications. The 
Provide Patients Electronic Access to Their Health Information measure 
is worth up to 40 points beginning with the MIPS performance period in 
CY 2019. No exclusions are available for this measure.
    Public Health and Clinical Data Exchange Objective Scoring: We are 
finalizing the Public Health and Clinical Data Exchange objective as 
proposed with the following modifications. MIPS eligible clinicians 
must submit a yes/no response for two different public health agencies 
or clinical data registries for any of the measures associated with the 
Public Health and Clinical Data Exchange objective to earn 10 points 
for the objective. Failure to report on two different public health 
agencies or clinical data registries or submitting a ``no'' response 
for a measure will earn a score of zero. Exclusions available for this 
objective are discussed in section III.I.3.h.(5)(f) of the preamble of 
this final rule. If an exclusion is claimed for one measure, but the 
MIPS eligible clinicians submits a ``yes'' response for another 
measure, they would earn the 10 points for the Public Health and 
Clinical Data Exchange objective. If a MIPS eligible clinician claims 
exclusions for both measures they select to report on, the 10 points 
would be redistributed to the Provide Patients Electronic Access to 
Their Health Information measure under the Provider to Patient Exchange 
objective.
    Tables 41 and 42 reflect the final policy for the objectives, 
measures, and maximum points available for the MIPS performance periods 
in CY 2019 and CY 2020. Please note, the maximum points available do 
not include points that would be redistributed in the event an 
exclusion is claimed:
    Tables 41 and 42 illustrate our final performance-based scoring 
methodology.

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    We proposed to codify the proposed new scoring methodology in new 
paragraphs (b)(4)(ii) and (iii) under Sec.  414.1380 and we are 
finalizing the proposed regulation text with modification.
(e) Promoting Interoperability/Advancing Care Information Objectives 
and Measures Specifications for the 2018 Performance Period
    The Advancing Care Information (now Promoting Interoperability) 
performance category Objectives and Measures for the 2018 performance 
period are as follows. For more information, we refer readers to the CY 
2017 Quality Payment Program and CY 2018 Quality Payment Program final 
rules (81 FR 77227 through 77229, and 82 FR 53674 through 53680, 
respectively).

    Objective: Protect Patient Health Information.
    Objective: Protect electronic protected health information (ePHI) 
created or maintained by the CEHRT through the

[[Page 59797]]

implementation of appropriate technical, administrative, and physical 
safeguards.
    Security Risk Analysis Measure: Conduct or review a security risk 
analysis in accordance with the requirements in 45 CFR 164.308(a)(1), 
including addressing the security (to include encryption) of ePHI data 
created or maintained by CEHRT in accordance with requirements in 
Sec. Sec.  164.312(a)(2)(iv) and 164.306(d)(3), implement security 
updates as necessary, and correct identified security deficiencies as 
part of the MIPS eligible clinician's risk management process.
    Objective: Electronic Prescribing.
    Objective: Generate and transmit permissible prescriptions 
electronically.
    e-Prescribing Measure: At least one permissible prescription 
written by the MIPS eligible clinician is queried for a drug formulary 
and transmitted electronically using CEHRT.
    Denominator: Number of prescriptions written for drugs requiring a 
prescription in order to be dispensed other than controlled substances 
during the performance period; or number of prescriptions written for 
drugs requiring a prescription in order to be dispensed during the 
performance period.
    Numerator: The number of prescriptions in the denominator 
generated, queried for a drug formulary, and transmitted electronically 
using CEHRT.
    Exclusion: Any MIPS eligible clinician who writes fewer than 100 
permissible prescriptions during the performance period.

    Objective: Patient Electronic Access.
    Objective: The MIPS eligible clinician provides patients (or 
patient-authorized representative) with timely electronic access to 
their health information and patient-specific education.
    Patient Access Measure: For at least one unique patient seen by the 
MIPS eligible clinician: (1) The patient (or the patient-authorized 
representative) is provided timely access to view online, download, and 
transmit his or her health information; and (2) The MIPS eligible 
clinician ensures the patient's health information is available for the 
patient (or patient-authorized representative) to access using any 
application of their choice that is configured to meet the technical 
specifications of the Application Programing Interface (API) in the 
MIPS eligible clinician's CEHRT.
    Denominator: The number of unique patients seen by the MIPS 
eligible clinician during the performance period.
    Numerator: The number of patients in the denominator (or patient 
authorized representative) who are provided timely access to health 
information to view online, download, and transmit to a third party and 
to access using an application of their choice that is configured meet 
the technical specifications of the API in the MIPS eligible 
clinician's CEHRT.
    Patient-Specific Education Measure: The MIPS eligible clinician 
must use clinically relevant information from CEHRT to identify 
patient-specific educational resources and provide electronic access to 
those materials to at least one unique patient seen by the MIPS 
eligible clinician.
    Denominator: The number of unique patients seen by the MIPS 
eligible clinician during the performance period.
    Numerator: The number of patients in the denominator who were 
provided electronic access to patient-specific educational resources 
using clinically relevant information identified from CEHRT during the 
performance period.

    Objective: Coordination of Care Through Patient Engagement.
    Objective: Use CEHRT to engage with patients or their authorized 
representatives about the patient's care.
    View, Download, Transmit (VDT) Measure: During the performance 
period, at least one unique patient (or patient-authorized 
representatives) seen by the MIPS eligible clinician actively engages 
with the EHR made accessible by the MIPS eligible clinician by either: 
(1) Viewing, downloading or transmitting to a third party their health 
information; or (2) accessing their health information through the use 
of an API that can be used by applications chosen by the patient and 
configured to the API in the MIPS eligible clinician's CEHRT; or (3) a 
combination of (1) and (2).
    Denominator: Number of unique patients seen by the MIPS eligible 
clinician during the performance period.
    Numerator: The number of unique patients (or their authorized 
representatives) in the denominator who have viewed online, downloaded, 
or transmitted to a third party the patient's health information during 
the performance period and the number of unique patients (or their 
authorized representatives) in the denominator who have accessed their 
health information through the use of an API during the performance 
period.
    Secure Messaging Measure: For at least one unique patient seen by 
the MIPS eligible clinician during the performance period, a secure 
message was sent using the electronic messaging function of CEHRT to 
the patient (or the patient-authorized representative), or in response 
to a secure message sent by the patient (or the patient-authorized 
representative).
    Denominator: Number of unique patients seen by the MIPS eligible 
clinician during the performance period.
    Numerator: The number of patients in the denominator for whom a 
secure electronic message is sent to the patient (or patient-authorized 
representative) or in response to a secure message sent by the patient 
(or patient-authorized representative), during the performance period.
    Patient-Generated Health Data Measure: Patient-generated health 
data or data from a non-clinical setting is incorporated into the CEHRT 
for at least one unique patient seen by the MIPS eligible clinician 
during the performance period.
    Denominator: Number of unique patients seen by the MIPS eligible 
clinician during the performance period.
    Numerator: The number of patients in the denominator for whom data 
from non-clinical settings, which may include patient-generated health 
data, is captured through the CEHRT into the patient record during the 
performance period.

    Objective: Health Information Exchange.
    Objective: The MIPS eligible clinician provides a summary of care 
record when transitioning or referring their patient to another setting 
of care, receives or retrieves a summary of care record upon the 
receipt of a transition or referral or upon the first patient encounter 
with a new patient, and incorporates summary of care information from 
other health care providers into their EHR using the functions of 
CEHRT.
    Send a Summary of Care Measure: For at least one transition of care 
or referral, the MIPS eligible clinician that transitions or refers 
their patient to another setting of care or health care provider (1) 
creates a summary of care record using CEHRT; and (2) electronically 
exchanges the summary of care record.
    Denominator: Number of transitions of care and referrals during the 
performance period for which the MIPS eligible clinician was the 
transferring or referring clinician.
    Numerator: The number of transitions of care and referrals in the 
denominator where a summary of care record was created using CEHRT and 
exchanged electronically.

[[Page 59798]]

    Exclusion: Any MIPS eligible clinician who transfers a patient to 
another setting or refers a patient fewer than 100 times during the 
performance period.
    Request/Accept Summary of Care Measure: For at least one transition 
of care or referral received or patient encounter in which the MIPS 
eligible clinician has never before encountered the patient, the MIPS 
eligible clinician receives or retrieves and incorporates into the 
patient's record an electronic summary of care document.
    Denominator: Number of patient encounters during the performance 
period for which a MIPS eligible clinician was the receiving party of a 
transition or referral or has never before encountered the patient and 
for which an electronic summary of care record is available.
    Numerator: Number of patient encounters in the denominator where an 
electronic summary of care record received is incorporated by the 
clinician into the CEHRT.
    Exclusion: Any MIPS eligible clinician who receives transitions of 
care or referrals or has patient encounters in which the MIPS eligible 
clinician has never before encountered the patient fewer than 100 times 
during the performance period.
    Clinical Information Reconciliation Measure: For at least one 
transition of care or referral received or patient encounter in which 
the MIPS eligible clinician has never before encountered the patient, 
the MIPS eligible clinician performs clinical information 
reconciliation. The MIPS eligible clinician must implement clinical 
information reconciliation for the following three clinical information 
sets: (1) Medication. Review of the patient's medication, including the 
name, dosage, frequency, and route of each medication; (2) Medication 
allergy. Review of the patient's known medication allergies; and (3) 
Current Problem list. Review of the patient's current and active 
diagnoses.
    Denominator: Number of transitions of care or referrals during the 
performance period for which the MIPS eligible clinician was the 
recipient of the transition or referral or has never before encountered 
the patient.
    Numerator: The number of transitions of care or referrals in the 
denominator where the following three clinical information 
reconciliations were performed: Medication list; medication allergy 
list; and current problem list.

    Objective: Public Health and Clinical Data Registry Reporting.
    Objective: The MIPS eligible clinician is in active engagement with 
a public health agency or clinical data registry to submit electronic 
public health data in a meaningful way using CEHRT, except where 
prohibited, and in accordance with applicable law and practice.
    Immunization Registry Reporting Measure: The MIPS eligible 
clinician is in active engagement with a public health agency to submit 
immunization data and receive immunization forecasts and histories from 
the public health immunization registry/immunization information system 
(IIS).
    Syndromic Surveillance Reporting Measure: The MIPS eligible 
clinician is in active engagement with a public health agency to submit 
syndromic surveillance data from a non-urgent care setting.
    Electronic Case Reporting Measure: The MIPS eligible clinician is 
in active engagement with a public health agency to electronically 
submit case reporting of reportable conditions.
    Public Health Registry Reporting Measure: The MIPS eligible 
clinician is in active engagement with a public health agency to submit 
data to public health registries.
    Clinical Data Registry Reporting Measure: The MIPS eligible 
clinician is in active engagement to submit data to a clinical data 
registry.
(f) Promoting Interoperability Performance Category Measures for MIPS 
Eligible Clinicians
(i) Measure Summary Overview
    In the CY 2019 PFS proposed rule (83 FR 35920 through 35932), we 
proposed to adopt beginning with the performance period in 2019 the 
existing Promoting Interoperability objectives and measures as 
finalized in the CY 2018 Quality Payment Program final rule (82 FR 
53674 through 53680) with several proposed changes as discussed herein, 
including the addition of new measures, removal of some of the existing 
measures, and modifications to the specifications of some of the 
existing measures. We did not propose to continue the Promoting 
Interoperability transition objectives and measures (see 82 FR 53674 
through 53676) beyond the 2018 MIPS performance period because the 2015 
Edition of CEHRT will be required beginning with the MIPS performance 
period in 2019. Our intent for these proposed changes is to ensure the 
measures better focus on the effective use of health IT, particularly 
for interoperability, and to address concerns stakeholders have raised 
through public forums and in public comments related to the perceived 
burden associated with the current measures in the program. As stated 
in the CY 2017 Quality Payment Program final rule (81 FR 77216) our 
priority is to finalize reporting requirements for the Promoting 
Interoperability performance category that incentivizes performance and 
reporting with minimal complexity and reporting burden. In addition, we 
acknowledged that while we believe all of the measures of the Promoting 
Interoperability performance category are important, we must also 
balance the need for these data with data collection and reporting 
burden (81 FR 77221).
    In CY 2017, we initiated an informal process outside of rulemaking 
for submission of new Promoting Interoperability performance category 
measures for potential inclusion in the Year 3 Quality Payment Program 
proposed rule. We prioritized measures that build on interoperability 
and health information exchange, the advanced use of CEHRT using 2015 
Edition Standards and Certification Criteria, improve program 
efficiency and flexibility, measure patient outcomes, emphasize patient 
safety, and support improvement activities and quality performance 
categories of MIPS. In addition, and as we indicated in the CY 2018 
Quality Payment Program proposed rule (82 FR 30079), we sought new 
measures that may be more broadly applicable to MIPS eligible 
clinicians who are Nurse Practitioners (NPs), Physician Assistants 
(PAs), Certified Registered Nurse Anesthetists (CRNAs) and Clinical 
Nurse Specialists (CNSs).
    During this initial submission period, various MIPS eligible 
clinicians, stakeholders and health IT developers submitted new 
measures for consideration via an application posted on the CMS 
website, now hosted at https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/CallForMeasures.html. Through our 
review process, which included representation from the ONC, as well as 
various stakeholder listening sessions, we identified measure 
submissions that met our criteria and aligned with the Promoting 
Interoperability performance category goals and priorities, as well as 
broader HHS initiatives related to the opioid crisis.\20\ As a result 
of this process, we proposed two measures, Query of PDMP and Verify 
Opioid Treatment Agreement.
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    \20\ https://www.hhs.gov/opioids/about-the-epidemic/index.html; 
https://www.healthit.gov/opioids.
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    We proposed to remove six measures from the Promoting 
Interoperability objectives and measures beginning with the performance 
period in 2019. Two of

[[Page 59799]]

the measures we proposed to remove--Request/Accept Summary of Care and 
Clinical Information Reconciliation--would be replaced by the Support 
Electronic Referral Loops by Receiving and Incorporating Health 
Information measure, which combines the functionalities and goals of 
the two measures it is replacing. Four of the measures--Patient-
Specific Education; Secure Messaging; View, Download, or Transmit; and 
Patient-Generated Health Data--would be removed because they have 
proven burdensome to MIPS eligible clinicians in ways that were 
unintended and may detract from clinicians' progress on current program 
priorities. We stated that although the measures proposed for removal 
would no longer need to be submitted if we finalize the proposal to 
remove them, MIPS eligible clinicians may still continue to use the 
standards and functions of those measures based on the preferences of 
their patients and their practice needs. We stated our belief that this 
burden reduction would enable MIPS eligible clinicians to focus on new 
measures that further interoperability, advances of innovation in the 
use of CEHRT and the exchange of health care information.
    As discussed in the proposed scoring methodology in section 
III.H.3.h.(5)(f) of the proposed rule, we proposed to add three new 
measures to the Promoting Interoperability objectives and measures 
beginning with the performance period in 2019. For the e-Prescribing 
objective, we proposed the two new measures referenced earlier, Query 
of PDMP and Verify Opioid Treatment Agreement, both of which support 
HHS initiatives related to the treatment of opioid and substance use 
disorders by helping health care providers avoid inappropriate 
prescriptions, improving coordination of prescribing amongst health 
care providers and focusing on the advanced use of CEHRT. For the 
Health Information Exchange objective, we proposed a new measure, 
Support Electronic Referral Loops by Receiving and Incorporating Health 
Information, which builds upon and replaces the existing Request/Accept 
Summary of Care and Clinical Information Reconciliation measures, while 
furthering interoperability and the exchange of health information.
    We also proposed to modify some of the existing Promoting 
Interoperability performance category objectives and measures beginning 
with the performance period in 2019. We proposed to rename the Send a 
Summary of Care measure to Support Electronic Referral Loops by Sending 
Health Information. In addition, we proposed to rename the Patient 
Electronic Access objective to Provider to Patient Exchange, and 
proposed to rename the remaining measure, Provide Patient Access to 
Provide Patients Electronic Access to Their Health Information. We 
proposed to eliminate the Coordination of Care Through Patient 
Engagement objective and all of its associated measures as described 
earlier. Finally, we proposed to rename the Public Health and Clinical 
Data Registry Reporting objective to Public Health and Clinical Data 
Exchange and require reporting on at least two measures of the MIPS 
eligible clinician's choice from the following: Immunization Registry 
Reporting; Syndromic Surveillance Reporting, Electronic Case Reporting; 
Public Health Registry Reporting; and Clinical Data Registry Reporting. 
In addition, we proposed exclusion criteria for each of these measures.
    Finally, we solicited comment on a potential new measure Health 
Information Exchange Across the Care Continuum under the Health 
Information Exchange objective in which a MIPS eligible clinician would 
send an electronic summary of care record, or receive and incorporate 
an electronic summary of care record, for transitions of care and 
referrals with a health care provider other than a MIPS eligible 
clinician. The measure would include health care providers in care 
settings including but not limited to long term care facilities and 
post-acute care providers such as skilled nursing facilities, home 
health, and behavioral health settings.
    As we stated in the proposed rule (83 FR 35921) we understand from 
previous listening sessions that EHR vendors and developers will need 
time to develop, test and implement new measures, and MIPS eligible 
clinicians will need time to implement as well as establish and test 
their processes and workflows. As indicated above and in the discussion 
of the proposed scoring methodology in section III.H.3.h.(5)(d) of the 
proposed rule, we proposed three new measures (Query of PDMP, Verify 
Opioid Treatment Agreement, and Support Electronic Referral Loops by 
Receiving and Incorporating Health Information). We proposed that the 
Query of PDMP and Verify Opioid Treatment Agreement measures would be 
optional for the performance period in 2019 and bonus points may be 
earned for reporting on them. We proposed that the Support Electronic 
Referral Loops by Receiving and Incorporating Health Information would 
be required beginning with the performance period in 2019 with 
exclusions available. We proposed to require the Query of PDMP and 
Verify Opioid Treatment Agreement measures beginning with the 
performance period in 2020, and we solicited public comment on this 
proposal.
    We noted that the proposals under the Health Information Exchange 
objective require only consolidation of existing workflows and actions, 
while certification criteria and standards remain the same as in the CY 
2018 Quality Payment Program final rule (82 FR 53677 through 53678). 
Therefore, we stated our belief that MIPS eligible clinicians could 
potentially implement this new measure for the performance period in 
2019.
    The following is a summary of the comments we received on our 
proposals.
    Comment: One commenter stated that for some measures MIPS eligible 
clinicians and group practices should be able to get credit for actions 
that are taken outside of the 90-day performance period.
    Response: Since the inception of the Quality Payment Program, we 
have limited the ability to increment the numerator and denominator of 
measures to actions occurring during the performance period chosen, 
with the exception of the Security Risk Analysis measure for which the 
relevant actions may occur any time during the calendar year. The MIPS 
eligible clinician may select a MIPS performance period that exceeds 
the 90-day minimum up to a maximum of the full calendar year if they 
choose. (82 FR 53670).
(ii) Measure Proposals for the e-Prescribing Objective
    In the CY 2019 PFS proposed rule (83 FR 35921 through 35925), we 
proposed two new measures under the e-Prescribing objective. In the CY 
2017 Quality Payment Program final rule, we stated that MIPS eligible 
clinicians will have the option to include or not include controlled 
substances in the definition of ``permissible prescriptions'' at their 
discretion where feasible and allowable by law in the jurisdiction 
where they provide care (81 FR 77227). We believe it is important to 
consider other requirements specific to electronic prescribing of 
controlled substances for health care providers to take into account 
and how this may interact with the proposals under this rulemaking. We 
are committed to combatting the opioid epidemic by making it a top 
priority for the agency and aligning its efforts with the HHS opioid 
initiative to combat misuse and promote programs that support treatment 
and recovery support services.

[[Page 59800]]

    We proposed to add two new measures to the e-Prescribing objective 
that are based on electronic prescriptions for controlled substances 
(EPCS): Query of PDMP; and Verify Opioid Treatment Agreement. These 
measures build upon the meaningful use of CEHRT as well as the security 
of electronic prescribing of Schedule II controlled substances while 
preventing diversion. For both measures, we proposed to define opioids 
as Schedule II controlled substances under 21 CFR 1308.12, as they are 
recognized as having a high potential for abuse with potential for 
severe psychological or physical dependence. We also proposed to apply 
the same policies for the existing e-Prescribing measure to both the 
Query of PDMP and Verify Opioid Treatment Agreement measures, including 
the requirement to use CEHRT as the sole means of creating the 
prescription and for transmission to the pharmacy. We stated that MIPS 
eligible clinicians have the option to include or exclude controlled 
substances in the e-Prescribing measure denominator as long as they are 
treated uniformly across patients and all available schedules and in 
accordance with applicable law. However, because the intent of these 
two new measures is to improve prescribing practices for controlled 
substances, MIPS eligible clinicians would have to include Schedule II 
opioid prescriptions in the numerator and denominator or claim the 
applicable exclusion. Additionally, we noted the intent of the proposed 
measures is not to dissuade the prescribing or use of opioids for 
patients with medical diagnoses or conditions that benefit from their 
use, such as patients diagnosed with cancer or those receiving hospice. 
We solicited comment on the impact that implementing this measure could 
have on patients who receive opioids due to medical diagnoses such as 
cancer or receiving hospice care as well as treatment of patients under 
a program involving substance abuse education, treatment, or prevention 
under 42 CFR part 2.
    Additionally, we solicited comment on the federal and state 
statutory and regulatory requirements that may impact implementation of 
the Query of PDMP and Verify Opioid Treatment Agreement measures.
    We stated that in the event we finalize the new scoring methodology 
that we proposed in section III.H.3.h.(5)(d) of the proposed rule, MIPS 
eligible clinicians who claim the exclusion under the existing e-
Prescribing measure would automatically receive an exclusion for all 
three of the measures under the e-Prescribing objective; they would not 
have to also claim exclusions for the other two measures, Query of PDMP 
and Verify Opioid Treatment Agreement. We are not finalizing this 
proposal because we are finalizing the two new measures (Query of PDMP 
and Verify Opioid Treatment Agreement) are optional, so exclusions 
would not be necessary for them.
(A) Query of Prescription Drug Monitoring Program (PDMP) Measure
    As we stated in the proposed rule (83 FR 35922 through 35923), a 
PDMP is an electronic database that tracks prescriptions of controlled 
substances at the State level. PDMPs play an important role in patient 
safety by assisting in the identification of patients who have multiple 
prescriptions for controlled substances or may be misusing or overusing 
them. Querying the PDMP is important for tracking the prescribed 
controlled substances and improving prescribing practices. The ONC, 
Centers for Disease Control and Prevention (CDC), Department of Justice 
(DOJ) and Substance Abuse and Mental Health Services Administration 
(SAMHSA) have had integral roles in the integration and expansion of 
PMDPs with health information technology systems. For example, the ONC 
and SAMHSA collaboratively led the ``Enhancing Access'' project to 
improve health care provider access to PDMP data utilizing health 
IT.\21\ Likewise, the CDC conducted a process and outcome evaluation of 
the PDMP EHR Integration and Interoperability Expansion (PEHRIIE) 
program funded by SAMHSA for nine states between FY 2012 and 2016. The 
PEHRIIE program goals were to integrate PDMPs into health IT and 
improve the comprehensiveness of PDMPs through initiating and/or 
improving interstate data exchange.\22\ In addition, the Bureau of 
Justice Assistance's Harold Rogers Prescription Monitoring Program 
supports Prescription Drug Monitoring Program Information Exchange 
(PMIX) through funding, the goal of PMIX is to help states implement a 
cost-effective solution to facilitate interstate data sharing among 
PDMPs.\23\ Integration of the PDMP with health information technology 
systems supports improves access to PDMP data, minimizes changes to 
current workflow and overall burden and optimizes prescribing 
practices. The intent of the Query of the PDMP measure is to build upon 
the current PDMP initiatives from Federal partners focusing on 
prescriptions generated and dispensing of opioids.
---------------------------------------------------------------------------

    \21\ https://www.healthit.gov/PDMP and https://www.healthit.gov/sites/default/files/work_group_document_integrated_paper_final_0.pdf.
    \22\ https://www.cdc.gov/drugoverdose/pdf/pehriie_report-a.pdf.
    \23\ https://www.bja.gov/funding/Category-5-awards.pdf.
---------------------------------------------------------------------------

    Proposed Measure Description: For at least one Schedule II opioid 
electronically prescribed using CEHRT during the performance period, 
the MIPS eligible clinician uses data from CEHRT to conduct a query of 
a Prescription Drug Monitoring Program (PDMP) for prescription drug 
history, except where prohibited and in accordance with applicable law.
    We stated that we recognize both the utility and value of 
addressing PDMP EHR integration and further recognizes the majority of 
states mandate use of State prescription monitoring programs (PMPs) 
requiring prescribers/dispensers to access PMP.\24\ According to the 
CDC, State-level policies that enhance PDMPs or regulate pain clinics 
helped several states drive down opioid prescriptions and overdose 
deaths.\25\ We stated that we are also further aware of the varying 
integration approaches underway including efforts to integrate a state 
PDMP into a health information exchange or EHR or other efforts to 
enhance a user interface of some type, such as risk assessment tools or 
red flags. We noted federal evaluation resources available to inform 
integration efforts \26\ and believe integration is critical for 
enhancing health care provider workflow, access to critical PDMP data, 
and improving clinical care including prescription management.
---------------------------------------------------------------------------

    \24\ http://www.namsdl.org/library/14D3122C-96F5-F53E-E8F23E906B4DE09D/.
    \25\ https://www.cdc.gov/drugoverdose/policy/successes.html.
    \26\ https://www.cdc.gov/drugoverdose/pdf/pehriie_report-a.pdf.
---------------------------------------------------------------------------

    We proposed that the query of the PDMP for prescription drug 
history must be conducted prior to the electronic transmission of the 
Schedule II opioid prescription. MIPS eligible clinicians would have 
flexibility to query the PDMP using CEHRT in any manner allowed under 
their State law.
    Although the query of the PDMP may currently be burdensome for some 
MIPS eligible clinicians as part of their current workflow practice, we 
stated our belief that querying the PDMP is beneficial to optimal 
prescribing practices and foresee progression toward fully automated 
queries of the PDMP building upon the current initiatives at the State 
level.
    We proposed to include in this measure all permissible 
prescriptions and dispensing of Schedule II opioids regardless of the 
amount prescribed during an encounter in order for MIPS

[[Page 59801]]

eligible clinicians to identify multiple health care provider episodes 
(physician shopping), prescriptions of dangerous combinations of drugs, 
prescribing rates and controlled substances prescribed in high 
quantities. We requested comment on these policy proposals, including 
whether additional queries should be performed and under which 
circumstances. In addition we solicited comment on whether the query 
should have additional constraints concerning when it should be 
performed.
    Denominator: Number of Schedule II opioids electronically 
prescribed using CEHRT by the MIPS eligible clinician during the 
performance period.
    Numerator: The number of Schedule II opioid prescriptions in the 
denominator for which data from CEHRT is used to conduct a query of a 
PDMP for prescription drug history except where prohibited and in 
accordance with applicable law. A numerator of at least one is required 
to fulfill this measure.
    Exclusion (beginning in 2020): Any MIPS eligible clinician who is 
unable to electronically prescribe Schedule II opioids in accordance 
with applicable law during the performance period. We proposed that the 
exclusion criteria would be limited to prescriptions of Schedule II 
opioids as the measure action is limited to prescriptions of Schedule 
II opioids only and does not include any other types of electronic 
prescriptions. We also requested comment on the proposed exclusion 
criteria and whether there are circumstances which may justify other 
exclusions for the Query of PDMP measure and what those circumstances 
might be including medical diagnoses such as cancer or patients under 
care of hospice.
    We noted that we also understand that PDMP integration is not 
currently in widespread use for CEHRT, and many MIPS eligible 
clinicians may require additional time and workflow changes at the 
point of care before they can meet this measure without experiencing 
significant burden. For instance, many MIPS eligible clinicians will 
likely need to manually enter the data into CEHRT to document the 
completion of the query of the PDMP action. In addition, some MIPS 
eligible clinicians may also need to conduct manual calculation of the 
measure. Even for those MIPS eligible clinicians that have achieved 
successful integration of a PDMP with their EHR, this measure may not 
be machine calculable, for instance, in cases where the MIPS eligible 
clinician follows a link within the EHR to a separate PDMP system. For 
the purposes of meeting this measure, we noted there is no existing 
certification criteria for the query of a PDMP. However, we stated our 
belief that the use of structured data captured in the CEHRT can 
support querying a PDMP through the broader use of health IT. We 
solicited public comment on whether ONC should consider adopting 
standards and certification criteria to support the query of a PDMP, 
and if such criteria were to be adopted, on what timeline should CMS 
require their use to meet this measure.
    We noted the NCPDP SCRIPT 2017071 standard for e-prescribing is now 
available and can help to support PDMP and EHR integration. We 
solicited public comment, especially from health care providers and 
health IT developers on whether they believe use of this standard can 
support MIPS eligible clinicians seeking to report on this measure, and 
whether HHS should encourage use of this standard through separate 
rulemaking.
    We solicited comment on the challenges associated with querying the 
PDMP with and without CEHRT integration and whether this proposed 
measure should require certain standards, methods or functionalities to 
minimize burden.
    In including EPCS as a component of the measure as proposed, we 
acknowledged and sought input on perceived and real technological 
barriers as part of its effective implementation including but not 
limited to input on two-factor authentication and on the effective and 
appropriate uses of technology, including the use of telehealth 
modalities to support established patient and health care provider 
relationships subsequent to in-person visit(s) and for prescribing 
purposes.
    We also proposed that in order to meet this measure, a MIPS 
eligible clinician must use the capabilities and standards as defined 
for CEHRT at 45 CFR 170.315(a)(10)(ii) and (b)(3).
    The following is a summary of the comments we received on these 
proposals.
    Comment: One commenter stated that the measure is overly burdensome 
because view-only data is not sufficient for clinicians and data should 
be in a format that is acceptable by the receiving EHR system.
    Response: We agree that if data exchanged is not supported in a 
computable format, it may create increased burden to the MIPS eligible 
clinician. Although we believe the Query of PDMP measure is a necessary 
step to combat the opioid crisis by taking advantage of health IT 
capabilities, we agree that the lack of EHR integration with PDMPs is 
an obstacle to widespread adoption of this measure. We will continue to 
work with our colleagues across HHS and with stakeholders to develop 
necessary standards and complementary resources to promote the 
advancement of PDMP functionality. Over time, we believe the continued 
advancement of this measure will help further patient safety and reduce 
provider burden. We are providing bonus points for this measure in CY 
2019 and will propose our policy for CY 2020 in future rulemaking.
    Comment: Some commenters supported this new measure but stated that 
there is little or no time for health IT developers to update their 
products, receive certification and roll these products out to users. 
Commenters requested that CMS give more lead-time for these type of 
changes and have the Query of PDMP measure be optional in the 2019 and 
2020 MIPS performance periods.
    Other commenters stated that while PDMPs play an important role in 
identifying high-risk patients, and recommended that CMS move more 
slowly with requiring the measure until PDMPs are more fully integrated 
into EHRs and clinician workflows.
    Response: We acknowledge that there is currently no certified 
functionality within CEHRT specific to connecting to a PDMP and that 
support for integration between PDMP systems and EHRs varies widely 
across States due to variations in laws and technical approaches. We 
believe that functionality currently in CEHRT may support integration 
with PDMP systems. While we understand the concern that there is not 
specific certified functionality to meet this measure, we stated in the 
proposed rule (83 FR 35923) that MIPS eligible clinicians have the 
flexibility to query the PDMP in any manner allowed under their State 
law. We also stated (83 FR 35923) that in order to meet the measure, 
MIPS eligible clinicians must use the capabilities of their CEHRT 
defined at Sec.  170.315(a)(10)(ii) and (b)(3).
    The certification criteria defined at Sec.  170.315(b)(3) supports 
this measure because it allows a MIPS eligible clinician to create a 
new prescription, change a prescription, cancel a prescription, refill 
a prescription, request fill status notifications and request and 
receive medication history information to and from pharmacies. PDMPs 
collect, monitor, and analyze electronically transmitted prescribing 
and dispensing data submitted by pharmacies and dispensing 
practitioners. Additionally, the CEHRT criteria defined at Sec.  
170.315(a)(10)(ii) defines drug formulary checks, which

[[Page 59802]]

are the most useful when utilized with e-Prescribing. These criteria 
ensure the availability of structured data to support PDMPs through the 
broader use of health IT and may increase the efficiency and safety of 
opioid prescribing, while potentially reducing the cost of care.
    We are aware of the need for additional time to implement this 
measure and thus we are making it optional in CY 2019 and will propose 
our policy for this measure for CY 2020 in future rulemaking.
    Comment: One commenter stated that CMS must recognize that the 
Query of PDMP measure may not provide a complete picture of the 
patient's medication history.
    Response: We agree that the Query of PDMP measure may not provide a 
complete picture of the patient's medication history; however, it can 
provide the clinician with information to make a more informed clinical 
decision, and we believe it is a valuable tool to consider in caring 
for patients.
    Comment: One commenter recommended that CMS and ONC work together 
to develop a set of national standards for PDMPs, so that the 
information can be exchanged across a variety of States. Another 
commenter recommended CMS and ONC develop standards to allow access to 
a PDMP through a HIE.
    Response: We understand States have varying technical approaches 
for PDMPs and that some states are pursuing strategies that utilize 
HIEs to help clinicians access PDMPs. We believe these strategies are 
an important way to increase interoperability and support clinicians' 
ability to connect with PDMP systems.
    We will continue to work with ONC and other stakeholders to 
encourage the development of standards, which facilitate increased 
interoperability between PDMPs and other systems, including HIEs and 
clinician health IT systems.
    Comment: A commenter stated that a State lacks a state-wide PDMP 
and requested an exclusion for MIPS eligible clinicians who do not have 
a State PDMP to query. Another commenter requested an exclusion for 
MIPS eligible clinicians who do not prescribe any Schedule II opioids 
during a 90-day performance period, because the lack of such exclusion 
could result in MIPS eligible clinicians prescribing an unnecessary 
Schedule II opioid just to avoid earning a zero for the Promoting 
Interoperability performance category. One commenter requested that in 
addition to the proposed exclusion CMS should add an exclusion for MIPS 
eligible clinicians in states that do not support PDMP integration 
using the NCPDP SCRIPT or SMART on FHIR standard.
    Response: We decline to add any exclusions to the Query of PDMP 
measure at this time. For CY 2019, exclusions are not available, as the 
measure is optional.
    Comment: Some commenters stated the development of interfaces to 
connect EHRs to a PDMP vendor solution is underway, but there is a cost 
to access the PDMP gateway. Other commenters noted that some states 
charge clinicians fees to use a PDMP and a mandatory measure using 
PDMPs could add considerable financial burden.
    Response: Our goal of burden reduction includes consideration of 
costs associated with meeting the Promoting Interoperability 
performance category requirements. We will continue to listen to 
feedback related to costs and mitigate burden wherever possible and as 
practicable within the MIPS programs. We will also continue to work 
with HHS partners and other stakeholder in the creation, harmonization, 
and promotion of free and open source interoperability standards for 
EHRs and PDMPs, and we encourage PDMPs across the country to connect to 
the free and open source RxCheck, a fully operational national hub that 
enables states to securely and efficiently share PDMP data.
    Comment: A few commenters stated that this measure should be Yes/No 
reporting instead of reporting a numerator and denominator since some 
states require health care providers to download current PDMP results 
that are not incorporated into CEHRT. The commenter further stated that 
having this measure as a numerator/denominator will create significant 
challenges to capture and calculate the performance of this measure.
    Response: We decline to change the format of the measure to a Yes/
No metric as we believe that a numerator/denominator reporting format 
captures the intent of the measure, which is to identify multiple 
provider episodes (physician shopping), prescriptions of dangerous 
combinations of drugs, prescribing rates and controlled substances 
prescribed in high quantities. We believe MIPS eligible clinicians need 
to demonstrate their performance in meeting these opioid measures.
    Comment: A commenter questioned what documentation is required to 
indicate that they fulfilled the Query of PDMP measure. The commenter 
stated that in the 2020 MIPS performance period, when the measure is 
required, MIPS eligible clinicians will need time to figure out how to 
generate the appropriate documentation.
    Response: We understand that many clinicians may be required to 
manually calculate this measure, and we plan to issue guidance 
regarding the documentation to retain. This may include MIPS eligible 
clinicians with EHR-integrated PDMPs, who still have to manually 
calculate the measure due to the lack of automated functionality. Due 
to challenges with reporting on this new measure, we will determine 
through future rulemaking the status of this measure for the 2020 MIPS 
performance period and beyond.
    Comment: A commenter requested that the denominator of the measure 
be changed from ``electronically prescribed'' to all prescribed 
Schedule II opioids because entities that are barred from e-prescribing 
controlled substances would still benefit from incorporating PDMP 
queries into their workflows.
    Response: As we stated in the proposed rule (83 FR 35922), intent 
of the Query of the PDMP measure is to build upon current PDMP 
initiatives from federal partners focusing on prescriptions generated 
and dispensing of opioids. The objectives and measures for the 
Promoting Interoperability performance category focus on the use of 
CEHRT. Therefore we decline to expand the denominator of the measure to 
include Schedule II opioids that are not electronically prescribed.
    Comment: One commenter requested clarification as to whether the 
numerator is intended to capture PMDP queries or user acknowledgement 
of conducting a PDMP query.
    Response: The numerator captures instances were a MIPS eligible 
clinician conducts a query of a PDMP for prescription medication 
history, except where prohibited and in accordance with the applicable 
law. We understand that many clinician systems may not have the ability 
to capture the number of PDMP queries in an automated fashion, and that 
these clinicians may need to capture the data and calculate the measure 
manually. The intent of the measure is to identify multiple provider 
episodes (physician shopping), prescriptions of dangerous combinations 
of drugs, prescribing rates and controlled substances prescribed in 
high quantities.
    Comment: A commenter stated that many state PDMPs are not ready to 
implement direct integration of the PDMP with the EHR. Many commenters 
stated that this functionality needs to be a part of CEHRT, so that 
prescribers do not need to leave their EHR and log into a separate 
system to conduct the query

[[Page 59803]]

of the PDMP. Commenters suggested that CMS redesign the measure so that 
only direct integration is included.
    Response: We agree that there are issues associated with the 
integration of the PDMP with CEHRT and that is why we will establish 
our policies for the measure for CY 2020 and beyond in future 
rulemaking.
    Comment: One commenter recommended that CMS allow MIPS eligible 
clinicians to use a health information exchange to access the Schedule 
II opioid prescription drug history and earn extra points.
    Response: We have stated that clinicians may query the PDMP in any 
fashion allowed under applicable state law, which would include the use 
of HIEs to access PDMP data.
    Comment: A commenter recommended CMS and ONC work together with 
PDMPs, PDMP health IT vendors, and key standards development 
organizations (NCPDP and HL7 in particular) to address the 
interoperability and integration issues when using PDMPs. We note that, 
while NCPDP provides medication history query specifications that CEHRT 
support as part of their electronic prescribing capabilities, none of 
the PDMPs currently support these. The commenter suggested that 
consideration should be given whether comprehensive interoperability 
with PDMPs to support both clinicians and patients would benefit from 
the use of HL7 FHIR(copyright) standards.
    Response: We recognize that interoperability and integration 
efforts are in various stages. CMS and ONC continue to work in tandem 
and with our stakeholders toward our shared goal of interoperability. 
We encourage work by PDMPs, pharmacies, and health IT developers to use 
existing and emerging open source standards to ensure greater 
interoperability between PDMPs and health IT systems and within 
efficient clinician workflows. The adoption and implementation of these 
open source standards is important not only for PDMP query 
functionality but for also other relevant tools, such as automated 
clinical decision support, that facilitate more informed prescribing 
practices and improved patient outcomes.
    Comment: The commenter stated their state does not let the PDMP be 
fully integrated with the electronic medical record. The commenter also 
questioned how CMS envisions clinicians attesting to querying of the 
PDMP, and it would be helpful to have more guidance from CMS.
    Response: If you choose to submit data for CY 2019 for the Query of 
PDMP measure, you will submit your numerator and denominator. We plan 
to provide additional information in future rulemaking regarding this 
measure in CY 2020 and beyond.
    Comment: A commenter stated that some states are not planning for 
EHR systems to interface with a PDMP and even those that are planning 
for this functionality may face a lengthy process to develop the 
ability for an EHR to integrate with a PDMP.
    Response: We will use this input to help inform our future work and 
ongoing collaborative efforts with our HHS colleagues, and with other 
public- and private-sector partners, as appropriate. We will seek 
comment and suggestions in future rulemaking to ascertain if additional 
exclusions are needed for MIPS eligible clinicians located in one of 
the States where PDMPs are not integrated with EHRs.
    Comment: Some commenters supported the intent of this measure but 
did not support the measure as written because it lacks standards. 
Commenters suggested that CMS work with ONC to develop a national 
standard for PDMPs.
    Response: We will continue to collaborate with our colleagues 
across HHS, and with other public-and private-sector partners as 
appropriate.
    Comment: A commenter addressed the impact the Query of PDMP measure 
may have on patients who receive opioids due to medical diagnoses such 
as cancer or receiving hospice. The commenter stated that patients with 
cancer, in hospice care and/or end of life patients should be excluded 
from this measure. The commenter also stated that CMS needed to do more 
work to define ``cancer patient,'' and whether this included cancer 
survivors or those with an active cancer diagnosis.
    Response: We decline to add an exclusion for this for the 2019 MIPS 
performance period because the measure is optional and not required. If 
we propose to require this measure in future years, we may consider 
this suggestion for an exclusion.
    After consideration of the comments we received, we are finalizing 
the Query of PDMP measure with modification:
    Measure Description: For at least one Schedule II opioid 
electronically prescribed using CEHRT during the performance period, 
the MIPS eligible clinician uses data from CEHRT to conduct a query of 
a PDMP for prescription drug history, except where prohibited and in 
accordance with applicable law.
    For the purposes of this measure, we are defining opioids as 
Schedule II controlled substances under 21 CFR 1308.12. We are 
finalizing the proposal to apply the same policies for the existing e-
Prescribing measure to the Query of PDMP measure, including the 
requirement to use CEHRT as the sole means of creating the prescription 
and for transmission to the pharmacy. The query of the PDMP for 
prescription drug history must be conducted prior to the electronic 
transmission of the Schedule II opioid prescription. MIPS eligible 
clinicians would have flexibility to query the PDMP using CEHRT in any 
manner allowed under their State law. This measure includes all 
permissible prescriptions and dispensing of Schedule II opioids 
regardless of the amount prescribed during an encounter in order for 
MIPS eligible clinicians to identify multiple health care provider 
episodes (physician shopping), prescriptions of dangerous combinations 
of drugs, prescribing rates and controlled substances prescribed in 
high quantities. To meet this measure, a MIPS eligible clinician must 
use the capabilities and standards as defined for CEHRT at Sec. Sec.  
170.315(a)(10)(ii) and (b)(3).
    Denominator: Number of Schedule II opioids electronically 
prescribed using CEHRT by the MIPS eligible clinician during the 
performance period.
    Numerator: The number of Schedule II opioid prescriptions in the 
denominator for which data from CEHRT is used to conduct a query of a 
PDMP for prescription drug history except where prohibited and in 
accordance with applicable law. A numerator of at least one is required 
to fulfill this measure.
    As this measure is optional in CY 2019, we are not finalizing 
exclusions for it. We will propose our policy for the Query of a PDMP 
measure for CY 2020 in future rulemaking.
(B) Verify Opioid Treatment Agreement Measure
    As we stated in the proposed rule at 83 FR 35923, the intent of 
this measure is for MIPS eligible clinicians to identify whether there 
is an existing opioid treatment agreement when they electronically 
prescribe a Schedule II opioid using CEHRT if the total duration of the 
patient's Schedule II opioid prescriptions is at least 30 cumulative 
days. We stated that we believe seeking to identify an opioid treatment 
agreement will further efforts to coordinate care between health care 
providers and foster a more informed review of patient therapy. The 
intent of the treatment agreement is to clearly outline the 
responsibilities of both patient and MIPS eligible clinician in the 
treatment plan. Such a treatment plan can be integrated into care 
coordination and care plan activities

[[Page 59804]]

and documents as discussed and agreed upon by the patient and MIPS 
eligible clinician. An opioid treatment agreement is intended to 
support and to enable further coordination and the sharing of substance 
use disorder (SUD) data with consent, as may be required of the 
individual.
    We stated that we understand from stakeholder feedback during 
listening sessions that there are varied opinions regarding opioid 
treatment agreements amongst health care providers. Some are supportive 
of their use, indicating that treatment agreements are an important 
part of the prescription of opioids for pain management, and help 
patients understand their role and responsibilities for maintaining 
compliance with terms of the treatment. Other health care providers 
object to their use citing ethical concerns, and creation of division 
and trust issues in the health care provider-patient relationship. 
Other concerns stem from possible disconnect between the language and 
terminology used in the agreement and the level of comprehension on the 
part of the patient. Because of the debate among practitioners, we 
requested comment on the challenges this proposed measure may create 
for MIPS eligible clinicians, how those challenges might be mitigated, 
and whether this measure should be included as part of the Promoting 
Interoperability performance category. We also acknowledged challenges 
related to prescribing practices and multiple State laws which may 
present barriers to the uniform implementation of this proposed 
measure. We solicited public comment on the challenges and concerns 
associated with opioid treatment agreements and how they could impact 
the feasibility of the proposal.
    Proposed Measure Description: For at least one unique patient for 
whom a Schedule II opioid was electronically prescribed by the MIPS 
eligible clinician using CEHRT during the performance period, if the 
total duration of the patient's Schedule II opioid prescriptions is at 
least 30 cumulative days within a 6-month look-back period, the MIPS 
eligible clinician seeks to identify the existence of a signed opioid 
treatment agreement and incorporates it into the patient's electronic 
health record using CEHRT.
    We proposed this measure would include all Schedule II opioids 
prescribed for a patient electronically using CEHRT by the MIPS 
eligible clinician during the performance period, as well as any 
Schedule II opioid prescriptions identified in the patient's medication 
history request and response transactions during a 6-month look-back 
period, where the total number of days for which a Schedule II opioid 
was prescribed for the patient is at least 30 days.
    We stated that there also may be MIPS eligible clinician burdens 
specific to identifying the existence of a treatment agreement which 
could require additional time and changes to existing workflows, 
determining what constitutes a treatment agreement due to a lack of a 
definition, standard or electronic format and manual calculation of the 
measure. We note that there is no certified capability specific to 
verification and incorporation of an opioid treatment agreement, 
however, clinicians must use the capabilities and standards defined for 
CEHRT at Sec. Sec.  170.315(a)(10) and (b)(3) and 170.205(b)(2) to meet 
the measure. In addition, limitations in the completeness of care team 
information may limit the ability of a MIPS eligible clinician to 
identify all potential sources for querying and obtaining information 
on a treatment agreement for a specific patient. There are currently 
pilots in development focused on increasing connectivity and data 
exchange among health care providers to better integrate behavioral 
health information, for instance, pilots taking place as part of the 
federal Demonstration Program for Certified Community Behavioral Health 
Clinics (CCBHC) \27\ includes criteria on how CCBHCs should use health 
IT to coordinate services and track data on quality measures. 
Participants in such pilots would potentially have the means necessary 
to leverage health IT connectivity to query behavioral health data 
resources and health care providers within their region to identify the 
existence of an opioid treatment agreement and to successfully 
integrate patient information from the hospital stay into the care plan 
for the patient. We solicited comment on other similar pathways to 
facilitate the identification and exchange of treatment agreements and 
opioid abuse treatment planning.
---------------------------------------------------------------------------

    \27\ https://www.samhsa.gov/section-223.
---------------------------------------------------------------------------

    We proposed the 6-month look-back period would begin on the date on 
which the MIPS eligible clinician electronically transmits their 
Schedule II opioid prescription using CEHRT and provided an 
illustrative example of this policy in the proposed rule.
    We proposed a 6-month look-back period to identify more egregious 
cases of potential overutilization of opioids and to cover timeframes 
for use outside the performance period. In addition, we proposed that 
the 6-month look-back period would utilize at a minimum the industry 
standard NCDCP SCRIPT v10.6 medication history request and response 
transactions codified at Sec.  170.205(b)(2)). As ONC has stated (80 FR 
62642), adoption of the requirements for NCDCP SCRIPT v10.6 does not 
preclude developers from incorporating and using technology standards 
or services not required by regulation in their health IT products.
    We did not propose to define an opioid treatment agreement as a 
standardized electronic document; nor did we propose to define the data 
elements, content structure, or clinical purpose for a specific 
document to be considered a ``treatment agreement.'' For this measure, 
we solicited comment on what characteristics should be part of an 
opioid treatment agreement including data, content and clinical purpose 
into CEHRT, including which functionalities could be utilized to 
accomplish this. We noted that a variety of standards available in 
CEHRT might support the electronic exchange of opioid abuse related 
treatment data, such as use of the Consolidated Clinical Document 
Architecture (C-CDA) care plan template that is currently optional in 
CEHRT.
    We also solicited comment on methods or processes for incorporation 
of the treatment agreement into CEHRT, including which functionalities 
could be utilized to accomplish this task.
    We solicited comment on whether there are specific data elements 
that are currently standardized that should be incorporated via 
reconciliation and if the ``patient health data capture'' functionality 
(Sec.  170.315(e)(3)) could be used to incorporate a treatment plan 
that is not a structured document with structured data elements.
    Denominator: Number of unique patients for whom a Schedule II 
opioid was electronically prescribed by the MIPS eligible clinician 
using CEHRT during the performance period and the total duration of 
Schedule II opioid prescriptions is at least 30 cumulative days as 
identified in the patient's medication history request and response 
transactions during a 6-month look-back period.
    Numerator: The number of unique patients in the denominator for 
whom the MIPS eligible clinician seeks to identify a signed opioid 
treatment agreement and, if identified, incorporates the agreement in 
CEHRT. A numerator of at least one is required to fulfill this measure.
    Exclusion (beginning in 2020): Any MIPS eligible clinician who is 
unable to electronically prescribe Schedule II opioids in accordance 
with applicable law during the performance period.

[[Page 59805]]

    We proposed that the exclusion criteria would be limited to 
prescriptions of Schedule II opioids as the measure action is limited 
to electronic prescriptions of Schedule II opioids only and does not 
include any other types of electronic prescriptions.
    We requested comment on the proposed exclusion criteria and whether 
there are additional circumstances that should be added to the 
exclusion criteria and what those circumstances might be including 
medical diagnoses such as cancer or patients under care of hospice.
    We solicited comment on whether these types of agreements could 
create a burden on clinicians and patients, particularly clinicians who 
serve patients with cancer or those practicing in hospice, as well as 
the patients they serve.
    We also proposed that, in order to meet this measure, a MIPS 
eligible clinician must use the capabilities and standards as defined 
for CEHRT at Sec. Sec.  170.315(a)(10) and (b)(3) and 170.205(b)(2).
    As discussed earlier, we recognize that many health care providers 
are only beginning to adopt electronic prescriptions for controlled 
substances (EPCS) at this time. Although we have proposed two new 
measures which combine EPCS with other actions, we requested comment on 
whether stakeholders would be interested in a measure focused only on 
the number of Schedule II opioids prescribed and the successful use of 
EPCS for permissible prescriptions electronically prescribed.
    We solicited comment about the feasibility of such a measure, and 
whether stakeholders believe this would help to encourage broader 
adoption of EPCS.
    The following is a summary of the comments we received on these 
proposals.
    Comment: A few commenters supported the new Verify Opioid Treatment 
Agreement measure, but stated concern about the amount of time 
available for EHR vendors to update systems to meet the requirements of 
the measure and request CMS give more lead-time for these type of 
changes. Another commenter requested that CMS remove the requirement to 
use the capabilities and standards of CEHRT to verify if an opioid 
treatment agreement exists.
    Response: We recognize the measure is technically complex and may 
require updates to a MIPS eligible clinician's EHR systems in order to 
effectively perform the functionality associated with this measure. 
However, we believe there are MIPS eligible clinicians who are already 
using health IT to verify whether there is an opioid treatment 
agreement in place before electronically prescribing opioids. We also 
believe it is important to continue to improve prescribing practices 
for controlled substances using currently available methods as part of 
existing workflow practices, and that this particular measure can help 
lead to improvement in prescribing practices.
    As discussed in the proposed rule, we believe there are some ways 
in which certified health IT may be able to support the electronic 
exchange of opioid related treatment data, such as use of the C-CDA 
care plan template that is currently optional in CEHRT. This template 
contains information on health concerns, goals, interventions, health 
status evaluation & outcomes sections that could support the 
development of an opioid treatment agreement. In addition, the 
``patient health data capture'' functionality which is part of the 2015 
Edition certification criteria (Sec.  170.315(e)(3)) could be used to 
incorporate a treatment plan that is not a structured document with 
structured data elements.
    We note that there is no capability within certified health IT to 
support verification of an opioid treatment agreement. We stated (83 FR 
35925) that in order to meet the measure, MIPS eligible clinicians must 
use the capabilities and standards defined for CEHRT at Sec. Sec.  
170.315(a)(10) and (b)(3) and 170.205(b)(2). The certification criteria 
defined at Sec.  170.315(a)(10) defines drug formulary checks and 
preferred drug check lists for a given patient and medication, which 
are the most useful when utilized with e-Prescribing. These criteria 
may enable health IT to provide structured data to support querying and 
may increase the efficiency and safety of opioid prescribing, while 
potentially reducing the cost of care and confronting the opioid 
crisis.
    The certification criteria defined at Sec.  170.315(b)(3) supports 
this measure because it allows a health care provider to create a new 
prescription, change a prescription, cancel a prescription, refill a 
prescription, request fill status notifications and request and receive 
medication history information. Additionally, certification criteria 
defined at Sec.  170.205(b)(2) adopts the NCPDP SCRIPT Standard v10.6 
standards and associated implementation specifications for electronic 
prescribing.
    While we understand the above regulations do not specifically 
define certification criteria and standards for the Verify Opioid 
Treatment Agreement measure, we believe they may help provide a 
framework for MIPS eligible clinicians who would like to implement the 
measure.
    Comment: Several commenters expressed concern regarding the 
calculation of the denominator and potential data inaccuracies because 
the data is from third party systems and the ability of the EHR to 
calculate the performance rate is reliant on the quality of the data 
received. The commenters stated there are no standards regarding the 
type or format of data that is received. Therefore, the EHR system may 
be incomplete, making the calculation inaccurate. The commenters 
recommended that the Verify Opioid Treatment Agreement measure be 
revised to acknowledge that the EHR will be able to calculate 
prescription duration only with data supplied.
    In addition, a commenter stated the measure is highly problematic 
and prone to error calculation because the denominator is based on 
patients who are receiving an electronic prescription for a Schedule II 
opioid medication and have a total of 30 or more cumulative 
prescription days on the Schedule II opioid being prescribed in a 6-
month look back period. The commenter stated that neither the NCPDP 
10.6 Medication History Query nor the NCPDP 2017071 Medication History 
Query has a required, discrete data field to capture the prescription 
days. The commenter requested CMS not finalize the measure and not 
proceed with making the measure optional until it can be better 
defined. The commenter also stated that if the measure is finalized, 
that CMS should change its denominator proposal to be based on doses 
prescribed, as opposed to prescription days.
    Response: We understand the measure would be technically complex 
and potentially burdensome for MIPS eligible clinicians to implement 
and that the results of the measure may be affected by data quality and 
availability issues. We may consider modifications to the denominator 
in future rulemaking.
    In addition, as opioid treatment agreements become more widely 
adopted, we believe this measure may help to encourage health IT 
vendors to develop innovative solutions to capture data and reduce 
workflow complexities.
    Comment: A commenter requested clarification of the meaning of 
``incorporates the agreement'' in CEHRT, as there are no standards 
about what data elements are included in opioid treatment agreements. 
The commenter also requested the numerator be changed to the number of

[[Page 59806]]

unique patients in the denominator for whom the MIPS eligible clinician 
has a signed opioid treatment agreement in CEHRT.
    Response: As we did not define standards, data elements, content 
structure or clinical purpose for a specific document to be considered 
an ``opioid treatment agreement,'' we also did not define what needs to 
be incorporated into the CEHRT to meet the measure. Rather the intent 
of an opioid treatment agreement is to support and enable further care 
coordination and shared decision making. Therefore, we leave it to the 
discretion of the MIPS eligible clinician to determine what is 
considered an opioid treatment agreement and how to capture this in 
their CEHRT.
    We decline to change the numerator to those patients for whom the 
MIPS eligible clinician has a signed opioid treatment agreement in 
CEHRT. The goal of this measure is to encourage MIPS eligible 
clinicians to seek to identify an existing opioid treatment agreement 
for those patients for whom they have prescribed Schedule II opioids, 
rather than those patients for whom they have successfully identified 
and incorporated an opioid treatment agreement.
    Comment: Many commenters suggested CMS align the requirements of 
this measure with the similar measure for eligible hospitals and CAHs 
under the Medicare Promoting Interoperability Program, so that the 
Verify Opioid Treatment Agreement measure would be optional in the 2019 
and 2020 MIPS performance periods.
    Response: We appreciate the suggestion to align the requirements of 
the Verify Opioid Treatment Agreement measure in the Promoting 
Interoperability performance category with the Medicare Promoting 
Interoperability Program for eligible hospitals and CAHs. CMS received 
many similar concerns and feedback on the Verify Opioid Treatment 
Agreement measure proposal for eligible hospitals and CAHs, which we 
discussed in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20528 
through 20530). The concerns noted by commenters on both the FY 2019 
IPPS/LTCH PPS proposed rule and the CY 2019 PFS proposed rule included 
the varied opinions on the effectiveness of opioid treatment 
agreements, lack of specified certification standards and criteria, and 
the complexities of implementing such a measure.
    We understand these concerns and believe additional time is 
necessary to implement this measure before we make it required. 
Therefore, we are aligning with the Medicare Promoting Interoperability 
Program for eligible hospitals and CAHs and making the Verify Opioid 
Treatment Agreement measure optional for the 2019 and 2020 MIPS 
performance periods. We will include proposals for this measure for 
future years in future rulemaking.
    Comment: Several commenters questioned whether MIPS eligible 
clinicians who do not prescribe opioids are allowed to claim an 
exclusion, or is the exclusion limited to those who cannot prescribe 
opioids because of applicable law.
    Response: We are not finalizing the Verify Opioid Treatment 
Agreement measure as proposed and therefore are not finalizing the 
exclusion we proposed at 83 FR 35925, which would have allowed any MIPS 
eligible clinician who is unable to electronically prescribe Schedule 
II opioids in accordance with applicable law during the performance 
period to claim an exclusion.
    Because we are finalizing the measure as optional for both the 2019 
and 2020 performance periods, we decline to offer any additional 
exclusions for this measure.
    Comment: One commenter suggested that this measure overlaps with 
existing quality and improvement activities and thus CMS should work to 
allow MIPS eligible clinicians who report on measures and activities 
under the quality and improvement activities performance categories to 
automatically receive credit in the Promoting Interoperability 
performance category.
    Response: We appreciate the suggestion and are currently 
considering possible ways that points could be earned across multiple 
performance categories. We refer readers to our request for comment (83 
FR 35932) where we requested input on ways to link these three 
performance categories.
    Comment: A commenter appreciated that the measure is intended to 
verify whether an opioid treatment agreement exists, rather than 
mandating the creation of an opioid treatment agreement.
    Response: We believe it is important for MIPS eligible clinicians 
to be able to use an existing opioid treatment agreement if one exists, 
rather than creating a potentially duplicative agreement.
    After consideration of the comments received, we are adopting our 
proposal for the addition of the Verify Opioid Treatment Agreement 
measure with modification:
    Measure Description: For at least one unique patient for whom a 
Schedule II opioid was electronically prescribed by the MIPS eligible 
clinician using CEHRT during the performance period, if the total 
duration of the patient's Schedule II opioid prescriptions is at least 
30 cumulative days within a 6-month look-back period, the MIPS eligible 
clinician seeks to identify the existence of a signed opioid treatment 
agreement and incorporates it into the patient's electronic health 
record using CEHRT.
    We define opioids as Schedule II controlled substances under 21 CFR 
1308.12. We are finalizing the proposal to apply the same policies for 
the existing e-Prescribing measure to the Verify Opioid Treatment 
Agreement measure, including the requirement to use CEHRT as the sole 
means of creating the prescription and for transmission to the 
pharmacy. This measure includes all Schedule II opioids prescribed for 
a patient electronically using CEHRT by the MIPS eligible clinician 
during the performance period, as well as any Schedule II opioid 
prescriptions identified in the patient's medication history request 
and response transactions during a 6-month look-back period, where the 
total number of days for which a Schedule II opioid was prescribed for 
the patient is at least 30 days.
    The 6-month look-back period begins on the date on which the MIPS 
eligible clinician electronically transmits their Schedule II opioid 
prescription using CEHRT. The 6-month look-back period must utilize at 
a minimum the industry standard NCDCP SCRIPT v10.6 medication history 
request and response transactions codified at Sec.  170.205(b)(2)).
    To meet this measure, a MIPS eligible clinician must use the 
capabilities and standards as defined for CEHRT at Sec. Sec.  
170.315(a)(10) and (b)(3) and 170.205(b)(2).
    Denominator: Number of unique patients for whom a Schedule II 
opioid was electronically prescribed by the MIPS eligible clinician 
using CEHRT during the performance period and the total duration of 
Schedule II opioid prescriptions is at least 30 cumulative days as 
identified in the patient's medication history request and response 
transactions during a 6-month look-back period.
    Numerator: The number of unique patients in the denominator for 
whom the MIPS eligible clinician seeks to identify a signed opioid 
treatment agreement and, if identified, incorporates the agreement in 
CEHRT. A numerator of at least one is required to fulfill this measure.
    This measure will be optional in the CY 2019 and 2020 performance 
periods, so we are not finalizing the proposed exclusion for CY 2020.

[[Page 59807]]

(iii) Measures for the Health Information Exchange Objective
    As we stated in the proposed rule (83 FR 35925) the Health 
Information Exchange measures for MIPS eligible clinicians hold 
particular importance because of the role they play within the care 
continuum. In addition, these measures encourage and leverage 
interoperability on a broader scale and promote health IT-based care 
coordination. However, through our review of the existing measures, we 
determined that we could potentially improve the measures to further 
reduce burden and better focus the measures on interoperability in 
health care provider to health care provider exchange. Such 
modifications would address a number of concerns raised by stakeholders 
including:
     Supporting the implementation of effective health IT 
supported workflows based on a specific organization's needs;
     Reducing complexity and burden associated with the manual 
tracking of workflows to support health IT measures; and
     Emphasizing within these measures the importance of using 
health IT to support closing the referral loop to improve care 
coordination.
    We stated that we believe we can potentially improve the existing 
Health Information Exchange measures to streamline measurement, remove 
redundancy, reduce complexity and burden, and address stakeholders' 
concerns about the focus and impact of the measures on the 
interoperable use of health IT.
    In the CY 2019 PFS proposed rule (83 FR 35925 through 35928), we 
proposed several changes to the current measures under the Health 
Information Exchange objective. First, we proposed to change the name 
of the Send a Summary of Care measure to Support Electronic Referral 
Loops by Sending Health Information. We also proposed to remove the 
Clinical Information Reconciliation measure and combine it with the 
Request/Accept Summary of Care measure to create a new measure, Support 
Electronic Referral Loops by Receiving and Incorporating Health 
Information. This proposed new measure would include actions from both 
the Request/Accept Summary of Care measure and Clinical Information 
Reconciliation measure.
(A) Modifications to the Send a Summary of Care Measure
    We proposed to change the name of the Send a Summary of Care 
measure to Support Electronic Referral Loops by Sending Health 
Information measure (83 FR 35925 through 35926), to better reflect the 
emphasis on completing the referral loop and improving care 
coordination.
    Through public comment and stakeholder correspondence, we have 
become aware that in the health care industry there is some 
misunderstanding of the scope of transitions and referrals which must 
be included in the denominator of this measure. In the event that a 
MIPS eligible clinician is the recipient of a transition of care or 
referral, and subsequent to providing care the MIPS eligible clinician 
transitions or refers the patient back to the referring provider of 
care, this transition of care should be included in the denominator of 
the measure for the MIPS eligible clinician. We expect this will help 
build upon the current provider to provider communication via 
electronic exchange of summary of care records created by CEHRT 
required under this measure, further promote interoperability and care 
coordination with additional health care providers, and prevent 
redundancy in creation of a separate measure.
    In the past, stakeholders have raised concerns that the summary 
care records shared according to the C-CDA standard included excessive 
information not relevant to immediate care needs, which increased 
burden on health care providers. Under the ONC Health IT Certification 
Program 2015 Edition, CEHRT must have the capability to exchange all of 
the information in the CCDS as part of a summary care record structured 
according to the C-CDA standard. We previously finalized in the final 
rule titled ``Medicare and Medicaid Programs Electronic Health Record 
Incentive Program--Stage 2: Health Information Technology, Standards 
Implementation Specifications, and Certification Criteria for 
Electronic Health Record Technology, 2014 Edition; Revisions to the 
Permanent Certification Program for Health Information Technology'' 
(hereafter referred to as the ``Stage 2 final rule'') (77 FR 53991 
through 53993) that health care providers must transmit all of the CCDS 
information as part of this summary care record, if known, and that 
health care providers must always transmit information about the 
problem list, medications, and medication allergies, or validate that 
this information is not known.
    As finalized in the final rule titled ``Medicare and Medicaid 
Programs; Electronic Health Record Incentive Program--Stage 3 and 
Modifications to Meaningful Use in 2015 Through 2017; Final Rule'' 
(hereafter referred to as the ``2015 EHR Incentive Programs final 
rule'') (80 FR 62852 through 62861), our policy allows health care 
providers to constrain the information in the summary care record to 
support transitions of care. For instance, we encouraged health care 
providers to send a list of items that he or she believes to be 
pertinent and relevant to the patient's care, rather than a list of all 
problems, whether active or resolved, that have ever populated the 
problem list. Although a current problem list must always be included, 
the health care provider can use his or her judgment in deciding which 
items historically present on the problem list, medical history list 
(if it exists in CEHRT), or surgical history list are relevant given 
the clinical circumstances.
    We also wish to encourage MIPS eligible clinicians to use the 
document template available within the C-CDA which contains the most 
clinically relevant information required by the receiver. Accordingly, 
we proposed that MIPS eligible clinicians may use any document template 
within the C-CDA standard for purposes of the measures under the Health 
Information Exchange objective. Although a MIPS eligible clinician's 
CEHRT must be capable of sending the full C-CDA upon request, we 
believe this additional flexibility will help support clinicians' 
efforts to ensure the information supporting a transition is relevant.
    For instance, when the MIPS eligible clinician is referring to 
another health care provider the recommended document is the ``Referral 
Note'' which is designed to communicate pertinent information from a 
MIPS eligible clinician who is requesting services of another health 
care provider of clinical or non-clinical services. When the receiving 
health care provider sends back the information, the most relevant C-
CDA document template may be the ``Consultation Note,'' which is 
generated by a request from a clinician for an opinion or advice from 
another clinician. Although the 2015 Edition transition of care 
certification criterion only requires testing to the Continuity of Care 
Document and Referral Note document templates, we proposed to allow 
MIPS eligible clinicians the flexibility to use additional C-CDA 
templates most appropriate to their clinical workflows. Clinicians 
would need to work with their health IT developer to determine 
appropriate technical workflows and implementation. For more 
information about the C-CDA and associated templates, see http://
www.hl7.org/documentcenter/public/standards/dstu/

[[Page 59808]]

CDAR2_IG_CCDA_CLINNOTES_R1_DSTUR2.1_2015AUG.zip.
    The following is a summary of the comments we received on these 
proposals.
    Comment: A commenter stated that renaming the measure creates too 
much confusion and inconvenience because there are too many MIPS 
eligible clinicians and locations per clinician to keep track of, which 
undermines the quality of care provided to patients. Other commenters 
stated that MIPS eligible clinicians are accustomed to the current name 
and changing the name will only contribute to confusion.
    Response: We respectfully decline to retain the current name as we 
believe that the proposed new name, Support Electronic Referral Loops 
by Sending Health Information measure, better reflects the emphasis on 
completing the referral loop and improving care coordination. We also 
believe that it is important to align measure names across the Medicare 
Promoting Interoperability Program and the Promoting Interoperability 
performance category to reduce confusion and burden for health care 
providers.
    Comment: A commenter requested that this measure be modified or 
removed from the Promoting Interoperability performance category 
because there is a limited number of specialists that are able to 
receive the summary of care.
    Response: While we understand that there may be challenges 
associated with this measure, we believe that the sharing of health 
information with other health care providers treating patients is 
imperative to improving the quality of care. While we understand that 
some specialists may be lagging behind in their adoption of CEHRT, the 
numbers of specialists using CEHRT continues to rise over time. We 
continue to believe that the use of paper records will continue to 
diminish and that use of CEHRT will continue to increase. Including 
this measure as a requirement of the Promoting Interoperability 
performance category will incentivize clinicians to electronically 
share the summary of care.
    Comment: One commenter addressed our proposal to allow MIPS 
eligible clinicians to use any document template within the C-CDA for 
the measures associated with this objective and requested that CMS not 
expect clinicians to manually select C-CDA templates or portions of 
templates when sending documents because it adds workflow steps and 
interferes with solutions that automate sending of information. The 
commenter recommended that CMS investigate the Integrated Healthcare 
Enterprise (IHE) summary sections profile for potential future 
adoption. Other commenters supported allowing MIPS eligible clinicians 
and groups to determine which data is most appropriate to be shared.
    Response: We believe that this additional flexibility allowing MIPS 
eligible clinicians to use any document template within the C-CDA will 
help support MIPS eligible clinicians efforts to ensure the information 
supporting a transition of care is relevant and note that the use of 
any additional template would be optional for MIPS eligible clinicians. 
Although MIPS eligible clinicians must have the capability to send the 
full CCDA upon request, they may choose to send just the items that are 
pertinent and relevant to the patient's care. The ability to select the 
most appropriate template will enable the most clinically relevant 
information to be transmitted. We will work with ONC to consider other 
suggestions regarding the adoption of other health IT standards and may 
consider the suggestion to include the IHE summary sections profile in 
future rulemaking.
    Comment: A few commenters requested that CMS allow for flexibility 
to use any C-CDA formats available to meet the HIE measures to create 
and electronically send summary of care records.
    Response: We believe the proposal to allow MIPS eligible clinicians 
to use any document template within the C-CDA will provide further 
flexibility for health care providers to focus on clinically relevant 
information. We note that CEHRT supports the ability to send and 
receive C-CDA documents according to Releases 1.1 and 2.1 to support 
interoperability and exchange. The 2015 Edition transitions of care 
certification criterion at Sec.  170.315(b)(1) requires Health IT 
Modules to support the Continuity of Care Document, Referral Note, and 
(inpatient settings only) Discharge Summary document templates.
    While MIPS eligible clinicians' CEHRT must be capable of sending 
the full C-CDA upon request, we believe this additional flexibility to 
utilize different functionality within the C-CDA will help support 
clinicians efforts to ensure the information supporting a transition is 
relevant. We note that in the use of a document template the clinician 
would need to work with their developer to determine appropriate 
technical workflows and implementation.
    Comment: Some commenters supported allowing MIPS eligible 
clinicians and groups to determine which data is most appropriate to be 
shared. A few commenters agreed with use of any C-CDA document 
templates available within the C-CDA which contains the most clinically 
relevant information that may be required by the recipient of the 
transition or referral. The commenters stated this proposal supports 
increased flexibility, enables increased information sharing between 
care providers, and will help providers better understand their 
patient's history.
    Response: We appreciate the feedback by the commenter and agree 
that this proposal will provide further flexibility for health care 
providers to focus on clinically relevant information and decrease 
burden associated with reporting requirements.
    Comment: Commenters questioned whether there was an exclusion for 
the Support Electronic Referral Loops by Sending Health Information 
measure. A few commenters stated that the lack of an exclusion will 
unfairly disadvantage MIPS eligible clinicians and practices that are 
unable to send at least one received summary of care.
    Response: While we proposed to change the name of the Send a 
Summary of Care measure, we did not propose changes to the numerator, 
denominator or exclusion for the measure. The exclusion remains for 
this measure.
    Exclusion: Any MIPS eligible clinician who transfers a patient to 
another setting or refers a patient fewer than 100 times during the 
performance period.
    After consideration of the comments received, we are finalizing the 
proposal to change the name of the Send a Summary of Care measure to 
Support Electronic Referral Loops by Sending Health Information 
measure. We are also finalizing the proposal that MIPS eligible 
clinicians may use any document template within the C-CDA standard for 
purposes of the measures under the Health Information Exchange 
objective.
(B) Removal of the Request/Accept Summary of Care Measure
    We proposed to remove the Request/Accept Summary of Care measure 
(83 FR 35926) based on our analysis of the existing measure and in 
response to stakeholder input.
    We stated that, through review of implementation practices based on 
stakeholder feedback, we believe that the existing Request/Accept 
Summary of Care measure is not feasible for machine calculation in the 
majority of cases. The intent of the measure is to identify when MIPS 
eligible clinicians are engaging with other providers of

[[Page 59809]]

care or care team members to obtain up-to-date patient health 
information and to subsequently incorporate relevant data into the 
patient record. However, stakeholders have noted the measure 
specification does not effectively further this purpose. Specifically, 
the existing measure specification results in unintended consequences 
where health care providers implement either:
    (1) A burdensome workflow to document the manual action to request 
or obtain an electronic record, for example, clicking a check box to 
document each phone call or similar manual administrative task, or
    (2) A workflow which is limited to only querying internal resources 
for the existence of an electronic document.
    Neither of these two implementation options is desirable when the 
intent of the measure is to incentivize and encourage health care 
providers to implement effective workflows to identify, receive, and 
incorporate patient health information from other health care providers 
into the patient record.
    In addition, our analysis identified that the definition of 
incorporate within the Request/Accept Summary of Care measure is 
insufficient to ensure an interoperable result. When this measure was 
initially finalized in the 2015 EHR Incentive Programs final rule at 80 
FR 62860, we did not define ``incorporate'' as we believed it would 
vary amongst health care provider's workflows, patient population and 
the referring health care provider. In addition, we noted that the 
information could be included as an attachment, as a link within the 
EHR, as imported structured data or reconciled within the record and 
not exclusively performed through use of CEHRT. Further, stakeholder 
feedback highlights the fact that the requirement to incorporate data 
is insufficiently clear regarding what data must be incorporated.
    Our intention was that ``incorporate'' would relate to the 
workflows undertaken in the process of clinical information 
reconciliation further defined in the Clinical Information 
Reconciliation measure (80 FR 62852 through 62862). Taken together, the 
three measures under the Health Information Exchange objective were 
intended to support the referral loop through sending, receiving, and 
incorporating patient health data into the patient record. However, 
stakeholder feedback on the measures suggests that the separation 
between receiving and reconciling patient health information is not 
reflective of clinical and care coordination workflows. Further, 
stakeholders noted, that when approached separately, the incorporate 
portion of the Request/Accept Summary of Care measure is both 
inconsistent with and redundant to the Clinical Information 
Reconciliation measure which causes unnecessary burden and duplicative 
measure calculation.
    The following is a summary of the comments we received on these 
proposals.
    Comment: Commenters supported the removal of this measure, and 
stated they appreciated CMS' acknowledgement of the challenges of the 
current Request/Accept Summary of Care measure.
    Response: We believe that removing the measure will reduce burden.
    Comment: One commenter stated that it is confusing for CMS to state 
in the proposed rule that measures will be removed, when they are truly 
just re-named. The commenter stated that the Request/Accept Summary of 
Care measure and the Clinical Information Reconciliation measure would 
not be removed. Rather, they would be combined into a new measure named 
Support Electronic Referral Loops by Receiving and Incorporating Health 
Information.
    Response: While we appreciate this comment, the result of our 
proposals would be to replace two measures with one measure, resulting 
in a reduction in the number of measures.
    Comment: A commenter requested that CMS maintain the current 
separate Request/Accept Summary of Care and Clinical Information 
Reconciliation measures instead of replacing them with the combined 
measure because MIPS eligible clinicians understand the separate 
measures.
    Response: We disagree and believe that reducing the number of 
measures reduces burden for MIPS eligible clinicians. Also the proposed 
measures, Support Electronic Referral Loops by Sending Health 
Information and Support Electronic Referral Loops by Receiving and 
Incorporating Health Information, align with our focus on the exchange 
of health care information and aligns with the measures for the 
Medicare Promoting Interoperability Program.
    After consideration of the comments received, we are removing the 
Request/Accept Summary of Care Measure as proposed.
(C) Removal of the Clinical Information Reconciliation Measure
    We proposed to remove the Clinical Information Reconciliation 
measure (83 FR 35927) to reduce redundancy, complexity, and MIPS 
eligible clinician burden.
    We stated that we believe the Clinical Information Reconciliation 
measure is redundant in regard to the requirement to ``incorporate'' 
electronic summaries of care in light of the requirements of the 
Request/Accept Summary of Care measure. In addition, the measure is not 
fully health IT based as the exchange of health care information is not 
required to complete the measure action and the measure specification 
is not limited to only the reconciliation of electronic information in 
health IT supported workflows. We stated in the 2015 EHR Incentive 
Programs final rule at 80 FR 62861 that the clinical information 
reconciliation process could involve both automated and manual 
reconciliation to allow the receiving health care provider to work with 
both electronic data received as well as the patient to reconcile their 
health information. Further, stakeholder feedback from hospitals, 
clinicians, and health IT developers indicates that because the measure 
is not fully based on the use of health IT to meet the measurement 
requirements, health care providers must engage in burdensome tracking 
of manual workflows. While the overall activity of clinical information 
reconciliation supports quality patient care and should be a part of 
effective clinical workflows, the process to record and track each 
individual action places unnecessary burden on MIPS eligible 
clinicians.
    The following is a summary of the comments we received on these 
proposals.
    Comment: Commenters supported the removal of the Clinical 
Information Reconciliation measure and its incorporation with the 
Request/Accept Summary of Care measure. Some commenters stated that 
removal of the Clinical Information Reconciliation measure would reduce 
burden.
    Response: We appreciate the support for our proposal and agree that 
it will reduce burden.
    After consideration of the comments received, we are removing the 
Clinical Information Reconciliation measure as proposed.
(D) Support Electronic Referral Loops by Receiving and Incorporating 
Health Information Measure
    We proposed to add the following new measure for inclusion in the 
Health Information Exchange objective: Support Electronic Referral 
Loops by Receiving and Incorporating Health Information (FR 83 35927). 
This measure would build upon and replace the existing Request/Accept 
Summary of Care and Clinical Information Reconciliation measures.

[[Page 59810]]

    Proposed name of measure and description: Support Electronic 
Referral Loops by Receiving and Incorporating Health Information: For 
at least one electronic summary of care record received for patient 
encounters during the performance period for which a MIPS eligible 
clinician was the receiving party of a transition of care or referral, 
or for patient encounters during the performance period in which the 
MIPS eligible clinician has never before encountered the patient, the 
MIPS eligible clinician conducts clinical information reconciliation 
for medication, medication allergy, and current problem list.
    We proposed to combine two existing measures, the Request/Accept 
Summary of Care measure and the Clinical Information Reconciliation 
measure, in this new Support Electronic Referral Loops by Receiving and 
Incorporating Health Information measure to focus on the exchange of 
health care information as the current Clinical Information 
Reconciliation measure is not reliant on the exchange of health care 
information to complete the measure action. We did not propose to 
change the actions associated with the existing measures; rather, we 
proposed to combine the two measures to focus on the exchange of the 
health care information, reduce administrative burden, and streamline 
and simplify reporting.
    CMS and ONC worked together to define the following for this 
measure:
    Denominator: Number of electronic summary of care records received 
using CEHRT for patient encounters during the performance period for 
which a MIPS eligible clinician was the receiving party of a transition 
of care or referral, and for patient encounters during the performance 
period in which the MIPS eligible clinician has never before 
encountered the patient.
    Numerator: The number of electronic summary of care records in the 
denominator for which clinical information reconciliation is completed 
using CEHRT for the following three clinical information sets: (1) 
Medication--Review of the patient's medication, including the name, 
dosage, frequency, and route of each medication; (2) Medication 
allergy--Review of the patient's known medication allergies; and (3) 
Current Problem List--Review of the patient's current and active 
diagnoses.
    Exclusions: (1) Any MIPS eligible clinician who is unable to 
implement the measure for a MIPS performance period in 2019 would be 
excluded from this measure. (2) Any MIPS eligible clinician who 
receives fewer than 100 transitions of care or referrals or has fewer 
than 100 encounters with patients never before encountered during the 
performance period would be excluded from this measure.
    We note that these two exclusions for the measure were proposed in 
different sections of the proposed rule (83 FR 35916, 35927).
    We requested comment on the proposed exclusion criteria and whether 
there are additional circumstances that should be added to the 
exclusion criteria and what those circumstances might be.
    For the proposed measure, the denominator would increment on the 
receipt of an electronic summary of care record after the MIPS eligible 
clinician engages in workflows to obtain an electronic summary of care 
record for a transition, referral or patient encounter in which the 
MIPS eligible clinician has never before encountered the patient. The 
numerator would increment upon completion of clinical information 
reconciliation of the electronic summary of care record for 
medications, medication allergies, and current problems. The MIPS 
eligible clinician would no longer be required to manually count each 
individual non-health-IT-related action taken to engage with other 
providers of care and care team members to identify and obtain the 
electronic summary of care record. Instead, the proposed measure would 
focus on the result of these actions when an electronic summary of care 
record is successfully identified, received, and reconciled with the 
patient record. We stated that we believe this approach would allow 
MIPS eligible clinicians to determine and implement appropriate 
workflows supporting efforts to receive the electronic summary of care 
record consistent with the implementation of effective health IT 
information exchange at an organizational level.
    Finally, we proposed to apply our existing policy for cases in 
which the MIPS eligible clinician determines no update or modification 
is necessary within the patient record based on the electronic clinical 
information received, and the MIPS eligible clinician may count the 
reconciliation in the numerator without completing a redundant or 
duplicate update to the record. We welcomed public comment on methods 
by which this specific action could potentially be electronically 
measured by the MIPS eligible clinician's health IT system--such as 
incrementing on electronic signature or approval by an authorized 
health care provider--to mitigate the risk of burden associated with 
manual tracking of the action, such as having to click check boxes.
    We welcomed public comment on these proposals. We solicited comment 
on methods and approaches to quantify the reduction in burden for MIPS 
eligible clinicians implementing streamlined workflows for this 
proposed health IT-based measure. We also solicited comment on the 
impact these proposed modifications may have for health IT developers 
in updating, testing, and implementing new measure calculations related 
to these proposed changes. Specifically, we solicited comment on 
whether ONC should require developers to recertify their EHR technology 
as a result of the changes proposed, or whether they should be able to 
make the changes and engage in testing without recertification, and on 
the appropriate timeline for such requirements factoring in the 
proposed continuous 90 day performance period within the calendar year 
for clinicians. Finally, we solicited comment on whether this proposed 
new measure that combines the Request/Accept Summary of Care and 
Clinical Information Reconciliation measures should be adopted, or 
whether either or both of the existing Request/Accept Summary of Care 
and Clinical Information Reconciliation measures should be retained in 
lieu of this proposed new measure.
    We stated that in the event we finalize the new scoring methodology 
we proposed in section III.H.3.h.(5)(d) of the proposed rule, an 
exclusion would be available for MIPS eligible clinicians who cannot 
implement the Support Electronic Referral Loops by Receiving and 
Incorporating Health Information measure for a performance period in CY 
2019 and an exclusion for MIPS eligible clinician who receives fewer 
than 100 transitions of care or referrals or has fewer than 100 
encounters with patients never before encountered during the 
performance period.
    We also proposed that, in order to meet this measure, a MIPS 
eligible clinician must use the capabilities and standards as defined 
for CEHRT at Sec.  170.315(b)(1) and (2).
    We solicited comment on these proposals and our summary and 
response are below.
    Comment: A commenter stated that the incorporation of clinical 
information within the C-CDA into the receiving clinician's CEHRT is 
limited by the CEHRT and not the clinician. The commenter recommended 
that the measure be eliminated and requested that CMS work with ONC to 
strengthen interoperability requirements.

[[Page 59811]]

    Response: We are working with ONC to explore and potentially 
implement many initiatives to strengthen interoperability. We 
understand that there may be limitations with 2015 CEHRT but we believe 
that EHR developers and vendors will update their products so the CEHRT 
will calculate the combined measure and not further burden the MIPS 
eligible clinician.
    Comment: Many commenters supported the proposal to combine the 
Clinical Information Reconciliation measure with the Request/Accept 
Summary of Care measure into the proposed Support Electronic Referral 
Loops by Receiving and Incorporating Health Information measure. Some 
commenters agreed that the proposed measure will allow MIPS eligible 
clinicians to focus on the exchange of health care information and 
reconcile the data in patients' medical records.
    Response: We appreciate the commenter's support for efforts to 
improve processes and technology solutions around closing referral 
loops. We believe that the combined measure focuses on the exchange of 
health care information and reduces administrative burden. We also 
believe that this measure will help incentivize further innovation 
around interoperable exchange of information to support these 
processes.
    Comment: Some commenters disagreed with our proposal to combine the 
Clinical Information Reconciliation measure with the Request/Accept 
Summary of Care measure stating that clinical information 
reconciliation is important and it should remain a stand-alone measure. 
They indicated that combining the Clinical Information Reconciliation 
measure with another measure diminishes its importance. Other 
commenters stated that combining these measures into one is onerous for 
both front line staff responsible for running reports, as well as EHR 
developers and clinicians hoping to improve scores, since they will not 
fully know which measure to target. Some commenters stated that the 
name change is extremely confusing. Other commenters stated that this 
new measure is more burdensome and it will be harder to specifically 
target issues within the measure because two workflows will be 
combined.
    Response: We believe that the current separation of the measures is 
burdensome and redundant in the action of incorporation of the summary 
of care record. In addition, we listened to stakeholder' concerns 
regarding the separate Request/Accept Summary of Care and Clinical 
Information Reconciliation measures, which indicated that the 
separation between receiving and reconciling patient health information 
is not reflective of clinical and care coordination workflows and the 
incorporation aspect is redundant to both measures. We agree the 
process of clinical information reconciliation includes both automated 
and manual reconciliation to allow the receiving health care provider 
to work with both the electronic data provided with any necessary 
review, and to work directly with the patient to reconcile their health 
information. In addition, we believe that combining the measures of 
Request/Accept Summary of Care and Clinical Information Reconciliation 
retains the focus on interoperability and exchange of health 
information as opposed to the separation of the measures where health 
information exchange and interoperability was not a focus for clinical 
information reconciliation.
    Comment: One commenter noted the measure exclusion (Any MIPS 
eligible clinician who receives fewer than 100 transitions of care or 
referrals or has fewer than 100 encounters with patients never before 
encountered during the performance period) is causing greater hardship 
for those clinicians that refer out more than 100 times and therefore 
must report this measure. While most primary care clinicians refer out 
more than 100 times in a 90-day period, many specialists do not. If a 
specialist can claim an exclusion, and therefore, not set up direct 
messaging capabilities, it may affect the performance on the measure of 
clinicians that are referring to those specialists if they cannot find 
someone they refer to that has the capability.
    Response: The use of direct messaging is not required to fulfill 
this measure. Our intent has been to promote and facilitate a wide 
range of options for the transmission of an electronic summary of care 
document. Examples of acceptable transmission methods include secure 
email, Health Information Service Provider (HISP), query-based exchange 
or use of third party HIE.
    Comment: Commenters supported the exclusions for Support Electronic 
Referrals Loops by Receiving and Incorporating Health Information.
    Response: We appreciate the support and believe the exclusions will 
benefit MIPS eligible clinicians who are unable to implement the 
measure because they do not refer or transition patients or because 
they cannot implement the measure for the 2019 MIPS performance period.
    After consideration of the public comments we received, we are 
finalizing the Support Electronic Referral Loops by Receiving and 
Incorporating Health Information measure as proposed. We are finalizing 
the proposal to apply the existing policy for cases in which the MIPS 
eligible clinician determines no update or modification is necessary 
within the patient record based on the electronic clinical information 
received, and the MIPS eligible clinician may count the reconciliation 
in the numerator without completing a redundant or duplicate update to 
the record.
    We are finalizing a MIPS eligible clinician must use the 
capabilities and standards as defined for CEHRT at Sec.  170.315(b)(1) 
and (b)(2).
    We are adopting the Support Electronic Referral Loops by Receiving 
and Incorporating Health Information measure as follows:
     Measure Description: Support Electronic Referral Loops by 
Receiving and Incorporating Health Information: For at least one 
electronic summary of care record received for patient encounters 
during the performance period for which a MIPS eligible clinician was 
the receiving party of a transition of care or referral, or for patient 
encounters during the performance period in which the MIPS eligible 
clinician has never before encountered the patient, the MIPS eligible 
clinician conducts clinical information reconciliation for medication, 
mediation allergy, and current problem list.
    Denominator: Number of electronic summary of care records received 
using CEHRT for patient encounters during the performance period for 
which a MIPS eligible clinician was the receiving party of a transition 
of care or referral, and for patient encounters during the performance 
period in which the MIPS eligible clinician has never before 
encountered the patient.
    Numerator: The number of electronic summary of care records in the 
denominator for which clinical information reconciliation is completed 
using CEHRT for the following three clinical information sets: (1) 
Medication--Review of the patient's medication, including the name, 
dosage, frequency, and route of each medication; (2) Medication 
allergy--Review of the patient's known medication allergies; and (3) 
Current Problem List--Review of the patient's current and active 
diagnoses.
    Exclusions: (1) Any MIPS eligible clinician who is unable to 
implement the measure for a MIPS performance period in 2019 would be 
excluded from this measure.

[[Page 59812]]

    (2) Any MIPS eligible clinician who receives fewer than 100 
transitions of care or referrals or has fewer than 100 encounters with 
patients never before encountered during the performance period.
(iv) Measures for the Provider to Patient Exchange Objective
    The Provider to Patient Exchange objective for MIPS eligible 
clinicians builds upon the goal of improved access and exchange of 
patient data, patient centered communication and coordination of care 
using CEHRT. We proposed a new scoring methodology in section 
III.H.3.h.(5)(d) of the proposed rule, under which we proposed to 
rename the Patient Electronic Access objective to Provider to Patient 
Exchange, remove the Patient-Specific Education measure and rename the 
Provide Patient Access measure to Provide Patients Electronic Access to 
Their Health Information. In addition, we proposed to remove the 
Coordination of Care through Patient Engagement objective and all 
associated measures. The existing Promoting Interoperability 
performance category Patient Electronic Access objective includes two 
measures and the existing Coordination of Care through Patient 
Engagement objective includes three measures.
    We reviewed the Promoting Interoperability performance category 
requirements and determined that these proposals could reduce program 
complexity and burden and better focus on leveraging the most current 
health IT functions and standards for patient flexibility of access and 
exchange of information.
    In the CY 2019 PFS proposed rule (83 FR 35928 through 35929), we 
proposed the Provider to Patient Exchange objective would include one 
measure, the existing Provide Patient Access measure, which we proposed 
to rename to Provide Patients Electronic Access to Their Health 
Information.
(A) Modifications To Provide Patient Access Measure
    We proposed to change the name of the Provide Patient Access 
measure to Provide Patients Electronic Access to Their Health 
Information measure (83 FR 35928) to better reflect the emphasis on 
patient engagement in their health care and patient's electronic access 
of their health information through use of APIs.
    We proposed to change the measure name to emphasize electronic 
access of patient health information as opposed to use of paper-based 
actions and limit the focus to only health IT solutions to encourage 
adoption and innovation in use of CEHRT (80 FR 62783 through 62784). In 
addition, we are committed to promoting patient engagement with their 
healthcare information and ensuring access in an electronic format.
    We solicited comment on these proposals and our summary and 
response are below.
    Comment: A commenter supported the new name for the measure but 
recommended that CMS not require widespread use of APIs for at least 3 
years after the final standard for the measure has been published.
    Response: We decline to provide additional time to implement this 
measure. In the 2015 Edition final rule, ONC finalized certification 
criteria that will enable clinicians using 2015 Edition CEHRT to share 
information through an API consistent with the requirements of this 
measure (80 FR 62675). As discussed, we believe that eligible 
clinicians have already implemented, or are prepared to implement, this 
functionality as part of the 2015 Edition of CEHRT for 2019 and will be 
able to fulfill this measure.
    Comment: One commenter recommended that CMS establish an exclusion 
for this measure if the MIPS eligible clinician cannot successfully 
identify an application that meets their security needs. Another 
requested an exclusion if the MIPS eligible clinician's EHR does not 
have the ability to have a portal. A commenter cautioned that CMS must 
address the risks that this measure poses for systems security and the 
confidentiality of health information because of its use of APIs and 
recommended that CMS provide an exclusion for this measure for MIPS 
eligible clinicians that cannot successfully identify an application 
that meets their security needs. The commenter also recommended that 
CMS work with the OCR and the FTC to develop an extensive education 
program so that consumers can be aware of how application companies may 
use their data.
    Response: We decline to implement exclusion criteria for the 
Provide Patients Electronic Access to Their Health Information measure 
as we believe MIPS eligible clinicians should work with their health IT 
vendors to identify applications that meet their security needs. While 
we appreciate stakeholder concerns regarding security issues, we 
believe there are already applications available to consumers that 
could satisfy security requirements. The 2015 Edition of CEHRT enables 
clinicians to provide patients with timely access to their health 
information and make the patient's health information available for the 
patient (or patient authorized representative) to access using any 
application of their choice that is configured to meet the technical 
specifications of the application programming interfaces (API) in the 
MIPS eligible clinician's CEHRT.
    We appreciate commenters' interest in additional educational 
materials for patients on how they can improve the privacy and security 
of their health information. We will take this comment into 
consideration as we consider what other consumer-facing materials are 
helpful, and we direct commenters to resources currently available from 
HHS (for example, content and materials such as those available at 
https://www.hhs.gov/hipaa/for-individuals/right-to-access/index.html) 
and FTC (for example, content and materials such as those available at 
https://www.consumer.ftc.gov/topics/online-security) websites.
    Comment: A few commenters requested that CMS confirm that this 
measure focuses on MIPS eligible clinicians making the information 
available to patients and does not account for patient use.
    Response: The Provide Patients Electronic Access to Their Health 
Information measure does not require that patients actually access 
their information. Patients should be able to access their health 
information on demand, and we encourage MIPS eligible clinicians to 
maintain the appropriate functionalities for patient access to their 
health information at all times unless the system is undergoing 
scheduled maintenance, which should be limited.
    Comment: A commenter stated that changing the names of measures 
with essentially the same meaning is confusing to MIPS eligible 
clinicians. The Provide Patients Electronic Access to Their Health 
Information measure should simply be called the Provide Patients 
Electronic Access measure.
    Response: We did not intend to confuse MIPS eligible clinicians. We 
believe that the name change effectively focuses the electronic aspect 
of the measure and our focus on leveraging advanced use of HIT. We also 
believe it is important to align the names of the measures of the 
Promoting Interoperability performance category with the Medicare 
Promoting Interoperability Program for eligible hospitals and CAHs. 
Many health care providers have noted frustration with the differing 
requirements between the two programs and we believe that through 
alignment we can reduce much of that frustration.

[[Page 59813]]

    After consideration of the comments we received, we finalizing the 
new name, Provide Patients Electronic Access to Their Health 
Information, as proposed.
(B) Removal of the Patient-Generated Health Data Measure
    We proposed to remove the Patient-Generated Health Data (PGHD) 
measure (83 FR 35928) to reduce complexity and focus on the goal of 
using advanced EHR technology and functionalities to advance 
interoperability and health information exchange.
    As finalized in the 2015 EHR Incentive Programs final rule at 80 FR 
62851, the measure is not fully health IT based as we did not specify 
the manner in which health care providers would incorporate the data 
received. Instead, we finalized that health care providers could work 
with their EHR developers to establish the methods and processes that 
work best for their practice and needs. We indicated that this could 
include incorporation of the information using a structured format 
(such as an existing field in the EHR or maintaining an isolation 
between the data and the patient record such as incorporation as an 
attachment, link or text reference which would not require the advanced 
use of CEHRT). Although we continue to believe that incorporating this 
data is valuable, we prioritized only those actions which are completed 
electronically using certified health IT.
    We solicited comment on these proposals and our summary and 
response are below.
    Comment: Several commenters disagreed with our proposal to remove 
this measure as it is essential for encouraging the collection and use 
of patient-reported outcomes. The commenters urged CMS to retain this 
measure to encourage MIPS eligible clinicians to establish workflows to 
collect and integrate these critical data into their medical records, 
thereby promoting interoperability and patient-centered care. One 
commenter stated that the removal of this measure signals that patient 
and caregiver engagement has taken a backseat to provider to provider 
care coordination. Another stated that the measure is crucial for 
healthcare to be truly interoperable and person-centered.
    Response: Functions and standards related to measures that are no 
longer required for the Promoting Interoperability performance category 
may still hold value for some health care providers and may be utilized 
as best suits their practice and the preferences of their patient 
population. The removal of measures is not intended to discourage the 
use of the standards, the implementation of best practices, or 
conducting and tracking the information for providers' own quality 
improvement goals.
    Comment: Another commenter stated that that the measure did not 
accomplish its intended goal since we did not specify the manner in 
which health care providers would incorporate the data received.
    Response: We agree that it is important to encourage providers to 
obtain data generated by patients, for instance, through the use of 
consumer-facing devices, and utilize this data to inform decision-
making and provide more effective patient-centered care. While we are 
finalizing removal of the Patient-Generated Health Data measure for the 
reasons discussed in the proposed rule, we will continue to consider 
ways to encourage this activity.
    Comment: Many commenters supported the removal of this measure. A 
commenter supported the removal of this measure because it is 
burdensome and takes valuable time away from patient care. Another 
commenter supported the removal of this measure but mentioned that 
allowing the transmission of key health data such as home blood 
pressure readings, finger-stick glucose levels, and other vitals is 
still beneficial to the patient. This functionality should thus remain 
available in CEHRT. Another suggested that CMS promote the use of 
patient-generated health data collected via remote monitoring by 
encouraging the development of open APIs across CEHRT developers.
    Response: While we are removing the measure from the Promoting 
Interoperability performance category, the functionality is not being 
removed from 2015 Edition CEHRT. We will continue to work with ONC to 
encourage the development of innovative API functionality that supports 
exchange of patient-generated health data.
    After consideration of the public comments we received, we are 
removing the Patient-Generated Health Data measure as proposed.
(C) Removal of the Patient-Specific Education Measure
    We proposed to remove the Patient-Specific Education measure (83 FR 
35928) as it has proven burdensome to MIPS eligible clinicians in ways 
that were unintended and detracts from their progress on current 
program priorities.
    The Patient-Specific Education measure was finalized as a 
performance score measure for MIPS eligible clinicians in the CY 2017 
Quality Payment Program final rule with the intent of improving patient 
health, increasing transparency and engaging patients in their care (81 
FR 77228 through 77237).
    We stated that we believe that the Patient-Specific Education 
measure does not align with the current emphasis of the Promoting 
Interoperability performance category to increase interoperability, or 
reduce burden for MIPS eligible clinicians. In addition to not 
including interoperability as a core focus, stakeholders have indicated 
that this measure does not capture many of the innovative activities 
around providing patient education, for instance new approaches to 
integrating patient education within clinical decision support modules. 
As a result of this lack of alignment, this measure could potentially 
increase clinician burden.
    We solicited comment on this proposal and our summary and response 
are below.
    Comment: Many commenters supported the removal of this measure. A 
commenter supported the removal of this measure because it is 
burdensome. Other commenters stated that reporting on this measure 
takes valuable time away from patient care and leads to clinician 
frustration and ultimately contributes to burnout. Another commenter 
agreed with the removal of the measure because it does not align with 
promoting interoperability.
    Response: We appreciate the commenters' support for the removal of 
this measure.
    Comment: Several commenters disagreed with the removal of this 
measure. One commenter stated that the removal of this measure signals 
that patient and caregiver engagement has taken a backseat to provider 
to provider care coordination. Another commenter stated that the 
measure is vital to improved health literacy that empowers patient 
self-care which reduces unnecessary utilization and decreases costs. 
One commenter stated the measure should be used to provide patients 
with information about relevant clinical trials, medication adherence 
tools, and opioid management strategies. A few commenters stated that 
providing patients with relevant education materials raises their 
health literacy and enables them to be more active in managing their 
own health. Several commenters recommended that the measure be 
available for bonus points.
    Response: We disagree that the Patient-Specific Education measure 
should be retained as a required measure. While we believe that there 
are

[[Page 59814]]

merits to the Patient-Specific Education measure as identified by the 
commenters, we affirm our position that the Patient-Specific Education 
measure does not align with the current emphasis of the Promoting 
Interoperability performance category which aims to increase 
interoperability, leverage the most current health IT functions and 
standards and reduce burden for MIPS eligible clinicians. We also 
decline to offer bonus points for this measure. We note that bonus 
points should be reserved for brand new measures to help to ease the 
transition to becoming a required measure.
    After consideration of the public comments we received, we are 
removing of the Patient-Specific Education measure as proposed.
(D) Removal of the Secure Messaging Measure
    We proposed to remove the Secure Messaging measure (82 FR 35929) as 
it has proven burdensome to MIPS eligible clinicians in ways that were 
unintended and detracts from MIPS eligible clinicians' progress on 
current program priorities.
    The Secure Messaging measure was finalized in the CY 2017 Quality 
Payment Program final rule with the intent to build upon the policy 
goals of Stage 2 under the EHR Incentive Programs of using CEHRT for 
health care provider-patient communication (81 FR 77227 through 77236). 
We stated that we believe that the Secure Messaging measure does not 
align with the current emphasis of the Promoting Interoperability 
performance category to increase interoperability or reduce burden for 
MIPS eligible clinicians. In addition, we stated that we believe there 
is burden associated with tracking secure messages, including the 
unintended consequences of workflows designed for the measure rather 
than for clinical and administrative effectiveness.
    We solicited comment on this proposal and our summary and response 
are below.
    Comment: Some commenters opposed the removal of this measure 
because it supports meaningful improvements in interoperability. Other 
commenter noted that it must remain a required measure because it 
ensures that patients can communicate confidentially with their health 
care providers. Some commenters stated that some health care providers 
rely on secure messaging to communicate with patients in an effective 
and timely manner.
    Response: We believe that there is a significant burden associated 
with tracking secure messages. Although we are not requiring the 
measure, the functionality remains in 2015 Edition CEHRT so MIPS 
eligible clinicians may continue to utilize the functionality if they 
choose.
    Comment: Many commenters supported the removal of this measure. 
Some commenters stated that they supported the removal of this measure 
because it is burdensome, and reporting on this measure takes valuable 
time away from patient care and leads to clinician frustration and 
ultimately contributes to burnout.
    Response: We agree that this measure may detract from MIPS eligible 
clinicians' progress on current program priorities such as increasing 
interoperability and reducing burden.
    After consideration of the public comments we received, we are 
removing the Secure Messaging measure as proposed.
(E) Removal of the View, Download or Transmit Measure
    We proposed to remove the View, Download or Transmit measure (83 FR 
35929) as it has proven burdensome to MIPS eligible clinicians in ways 
that were unintended and detracts from their progress on current 
program priorities.
    We stated that we have received MIPS eligible clinician and 
stakeholder feedback through correspondence, public forums, and 
listening sessions indicating there is ongoing concern with measures 
which require patient action for successful submission. We have noted 
that data analysis on the patient action measures supports stakeholder 
concerns that barriers exist which impact a clinician's ability to meet 
them. Stakeholders have indicated that successful submission of the 
measure is reliant upon the patient, who may face barriers to access 
which are outside a clinician's control.
    After additional review, we noted that successful performance 
predicated solely on a patient's action has inadvertently created 
burdens to MIPS eligible clinicians and detracts from progress on 
Promoting Interoperability measure goals of focusing on patient care, 
interoperability and leveraging advanced used of health IT. Therefore, 
we proposed to remove the View, Download or Transmit measure.
    We solicited comment on this proposal and our summary and response 
are below.
    Comment: Commenters supported the removal of this measure. One 
commenter stated that the View, Download, and Transmit measure is 
challenging because many practices that care for a much older 
population of patients are at a disadvantage for this measure because 
many of those patients do not own a computer or even have an email 
address and in some cases, do not own a cell phone. Another commenter 
appreciated the proposal to remove this measure and noted that CMS 
should not hold MIPS eligible clinicians accountable for actions beyond 
their control.
    Response: Previous stakeholder feedback through correspondence, 
public forums, and listening sessions indicated there is ongoing 
concern with measures which require health care providers to be 
accountable for patient actions such as viewing, downloading, or 
transmitting. We further understand that there are barriers which could 
negatively impact a MIPS eligible clinician's ability to successfully 
meet a measure requiring patient action, such as location in remote, 
rural areas and access to technology including computers, internet and/
or email. We believe that removing the patient action measures will 
allow for focus on program goals of increasing interoperability and 
patient access to their health information.
    Comment: One commenter expressed concern about the removal of this 
measure and noted that it will limit the effectiveness of driving 
meaningful improvements in interoperability. One commenter stated that 
the removal of this measure signals that patient and caregiver 
engagement has taken a backseat to provider to provider care 
coordination.
    Response: We disagree that the removal of this measure devalues 
patient and caregiver engagement as we are weighting the Provide 
Patients Electronic Access to their Health Information measure at 40 
points, the highest of any measure in the Promoting Interoperability 
performance category in recognition of the value of patients having 
electronic access to their health information. We are removing the 
View, Download, Transmit measure because of the burden it places on 
MIPS eligible clinicians to be accountable for patient action.
    After consideration of the public comments we received, we are 
removing the View, Download or Transmit measure as proposed.
    In summary, we are removing the Coordination of Care Through 
Patient Engagement objective and its associated measures: View, 
Download or Transmit; Secure Messaging; and Patient-Generated Health 
Data. We are renaming the Patient Electronic Access objective to 
Provider to Patient Exchange objective and removing the Patient-
Specific Education measure. We are renaming the Provide Patient Access

[[Page 59815]]

measure to Provide Patients Electronic Access to their Health 
Information.
(v) Modifications to the Public Health and Clinical Data Registry 
Reporting Objective and Measures
    In connection with the scoring methodology proposed in section 
III.H.3.h.(5)(d) of the proposed rule, in the CY 2019 PFS proposed rule 
(83 FR 35929 through 35931), we proposed changes to the Public Health 
and Clinical Data Registry Reporting objective and five associated 
measures.
    We stated that we believe that public health reporting through EHRs 
will extend the use of electronic reporting solutions to additional 
events and care processes, increase timeliness and efficiency of 
reporting and replace manual data entry.
    We proposed to change the name of the objective to Public Health 
and Clinical Data Exchange and proposed exclusions for each of the 
associated measures.
    Under the new scoring methodology proposed in section 
III.H.3.h.(5)(d) of the proposed rule, we proposed that a MIPS eligible 
clinician would be required to submit two of the measures of the 
clinician's choice from the five measures associated with the 
objective: Immunization Registry Reporting, Syndromic Surveillance 
Reporting, Electronic Case Reporting, Public Health Registry Reporting, 
and Clinical Data Registry Reporting.
    In prior rulemaking, we recognized the goal of increasing 
interoperability through public health registry exchange of data (80 FR 
62771). We stated that we continue to believe that public health 
reporting is valuable in terms of health information exchange between 
MIPS eligible clinicians and public health and clinical data 
registries. For example, when immunization information is directly 
exchanged between EHRs and registries, patient information may be 
accessed by all of a patient's health care providers for improved 
continuity of care and reduced health care provider burden, as well as 
supporting population health monitoring.
    We also proposed exclusion criteria for each of the Public Health 
and Clinical Data Exchange measures beginning with the performance 
period in 2019. Under the scoring methodology for the Promoting 
Interoperability performance category for the performance period in 
2018 (82 FR 53676 through 53677), the measures associated with the 
Public Health and Clinical Data Registry Reporting objective are not 
required for the base score, and thus we did not establish exclusion 
criteria for them. However, we understand that some MIPS eligible 
clinicians may not be able to report to public health agencies or 
clinical data registries due to their scope of practice. Therefore, we 
proposed the following measure exclusions based on the exclusions 
finalized in previous rulemaking under the EHR Incentive Programs (80 
FR 62862 through 62871).
    Measure: Immunization Registry Reporting.
    Proposed Exclusions: Any MIPS eligible clinician meeting one or 
more of the following criteria may be excluded from the Immunization 
Registry Reporting measure if the MIPS eligible clinician:
    1. Does not administer any immunizations to any of the populations 
for which data is collected by its jurisdiction's immunization registry 
or immunization information system during the performance period.
    2. Operates in a jurisdiction for which no immunization registry or 
immunization information system is capable of accepting the specific 
standards required to meet the CEHRT definition at the start of the 
performance period.
    3. Operates in a jurisdiction where no immunization registry or 
immunization information system has declared readiness to receive 
immunization data as of 6 months prior to the start of the performance 
period.
    Measure: Syndromic Surveillance Reporting.
    Proposed Exclusions: Any MIPS eligible clinician meeting one or 
more of the following criteria may be excluded from the Syndromic 
Surveillance Reporting measure if the MIPS eligible clinician:
    1. Is not in a category of health care providers from which 
ambulatory syndromic surveillance data is collected by their 
jurisdiction's syndromic surveillance system.
    2. Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic syndromic surveillance data in the 
specific standards required to meet the CEHRT definition at the start 
of the performance period.
    3. Operates in a jurisdiction where no public health agency has 
declared readiness to receive syndromic surveillance data from MIPS 
eligible clinicians as of 6 months prior to the start of the 
performance period.
    Measure: Electronic Case Reporting.
    Proposed Exclusions: Any MIPS eligible clinician meeting one or 
more of the following criteria may be excluded from the Electronic Case 
Reporting measure if the MIPS eligible clinician:
    1. Does not treat or diagnose any reportable diseases for which 
data is collected by their jurisdiction's reportable disease system 
during the performance period.
    2. Operates in a jurisdiction for which no public health agency is 
capable of receiving electronic case reporting data in the specific 
standards required to meet the CEHRT definition at the start of the 
performance period.
    3. Operates in a jurisdiction where no public health agency has 
declared readiness to receive electronic case reporting data as of 6 
months prior to the start of the performance period.
    Measure: Public Health Registry Reporting.
    Proposed Exclusions: Any MIPS eligible clinician meeting one or 
more of the following criteria may be excluded from the Public Health 
Reporting measure if the MIPS eligible clinician;
    1. Does not diagnose or directly treat any disease or condition 
associated with a public health registry in the MIPS eligible 
clinician's jurisdiction during the performance period.
    2. Operates in a jurisdiction for which no public health agency is 
capable of accepting electronic registry transactions in the specific 
standards required to meet the CEHRT definition at the start of the 
performance period.
    3. Operates in a jurisdiction where no public health registry for 
which the MIPS eligible clinician is eligible has declared readiness to 
receive electronic registry transactions as of 6 months prior to the 
start of the performance period.
    Measure: Clinical Data Registry Reporting.
    Proposed Exclusions: Any MIPS eligible clinician meeting one or 
more of the following criteria may be excluded from the Clinical Data 
Registry Reporting measure if the MIPS eligible clinician;
    1. Does not diagnose or directly treat any disease or condition 
associated with a clinical data registry in their jurisdiction during 
the performance period.
    2. Operates in a jurisdiction for which no clinical data registry 
is capable of accepting electronic registry transactions in the 
specific standards required to meet the CEHRT definition at the start 
of the performance period.
    3. Operates in a jurisdiction where no clinical data registry for 
which the MIPS eligible clinician is eligible has declared readiness to 
receive electronic registry transactions as of 6 months prior to the 
start of the performance period.
    We solicited comment on the proposed exclusions and whether there 
are circumstances that would require

[[Page 59816]]

additional exclusion criteria for the measures.
    In addition, we stated that we intend to propose in future 
rulemaking to remove the Public Health and Clinical Data Exchange 
objective and measures no later than CY 2022, and solicited public 
comment on whether MIPS eligible clinicians will continue to share such 
data with public health entities once the Public Health and Clinical 
Data Exchange objective is removed, as well as other policy levers 
outside of the Promoting Interoperability performance category that 
could be adopted for continued reporting to public health and clinical 
data registries, if necessary. As noted above, although we believe that 
these registries provide the necessary monitoring of public health 
nationally and contribute to the overall health of the nation, we are 
also focused on reducing burden and identifying other appropriate 
venues in which reporting to public health and clinical data registries 
could be reported. We solicited public comment on the role that each of 
the public health and clinical data registries should have in the 
future of the Promoting Interoperability performance category and 
whether the submission of this data should still be required.
    Lastly, we solicited public comment on whether the Promoting 
Interoperability performance category is the best means for promoting 
sharing of clinical data with public health entities.
    We solicited comment on these proposals and our summary and 
response are below.
    Comment: One commenter stated that these measures should be 
optional as they continue to remain difficult for MIPS eligible 
clinicians due to the lack of availability of interoperable public 
health registries. Another commenter noted that the measures should be 
a bonus and not required as they note that the path for participation 
is convoluted and will require an onerous amount of effort on the part 
of the clinician. Commenters also noted issues with AHRQ's Registry of 
Patient Registries such as difficulty searching for registries that 
would fulfill the Promoting Interoperability performance category's 
requirement.
    Response: We disagree as we are trying to simplify scoring by 
limiting bonus opportunities to brand new measures. Hence we are 
offering bonus points for reporting the two new measures under the e-
Prescribing objective but not the ``new'' measure under the Health 
Information Exchange objective because it is simply the combination of 
two existing measures. We know that there are some improvements that 
need to be made to AHRQ's Registry of Patient Registries and we are 
working with AHRQ and CDC to improve the search capabilities so that 
available registries can be easily located.
    Comment: Many commenters opposed CMS' intent to remove the Public 
Health and Clinical Data Exchange objective and measures in the future 
and noted that interoperability of public health data is still evolving 
and incentivizes MIPS eligible clinicians to share data with public 
health agencies. One commenter encouraged CMS to reconsider removing 
the objective and measures for the following reasons: Many states do 
not have other policy levers outside the Promoting Interoperability 
programs and performance category to encourage or enforce public health 
reporting; CMS and States have spent many years now, using HITECH Act 
funding, supporting improvements to public health systems and HIEs to 
encourage health care providers to submit public health data, and thus, 
the reporting should continue; and in some states public health 
reporting is one of the driving use cases for participants to connect 
to their statewide HIE and removing these measures would remove an 
incentive to encourage health care providers to participate in HIEs. 
Another commenter expressed concerns about CMS' intention to remove the 
Public Health and Clinical Data Exchange objectives and measures noting 
that it is a significant policy lever for those who have yet to engage 
in this aspect of the program.
    Response: We understand the importance of reporting to public 
health and clinical data registries. We are continuing to focus on 
burden reduction, as well as other platforms and venues for reporting 
data to public health and clinical data registries outside of the 
Promoting Interoperability performance category. We will continue to 
monitor the data we compile specific to the public health reporting 
requirements and take the commenters' concerns into consideration in 
future rulemaking.
    Comment: One commenter requested clarification of whether a MIPS 
eligible clinician can submit to two different registries for purposes 
of the same measure and get credit for submitting to two registries, or 
must they report to different registries for purposes of two different 
measures to receive full credit for the objective.
    Response: Although we proposed that a MIPS eligible clinician must 
report on two measures of their choice to fulfill the Public Health and 
Clinical Data Registry Reporting objective, we agree that a MIPS 
eligible clinician should be able to report to two different public 
health agencies or clinical data registries for purposes of the same 
measure. Therefore, as previously discussed in section III.H.3.(5)(d) 
of this final rule, we are finalizing the proposal with modification so 
that a MIPS eligible clinician may earn full credit for this objective 
by reporting to two different public health agencies or clinical data 
registries for purposes of the same measure.
    Comment: Some commenters agreed with the Public Health and Clinical 
Data Exchange reporting requirements proposed, stating they would 
continue to advance interoperability and improve early detection of 
outbreaks as well as promote population health strategies.
    Response: We appreciate the support for our proposal and believe 
that public health reporting through EHRs will extend the use of 
electronic reporting solutions to additional events and care processes 
and increase the timeliness and efficiency of reporting.
    Comment: A few commenters supported the proposed exclusions for the 
Public Health and Clinical Data Exchange measures. One commenter 
suggested that the first exclusion for the Immunization Registry 
Reporting measure be modified to 100 or less immunizations in a 
performance period.
    Response: We decline to expand the first exclusion for the 
Immunization Registry Reporting measure because if the MIPS eligible 
clinician is performing any immunizations we believe that the 
information should be reported to an immunization registry.
    Comment: One commenter recommended that CMS specify that exclusions 
may only be claimed if a MIPS eligible clinician meets exclusions for 
all of the measures associated with the Public Health and Clinical Data 
Exchange objective and has made all possible efforts to report on the 
measures for this objective. The commenter suggested that participation 
in this objective should be encouraged instead of claiming exclusions, 
which would not improve interoperability or support improvements to 
population health. Commenters also stated that public health reporting 
also supports added value for individuals and reporters by enabling 
bidirectional information exchange between clinical care and public 
health.
    Response: We agree that MIPS eligible clinicians should try to find 
public health registries with which they can be in active engagement. 
We understand the concerns of the commenters and are committed to 
reducing provider burden

[[Page 59817]]

while increasing flexibility. As previously discussed in section 
III.H.3.(5)(d) of this final rule, we believe the ability to report to 
two different public health agencies or clinical data registries will 
promote flexibility in reporting and enables MIPS eligible clinicians 
to focus on the measures that are most relevant to them and their 
patient population.
    After consideration of the comments we received, we are finalizing 
our proposals with modification. We are changing the name of the 
objective to Public Health and Clinical Data Exchange and adopting 
exclusions for each of the associated measures. As previously discussed 
in section III.H.3.(5)(d) of this final rule, we are adopting a final 
policy to allow MIPS eligible clinicians to earn full credit for this 
objective by reporting to two different public health agencies or 
clinical data registries for any of the measures associated with the 
objective.
    We may use the comments that we received on the removal of the 
Public Health and Clinical Data Exchange objectives and measures to 
inform future rulemaking.
    To assist readers in identifying the requirements of CEHRT for the 
Promoting Interoperability performance category objectives and measures 
under the scoring methodology we are finalizing in section 
III.I.3.h.(5)(d) of this final rule, we include Table 43, which 
includes the 2015 Edition certification criteria required to meet the 
objectives and measures.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR23NO18.050

BILLING CODE 4120-01-C
(vi) Request for Comment--Potential New Measures Health Information 
Exchange Across the Care Continuum
    We are working to introduce additional flexibility to allow MIPS 
eligible clinicians a wider range of options in selecting measures that 
are most appropriate to their setting, patient population, and clinical 
practice improvement goals. For this reason, in the CY 2019 PFS 
proposed rule (83 FR 35931) we solicited comment on a potential concept 
for future rulemaking to add two additional measure options related to 
health information exchange for MIPS eligible clinicians.
---------------------------------------------------------------------------

    \28\ References from Title 45.
---------------------------------------------------------------------------

    We received many comments in response to our request, and we will 
consider them as we develop future policy regarding the potential new 
measures that focus on health information exchange across the care 
continuum.

[[Page 59818]]

(g) Improvement Activities Bonus Score Under the Promoting 
Interoperability Performance Category and Future Reporting 
Considerations
    In the CY 2017 Quality Payment Program final rule (81 FR 77202), we 
discussed our approach to the measurement of the use of CEHRT to allow 
MIPS eligible clinicians and groups the flexibility to implement CEHRT 
in a way that supports their clinical needs. Toward that end, we 
adopted a policy for the 2017 and 2018 performance periods (81 FR 
77202-77209 and 82 FR 53664-53670) and codified it at Sec.  
414.1380(b)(4)(i)(C)(2) to award a bonus score to MIPS eligible 
clinicians who use CEHRT to complete certain activities in the 
improvement activities performance category based on our belief that 
the use of CEHRT in carrying out these activities could further the 
outcomes of clinical practice improvement.
    In the CY 2019 PFS proposed rule (83 FR 35932 through 35935), we 
proposed significant changes to the scoring methodology and measures 
beginning with the performance period in 2019. In connection with these 
changes, we did not propose to continue the bonus for completing 
certain improvement activities using CEHRT for the performance period 
in 2019 and subsequent performance periods. As discussed in section 
III.H.3.h.(5)(b) of the proposed rule, we shifted the focus of this 
performance category to put a greater emphasis on interoperability and 
patient access to health information, and we stated that we do not 
believe awarding a bonus for performing an improvement activity using 
CEHRT would directly support those goals. While we continued to believe 
that the use of CEHRT in completing improvement activities is extremely 
valuable and vital to the role of CEHRT in practice improvement, 
awarding a bonus in the Promoting Interoperability performance category 
would not be appropriate in light of the new direction we wanted to 
take, and we solicited comment on other ways to promote the use of 
CEHRT.
    We invited comments on our decision not to propose to continue the 
bonus for completing certain improvement activities using CEHRT for the 
performance period in 2019 and subsequent performance periods, and our 
responses are below.
    Comment: Commenters supported our decision not to continue the 
bonus points for completing improvement activities using CEHRT.
    Response: We appreciate the support and although we are 
discontinuing the bonus points, we will continue to seek other 
opportunities to promote the use of CEHRT.
    Comment: Some commenters stated that they opposed our decision not 
to continue the bonus points for completing improvement activities 
using CEHRT stating that providing bonus points in the Promoting 
Interoperability performance category represented CMS' understanding 
that health IT can play an invaluable role in improving outcomes and 
incentivized MIPS eligible clinicians to incorporate health IT into 
their practice workflows and clinical activities. The commenters 
requested that CMS continue to incentivize--but not require--clinicians 
to use health IT as they accomplish improvement activities.
    Response: We are limiting bonus points to brand new measures in the 
Promoting Interoperability performance category such as the Verify 
Opioid Treatment Agreement measure. We are exploring opportunities that 
would allow MIPS eligible clinicians to earn credit across multiple 
MIPS performance categories. We continue to believe that the use of 
health IT, telehealth, and connection of patients to community-based 
services is important. We encourage the use of health IT as we 
understand it is an important aspect of the care delivery processes 
described in many of the established improvement activities found at 
https://qpp.cms .gov/. In addition, we encourage stakeholders to submit 
new improvement activities through the Annual Call for Activities that 
encourage the use of health IT.
    After consideration of the comments received, we are not continuing 
the bonus points for completing improvement activities using CEHRT.
    We acknowledged that the omission of this bonus could be viewed as 
increasing burden, and sought to counteract that concern by evaluating 
other methods to reduce burden to offset this potential increase. We 
have also considered various ways to align and streamline the different 
performance categories under the MIPS. In lieu of the improvement 
activities bonus score, we have looked extensively at ways to link 
three of the performance categories--quality, improvement activities 
and Promoting Interoperability--to reduce burden and create a more 
cohesive and closely linked MIPS program. One possibility we have 
identified is to establish several sets of new multi-category measures 
that would cut across the different performance categories and allow 
MIPS eligible clinicians to report once for credit in all three 
performance categories. Our goal would be to establish several of 
combined measures so MIPS eligible clinicians could report once for 
credit across all three performance categories. We only solicited 
comment on this concept, as we are still evaluating the appropriate 
measure combinations and feasibility of a multi-category model.
    Furthermore, we stated that to promote measurement that provides 
clinicians with measures that are meaningful to their practices, we 
intend to consider proposing in future rulemaking MIPS public health 
priority sets across the four performance categories (quality, 
improvement activities, Promoting Interoperability, and cost), and 
solicited comments on this topic.
    We thank commenters for their views and we will consider their 
views as we develop future policy proposals.
(h) Additional Considerations
(i) Nurse Practitioners, Physician Assistants, Clinical Nurse 
Specialists, and Certified Registered Nurse Anesthetists
    In prior rulemaking (82 FR 30079), we discussed our belief that 
certain types of MIPS eligible clinicians (NPs, PAs, CNSs, and CRNAs) 
may lack experience with the adoption and use of CEHRT. Because many of 
these non-physician clinicians were or are not eligible to participate 
in the Medicare or Medicaid EHR Incentive Program (now known as the 
Promoting Interoperability Program), we stated that we have little 
evidence as to whether there are sufficient measures applicable and 
available to these types of MIPS eligible clinicians under the 
advancing care information (now known as Promoting Interoperability) 
performance category. We established a policy for the performance 
periods in 2017 and 2018 under section 1848(q)(5)(F) of the Act to 
assign a weight of zero to the advancing care information performance 
category in the MIPS final score if there are not sufficient measures 
applicable and available to NPs, PAs, CRNAs, and CNSs. We will assign a 
weight of zero only in the event that an NP, PA, CRNA, or CNS does not 
submit any data for any of the measures specified for the advancing 
care information performance category, but if they choose to report, 
they will be scored on the advancing care information performance 
category like all other MIPS eligible clinicians and the performance 
category will be given the weighting prescribed by section 
1848(q)(5)(E) of the Act. We stated our intention to use data from the 
first performance period (2017) to further evaluate the participation 
of

[[Page 59819]]

these MIPS eligible clinicians in the advancing care information 
performance category and consider for subsequent years whether the 
measures specified for this category are applicable and available to 
these MIPS eligible clinicians. In the CY 2019 PFS proposed rule (83 FR 
35933), we stated that as we have not yet analyzed the data for the 
first MIPS performance period, it would be premature to propose to 
alter our treatment of these MIPS eligible clinicians in year 3.
    Accordingly, we proposed to continue this policy for the 
performance period in 2019 and to codify the policy at Sec.  
414.1380(c)(2)(i)(A)(5). We requested public comments on this proposal.
    The following is a summary of the comments we received on this 
proposal.
    Comment: One commenter suggested that PAs and NPs not have their 
Promoting Interoperability performance category reweighted with 
possible exceptions for small PA and NP-owned practices. The commenter 
indicated that PAs have been using CEHRT for years and should be held 
to the same standards and expectations as physicians.
    Response: We agree that the goal is to have all MIPS eligible 
clinicians use CEHRT. However, we believe that at this point in time it 
is premature to determine whether there are sufficient measures 
applicable and available to NPs, PAs, CNSs, and CRNAs. We plan to 
analyze performance data as it becomes available to inform future 
rulemaking. We note that if NPs and PAs choose to report data for the 
Promoting Interoperability performance category, they will be scored 
like all other MIPS eligible clinicians and the performance category 
will be given the weighting prescribed by section 1848(q)(5)(E) of the 
Act regardless of their Promoting Interoperability performance category 
score.
    After consideration of the comments we received, we will continue 
the policy for NPs, PAs, CRNAs, and CNSs for the performance period in 
2019 as proposed. We are codifying the policy at Sec.  
414.1380(c)(2)(i)(A)(5) as proposed.
(ii) Physical Therapists, Occupational Therapists, Clinical Social 
Workers, and Clinical Psychologists
    As discussed in section III.H.3.a. of the proposed rule, in 
accordance with section 1848(q)(1)(C)(i)(II) of the Act, we proposed to 
add the following clinician types to the definition of a MIPS eligible 
clinician, beginning with the performance period in 2019: Physical 
therapists; occupational therapists; clinical social workers; and 
clinical psychologists (83 FR 35883 through 35884). For the reasons 
discussed in prior rulemaking and in the preceding section 
III.H.3.h.(5)(f) of the proposed rule, we proposed(83 FR 35933) to 
apply the same policy we adopted for NPs, PAs, CNSs, and CRNAs for the 
performance periods in 2017 and 2018 to these new types of MIPS 
eligible clinicians for the performance period in 2019. Because many of 
these clinician types were or are not eligible to participate in the 
Medicare or Medicaid Promoting Interoperability Program, we stated that 
we have little evidence as to whether there are sufficient measures 
applicable and available to them under the Promoting Interoperability 
performance category. Thus, we proposed to rely on section 
1848(q)(5)(F) of the Act to assign a weight of zero to the Promoting 
Interoperability performance category if there are not sufficient 
measures applicable and available to these new types of MIPS eligible 
clinicians (physical therapists, occupational therapists, clinical 
social workers, and clinical psychologists). We encouraged all of these 
new types of MIPS eligible clinicians to report on these measures to 
the extent they are applicable and available; however, we understand 
that some of them may choose to accept a weight of zero for this 
performance category if they are unable to fully report the Promoting 
Interoperability measures. We stated that we believe this approach is 
appropriate for their first performance period (in 2019) based on the 
payment consequences associated with reporting, the fact that many of 
these types of MIPS eligible clinicians may lack experience with EHR 
use, and our current uncertainty as to whether we have proposed 
sufficient measures that are applicable and available to these types of 
MIPS eligible clinicians. We would use their first performance period 
to further evaluate the participation of these MIPS eligible clinicians 
in the Promoting Interoperability performance category and would 
consider for subsequent years whether the measures specified for this 
category are applicable and available to these MIPS eligible 
clinicians.
    We stated that these MIPS eligible clinicians may choose to submit 
Promoting Interoperability performance category measures if they 
determine that these measures are applicable and available to them; 
however, if they choose to report, they would be scored on the 
Promoting Interoperability performance category like all other MIPS 
eligible clinicians and the performance category would be given the 
weighting prescribed by section 1848(q)(5)(E) of the Act regardless of 
their Promoting Interoperability performance category score.
    We proposed to codify this policy at Sec.  414.1380(c)(2)(i)(A)(4).
    The following is a summary of the comments we received on this 
proposal.
    Comment: A few commenters stated that they are very pleased that 
CMS proposed to assign a weight of zero to the Promoting 
Interoperability performance category for physical and occupational 
therapists. The commenters stated that this is appropriate because the 
four included objectives have minimal relevance to therapy. 
Additionally, commenters noted that PTs and OTs have not received any 
financial incentives or support for implementing CEHRT, and therefore, 
it would be inappropriate to require them to report on measures for the 
Promoting Interoperability performance category.
    Response: We will continue to monitor participation of physical 
therapists, occupational therapists, and clinical psychologists to 
evaluate whether there are sufficient measures applicable and available 
to them. Our intention is not to continue the proposed policy in 
perpetuity. We believe that for increased interoperability and health 
information exchange it is important for all types of MIPS eligible 
clinicians to use CEHRT, and we aim to adopt measures for the Promoting 
Interoperability performance category that are available and applicable 
to all types of MIPS eligible clinicians.
    Comment: A commenter recommended that these types of clinicians not 
be automatically reweighted and instead recommended the creation of 
some sort of methodology to encourage health IT utilization and 
interoperability goals for these clinician types.
    Response: We disagree. We believe these specialties may not have 
sufficient measures applicable and available to them. We believe that 
through enabling these specialties to report if they are able or be 
reweighted if they are not, will give these specialties more time if 
they need it as they may not be familiar with the use of CEHRT. The 
reweighting will not be forever, but will be in place until we can 
determine through data analysis that these specialties are reporting in 
sufficient numbers to require their participation in the Promoting 
Interoperability performance category.
    After consideration of the comments that we received, we are 
adopting our proposal with modification. In section

[[Page 59820]]

III.I.3.a. of this final rule, we are adopting a final policy to add 
the following types of clinicians to the definition of MIPS eligible 
clinician: Physical therapist, occupational therapist. qualified 
speech-language pathologist, qualified audiologist, clinical 
psychologist, and registered dietitian or nutritional professional. For 
the reasons discussed in the proposed rule, we will apply the same 
policy we adopted for NPs, PAs, CNSs, and CRNAs for the performance 
periods in 2017 and 2018 to each of these new types of MIPS eligible 
clinicians for the performance period in 2019. We are not adopting a 
policy related to clinical social workers because they are not being 
added as MIPS eligible clinicians at this time. We are finalizing the 
proposed regulation text at Sec.  414.1380(c)(2)(i)(A)(4) to reflect 
these modifications.
(6) APM Scoring Standard for MIPS Eligible Clinicians Participating in 
MIPS APMs
(a) Overview
    As codified at Sec.  414.1370, MIPS eligible clinicians, including 
those participating in MIPS APMs, are subject to MIPS reporting 
requirements and payment adjustments, unless excluded on another basis.
    In the CY 2017 Quality Payment Program rule, we finalized the APM 
scoring standard, which is designed to reduce reporting burden for 
participants in certain APMs by reducing the need for duplicative data 
submission to MIPS and their respective APMs, and to avoid potentially 
conflicting incentives between those APMs and the MIPS.
    We established at Sec.  414.1370(c) that the MIPS performance 
period under Sec.  414.1320 applies for the APM scoring standard. We 
finalized under Sec.  414.1370(f) that, under the APM scoring standard, 
MIPS eligible clinicians will be scored at the APM entity group level 
and each MIPS eligible clinician will receive the APM Entity's final 
MIPS score. In the CY 2019 PFS proposed rule, we proposed to amend 
Sec.  414.1370(f)(2) to state that if the APM Entity group is excluded 
from MIPS, all eligible clinicians within that APM Entity group are 
also excluded from MIPS.
    The MIPS final score under the APM scoring standard is comprised of 
the four MIPS performance categories as finalized at Sec.  414.1370(g): 
Quality; cost; improvement activities; and advancing care information. 
In 2018, these performance categories are scored at 50 percent, 0 
percent, 30 percent, and 20 percent, respectively.
(b) Summary of Proposals
    In the CY 2019 PFS proposed rule, we discussed the following 
proposed policies:
     We proposed to revise Sec.  414.1370(b)(3) to clarify the 
requirement for MIPS APMs to assess performance on quality measures and 
cost/utilization.
     We proposed to modify the Shared Savings Program quality 
reporting requirements by expanding the reporting exception for solo 
practitioners such that, beginning in 2019, in the case of a Shared 
Savings Program ACO's failure to report quality measures as required by 
the Shared Saving Program, we will allow a solo practitioner to report 
on any available MIPS measures, including individual measures.
     We proposed to clarify that, beginning in 2019, the 
complete reporting requirement for Web Interface reporters be modified 
to specify that if an APM Entity fails to complete reporting for Web 
Interface measures but successfully reports the CAHPS for ACOs survey, 
we will score the CAHPS for ACOs survey and apply it towards the APM 
Entity's quality performance category score. In this scenario, the 
Shared Savings Program TIN-level reporting exception will not be 
triggered and all MIPS eligible clinicians within the ACO will receive 
the APM Entity score.
     We clarified that we will consider each distinct track of 
an APM and whether it meets the criteria necessary to be a MIPS APM 
under Sec.  414.1370(b)(1). We further clarified the term ``track'' to 
refer to a distinct arrangement through which an APM Entity 
participates in the APM, and that such participation is mutually 
exclusive of the APM Entity's participation in another ``track'' within 
the same APM.
     We clarified our interpretation of the rule at Sec.  
414.1370(b)(4)(i) for APMs that begin after the first day of the MIPS 
performance period for the year (currently January 1), where quality 
measures tied to payment must be reported for purposes of the APM from 
the first day of the MIPS performance period, and indicated that we 
consider the first performance year for an APM to begin as of the first 
date for which eligible clinicians and APM entities participating in 
the model must report on quality measures under the terms of the APM.
     We proposed to remove the Promoting Interoperability 
(formerly advancing care information) full-TIN reporting requirement 
for participants in the Shared Savings Program to allow individual TIN/
NPIs to report for the Promoting Interoperability performance category.
     We explained how performance feedback may be accessed by 
ACO participant TINs in the Shared Savings Program.
     We proposed to update the MIPS APM measure sets that apply 
for purposes of the APM scoring standard.
(c) MIPS APM Criteria
    In the CY 2017 Quality Payment Program final rule, we established 
at Sec.  414.1370(b) that for an APM to be considered a MIPS APM, it 
must satisfy the following criteria: APM Entities must participate in 
the APM under an agreement with CMS or by law or regulation, the APM 
must require that APM Entities include at least one MIPS eligible 
clinician on a participation list, the APM must base payment incentives 
on performance (either at the APM entity or eligible clinician level) 
on cost/utilization and quality measures, and the APM must be neither a 
new APM for which the first performance period begins after the first 
day of the MIPS performance year, nor an APM in the final year of 
operation for which the APM scoring standard is impracticable.
    As stated in the CY 2019 PFS proposed rule (83 FR 35934), it has 
come to our attention that there may have been some ambiguity in the 
third criterion at Sec.  414.1370(b)(3). We have received questions as 
to whether the criterion requires MIPS APMs to base payment incentives 
on performance on cost/utilization ``measures'', or whether it requires 
more generally that MIPS APMs base payment incentives on ``cost/
utilization.'' Because we did not address this exact point in prior 
rulemaking and our intended policy is not strictly clear from the 
regulation text, we clarified in the CY 2019 PFS proposed rule that we 
intended the word ``measures'' at Sec.  414.1370(b)(3) to modify only 
``quality'' and not ``cost/utilization.'' To make this criterion clear, 
we proposed to modify the regulation to specify that a MIPS APM must be 
designed in such a way that participating APM Entities are incentivized 
to reduce costs of care or utilization of services, or both. This 
proposed change to Sec.  414.1370(b)(3) would make it clear that a MIPS 
APM could take into account performance in terms of cost/utilization 
using model design features other than the direct use of cost/
utilization measures.
    We solicited comment on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:

[[Page 59821]]

    Comment: We received several comments supporting our proposal to 
modify the criterion at Sec.  414.1370(b)(3) to clarify that the word 
``measures'' only modifies the word ``quality'' and not ``cost/
utilization.'' Commenters stated that as proposed, this revision would 
mean that a MIPS APM could take into account performance in terms of 
cost/utilization using a cost/utilization measure and/or through other 
model design features. One commenter noted appreciation of this 
clarification and stated that this update to Sec.  414.1370(b)(3) will 
allow participating APM Entities more flexibility when reporting cost/
utilization information. Further, this commenter stated that our 
proposed clarification is consistent with CMS's intent and the implied 
intent of MACRA. Another commenter expressed appreciation for this 
clarification and noted that this may increase participation in MIPS.
    Response: We agree with commenters that the policy as intended and 
clarified allows for flexibility in how reporting cost/utilization 
information is reported. We continue to believe that accounting for 
cost/utilization performance can be accomplished by taking model design 
features into account and it is unnecessary to rely solely on cost/
utilization measures. Therefore, we are finalizing our proposal to 
modify Sec.  414.1370(b)(3) to specify that a MIPS APM must be designed 
in a way that participating APM Entities are incentivized to reduce 
costs of care or utilization of services, or both. We continue to 
believe that this change to the regulation text will clarify our intent 
that a MIPS APM could take into account performance in terms of cost/
utilization using model design features other than the direct use of 
cost/utilization measures. We are revising Sec.  414.1370(b)(3), as 
proposed, to state that the APM bases payment on performance (either at 
the APM entity or eligible clinician level) on quality measures and 
cost/utilization.
    We also proposed to clarify that we will consider each distinct 
track of an APM and whether it meets the criteria, in this final rule, 
to be a MIPS APM, and that it is possible for an APM to have tracks 
that are MIPS APMs and tracks that are not MIPS APMs. However, we 
specified that we will not further consider whether the individual APM 
Entities or MIPS eligible clinicians participating within a given track 
each satisfy all of the MIPS APM criteria.
    For purposes of this clarification, we understand the term 
``track'' to refer to a distinct arrangement through which an APM 
Entity participates in the APM, and that such participation is mutually 
exclusive of the APM Entity's participation in another ``track'' within 
the same APM. For example, we consider the three risk arrangements 
under OCM to be three separate ``tracks.''
    The following is a summary of the public comments received on this 
clarification and our responses:
    Comment: Some commenters supported our clarification. One commenter 
noted that this clarification allows for maximum flexibility, and 
allows APM the ability to offer different risk levels, which would, in 
turn, expand the pool of participants able to join APMs.
    Response: We appreciate the support, and agree with the commenter 
that identifying MIPS APMs by considering each distinct track of an APM 
against our criteria to be a MIPS APM would be likely to increase the 
potential number of eligible participants to join MIPS APMs.
    We will continue to evaluate whether each distinct track of an APM 
meets our criteria to be a MIPS APM. We note that this may result in an 
APM having tracks that are MIPS APMs and tracks that are not MIPS APMs.
    We also clarified our interpretation of the regulation at Sec.  
414.1370(b)(4)(i) for APMs that begin after the first day of the MIPS 
performance period for the year (currently January 1), but require 
participants to report quality data for quality measures tied to 
payment for the full MIPS performance period, beginning January 1. 
Under these circumstances where quality measures tied to payment must 
be reported for purposes of the APM from the first day of the MIPS 
performance period, we consider the first performance year for an APM 
to begin as of the first date for which eligible clinicians and APM 
entities participating in the model must report on quality measures 
under the terms of the APM.
    The following is a summary of the public comments received on this 
clarification and our responses:
    Comment: Commenters noted that this clarification will provide 
flexibility to those eligible clinicians and APM entities participating 
in an APM that begins after January 1. Commenters also stated that this 
clarification would prevent duplicative reporting of quality measures 
for both the APM and for MIPS, and would be consistent with CMS's 
efforts to reduce administrative burden.
    Response: We appreciate the commenters' support of our 
clarification. We agree that our interpretation of Sec.  
414.1370(b)(4)(i) will prevent duplicative reporting of quality 
measures and is consistent with our other efforts to reduce 
administrative burden.
    We are clarifying our interpretation of the regulation at Sec.  
414.1370(b)(4)(i). Therefore, we consider the first performance year 
for an APM to begin as of the first date for which eligible clinicians 
and APM entities participating in the model must report on quality 
measures under the terms of the APM. We believe that this 
interpretation will eliminate possibly conflicting incentives between 
the quality scoring requirements and payment incentive structures under 
the APM and MIPS and will reduce the likelihood of duplicative 
reporting of quality information.
    Based on the MIPS APM criteria we expect that the following 10 APMs 
likely will satisfy the requirements to be MIPS APMs for the 2019 
performance year:
     Comprehensive ESRD Care Model (all Tracks).
     Comprehensive Primary Care Plus Model (all Tracks).
     Next Generation ACO Model.
     Oncology Care Model (all Tracks).
     Medicare Shared Savings Program (all Tracks).
     Medicare ACO Track 1+ Model.
     Bundled Payments for Care Improvement Advanced.
     Independence at Home Demonstration.
     Maryland Total Cost of Care Model (Maryland Primary Care 
Program).
     Vermont All-Payer ACO Model (Vermont Medicare ACO 
Initiative).
    Final CMS determinations of MIPS APMs for the 2019 MIPS performance 
year will be announced via the Quality Payment Program website at 
https://qpp.cms.gov/. Further, we make these determinations based on 
the established MIPS APM criteria as specified in Sec.  414.1370(b) of 
our regulation, taking into account the clarifications made in this 
final rule.
(d) Calculating MIPS APM Performance Category Scores
(i) Quality Performance Category
    For the quality performance category, MIPS eligible clinicians in 
APM Entities will continue to be scored only on the quality measures 
that are required under the terms of their respective APMs, and 
available for scoring as specified in Sec.  414.1370(g)(1) and 
explained in the CY 2017 Quality Payment Program final rule (82 FR 
53698, 53692).
(A) Web Interface Reporters
    In the CY 2018 Quality Payment Program final rule, we discussed the

[[Page 59822]]

requirements for MIPS eligible clinicians participating in a MIPS APM 
that requires use of the CMS Web Interface for quality reporting, 
subsequently referred to as ``Web Interface Reporters'' (82 FR 53954). 
In that rule we finalized a policy to use quality measure data that 
participating APM Entities submit using the CMS Web Interface and CAHPS 
surveys as required under the terms of the APM (82 FR 53568, 53692). We 
also codified at Sec.  414.1370(f)(1) a policy under which, in the 
event a Shared Savings Program ACO does not report quality measures as 
required by the Shared Savings Program under Sec.  425.508, each ACO 
participant TIN will be treated as a unique APM entity for purposes of 
the APM scoring standard, and may report data for the MIPS quality 
performance category according to the MIPS submission and reporting 
requirements.
    For the 2019 MIPS performance year, we anticipate that there will 
be four Web Interface Reporter APMs: The Shared Savings Program; the 
Medicare ACO Track 1+ Model; Next Generation ACO Model; and the Vermont 
All-Payer ACO Model (Vermont Medicare ACO Initiative).
(aa) Complete Reporting Requirement
    Under Sec.  414.1370(f)(1), if a Shared Savings Program ACO does 
not report data on quality measures as required by the Shared Savings 
Program under Sec.  425.508, each ACO participant TIN will be treated 
as a unique APM Entity for purposes of the APM scoring standard and the 
ACO participant TINs may report data for the MIPS quality performance 
category according to the MIPS submission and reporting requirements. 
In the CY 2019 PFS proposed rule (83 FR 35935), we stated that we would 
like to clarify that any ``partial'' reporting through the CMS Web 
Interface that does not satisfy the requirements of the Shared Savings 
Program will be considered a failure to report. Should a Shared Savings 
Program ACO fail to report, the exception under Sec.  414.1370(f)(1) is 
triggered. In this scenario, each ACO participant TIN has the 
opportunity to report quality data to MIPS according to MIPS group 
reporting requirements to avoid a score of zero for the quality 
performance category (81 FR 77256).
    We recognized that, under this policy, successfully reporting to 
MIPS according to group reporting requirements may be difficult for 
solo practitioners, for whom case thresholds and other requirements may 
make many group reporting measures unavailable. Therefore, we proposed 
to modify the exception such that beginning in 2019, in the case of a 
Shared Savings Program ACO's failure to report quality measures as 
required by the Shared Saving Program, we will also allow a solo 
practitioner (a MIPS eligible clinician who has only one NPI billing 
through their TIN), to report on any available MIPS measures, including 
individual measures, in the event that their ACO fails to complete 
reporting for all Web Interface measures.
    The following is a summary of the public comments received on this 
clarification and our responses:
    Comment: One commenter noted that this modification will increase 
Shared Savings Program ACO participants' flexibility in the unlikely 
event that the ACO does not submit quality measures.
    Response: We agree with the commenter that allowing solo 
practitioners to report any available MIPS measures, including 
individual measures, will allow additional flexibility when reporting 
to MIPS in the event their ACO fails to complete the reporting of all 
Web Interface measures.
    After consideration of all public comments, we are clarifying that 
beginning in 2019, in the case of a Shared Savings Program ACO's 
failure to completely report all Web Interface measures as required by 
the Shared Savings Program, we will allow a solo practitioner to report 
on any available MIPS measures, including individual measures.
    We also proposed, beginning with the 2019 performance period, to 
modify the complete reporting requirement for Web Interface reporters 
to specify that if an APM Entity (in this case, an ACO) fails to 
complete reporting for Web Interface measures but successfully reports 
the CAHPS for ACOs survey, we will score the CAHPS for ACOs survey and 
apply it towards the APM Entity's quality performance category score. 
In this scenario the Shared Savings Program TIN-level reporting 
exception will not be triggered and all MIPS eligible clinicians within 
the ACO will receive the APM Entity score.
    We solicited comment on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Some commenters supported our proposal. Other commenters 
expressed concern about applying the CAHPS score for ACOs to the APM 
Entity's quality performance score.
    Response: Upon further consideration, we believe that the proposed 
change could unduly limit the ACO participant TINs' opportunity to 
achieve the highest possible quality performance category score: By 
scoring the ACO entity's CAHPS score in this scenario, the entity's 
total possible quality score would be capped at the total possible 
CAHPS score. Therefore, in the case where an ACO entity fails to 
successfully report Web Interface measures but does successfully report 
CAHPS, we will continue to treat ACO participant TINs as unique APM 
Entities under the APM scoring standard and will score each TIN only on 
the MIPS measures it has reported, up to a score of 100 percent for the 
performance category.
    After taking all comments into account, we are not finalizing our 
proposal to modify the complete reporting requirement for Web Interface 
reporters to apply the CAHPS for ACOs survey score toward an APM 
Entity's quality performance category score if an ACO fails to complete 
reporting for Web Interface measures but successfully reports the CAHPS 
for ACOs survey.
(B) Other MIPS APMs
    Under Sec.  414.1370(g)(1)(ii), the MIPS quality performance 
category score for a MIPS performance period is calculated for the APM 
Entity using the data submitted by the APM Entity based on measures 
specified by us through notice and comment rulemaking and available for 
scoring for each Other MIPS APM from among those used under the terms 
of the Other MIPS APM.
    In the 2019 MIPS performance year, we anticipate that there will be 
up to six Other MIPS APMs for which we will use this scoring 
methodology, based on their respective measure sets and reporting 
requirements:
     The Oncology Care Model.
     Comprehensive ESRD Care Model.
     Comprehensive Primary Care Plus Model.
     Bundled Payments for Care Improvement Advanced.
     Maryland Total Cost of Care Model (Maryland Primary Care 
Program).
     Independence at Home Demonstration.
(ii) Promoting Interoperability Performance Category
    In the CY 2017 Quality Payment Program final rule (81 FR 77262 
through 77264; 81 FR 77266 through 77269), we established a policy at 
Sec.  414.1370(g)(4)(ii) for MIPS APMs other than the Shared Savings 
Program, under which we attribute one Promoting Interoperability 
performance category score to each MIPS eligible clinician in an APM 
Entity group based on the higher of either individual or group-level 
data submitted for the MIPS

[[Page 59823]]

eligible. We will then use these scores to create an APM Entity group 
score equal to the average of the highest scores available for each 
MIPS eligible clinician in the APM Entity group.
    For the Shared Savings Program, we also finalized at Sec.  
414.1370(g)(4)(i) that ACO participant TINs are required to report on 
the Promoting Interoperability performance category, and we will weight 
and aggregate the ACO participant TIN scores to determine an APM Entity 
group score (81 FR 77258 through 77260). This policy was meant to align 
requirements between the MIPS Promoting Interoperability measures and 
the Shared Savings Program ACO-11 measure, which is used to assess 
Shared Savings Program ACOs based on the MIPS Promoting 
Interoperability measures. However, we have found that limiting 
reporting to the ACO participant TIN creates unnecessary confusion, and 
restricts Promoting Interoperability reporting options for MIPS 
eligible clinicians who participate in the Shared Savings Program. 
Therefore, beginning in the 2019 MIPS performance period, we proposed 
(83 FR 35935) to no longer apply the requirement as finalized at Sec.  
414.1370(g)(4)(i) and instead to apply the existing policy at Sec.  
414.1370(g)(4)(ii) to MIPS eligible clinicians who participate in the 
Shared Savings Program so that they may report on the Promoting 
Interoperability performance category at either the individual or group 
level like all other MIPS eligible clinicians under the APM scoring 
standard.
    We solicited comment on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Several commenters supported our proposed policy. One 
commenter recommended that CMS allow reporting at the individual level 
only when group-level information is not reported.
    Response: We believe that by aligning Shared Savings Program 
Promoting Interoperability scoring rules with those for the rest of 
MIPS and MIPS APMs we will reduce confusion while creating 
opportunities for individual MIPS eligible clinicians to contribute 
positively to the total ACO Entity score in the event that a 
participant TIN fails to report on this performance category.
    Comment: One commenter requested that CMS maintain the current 
requirement for ACO participant TIN-level reporting for Promoting 
Interoperability performance category measures. The commenter noted 
that although the proposed change increases flexibility, larger ACOs 
may encounter difficulty managing the Promoting Interoperability 
reporting for all of the individual MIPS eligible clinicians that bill 
through TINs of ACO participants, risking a payment consequences for 
failing to report.
    Response: The Promoting Interoperability performance category may 
be reported at either the individual or group level, not the APM Entity 
(ACO) level; therefore, this policy change will increase MIPS eligible 
clinicians' opportunities to report in the event that an ACO 
participant TIN does not, but should not give rise to a scenario where 
an ACO's performance category score would be negatively impacted. If 
the participant TIN reports for the PI performance category, there 
would be no need for the ACO to manage reporting for individual MIPS 
eligible clinicians; if the TIN fails to report, the individual MIPS 
eligible clincians within that TIN would have an opportunity to reduce 
the negative impact of that failure by reporting individually.
    After consideration of the comments received, we are finalizing the 
proposal to allow MIPS eligible clinicians participating in the Shared 
Savings Program to report on the Promoting Interoperability performance 
category at either the individual or group level.
(e) MIPS APM Performance Feedback
    As we discussed in the CY 2017 and 2018 Quality Payment Program 
final rules (81 FR 77270, and 82 FR 53704 through 53705, respectively), 
MIPS eligible clinicians who are scored under the APM scoring standard 
will receive performance feedback under section 1848(q)(12) of the Act.
    Regarding access to performance feedback, we should note that 
whereas split-TIN APM Entities and their participants can only access 
their performance feedback at the APM Entity or individual MIPS 
eligible clinician level, MIPS eligible clinicians participating in the 
Shared Savings Program, which is a full-TIN APM, will be able to access 
their performance feedback at the ACO participant TIN level.
(f) Summary of Finalized Policies
    In this section, we are finalizing the following policies:
    MIPS APM Criteria:
     We are modifying the MIPS APM criterion at Sec.  
414.1370(b)(3) to state that the APM bases payment on performance 
(either at the APM entity or eligible clinician level) on quality 
measures and cost/utilization.
     We are finalizing our clarification that we separately 
evaluate to each distinct track of an APM to determine whether it meets 
our criteria to be a MIPS APM. We note that this may result in an APM 
having some tracks that are MIPS APMs and other tracks that are not 
MIPS APMs.
     We are finalizing our clarification of our interpretation 
of the regulation at Sec.  414.1370(b)(4)(i). Therefore, we consider 
the first performance year for an APM to begin as of the first date for 
which eligible clinicians and APM entities participating in the model 
must report on quality measures under the terms of the APM. We believe 
that this will eliminate possibly conflicting incentives between the 
quality scoring requirements and payment incentive structures under the 
APM and MIPS and will reduce the likelihood of duplicative reporting of 
quality information.
     Final determinations of MIPS APMs for the 2019 MIPS 
performance year will be made by CMS and announced on the QPP website 
at https://qpp.cms.gov/. Further, in making these final determinations 
for 2019, we will use the MIPS APM criteria established in Sec.  
414.1370(b), taking into account the clarifications we are finalizing 
in this final rule.
    Complete Reporting Requirements:
     We are finalizing our policy as proposed so that beginning 
in 2019, if a Shared Savings Program ACO fails to report quality 
measures as required by the Shared Savings Program we would also allow 
a solo practitioner (a MIPS eligible clinician who has only one NPI 
billing through their TIN), to report on any available MIPS measures, 
including individual measures.
     We are not finalizing our proposal to modify the complete 
reporting requirement for Web Interface reporters so that, in the case 
where a Shared Savings Program ACO fails to complete reporting for Web 
Interface measures but successfully reports the CAHPS for ACOs survey, 
we would apply the CAHPS for ACOs survey toward and APM Entity's 
quality performance category score. Therefore, in the case where a 
Shared Savings Program ACO fails to successfully report Web Interface 
measures but does successfully report the CAHPS for ACOs survey, we 
will continue to treat the ACO participant TINs as unique APM Entities 
under the APM scoring standard and will score each TIN only on the MIPS 
measures it has reported.
    Promoting Interoperability Performance Category:
     We are finalizing the proposal to allow MIPS eligible 
clinicians participating in the Shared Savings

[[Page 59824]]

Program to report on the Promoting Interoperability performance 
category at either the individual or group level.
(g) Measure Sets
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Vol. 83

Friday,

No. 226

November 23, 2018

Part II--Continued

Book 2 of 2 Books

Pages 59835-60332





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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42 CFR Parts 405, 410, 411, et al.



 Medicare Program; Revisions to Payment Policies Under the Physician 
Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared 
Savings Program Requirements; Quality Payment Program; Medicaid 
Promoting Interoperability Program; Quality Payment Program--Extreme 
and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; 
Provisions From the Medicare Shared Savings Program--Accountable Care 
Organizations--Pathways to Success; and Expanding the Use of Telehealth 
Services for the Treatment of Opioid Use Disorder Under the Substance 
Use-Disorder Prevention That Promotes Opioid Recovery and Treatment 
(SUPPORT) for Patients and Communities Act; Final Rules and Interim 
Final Rule

Federal Register / Vol. 83 , No. 226 / Friday, November 23, 2018 / 
Rules and Regulations

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    We proposed to update the MIPS APM measure sets that apply for 
purposes of the APM scoring standard (83 FR 35933 through 35934). The 
following is a summary of the public comments received on these measure 
sets and our responses:
    Comment: Several commenters supported the measure sets set forth in 
the proposed rule. Other commenters recommended additional measures to 
be used in future years or suggested modifications to the measures 
themselves.
    Response: We thank the commenters for their support and note that, 
consistent with Sec.  414.1370(g)(1)(i)(A) and (ii)(A), we are using 
only measures that are included or that CMS intends to include in each 
APM measures set at the time of publication of this final rule. Should 
those measures be removed or revised from that measure set before the 
end of the performance year, we will not score APM Entities on their 
performance on those measures, but will include updated measures in 
future rulemaking.
    Per our policy expressed in last year's final rule (82 FR 53695 and 
53696), the measure sets on the MIPS APM measure list for the year will 
represent all possible measures which may contribute to an APM Entity's 
MIPS score for the MIPS quality performance category, and may include 
measures that are the same as or similar to those used by MIPS. 
However, a given measure ultimately might not be used for scoring, for 
example if its data becomes inappropriate or unavailable for scoring.
    After consideration of the comments received, we are finalizing our 
proposal to update the MIPS APM measure sets that apply for purposes of 
the APM scoring standard and will score only measures that already have 
been included in the measure sets of their given APM, according to the 
terms of participation in that APM. We note that Table 48 has been 
updated to reflect the most current APM measure sets.
i. MIPS Final Score Methodology
(1) Converting Measures and Activities Into Performance Category Scores
(a) Background
    For the 2021 MIPS payment year, we intend to build on the scoring 
methodology we finalized for the transition years, which allows for 
accountability and alignment across the performance categories and 
minimizes burden on MIPS eligible clinicians. The rationale for our 
scoring methodology continues to be grounded in the understanding that 
the MIPS scoring system has many components and various moving parts.
    As we continue to move forward in implementing the MIPS program, we 
strive to balance the statutory requirements and programmatic goals 
with the ease of use, stability, and meaningfulness for MIPS eligible 
clinicians. We do so while also emphasizing simplicity and the 
continued development of a scoring methodology that is understandable 
for MIPS eligible clinicians.

[[Page 59841]]

    In the CY 2017 Quality Payment Program final rule, we finalized a 
unified scoring system to determine a final score across the 4 
performance categories (81 FR 77273 through 77276). For the 2019 MIPS 
performance period, we proposed to build on the scoring methodology we 
previously finalized, focusing on encouraging MIPS eligible clinicians 
to meet data completeness requirements (83 FR 35948 through 35949). For 
quality performance category scoring, we proposed to extend some of the 
transition year policies to the 2019 MIPS performance period, and we 
also proposed several modifications to existing policies (83 FR 35947 
through 35949). In the CY 2018 Quality Payment Program final rule (82 
FR 53712 through 53714), we established a methodology for scoring 
improvement in the cost performance category. However, as required by 
section 51003(a)(1)(B) of the Bipartisan Budget Act of 2018, we 
proposed that the cost performance category score would not take into 
account improvement until the 2024 MIPS payment year (83 FR 35956). In 
the CY 2018 Quality Payment Program final rule (82 FR 53753 through 
53767), we finalized the availability of a facility-based measurement 
option for clinicians who met certain requirements, beginning with the 
2019 MIPS performance period. As discussed in section III.I.3.i.(1)(d) 
of this final rule, we are finalizing our proposal to change the 
determination of facility-based measurement to include consideration of 
presence in the on-campus outpatient hospital. The policies for scoring 
the 4 performance categories are described in detail in section 
III.I.3.i.(1) of this final rule.
    These policies will help eligible clinicians as they participate in 
the 2019 MIPS performance period/2021 MIPS payment year, and as we move 
beyond the transition years of the program. Section 51003 of the 
Bipartisan Budget Act of 2018 provides flexibility to continue the 
gradual ramp up of the Quality Payment Program and enables us to extend 
some of the transition year policies to the 2019 performance period.
    Unless otherwise noted, for purposes of this section III.I.3.i. of 
this final rule, the term ``MIPS eligible clinician'' will refer to 
MIPS eligible clinicians who collect and submit data and are scored at 
either the individual or group level, including virtual groups; it will 
not refer to MIPS eligible clinicians who are scored by facility-based 
measurement, as discussed in section III.I.3.i.(1)(d) of this final 
rule. We also note that the APM scoring standard applies to MIPS 
eligible clinicians in APM Entities in MIPS APMs, and those policies 
take precedence where applicable. Where those policies do not apply, 
scoring for MIPS eligible clinicians as described in section 
III.I.3.h.(6) of this final rule will apply. We refer readers to 
section III.I.4. of this final rule for additional information about 
the APM scoring standard.
(b) Scoring the Quality Performance Category for the Following 
Collection Types: Part B Claims Measures, eCQMs, MIPS CQMs, QCDR 
Measures, CMS Web Interface Measures, the CAHPS for MIPS Survey Measure 
and Administrative Claims Measures
    Although we did not propose changing the basic scoring system that 
we finalized in the CY 2018 Quality Payment Program final rule for the 
2021 MIPS payment year (82 FR 53712 through 53748), we proposed several 
modifications to scoring the quality performance category, including 
removing high-priority measure bonus points for CMS Web Interface 
measures and extending the bonus point caps, and adding a small 
practice bonus to the quality performance category score. The following 
section describes these previously finalized policies and our proposals 
(83 FR 35950 through 35952).
    We also proposed updates to Sec.  414.1380(b)(1) in an effort to 
more clearly and concisely capture previously established policies (83 
FR 35946 through 35955). These proposed updates are not intended to be 
substantive in nature, but rather to bring more clarity to the 
regulatory text. We will make note of the updated regulatory citations 
in their relevant sections below.
(i) Scoring Terminology
    In the CY 2017 and CY 2018 Quality Payment Program final rules (81 
FR 77008 through 77831 and 82 FR 53568 through 54229, respectively), we 
used the term ``submission mechanisms'' in reference to the various 
ways in which a MIPS eligible clinician or group can submit data to 
CMS. As discussed in section III.I.3.h.(1)(b) of this final rule, it 
has come to our attention that the way we have described the various 
ways in which MIPS eligible clinicians, groups and third-party 
intermediaries can submit data to our systems does not accurately 
reflect the experience users have when submitting data to us. We refer 
readers to section III.I.3.h.(1)(b) of this final rule for further 
discussion on our finalized changes to the scoring terminology related 
to measure specification and data collection and submission. For 
additional discussion on the impact of the proposed terminology change 
on our benchmarking methodology, validation process, and end-to-end 
reporting bonus, we refer readers to sections III.I.3.i.(1)(b)(ii), 
(v), and (x) of this final rule.
(ii) Quality Measure Benchmarks
    We refer readers to the CY 2017 and CY 2018 Quality Payment Program 
final rules (81 FR 77282 and 82 FR 53718, respectively) for our 
previously established benchmarking policies. As part of our proposed 
technical updates to Sec.  414.1380(b)(1) discussed in section 
III.I.3.i.(1)(a)(i) of this final rule, our previously established 
benchmarking policies at Sec.  414.1380(b)(1)(i) through (iii) would 
now be referenced at Sec.  414.1380(b)(1)(i) through (ii).
    When we developed the quality measure benchmarks, we sought to 
develop a system that enables MIPS eligible clinicians, beneficiaries, 
and other stakeholders to understand what is required for a strong 
performance in MIPS while being consistent with statutory requirements 
(81 FR 28249 through 28250). The feedback we have received thus far 
from stakeholders on our benchmarks is helping to inform our approach 
to the benchmarking methodology, especially as we look for possible 
ways of aligning with Physician Compare benchmarks. As described in 
section III.I.3.i.(1)(b)(xii) of this final rule, we solicited comment 
on potential future approaches to scoring the quality performance 
category to continue to promote value and improved outcomes.
    We anticipate changes in scoring would be paired with potential 
modifications to measure selection and criteria discussed in section 
III.I.3.h.(2)(b) of this final rule. In the CY 2019 PFS proposed rule 
(83 FR 35947), we sought input on opportunities to further reduce 
confusion about our benchmarking methodology described in the CY 2017 
Quality Payment Program final rule (81 FR 77277 through 77278), which 
includes further clarification of our benchmarking process and 
potential areas of alignment between the MIPS and Physician Compare 
benchmarking methodologies.
    We thank commenters for their input and may take this input into 
consideration in future years.
(A) Revised Terminology for MIPS Benchmarks
    We previously established at Sec.  414.1380(b)(1)(iii) separate 
benchmarks for the following submission mechanisms: EHR; QCDR/registry, 
claims; CMS Web Interface; CMS-approved survey vendor; and 
administrative claims. In the CY 2019

[[Page 59842]]

PFS proposed rule, we did not propose to change our basic approach to 
our benchmarking methodology; however, we proposed to amend Sec.  
414.1380(b)(1)(ii) consistent with the proposed data submission 
terminology changes discussed in section III.I.3.h.(1)(b) of this final 
rule (83 FR 35947). Specifically, beginning with the 2021 MIPS payment 
year, we proposed to establish separate benchmarks for the following 
collection types: eCQMs; QCDR measures (as described at Sec.  
414.1400(e)); MIPS CQMs; Medicare Part B claims measures; CMS Web 
Interface measures; the CAHPS for MIPS survey; and administrative 
claims measures. We would apply benchmarks based on collection type 
rather than submission mechanism. For example, for an eCQM, we would 
apply the eCQM benchmark regardless of submitter type (MIPS eligible 
clinician, group, third party intermediary). In addition, we would 
establish separate benchmarks for QCDR measures and MIPS CQMs since 
these measures do not have comparable specifications. In addition, we 
note that our proposed benchmarking policy allows for the addition of 
future collection types as the universe of measures continues to evolve 
and as new technology is introduced. Specifically, we proposed to amend 
Sec.  414.1380(b)(1)(ii) to remove the mention of each individual 
benchmark and instead state that benchmarks will be based on collection 
type, from all available sources, including MIPS eligible clinicians 
and APMs, to the extent feasible, during the applicable baseline or 
performance period.
    The following is a summary of the public comments on these 
proposals and our responses:
    Comment: A few commenters expressed support for our proposal to 
establish separate benchmarks by collection types, citing the 
difference in measure performance across collection types. One 
commenter stated this update would maintain consistency when migrating 
between current MIPS terminology to proposed MIPS terminology.
    Response: We thank commenters for their support as we continue to 
clarify and improve our benchmarking policies.
    Comment: One commenter expressed concern about the proposal to 
update our regulatory text to state that benchmarks are based on 
collection types from all available sources, including APMs. 
Specifically, the commenter noted that incorporating APM data into 
benchmark calculations will set the benchmarks too high since APM 
participants tend to be high performers.
    Response: We recognize commenter's concern; however, this is not a 
new policy, and we refer readers to the CY 2017 Quality Payment Program 
final rule (81 FR 77279) for additional discussion on the inclusion of 
APMs in the MIPS benchmarks. As measures and technology evolve, we are 
constantly reviewing and evaluating what data sources are appropriate 
for benchmarks.
    Comment: One commenter requested clarification on whether QCDR 
measures that have an e-specified collection type and a manual 
collection type will also be considered separate collection types with 
distinct benchmarks.
    Response: We expect that a QCDR measure for which data is 
abstracted through EHRs or manually (that is, paper records) would have 
to be approved as two separate measures. As a result, each measure 
would only be compared to its own benchmark.
    After consideration of public comments, we are finalizing our 
proposal, beginning with the 2021 MIPS payment year, to amend Sec.  
414.1380(b)(1)(ii) to establish separate benchmarks based on collection 
type and to remove the mention of each individual benchmark and state 
that benchmarks will be based on collection type, from all available 
sources, including MIPS eligible clinicians and APMs, to the extent 
feasible, during the applicable baseline or performance period.
(iii) Assigning Points Based on Achievement
    In the CY 2017 Quality Payment Program final rule, we established 
the policies for scoring quality measures performance (81 FR 77286). We 
refer readers to Sec.  414.1380(b)(1) for more on these policies.
(A) Floor for Scored Quality Measures
    For the 2019 and 2020 MIPS payment years, we finalized at Sec.  
414.1380(b)(1)(i) a global 3-point floor for each scored quality 
measure, as well as for the hospital readmission measure (if 
applicable). In this way, MIPS eligible clinicians would receive 
between 3 and 10 measure achievement points for each submitted measure 
that can be reliably scored against a benchmark, which requires meeting 
the case minimum and data completeness requirements (81 FR 77286 
through 77287; 82 FR 53719). For measures with a benchmark based on the 
performance period (rather than on the baseline period), we stated that 
we would continue to assign between 3 and 10 measure achievement points 
for performance periods after the first transition year (81 FR 77282, 
77287; 82 FR 53719). For measures with benchmarks based on the baseline 
period, we stated that the 3-point floor was for the transition year 
and that we would revisit the 3-point floor in future years (81 FR 
77286 through 77287; 82 FR 53719).
    For the 2021 MIPS payment year, we proposed to again apply a 3-
point floor for each measure that can be reliably scored against a 
benchmark based on the baseline period, and to amend Sec.  
414.1380(b)(1)(i) accordingly (83 FR 35947). We will revisit the 3-
point floor for such measures again in future rulemaking.
    We requested comments on the proposal above. These comments and our 
responses are discussed below.
    Comment: Several commenters expressed support for the three-point 
floor for measures that can be reliably scored against a benchmark 
based on the baseline period because it would reduce confusion, help 
reduce burden, maintain stability, and encourage physicians to continue 
to participate in MIPS.
    Response: We thank commenters for their support.
    After consideration of public comments, we are finalizing our 
proposal, for the 2021 MIPS payment year, to apply a 3-point floor for 
each measure that can be reliably scored against a benchmark, and to 
amend Sec.  414.1380(b)(1)(i) accordingly.
(B) Additional Policies for the CAHPS for MIPS Measure Score
    Although participating in the CAHPS for MIPS survey is optional for 
all groups, some groups will be unable to participate in the CAHPS for 
MIPS survey because they do not meet the minimum beneficiary sampling 
requirements. CMS has sampling requirements for groups of 100 or more 
eligible clinicians, 25 to 99 eligible clinicians, and 2 to 24 eligible 
clinicians to ensure an adequate number of survey responses and the 
ability to reliably report data. Our sampling timeframes necessitate 
notifying groups of their inability to meet the sampling requirements 
late in the performance period (see 82 FR 53630 through 53632). As a 
result, we are concerned that some groups that expect and plan to meet 
the quality performance category requirements using the CAHPS for MIPS 
survey may find out late in the performance period that they are unable 
to meet the sampling requirements and, therefore, are unable to have 
their performance assessed on this measure. These groups may need to 
report on another measure to meet the

[[Page 59843]]

requirements of the quality performance category.
    We want to encourage the reporting of the CAHPS for MIPS survey and 
do not want the uncertainty regarding sampling requirements to be a 
barrier to selecting the CAHPS for MIPS survey. To mitigate this 
concern, beginning with the 2021 MIPS payment year, we proposed to 
reduce the denominator (that is, the total available measure 
achievement points) for the quality performance category by 10 points 
for groups that register for the CAHPS for MIPS survey but do not meet 
the minimum beneficiary sampling requirements (83 FR 35948). By 
reducing the denominator instead of only assigning the group a score of 
zero measure achievement points (because the group would be unable to 
submit any CAHPS for MIPS survey data), we are effectively removing the 
impact of the group's inability to submit the CAHPS for MIPS survey. We 
believe this reduction in denominator would remove any need for groups 
to find another measure if they are unable to submit the CAHPS for MIPS 
survey. Therefore, we proposed to amend Sec.  414.1380 to add paragraph 
(b)(1)(vii)(B) to state that we will reduce the total available measure 
achievement points for the quality performance category by 10 points 
for groups that registered for the CAHPS for MIPS survey but do not 
meet the minimum beneficiary sampling requirements.
    We requested comments on the proposal above. These comments and our 
responses are discussed below.
    Comment: Several commenters supported our proposed policy. One 
commenter believes this will encourage more groups to conduct the 
survey.
    Response: We appreciate the commenters' support.
    Comment: One commenter requested clarification on when groups would 
be notified that they did not meet the beneficiary sampling 
requirement. The commenter also requested clarification on what 
protections the agency will institute for groups who must cancel their 
contracts with survey vendors ``late in the performance period'' when 
they are notified that they did not meet the beneficiary sampling 
requirement. The commenter stated that CMS should not hold groups 
accountable for vendor costs that result from the agency's late 
notification process.
    Response: We do not anticipate the notification process for minimum 
beneficiary sample requirements will change. CMS provides information 
on sample design and sample size requirements in the QPP Resource 
Library to aid groups in deciding whether or not to elect CAHPS for 
MIPS. CMS sends communication about sample size eligibility to the 
point of contact provided by each group during the registration process 
for CAHPS for MIPS. Providing more than one point of contact will help 
to promote timely delivery of the information on sample size 
eligibility to the group. Groups should coordinate with their vendors 
to address any questions regarding costs in the event the group does 
not meet the beneficiary sampling requirement. For any additional 
questions please visit the Quality Payment Program website at 
qpp.cms.gov.
    Comment: One commenter sought clarification whether CMS would 
automatically apply the scoring policy or first provide groups with the 
option to report on an alternate quality measure or improvement 
activity.
    Response: We will not automatically apply the scoring policy. 
Notifications will be sent twice to groups that have registered for the 
CAHPS for MIPS survey and who have an insufficient sample size, with 
the second notification usually occurring in September. These 
notifications also encourage groups to select other relevant measures 
that can be completed. We believe that this policy is necessary because 
the notification late in the performance period might not allow 
sufficient time for groups to collect and report a different quality 
measure, however, some practices may have other quality measures 
(beyond the 6 minimum) that they have been reporting on that could be 
submitted within the performance period. For groups that submitted 5 or 
fewer quality measures and do not meet the CAHPS for MIPS sampling 
requirements, the quality denominator will be reduced by 10 points. For 
groups that submitted 6 or more quality measures and do not meet the 
CAHPS for MIPS sampling requirements, we will score the 6 measures with 
the highest achievement points.
    The notification will also encourage groups to select other 
relevant improvement activities that can be completed within the 
performance period. We refer readers to section III.I.3.h.(4)(b) of 
this final rule for further information on submission criteria for the 
improvement activities performance category.
    After consideration of public comments, we are finalizing our 
proposal to amend Sec.  414.1380 to add paragraph (b)(1)(vii)(B) to 
state that we will reduce the total available measure achievement 
points for the quality performance category by 10 points for groups 
that submit 5 or fewer quality measures and register for the CAHPS for 
MIPS survey, but do not meet the minimum beneficiary sampling 
requirements.
    We do not want groups to register for the CAHPS for MIPS survey if 
they know in advance that they are unlikely to be able to meet the 
sampling requirement, so we solicited comments on whether we should 
limit this proposed policy to groups for only one MIPS performance 
period. For example, for the performance period following the 
application of this proposed policy, a notice could be provided to 
groups during registration indicating that if the sampling requirement 
is not met for a second consecutive performance period, the proposed 
policy will not be applied. This would provide notice to the group that 
they may not meet the sampling requirement needed for the CAHPS for 
MIPS survey and may need to look for alternate measures but does not 
preclude the group from registering for the CAHPS for MIPS survey if 
they expect to meet the minimum beneficiary sampling requirements in 
the second MIPS performance period.
    We thank commenters for their suggestions and may consider them for 
future rulemaking.
(iv) Assigning Measure Achievement Points for Topped Out Measures
    We refer readers to CY 2017 Quality Payment Program final rule (82 
FR 53721 through 53727) for our established policies for scoring topped 
out measures.
    Under Sec.  414.1380(b)(1)(xiii)(A), for the 2020 MIPS payment 
year, 6 measures will receive a maximum of 7 measure achievement 
points, provided that the applicable measure benchmarks are identified 
as topped out again in the benchmarks published for the 2018 MIPS 
performance period. Under Sec.  414.1380(b)(1)(xiii)(B), beginning with 
the 2021 MIPS payment year, measure benchmarks (except for measures in 
the CMS Web Interface) that are identified as topped out for 2 or more 
consecutive years will receive a maximum of 7 measure achievement 
points beginning in the second year the measure is identified as topped 
out (82 FR 53726 through 53727). As part of our technical updates to 
Sec.  414.1380(b)(1) outlined in section III.I.3.i.(1)(b) of this final 
rule, our previously finalized topped out scoring policies are now 
referenced at Sec.  414.1380(b)(1)(iv).
    We refer readers to the 2018 MIPS Quality Benchmarks' file that is 
located on the Quality Payment Program resource library (https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/Resource-library.html) to determine which measure

[[Page 59844]]

benchmarks are topped out for 2018 and would be subject to the cap if 
they are also topped out in the 2019 MIPS Quality Benchmarks' file. We 
note that the final determination of which measure benchmarks are 
subject to the topped out cap will not be available until the 2019 MIPS 
Quality Benchmarks' file is released in late 2018.
    We did not propose to apply our previously finalized topped out 
scoring policy to the CAHPS for MIPS survey (82 FR 53726). Because the 
CAHPS for MIPS survey was revised in 2018 (82 FR 53632), we do not have 
historical benchmarks for the 2018 performance period, so the topped 
out policy would not be applied for the 2019 performance period. Last 
year, we received limited feedback when we sought comment on how the 
topped out scoring policy should be applied to CAHPS for MIPS survey. 
In CY 2019 PFS proposed rule, we sought feedback on potential ways we 
can score CAHPS for MIPS Summary Survey Measures (SSM) (83 FR 35948). 
For example, we could score all SSMs, which means there would 
effectively be no topped out scoring for CAHPS for MIPS SSMs, or we 
could cap the SSMs that are topped out and score all other SSMs. We 
sought comment on these approaches and additional approaches to the 
topped out scoring policy for CAHPS for MIPS SSMs. We noted that we 
encourage groups to report the CAHPS for MIPS survey as it incorporates 
beneficiary feedback.
    We thank commenters for their suggestions and will consider them 
for future rulemaking.
(v) Scoring Measures That Do Not Meet Case Minimum, Data Completeness, 
and Benchmarks Requirements
    In the CY 2017 Quality Payment Program final rule (81 FR 77288 
through 77289), we established scoring policies for a measure that is 
submitted but is unable to be scored because it does not meet the 
required case minimum, does not have a benchmark, or does not meet the 
data completeness requirement. As part of our technical updates to 
Sec.  414.1380(b)(1) discussed in section III.I.3.i.(1)(b) of this 
final rule, our previously finalized scoring policies are now 
referenced at Sec.  414.1380(b)(1)(i)(A) and (B).
    A summary of the current and proposed policies is provided in Table 
50. For more of the statutory background and details on current 
policies, we refer readers to the CY 2017 and CY 2018 Quality Payment 
Program final rules (81 FR 77288 through 77289 and 82 FR 53727 through 
53730, respectively).
[GRAPHIC] [TIFF OMITTED] TR23NO18.065

    As the MIPS program continues to mature, we are looking to find 
ways to improve our policies, including what to do with measures that 
do not meet the case minimum. Although many MIPS eligible clinicians 
can meet the 20-case minimum requirement, we recognize that small 
practices and individual MIPS eligible clinicians may have difficulty 
meeting this standard. Although we process data from the CY 2017 MIPS 
performance period to determine how often submitted measures do not 
meet case minimums, we invited public comment on ways we can improve 
our case-minimum policy. In determining future improvements to our case 
minimum policy, our goal is to

[[Page 59845]]

balance the concerns of MIPS eligible clinicians who are unable to meet 
the case minimum requirement and for whom we cannot capture enough data 
to reliably measure performance, while not creating incentives for MIPS 
eligible clinicians to choose measures that do not meet case minimum 
even though other more relevant measures are available.
    We thank commenters for their suggestions and will consider them 
for future rulemaking.
    In the CY 2019 PFS proposed rule (83 FR 35949), we proposed to 
maintain the policies finalized for the CY 2018 MIPS performance period 
regarding measures that do not meet the case-minimum requirement, do 
not have a benchmark, or do not meet the data-completeness criteria for 
the CY 2019 MIPS performance period, and to amend Sec.  
414.1380(b)(1)(i) accordingly.
    We also proposed to assign zero points for measures that do not 
meet data completeness starting with the CY 2020 MIPS performance 
period and to amend Sec.  414.1380(b)(1)(i)(B)(1) accordingly (83 FR 
35949). This policy is part of our effort to move toward complete and 
accurate reporting that reflects meaningful effort to improve the 
quality of care that patients receive. Measures submitted by small 
practices would continue to receive 3 points for all future CY MIPS 
performance periods, although we may revisit this policy through future 
rulemaking.
    We requested comments on the proposals above. These comments and 
our responses are discussed below.
    Comment: Several commenters supported the proposal to maintain the 
policies finalized for the CY 2018 MIPS performance period regarding 
measures that do not meet the case minimum requirement, do not have a 
benchmark, or do not meet the data-completeness criteria for the CY 
2019 MIPS performance period.
    Response: We thank commenters for their support. However, we want 
to stress that these policies were not meant to be permanent and as 
clinicians continue to gain experience with the program we will revisit 
the appropriateness of these policies in future rulemaking.
    Comment: A few commenters did not support our proposal to reduce 
points for measures that do not meet data completeness to zero starting 
with the CY 2020 MIPS performance period because of concerns that it 
would add complexity and burden as clinicians are continuing to learn 
the program. A few commenters suggested that CMS should return to 
assigning these measures 3 points or, at a minimum, continue to assign 
them 1 point or provide special scoring for MIPS eligible clinicians 
with significant administrative burdens. A few commenters recommended 
that clinicians should at least get some credit for attempting to 
report and, through no fault of their own, fail to meet the data 
completeness threshold, citing the difficulty of getting all the 
necessary data from hospitals and/or their billing companies to report 
on 60 percent of all applicable patients.
    Response: We understand and recognize commenters' concerns. 
However, as the program is being fully implemented, we want to ensure 
that our policies align with our goal of improving quality. This 
scoring policy was intended to be temporary, and we believe that data 
completeness is something that is within the direct control of 
clinicians. Although we understand that many clinicians have 
administrative burdens and we continuously strive to reduce paperwork, 
we also believe that it is important to develop policies that align 
with the program's goal to improve quality of care. By the fourth year 
of implementation, we believe this policy is no longer needed and that 
removing this policy helps streamline our scoring policies.
    After consideration of public comments, we are finalizing the 
proposal to maintain the policies finalized for the CY 2018 MIPS 
performance period regarding measures that do not meet the case-minimum 
requirement, do not have a benchmark, or do not meet the data-
completeness criteria for the CY 2019 MIPS performance period, and the 
amending of Sec.  414.1380(b)(1)(i) accordingly.
    After consideration of public comments, we are finalizing our 
proposal to assign zero points for measures that do not meet data 
completeness starting with the CY 2020 MIPS performance period and to 
amend Sec.  414.1380(b)(1)(i)(B)(1) accordingly. Measures submitted by 
small practices will continue to receive 3 points for all future MIPS 
performance periods.
(vi) Scoring Flexibility for Measures With Clinical Guideline Changes 
During the Performance Period
    In the CY 2018 Quality Payment Program final rule (82 FR 53714 
through 53716), we finalized that, beginning with the 2018 MIPS 
performance period, we will assess performance on measures considered 
significantly impacted by ICD-10 updates based only on the first 9 
months of the 12-month performance period (for example, January 1, 
2018, through September 30, 2018, for the 2018 MIPS performance 
period). We noted that performance on measures that are not 
significantly impacted by changes to ICD-10 codes would continue to be 
assessed on the full 12-month performance period (January 1 through 
December 31). Lastly, we finalized that we will publish the list of 
measures requiring a 9-month assessment process on the CMS website by 
October 1st of the performance period if technically feasible, but by 
no later than the beginning of the data submission period (for example, 
January 2, 2019, for the 2018 MIPS performance period). As part of our 
technical updates to Sec.  414.1380(b)(1) outlined in section 
III.I.3.i.(1)(b) of this final rule, these previously finalized 
policies are now referenced at Sec.  414.1380(b)(1)(viii).
    We remain concerned about instances where clinical guideline 
changes or other changes to evidence supporting a measure occur during 
the performance period that may significantly impact a measure. 
Clinical guidelines and protocols developed by clinical experts and 
specialty medical societies often underpin quality measures. At times, 
measure stewards must amend quality measures to reflect new research 
and changed clinical guidelines, and sometimes, as a result of the 
change in these guidelines, adherence to guidelines in the existing 
measures could result in patient harm or otherwise provide misleading 
results as to good quality care. We sought comment in the CY 2018 
Quality Payment Program final rule regarding whether we should apply 
scoring flexibility to measures significantly impacted by clinical 
guideline changes (82 FR 53716). We refer readers to the CY 2019 PFS 
proposed rule for a summary of the comments we received (83 FR 35949 
through 35950).
    We remain concerned that findings of evidence-based research, 
providing the basis for sound clinical practice guidelines and 
recommendations that are the foundation of a quality measure, may 
change outside of the rulemaking cycle. As the clinical evidence and 
guidelines change, approved measures may no longer reflect the most up-
to-date clinical evidence and could be contrary to patient well-being. 
There may be instances in which changes to clinical guidelines are so 
significant, that an expedited review is needed outside of the 
rulemaking cycle because measures may result in a practice that is 
harmful to patients. To further align with policies adopted within 
other value based programs such as the Hospital VBP Program (83 FR 
20409), we proposed to suppress a measure without rulemaking, if during 
the performance period a measure is

[[Page 59846]]

significantly impacted by clinical guideline changes or other changes 
that CMS believes may pose patient safety concerns (83 FR 35950). We 
would rely on measure stewards for notification in changes to clinical 
guidelines. We will publish on the CMS website suppressed measures 
whenever technically feasible, but by no later than the beginning of 
the data submission period.
    In the CY 2019 PFS proposed rule (83 FR 35950), we proposed 
policies to provide scoring flexibility in the event that we need to 
suppress a measure during a performance period. Scoring for a 
suppressed measure would result in a zero achievement points for the 
measure and a reduction of the total available measure achievement 
points by 10 points. We believe that this approach effectively removes 
the impact of the eligible clinician's inability to receive measure 
achievement points for the measure, if a submitted measure is later 
suppressed.
    We also proposed to add a new paragraph at Sec.  
414.1380(b)(1)(vii) that, beginning with the 2019 MIPS performance 
period, CMS will reduce the total available measure achievement points 
for the quality performance category by 10 points for MIPS eligible 
clinicians that submit a measure significantly impacted by clinical 
guideline changes or other changes that CMS believes may pose patient 
safety concerns (83 FR 35950).
    We requested comments on the proposal above. These comments and our 
responses are discussed below.
    Comment: A few commenters supported the proposal because it holds 
the clinician harmless from clinical guideline changes that impact 
quality measures. One commenter noted that it is important that 
clinicians are protected from any adverse impacts on their scoring when 
they are following updated clinical guidelines to ensure proper patient 
care and safety.
    Response: We appreciate the support of the proposal.
    Comment: Several commenters did not support the proposal. 
Commenters questioned whether there would be an expectation that the 
clinician would continue collecting data on the measure, or whether 
they would be allowed to submit the measure with less than 12 months' 
data for the suppressed measure. A few commenters stated the policy 
should only be applied if the clinical guideline change relates to 
patient harm or patient safety, in which case data collection on the 
quality measure should cease immediately. A few commenters indicated 
that clinicians invest significant time and resources to assess and 
improve their performance over the course of the performance period, 
and thus suppressing the scoring of a quality measure, unless patient 
harm is involved, does not appropriately recognize these efforts. One 
commenter suggested that CMS establish an attestation process through 
the EIDM system to allow clinicians the option to attest their intent 
to report the measure, and CMS should adjust their scoring accordingly.
    Response: We appreciate the commenters' suggestions. There are rare 
instances in which changes to clinical knowledge and guidelines can 
significantly impact measure specifications and the intent of the 
measure, which we believe requires suppression of scoring so as to 
encourage the clinicians to follow the guidelines that are best for the 
patient, rather than tracking the guidelines that were finalized in the 
measure set, which may negatively impact patient care. Clinical 
guideline changes that occur between rulemaking cycles would need to be 
significant enough that the change in the most up-to-date clinical 
evidence could result in patient harm if the clinician does not follow 
these new guidelines or otherwise provide misleading results as to what 
is measured as good quality care. We believe there are rare instances 
in which we should not delay our support of the use of the most current 
clinical evidence by continuing to require the collection of data and 
scoring the measure until the next rulemaking cycle. For example, a 
guideline may be updated because clinical evidence indicates that a new 
medication should replace a medication specified in a quality measure. 
If this occurs between rulemaking cycles, we would not want the scoring 
policy to disadvantage the clinicians adopting the updated guideline 
and using the recommended medication. We envision that this policy 
would be applied in two circumstances. First, there is a newly issued 
or updated guideline where there is wide consensus that would result in 
a significant change to a quality measure. In these cases, it would be 
expected that clinicians would adopt clinical processes to support the 
new guideline which may not be compatible with the existing measures 
and could provide misleading results or patient harm. In this case, we 
anticipate the quality measure would be reviewed and updated during the 
next rulemaking process. Second, we envision using this policy in rare 
cases where there is a new or revised guideline, even if there is no 
broad consensus within the specialty, because some clinicians will 
begin to adopt the new guideline which would not be consistent with the 
quality measures and scoring the measure could cause misleading results 
for those clinicians. We believe it important to suppress the measure 
until guideline and quality measure are reviewed by the Measures 
Application Partnership (MAP) and other processes to support the Annual 
List of Measures, including rulemaking. We do not envision using this 
policy solely based on indications that guideline revisions are 
anticipated but not completed. Until the guideline is updated, 
clinicians would be expected to follow the existing guideline and it 
would not be prudent to use the scoring policy. Nor would we activate 
the policy if the guideline change does not significantly impact the 
measure results.
    In the event of the need for the special scoring policy, we would 
communicate to clinicians through multiple channels regarding the 
changes. We appreciate that clinicians invest significant time and 
resources to select measures, we also believe it is critical that the 
measure results do not cause patient harm or otherwise harm clinician 
performance by scoring potentially misleading data. We believe 
suppressing the measure and reducing the total possible achievement 
points by 10 would recognize this effort by not forcing clinicians in 
the middle of a performance to select a new measure to report.
    We appreciate the time and resources clinicians expend to collect 
data for a quality measure; however, we believe the policy will only be 
used in rare occasions, which will limit disruption to clinicians. We 
also believe that the policy will not disadvantage the clinician and 
will ``hold harmless'' any clinician submitting data on the measure. 
Scoring would be suppressed for any clinician that submitted data on 
the measure prior to the announcement. Similarly, given how rarely we 
anticipate we will need to use this policy, we do not believe we 
require a process for attestation regarding which measures will be 
selected prior to the performance period.
    Comment: A few commenters recommended regular communication between 
CMS and measure stewards and supported the proposal that it would be 
the responsibility of the measure steward to notify CMS of changes to 
the clinical guidelines that may impact existing quality measures. One 
commenter requested that CMS allow multiple sources, rather than just 
measure stewards, to identify potential significant changes to clinical 
guidelines that may pose patient safety

[[Page 59847]]

risks. Another commenter stated that only measure stewards should 
notify CMS of significant changes to clinical guidelines.
    Response: We regularly monitor changes to quality measures and work 
closely with clinical organizations that maintain clinical guidelines 
and measure stewards to identify quality measures impacted by 
significant changes to clinical guidelines during the performance 
period. We will mainly rely on measure stewards to identify significant 
changes, especially those relating to potential patient harm. We 
clarify that measure stewards are not necessarily the owner and/or 
developer of the clinical guidelines. In many instances measure 
stewards defer to the clinical organizations or stakeholders who own, 
maintain and update the clinical guideline when changes are warranted. 
We intend to continue to work collaboratively with measure stewards, 
clinical organizations, measure owners and other key stakeholders 
responsible for the maintenance of these guidelines prior to deciding 
to suppress the scoring of a measure. As noted above, if we decide to 
suppress these measures, we would notify clinicians through multiple 
means.
    After consideration of public comments, we are finalizing a 
modification of our proposal and adding a new paragraph at Sec.  
414.1380(b)(1)(vii) stating that, beginning with the 2021 MIPS payment 
year, we will reduce the denominator of available measure achievement 
points for the quality performance category by 10 points for MIPS 
eligible clinicians for each measure submitted that is significantly 
impacted by clinical guideline changes or other changes when we believe 
adherence to the guidelines in the existing measures could result in 
patient harm or otherwise provide misleading results as to good quality 
care. To clarify, we regularly monitor changes to quality measures and 
clinical guidelines and we will rely mainly on measure stewards, who 
often defer to the clinical organizations or other stakeholders who 
own, maintain and update the clinical guideline when a guideline change 
is warranted, for notification in changes to clinical guidelines. We 
will publish on the CMS website suppressed measures whenever 
technically feasible, but by no later than the beginning of the data 
submission period.
(vii) Scoring for MIPS Eligible Clinicians That Do Not Meet Quality 
Performance Category Criteria
    In the CY 2018 Quality Payment Program final rule (82 FR 53732), we 
finalized that, beginning with the 2021 MIPS payment year, we will 
validate the availability and applicability of quality measures only 
with respect to the collection type that a MIPS eligible clinician 
utilizes for the quality performance category for a performance period, 
and only if a MIPS eligible clinician collects via claims only, MIPS 
CQMs only, or a combination of MIPS CQMs and claims collection types. 
We will not apply the validation process to any data collection type 
that the MIPS eligible clinician does not utilize for the quality 
performance category for the performance period. We sought comment on 
how to modify the validation process for the 2021 MIPS payment year 
when clinicians may submit measures collected via multiple collection 
types.
    As discussed in section III.I.3.h.(1)(b) of this final rule, we 
proposed to revise our terminology regarding data submission. This 
updated terminology will more accurately reflect our current 
submissions and validation policies. In the CY 2019 PFS proposed rule 
(83 FR 35950), we proposed to modify our validation process to provide 
that it only applies to MIPS CQMs and the claims collection type, 
regardless of the submitter type chosen. For example, this policy would 
not apply to eCQMs even if they are submitted by a registry.
    We note that a MIPS eligible clinician may not have available and 
applicable quality measures. If we are unable to score the quality 
performance category, then we may reweight the clinician's score 
according to the reweighting policies described in sections 
III.I.3.i.(2)(b)(ii) and III.I.3.i.(2)(b)(iii) of this final rule.
    We did not receive any comments on this proposal.
    We are finalizing our proposal to modify our validation process to 
provide that it only applies to MIPS CQMs and the claims collection 
type, regardless of the submitter type chosen.
(viii) Small Practice Bonus
    In the CY 2018 Quality Payment Program final rule (82 FR 53788), we 
finalized at Sec.  414.1380(c)(4) to add a small practice bonus of 5 
points to the final score for the 2020 MIPS payment year for MIPS 
eligible clinicians, groups, APM Entities, and virtual groups that meet 
the definition of a small practice as defined at Sec.  414.1305 and 
submit data on at least one performance category in the 2018 MIPS 
performance period.
    We continue to believe an adjustment for small practices is 
generally appropriate due to the unique challenges small practices 
experience related to financial and other resources, as well as the 
performance gap we have observed (based on historical PQRS data) for 
small practices in comparison to larger practices. We believe a small 
practice bonus specific to the quality performance category is 
preferable for the 2021 MIPS payment year and future years. We believe 
it is appropriate to apply a small practice bonus points to the quality 
performance category based on observations using historical data, which 
indicates that small practices are less likely to submit quality 
performance data, less likely to report as a group and use the CMS Web 
Interface, and more likely to have lower performance rates in the 
quality performance category than other practices. We want the final 
score to reflect performance, rather than the ability and 
infrastructure to support submitting quality performance category data.
    We considered whether we should continue to apply the small 
practice bonus through bonus points in all 4 performance categories, 
but believe the need for doing so is less compelling. The improvement 
activities performance category already includes special scoring for 
small practices (please refer to Sec.  414.1380(b)(3) and see section 
III.I.3.i.(1)(e) of this final rule for more information). In addition, 
for the Promoting Interoperability performance category, small 
practices can apply for a significant hardship exception if they have 
issues acquiring an EHR (see section III.I.3.h.(5) of this final rule). 
Finally, the cost performance category does not require submission of 
any data; therefore, there is less concern about a small practice being 
burdened by those requirements. For these reasons, we proposed to 
transition the small practice bonus to the quality performance 
category.
    Starting with the 2021 MIPS payment year, we proposed at Sec.  
414.1380(b)(1)(v)(C) to add a small practice bonus of 3 points in the 
numerator of the quality performance category for MIPS eligible 
clinicians in small practices if the MIPS eligible clinician submits 
data to MIPS on at least 1 quality measure (83 FR 35950). Because MIPS 
eligible clinicians in small practices are not measured on the 
readmission measure and are not able to participate in the CMS Web 
Interface, they generally have a quality performance category 
denominator of 60 total possible measure achievement points. Thus, our 
proposal of 3 measure bonus points generally represents 5 percent of 
the quality performance category score. As described in section 
III.I.3.i.(2)(b)(iii) of this final rule, for clinicians in many small 
practices, the

[[Page 59848]]

quality performance category weight may be up to 85 percent of the 
final score. (For example, if a small practice applies for the 
Promoting Interoperability significant hardship application and does 
not meet the sufficient case minimum for cost measures, then the 
weights of Promoting Interoperability and cost performance categories 
are redistributed to quality and the quality performance category 
weight would be 85 percent.)
    With a weight of 85 percent, a small practice bonus of 3 points 
added to the quality performance category will result in 4.25 bonus 
points added to the final score for clinicians in small practices.\29\ 
We believe this is appropriate because it is similar to the impact of 
the small practice bonus we finalized for the 2020 MIPS payment year (5 
points added to the final score). Although we recognize that the impact 
of the small practice bonus for MIPS eligible clinicians in small 
practices who do not receive reweighting for the cost and/or Promoting 
Interoperability performance categories will be less than 4.25 points 
added to the final score, we believe a consistent approach is 
preferable for simplicity, and we do not believe that a larger bonus is 
appropriate as that could potentially inflate the quality performance 
category score and the final score and mask poor performance.
---------------------------------------------------------------------------

    \29\ We get 4.25 points using the following calculation: (3 
measure bonus point/60 total measure points) * 85 percent * 100 = 
4.25.
---------------------------------------------------------------------------

    We requested comments on the proposal above. These comments and our 
responses are discussed below.
    Comment: Some commenters supported the proposal and recommended 
that CMS continue to evaluate the least complicated method to apply the 
small practice bonus in future years. One commenter indicated that a 
small practice bonus should be retained as long as possible to support 
small practices. A few commenters recommended stability over several 
performance periods for the small practice bonus, with incentives 
maintained over time with no changes from year-to-year. One commenter 
recommended that CMS codify the small practice bonus for at least 3 
years.
    Response: We will evaluate MIPS data to determine whether any 
future adjustment is still needed based on analysis of the performance 
of small group practices compared to larger practices. While we 
appreciate commenters' recommendations for stability in the bonus over 
time, we believe that we must be guided by the annual analysis of small 
practices' experience with the Quality Payment Program to determine if 
the adjustment is still warranted. Any extension to the small practice 
bonus would be proposed through future rulemaking.
    Comment: One commenter recommended bonus points be applied evenly 
across the following performance categories: Quality; improvement 
activities; and Promoting Interoperability. Another commenter indicated 
that it did not support a bonus based on the size or location of the 
practice and recommended aligning the four performance categories and 
awarding bonuses for activities that apply across the performance 
categories. One commenter recommended that the clinician be allowed the 
option to have bonus points added to a performance category of his or 
her choice. A few commenters stated that small practices are 
consistently disadvantaged compared to large health systems for not 
only quality reporting, but also requirements of other performance 
categories including Promoting Interoperability and improvement 
activities.
    Response: We considered dividing the small practice bonus between 
the performance categories; however, we believe that spreading the 
bonus across performance categories may not be appropriate, and the 
other performance categories already take small practices into account. 
As stated earlier, the improvement activities performance category 
already includes special scoring for small practices. The Promoting 
Interoperability performance category has a hardship exception for 
small practices. The cost performance category does not require 
submission of any data. For these reasons, we believe that it is 
appropriate for the small practice bonus to be in the quality 
performance category.
    Comment: Many commenters did not support reducing the small 
practice bonus from 5 points in the final score to 3 measure bonus 
points in the quality performance category because of concerns that 
small practices will receive less points, which may not support small 
practices sufficiently. Several commenters stated that the bonus needs 
to be significant enough so that adjustments provide more equitable 
scoring to small practices. One commenter recommended that if the bonus 
is applied in the quality performance category, 5 points should be 
awarded.
    Response: We understand commenters' concerns. We recently estimated 
quality performance category scores for the 2019 MIPS performance 
period using data from the 2017 MIPS performance period. This new data 
was not available before the publication of the proposed rule. In this 
new analysis, we found that the number of eligible clinicians whose 
quality performance category was reweighted to 85 percent of the final 
score was lower than we anticipated. We found that for approximately 
three-fourths of the clinicians in small practices (and those not 
subject to the APM scoring standard), quality was weighted between 45 
and 60 percent when we applying our proposed CY 2019 performance period 
policies to MIPS year 1 data. Thus, the 3 bonus points proposed (which 
generally represents 5 percent of the quality performance category 
score for small practices) would represent a lower overall bonus when 
added to the final score than we had originally anticipated. While we 
still believe that the small practice bonus should be applied to the 
quality category performance score, it was not our intention to lower 
the overall impact on the final score.
    With our updated impact analysis in this final rule, we discovered 
that trends identified when we originally established the small 
practice bonus still exist. For example, in the CY 2018 Quality Payment 
Program proposed rule (82 FR 30139 through 30140), we noted that 
clinicians in practices with more than 100 clinicians may perform 
better in the Quality Payment Program on average compared to clinicians 
in smaller practices. We believed this trend was due primarily to two 
factors: Participation rates and Web Interface reporting. While we 
estimate more clinicians in small practices are participating in MIPS 
in our updated model in this final rule compared to our estimates in 
the 2019 PFS proposed rule, we still see a gap in quality participation 
when comparing clinicians in small practices to clinicians in large 
practices (89.8 percent compared to 100.0 percent respectively). We 
also noticed a discrepancy in performance among those who submitted 
data for the quality performance category. Prior to applying a small 
practice bonus, the average quality score for submitters in small 
practices was 62 percent compared to 82 percent for clinicians in large 
groups. It is unclear whether the cause of the discrepancy is related 
to Web Interface reporting, to performance, or to factors related to 
data collection. While we continue to analyze the implications of these 
results, we believe increasing the small practice bonus from 3 to 6 
measure bonus points for 1 year would be appropriate to ensure that we 
are correctly incentivizing participation

[[Page 59849]]

during the transition years without lowering the impact of the small 
practice bonus. The other bonuses in the quality performance category 
(for high-priority measures and end-to-end electronic reporting) are 
capped at 10 percent of the denominator of the quality performance 
category, which in almost all cases for small practices is 60 total 
possible measure achievement points. Setting the bonus at 6 points 
generally represents 10 percent of the quality performance category 
score. For those clinicians who have six measures and for whom the 
quality performance category weight is 45 percent, then the small 
practice bonus would equate to 4.5 final score points. For those with a 
quality performance category weight of 60 percent, the small practice 
bonus would equate to 6 final score points. We recognize that for some 
practices whose quality score is reweighted to 85 percent of their 
final score, this may account for a large part of the final score; 
however, based on the new CY 2017 MIPS performance period data, we do 
not believe this will be the case for a large proportion of small 
practices. On average, we estimate this change to the small practice 
bonus will add 4.4 points to the final score for clinicians in small 
practices who submit quality information to MIPS.
    We want to remind readers that the small practice bonus was only 
meant to be temporary and as we further analyze CY 2017 MIPS 
performance period data we expect that the bonus will likely be reduced 
or removed in future rulemaking. While we currently believe that it is 
appropriate due to the unique challenges small practices experience 
related to financial and other resources, as well as the performance 
gap for small practices in comparison to larger practices, we believe 
that upon further analysis of CY 2017 MIPS performance period data the 
small practice bonus may not address the underlying reasons for the 
disparate performance between small practices and other clinicians. As 
a result, we intend to revisit this bonus during next year's rulemaking 
cycle.
    Comment: Many commenters stated that the small practice bonus 
should not be embedded in the quality performance category and should 
be a standalone bonus at the final score level to reduce complication 
in scoring, provide greater flexibility, and reduce burden on small 
practices. Several commenters stated that the quality performance 
category is contributing less to the final score, since it is being 
reduced from 50 percent to 45 percent, and may be reduced in the 
future, which would continually reduce the small practice bonus. A few 
commenters noted that moving the bonus to the quality performance 
category provides additional scoring complexity and will not be 
equitable, since the bonus will be applied to small practices 
regardless of the number of measures submitted for the quality 
performance category. For example, the bonus of 3 points for a 
clinician being scored on one quality measure would translate to a 
higher contribution to the final score than applying a bonus of 3 
points for a clinician being scored on 6 measures. One commenter was 
concerned that moving the small practices bonus to the quality 
performance category will remove the opportunity for a bonus from 
clinicians who do not, or cannot, report quality measures.
    Response: We believe it is more appropriate for the small practice 
bonus to reside in the quality performance category because small 
practices have different reporting options than larger practices (for 
example, only small practices are able to submit data via Medicare Part 
B claims, but they cannot do so via the Web Interface), and burdens 
associated with submitting data could affect the quality performance 
category score. We also believe there is at least one quality measure 
that is relevant to the vast majority of clinicians in the Quality 
Payment Program. The small practice bonus is available to any small 
practice submitting at least one quality measure. We reiterate that we 
have special policies to assist small practices in the improvement 
activities and Promoting Interoperability performance categories, which 
limit the need for a small practice bonus in those performance 
categories. The cost performance category does not require additional 
burden to submit information and does not have the same reporting 
restrictions as the quality performance category. Over time, we will 
monitor the weight of the quality performance category and the small 
practice contribution to the final score to determine if the amount of 
the small practice bonus needs to be adjusted. We acknowledge that 
moving the small practice bonus may add to the complexity of scoring, 
but, on balance, we believe it is appropriate to encourage the 
submission of quality measures. Also, we note that previously the small 
practice bonus was added to the final score regardless of the number of 
quality measures that were submitted. Although the bonus is now in the 
quality category, the equity of the bonus does not change with this 
policy. In addition, we will continue to monitor data to evaluate the 
performance of small practices in the quality performance category to 
determine differences between small and large practices and propose any 
necessary changed in future rulemaking.
    Comment: One commenter requested clarification on how CMS will 
extend the small practice bonus to MIPS APMs.
    Response: The small practice bonus will be applied to the final 
quality performance category score for MIPS APMs at the MIPS APM 
entity-level. For further discussion on our MIPS APM scoring policies, 
we refer readers to section III.I.3.h.(6) of this final rule.
    Comment: One commenter indicated that the bonus score changes based 
on the reweighting of certain performance categories for clinicians, 
which they believe gives an advantage to clinicians who have a higher 
percentage of the score weighed to the quality performance category. 
One commenter did not support moving the bonus to the quality 
performance category, because the potential to reweight performance 
categories results in a bonus that is not predictable during the 
performance period for clinicians, who do not know which performance 
categories will be reweighted.
    Response: We appreciate that there might be differences in the 
reweighting of performance categories for small practices. As stated 
previously, we believe the quality performance category is an important 
component of the Quality Payment Program. While it was our intention to 
apply a bonus to the quality performance category with a cap 
approximately equal to the final score small practice bonus for the 
2018 MIPS performance period/2020 MIPS payment year, we recognize that 
due to reweighting, the magnitude of the bonus will vary; however, in 
order to reduce complexity, we believe that a uniform bonus of 6 
measure bonus points added to the numerator for quality is appropriate. 
As discussed in our response above, the policy is consistent with our 
other quality performance category bonuses because, for most 
clinicians, 6 measure bonus points is 10 percent of the 60-point 
denominator within the quality performance category. In addition, 
clinicians can predict whether their scores will be reweighted based on 
eligibility and special status information in the lookup tool. We will 
monitor the extent to which reweighting the quality performance 
category contribution to the final score affects quality measure bonus 
points awarded and so that we may keep the bonuses as equitable as 
possible.
    Comment: A few commenters indicated that the small practice bonus 
should be extended to rural practices and different practice sizes. One

[[Page 59850]]

commenter recommended extending the bonus to all rural practices, 
regardless of practice size, because of the belief that all rural 
practices struggle with access to resources. One commenter indicated a 
belief that the program offers few bonus points and opportunities for 
high scores for small and rural practices, which may result in a skewed 
scoring system that rewards large groups with resources to support 
participation. One commenter recommended that the small practice bonus 
be available to groups with 10 or less participants, to align the 
definition with virtual group requirements. One commenter indicated 
that groups with more than 15 clinicians should be considered a small 
practice for purposes of the bonus.
    Response: As discussed in the CY 2018 Quality Program final rule 
(82 FR 53778), we observed that performance for rural MIPS eligible 
clinicians is very similar to performance for non-rural MIPS clinicians 
once we account for practice size, so we do not believe a bonus for 
MIPS clinicians practicing in a rural setting is appropriate at this 
time. Additionally, we discussed in the CY 2018 Quality Payment Program 
final rule (82 FR 53777) that we believe it is important to maintain a 
consistent definition of small practices within the Quality Payment 
Program. In addition, we have not seen discrepancies between simulated 
MIPS final scores for practices of 16 to 24 clinicians and for 
practices of 15 or fewer clinicians. However, we will continue to 
monitor this issue and assess whether there are scoring differences 
between small rural and small urban practices and, if so, address it in 
future rulemaking.
    Comment: One commenter requested that CMS articulate how the 
policies proposed align with other CMS efforts to support the long-
term, sustainable transformation of small practices and those serving 
rural and underserved communities.
    Response: We recognize the unique challenges that eligible 
clinicians in small practices face and have established a unique set of 
policies to reduce their participation burden and ease their transition 
into the program. The special policies include the provisions related 
to the assignment of 3 points for measures that do not meet data 
completeness criteria which are finalized in section 
III.I.3.i.(1)(b)(v) of this final rule; the significant hardship 
exception for Promoting Interoperability performance category and the 
associated reweighting policies available for small practices that do 
not have CEHRT (2018 Quality Payment Program final rule (82 FR 53683)); 
special scoring provisions available for the improvement activities 
performance category (82 FR 53656), and the provisions related to the 
low-volume threshold at section III.I.3.c. of this final rule. We are 
also continuing the Small, Underserved, and Rural Support initiative, 
which provides no-cost technical assistance to MIPS eligible clinicians 
in small practices. The initiative offers customized, one-on-one 
support to help MIPS eligible clinicians in small practices familiarize 
themselves with the program requirements, develop a strategy to 
successfully participate, and continue improving outcomes for 
beneficiaries. See: https://qpp.cms.gov/about/small-underserved-rural-
practices for further information.
    As discussed in the response above, we have estimated quality 
performance category scores using data from the 2017 MIPS performance 
period. As a result of this new data that was not available before the 
publication of the proposed rule we believe increasing the small 
practice bonus from 3 to 6 measure bonus points would be appropriate to 
ensure that we are correctly incentivizing participation without 
lowering the final score of small practices. The other bonuses in the 
quality performance category (for high-priority measures and end-to-end 
electronic reporting) are capped at 10 percent of the denominator of 
the quality performance category, which in almost all cases for small 
practices is 60 total possible measure achievement points. Setting the 
bonus at 6 points generally represents 10 percent of the quality 
performance category score.
    After consideration of public comments, we are not finalizing as 
proposed the proposal to amend Sec.  414.1380(b)(1)(v)(C) to add, 
beginning with the 2021 MIPS payment year, a small practice bonus of 3 
measure bonus points in the numerator of the quality performance 
category for MIPS eligible clinicians in small practices if the MIPS 
eligible clinician submits data to MIPS on at least 1 quality measure. 
Instead, based on the rationale discussed previously, we are finalizing 
the amendment of Sec.  414.1380(b)(1)(v)(C) to add, beginning with the 
2021 MIPS payment year, a small practice bonus of 6 measure bonus 
points in the numerator of the quality performance category for MIPS 
eligible clinicians in small practices if the MIPS eligible clinician 
submits data to MIPS on at least 1 quality measure.
(ix) Incentives To Report High-Priority Measures
    In the CY 2017 Quality Payment Program final rule, we established a 
cap on high-priority measure bonus points for the first 2 years of MIPS 
at 10 percent of the denominator (total possible measure achievement 
points the MIPS eligible clinician could receive in the quality 
performance category) of the quality performance category (81 FR 
77294). As part of our proposed technical updates to Sec.  
414.1380(b)(1) discussed in section III.I.3.i.(1)(b) of this final 
rule, our previously established policy on incentives to report high-
priority measures is now referenced at Sec.  414.1380(b)(1)(v)(A). In 
the CY 2019 PFS proposed rule, we proposed to maintain the cap on 
measure bonus points for reporting high-priority measures for the 2021 
MIPS payment year, and to amend Sec.  414.1380(b)(1)(v)(A)(1)(ii), 
accordingly (83 FR 35951).
    We requested comments on the proposal above. These comments and our 
responses are discussed below.
    Comment: One commenter supported the proposal to maintain the cap 
on measure bonus points for reporting high-priority measures for the 
2019 performance period/2021 MIPS payment year.
    Response: We thank the commenter for its support of our proposal.
    After consideration of public comments, we are finalizing our 
proposal to maintain the cap on measure bonus points for reporting 
high-priority measures for the 2021 MIPS payment year, and to amend 
Sec.  414.1380(b)(1)(v)(A)(1)(ii), accordingly.
    We established the scoring policies for high-priority measure bonus 
points in the CY 2017 Quality Payment Program final rule (81 FR 77293). 
We noted that, in addition to the required measures, CMS Web Interface 
reporters may also report the CAHPS for MIPS survey and receive measure 
bonus points for submitting that measure (81 FR 77293). We refer 
readers to Sec.  414.1380(b)(1)(v)(A) for more details on the high-
priority measure bonus points scoring policies.
    For the 2021 MIPS payment year, we proposed to modify the policies 
finalized in the CY 2017 Quality Payment Program final rule (and amend 
Sec.  414.1380(b)(1)(v)(A) accordingly) to discontinue awarding measure 
bonus points to CMS Web Interface reporters for reporting high-priority 
measures (83 FR 35951). As we continue to move forward in implementing 
the MIPS program, we no longer believe that it is appropriate to award 
CMS Web Interface reporters measure bonus points to be consistent with 
other policies regarding selection of measures. Based on additional 
data analyses since the first-year policy was implemented,

[[Page 59851]]

we have found that practices that elect to report via CMS Web Interface 
generally perform better than other practices that select other 
collection types. Therefore, the benefit of the bonus points is limited 
and instead we believe will create higher than normal scores. Bonus 
points were created as transition policies which were not meant to 
continue through the life of the program. Measure bonus points are also 
used to encourage the selection of additional high-priority measures. 
As the program matures, we have established other policies related to 
measures selection, such as applying a cap of 7 measure achievement 
points if a clinician selects and submits a measure that has been 
topped out for 2 or more years; however, we have excluded CMS Web 
Interface reporters from the topped out policies because reporters have 
no choice in measures. By the same logic, since CMS Web Interface 
reporters have no choice in measures, we do not believe it is 
appropriate to continue to provide additional high-priority measure 
bonuses for reporting CMS Web Interface measures. We note the CMS Web 
Interface users may still elect to report the CAHPS for MIPS survey in 
addition to the CMS Web Interface, and if they do, they would receive 
the high priority bonus points for reporting the survey.
    We requested comments on the proposal above. These comments and our 
responses are discussed below.
    Comment: A few commenters supported the proposal to discontinue 
awarding high-priority measure bonus points to CMS Web Interface 
reporters because it strengthens the incentive to report high-priority 
measures for those who actively elect to report these measures and 
reduces the advantage for the large practices that are able to report 
through CMS Web Interface. One commenter expressed support for the 
proposal because groups who report via Web Interface perform better 
than groups who use alternative data collection types, have an 
increased probability of earning higher quality performance category 
and overall higher MIPS scores, and can still earn bonus points for 
reporting CAHPS for MIPS survey measures.
    Response: We thank the commenters for their support as we look for 
ways to improve our scoring policy.
    Comment: Several commenters did not support the proposal to remove 
high-priority bonus points for CMS Web Interface reporters. One 
commenter stated it would disincentivize clinicians and groups from 
participating in APMs and stated that ACOs do not have an alternative 
submission method. Another commenter suggested that the bonus points 
should continue for non-MIPS APM participants because these submitters 
voluntarily choose a larger and more difficult and complex set of 
measures than are required. A few commenters stated that there is not 
an option to submit additional high-priority measures to earn these 
bonus points and that this proposal disadvantages ACOs which have 
demonstrated a high commitment to quality as evidenced by recent MIPS 
performance feedback reports. One commenter recommended that CMS should 
not remove all bonus points until it proposes to do the same for the 
other collection types. A few commenters suggested delaying removal of 
the bonus points to allow clinicians sufficient notice and until 
further information and insight is gained about performance in these 
measures. One commenter stated that the policy penalizes Web Interface 
reporters for their commitment to measures that truly reflects their 
practices.
    Response: The high priority measure bonus points were intended to 
encourage the selection of certain measures. As we work towards 
improving our scoring policy to align with our goals of improving 
quality of care, we no longer believe we should award bonus points to 
CMS Web Interface reporters because they do not select individual 
measures to report, rather the Web Interface is a measurement set. This 
bonus policy was meant to be temporary, and we believe that as the MIPS 
program goes into its third year it is an appropriate time to begin to 
limit the assignment of high priority bonus points. While we recognize 
the commenters' concerns, the removal of the bonus was not intended to 
penalize Web Interface reporters and we still have several special 
policies available for Web Interface reporters. We have excluded CMS 
Web Interface reporters from the topped out measure cap (82 FR 53576), 
so although they are no longer able to receive this bonus, they are 
still able to receive maximum achievement points for all measures, even 
though some of the CMS Web Interface measures may be considered topped 
out. Additionally, CMS Web Interface reporters are still able to 
receive measure bonus points for reporting the CAHPS for MIPS survey 
and for end-to-end reporting.
    We will consider commenters' concerns in future rulemaking.
    After consideration of public comments, we are finalizing our 
proposal, beginning with the 2021 MIPS payment year, to discontinue 
awarding measure bonus points to CMS Web Interface reporters for 
reporting high-priority measures and to amend Sec.  
414.1380(b)(1)(v)(A) accordingly.
    As part of our move towards fully implementing the high value 
measures as discussed in section III.I.3.h.(2)(b)(iv) of this final 
rule, we believe that bonus points for high priority measures for all 
collection types may no longer be needed, and as a result, we intend to 
consider in future rulemaking whether to modify our scoring policy to 
no longer offer high priority bonus points after the 2021 MIPS payment 
year (83 FR 35951).
    We thank commenters for suggestions and may consider them for 
future rulemaking.
(x) Incentives To Use CEHRT To Support Quality Performance Category 
Submissions
    Section 1848(q)(5)(B)(ii) of the Act requires the Secretary to 
encourage MIPS eligible clinicians to report on applicable quality 
measures through the use of CEHRT. Under Sec.  414.1380(b)(1)(xv), 1 
bonus point is available for each quality measure submitted with end-
to-end electronic reporting, under certain criteria. In order to 
receive the bonus for end-to-end reporting, eligible clinicians must 
use the 2015 Edition CEHRT. We refer readers to the CY 2017 Quality 
Payment Program final rule (81 FR 77297) and section 
III.I.3.h.(2)(b)(i) of this final rule for further discussion on our 
certification requirements for the end-to-end reporting bonus. As part 
of our proposed technical updates to Sec.  414.1380(b)(1) discussed in 
section III.I.3.i.(1)(b) of this final rule, our previously established 
electronic end-to-end reporting bonus point scoring policy is now 
referenced at Sec.  414.1380(b)(1)(v)(B).
    In the CY 2019 PFS proposed rule, we proposed to maintain the cap 
on measure bonus points for end-to-end electronic reporting for the 
2021 MIPS payment year (83 FR 35951). We also proposed to continue to 
assign bonus points for end-to-end electronic reporting for the 2021 
MIPS payment year, as we have seen that this policy encourages 
electronic reporting. We proposed to amend Sec.  414.1380(b)(1)(v)(B) 
accordingly.
    We requested comments on the proposal above. These comments and our 
responses are discussed below.
    Comment: Several commenters supported maintaining the bonus points 
for end-to-end electronic reporting for the 2021 MIPS payment year and 
requested that CMS continue to assign them in future years. One 
commenter

[[Page 59852]]

noted that continuing the bonus points beyond the 2021 MIPS payment 
year will allow clinicians in smaller practices who are not yet capable 
of end-to-end electronic reporting an opportunity to do so. Another 
commenter supported the bonus only if those that are not able to submit 
using end-to-end electronic reporting have access to CEHRT at no cost 
to the clinician. One commenter suggested that CMS continue the bonus 
points until the program is more mature and additional data on 
performance and reporting is gathered. A few commenters who supported 
maintaining the bonus points beyond the 2021 MIPS payment year, stated 
that the removal of the bonus points would result in increased 
administrative burden to CMS and clinicians, and would adversely affect 
the ability for clinicians with limited quality measures available to 
earn bonus points.
    Response: While we signaled our intent to discontinue bonus points 
for end-to-end electronic reporting in the future (83 FR 35951), we are 
taking into consideration the suggestions we received on additional 
ways we can incentivize and encourage these reporting methods for 
future rulemaking.
    After consideration of public comments, we are finalizing our 
proposals to continue to assign and maintain the cap on measure bonus 
points for end-to-end electronic reporting for the 2021 MIPS payment 
year and to amend Sec.  414.1380(b)(1)(v)(B) accordingly.
    We also proposed to modify our end-to-end reporting bonus point 
scoring policy based on the changes to the submission terminology 
discussed in section III.I.3.h.(1)(b) of this final rule (83 FR 35951). 
We proposed that the end-to-end reporting bonus can only apply to the 
subset of data submitted by direct, log in and upload, and CMS Web 
Interface that meet the criteria finalized in the CY 2017 Quality 
Payment Program final rule (81 FR 77297 through 77298). However, the 
end-to-end reporting bonus would not be applied to the claims 
submission type because it does not meet the criteria discussed above. 
This is not a policy change but rather a clarification of our current 
process in light of the proposed terminology changes.
    We did not receive any comments on this proposal.
    After consideration of public comments, we are finalizing our 
proposals to modify our end-to-end reporting bonus point scoring policy 
based on the changes to the submission terminology and only apply the 
bonus to the subset of data submitted by direct, log in and upload, and 
CMS Web Interface that meet the criteria finalized in the CY 2017 
Quality Payment Program final rule (81 FR 77297 through 77298).
    As discussed in section III.I.3.i.(1)(b)(x) of this final rule, we 
believe that in the future, bonus points for end-to-end reporting for 
all submission types will no longer be needed as we move towards fully 
implementing the program, and as a result we intend to consider in 
future rulemaking modifying our scoring policy to no longer offer end-
to-end reporting bonus points after the 2021 MIPS payment year (83 FR 
35951). Consistent with the section 1848(q)(5)(B)(ii) of the Act, which 
requires the Secretary to encourage the use of CEHRT for quality 
reporting, we will continue to be committed to ways that we can 
incentivize and encourage these reporting methods. We invited comment 
on other ways that we can encourage the use of CEHRT for quality 
reporting.
    We thank commenters for suggestions and will consider them for 
future rulemaking.
(xi) Calculating Total Measure Achievement and Measure Bonus Points
(A) Calculating Total Measure Achievement and Measure Bonus Points for 
Non-CMS Web Interface Reporters
    In the CY 2017 and 2018 Quality Payment Program final rules (81 FR 
77300, and 82 FR 53733 through 53736, respectively), we established the 
policy for calculating total measure achievement and measure bonus 
points for Non-CMS Web Interface reporters. We refer readers to Sec.  
414.1380(b)(1) for more details on these policies.
    We did not propose any changes to the policy for scoring submitted 
measures collected across multiple collection types; however, we 
provided a summary of how this policy will be scored using our new 
terminology (83 FR 35952). We noted that CMS Web Interface and 
facility-based measurement each have a comprehensive set of measures 
that meet the proposed MIPS category requirements. As a result, we did 
not combine CMS Web Interface measures or facility-based measurement 
with other ways groups can be scored for data submitted for MIPS (other 
than CAHPS for MIPS, which can be submitted in conjunction with the CMS 
Web Interface). We refer readers to section III.I.3.i.(1)(d) of this 
final rule for a description of our policies on facility-based 
measurement (83 FR 35956 through 35963).
    Although we have established a policy to account for scoring in 
circumstances when the same measure is collected via multiple 
collection types, we anticipate that this will be a rare circumstance 
and do not encourage clinicians to submit the same measure collected 
via multiple collection types. Table 51 is included in this final rule 
for illustrative purposes and clarity due to the changes in terminology 
discussed in section III.I.3.h.(1)(b) of this final rule (83 FR 35893 
through 35895). For further discussion of this example, we refer 
readers to the CY 2018 Quality Payment Program final rule (82 FR 
53734).
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    We did not propose any changes to our policy regarding scoring 
measure achievement points and bonus points when using multiple 
collection types for non-Web Interface MIPS eligible clinicians in the 
quality performance category for the 2019 MIPS performance period.
(B) Calculating Total Measure Achievement and Measure Bonus Points for 
CMS Web Interface Reporters
    In the CY 2017 and 2018 Quality Payment Program final rules (81 FR 
77302 through 77306, and 82 FR 53736 through 82 FR 53737, 
respectively), we finalized the scoring policies for CMS Web Interface 
reporters. As part of our technical updates to Sec.  414.1380(b)(1) 
discussed in section III.I.3.i.(1)(b) of this final rule, our 
previously established policies for CMS Web Interface reporters are now 
referenced at Sec.  414.1380(b)(1)(i)(A)(2)(i) and (b)(1)(v)(A).
(xii) Future Approaches To Scoring the Quality Performance Category
    As we discuss in section III.I.3.h.(2)(b)(iv) of this final rule, 
we anticipate making changes to the quality performance category to 
reduce burden and increase the value of the measures we are collecting. 
We discussed that existing measures have differing levels of value and 
our approaches for implementing a system where points are awarded based 
on the value of the measure. Should we adopt these approaches, we 
anticipate needing to modify our scoring approaches accordingly. In 
addition, we have received stakeholder feedback requesting that we 
simplify scoring for the quality performance category. Therefore, we 
solicited comment on the following approaches to scoring that we may 
consider in future rulemaking and whether these approaches move the 
clinicians towards reporting high value measures and more accurate 
performance measurement (83 FR 35954 through 35955).
    One option for simplification is restructuring the quality 
requirements with a pre-determined denominator, for example, 50 points, 
but no specific requirements regarding the number of measures that must 
be submitted. Further, we would categorize MIPS and QCDR measures by 
value, because we recognize that not all measures are created equal. We 
seek to ensure that the collection and submission of data is valuable 
to clinicians and worth the cost and burden of collection of 
information. A system to classify measures as a particular value (for 
example, gold, silver, or bronze) is discussed in section 
III.I.3.h.(2)(b)(iv) of this final rule. In this approach, the highest 
tier would include measures that are considered ``gold'' standard, such 
as outcome measures, composite measure, or measures that address agency 
priorities (such as opioids). The CAHPS for MIPS survey, which collects 
patient experience data, may also be considered a high-value measure. 
Measures considered in the second tier, or at a ``silver'' standard, 
would be process measures that are directly related to outcomes and 
have a good gap in performance (there is no high, unwavering 
performance) and demonstrate room for improvement, or topped out 
outcome measures. Lower value measures, such as standard of care 
process measures or topped out process measures, would have scoring 
caps in place that would reflect the measure's status as a ``bronze 
measure.'' In this scenario, we could envision awarding points for 
achievement as follows: Up to 15 to 20 points in the top tier; up to 10 
points in the next tier; and up to 5 points in the lowest tier. Similar 
to the structure of the improvement activities performance category, a 
clinician that chooses a top-tier measure would not have to submit as 
many measures to MIPS. We would still want to ensure the submission of 
high value measures and might include requirements that restrict the 
number of lower tier measures that could be submitted; alternatively, 
we could add a requirement that a certain number of higher tier 
measures would need to be submitted. With this approach, we could still 
incentivize reporting on high-priority measures by classifying them as 
``gold'' standard measures which would be eligible for up to 15 to 20 
achievement points.
    Alternatively, we could keep our current approach for the quality 
performance category requiring 6 measures including one outcome 
measure, with every measure worth up to 10 measure achievement points 
in the denominator but change the minimum number of measure achievement 
points available to vary by the measure tier. For example, high-tier 
measures could qualify for high priority bonus and/or have a higher 
potential floor (for example, 5 measure achievement points instead of 
the floor of 3 measure achievement points for ``gold'' standard 
measures, which would be eligible for up to 10 measure achievement 
points.); whereas low-tier measures could have a lower floor (for 
example, 1 measure achievement point instead of the floor of 3 measure 
achievement points for ``bronze standard' measures).
    Taking into consideration the potential future quality performance 
category change, we also believe that removing the validation process 
to determine whether the eligible clinician has measures that are 
available and applicable would simplify the quality performance 
category significantly. Several stakeholders have expressed their 
confusion with the validation process. A move to sets of measures in 
the quality performance category, potentially with some criteria to 
define the clinicians for whom these measures are applicable, would 
eliminate the need for a validation process for measures that are 
available and

[[Page 59855]]

applicable. Moving to sets of measures would also enable us to develop 
more robust benchmarks. We also believe that in the next few years, we 
could remove the validation process for measures that are available and 
applicable if we set the denominator at a pre-determined level (as 
outlined in the example above at 50 points) and let clinicians 
determine the best method to achieve 50 points. For the 2019 and 2020 
MIPS payment years, MIPS eligible clinicians and groups who report on 
QCDR measures that do not have an available benchmark based on the 
baseline or performance period but meet data completeness are assigned 
a score of 3 measure achievement points (small practices receive 3 
points regardless of whether they meet data completeness). Through 
stakeholder engagement, particularly feedback provided by QCDRs who 
have developed their own measures, we have heard that MIPS eligible 
clinicians are hesitant to report QCDR measures without established 
benchmarks. Eligible clinicians have voiced concern on reporting on 
QCDR measures without benchmarks because they are not certain that a 
benchmark could be calculated and established for the MIPS performance 
period, and they would therefore be limited to a 3-point score for that 
QCDR measure. In addition, QCDRs have inquired about the possibility of 
creating QCDR benchmarks. To encourage reporting of QCDR measures, we 
sought comment on an approach to develop QCDR measure benchmarks based 
off historical measure data. This may require QDCRs to submit 
historical data in a form and manner that meets benchmarking needs as 
required by CMS. We anticipate that the historical QCDR measure data 
would need to be submitted at the time of self-nomination of the QCDR 
measure, during the self-nomination period. Detailed discussion of the 
self-nomination period timeline and requirements can be found in 
section III.I.3.k of this final rule. Our concern with utilizing 
historical data provided by QCDRs to develop benchmarks is whether 
QCDRs have the capability to filter through their historical measure 
data to extract only data from MIPS eligible clinicians and groups 
prior to submitting the historical data to CMS for QCDR measure 
benchmarking consideration. Furthermore, once the historical data is 
submitted by the QCDR, CMS would analyze the data to ensure that it met 
benchmarking standards prior to it being accepted to form a benchmark. 
However, to perform this analysis CMS may need additional data elements 
such as the sources of the data, data completeness, and the collection 
period. In addition to seeking comment on developing QCDR measure 
benchmarks from historical data, we also solicited comment as to how 
our aforementioned concerns may be addressed in future rulemaking.
    We also recognize that improving the electronic capture, 
calculation, and reporting of quality measures is also an important 
component of reducing provider burden. We invited comment on how we can 
incorporate incentives for the use of electronic clinical quality 
measurement into the future approaches described under this section, as 
well as other ways to encourage more efficient technology-enabled 
measurement approaches.
    We solicited comment on these approaches and other approaches to 
simplify scoring, provide incentives to submit more impactful measures 
that assess outcomes rather than processes, and develop data that can 
show differences in performance and determine clinicians that provide 
high value care (83 FR 35954 through 35955).
    We thank commenters for suggestions and will consider them for 
future rulemaking.
(xiii) Improvement Scoring for the MIPS Quality Performance Category 
Percent Score
    Section 1848(q)(5)(D)(i) of the Act stipulates that, beginning with 
the second year to which the MIPS applies, if data sufficient to 
measure improvement is available, the improvement of the quality 
performance category score for eligible clinicians should be measured. 
To measure improvement, we require a direct comparison of data from one 
Quality Payment Program year to another (82 FR 52740). For more 
descriptions of our current policies, we refer readers to the CY 2018 
Quality Payment Program final rule (82 FR 53737 to 53747). As part of 
our technical updates to Sec.  414.1380(b)(1) discussed in section 
III.I.3.i.(1)(b) of this final rule, our previously established 
improvement scoring policies are now referenced at Sec.  
414.1380(b)(1)(vi).
    In the CY 2018 Quality Payment Program final rule, we adopted a 
policy that MIPS eligible clinicians must fully participate to receive 
a quality performance category improvement percent score greater than 
zero (82 FR 53743 through 53745). In Sec.  414.1380(b)(1)(vi)(F), we 
determined ``participation'' to mean compliance with Sec.  414.1330 and 
Sec.  414.1340 in the current performance period. We issued a technical 
correction for the CY 2018 Quality Payment Year final rule, replacing 
Sec.  414.1330 with Sec.  414.1335 since Sec.  414.1335 is more 
specific because it discusses the quality performance category 
requirements.
    We finalized at Sec.  414.1380(b)(1)(vi)(C)(4) that we would 
compare the 2018 performance to an assumed 2017 quality performance 
category achievement percent score of 30 percent if a MIPS eligible 
clinician earned a quality performance category score less than or 
equal to 30 percent in the previous year (82 FR 53744 through 53745). 
In the CY 2019 PFS proposed rule, we proposed to continue this policy 
for the 2019 MIPS performance period and amend Sec.  
414.1380(b)(1)(vi)(C)(4), accordingly (83 FR 35955). We proposed to 
compare the 2019 performance to an assumed 2018 quality performance 
category achievement percent score of 30 percent.
    The following is a summary of the public comments on the proposal 
and our responses:
    Comment: One commenter supported the proposal.
    Response: We thank the commenter for its support.
    After consideration of public comments, we are finalizing the 
proposal to continue our previously established policy for the 2019 
MIPS performance period and amend Sec.  414.1380(b)(1)(vi)(C)(4), 
accordingly. Specifically, we will compare the 2019 performance to an 
assumed 2018 quality performance category achievement percent score of 
30 percent if a MIPS eligible clinician earned a quality performance 
category score less than or equal to 30 percent in the previous year.
(xiv) Calculating the Quality Performance Category Percent Score 
Including Achievement and Improvement Points
    In the CY 2017 and CY 2018 Quality Payment Program final rules (81 
FR 77300 and 82 FR 53747 through 53748, respectively), we finalized the 
policies on incorporating the improvement percent score into the 
quality performance category percent score. As part of our technical 
updates to Sec.  414.1380(b)(1) discussed in section III.I.3.i.(1)(b) 
of this final rule, our previously established policies are now 
referenced at Sec.  414.1380(b)(1)(vii).
(c) Scoring the Cost Performance Category
(i) Scoring Achievement in the Cost Performance Category
    For a description of the statutory basis and our existing policies 
for scoring achievement in the cost performance

[[Page 59856]]

category, we refer readers to the CY 2017 Quality Payment Program final 
rule (81 FR 77308 through 77311) and the CY 2018 Quality Payment 
Program final rule (82 FR 53748 through 53749). In the CY 2017 Quality 
Payment Program final rule (81 FR 77308 through 77309), we established 
that we will determine cost measure benchmarks based on cost measure 
performance during the performance period. We also established that at 
least 20 MIPS eligible clinicians or groups must meet the minimum case 
volume that we specify for a cost measure in order for a benchmark to 
be determined for the measure, and that if a benchmark is not 
determined for a cost measure, the measure will not be scored. We 
proposed to codify these final policies at Sec.  414.1380(b)(2)(i) (83 
FR 35955 through 35956).
    While we did not receive any public comments for this proposal, we 
are finalizing our proposal to codify these final policies at Sec.  
414.1380(b)(2)(i).
(ii) Scoring Improvement in the Cost Performance Category
    For a description of the statutory basis and our existing policies 
for scoring improvement in the cost performance category, we refer 
readers to the CY 2018 Quality Payment Program final rule (82 FR 53749 
through 53752). Section 51003(a)(1)(B) of the Bipartisan Budget Act of 
2018 modified section 1848(q)(5)(D) of the Act such that the cost 
performance category score shall not take into account the improvement 
of the MIPS eligible clinician for each of the second, third, fourth, 
and fifth years for which the MIPS applies to payments. We do not 
believe this change requires us to remove our existing methodology for 
scoring improvement in the cost performance category (see 82 FR 53749 
through 53752), but it does prohibit us from including an improvement 
component in the cost performance category percent score for each of 
the 2020 through 2023 MIPS payment years. Therefore, we proposed to 
revise Sec.  414.1380(b)(2)(iv)(E) to provide that the maximum cost 
improvement score for the 2020, 2021, 2022, and 2023 MIPS payment years 
is zero percentage points (83 FR 35955). Under our existing policy (82 
FR 53751 through 53752), the maximum cost improvement score for the 
2020 MIPS payment year is 1 percentage point, but due to the statutory 
changes and under our proposal, the maximum cost improvement score for 
the 2020 MIPS payment year would be zero percentage points. We also 
proposed at Sec.  414.1380(a)(1)(ii) to modify the performance 
standards to reflect that the cost performance category percent score 
will not take into account improvement until the 2024 MIPS payment year 
(83 FR 35956). The following is a summary of the public comments 
received on these proposals and our responses:
    Comment: A few commenters supported the proposals to set the 
maximum cost improvement score for the 2020, 2021, 2022, and 2023 MIPS 
payment years at zero percentage points.
    Response: We thank the commenter for their support.
    Comment: Several commenters requested that the cost performance 
category score be determined in a different manner because of the 
proposed inclusion of episode-based measures. A few commenters 
recommended that the new measures have a lower weight in determining 
the cost performance category score than the previously-established 
MSPB and total per capita cost measures. A few commenters recommend 
that similar to the quality performance category, only the 6 measures 
with the highest scores among those for which the clinician or group 
met the case minimum should be included in calculating the cost 
performance category score. Likewise, a few commenters recommended that 
similar to the quality performance category, scores for cost measures 
should not be below 3 out of 10 points. One commenter recommended that 
a cost performance category score not be calculated if a clinician or 
group only meets the case minimum for a single cost measure.
    Response: We do not believe that the inclusion of new measures in 
the cost performance category necessitates a change in the 
determination of the cost performance category score. Measures in the 
cost performance category differ from quality measures because they do 
not require reporting on the part of the clinicians outside of the 
usual claims submission process. Therefore, there is no choice of 
measures for clinicians nor burden of reporting. We believe that this 
is an important consideration in maintaining a simpler scoring 
mechanism in the cost performance category and scoring all measures for 
which an individual or group meets the case minimum. Some groups due to 
their size and comprehensiveness will meet the case minimum for all 
cost measures. Other individuals and groups will meet the case minimum 
for fewer measures. A scoring policy that would only score the top 6 
measures in the cost performance category would provide an advantage 
for those groups with more than 6 measures because it would disregard 
those measures on which performance was poorest. For example, a group 
that met the case minimum for 10 measures and scored in the lowest 
decile for the total per capita cost score and the highest decile for 
all other measures, would have the score for the total per capita 
measure dropped and would receive the highest possible score in the 
cost performance category. A group that met the case minimum for only 6 
measures, and also performed in the lowest decile for the total per 
capita cost score and the highest decile for the other 5 cost measures 
for which it met the case minimum, would not have performance on this 
measure disregarded and receive a lower score.
    We believe that not scoring clinicians and groups that meet the 
case minimum for only a single measure would fail to recognize that a 
single measure, such as total per capita cost, could reflect care 
provided to a large number of patients.
    After consideration of the public comments, we are finalizing as 
proposed our proposal to revise Sec.  414.1380(b)(2)(iv)(E) to provide 
that the maximum cost improvement score for the 2020, 2021, 2022, and 
2023 MIPS payment years is zero percentage points. We are also 
finalizing as proposed our proposal at Sec.  414.1380(a)(1)(ii) to 
modify the performance standards to reflect that the cost performance 
category percent score will not take into account improvement until the 
2024 MIPS payment year.
(d) Facility-Based Measures Scoring Option for the 2021 MIPS Payment 
Year for the Quality and Cost Performance Categories
(i) Background
    In the CY 2018 Quality Payment Program final rule, we established a 
facility-based measurement scoring option for clinicians that meet 
certain criteria beginning with the 2019 MIPS performance period/2021 
MIPS payment year (82 FR 53752 through 53767). We originally proposed a 
facility-based measurement scoring option for the 2018 MIPS performance 
period. We did not finalize the policy because we were concerned that 
we would not have the operational ability to inform clinicians early 
enough in the 2018 MIPS performance period to allow them to consider 
the consequences and benefits of participation (82 FR 53755).
(ii) Facility-Based Measurement Applicability
(A) General
    In the CY 2018 Quality Payment Program final rule, we limited 
facility-based reporting to the inpatient hospital in the first year 
for several reasons,

[[Page 59857]]

including because a more diverse group of clinicians (and specialty 
types) provide services in an inpatient setting than in other settings, 
and because the Hospital Value-Based Purchasing (VBP) Program adjusts 
payment to hospitals for inpatient services in connection with their 
performance under that program (82 FR 53753 through 53755). We also 
limited measures applicable for facility-based measurement to those 
used in the Hospital VBP Program because the Hospital VBP Program 
compares hospital performance on a series of different measures 
intended to capture the breadth of inpatient care in the facility (82 
FR 53753). We noted that we were open to the consideration of 
additional facility types in the future but recognized that adding a 
facility type would be dependent upon whether CMS has established a 
value-based purchasing program for that facility type, the 
applicability of measures, and our ability to appropriately attribute a 
clinician to a facility (82 FR 53754). Please note that when we use the 
term value-based purchasing, we are referring in general to value-based 
purchasing programs or scores, and not specifically the Hospital VBP 
Program, unless specifically stated.
    We did not propose to add additional facility types for facility-
based measurement, but we are interested in potentially expanding to 
other settings in future rulemaking. Therefore, in section 
III.I.3.i.(1)(d)(vii) of this final rule, we outline several issues on 
which we requested feedback and would need to be resolved in order to 
expand this option to a wider group of facility-based clinicians in 
future years.
(B) Facility-Based Measurement by Individual Clinicians
    In the CY 2018 Quality Payment Program final rule, we established 
individual eligibility criteria for facility-based measurement at Sec.  
414.1380(e)(2)(i). We established that a MIPS eligible clinician who 
furnishes 75 percent or more of his or her covered professional 
services in sites of service identified by the POS codes used in the 
HIPAA standard transaction as an inpatient hospital or emergency room 
based on claims for a period prior to the performance period as 
specified by CMS (82 FR 53756 through 53757) is eligible as an 
individual for facility-based measurement. We had noted, as a part of 
our proposal summary, that we would use the definition of professional 
services in section 1848(k)(3)(A) of the Act in applying this standard 
(82 FR 53756). For purposes of determining eligibility for facility-
based measurement, we discussed CMS using data from the period between 
September 1 of the calendar year, 2 years preceding the MIPS 
performance period, through August 31 of the calendar year preceding 
the MIPS performance period, with a 30-day claims run out but did not 
finalize that as part of the applicable regulation (82 FR 53756 through 
53757). Because we are using the quality measures associated with the 
inpatient hospital to determine the MIPS quality and cost performance 
category score, we wanted to ensure that eligible clinicians 
contributed to care in that setting during that time period.
    We indicated that CMS will use POS code 21 (inpatient) and POS code 
23 (emergency department) for this purpose (82 FR 53756). Commenters on 
our proposal (as summarized in the CY 2018 Quality Payment Program 
final rule (82 FR 53756 through 53757)) expressed concern that adopting 
the definition that we did for facility-based clinicians would limit 
the number of clinicians who would be eligible.
    In the CY 2019 PFS proposed rule, we proposed to modify our 
determination of a facility-based individual at Sec.  414.1380(e)(2)(i) 
in four ways (83 FR 35957). First, we proposed to add on-campus 
outpatient hospital (as identified in the POS code in the HIPAA 
standard transaction, that is, POS code 22) to the settings that 
determine whether a clinician is facility-based. Second, we proposed 
that a clinician must have at least a single service billed with the 
POS code used for the inpatient hospital or emergency room. Third, we 
proposed that, if we are unable to identify a facility with a value-
based purchasing score to attribute as a clinician's performance, that 
clinician is not eligible for facility-based measurement. Fourth, we 
proposed to align the time period for determining eligibility for 
facility-based measurement with changes to the dates used to determine 
MIPS eligibility and special status detailed in section III.I.3.b. of 
this final rule. We explain these four proposals from the proposed rule 
in this section. In the CY 2019 PFS proposed rule, we stated our belief 
that these proposals will further expand the opportunity for facility-
based measurement and eliminate issues associated with the provision of 
observation services while still restricting eligibility to those who 
work in an inpatient setting.
    First, we proposed to add the on-campus outpatient hospital (POS 
code 22) to the list of sites of service used to determine eligibility 
for facility-based measurement (83 FR 35957). We agree with commenters 
that limiting the eligibility to our current definition may prevent 
some clinicians who are largely hospital-based from being eligible. 
However, expanding eligibility without taking into account the 
relationship between the clinician and the facility and facility's 
performance could result in unfairly attributing to a clinician 
performance for which the clinician is not responsible or has little to 
no role in improving. We do believe that a significant provision of 
services in the on-campus outpatient hospital are reflected in the 
quality captured by the Hospital VBP Program. For example, patients in 
observation status are typically treated by the same staff and 
clinicians as those who meet the requirements for inpatient status. 
Although there are some clinical differences that may result in a 
patient having observation status, we believe that the quality of care 
provided to these patients in this same setting would be comparable, 
reflecting the overall healthcare system at that particular location. 
In the CY 2019 PFS proposed rule, we stated our conviction, based on 
this that a sufficient nexus exists for attributing the hospital's VBP 
Total Performance Score to clinicians that provide services in on-
campus outpatient hospital settings.
    Second, we proposed to require that clinicians bill at least a 
single service with the POS codes for inpatient hospital or the 
emergency room in order to be eligible for facility-based measurement 
(83 FR 35957). Although we generally believe that clinicians who 
provide services in the outpatient hospital can affect the quality of 
care for inpatients, we noted in the CY 2019 PFS proposed rule our 
belief that a clinician who is measured according to the performance of 
a hospital should at least have a minimal presence in the inpatient or 
emergency room setting. We explained our concern about attributing 
inpatient facility performance to clinicians who provide at least 75 
percent of their services at on-campus outpatient hospitals (with POS 
code 22) when such clinicians exclusively provide outpatient services 
that are unrelated to inpatient hospital service by describing an 
example: A dermatologist who provides office-based services in a 
hospital-owned clinic but who never admits or treats patients within 
the inpatient or emergency room setting does not meaningfully 
contribute to the quality of care for patients measured under the 
Hospital VBP Program.
    We stated in the CY 2019 PFS proposed rule how we had considered 
different ways to best identify those who contribute to the quality of 
care in the inpatient setting while keeping the

[[Page 59858]]

facility-based scoring option as simple as possible. We provided one 
explanation of an alternative we had considered: Separately measuring 
the HCPCS codes for observation services; however, as also noted in the 
proposed rule, we believe that such a measurement may not fairly 
consider services provided by clinicians for whom observations services 
may be embedded in a global code for a procedure rather than billed as 
a separate observation service. We also considered requiring a 
clinician to provide a certain percentage of services with the 
inpatient hospital POS. We described how we had not identified a 
threshold (other the one claim threshold we proposed) that would more 
meaningfully differentiate clinicians who provide services with the 
outpatient hospital POS code versus those who do not contribute to the 
services that would be measured under the Hospital VBP Program. We 
identified our goal of ensuring that the program rules are clear and 
easily applied to clinicians, so as to both avoid confusion on program 
participation requirements and to meet overall agency goals to increase 
transparency in the agency's activities. Our proposal of using a single 
service as the threshold would provide a simple, bright-line to 
differentiate those who never provide inpatient services from 
clinicians that do provide inpatient services as well as outpatient 
services. We explained in the proposed rule that this would limit the 
chance of clinicians who exclusively practice in the outpatient setting 
being measured on the Hospital VBP Program's performance of an 
unrelated hospital. We recognized this requirement of one service with 
the inpatient or emergency department POS may not demonstrate a 
significant presence in a particular facility and solicited comment on 
whether a better threshold could be used to identify those who are 
contributing to the quality of care for patients in the inpatient 
setting without creating unnecessary or inappropriate barriers to 
eligibility for facility-based measurement.
    We explained in the proposed rule our rationale and reasoning for 
these first two proposals as being based in large part on our analysis 
of the previously finalized policy for eligibility for the facility-
based measurement scoring option. Using claims data, we had identified 
all clinicians that would be MIPS eligible as either an individual or 
group, and identified the POS codes submitted for PFS services provided 
by those clinicians. We then modeled the existing final policy based on 
inpatient and ER services. Although almost all ER physicians would be 
scored under facility-based measurement, a relatively small percentage 
of clinicians in other specialties, even those which we expected to 
have significant presence in the hospital, would be eligible for the 
facility-based measurement scoring option. For example, only 13.45 
percent of anesthesiologists would be eligible for the facility-based 
measurement scoring option under the policy finalized in the CY 2018 
Quality Payment Program final rule. Adding the on-campus outpatient 
hospital POS code substantially increased eligibility for the facility-
based measurement scoring option in our modeling, even after we 
adjusted for requiring one service with the inpatient or emergency 
department POS. Under our proposal, our model illustrated that 72.55 
percent of anesthesiologists would be eligible. However, the model did 
not show that the proposal would substantially increase the number of 
clinicians eligible for the facility-based measurement scoring option 
who, based on specialty identification, may not have a significant 
presence in the hospital. For example, the modeling of the proposed 
policy projected an increase in the percentage of family physicians 
eligible for the facility-based measurement scoring option from 11.34 
percent to 13.86 percent, which is still a very small percentage of 
those clinicians.
    Third, we proposed to add a new criterion (to be codified at Sec.  
414.1380(e)(2)(i)(C)) that stated to be eligible for facility-based 
measurement, we must be able to attribute a clinician to a particular 
facility that has a value-based purchasing score (83 FR 35957 through 
35958). We explained in the proposed rule how, for facility-based 
measurement to be applicable, we must be able to attribute a clinician 
to a facility with a value-based purchasing score. Based on our 
definition of facility-based measurement, we stated that this means a 
clinician must be associated with a hospital with a Hospital VBP 
Program Total Performance Score. We explained our concern that the 
proposed expansion of eligibility for facility-based measurement would 
increase the number of clinicians eligible for facility-based 
measurement but to whom we would be unable to attribute the performance 
of a particular facility that has a value-based purchasing score. As we 
noted in the CY 2018 Quality Payment Program final rule (82 FR 53766), 
some hospitals do not have a Hospital VBP Program Total Performance 
Score that could be used to determine a MIPS quality and cost 
performance category score, such as hospitals in the state of Maryland. 
Hence, clinicians associated with those hospitals would not be able to 
use facility-based measurement but could report quality measures 
through another method and have cost measures calculated if applicable. 
We explained that, under our proposal, a similar result, although 
relatively rare, would happen if we could not attribute a clinician 
identified as facility-based to a specific facility; those clinicians 
who are identified as facility-based but whom we cannot attribute to a 
hospital would have to participate in MIPS quality reporting through 
another method, or they would receive a score of zero in the quality 
performance category. Therefore, we proposed to add the requirement to 
Sec.  414.1380(e)(2)(i)(C) that a clinician must be able to be 
attributed to a particular facility with a value-based purchasing score 
under the methodology specified in Sec.  414.1380(e)(5) to be eligible 
for facility-based measurement. The cross-reference to paragraph (e)(5) 
is to the methodology we also proposed for determining the applicable 
facility score to be used. Our proposed new regulatory text at Sec.  
414.1380(e)(2)(i)(C) addresses both attribution to a facility and the 
need for that facility to have a value-based purchasing score by 
conditioning eligibility for facility-based scoring for an individual 
clinician on the clinician being attributed under the methodology in 
paragraph (e)(5) to a facility with a value-based purchasing score.
    Fourth, we proposed to change the dates of determining eligibility 
for facility-based measurement (83 FR 35958). In section III.M.3.b. of 
the proposed rule, we proposed to modify the dates of the MIPS 
determination period that would provide eligibility determination for 
small practice size, non-patient facing, low-volume threshold, ASC, 
hospital-based, and facility-based determination periods. To align this 
regulation controlling facility-based scoring with these other 
determination periods, we proposed that CMS would use data from the 
initial 12-month segment beginning on October 1 of the calendar year 2 
years prior to the applicable performance period and ending on 
September 30 of the calendar year preceding the applicable performance 
period, with a 30-day claims run out, in determining eligibility for 
facility-based measurement.

[[Page 59859]]

    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Many commenters supported the four proposed changes to the 
determination of a facility-based individual.
    Response: We appreciate the commenters' support.
    Comment: One commenter recommended that CMS include the place of 
service code used for the off-campus outpatient hospital (POS code 19) 
in determining individual eligibility for facility-based measurement, 
noting that many clinicians work in both on-campus and off-campus 
outpatient hospital settings. The commenter further suggested the 
inclusion of the measures from the Hospital Outpatient Quality 
Reporting Program.
    Response: While we are finalizing our proposal to add on the on-
campus outpatient code (POS code 22), we disagree that the off-campus 
outpatient hospital setting (POS code 19) indicates that a clinician 
has a significant impact on the quality and cost within an inpatient 
hospital setting in the way that POS code 22 might. A clinician may 
work at an off-campus outpatient hospital setting that is miles from 
the hospital and not have any involvement with patients that are 
hospitalized. We do not believe the Hospital VBP Program measures, 
which reflect the quality of care furnished to patients in hospitals in 
inpatient settings, are applicable to (or relate to the performance of) 
those clinicians who primarily bill within the off-campus outpatient 
hospital setting; therefore, we do not believe such clinicians should 
be eligible for facility-based measurement.
    While the measures used in the Hospital Outpatient Quality 
Reporting Program do reflect quality for the off-campus outpatient 
hospital, section 1848(q)(2)(C)(ii) of the Act provides that we may not 
use measures for hospital outpatient departments, except in the case of 
items and services furnished by emergency physicians, radiologists, and 
anesthesiologists. Our determination of facility-based measurement does 
not consider the specialty of clinicians, so we therefore do not 
believe it is appropriate or consistent with the statutory authority to 
add this setting or these measures at this time.
    Comment: One commenter recommended that the threshold of services 
required to be provided in facilities to be eligible for facility-based 
measurement be reduced from 75 percent to more than 50 percent of 
services, because clinicians often work in multiple settings.
    Response: As we stated in the CY 2018 Quality Payment Program final 
rule (82 FR 53757), we believe the 75 percent threshold is appropriate 
to use because it is similar to our determination of hospital-based 
eligible clinicians in the Promoting Interoperability performance 
category. In the context of our proposal to change the eligibility 
criteria for facility-based measurement, we still believe that a 75 
percent threshold indicates that a clinician is spending much of their 
clinical time working in a hospital and the quality of their work is 
reflected in that setting. Clinicians who work in more varied settings 
may be better measured through another method of participating in MIPS.
    Comment: One commenter recommended that CMS not include the 
requirement to bill at least a single service with the POS code used 
for the inpatient hospital or emergency room as this requirement could 
easily be gamed.
    Response: We continue to believe that that using a single service 
as the threshold provides a simple, bright line to differentiate those 
who never provide inpatient services from clinicians that do provide 
inpatient services, as well as outpatient services. We will monitor 
this requirement and may consider changing it in future rulemaking if 
we find evidence or examples of gaming, such as that clinicians are 
providing services in the inpatient setting primarily so they may meet 
the requirements of facility-based measurement.
    Comment: Several commenters supported the facility-based 
measurement and the proposed policies because this option would reduce 
burden and recognize the joint accountability for measures in the 
hospital environment.
    Response: We appreciate the commenters' support as we begin to 
implement facility-based measurement in the 2019 MIPS performance 
period/2021 MIPS payment year.
    Comment: Several commenters requested that CMS provide more data 
analysis on the implementation of facility-based measurement. A few 
commenters noted concerns with how the facility-based scoring option 
could contribute to an uneven playing field. Commenters' concerns 
highlighted that automatically applying a quality and cost score 
eliminates incentives to coordinate care which may place these 
clinicians at an unfair advantage over those who must report on 
measures and take steps to perform well on those measures. Hence, 
commenters encouraged CMS to closely monitor the impact of the 
facility-based scoring option policy. One commenter suggested that CMS 
provide more data on how MIPS eligible clinicians might score in the 
facility-based scoring option. Another commenter suggested that CMS 
provide data on the percentage of certain specialists who would be 
eligible. A few commenters suggested that CMS should closely monitor 
how facility-based measurement impacts total MIPS scores between 
specialties and groups working within the same hospital, as well as the 
effect of facility-based measurement on those who are not eligible. One 
commenter suggested that CMS provide more information via educational 
resources; another commenter requested that CMS explain how the 
Hospital VBP Program Total Performance Score is converted into MIPS 
scoring and requirements for group reporting options.
    Response: We recognize the value of data analysis when developing 
additional scoring options for MIPS eligible clinicians. We continue to 
believe that the facility-based scoring option will reduce 
administrative burden by streamlining reporting and allowing clinicians 
to focus on quality improvement. We disagree that clinicians have an 
advantage under facility-based scoring option given that we have 
established an eligibility threshold to identify those clinicians that 
have a significant impact on the care delivered within the facility and 
the facility's performance under the Hospital VBP Program. The scoring 
methodology developed for facility-based measurement translates scores 
in the Hospital VBP Program to scores in the Quality and Cost 
performance category. Because that translation takes into account the 
distribution of scores in the Hospital VBP program, which is analogous 
to the distribution of scores in MIPS, clinicians who are scored using 
facility-based measurement will have a similar range of scores as those 
who are not eligible for facility-based measurement. We will continue 
to monitor the impact of the finalized facility-based scoring policies 
in efforts to avoid unfair advantages within the MIPS program.
    Comment: Several commenters expressed concern about the 
availability of facility-based measurement beginning in the 2019 MIPS 
performance period/2021 MIPS payment year. The commenters expressed 
concern that the measures included in the Hospital VBP Program were not 
representative of the care provided by clinicians and would distract 
from efforts to focus on measures on which these clinicians could have 
an effect. A few commenters

[[Page 59860]]

supported facility-based measurement as a short-term solution to 
reducing administrative burden for clinicians who primarily work within 
an inpatient setting but encouraged movement towards measures that are 
more meaningful for certain specialists who also predominantly work 
within an inpatient setting.
    Response: We recognize that the Hospital VBP Program was not 
designed to measure clinicians' performance but rather hospitals' 
performance. However, we believe that by using the established 75 
percent threshold to identify clinicians as eligible for facility-based 
scoring, we are distinguishing between those clinicians who ultimately 
have a significant impact on the hospital's performance score for the 
care and cost rendered within that facility versus those who do not. We 
therefore believe that the Hospital VBP Program measures do reflect the 
performance of the clinicians in a team-based environment. We note that 
there may be more opportunities for clinicians, particularly 
specialists who wish to report on more clinically meaningful measures, 
to participate in MIPS using qualified registries or QCDRs that may be 
related to care provided to those specific patients in a facility 
setting, and we encourage clinicians who find the MIPS measures more 
meaningful in the context of their patient population to report in that 
manner.
    After consideration of the public comments, we are finalizing our 
proposals to add the on-campus outpatient hospital (POS code 22) to the 
list of sites of service used to determine eligibility for facility-
based measurement and to require that clinicians bill at least a single 
service with the POS codes for inpatient hospital or the emergency room 
in order to be eligible for facility-based measurement as reflected in 
the regulation text at Sec.  414.1380(e)(2)(i)(A) and (B). We are also 
finalizing our proposal that we must be able to attribute a clinician 
to a particular facility that has a value-based purchasing score under 
the methodology specified in Sec.  414.1380(e)(5) to meet eligibility 
for facility-based measurement as codified at Sec.  
414.1380(e)(2)(i)(C). We are also finalizing our proposed policy that 
CMS would use data from the initial 12-month segment beginning on 
October 1 of the calendar year 2 years prior to the applicable 
performance period and ending on September 30 of the calendar year 
preceding the applicable performance period, with a 30-day claims run 
out to determine eligibility for facility-based measurement.
(C) Facility-Based Measurement by Group
    In the CY 2018 Quality Payment Program final rule (82 FR 53757), we 
finalized at Sec.  414.1380(e)(2)(ii) that a MIPS eligible clinician is 
eligible for facility-based measurement under MIPS if they are 
determined to be facility-based as part of a group. We established at 
Sec.  414.1380(e)(2)(ii) that a facility-based group is a group in 
which 75 percent or more of its eligible clinician NPIs billing under 
the group's TIN meet the requirements at Sec.  414.1380(e)(2)(i) (82 FR 
53758). We did not propose any changes to the determination of a 
facility-based group but acknowledged that our proposal to change how 
individual clinicians are determined to be eligible for facility-based 
measurement will necessarily have a practical impact for practice 
groups. For more of the statutory background and descriptions of our 
current policies on determining a facility-based group, we refer 
readers to the CY 2018 Quality Payment Program final rule (82 FR 53757 
through 53758).
(iii) Facility Attribution for Facility-Based Measurement
    In the CY 2018 Quality Payment Program final rule (82 FR 53759), we 
finalized at Sec.  414.1380(e)(5) a method to identify the hospital 
whose scores would be associated with a MIPS eligible clinician or 
group for purposes of facility-based measurement scoring. However, 
because of a discrepancy in the preamble and the proposed regulation 
text in the CY 2018 Quality Payment Program proposed rule (82 FR 
53759), we indicated we would address this issue as part of the next 
Quality Payment Program rulemaking cycle. Under the current regulation 
text Sec.  414.1380(e)(5), a facility-based clinician or group receives 
a score under the facility-based measurement scoring standard derived 
from the value-based purchasing score for the facility at which the 
clinician or group provided services to the most Medicare beneficiaries 
during the year claims are drawn (that is, the 12-month period 
described in paragraph (e)(2)). Although we did not propose any 
changes, we are revising this section to replace the word ``segment'' 
with ``period'' for clarity purposes.
    If an equal number of Medicare beneficiaries are treated at more 
than one facility, then we will use the value-based purchasing score 
for the highest-scoring facility (82 FR 53759 through 53760). For more 
of the statutory background and descriptions of our current policies 
for attributing a facility to a MIPS eligible clinician, we refer 
readers to the CY 2018 Quality Payment Program final rule (82 FR 53759 
through 53760).
    In considering the issue of facility attribution for a facility-
based group, we stated in the CY 2019 PFS proposed rule that we believe 
that a change to facility-based attribution is appropriate to better 
align the policy with the determination of a facility-based group at 
Sec.  414.1380(e)(2)(ii). A facility-based group is one in which 75 
percent or more of the eligible clinician NPIs billing under the 
group's TIN are eligible for facility-based measurement as individuals. 
Additionally, under the current regulation, the value-based purchasing 
score for the highest scoring facility would be used in the case of a 
tie among the number of facilities at which the group provided services 
to Medicare beneficiaries. We proposed to revise Sec.  414.1380(e)(5) 
to differentiate how a facility-based clinician or group receives a 
score based on whether they participate as a clinician or a group (83 
FR 35958).
    We proposed to remove ``or group'' from Sec.  414.1380(e)(5) and 
redesignate that paragraph as (e)(5)(i) so that it only applies to 
individual MIPS eligible clinicians (83 FR 35958). Under our proposal, 
newly redesignated paragraph (e)(5)(i) would retain the rule for 
facility attribution for an individual MIPS eligible clinician as 
finalized in the CY 2018 Quality Payment Program final rule; we also 
proposed a few minor edits to the paragraph for grammar and to improve 
the sentence flow. We also proposed to add a new paragraph (e)(5)(ii) 
to provide that a facility-based group receives a score under the 
facility-based measurement scoring standard derived from the value-
based purchasing score for the facility at which the plurality of 
clinicians identified as facility-based would have had their score 
determined under the methodology described in Sec.  414.1380(e)(5)(i) 
if the clinicians had been scored under facility-based measurement as 
individuals (83 FR 35958). We made this proposal because of our wish to 
emphasize the connection between an individual clinician and a 
facility. We explained in the CY 2019 PFS proposed rule that using the 
plurality of clinicians reinforces the connection between an individual 
clinician and facility and is more easily understandable for larger 
groups.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: A few commenters suggested that CMS consider additional 
rules or standards for attribution of a

[[Page 59861]]

clinician or group to a facility for purposes of using that facility's 
Total Performance Score. One commenter requested that CMS consider 
using an eligible clinician's/group's second most utilized facility in 
cases where the top utilized facility does not have a Hospital VBP 
Program Total Performance Score. Another commenter encouraged CMS 
develop a group level attribution methodology to account for groups 
that practice in multiple sites and the commenter believed that an 
accountability model will be more meaningful and actionable for these 
groups.
    Response: We are finalizing our proposal that if we are unable to 
identify a particular facility with a value-based purchasing score 
under the methodology specified in Sec.  414.1380(e)(5), such as those 
facilities in the state of Maryland, to attribute for use as an 
individual clinician's performance, then that clinician is not eligible 
for facility-based measurement. We are concerned that using a hospital 
other than the most utilized could result in assigning a score based on 
a hospital at which the clinician rarely works. For example, in the 
case of using the second most utilized facility, an individual 
clinician may have primarily worked in the facility without a Hospital 
VBP Program Total Performance Score and then only have seen a single 
patient at the second most utilized hospital with a Hospital VBP Total 
Performance Score. However, we will consider looking into this issue in 
future rulemaking, including whether it may be appropriate to allow for 
the score to be based upon a facility other than the one at which a 
clinician provides services to the most patients.
    We understand that some groups that may be facility-based include 
clinicians that practice in a number of different facilities. However, 
we believe this issue is similar to that experienced in other clinician 
groups that may have a diversity of clinicians and settings. In section 
III.I.3.e of the proposed rule (83 FR 35891), we requested comments on 
developing an opportunity for clinicians to participate in MIPS as 
subgroups. We believe that our consideration of that issue could inform 
the determination of members of a group that practice in a single TIN 
but who serve patients in many different facilities.
    After consideration of the public comments, we are finalizing our 
proposals to remove ``or group'' from Sec.  414.1380(e)(5); redesignate 
that paragraph as (e)(5)(i) so that it only applies to individual MIPS 
eligible clinicians; and add a new paragraph (e)(5)(ii) to Sec.  
414.1380(e)(5) regarding group scoring methodologies in which a 
facility-based group receives a score under the facility-based 
measurement scoring standard derived from the value-based purchasing 
score for the facility at which the plurality of clinicians identified 
as facility-based would have had their score determined under the 
methodology described in Sec.  414.1380(e)(5)(i) if the clinicians had 
been scored under facility-based measurement as individuals.
(iv) No Election of Facility-Based Measurement
    In the CY 2018 Quality Payment Program final rule (82 FR 53760), we 
did not finalize our proposal for how individual MIPS eligible 
clinicians or groups who wish to have their quality and cost 
performance category scores determined based on a facility's 
performance would elect to do so through an attestation. We did 
finalize, and reflect in the introductory text at Sec.  414.1380(e), 
that an individual clinician or group would elect to use a facility-
based score. In the CY 2019 PFS proposed rule (82 FR 53760), we 
specified that such clinicians or groups would be required to submit 
their election during the data submission period through the 
attestation submission mechanism established for the improvement 
activities and the Promoting Interoperability performance categories. 
An alternative approach, which likewise was not finalized, did not 
require an election process, but instead would have automatically 
applied a facility-based measurement to MIPS eligible clinicians and 
groups who met the eligibility criteria for facility-based measurement, 
if such an application were technically feasible (82 FR 53760). We 
noted in the CY 2018 Quality Payment Program final rule (82 FR 53760) 
that we would examine both the attestation process and the opt-out 
process, and work with stakeholders to identify a new proposal in 
future rulemaking. We explained in the CY2018 Quality Payment Program 
final rule (82 FR 53760) our interest in a process that would impose 
less burden on clinicians than an attestation requirement and requested 
comment on automatically assigning a clinician or group a facility-
based score, but with a notice and opportunity to opt-out of facility-
based measurement. We summarized those comments in the CY 2019 PFS 
proposed rule (83 FR 35958).
    After further considering the advantages and disadvantages of an 
opt-in or an opt-out process, we proposed a modified policy that would 
not require an election process. We proposed to automatically apply 
facility-based measurement to MIPS eligible clinicians and groups who 
are eligible for facility-based measurement and who would benefit by 
having a higher combined quality and cost performance category score 
(83 FR 35959). Under our proposal, if the MIPS eligible clinician or 
group is eligible for facility-based measurement, we would calculate a 
combined quality and cost performance category score. We proposed to 
use the facility-based score to determine the MIPS quality and cost 
performance category scores, unless we received another submission of 
quality data for or on behalf of that clinician or group and the 
combined quality and cost performance category score for the other 
submission results in a higher combined quality and cost performance 
score. If the other submission has a higher combined quality and cost 
performance score, then we would not apply the facility-based 
performance scores for either the quality or cost performance 
categories (83 FR 35959). Under our proposal, the combined score for 
the quality and cost performance categories would determine the scores 
to be used for both the quality and cost performance categories, for 
both individual clinicians and for groups that meet the requirements of 
paragraph (e)(2). We did not propose to adopt a formal opt-out process 
because, under our proposal, the higher of the combined quality and 
cost performance scores for the clinician or clinician group would be 
used, which would only benefit the clinician or group. We explained in 
the proposed rule our strong commitment to reducing burden as part of 
the Quality Payment Program and that we believe that requiring a 
clinician or group to elect a measurement process (or to opt-out of a 
measurement process) based on facility performance would add 
unnecessary burden.
    In MIPS, we score clinicians as individuals unless they submit data 
as a group. We stated in the proposed rule that the same policy should 
apply to facility-based measurement, even though there are no 
submission requirements for the quality performance category for 
individuals under facility-based measurement. We proposed to revise 
Sec.  414.1380(e)(4) to state that there are no submission requirements 
for individual clinicians in facility-based measurement, but a group 
must submit data in the improvement activities or Promoting 
Interoperability performance categories in order to be measured as a 
group under facility-based measurement. We explained how, if a group 
does not

[[Page 59862]]

submit improvement activities or Promoting Interoperability measures, 
we would apply facility-based measurement to the individual clinicians 
and such clinicians would not be scored as a group under our proposal. 
In the case of virtual groups, MIPS eligible clinicians will have 
formed virtual groups prior to the MIPS performance period; as a 
result, virtual groups eligible for facility-based measurement will 
always be measured as a virtual group (83 FR 35959). Although we can 
calculate a score for a TIN without the submission of data by the TIN, 
we would not be certain if the clinicians in that group actually wanted 
to be measured as a group without an active submission (in other words, 
if the group did not submit data as a group). As we explained in the 
proposed rule, we view submission of data on the improvement activities 
or Promoting Interoperability measures as an indication by the 
clinicians in that group that they want to be scored as a group; using 
the choice to submit data as a group to identify a group in the context 
of facility-based scoring would preserve and respect choices made by 
clinicians and groups while avoiding the burden of an election process 
to be scored as a group solely for the purpose of facility-based 
scoring. We solicited comment specifically on this proposal and other 
means to achieve the same ends.
    In the CY 2018 Quality Payment Program final rule, we established 
that if a clinician or group elects facility-based measurement but also 
submits MIPS quality data, then the clinician or group would be 
measured on the method that results in the higher quality score (82 FR 
53767). We proposed to adopt this same scoring principle in conjunction 
with our proposal not to use (or require) an election process. 
Therefore, we proposed at Sec.  414.1380(e)(6)(vi) that the MIPS 
quality and cost score for clinicians and groups eligible for facility-
based measurement would be based on the facility-based measurement 
scoring methodology described in Sec.  414.1380(e)(6) unless the 
clinician or group receives a higher combined score for the MIPS 
quality and cost performance categories through data submitted to CMS 
for MIPS (83 FR 35959). We stated in the proposed rule that this policy 
is not applicable to any MIPS eligible clinicians scored under the APM 
scoring standard described at Sec.  414.1370; we further clarify here 
that this includes Shared Savings Program participant TINs in ACOs that 
have failed to complete web interface reporting, unless these measures 
are specifically required under the terms of the applicable APM.
    We also proposed conforming changes in two other sections of 
regulatory text. We proposed to revise the introductory text at Sec.  
414.1380(e) to remove ``elect to,'' and therefore, reflect that 
clinicians and groups who are determined to be facility-based will 
receive MIPS quality and cost performance categories under the 
methodology in paragraph (e) (83 FR 35959 through 35960). Because of 
our proposal to not require clinicians to opt-in into facility-based 
measurement, we acknowledged that there may be clinicians that will 
continue to submit data via other methods. We explained that these 
clinicians and groups are not prohibited from submitting quality 
measures to CMS for purposes of MIPS. However, under our proposal, if a 
higher combined quality and cost score is achieved using data submitted 
to CMS for purposes of MIPS, then we will use the MIPS scores based on 
the submission. We also proposed to revise Sec.  414.1380(e)(4) and 
(e)(6)(v)(A) to reflect that facility-based measurement does not 
require election and to replace the phrase ``clinicians that elect 
facility-based measurement'' with ``clinicians and groups scored under 
facility-based measurement'' (83 FR 35960) as part of this policy.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Many commenters supported our proposal to automatically 
apply facility-based measurement to MIPS eligible clinicians and groups 
who are eligible for facility-based measurement and who would benefit 
by having a higher combined quality and cost performance category 
score.
    Response: We thank the commenters for their support.
    Comment: A few commenters opposed our proposal to require a group 
to submit information in the improvement activities or Promoting 
Interoperability performance categories to be measured as a facility-
based group. A few of these commenters requested that rather than 
requiring the submission of information in these categories, CMS offer 
an election process. One commenter questioned how a group that was 
excluded from both the improvement activities and Promoting 
Interoperability performance categories could participate as a 
facility-based group. One commenter suggested that it would be 
difficult to complete an improvement activity if members of the group 
practice at more than one facility.
    Response: We continue to believe that our proposal of a clinician 
receiving the higher of the quality and cost performance score 
available would only benefit the individual MIPS eligible clinician or 
group. If we do not require groups to submit data in the improvement 
activity or Promoting Interoperability performance categories, then we 
will be unable to tell whether the clinician should be measured as part 
of a group. We will consider whether there would be an opportunity for 
a facility-based group to elect to participate without submitting data 
on another performance category in the future as feasible. We do not 
believe that we would need to establish additional policies for groups 
that would have their improvement activities performance score re-
weighted specifically because we generally expect reweighting to occur 
for the improvement activities performance category only in rare cases 
of extreme and uncontrollable events. We do note that the clinicians in 
a facility-based group who meet the requirements for facility-based 
measurement as individuals will have scores in the quality and cost 
performance categories determined for them as individuals if there is 
no data submission from the group in the improvement activity or 
Promoting Interoperability performance categories.
    Comment: Commenters encouraged CMS to provide as much information 
as possible to eligible clinicians including information on eligibility 
for facility-based measurement, clinician type, potential performance 
score under facility-based scoring, and to which facility the eligible 
clinician will be attributed. Several commenters noted that more 
information would give clinicians the opportunity to assess the 
advantages and disadvantages of various reporting options under MIPS. 
One commenter stated that more information will avoid confusion as to 
how the facility-based scoring option will work during the performance 
period. A few commenters noted concerns with the timing of receiving 
information about facility-based measurement. Some commenters noted the 
risk of a clinician assuming that he or she will meet the criteria for 
facility-based measurement when that may not be the case. Another 
commenter noted that the timing is important in making decisions as to 
whether to report as a group or an individual under the facility-based 
scoring option.
    Response: We intend to provide as much information as possible as 
early as possible to clinicians about their eligibility and the 
hospital performance upon which a MIPS eligible clinician's score would 
be based. We acknowledge

[[Page 59863]]

that clinicians may want to consider this information to make financial 
and operational decisions, regardless of not having to be required to 
opt-in to facility-based scoring. We intend to provide additional 
information to clinicians regarding their status with facility-based 
measurement eligibility, facility attribution, and a preview score 
based on data from the previous performance period. We anticipate that 
this information will be released during the first quarter of the 
performance period, if technically feasible, beginning with the 2019 
performance period, and we aim to notify clinicians as soon as this 
information is available.
    Comment: Many commenters expressed concern with our proposal to not 
require an opt-in or offer an opt-out for facility-based measurement. A 
few commenters noted that performing this calculation automatically 
would reduce the control that clinicians have over their participation 
in MIPS. A few commenters suggested that automatically calculating a 
score for facility-based clinicians would reduce the incentive to 
participate in clinical data registries. A few commenters suggested 
that not requiring an opt-in would provide a performance advantage to 
facility-based clinicians over those who are not eligible for facility-
based measurement. One commenter expressed concern that clinicians 
could have measures displayed on Physician Compare from facility-based 
measurement.
    Response: Receiving the higher of the combined quality and cost 
performance scores available would only benefit the applicable 
individual MIPS eligible clinician or group; however, we are uncertain 
that facility-based clinicians would necessarily perform better than 
those who submit MIPS data, because the opportunity to submit data via 
other methods provides individual clinicians or groups the opportunity 
to select quality measures. We continue to believe that adding a formal 
opt-in or opt-out process would add unnecessary burden for both 
individual clinicians and groups. Additionally, we believe that those 
MIPS eligible clinicians who will not be required to submit MIPS data 
will benefit from a reduction in administrative burden while being 
measured in a facility in which their care has a significant impact on 
the facility's performance. We note that clinicians who wish to better 
control their performance in MIPS may submit measures through another 
method. Hence, we are finalizing our proposal to not require an opt-in 
or opt-out for facility-based measurement. Additionally, we did not 
propose any policies for how facility-based measures, other than the 
scores derived from those measures and included as quality and cost 
performance category scores, will be displayed on Physician Compare, 
but we thank commenters for their input and will take this input into 
consideration in future years.
    Comment: One commenter requested clarification on how CMS would 
score a facility-based clinician who submits data on the quality 
performance category but does not have a cost performance category 
score, and thus, the cost performance category weight would need to be 
redistributed to the quality performance category.
    Response: The cost performance category can be reweighted to 0 
percent if there are not sufficient cost measures applicable and 
available (for example, if the clinician does not meet the minimum case 
requirements for the cost measures). In cases in which a clinician or 
group does not have a score in the cost performance category, in 
general, the weight of the cost performance category would be 
redistributed to the quality performance category. In that case, the 
points assigned under Sec.  414.1380(b) for purposes of calculating/
assigning the MIPS final score in the cost and quality categories will 
be compared to the points that contribute to the final score from the 
quality and cost scores established under facility-based measurement. 
For example, a clinician whose data was submitted on their behalf by a 
third-party intermediary and received a MIPS quality performance 
category percent score of 50 percent but did not meet the case minimum 
for cost measures, would have a total of 30 points as the combined 
score for the quality and cost performance categories. If that same 
clinician were eligible for facility-based measurement, the score based 
on that third party intermediary submission would be used unless the 
combination of the quality and cost scores established under facility-
based measurement (as calculated under Sec.  414.1380(e)(6)) resulted 
in more than 30 points towards the final score.
    Comment: One commenter requested guidance and language as to how to 
account for MIPS eligible clinicians who wish to use their facility's 
Hospital VBP Program Total Performance Score for the quality and cost 
performance categories, yet still use a QCDR to report.
    Response: Our proposed policy to not require an opt-in or offer an 
opt-out for facility-based measurement anticipates that there may be 
some clinicians and groups who will both receive a score based upon 
facility-based measurement and submit quality measures via various 
collection types. These clinicians may believe these quality measures 
better represent their performance or that they will perform better 
submitting these measures. In all cases, under the policy we are 
finalizing here, we will compare combined performance in these two 
categories and assign the clinician or group the higher combined score, 
whether based on the facility-based measurement or through another 
submission type. We note that facility-based measurement only applies 
to the quality and cost performance categories; the Promoting 
Interoperability and improvement activity performance categories would 
still require reporting on the part of the clinicians or group.
    After consideration of the public comments, we are finalizing our 
proposal to automatically apply facility-based measurement to MIPS 
eligible clinicians and groups who are eligible for facility-based 
measurement and those who have a higher combined quality and cost 
performance category score. Additionally, we are finalizing our 
proposal to revise Sec.  414.1380(e)(4) to state that there are no 
submission requirements for individual clinicians in facility-based 
measurement and that a group must submit data in the improvement 
activities or Promoting Interoperability performance categories to be 
measured as a group under facility-based measurement. Additionally, we 
are also revising the proposed regulation text for Sec.  414.1380(e)(4) 
by adding ``to be'' between ``clinicians'' and ``scored'' to clarify 
that this paragraph is establishing the data submissions necessary for 
facility-based scoring to be possible as opposed to a provision 
governing MIPS reporting as a whole for all categories. We are also 
finalizing the conforming changes at Sec.  414.1380(e)(4) and (e)(6) to 
revise text that referred to an election by the clinician or group to 
use facility-based scoring. Additionally, while we did not propose any 
changes, we are revising Sec.  414.1380(e) to state, for the payment in 
2021 MIPS payment year and subsequent years and subject to paragraph 
(e)(6)(vi) of this section, a MIPS eligible clinician or group will be 
scored under the quality and cost performance categories under the 
methodology described in this paragraph (e). These technical changes 
are made to conform to our policy in this section to not require or 
offer an election and to improve readability.
(v) Facility-Based Measures
(A) Background
    Section 1848(q)(2)(C)(ii) of the Act provides that the Secretary 
may use

[[Page 59864]]

measures used for payment systems other than for physicians, such as 
measures for inpatient hospitals, for purposes of the quality and cost 
performance categories. However, the Secretary may not use measures for 
hospital outpatient departments, except in the case of items and 
services furnished by emergency physicians, radiologists, and 
anesthesiologists. In the CY 2018 Quality Payment Program proposed 
rule, we proposed to include for the 2020 MIPS payment year all the 
measures adopted for the FY 2019 Hospital VBP Program on the MIPS list 
of quality measures and cost measures for purposes of facility-based 
measurement (82 FR 30125). We noted how these measures meet the 
definition of additional system-based measures provided in section 
1848(q)(2)(C)(ii) of the Act (82 FR 30125). In the CY 2018 Quality 
Payment Program final rule, we did not finalize our proposal that the 
facility-based measures available for the 2018 MIPS performance period 
would be the measures adopted for the FY 2019 Hospital VBP Program; nor 
did we finalize our proposal that, for the 2020 MIPS payment year, 
facility-based individual MIPS eligible clinicians or groups that were 
attributed to a facility would be scored on all measures on which the 
facility is scored via the Hospital VBP Program's Total Performance 
Score methodology (82 FR 53762).
    We did finalize a facility-based measurement scoring standard but 
not the specific instance of using the FY 2019 Hospital VBP Program 
Total Performance Score methodology (82 FR 53755). We expressed our 
belief that using all measures from the Hospital VBP Program is 
appropriate; nevertheless, because we did not finalize the facility-
based measurement scoring option for the 2018 MIPS performance period/
2020 MIPS payment year, it was not appropriate to adopt these policies 
at that time (82 FR 53762 through 53763). We noted that we intended to 
propose measures that would be available for facility-based measurement 
for the 2019 MIPS performance period/2021 MIPS payment year in future 
rulemaking (82 FR 53763).
(B) Measures in Facility-Based Scoring
    As we noted in the proposed CY 2019 PFS rule, we continue to 
believe it is appropriate to adopt all the measures for the Hospital 
VBP Program into MIPS for purposes of facility-based scoring; these 
Hospital VBP Program measures meet the definition of additional system-
based measures provided in section 1848(q)(2)(C)(ii) of the Act. We 
also stated how it is appropriate to adopt the performance periods for 
the measures, which generally are consistent with the dates that we use 
to determine eligibility for facility-based measurement.
    Beginning with the 2019 MIPS performance period, we proposed at 
Sec.  414.1380(e)(1)(i) to adopt for facility-based measurement, the 
measure set that we finalize for the fiscal year Hospital VBP Program 
for which payment begins during the applicable MIPS performance period. 
For the 2019 MIPS performance period (which runs on the 2019 calendar 
year), we proposed to adopt the FY 2020 Hospital VBP Program measure 
set, for which payment begins on October 1, 2019. The performance 
period for these measures varies but performance ends in 2018 for all 
measures.
    We also proposed at Sec.  414.1380(e)(1)(ii) that, starting with 
the 2021 MIPS payment year, the scoring methodology applicable for MIPS 
eligible clinicians scored with facility-based measurement is the Total 
Performance Score methodology adopted for the Hospital VBP Program, for 
the fiscal year for which payment begins during the applicable MIPS 
performance period. Additionally, we note a typographical error in the 
CY 2019 PFS proposed rule (83 FR 35960) in which we state FY 2019 
instead of FY 2020, which we believe commenters have likely understood 
given the comments we have received on FY 2020 measures. However, we 
provide additional clarification in this final rule.
    We noted in the proposed rule that this approach of adopting all 
the measures in the Hospital VBP Program can be applied to other value-
based purchasing programs in the future, should we decide to expand 
facility-based measurement to settings other than hospitals.
    In the CY 2018 Quality Payment Program final rule we also 
established at Sec.  414.1380(e)(6)(i) that the available quality and 
cost measures for facility-based measurement are those adopted under 
the value-based purchasing program of the facility for the year 
specified. We established at Sec.  414.1380(e)(6)(ii) that we will use 
the benchmarks adopted under the value-based purchasing program of the 
facility program for the year specified (82 FR 53763 through 53764). We 
noted that we would determine the particular value-based purchasing 
program to be used for facility-based measurement in future rulemaking 
but would routinely use the benchmarks associated with that program (82 
FR 53764). Likewise, at Sec.  414.1380(e)(6)(iii), we established that 
the performance period for facility-based measurement is the 
performance period for the measures adopted under the value-based 
purchasing program of the facility program for the year specified (82 
FR 53755). We noted that these provisions referred to the general 
parameters of our method of facility-based measurement and that we 
would address specific programs and years in future rulemaking (82 FR 
53763). For the CY 2019 performance period, we proposed regulation text 
for these three provisions to specify that the measures, performance 
period, and benchmark period for facility-based measurement are the 
measures, performance period, and benchmark period established for the 
value-based purchasing program used to determine the score as described 
in Sec.  414.1380(e)(1) (83 FR 35960). We provided an example in the 
proposed rule to illustrate this policy: For the 2019 MIPS performance 
period and 2021 MIPS payment year, the measures used would be those for 
the FY 2019 Hospital VBP Program along with the associated benchmarks 
and performance periods. As explained earlier, we intended this to mean 
that for the 2019 MIPS performance period and 2021 MIPS payment year, 
the measures used would be those for the FY 2020 Hospital VBP Program 
along with the associated benchmarks and performance periods.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Several commenters noted their appreciation of the 
facility-based scoring option but requested that CMS consider 
additional measures that are more relevant to specific specialties as 
that would capture clinically meaningful information. One commenter 
suggested CMS develop episode-based risk adjusted measures even if they 
are not used in the Hospital VBP Program. Another commenter suggested 
that CMS consider additional avenues to collect more meaningful 
information.
    Response: Section 1848(q)(2)(C)(ii) of the Act provides that the 
Secretary may use measures used for payment systems other than for 
physicians, such as measures for inpatient hospitals, for purposes of 
the quality and cost performance categories. Based on this statutory 
requirement and because we want to align incentives between clinicians 
and hospitals, we proposed to use measures that are developed and 
implemented in other programs, as opposed to new measures that reflect 
a facility's performance. Due to this limitation, we note that there 
may be additional avenues for clinicians to participate in MIPS using 
qualified

[[Page 59865]]

registries or QCDRs that measure quality for services that may be 
provided in a facility setting, such as inpatient surgeries, without 
being measured in facility-based measurement.
    After consideration of the public comments, we are finalizing the 
proposed regulation text at Sec.  414.1380(e)(1)(i) that the measures 
for facility-based measurement will be the measure set finalized for 
the fiscal year value-based purchasing program for which payment begins 
during the applicable MIPS performance period. We are also finalizing 
the proposed regulation text at Sec.  414.1380(e)(1)(ii) that, 
beginning with the 2021 MIPS payment year, the scoring methodology 
applicable for MIPS eligible clinicians scored with facility-based 
measurement is the Total Performance Score methodology adopted for the 
Hospital VBP Program for the fiscal year for which payment begins 
during the applicable MIPS performance period. This means that for the 
2021 MIPS payment year, the Total Performance Score for FY 2020 will be 
applied for the MIPS performance year 2019. Additionally, while we did 
not propose any changes, we are revising the regulation text at Sec.  
414.1380(e)(1)(i) to stated that the measures used for facility-based 
measurement are the measure set finalized for the fiscal year VBP 
program for which payment begins during the applicable MIPS performance 
period. This update is not intended to be substantive in nature, but 
rather to bring more clarity to the regulatory text. We have also made 
a technical revision in which we revise Sec.  414.1380(e)(6)(ii), (iv), 
and (v) to reference only (e)(1) rather than (e)(1)(i) for improvements 
in readability and clarity of the regulation.
(C) Measures for MIPS 2019 Performance Period/2021 MIPS Payment Year
    For informational purposes, we provided a list of measures included 
in the FY 2020 Hospital VBP Program that would be used in determining 
the quality and cost performance category scores for the 2019 MIPS 
performance period/2021 MIPS payment year. The FY 2020 Hospital VBP 
Program has adopted 12 measures covering 4 domains (83 FR 20412 through 
20413). The performance period for measures in the Hospital VBP Program 
varies depending on the measure, and some measures include multi-year 
performance periods. We noted in the proposed rule that these measures 
are determined through separate rulemaking (83 FR 38244); the 
applicable rulemaking is usually the Hospital Inpatient Prospective 
Payment Systems for Acute Care Hospitals and the Long-Term Care 
Hospital Prospective Payment System rule. We are using these measures, 
benchmarks, and performance periods for the purposes of facility-based 
measurement based on Sec.  414.1380(e)(1) as finalized here. We repeat 
the list of measures finalized for the FY 2020 Hospital VBP measure set 
and Total Performance Score in Table 52.

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(vi) Scoring Facility-Based Measurement
(A) Scoring Achievement in Facility-Based Measurement
    In the CY 2018 Quality Payment Program final rule, we adopted 
certain scoring policies for clinicians and groups in facility-based 
measurement. We established at Sec.  414.1380(e)(6)(iv) and (v) that 
the quality and cost performance category percent scores would be 
established by determining the percentile performance of the facility 
in the value-based purchasing program for the specified year, then 
awarding scores associated with that same percentile performance in the 
MIPS quality and cost performance categories for those MIPS eligible 
clinicians who are not scored using facility-based measurement for the 
MIPS payment year (82 FR 53764). We also finalized at Sec.  
414.1380(e)(6)(v)(A) that clinicians scored under facility-based 
measurement would not be scored on other cost measures (82 FR 53767).
    For detailed descriptions of the current policies related to 
scoring achievement in facility-based measurement, we refer readers to 
the CY 2018 Quality Payment Program final rule (82 FR 53763). Because 
we proposed to not require or allow an opt-in process for facility-
based measurement, we proposed a change to the determination of the 
quality and cost performance category scores. We proposed that the 
quality and cost performance category percent scores would be 
established by determining the percentile performance of the facility 
in the Hospital VBP Program for the specified year, then awarding a 
score associated with that same percentile performance in the MIPS 
quality and cost performance categories for those MIPS eligible 
clinicians who are not eligible to be scored under facility-based 
measurement for the MIPS payment year (83 FR 35961). Under our 
proposal, the determination of percentile performance would be 
independent of those clinicians who would not have their quality or 
cost scores determined until we make the determination of their status 
under facility-based measurement.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: A few commenters supported our proposal that the quality 
and cost performance category percent scores for clinicians in 
facility-based measurement would be established by

[[Page 59867]]

determining the percentile performance of the facility in the Hospital 
VBP Program for the specified year, then awarding a score associated 
with that same percentile performance in the MIPS quality and cost 
performance categories for those MIPS eligible clinicians who are not 
eligible to be scored under facility-based measurement for the MIPS 
payment year.
    Response: We thank the commenters for their support.
    After consideration of the public comments, we are finalizing our 
proposal to change the determination of the quality and cost 
performance category scores at Sec.  414.1380(e)(6)(iv) and (v) to 
establish both scores by determining the percentile performance of the 
facility in value-based purchasing program for the specified year, then 
awarding a score associated with that same percentile performance in 
the MIPS quality and cost performance categories for those MIPS 
eligible clinicians who are not eligible to be scored under facility-
based measurement for the MIPS payment year. Also, we have revised the 
last sentence in paragraphs (e)(6)(iv) and (v) to more clearly state 
that a clinician or group receiving a facility-based performance score 
will not earn improvement points based on prior performance in the MIPS 
quality or cost categories.
(B) Scoring Improvement in Facility-Based Measurement
    In the CY 2018 Quality Payment Program final rule, we finalized 
that we would not give a clinician or group participating in facility-
based measurement the opportunity to earn improvement points based on 
prior performance in the MIPS quality and cost performance categories; 
we noted that the Hospital VBP Program already takes improvement into 
account in determining the Total Performance Score (82 FR 53764 through 
53765). We proposed to add this previously finalized policy to 
regulatory text at Sec.  414.1380(e)(6)(iv) and (v) (83 FR 35961).
    We did not address in the CY 2018 Quality Payment Program final 
rule a policy for a clinician or group who participates in facility-
based measurement for one performance period, and then does not 
participate in facility-based measurement in a subsequent performance 
period (for example, a clinician who is scored using facility-based 
measurement in the 2019 MIPS performance period and is not eligible for 
facility-based measurement in the 2020 MIPS performance period). After 
further considering the issue, we stated in the CY 2019 PFS proposed 
rule our position that it is not possible to assess improvement in the 
quality performance category for those who are measured under facility-
based measurement in 1 year and then through another method in the 
following year. Our method of assessing and rewarding improvement in 
the MIPS quality performance category separates points awarded for 
measure performance from those received for bonus points (82 FR 53745). 
Our method of determining the quality performance category score using 
facility-based measurement does not allow for the separation of 
achievement from bonus points. For this reason, we proposed at Sec.  
414.1380(b)(1)(vi)(A)(4) \30\ to not assess improvement for MIPS-
eligible clinicians who are scored in MIPS through facility-based 
measurement in 1 year but through another method in the following year 
(83 FR 39561).
---------------------------------------------------------------------------

    \30\ The codification was misidentified in the preamble of the 
proposed rule as Sec.  414.1380(b)(1)(xi)(A)(4) but the regulation 
text was proposed, at 83 FR 36081, to be codified at Sec.  
414.1380(b)(1)(vi)(A)(4), where we are finalizing it.
---------------------------------------------------------------------------

    We did not receive any public comments on this proposal, so we will 
finalize our proposal to add regulatory text at Sec.  
414.1380(e)(6)(iv) and (v) and our proposal at Sec.  
414.1380(b)(1)(vi)(A)(4) to not assess improvement for MIPS-eligible 
clinicians who are scored in MIPS through facility-based measurement in 
1 year but through another method in the following year.
(vii) Expansion of Facility-Based Measurement To Use in Other Settings
    We initiated the process of facility-based measurement focusing on 
the inpatient hospital setting, but have noted in the past our policy 
goal of expanding the concept into other facilities and programs and 
future, in particular to use the post-acute care (PAC) and the end-
stage renal disease (ESRD) settings as the basis for facility-based 
measurement and scoring. In the proposed rule, we summarized a number 
of issues and topics related to the use of PAC and ESRD facilities (83 
FR 35962 through 35963). We solicited comment on these topics, 
including:
     How to attribute the quality and cost of care for patients 
in PAC settings to clinicians;
     Whether using a value-based purchasing program, that is, a 
similar approach to Sec.  414.1380(e)(1), could work for PAC given the 
number and variation of PAC settings and clinicians;
     The level of influence MIPS-eligible clinicians have in 
determining performance on quality measures for individual settings and 
programs in the PAC setting;
     Which PAC QRP measures may be best utilized to measure 
clinician performance;
     Methods to identify the appropriate measures for scoring, 
and what measures would be most influenced by clinicians;
     Whether all measures that are reported as part of the PAC 
QRPs should be included or whether we should identify a subset of 
measures;
     Whether we should limit facility-based measurement to 
specific PAC settings and programs such as the IRF QRP or LTCH QRP, or 
whether we should consider all PAC settings in the facility-based 
measurement discussion;
     The extent to which the quality measures of dialysis 
centers reflect clinician performance; and
     Practical and policy considerations related to whether we 
could to attribute the performance of a specific ESRD facility to an 
individual clinician.
    We appreciate the comments received in response to these 
considerations and may consider these suggestions in policies that will 
be proposed as part of future rulemaking.
(e) Scoring the Improvement Activities Performance Category
    For our previously established policies regarding scoring the 
improvement activities performance category, we refer readers to Sec.  
414.1380(b)(3) and the CY 2018 Quality Payment Program final rule (82 
FR 53767 through 53769). We also refer readers to Sec.  414.1355 and 
the CY 2018 Quality Payment Program final rule (82 FR 53648 through 
53662) and CY 2017 Quality Payment Program final rule (81 FR 77177 
through 77199) for previously established policies regarding the 
improvement activities performance category generally.
(i) Regulatory Text Updates
    In the CY 2019 PFS proposed rule, we proposed updates to both 
Sec. Sec.  414.1380(b)(3) and 414.1355 to more clearly and concisely 
capture previously established policies (83 FR 35963). We also proposed 
one substantive change with respect to patient-centered medical homes 
and comparable specialty practices (83 FR 35963). These are discussed 
in more detail in this section.

[[Page 59868]]

(A) Improvement Activities Performance Category Score and Total 
Required Points
    In an effort to more clearly and concisely capture previously 
established policies, we proposed updates to Sec.  414.1380(b)(3) and 
refer readers to the CY 2019 PFS proposed rule for more details (83 FR 
35963). We also clarified that the improvement activities performance 
category score cannot exceed 100 percent (83 FR 35963).
    We solicited comments on the above proposal. We did not receive any 
comments on this proposal. We are finalizing our changes to regulation 
text at Sec.  414.1380(b)(3) as proposed.
(B) Weighting of Improvement Activities
    In an effort to more clearly and concisely capture previously 
established policies, we proposed updates to Sec.  414.1380(b)(3) and 
refer readers to the CY 2019 PFS proposed rule for more details (83 FR 
35963).
    We solicited comments on the above proposal. We did not receive any 
comments on this proposal. We are finalizing our changes to regulation 
text at Sec.  414.1380(b)(3) as proposed.
(C) APM Improvement Activities Performance Category Score
    In an effort to more clearly and concisely capture previously 
established policies, we proposed updates to Sec.  414.1380(b)(3)(i) 
and refer readers to the CY 2019 PFS proposed rule for more details (83 
FR 35963).
    We solicited comments on the above proposal. We did not receive any 
comments on this proposal. We are finalizing our changes to regulation 
text at Sec.  414.1380(b)(3)(i) as proposed.
(D) Patient-Centered Medical Homes and Comparable Specialty Practices
    In the CY 2019 PFS proposed rule (83 FR 35963), we proposed to 
modify our regulations at Sec.  414.1380(b)(3)(ii) to more clearly and 
concisely capture our previously established policies for patient-
centered medical homes and comparable specialty practices and refer 
readers to the CY 2019 PFS proposed rule for more details.
    In addition, it had come to our attention that in the preamble of 
the CY 2017 Quality Payment Program final rule (81 FR 77186 and 77179), 
the terminology ``automatic'' was used in reference to patient-centered 
medical home or comparable specialty practice improvement activities 
scoring credit. In that rule (81 FR 77186), in response to one comment, 
we stated, ``. . . any MIPS eligible clinician or group that does not 
qualify by October 1st of the performance year as a certified patient-
centered medical home or comparable specialty practice cannot receive 
automatic credit as such for the improvement activities performance 
category.'' In response to another comment in that rule (81 FR 77179), 
we stated, ``Other certifications that are not for patient-centered 
medical homes or comparable specialty practices would also not qualify 
automatically for the highest score.''
    While we used the term ``automatic'' then, we have since come to 
realize it is inaccurate because an eligible clinician or group must 
attest to their status as a patient-centered medical home or comparable 
specialty practice in order to receive full credit for the improvement 
activities performance category. In the CY 2018 Quality Payment Program 
final rule (82 FR 53649), in response to comments we received regarding 
patient-centered medical homes or comparable specialty practices 
receiving full credit for the improvement activities performance 
category for MIPS, we stated that we would like to make clear that 
credit is not automatically granted; MIPS eligible clinicians and 
groups must attest in order to receive the credit.
    Therefore, in the CY 2019 PFS proposed rule (83 FR 35963), we 
proposed codifying at Sec.  414.1380(b)(3)(ii) to require that an 
eligible clinician or group must attest to their status as a patient-
centered medical home or comparable specialty practice in order to 
receive this credit. Specifically, MIPS eligible clinicians who wish to 
claim this status for purposes of receiving full credit in the 
improvement activities performance category must attest to their status 
as a patient-centered medical home or comparable specialty practice for 
a continuous 90-day minimum during the performance period.
    We solicited comments on the above proposal. We received the 
following comment on this proposal.
    Comment: One commenter supported the proposal to modify current 
regulations to more clearly and concisely capture previously 
established policies for patient-centered Medical Homes and comparable 
specialty practices.
    Response: We thank the commenter for your support.
    After consideration of the comment we received, we are finalizing 
our changes to regulation text at Sec.  414.1380(b)(3)(ii) as proposed.
(E) Improvement Activities Performance Category Weighting for Final 
Scoring
    In the CY 2019 PFS proposed rule (83 FR 35963), in an effort to 
more clearly and concisely capture previously established policies, we 
proposed to make technical changes to Sec.  414.1355(b) to state that 
unless a different scoring weight is assigned by CMS under section 
1848(q)(5)(F) of the Act, performance in the improvement activities 
performance category comprises 15 percent of a MIPS eligible 
clinician's final score for the 2019 MIPS payment year and for each 
MIPS payment year thereafter). We stated that we believe these changes 
would better align the regulation text with the text of the statute.
    We solicited comments on the above proposal. We did not receive any 
comments on this proposal. We are finalizing our changes to regulation 
text at Sec.  414.1355(b) as proposed.
(ii) CEHRT Bonus
    In the CY 2017 Quality Payment Program final rule (81 FR 77202 
through 77209) and the CY 2018 Quality Payment Program final rule (82 
FR 53664 through 53670), we established that certain activities in the 
improvement activities performance category will qualify for a bonus 
under the Promoting Interoperability performance category if they are 
completed using CEHRT. This bonus is applied under the Promoting 
Interoperability performance category and not under the improvement 
activities performance category. In the CY 2019 PFS proposed rule (83 
FR 35932), we proposed a new approach for scoring the Promoting 
Interoperability performance category that is aligned with our MIPS 
program goals of flexibility and simplicity. We refer readers to 
section III.I.3.h.(5)(g) of this final rule for a summary of the 
comments we received regarding this proposal and our responses.
(f) Scoring the Promoting Interoperability Performance Category
    We refer readers to section III.I.3.h.(5) of this final rule, where 
we discuss our proposals for scoring the Promoting Interoperability 
performance category.
(2) Calculating the Final Score
    For a description of the statutory basis and our policies for 
calculating the final score for MIPS eligible clinicians, we refer 
readers to Sec.  414.1380(c), the discussion in the CY 2017 Quality 
Payment Program final rule (81 FR 77319 through 77329), and the 
discussion in the CY 2018 Quality Payment Program final rule (82 FR 
53769 through 53785). In this final rule, we discuss our proposal to 
continue the complex patient bonus for the 2021 MIPS payment year, as 
well as a

[[Page 59869]]

modification to the final score calculation for the 2021 MIPS payment 
year. Finally, we discuss refinements to reweighting policies.
(a) Accounting for Risk Factors
    Section 1848(q)(1)(G) of the Act requires us to consider risk 
factors in our scoring methodology. Specifically, it provides that the 
Secretary, on an ongoing basis, shall, as the Secretary determines 
appropriate and based on individuals' health status and other risk 
factors, assess appropriate adjustments to quality measures, cost 
measures, and other measures used under MIPS and assess and implement 
appropriate adjustments to payment adjustments, final scores, scores 
for performance categories, or scores for measures or activities under 
MIPS. In doing so, the Secretary is required to take into account the 
relevant studies conducted under section 2(d) of the Improving Medicare 
Post-Acute Care Transformation Act of 2014 (IMPACT Act) and, as 
appropriate, other information, including information collected before 
completion of such studies and recommendations.
(i) Considerations for Social Risk
    In the CY 2019 PFS proposed rule (83 FR 35964), we summarized our 
efforts related to social risk and the relevant studies conducted under 
section 2(d) of the IMPACT Act. We received several comments suggesting 
various approaches to adjust for social risk factors in the Quality 
Payment Program going forward. We thank commenters for their input and 
will take this input into consideration in future years. We also plan 
to continue working with ASPE, the public, and other key stakeholders 
on this important issue to identify policy solutions that achieve the 
goals of attaining health equity for all beneficiaries and minimizing 
unintended consequences.
(ii) Complex Patient Bonus for the 2021 MIPS Payment Year
    In the CY 2018 Quality Payment Program final rule, under the 
authority in section 1848(q)(1)(G) of the Act, we finalized at Sec.  
414.1380(c)(3) a complex patient bonus of up to 5 points to be added to 
the final score for the 2020 MIPS payment year (82 FR 53771 through 
53776). We intended for this bonus to serve as a short-term strategy to 
address the impact patient complexity may have on MIPS scoring while we 
continue to work with stakeholders on methods to account for patient 
risk factors. Our overall goal for the complex patient bonus was two-
fold: (1) To protect access to care for complex patients and provide 
them with excellent care; and (2) to avoid placing MIPS eligible 
clinicians who care for complex patients at a potential disadvantage 
while we review the completed studies and research to address the 
underlying issues. We noted that we would assess on an annual basis 
whether to continue the bonus and how the bonus should be structured 
(82 FR 53771). For a detailed description of the complex patient bonus 
finalized for the 2020 MIPS payment year, please refer to the CY 2018 
Quality Payment Program final rule (82 FR 53771 through 53776).
    For the 2019 MIPS performance period/2021 MIPS payment year, we 
proposed in the CY 2019 PFS proposed rule to continue the complex 
patient bonus as finalized for the 2018 MIPS performance period/2020 
MIPS payment year and to revise Sec.  414.1380(c)(3) to reflect this 
policy (83 FR 35964 through 35965). Although we intended to maintain 
the complex patient bonus as a short-term solution, we did not believe 
we had sufficient information available at the time of the proposed 
rule to develop a long-term solution to account for patient risk 
factors in MIPS such that we would be able to propose a different 
approach for the 2019 MIPS performance period/2021 MIPS payment year. 
At the time of the proposed rule, we did not believe additional data 
sources were available that would be feasible to use as the basis for a 
different approach to account for patient risk factors in MIPS. In the 
CY 2019 PFS proposed rule, we noted our intention to analyze data when 
feasible from the 2017 MIPS performance period to identify differences 
in performance that are consistent across performance categories and 
that we may, in the future, shift the complex patient bonus to specific 
performance categories (83 FR 35965). In the absence of data analysis 
from the first year of MIPS, we did not believe that a change was 
appropriate at that time. Therefore, we stated that while we work with 
stakeholders to identify a long-term approach to account for patient 
risk factors in MIPS, we believed it was appropriate to continue the 
complex patient bonus for another year to support MIPS eligible 
clinicians who treat patients with risk factors, as well as to maintain 
consistency with the 2020 MIPS payment year and minimize confusion. We 
had received significant feedback from MIPS eligible clinicians that 
consistency in the MIPS program over time is valued when possible in 
order to minimize confusion and to help MIPS eligible clinicians 
predict how they will be scored under MIPS. Therefore, we stated our 
belief that it is appropriate to maintain consistent policies for the 
complex patient bonus in the 2021 MIPS payment year until we have 
sufficient evidence and new data sources that support an updated 
approach to account for patient risk factors.
    Although we did not propose changes to the complex patient bonus 
for the 2021 MIPS payment year, we stated that the dates used in the 
calculation of the complex patient bonus may change as a result of 
other proposals we made in the CY 2019 PFS proposed rule (83 FR 35885 
through 35886). For the 2020 MIPS payment year, we finalized that we 
will use the second 12-month segment of the eligibility determination 
period to calculate average HCC risk scores and the proportion of full 
benefit or partial benefit dual eligible beneficiaries for MIPS 
eligible clinicians (82 FR 53771 through 53772). We proposed to change 
the dates of the eligibility determination period (now referred to as 
the MIPS determination period) beginning with the 2021 MIPS payment 
year (83 FR 35885 through 35886). Specifically, the second 12-month 
segment would begin on October 1 of the calendar year preceding the 
applicable performance period and end on September 30 of the calendar 
year in which the applicable performance period occurs. We indicated 
that if this proposed change to the MIPS determination period is 
finalized, then beginning with the 2021 MIPS payment year, the second 
12-month segment of the MIPS determination period (beginning on October 
1 of the calendar year preceding the applicable performance period and 
ending on September 30 of the calendar year in which the applicable 
performance period occurs) would be used when calculating average HCC 
risk scores and proportion of full benefit or partial benefit dual 
eligible beneficiaries for MIPS eligible clinicians.
    We solicited comments on the above proposals. These comments and 
our responses are discussed below.
    Comment: Several commenters supported our proposal to continue the 
complex patient bonus for the 2019 MIPS performance period/2021 MIPS 
payment year. Commenters stated that the bonus helps to create fairer 
scoring for MIPS eligible clinicians. Some commenters requested that we 
continue the bonus beyond the 2019 MIPS performance period/2021 MIPS 
payment year. A few commenters supported the complex patient bonus but 
requested that we increase the complex patient bonus above the proposed 
5 points, stating that 5 points

[[Page 59870]]

will have a minimal impact on the final score.
    Response: We thank commenters for their support of our proposal to 
maintain the complex patient bonus for the 2019 MIPS performance 
period/2021 MIPS payment year. We plan to review available information, 
including any updated data, in future years to determine if it is 
appropriate to modify our approach to adjusting for social risk 
factors. As we stated in the CY 2018 Quality Payment Program final rule 
(82 FR 53775), we believe a complex patient bonus of 5 points added to 
the final score is appropriate and is justified by information 
currently available at this time.
    Comment: Several commenters did not support our approach for the 
complex patient bonus. Commenters pointed out limitations in the use of 
HCC and dual-eligibility to calculate the complex patient bonus. For 
instance, commenters stated that these indicators are not sufficient to 
adjust for differences in performance and suggested other indicators 
that might be more appropriate (such as income or education). 
Commenters urged us to continue to explore alternative methods to 
adjust for patient complexity in future years.
    Response: We understand that both HCC risk scores and dual 
eligibility have some limitations as proxies for social risk factors. 
However, we are not aware of data sources for indicators such as income 
and education that are readily available for all Medicare beneficiaries 
that would be more complete indices of a patient's complexity. We have 
decided to pair the HCC risk score with the proportion of dual eligible 
patients to create a more complete complex patient indicator than can 
be captured using HCC risk scores alone. We will evaluate additional 
options in future years based on any updated data or additional 
information in order to better account for social risk factors while 
minimizing unintended consequences.
    Comment: One commenter recommended that we use the 12-month 
performance period to determine the complex patient bonus, stating that 
it is the most accurate representation of the patient population of a 
MIPS eligible clinician.
    Response: We believe that aligning the time period for assigning 
beneficiaries for purposes of calculating the complex patient bonus 
with the MIPS determination period is preferable for simplicity. In 
addition, when we designed our systems, we incorporated user feedback 
that requested eligibility information be connected to data submission. 
In order to be able to provide this information on the complex patient 
bonus at or near the time of data submission, it is necessary to use 
the second 12-month segment of the MIPS determination period as 
proposed to identify beneficiaries for purposes of assigning HCC risk 
scores and full benefit or partial benefit dual eligible beneficiaries 
to MIPS eligible clinicians, rather than the performance period. We 
note that this second 12-month segment begins 3 months before the year 
in which the performance period occurs and ends 9 months into the year 
in which the performance period occurs, creating a considerable overlap 
between the MIPS determination period and the year in which the 
performance period occurs (9 months).
    After consideration of public comments, we are finalizing our 
proposal to continue the complex patient bonus for the 2019 MIPS 
performance period/2021 MIPS payment year as proposed. We are also 
finalizing the changes to the regulation text at Sec.  414.1380(c)(3) 
as proposed. We are also modifying the timing used to calculate the 
complex patient bonus based on our changes to the MIPS determination 
period finalized in III.I.3.b. of this final rule. The second 12-month 
segment of the MIPS determination period will be used when calculating 
average HCC risk scores and the proportion of full benefit or partial 
benefit dual eligible beneficiaries for MIPS eligible clinicians.
(b) Final Score Performance Category Weights
(i) General Weights
    Section 1848(q)(5)(E)(i) of the Act specifies weights for the 
performance categories included in the MIPS final score: In general, 30 
percent for the quality performance category; 30 percent for the cost 
performance category; 25 percent for the Promoting Interoperability 
(formerly advancing care information) performance category; and 15 
percent for the improvement activities performance category. For more 
of the statutory background and descriptions of our current policies, 
we refer readers to the CY 2017 and CY 2018 Quality Payment Program 
final rules (81 FR 77320 and 82 FR 53779, respectively). Under the 
proposals we are finalizing in sections III.I.3.h.(3)(a) and 
III.I.3.h.(2)(a)(ii) of this final rule, for the 2021 MIPS payment 
year, the cost performance category will make up 15 percent and the 
quality performance category will make up 45 percent of a MIPS eligible 
clinician's final score. Table 53 summarizes the weights specified for 
each performance category.

                 Table 53--Finalized Weights by MIPS Performance Category and MIPS Payment Year
----------------------------------------------------------------------------------------------------------------
                                                                     2019 MIPS       2020 MIPS
                                                                   payment year    payment year      2021 MIPS
                      Performance category                          (previously     (previously    payment year
                                                                    finalized)      finalized)      (finalized)
                                                                     (percent)       (percent)       (percent)
----------------------------------------------------------------------------------------------------------------
Quality.........................................................              60              50              45
Cost............................................................               0              10              15
Improvement Activities..........................................              15              15              15
Promoting Interoperability......................................              25              25              25
----------------------------------------------------------------------------------------------------------------

(ii) Flexibility for Weighting Performance Categories
    Under section 1848(q)(5)(F) of the Act, if there are not sufficient 
measures and activities applicable and available to each type of MIPS 
eligible clinician involved, the Secretary shall assign different 
scoring weights (including a weight of zero) for each performance 
category based on the extent to which the category is applicable to the 
type of MIPS eligible clinician involved and for each measure and 
activity with respect to each performance category based on the extent 
to which the measure or activity is applicable and available to the 
type of MIPS eligible clinician involved. Under section 
1848(q)(5)(B)(i) of the Act, in the case of a MIPS eligible clinician 
who fails to report on an applicable measure or activity that is 
required to be reported by the clinician, the clinician must be treated 
as

[[Page 59871]]

achieving the lowest potential score applicable to such measure or 
activity. In this scenario of failing to report, the MIPS eligible 
clinician would receive a score of zero for the measure or activity, 
which would contribute to the final score for that MIPS eligible 
clinician. Assigning a scoring weight of zero percent and 
redistributing the weight to the other performance categories differs 
from the scenario of a MIPS eligible clinician failing to report on an 
applicable measure or activity that is required to be reported.
(A) Scenarios Where the Quality, Cost, Improvement Activities, and 
Promoting Interoperability Performance Categories Would Be Reweighted
    In the CY 2017 and CY 2018 Quality Payment Program final rules (81 
FR 77322 through 77325 and 82 FR 53779 through 53780, respectively), we 
explained our interpretation of what it means for there to be 
sufficient measures applicable and available for the quality and cost 
performance categories, and we finalized policies for the 2019 and 2020 
MIPS payment years under which we would assign a scoring weight of zero 
percent to the quality or cost performance category and redistribute 
its weight to the other performance categories in the event there are 
not sufficient measures applicable and available, as authorized by 
section 1848(q)(5)(F) of the Act. For the quality performance category, 
we stated that having sufficient measures applicable and available 
means that we can calculate a quality performance category percent 
score for the MIPS eligible clinician because at least one quality 
measure is applicable and available to the clinician (82 FR 53780). For 
the cost performance category, we stated that having sufficient 
measures applicable and available means that we can reliably calculate 
a score for the cost measures that adequately captures and reflects the 
performance of a MIPS eligible clinician (82 FR 53780). We established 
that if a MIPS eligible clinician is not attributed enough cases for a 
cost measure (in other words, has not met the required case minimum for 
the measure), or if a cost measure does not have a benchmark, then the 
measure will not be scored for that clinician (81 FR 77323). We stated 
that if we do not score any cost measures for a MIPS eligible clinician 
in accordance with this policy, then the clinician would not receive a 
cost performance category percent score (82 FR 53780).
    In the CY 2019 PFS proposed rule, we proposed to codify these 
policies for the quality and cost performance categories at Sec.  
414.1380(c)(2)(i)(A)(1) and (2), respectively, and to continue them for 
the 2021 MIPS payment year and each subsequent MIPS payment year (83 FR 
35966).
    For the Promoting Interoperability performance category, in the CY 
2017 Quality Payment Program final rule (81 FR 77238 through 77245) and 
the CY 2018 Quality Payment Program final rule (82 FR 53680 through 
53687), we established policies for assigning a scoring weight of zero 
percent to the Promoting Interoperability performance category and 
redistributing its weight to the other performance categories in the 
final score. We proposed to codify those policies under Sec.  
414.1380(c)(2)(i) and (iii) (83 FR 35966).
    For the improvement activities performance category, we stated in 
the CY 2019 proposed rule (83 FR 35967 through 35968) that we continue 
to believe that all MIPS eligible clinicians will have sufficient 
activities applicable and available, except for limited extreme and 
uncontrollable circumstances, such as natural disasters, where a 
clinician is unable to report improvement activities, and circumstances 
where a MIPS eligible clinician joins a practice in the final 3 months 
of the performance period as discussed in the CY 2019 PFS proposed rule 
(83 FR 35967 through 35968). We stated that, barring these 
circumstances, we believe that all MIPS eligible clinicians will have 
sufficient improvement activities applicable and available (82 FR 
53780).
    We solicited comments on the above proposals. These comments and 
our responses are discussed below.
    Comment: One commenter supported our reweighting policies, stating 
that they provide flexibility for MIPS eligible clinicians who are 
unable to participate in specific performance categories.
    Response: We thank this commenter for its support.
    Comment: One commenter expressed concern with our reweighting 
policies, because the commenter believes MIPS eligible clinician may 
expend resources to submit data to us, and then receive reweighting 
based on our determination that there are not sufficient measures or 
activities applicable and available.
    Response: Our reweighting policies would not lead us to reweight a 
MIPS eligible clinician after they submit data for a given performance 
category. Rather, we would consider whether these policies are 
applicable in the event that we do not receive any data for a MIPS 
eligible clinician for a particular performance category. If we 
determine that the clinician is eligible for reweighting under our 
policies, then we would redistribute the weight of the performance 
category, rather than awarding a score of zero to the clinician for 
that performance category.
    After consideration of public comments, we are finalizing our 
proposal to codify the reweighting policies for the quality and cost 
performance categories at Sec.  414.1380(c)(2)(i)(A)(1) and (2), 
respectively, and to continue them for the 2021 MIPS payment year and 
each subsequent MIPS payment year, as proposed. We are also finalizing 
our proposal to codify the Promoting Interoperability reweighting 
policies under Sec.  414.1380(c)(2)(i) and (iii) as proposed.
(B) Reweighting the Quality, Cost, and Improvement Activities 
Performance Categories for Extreme and Uncontrollable Circumstances
    For a summary of the final policy we adopted beginning with the 
2018 MIPS performance period/2020 MIPS payment year to reweight the 
quality, cost, and improvement activities performance categories based 
on a request submitted by a MIPS eligible clinician, group, or virtual 
group that was subject to extreme and uncontrollable circumstances, we 
refer readers to the CY 2018 Quality Payment Program final rule (82 FR 
53780 through 53783). In the proposed rule (83 FR 35966), we proposed 
to codify this policy at Sec.  414.1380(c)(2)(i)(A)(5), but we 
inadvertently referred to the wrong paragraph of the regulation text, 
and the citation should have read Sec.  414.1380(c)(2)(i)(A)(6).
    We proposed a few minor modifications to our extreme and 
uncontrollable circumstances policy (83 FR 35967). First, beginning 
with the 2019 MIPS performance period/2021 MIPS payment year, we 
proposed at Sec.  414.1380(c)(2)(i)(A)(5) (which should have read Sec.  
414.1380(c)(2)(i)(A)(6)) that, if a MIPS eligible clinician submits an 
application for reweighting based on extreme and uncontrollable 
circumstances, but also submits data on the measures or activities 
specified for the quality or improvement activities performance 
categories in accordance with Sec.  414.1325, he or she would be scored 
on the submitted data like all other MIPS eligible clinicians, and the 
categories would not be reweighted (83 FR 35967). We proposed this 
modification to align with a similar policy for the Promoting 
Interoperability performance category (82 FR 53680 through 53682). We 
stated that if a MIPS eligible clinician reports on measures or 
activities specified for the quality or improvement activities 
performance categories, then we assume the clinician

[[Page 59872]]

believes there are sufficient measures or activities applicable and 
available to the clinician.
    For most quality measures and improvement activities, the data 
submission occurs after the end of the MIPS performance period, so 
clinicians would know about the extreme and uncontrollable circumstance 
prior to submission. However, for the quality performance category, 
measures submitted via the Medicare Part B claims collection type are 
submitted by adding quality data codes to a claim. As a result, it is 
possible that a MIPS eligible clinician could have submitted some 
Medicare Part B claims collection type data prior to the submission of 
a reweighting application for extreme and uncontrollable events. Under 
our proposal, we would score the quality performance category because 
we have received data. However, we previously finalized at Sec.  
414.1380(c) that if a MIPS eligible clinician is scored on fewer than 
two performance categories, he or she will receive a final score equal 
to the performance threshold (81 FR 77320 through 77321 and 82 FR 53778 
through 53779). If a clinician experiences an extreme and 
uncontrollable event that affects all of the performance categories, 
then under our proposal, the clinician would only be scored on the 
quality performance category if they submit data for only that 
category. The clinician would also have to submit data for the 
improvement activities or the Promoting Interoperability performance 
categories in order to be scored on two or more performance categories 
and receive a final score different than the performance threshold.
    This proposal did not include administrative claims data that we 
receive through the claims submission process and use to calculate the 
cost measures and certain quality measures. As finalized in the CY 2017 
Quality Payment Program final rule (81 FR 77094 through 77095), and as 
we are codifying in this final rule at Sec.  414.1325(a)(2), there are 
no data submission requirements for the cost performance category and 
for certain quality measures used to assess performance in the quality 
performance category. Please see section III.I.3.h.(1)(b) of this final 
rule for a description of collection types, submission types, and 
submitter types. We calculate performance on these measures using 
administrative claims data, and clinicians are not required to submit 
any additional data for these measures. Therefore, we stated that we 
did not believe that it would be appropriate to void a reweighting 
application based on administrative claims data we receive for measures 
that do not require data submission for purposes of MIPS.
    We also proposed to apply the policy we finalized for virtual 
groups in the CY 2018 Quality Payment Program final rule (82 FR 53782 
through 53783) to groups submitting reweighting applications for the 
quality, cost, or improvement activities performance categories based 
on extreme and uncontrollable circumstances (83 FR 35967). For groups, 
we would evaluate whether sufficient measures and activities are 
applicable and available to MIPS eligible clinicians in the group on a 
case-by-case basis and determine whether to reweight a performance 
category based on the information provided for the individual 
clinicians and practice location(s) affected by extreme and 
uncontrollable circumstances and the nature of those circumstances. In 
the CY 2019 PFS proposed rule (83 FR 35967), we stated that although we 
did not specifically propose to apply this policy to groups in the CY 
2018 Quality Payment Program proposed rule, our intention was to apply 
the same policy for groups and virtual groups, and thus if we adopt 
this proposal, we would apply the policy to groups beginning with the 
2018 performance period/2020 MIPS payment year.
    We solicited comments on the above proposals. These comments and 
our responses are discussed below.
    Comment: One commenter supported our proposal for groups, stating 
that all MIPS eligible clinicians in the group will likely be facing 
the same barriers and a group application will reduce administrative 
burden and redundancy.
    Response: We thank the commenter for its support of our proposal to 
apply the same policy we established for virtual groups to groups. 
Under the proposed policy, we would evaluate whether sufficient 
measures and activities are applicable and available to MIPS eligible 
clinicians in the group on a case-by-case basis and determine whether 
to reweight a performance category based on the information provided 
for the individual clinicians and practice location(s) affected by 
extreme and uncontrollable circumstances and the nature of those 
circumstances.
    Comment: One commenter expressed concern that MIPS eligible 
clinicians who submit an application for reweighting based on extreme 
and uncontrollable circumstances, but who also report via Medicare Part 
B claims collection type may be unfairly penalized if claims data is 
received prior to the extreme and uncontrollable event. Another 
commenter suggested that we should score data received from MIPS 
eligible clinicians who submit a reweighting application only if they 
would receive a score that would result in a payment adjustment no 
lower than a neutral adjustment.
    Response: If a MIPS eligible clinician reports via Medicare Part B 
claims collection type for the quality performance category, and we 
receive an application for reweighting for the clinician based on 
extreme and uncontrollable circumstances, their Medicare Part B claims 
data would only contribute to their final score if they also submit 
data for either the Promoting Interoperability or the improvement 
activities performance categories. We previously finalized at Sec.  
414.1380(c) that if a MIPS eligible clinician is scored on fewer than 
two performance categories, he or she will receive a final score equal 
to the performance threshold (81 FR 77320 through 77321 and 82 FR 53778 
through 53779). The clinician's cost performance category score would 
not contribute to their final score because as we discuss above, there 
are no data submission requirements for the cost performance category, 
and we do not believe that it would be appropriate to void a 
reweighting application based on administrative claims data we receive 
for measures that do not require data submission for purposes of MIPS.
    We assume that if a MIPS eligible clinician submits data to us 
following the submission of an application for reweighting based on 
extreme and uncontrollable circumstances, the clinician believes there 
are sufficient measures or activities applicable and available to them 
and would like their data to contribute to their final score. However, 
once the data is submitted, it will be scored based on performance in 
accordance with our policies, and the clinician could receive a 
negative payment adjustment.
    After consideration of public comments, we are finalizing our 
proposal to codify the final policy we adopted beginning with the 2018 
MIPS performance period/2020 MIPS payment year to reweight the quality, 
cost, and improvement activities performance categories based on a 
request submitted by a MIPS eligible clinician, group, or virtual group 
that was subject to extreme and uncontrollable circumstances. We are 
finalizing our proposal that, beginning with the 2019 performance 
period/2021 MIPS payment year, if a MIPS eligible clinician submits an 
application for reweighting based on extreme and uncontrollable 
circumstances, but also

[[Page 59873]]

submits data on the measures or activities specified for the quality or 
improvement activities performance categories in accordance with Sec.  
414.1325, he or she will be scored on the submitted data like all other 
MIPS eligible clinicians, and the categories will not be reweighted. We 
are also finalizing our proposal, beginning with the 2018 performance 
period/2020 MIPS payment year, that, for groups, we will evaluate 
whether sufficient measures and activities are applicable and available 
to MIPS eligible clinicians in the group on a case-by-case basis and 
determine whether to reweight a performance category based on the 
information provided. We are finalizing the regulation text at Sec.  
414.1380(c)(2)(i)(A)(6) as proposed.
(C) Reweighting the Quality, Cost, Improvement Activities, and 
Promoting Interoperability Performance Categories for MIPS Eligible 
Clinicians Who Join a Practice in the Final 3 Months of the Performance 
Period Year
    Beginning with the 2019 MIPS performance period, we proposed that a 
MIPS eligible clinician who joins an existing practice (existing TIN) 
during the final 3 months of the calendar year in which the MIPS 
performance period occurs (the performance period year) that is not 
participating in MIPS as a group would not have sufficient measures 
applicable and available (83 FR 35967 through 35968). We also proposed 
that a MIPS eligible clinician who joins a practice that is newly 
formed (new TIN) during the final 3 months of the performance period 
year would not have sufficient measures applicable and available, 
regardless of whether the clinicians in the practice report for 
purposes of MIPS as individuals or as a group (83 FR 35967 through 
35968). In each of these scenarios, we proposed to reweight all four of 
the performance categories to zero percent for the MIPS eligible 
clinician and, because he or she would be scored on fewer than two 
performance categories, the MIPS eligible clinician would receive a 
final score equal to the performance threshold and a neutral MIPS 
payment adjustment under the policy at Sec.  414.1380(c) (83 FR 35967 
through 35968). We proposed to codify these policies at Sec.  
414.1380(c)(2)(i)(A)(3).
    We proposed this policy because we are not currently able to 
identify these MIPS eligible clinicians (or groups if the group is 
formed in the final 3 months of the performance period year) at the 
start of the MIPS submission period. When we designed our systems, we 
incorporated user feedback that requested eligibility information be 
connected to the submission process. In order to submit data, an 
individual TIN/NPI or the group TIN must be in the files generated from 
the MIPS eligibility determination periods. As discussed in the CY 2019 
PFS proposed rule (83 FR 35885 through 35886), we have two 12-month 
determination periods for eligibility. We proposed and are finalizing 
in section III.II.3.b. of this final rule that the second 12-month 
segment of the MIPS eligibility determination period will end on 
September 30 of the calendar year in which the applicable MIPS 
performance period occurs; therefore, we will have no eligibility 
information about clinicians who join a practice after September 30 of 
the performance period year. MIPS eligible clinicians who join an 
existing practice (existing TIN) in the final 3 months of the 
performance period year that is not participating in MIPS as a group 
will not be identified by our systems, and we will not have the ability 
to inform them that they are eligible or to receive MIPS data from 
them. Similarly, practices that form (new TIN) in the final 3 months of 
the performance period year will not be in the MIPS determination 
files. Accordingly, we stated that the measures and activities would 
not be available because any data from these MIPS eligible clinicians 
would not be accessible to us.
    If a MIPS eligible clinician joins a practice (existing TIN) in the 
final 3 months of the performance period year, and the practice is not 
newly formed and is reporting as a group for the performance period, 
the MIPS eligible clinician will be able to report as part of that 
group. In this case, we are able to accept data for the group because 
the TIN would be in our MIPS eligibility determination files. 
Therefore, we stated that we believe the measures and activities would 
be available in this scenario, and reweighting would not be necessary 
for the MIPS eligible clinician. We noted that, if a MIPS eligible 
clinician's TIN/NPI combination was not part of the group practice 
during the MIPS determination period, the TIN/NPI combination will not 
be identified in our system at the start of the MIPS data submission 
period; however, if the MIPS eligible clinician qualifies to receive 
the group final score under our proposal, we would apply the group 
final score to the MIPS eligible clinician's TIN/NPI combination as 
soon as the information becomes available. Please see section 
III.I.3.j.(1) of this final rule for more information about assigning 
group scores to MIPS eligible clinicians.
    We solicited comments on the above proposals. These comments and 
our responses are discussed below.
    Comment: Several commenters supported our proposal to reweight MIPS 
eligible clinicians who form a new practice in the final 3 months of 
the performance period year or join an existing practice that does not 
participate in MIPS as a group.
    Response: We thank commenters for their support of our proposal.
    Comment: One commenter requested that we extend this policy to the 
2018 performance period as well.
    Response: We note that we did not propose to apply the policy to 
the 2018 performance period, and as such, we will not be extending it 
in this final rule.
    Comment: One commenter did not support our proposal to treat MIPS 
eligible clinicians who join a new or existing practice in the final 3 
months of the performance period year differently depending on whether 
the practice reports as a group. The commenter also requested that we 
reweight MIPS eligible clinicians who switch practices at any time 
during the performance period, because a MIPS eligible clinician's 
previous practice may not report on their behalf and because clinicians 
are impacted by training and other requirements associated with 
switching practices that may impact performance.
    Response: A MIPS eligible clinician who joins an existing practice 
that is participating in MIPS as a group would have the opportunity to 
contribute to the group's performance and final score. We refer readers 
to section III.I.3.j.(1) of this final rule for a discussion of which 
MIPS eligible clinicians may receive a group final score. We do not 
believe it would be appropriate to reweight the performance categories 
for MIPS eligible clinicians who change practices at any time during 
the performance period year because, consistent with our discussion in 
the CY 2019 PFS proposed rule (83 FR 35967 through 35968), we would be 
able to identify these clinicians at the beginning of the MIPS 
submission period if they change practices prior to the final 3 months 
of the performance period year. We also believe MIPS eligible 
clinicians who change practices prior to the final 3 months of the 
performance period year generally should have sufficient time to 
prepare for MIPS reporting, in the event that their prior practice does 
not submit data for them.
    After consideration of public comments, we are finalizing as

[[Page 59874]]

proposed our proposal to reweight the quality, cost, improvement 
activities, and Promoting Interoperability performance categories to 
zero percent for MIPS eligible clinicians who join an existing practice 
(existing TIN) during the final 3 months of the performance period year 
that is not participating in MIPS as a group, or a practice that is 
newly formed (new TIN) during the final 3 months of the performance 
period year regardless of whether the clinicians in the practice report 
for purposes of MIPS as individuals or as a group. We are finalizing 
the proposed regulation text at Sec.  414.1380(c)(2)(i)(A)(3) as 
proposed.
(D) Automatic Extreme and Uncontrollable Circumstances Policy Beginning 
With the 2020 MIPS Payment Year
    In conjunction with the CY 2018 Quality Payment Program final rule, 
and due to the impact of Hurricanes Harvey, Irma, and Maria, we issued 
an interim final rule with comment period (IFC) in which we adopted on 
an interim final basis a policy for automatically reweighting the 
quality, improvement activities, and advancing care information (now 
referred to as Promoting Interoperability) performance categories for 
the transition year of MIPS (the 2017 performance period/2019 MIPS 
payment year) for MIPS eligible clinicians who are affected by extreme 
and uncontrollable circumstances affecting entire regions or locales 
(82 FR 53895 through 53900).
    In the CY 2019 PFS proposed rule (83 FR 35968), we stated that we 
believe that a similar automatic extreme and uncontrollable 
circumstances policy would be appropriate for any year of the MIPS 
program to account for natural disasters and other extreme and 
uncontrollable circumstances that impact an entire region or locale. As 
we discussed in the interim final rule (82 FR 53897), we believe such a 
policy would reduce burden on clinicians who have been affected by 
widespread catastrophes and would align with existing policies for 
other Medicare programs. We proposed at Sec.  414.1380(c)(2)(i)(A)(7) 
and (c)(2)(i)(C)(3) to apply the automatic extreme and uncontrollable 
circumstances policy we adopted for the transition year to subsequent 
years of the MIPS program, beginning with the 2018 MIPS performance 
period and the 2020 MIPS payment year, with a few additions to address 
the cost performance category (83 FR 35968). We note that we 
inadvertently referred to the wrong paragraph of the regulation text in 
the proposed rule, and the citation should have read Sec.  
414.1380(c)(2)(i)(A)(8) instead of Sec.  414.1380(c)(2)(i)(A)(7). For a 
description of the policy we adopted for the MIPS transition year, we 
refer readers to the discussion in the interim final rule (82 FR 53895 
through 53900).
    In the interim final rule (82 FR 53897), we stated that we were not 
including the cost performance category in the automatic extreme and 
uncontrollable circumstances policy for the transition year because the 
cost performance category is weighted at zero percent in the final 
score for the 2017 MIPS performance period/2019 MIPS payment year. We 
finalized a 10 percent weight for the cost performance category for the 
2018 MIPS performance period/2020 MIPS payment year (82 FR 53643) and 
are finalizing a 15 percent weight for the 2019 performance period/2021 
MIPS payment year (see section III.I.3.h.(3)(a) of this final rule). In 
the CY 2019 PFS proposed rule (83 FR 35968), we stated that for the 
reasons discussed in the CY 2018 Quality Payment Program final rule (82 
FR 53781), we believe a MIPS eligible clinician's performance on 
measures calculated based on administrative claims data, such as the 
measures specified for the cost performance category, could be 
adversely affected by a natural disaster or other extreme and 
uncontrollable circumstance, and that the cost measures may not be 
applicable to that MIPS eligible clinician. Therefore, we proposed to 
include the cost performance category in the automatic extreme and 
uncontrollable circumstances policy beginning with the 2018 MIPS 
performance period/2020 MIPS payment year (83 FR 35968). Under our 
policy for the transition year, if a MIPS eligible clinician in an 
affected area submits data for any of the MIPS performance categories 
by the applicable submission deadline for the 2017 MIPS performance 
period, he or she will be scored on each performance category for which 
he or she submits data, and the performance category will not be 
reweighted to zero percent in the final score (82 FR 53898). Our policy 
for the transition year did not include measures that are calculated 
based on administrative claims data (82 FR 53898). As finalized in the 
CY 2017 Quality Payment Program final rule (81 FR 77094 through 77095), 
and as we are codifying in this final rule at Sec.  414.1325(a)(2), 
there are no data submission requirements for the cost performance 
category, and we will calculate performance on the measures specified 
for the cost performance category using administrative claims data. We 
proposed for the cost performance category, if a MIPS eligible 
clinician is located in an affected area, we would assume the clinician 
does not have sufficient cost measures applicable to him or her and 
assign a weight of zero percent to that category in the final score, 
even if we receive administrative claims data that would enable us to 
calculate the cost measures for that clinician (83 FR 35968).
    In the interim final rule (82 FR 53897), we did not include an 
automatic extreme and uncontrollable circumstances policy for groups or 
virtual groups, and we stated in the CY 2019 PFS proposed rule (83 FR 
35968) that we continue to believe such a policy is not necessary. 
Unless we receive data from a TIN indicating that the TIN would like to 
be scored as a group for MIPS, performance by default is assessed at 
the individual MIPS eligible clinician level. Similarly, performance is 
not assessed at the virtual group level unless the member TINs submit 
an application in accordance with Sec.  414.1315. We stated that if we 
receive data from a group or virtual group, we would score that data, 
even if individual MIPS eligible clinicians within the group or virtual 
group are impacted by an event that would be included in our automatic 
extreme and uncontrollable circumstances policy. Regardless of whether 
we receive data from a group or virtual group, we would have no 
mechanism to determine whether the group or virtual group did not 
submit data, or submitted data and performed poorly, because it had 
been affected by an extreme and uncontrollable event unless the group 
notifies us of its circumstances. Instead of establishing a threshold 
for groups or virtual groups to receive automatic reweighting based on 
the number of clinicians in the group or virtual group impacted by 
extreme and uncontrollable events, we stated that we believe it is 
preferable that these groups and virtual groups submit an application 
for reweighting based on extreme and uncontrollable circumstances under 
our existing policy (82 FR 53780 through 53783) where they may be 
eligible for reweighting if they establish that the group or virtual 
group was sufficiently impacted by the extreme and uncontrollable 
event.
    We solicited comments on the above proposals. These comments and 
our responses are discussed below.
    Comment: Several commenters supported our proposed application of 
the automatic extreme and uncontrollable policy starting with the 2018 
MIPS performance period/2020 MIPS payment year to reduce burden on

[[Page 59875]]

impacted MIPS eligible clinicians. A few commenters supported our 
proposal to extend the automatic extreme and uncontrollable policy to 
include the cost performance category for the 2018 MIPS performance 
period/2020 MIPS payment year and future years.
    Response: We thank commenters for their support of our proposals.
    Comment: One commenter suggested that we only score performance 
categories (including the cost performance category) for MIPS eligible 
clinicians impacted by the automatic extreme and uncontrollable policy 
if they would receive a positive or neutral payment adjustment.
    Response: If a MIPS eligible clinician reports via Medicare Part B 
claims collection type for the quality performance category, and we 
receive data for the clinician prior to a triggering event for the 
automatic extreme and uncontrollable circumstances policy, their 
Medicare Part B claims data would only contribute to their final score 
if they also submit data for either the Promoting Interoperability or 
the improvement activities performance categories. We previously 
finalized at Sec.  414.1380(c) that if a MIPS eligible clinician is 
scored on fewer than two performance categories, he or she will receive 
a final score equal to the performance threshold (81 FR 77320 through 
77321 and 82 FR 53778 through 53779). We assume that if a MIPS eligible 
clinician submits data to us following a triggering event, the 
clinician believes there are sufficient measures or activities 
applicable and available to them and would like their data to 
contribute to their final score. However, once the data is submitted, 
it will be scored based on performance in accordance with our policies, 
and the clinician could receive a negative payment adjustment.
    Comment: One commenter disagreed with our decision to not propose 
an automatic extreme and uncontrollable circumstances policy for 
groups, because clinicians who choose to report as group for purposes 
of MIPS conduct all aspects of MIPS at a group level.
    Response: We continue to believe that a group policy is not 
necessary and that there are barriers to implementing such a policy. 
For example, because group reporting is optional, we would have no 
mechanism to determine who would have been intending to report without 
receiving a data submission. Additionally, some groups may be split 
between areas that are impacted by the triggering event and areas that 
are not. We do not believe that it would be appropriate to make a 
decision about how the group is impacted without additional 
information. We believe our application-based extreme and 
uncontrollable circumstances policy provides the mechanism for such an 
assessment. Finally, we note that if all the MIPS eligible clinicians 
in a group are located in an area affected by the extreme and 
uncontrollable circumstance, and the group is not able to submit for 
MIPS as a group, then all the MIPS eligible clinicians in the group 
would be considered as individuals and covered by the automatic extreme 
and uncontrollable circumstances policy.
    After consideration of public comments received, we are finalizing 
these proposals and the regulation text at Sec.  
414.1380(c)(2)(i)(A)(8) and (c)(2)(i)(C)(3) as proposed.
iii. Extreme and Uncontrollable Circumstance Policy for the 2017 
Performance Period/2019 MIPS Payment Year
    As discussed in the preceding section III.I.3.i.(2)(b)(ii)(D), in 
conjunction with the CY 2018 Quality Payment Program final rule, and 
due to the impact of Hurricanes Harvey, Irma, and Maria, we issued an 
interim final rule with comment period (IFC) in which we adopted on an 
interim final basis a policy for automatically reweighting the quality, 
improvement activities, and advancing care information (now referred to 
as Promoting Interoperability) performance categories for the 
transition year of MIPS (the 2017 performance period/2019 MIPS payment 
year) for MIPS eligible clinicians who are affected by extreme and 
uncontrollable circumstances affecting entire regions or locales (82 FR 
53895 through 53900). In the CY 2019 PFS proposed rule (83 FR 35968), 
we proposed to codify this policy for the quality and improvement 
activities performance categories at Sec.  414.1380(c)(2)(i)(A)(6) and 
for the advancing care information (now Promoting Interoperability) 
performance category at Sec.  414.1380(c)(2)(i)(C)(3). We note that we 
inadvertently referred to the wrong paragraph of the regulation text in 
the proposed rule, and the citation should have read Sec.  
414.1380(c)(2)(i)(A)(7) instead of Sec.  414.1380(c)(2)(i)(A)(6).
    A summary of the comments we received on the IFC and our responses 
are included below.
    Comment: Many commenters supported the automatic extreme and 
uncontrollable circumstance policy for the 2017 MIPS performance 
period. Several commenters stated that the policy is appropriate given 
the burden these events have had on impacted MIPS eligible clinicians. 
Several commenters supported the flexibility afforded by this policy 
and noted that the policy will allow impacted MIPS eligible clinicians 
to focus on providing patient care during natural disasters without 
having to focus on MIPS reporting. Several commenters supported our 
policy to allow clinicians impacted by extreme and uncontrollable 
events to report for MIPS if they choose because commenters believe 
some MIPS eligible clinicians may be less impacted by natural disasters 
and may have interest in reporting for MIPS. One commenter supported 
including events that have been designated by FEMA in the automatic 
extreme and uncontrollable circumstance policy. Another commenter 
supported using the practice location listed in PECOS to determine 
eligibility for the automatic extreme and uncontrollable policy.
    Response: We believe that the automatic extreme and uncontrollable 
circumstance policy is appropriate to provide relief to MIPS eligible 
clinicians experiencing natural disasters and will help to ensure they 
are able to focus on providing patient care. In the CY 2018 Quality 
Payment Program final rule, we noted that we anticipate the types of 
events that could trigger this policy would be events designated as 
FEMA major disasters or a public health emergency declared by the 
Secretary, although we will review each situation on a case-by-case 
basis (82 FR 53897).
    Comment: One commenter urged CMS to develop a clear communications 
plan for alerting MIPS eligible clinicians that they are eligible for 
the automatic extreme and uncontrollable circumstance policy.
    Response: We agree that it will be important to effectively alert 
MIPS eligible clinicians who we determine are covered by the automatic 
extreme and uncontrollable circumstance policy. Similar to other CMS 
programs, we communicated applicability information through routine 
communication channels, including, but not limited to, issuing memos, 
emails, and notices on the QPP website, qpp.cms.gov.
    Comment: One commenter stated that providing MIPS eligible 
clinicians who are impacted by extreme and uncontrollable events with a 
final score that is equal to the performance threshold if they report 
on only one performance category does not recognize their efforts for 
that performance category. Instead, commenter stated CMS should score 
the MIPS eligible clinician on that category.
    Response: We continue to believe that the final score for MIPS 
should be a composite score. Therefore, for MIPS

[[Page 59876]]

eligible clinicians who are subject to the automatic extreme and 
uncontrollable circumstance policy, we will continue to apply our 
general MIPS policy codified at Sec.  414.1380(c) that MIPS eligible 
clinicians who are scored on fewer than 2 performance categories 
receive a score equal to the performance threshold (82 FR 53958). MIPS 
eligible clinicians who are located in an area affected by extreme and 
uncontrollable circumstances who submit data for the quality 
performance category would also have to submit data for the Promoting 
Interoperability or improvement activities performance categories in 
order for the data submitted to contribute to their final score.
    Comment: One commenter stated that scoring data that are submitted 
by impacted MIPS eligible clinicians is unfair because they are being 
assessed against MIPS eligible clinicians who were not impacted by 
natural disasters.
    Response: Because the performance threshold is set very low (at 3 
points) for the 2017 MIPS performance period, we believe that MIPS 
eligible clinicians who are eligible for the automatic extreme and 
uncontrollable circumstance policy but submit data will easily exceed 
the performance threshold and thus will not be negatively impacted. 
Furthermore, we assume that MIPS eligible clinicians who are located in 
an area affected by extreme and uncontrollable circumstances but then 
submit data for more than one performance category believe there are 
sufficient measures or activities applicable and available to them and 
would like their data to contribute to their final score.
    Comment: One commenter suggested that CMS should not score Medicare 
Part B claims measures that are submitted by MIPS eligible clinicians 
impacted by extreme and uncontrollable events.
    Response: If a MIPS eligible clinician reports via Medicare Part B 
claims for the quality performance category and we receive data prior 
to the extreme and uncontrollable event, their Medicare Part B claims 
data would only contribute to their final score if they also submit 
data for either the Promoting Interoperability or improvement 
activities performance categories. We previously finalized at Sec.  
414.1380(c) that if a MIPS eligible clinician is scored on fewer than 
two performance categories, he or she will receive a final score equal 
to the performance threshold (81 FR 77320 through 77321 and 82 FR 53778 
through 53779).
    Comment: One commenter suggested that CMS consider providing a 
positive payment adjustment for MIPS eligible clinicians who are 
eligible for the automatic extreme and uncontrollable circumstance 
policy instead of providing a neutral payment adjustment because this 
will help to incentivize MIPS eligible clinicians to return to affected 
areas.
    Response: It is unclear to us how a positive payment adjustment 
would incentivize clinicians to return to affected areas, or how we 
would go about verifying whether and why they have returned, since many 
factors influence clinician choice in practice location.
    After consideration of the public comments, we are adopting the IFC 
as a final rule without any modifications. We are finalizing the 
regulation text at Sec.  414.1380(c)(2)(i)(A)(7) and Sec.  
414.1380(c)(2)(i)(C)(3) as proposed.
(iv) Redistributing Performance Category Weights
    In the CY 2017 and CY 2018 Quality Payment Program final rules, we 
established policies for redistributing the weights of performance 
categories for the 2019 and 2020 MIPS payment years in the event that a 
scoring weight different from the generally applicable weight is 
assigned to a category or categories (81 FR 77325 through 77329; 82 FR 
53783 through 53785, 53895 through 53900). We proposed to codify these 
policies under Sec.  414.1380(c)(2)(ii) (83 FR 35969).
    For the 2021 MIPS payment year, we proposed at Sec.  
414.1380(c)(2)(ii)(B) to apply similar reweighting policies as 
finalized for the 2020 MIPS payment year (83 FR 35969). We note that we 
inadvertently referred to the wrong paragraph of the regulation text in 
the proposed rule, and the citation should have read Sec.  
414.1380(c)(2)(ii)(C) instead of Sec.  414.1380(c)(2)(ii)(B). In 
general, we would redistribute the weight of a performance category or 
categories to the quality performance category. We stated that 
redistributing weight to the quality performance category is 
appropriate because of the experience MIPS eligible clinicians have had 
reporting on quality measures under other CMS programs. We proposed to 
continue to redistribute the weight of the quality performance category 
to the improvement activities and Promoting Interoperability 
performance categories (83 FR 35969). However, for the 2021 MIPS 
payment year, based on our proposal to weight the cost performance 
category at 15 percent, we proposed to reweight the Promoting 
Interoperability performance category to 45 percent and the improvement 
activities performance category to 40 percent when the quality 
performance category is weighted at zero percent (83 FR 35969). We 
chose to weigh Promoting Interoperability higher in order to align with 
goals of interoperability and for simplicity because we generally have 
avoided assigning partial percentage points to performance category 
weights. Reweighting scenarios under the proposal are presented in 
Table 54.

[[Page 59877]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.069

    We stated that we have heard from stakeholders in previous years 
that our reweighting policies place undue weight on the quality 
performance category, and, although we continue to believe the policies 
are appropriate, we solicited comment on alternative redistribution 
policies in which we would also redistribute weight to the improvement 
activities performance category (see Table 55). Under the alternative 
redistribution policy we considered, we would redistribute the weight 
of the Promoting Interoperability performance category to the quality 
and improvement activities performance categories (83 FR 35969 through 
35970). We would redistribute 15 percent of the Promoting 
Interoperability performance category weight to the quality performance 
category, and 10 percent to the improvement activities performance 
category. We stated that redistributing more of the weight of the 
Promoting Interoperability performance category to the quality 
performance category is appropriate because MIPS eligible clinicians 
have had more experience reporting on quality measures under other CMS 
programs than reporting on improvement activities. We would 
redistribute the cost performance category weight equally to the 
quality and improvement activities performance categories (5 percent to 
each) under this alternative policy.
[GRAPHIC] [TIFF OMITTED] TR23NO18.070


[[Page 59878]]


    We solicited comments on the above proposals. These comments and 
our responses are discussed below.
    Comment: A few commenters supported our proposed reweighting 
policies for the 2019 MIPS performance period/2021 MIPS payment year.
    Response: We thank commenters for their support of our proposal.
    Comment: Several commenters supported the alternative policy we 
considered to reweight to both quality and improvement activities, and 
stated our primary proposal which generally reweights to quality, 
places undue weight on the quality performance category. Some 
commenters stated that reweighting to the improvement activities 
performance category is appropriate given the importance of practice 
improvement. A few commenters stated that the quality performance 
category is particularly challenging, and therefore, placing additional 
weight on this performance category would not be fair to MIPS eligible 
clinicians who receive reweighting for the cost or Promoting 
Interoperability performance categories. A few commenters also 
mentioned that our reweighting policies place undue burden on small and 
rural practices who have particular difficulty performing well on the 
quality performance category. A few commenters requested that we 
redistribute all of the weight of the Promoting Interoperability or 
cost performance categories to the improvement activities performance 
category, in order to avoid placing undue focus on quality and due to 
the importance of quality improvement.
    Response: We continue to believe reweighting to the quality 
performance category is appropriate as the quality performance category 
is a critical component of value-based care, and therefore, we believe 
performance on quality measures is important. While there is variation 
in performance for the quality performance category, for the 
improvement activities we are only assessing whether the MIPS eligible 
clinician completed activities. We believe that reweighting to the 
quality performance category will encourage MIPS eligible clinicians to 
report on the quality performance category due to the higher category 
weight (that is, a zero score for this performance category would have 
more significant impact), particularly those clinicians who may have 
only reported to the improvement activities performance category, and 
will minimize complexity. We believe it is important to encourage MIPS 
eligible clinicians to report on quality while the performance 
threshold is still relatively low. In regards to the concern on small 
and rural practice performance in the quality performance category, we 
note that small practices that report quality measures can receive the 
small practice bonus we are finalizing in section 
III.I.3.i.(1)(b)(viii) of this final rule and we have not seen 
differences in performance for rural practices. We plan to review 
available approaches to reweighting in future years including impact on 
small and rural practices and may revisit our policies to ensure they 
are fair and not overly complex.
    Comment: One commenter disagreed with our proposal to reweight the 
quality performance category to the improvement activities and 
Promoting Interoperability performance categories, because the 
commenter noted concern with our discussion of available and applicable 
measures for the quality performance category and reweighting this 
category would place greater weight on other performance categories. 
Another commenter noted that reweighting the quality performance 
category may lead to MIPS eligible clinicians inaccurately receiving a 
positive, neutral, or negative payment adjustment.
    Response: We believe reweighting to the improvement activities and 
Promoting Interoperability performance categories in the rare cases 
when the quality performance category is reweighted is appropriate 
because MIPS eligible clinicians have limited experience being scored 
on the cost performance category. We also expect the cases when a MIPS 
eligible clinician does not have any quality measures to be very rare.
    After consideration of public comments, we are finalizing these 
proposals and the regulation text at Sec.  414.1380(c)(2)(ii)(A) 
through (C) as proposed.
    Because the cost performance category was zero percent of a MIPS 
eligible clinician's final score for the 2017 MIPS performance period, 
we stated in the CY 2019 PFS proposed rule (83 FR 35970) that it is not 
appropriate to redistribute weight to the cost performance category for 
the 2019 MIPS performance period because MIPS eligible clinicians have 
limited experience being scored on cost measures for purposes of MIPS. 
In addition, we were concerned that there would be limited measures in 
the cost performance category under our proposals for the 2019 MIPS 
performance period and stated that it may be appropriate to delay 
shifting additional weight to the cost performance category until 
additional measures are developed. However, we also noted that cost is 
a critical component of the Quality Payment Program and believe placing 
additional emphasis on the cost performance category in future years 
may be appropriate. Therefore, we solicited comment on redistributing 
weight to the cost performance category in future years.
    We thank commenters for their input and will take this input into 
consideration in future years.
(c) Final Score Calculation
    We proposed to revise the formula at Sec.  414.1380(c) for 
calculating the final score (83 FR 35970). We did not propose to 
continue to add the small practice bonus to the final score for the 
2021 MIPS payment year and proposed to add a small practice bonus to 
the quality performance category score instead starting with the 2021 
MIPS payment year (83 FR 35950 through 35951). Therefore, we proposed 
to revise the formula to omit the small practice bonus from the final 
score calculation beginning with the 2021 MIPS payment year (83 FR 
35970). We requested public comments on this proposal.
    Although we received several comments on the small practice bonus, 
we did not receive any comments on our proposed revisions to the 
formula to calculate the final score. We discuss our policy for our 
revised small practice bonus in the quality performance category in 
section III.I.3.i.(1)(b)(viii) of this final rule.
    After consideration of public comments, we are finalizing our 
proposed revisions to Sec.  414.1380(c) as proposed.
    In the CY 2019 PFS proposed rule, we solicited comments on 
approaches to simplify calculation of the final score (83 FR 35970). We 
thank commenters for their input and will take this input into 
consideration in future years.
j. MIPS Payment Adjustments
(1) Final Score Used in Payment Adjustment Calculation
    For our previously established policies regarding the final score 
used in payment adjustment calculations, we refer readers to the CY 
2017 Quality Payment Program final rule (81 FR 77330 through 77332) and 
the CY 2018 Quality Payment Program final rule (82 FR 53785 through 
53787). Under our policies, for groups submitting data using the TIN 
identifier, we will apply the group final score to all the TIN/NPI 
combinations that bill under that TIN during the performance period (82 
FR 53785). We proposed to modify this policy for the application of the 
group final score, beginning with the 2019

[[Page 59879]]

performance period/2021 MIPS payment year (83 FR 35971). We proposed a 
15-month window that starts with the second segment of the MIPS 
determination period (October 1 prior to the MIPS performance period 
through September of the MIPS performance period) and also includes the 
final 3 months of the calendar year of the performance period (October 
1 through December 31 of the performance period year) (83 FR 35971). We 
proposed for groups submitting data using the TIN identifier, we would 
apply the group final score to all of the TIN/NPI combinations that 
bill under that TIN during the proposed 15-month window (83 FR 35971). 
We stated that we believe that partially aligning with the second 
segment of the MIPS determination period creates consistency with our 
eligibility policies that informs a group or eligible clinician of who 
is eligible. We refer readers to the CY 2019 PFS proposed rule (83 FR 
35884 through 35886) where we discuss our proposals related to MIPS 
determination periods.
    We noted that, if a MIPS eligible clinician's TIN/NPI combination 
was not part of the group practice during the MIPS determination 
period, the TIN/NPI combination would not be identified in our system 
at the start of the MIPS data submission period; however, if the MIPS 
eligible clinician qualifies to receive the group final score under our 
proposal, we would apply the group final score to the MIPS eligible 
clinician's TIN/NPI combination as soon as the information becomes 
available.
    We solicited comments on the above proposal.
    Comment: One commenter supported the concept of assigning a group 
score to clinicians who are in a group during the final 3 months of the 
calendar year of the performance period, stating that it is 
administratively burdensome for large organizations to track clinicians 
who join their practice during the last 3 months of the calendar year 
of the performance period and determine whether or not their previous 
practice intends to submit data on their behalf for the same calendar 
year of the performance period.
    Response: We thank the commenter for their support.
    Comment: One commenter expressed concern with the 15-month gap 
between the end of the first segment of the MIPS determination period 
and the end of the calendar year of the MIPS performance period for 
clinicians in groups who qualify for a group final score. The commenter 
stated that many clinicians move from one TIN to another and 
recommended we allow groups to report both on behalf of individual 
clinicians or as a group for all clinicians who have assigned their 
billing rights to the TIN during the calendar year of the performance 
period.
    Response: We realize that the first segment of the MIPS 
determination period, as codified in this final rule at Sec.  414.1305, 
ends 15 months before the end of the calendar year of the performance 
period; however, we believe the performance of a group should coincide, 
to the extent possible, with clinicians who are in the group during the 
performance period. Therefore, we believe it is appropriate to use the 
15-month window which includes the second segment of the MIPS 
determination period and the last 3 months of the calendar year of the 
performance period. We note that group reporting is an option and 
practices may elect to submit for individual eligible clinicians, 
rather than as a group, as long as eligible clinicians are identified 
prior to end of the second segment of the MIPS determination period. As 
discussed in section III.I.3.i.(2)(b)(ii)(C) of this final rule, we do 
not have the ability to accept data for new group practices formed in 
the last 3 months of the calendar year of the performance period, or 
for individual MIPS eligible clinicians who switch practices in the 
last 3 months of the calendar year of the performance period if their 
new practice is not participating in MIPS as a group.
    Comment: One commenter did not support the proposed 15-month 
window, citing the need for additional clarity and guidance to avoid 
complexity and confusion, and suggested that CMS provide examples of 
how this policy would apply in different scenarios. This commenter also 
recommended that CMS consider the implications of the proposal on 
clinician employment and how the proposal may negatively impact the 
ability of clinicians to switch practices.
    Response: We do not agree that this proposal would cause confusion 
or add complexity. We believe the 15-month window aligns with our 
eligibility policies and better informs clinicians about their 
eligibility, streamlining the program. For example, for the 2019 MIPS 
performance period, if an eligible clinician joins a group practice in 
November of 2019 and that group practice existed prior to the last 3 
months of the year (that is, prior to October 1, 2019) and submits MIPS 
data as a group, we would apply the group final score to that eligible 
clinician if the clinician bills under the group's TIN during the 
proposed 15-month window. Another example is a MIPS eligible clinician 
who joins a group practice in October of 2018 and that group practice 
submits MIPS data as a group for the 2019 MIPS performance period; for 
the 2019 performance period, we would apply the group final score to 
that eligible clinician if the clinician bills under the group's TIN 
during the proposed 15-month window. We appreciate the suggestion to 
consider the policy's implications on clinician employment and will 
take this into consideration in future rulemaking.
    After consideration of the comments we received, we are finalizing 
our proposed 15-month window that starts with the second segment of the 
MIPS determination period (October 1 prior to the calendar year of the 
performance period through September 30 of the calendar year of the 
performance period) and also includes the final 3 months of the 
calendar year of the performance period (October 1 through December 31 
of the calendar year of the performance period). We are also finalizing 
that for groups submitting data using the TIN identifier, we will apply 
the group final score to all of the TIN/NPI combinations that bill 
under that TIN during the 15-month window. We refer readers to section 
III.I.3.i.(2)(b)(ii)(C) of this final rule for a detailed discussion of 
the reweighting of the quality, cost, improvement activities and 
Promoting Interoperability performance categories for MIPS eligible 
clinicians who join a group practice in the final 3 months of the 
calendar year of the performance period.
(2) Establishing the Performance Threshold
    Under section 1848(q)(6)(D)(i) of the Act, for each year of MIPS, 
the Secretary shall compute a performance threshold with respect to 
which the final scores of MIPS eligible clinicians are compared for 
purposes of determining the MIPS payment adjustment factors under 
section 1848(q)(6)(A) of the Act for a year. The performance threshold 
for a year must be either the mean or median (as selected by the 
Secretary, and which may be reassessed every 3 years) of the final 
scores for all MIPS eligible clinicians for a prior period specified by 
the Secretary.
    Section 1848(q)(6)(D)(iii) of the Act included a special rule for 
the initial 2 years of MIPS, which requires the Secretary, prior to the 
performance period for such years, to establish a performance threshold 
for purposes of determining the MIPS payment adjustment factors under 
section 1848(q)(6)(A) of the Act and an additional performance 
threshold for purposes of determining the additional MIPS payment 
adjustment factors under section 1848(q)(6)(C) of the Act, each of

[[Page 59880]]

which shall be based on a period prior to the performance period and 
take into account data available for performance on measures and 
activities that may be used under the performance categories and other 
factors determined appropriate by the Secretary. Section 51003(a)(1)(D) 
of the Bipartisan Budget Act of 2018 amended section 1848(q)(6)(D)(iii) 
of the Act to extend the special rule to apply for the initial 5 years 
of MIPS instead of only the initial 2 years of MIPS.
    In addition, section 51003(a)(1)(D) of the Bipartisan Budget Act of 
2018 added a new clause (iv) to section 1848(q)(6)(D) of the Act, which 
includes an additional special rule for the third, fourth, and fifth 
years of MIPS (the 2021 through 2023 MIPS payment years). This 
additional special rule provides, for purposes of determining the MIPS 
payment adjustment factors under section 1848(q)(6)(A) of the Act, in 
addition to the requirements specified in section 1848(q)(6)(D)(iii) of 
the Act, the Secretary shall increase the performance threshold for 
each of the third, fourth, and fifth years to ensure a gradual and 
incremental transition to the performance threshold described in 
section 1848(q)(6)(D)(i) of the Act (as estimated by the Secretary) 
with respect to the sixth year (the 2024 MIPS payment year) to which 
the MIPS applies.
    To determine a performance threshold to propose for the third year 
of MIPS (2019 MIPS performance period/2021 MIPS payment year), in the 
CY 2019 PFS proposed rule (83 FR 35971), we again relied upon the 
special rule in section 1848(q)(6)(D)(iii) of the Act, as amended by 
51003(a)(1)(D) of the Bipartisan Budget Act of 2018. As required by 
section 1848(q)(6)(D)(iii) of the Act, we considered data available 
from a prior period with respect to performance on measures and 
activities that may be used under the MIPS performance categories. In 
accordance with newly added clause (iv) of section 1848(q)(6)(D) of the 
Act, we also considered which data could be used to estimate the 
performance threshold for the 2024 MIPS payment year to ensure a 
gradual and incremental transition from the performance threshold we 
would establish for the 2021 MIPS payment year. In the CY 2019 PFS 
proposed rule (83 FR 35971), we noted that we considered using the 
final scores for the 2017 MIPS performance period/2019 MIPS payment 
year; however, the data used to calculate the final scores was 
submitted through the first quarter of 2018, and final scores for MIPS 
eligible clinicians were not available in time for us to use in our 
analyses. We noted that if technically feasible, we would consider 
using the actual data used to determine the final scores for the 2019 
MIPS payment year to estimate a performance threshold for the 2024 MIPS 
payment year in the final rule.
    Because the final scores for MIPS eligible clinicians were not yet 
available at the time of the CY 2019 PFS proposed rule, we reviewed the 
data relied upon for the CY 2017 Quality Payment Program final rule 
regulatory impact analysis (81 FR 77514 through 77536) as we believed 
it was the best data available to us to estimate the actual data for 
the 2017 MIPS performance period/2019 MIPS payment year (83 FR 35971). 
Please refer to the CY 2019 PFS proposed rule (83 FR 35971 through 
35973) for more details about the data we used.
    In accordance with section 1848(q)(6)(D)(i) of the Act, the 
performance threshold for the 2024 MIPS payment year would be either 
the mean or median of the final scores for all MIPS eligible clinicians 
for a prior period specified by the Secretary. In the CY 2019 PFS 
proposed rule (83 FR 35972), we stated that when we analyzed the 
estimated final scores for the first year of the program (the 2019 MIPS 
payment year), the mean final score was between 63.50 and 68.98 points 
and the median was between 77.83 and 82.5 points based on the different 
participation assumptions. For purposes of estimating the performance 
threshold for the 2024 MIPS payment year, we used the mean final score 
based on data used for the CY 2017 Quality Payment Program final rule 
regulatory impact analysis (81 FR 77514 through 77536), which resulted 
in an estimated performance threshold between 63.50 and 68.98 points 
for the 2024 MIPS payment year. We noted that this is only an 
estimation we are providing in accordance with section 
1848(q)(6)(D)(iv) of the Act, and we will propose the actual 
performance threshold for the 2024 MIPS payment year in future 
rulemaking.
    We proposed a performance threshold of 30 points for the 2021 MIPS 
payment year to be codified at Sec.  414.1405(b)(6) (83 FR 35972). A 
performance threshold of 30 points would be a modest increase over the 
performance threshold for the 2020 MIPS payment year (15 points), and 
we stated that we believe it would provide a gradual and incremental 
transition to the performance threshold we will establish for the 2024 
MIPS payment year, which we have estimated would be between 63.50 and 
68.98 points.
    We stated that we want to encourage continued participation and the 
collection of meaningful data by MIPS eligible clinicians. A higher 
performance threshold would help MIPS eligible clinicians strive to 
achieve more complete reporting and better performance and prepare MIPS 
eligible clinicians for the 2024 MIPS payment year. However, a 
performance threshold set too high could also create a performance 
barrier, particularly for MIPS eligible clinicians who did not 
previously participate in PQRS or the EHR Incentive Programs. 
Additionally, we stated that we believe a modest increase from the 
performance threshold for the 2020 MIPS payment year would be 
particularly important to reduce the burden for MIPS eligible 
clinicians in small or solo practices. We stated that we believe that 
active participation of MIPS eligible clinicians in MIPS will improve 
the overall quality, cost, and care coordination of services provided 
to Medicare beneficiaries.
    In the CY 2019 PFS proposed rule (83 FR 35972), we noted that we 
heard from stakeholders requesting that we continue a low performance 
threshold and from stakeholders that requested we ramp up the 
performance threshold to help MIPS eligible clinicians prepare for a 
future performance threshold of the mean or median of final scores and 
to meaningfully incentivize higher performance. We also noted that we 
heard from stakeholders who stated a higher performance threshold may 
incentivize higher performance by MIPS eligible clinicians through 
higher positive MIPS payment adjustments for those who exceed the 
performance threshold. We noted our belief that a performance threshold 
of 30 points for the 2021 MIPS payment year would provide a gradual and 
incremental increase from the performance threshold of 15 points for 
the 2020 MIPS payment year and could incentivize higher performance by 
MIPS eligible clinicians.
    We also noted our belief that a performance threshold of 30 points 
represents a meaningful increase compared to 15 points, while 
maintaining flexibility for MIPS eligible clinicians in the pathways 
available to achieve this performance threshold, and we provided 
examples to support our belief in the CY 2019 PFS proposed rule (83 FR 
35972). We invited public comment on the proposal to set the 
performance threshold for the 2021 MIPS payment year at 30 points (83 
FR 35972). Alternatively, we considered whether the performance 
threshold should be set at a higher or lower number, for example, 25 
points or 35 points, and also sought comment on

[[Page 59881]]

alternative numerical values for the performance threshold for the 2021 
MIPS payment year (83 FR 35972).
    We solicited comments on the above proposal.
    Comment: Many commenters supported the proposed performance 
threshold of 30 points, indicating that the increase is reasonable; is 
aligned with what they believe to be Congress's intent to ensure that 
clinicians continue to be held accountable for quality and cost; is not 
a significant change from the prior year; encourages clinicians to 
increase their engagement and performance in MIPS; and is low enough to 
protect eligible clinicians who may not have experience reporting in 
MIPS from negative payment adjustments. One commenter stated that 
raising the performance threshold may help limit the flattening impact 
of the overall cost performance category score. One commenter stated 
the modest increase would not disadvantage small practices if the small 
practice bonus and other special scoring policies remain available to 
them and is reasonable considering that a fair portion of clinicians 
are excluded from MIPS under the low-volume threshold.
    Response: We thank the commenters for their support.
    Comment: Many commenters did not support the proposed performance 
threshold of 30 points and stated it is too high, is not gradual 
enough, would be unduly taxing, and many eligible clinicians are still 
adapting to the complexities of the MIPS program. Several commenters 
did not support the performance threshold citing the number of policy 
changes to the MIPS program and stated that group practices and 
clinicians, including newly eligible clinicians, should gain experience 
with MIPS policy changes, including changes to episode-based cost 
measures and the restructuring of the Promoting Interoperability 
performance category, before the performance threshold is raised. 
Several commenters recommended a performance threshold of 20 points 
given the number of changes being proposed. Commenters also indicated 
20 points would help newly eligible clinicians adjust to program 
reporting requirements and that it could be met or exceeded by 
reporting on 6 quality measures that receive at least 3 points per 
measure and one high weighted improvement activity or 2 medium weighted 
improvement activities to avoid a negative MIPS payment adjustment. A 
few commenters indicated that clinicians need more time to be educated 
about the MIPS program.
    Response: We acknowledge the concerns submitted by many commenters. 
We recognize that many requirements and scoring policies in the MIPS 
program have changed since the 2017 MIPS performance period/2019 MIPS 
payment year, but we believe the proposed performance threshold of 30 
points is an appropriate increase that encourages increased 
participation and engagement in the MIPS program and that incentivizes 
clinicians to transition to value-based care with a focus on the 
delivery of high-value care.
    We also do not believe that increasing the performance threshold to 
30 points is unreasonable or too steep, but is rather a moderate step 
that encourages clinicians to gain experience with all MIPS performance 
categories. In the CY 2019 PFS proposed rule, we estimated the 
performance threshold we would establish for the 2024 MIPS payment year 
would be between 63.50 and 68.98 points. This information was based on 
year 1 estimates from the regulatory impact analysis (83 FR 35972; 81 
FR 77514 through 77536). When we looked at the actual final scores for 
MIPS eligible clinicians for the 2017 MIPS performance period/2019 MIPS 
payment year, we found the mean final score was 74.01 points and the 
median final score was 88.97 points. As discussed in section VII.F.8.d. 
of the Regulatory Impact Analysis (RIA) of this final rule, we also 
estimated the potential final scores for the 2019 MIPS performance 
period/2021 MIPS payment year. In the RIA, we updated our estimates by 
using data submitted for the first year of MIPS (2017 MIPS performance 
period/2019 MIPS payment year) and applying the scoring and eligibility 
policies for the third year of MIPS (the 2019 MIPS performance period/
2021 MIPS payment year). In the RIA, we estimated the mean final score 
for the 2019 performance period/2021 MIPS payment year at 69.53 points 
and the median final score at 78.72 points. Based on these numbers, we 
estimate the performance threshold that we would establish for the 2024 
MIPS payment year would likely be over 65 points. We believe that if we 
set the performance threshold at 20 points (or another number lower 
than 30 points) for the 2021 MIPS payment year, then the increases in 
the performance threshold for each of the 2022 and 2023 MIPS payment 
years would have to be steeper to ensure a gradual and incremental 
transition to the performance threshold for the 2024 MIPS payment year, 
in accordance with 1848(q)(6)(D)(iv) of the Act.
    Additionally, we recognize that some policy changes, such as those 
finalized in this final rule for the Promoting Interoperability 
performance category, the impact of topped out measures on the quality 
performance category, the increased weighting of the cost performance 
category, and the introduction of episode-based cost measures may 
dampen final scores because it will be more difficult to achieve a 
perfect performance category score of 100 percent. However, we believe 
there are also many options for a MIPS eligible clinician, including a 
newly eligible clinician, to earn a final score at or above a 
performance threshold of 30 points that do not require a perfect score 
in every performance category and that these policies do not preclude a 
MIPS eligible clinician from performing well. For example, a MIPS 
eligible clinician that submits the maximum number of improvement 
activities (achieving 40 points out of a possible 40 points) that is 
weighted at 15 percent of the final score (100 percent improvement 
activities performance category score x 15 percent x 100 equals 15 
points toward the final score) and achieves a quality performance 
category score of 35 percent \31\ that could be achieved through a 
minimum of complete reporting of quality measures at varying levels of 
performance (35 percent quality performance category score x 45 percent 
x 100 equals 15.75 points toward the final score) would qualify for 
30.75 points and exceed the performance threshold. When we also 
consider the cost and Promoting Interoperability performance categories 
scores, clinicians have even more options to exceed a 30-point 
performance threshold. While the performance threshold could be met or 
exceeded without clinician participation in the quality performance 
category, we encourage clinicians to participate in multiple 
performance categories, including the quality performance category, to 
help facilitate successful participation in MIPS when the performance 
threshold will be increased in future years and to align with the MIPS 
program's focus on value-based care and the delivery of high quality 
care for Medicare beneficiaries.
---------------------------------------------------------------------------

    \31\ The score for the quality performance category would be (6 
measure achievement points x 1 measure plus 3 measure achievement 
points x 5 measures)/60 total possible achievement points or 35 
percent. This assumes an outcome measure is submitted. That score 
could be higher if the clinician qualifies for bonuses in the 
quality performance category.
---------------------------------------------------------------------------

    We agree with commenters about the need to educate clinicians, 
including newly eligible clinicians, about MIPS program policies and 
policy changes from year to year and encourage

[[Page 59882]]

clinicians to utilize the resources available to educate clinicians 
about the MIPS program at the CMS Quality Payment Program Resource 
library at https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/Resource-library.html.
    Comment: Several commenters recommended a lower performance 
threshold specifically for eligible clinicians in their first year of 
MIPS eligibility, citing that this flexibility is more equitable and 
allows for a greater chance of successful participation, is a 
reasonable approach, and that 30 points creates an unlevel playing 
field. A few commenters recommended 25 points and other scoring 
accommodations for newly eligible clinicians, including occupational 
therapists and physical therapists. A few commenters suggested 
alternative performance thresholds for newly eligible clinicians 
including 3 points and a modified ``pick your pace'' threshold for 
these clinicians. One commenter recommended a performance threshold of 
20 points and stated a 30-point performance threshold is a very high 
standard for eligible clinicians in their first year of eligibility.
    Response: As described in section III.I.3.j.(2) of this final rule, 
the MIPS program is still ramping up, and we will continue to increase 
the performance threshold to ensure a gradual and incremental 
transition to the performance threshold for the 2024 MIPS payment year 
(year 6). Therefore, a clinician who is a MIPS eligible clinician 
beginning with the 2021 MIPS payment year would have 4 years in the 
program to ramp up to year 6. Conversely, a clinician who first becomes 
a MIPS eligible clinician in a later year would be afforded less time 
to ramp up the closer the program gets to year 6. We refer readers to 
section III.I.3.a. of this final rule for our discussion of new 
eligible clinician types.
    Comment: Many commenters stated that CMS should not increase the 
performance threshold until there is actual MIPS participation data 
available to analyze and share with clinicians, indicating that there 
is insufficient historical MIPS data on which to set benchmarks and 
determine the feasibility of the current performance threshold, the 
program is still in its early stages, and that use of actual data would 
provide eligible clinicians a greater sense of how they performed in 
the program overall.
    Response: We appreciate the commenters' concerns with the proposed 
performance threshold and their request for a delay in increasing the 
performance threshold until we have more information about how 
clinicians are actually performing under MIPS. As discussed earlier in 
this section, we estimate that we would likely set the performance 
threshold for the 2024 MIPS payment year at over 65 points. We did 
analyze the actual final scores for the 2019 MIPS payment year and 
found the mean final score was 74.01 points and the median final score 
was 88.97 points for MIPS eligible clinicians. We believe that setting 
the performance threshold at 30 points for the 2019 performance period/
2021 MIPS payment year is appropriate because it encourages increased 
participation and prepares clinicians for the additional participation 
requirements to meet or exceed the performance thresholds that will be 
set for later years. Additionally, we do not believe that keeping the 
performance threshold at 15 points (which was the performance threshold 
for the 2020 MIPS payment year) would provide the gradual and 
incremental transition to the performance threshold for the 2024 MIPS 
payment year required by section 1848(q)(6)(D)(iv) of the Act.
    We also note that eligible clinicians have received performance 
feedback based on their performance in year 1 of MIPS. As previously 
finalized in the CY 2018 Quality Payment Program final rule (82 FR 
53801 through 53802), on an annual basis, beginning July 1, 2018, 
performance feedback will be provided to MIPS eligible clinicians and 
groups for the quality and cost performance categories for the 2017 
performance period, and if technically feasible, for the improvement 
activities and advancing care information (now known as Promoting 
Interoperability) performance categories. For details on the release of 
the feedback reports for the first year of MIPS, we refer readers to 
section III.I.3.g. of this final rule.
    Comment: Several commenters did not support the proposed 
performance threshold of 30 points, stating their belief that it 
burdens smaller practices, especially individual clinicians who are 
unable to afford CEHRT. A few commenters recommended that CMS consider 
a bonus for solo practitioners.
    Response: We acknowledge the concerns of commenters regarding the 
potential burden on small practices, particularly solo practitioners. 
We also recognize the unique challenges for solo practitioners who 
participate in MIPS and have established a set of policies for small 
practices that apply to solo practitioners as well. The special 
policies available for small practices include the small practice bonus 
which is finalized in section III.I.3.i.(1)(b)(viii) of this final 
rule; the provisions related to the assignment of 3 points for measures 
that do not meet data completeness criteria which are finalized in 
section III.I.3.i.(1)(b)(v) of this final rule; the significant 
hardship exception for Promoting Interoperability performance category 
and the associated reweighting policies available for small practices 
(CY 2018 Quality Payment Program final rule (82 FR 53683)); and special 
scoring provisions available for the improvement activities performance 
category (81 FR 77185, 77188; 82 FR 53656. We also note that clinicians 
in small practices are more likely than clinicians in larger practices 
to fall below one of the low-volume criteria and would not be required 
to submit to MIPS; however, if they exceed at least one, but not all, 
of the low volume criteria, then they would be able to take advantage 
of the opt-in policy. We refer readers to section III.I.3.c. of this 
final rule for more details.
    Comment: A few commenters recommended a more modest increase to the 
performance threshold and asked us to consider specialty-specific 
performance thresholds, or special scoring policies for clinicians in 
specialty practices, stating this would allow for more fair comparisons 
among clinicians. One commenter stated concerns with ambulatory 
surgical center-based clinicians being able to meet a 30-point 
threshold and requested that CMS consider scoring relief for ambulatory 
surgical center-based clinicians and groups. One commenter stated 
concerns for certified registered nurse anesthetists (CRNAs) meeting 
the performance threshold, citing the lack of anesthesia-related 
measures, low achievable points due to quality measure benchmarking, 
the lack of applicable cost measures, and the inability of CRNAs to 
participate in the Promoting Interoperability performance category that 
places a significant amount of time, money and resources into achieving 
performance scores to meet the minimum performance threshold. One 
commenter did not support the proposed performance threshold and 
believed that clinicians who are not capable of submitting data for 
more than one MIPS performance category could not meet the performance 
threshold.
    Response: We appreciate the unique challenges faced by MIPS 
eligible clinicians that are in specialty practices, including 
clinicians based in ambulatory surgical centers and CRNAs. However, we 
believe that different performance criteria for certain types of 
clinicians would create more confusion and burden than a cohesive set 
of criteria. We also do not believe the

[[Page 59883]]

proposed increase in the performance threshold is overly aggressive or 
unfair to specialty practices and note that there are multiple pathways 
for clinicians, including specialty practices, to meet or exceed the 
performance threshold. We also believe that except for a few 
circumstances, such as extreme and uncontrollable circumstances, rare 
cases where there are no quality measures, or clinicians joining an 
existing practice (existing TIN) during the final 3 months of the 
calendar year in which the performance period occurs (the performance 
period year) that is not participating in MIPS as a group, most MIPS 
eligible clinicians would have sufficient measures and activities 
available and applicable to them for the quality and improvement 
activities performance categories and would be scored on these two 
categories. We also have policies in place, such as data validation 
process discussed in section III.I.3.i.(1)(b)(vii) of this final rule, 
to assess if clinicians have fewer than 6 measures available and 
applicable for the quality performance category. We refer the readers 
to the discussion of our reweighting policies for extreme and 
uncontrollable circumstances at section III.I.3.i.(2)(b)(ii) of this 
final rule.
    Comment: A few commenters supported keeping a performance threshold 
of 15 points to minimize administrative burdens as part of the 
``Patients over Paperwork'' initiative and to give clinicians adequate 
time to adjust their practice to meet the program's requirements.
    Response: We are mindful of the efforts and requirements for 
eligible clinician participation in MIPS and agree that many clinicians 
need time to become familiar with the program's policies and 
requirements and gain experience with increased participation under the 
MIPS program. However, we do not believe that maintaining the 
performance threshold at 15 points for the 2019 performance period/2021 
MIPS payment year appropriately encourages clinicians to actively 
participate in MIPS and incentivizes clinicians to transition to value-
based care with a focus on the delivery of high-value care. 
Additionally, we do not believe that keeping the performance threshold 
at 15 points (which was the performance threshold for the 2020 MIPS 
payment year) would provide the gradual and incremental transition to 
the performance threshold for the 2024 MIPS payment year that the 
statute requires. We believe a meaningful increase to a performance 
threshold of 30 points maintains appropriate flexibility for clinicians 
to meet or exceed the performance threshold, while requiring increased 
participation over the level of engagement required to meet or exceed 
the 15-point threshold for year 2 of MIPS. We also believe the 
increased participation better prepares clinicians to succeed under 
MIPS in future years, will encourage a transition to the MIPS program's 
focus on value-based care, and will improve the overall quality, cost, 
and care coordination of services to Medicare beneficiaries.
    Comment: Several commenters recommended a higher performance 
threshold believing that the proposed performance threshold punishes 
eligible clinicians who have invested time and money to achieve high 
MIPS performance, compromises the ability of high performers to earn 
the maximum payment adjustment, and dilutes program effectiveness to 
drive quality improvement and reduce spending growth. A few commenters 
recommended a performance threshold between 30 points and 60 points. 
One commenter recommended a performance threshold of 50 points, stating 
it would better reward clinicians and groups who are engaged with the 
program and encourage the examination of alternative payment models.
    Response: The MIPS statute requires budget neutrality, and 
clinicians will receive a positive, negative, or neutral payment 
adjustment factor that is determined by their performance and the 
distribution of final scores across all MIPS eligible clinicians; 
accordingly, high performers would likely receive higher payment 
adjustments if fewer MIPS eligible clinicians meet or exceed the 
performance threshold. While a higher performance threshold provides a 
greater financial reward for high performers, we believe the proposal 
of 30 points is warranted to encourage clinician participation in MIPS 
and to encourage a movement toward value-based care with a focus on the 
delivery of high quality care. We also believe that the additional 
performance threshold for exceptional performance discussed later in 
section III.I.3.j.(3) of this final rule provides an additional 
financial incentive and financial reward for high performers and will 
continue to incentivize their exceptional performance. Moreover, we 
believe setting the performance threshold higher than 30 points would 
not provide a gradual and incremental transition to the performance 
threshold for the 2024 MIPS payment year, as required by the statute, 
but rather would result in a sharp increase over the performance 
threshold of 15 points for the 2020 MIPS payment year.
    After consideration of the comments, we are finalizing our proposal 
to set the performance threshold at 30 points for the 2021 MIPS payment 
year as proposed. We are codifying the performance threshold for the 
2021 MIPS payment year and finalizing the regulation text at Sec.  
414.1405(b)(6) as proposed.
    We also solicited comment on our approach to estimating the 
performance threshold for the 2024 MIPS payment year, which in the CY 
2019 PFS proposed rule we based on the estimated mean final score for 
the 2019 MIPS payment year (83 FR 35972). We were particularly 
interested in whether we should use the median, instead of the mean, 
and whether in the future we should estimate the mean or median based 
on the final scores for another MIPS payment year. We also solicited 
comment on whether establishing a path forward to a performance 
threshold for the 2024 MIPS payment year that provides certainty to 
clinicians and ensures a gradual and incremental increase from the 
performance threshold for the 2021 MIPS payment year to the estimated 
performance threshold for the 2024 MIPS payment year would be 
beneficial, and whether it would be beneficial for MIPS eligible 
clinicians to know in advance the performance threshold for the 2022 
and 2023 MIPS payment years to encourage and facilitate increased 
clinician engagement and prepare clinicians for meeting the performance 
threshold for the 2024 MIPS payment year.
    We thank commenters for their input on these topics and will take 
this input into consideration in future years.
(3) Additional Performance Threshold for Exceptional Performance
    Section 1848(q)(6)(D)(ii) of the Act requires the Secretary to 
compute, for each year of the MIPS, an additional performance threshold 
for purposes of determining the additional MIPS payment adjustment 
factors for exceptional performance under section 1848(q)(6)(C) of the 
Act. For each such year, the Secretary shall apply either of the 
following methods for computing the additional performance threshold: 
(1) The threshold shall be the score that is equal to the 25th 
percentile of the range of possible final scores above the performance 
threshold determined under section 1848(q)(6)(D)(i) of the Act; or (2) 
the threshold shall be the score that is equal to the 25th percentile 
of the actual final scores for MIPS eligible clinicians with final 
scores at or above the performance threshold for the prior period 
described in section 1848(q)(6)(D)(i) of the Act.
    Under section 1848(q)(6)(C) of the Act, a MIPS eligible clinician 
with a

[[Page 59884]]

final score at or above the additional performance threshold will 
receive an additional MIPS payment adjustment factor and may share in 
the $500,000,000 of funding available for the year under section 
1848(q)(6)(F)(iv) of the Act.
    As we discussed in the CY 2019 PFS proposed rule (83 FR 35971), we 
relied on the special rule under section 1848(q)(6)(D)(iii) of the Act, 
as amended by section 51003(a)(1)(D) of the Bipartisan Budget Act of 
2018, to propose a performance threshold of 30 points for the 2021 MIPS 
payment year. The special rule under section 1848(q)(6)(D)(iii) of the 
Act also applies for purposes of establishing an additional performance 
threshold for a year. For the 2021 MIPS payment year, we proposed to 
again decouple the additional performance threshold from the 
performance threshold (83 FR 35973 through 35974).
    During the time period in which we were drafting the CY 2019 PFS 
proposed rule, we did not have actual MIPS final scores for a prior 
performance period. We noted in the CY 2019 PFS proposed rule (83 FR 
35973) that if we did not decouple the additional performance threshold 
from the performance threshold, then we would have to set the 
additional performance threshold at the 25th percentile of possible 
final scores above the performance threshold. With a performance 
threshold set at 30 points, the range of total possible points above 
the performance threshold is 30.01 to 100 points and the 25th 
percentile of that range is 47.5, which is less than one-half of the 
possible 100 points in the MIPS final score. We stated that we do not 
believe it would be appropriate to lower the additional performance 
threshold to 47.5 points because we do not believe a final score of 
47.5 points demonstrates exceptional performance by a MIPS eligible 
clinician, as these additional incentives should only be available to 
those clinicians with very high performance on the MIPS measures and 
activities. Therefore, we relied on the special rule under section 
1848(q)(6)(D)(iii) of the Act and proposed at Sec.  414.1405(d)(5) to 
set the additional performance threshold at 80 points for the 2021 MIPS 
payment year, which is higher than the 25th percentile of the range of 
the possible final scores above the performance threshold (83 FR 
35973).
    As required by section 1848(q)(6)(D)(iii) of the Act, we took into 
account the data available and the modeling described in the CY 2019 
PFS proposed rule to estimate final scores for the 2021 MIPS payment 
year (83 FR 35973). We stated that we believed 80 points was 
appropriate to incentivize clinicians who have made greater strides to 
meaningfully participate in the MIPS program to perform at even higher 
levels. An additional performance threshold of 80 points would require 
a MIPS eligible clinician to perform well on at least two performance 
categories. We stated that, generally, a MIPS eligible clinician could 
receive a maximum score of 45 points for the quality performance 
category, which is below the 80-point additional performance threshold. 
In addition, 80 points is at a high enough level that MIPS eligible 
clinicians must submit data for the quality performance category to 
achieve this target. We noted the additional performance threshold at 
80 points could increase the incentive for excellent performance while 
keeping the focus on quality performance.
    We also stated an increase would encourage increased engagement and 
further incentivize clinicians whose performance meets or exceeds the 
additional performance threshold, recognizing that a fixed amount is 
available for a year under section 1848(q)(6)(F)(iv) of the Act to fund 
the additional MIPS payment adjustments and that the more clinicians 
who receive an additional MIPS payment adjustment, the lower the 
average clinician's additional MIPS payment adjustment will be.
    For future years, we stated that we may consider additional 
increases to the additional performance threshold.
    We solicited comments on these proposals.
    Comment: Many commenters recommended the additional performance 
threshold remain at 70 points. Several commenters stated it would be 
more difficult to reach 80 points rather than 70 points because of 
proposed changes to the Promoting Interoperability performance 
category, changes to quality measures, more topped out measures, the 
increased weighting of the cost performance category, the introduction 
of episode-based cost measures, and the removal of bonus points. One 
commenter recommended that the additional performance threshold remain 
at 70 points for at least another year because clinicians are still 
learning to interpret their feedback reports and make adjustments to 
their practices accordingly. One commenter stated that clinicians in 
specialty practices without a significant breadth of reportable 
measures would be adversely affected while those specialties that do 
have large numbers of measures with full scoring potential would 
benefit and that this was unfair and would discourage high performance 
for those clinicians and groups within specialties. One commenter 
indicated that the increase may cause more clinicians to report on 
measures that bring more points rather than the most value to their 
patients and practice. Another commenter stated the increase seemed 
arbitrary and that clinicians who earn 70 points should be considered 
exceptional. One commenter stated that keeping the additional 
performance threshold at 70 points would allow the payment adjustment 
to be spread more evenly rather than to only a select few and alleviate 
some of the lack of positive payment adjustment incentive due to the 
very low 30-point performance threshold.
    A few commenters stated the additional performance threshold should 
not be increased until information is available and data shared with 
clinicians from the first 2 years of the program about the number of 
eligible clinicians who were able to earn the additional payment 
adjustment, including the number of psychiatrists who exceeded the 
additional performance threshold during the 2017 MIPS performance 
period.
    Response: We note that many commenters recommended that we maintain 
70 points for the additional performance threshold for the 2019 
performance period/2021 MIPS payment year. However, we believe for year 
3 it is appropriate to raise the bar on what is rewarded as exceptional 
performance and that increasing the additional performance threshold 
will encourage clinicians to increase their focus on value-based care 
and enhance the delivery of high quality care for Medicare 
beneficiaries. Based on our current data, our belief that raising the 
additional performance threshold will incentivize continued improved 
performance, and our concern that policy changes may make it 
challenging for clinicians to reach an additional performance threshold 
of 80 points while they are becoming familiar and comfortable with the 
policy changes, we believe it is important to raise the additional 
performance threshold, but by less than the original amount proposed. 
Therefore, for year 3 of the MIPS program, we are finalizing the 
additional performance threshold at 75 points, which is halfway between 
our proposal of 80 points and the level recommended by many commenters 
of 70 points.
    We appreciate commenters' concerns about the proposed policy 
changes for MIPS impacting clinicians' ability to exceed the additional 
performance threshold. While we recognize that some of the policy 
changes being

[[Page 59885]]

finalized in this rule, including new scoring policies for the 
Promoting Interoperability performance category, changes to quality 
measures, the identification of more topped out measures, the increased 
weighting of the cost performance category, and the introduction of 
episode-based cost measures, may make it more challenging for 
clinicians to achieve higher scores while they are becoming more 
familiar and comfortable with these new policies, we also believe these 
policy changes help simplify and streamline the MIPS program and reduce 
overall burden after an initial adjustment period. Thus, we believe it 
is appropriate to slightly increase the additional performance 
threshold for year 3 and will consider raising it more in future years.
    In addition, despite these changes, we believe that 75 points is 
achievable for many clinicians. Based on our most current data, we 
estimated for the 2019 performance period/2021 MIPS payment year a mean 
final score of 69.53 points and a median final score of 78.72 points as 
discussed elsewhere in this section and in section VII.F.8.d. of the 
RIA of this final rule. We also believe a modest increase above the 
additional performance threshold for the 2018 MIPS performance period/
2020 MIPS payment year would result in an additional performance 
threshold that is attainable and that would allow for multiple pathways 
for clinicians, including clinicians in specialty practices whose 
choice of applicable and available measures will likely vary according 
to specialty, to perform exceptionally well and would encourage higher 
performance by clinicians for year 3 of the MIPS program.
    We acknowledge that the number of quality measures available to 
clinicians can vary by specialty and practice. We believe our quality 
performance category scoring validation policy accounts for certain 
instances where clinicians have less than 6 measure available. We 
believe these adjustments allow us to develop a fair comparison across 
different MIPS eligible clinicians and would not preclude clinicians 
from reaching the final additional performance threshold.
    We also note that we have shared performance feedback with 
clinicians and groups based on their performance in year 1 of MIPS and 
recognize that clinicians may make adjustments to their clinical 
practice in response to that feedback, and because we are trying to 
balance that year 3 is a transition year with the goal of encouraging 
clinicians to improve their performance and to deliver value-based, 
high quality care, we believe that a moderate increase to 75 points is 
appropriate.
    Comment: Many commenters supported the proposal to increase the 
additional performance threshold for exceptional performance to 80 
points for the 2021 MIPS payment year and stated it encourages strong 
performance from clinicians and health systems, supports continuous 
performance improvement, motivates and holds clinicians accountable to 
deliver quality care, creates a competitive playing field for high 
performers, rewards clinicians who have invested time and resources and 
have demonstrated success under MIPS performance standards, seems 
reasonable, and is an appropriate increase for year 3 of the program. 
One commenter supported the proposal because it ensures clinicians are 
considering both cost and quality. One commenter stated that raising 
the threshold may help with flattening the overall cost performance 
score. One commenter supported the proposal because it is high enough 
to identify exceptional scores, but was uncertain if it would translate 
into improved patient outcomes or would meet CMS objectives. One 
commenter supported the proposal should CMS continue its policies that 
provide bonus points in the MIPS program and allow for claims-based 
reporting.
    Response: We received many comments in support of our proposal for 
an additional performance threshold of 80 points. We agree with the 
commenters that raising the performance threshold encourages strong 
clinician performance, participation in multiple performance 
categories, and continuous performance improvement; provides an 
appropriate financial reward for high performers; and promotes a focus 
on the delivery of high quality, value-based care by clinicians.
    We also note that there were many commenters recommending that the 
additional performance threshold remain at 70 points and other 
commenters recommending 75 points. We have considered the totality of 
the comments and are swayed by the comments requesting a more modest 
increase to the additional performance threshold. We have also 
considered the updated regulatory impact analysis which incorporates 
Quality Payment Program year 1 data to estimate performance for the 
2019 performance period/2021 MIPS payment year in section VII.F.8.d. of 
this final rule and found a mean score of 69.53 points and a median 
final score of 78.72 points. Given these findings, we believe that a 
small decrease from the proposed additional performance threshold of 80 
points that would fall between the mean and the median would help the 
additional performance threshold remain attainable and would allow for 
a larger number of clinicians to receive the additional payment 
adjustment.
    We also believe an increase in the additional performance threshold 
would incentivize clinicians to increase their focus on value-based 
care with an emphasis on the delivery of high quality care for 
patients, but that an increase of 10 points is too steep, and thus, are 
finalizing an additional performance threshold of 75 points that is 
midway between our original proposal of 80 points and the additional 
performance threshold for the 2018 MIPS performance period/2020 MIPS 
payment year of 70 points.
    Comment: A few commenters stated an increase to 80 points would 
disproportionately impact small practices and make it difficult for 
them to participate successfully in the MIPS program. One commenter 
recommended CMS should not increase the additional performance 
threshold until data was available to consider the impact on small 
practices and then set a fair threshold.
    Response: We recognize the unique challenges to eligible clinicians 
in small practices participating in MIPS and believe the special 
policies for small practices provide some relief for small practices 
seeking to perform well. We refer readers to special policies for small 
practices including: The small practice bonus which is finalized in 
section III.I.3.i.(1)(b)(viii) of this final rule; the significant 
hardship exception for the Promoting Interoperability performance 
category available for small practices (CY 2018 Quality Payment Program 
final rule 82 FR 53683); the special scoring provisions available for 
the improvement activities performance category (81 FR 77185, 77188; 82 
FR 53656); and the provisions related to the assignment of 3 points for 
measures that do not meet data completeness criteria which are 
finalized in section III.I.3.i.(1)(b)(v) of this final rule). We also 
note that small practices are more likely than larger practices to fall 
below one or more of the provisions related to the low-volume threshold 
and would be able to take advantage of the opt-in policy and refer 
readers to a discussion of the low-volume threshold at section 
III.I.3.c. of this final rule.
    We also analyzed the data referenced in section VII.F.8.d. of the 
RIA of this final rule, and found that more small practices than larger 
practices may find it harder to meet or exceed the additional 
performance threshold. We

[[Page 59886]]

agree with commenters referenced here and elsewhere in this section 
that an additional performance threshold of 80 points is too steep of 
an increase from 70 points, but we believe that an increase is 
appropriate for year 3 and that the current policies that provide 
flexibilities for small practice provide a pathway for a successful 
transition for clinicians who have made a commitment toward value and 
the delivery of high quality care in the MIPS program. Based on these 
competing concerns, as noted above, we are finalizing an additional 
performance threshold of 75 points.
    We also note that the additional performance threshold rewards 
exceptional performance in the MIPS program and a clinician could 
successfully participate in MIPS by meeting or exceeding the 
performance threshold and receive a neutral or positive payment 
adjustment.
    Comment: A few commenters recommended 75 points because it is a 
more modest, 5-point increase from the previous performance threshold 
of 70 points. One commenter supported 75 points believing the increase 
seems fair because the threshold is more attainable for many eligible 
clinicians who are specialists, such as those practicing interventional 
pain management, who may have difficulty identifying relevant measures 
that improve patient quality of care. One commenter supported 75 points 
should CMS finalize its proposal to remove claims-based reporting and 
finalize its proposal to remove bonus points for improvement activities 
completed using CEHRT.
    Response: We agree with an additional performance threshold of 75 
points. We believe for year 3 it is appropriate to raise the bar on 
what is rewarded as exceptional performance and that increasing the 
additional performance threshold will encourage clinicians to increase 
their focus on value-based care and promote the delivery of high 
quality care for patients. We also believe that a more modest increase 
of 5 points, rather than an increase of 10 points, over the additional 
performance threshold for year 2 is appropriate because year 3 is still 
a transition year and we want to encourage increased clinician 
engagement and increased performance in the MIPS program that drives 
toward the delivery of value-based, high quality care for Medicare 
beneficiaries. We also note that some commenters stated that the 
proposed 10-point increase may have unintended consequences especially 
because of the impact that proposed policy changes could have on final 
scores as clinicians are becoming familiar with these changes. We want 
to reward exceptional performance that, given the impact of the policy 
changes in this final rule, could be less than 80 points. As such, we 
are swayed by comments that an increase to 75 points is more modest and 
a reasonable half-way point that still would raise the bar on what is 
rewarded as exceptional performance for the 2019 MIPS performance 
period.
    We note that a lower additional performance threshold could reduce 
the maximum additional payment adjustment that a MIPS eligible 
clinician could potentially receive if the funds available (up to $500 
million for the year) are distributed over more clinicians that score 
above the lower additional performance threshold. For the reasons 
discussed above, we believe 75 points is appropriate for year 3 and 
note that the additional performance threshold will be raised in future 
years.
    Comment: A few commenters recommended a higher additional 
performance threshold for exceptional performers. One commenter 
recommended an additional performance threshold of 85 points to further 
efforts to engage clinicians and groups through financial incentives 
tied to metric performance. One commenter recommended a steeper scale 
for awarding exceptional performance for scores of 90 points or 
greater.
    Response: We believe that a steeper increase in the additional 
performance threshold is not appropriate given that MIPS is still in a 
transition period and because of the MIPS policy changes we are making 
in this final rule that include scoring changes to the Promoting 
Interoperability performance category and the addition of episode-based 
cost measures to the cost performance category, that could impact final 
scores for year 3 of the MIPS program as eligible clinicians become 
more familiar and comfortable with these policy changes. We want to 
reward exceptional performance that, given the impact of our policy 
changes in this final rule, could include performance below 85 or 90 
points, particularly for small practices which may not have sufficient 
case minimum to achieve maximum quality performance category score. We 
recognize a higher additional performance threshold will allow for a 
higher financial reward for high performers, but we want to encourage 
participation with wider availability of this funding.
    Comment: One commenter recommended that CMS increase the thresholds 
in the CY 2020 performance period and going forward because higher 
thresholds will result in a wider array of payment adjustments, thereby 
encouraging more participation and rewarding those that invest in 
improving their quality of care.
    Response: We thank the commenter for the input and will take this 
comment into consideration in future rule-making.
    After consideration of the comments, we are not finalizing our 
proposal of 80 points for the additional performance threshold and 
instead are finalizing 75 points for the additional performance 
threshold for the 2021 MIPS payment year. We are codifying the 
additional performance threshold for the 2021 MIPS payment year and 
finalizing the proposed regulation text at Sec.  414.1405(d)(5) with 
modification to reflect 75 points instead of 80 points.
(4) Application of the MIPS Payment Adjustment Factors
(a) Application to the Medicare Paid Amount for Covered Professional 
Services
    In the CY 2018 Quality Payment Program final rule (82 FR 53795), we 
finalized the application of the MIPS payment adjustment factor, and if 
applicable, the additional MIPS payment adjustment factor, to the 
Medicare paid amount for items and services paid under Part B and 
furnished by the MIPS eligible clinician during the year. Sections 
51003(a)(1)(A)(i) and 51003(a)(1)(E) of the Bipartisan Budget Act of 
2018 amended sections 1848(q)(1)(B) and 1848(q)(6)(E) of the Act, 
respectively, by replacing the references to ``items and services'' 
with ``covered professional services'' (as defined in section 
1848(k)(3)(A) of the Act). Covered professional services as defined in 
section 1848(k)(3)(A) of the Act are those services for which payment 
is made under, or is based on, the Medicare PFS and which are furnished 
by an eligible professional. As a result of these changes, the MIPS 
payment adjustment factor determined under section 1848(q)(6)(A), and 
as applicable, the additional MIPS payment adjustment factor determined 
under section 1848(q)(6)(C) of the Act, will be applied to Part B 
payments for covered professional services furnished by a MIPS eligible 
clinician during a year beginning with the 2019 MIPS payment year and 
not to Part B payments for other items and services.
    To conform with these amendments to the statute, we proposed to 
revise Sec.  414.1405(e) to apply the MIPS payment adjustment factor 
and, if applicable, the additional MIPS payment adjustment factor, to 
the

[[Page 59887]]

Medicare Part B paid amount for covered professional services furnished 
by a MIPS eligible clinician during a MIPS payment year (beginning with 
2019) (83 FR 35973 through 35974). We also proposed to revise Sec.  
414.1405(e) to specify the formula for applying these adjustment 
factors in a manner that more closely tracks the statutory formula 
under section 1848(q)(6)(E) of the Act (83 FR 35973 through 35974). 
Specifically, we proposed the following formula: In the case of covered 
professional services (as defined in section 1848(k)(3)(A) of the Act) 
furnished by a MIPS eligible clinician during a MIPS payment year 
beginning with 2019, the amount otherwise paid under Part B with 
respect to such covered professional services and MIPS eligible 
clinician for such year, is multiplied by 1, plus the sum of: The MIPS 
payment adjustment factor divided by 100, and as applicable, the 
additional MIPS payment adjustment factor divided by 100 (83 FR 35974).
    We did not receive any comments on this proposal.
    We are finalizing our proposed changes to the regulation text at 
Sec.  414.1405(e) as proposed. We also refer readers to section 
III.I.3.a. of this final rule where we discuss the covered professional 
services to which the MIPS payment adjustment could be applied. We also 
refer readers to section III.I.3.c.(3) of this final rule where we 
discuss other conforming edits to the regulation text at Sec. Sec.  
414.1310(a), 414.1310(b), and 414.1310(d) that specify the 
circumstances when the MIPS payment adjustment would not apply to 
payments for covered professional services furnished by MIPS eligible 
clinicians on or after January 1, 2019.
(b) Application for Non-Assigned Claims for Non-Participating 
Clinicians
    In the CY 2018 Quality Payment Program final rule, we did not 
address the application of the MIPS payment adjustment for non-assigned 
claims for non-participating clinicians. In the CY 2018 Quality Payment 
Program final rule (82 FR 53795), we responded to a comment requesting 
guidance on how the MIPS payment adjustment and the calculation of the 
Medicare limiting charge amount would be applied for non-participating 
clinicians, and we stated our intention to address these issues in 
future rulemaking. Beginning with the 2019 MIPS payment year, we 
proposed that the MIPS payment adjustment does not apply for non-
assigned claims for non-participating clinicians (83 FR 35974). This 
approach is consistent with the policy for application of the value 
modifier that was finalized in the CY 2015 PFS final rule (79 FR 67950 
through 67951). Sections 1848(q)(6)(A) and 1848(q)(6)(C) of the Act 
require that we specify a MIPS payment adjustment factor, and if 
applicable, an additional MIPS payment adjustment factor for each MIPS 
eligible clinician, and section 1848(q)(6)(E) of the Act (as amended by 
section 51003(a)(1)(E) of the Bipartisan Budget Act of 2018) requires 
that these payment adjustment factor(s) be applied to adjust the amount 
otherwise paid under Part B for covered professional services furnished 
by the MIPS eligible clinician during the MIPS payment year. When non-
participating clinicians choose not to accept assignment for a claim, 
Medicare makes payment directly to the beneficiary, and the clinician 
collects payment from the beneficiary. This is referred to as a non-
assigned claim. Application of the MIPS payment adjustment to these 
non-assigned claims would not affect payment to the MIPS eligible 
clinician. Rather, it would only affect Medicare payment to the 
beneficiary. If the MIPS payment adjustment were to be applied to non-
assigned services, then the Medicare payment to a beneficiary would be 
increased when the MIPS payment adjustment is positive and decreased 
when the MIPS payment adjustment is negative. Although the statute does 
not directly address this situation, it does suggest that the MIPS 
payment adjustment is directed toward payment to the MIPS eligible 
clinician and the covered professional services they furnish. We 
continue to believe that it is important that beneficiary liability not 
be affected by the MIPS payment adjustment and that the MIPS payment 
adjustment should be applied to the amount that Medicare pays to MIPS 
eligible clinicians.
    On that basis, we proposed to apply the MIPS payment adjustment to 
claims that are billed and paid on an assignment-related basis, and not 
to any non-assigned claims, beginning with the 2019 MIPS payment year 
(83 FR 35974). We do not expect this proposal would be likely to affect 
a clinician's decision to participate in Medicare or to otherwise 
accept assignment for a particular claim, but we solicited comment on 
whether stakeholders and others believe clinician behavior would change 
as a result of this policy.
    We solicited comments on the above proposal.
    Comment: A few commenters supported the proposal to apply the 
adjustment to claims that are billed and paid on an assignment-related 
basis and not to any non-assigned claims.
    Response: We thank the commenters for their support.
    Comment: One commenter recommended that this policy be revisited in 
the next year and evaluated for unintended consequences, including 
whether there are any adverse effects on Medicare beneficiaries who see 
a non-participating clinician who does not accept assignment for a 
claim.
    Response: We thank the commenter for the input and will take this 
comment into consideration in future rulemaking.
    After consideration of the comments, we are finalizing our proposal 
to apply the MIPS payment adjustment to claims that are billed and paid 
on an assignment-related basis, and not to any non-assigned claims, 
beginning with the 2019 MIPS payment year.
(c) Waiver of the Requirement To Apply the MIPS Payment Adjustment 
Factors to Certain Payments in Models Tested Under Section 1115A of the 
Act
(i) Overview
    CMS tests models under section 1115A of the Act that may include 
model-specific payments made only to model participants under the terms 
of the model and not to any other providers of services or suppliers. 
Some of these model-specific payments may be considered payments for 
covered professional services furnished by a MIPS eligible clinician, 
meaning that the MIPS payment adjustment factor, and, as applicable, 
the additional MIPS payment adjustment factor (collectively referred to 
as the MIPS payment adjustment factors) applied under Sec.  414.1405(e) 
of our regulations would normally apply to those payments.
(ii) Summary of Proposals and Comments Received
    Section 1115A(d)(1) of the Act authorizes the Secretary to waive 
requirements of Title XVIII of the Act (and certain other requirements) 
as may be necessary solely for the purposes of testing models under 
section 1115A. We stated in the proposed rule (83 FR 35974 through 
35975) that we believe it is necessary to waive the requirement to 
apply the MIPS payment adjustment factors to a model-specific payment 
or payments (to the extent such a payment or payments are subject to 
the requirement to apply the MIPS payment adjustment factors) for 
purposes of testing a section 1115A model under which such model-
specific payment or payments are made in a specified payment amount 
(for example, $160 per-beneficiary, per-month); or paid according to a 
methodology for calculating a model-specific payment

[[Page 59888]]

that is applied in a consistent manner to all model participants. In 
both cases, applying the MIPS payment adjustment factors to these 
model-specific payments would introduce variation in the amounts of 
model-specific payments paid across model participants, which could 
compromise the model test and the evaluation thereof.
    We proposed to amend Sec.  414.1405 to add a new paragraph (f) to 
specify that the MIPS payment adjustment factors applied under Sec.  
414.1405(e) would not apply to certain model-specific payments as 
described above for the duration of a section 1115A model's testing 
beginning in the 2019 MIPS payment year (83 FR 35974 through 35975). We 
proposed to use the authority under section 1115A(d)(1) of the Act to 
waive the requirement to apply the MIPS payment adjustment factors 
under section 1848(q)(6)(E) of the Act and Sec.  414.1405(e) 
specifically for these types of payments because the waiver is 
necessary solely for purposes of testing models that involve such 
payments (83 FR 35974 through 35975). To illustrate how the proposed 
waiver would apply, and to provide notice regarding one model-specific 
payment to which this proposed waiver would apply, we included an 
example in the proposed rule involving the Monthly Enhanced Oncology 
Services (MEOS) payment in the Oncology Care Model (OCM) (83 FR 35975).
    We solicited comment on this proposal.
    The following is a summary of the public comments received in 
response to our request for comment and our responses:
    Comment: A few commenters supported our proposal to waive the 
application of the MIPS payment adjustment factors to certain model-
specific payments. The commenters agreed that these waivers are 
necessary to test models that would involve these types of model-
specific payments, and without such waivers the evaluation of certain 
models could be compromised.
    Response: We appreciate the commenters' support.
    Comment: One commenter noted that the proposed amendment at Sec.  
414.1405(f) is ambiguous as to whether paragraphs (l), (2), and (3) 
refer to three different classes of payments, or to one class of 
payments that meet all three conditions. The commenter suggested that 
we clarify our intended policy.
    Response: We clarify that only payments meeting all three 
conditions set forth at Sec.  414.1405(f) will qualify for the waiver 
of the MIPS payment adjustment factors under section 1848(q)(6)(E) of 
the Act and Sec.  414.1405(e). We have amended Sec.  414.1405(f) to 
specify that payments must meet all three conditions to reduce any 
potential ambiguity, and made further amendments to Sec.  414.1405(f) 
for greater clarity and readability and to more closely align with the 
policy described in the preamble text of the proposed rule, including 
to clarify that the regulatory text in Sec.  414.1405(f)(3) refers to 
payments made in a consistent manner to all model participants, 
including those participants subject to the MIPS payment adjustment 
factors and participants not subject to the MIPS payment adjustment 
factors.
    After considering public comments, we are finalizing our proposal 
to use the authority under section 1115A(d)(1) of the Act to waive the 
requirement to apply the MIPS payment adjustment factors under section 
1848(q)(6)(E) of the Act and Sec.  414.1405(e) specifically for 
payments specified at Sec.  414.1405(f) with the clarifying amendments 
described herein. As discussed in the CY 2019 PFS proposed rule (83 FR 
35975), one model-specific payment to which this finalized waiver will 
apply is the Monthly Enhanced Oncology Services (MEOS) payment in the 
Oncology Care Model (OCM). The duration of this waiver will begin with 
the 2019 MIPS payment year and continue for the duration of OCM.
    We proposed to provide the public with notice that this proposed 
new regulation applies to model-specific payments that the Innovation 
Center elects to test in the future in two ways: first, we would update 
the Quality Payment Program website (www.qpp.cms.gov) when new model-
specific payments subject to this proposed waiver are announced; and 
second, we would provide a notice in the Federal Register to update the 
public on any new model-specific payments to which this waiver would 
apply (83 FR 35974 through 35975).
    We solicited comment on this proposal.
    The following is a summary of the public comments received in 
response to our request for comment and our responses:
    Comment: One commenter urged CMS to denote which models and model 
specific payments are subject to this new policy on the Quality Payment 
Program website and Federal Register as soon as possible.
    Response: We plan to provide the public with notice as soon as 
practicable for model-specific payments subject to this waiver via the 
Quality Payment Program website (www.qpp.cms.gov), and separate notice 
in the Federal Register.
    After considering public comments, we are finalizing our policy as 
proposed to provide the public with notice in the following two ways: 
(1) We will update the Quality Payment Program website 
(www.qpp.cms.gov) when new model-specific payments subject to this 
waiver are announced; and (2) we will provide a notice in the Federal 
Register to update the public on any new model-specific payments to 
which this waiver will apply.
(d) CY 2018 Exclusion of MIPS Eligible Clinicians Participating in the 
Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) 
Demonstration
(i) Overview
    In conjunction with releasing the CY 2019 PFS proposed rule, CMS 
announced the Medicare Advantage Qualifying Payment Arrangement 
Incentive (MAQI) Demonstration, established by CMS using our 
demonstration authority under section 402 of the Social Security 
Amendments of 1967 (as amended). The MAQI Demonstration is designed to 
test whether excluding MIPS eligible clinicians who participate to a 
sufficient degree in certain payment arrangements with Medicare 
Advantage Organizations (MAOs) from the MIPS reporting requirements and 
payment adjustments will increase or maintain participation in payment 
arrangements similar to Advanced APMs with MAOs and change the manner 
in which clinicians deliver care.
(ii) Summary of Proposals
    We proposed to use the authority in section 402(b) of the Social 
Security Amendments of 1967 (as amended) to waive requirements of 
section 1848(q)(6)(E) of the Act and the regulations implementing it in 
order to waive the payment consequences (positive, negative or neutral 
adjustments) of the MIPS and to waive the associated MIPS reporting 
requirements in 42 CFR part 414 adopted to implement the payment 
consequences, subject to conditions outlined in the Demonstration. We 
noted, relating to our proposal to waive payment consequences, that the 
Demonstration would have the effect of removing MIPS eligible 
clinicians from the population across which positive and negative 
payment adjustments are calculated under MIPS, and because of the 
requirement to ensure budget neutrality with regard to the MIPS payment 
adjustments under section 1848(q)(6)(F)(ii) of the Act, the 
Demonstration may affect the payment

[[Page 59889]]

adjustments for other MIPS eligible clinicians.
    We proposed that these waivers would be applicable for a MIPS 
eligible clinician participating in the Demonstration if they meet 
combined thresholds for Medicare payments or patients through 
Qualifying Payment Arrangements with MAOs and Advanced APMs, and that 
these thresholds would match the thresholds for participation in 
Advanced APMs under the Medicare Option of the Quality Payment Program. 
We also proposed to calculate thresholds based on aggregate 
participation in Advanced APMs and Qualifying Payment Arrangements with 
MAOs, without applying a specific minimum threshold to participation in 
either type of payment arrangement. For purposes of the Demonstration, 
we proposed to make determinations about clinicians' Qualifying Payment 
Arrangements with MAOs, consistent with the criteria used for Other 
Payer Advanced APMs under the Quality Payment Program and as set forth 
in Sec.  414.1420. We proposed to begin the MAQI Demonstration in CY 
2018, with the 2018 Performance Period, and operate the project for a 
total of 5 years.
    We also noted in the proposed rule that, for eligible clinicians 
who are excluded from the MIPS reporting requirements and payment 
adjustment under the MAQI Demonstration, we would waive the provision 
in section 1848(q)(1)(A)(iii) of the Act requiring that the Secretary 
shall permit any eligible clinician to voluntarily report on applicable 
measures and activities. We clarify that, with this waiver, the 
Demonstration will prohibit voluntary reporting under the MIPS by 
eligible clinicians who participate in the Demonstration and are not 
subject to the MIPS reporting requirements and payment adjustment for a 
given year. This last waiver is intended to prevent potential gaming in 
the form of an eligible clinician intentionally submitting data showing 
poor performance for a year for which they are not subject to the MIPS 
reporting requirements and payment adjustment pursuant to the terms of 
the Demonstration in order to show improvement in their performance in 
future years when that improvement could result in higher MIPS scoring.
(iii) Applicable Waivers
    Section 402(b) of the Social Security Amendments of 1967 (as 
amended) authorizes the Secretary to waive requirements of Title XVIII 
that relate to payment and reimbursement in order to carry out 
demonstrations under section 402(a). We proposed to use this authority 
to waive certain requirements of section 1848(q) of the Act and the 
regulations implementing it, specifically the payment consequences 
(positive, negative or neutral adjustments) of the MIPS and the 
associated MIPS reporting requirements in 42 CFR part 414 (adopted to 
implement the payment consequences), subject to conditions outlined in 
the Demonstration.
    We solicited comment on these proposals.
    The following is a summary of the public comments, relating to 
proposed waivers, received in response to our request for comment and 
our responses:
    Comment: Many commenters supported the proposal to use 
demonstration waiver authority (under section 402 of the Social 
Security Amendments of 1967 (as amended)) to test the MAQI 
Demonstration.
    Response: We appreciate the commenters' support of the MAQI 
Demonstration.
    Comment: Many commenters urged CMS to use its waiver authority in 
the MAQI Demonstration to allow another path towards QP status and 
provide eligible clinicians with the 5 percent incentive payment 
offered to QPs.
    Response: Demonstration projects under the authority of section 
402(a)(1)(A) of the Social Security Amendments of 1967 are intended to 
test whether changes in payment or reimbursement will increase the 
efficiency or economy of health care services. Our actuarial analyses 
determined that a demonstration design that would grant QP status, 
including a 5 percent incentive payment, to eligible clinicians who met 
the thresholds would have introduced a significant level of new costs 
to CMS, without adequate evidence for realizing an equal amount of 
savings from the proposed interventions. Without a basis to believe 
that the economy or efficiency of health care services would be 
increased, we do not believe that it is appropriate to design a 
demonstration with such parameters. Considering that the proposed 
exclusions from MIPS reporting and payment consequences under the MAQI 
Demonstration are not anticipated to have a net cost to CMS, we plan to 
test whether these exclusions will increase or maintain clinician 
participation in payment arrangements with MAOs that are similar to 
Advanced APMs and change the manner in which clinicians deliver care. 
This test is consistent with the standards set forth in section 
402(a)(1)(A) of the Social Security Amendments of 1967.
    Comment: Some commenters urged CMS to monitor the impact of the 
Demonstration on MIPS payment adjustments, including one commenter that 
expressed concern that the MIPS- eligible population pool would be 
reduced and another commenter that expressed concern about whether the 
potential benefits being tested under the MAQI Demonstration outweigh 
any potential impacts on the level of MIPS payment adjustments.
    Response: We agree that it will be important to monitor the impact 
of the Demonstration on payments received by MIPS eligible clinicians 
to whom the waivers do not apply, but we note that it may be 
challenging to draw significant conclusions from such monitoring as 
there are many variables that may impact and influence a clinician's 
final MIPS payment adjustment. We plan to share information on 
participation levels in the MAQI Demonstration with the public as soon 
as this information is available.
    Comment: A few commenters commended CMS on starting the MAQI 
Demonstration in 2018, while a few commenters advised CMS to clarify 
the timeline associated with a CY 2018 implementation of the 
Demonstration and when determinations would be made under the 
Demonstration to identify participating eligible clinicians who are 
excluded from the MIPS reporting requirements and payment adjustments.
    Response: We appreciate certain commenters' support for beginning 
the Demonstration in CY 2018, and note that by doing so, clinicians 
that meet threshold levels of participation in Qualifying Payment 
Arrangements with MAOs in 2018 can be considered for exclusion from the 
MIPS reporting requirements and payment adjustment under the 
Demonstration a year before participation in such Qualifying Payment 
Arrangements could be considered under the All-Payer Combination 
Option. We anticipate collecting Qualifying Payment Arrangement and 
threshold information for eligible clinicians participating in the 
Demonstration starting in late fall of 2018, and making final CMS 
determinations on whether eligible clinicians meet the criteria to be 
excluded from the MIPS reporting requirements and payment adjustment, 
based on this submitted information, by December 2018 or (January 2019 
at the latest). We note that eligible clinicians participating in the 
MAQI Demonstration in 2018 will be evaluated to determine whether they 
meet the criteria to be excluded from MIPS reporting requirements for 
the 2018 MIPS performance year, and from the

[[Page 59890]]

MIPS payment adjustment for the corresponding 2020 MIPS payment year.
    Comment: Some commenters recommended that CMS make changes to the 
Demonstration criteria relating to clinician eligibility for the 
exclusion from the MIPS reporting requirements and payment adjustment, 
such as Qualifying Payment Arrangements and thresholds.
    Response: As noted in the proposed rule, we intend to use criteria 
and requirements that are consistent with the Medicare and Other Payer 
Advanced APM Options under the Quality Payment Program. Changing the 
clinician eligibility for exclusion from the MIPS reporting 
requirements and payment adjustment would not be consistent with this 
intent.
    We also received comments on other provisions associated with the 
Demonstration.
    Comment: Some commenters advised CMS to make changes to the 
Demonstration application and data collection process.
    Response: The application and data collection process are outside 
the scope of the proposals in the CY 2019 PFS proposed rule; however, 
we will seek to balance reporting burden with the need to solicit 
information necessary to ensure that the demonstration is being 
implemented, tested and evaluated appropriately.
    Comment: A few commenters requested additional agency focus in 
helping physicians and practices better understand their options under 
Medicare, Medicare Advantage, the Quality Payment Program, the MAQI 
Demonstration and other value-based payment arrangements.
    Response: We are committed to reaching our stakeholders, including 
clinicians, the technology community, private payers, and 
beneficiaries, to raise awareness that Medicare is evolving quickly to 
a value-based system. In addition to raising awareness that change is 
occurring, we will continue current efforts to engage in a learning 
process with stakeholders where they may voice opinions and suggestions 
to help collaboratively drive the goals of the Quality Payment Program. 
We will continue to set expectations that this will be an iterative 
process, and, while change will not happen overnight, we are committed 
to continuing our work to improve how Medicare pays for quality and 
value, instead of the quantity of services. We will continue to reach 
out to the clinician community and others to partner in the development 
of ongoing education, support, and technical assistance materials and 
activities to help clinicians understand program and model 
requirements, how to use available tools to enhance their practices, 
improve quality, reduce expenditures, and progress to participation in 
Advanced APMs if that is the best choice for their practice.
    We are offering support in the form of fact sheets, webinars, 
online courses, and direct technical assistance to help clinicians 
successfully participate in the Quality Payment Program, the MIPS or 
the Advanced APM track. This range of support to help clinician 
practices actively participate in the Quality Payment Program that can 
be found at the following website at https://qpp.cms.gov/.
    We also discussed that the Demonstration would waive the provision 
in section 1848(q)(1)(A)(iii) of the Act that the Secretary shall 
permit any eligible clinician to voluntarily report on applicable 
measures and activities, so that the Demonstration would prohibit 
reporting under the MIPS by eligible clinicians who participate in the 
Demonstration and meet the thresholds to be excluded from the MIPS 
reporting requirements and payment adjustment for a given year. We did 
not receive any comments on this proposal. We explained that this 
waiver is necessary to prevent the potential gaming opportunity wherein 
participating clinicians could intentionally report artificially poor 
performance under the MIPS for years in which they receive waivers from 
MIPS payment consequences, then receive artificially inflated quality 
improvement points under MIPS in later years when they do not receive 
waivers from MIPS payment consequences. We note here that by 
prohibiting reporting under MIPS we are also, in effect, disallowing 
MIPS performance feedback for those clinicians who participate in the 
Demonstration and meet the criteria to be excluded from the MIPS 
reporting requirements and payment adjustments. Eligible clinicians who 
participate in the Demonstration but are not excluded from the MIPS 
reporting requirements and payment adjustment (whether through 
participation in the Demonstration or otherwise) would continue to be 
MIPS eligible clinicians who are subject to the MIPS reporting 
requirements and payment adjustment as usual.
(iv) Summary of Finalized Policies
    After considering public comments, we are finalizing our proposals 
to implement the MAQI Demonstration in CY 2018 and use the authority in 
section 402(b) of the Social Security Amendments of 1967 (as amended) 
to waive certain requirements of section 1848(q)(6)(E) of the Act, 
specifically the payment consequences (positive, negative or neutral 
adjustments) of the MIPS and the associated MIPS reporting requirements 
in 42 CFR part 414 adopted to implement the payment consequences, 
subject to conditions outlined in the Demonstration. We are also 
finalizing that we will waive the provision in section 
1848(q)(1)(A)(iii) of the Act that the Secretary shall permit any 
eligible clinician to voluntarily report on applicable measures and 
activities, so that the Demonstration will prohibit reporting under the 
MIPS by eligible clinicians who participate in the Demonstration and 
meet the thresholds that will trigger application of the waivers from 
the MIPS reporting requirements and payment adjustment for a given 
year. Related to this waiver of the last sentence of section 
1848(q)(1)(A)(iii) of the Act, MAQI Participants who are not subject to 
the MIPS reporting requirements and payment adjustments will therefore 
not receive MIPS performance feedback under section 1848(q)(12) of the 
Act.
    In addition, we are also announcing our final policies that, under 
the waivers identified previously: (1) Eligibility for exclusion from 
the MIPS reporting requirements and payment adjustment under the MAQI 
Demonstration will be determined using thresholds of combined 
participation in Qualifying Payment Arrangements and Advanced APMs that 
are the same as the QP thresholds under the Medicare Option of the 
Quality Payment Program codified at Sec.  414.1430(a); and (2) 
Qualifying Payment Arrangements under the MAQI Demonstration will be 
identified using criteria consistent with those used to identify Other 
Payer Advanced APMs codified at Sec.  414.1420. To qualify for 
exclusion from the MIPS reporting requirements and payment adjustment 
under the MAQI Demonstration, a MAQI participating clinician must meet 
combined thresholds for Medicare payments or patients through 
Qualifying Payment Arrangements with MAOs and Advanced APMs, using 
Demonstration thresholds that match the thresholds for participation in 
Advanced APMs under the Medicare Option of the Quality Payment Program, 
and based on aggregate participation in Advanced APMs and Qualifying 
Payment Arrangements with MAOs, without applying a specific minimum 
threshold to participation in either type of payment arrangement.

[[Page 59891]]

(e) Example of Adjustment Factors
    In the CY 2019 PFS proposed rule (83 FR 35978 through 35981), we 
provided a figure and several tables as illustrative examples of how 
various final scores would be converted to a MIPS payment adjustment 
factor, and potentially an additional MIPS payment adjustment factor, 
using the statutory formula and based on our proposed policies for the 
2021 MIPS payment year. We updated the figure and tables based on the 
policies we are adopting in this final rule, as follows.
    Figure 3 provides an example of how various final scores would be 
converted to a MIPS payment adjustment factor, and potentially an 
additional MIPS payment adjustment factor, using the statutory formula 
and based on the policies adopted in this final rule for the 2021 MIPS 
payment year. In Figure 3, the performance threshold is 30 points. The 
applicable percentage is 7 percent for the 2021 MIPS payment year. The 
MIPS payment adjustment factor is determined on a linear sliding scale 
from zero to 100, with zero being the lowest possible score which 
receives the negative applicable percentage (negative 7 percent for the 
2021 MIPS payment year) and resulting in the lowest payment adjustment, 
and 100 being the highest possible score which receives the highest 
positive applicable percentage and resulting in the highest payment 
adjustment. However, there are two modifications to this linear sliding 
scale. First, there is an exception for a final score between zero and 
one-fourth of the performance threshold (zero and 7.5 points based on 
the performance threshold of 30 points for the 2021 MIPS payment year). 
All MIPS eligible clinicians with a final score in this range would 
receive the lowest negative applicable percentage (negative 7 percent 
for the 2021 MIPS payment year). Second, the linear sliding scale line 
for the positive MIPS payment adjustment factor is adjusted by the 
scaling factor, which cannot be higher than 3.0.
    If the scaling factor is greater than zero and less than or equal 
to 1.0, then the MIPS payment adjustment factor for a final score of 
100 would be less than or equal to 7 percent. If the scaling factor is 
above 1.0, but less than or equal to 3.0, then the MIPS payment 
adjustment factor for a final score of 100 would be higher than 7 
percent.
    Only those MIPS eligible clinicians with a final score equal to 30 
points (which is the performance threshold in this example) would 
receive a neutral MIPS payment adjustment. Because the performance 
threshold is 30 points, we anticipate that more clinicians will receive 
a positive adjustment than a negative adjustment and that the scaling 
factor would be less than 1 and the MIPS payment adjustment factor for 
each MIPS eligible clinician with a final score of 100 points would be 
less than 7 percent.
    Figure 3 illustrates an example of the slope of the line for the 
linear adjustments and has been updated from prior rules, but it could 
change considerably as new information becomes available. In this 
example, the scaling factor for the MIPS payment adjustment factor is 
0.159. In this example, MIPS eligible clinicians with a final score 
equal to 100 would have a MIPS payment adjustment factor of 1.11 
percent (7 percent x 0.159). (Note that this is prior to adding the 
additional payment adjustment for exceptional performance, which is 
explained below.)
    The additional performance threshold is 75 points. An additional 
MIPS payment adjustment factor of 0.5 percent starts at the additional 
performance threshold and increases on a linear sliding scale up to 10 
percent. This linear sliding scale line is also multiplied by a scaling 
factor that is greater than zero and less than or equal to 1.0. The 
scaling factor will be determined so that the estimated aggregate 
increase in payments associated with the application of the additional 
MIPS payment adjustment factors is equal to $500,000,000. In Figure 3, 
the example scaling factor for the additional MIPS payment adjustment 
factor is 0.358. Therefore, MIPS eligible clinicians with a final score 
of 100 would have an additional MIPS payment adjustment factor of 3.58 
percent (10 percent x 0.358). The total adjustment for a MIPS eligible 
clinician with a final score equal to 100 would be 1 + 0.0111 + 0.0358 
= 1.0469, for a total positive MIPS payment adjustment of 4.69 percent.

BILLING CODE 4120-01-P

[[Page 59892]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.071

    The final MIPS payment adjustments will be determined by the 
distribution of final scores across MIPS eligible clinicians and the 
performance threshold. More MIPS eligible clinicians above the 
performance threshold means the scaling factors would decrease because 
more MIPS eligible clinicians receive a positive MIPS payment 
adjustment factor. More MIPS eligible clinicians below the performance 
threshold means the scaling factors would increase because more MIPS 
eligible clinicians would receive a negative MIPS payment adjustment 
factor and relatively fewer MIPS eligible clinicians would receive a 
positive MIPS payment adjustment factor.
    Table 56 illustrates the changes in payment adjustments based on 
the final policies from the 2019 MIPS payment year and the 2020 MIPS 
payment year, and on final policies for the 2021 MIPS payment year 
adopted in this final rule, as well as the statutorily required 
increase in the applicable percent as required by section 1848(q)(6)(B) 
of the Act.

[[Page 59893]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.072

BILLING CODE 4120-01-C

    We note that in this final rule, with the exception of the increase 
in our small practice bonus in the quality performance category from 3 
measure bonus points to 6 measure bonus points, our scoring algorithms 
have not changed from the CY 2019 PFS proposed rule and that the only 
policy change from the CY 2019 PFS proposed rule reflected in Figure 3 
and Table 56 is that final scores greater than or equal to 75 points 
qualify for the additional payment adjustment for exceptional 
performance discussed at section III.I.3.j.(3) of this final rule. 
Please refer to the CY 2019 PFS proposed rule (83 FR 35979 through 
35981) for examples of scenarios in

[[Page 59894]]

which MIPS eligible clinicians can achieve a final score at or above 
the performance threshold of 30 points for the 2021 MIPS payment year.
k. Third Party Intermediaries
    We refer readers to Sec.  414.1400, the CY 2017 Quality Payment 
Program final rule (81 FR 77362 through 77390) and the CY 2018 Quality 
Payment Program final rule (82 FR 53806 through 53819) for our 
previously established policies regarding third party intermediaries.
    In the CY 2019 PFS proposed rule (83 FR 35981 through 35986), we 
proposed to: (1) Define third party intermediary and require third 
party intermediaries to be based in the U.S.; (2) update certification 
requirements for data submission; (3) update the definition of 
Qualified Clinical Data Registry (QCDR); revise the self-nomination 
period for QCDRs; update of information required for QCDRs at the time 
of self-nomination; update consideration criteria for approval of QCDR 
measures; define the topped out timeline for QCDR measures; (4) revise 
the self-nomination period for qualified registries; (5) define health 
IT vendor; (6) update the definition, criteria, and requirements for 
CMS-approved survey vendor; auditing criteria; and (7) revise probation 
and disqualification criteria. We finalize these proposals in the 
manner discussed herein.
(1) Third Party Intermediaries Definition
    In the CY 2019 PFS proposed rule (83 FR 35981), at Sec.  414.1305, 
we proposed a new definition to define a third party intermediary as an 
entity that has been approved under Sec.  414.1400 to submit data on 
behalf of a MIPS eligible clinician, group, or virtual group for one or 
more of the quality, improvement activities, and Promoting 
Interoperability performance categories. A QCDR, qualified registry, 
health IT vendor, or CMS-approved survey vendor are considered third 
party intermediaries. We also proposed to change the section heading at 
Sec.  414.1400 from ``Third party data submissions'' to ``Third party 
intermediaries'' to elucidate the definition and function of a third 
party intermediary (83 FR 35981).
    As discussed in the CY 2019 PFS proposed rule (83 FR 35981), CMS IT 
systems are required to adhere to multiple agency and federal security 
standards and policy. CMS policy prohibits non-U.S. citizens from 
accessing CMS IT systems, and also requires all CMS program data to be 
retained in accordance with U.S. Federal policy, specifically National 
Institute of Standards and Technology (NIST) Special Publication (SP) 
800-63, which outlines enrollment and identity proofing requirements 
(levels of assurance) for federal IT system access. Access to the 
Quality Payment Program would necessitate passing a remote or in-person 
Federated Identity Proofing process (that is, Equifax or equivalent). A 
non-U.S. based third party intermediary's potential lack of a SSN, TIN, 
U.S. based address, and other elements required for identity proofing 
and identity verification would impact their ability to pass the 
necessary background checks. An inability to pass identity proofing may 
limit or fully deny access to the Quality Payment Program if the intent 
is to interact with the Quality Payment Program outside of the U.S. for 
the purposes of reporting and storing data.
    These requirements are existing federal policies applicable to all 
HHS/CMS FISMA systems and assets, and the requirements are not specific 
to the Quality Payment Program. More information on these policies is 
available at the following websites: HHS Information Security and 
Privacy Policy (IS2P) (https://www.hhs.gov/about/agencies/asa/ocio/cybersecurity/index.html); CMS Information Systems Security and Privacy 
Policy (IS2P2) (https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Info-Security-Library-Items/CMS-Information-Systems-Security-and-Privacy-Policy-IS2P2.html); OMB Memorandum 04-04, E-Authentication Guidance for 
Federal Agencies (https://georgewbush-whitehouse.archives.gov/omb/memoranda/fy04/m04-04.pdf); and NIST SP 800-63 Digital Identity 
Guidelines (https://pages.nist.gov/800-63-3/). Therefore, in the CY 
2019 PFS proposed rule (83 FR 35982) we proposed to amend Sec.  
414.1400(a)(4) to indicate that a third party intermediary's principle 
place of business and retention of associated CMS data must be within 
the U.S.
    We would like to note, third party intermediaries that are 
authorized by us to submit data on behalf of MIPS eligible clinicians, 
groups, or virtual groups have not otherwise been evaluated for the 
capabilities, quality, or any other features or its products. The 
United States Government and CMS do not endorse or recommend any third 
party intermediary or its products. Prior to selecting or using any 
third party intermediary or its products, MIPS eligible clinicians, 
groups or virtual groups should perform their own due diligence on the 
entity and its products, including contacting the entity directly to 
learn more about its products.
    The following is a summary of the public comments received on the 
``Third Party Intermediaries Definition'' proposals and our responses:
    Comment: One commenter appeared to advocate that clinicians who 
must comply with MACRA should be prohibited from using online and/or 
software-based third party intermediaries that do not use attorneys to 
advise clinicians on the law. The commenter stated that, in order to 
protect clinicians from failure to comply with MACRA and to achieve 
higher MACRA compliance rates, CMS should restrict MIPS participants 
from using online or software-based third party intermediaries entirely 
unless the use is through an EMR/EHR dashboard. In addition, the 
commenter stated that CMS should only allow clinicians to achieve 
compliance themselves or to achieve compliance through the use of an 
attorney or an EMR/EHR dashboard.
    Response: We do not believe it is appropriate to require third 
party intermediaries to furnish legal advice to clinicians. If a 
clinician wishes to receive legal advice regarding compliance with 
MACRA, or any other law or regulation, the clinician may hire his or 
her own legal counsel. To the extent the commenter is advocating to 
eliminate a clinician's ability to report MIPS data through a third 
party intermediary, the comment is outside the scope of the rulemaking.
    Comment: One commenter provided a comment related to the proposed 
opt-in policy. The commenter encouraged us to allow third-party 
intermediaries, such as qualified registries, to opt-in on behalf of 
clinicians and groups as a function of the services they provide and 
that the clinician opt-in should be at the TIN/NPI level.
    Response: The opt-in policy is discussed in section III.I.3.c.(5) 
in this final rule, where we finalized that a clinician who is eligible 
to opt-in would be required to make an affirmative election to opt-in 
to participate in MIPS, elect to be a voluntary reporter, or by not 
submitting any data the clinician is choosing to not report. We believe 
that an election to opt-in to MIPS must be made by the clinician or 
group through a definitive opt-in decision to participate in MIPS 
regardless of the way in which the data is submitted. We agree that 
after this decision is confirmed by the clinician or group it should be 
deliverable through a third party intermediary, if a clinician or group 
is utilizing a third party intermediary for their data submission. As a 
result, the third party intermediary

[[Page 59895]]

should be able to transmit the clinician's opt-in decision to CMS. 
Therefore, we are amending Sec.  414.1400(a)(4)(iv) that if the 
clinician chooses to opt-in in accordance with Sec.  414.1310, the 
third party intermediary must be able to transmit that decision to CMS. 
We refer readers to section III.I.3.c.(5) of this final rule for more 
information regarding low volume threshold exclusion.
    After consideration of the public comments received, we are 
finalizing our proposal, as proposed, at Sec.  414.1305, to define a 
third party intermediary as an entity that has been approved under 
Sec.  414.1400 to submit data on behalf of a MIPS eligible clinician, 
group, or virtual group for one or more of the quality, improvement 
activities, and Promoting Interoperability performance categories. A 
QCDR, qualified registry, health IT vendor, or CMS-approved survey 
vendor are considered third party intermediaries. We are also 
finalizing our proposal, as proposed, to change the section heading at 
Sec.  414.1400 from ``Third party data submissions'' to ``Third party 
intermediaries'' to elucidate the definition and function of a third 
party intermediary. In addition, we are finalizing our proposal, as 
proposed, to amend previously finalized policies at Sec.  
414.1400(a)(4) to indicate that a third party intermediary's principle 
place of business and retention of associated CMS data must be within 
the U.S. Lastly, we are amending Sec.  414.1400(a)(4)(iv) to state that 
if the clinician chooses to opt-in in accordance with Sec.  414.1310, 
the third party intermediary must be able to transmit that decision to 
CMS.
(2) Certification
    We previously finalized in the CY 2018 Quality Payment Program 
final rule (82 FR 53807) at Sec.  414.1400(a)(5), that all data 
submitted to us by a third party intermediary on behalf of a MIPS 
eligible clinician, group or virtual group must be certified by the 
third party intermediary to the best of its knowledge as true, 
accurate, and complete; and that this certification must occur at the 
time of the submission and accompany the submission. We have discovered 
it is not operationally feasible to require certification at the time 
of submission, or to require that the certification accompany the 
submission, for submission types by third party intermediaries, 
including data via direct, login and upload, login and attest, CMS Web 
Interface or Medicare Part B claims. We refer readers to section 
III.I.3.h.(1)(b) of this final rule for our proposed modifications to 
the previously established data submission terminology. In order to 
address these various submission types that are currently available, in 
the CY 2019 PFS proposed rule (83 FR 35982), we proposed to amend Sec.  
414.1400(a)(5) to state that all data submitted to CMS by a third party 
intermediary must be certified as true, accurate, and complete to the 
best of its knowledge and that such certification must be made in a 
form and manner and at such time as specified by CMS.
    We did not receive any public comments on our proposed amendments 
to the certification requirement imposed on third party intermediaries.
    We are finalizing our proposal, as proposed, at Sec.  
414.1400(a)(5) to state that all data submitted to CMS by a third party 
intermediary on behalf of a MIPS eligible clinician, group or virtual 
group must be certified by the third party intermediary as true, 
accurate, and complete to the best of its knowledge, and that such 
certification must be made in a form and manner and at such time as 
specified by CMS.
(3) Qualified Clinical Data Registries (QCDRs)
    We refer readers to the CY 2018 Quality Payment Program final rule 
(82 FR 53807 through 53815) and Sec.  414.1400 for our previously 
finalized policies regarding QCDRs. In the CY 2019 PFS proposed rule 
(83 FR 35982 through 35984) we proposed to update the following: The 
definition of QCDR, the self-nomination period for QCDRs, information 
required for QCDRs at the time of self-nomination, and consideration of 
criteria for approval of QCDR measures.
(a) Proposed Update to the Definition of a QCDR
    In the CY 2017 Quality Payment Program final rule (81 FR 77363 
through 77364) at Sec.  414.1305, we finalized the definition of a QCDR 
to be a CMS-approved entity that has self-nominated and successfully 
completed a qualification process to determine whether the entity may 
collect medical or clinical data for the purpose of patient and disease 
tracking to foster improvement in the quality of care provided to 
patients.
    As described in the CY 2019 PFS proposed rule (83 FR 35982), we 
want to ensure that QCDRs that participate in MIPS have access to 
clinical expertise in quality measurement and are able to provide and 
demonstrate an understanding of the clinical medicine, evidence-based 
gaps in care, and opportunities for improvement in the quality of care 
delivered to patients and priorities that are important to MIPS 
eligible clinicians. From our experiences with QCDRs to date, we have 
discovered that certain entities with predominantly technical 
backgrounds have limited understanding of medical quality metrics or 
the process for developing quality measures are seeking approval as a 
QCDR. A large number of entities that do not have the necessary 
clinical expertise to foster quality improvement have self-nominated or 
indicated their interest in becoming QCDRs. In reviewing previous QCDR 
measure submissions during the self-nomination and QCDR measure review 
and approval cycles in MIPS, we have observed that some entities were 
developing QCDR measures without a complete understanding of measure 
constructs (such as what is required of a composite measure or what it 
means to risk-adjust), and in some instances, QCDRs were developing 
QCDR measures in clinical areas in which they did not have expertise. 
We are concerned that QCDR measures submitted by such entities for 
approval have not undergone the same consensus development, scientific 
rigor, and clinical assessment that is required for measure 
development, compared to those QCDR measures that are developed by 
specialty societies and other entities with clinical expertise.
    We recognize the importance of these organizations' expertise 
within the Quality Payment Program; however, do not believe that these 
types of entities with the absence of clinical expertise in quality 
measurement, meet the intent of QCDRs. We believe that with the 
increasing interest in QCDRs and QCDR measure development, it is 
important to ensure that QCDRs that participate in MIPS are first and 
foremost in the business of improving the quality of care clinicians 
provide to their patients through quality measurement and/or disease 
tracking and have the clinical expertise to do so.
    In the CY 2019 PFS proposed rule (83 FR 35982 through 35983), we 
proposed beginning with the 2022 MIPS payment year, to amend Sec.  
414.1305 to modify the definition of a QCDR to state that the approved 
entity must have clinical expertise in medicine and quality measure 
development. Specifically, a QCDR would be defined as an entity with 
clinical expertise in medicine and in quality measurement development 
that collects medical or clinical data on behalf of a MIPS eligible 
clinician for the purpose of patient and disease tracking to foster 
improvement in the quality of care provided to patients.

[[Page 59896]]

    As described in the CY 2019 PFS proposed rule (83 FR 35983), under 
Sec.  414.1400(b)(2)(ii), an entity that uses an external organization 
for purposes of data collection, calculation, or transmission may meet 
the definition of a QCDR as long as the entity has a signed, written 
agreement that specifically details the relationship and 
responsibilities of the entity with the external organization effective 
as of September 1 the year prior to the year for which the entity seeks 
to become a QCDR. Thus, we expect entities without clinical expertise 
in medicine and quality measure development that want to become QCDRs 
would collaborate or align with entities with such expertise in 
accordance with Sec.  414.1400(b)(2)(ii).
    As a part of the self-nomination process, we will look for entities 
that have quality improvement, measure development, as well as clinical 
expertise. We will also follow up with the entity via, for example, 
email or teleconference, should we question whether or not the entity 
meets our standards. Alternatively, such entities may seek to qualify 
as another type of third party intermediary, such as a qualified 
registry. Becoming a qualified registry does not require the level of 
measure development expertise that is needed to be a QCDR that develops 
measures.
    The following is a summary of the public comments received on the 
proposal to update the definition of a QCDR and our responses:
    Comment: Many commenters supported the proposal to modify the 
definition of a QCDR to limit approval to entities that have clinical 
expertise in medicine and quality measure development. Several 
commenters recommended CMS provide clarification on how such clinical 
and quality measure development expertise will be evaluated, with one 
commenter suggesting the definition of clinical expertise include 
having a majority-led physician Board of Directors or governing body 
and that expertise in clinical measure development include demonstrated 
QCDR measure development processes that take into account the CMS 
Blueprint for measure development and maintenance activities. A few 
commenters stated that CMS should establish processes for denying 
applications and/or measures that appear to not have had any clinical 
influence rather than requiring the entire entity to have ``expertise'' 
and provide a definition of what constitutes ``clinical expertise in 
medicine and quality measure development.''
    Response: We appreciate the commenters' support to update the 
definition of a QCDR, limiting approval to entities that have clinical 
expertise in medicine and quality measure development. Specifically, we 
proposed that a QCDR would be defined as an entity with clinical 
expertise in medicine and in quality measurement development that 
collects medical or clinical data on behalf of a MIPS eligible 
clinician for the purpose of patient and disease tracking to foster 
improvement in the quality of care provided to patients. We appreciate 
the commenters' suggestion that CMS provide more clarification on how 
such clinical and quality measure development expertise will be 
evaluated. For example, while not exhaustive, some aspects that may be 
considered during our evaluation are a QCDR's: Previous measure 
development experience (serving on an NQF TEP, for example); experience 
with the measure development Blueprint process, which can be found at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint-130.pdf; ability to create and use 
multi-strata and composite measures where appropriate; ability to risk 
adjust its own QCDR outcomes measures; technical expertise to run a 
registry; and ability to reliably collect, retain, aggregate, 
disseminate, and analyze data from their clinicians. We appreciate the 
commenter's suggestion to include having a majority-led physician Board 
of Directors or governing body, but we do not mandate that the QCDR be 
led by a majority of physicians. We do consider clinical expertise and 
experience in QCDR measure development and maintenance important, as 
shown in our updated definition of a QCDR.
    Comment: One commenter expressed concern regarding how CMS will 
allow technical entities to partner with an external organization to 
gain clinical expertise, citing its opinion that doing so would render 
the policy ineffective if this enables technical entities to bypass 
this requirement too easily. Another commenter stated that neither 
small nor large EHR vendors should be allowed to enter the QCDR space 
due to the former potentially collecting skewed data related to certain 
practice arrangements and patient populations and the latter 
potentially lacking the perspective of care improvement in medical 
specialties.
    Response: We disagree that allowing technical entities to partner 
with an external organization to gain clinical expertise would render 
the policy ineffective. The policy is intended to include entities that 
are able to meet the definition, whether that be by a partnership with 
a clinical entity, or on their own. In addition, we disagree that 
neither small nor large EHR vendors should be allowed to collaborate to 
become a QCDR. As stated in the proposed rule, entities without 
clinical expertise in medicine and quality measure development, such as 
small or large EHR vendors, may collaborate or align with entities with 
such expertise in accordance with Sec.  414.1400(b)(2)(ii). In general, 
we do not believe that Health IT vendors, including EHR vendors, alone 
have the necessary clinical expertise. Having the option to collaborate 
could alleviate the likelihood of skewed data or the absence of 
perspective regarding care improvement in medical specialties, because 
a collaboration with a clinical organization would provide knowledge of 
patient populations, practice arrangements, and care improvement.
    Comment: A few commenters disagreed with the proposed update to the 
definition of a QCDR, citing their beliefs that the updated definition 
is contrary to the promotion of the benefits of technology; will impose 
artificial barriers to entry into the market; dictate who can provide 
services to physicians instead of letting the free market decide; and 
discriminate against potential vendors because of a perceived advantage 
at quality measurement based on education, experience, etc. The 
commenters stated that CMS should only require QCDRs to collaborate 
with specialty societies in the development of measures to ensure 
validity, clinical relevance, and proper risk adjustment.
    Response: We disagree that the modified definition of QCDR opposes 
promoting the benefits of technology because there are many options 
through which MIPS eligible clinicians can utilize different third-
party intermediaries to submit data, and this proposed change will not 
impact the ability for MIPS eligible clinicians to use these 
mechanisms. We also disagree that the modified definition of QCDR 
imposes barriers into the market or discriminates against potential 
vendors because we offer vendors with more of a technical background 
the opportunity to partner with an organization with greater clinical 
expertise in order to meet the new QCDR definition. The intent of the 
modified definition is to promote useful measure development and to 
emphasize that clinical expertise is critical in gaining useful 
measures. Furthermore, we believe that updating the definition of a 
QCDR will help organizations understand the criteria in which we 
evaluate them against. We want to ensure that the vendors we approve to 
participate as a QCDR are of

[[Page 59897]]

a higher standard and understand the clinical science based off which 
they develop measures. It is important that QCDRs also understand how 
to construct measures, the analytics, and are able to ensure the 
measures are reliable and valid, not doing so may negatively impact the 
clinician's reporting and final score. Health IT vendors and/or EHR 
vendors should collaborate with clinical organizations such as 
specialty societies for their experience not only in measure 
development but for their clinical expertise as well.
    Comment: Some commenters stated that CMS should develop a process 
by which a clinician who believes they are unsupported by a QCDR can 
submit information to CMS for further investigation.
    Response: If an eligible clinician would like to bring information 
to CMS' attention regarding a QCDR being unsupportive as it pertains to 
reporting issues, we suggest the clinician contact the Quality Payment 
Program Service Center by emailing: [email protected].
    Comment: One commenter noted that the proposed change may preclude 
its continued approval by CMS as a QCDR because it does not dictate the 
timeline in which specialty societies perform measure development and 
without this approval, it would not be able to assist them in measure 
development when necessary.
    Response: Our updated definition of a QCDR would be effective 
beginning with the 2022 MIPS payment year; and to clarify, we will not 
be ``grandfathering'' in existing QCDRs who do not meet the updated 
QCDR definition for the 2020 performance period. In coordination with 
the finalization of the new QCDR definition and the publication of the 
CY 2019 PFS final rule, we intend to notify existing QCDRs as to 
whether they would meet the new QCDR definition or not based on 
information submitted for a previous MIPS payment year.
    Comment: A few commenters stated that CMS should finalize its 
proposal for the 2019 performance year instead of the 2020 performance 
year because removing non-clinician led vendors from the list of QCDRs 
will not pose a significant burden on eligible clinicians or group 
practices in 2019.
    Response: While we appreciate commenters' support, we would like to 
keep the effective timeframe of this policy (that is, the 2020 
performance year) as proposed to provide existing QCDRs that would not 
meet the updated QCDR definition with an appropriate amount of time to 
comply or take other paths.
    Comment: Many commenters who supported the proposal to update the 
definition of a QCDR also provided recommendations including: 
Development of a separate definition for QCDRs put forth by technology 
companies to differentiate them from QCDRs managed by specialty 
societies; requiring third-party entities that are not specialty 
societies that would like to become QCDRs to collaborate with specialty 
society QCDRs; and expansion of the definition of a QCDR to align with 
the 21st Century Cures Act (especially with regard to entities being 
clinician-led) or at minimum, revision of the definition to include 
clinical expertise in medicine, quality improvement, and quality 
measure/guideline development, as well as providing methods to ensure 
data quality, routine metric reporting, and quality improvement 
consultation.
    Response: We do not agree that separate definitions are necessary 
to differentiate between QCDRs, as the definition includes criteria set 
for all QCDRs; or that the definition requires criteria as prescriptive 
as entities being clinician-led. There are flexibilities in place, such 
as collaboration with other entities such as large healthcare systems, 
regional collaboratives, or specialty societies, in order for vendors 
to meet the criteria in the definition. We believe we cover the areas 
of clinical expertise, measure development, and quality improvement 
work through this new definition. We believe that experience with data 
quality and routine metric reporting is related to their measure 
development experience and their registry experience, which is covered 
by the new QCDR definition and the criteria of requiring that the 
vendor must exist by January 1 of the performance period and have 25 
participants submitting data to the QCDR (not necessarily for purposes 
of MIPS).
    After consideration of the public comments received, we are 
finalizing our proposal to update the definition of a QCDR at Sec.  
414.1305 beginning with the 2022 MIPS payment year, as proposed, to 
state that a QCDR is an entity with clinical expertise in medicine and 
in quality measurement development that collects medical or clinical 
data on behalf of a MIPS eligible clinician for the purpose of patient 
and disease tracking to foster improvement in the quality of care 
provided to patients.
(b) Establishment of an Entity Seeking To Qualify as a QCDR
    In the CY 2017 Quality Payment Program final rule (81 FR 77364), we 
require at Sec.  414.1400(c)(2) that the QCDR must have at least 25 
participants by January 1 of the performance period. These participants 
do not need to use the QCDR to report MIPS data to us; rather, they 
need to submit data to the QCDR for quality improvement. We realize 
that a QCDR's lack of preparedness to accept data from MIPS eligible 
clinicians and groups beginning on January 1 of the performance period 
may negatively impact a clinician's ability to use a QCDR to report, 
monitor the quality of care they provide to their patients (and act on 
these results) and may inadvertently increase clinician burden. For 
these reasons, we proposed to redesignate Sec.  414.1400(c)(2) as Sec.  
414.1400(b)(2)(i) to state that beginning with the 2022 MIPS Payment 
Year, the QCDR must have at least 25 participants by January 1 of the 
year prior to the performance period (83 FR 35983). These participants 
do not need to use the QCDR to report MIPS data to us; rather, they 
need to submit data to the QCDR for quality improvement.
    The following is a summary of the public comments received on the 
``Establishment of an Entity Seeking To Qualify as a QCDR'' proposals 
and our responses:
    Comment: Many commenters disagreed with the proposal to require 
QCDRs to have 25 participants by January 1 of the year prior to 
performance period. Commenters noted it would place an undue burden on 
QCDRs serving small specialties and inhibit the ability of new 
registries to qualify as QCDRs, thus discouraging the use of QCDRs to 
report MIPS data. One commenter suggested CMS work with stakeholders to 
develop a timeline that is feasible and leads to properly functioning 
QCDRs that can meet the goals of the MIPS program and the requirements 
of the MACRA law. Another commenter stated that the existing 
requirement is sufficient to ensure QCDR preparedness, while another 
commenter stated that the threshold should be lowered or removed 
completely, at least for those QCDRs that have already been in 
operation and have lost participants when the low volume threshold 
increased significantly.
    Response: We disagree with commenters that this proposed policy 
would cause undue burden or the ability of new entities to qualify as 
QCDRs. To clarify, this requirement would demonstrate that the entity 
has prior registry experience and the capability to accept, aggregate, 
calculate, provide feedback to their participants on, retain, and 
submit the data to CMS on the behalf of MIPS eligible clinicians. We 
have previously experienced during

[[Page 59898]]

the past two performance periods that there have been instances of new 
QCDRs that are not ready to accept data from eligible clinicians from 
the start of the performance period due to operational issues within 
the QCDR, including instances of QCDRs withdrawing during the 
performance period because of reporting inexperience. We proposed this 
requirement to ensure that organizations have this experience prior to 
self-nomination. We continue to provide educational materials for QCDRs 
on what is necessary to meet program criteria and requirements. We 
clarify that the requirement to have at least 25 participants by 
January 1 of the year prior to performance period does not require that 
the entity's prior registry experience be under MIPS or any other CMS 
program or that the participants be MIPS eligible clinicians. With 
increasing stakeholder interest in the use of third-party 
intermediaries to report for MIPS, we believe the threshold of 25 
participants is a reasonable thresholds for QCDRs to attain.
    After consideration of the public comments received, we are 
finalizing our proposal, as proposed, to redesignate Sec.  
414.1400(c)(2) as Sec.  414.1400(b)(2)(i) to state that beginning with 
the 2022 MIPS Payment Year, the QCDR must have at least 25 participants 
by January 1 of the year prior to the applicable performance period.
(c) Self-Nomination Process
    We refer readers to the CY 2018 Quality Payment Program final rule 
(82 FR 53808 through 53813) for our previously established policies 
regarding the simplified self-nomination process for existing QCDRs in 
MIPS that are in good standing and web-based submission of self-
nomination forms. We did not propose any changes to those policies in 
this final rule; however, in the CY 2019 PFS proposed rule (83 FR 
35983), we proposed to update: (1) The self-nomination period; and (2) 
information required at the time of self-nomination.
(i) Self-Nomination Period
    Under Sec.  414.1400(b), QCDRs must self-nominate from September 1 
of the year prior to the applicable performance period until November 1 
of the same year and must, among other things, provide all information 
requested by us at the time of self-nomination. As indicated in the CY 
2017 Quality Payment Program final rule (81 FR 77366), our goal has 
been to publish the list of approved QCDRs along with their approved 
QCDR measures prior to the beginning of the applicable performance 
period.
    We have received feedback from entities that have self-nominated to 
be a QCDR about the need for additional time to respond to requests for 
information during the review process, particularly with respect to 
QCDR measures that the entity intends to submit to us for the 
applicable performance period. In addition, based on our observations 
of the previous two self-nomination cycles, we anticipate an increase 
in the number of QCDR measure submissions for our review and 
consideration. For the transition year of MIPS, we received over 1,000 
QCDR measure submissions for review, and for the CY 2018 performance 
period, we received over 1,400 QCDR measure submissions. In order for 
us to process, review, and approve the QCDR measure submissions and 
provide QCDRs with sufficient time to respond to requests for 
information during the review process, while still meeting our goal to 
publish the list of approved QCDRs along with their approved QCDR 
measures prior to the start of the applicable performance period, we 
believe that an earlier self-nomination period is needed.
    Therefore, in the CY 2019 PFS proposed rule (83 FR 35983), we 
proposed to update the self-nomination period from September 1 of the 
year prior to the applicable performance period until November 1 to 
July 1 of the calendar year prior to the applicable performance period 
until September 1. Therefore, in the CY 2019 PFS proposed rule (83 FR 
35983), we also proposed to amend Sec.  414.1400(b)(1) to provide that, 
beginning with the 2022 MIPS payment year, entities seeking to qualify 
as QCDRs must self-nominate during a 60-day period beginning on July 1 
of the calendar year prior to the applicable performance period and 
ending on September 1 of the same year; must provide all information 
required by us at the time of self-nomination; and must provide any 
additional information requested by us during the review process. For 
example, for the 2022 MIPS payment year, the applicable performance 
period would be CY 2020, as discussed in section III.I.3.g. of this 
final rule. Therefore for the CY 2020 performance period, the self-
nomination period would begin on July 1st, 2019 and end on September 
1st, 2019, and we will make QCDRs aware of this through our normal 
communication channels. We believe that updating the self-nomination 
period would allow for additional review time and measure discussions 
with QCDRs.
    We refer readers to section III.I.3.k.(3)(c)(ii) of this final rule 
for a summary of the public comments received on these proposals and 
our responses.
(ii) Information Required at the Time of Self-Nomination
    We refer readers to the CY 2018 Quality Payment Program final rule 
(82 FR 53814), where we finalized that as a part of the self-nomination 
review and approval process for the CY 2018 performance period and 
future years, we will assign QCDR measure IDs to approved QCDR 
measures, and the same measure ID must be used by any other QCDRs that 
have received permission to also report the measure. We have received 
some questions from stakeholders as to whether the QCDR measure ID must 
be utilized or whether it is optional. As stated in the CY 2018 Quality 
Payment Program final rule, QCDRs, including any other QCDRs that have 
received permission to also report the measure, must use the CMS-
assigned QDCR measure ID. It is important that the CMS-assigned QCDR 
measure ID is posted and used accordingly, because without this ID we 
are not able to accurately identify and calculate the QCDR measures 
according to their specifications. Therefore, in the CY 2019 PFS 
proposed rule (83 FR 35983), we proposed to update Sec.  
414.1400(b)(3)(iii) to state that QCDRs must include their CMS-assigned 
QCDR measure ID number when posting their approved QCDR measure 
specifications, and also when submitting data on the QCDR measures to 
us.
    The following is a summary of the public comments received on the 
``Self-Nomination Process'' proposals and our responses:
    Comment: Several commenters noted they would support the proposed 
change to the self-nomination timeline if CMS would adopt multi-year 
approval of QCDRs as they noted doing so would reduce burden, alleviate 
a shortened nomination timeline, potentially strengthen the measure 
development process in future years, encourage uptake of new measures, 
allow for uninterrupted data collection, and allow for more consistent 
and robust data collection and benchmarking.
    Response: In the CY 2018 Quality Payment Program final rule (82 FR 
53808), we discussed our concerns with multi-year approval and sought 
comment from stakeholders as to how to mitigate our concerns. Moreover, 
a multi-year approval process would not take into consideration 
potential changes in criteria or requirements of participation for 
QCDRs that may occur

[[Page 59899]]

as the MIPS program develops through future program years. We did not 
receive any suggestions or responses from stakeholders that would 
alleviate our concerns with adopting this policy. Therefore, we 
continue to believe multi-year approval of QCDRs is inappropriate at 
this time.
    Comment: One commenter stated that in order to encourage QCDRs to 
continue seeking QCDR status, CMS should work with specialty-led QCDR 
stewards to further improve the self-nomination process and ensure a 
viable and private sector-run reporting option to alleviate burden and 
increase evidence-based decisions.
    Response: We value stakeholder input and conduct process 
improvement on an ongoing basis. We will continue to seek opportunities 
to receive input throughout the year.
    Comment: Many commenters disagreed with the proposal to change the 
QCDR self-nomination period, citing their beliefs that maintaining the 
September 1 through November 1 self-nomination period without change is 
necessary to minimize additional burden and constraints on QCDRs; 
provide QCDRs the time to prepare data to support measures in the 
application process; provide QCDRs an opportunity to gain insight into 
recent policy changes; and negate potentially adverse impacts to the 
life cycle of QCDRs, the maintenance process for existing QCDR 
measures, and/or development of new measures. One commenter stated that 
due to additional data being required as part of the self-nomination 
process, the revised self-nomination period would be more difficult. 
Another commenter suggested the change should not be implemented until 
the CY 2021 performance period and noted QCDR approval will need to 
expand beyond 12 months to avoid a scenario where a QCDR is only 
approved for a few months before they must go through the self-
nomination process again. Finally, another commenter suggested the 
self-nomination period be extended to 90 days due to its belief that 
the 60-day period is excessively challenging and burdensome in terms of 
the information required and additional requests to which QCDRs must be 
respond.
    Response: As described in the CY 2019 PFS proposed rule (83 FR 
35983), we have heard from QCDRs that they need additional time to 
respond to our requests for additional information during the QCDR 
measure review process, as well as requests for feedback or measure 
harmonization across QCDRs in a more extensive manner that would not be 
feasible with the current timeline. We believe with sufficient notice, 
providing stakeholders with educational material, and the 
implementation of the simplified self-nomination process we are 
minimalizing additional burden on QCDRs. Through the publication of 
self-nomination reference material prior to the self-nomination period, 
as we have done for the 2019 self-nomination period, we intend on 
giving QCDRs the utmost resources and support as they prepare to self-
nominate prior to the closing of the self-nomination period. We plan to 
post self-nomination material prior to the start of the self-nomination 
period in July, thereby giving stakeholders' time to prepare the 
necessary materials needed, inclusive of the additional information 
requested as a part of the self-nomination process. As we develop QCDR 
and qualified registry related policies for future rulemaking, we will 
factor in how the proposals impact an entity's ability to self-nominate 
and participate in the program prior to deciding what year to implement 
the policies for. We do not believe that delaying the finalization of 
this proposal until the 2021 performance period of MIPS would benefit 
the QCDRs, as we have previously explained, QCDR self-nomination must 
occur on an annual basis to take into consideration policy, 
participation requirement, and considerations to a QCDR or registry's 
standing (if they are on probation or have been precluded).
    We believe the benefits of moving up the self-nomination period to 
allow for additional time and discussion of QCDR measures is beneficial 
for both QCDRs and CMS. We disagree that the self-nomination period 
needs to be extended to a 90-day period, we believe with the resource 
materials provided, as well as us offering to meet with QCDRs prior to 
self-nomination to discuss their QCDR measures and receive preliminary 
feedback, QCDRs have the ability to better prepare for the self-
nomination period.
    Comment: A few commenters supported the proposal to update the QCDR 
self-nomination timeline. One commenter stated that CMS should use the 
updated nomination period to facilitate additional discussion with 
QCDRs regarding measure development. Another commenter stated that CMS 
should change its expectations for providing data for measures 
accordingly and allow a transition year to lessen the impact on the 
measure development life cycle and maintenance of existing measures.
    Response: We agree that this change in the self-nomination period 
will allow for additional conversations on measure development and QCDR 
measure feedback. We disagree with the implementation of a transition 
year, considering that on annual basis we must review performance data 
to evaluate whether the measure demonstrates a gap in performance or 
whether the measure demonstrates topped out performance where no 
meaningful measurement can be obtained. As previously mentioned, QCDR 
measures do not have to go through the NQF's Measures Application 
Partnership (MAP) committee prior to implementing them in MIPS. If a 
QCDR is unable to provide performance data reflecting a gap, the QCDR 
may provide for our consideration citations to recent studies or 
clinical journals that demonstrate a need for measurement.
    Comment: One commenter suggested CMS provide a definition of 
``minimal changes'' regarding the QCDR self-nomination process as well 
as specifications around data requests to support QCDR measures.
    Response: In the CY 2018 Quality Payment Program final rule (82 FR 
53811), we stated that minimal changes include, but are not limited to: 
Limited changes to performance categories, adding or removing MIPS 
quality measures, and adding or updating existing services and/or cost 
information. Additional educational resources are available in the QPP 
resource library at https://qpp.cms. gov/.
    Comment: One commenter recommended changes to the QCDR self-
nomination process, including updating QCDR self-nomination application 
and materials to outline all of the information needed to determine 
QCDR status to avoid delays and misunderstandings and providing at 
least a 60-day notice of any changes to the QCDR vetting process, 
including review of measures and a minimum of 30 days to appeal 
changes. The commenter further stated that changes to the 2019 QCDR 
application requirements should not be made until after the final rule 
is released due to the current QCDR application timeline closing on 
November 1 coinciding with publication of the final rule and that since 
the majority of specialty QCDRs stewards are currently submitting QCDR 
applications, CMS should allow these QCDRs to fully comment on these 
new proposed standards to which they are being held and which they may 
not support. Alternatively, the commenter suggested CMS allow for a 
nimble 2019 QCDR application process, including changes to the 
licensing standards given

[[Page 59900]]

the significant changes CMS proposes for 2019.
    Response: To clarify, we proposed that the self-nomination period 
be moved for the 2020 performance period, not the 2019 performance 
period as indicated by the commenter, to allow for sufficient time and 
notice of the changes. We will continue to provide educational 
materials that will outline all of the information needed to evaluate a 
QCDR's ability to meet participation standards and QCDR measure 
evaluation criteria prior to the start of the self-nomination period. 
With the publication of this final rule, we intend on communicating any 
changes to the review process. For the 2019 performance period, it is 
not feasible to allow for a minimum of 30 days to appeal changes due to 
our goal of approving and publicizing the QCDRs by the start of the 
performance period. By moving up the self-nomination period, we will be 
able to allow QCDRs to have more time to consider our QCDR measure 
feedback. Additionally, moving the timeline to earlier in the year will 
allow CMS to review the measures fully and provide feedback to the QCDR 
who submitted the measures. The earlier self-nomination will also allow 
QCDRs who submit clinically similar measures to another QCDR and whose 
measure(s) are rejected to reach out to the QCDR whose measures are 
approved to attempt to enter into a licensing use agreement with the 
QCDR with the approved measures if desired. It is the goal of CMS to 
post the most comprehensive list of approved QCDRs and their measures 
before the start of the performance period so that eligible clinicians 
intending to use a QCDR can review these materials and select the QCDR 
that best meets their needs. In this way, the eligible clinician may 
begin submitting data to the QCDR at the start of the performance 
period. By doing so, the clinician will be more likely to receive 
timely feedback from the QCDR regarding his/her performance (earlier in 
the year) which will allow for quality improvement to occur during the 
performance period instead of receiving this data later in the year or 
after the conclusion of the performance period.
    The CY 2019 performance period self-nomination form reflects the 
proposed MIPS quality measures, Promoting Interoperability measures, 
and Improvement Activities as proposed in the CY 2019 PFS proposed 
rule. We include disclaimer language that indicates that measures and 
activity availability are subject to change, pending upon what is 
finalized in the final rule. We continuously take into consideration 
stakeholder feedback as we look into process improvements and policy 
development for future program years. We appreciate the commenters' 
suggestions, and ask that they provide more detail as to the changes to 
the licensing standards that they recommend we implement for future 
consideration.
    After consideration of the public comments received, we are 
finalizing our proposal to amend Sec.  414.1400(b)(1) to provide that, 
beginning with the 2022 MIPS payment year, entities seeking to qualify 
as QCDRs must self-nominate during a 60-day period beginning on July 1 
of the calendar year prior to the applicable performance period and 
ending on September 1 of the same year; must provide all information 
required by us at the time of self-nomination; and must provide any 
additional information requested by us during the review process. In 
addition, we are finalizing our proposal to update Sec.  
414.1400(b)(3)(iii) to state that QCDRs must include their CMS-assigned 
QCDR measure ID number when posting their approved QCDR measure 
specifications, and also when submitting data on the QCDR measures to 
us.
(d) QCDR Measure Requirements
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77374 through 77375) for where we previously finalized standards 
and criteria used for selecting and approving QCDR measures. We 
finalized that QCDR measures must: Provide specifications for each 
measure, activity, or objective the QCDR intends to submit to CMS; and 
provide CMS descriptions and narrative specifications for each measure, 
activity, or objective no later than November 1 of the applicable 
performance period for which the QCDR wishes to submit quality measures 
or other performance category (improvement activities and Promoting 
Interoperability) data starting with the 2018 performance period and in 
future program years. In the CY 2019 PFS proposed rule (83 FR 35983), 
we proposed to consolidate our previously finalized standards and 
criteria used for selecting and approving QCDR measures at Sec.  
414.1400(e) and (f) at Sec.  414.1400(b)(3). We also proposed to apply 
certain criteria used under the Call for Quality Measures Process when 
considering QCDR measures for possible inclusion in MIPS beginning with 
the MIPS 2021 payment year (83 FR 35983).
    In the CY 2018 Quality Payment Program final rule (82 FR 53814), we 
noted our interest in elevating the standards for which QCDR measures 
are selected and approved for use and sought comment on whether the 
standards and criteria used for selecting and approving QCDR measures 
should be more closely aligned with those used for the Call for Quality 
Measures process described in the CY 2017 Quality Payment Program final 
rule (81 FR 77151). Some commenters expressed concern with this 
alignment, stating that the Call for Measures process is cumbersome, 
and would increase burden. Other commenters expressed the belief that 
the Call for Measures process does not recognize the uniqueness of 
QCDRs, and is not agile. We would like to clarify that our intention 
with any future alignment is to work towards consistent standards and 
evaluation criteria that would be applicable to all MIPS quality 
measures, including QCDR measures. We understand that some of the 
criteria under the Call for Measures process may be difficult for QCDRs 
to meet prior to submitting a particular measure for approval; however, 
we believe that the criteria under the Call for Measures process helps 
ensure that any new measures are reliable and valid for use in the 
program. Having a greater alignment in measure standards helps ensure 
that MIPS eligible clinicians and groups are able to select from an 
array of measures that are considered to be higher quality and provide 
meaningful measurement. As such, we believe that as we gain additional 
experience with QCDRs in MIPS, it would be appropriate to further align 
these criteria for QCDR measures with those of MIPS quality measures in 
future program years.
    Therefore, in addition to the QCDR measure criteria previously 
finalized at Sec.  414.1400(f), we proposed in the CY 2019 PFS proposed 
rule (83 FR 35984) to apply select criteria used under the Call for 
Measures Process, as described in the CY 2018 Quality Payment Program 
final rule (82 FR 53636). Specifically, in addition to the QCDR measure 
criteria at proposed Sec.  414.1400(b)(3), we proposed in the CY 2019 
PFS proposed rule (83 FR 35984) to apply the following criteria 
beginning with the 2021 MIPS payment year when considering QCDR 
measures for possible inclusion in MIPS:
     Measures that are beyond the measure concept phase of 
development.
     Preference given to measures that are outcome-based rather 
than clinical process measures.
     Measures that address patient safety and adverse events.
     Measures that identify appropriate use of diagnosis and 
therapeutics.
     Measures that address the domain for care coordination.

[[Page 59901]]

     Measures that address the domain for patient and caregiver 
experience.
     Measures that address efficiency, cost and resource use.
     Measures that address significant variation in 
performance.
    We believe that as we gain additional experience with QCDRs in 
MIPS, it would be appropriate to further align these criteria for QCDR 
measures with those of MIPS quality measures in future program years. 
Specifically, we are considering proposing to require reliability and 
feasibility testing as an added criteria in order for a QCDR measure to 
be considered for MIPS in future rulemaking.
    In addition, we refer readers to the CMS Quality Measure 
Development Plan at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf for more information regarding the measure 
development process.
    The following is a summary of the public comments received on the 
``QCDR Measure Requirements'' proposals and our responses:
    Comment: A few commenters stated that CMS should offer multi-year 
approval of QCDR measures to maximize stability and predictability 
while minimizing redundancy. The commenters further stated that QCDRs 
should be allowed to make minor modifications to measures under this 
multi-year approval process based on updated guidelines, evidence, or 
measure methodologies and if QCDR measures were approved for 2 to 3 
years, the earlier self-nomination deadline would not be as problematic 
for registry vendors and would streamline CMS' process.
    Response: We disagree that offering multi-year approval of QCDR 
measures would minimize redundancy, as this may actually lead to 
duplicative measures which is counter intuitive to our meaningful 
measures initiative. Multi-year approvals of QCDR measures does not 
account for the possibility of there being more robust QCDR measures of 
similar concepts being submitted for CMS consideration. We may consider 
a similar process for future years, which is used with MIPS quality 
measures, where we'd continue to evaluate all the measures on an annual 
basis and compare them to those submitted during the measure 
consideration period (self-nomination period) to determine what QCDR 
measures would be best to include for the upcoming performance period. 
QCDRs making changes to their measures would have to self-nominate 
those changes for CMS' approval, and if we receive measures of similar 
concept that are more robust they may be considered to replace the 
existing approved QCDR measures.
    Comment: One commenter supported the proposal to include the CMS-
assigned QCDR measure ID number when posting the approved QCDR measure 
specifications, and also when submitting data on the QCDR measures to 
CMS.
    Response: We appreciate the commenter's support.
    Comment: One commenter stated that CMS should not approve highly 
duplicative measure concepts submitted at a later time as doing so 
increases confusion among physicians and competition among QCDRs while 
disregarding the time, resources, and intellectual property rights of 
the measure owners. Some commenters noted that measures are misaligned, 
overlapping and duplicative across QCDR and MIPS measures.
    Response: We agree that duplicative measures are counterintuitive 
to the Meaningful Measures initiative that promotes more focused 
quality measure development towards outcomes that are meaningful to 
patients, families and their providers. It is our intent to move toward 
measure harmonization, which supports our efforts to increase measure 
alignment and eliminate redundancy both within the MIPS measure set and 
across CMS programs.
    Comment: A few commenters supported the proposal to update QCDR 
measure criteria and encouraged CMS to have dialogue with QCDRs 
regarding the submission of measures. One commenter stated that CMS 
should expand the policy toward having a common national framework for 
endorsement of measures by a national consensus body (which currently 
is the National Quality Forum) and set expectations when accepting QCDR 
measures that measure stewards would be expected to get endorsement 
after a certain defined time period.
    Response: We will continue dialogue with QCDRs during our scheduled 
calls. As far as expanding our policy toward having a common national 
framework for endorsement of measures by a national consensus body, we 
agree this would be valuable and encourage QCDRs to have their measures 
NQF endorsed. However, it is not a necessary requirement at this time 
because of its potential increase in burden and potential unintended 
impacts on the ability of QCDRs to adapt their measures.
    Comment: A few commenters stated that CMS should work with both 
specialty societies and vendors in facilitating the time and effort 
needed to successfully encourage reporting of specialty-specific 
process and outcome measures while ensuring proper review and that 
appropriate data can be collected and shared. One commenter suggested 
CMS develop a review process where CMS and its contractor consult with 
appropriate physician experts and QCDR stewards to ensure sufficient 
clinical expert review on the importance and relevancy of a measure.
    Response: We hold QCDR measure preview calls to provide a forum to 
work with both specialty societies and vendors wishing to self-nominate 
QCDR measures. New entities wishing to review QCDR measure concepts 
with CMS, may request a meeting with CMS by contacting the Quality 
Payment Program Service Center at [email protected]. Existing QCDRs may 
contact our contractor support team to set up a QCDR measure preview 
call. We have several measure experts as part of our review process, 
many of which have specialty specific expertise. Furthermore, we hold 
calls prior to self-nomination to allow experts to discuss their QCDR 
measure concepts, and will also continue to schedule calls with QCDRs 
after the self-nomination period closes to provide feedback, which 
provides time for QCDRs to invite their clinical experts to provide 
additional information and explanation that would provide us with 
clarifications that may lead to a QCDR measure reexamination.
    Comment: Many commenters did not support the proposal to align QCDR 
measure requirements with the criteria used under the Call for Quality 
Measures Process due to their beliefs that applying this criteria to 
QCDR measures fails to recognize the unique role of QCDRs who fill 
critical gaps in traditional quality measure sets as they support 
different specialties, and that doing so would limit the number of 
measures available for QCDR participants, would create more stringent 
standards for QCDR measures resulting in additional burden, and be 
counterproductive toward the goal of encouraging the use of QCDRs. 
Commenters stated that rather than require these criteria, the criteria 
should be made optional, but strongly preferred, as there are existing 
evidence-based process measures that are still valuable to improving 
patient care and should still be considered for inclusion in the QCDR 
program; and that since some outcome measures which evaluate 
degenerative or rare incidences, conditions that are terminal with 
limited treatment options, or conditions which result in increased co-
morbidities require measurement over the course of multiple years to 
have sufficient

[[Page 59902]]

statistical power, CMS should continue the use of certain process 
measures until they can be easily converted to meaningful outcome 
measures.
    Response: We believe that our process seeks to ensure reliable 
measures and expect all measures in the program, including QCDRs, to be 
held to that standard. We believe that it is imperative to raise the 
bar with QCDR measures in order to ensure that we move away from 
standard of care, low-bar, process, and/or duplicative measures. 
Specifically, we are considering proposing to require reliability and 
feasibility testing as an added criteria in order for a QCDR measure to 
be considered for MIPS in future rulemaking. In the CY 2018 Quality 
Payment Program final rule (82 FR 53814), we state that as the MIPS 
program progresses in its implementation, we are interested in 
elevating the standards for which QCDR measures are selected and 
approved for use. As a part of our QCDR measure review process, we do 
consider the complexity of what is being measured, while being mindful 
that measures with high performance do not provide value with regards 
to the quality performance category in MIPS. There are process measures 
in MIPS that are considered high priority, we believe it is important 
to retain those so long as they demonstrate room for improvement and 
lead to meaningful outcomes.
    Comment: One commenter suggested CMS clarify the process by which a 
measure would be assigned within the domains provided under the 
proposed alignment with the Call for Quality Measures process and offer 
greater transparency in the rationale for this assignment or outcome 
status. In addition, the commenter recommended that CMS defer to the 
rationale and status identified by the QCDR, in particular for 
clinician-led registries.
    Response: During the self-nomination process, we ask the QCDR to 
assign their QCDR measure a NQS domain, Meaningful Measure Area, 
whether or not their measure is high priority and/or an outcome 
measure. As a part of the vetting process, we review those selections 
and will reach out to the QCDR should we not agree with their 
assignment.
    Comment: One commenter stated that due to the announcement of 
approved measures continuing to occur on a fixed schedule shortly 
before the start of each MIPS performance period despite the rolling 
submission process for new MIPS measures through the Call for Quality 
Measures Process, CMS should transition to a rolling review and 
approval process for QCDR measures to allow stakeholders more time to 
implement new measures prior to the MIPS performance period. This 
commenter also stated that if CMS is unwilling to move to a rolling 
review and approval process, the quality category performance period 
should be reduced. The commenter noted that the rolling submission 
process has not benefited measure owners, QCDRs, registries, and EHR 
vendors, all of which have very little time to modify their systems to 
include new measures post-approval and prior to the start of the next 
MIPS performance period.
    Response: We note that a rolling review basis would adversely 
impact our ability to limit the number of duplicative measures that are 
similar in concept, which is inconsistent with the meaningful measure 
initiative. We believe that the change in the self-nomination period 
would allow for increased time in the measure review process, as well 
as provide additional time for QCDRs to respond to feedback provided by 
CMS. We do not believe a rolling review and approval process is 
appropriate, as it is not a process that is used for MIPS quality 
measures. We do not agree that the quality performance period should be 
reduced dependent on whether or not a rolling review and approval 
process is implemented as there is no correlation between the two 
processes.
    Comment: One commenter suggested CMS should require measure 
developers to include a section in each measure that specifies how 
eligible clinicians and TINs should be attributed for that measure to 
assist in preventing different interpretations for measure attribution 
which could lead to TIN/NPI mismatches and resulting determinations by 
CMS that submitted data is inaccurate.
    Response: We agree that attribution should be clearly stated in the 
QCDR measure specifications and appreciate the commenter's feedback. We 
will take this suggestion into consideration as we review QCDR measure 
concepts, and will share this feedback with the QCDRs for their 
consideration.
    After consideration of the public comments received, we are 
finalizing our proposal to consolidate our previously finalized 
standards and criteria used for selecting and approving QCDR measures 
at Sec.  414.1400(e) and (f) at Sec.  414.1400(b)(3) and to apply 
certain criteria used under the Call for Quality Measures Process when 
considering QCDR measures for possible inclusion in MIPS beginning with 
the MIPS 2021 payment year. We are also finalizing our proposal to 
apply select criteria used under the Call for Measures Process, as 
described in the CY 2018 Quality Payment Program final rule (82 FR 
53636) in addition to the QCDR measure criteria previously finalized at 
Sec.  414.1400(f). Specifically, in addition to the QCDR measure 
criteria that we are finalizing at Sec.  414.1400(b)(3), we are also 
finalizing our proposal to apply the following criteria beginning with 
the 2021 MIPS payment year when considering QCDR measures for possible 
inclusion in MIPS:
     Measures that are beyond the measure concept phase of 
development.
     Preference given to measures that are outcome-based rather 
than clinical process measures.
     Measures that address patient safety and adverse events.
     Measures that identify appropriate use of diagnosis and 
therapeutics.
     Measures that address the domain for care coordination.
     Measures that address the domain for patient and caregiver 
experience.
     Measures that address efficiency, cost and resource use.
     Measures that address significant variation in 
performance.
(e) QCDRs Seeking Permission From Another QCDR To Use an Existing, 
Approved QCDR Measure
    In the CY 2018 Quality Payment Program final rule (82 FR 53813), we 
finalized that beginning with the 2018 performance period and for 
future program years, QCDR vendors may seek permission from another 
QCDR to use an existing measure that is owned by the other QCDR. We 
intended for this policy to help reduce the number of QCDR measures 
that are similar in concept or clinical topic, or duplicative of other 
QCDR measures that are being approved. Furthermore, having multiple 
QCDRs report on the same QCDR measure allows for a larger cohort of 
clinicians to report on the measure, which helps establish more 
reliable benchmarks and may give some eligible clinicians or group a 
better chance of obtaining a higher score on a particular measure. 
However, we have experienced that this policy has created unintended 
financial burden for QCDRs requesting permission from other QCDRs who 
own QCDR measures, as some QCDRs charge a fee for the use of their QCDR 
measures. MIPS quality measures, while stewarded by specific specialty 
societies or organizations, are generally available for third party 
intermediaries, MIPS eligible clinicians, and groups to report on for 
purposes of MIPS without a fee for use. Similarly, we believe, that 
once a QCDR measure is approved for reporting in MIPS, it should be 
generally available for other

[[Page 59903]]

QCDRs to report on for purposes of MIPS without a fee for use. In the 
CY 2019 PFS proposed rule (83 FR 35984), we proposed at Sec.  
414.1400(b)(3)(ii)(C) that beginning with the 2021 MIPS payment year, 
as a condition of a QCDR measure's approval for purposes of MIPS, the 
QCDR measure owner would be required to agree to enter into a license 
agreement with CMS permitting any approved QCDR to submit data on the 
QCDR measure (without modification) for purposes of MIPS and each 
applicable MIPS payment year. In the CY 2019 PFS proposed rule (83 FR 
35984) we also proposed at Sec.  414.1400(b)(3)(iii) that other QCDRs 
would be required to use the same CMS-assigned QCDR measure ID. If a 
QCDR refuses to enter into such a license agreement, the QCDR measure 
would be rejected and another QCDR measure of similar clinical concept 
or topic may be approved in its place.
    The following is a summary of the public comments received on the 
``QCDRs Seeking Permission from another QCDR to Use an Existing, 
Approved QCDR Measure'' proposals and our responses:
    Comment: Many commenters disagreed with CMS' proposal to require 
QCDRs to enter into a measure licensing agreement with CMS beginning 
with the 2021 MIPS payment year, stating that QCDRs would be required 
to attest to these measures before knowledge that this proposal would 
be finalized and that they, therefore, did not know that they would be 
required to enter into mandatory licensing agreements for these 
measures at the time of attestation. Commenters specifically stated 
that this timeline would violate the Administrative Procedure Act. 
Other commenters stated that should the proposal be finalized, it would 
be unreasonable for QCDR measure stewards to implement the policy by 
January 1 of the 2019 performance period given that the self-nomination 
period closes prior to publication of the CY 2019 PFS final rule. 
Commenters stated that the proposal, if it is finalized, should be 
delayed at least 1 year to give QCDRs an opportunity to decide whether 
to continue participating in the program. One commenter stated that 
some specialty societies may delay their QCDR application until this 
issue has been addressed by CMS.
    Response: Based on the feedback and concerns raised by 
stakeholders, in the interim, we are not finalizing this proposal. 
Rather, while we believe our proposal is consistent with the 
Administrative Procedure Act, we are persuaded by the other concerns 
raised by stakeholders on the implementation of this policy and are 
therefore retaining our existing policy that QCDR vendors may seek 
permission from another QCDR to use an existing measure that is owned 
by the other QCDR (82 FR 53813).
    Comment: Many commenters disagreed with the proposal to require 
QCDR measure owners to allow other QCDRs to submit data on the QCDR 
measure as a condition of measure approval. Reasons cited for 
disagreeing with the proposal include beliefs that it does not 
acknowledge the cost in developing complex measures; would unfairly 
reduce costs for QCDRs that do not develop their own measures while 
increasing costs for QCDRs that do; would compromise the intellectual 
property of measure stewards as CMS would have a mandatory, exclusive, 
and unfettered right to sublicense their QCDR measures for MIPS 
purposes as a condition of measure approval; would undermine the smooth 
operation of the QCDR measure market; is an arbitrary and capricious 
reversal of existing policy; violates intellectual property law, 
judicial precedent, executive order, and copyrights; nullifies the 
rights of copyright owners to collect reasonable royalties, maintain 
measure integrity, and limit inappropriate use; might remove the right 
of QCDR developers to have input into how CMS uses their measures; may 
result in a developer having to seek CMS's approval prior to working 
with another payer entity for reporting of its measures; and ignores 
the time and resources spent in developing and maintaining measures.
    Response: As noted above we are not finalizing this proposal. We 
note that we do not believe this proposal would have violated 
intellectual property rights or law, as QCDRs would not have been 
required to submit QCDR measures for approval, and if a QCDR had 
refused to enter into such a license agreement, the QCDR measure would 
have been rejected and another QCDR measure of similar clinical concept 
or topic may have been approved in its place. We will take the many 
concerns raised by commenters into consideration as we work with 
stakeholders to address this issue in the future.
    Comment: Many commenters disagreed with the proposal to require 
QCDR measure owners to allow other QCDRs to submit data on the QCDR 
measure as a condition of measure approval believing it contradicts the 
intent of the Meaningful Measure Initiative by eliminating the 
incentive to develop innovative quality measures that focus on 
meaningful outcomes; will disincentivize societies from investing in 
the development of new and improved measures; may increase the 
incidence of inappropriate use of measures by QCDRs lacking the 
necessary clinical breadth of exposure/experience resulting in lower 
quality data being collected, decreased reliability and validity of 
results, and potential misclassification of providers; would negatively 
impact the quality of available measures and physician community 
support for the Quality Payment Program in general; would 
disincentivize QCDRs from remaining in business, resulting in loss of 
significant private sector knowledge and experience, as well as 
increasing the financial burden on the government to hire more federal 
contractors to replace lost innovation and creativity; and disregards 
the original intent of QCDRs to submit data on non-MIPS measures 
focused on disease, condition, procedure, or therapy-specific patient 
populations.
    Response: We do not believe this proposed policy contradicts the 
Meaningful Measure Initiative, which seeks to reduce the number of 
duplicative measures in quality performance programs, thereby reducing 
clinician burden and complexity. However, as noted above we are not 
finalizing this proposal. We also note that with the finalization of 
the updated QCDR definition, we believe we will be able to negate any 
concerns of inappropriate use of QCDR measures by QCDRs who do not have 
the clinical expertise needed to understand the measure at hand. We 
have observed increasing interest in stakeholders becoming QCDRs, and 
believe that they will continue to drive innovation and competition 
within the market.
    Comment: A few commenters suggested alternatives to the proposal to 
require QCDRs to license their measures to CMS. These alternatives 
include encourage licensing agreements between QCDRs and reinforcing 
the ability of QCDRs to develop their own measures should they elect 
not to license them from other QCDRs. One commenter suggested that CMS 
should create a ``measure complexity score'' with a corresponding, 
volume-based, licensing fee payable to the QCDR holding the original 
measure in conjunction with an annual consolidation of measures to 
support harmonization requiring stakeholders to collaborate on a 
``shared'' measure creation (with licensing fees split evenly) or lose 
the opportunity for future licensing fee payments. Another commenter 
recommended CMS propose including a cost-based algorithm that would be 
used to determine a specific QCDR measure fee which would protect 
organizations

[[Page 59904]]

that could not afford the development of a quality measure or that were 
not able to develop a measure because a similar measure exists, as well 
as preventing QCDR measure developers from assigning unreasonable fees 
to their measures. One commenter recommended CMS establish a pilot 
program that would encourage collaboration across QCDRs and require 
users of QCDR measures to agree to adhere to certain requirements of 
the measure steward, as well as share measure performance information 
to implement and test measure changes, progressing all concepts to 
patient-centered outcome measures through measure retirement. Another 
commenter recommended that CMS follow NQF's example that anyone can 
report the measure scores and there has to be public/free access for 
the measures to be used in clinical care, but the measure steward 
should be permitted to require licensing and fees for anyone who wants 
to use the measures for more sophisticated purposes, such as 
programming into software that will result in sales/profit. Other 
commenters cited their opinions that should the proposal be finalized, 
it should be done with modification to require a standard data 
dictionary be used for all QCDR measures and include risk adjustment as 
well as the same standard methodology used by the measure developer.
    Response: We note that the suggestion to encourage licensing 
agreements between QCDRs was implemented in the CY 2018 Quality Payment 
Program final rule (82 FR 53813 through 53814); however, we have 
decided not to finalize the measure licensure policy at this time. Our 
goal in enacting such a policy was to promote measure harmonization and 
decrease the number of duplicative QCDR measures in the program. We 
appreciate the suggestion of a ``measure complexity score'' but 
envision such an approach would be difficult to implement. We would 
need additional information from stakeholders prior to implementing 
such a policy, such as how would CMS know how to correlate the volume 
and complexity to a specific score? What would that entail if on an 
annual basis the number of QCDRs who submit a similar measure concept 
increases, and what would they have to do in order to be a part of the 
harmonization effort? We request clarification on how a cost-based 
algorithm can be developed, and would also like to clarify that CMS 
does not regulate the minimum or maximum amounts that a QCDR may charge 
as a licensing fee.
    We thank the commenter for their suggestion of implementing a pilot 
program where QCDRs would need to share measure performance 
information, test and implement measure changes, and work towards 
patient-centered outcome measures. We agree that the sharing of 
performance data, testing results, and moving towards outcome based 
measures are all important, but will need to look into the feasibility 
and operations of implementing such requirements. With regards to the 
development of a standard data dictionary, as described in the CY 2018 
Quality Payment Program final rule (82 FR 53813), we encourage QCDR 
measure developer to utilize the current Measure Development Plan 
available at https://www.cms.gov/Medicare/Quality-Payment-Program/Measure-Development/2018-MDP-annual-report.PDF. Furthermore, as 
explained through posted sub-regulatory documents for the 2019 self-
nomination period, the current Blueprint for the CMS Measures 
Management System available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/BlueprintVer14.pdf. Both resources provide information on standardized 
terminology, measure concepts and constructs.
    Comment: Many commenters requested CMS work with them to adopt a 
market-based solution to create safeguards to protect the proper 
implementation of QCDR measures and enforce the intellectual property 
rights of developers of QCDR measures, while also ensuring that the 
measures are readily available to other QCDRs with clinical expertise 
and experience in quality measure development.
    Response: We will look to provide listening sessions to better 
understand and explore the feasibility of this approach.
    Comment: Many commenters expressed concern with CMS' requests for 
harmonization of similar MIPS measures due to their belief that some 
vendors may be misusing measures and diminishing the integrity of the 
data, the quality of feedback to physicians, and ability to compare 
performance. The commenters further cited their belief that such 
harmonization can lead to inconsistencies in implementation, yielding 
incomparable results and inaccurate benchmarking due to lack of 
accountability and standardization across registries which may be 
employing different methods for obtaining, risk adjusting, and 
aggregating data, thereby creating variations in how clinicians are 
measured and how their care is classified.
    Response: To clarify, in the CY 2019 PFS proposed rule (83 FR 
35984), we indicated that the QCDRs would be required to use the QCDR 
measure without any modification, and would have to report on the 
measure utilizing the CMS assigned measure ID. We encourage QCDRs to 
work together through measure harmonization, and to reach out to QCDR 
measure owners when they believe a revision to the measure 
specification is appropriate, for the QCDR measure owner to consider.
    Comment: A few commenters suggested the proposal to require QCDRs 
to license measures to CMS should include allowing qualified registries 
and other non-QCDR submitter types to also report QCDR measures; only 
counting measures developed by a QCDR to count toward the 30 measure 
threshold; and requiring QCDR measure owners to provide detailed 
specifications including ICD-10-CM codes, CPT codes, required clinical 
data elements, et cetera, so that all QCDR registries administer the 
specification uniformly, and developing a system to properly record and 
track ownership rights, including making ownership information CMS 
collects available to QCDRs to better facilitate sharing of QCDR 
measures between QCDR stewards. Commenters also suggested that CMS 
reserve the right of the measure owner to review interim performance 
results of other QCDRs utilizing their measures with full cooperation 
of the other QCDRs to ensure performance results do not vary 
significantly between QCDRs, thereby ensuring alignment on execution of 
the measure specification between QCDRs before performance is scored 
and future benchmarks are impacted.
    Response: To clarify, we are only allowing other QCDRs to report on 
the QCDR measures. Other submitter types would not have the QCDR 
measures available for reporting. As discussed in the CY 2018 Quality 
Payment Program final rule (82 FR 53811), QCDRs have the capability to 
develop and submit for consideration up to 30 QCDR measures per 
performance period. However, there is no limit as to the number of MIPS 
quality measures they intend on supporting for a given performance 
period. We disagree that QCDR measures should be available for 
reporting by non-QCDR submitter types. As we provide QCDRs with 
feedback on harmonizing or using QCDR measures owned by other QCDRs, we 
encourage them to reach out to the QCDRs specifically for the detailed 
specification inclusive of ICD-10 and CPT codes, as each measure owner 
is responsible for tracking ownership

[[Page 59905]]

rights. The MIPS quality measures provide a detailed measure 
specification to allow consistency in implementation, but data 
abstraction may include multiple methods. We would require QCDRs to 
follow a similar approach, where QCDRs would need to provide a detailed 
specification to the QCDRs approved to submit the QCDR measure. This 
would include any applicable ICD-10-CM codes, CPT codes, required 
clinical data elements, et cetera, to allow implementation with minimal 
variance. We would like to hear from QCDRs on whether or not they would 
find this useful; and if this effort will increase burden on their end 
regarding measure specification development. We will take the 
suggestion that CMS reserve the right of the measure owner to review 
interim performance results of other QCDRs utilizing their measures 
into consideration for future rulemaking.
    Comment: A few commenters stated that the proposal blurs the line 
between QCDR measures and Quality Payment Program measures and would 
eliminate the ability for a QCDR to ``test'' a measure in the sandbox 
of their own QCDR before submitting it to CMS to become a Quality 
Payment Program measure under the Measures Under Consideration (MUC) 
process. Finally, one commenter suggested that if a measure owner was 
ready to make a measure available for reporting by all of the Quality 
Payment Program, they should submit it to CMS under the MUC process.
    Response: The QCDR measure approval process is not intended to act 
as a test bed for measure concepts, we expect QCDRs to have measures 
that are analytically sound, are reliable, and feasible. Furthermore, 
we certainly encourage that if a measure owner is ready to make a 
measure available for reporting by all of the Quality Payment Program, 
they should submit it to CMS under the MUC process as discussed in 
section III.I.3.h.(2)(b)(i) of the CY 2019 PFS proposed rule (83 FR 
35898 through 35899).
    Comment: One commenter stated its belief that the proposal does not 
align with the intended purpose of the MACRA grant for measure 
development, which they further noted demonstrates the federal 
government's recognition of measure development expense. A second 
commenter stated that the proposal lacks provisions on how to determine 
whether a specific measure is intended for another population and that 
the absence of such provisions can lead to inappropriate 
implementations in patient populations with the inability of the 
measure owner to review data collected on their measures and maintain 
the measures appropriately.
    Response: We do not believe this policy would not align with the 
MACRA grant for measure development, since generally across all quality 
programs we are looking to reduce the number of duplicative measures 
available for reporting and to transition to more outcomes based 
measures. We believe that QCDRs exist to address measurement gaps as 
identified by the specialists and that QCDRs are intended to address 
gaps in measurement that would better reflect a clinician's scope of 
practice. Based on the updates to the QCDR definition we have finalized 
in this final rule (in the above section) for the 2020 performance 
period of MIPS, we believe we will be able to further vet QCDR 
applications to ensure that approved QCDRs would have the clinical 
expertise and measure development experience. We are also streamlining 
the number of measures available to clinicians in order to align with 
our Meaningful Measures initiative. We note that our review and 
approval of the QCDR measures will follow our existing process 
utilizing the QCDR measure evaluation criteria as detailed through sub-
regulatory guidance in the 2019 QCDR Measure Development Handbook, 
located in the 2019 Self-Nomination Toolkit on the Quality Payment 
Program Resource Library web page at https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/2018-Resources.html. Once the 
QCDR measures have been finalized for the performance period, and the 
specification has been finalized, we intend to post the list of QCDR 
measure specifications for QCDRs to review and consider prior to 
deciding whether or not they wish to support additional QCDR measures. 
As a part of this consideration, we encourage QCDRs to review the 
measure specifications to determine the populations addressed.
    Comment: A few commenters supported the proposal to require QCDRs 
to enter into licensing agreements with CMS as a condition of approval. 
Reasons cited include their beliefs that the proposal allows different 
vendors to have the ability to address different specialty needs 
appropriately thereby providing greater choice to eligible clinicians, 
increases the effectiveness of quality measurement, and increases the 
relevance and usefulness of measures in evaluating the quality of care 
provided to patients nationally by increasing the number of providers 
reporting data.
    Response: We thank the commenters for their support but as noted 
previously we are not finalizing this policy at this time.
    Comment: A few commenters stated that CMS should adopt a model 
where one measure is supported by one entity that represents a single 
clinical domain or subspecialty as they noted doing so will enhance 
consistency and validity across measurements; allow for a single method 
for data aggregation, analytics, and reporting; reduce benchmarking 
issues; decrease the risk of clinicians being misclassified in the 
quality of care they provide; and remedy CMS' lack of ability to co-
aggregate data from multiple data sources and properly risk-adjust 
measures. The commenters noted that the approved registry should be 
required to meet standards for data which include rigor in explicitly 
defining data elements used in the measurement, serve as a single 
source of data aggregation and data normalization to secure data 
integrity, apply approved and consistent statistical standards for 
analytics, respond to clinical and methodological questions, and be 
responsible for reporting requirements as defined by CMS. One commenter 
further noted that CMS policy should require QCDRs to always refer 
eligible clinician questions on specific measures back to the measure 
steward, prohibit vendors and other QCDRs from specifying CQMs into 
eCQMs without permission, require QCDRs to use current measure 
specifications, and require CMS to publicly post complete measure 
specifications, where appropriate, to the CMS Quality Payment Program 
resources website to ensure all registries are implementing the most 
updated measure specifications.
    Response: We are not looking to set limitations, such as, one 
clinical domain being assigned to one entity. We have multiple 
instances where there are a few QCDRs covering similar areas (that is, 
surgery, anesthesia, rheumatology). We would appreciate thoughts on how 
we can reduce benchmarking issues to thereby incentivize QCDR measure 
reporting. QCDRs are required to meet CMS data aggregation and 
reporting requirements and agree that it is important that QCDRs are 
able to meet data integrity standards in using data elements for 
purposes of measurement. We believe there are circumstances out of CMS' 
control where the clinician will reach out to the QPP service center 
for assistance with a measure related question or to the QCDR they are 
specifically working with. It would not be feasible to set such a 
requirement when we could not monitor that it would be followed. We 
encourage clinicians who have questions on the

[[Page 59906]]

QCDR measure specifications to reach out directly to the QCDR measure 
owner in order to gain clarity on their questions. We agree, however, 
that the QCDR must use the measure in its original state. QCDRs have to 
use the measure in its ``as is'' state; meaning, how it was approved 
for the given performance period. We post QCDR measure specifications, 
inclusive of: The measure's specialty; QCDR name; measure title; 
measure description; denominator; numerator; denominator exclusions; 
denominator exceptions; numerator exclusions; data source used; NQF 
number (if applicable); NQS domain; whether the measure is high 
priority, outcome; measure type; whether the measure is inverse, 
proportional, continuous variable, ratio; the range of scores if the 
measure is continuous variable or ratio measures; number of performance 
rates submitted; overall performance rate; whether the measure is risk-
adjusted; if risk-adjusted, and which score is risk-adjusted within the 
QPP resource library. The systems are programmed on an annual basis to 
only accept those QCDR measures and correlated specifications as 
approved for the upcoming performance period.
    Based on the feedback and concerns raised by stakeholders, in the 
interim, we are not finalizing at Sec.  414.1400(b)(3)(ii)(C) that as a 
condition of a QCDR measure's approval for purposes of MIPS, the QCDR 
measure owner would be required to agree to enter into a license 
agreement with CMS, permitting any approved QCDR to submit data on the 
QCDR measure (without modification) for purposes of MIPS and each 
applicable MIPS payment year. Rather we are retaining our existing 
policy that QCDR vendors may seek permission from another QCDR to use 
an existing measure that is owned by the other QCDR (82 FR 53813). We 
remain very concerned about duplicative measures and their impact to 
our meaningful measures initiative. We are eager to work with the 
stakeholder community to determine solutions for this issue and will 
continue to look for policy resolutions to address this issue.
    We are finalizing our proposal at Sec.  414.1400(b)(3)(iii) that 
other QCDRs would be required to use the same CMS-assigned QCDR measure 
ID.
(4) Qualified Registries
    We refer readers to Sec.  414.1400 and the CY 2018 Quality Payment 
Program final rule (82 FR 53815 through 53818) for our previously 
finalized policies regarding qualified registries. In the CY 2019 PFS 
proposed rule (83 FR 35984), we proposed to update: Information 
required for qualified registries at the time of self-nomination and 
the self-nomination period for qualified registries.
(a) Establishment of an Entity Seeking To Qualify as a Qualified 
Registry
    In the CY 2017 Quality Payment Program final rule (81 FR 77383), we 
state at Sec.  414.1400(h)(2) that the qualified registry must have at 
least 25 participants by January 1 of the performance period. These 
participants do not need to use the qualified registry to report MIPS 
data to us; rather, they need to submit data to the qualified registry 
for quality improvement. We realize that a qualified registry's lack of 
preparedness to accept data from MIPS eligible clinicians and groups 
beginning on January 1 of the performance period may negatively impact 
a clinician's ability to use a Qualified Registry to report, monitor 
the quality of care they provide to their patients (and act on these 
results) and may inadvertently increase clinician burden. For these 
reasons, in the CY 2019 PFS proposed rule (83 FR 35984), we proposed to 
redesignate Sec.  414.1400(h)(2) as Sec.  414.1400(c)(2) to state that 
beginning with the 2022 MIPS Payment Year, the qualified registry must 
have at least 25 participants by January 1 of the year prior to the 
applicable performance period. These participants do not need to use 
the qualified registry to report MIPS data to us; rather, they need to 
submit data to the qualified registry for quality improvement.
    We did not receive any comments on the ``Establishment of an Entity 
Seeking To Qualify as a Qualified Registry.'' We are finalizing our 
proposal to redesignate Sec.  414.1400(h)(2) as Sec.  414.1400(c)(2) to 
state that beginning with the 2022 MIPS Payment Year, the qualified 
registry must have at least 25 participants by January 1 of the year 
prior to the applicable performance period.
(b) Self-Nomination Process
    We refer readers to Sec.  414.1400(g), the CY 2017 and CY 2018 
Quality Payment Program final rules (81 FR 77383 and 82 FR 53815, 
respectively) for our previously established policies regarding the 
self-nomination process for qualified registries. We did not propose 
any changes to this policy.
(c) Self-Nomination Period
    Under the previously finalized policy at Sec.  414.1400(g), 
qualified registries must self-nominate from September 1 of the year 
prior to the applicable performance period until November 1 of the same 
year and must, among other things, provide all information requested by 
us at the time of self-nomination. To maintain alignment with the 
timelines proposed for QCDR self-nomination, as discussed in section 
III.I.3.k.(3)(c) of this final rule, we also proposed in the CY 2019 
PFS proposed rule (83 FR 35985) to update the self-nomination period 
from September 1 of the year prior to the applicable performance period 
until November 1 to July 1 of the calendar year prior to the applicable 
performance period until September 1. Specifically, we proposed in the 
CY 2019 PFS proposed rule (83 FR 35985) at Sec.  414.1400(c)(1) that, 
beginning with the 2022 MIPS payment year, entities seeking to qualify 
as qualified registries must self-nominate during a 60-day period 
beginning on July 1 of the calendar year prior to the applicable 
performance period and ending on September 1 of the same year; must 
provide all information required by us at the time of self-nomination; 
and must provide any additional information requested by us during the 
review process. For example, for the 2022 MIPS payment year, the 
applicable performance period would be CY 2020, as discussed in section 
III.I.3.g. of this final rule. Therefore, the self-nomination period 
for qualified registries would begin on July 1, 2019 and end on 
September 1, 2019.
    We did not receive any comments on the ``Self-nomination Period'' 
for Qualified Registries. We are finalizing our proposal to amend Sec.  
414.1400(c)(1) to provide that, beginning with the 2022 MIPS payment 
year, entities seeking to qualify as qualified registries must self-
nominate during a 60-day period beginning on July 1 of the calendar 
year prior to the applicable performance period and ending on September 
1 of the same year; must provide all information required by us at the 
time of self-nomination; and must provide any additional information 
requested by us during the review process.
(5) Health IT Vendors or Other Authorized Third Parties That Obtain 
Data From MIPS Eligible Clinicians' Certified EHR Technology (CEHRT)
    We refer readers to Sec.  414.1400 and the CY 2017 Quality Payment 
Program final rule (81 FR 77377 through 77382) for our previously 
finalized policies regarding health IT vendors or other authorized 
third parties that obtain data from MIPS eligible clinicians. We 
finalized that health IT vendors that obtain data from a MIPS eligible 
clinician, like other third party intermediaries, would have to meet 
all criteria designated by us as a condition

[[Page 59907]]

of their qualification or approval to participate in MIPS as a third 
party intermediary. This includes submitting data in the form and 
manner specified by us. In the CY 2019 PFS proposed rule (83 FR 35985), 
we proposed to codify these policies at Sec.  414.1400(d). Although we 
specified criteria for a health IT vendor in the CY 2017 Quality 
Payment Program final rule, we failed to codify the definition of a 
health IT vendor. Therefore, in the CY 2019 PFS proposed rule (83 FR 
35985), we proposed to define at Sec.  414.1305, that health IT vendor 
means an entity that supports the health IT requirements on behalf of a 
MIPS eligible clinician (including obtaining data from a MIPS eligible 
clinician's CEHRT).
    As indicated in footnote 1 of the CY 2017 Quality Payment Program 
final rule (81 FR 77014 through 77015), the term ``health IT vendor'' 
encompasses many types of entities that support the health IT 
requirements on behalf of a MIPS eligible clinician. A ``health IT 
vendor'' may or may not also be a ``health IT developer'' for the 
purposes of the ONC Health IT Certification Program (Program), and, in 
some cases, the developer and the vendor of a single product may be 
different entities. Under the Program, a health IT developer 
constitutes a vendor, self-developer, or other entity that presents 
health IT for certification or has health IT certified under the 
Program. Other health IT vendors may maintain a range of data 
transmission, aggregation, and calculation services or functions, such 
as organizations which facilitate health information exchange.
    We did not receive any comments on the ``Health IT Vendors or Other 
Authorized Third Parties That Obtain Data From MIPS Eligible 
Clinicians' Certified EHR Technology (CEHRT).'' Therefore, we are 
finalizing our proposal to codify our previously established policies 
at Sec.  414.1400(d). We are also finalizing our proposal to define at 
Sec.  414.1305, that health IT vendor means an entity that supports the 
health IT requirements on behalf of a MIPS eligible clinician 
(including obtaining data from a MIPS eligible clinician's CEHRT).
(6) CMS-Approved Survey Vendors
    In the CY 2017 Quality Payment Program final rule (81 FR 77386), we 
finalized the criteria, required forms, and vendor business 
requirements needed to participate in MIPS as a CMS-approved survey 
vendor. In the CY 2019 PFS proposed rule (83 FR 35985), we proposed at 
Sec.  414.1400(e) to codify these previously finalized criteria and 
requirements. Accordingly, we proposed in the CY 2019 PFS proposed rule 
(83 FR 35985) at Sec.  414.1400(e) that an entity seeking to be a CMS-
approved survey vendor for any MIPS performance period must submit a 
survey vendor application to CMS in a form and manner specified by CMS 
for each MIPS performance period for which it wishes to transmit such 
data. We also proposed to require that the application and any 
supplemental information requested by CMS must be submitted by 
deadlines specified by CMS. In addition, we proposed that a CMS-
approved survey vendor must meet several criteria. First, we proposed 
to require that an entity have sufficient experience, capability, and 
capacity to accurately report CAHPS data, including:
     At least 3 years of experience administering mixed-mode 
surveys (surveys that employ multiple modes to collect data) that 
include mail survey administration followed by survey administration 
via Computer Assisted Telephone Interview (CATI);
     At least 3 years of experience administering surveys to a 
Medicare population;
     At least 3 years of experience administering CAHPS surveys 
within the past 5 years;
     Experience administering surveys in English and one of the 
following languages: Cantonese; Korean; Mandarin; Russian; or 
Vietnamese;
     Use of equipment, software, computer programs, systems, 
and facilities that can verify addresses and phone numbers of sampled 
beneficiaries, monitor interviewers, collect data via CATI, 
electronically administer the survey and schedule call-backs to 
beneficiaries at varying times of the day and week, track fielded 
surveys, assign final disposition codes to reflect the outcome of data 
collection of each sampled case, and track cases from mail surveys 
through telephone follow-up activities; and
     Employment of a program manager, information systems 
specialist, call center supervisor and mail center supervisor to 
administer the survey.
    Furthermore, we proposed in the CY 2019 PFS proposed rule (83 FR 
35985) that to be a CMS-approved survey vendor, the entity must also 
meet the following criteria:
     It must have certified that it has the ability to maintain 
and transmit quality data in a manner that preserves the security and 
integrity of the data;
     The entity must have successfully completed, and required 
its subcontractors to successfully complete, vendor training(s) 
administered by CMS or its contractors;
     The entity must have submitted a quality assurance plan 
and other materials relevant to survey administration, as determined by 
CMS, including cover letters, questionnaires and telephone scripts;
     The entity must have agreed to participate and cooperate, 
and have required its subcontractors to participate and cooperate, in 
all oversight activities related to survey administration conducted by 
CMS or its contractors; and
     The entity must have sent an interim survey data file to 
CMS that establishes the entity's ability to accurately report CAHPS 
data.
    We also refer readers to the CY 2018 Quality Payment Program final 
rule (82 FR 53818 through 53819) for our previously established 
policies regarding the updated survey vendor application deadline.
    The following is a summary of the public comments received on the 
``CMS-Approved Survey Vendors'' proposals and our responses:
    Comment: A few commenters commended CMS for making the CAHPS for 
Physician Quality Reporting System (PQRS) survey available in 
Cantonese, Korean, Mandarin, Russian, Spanish, and Vietnamese and for 
making the Medicare Accountable Care Organization CAHPS survey 
available in Cantonese, Korean, Mandarin, Portuguese, Russian, Spanish, 
and Vietnamese. These commenters encouraged CMS to work with 
stakeholders to develop validated translations of all CAHPS surveys 
used in MIPS and APMs in at least the top ten primary languages among 
Medicare beneficiaries.
    Response: We appreciate the commenters' feedback. We have made the 
CAHPS for MIPS survey available in Spanish and we will continue to work 
with stakeholders to develop additional translations of the surveys. In 
addition, because the CAHPS for MIPS survey is available in Spanish and 
may become available in other languages in the future, we believe it is 
appropriate to modify our proposed requirement at Sec.  
414.1400(e)(1)(iv) to more broadly state that an entity must have 
experience administering surveys in English and at least one other 
language for which a translation of the CAHPS for MIPS survey is 
available. These languages currently consist of Cantonese, Korean, 
Mandarin, Russian, Spanish, and Vietnamese.
    After consideration of the public comments received, we are 
finalizing our proposal at Sec.  414.1400(e) to state that entities 
seeking to be a CMS-approved survey vendor for any MIPS

[[Page 59908]]

performance period must submit a survey vendor application to CMS in a 
form and manner specified by CMS for each MIPS performance period for 
which it wishes to transmit such data; and that the application and any 
supplemental information requested by CMS must be submitted by 
deadlines specified by CMS. We are also finalizing our proposal at 
Sec.  414.1400(e) that a CMS-approved survey vendor must meet several 
criteria that consists of the following:
    An entity must have sufficient experience, capability, and capacity 
to accurately report CAHPS data, including:
     At least 3 years of experience administering mixed-mode 
surveys (surveys that employ multiple modes to collect data) that 
include mail survey administration followed by survey administration 
via Computer Assisted Telephone Interview (CATI);
     At least 3 years of experience administering surveys to a 
Medicare population;
     At least 3 years of experience administering CAHPS surveys 
within the past 5 years;
     Experience administering CAHPS surveys in English and at 
least one other language for which a translation of the CAHPS for MIPS 
survey is available. These languages currently consist of Cantonese, 
Korean, Mandarin, Russian, Spanish or Vietnamese;
     Use of equipment, software, computer programs, systems, 
and facilities that can verify addresses and phone numbers of sampled 
beneficiaries, monitor interviewers, collect data via CATI, 
electronically administer the survey and schedule call-backs to 
beneficiaries at varying times of the day and week, track fielded 
surveys, assign final disposition codes to reflect the outcome of data 
collection of each sampled case, and track cases from mail surveys 
through telephone follow-up activities; and
     Employment of a program manager, information systems 
specialist, call center supervisor and mail center supervisor to 
administer the survey.
    In addition, we are finalizing without change our proposal that an 
entity must have certified that it has the ability to maintain and 
transmit quality data in a manner that preserves the security and 
integrity of the data; the entity must have successfully completed, and 
has required its subcontractors to successfully complete, vendor 
training(s) administered by CMS or its contractors; the entity must 
have submitted a quality assurance plan and other materials relevant to 
survey administration, as determined by CMS, including cover letters, 
questionnaires and telephone scripts; the entity must have agreed to 
participate and cooperate, and have required its subcontractors to 
participate and cooperate, in all oversight activities related to 
survey administration conducted by CMS or its contractors; and the 
entity must have sent an interim survey data file to CMS that 
establishes the entity's ability to accurately report CAHPS data.
(7) Auditing of Third Party Intermediaries Submitting MIPS Data
    In the CY 2018 Quality Payment Program final rule (82 FR 53819), we 
established at Sec.  414.1400(j) policies regarding auditing of third 
party intermediaries submitting MIPS data. In the CY 2019 PFS proposed 
rule (83 FR 35985), we did not propose any changes to these policies. 
In this final rule, the provision that currently appears at Sec.  
414.1400(j) is redesignated as Sec.  414.1400(g) and contains no 
substantive changes.
(8) Remedial Action and Termination of Third Party Intermediaries
    In the CY 2017 Quality Payment Program final rule (81 FR 77548), we 
finalized the criteria for probation and disqualification for third 
party intermediaries at Sec.  414.1400(k). In the CY 2019 PFS proposed 
rule (83 FR 35986), we proposed to revise the numbering of this section 
and the title to more accurately describe the policies in this section. 
Specifically, we proposed to renumber this section as Sec.  414.1400(f) 
and to rename it as ``remedial action and termination of third party 
intermediaries.'' Additionally, we proposed in the CY 2019 PFS proposed 
rule (83 FR 35986) changes to Sec.  414.1400(f) to amend, clarify, and 
streamline our policies related to remedial action and termination.
    Our intent with these policies is to identify and remedy 
noncompliance with the applicable third party intermediary criteria, as 
well as identify issues that may impact the accuracy of or our ability 
to use the data submitted by third party intermediaries. Accordingly, 
in the CY 2019 PFS proposed rule (83 FR 35986), we proposed to amend 
Sec.  414.1400(f)(1) to state that we may take remedial action for 
noncompliance with applicable third party intermediary criteria for 
approval (a deficiency) or for the submission of inaccurate, unusable, 
or otherwise compromised data. In the CY 2017 Quality Payment Program 
final rule, we finalized our policy regarding data inaccuracies at 
Sec.  414.1400(k)(4). In the CY 2019 PFS proposed rule (83 FR 35986), 
we proposed at Sec.  414.1400(f)(3) to expand data inaccuracies to 
include a determination by us that data is inaccurate, unusable, or 
otherwise compromised. However, we did not propose to change the 
factors we may consider to make such a determination. In the CY 2019 
PFS proposed rule (83 FR 35986), we also proposed to move the 
notification requirement at Sec.  414.1400(k)(6) to Sec.  
414.1400(f)(1) and to apply the requirement to all deficiencies and 
data errors.
    Based on our early experience with third party intermediaries under 
MIPS and the challenges for both third party intermediaries and us in 
regards to timing and trying to resolve deficiencies and data errors 
within the various reporting and performance periods, we proposed in 
the CY 2019 PFS proposed rule (83 FR 35986) to amend the timeframes by 
which a third party intermediary must submit a Corrective Action Plan 
(CAP) to us or come into compliance. Specifically, we proposed Sec.  
414.1400(f)(2), which requires third party intermediaries to submit a 
CAP or correct the deficiencies or data errors by the date specified by 
us (83 FR 35986).
    Additionally, we proposed in the CY 2019 PFS proposed rule (83 FR 
35986) to consolidate at Sec.  414.1400(f)(1) the grounds for remedial 
action against a third party intermediary currently specified at Sec.  
414.1400(k)(1) and (4) and to consolidate at Sec.  414.1400(f)(2) the 
grounds for terminating a third party intermediary currently found at 
Sec.  414.1400(k)(3), (5) and (7). Therefore, we proposed at Sec.  
414.1400(f)(1) that if at any time we determine that a third party 
intermediary has ceased to meet one or more of the applicable criteria 
for approval, or has submitted data that is inaccurate, unusable, or 
otherwise compromised, we may take certain remedial actions (for 
example, request a CAP) (83 FR 35986). In the CY 2019 PFS proposed rule 
(83 FR 35986), we also proposed at Sec.  414.1400(f)(2) that we may 
terminate, immediately or with advance notice, the ability of a third 
party intermediary to submit MIPS data on behalf of a MIPS eligible 
clinician, group, or virtual group for one or more of the following 
reasons: We have grounds to impose remedial action, we have not 
received a CAP within the specified time period or the CAP is not 
accepted by us, or the third party intermediary fails to correct the 
deficiencies or data errors by the date specified by us.
    Additionally, in the CY 2019 PFS proposed rule (83 FR 35986), we 
proposed to consolidate at Sec.  414.1400(f)(1) the actions we may take

[[Page 59909]]

if we identify a deficiency or data error that are set forth at Sec.  
414.1400(k)(3) and (7). Thus, we proposed at Sec.  414.1400(f)(1) in 
the CY 2019 PFS proposed rule (83 FR 35986) that if we determine a 
third party intermediary has ceased to meet one or more of the 
applicable criteria for approval, or has submitted data that is 
inaccurate, unusable, or otherwise compromised, we may require the 
third party intermediary to submit a CAP to us to address the 
identified deficiencies or data issue, including the actions it will 
take to prevent the deficiencies or data issues from recurring. We 
proposed to require that the CAP be submitted to CMS by a date 
specified by CMS.
    In the CY 2019 PFS proposed rule (83 FR 35986), we also proposed 
that CMS may determine that submitted data is inaccurate, unusable, or 
otherwise compromised if the submitted data: (1) Includes, without 
limitation, TIN/NPI mismatches, formatting issues, calculation errors, 
or data audit discrepancies; and (2) affects more than 3 percent (but 
less than 5 percent) of the total number of MIPS eligible clinicians or 
group for which data was submitted by the third party intermediary. In 
addition, we proposed in the CY 2019 PFS proposed rule (83 FR 35986) 
that if the third party intermediary has a data error rate of 3 percent 
or more, we will publicly disclose the entity's data error rate on the 
CMS website until the data error rate falls below 3 percent.
    We clarify in this final rule that CMS may determine that submitted 
data is inaccurate, unusable, or otherwise compromised if the submitted 
data affects more than 3 percent of the total number of MIPS eligible 
clinicians or group for which data was submitted by the third party 
intermediary. In the CY 2017 Quality Payment Program final rule (81 FR 
77387 through 77388), we explained that if a third party intermediary 
has data inaccuracies including (but not limited to) TIN/NPI 
mismatches, formatting issues, calculation errors, data audit 
discrepancies affecting in excess of 3 percent (but less than 5 
percent) of the total number of MIPS eligible clinicians or groups 
submitted by the third party intermediary, we would annotate on the CMS 
qualified posting that the third party intermediary furnished data of 
poor quality and would place the entity on probation for the subsequent 
MIPS performance period. If a third party intermediary does not reduce 
their data error rate below 3 percent for the subsequent performance 
period, the third party intermediary would continue to be on probation 
and have their listing on the CMS website continue to note the poor 
quality of the data they are submitting for MIPS for one additional 
performance year. After 2 years on probation, the third party 
intermediary would be disqualified for the subsequent performance year. 
We also explained that data errors affecting in excess of 5 percent of 
MIPS eligible clinicians or group submitted by the third party 
intermediary may lead to the disqualification of the third party 
intermediary from participation for the following performance period 
(that is, without first placing the third party intermediary on 
probation).
    Accordingly, it was always our intent that data errors affecting in 
excess of 3 percent of the MIPS eligible clinicians or group submitted 
by a third party intermediary would result in remedial action or 
disqualification (termination) of the third party intermediary. In this 
final rule, we are correcting an obvious error in the regulation text 
we proposed at Sec.  414.1400(f)(3)(ii) to clarify that if submitted 
data is inaccurate, unusable, or otherwise compromised if errors in the 
submitted data affect more than 3 percent of the total number of MIPS 
eligible clinicians or group for which data was submitted by the third 
party intermediary.
    Finally, we proposed to remove our probation policy. Therefore, we 
proposed in the CY 2019 PFS proposed rule (83 FR 35986) to remove the 
definition of probation at Sec.  414.1400(k)(2) and references to 
probation in Sec.  414.1400(k)(1), (3) and (5).
    The following is a summary of the public comments received on the 
``Remedial Action and Termination of Third Party Intermediaries'' 
proposals and our responses:
    Comment: One commenter stated that CMS should put in place a safe 
harbor policy in order to minimize the impact on clinicians when a data 
issue outside of a clinician's or group's control occurs due to a third 
party intermediary. The commenter indicated that, under those 
circumstances, CMS should automatically consider the clinician or group 
to have satisfied the quality performance category. The commenter cited 
concerns with the transition and upgrade to 2015 CEHRT and references 
data issues under 2016 PQRS related to the 2014 CEHRT upgrade.
    Response: We do not agree that we should create a safe harbor 
policy to address the circumstances described by the commenter. 
Instead, we believe it would be appropriate to address data issues on a 
case-by-case basis. As we discussed in the CY 2018 Quality Payment 
Program final rule (82 FR 53807), we expect third party intermediaries 
to develop processes to ensure that the data and information they 
submit to CMS on behalf of MIPS eligible clinicians, groups, and 
virtual groups are true, accurate, and complete; we also rely on the 
third party intermediaries to address these issues in its arrangements 
and agreements with other entities, including MIPS eligible clinicians, 
groups, and virtual groups.
    Comment: One commenter agreed with the proposal to remove the 
probation policy.
    Response: We appreciate the commenter's support.
    Comment: A few commenters disagreed with our proposal at Sec.  
414.1400(f)(2) because it would allow us to immediately or with advance 
notice terminate a third party intermediary's ability to submit MIPS 
data without first placing the third party intermediary on probation. 
The commenters believe that termination should occur only with advance 
notice through a clearly defined process that reflects the current 
procedure set forth at Sec.  414.1400(f). Commenters suggested that 
CMS' termination procedure include formal consideration of a CAP.
    Response: We appreciate the commenters' concerns, and therefore, we 
expect that in most circumstances, we would take remedial action, 
including imposition of a CAP, prior to terminating the ability of a 
third party intermediary to submit MIPS data on behalf of a MIPS 
eligible clinician, group, or virtual group. Before deciding whether to 
terminate a third party intermediary's ability to submit MIPS data, we 
would take into account a third party intermediary's actions, the 
severity of the non-compliance or errors at issue, and the potential 
for undue hardship or negative impact on affected eligible clinicians. 
In addition, we would expect to provide advance notice of most 
terminations; we would likely impose immediate termination on a third 
party intermediary's ability to submit MIPS data only in circumstances 
where egregious non-compliance or data errors have occurred. However, 
if we have not received a CAP within the specified time period or the 
CAP is not accepted by us, or the third party intermediary fails to 
correct the deficiencies or data errors by the date specified by us, we 
may terminate the third party intermediary, immediately or with advance 
notice.
    Comment: A few commenters stated that the proposed termination 
policy could result in undue hardship on or negatively impact affected 
eligible clinicians should termination occur during a performance 
period.

[[Page 59910]]

    Response: We recognize that termination of a third party 
intermediary's ability to submit MIPS data during a performance period 
may result in undue hardship on eligible clinicians who are supported 
by the third party intermediary. Therefore, we would consider whether a 
third party intermediary is supporting eligible clinicians in deciding 
when to terminate the ability of the third party intermediary to submit 
MIPS data. In addition, we will consider for future rulemaking whether 
a third party intermediary should be required to submit to CMS a 
transition plan that addresses how submission of data would be handled 
in the event that termination occurs during a performance period.
    Comment: A few commenters representing QCDRs and qualified 
registries stated that CMS should clearly define, and provide examples 
of, a ``data error'' for purposes of determining a third party 
intermediary's data error rate, which may be disclosed publicly by CMS 
if it exceeds 3 percent. In addition, the commenters stated that CMS 
should set forth how the data error rate is calculated and develop a 
report that describes and differentiates data errors and other 
``issues'' that should be brought to a third party intermediary's 
attention.
    Response: The ``data error rate'' measures the amount of data 
submitted by a third party intermediary that was ``inaccurate, 
unusable, or otherwise compromised.'' Additional material regarding 
data inaccuracies and error rates is available in the ``2019 Qualified 
Clinical Data Registry (QCDR) Fact Sheet'' and the ``2019 Qualified 
Registry Fact Sheet'' in the 2019 Self-Nomination Toolkit for QCDRs & 
Registries, located in the Quality Payment Program Resource Library at 
https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/2018-Resources.html. We appreciate the suggestion of creating a report 
that describes data errors and ``other issues,'' however, we believe 
that our existing material addresses the commenters' concern.
    After consideration of the public comments received, we are 
finalizing our proposal to revise the numbering of Sec.  414.1400(k) as 
Sec.  414.1400(f) and to rename it as ``remedial action and termination 
of third party intermediaries.'' We are also finalizing our proposal to 
amend, clarify, and streamline our policies related to remedial action 
and termination as follows:
     We are finalizing Sec.  414.1400(f)(1) to state that CMS 
may take one or more of the following remedial actions if we determine 
that a third party intermediary has ceased to meet one or more of the 
applicable third party intermediary criteria for approval or has 
submitted data that is inaccurate, unusable, or otherwise compromised: 
We will require the third party intermediary to submit by a deadline 
specified by CMS a CAP that addressed the identified deficiencies or 
data issue, including the actions it will take to prevent the 
deficiencies or data issues from recurring; or we will publicly 
disclose the entity's data error rate on the CMS website until the data 
error rate falls below 3 percent.
     We are finalizing Sec.  414.1400(f)(2) to state that CMS 
may immediately or with advance notice terminate the ability of a third 
party intermediary to submit MIPS data on behalf of a MIPS eligible 
clinician group, or virtual group for one or more of the following 
reasons: CMS has grounds to impose remedial action; CMS has not 
received a CAP within the specified time period or the CAP is not 
accepted by CMS; or, the third party intermediary fails to correct the 
deficiencies or data errors by the date specified by CMS.
     We are finalizing Sec.  414.1400(f)(3) to state that, for 
purposes of paragraph (f), CMS may determine that submitted data is 
inaccurate, unusable, or otherwise compromised if it: Includes, without 
limitation, TIN/NPI mismatches, formatting issues, calculation errors, 
or data audit discrepancies; and affects more than 3 percent of the 
total number of MIPS eligible clinicians or group for which data was 
submitted by the third party intermediary.
l. Public Reporting on Physician Compare
    This section contains our approach for public reporting on 
Physician Compare for year 3 of the Quality Payment Program (2019 data 
available for public reporting in late 2020) and future years, 
including MIPS, APMs, and other information as required by the MACRA 
and building on our previously finalized public reporting policies (see 
82 FR 53819 through 53832).
    Physician Compare (http://www.medicare.gov/physiciancompare) draws 
its operating authority from section 10331(a)(1) of the Affordable Care 
Act. Consistent with section 10331(a)(2) of the Affordable Care Act, 
Physician Compare initiated a phased approach to publicly reporting 
performance scores that provide comparable information on quality and 
patient experience measures. A complete history of public reporting on 
Physician Compare is detailed in the CY 2016 PFS final rule (80 FR 
71117 through 71122). More information about Physician Compare, 
including the history of public reporting and regular updates about 
what information is currently available, can also be accessed on the 
Physician Compare Initiative website at https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/physician-compare-initiative/.
    As discussed in the CY 2018 Quality Payment Program final rule (82 
FR 53820), Physician Compare has continued to pursue a phased approach 
to public reporting under the MACRA in accordance with section 
1848(q)(9) of the Act. Generally, all data available for public 
reporting on Physician Compare must meet our established public 
reporting standards under Sec.  414.1395(b). In addition, for each 
program year, CMS provides a 30-day preview period for any clinician or 
group with Quality Payment Program data before the data are publicly 
reported on Physician Compare under Sec.  414.1395(d). All data 
available for public reporting--measure rates, scores, and 
attestations, objectives, etc.--are available for review and correction 
during the targeted review process. See the CY 2018 Quality Payment 
Program final rule for details on this process (82 FR 53820).
    Lastly, section 104(e) of the MACRA requires the Secretary to make 
publicly available, on an annual basis, in an easily understandable 
format, information for physicians and, as appropriate, other eligible 
clinicians related to items and services furnished to Medicare 
beneficiaries under Title XVIII of the Act. In accordance with section 
104(e) of the MACRA, we finalized a policy in the CY 2016 PFS final 
rule (80 FR 71131) to add utilization data to the Physician Compare 
downloadable database.
    We believe section 10331 of the Affordable Care Act supports the 
overarching goals of the MACRA by providing the public with performance 
information that will help them make informed decisions about their 
health care, while encouraging clinicians to improve the quality of 
care they provide to their patients. In accordance with section 10331 
of the Affordable Care Act, section 1848(q)(9) of the Act, and section 
104(e) of the MACRA, we plan to continue to publicly report performance 
information on Physician Compare. As such, the following sections 
discuss the information previously finalized for inclusion on Physician 
Compare for all program years, as well as our finalized policies for 
public reporting on Physician Compare for year 3 of the Quality

[[Page 59911]]

Payment Program (2019 data available for public reporting in late 2020) 
and future years.
    We received several miscellaneous comments, but since these were 
not applicable to specific proposals made, these comments are outside 
the scope of this section and the proposed rule.
(1) Final Score, Performance Categories, and Aggregate Information
    In the CY 2018 Quality Payment Program final rule (82 FR 53823), we 
finalized a policy to publicly report on Physician Compare, either on 
profile pages or in the downloadable database, the final score for each 
MIPS eligible clinician and the performance of each MIPS eligible 
clinician for each performance category, and to periodically post 
aggregate information on the MIPS, including the range of final scores 
for all MIPS eligible clinicians and the range of performance of all 
the MIPS eligible clinicians for each performance category, as 
technically feasible, for all future years. We will use statistical 
testing and user testing, as well as consultation with the Physician 
Compare Technical Expert Panel convened by our contractor, to determine 
how and where these data are best reported on Physician Compare.
    A summary of the previously finalized policies related to each 
performance category of MIPS data, as well as finalized policies for 
year 3 and future years, follows. It is important to note just because 
performance information is available for public reporting, it does not 
mean all data under all performance categories will be included on 
either public-facing profile pages or the downloadable database. These 
data must meet the public reporting standards, first. And, second, we 
are careful to ensure that we do not include too much information on 
public-facing profile pages in an effort not to overwhelm website 
users. Although all information submitted under MIPS is technically 
available for public reporting, we will continue our phased approach to 
making this information public.
(2) Quality
    In the CY 2018 Quality Payment Program final rule (82 FR 53824), we 
finalized a policy to make all measures under the MIPS quality 
performance category available for public reporting on Physician 
Compare, either on profile pages or in the downloadable database, as 
technically feasible. This includes all available measures across all 
collection types for both MIPS eligible clinicians and groups, for all 
future years. We will use statistical testing and website user testing 
to determine how and where measures are reported on Physician Compare. 
We will not publicly report first year quality measures, meaning any 
measure in its first year of use in the quality performance category, 
under Sec.  414.1395(c). We will also include the total number of 
patients reported on for each measure included in the downloadable 
database (82 FR 53824).
    We proposed to modify Sec.  414.1395(b) to reference ``collection 
types'' instead of ``submission mechanisms'' to accurately update the 
terminology (83 FR 35987), consistent with the proposal to add this 
term and its definition under Sec.  414.1305. We also proposed to 
revise Sec.  414.1395(c) to indicate that we will not publicly report 
first year quality measures for the first 2 years a measure is in use 
in the quality performance category (83 FR 35987). We proposed this 
change to encourage clinicians and groups to report new measures, get 
feedback on those measures, and learn from the early years of reporting 
measures before measure are made public. We requested comment on these 
proposals.
    The following is a summary of the comments we received on these 
proposals and our responses.
    Comment: Most commenters supported not publicly reporting first 
year data on quality measures for the first 2 years to encourage 
adoption of new measures and allow clinicians and groups to get 
experience with and feedback on these measures before they are publicly 
reported. One commenter noted concern with delaying the public 
reporting of first year quality measures for the first 2 years they are 
in use, stating it would slow the progress toward full Quality Payment 
Program implementation and in fostering evaluation of more clinicians 
reporting a consistent set of measures. A few commenters suggested that 
3 years is a more appropriate length of time for delaying publicly 
reporting first year measures, stating this timeframe would allow CMS 
to adequately evaluate meaningful trends over time and provide 
clinicians with an adequate period to fix data collection issues and 
give clinicians more time to respond to performance feedback. A few 
commenters requested that public reporting on Physician Compare be 
delayed until the transition years to full Quality Payment Program 
implementation end and there is more predictability, continuity, 
consistency, and decreased complexity in the program. In addition, 
several commenters submitted suggestions regarding transparency of 
publicly reported performance data. One commenter requested that 
Physician Compare note for publicly reported measures if a change to 
clinical guidelines occurred during the performance year, so that the 
data provided is not misleading to the public.
    Response: We agree that not publicly reporting first year data on 
quality measures for the first 2 years they are in use is sufficient 
time to gain experience with them before they are considered for public 
reporting and believe 2 years also meets the goal of providing more 
timely and transparent information to the public on clinician 
performance for making their healthcare decisions. We believe that 
waiting 3 years to publicly report first year measures unnecessarily 
hinders the ability to provide the public with transparent performance 
information after clinicians have already received such feedback and 
also reduces the non-financial incentive for clinicians to improve 
their performance. Additionally, we do not believe that delaying the 
public reporting of first year quality measures for the first 2 years 
they are in use delays Quality Payment Program implementation or 
evaluation of more clinicians reporting a consistent set of measures, 
since, at this time, eligible clinicians and groups have the 
flexibility to select from a broad list of measures and do not all need 
to report the exact same measures. Regarding the comment suggesting 
public reporting be delayed until the Quality Payment Program is fully 
implemented, we note that we are required under section 1848(q)(9)(A) 
and (D) of the Act to publicly report certain MIPS eligible clinician 
and group performance information on Physician Compare. However, we do 
recognize that we are in early stages of MIPS, which is why we are 
continuing to publicly report this information under a phased approach. 
In response to the suggestion to indicate, on Physician Compare, when a 
measure specification has changed, we note that if there are 
significant changes to a clinical guideline during the performance year 
and the measure specifications do not reflect the current standard of 
care, the measure is suppressed from MIPS scoring. Refer to 
III.I.3.i.(1)(b)(vii) of this final rule for more information on the 
scoring policy. Only data that meet our established public reporting 
standards under Sec.  414.1395(b) will be publically reported on 
Physician Compare.
    Regarding the comments supporting data transparency, we agree that 
for public reporting to be meaningful to all stakeholders, transparency 
is key. Each year we strive to actively share information, via the 
Physician Compare

[[Page 59912]]

initiative page and other channels, on our public reporting efforts as 
testing is completed and measures to be publicly reported are 
finalized. Last year in response to similar comments, we produced 
additional educational materials about the 5-star rating methodology 
and cut-offs, for example. We will continue our educational efforts as 
public reporting on Physician Compare evolves. We also reiterate our 
belief in the importance of clinicians reviewing their data for 
accuracy prior to it being publicly reported. All performance data 
publicly reported on Physician Compare will reflect the scores eligible 
clinicians and groups receive in their MIPS performance feedback, which 
are available for review and correction during the targeted review 
process.
    After consideration of the comments, we are finalizing our proposal 
to revise Sec.  414.1395(c) to indicate that we will not publicly 
report first year quality measures for the first 2 years a measure is 
in use in the quality performance category. We did not receive any 
comments on changing ``submission mechanism'' to ``collection type'' 
for the purposes of public reporting, and as a result are finalizing 
our proposal to modify Sec.  414.1395(b) to reference ``collection 
types'' instead of ``submission mechanisms''.
(3) Cost
    In the CY 2018 Quality Payment Program final rule (82 FR 53825), we 
finalized a policy to include on Physician Compare a subset of cost 
measures that meet the public reporting standards at Sec.  414.1395(b), 
either on profile pages or in the downloadable database, if technically 
feasible, for all future years. This includes all available cost 
measures, and applies to both MIPS eligible clinicians and groups. We 
will use statistical testing and website user testing to determine how 
and where measures are reported on Physician Compare. We previously 
finalized that we will not publicly report first year cost measures, 
meaning any measure in its first year of use in the cost performance 
category, under Sec.  414.1395(c).
    Consistent with our proposal for first year quality measures, we 
proposed to revise Sec.  414.1395(c) to indicate that we will not 
publicly report first year cost measures for the first 2 years a 
measure is in use in the cost performance category (83 FR 35987). We 
proposed this change to help clinicians and groups get feedback on 
these measures and learn from the early years of these new measures 
being calculated before measure are made public (83 FR 35987). We 
requested comment on this proposal.
    The following is a summary of the comments we received on this 
proposal and our responses.
    Comment: Most commenters supported not publicly reporting first 
year data on cost measures for the first 2 years to encourage adoption 
of new measures and allow clinicians and groups to get experience with 
and feedback on these measures before they are publicly reported. One 
commenter expressed concern that delaying the public reporting of first 
year cost measures for the first 2 years they are in use, stating it 
would slow the progress toward full Quality Payment Program 
implementation and in fostering evaluation of more clinicians reporting 
a consistent set of measures. Another commenter recommended, separately 
from the other cost measures, that we consider extending the timeframe 
for which the new episode-based cost measures are publicly reported, so 
that there is time to gain experience with collecting and analyzing 
these measures.
    Response: We agree that not publicly reporting first-year data on 
cost measures for the first 2 years they are in use is sufficient time 
to gain experience with them, including for the new episode-based cost 
measures, before they are considered for public reporting and believe 2 
years also meets the goal of providing more timely and transparent 
information to the public on clinician performance for making their 
healthcare decisions. We believe that waiting 3 years to publicly 
report first year measures hinders the ability to provide the public 
with transparent information after clinicians will have already 
received such feedback and also reduces the non-financial incentive for 
clinicians to improve their performance. Additionally, we do not 
believe that delaying the public reporting of first year quality 
measures for the first 2 years they are in use delays Quality Payment 
Program implementation and in fostering evaluation of more clinicians 
reporting a consistent set of measures, as the cost performance 
category's full implementation is already delayed. We also do not 
believe there is a need or benefit to set a different timeframe for 
episode-based measures than there is for other cost measures that will 
also have 2 years of usage prior to being considered for public 
reporting.
    After consideration of the comments, we are finalizing our proposal 
to revise Sec.  414.1395(c) to indicate that we will not publicly 
report first year cost measures for the first 2 years a measure is in 
use.
(4) Improvement Activities
    In the CY 2018 Quality Payment Program final rule (82 FR 53826), we 
finalized a policy to include a subset of improvement activities 
information on Physician Compare, either on the profile pages or in the 
downloadable database, if technically feasible, for all future years. 
This includes all available activities reported via all available 
collection types, and applies to both MIPS eligible clinicians and 
groups. For those eligible clinicians and groups that successfully meet 
the improvement activities performance category requirements, this 
information will be posted on Physician Compare as an indicator. We 
also finalized for all future years to publicly report first year 
activities if all other public reporting criteria are satisfied.
(5) Promoting Interoperability (PI)
    In the CY 2018 Quality Payment Program final rule (82 FR 53827), we 
finalized a policy to include an indicator on Physician Compare for any 
eligible clinician or group who successfully meets the Promoting 
Interoperability performance category, as technically feasible, for all 
future years. ``Successful'' performance is defined as obtaining the 
base score of 50 percent (82 FR 53826). We also finalized a policy to 
include on Physician Compare, either on the profile pages or in the 
downloadable database, as technically feasible, additional information, 
including, but not limited to, objectives, activities, or measures 
specified in the CY 2018 Quality Payment Program final rule (82 FR 
53827; see 82 FR 53663 through 53688). This includes all available 
objectives, activities, or measures reported via all available 
collection types, and applies to both MIPS eligible clinicians and 
groups (82 FR 53827). We will use statistical testing and website user 
testing to determine how and where objectives, activities, and measures 
are reported on Physician Compare. We also finalized for all future 
years to publicly report first year Promoting Interoperability 
objectives, activities, and measures if all other public reporting 
criteria are satisfied.
    In addition, we finalized that we will indicate ``high'' 
performance, as technically feasible and appropriate, in year 2 of the 
Quality Payment Program (2018 data available for public reporting in 
late 2019). ``High'' performance is defined as obtaining a score of 100 
percent (82 FR 53826 through 53827).

[[Page 59913]]

    As the Quality Payment Program progresses into year 3, and 
consistent with our work to simplify the requirements under the 
Promoting Interoperability performance category of MIPS, we proposed 
not to include the indicator of ``high'' performance and to maintain 
only an indicator for ``successful'' performance in the Promoting 
Interoperability performance category beginning with year 2 of the 
Quality Payment Program (2018 data available for public reporting in 
late 2019) (83 FR 35988). Not including the ``high'' performance 
indicator while maintaining the ``successful'' performance indicator 
continues to provide useful information to patients and caregivers 
without burdening website users with the additional complexity of 
accurately differentiating between ``successful'' and ``high'' 
performance, as this proved difficult for users in testing. User 
testing to date shows that website users value this information 
overall, however, as they appreciate knowing clinicians and groups are 
effectively using EHR technology to improve care quality (83 FR 35988).
    We requested comment on our proposal not to include the indicator 
for ``high'' performance in the Promoting Interoperability performance 
category beginning with year 2 of the Quality Payment Program (2018 
data available for public reporting in late 2019) (83 FR 35988).
    The following is a summary of the comments we received on our 
proposal and our responses.
    Comment: The majority of commenters supported the proposal to move 
to a designation of ``successful'' only and to remove the ``high'' 
designation in the Promoting Interoperability performance category, as 
it offers a clear indication that clinicians are effectively using EHRs 
and would make the user experience more straightforward than 
delineating between multiple indicators. One commenter opposed the 
proposal to only include a ``successful'' indicator, since in future 
years it would be difficult to be ``successful,'' as defined, when the 
base scores, performance scores, and bonus scores are changed or 
removed. Another commenter requested clarification on how 
``successful'' would be defined when the Promoting Interoperability 
performance category no longer includes a base score.
    Response: We agree that moving from having both a ``successful'' 
and ``high'' indicator of an eligible clinician or group's Promoting 
Interoperability performance to having a single indicator of 
``successful'' not only shows that clinicians are effectively using 
EHRs, but also is easier for patients to understand. Additionally, it 
is more technically feasible to designate a single ``successful'' 
indicator than both a ``successful'' and ``high'' indicator as the 
Promoting Interoperability performance category scoring methodology 
evolves and as we evaluate operational facets of the data. We wish to 
also clarify that having only a ``successful'' indicator will apply to 
individuals and groups who have a Promoting Interoperability 
performance category score above zero.
    After consideration of the public comments received, we are 
finalizing our proposal to not include the indicator of ``high'' 
performance and to maintain only an indicator for ``successful'' 
performance in the Promoting Interoperability performance category 
beginning with year 2 of the Quality Payment Program. We note that in 
the CY 2017 Quality Payment Program final rule (81 FR 77397), we 
finalized a policy to include, as technically feasible, additional 
indicators, including but not limited to indicators such as, 
identifying if the eligible clinician or group scores high performance 
in patient access, care coordination and patient engagement, or health 
information exchange. We have since determined that it is not 
technically feasible to include an indicator of ``high'' performance 
that meets our public reporting standards as defined at Sec.  
414.1395(b) for year 1 of the Quality Payment Program. The reason we 
are not reporting this indicator, is because based upon conducting 
analysis against our public reporting standards, the scoring 
variability in the Promoting Interoperability performance category of 
the Quality Payment Program (year 1 to year 3) creates challenges that 
we are still uncovering for making the data useful to Physician 
Compare's primary patient and caregiver audience. Additionally, in 
reviewing the year 1 data (which was not available at the time the CY 
2019 proposed rule was released) we have learned through user testing 
that patients and caregivers find clinician and group usage of EHR 
technology to generally be a meaningful indicator of quality, 
regardless of whether ``successful'' or ``high'' was noted. That is, 
including the word ``high'' did not result in patients and caregivers 
believing the clinician or group to be of higher quality than those 
that had the word ``successful'' next to their Promoting 
Interoperability performance category indicator. Therefore, the high 
performing indicator will not be reported in year 1, 2, 3 or future 
years of the Quality Payment Program on Physician Compare.
    As noted above, we previously defined ``successful'' performance as 
obtaining the base score of 50 percent (82 FR 53826). As discussed in 
section III.I.3.h.(5) of this final rule, the Promoting 
Interoperability performance category will no longer have a base score 
beginning with year 3. To account for this change, we are finalizing a 
modified definition of ``successful'' performance to mean a Promoting 
Interoperability performance category score above zero beginning with 
year 3. We will include the modified indicator (above zero) for years 
1, 2, and 3 to avoid confusion and preserve year-to-year comparability, 
and the previously finalized indicator (base score) for years 1 and 2 
for transparency and consistency with our previously finalized policy, 
as technically feasible.
    We also solicited comment on the type of EHR utilization 
performance information stakeholders would like CMS to consider adding 
to Physician Compare. This information may be considered for possible 
future inclusion on the website. We did not receive any comments.
(6) Achievable Benchmark of Care (ABCTM)
    Benchmarks are important to ensuring that the quality data 
published on Physician Compare are accurately understood. A benchmark 
allows website users to more easily evaluate the information published 
by providing a point of comparison between groups and between 
clinicians. In the CY 2018 Quality Payment Program final rule (82 FR 
53829), we finalized a policy to use the Achievable Benchmark of Care 
(ABCTM) methodology to determine a benchmark for the 
quality, cost, improvement activities, and Promoting Interoperability 
data, as feasible and appropriate, by measure and collection type for 
each year of the Quality Payment Program based on the most recently 
available data each year. We also finalized a policy to use this 
benchmark as the basis of a 5-star rating for each available measure, 
as feasible and appropriate. For a detailed discussion of the 
ABCTM methodology, and more information about how this 
benchmark together with the equal ranges method is currently used to 
determine the 5-star rating system for Physician Compare, see the CY 
2018 Quality Payment Program final rule (82 FR 53827 through 53829). 
Additional information, including the Benchmark and Star Rating Fact 
Sheet, is available on the Physician Compare Initiative website at 
https://www.cms.gov/

[[Page 59914]]

Medicare/Quality-Initiatives-Patient-Assessment-Instruments/physician-
compare-initiative/index.html. We appreciate comments received for this 
section, but since no proposals were made, these comments are outside 
the scope of this section and the proposed rule.
(a) Historical Data-Based Benchmarks
    Benchmarks, and the resulting star rating, are valuable tools for 
patients and caregivers to use to best understand the performance 
information included on Physician Compare. Benchmarks can also help the 
clinicians and groups reporting performance information understand 
their performance relative to their peers, and therefore, help foster 
continuous quality improvement. In the initial years of the Quality 
Payment Program, we anticipated year-to-year changes in the measures 
available. As noted, we previously finalized a policy to determine the 
benchmark using the most recently available data (82 FR 53829). This 
ensured that a benchmark could be calculated despite potential year-to-
year measure changes, but it also meant that the benchmark was not 
known to clinicians and groups prior to the performance period.
    By year 3 of the Quality Payment Program (2019 data available for 
public reporting in late 2020), we expect enough year-to-year stability 
in the measures available for reporting across all MIPS performance 
categories to use historical data to produce a reliable and 
statistically sound benchmark for most measures, by measure and 
collection type (83 FR 35988). Therefore, we proposed to modify our 
existing policy to use the ABCTM methodology to determine 
benchmarks for the quality, cost, improvement activities, and Promoting 
Interoperability performance categories based on historical data, as 
feasible and appropriate, by measure and collection type beginning with 
year 3 of the Quality Payment Program (2019 data available for public 
reporting in late 2020) (83 FR 35988). Specifically, benchmarks would 
be based on performance data from a baseline period or, if such data is 
not available, performance data from the performance period. The 
baseline period would be the 12-month calendar year that is 2 years 
prior to the applicable performance period. The benchmarks would be 
published prior to the start of the performance period, as technically 
feasible. For example, for the CY 2019 performance period, the 
benchmark developed using the ABCTM methodology would be 
calculated using CY 2017 performance period data and would be published 
by the start of CY 2019, as feasible and appropriate. If historical 
data is not available for a particular measure, we would indicate that 
and calculate the benchmark using performance data from the performance 
period. In this example, we would use CY 2019 performance period data 
to calculate the benchmark for CY 2019 performance period measures, as 
needed. This approach of utilizing historical data would be consistent 
with how the MIPS benchmarks are calculated for purposes of scoring the 
quality performance category. But, most importantly, this approach 
would provide eligible clinicians and groups with valuable information 
about the benchmark to meet to receive a 5-star rating on Physician 
Compare before data collection starts for the performance period (83 FR 
35988). We requested comment on this proposal.
    The following is a summary of the comments we received regarding 
our proposal to modify our existing policy to use the ABCTM 
methodology to determine benchmarks for the quality, cost, improvement 
activities, and Promoting Interoperability performance categories based 
on historical data, as feasible and appropriate, by measure and 
collection type beginning with year 3 of the Quality Payment Program 
(2019 data available for public reporting in late 2020) and our 
responses.
    Comment: Two commenters supported using benchmarks based on 
performance from a prior period so that clinicians are able to 
understand how their measure scores will translate into a 5-star 
rating. One commenter cautioned that historical benchmarks may penalize 
those clinicians who successfully managed costs at the onset of the 
benchmark while inadvertently incentivizing high spenders. Another 
commenter questioned whether there was enough stability year-to-year in 
MIPS to create valid and reliable benchmarks. Another commenter noted 
concern that historical benchmarks would be based on data from a small 
number of clinicians from various legacy programs such as the Physician 
Quality Reporting System (PQRS). Another commenter cautioned that CMS 
needs to consider certain clinicians' ability to affect quality and 
cost when treating patients. One commenter recommended we postpone 
using benchmarks for measures with no historical data, for example, a 
new MIPS measure with no performance data from a prior performance 
year.
    Response: Regarding the concern that historical benchmarks would be 
based on data from a small number of clinicians from various legacy 
programs such as the PQRS, we wish to clarify that only historical MIPS 
data will be used to create benchmarks; for example, year 3, which is 
2019 data available for public reporting in late 2020, would use year 1 
(CY 2017) MIPS data. Additionally, since these benchmarks will be based 
on the MIPS performance information that eligible clinicians choose to 
report, we assume that these measures, upon which the benchmarks will 
be based, reflect the areas in which eligible clinicians and groups 
believe they can most affect quality of care furnished. Since we are 
finalizing that we will not publicly report first year measures for the 
first 2 years they are in the program, new measures, which have no 
prior MIPS performance data, would not be available for public 
reporting until the third year they are in use, at which point there 
should be historical data upon which to set a historical benchmark if 
eligible clinicians and groups reported them. If, however, a measure 
does not meet our public reporting standards, for example due to lack 
of performance data available or insufficient sample size, then the 
measure would not be available for public reporting, and would not need 
a benchmark. Regarding the concern about stability of data, we do 
believe that if a measure is in use for multiple years of MIPS that the 
performance should stabilize. We do not expect that clinicians and 
groups who manage costs effectively in 2017 should suffer a penalty by 
comparing their 2019 data to 2017 benchmarks. We appreciate the comment 
about high spenders and will plan to analyze impact. That said, we 
appreciate the concerns raised and will continuously evaluate the data 
against our public reporting standards for year-to-year stability. We 
will also monitor whether the historical benchmarking approach 
inadvertently creates negative incentives, though early testing has not 
shown this to be the case. Regarding the suggestion to postpone using 
benchmarks for measures without historical data, we disagree and 
believe it is important for website users to understand clinician 
performance in a meaningful way. Our testing and experience to date has 
shown that the next best way to create benchmarks for information 
reported on Physician Compare, in the absence of historical data, is by 
using information from the most recent performance period.
    After consideration of the comments, we are finalizing our proposal 
to modify our existing policy to use the ABCTM methodology 
to determine benchmarks for the quality, cost, improvement activities, 
and Promoting Interoperability performance categories

[[Page 59915]]

based on historical data, as feasible and appropriate, by measure and 
collection type beginning with year 3 of the Quality Payment Program 
(2019 data available for public reporting in late 2020). Specifically, 
benchmarks will be based on performance data from a baseline period or, 
if such data is not available, performance data from the performance 
period. The baseline period will be the 12-month calendar year that is 
2 years prior to the applicable performance period. The benchmarks will 
be published prior to the start of the performance period, as 
technically feasible.
(b) QCDR Measure Benchmarks
    Currently, only MIPS measures are star rated on Physician Compare. 
QCDR measures, as that term is used in Sec.  414.1400(e), are publicly 
reported as percent performance rates. As more QCDR measure data is 
available for public reporting, and appreciating the value of star 
rating the measures presented to website users, we believe star rating 
the QCDR measures will greatly benefit patients and caregivers as they 
work to make informed health care decisions. Particularly in the 
quality performance category, we believe that reporting all measure 
data in the same way will ease the burden of interpretation placed on 
site users and make the data more useful to them. Therefore, we 
proposed (83 FR 35988 through 35989) to further modify our existing 
policy to extend the use of the ABCTM methodology and equal 
ranges method to determine, by measure and collection type, a benchmark 
and 5-star rating for QCDR measures, as that term is used in proposed 
Sec.  414.1400(b)(3), as feasible and appropriate, using current 
performance period data in year 2 of the Quality Payment Program (2018 
data available for public reporting in late 2019), and using historical 
benchmark data when possible as proposed above, beginning with year 3 
of the Quality Payment Program (2019 data available for public 
reporting in late 2020). We requested comment on this proposal.
    The following is a summary of the comments we received to further 
modify our existing policy to extend the use of the ABCTM 
methodology and equal ranges method to determine, by measure and 
collection type, a benchmark and 5-star rating for QCDR measures and 
our responses.
    Comment: One commenter supported using the ABCTM 
methodology to create a benchmark for MIPS and QCDR measures, as well 
as creating a 5-star rating for QCDR measures, beginning with year 3 of 
the Quality Payment Program. Several commenters expressed concern about 
QCDR benchmarks, noting that measure scores could be misinterpreted on 
Physician Compare, particularly if the ABCTM methodology is 
used, since it may differ from the QCDR's own rating methodology and 
further confuse patients. One commenter also noted that use of the 
ABCTM methodology for QCDR measures would cause clinician 
confusion and potentially misrepresent clinicians in the public domain 
if it results in benchmarks that are also different from the ones used 
in the MIPS scoring methodology. Another commenter noted the sample 
size for some QCDR measures will be too small for public reporting and 
encouraged CMS to work with QCDR measure owners in establishing 
benchmarks for QCDR measures.
    Response: We reiterate our belief that star rating the QCDR 
measures will greatly benefit patients and caregivers. Because the 
QCDRs do not uniformly measure performance and each uses their own 
methodology, as commenters pointed out, in our experience it makes it 
more difficult for patients to use this information to make informed 
healthcare decisions. Regarding the concern about differences in MIPS 
scoring benchmarks and public reporting benchmarks, we note that we 
will continue to evaluate approaches to alignment, but reiterate that 
it is not always necessary or ideal to use the same methodology for 
scoring and public reporting given the unique goals of each. QCDR 
measures will undergo the same statistical testing as other measures do 
to ensure they meet our public reporting standards before they are 
publicly reported, and this testing does account for sample size 
concerns.
    After consideration of the comments, we are finalizing our proposal 
to further modify our existing policy to extend the use of the 
ABCTM methodology and equal ranges method to determine, by 
measure and collection type, a benchmark and 5-star rating for QCDR 
measures, as that term is used in proposed Sec.  414.1400(b)(3), as 
feasible and appropriate. This benchmark will use current performance 
period data in year 2 of the Quality Payment Program (2018 data 
available for public reporting in late 2019), and using historical 
benchmark data when possible as proposed above, beginning with year 3 
of the Quality Payment Program (2019 data available for public 
reporting in late 2020).
(7) Voluntary Reporting
    In the CY 2018 Quality Payment Program final rule (82 FR 53830), we 
finalized a policy to make available for public reporting all data 
submitted voluntarily across all MIPS performance categories, 
regardless of collection type, by eligible clinicians and groups that 
are not subject to the MIPS payment adjustments, as technically 
feasible, for all future years. If an eligible clinician or group that 
is not subject to the MIPS payment adjustment chooses to submit data on 
quality, cost (if applicable), improvement activities, or Promoting 
Interoperability, these data are available for public reporting. We 
also finalized that during the 30-day preview period, these eligible 
clinicians and groups may opt out of having their data publicly 
reported on Physician Compare (82 FR 53830). If these eligible 
clinicians and groups do not opt out during the 30-day preview period, 
their data will be available for inclusion on Physician Compare if the 
data meet all public reporting standards at Sec.  414.1395(b).
(8) APM Data
    In the CY 2018 Quality Payment Program final rule (82 FR 53830), we 
finalized a policy to publicly report the names of eligible clinicians 
in Advanced APMs and the names and performance of Advanced APMs and 
APMs that are not considered Advanced APMs related to the Quality 
Payment Program, such as Track 1 Shared Savings Program Accountable 
Care Organizations (ACOs), as technically feasible, for all future 
years. We also finalized a policy to link clinicians and groups and the 
APMs they participate in on Physician Compare, as technically feasible.
4. Overview of the APM Incentive
a. Overview
    Section 1833(z) of the Act requires that an incentive payment be 
made (or, in years after 2025, a different PFS update) to QPs for 
achieving threshold levels of participation in Advanced APMs. In the CY 
2017 Quality Payment Program final rule (81 FR 77399 through 77491), we 
finalized the following policies:
     Beginning in payment year 2019, if an eligible clinician 
participated sufficiently in an Advanced APM during the QP Performance 
Period, that eligible clinician may become a QP for the year. Eligible 
clinicians who are QPs are excluded from the MIPS reporting 
requirements for the performance year and payment adjustment for the 
payment year.
     For payment years from 2019 through 2024, QPs receive a 
lump sum incentive payment equal to 5 percent of their prior year's 
estimated aggregate payments for Part B covered

[[Page 59916]]

professional services. Beginning in payment year 2026, QPs receive a 
higher update under the PFS for the year than non-QPs.
     For payment years 2019 and 2020, eligible clinicians may 
become QPs only through participation in Advanced APMs.
     For payment years 2021 and later, eligible clinicians may 
become QPs through a combination of participation in Advanced APMs and 
Other Payer Advanced APMs (which we refer to as the All-Payer 
Combination Option).
    In the CY 2018 Quality Payment Program final rule (82 FR 53832 
through 53895), we finalized clarifications, modifications, and 
additional details pertaining to Advanced APMs, Qualifying APM 
Participant (QP) and Partial QP determinations, Other Payer Advanced 
APMs, Determination of Other Payer Advanced APMs, Calculation of All-
Payer Combination Option Threshold Scores and QP Determinations, and 
Physician-Focused Payment Models (PFPMs). In the CY 2019 PFS proposed 
rule (83 FR 35989 through 36006), we proposed clarifications and 
modifications to policies that we previously finalized pertaining to 
Advanced APMs, QP and Partial QP determinations, Other Payer Advanced 
APMs, Determination of Other Payer Advanced APMs, and the Calculation 
of All-Payer Combination Option Threshold Scores and QP Determinations. 
In this CY 2019 PFS final rule, we respond to public comments on those 
proposals and announce our final policies.
    The following is a summary of the general public comments received 
on Advanced APMs and our responses:
    Comment: Many commenters encouraged us to accelerate our efforts to 
develop more Advanced APM opportunities for clinicians. These 
commenters noted that Advanced APMs have great potential to incentivize 
high-quality and coordinated care while driving down overall costs, and 
encouraged us to continue developing Advanced APMs to offer clinicians 
more opportunity to participate in value-based payment and care 
delivery. Some commenters noted concern that no progress has been made 
in creating more opportunities for specialists and non-physician 
professionals to participate in Advanced APMs. The commenters 
encouraged CMS to develop Advanced APMs that provide opportunities for 
specialists and non-physician professionals, and to create additional 
pathways for specialists and non-physician professionals to 
meaningfully participate in existing Advanced APMs.
    Response: We agree that APMs represent an important step forward in 
our efforts to move our healthcare system from volume-based to value-
based care. We note that in 2018 a number of additional Advanced APM 
opportunities were made available, including the introduction of the 
Medicare ACO Track 1+ Model, and the introduction of new participants 
into some existing Advanced APMs, such as the Next Generation ACO Model 
and Comprehensive Primary Care Plus (CPC+) Model. In 2019, there will 
be even more available Advanced APM opportunities including the Bundled 
Payments for Care Improvement Advanced Model, which began in October 
2018, and the Maryland Total Cost of Care (which includes the Care 
Redesign Program and the Maryland Primary Care Program). Additionally, 
we are in the process of developing several new APMs and Advanced APMs, 
and continue to work with stakeholders on new model concepts.
    Comment: Some commenters suggested CMS establish a clear pathway 
for clinicians to transition from MIPS to MIPS APMs and then to 
Advanced APMs. The commenters noted that MIPS APMs represent a stepping 
stone between MIPS and Advanced APMs providing clinicians a necessary 
glide path into risk-based contracts.
    Response: The Quality Payment Program represents a significant 
opportunity to collaborate with the clinical community to advance 
policy that pays for what works--both for clinicians and patients--to 
create a simpler, sustainable Medicare program. We believe that the 
Quality Payment Program provides new opportunities to improve care 
delivery by supporting and rewarding clinicians as they find new ways 
to engage patients, families, and caregivers and to improve care 
coordination and population health management. In addition, we believe 
that by developing a program that is flexible instead of one-size-fits-
all, clinicians will be able to choose to participate in a way that is 
best for them, their practice, and their patients. For clinicians 
interested in APMs, including MIPS APMs and Advanced APMs, we believe 
that by setting ambitious yet achievable goals, eligible clinicians 
will move with greater certainty toward these new approaches that 
incentivize the delivery of high-value care.
    We will continue to reach out to the clinician community and others 
to partner in the development of ongoing education, support, and 
technical assistance materials and activities to help clinicians 
understand Quality Payment Program requirements, how to use available 
tools to enhance their practices, improve quality, reduce cost, and 
progress to participation in APMs and Advanced APMs if that is the best 
choice for their practice.
    Comment: Many commenters requested that we implement and test new 
models recommended by the Physician-Focused Payment Model Technical 
Advisory Committee (PTAC). The commenters noted that the stakeholder 
community is also well aware the Department has not selected any PTAC 
recommended models for testing. Specifically, the commenters noted that 
the PTAC had received 27 proposals for new physician-focused payment 
models, 15 of which have been reviewed by the PTAC with comments and 
recommendations sent to the Secretary. Of those, the commenters stated 
that 10 proposals were recommended favorably with six recommended for 
limited scale testing and four recommended for implementation, but the 
agency has taken no action to test or implement any of the recommended 
models.
    Some commenters suggested we provide more direct, regular feedback 
to the PTAC and stakeholders to ensure they can address concerns and 
shortcomings earlier in the development process, so that the PTAC 
comment and recommendation process can yield physician-led APMs that 
will be tested and implemented. The commenters also requested that we 
provide technical assistance to stakeholders working to develop 
proposals for the PTAC, and specifically that we make claims data 
available to allow for more detailed financial modeling to be part of 
the development process.
    Many commenters requested that we establish a clear process and 
timeline for responding to PTAC proposals in the future. The commenters 
suggested that a 60-day window from the date that the Secretary 
receives a recommendation from the PTAC would be appropriate.
    Response: We believe that PTAC can help us make the shift from a 
healthcare system that pays for volume to one that pays for value. The 
commitment to health care payment innovation by the PTAC and the 
broader stakeholder community is evident in the number and types of 
specialties represented in the proposals being submitted to PTAC. CMS' 
Center for Medicare and Medicaid Innovation (CMS Innovation Center) 
staff have met with stakeholders about proposed models, including some 
stakeholders that have submitted proposed physician-focused payment 
models to the PTAC.

[[Page 59917]]

    We note that while it seems unlikely that all of the features of 
any PTAC-reviewed proposed model will be tested exactly as presented in 
the proposal, certain features of proposed models may be incorporated 
into new or existing models. As the CMS Innovation Center launches new 
value-based payment and service delivery models, the PTAC's critical 
review of proposals will be a valuable resource. Additionally, the CMS 
Innovation Center will further engage with stakeholders that have 
submitted proposals related to new or existing models to leverage their 
experiences in the field.
    While we will not provide technical assistance to individual 
stakeholders before they submit proposals, we encourage potential 
submitters to review the detailed responses from the Secretary to past 
comments and recommenations from the PTAC to guide development of their 
proposals. We also encourage stakeholders designing proposals to review 
the data resources available on the Office of the Assistance Secretary 
for Planning and Evaluation (ASPE) website at https://aspe.hhs.gov/resources-public-comment-physician-focused-payment-model-technical-advisory-committee. Lastly, available from the CMS Innovation Center 
website is a toolkit for Alternative Payment Model Design (APM Toolkit) 
to serve as a resource for any entities or individuals interested in 
developing ideas for APMs (https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/Alternative-Payment-Model-APM-Design-Toolkit.pdf provides a detailed and comprehensive set of resources to 
help design an APM).
    We note that PTAC meets on a periodic basis to review proposals for 
physician-focused payment models submitted by individuals and 
stakeholder entities. The PTAC prepares comments and recommendations on 
proposals that are received, determining whether such models meet the 
criteria established by the Secretary for physician-focused payment 
models in the CY 2017 Quality Payment Program final rule with comment 
period (81 FR 77008, 77496-77499) and codified at Sec.  414.1465. The 
PTAC's comments and recommendations generally must be discussed during 
their public meetings and must be submitted to the Secretary. 
Subsequently, the Secretary reviews the comments and recommendations 
submitted by PTAC and posts a detailed response to these 
recommendations on the CMS Innovation Center website at https://innovation.cms.gov/initiatives/pfpms/. Given this standard timeline, we 
do not believe it would be realistic to set a strict 60-day timeframe 
for responding to physician-focused payment models recommended by the 
PTAC. As discussed in the CY 2018 Quality Payment Program final rule, 
the variation in the number and nature of proposals makes it difficult 
to establish such a deadline. However, HHS will continue to make every 
effort to respond expeditiously to the PTAC's comments and 
recommendations.
b. Terms and Definitions
    In the CY 2019 PFS proposed rule, we explained that as we continue 
to develop the Quality Payment Program, we have identified the need to 
propose changes to some of the previously finalized definitions. A 
complete list of the original definitions is available in the CY 2017 
Quality Payment Program final rule (81 FR 77537 through 77540).
    In the CY 2018 Quality Payment Program final rule, to consolidate 
our regulations and avoid unnecessarily defining a term, we finalized 
removal of the defined term for ``Advanced APM Entity'' in Sec.  
414.1305 and replaced instances of that term throughout the regulation 
with ``APM Entity.'' Similarly, we finalized replacing ``Advanced APM 
Entity group'' with ``APM Entity group'' where it appears throughout 
our regulations (82 FR 53833). We noted that these changes were 
technical and had no substantive effect on our policies.
    In the CY 2019 PFS proposed rule, to further consolidate our 
regulations and to clarify any potential ambiguity, we proposed to 
revise the definition of Qualifying APM Participant (QP) at Sec.  
414.1305 to provide that a QP is an eligible clinician determined by 
CMS to have met or exceeded the relevant QP payment amount or QP 
patient count threshold for the year based on participation in or with 
an APM Entity that is participating in an Advanced APM. The current 
definition of QP is based on an eligible clinician's participation in 
an Advanced APM Entity, which no longer is a defined term. Simply 
replacing the term ``Advanced APM Entity'' with the term ``APM 
Entity,'' as we had in the CY 2018 Quality Payment Program final rule, 
does not fully convey the definition of QP because, as noted at the 
time, an APM Entity can participate in an APM that is, or is not, an 
Advanced APM; and QP status is attainable only through participation in 
an Advanced APM (82 FR 53833). Again we note that this proposed change 
is technical and will not have a substantive effect on our policies.
    We solicited comments on this proposal.
    We did not receive any comments in response to this proposal.
    We are finalizing our proposal to revise the definition of 
Qualifying APM Participant (QP) at Sec.  414.1305 to provide that a QP 
is an eligible clinician determined by CMS to have met or exceeded the 
relevant QP payment amount or QP patient count threshold for the year 
based on participation in or with an APM Entity that is participating 
in an Advanced APM.
c. Advanced APMs
(1) Overview
    In the CY 2017 Quality Payment Program final rule (81 FR 77408), we 
finalized the criteria that define an Advanced APM based on the 
requirements set forth in sections 1833(z)(3)(C) and (D) of the Act. An 
Advanced APM is an APM that:
     Requires its participants to use certified EHR technology 
(CEHRT) (81 FR 77409 through 77414);
     Provides for payment for covered professional services 
based on quality measures comparable to measures under the quality 
performance category under MIPS (81 FR 77414 through 77418); and
     Either requires its participating APM Entities to bear 
financial risk for monetary losses that are in excess of a nominal 
amount, or is a Medical Home Model expanded under section 1115A(c) of 
the Act (81 FR 77418 through 77431). We refer to this criterion as the 
financial risk criterion.
(2) Summary of Proposals
    In the CY 2019 PFS proposed rule (83 FR 35989-35992), we included 
the following proposals, each of which is discussed in further detail 
below:
Use of CEHRT
     We proposed to revise Sec.  414.1415(a)(i) to specify that 
an Advanced APM must require at least 75 percent of eligible clinicians 
in each APM Entity use CEHRT as defined at Sec.  414.1305 to document 
and communicate clinical care with patients and other health care 
professionals.
MIPS-Comparable Quality Measures
     We proposed to revise Sec.  414.1415(b)(2) to clarify, 
effective January 1, 2020, that at least one of the quality measures 
upon which an Advanced APM bases the payment must either be finalized 
on the MIPS final list of measures, as described in Sec.  414.1330; 
endorsed by a consensus-based entity; or determined by CMS to be 
evidenced-based, reliable, and valid.
     We also proposed to revise Sec.  414.1415(b)(3), effective 
January 1, 2020, to provide that at least one

[[Page 59918]]

outcome measure, for which measure results are included as a factor 
when determining payment to participants under the terms of the APM 
must either be finalized on the MIPS final list of measures as 
described in Sec.  414.1330, endorsed by a consensus-based entity; or 
determined by CMS to be evidence-based, reliable, and valid.
Bearing Financial Risk for Monetary Losses
     We proposed to revise Sec.  414.1415(c)(3)(i)(A) to 
maintain the generally applicable revenue-based nominal amount standard 
at 8 percent of the average estimated total Medicare Parts A and B 
revenue of all providers and suppliers in participating APM Entities 
for QP Performance Periods 2021 through 2024.
(3) Use of CEHRT
(a) Overview
    In the CY 2017 Quality Payment Program final rule, we finalized 
that an Advanced APM must require at least 50 percent of eligible 
clinicians in each APM Entity to use CEHRT as defined at Sec.  414.1305 
to document and communicate clinical care with patients and other 
health care professionals. Further, we proposed but did not finalize an 
increase to the requirement wherein Advanced APMs must require 75 
percent CEHRT use in the subsequent year. Instead we maintained the 50 
percent CEHRT use requirement for the second performance year and 
beyond and indicated that we would consider making any potential 
changes through future rulemaking (81 FR 77412).
(b) Increasing the CEHRT Use Criterion for Advanced APMs
    In the CY 2019 PFS proposed rule, we proposed that, beginning for 
CY 2019, to be an Advanced APM, the APM must require at least 75 
percent of eligible clinicians in each APM Entity use CEHRT as defined 
at Sec.  414.1305 to document and communicate clinical care with 
patients and other health care professionals.
    According to data collected by the Office of the National 
Coordinator for Health Information Technology (ONC), over 3 in 4 
office-based physicians adopted a certified EHR in CY 2015,\32\ and 
approximately 9 in 10 clinicians have 2015 Edition certified technology 
available from their EHR developer.\33\ Additionally, in response to 
the CY 2017 Quality Payment Program proposed rule, commenters 
encouraged us to raise the CEHRT use criterion to 75 percent (see 81 FR 
77411). We believe that this proposed change aligns with the increased 
adoption of CEHRT among providers and suppliers that is already 
happening, and will encourage further CEHRT adoption. We further 
believe that most existing Advanced APMs already include provisions 
that would require participants to adhere to the level of CEHRT use 
specified in our regulations, and therefore this increase will not 
negatively impact the Advanced APM status of those APMs.
---------------------------------------------------------------------------

    \32\ Office of the National Coordinator for Health Information 
Technology. 'Office-based Physician Electronic Health Record 
Adoption,' Health IT Quick-Stat #50. dashboard.healthit.gov/quickstats/pages/physician-ehr-adoption-trends.php. December 2016.
    \33\ Office of the National Coordinator for Health Information 
Technology. '2015 Edition Market Readiness for Hospitals and 
Clinicians,' Health IT Quick-Stat #55. dashboard.healthit.gov/quickstats/pages/2015-edition-market-readiness-hospitals-clinicians.php. October 2018.
---------------------------------------------------------------------------

    We solicited comment on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Many commenters supported our proposal to increase the 
Advanced APM minimum CEHRT use threshold from 50 percent to 75 percent 
in 2019. Some commenters noted that the use of CEHRT is a fundamental 
component of any Advanced APM and that such APMs are more likely to be 
successful if physicians are able to receive information on their 
patients in a seamless manner, as well as document and communicate 
clinical care with patients and other health care professionals.
    Response: We appreciate the commenters' support of our proposal to 
increase the Advanced APM minimum CEHRT use threshold from 50 percent 
to 75 percent beginning in 2019.
    Comment: Many commenters requested that CMS not finalize the 
proposed increase in the Advanced APM minimum CEHRT use threshold from 
50 percent to 75 percent beginning in 2019. Some commenters stated that 
such an increase could be too burdensome for some APM participants, 
especially in light of the regulatory requirement to upgrade from 2014 
Edition CEHRT to 2015 Edition CEHRT in CY 2019. Other commenters noted 
the proposed increase could create a barrier to entry into Advanced 
APMs or create additional obstacles in designing APMs targeted for 
small or rural practices.
    Response: We do not believe that the proposed increase in the 
Advanced APM minimum CEHRT use threshold from 50 to 75 percent will be 
burdensome for APM participants. As noted above, approximately 9 in 10 
clinicians have 2015 Edition certified technology available from their 
most recently reported EHR developer, and we believe it is appropriate 
to require the use of 2015 Edition CEHRT beginning in CY 2019. Also, in 
the CY 2017 Quality Payment Program final rule, we acknowledged that 
eligible clinicians would be expected to upgrade from technology 
certified to the 2014 Edition to technology certified to the 2015 
Edition for use in 2018, and that some eligible clinicians who had not 
yet adopted CEHRT may wish to delay acquiring CEHRT products until a 
2015 Edition certified product is available. We also note that the 
requirement to use 2015 Edition CEHRT was delayed in the CY 2018 
Quality Payment Program final rule (82 FR 53671-53672), to provide 
eligible clinicians an additional year to upgrade from technology 
certified to the 2014 Edition to technology certified to the 2015 
Edition for use in 2019. Further, we note that most current Advanced 
APMs already include provisions that would require participants to 
adhere to this new level of CEHRT use specified in our regulations, and 
therefore this increase will not negatively impact the Advanced APM 
status of those APMs. Moving forward, though, we will consider the 
applicability of the CEHRT requirement for any potential models 
designed specifically for small or rural practices.
    Comment: Many commenters requested that we consider delaying our 
proposal to increase the Advanced APM minimum CEHRT use threshold from 
50 percent to 75 percent until CY 2020. Commenters stated there already 
is a regulatory requirement to upgrade to 2015 edition CEHRT in CY 2019 
and that clinicians participating in Advanced APMs should not be 
subject to additional health information technology requirements in a 
single year. Commenters also noted that maintaining the current 
Advanced APM minimum CEHRT use threshold for an additional year will 
allow time for organizations and clinicians to implement the upgrade to 
2015 edition CEHRT and not discourage smaller practices that are in the 
process of upgrading their systems from participating in Advanced APMs.
    Response: We appreciate commenters' concerns, but as noted 
previously in this final rule, the requirement to use 2015 Edition 
CEHRT was delayed in the CY 2018 Quality Payment Program final rule (82 
FR 53671 through 53672), to provide eligible clinicians an additional 
year to upgrade from technology

[[Page 59919]]

certified to the 2014 Edition to technology certified to the 2015 
Edition for use in 2019. We believe organizations and clinicians had 
sufficient time to implement upgrades and that it is appropriate to 
require the use of 2015 Edition CEHRT beginning in CY 2019. Thus, we 
believe a delay in implementation of the increase in the Advanced APM 
minimum CEHRT use threshold increase is unnecessary.
    Comment: Many commenters requested that CMS phase in the increase 
in the Advanced APM minimum CEHRT use threshold over time, or develop a 
glide path more reflective of the multi-year contracting cycles of APMs 
given that current contracts with Advanced APMs, were signed with the 
current Advanced APM minimum CEHRT use threshold in place. Some 
commenters also suggested that CMS could retain the current 50 percent 
Advanced APM minimum CEHRT use threshold, but allow APM Entities to 
attest that an additional percentage of eligible clinicians are either 
using CEHRT or other health information technology that augments or is 
an extension of CEHRT to achieve the specific goals of the APM.
    Response: We reiterate that in the CY 2017 Quality Payment Program 
final rule, we stated that setting the threshold at 50 percent of 
eligible clinicians would allow APMs sufficient room to meet this 
requirement even if the APM includes some participants who do not have 
internet access, lack face-to-face interactions with patients, or are 
hospital-based. At that time, we recognized commenters' concerns that 
raising the threshold to 75 percent in 2018 risked creating an overly 
rigorous standard for Advanced APMs and that it would be prudent to 
wait until we have more information on how the threshold would impact 
specific APMs, such as specialty APMs, before increasing the threshold. 
As noted previously in this final rule, we now understand that 
certified EHR adoption has been more widespread, and therefore do not 
believe that it is necessary to phase in the increase in the Advanced 
APM minimum CEHRT use threshold over time any more so than we already 
have by maintaining the threshold at 50 percent for the 2017 and 2018 
QP performance periods. We also note that most current Advanced APMs 
already include provisions that require participants to adhere to this 
new level of CEHRT use specified in our regulations, and therefore this 
increase will not negatively impact the Advanced APM status of those 
APMs.
    Comment: One commenter suggested that CMS provide flexibility for 
APM Entities participating in Advanced APMs by allowing them to include 
eligible clinicians in the 75 percent threshold calculation who are 
actively working with their EMR vendors to transition to the 2015 
Edition CEHRT. The commenter noted that there may be instances where 
EMR vendors are finalizing their certification process during the 2019 
performance year, and that may prevent an APM Entity from fully 
complying with the 75 percent threshold.
    Response: We reiterate that the Advanced APM CEHRT use criterion 
applies to APMs and the requirements they impose on participating APM 
Entities, not to the individual APM Entities participating in APMs. 
This means that once an APM has been determined to be an Advanced APM 
(by requiring the specified percentage of eligible clinicians in each 
of its participating APM Entities to use CEHRT), the methods used in 
the Advanced APM to ascertain whether the required percentage of CEHRT 
use is met may be unique to each APM and may not involve a threshold 
calculation. We acknowledge there may be instances where EMR vendors 
are finalizing their certification process, but as noted previously, 
the requirement to use 2015 Edition CEHRT was delayed to provide 
eligible clinicians an additional year to upgrade from technology 
certified to the 2014 Edition to technology certified to the 2015 
Edition for use in 2019. Therefore, we believe it is appropriate to 
require the use of 2015 Edition CEHRT beginning in CY 2019.
    Comment: Many commenters noted that the proposed increase in the 
Advanced APM minimum CEHRT use threshold could limit the ability of 
non-physician professionals, such as physical therapists, occupational 
therapists, audiologists, and speech-language pathologists, to 
meaningfully participate in APMs. The commenters noted that current 
CEHRT requirements are designed for prescribing professionals and do 
not capture tasks performed by non-physician professionals using 
different types of EHRs. Specifically, the commenters stated that the 
EHRs non-physician professionals often use have not been taken into 
account by ONC in developing the CEHRT standards and certification 
criteria, and therefore, they would not be able to meet the definition 
of CEHRT required for purposes of the Advanced APM minimum CEHRT use 
threshold. The commenters suggested that CMS establish a dedicated 
CEHRT program for non-physician and non-prescribing professionals and 
that CMS offer assistance in the form of funding and technical support 
to help these types of clinicians participate in Advanced APMs.
    Response: We reiterate that the Advanced APM minimum CEHRT use 
threshold applies to APMs and the requirements they impose on 
participating APM Entities, not to the individual APM Entities 
participating in APMs. We also note that the Advanced APM minimum CEHRT 
use threshold does not mean that all eligible clinicians in each 
participating APM Entity are required to use CEHRT, and that the 
methods used in the Advanced APM to ascertain whether the required 
percentage of CEHRT use is met may be unique to each APM. This means 
there can be a percentage of eligible clinicians participating in an 
APM Entity who are not using CEHRT and the APM Entity will still be in 
compliance with the APM's terms and conditions. Understanding this may 
have a greater effect on non-physician or non-prescribing eligible 
clinicians, moving forward, we will monitor this issue for new APMs and 
will consider possible solutions to facilitate participation in 
Advanced APMs by non-physician or non-prescribing eligible clinicians 
that may not use CEHRT due to lack of certified systems for that 
specific specialty.
    After considering public comments, we are finalizing our proposal 
that, for QP Performance Periods beginning in 2019, to be an Advanced 
APM, the APM must require at least 75 percent of eligible clinicians in 
each APM Entity (or, for APMs in which hospitals are the APM Entities, 
each hospital, as specified in our current regulation) to use CEHRT as 
defined at Sec.  414.1305 to document and communicate clinical care 
with patients and other health care professionals. We are amending 
Sec.  414.1414(a)(1) to reflect this change.
(4) MIPS-Comparable Quality Measures
(a) Overview
    In the CY 2017 Quality Payment Program final rule, we explained 
that one of the criteria for an APM to be an Advanced APM is that it 
must provide for payment for covered professional services based on 
quality measures comparable to measures under the performance category 
described in section 1848(q)(2)(A) of the Act, which is the MIPS 
quality performance category. We generally refer to these measures in 
the remainder of this discussion as ``MIPS-comparable quality 
measures.'' We also explained that we interpret this criterion to 
require the APM to incorporate quality measure results as a factor when 
determining

[[Page 59920]]

payment to participants under the terms of the APM (81 FR 77414).
    In the CY 2017 Quality Payment Program proposed rule, we proposed 
that to be an Advanced APM, an APM must base payment on quality 
measures that are evidence-based, reliable, and valid; and that at 
least one measure must be an outcome measure unless there is not an 
applicable outcome measure on the MIPS quality list at the time the APM 
is developed. The required outcome measure does not have to be one of 
those on the MIPS quality measure list. We did not specify that the 
outcome measure is required to be evidence-based, reliable, and valid. 
(81 FR 28302). We finalized these policies in the CY 2017 Quality 
Payment Program final rule and codified at Sec.  414.1415(b).
(b) General Quality Measures: Evidence-Based, Reliable, and Valid
    In the CY 2017 Quality Payment Program final rule, we codified at 
Sec.  414.1415(b)(2) that at least one of the quality measures upon 
which an Advanced APM bases the payment must have an evidence-based 
focus, be reliable, and valid, and meet at least one of the following 
criteria: Used in the MIPS quality performance category as described in 
Sec.  414.1330; endorsed by a consensus-based entity; developed under 
section 1848(s) of the Act; submitted in response to the MIPS Call for 
Quality Measures under section 1848(q)(2)(D)(ii) of the Act; or any 
other quality measures that CMS determines to have an evidence-based 
focus and to be reliable and valid.
    It has come to our attention that some have interpreted Sec.  
414.1415(b)(2) to mean that measures on the MIPS final list or 
submitted in response to the MIPS Call for Quality Measures necessarily 
are MIPS-comparable quality measures, even if they are not evidence-
based, reliable, and valid. We did not intend to imply that any measure 
that was merely submitted in response to the annual call for quality 
measures or developed using Quality Payment Program funding will 
automatically qualify as MIPS-comparable even if the measure was never 
endorsed by a consensus-based entity, adopted under MIPS, or otherwise 
determined to be evidence-based, reliable, and valid. Although we 
believe such measures may be evidence-based, reliable, and valid, we 
did not intend to consider them so for purposes of Sec.  414.1415(b)(2) 
without independent verification by a consensus-based entity, or based 
on our own assessment and determination, that they are evidence-based, 
reliable, and valid. We further believe the same principle applies to 
Qualified Clinical Data Registry (QCDR) measures. If QCDR measures are 
endorsed by a consensus-based entity they are presumptively considered 
MIPS-comparable quality measures for purposes of Sec.  414.1415(b)(2); 
otherwise we would have needed independent verification, or to make our 
own assessment and determination, that the measures are evidence-based, 
reliable, and valid before considering them to be MIPS-comparable 
quality measures (see 81 FR 77415 through 77417).
    Because of the potential ambiguity in the existing definition and 
out of an abundance of caution to avoid any adverse impact on APM 
entities, eligible clinicians, or other commenters, we have used the 
more permissive interpretation of the regulation text, wherein measures 
developed under section 1848(s) of the Act and submitted in response to 
the MIPS Call for Quality Measures will meet the quality criterion in 
implementing the program thus far, and intend to use this 
interpretation for the 2019 QP Performance Period until our new 
proposal described, in this final rule, is effective on January 1, 
2020. Recognizing that APMs and other payer payment arrangements that 
we might consider for Advanced APM and Other Payer Advanced APM 
determinations are well into development for 2019, we proposed to amend 
Sec.  414.1415(b)(2) to be effective as of January 1, 2020. 
Specifically, we proposed that at least one of the quality measures 
upon which an Advanced APM bases payment must be finalized on the MIPS 
final list of measures, as described in Sec.  414.1330; be endorsed by 
a consensus-based entity; or otherwise determined by CMS to be 
evidenced-based, reliable, and valid.
    That is, for QP Performance Period 2020 and all future QP 
Performance Periods, we would treat any measure that is either included 
in the MIPS final list of measures or has been endorsed by a consensus-
based entity as presumptively evidence-based, reliable, and valid. All 
other measures would need to be independently determined by CMS to be 
evidence-based, reliable, and valid, to be considered MIPS-comparable 
quality measures.
    We solicited comment on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Many commenters supported the proposal. Some commenters 
suggested that Advanced APMs should be required to include more than 
one MIPS-comparable quality measure.
    Response: We appreciate the commenters' support of our proposal. We 
reiterate that the quality measures criterion stipulates that to be an 
Advanced APM an APM must require at least one of the quality measures 
upon which an Advanced APM bases payment to be MIPS-comparable. This 
does not preclude an Advanced APM from including more than one MIPS-
comparable quality measure. However, we also note that under the 
statute, not all quality measures under which an APM is assessed are 
required to be MIPS-comparable and not all payments under the APM must 
be based on MIPS-comparable quality measures. As such, we believe that 
by requiring only one quality measures upon which an Advanced APM bases 
payment to be MIPS-comparable, APMs have the latitude to base payment 
on quality measures that meet the goals of the APM and assess the 
quality of care provided to the population of patients that the APM 
participants are serving.
    Comment: One commenter suggested that CMS consider Core Quality 
Measure Collaborative (CQMC) endorsement as meeting the criterion for a 
measure being endorsed by a consensus-based entity. The commenter noted 
that as more health care providers move toward the adoption of the CQMC 
Core Measure Sets, using the CQMC multi-stakeholder, consensus-based 
process in determining MIPS-comparable measures would further CMS's 
goal of alignment between its programs and the CQMC Core Measure Sets.
    Response: We note that, under MIPS, we currently try to align with 
the CQMC measures as much as possible. However, for a measure to meet 
the criterion of MIPS-comparable, only measures on the list of 
consensus-endorsed measures maintained by the NQF will currently meet 
the criterion as being endorsed by a consensus-based entity because NQF 
is the consensus-based entity that endorses standardized healthcare 
performance measures for CMS as defined under 1890(b)(2) and (3) of the 
Act. Therefore, CQMC endorsement does not currently meet the criterion 
for a measure being endorsed by a consensus-based entity.
    We also note, that we believe the revised criteria for the MIPS-
comparable measures used in Advanced APMs do not prevent an APM from 
using a core measure set or using measures developed and included in 
other CMS programs, but instead provides the criteria for what 
constitutes a MIPS-comparable measure to meet the Advanced APM 
requirement (81 FR 77417). Not all quality measures upon

[[Page 59921]]

which an APM bases payment are required to be MIPS-comparable, and not 
all payments under the APM must be based on MIPS-comparable measures. 
However, at least some payments must be tied to MIPS-comparable 
measures.
    Comment: Some commenters expressed concern that designating 
measures determined to be evidenced-based, reliable, and valid by CMS 
as MIPS-comparable amounts to bypassing the standard vetting process of 
consensus-based entities; publishing in applicable specialty-
appropriate, peer-reviewed journals; notice-and-comment rulemaking or 
separate publication in the Federal Register. The commenters suggested 
that all MIPS-comparable quality measures for the Advanced APM pathway 
should go through a fair and standard vetting process open to the 
medical profession rather than being independently determined and 
approved by CMS.
    Response: As finalized in the CY 2017 Quality Payment Program final 
rule, we established an Innovation Center quality measure review 
process for those measures that are not NQF-endorsed or included on the 
final MIPS measure list. The sole purpose of this process is to assess 
for purposes of the Advanced APM MIPS-comparable measure criterion 
whether these measures have an evidence-based focus, and are reliable 
and valid (81 FR 77418). In most instances, the Innovation Center 
internal committee responsible for this review process will make this 
determination for measures that were tested for use in Innovation 
Center models using internal analyses and other experts to demonstrate 
that the measure meets these criteria, and thus can be used as a MIPS-
comparable measure before it is considered for inclusion in MIPS or 
submitted to the consensus based entity for endorsement consideration. 
The Innovation Center committee is not a substitute for those existing 
processes but allows the Innovation Center to innovate by using new 
measures that meet the same standards as MIPS measures. Therefore, we 
appreciate the commenters' concerns but do not believe that the 
Innovation Center quality measure review process bypasses the currently 
established vetting process for quality measures.
    After considering public comments, we are finalizing our proposal 
to revise Sec.  414.1415(b)(2) to clarify, effective January 1, 2020, 
to clarify that at least one of the quality measures upon which an 
Advanced APM bases payment must either be finalized on the MIPS final 
list of measures, as described in Sec.  414.1330; endorsed by a 
consensus-based entity; or determined by CMS to be evidenced-based, 
reliable, and valid.
(c) Outcome Measures: Evidence-Based, Reliable, and Valid
    In Sec.  414.1415(b)(3), we generally require that the measures 
upon which an Advanced APM bases payment must include at least one 
outcome measure, but specify that this requirement does not apply if 
CMS determines that there are no available or applicable outcome 
measures in the MIPS quality measure lists for the Advanced APM's first 
QP Performance Period. We note that the current regulation does not 
require that the outcome measure be evidence-based, reliable, and 
valid. Although it was our general expectation when developing the CY 
2017 Quality Payment Program final rule that outcome measures will meet 
this standard, we did not explicitly include this requirement.
    In the CY 2019 PFS proposed rule, we proposed to modify Sec.  
414.1415(b)(3) to explicitly require that an outcome measure must be 
evidence-based, reliable, and valid (unless, as specified in the 
current regulation, there is no available or applicable outcome 
measure), so that at least one outcome measure used for purposes of 
Sec.  414.1415(b)(1) must also be:
     Finalized on the MIPS final list of measures, as described 
in Sec.  414.1330;
     Endorsed by a consensus-based entity; or
     Determined by CMS to be evidence-based, reliable, and 
valid.
    We proposed that this change would have an effective date of 
January 1, 2020, and would specifically require that at least one 
outcome measure for which measure results are included as a factor when 
determining payment to participants under the terms of the APM must 
also be a MIPS-comparable quality measure. This is intended to align 
with our parallel proposal for the Other Payer Advanced APM criteria 
that we discuss in section III.I.4.e.(3)(d)(iii) of this final rule.
    We solicited comment on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Commenters supported the proposal to explicitly require 
that an outcome measure must be finalized on the MIPS final list of 
measures; be endorsed by a consensus-based entity; or otherwise 
determined by CMS to be evidenced-based, reliable, and valid. One 
commenter noted that this proposal is reasonable given the general 
growth in the use of outcome measures.
    Response: We appreciate the commenters' support, but note that our 
proposal does not eliminate the exception for models where there are no 
available or applicable outcome measures at the performance start date 
of the model.
    Comment: One commenter expressed concerns with the proposal to 
explicitly require that an outcome measure must be finalized on the 
MIPS final list of measures; be endorsed by a consensus-based entity; 
or otherwise determined by CMS to be evidenced-based, reliable, and 
valid. The commenter noted that there is little variation in outcomes 
for many surgical procedures as judged by existing outcome measures, 
and that outcome measures alone are not sufficient to verify that the 
highest quality care is made available to patients. The commenter 
suggested CMS implement a framework that could provide a much clearer 
picture of the quality of care provided to the patient and includes 
elements such as: Standards-based facility-level verification programs; 
patient reported experience and outcomes measures; and traditional 
quality measures including registry and claims-based measures.
    Response: We acknowledge the commenter's concerns regarding this 
use of outcomes measures and appreciate the commenter's suggestions. 
The Advanced APM requirement for inclusion of one MIPS-comparable 
measure that is also an outcome measure does not represent a quality 
measure strategy for Advanced APMs. Rather, the statute identifies 
outcome measures as a priority measure type, and we wanted to encourage 
the use of outcome measures for quality performance assessment in APMs. 
The quality strategy for most Advanced APMs typically includes quality 
and/or utilization measures that correspond with the key payment and 
practice transformation activities being tested in the APM. This is why 
the majority of APMs include more than just one quality measure and 
many different types of quality performance measures (for example, 
process, clinical outcome, patient experience of care or patient 
reported outcome measures) to assess the clinical care provided by 
eligible clinicians under the APM. Our goal in developing APMs is to 
ensure that all patients realize better care, improved clinical 
outcomes and more efficient cost-effective care. We believe our 
requirement that at least one outcome measure for which measure results 
are included as a factor when determining payment to participants under 
the terms of the APM must also be a MIPS-

[[Page 59922]]

comparable quality measure further reinforces these goals.
    Comment: One commenter expressed concern that CMS is placing too 
much emphasis on outcome measures. Specifically, the commenter 
suggested that CMS continue to support the use of process measures 
until meaningful outcome measures are available in more specialty 
areas.
    Response: We note that we require only one of the quality measures 
to be an outcome measure, and have established an exception for models 
where there is no available or applicable outcome measure at the 
performance start date of the model. As such, we do not agree that we 
are emphasizing outcome measures over process measures.
    After considering public comments, we are finalizing our proposal 
to revise Sec.  414.1415(b)(3), effective January 1, 2020, to require 
that at least one outcome measure, for which measure results are 
included as a factor when determining payment to participants under the 
terms of the APM, must either be finalized on the MIPS final list of 
measures as described in Sec.  414.1330, endorsed by a consensus-based 
entity; or determined by CMS to be evidence-based, reliable, and valid. 
As specified in the current regulation, this requirement does not apply 
if CMS determines that there are no available or applicable outcome 
measures included in the MIPS quality measures list for the Advanced 
APM's first QP Performance Period.
(5) Bearing Financial Risk for Monetary Losses
(a) Overview
    In the CY 2017 Quality Payment Program final rule, we finalized the 
amount of the generally applicable revenue-based nominal amount 
standard at 8 percent for the first two QP Performance Periods only, 
and we sought comment on what the revenue-based nominal amount standard 
should be for the third and subsequent QP Performance Periods. 
Specifically, we sought comment on: (1) Setting the revenue-based 
standard for 2019 and later at up to 15 percent of revenue; or (2) 
setting the revenue-based standard at 10 percent so long as risk is at 
least equal to 1.5 percent of expected expenditures for which an APM 
Entity is responsible under an APM (81 FR 77427).
    In the CY 2018 Quality Payment Program final rule, we finalized our 
proposal to maintain the generally applicable revenue-based nominal 
amount standard at 8 percent for the 2019 and 2020 QP Performance 
Periods at Sec.  414.1415(c)(3)(i)(A). We also specified that the 
standard is based on the average estimated total Medicare Parts A and B 
revenue of all providers and suppliers in participating APM Entities. 
We stated that we will address the nominal amount standard for QP 
Performance Periods after 2020 in future rulemaking (82 FR 53838).
(b) Generally Applicable Nominal Amount Standard
    We proposed to amend Sec.  414.1415(c)(3)(i)(A) to maintain the 
generally applicable revenue-based nominal amount standard at 8 percent 
of the average estimated total Medicare Parts A and B revenue of all 
providers and suppliers in participating APM Entities for QP 
Performance Periods 2021 through 2024.
    We solicited comment on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Many commenters supported our proposal to maintain the 8 
percent generally applicable revenue-based standard for QP performance 
periods 2021-2024. Commenters noted that maintaining the 8 percent 
revenue-based standard through the 2024 QP performance period will 
promote consistency for participants across performance periods and 
further support CMS' efforts to transition clinicians into Advanced 
APMs.
    Response: We appreciate the commenters' support of our proposal to 
maintain the 8 percent generally applicable revenue-based standard for 
QP performance periods 2021-2024.
    Comment: Two commenters suggested that we limit the generally 
applicable revenue-based nominal amount standard to only include the 
average estimated total Part B revenue of participating providers and 
suppliers in APM Entities, rather than the average estimated total Part 
A and Part B revenues of providers and suppliers in APM Entities. The 
commenters stated that by including Part A revenue, CMS significantly 
disadvantages APM Entities, such as ACOs, that have hospital 
participants. The commenters noted that the APM Incentive Payment is 
based on payments for Part B covered professional services under the 
Medicare PFS, and as such, recommends that we revise the generally 
applicable revenue-based nominal amount standard to only consider Part 
B revenue under the Medicare PFS.
    Response: We note that we did not propose to make changes to the 
types of revenue that are included in the generally applicable revenue-
based nominal amount standard. However, we note that we disagree that 
the generally applicable revenue-based nominal amount standard should 
only include Part B revenues, as many APM Entities participating in 
Advanced APMs often include hospitals and other types of institutional 
providers or suppliers that may receive both Part A and B revenues. 
Additionally, the generally applicable revenue-based nominal amount 
standard is inclusive only of the Medicare Part A and B revenues of 
providers and suppliers in participating APM Entities; therefore, if 
the providers and suppliers in a given APM Entity have only Medicare 
Part B revenues, only such revenues will be considered.
    Comment: Some commenters suggested we reconsider establishing a 
separate, lower nominal amount standard for small and rural practices. 
The commenters stated that a lower revenue-based nominal amount 
standard is necessary to ensure that the challenging operational risks 
and expenses, which put such practices at greater financial risk when 
compared to larger practices, do not prevent participation in Advanced 
APMs. The commenters suggested establishing a nominal amount standard 
for small and rural practices that would be aligned with the Medical 
Home Model nominal amount standard or set equal to the percentage of 
the APM incentive payment that an eligible clinician might attain based 
on their participation in an Advanced APM. The commenters noted that a 
lower revenue-base nominal amount standard may encourage greater 
participation in APMs by small and rural practices.
    Response: We will continue to monitor the impact of the generally 
applicable revenue-based nominal amount standard and Medical Home Model 
nominal amount standard on small practices and those in rural areas. We 
did not include any proposals in the CY 2019 PFS proposed rule 
regarding a separate standard for small or rural practices, but may 
consider revisiting establishing a lower revenue-based nominal amount 
standard for small practices and those in rural areas in future 
rulemaking.
    Comment: Some commenters requested CMS consider the financial and 
administrative risk that non-physician practitioners face when joining 
Advanced APMs. Specifically, the commenters suggested that CMS should 
adopt a more inclusive interpretation of financial risk for monetary 
losses by including any losses incurred in the operation of the APM

[[Page 59923]]

Entity rather than limiting financial risk only to losses or increased 
spending in the Medicare program. The commenters stated that the 
magnitude of risk CMS currently requires for participation in an 
Advanced APM may prevent many eligible clinicians from considering 
participation in the limited Advanced APMs available.
    Response: As we stated in the CY 2018 Quality Payment Program final 
rule, we recognize the substantial investments that many APM Entities 
make to become successful APM participants, and also the financial and 
administrative burden that eligible clinicians of all types face when 
deciding to join an APM Entity. Nonetheless, as we discussed in the CY 
2017 Quality Payment Program final rule, we continue to believe that 
there would be significant complexity involved in creating an objective 
and enforceable standard for determining whether an entity's business 
risk exceeds a nominal amount. We also reiterate that business risk is 
generally a cost that is unrelated to performance-based payment under 
an APM. No matter how well or poorly an APM Entity performs when 
assessed for purposes of the APM, costs associated with business risk 
are not reduced or increased correspondingly. Therefore, we maintain 
our view that business risk is not analogous to performance risk in the 
APM context because the costs of those activities and investments are 
not incorporated into the performance-based financial calculations of 
an APM, and are therefore not appropriate for consideration for 
purposes of the Advanced APM financial risk criterion (81 FR 77420).
    After considering public comments, we are finalizing our proposal 
to revise Sec.  414.1415(c)(3)(i)(A) to maintain the generally 
applicable revenue-based nominal amount standard at 8 percent of the 
average estimated total Medicare Parts A and B revenue of all providers 
and suppliers in participating APM Entities for QP Performance Periods 
2021 through 2024. We continue to believe that 8 percent of Medicare 
Parts A and B revenues of all providers and suppliers in participating 
APM Entities generally represents an appropriate standard for more than 
a nominal amount of financial risk at this time. We also believe that 
maintaining a consistent standard for several more years will help APM 
Entities to plan for multi-year Advanced APM participation. We further 
believe that maintaining a consistent standard will allow us to 
evaluate how APM Entities succeed within these parameters over the 
applicable timeframe.
    We also sought comment on whether, as APM entities and 
participating eligible clinicians grow more comfortable with assuming 
risk, we should consider increasing the nominal amount standard. 
Specifically, we requested comments on whether we should consider 
raising the revenue-based nominal amount standard to 10 percent, and 
the expenditure-based nominal amount standard to 4 percent starting for 
QP Performance Periods in 2025 and later.
    Several comments stated we should consider raising the revenue-
based nominal amount standard to 10 percent, and the expenditure-based 
nominal amount standard to 4 percent starting for QP Performance 
Periods in 2025 and later. We thank commenters for their feedback and 
will take this input into consideration for future years.
(6) Summary of Final Policies
Use of CEHRT
     We are finalizing revisions to Sec.  414.1415(a)(i) to 
specify that an Advanced APM must require at least 75 percent of 
eligible clinicians in each APM Entity, or, for APMs in which hospitals 
are the APM Entities, each hospital, to use CEHRT as defined at Sec.  
414.1305 to document and communicate clinical care with patients and 
other health care professionals.
MIPS-Comparable Quality Measures
     We are finalizing revisions to clarify at Sec.  
414.1415(b)(2), effective January 1, 2020, that at least one of the 
quality measures upon which an Advanced APM bases the payment in 
paragraph (b)(1) of this section must either be finalized on the MIPS 
final list of measures, as described in Sec.  414.1330; endorsed by a 
consensus-based entity; or determined by CMS to be evidenced-based, 
reliable, and valid.
     We are finalizing revisions at Sec.  414.1415(b)(3), 
effective January 1, 2020, to provide that at least one outcome 
measure, for which measure results are included as a factor when 
determining payment to participants under the terms of the APM must 
either be finalized on the MIPS final list of measures as described in 
Sec.  414.1330, endorsed by a consensus-based entity; or determined by 
CMS to be evidence-based, reliable, and valid.
Bearing Financial Risk for Monetary Losses
     We are finalizing revisions at Sec.  414.1415(c)(3)(i)(A) 
to maintain the generally applicable revenue-based nominal amount 
standard at 8 percent of the average estimated total Medicare Parts A 
and B revenue of all providers and suppliers in participating APM 
Entities for QP Performance Periods 2021 through 2024.
d. Qualifying APM Participant (QP) and Partial QP Determinations
(1) Overview
    We finalized policies relating to QP and Partial QP determinations 
in the CY 2017 Quality Payment Program final rule (81 FR 77433 through 
77450).
(2) Summary of Proposals
    In the CY 2019 PFS proposed rule (83 FR 3599 through 35994), we 
included the following proposals, each of which is discussed in further 
detail below:
QP Performance Period
     We proposed that for each of the three QP determinations, 
we will allow for claims run-out for 60 days (approximately 2 months), 
before calculating the Threshold Scores so that the three QP 
determinations can be completed approximately 3 months after the end of 
that determination time period.
Partial QP Election To Report to MIPS
     We proposed that when an eligible clinician is determined 
to be a Partial QP for a year at the individual eligible clinician 
level, the individual eligible clinician will make an election whether 
to report to MIPS. If the eligible clinician elects to report to MIPS, 
they will be subject to the MIPS reporting requirements and payment 
adjustment. If the eligible clinician elects not to report, they will 
be excluded from the MIPS reporting requirements and payment 
adjustment. In the absence of an explicit election to report to MIPS, 
the eligible clinician will be excluded from the MIPS reporting 
requirements and payment adjustment. This means that no actions other 
than the eligible clinician's affirmative election to participate in 
MIPS will result in that eligible clinician becoming subject to the 
MIPS reporting requirements and payment adjustment.
(3) QP Performance Period
    In the CY 2017 Quality Payment Program final rule, we finalized for 
the timing of QP determinations that a QP Performance Period runs from 
January 1 through August 31 of the calendar year that is 2 years prior 
to the payment year (81 FR 77446-77447). During that QP Performance 
Period, we will make QP determinations at three separate snapshot dates 
(March 31, June 30, and August 31), each of which will be a final 
determination for the eligible clinicians who are determined to be QPs. 
The QP Performance Period and the three

[[Page 59924]]

separate QP determinations apply similarly for both the group of 
eligible clinicians on a Participation List and the individual eligible 
clinicians on an Affiliated Practitioner List.
    We also finalized that for each of the three QP determinations, we 
will allow for claims run-out for 3 months, or 90 days, before 
calculating the Threshold Scores so that QP determinations will be 
completed approximately 4 months after each snapshot date. As a result, 
the last of these three QP determinations is complete on or around 
January 1 of the subsequent calendar year, which is the year 
immediately prior to the MIPS payment year. For most MIPS data 
submission types, January 1 of the subsequent calendar year is also the 
beginning of the MIPS data submission period. This way, eligible 
clinicians know of their QP status prior to or near the beginning of 
the MIPS data submission period and know whether they should report any 
performance period data to MIPS for the applicable MIPS payment year.
    Upon further consideration and based on our experience implementing 
the program to date, we believe providing eligible clinicians 
notification of their QP status more quickly after each of the three QP 
determination snapshot dates, and prior to the beginning of the MIPS 
data submission period after the last determination, will potentially 
reduce burden for eligible clinicians and APM Entities while improving 
their overall experience participating in the program.
    We proposed that beginning in 2019 for each of the three QP 
determination dates, we will allow for claims run-out for 60 days 
(approximately 2 months), before calculating the Threshold Scores so 
that the three QP determinations will be completed approximately 3 
months after the end of that determination time period. We note that 
this proposal does not affect the QP Performance Period per se, but 
rather the date by which claims for services furnished during the QP 
Performance Period will need to be processed for those services to be 
included in calculating the Threshold Scores. To the extent that claims 
are used for calculating the Threshold Scores, such claims will have to 
be processed by no later than 60 days after each of the three QP 
determination dates, for information on the claims to be included in 
our calculations.
    We solicited comment on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Many commenters supported the proposal to allow for claims 
run-out of 60 days (approximately 2 months), before calculating the QP 
threshold scores so that the three QP determinations can be completed 
approximately 3 months after the end of that determination time period. 
Commenters noted the importance for APM Entities to have information 
about their QP status as soon as possible after each snapshot to 
determine if they will need to take any additional action to report to 
MIPS or seek a QP determination under the All-Payer Combination Option 
should they fall short of the QP thresholds under the Medicare Option.
    Response: We appreciate the commenters' support of our proposal to 
allow for a claims run-out of 60 days before calculating the QP 
threshold scores so that the three QP determinations can be completed 
approximately 3 months after the end of that determination time period.
    After considering public comments, we are finalizing our proposal 
that for each of the three QP determinations, we will allow for claims 
run-out for 60 days (approximately 2 months), before calculating the 
Threshold Scores so that the three QP determinations can be completed 
approximately 3 months after the end of that determination time period.
(4) Partial QP Election To Report to MIPS
(a) Overview
    Section 1848(q)(1)(C)(ii)(II) of the Act excludes from the 
definition of MIPS eligible clinician an eligible clinician who is a 
Partial QP for a year and who does not report on applicable measures 
and activities as required under MIPS for the year. However, under 
section 1848(q)(1)(C)(vii) of the Act, an eligible clinician who is a 
Partial QP for a year and reports on applicable measures and activities 
as required under the MIPS is considered to be a MIPS eligible 
clinician for the year.
    In the CY 2017 Quality Payment Program final rule, we finalized 
that following a determination that eligible clinicians in an APM 
Entity group in an Advanced APM are Partial QPs for a year, the APM 
Entity will make an election whether to report on applicable measures 
and activities as required under MIPS. If the APM Entity elects to 
report to MIPS, all eligible clinicians in the APM Entity will be 
subject to the MIPS reporting requirements and payment adjustments for 
the relevant year. If the APM Entity elects not to report, all eligible 
clinicians in the APM Entity group will be excluded from the MIPS 
reporting requirements and payment adjustments for the relevant year 
(81 FR 77449).
    We also finalized that in cases where the Partial QP determination 
is made at the individual eligible clinician level, if the individual 
eligible clinician is determined to be a Partial QP, the eligible 
clinician will make the election whether to report on applicable 
measures and activities as required under MIPS and, as a result, be 
subject to the MIPS reporting requirements and payment adjustment (81 
FR 77449). If the individual eligible clinician elects to report to 
MIPS, he or she will be subject to the MIPS reporting requirements and 
payment adjustments for the relevant year. If the individual eligible 
elects not to report to MIPS, he or she will be excluded from the MIPS 
reporting requirements and payment adjustments for the relevant year. 
We note that QP determinations are made at the individual eligible 
clinician level when the clinician is identified as participating in an 
Advanced APM on an Affiliated Practitioner List rather than a 
Participation List, or when an eligible clinician is in more than one 
APM Entity group in one or more Advanced APMs, and does not achieve QP 
status as part of any single APM Entity group (see Sec.  414.1425(b)(2) 
and (c)(4) our regulations).
    We also clarified how we consider the absence of an explicit 
election to report to MIPS or to be excluded from MIPS. We finalized 
that for situations in which the APM Entity is responsible for making 
the decision on behalf of all eligible clinicians in the APM Entity 
group, the group of Partial QPs will not be considered MIPS eligible 
clinicians unless the APM Entity opts the group into MIPS 
participation, so that no actions other than the APM Entity's election 
for the group to participate in MIPS will result in MIPS participation 
(81 FR 77449).
    For eligible clinicians who are determined to be Partial QPs 
individually, we finalized that we will use the eligible clinician's 
actual MIPS reporting activity to determine whether to exclude the 
Partial QP from MIPS in the absence of an explicit election. Therefore, 
if an eligible clinician who is individually determined to be a Partial 
QP submits information to MIPS (not including information automatically 
populated or calculated by CMS on the Partial QP's behalf), we will 
consider the Partial QP to have reported, and thus to be participating 
in MIPS. Likewise, if such an individual does not take any action to 
submit information to MIPS, we will consider the Partial QP to have 
elected to be excluded from MIPS (81 FR 77449).

[[Page 59925]]

(b) Alignment of Partial QP Election Policies
    We proposed that when an eligible clinician is determined to be a 
Partial QP for a year at the individual eligible clinician level, the 
individual eligible clinician will make an election whether to report 
to MIPS. If the eligible clinician elects to report to MIPS, they will 
be subject to MIPS reporting requirements and payment adjustments. If 
the eligible clinician elects to not report to MIPS, they will not be 
subject to the MIPS reporting requirements and payment adjustment. If 
the eligible clinician does not make any election, they will not be 
subject to the MIPS reporting requirements and payment adjustment.
    We note that this proposed policy change would affect only 
situations where the Partial QP makes no election to either report to 
MIPS or to be excluded from the MIPS reporting requirements and payment 
adjustment. Under our proposed policy, all Partial QPs retain the full 
right to affirmatively decide through the election process whether or 
not to be subject to the MIPS reporting requirements and payment 
adjustment; whereas, if the Partial QP does not make any election, they 
will not be subject to the MIPS reporting requirements and payment 
adjustment.
    We solicited comment on this proposal.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: Some commenters supported our proposal. Specifically, the 
commenters supported our proposal to exclude eligible clinicians 
determined to be a Partial QP for a year at the individual eligible 
clinician level from the MIPS reporting requirements and payment 
adjustment, in the absence of an explicit election to report to MIPS. 
Commenters noted this proposal will help to avoid confusion and prevent 
inadvertently subjecting eligible clinicians to MIPS reporting 
requirements and payment adjustments when information has been reported 
on their behalf.
    Response: We appreciate the commenters' support of our proposal to 
align the Partial QP election policy for eligible clinicians who are 
determined to be Partial QPs individually and for eligible clinicians 
who are determined to be Partial QPs at the APM Entity level.
    Comment: One commenter expressed concern that our proposal may 
create additional confusion for eligible clinicians. Specifically, the 
commenter noted that many eligible clinicians may not be aware that 
they attained Partial QP status, and that an affirmative election is 
required to participate in MIPS. The commenter also noted that such 
clinicians may assume that their MIPS data is being reported on their 
behalf by their practice or TIN, and as a result may inadvertently 
forego a potential positive MIPS payment adjustment.
    The commenter suggested an alternative approach where CMS would 
apply the policy which yields the most advantageous MIPS final score 
and subsequently the most advantageous MIPS payment adjustment. The 
commenter noted that this alternative approach would work in such a 
manner that in cases where data is submitted by a Partial QP, or on 
their behalf, that would earn the Partial QP a MIPS final score 
resulting in a positive MIPS payment adjustment, CMS would use that 
data to provide them a MIPS final score, regardless of whether they 
made an election to participate in MIPS. In cases where data is 
submitted by a Partial QP, or on their behalf, that would earn the 
Partial QP a MIPS final score resulting in a negative MIPS payment 
adjustment, CMS would not use that data to provide them a MIPS final 
score, and they would be exempt from MIPS based on the Partial QP 
status.
    The commenter noted this alternative approach would eliminate all 
potential unintended consequences and would be consistent with other 
CMS policies to use data that yields the most advantageous result. The 
commenter also noted the alternative approach may further incentivize 
participation in APMs and reduce burden on both eligible clinicians and 
CMS because eligible clinicians would no longer have to make an 
election to affirmatively opt-in or opt-out of MIPS.
    Response: We acknowledge that our proposal could, in certain 
limited instances, create additional confusion for eligible clinicians, 
particularly eligible clinicians who may not be aware that they 
attained Partial QP status and an affirmative election is required for 
them to participate in MIPS. However, we note that clinicians' QP 
status, including Partial QP status, is accessible via the QPP 
Participation Status Tool via the Quality Payment Program website at 
https://qpp.cms.gov/participation-lookup. We also continue to believe 
our proposed approach will allow for greater operational simplicity 
while minimizing the possibility of unexpected participation in MIPS. 
We reiterate that all Partial QPs retain the full right to 
affirmatively decide through the election process whether or not to be 
subject to the MIPS reporting requirements and payment adjustment.
    After considering public comments, we are finalizing our proposal 
that when an eligible clinician is determined to be a Partial QP for a 
year at the individual eligible clinician level, the individual 
eligible clinician will make an election whether to report to MIPS. If 
the eligible clinician elects to report to MIPS, they will be subject 
to the MIPS reporting requirements and payment adjustment. If the 
eligible clinician elects not to report, they will be excluded from the 
MIPS reporting requirements and payment adjustment. In the absence of 
an explicit election to report to MIPS, the eligible clinician will be 
excluded from the MIPS reporting requirements and payment adjustment. 
This means that no actions other than the eligible clinician's 
affirmative election to participate in MIPS would result in that 
eligible clinician becoming subject to the MIPS reporting requirements 
and payment adjustment.
(5) Summary of Final Policies
    In this section, we are finalizing the following policies:
QP Performance Period
     We are finalizing our proposal that for each of the three 
QP determinations, we will allow for claims run-out for 60 days 
(approximately 2 months), before calculating the Threshold Scores so 
that the three QP determinations can be completed approximately 3 
months after the end of that determination time period.
Partial QP Election To Report to MIPS
     We are finalizing our proposal that when an eligible 
clinician is determined to be a Partial QP for a year at the individual 
eligible clinician level, the individual eligible clinician will make 
an election whether to report to MIPS. If the eligible clinician elects 
to report to MIPS, they will be subject to the MIPS reporting 
requirements and payment adjustment. If the eligible clinician elects 
not to report, they will be excluded from the MIPS reporting 
requirements and payment adjustment. In the absence of an explicit 
election to report to MIPS, the eligible clinician will be excluded 
from the MIPS reporting requirements and payment adjustment. This means 
that no actions other than the eligible clinician's affirmative 
election to participate in MIPS would result in that eligible clinician 
becoming subject to the MIPS reporting requirements and payment 
adjustment.

[[Page 59926]]

e. All-Payer Combination Option
(1) Overview
    Section 1833(z)(2)(B)(ii) of the Act requires that beginning in 
payment year 2021, in addition to the Medicare Option, eligible 
clinicians may become QPs through the Combination All-Payer and 
Medicare Payment Threshold Option, which we refer to as the All-Payer 
Combination Option. In the CY 2017 Quality Payment Program final rule, 
we finalized our overall approach to the All-Payer Combination Option 
(81 FR 77459). The Medicare Option focuses on participation in Advanced 
APMs, and we make QP determinations under this option based on Medicare 
Part B covered professional services attributable to services furnished 
through an APM Entity. The All-Payer Combination Option does not 
replace or supersede the Medicare Option; instead, it will allow 
eligible clinicians to become QPs by meeting the QP thresholds through 
a pair of calculations that assess a combination of both Medicare Part 
B covered professional services furnished through Advanced APMs and 
services furnished through Other Payer Advanced APMs. We finalized that 
beginning in payment year 2021, we will conduct QP determinations 
sequentially so that the Medicare Option is applied before the All-
Payer Combination Option (81 FR 77438). The All-Payer Combination 
Option encourages eligible clinicians to participate in payment 
arrangements that satisfy the Other Payer Advanced APM criteria with 
payers other than Medicare. It also encourages sustained participation 
in Advanced APMs across multiple payers.
    We finalized that the QP determinations under the All-Payer 
Combination Option are based on payment amounts or patient counts as 
illustrated in Tables 36 and 37, and Figures 1 and 2 of the CY 2017 
Quality Payment Program final rule (81 FR 77460 through 77461). We also 
finalized that, in making QP determinations with respect to an eligible 
clinician, we will use the Threshold Score that is most advantageous to 
the eligible clinician toward achieving QP status, or if QP status is 
not achieved, Partial QP status, for the year (81 FR 77475).
BILLING CODE 4120-01-P
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[[Page 59927]]


[GRAPHIC] [TIFF OMITTED] TR23NO18.075

    Unlike the Medicare Option, where we have access to all of the 
information necessary to determine whether an APM meets the criteria to 
be an Advanced APM, we cannot determine whether an other payer 
arrangement meets the criteria to be an Other Payer Advanced APM 
without receiving information about the payment arrangement from an 
external source. Similarly, we do not have the necessary payment amount 
and patient count information to determine under the All-Payer 
Combination Option whether an eligible clinician meets the payment 
amount or patient count threshold to be a QP without receiving certain 
information from an external source.
    In the CY 2018 Quality Payment Program final rule, we established 
additional policies to implement the All-Payer Combination Option and 
finalized certain modifications to our previously finalized policies 
(82 FR 53844 through 53890). A detailed summary of those policies can 
be found at 82 FR 53874 through 53876 and 53890 through 53891. In 
relevant part, we finalized the following:
Payer Initiated Process
     We finalized at Sec.  414.1445(a) and (b)(1) that certain 
other payers, including payers with payment arrangements authorized 
under Title XIX (the Medicaid statute), Medicare Health Plan payment 
arrangements, and payers with payment arrangements aligned with a CMS 
Multi-Payer Model, can request that we determine whether their other 
payer arrangements are Other Payer Advanced APMs starting prior to the 
2019 QP Performance Period and each year thereafter. We finalized that 
Remaining Other Payers, including

[[Page 59928]]

commercial and other private payers, could request that we determine 
whether other payer arrangements are Other Payer Advanced APMs starting 
in 2019 prior to the 2020 QP Performance Period, and annually each year 
thereafter. We generally refer to this process as the Payer Initiated 
Other Payer Advanced APM Determination Process (Payer Initiated 
Process), and we finalized that the Payer Initiated Process would 
generally involve the same steps for each payer type for each QP 
Performance Period. If a payer uses the same other payer arrangement in 
other commercial lines of business, we finalized our proposal to allow 
the payer to concurrently request that we determine whether those other 
payer arrangements are Other Payer Advanced APMs as well. This policy 
is relevant only to the initial year of Payer Initiated Other Payer 
Advanced APM determinations for which these submissions can be made 
only by payers with arrangements under Title XIX, Medicare Health 
Plans, or arrangements aligned with CMS multi-payer models.
Eligible Clinician Initiated Process
     We finalized at Sec.  414.1445(a) and (b)(2) that, through 
the Eligible Clinician Initiated Process, APM Entities and eligible 
clinicians participating in other payer arrangements would have an 
opportunity to request that we determine for the year whether those 
other payer arrangements are Other Payer Advanced APMs. The Eligible 
Clinician Initiated Process can be used to submit requests for 
determinations before the beginning of a QP Performance Period for 
other payer arrangements authorized under Title XIX. The Eligible 
Clinician Initiated Process is available for the 2019 QP Performance 
Period and each year thereafter.
Submission of Information for Other Payer Advanced APM Determinations
     We finalized that, for each other payer arrangement for 
which a payer requests us to make an Other Payer Advanced APM 
determination, the payer must complete and submit the Payer Initiated 
Submission Form by the relevant Submission Deadline.
     We finalized that, for each other payer arrangement for 
which an APM Entity or eligible clinician requests us to make an Other 
Payer Advanced APM determination, the APM Entity or eligible clinician 
must complete and submit the Eligible Clinician Initiated Submission 
Form by the relevant Submission Deadline.
     We removed the requirement, previously established at 
Sec.  414.1445(b)(3), that payers must attest to the accuracy of 
information submitted by eligible clinicians, and we also removed the 
related attestation requirement at Sec.  414.1460(c). Instead, we 
finalized an additional requirement at Sec.  414.1445(d) that an APM 
Entity or eligible clinician that submits information under Sec.  
414.1445(c) must certify that, to the best of its knowledge, the 
information it submits to us is true, accurate, and complete.
QP Determinations Under the All-Payer Combination Option
     We finalized at Sec.  414.1440(e) that eligible clinicians 
may request that we make QP determinations at the individual eligible 
clinician level and that APM Entities may request that we make QP 
determinations at the APM Entity level.
     We finalized at Sec.  414.1440(d)(1) that we will make QP 
determinations under the All-Payer Combination Option based on eligible 
clinicians' participation in Advanced APMs and Other Payer Advanced 
APMs for three time periods of the QP Performance Period: January 1 
through March 31; January 1 through June 30; and January 1 through 
August 31. We finalized that we will use patient or payment data for 
the same time periods to calculate both the Medicare and the other 
payer portion of the Threshold Score calculation under the All-Payer 
Cominbation Option.
     We finalized at Sec.  414.1440(e)(4) that, to request a QP 
determination under the All-Payer Combination Option, APM Entities or 
eligible clinicians must submit all of the payment amount and patient 
count information sufficient for us to make QP determinations by 
December 1 of the calendar year that is 2 years to prior to the payment 
year, which we refer to as the QP Determination Submission Deadline.
    In this section of the final rule, we address policies within the 
following topics: Other Payer Advanced APM Criteria; Other Payer 
Advanced APM determinations; and Calculation of the All-Payer 
Combination Option Threshold Scores and QP Determinations.
(2) Summary of Proposals
    In the CY 2019 PFS proposed rule (83 FR 35999-36006), we included 
the following proposals, each of which is discussed below:
Other Payer Advanced APM Criteria
     We proposed to change the CEHRT use criterion so that in 
order to qualify as an Other Payer Advanced APM as of January 1, 2020, 
the other payer arrangement must require at least 75 percent of 
participating eligible clinicians in each APM Entity use CEHRT.
     We proposed to allow payers and eligible clinicians to 
submit evidence as part of their request for an Other Payer Advanced 
APM determination that CEHRT is used by the requisite percentage of 
eligible clinicians participating in the payment arrangement (50 
percent for 2019, and 75 percent for 2020 and beyond) to document and 
communicate clinical care, whether or not CEHRT use is explicitly 
required under the terms of the payment arrangement.
     We proposed the following clarification to Sec.  
414.1420(c)(2), effective January 1, 2020, to provide that at least one 
of the quality measures used in the payment arrangement in paragraph 
(c)(1) of this regulation must be:
    ++ Finalized on the MIPS final list of measures, as described in 
Sec.  414.1330;
    ++ Endorsed by a consensus-based entity; or
    ++ Determined by CMS to be evidenced-based, reliable, and valid.
     We proposed to revise Sec.  414.1420(c)(3) to require 
that, effective January 1, 2020, unless there is no applicable outcome 
measure on the MIPS quality measure list, an Other Payer Advanced APM 
must use an outcome measure, that must be:
    ++ Finalized on the MIPS final list of measures, as described in 
Sec.  414.1330;
    ++ Endorsed by a consensus-based entity; or
    ++ Determined by CMS to be evidenced-based, reliable, and valid.
     We also proposed to revise our regulation at Sec.  
414.1420(c)(3)(i) to provide that, for payment arrangements determined 
to be Other Payer Advanced APMs for the 2019 performance year that did 
not include an outcome measure that is evidence-based, reliable, and 
valid, and that are resubmitted for an Other Payer Advanced APM 
determination for the 2020 performance year (whether for a single year, 
or for a multi-year determination as proposed in section 
III.I.4.e.(4)(b) of this final rule), we would continue to apply the 
current regulation for purposes of those determinations. This proposed 
revision also applies to payment arrangements in existence prior to the 
2020 performance year that are submitted for determination to be Other 
Payer Advanced APMs for the 2020 performance year and later.

[[Page 59929]]

Determination of Other Payer Advanced APMs
     We proposed details regarding the Payer Initiated Process 
for Remaining Other Payers. To the extent possible, we aligned the 
Payer Initiated Process for Remaining Other Payers with the previously 
finalized Payer Initiated Process for Medicaid, Medicare Health Plans, 
and CMS Multi-Payer Models.
     We proposed to eliminate the Payer Initiated Process that 
is specifically for CMS Multi-Payer Models. We believe that payers 
aligned with CMS Multi-Payer Models can submit their arrangements 
through the Payer Initiated Process for Remaining Other Payers proposed 
in section III.I.4.e.(4)(c) of this final rule, or through the Medicaid 
or Medicare Health Plan payment arrangement submission processes.
Calculation of All-Payer Combination Option Threshold Scores and QP 
Determinations
     We proposed to add a third alternative to allow requests 
for QP determinations at the TIN level in instances where all 
clinicians who reassigned billing rights under the TIN participate in a 
single APM Entity. We proposed to modify our regulation at Sec.  
414.1440(d) by adding this third alternative to allow QP determinations 
at the TIN level in instances where all clinicians who have reassigned 
billing under the TIN participate in a single APM Entity, as well as to 
assess QP status at the most advantageous level for each eligible 
clinician.
     We also clarified that, in making QP determinations using 
the All-Payer Combination Option, eligible clinicians may meet the 
minimum Medicare threshold using one method, and the All-Payer 
threshold using the same or a different method. We proposed to codify 
this clarification by adding Sec.  414.1440(d)(4).
     We proposed to extend the weighting methodology that is 
used to ensure that an eligible clinician does not receive a lower 
score on the Medicare portion of their all-payer calculation under the 
All-Payer Combination Option than the Medicare Threshold Score they 
received at the APM Entity level in order to apply a similar policy to 
the proposed TIN level Medicare Threshold Scores.
(3) Other Payer Advanced APM Criteria
(a) Overview
    In general, our goal is to align the Advanced APM criteria under 
the Medicare Option and the Other Payer Advanced APM criteria under the 
All-Payer Combination Option as permitted by statute and as feasible 
and appropriate. We believe this alignment helps simplify the Quality 
Payment Program and encourage participation in Other Payer Advanced 
APMs (82 FR 53847).
(b) Investment Payments
    Some stakeholders have requested that we take into account 
``business risk'' costs such as IT, personnel, and other administrative 
costs associated with APM Entities' participation in Other Payer 
Advanced APMs when implementing the financial risk standard. We did not 
propose to modify our financial risk standard in response to this 
suggestion, and note that financial risk in the context of Other Payer 
Advanced APMs is defined both in the Act (at section 
1833(z)(2)(B)(iii)(II)(cc) for payment years 2021 and 2022, and section 
1833(z)(3)(B)(iii)(II)(cc) for subsequent years) and our regulations at 
Sec.  414.1420(d) so as to require that APM Entities in the payment 
arrangement must assume financial risk when actual expenditures exceed 
expected expenditures. However, we note that a payment arrangement with 
an other payer, like some APMs, can be structured so that the APM 
provides an investment payment to the participating APM Entities to 
assist with the practice transformation that may be required for 
participation in the payment arrangement. This investment payment could 
be structured in various ways; for example, it could be structured 
similarly to the Medicare ACO Investment Model under, which expected 
shared savings payment were pre-paid to encourage new ACOs to form in 
rural and underserved areas and to assist existing ACOs in meeting 
certain criteria; or it could be structured so that the payment is made 
specifically to encourage participating APM Entities to continue to 
make staffing, infrastructure, and operations investments as a means of 
practice transformation; or it could have a different structure 
entirely.
    Although CMS did not solicit comments regarding our statement on 
investment payments, the following is a summary of the public comments 
we received:
    Comment: Many commenters expressed concern that CMS will continue 
the current policy that does not include investment payments in the 
definition and calculation of risk. The commenters stated that this 
approach fails to recognize the significant investment that APM 
Entities and eligible clinicians make in start-up and overhead costs in 
the development and operations of APMs. Some commenters suggested that 
CMS should develop a method to capture and quantify such risk.
    Response: We reiterate that our policy has not changed. As we 
discussed in the CY 2017 Quality Payment Program final rule, we 
continue to believe that there would be significant complexity involved 
in creating an objective and enforceable standard for determining 
whether an entity's investment risk or business risk exceeds a nominal 
amount (81 FR 77420). Therefore, we maintain our view that investment 
risk or business risk is not analogous to performance risk in the APM 
context because the costs of those activities and investments are not 
incorporated into the performance-based financial calculations of an 
APM, and therefore, are not appropriate for consideration for purposes 
of the Advanced APM financial risk criterion (81 FR 77420). Other Payer 
Advanced APMs, like Advanced APMs, can be designed so that they include 
investment payments for participants, but those investment payments 
will not be considered financial risk when assessing whether a payment 
arrangement meets the Other Payer Advanced APM financial risk 
criterion.
(c) Use of CEHRT
(i) Overview
    In the CY 2017 Quality Payment Program final rule, we finalized 
that to be an Other Payer Advanced APM, the other payer arrangement 
must require at least 50 percent of participating eligible clinicians 
in each APM Entity, or each hospital if hospitals are the APM Entities, 
to use CEHRT to document and communicate clinical care (81 FR 77465). 
This CEHRT use criterion directly paralleled the criterion established 
for Advanced APMs in Sec.  414.1415(a)(1)(i).
    In the CY 2018 Quality Payment Program final rule, we finalized 
that we would presume that an other payer arrangement meets the 50 
percent CEHRT use criterion if we receive information and documentation 
from the eligible clinician through the Eligible Clinician Initiated 
Process showing that the other payer arrangement requires the 
requesting eligible clinician to use CEHRT to document and communicate 
clinical care (see Sec.  414.1445(c)(2)).
(ii) Increasing the CEHRT Use Criterion for Other Payer Advanced APMs
    We proposed to change the current CEHRT use criterion for Other 
Payer

[[Page 59930]]

Advanced APMs so that in order to qualify as an Other Payer Advanced 
APM as of January 1, 2020, the other payer arrangement must require at 
least 75 percent of participating eligible clinicians in each APM 
Entity to use CEHRT; this aligns with our proposals for the CEHRT use 
criterion for Advanced APMs.
    According to data collected by ONC, since the CY 2017 Quality 
Payment Program final rule was published, EHR adoption has been 
widespread, and we want to encourage continued adoption. Additionally, 
in response to the CY 2017 Quality Payment Program proposed rule 
stakeholders encouraged us to raise the CEHRT use criterion to 75 
percent (see 81 FR 77411). We believe that this proposed change aligns 
with the increased adoption of CEHRT among providers and suppliers that 
is already happening, and will encourage further CEHRT adoption. (83 FR 
35990).
    We solicited comment on this proposal.
    The following is a summary of the public comments received in 
response to our request for comment and our responses:
    Comment: A few commenters supported increasing the CEHRT use 
criterion as of January 1, 2020, to 75 percent of participating 
eligible clinicians in each APM Entity.
    Response: We appreciate the support for our proposal to change the 
Other Payer Advanced APM CEHRT use criterion to 75 percent.
    Comment: Many commenters expressed concern with the proposed change 
to the current CEHRT use criterion stating that raising it to 75 
percent of participating eligible clinicians in each APM Entity may be 
too burdensome. A few commenters noted that the CEHRT use criterion 
should not be increased by any amount. One commenter stated that the 
CEHRT use criterion should remain at 50 percent and allow APM entities 
to attest that APM participants are using health IT. Some commenters 
stated the increase is premature as the All-Payer Combination Option is 
beginning in 2019. Some commenters suggested that the increase in the 
threshold should occur over a longer period of time to accommodate 
multi-year cycles of APM contracts.
    Response: We do not believe that such an increase in the Other 
Payer Advanced APM minimum CEHRT use threshold will be burdensome for 
APM participants. According to data collected by ONC, certified EHR 
adoption has been widespread with over 3 in 4 office-based physicians 
adopted a certified EHR in CY 2015, and we want to continue to 
encourage such adoption and use of CEHRT. Further, regarding the 
comments that the increase in the threshold should occur over a longer 
period of time to accommodate multi-year cycles of APM contracts, we 
remind the commenters that, although we proposed the same increase in 
the Advanced APM minimum CEHRT use threshold beginning January 1, 2019, 
the proposed increase for Other Payer Advanced APMs would not apply 
until January 1, 2020. We believe this is a sufficient amount of lead 
time, especially given the widespread adoption of EHRs.
    After considering public comments, we are finalizing our proposal 
to change the current CEHRT use criterion for Other Payer Advanced APMs 
so that in order to qualify as an Other Payer Advanced APM as of 
January 1, 2020, the other payer arrangement must require at least 75 
percent of participating eligible clinicians in each APM Entity to use 
CEHRT.
(iii) Evidence of CEHRT Use
    In the CY 2017 Quality Payment Program final rule, we adopted a 
CEHRT use criterion for Other Payer Advanced APMs that directly 
paralleled the CEHRT use criterion for Advanced APMs wherein Other 
Payer Advanced APMs must require at least 50 percent of eligible 
clinicians in each participating APM Entity, or each hospital if 
hospitals are the APM Entities, to use CEHRT to document and 
communicate clinical care.
    We have since heard from payers and other stakeholders that CEHRT 
is often used under other payer arrangements even if it is not 
expressly required under the payment arrangement. Because CEHRT use is 
increasingly common among eligible clinicians, payers may not believe 
it is necessary to specifically require the use of CEHRT under the 
terms of an Other Payer payment arrangement.
    Given this, we believe our current policy may needlessly exclude 
certain existing payment arrangements that could meet the statutory 
requirements for Other Payer Advanced APMs--including some where the 
majority of eligible clinicians use CEHRT, even if they are not 
explicitly required to do so under the terms of their payment 
arrangements.
    We proposed that a payer or eligible clinician must provide 
documentation to CMS that CEHRT is used to document and communicate 
clinical care under the payment arrangement by at least 50 percent of 
eligible clinicians in 2019, and 75 percent of the eligible clinicians 
in 2020 and beyond, whether or not such CEHRT use is explicitly 
required under the terms of the payment arrangement. We specifically 
proposed to modify the regulation at Sec.  414.1420(b) to specify that 
to be an Other Payer Advanced APM, CEHRT must be used by at least 50 
percent of eligible clinicians participating in the arrangement in 2019 
(or, beginning in 2020, 75 percent) of such eligible clinicians).
    We solicited comment on this proposal.
    The following is a summary of the public comments received in 
response to our request for comment and our responses:
    Comment: Many commenters expressed support for CMS' proposal that a 
payer or eligible clinician must provide documentation to CMS that 
CEHRT is used by at least 50 percent of eligible clinicians in 2019, 
and 75 percent of eligible clinicians in 2020 and beyond, whether or 
not such CEHRT use is explicitly required under the terms of the 
payment arrangement.
    Response: We appreciate the support for our proposal to allow for 
documentation that CEHRT is used at required levels by eligible 
clinicians.
    After considering public comments, we are finalizing our proposal 
that a payer or eligible clinician must provide documentation to CMS 
that CEHRT is used to document and communicate clinical care under the 
payment arrangement by at least 50 percent of eligible clinicians in 
2019, and 75 percent of the eligible clinicians in 2020 and beyond, 
whether or not such CEHRT use is explicitly required under the terms of 
the payment arrangement. Specifically, we are finalizing our proposal 
to modify the regulation at Sec.  414.1420(b) to specify that to be an 
Other Payer Advanced APM, CEHRT must be used by at least 50 percent of 
eligible clinicians participating in the arrangement in 2019 (or, 
beginning in 2020, 75 percent) of such eligible clinicians.
(d) MIPS Comparable Quality Measures
(i) Overview
    In the CY 2017 Quality Payment Program final rule, we explained 
that one of the criteria for a payment arrangement to be an Other Payer 
Advanced APM is that it must apply quality measures comparable to those 
under the MIPS quality performance category (81 FR 77465).
    In the CY 2017 Quality Payment Program proposed rule, we proposed 
that to be an Other Payer Advanced APM, a payment arrangement must have 
quality measures that are evidence-

[[Page 59931]]

based, reliable, and valid; and that at least one measure must be an 
outcome measure if there is an applicable outcome measure on the MIPS 
quality measure list. We generally refer to these measures in the 
remainder of this discussion as ``MIPS-comparable quality measures.'' 
We did not specify in our regulation that the outcome measure is 
required to be evidence-based, reliable, and valid (81 FR 77466). We 
finalized these policies in the CY 2017 Quality Payment Program final 
rule and codified them in the regulation at Sec.  414.1420(c).
(ii) General Quality Measures: Evidence-Based, Reliable, and Valid
    In the CY 2017 Quality Payment Program final rule, we codified at 
Sec.  414.1420(c)(2) that at least one of the quality measures used in 
the payment arrangement with an APM Entity must have an evidence-based 
focus, be reliable, and valid, and meet at least one of the following 
criteria:
     Used in the MIPS quality performance category as described 
in Sec.  414.1330;
     Endorsed by a consensus-based entity;
     Developed under section 1848(s) of the Act;
     Submitted in response to the MIPS Call for Quality 
Measures under section 1848(q)(2)(D)(ii) of the Act; or
     Any other quality measures that CMS determines to have an 
evidence-based focus and to be reliable and valid.
    It has come to our attention that, as with the comparable policy 
for Advanced APMs as discussed at 81 FR 28302, some have read the 
regulation at Sec.  414.1420(c)(2) to mean that measures on the MIPS 
final list or submitted in response to the MIPS Call for Quality 
Measures necessarily are MIPS-comparable quality measures, even if they 
have not been determined to be evidence-based, reliable, and valid. We 
did not intend to imply that any measure that was merely submitted in 
response to the annual call for quality measures or developed using 
Quality Payment Program funding would automatically qualify as MIPS-
comparable regardless of whether the measure was endorsed by a 
consensus-based entity, adopted under MIPS, or otherwise determined to 
be evidence-based, reliable, and valid. While we believe such measures 
may be evidence-based, reliable, and valid, we did not intend to 
consider them so for purposes of Sec.  414.1420(c)(2) without 
independent verification by a consensus-based entity or based on our 
own assessment and determination that they are evidence-based, 
reliable, and valid. We further believe the same principle applies to 
QCDR measures. If QCDR measures are endorsed by a consensus-based 
entity they are presumptively considered MIPS-comparable quality 
measures for purposes of Sec.  414.1420(c)(2); otherwise we would have 
needed independent verification, or to make our own assessment and 
determination, that the measures are evidence-based, reliable, and 
valid before considering them to be MIPS-comparable (see 81 FR 77415 
through 77417).
    Because of the potential ambiguity in the existing definition and 
out of an abundance of caution in order to avoid any adverse impact on 
APM entities, eligible clinicians or other stakeholders, we have used 
the more permissive interpretation of the text, wherein measures 
developed under section 1848(s) of the Act and submitted in response to 
the MIPS Call for Quality Measures will meet the quality criterion in 
implementing the program thus far, and intend to use this 
interpretation for the 2019 QP Performance Period. Recognizing that 
APMs and other payer arrangements that we might consider for Advanced 
APM and Other Payer Advanced APM determinations are well into 
development for 2019, we proposed to use this interpretation until our 
new proposal described below is effective on January 1, 2020.
    Therefore, at Sec.  414.1420(c)(2), we proposed, effective January 
1, 2020, that at least one of the quality measures used in the payment 
arrangement with an APM Entity must meet at least one of the following 
criteria:
     Finalized on the MIPS final list of measures, as described 
in Sec.  414.1330;
     Endorsed by a consensus-based entity; or
     Otherwise determined by CMS to be evidenced-based, 
reliable, and valid.
    That is, for QP Performance Period 2020 and all future QP 
Performance Periods, we would treat any measure that is either included 
in the MIPS final list of measures or has been endorsed by a consensus-
based entity as presumptively evidence-based, reliable, and valid. All 
other measures would need to be independently determined by CMS to be 
evidence-based, reliable, and valid, in order to be considered MIPS-
comparable quality measures.
    We solicited comment on this proposal.
    The following is a summary of the public comments received in 
response to our request for comment and our responses:
    Comment: A few commenters supported the proposal that at least one 
of the quality measures used in the payment arrangement with and APM 
Entity must meet at least one of the three proposed criteria to assure 
that it is evidence-based, reliable, and valid.
    Response: We appreciate the support for our proposal.
    Comment: One commenter urged CMS to include a fourth way to 
determine a quality measure is ``MIPS-like'' by clarifying that all 
Medicare Advantage Star Rating measures are determined to be evidence-
based, reliable, and valid by CMS. The commenter stated that these 
metrics were determined by CMS to be valid and reliable enough to use 
as a basis of MA plan payment.
    Response: We believe that all active Medicare Advantage Star Rating 
quality measures (https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/PerformanceData.html) are evidenced-
based, reliable, and valid when used at the health plan level. However, 
if a payer has changed the unit of analysis from applying it at the 
health plan level to using it at the provider level, as would likely be 
necessary in this context, this may have affected the reliability and 
validity of the measure. As such, we believe it is important that all 
such measures be independently determined by CMS to be evidenced-based, 
reliable, and valid in the context of their use in the payment 
arrangement in order to satisfy the Other Payer Advanced APM criterion. 
We would note that this determination that a quality measure is MIPS-
comparable would be made using the information collected by CMS as part 
of the data submission process for Other Payer Advanced APM 
determinations.
    After considering public comments, we are finalizing our proposal 
to revise Sec.  414.1420(c)(2) to clarify, effective as of January 1, 
2020, that at least one of the quality measures used in the payment 
arrangement with an APM Entity must either be finalized on the MIPS 
final list of measures, as described in Sec.  414.1330; endorsed by a 
consensus-based entity; or determined by CMS to be evidenced-based, 
reliable, and valid.
(iii) Outcome Measures: Evidence-Based, Reliable, and Valid
    In Sec.  414.1420(c)(3), we generally require that, to be an Other 
Payer Advanced APM, the payment arrangement must use an outcome measure 
if there is an applicable outcome measure on the MIPS quality measure 
list. We note that the current regulation does not require that the 
outcome measure be evidence-based, reliable, and valid.
    We proposed to revise Sec.  414.1420(c)(3), to explicitly require 
that, unless there is no applicable

[[Page 59932]]

outcome measure on the MIPS quality measure list, at least one outcome 
measure that is used in the payment arrangement must be evidence-based, 
reliable, and valid. This proposal would have an effective date of 
January 1, 2020, and would specifically require that an outcome measure 
must also be MIPS-comparable. This proposal aligns with the similar 
proposal for Advanced APMs discussed at section III.I.4.e.(3)(d)(ii) of 
this final rule, so that an outcome measure used in the payment 
arrangement must also be:
     Finalized on the MIPS final list of measures, as described 
in Sec.  414.1330;
     Endorsed by a consensus-based entity; or
     Determined by CMS to be evidence-based, reliable, and 
valid.
    The proposal would have an effective date of January 1, 2020. This 
proposed effective date is intended to provide stakeholders sufficient 
notice of, and opportunity to respond to, this change in our regulation 
because the current regulation does not explicitly require that an 
outcomes measures must be evidence-based, reliable, and valid and, as a 
result some Other Payer Advanced APMs that were submitted for 
determination in CY 2018 for the CY 2019 performance year may not 
include outcomes measures that are evidence-based, reliable, and valid.
    We also proposed that, for such payment arrangements that are 
determined to be Other Payer Advanced APMs for the 2019 performance 
year and did not include an outcome measure that is evidence-based, 
reliable, and valid, and that are resubmitted for an Other Payer 
Advanced APM determination for the 2020 performance year (whether for a 
single year, or for a multi-year determination as proposed in section 
III.I.4.e.(4)(b) of this final rule), we will continue to apply the 
current regulation for purposes of those determinations. Additionally, 
payment arrangements in existence prior to the 2020 performance year 
that are submitted for determination to be Other Payer Advanced APMs 
for the 2020 performance year and later, will be assessed under the 
rules of the current regulation meaning they do not need to include an 
outcome measure that is evidence-based, reliable, and valid to be an 
Other Payer Advanced APM. For all other payment arrangements the 
proposed revised regulation would apply beginning in CY 2020.
    We solicited comment on this proposal.
    The following is a summary of the public comments received in 
response to our request for comment and our responses:
    Comment: One commenter supported the proposal that at least one 
outcome measure must be among the quality measures used in the payment 
arrangement with an APM Entity, and that the outcome measure must meet 
at least one of the three proposed criteria to assure that it is 
evidence-based, reliable, and valid.
    Response: We appreciate the support for our proposal.
    After considering public comments, we are finalizing our proposal 
to revise Sec.  414.1420(c)(3), effective January 1, 2020, to 
explicitly require that, unless there is no applicable outcome measure 
on the MIPS quality measure list, at least one outcome measure that 
applies in the payment arrangement must either be finalized on the MIPS 
final list of measures as described in Sec.  414.1330, endorsed by a 
consensus-based entity, or determined by CMS to be evidence-based, 
reliable, and valid.
(e) Financial Risk for Monetary Losses
(i) Overview
    In the CY 2018 Quality Payment Program final rule, we finalized our 
proposal to add a revenue-based nominal amount standard to the 
generally applicable nominal amount standard for Other Payer Advanced 
APMs that is parallel to the generally applicable revenue-based nominal 
amount standard for Advanced APMs. Specifically, we finalized that an 
other payer arrangement would meet the total risk component of the 
proposed nominal risk standard if, under the terms of the other payer 
arrangement, the total amount that an APM Entity potentially owes the 
payer or foregoes is equal to at least: For the 2019 and 2020 QP 
Performance Periods, 8 percent of the total combined revenues from the 
payer of providers and suppliers in participating APM Entities. This 
standard is in addition to the previously finalized expenditure-based 
standard. We explained that a payment arrangement would only need to 
meet one of the two standards. We would use this standard only for 
other payer arrangements where financial risk is expressly defined in 
terms of revenue in the payment arrangement.
(ii) Generally Applicable Nominal Amount Standard
    We proposed to amend Sec.  414.1420(d)(3)(i) to maintain the 
generally applicable revenue-based nominal amount standard at 8 percent 
of the total combined revenues from the payer of providers and 
suppliers in participating APM Entities for QP Performance Periods 2019 
through 2024. This change is consistent with the proposed amendment to 
our regulation to maintain the generally applicable revenue-based 
nominal standard at 8 percent for Advanced APMs during the same 
timeframe.
    We solicited comment on this proposal.
    The following is a summary of the public comments received in 
response to our request for comment and our responses:
    Comment: Commenters expressed support for the proposal to maintain 
the general applicable revenue-based nominal amount standard at 8 
percent for QP Performance Periods 2021 through 2024.
    Response: We appreciate the support for our proposal to maintain 
the generally applicable revenue-based nominal amount standard.
    After considering public comments, we are finalizing our proposal 
to revise Sec.  414.1420(d)(3)(i) to maintain the generally applicable 
revenue-based nominal amount standard at 8 percent of the total 
combined revenues from the payer of providers and suppliers in 
participating APM Entities for QP Performance Periods 2021 through 
2024.
(4) Determination of Other Payer Advanced APMs
(a) Overview
    In the CY 2017 Quality Payment Program final rule, we specified 
that an APM Entity or eligible clinician must submit, by a date and in 
a manner determined by us, information necessary to identify whether a 
given payment arrangement satisfies the Other Payer Advanced APM 
criteria (81 FR 77480).
    In the CY 2018 Quality Payment Program final rule, we codified at 
Sec.  414.1445 the Payer Initiated Other Payer Advanced APM 
Determination Process and the Eligible Clinician Initiated Other Payer 
Advanced APM Determination Process pertaining to the determination of 
Other Payer Advanced APMs, as well as specifying the information 
required for Other Payer Advanced APM determinations (82 FR 53814 
through 53873).
(b) Multi-Year Other Payer Advanced APM Determinations
    In the CY 2018 Quality Payment Program final rule, we finalized 
that Other Payer Advanced APM determinations made in response to 
requests submitted either through the Payer Initiated Other Payer 
Advanced APM Determination Process (Payer Initiated Process) or the 
Eligible Clinician Initiated Other Payer

[[Page 59933]]

Advanced APM Determination Process (Eligible Clinician Initiated 
Process) would be in effect for only one year at a time. We sought 
additional comment regarding the current duration of payment 
arrangements and whether creating a multi-year determination process 
would encourage the creation of more multi-year payment arrangements as 
opposed to payment arrangements that are for one year only. We also 
sought comment on what kind of information should be submitted annually 
after the first year to update an Other Payer Advanced APM 
determination (82 FR 53869 through 53870).
    After consideration of this feedback, we proposed to maintain the 
annual submission process with the modifications outlined below for 
both the Payer Initiated Process and the Eligible Clinician Initiated 
Process. We proposed that beginning with the 2019 and 2020 submission 
periods for Other Payer Advanced APM determinations for performance 
year 2020, after the first year that a payer, APM Entity, or eligible 
clinician (which we refer to as the ``requester'' in the remainder of 
this discussion) submits a multi-year payment arrangement that we 
determine to be an Other Payer Advanced APM for that year, the 
requester would need to submit information only on changes to the 
payment arrangement that are relevant to the Other Payer Advanced APM 
criteria for each successive year for the remaining duration of the 
payment arrangement. In the initial submission, the requester would 
certify as usual that the information provided about the payment 
arrangement using the Payer Initiated Process or Eligible Clinician 
Initiated Process, as applicable, is true, accurate, and complete; 
would authorize CMS to verify the information; and would certify that 
they would submit revised information in the event of a material change 
to the payment arrangement. For multi-year payment arrangements, we 
proposed to require as part of the submission that the certifying 
official for the requester must agree to review the submission at least 
once annually, to assess whether there have been any changes to the 
information since it was submitted, and to submit updated information 
notifying us of any changes to the payment arrangement that would be 
relevant to the Other Payer Advanced APM criteria, and thus, to our 
determination of the arrangement to be an Other Payer Advanced APM, for 
each successive year of the arrangement. Absent the submission by the 
requester of updated information to reflect changes to the payment 
arrangement, we would continue to apply the original Other Payer 
Advanced APM determination for each successive year through the earlier 
of the end of that multi-year payment arrangement or 5 years.
    We solicited comment on this proposal.
    The following is a summary of the public comments received in 
response to our request for comment and our responses:
    Comment: Many commenters supported the proposal that the requester 
would need to submit information only on any changes to the payment 
arrangement that are relevant to the Other Payer Advanced APM criteria 
for each successive year for the remaining duration of the payment 
arrangement.
    Response: We appreciate the support for our proposal to allow for 
multi-year submissions of payment arrangements.
    After considering public comments, we are finalizing our proposal 
to maintain the annual submission process with the modifications 
outlined above for both the Payer Initiated Process and the Eligible 
Clinician Initiated Process.
    For multi-year payment arrangements, we proposed to require as part 
of the submission that the certifying official for the requester must 
agree to review the submission at least once annually, to assess 
whether there have been any changes to the information since it was 
submitted, and to submit updated information notifying us of any 
changes to the payment arrangement that would be relevant to the Other 
Payer Advanced APM criteria, and thus, to our determination of the 
arrangement to be an Other Payer Advanced APM, for each successive year 
of the arrangement. Absent the submission by the requester of updated 
information to reflect changes to the payment arrangement, we would 
continue to apply the original Other Payer Advanced APM determination 
for each successive year through the earlier of the end of that multi-
year payment arrangement or 5 years.
    We solicited comment on this proposal.
    The following is a summary of the public comments received in 
response to our request for comment and our responses:
    Comment: Many commenters supported our proposal to require as part 
of the submission that the certifying official for the requester must 
agree to review the submission at least once annually, to assess 
whether there have been any changes to the information since it was 
submitted, and to submit updated information notifying us of any 
changes to the payment arrangement that would be relevant to the Other 
Payer Advanced APM criteria, and thus, to our determination of the 
arrangement to be an Other Payer Advanced APM, for each successive year 
of the arrangement. Commenters supported the proposal that this process 
remain in place through the earlier of the end of the multi-payment 
arrangement or 5 years.
    Response: We appreciate the support for our proposal.
    After considering public comments, we are finalizing our proposal 
to require as part of the submission that the certifying official for 
the requester must agree to review the submission at least once 
annually, to assess whether there have been any changes to the 
information since it was submitted, and to submit updated information 
notifying us of any changes to the payment arrangement that would be 
relevant to the Other Payer Advanced APM criteria, and thus, to our 
determination of the arrangement to be an Other Payer Advanced APM, for 
each successive year of the arrangement. Absent the submission by the 
requester of updated information to reflect changes to the payment 
arrangement, we will continue to apply the original Other Payer 
Advanced APM determination for each successive year through the earlier 
of the end of that multi-year payment arrangement or 5 years.
(c) Payer Initiated Other Payer Advanced APM Determination Process 
(Payer Initiated Process)--Remaining Other Payers
    In the CY 2018 Quality Payment Program final rule, we finalized 
that we will allow certain other payers, including payers with payment 
arrangements authorized under Title XIX, Medicare Health Plan payment 
arrangements (Medicare Advantage plans, section 1876 cost plans PACE 
organization operated under section 1894 of the Act, and similar plans, 
other than an APM under section 1833(z)(3)(C) of the Act, that provide 
Medicare benefits under demonstration or waiver authority), and payers 
with payment arrangements aligned with a CMS Multi-Payer Model to use 
the Payer Initiated Process to request that we determine whether their 
other payer arrangements are Other Payer Advanced APMs starting prior 
to the 2019 QP Performance Period and each year thereafter (82 FR 
53854). We codified this policy at Sec.  414.1445(b)(1).
    We also finalized that the Remaining Other Payers, including 
commercial and other private payers, may request that

[[Page 59934]]

we determine whether other payer arrangements are Other Payer Advanced 
APMs starting prior to the 2020 QP Performance Period and each year 
thereafter (82 FR 53867).
    In the CY 2019 PFS proposed rule, we proposed details regarding the 
Payer Initiated Process for the Remaining Other Payers that were not 
among those other payers permitted to use the Payer Initiated Process 
to submit their arrangements for Other Payer Advanced APM 
Determinations in 2018 (Remaining Other Payers). To the extent 
possible, we are aligning the Payer Initiated Process for Remaining 
Other Payers with the previously finalized Payer Initiated Process for 
Medicaid, Medicare Health Plans, and CMS Multi-Payer Models.
    In the CY 2018 Quality Payment Program final rule, we finalized 
that the Payer Initiated Process will be voluntary for all payers (82 
FR 53855). We note that the Payer Initiated Process will be similarly 
voluntary for payers that were permitted to submit payment arrangements 
in 2018 and for Remaining Other Payers starting in 2019.
    Guidance and Submission Form: As we have for the other payers 
included in the Payer Initiated Process (82 FR 53874), we intend to 
make guidance available regarding the Payer Initiated Process for 
Remaining Other Payers prior to their first Submission Period, which 
will occur during 2019. We intend to modify the submission form (which 
we refer to as the Payer Initiated Submission Form) for use by 
Remaining Other Payers to request Other Payer Advanced APM 
determinations, and to make this Payer Initiated Submission Form 
available to Remaining Other Payers prior to the first Submission 
Period. We proposed that a Remaining Other Payer will be required to 
use the Payer Initiated Submission Form to request that we make an 
Other Payer Advanced APM determination. We intend for the Payer 
Initiated Submission Form to include questions that are applicable to 
all payment arrangements and some questions that are specific to a 
particular type of payment arrangement, and we intend for it to include 
a way for payers to attach supporting documentation.
    We solicited comment on this proposal.
    The following is a summary of the public comments received in 
response to our request for comment and our responses:
    Comment: Commenters supported the proposal to require Remaining 
Other Payers to use the Payer Initiated Submission Form to request that 
CMS make an Other Payer Advanced APM determination.
    Response: We appreciate the support for our proposal.
    After considering public comments, we are finalizing our proposal 
that Remaining Other Payers will use the Payer Initiated Submission 
Form to request that CMS make an Other Payer Advanced APM 
determination.
    We proposed that Remaining Other Payers may submit requests for 
review of multiple other payer arrangements through the Payer Initiated 
Process, though we would make separate determinations as to each other 
payer arrangement and a payer would be required to use a separate Payer 
Initiated Submission Form for each other payer arrangement. Remaining 
Other Payers may submit other payer arrangements with different tracks 
within that arrangement as one request along with information specific 
to each track.
    We solicited comment on this proposal.
    We did not receive any comment in response to this proposal.
    We are finalizing our proposal that Remaining Other Payers may 
submit requests for review of multiple other payer arrangements through 
the Payer Initiated Process, though we would make separate 
determinations as to each other payer arrangement and a payer would be 
required to use a separate Payer Initiated Submission Form for each 
other payer arrangement.
    Submission Period: We proposed that the Submission Period for the 
Payer Initiated Process for use by Remaining Other Payers to request 
Other Payer Advanced APM determinations will open on January 1 of the 
calendar year prior to the relevant QP Performance Period for which we 
would make Other Payer Advanced APM determinations.
    We solicited comment on this proposal.
    The following is a summary of the public comments received in 
response to our request for comment and our responses:
    Comment: One commenter supported the CMS proposal that the Payer 
Initiated Process for use by Remaining Other Payers to request Other 
Payer Advanced APM determinations would open on January 1.
    Response: We appreciate the support for our proposal.
    After considering public comments, we are finalizing our proposal 
that the Payer Initiated Process for use by Remaining Other Payers to 
request Other Payer Advanced APM determinations would open on January 
1.
    The finalized timeline for the Payer Initiated Process for 
Remaining Other Payers as well as the previously finalized timeline for 
the Payer Initiated Process for Medicaid and Medicare Health Plans, is 
summarized in Table 59 alongside the final timeline for the Eligible 
Clinician Initiated Process.

[[Page 59935]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.076

    CMS Determination: Upon the timely receipt of a Payer Initiated 
Submission Form, we will use the information submitted to determine 
whether the other payer arrangement meets the Other Payer Advanced APM 
criteria. We proposed that if we find that the Remaining Other Payer 
has submitted incomplete or inadequate information, we will inform the 
payer and allow them to submit additional information no later than 15 
business days from the date we inform the payer of the need for 
additional information. For each other payer arrangement for which the 
Remaining Other Payer does not submit sufficient information in a 
timely fashion, we will not make a determination in response to that 
request submitted via the Payer Initiated Submission Form. As a result, 
the other payer arrangement will not be considered an Other Payer 
Advanced APM for the year. These determinations are final and not 
subject to reconsideration.
    We solicited comment on this proposal.
    We did not receive any comments in response to this proposal.
    We are finalizing our proposal that if we find that the Remaining 
Other Payer has submitted incomplete or inadequate information, we 
would inform the payer and allow them to submit additional information 
no later than 15 business days from the date we inform the payer of the 
need for additional information.
    CMS Notification: We intend to notify Remaining Other Payers of our 
determination for each request as soon as practicable after the 
relevant Submission Deadline. We note that Remaining Other Payers may 
submit information regarding an other payer arrangement for a 
subsequent QP Performance Period even if we have determined that the 
other payer arrangement is not an Other Payer Advanced APM for a prior 
year.
    CMS Posting of Other Payer Advanced APMs: We intend to post on the 
CMS website a list (which we refer to as the Other Payer Advanced APM 
List) of all other payer arrangements that we determine to be Other 
Payer Advanced APMs. Prior to the start of the relevant QP Performance 
Period, we intend to post a list of the payment arrangements that we 
determine to be Other Payer Advanced APMs through the Payer Initiated 
Process, and Other Payer Advanced APMs under Title XIX through the 
Eligible Clinician Initiated Process. After the QP Performance Period, 
we will update this list to include payment arrangements that we 
determine to be Other Payer Advanced APMs based on other requests 
through the Eligible Clinician Initiated Process. We intend to post the 
list of other payer arrangements that we determine to be Other Payer 
Advanced APMs through the Payer Initiated Process prior to the start of 
the relevant QP Performance Period, and then to update the list to 
include payment arrangements that we determine to be Other Payer 
Advanced APMs based on requests received through the Eligible Clinician 
Initiated Process.
(d) Payer Initiated Process--CMS Multi-Payer Models
    In the CY 2018 Quality Payment Program final rule, we finalized 
that beginning for the first QP Performance Period under the All-Payer 
Combination Option, payers with a payment arrangement aligned with a 
CMS Multi-Payer Model may request that we determine whether that 
aligned payment arrangement is an Other Payer Advanced APM.
    In the CY 2019 PFS proposed rule, we proposed to eliminate the 
Payer Initiated Process and submission form that are specifically for 
CMS Multi-Payer Models. We believe that payers aligned with CMS Multi-
Payer Models can submit their arrangements through the Payer Initiated 
Process for

[[Page 59936]]

Remaining Other Payers we have proposed in section III.I.4.g.(3)(c) of 
this final rule, or through the existing Medicaid or Medicare Health 
Plan payment arrangement submission process, as applicable.
    We solicited comment on this proposal.
    We did not receive any comment in response to this proposal.
    We are finalizing our proposal to eliminate the Payer Initiated 
Process and submission form that are specifically for CMS Multi-Payer 
Models.
(5) Calculation of All-Payer Combination Option Threshold Scores and QP 
Determinations
(a) Overview
    In the CY 2017 Quality Payment Program final rule, we finalized our 
overall approach to the All-Payer Combination Option (81 FR 77463). 
Beginning in 2021, in addition to the Medicare Option, an eligible 
clinician may alternatively become a QP through the All-Payer 
Combination Option, and an eligible clinician need only meet the QP 
threshold under one of the two options to be a QP for the payment year 
(81 FR 77459). We finalized that we will conduct the QP determination 
sequentially so that the Medicare Option is applied before the All-
Payer Combination Option (81 FR 77459).
    In the CY 2017 Quality Payment Program final rule, we finalized 
that we will calculate Threshold Scores under the Medicare Option 
through both the payment amount and the patient count methods, compare 
each Threshold Score to the relevant QP and Partial QP Thresholds, and 
use the most advantageous scores to make QP determinations (81 FR 
77457). We finalized the same approach for the All-Payer Combination 
Option wherein we will use the most advantageous method for QP 
determinations with the data that has been provided (81 FR 77475).
(b) QP Determinations Under the All-Payer Combination Option
    In the CY 2018 Quality Payment Program final rule, we finalized 
that an eligible clinician may request a QP determination at the 
eligible clinician level, and that an APM Entity may request a QP 
determination at the APM Entity Level (82 FR 53880 through 53881). In 
the event that we receive a request for QP determination from an 
individual eligible clinician and also separately from that individual 
eligible clinician's APM Entity, we would make a determination at both 
levels. The eligible clinician could become a QP on the basis of either 
of the two determinations (82 FR 53881).
    We proposed to add a third alternative to allow requests for QP 
determinations at the TIN level in instances where all clinicians who 
have reassigned billing rights under the TIN participate in a single 
(meaning the same) APM Entity. Therefore, this option would be 
available to all TINs participating in Full TIN APMs, such as the 
Medicare Shared Savings Program. It would also be available to any 
other TIN for which all clinicians who have reassigned their billing 
rights to the TIN are participating in the same APM Entity.
    We solicited comment on this proposal.
    The following is a summary of the public comments received in 
response to our request for comment and our responses:
    Comment: Many commenters supported the proposal to add a third 
alternative to allow requests for QP determinations at the TIN level in 
instances where all clinicians who have reassigned billing rights under 
the TIN participate in a single APM Entity.
    Response: We appreciate the support for our proposal.
    After considering public comments, we are finalizing our proposal 
to add a third alternative to allow requests for QP determinations at 
the TIN level in instances where all clinicians who have reassigned 
billing rights under the TIN participate in a single APM Entity.
    We proposed that, similar to our existing policies for individual 
and APM Entity requests for QP determinations under the All-Payer 
Combination Option, we would assess QP status based on the most 
advantageous result for each individual eligible clinician. That is, if 
we receive any combination of QP determination requests (at the TIN-
level, APM Entity level, or individual level) we will make QP 
assessments at all requested levels and determine QP status on the 
basis of the QP assessment that is most advantageous to the eligible 
clinician.
    We solicited comment on this proposal.
    The following is a summary of the public comments received in 
response to our request for comment and our responses:
    Comment: Many commenters supported the proposal to assess QP status 
based on the most advantageous result for each individual eligible 
clinician.
    Response: We appreciate the support for our proposal.
    After considering public comments, we are finalizing our proposal 
to assess QP status based on the most advantageous result for each 
individual eligible clinician.
(c) Use of Individual or APM Entity Information for Medicare Payment 
Amount and Patient Count Calculation Under the All-Payer Combination 
Option
(i) Flexibility in the Medicare Option and All-Payer Combination Option 
Threshold Methods
    In the CY 2018 Quality Payment Program final rule, we finalized 
that when we make QP determinations at the individual eligible 
clinician level, we would use the individual eligible clinician payment 
amounts and patient counts for the Medicare calculations in the All-
Payer Combination Option. When we make QP determinations at the APM 
Entity level, we will use APM Entity level payment amounts and patient 
counts for the Medicare calculations in QP determinations under the 
All-Payer Combination Option. Eligible clinicians assessed at the 
individual eligible clinician level under the Medicare Option at Sec.  
414.1425(b)(2) will be assessed at the individual eligible clinician 
level only under the All-Payer Combination Option. We codified these 
policies at Sec.  414.1440(d)(2) (82 FR 53881).
    We noted in the CY 2019 PFS proposed rule that some may have read 
our regulation at Sec.  414.1440(d)(2) to suggest that consistency is 
required across the two thresholds requiring eligible clinicians or APM 
Entities to meet the minimum Medicare threshold needed to qualify for 
the All-Payer Combination Option and the All-Payer threshold using the 
same method--either payment amounts or patient counts. Although we did 
not directly address this specific question in our current regulation 
or in prior rulemaking, we are clarifying that eligible clinicians or 
APM Entities can meet the minimum Medicare threshold for the All-Payer 
Combination option using one method (whichever is most favorable), and 
the All-Payer threshold for the All-Payer Combination Option using 
either the same, or the other method. All data submitted to us for 
Other Payer Advanced APM determinations and, when applicable, QP 
determinations using the All-Payer Combination Option will be 
considered and evaluated; and eligible clinicians (or APM Entities or 
TINs, as appropriate) may submit all data relating to both the payment 
amount and patient count methods. To avoid any potential ambiguity for 
the future, we proposed a change to Sec.  414.1440(d)

[[Page 59937]]

to codify this clarification. We proposed to add a new Sec.  
414.1440(d)(4) to expressly allow eligible clinicians or APM Entities 
to meet the minimum Medicare threshold using the most favorable of the 
payment amount or patient count method, and then to meet the All-Payer 
threshold using either the same method or the other method. We note 
that, in the preamble in the CY 2019 PFS proposed rule, we indicated 
that we would codify this proposed policy by adding a new Sec.  
414.1440(d)(4) to our regulations. However, the corresponding proposed 
regulation text included the proposed policy as an amendment to the 
regulation text at Sec.  414.1440(d)(1). We intended to propose the 
policy reflected in the propoed regulation text, and due to a clerical 
error, inadvertently neglected to revise the description of the 
proposal in the preamble. As such, rather than adding a new Sec.  
414.1440(d)(4), we intended to propose to amend the regulation at Sec.  
414.1440(d)(1) to expressly allow eligible clinicians or APM Entities 
to meet the minimum Medicare threshold using the most favorable of the 
payment amount or patient count method, and then to meet the All-Payer 
threshold using either the same method or the other method.
    We solicited comment on this proposal.
    The following is a summary of the public comments received in 
response to our request for comment and our responses:
    Comment: Some commenters supported the proposal to allow eligible 
clinicians or APM Entities to meet the minimum Medicare threshold using 
the most favorable of the payment amount or patient count method, and 
then to meet the All-Payer threshold using either the same method or 
the other method.
    Response: We appreciate the support for our proposal.
    After considering public comments, we are finalizing our proposal 
with the correction noted above, that we are amending the text in our 
regulation at Sec.  414.1440(d)(1) to expressly allow eligible 
clinicians or APM Entities to meet the minimum Medicare threshold using 
the most favorable of the payment amount or patient count method, and 
then to meet the All-Payer threshold using either the same method or 
the other method.
(ii) Extending the Medicare Threshold Score Weighting Methodology to 
TIN Level All-Payer Combination Option Threshold Score Calculations
    In the CY 2018 Quality Payment Program final rule, we explained 
that we recognize that in many cases an individual eligible clinician's 
Medicare Threshold Scores would likely differ from the corresponding 
Threshold Scores calculated at the APM Entity group level, which would 
benefit those eligible clinicians whose individual Threshold Scores 
would be higher than the group Threshold Scores and disadvantage those 
eligible clinicians whose individual Threshold Scores are equal to or 
lower than the group Threshold Scores (82 FR 53881-53882). In 
situations where eligible clinicians are assessed under the Medicare 
Option as an APM Entity group, and receive a Medicare Threshold Score 
at the APM Entity group level, we believe that the Medicare portion of 
their All-Payer calculation under the All-Payer Combination Option 
should not be lower than the Medicare Threshold Score that they 
received by participating in an APM Entity group.
    To accomplish this outcome, we finalized a modified weighting 
methodology. We finalized that when the eligible clinician's Medicare 
Threshold Score calculated at the individual level would be lower than 
the Medicare Threshold Score calculated at the APM Entity group level, 
we would apply a weighting methodology to calculate the Threshold Score 
for the eligible clinician. This methodology allows us to apply the APM 
Entity group level Medicare Threshold Score (if higher than the 
individual eligible clinician level Medicare Threshold Score), to the 
eligible clinician, under either the payment amount or patient count 
method, but weighted to reflect the individual eligible clinician's 
Medicare volume. We multiply the eligible clinician's APM Entity group 
Medicare Threshold Score by the total Medicare payments or patients 
made to that eligible clinician as follows:
[GRAPHIC] [TIFF OMITTED] TR23NO18.077

    In the CY 2019 PFS proposed rule, we proposed to extend the same 
weighting methodology to TIN level Medicare Threshold Scores in 
situations where a TIN is assessed under the Medicare Option as part of 
an APM Entity group, and receives a Medicare Threshold Score at the APM 
Entity group level. In this scenario, we believe that the Medicare 
portion of the TIN's All-Payer Combination Option Threshold Score 
should not be lower than the Medicare Threshold Score that they 
received by participating in an APM Entity group (82 FR 53881-53882). 
We note this extension of the weighting methodology would only apply to 
a TIN when that TIN represents a subset of the eligible clinicians in 
the APM Entity, because when the TIN and the APM Entity are the same 
there is no need for this weighted methodology. We would multiply the 
TIN's APM Entity group Medicare Threshold Score by the total Medicare 
payments or patients for that TIN as follows:
[GRAPHIC] [TIFF OMITTED] TR23NO18.288

    We proposed to calculate the TIN's Threshold Scores both on its own 
and with this weighted methodology, and then use the most advantageous 
score when making a QP determination. We believe that, as it does for 
QP determinations made at the APM Entity level, this approach promotes 
consistency between the Medicare Option and the All-Payer Combination 
Option to the extent possible. Additionally, the proposed application 
of this weighting approach in the case of a TIN level QP determination 
would be consistent with our established policy.
    We solicited comment on this proposal.
    The following is a summary of the public comments received in 
response to our request for comment and our responses:
    Comment: Commenters supported the proposal to extend the same 
weighting

[[Page 59938]]

methodology to TIN level Medicare Threshold Scores in situations where 
a TIN is assessed under the Medicare Option as part of an APM Entity 
group, and receives a Medicare Threshold Score at the APM Entity group 
level.
    Response: We appreciate support for our proposal.
    After considering public comments, we are finalizing our proposal 
to extend the same weighting methodology to TIN level Medicare 
Threshold Scores in situations where a TIN is assessed under the 
Medicare Option as part of an APM Entity group, and receives a Medicare 
Threshold Score at the APM Entity group level.
(6) Summary of Final Policies
    In this section, we are finalizing the following policies:
    Other Payer Advanced APM Criteria:
     We are finalizing our proposal to change the CEHRT use 
criterion so that in order to qualify as an Other Payer Advanced APM as 
of January 1, 2020, the percentage of eligible clinicians participating 
in the other payer arrangement who are using CEHRT must be 75 percent.
     We are finalizing our proposal to allow payers and 
eligible clinicians to submit evidence as part of their request for an 
Other Payer Advanced APM determination that CEHRT is used by the 
requisite percentage of eligible clinicians participating in the 
payment arrangement (50 percent for 2019, and 75 percent for 2020 and 
beyond) to document and communicate clinical care, whether or not CEHRT 
use is explicitly required under the terms of the payment arrangement. 
We codifying this change at Sec.  414.1420(b).
     We are finalizing the following clarification to Sec.  
414.1420(c)(2), effective January 1, 2020, to provide that at least one 
of the quality measures used in the payment arrangement in paragraph 
(c)(1) of this regulation must be:
    ++ Finalized on the MIPS final list of measures, as described in 
Sec.  414.1330;
    ++ Endorsed by a consensus-based entity; or
    ++ Determined by CMS to be evidenced-based, reliable, and valid.
     We are finalizing our proposal to revise Sec.  
414.1420(c)(3) to require that, effective January 1, 2020, unless there 
is no applicable outcome measure on the MIPS quality measure list, an 
Other Payer Advanced APM must use an outcome measure, that meets the 
proposed criteria in paragraph (c)(2) of this regulation.
     We are also finalizing our proposal at Sec.  
414.1420(c)(3)(i) that, for payment arrangements determined to be Other 
Payer Advanced APMs for the 2019 performance year which did not include 
an outcome measure that is evidence-based, reliable, and valid, that 
are resubmitted for an Other Payer Advanced APM determination for the 
2020 performance year (whether for a single year, or for a multi-year 
determination as proposed in section III.I.4.g.(3)(b) of this final 
rule), we would continue to apply the current regulation for purposes 
of those determinations. This revision also applies to payment 
arrangements in existence prior to the 2020 performance year that are 
submitted for determination to be Other Payer Advanced APMs for the 
2020 performance year and later.
Determination of Other Payer Advanced APMs
     We are finalizing details regarding the Payer Initiated 
Process for Remaining Other Payers. To the extent possible, we are 
aligning the Payer Initiated Process for Remaining Other Payers with 
the previously finalized Payer Initiated Process for Medicaid, Medicare 
Health Plans, and CMS Multi-Payer Models.
     We are finalizing our proposal to eliminate the Payer 
Initiated Process that is specifically for CMS Multi-Payer Models. We 
believe that payers aligned with CMS Multi-Payer Models can submit 
their arrangements through the Payer Initiated Process for Remaining 
Other Payers that we are finalizing as described in section 
III.I.4.g.(3)(c) of this final rule, or through the Medicaid or 
Medicare Health Plan payment arrangement submission processes.
Calculation of All-Payer Combination Option Threshold Scores and QP 
Determinations
     We are finalizing our proposal to add a third alternative 
to allow requests for QP determinations at the TIN level in instances 
where all clinicians who reassigned billing rights under the TIN 
participate in a single APM Entity. We are finalizing this proposal to 
revise Sec.  414.1440(d), by adding this third alternative to allow QP 
determinations at the TIN level in instances where all clinicians who 
have reassigned billing under the TIN participate in a single APM 
Entity, as well as to assess QP status at the most advantageous level 
for each eligible clinician.
     We also are finalizing our clarification that, in making 
QP determinations using the All-Payer Combination Option, eligible 
clinicians may meet the minimum Medicare threshold using one method, 
and the All-Payer threshold using the same or a different method. We 
are finalizing our proposal with a correction to codify this 
clarification by amending Sec.  414.1440(d)(1).
     We are finalizing our proposal to extend the same 
weighting methodology to TIN level Medicare Threshold Scores in 
situations where a TIN is assessed under the Medicare Option as part of 
an APM Entity group, and receives a Medicare Threshold Score at the APM 
Entity group level.
5. Quality Payment Program Technical Correction: Regulation Text 
Changes
a. Overview
    We proposed certain technical revisions to our regulations in order 
to correct several technical errors and to reconcile the text of 
several of our regulations with the final policies we adopted through 
notice and comment rulemaking.
b. Regulation Text Changes
    We proposed a technical correction to Sec.  414.1415(b)(1) of our 
regulations to specify that an Advanced APM must require quality 
measure performance as a factor when determining payment to 
participants for covered professional services under the terms of the 
APM (83 FR 36005). The addition of the word ``quality'' better aligns 
with section 1833(z)(3)(D) of the Act and with the policy that was 
finalized in the CY 2017 Quality Payment Program final rule (81 FR 
77406), and corrects a clerical error we made in the course of revising 
the text of Sec.  414.1415(b)(1) for inclusion in the CY 2017 QPP final 
rule. This proposed revision would not change our current policy for 
this Advanced APM criterion.
    We solicited comment on this proposal.
    We did not receive any comments in response to this proposal.
    We are finalizing the technical correction to Sec.  414.1415(b)(1) 
to specify that an Advanced APM must require quality measure 
performance as a factor when determining payment to participants for 
covered professional services under the terms of the APM.
    We also proposed technical corrections to Sec.  
414.1420(d)(3)(ii)(B) (83 FR 36005). These changes align with the 
generally applicable nominal amount standard for Other Payer Advanced 
APMs that was finalized in the CY 2017 Quality Payment Program final 
rule, and the change to the generally applicable nominal amount 
standard in the CY 2018 Quality Payment Program final rule where we 
established a revenue-based nominal amount standard as part of the 
Other Payer Advanced APM

[[Page 59939]]

criteria (82 FR 53849-53850). We finalized that a payment arrangement 
must require APM Entities to bear financial risk for at least 3 percent 
of the expected expenditures for which an APM Entity is responsible 
under the payment arrangement, and that a payment arrangement's level 
of marginal risk must be at least 30 percent of losses in excess of the 
expected expenditures, and the maximum allowable minimum loss rate must 
be 4 percent (81 FR 77471). Due to a clerical oversight, we 
inadvertently published two conflicting provisions in regulation text. 
At Sec.  414.1420(d)(3)(i), we correctly finalized that a payment 
arrangement must require APM Entities to bear financial risk for at 
least 3 percent of the expected expenditures for which an APM Entity is 
responsible under the payment arrangement, and at Sec.  
414.1420(d)(3)(ii)(B) we incorrectly finalized that the risk 
arrangement must have a total potential risk of at least 4 percent of 
expected expenditures. We are effectuating this change by removing the 
Other Payer Advanced APM Criteria, Financial Risk, Generally Applicable 
Nominal Amount Standard provision at Sec.  414.1420(d)(3)(ii)(B) and 
consolidating Sec.  414.1420(d)(3)(ii)(A) into Sec.  
414.1420(d)(3)(ii).
    We solicited comment on this proposal.
    The following is a summary of the public comments received in 
response to our request for comment and our responses:
    Comment: One commenter thanked the agency for making the technical 
correction to clarify that an Other Payer payment arrangement must 
require APM Entities to bear financial risk for at least 3 percent, not 
4 percent.
    Response: We thank the commenter for their support of this 
technical correction.
    After considering public comments, we are finalizing this technical 
correction by removing the Other Payer Advanced APM Criteria, Financial 
Risk, Generally Applicable Nominal Amount Standard provision at Sec.  
414.1420(d)(3)(ii)(B) and consolidating Sec.  414.1420(d)(3)(ii)(A) 
into Sec.  414.1420(d)(3)(ii).
    In the CY 2017 Quality Payment Program final rule, we finalized a 
capitation standard for the financial risk criterion under the Advanced 
APM Criteria and the Other Payer Advanced APM Criteria, respectively. 
We finalized that full capitation arrangements would meet the Advanced 
APM financial risk criterion and Other Payer Advanced APM financial 
risk criterion, and would not separately need to meet the generally 
applicable financial risk standard and generally applicable nominal 
amount standard in order to satisfy the financial risk criterion for 
Advanced APMs and Other Payer Advanced APMs (81 FR 77431; 77472). We 
proposed to clarify the application of the capitation standard by 
revising Sec.  414.1415(c) and Sec.  414.1420(d) to refer to the full 
capitation exception that is expressed in paragraphs (c)(6) and (d)(7), 
respectively (83 FR 36006).
    We solicited comment on this proposal.
    We did not receive any comments in response to this proposal.
    We are finalizing our proposal to clarify the application of the 
capitation standard by revising Sec.  414.1415(c) and Sec.  414.1420(d) 
to refer to the full capitation exception that is expressed in 
paragraphs (c)(6) and (d)(7), respectively.
    In finalizing Sec. Sec.  414.1415(c)(6) and 414.1420(d)(7), we 
specified that a capitation arrangement means a payment arrangement in 
which a per capita or otherwise predetermined payment is made under the 
APM for all items and services for which payment is made through the 
APM furnished to a population of beneficiaries, and no settlement is 
performed to reconcile or share losses incurred or savings earned by 
the APM Entity. This language does not completely reflect our 
definition of capitation risk arrangements as discussed in the preamble 
at 81 FR 77430 where we state that, ``capitation risk arrangements, as 
defined here, involve full risk for the population of beneficiaries 
covered by the arrangement, recognizing that it might require no 
services whatsoever or could require exponentially more services than 
were expected in calculating the capitation rate. . . . [a] capitation 
risk arrangement adheres to the idea of a global budget for all items 
and services to a population of beneficiaries during a fixed period of 
time.'' Therefore, we proposed to revise these regulations to align the 
Advanced APM Criteria, Financial Risk, Capitation provision at Sec.  
414.1415(c)(6), and the Other Payer Advanced APM Criteria, Financial 
Risk, Capitation provision at Sec.  414.1420(d)(7) with the definition 
of capitation risk arrangements that we expressed in the preamble of 
the CY 2017 Quality Payment Program final rule at 81 FR 77430-77431 (83 
FR 36006).
    We solicited comment on this proposal.
    We did not receive any comments in response to this proposal.
    We are finalizing our proposal to revise the Advanced APM Criteria, 
Financial Risk, Capitation provision at Sec.  414.1415(c)(6), and the 
Other Payer Advanced APM Criteria, Financial Risk, Capitation provision 
at Sec.  414.1420(d)(7) to align with the definition of capitation risk 
arrangements that we expressed in the preamble of the CY 2017 Quality 
Payment Program final rule at 81 FR 77430-77431.
    We also proposed a technical correction to remove the ``; or'' and 
replace it with a ``.'' at Sec.  414.1420(d)(3)(i) because the 
paragraph that follows that section does not specify a standard that is 
necessarily an alternative to the standard under Sec.  
414.1420(d)(3)(i), but rather expresses a standard that is independent 
of the standard under Sec.  414.1420(d)(3)(i) (83 FR 36006). As 
indicated in the CY 2018 Quality Payment Program final rule at 82 FR 
53849-53850, where we established a revenue-based nominal amount 
standard for Other Payer Advanced APMs, in order to meet the generally 
applicable nominal amount standard under the Other Payer Advanced APM 
criteria, the total amount that an APM Entity potentially owes the 
payer or foregoes under a payment arrangement must be equal to at 
least: For the 2019 and 2020 QP Performance Periods, 8 percent of the 
total combined revenues from the payer to providers and other entities 
under the payment arrangement; or, 3 percent of the expected 
expenditures for which an APM Entity is responsible under the payment 
arrangement.
    We solicited comment on this proposal.
    We did not receive any comments in response to this proposal.
    We are finalizing our proposal to remove the ``; or'' and replace 
it with a ``.'' at Sec.  414.1420(d)(3)(i) because the paragraph that 
follows that section does not specify a standard that is necessarily an 
alternative to the standard under Sec.  414.1420(d)(3)(i), but rather 
expresses a standard that is independent of the standard under Sec.  
414.1420(d)(3)(i).
    We also proposed to revise Sec.  414.1440(d)(3) to correct a 
typographical error by replacing the ``are'' with ``is'' in the third 
clause of the second sentence (83 FR 36006).
    We solicited comment on this proposal.
    We did not receive any comments in response to this proposal.
    We are finalizing our proposal to revise Sec.  414.1440(d)(3) to 
correct a typographical error by replacing the ``are'' with ``is'' in 
the third clause of the second sentence.
c. Summary of Final Policies
    We are finalizing these technical corrections to our regulations at 
Sec. Sec.  414.1415(b)(1), 414.1420(d)(3)(ii),

[[Page 59940]]

414.1415(c), 414.1420(d), 414.1415(c)(6), 414.1420(d)(7), 
414.1420(d)(3)(i), and 414.1440(d)(3) as proposed.

IV. Requests for Information

    This section addressed two requests for information (RFI).

A. Request for Information on Promoting Interoperability and Electronic 
Healthcare Information Exchange Through Possible Revisions to the CMS 
Patient Health and Safety Requirements for Hospitals and Other 
Medicare- and Medicaid-Participating Providers and Suppliers

    In the CY 2019 PFS proposed rule (83 FR 35704 through 36368), we 
included an RFI related to promoting interoperability and electronic 
health care information exchange (83 FR 36006 through 36009). We 
received approximately 79 timely pieces of correspondence on this RFI. 
We appreciate the input provided by commenters.

B. Request for Information on Price Transparency: Improving Beneficiary 
Access to Provider and Supplier Charge Information

    In the CY 2019 PFS proposed rule (83 FR 35704 through 36368), we 
included an RFI related to price transparency and improving beneficiary 
access to provider and supplier charge information (83 FR 36009 through 
36010). We received approximately 94 timely pieces of correspondence on 
this RFI. We appreciate the input provided by commenters.

V. Medicare Shared Savings Program; Accountable Care Organizations--
Pathways to Success

A. Statutory and Regulatory Background

    On March 23, 2010, the Patient Protection and Affordable Care Act 
(Pub. L. 111-148) was enacted, followed by enactment of the Health Care 
and Education Reconciliation Act of 2010 (Pub. L. 111-152) on March 30, 
2010, which amended certain provisions of the Patient Protection and 
Affordable Care Act (hereinafter collectively referred to as ``the 
Affordable Care Act''). Section 3022 of the Affordable Care Act amended 
Title XVIII of the Act (42 U.S.C. 1395 et seq.) by adding section 1899 
to the Act to establish the Shared Savings Program to facilitate 
coordination and cooperation among health care providers to improve the 
quality of care for Medicare FFS beneficiaries and reduce the rate of 
growth in expenditures under Medicare Parts A and B. See 42 U.S.C. 
1395jjj.
    The final rule establishing the Shared Savings Program appeared in 
the November 2, 2011 Federal Register (Medicare Program; Medicare 
Shared Savings Program: Accountable Care Organizations; Final Rule (76 
FR 67802) (hereinafter referred to as the ``November 2011 final 
rule'')). We viewed this final rule as a starting point for the 
program, and because of the scope and scale of the program and our 
limited experience with shared savings initiatives under FFS Medicare, 
we built a great deal of flexibility into the program rules.
    Through subsequent rulemaking, we have revisited and amended Shared 
Savings Program policies in light of the additional experience we 
gained during the initial years of program implementation as well as 
from testing through the Pioneer ACO Model, the Next Generation ACO 
Model and other initiatives conducted by the Center for Medicare and 
Medicaid Innovation (Innovation Center) under section 1115A of the Act. 
A major update to the program rules appeared in the June 9, 2015 
Federal Register (Medicare Program; Medicare Shared Savings Program: 
Accountable Care Organizations; Final Rule (80 FR 32692) (hereinafter 
referred to as the ``June 2015 final rule'')). A final rule addressing 
changes related to the program's financial benchmark methodology 
appeared in the June 10, 2016 Federal Register (Medicare Program; 
Medicare Shared Savings Program; Accountable Care Organizations--
Revised Benchmark Rebasing Methodology, Facilitating Transition to 
Performance-Based Risk, and Administrative Finality of Financial 
Calculations (81 FR 37950) (hereinafter referred to as the ``June 2016 
final rule'')). We have also made use of the annual calendar year (CY) 
Physician Fee Schedule (PFS) rules to address updates to the Shared 
Savings Program quality measures, scoring, and quality performance 
standard, the program's beneficiary assignment methodology and certain 
other issues.\34\
---------------------------------------------------------------------------

    \34\ See for example: Medicare Program; Revisions to Payment 
Policies under the Physician Fee Schedule, Clinical Laboratory Fee 
Schedule & Other Revisions to Part B for CY 2014; Final Rule (78 FR 
74230, Dec. 10, 2013). Medicare Program; Revisions to Payment 
Policies under the Physician Fee Schedule, Clinical Laboratory Fee 
Schedule & Other Revisions to Part B for CY 2015; Final Rule (79 FR 
67548, Nov. 13, 2014). Medicare Program; Revisions to Payment 
Policies under the Physician Fee Schedule, Clinical Laboratory Fee 
Schedule & Other Revisions to Part B for CY 2016; Final Rule (80 FR 
70886, Nov. 16, 2015). Medicare Program; Revisions to Payment 
Policies under the Physician Fee Schedule, Clinical Laboratory Fee 
Schedule & Other Revisions to Part B for CY 2017; Final Rule (81 FR 
80170, Nov. 15, 2016). Medicare Program; Revisions to Payment 
Policies under the Physician Fee Schedule, Clinical Laboratory Fee 
Schedule & Other Revisions to Part B for CY 2018; Final Rule (82 FR 
52976, Nov. 15, 2017).
---------------------------------------------------------------------------

    Policies applicable to Shared Savings Program ACOs have continued 
to evolve based on changes in the law. The Medicare Access and CHIP 
Reauthorization Act of 2015 (Pub. L. 114-10) (MACRA) established the 
Quality Payment Program. In the CY 2017 Quality Payment Program final 
rule with comment period (81 FR 77008), CMS established regulations for 
the Merit-Based Incentive Payment System (MIPS) and Advanced 
Alternative Payment Models (APMs) and related policies applicable to 
eligible clinicians who participate in the Shared Savings Program.
    The requirements for assignment of Medicare FFS beneficiaries to 
ACOs participating under the program were amended by the 21st Century 
Cures Act (Pub. L. 114-255). Accordingly, we revised the program's 
regulations in the CY 2018 PFS final rule to reflect these new 
requirements.
    On February 9, 2018, the Bipartisan Budget Act of 2018 was enacted 
(Pub. L. 115-123), amending section 1899 of the Act to provide for the 
following: Expanded use of telehealth services by physicians or 
practitioners participating in an applicable ACO to a prospectively 
assigned beneficiary, greater flexibility in the assignment of Medicare 
FFS beneficiaries to ACOs by allowing ACOs in tracks under 
retrospective beneficiary assignment a choice of prospective assignment 
for the agreement period, permitting Medicare FFS beneficiaries to 
voluntarily identify an ACO professional as their primary care provider 
and mandating that any such voluntary identification will supersede 
claims-based assignment, and allowing ACOs under certain two-sided 
models to establish CMS-approved beneficiary incentive programs.
    On August 17, 2018 a proposed rule, titled ``Medicare Program; 
Medicare Shared Savings Program; Accountable Care Organizations--
Pathways to Success'' (hereinafter referred to as the ``August 2018 
proposed rule''), appeared in the Federal Register (83 FR 41786). This 
proposed rule would provide a new direction for the Shared Savings 
Program by establishing pathways to success through redesigning the 
participation options available under the program to encourage ACOs to 
transition to two-sided models (in which they may share in savings and 
are also accountable for repaying any shared losses). As part of the 
proposed redesign of the program, we proposed to

[[Page 59941]]

establish two tracks under the program--the BASIC track and the 
ENHANCED track. These new participation options were designed to 
increase savings for the Trust Funds and mitigate losses, reduce gaming 
opportunities, and promote regulatory flexibility and free-market 
principles. The August 2018 proposed rule would also provide new tools 
to support coordination of care across settings and strengthen 
beneficiary engagement; ensure rigorous benchmarking; and promote the 
use of interoperable electronic health record technology among ACO 
providers/suppliers. We received 470 timely pieces of correspondence in 
response to the August 2018 proposed rule. In the following sections of 
this final rule, we address a subset of the proposals described in the 
August 2018 proposed rule. We summarize and respond to the significant 
public comments on these proposals and discuss our final policies with 
respect to these issues after taking into consideration the public 
comments we received on this subset of proposals. We are not addressing 
the other topics included in the August 2018 proposed rule at this 
time. We will summarize and respond to public comments on these other 
proposed policies in a forthcoming final rule. We also received 
comments that are outside the scope of the August 2018 proposed rule. 
We may consider these comments when evaluating current Shared Savings 
Program policies and contemplating future refinements to the program.

B. Finalization of Certain Provisions of the Shared Savings Program 
August 2018 Proposed Rule

    In this section of the final rule, we discuss the proposal, the 
comments received, and the final action that we are taking for the 
following proposals in the August 2018 proposed rule:
     A voluntary 6-month extension for existing ACOs whose 
participation agreements expire on December 31, 2018, and the 
methodology for determining financial and quality performance for this 
6-month performance year from January 1, 2019 through June 30, 2019. We 
believe it is necessary to finalize the extension before these ACOs' 
participation agreements expire on December 31, 2018, so that they can 
continue their participation in the program without interruption. It is 
also necessary to finalize the methodology for determining ACO quality 
and financial performance for the extension period in advance of the 6-
month performance year beginning on January 1, 2019.
     Implementation of the provisions of section 50331 of the 
Bipartisan Budget Act of 2018 on voluntary alignment. The Bipartisan 
Budget Act was enacted earlier this year, and we believe it is most 
consistent with the requirements of the statute to revise our voluntary 
alignment policies effective with assignment for performance years 
starting on January 1, 2019, to reflect the additional flexibility 
given to beneficiaries in selecting their primary care provider.
     A modification to the definition of primary care services 
used in assigning beneficiaries to ACOs to reflect recent code changes. 
Including these codes in the definition of primary care services will 
improve the accuracy of the assignment methodology and help to ensure 
that beneficiaries are assigned to the ACO that is responsible for 
coordinating their overall care.
     Relief for ACOs and their clinicians impacted by extreme 
and uncontrollable circumstances in performance year 2018 and 
subsequent years. We believe it is necessary to finalize the changes to 
the extreme and uncontrollable circumstances policies for the Shared 
Savings Program as quickly as possible to ensure that relief is 
available for ACOs affected by the recent hurricanes in North Carolina 
and Florida and other disasters during 2018.
     Revisions to program requirements to further promote 
interoperability among ACO providers and suppliers. We believe it is 
necessary to finalize changes to our CEHRT use requirements to align 
with the Quality Payment Program.
    We are also making technical changes to update the authority 
citation for 42 CFR part 425 to conform with OFR requirements.
    The changes will be effective on December 31, 2018. Applicability 
or implementation dates may vary, depending on the policy, and the 
timing specified in this final rule. By indicating that a provision is 
applicable to a performance year (PY) or agreement period, activities 
related to implementation of the policy may precede the start of the 
performance year or agreement period.
1. Participation Options for Agreement Periods Beginning in 2019
    In this final rule, we are addressing a subset of the proposals in 
the August 2018 proposed rule for participation options for agreement 
periods beginning in 2019. In the August 2018 proposed rule, we stated 
that we would forgo an application cycle for a January 1, 2019 
agreement start date and proposed to allow for a July 1, 2019 agreement 
start date. We proposed an approach for determining financial and 
quality performance for two 6-month performance years during 2019, with 
the first from January 1, 2019 through June 30, 2019, for ACOs with 
participation agreements expiring on December 31, 2018, that elect a 
voluntary 6-month extension, and the second from July 1, 2019 through 
December 31, 2019, for ACOs entering a new agreement period beginning 
July 1, 2019. We also proposed an approach for determining financial 
and quality performance for the performance period from January 1, 2019 
through June 30, 2019 for an ACO starting a 12-month performance year 
on January 1, 2019, that terminates its participation agreement with an 
effective date of termination of June 30, 2019, and enters a new 
agreement period beginning on July 1, 2019, referred to as ``early 
renewals.''
    In this final rule, we are addressing our proposals to allow for a 
voluntary 6-month extension for ACOs whose agreement periods expire on 
December 31, 2018, and to establish a methodology for determining 
financial and quality performance for the 6-month performance year from 
January 1, 2019 through June 30, 2019. These proposals were necessary 
to prevent some ACOs from experiencing an involuntary gap in 
participation as a result of our decision to forgo an application cycle 
in 2018 for a January 1, 2019 agreement start date. Therefore, in this 
section of the final rule, we summarize and respond to comments and 
address final actions specific to our proposals regarding the 6-month 
extension and the methodology for determining financial and quality 
performance for the 6-month performance year from January 1, 2019 
through June 30, 2019. As we describe in this section, some 
modifications to our proposals are necessary because of the limited 
scope of this final rule.
    In a forthcoming final rule, we anticipate summarizing and 
responding to public comments on the other proposed policies related to 
determining financial and quality performance in 2019 for the 
following: (1) The performance period from January 1, 2019 through June 
30, 2019, for ACOs starting a 12-month performance year on January 1, 
2019, that terminate their participation agreement with an effective 
date of termination of June 30, 2019, and enter a new agreement period 
beginning on July 1, 2019; and (2) the 6-month performance year from 
July 1, 2019 through December 31, 2019, for ACOs entering an agreement 
period beginning on July 1, 2019.

[[Page 59942]]

a. Voluntary Extension for a 6-Month Performance Year From January 1, 
2019 Through June 30, 2019, for ACOs Whose Current Agreement Period 
Expires on December 31, 2018
    In section II.A.7. of the August 2018 proposed rule (83 FR 41847), 
we explained that we were forgoing the application cycle that otherwise 
would take place during CY 2018 for a January 1, 2019 start date for 
new Shared Savings Program participation agreements, initial use of the 
Skilled Nursing Facility (SNF) 3-day rule waiver, and entry into the 
Track 1+ Model, and we proposed to offer a July 1, 2019 start date as 
the initial opportunity for ACOs to enter an agreement period under the 
proposed BASIC track or ENHANCED track, which would be offered under 
the proposed redesign of the program's participation options. We 
proposed the July 1, 2019 start date as a one-time opportunity, and 
thereafter we would resume our typical process of offering an annual 
application cycle that allows for review and approval of applications 
in advance of a January 1 agreement start date.
    We proposed that ACOs that entered a first or second agreement 
period with a start date of January 1, 2016 could elect to extend their 
agreement period for an optional fourth performance year, defined as 
the 6-month period from January 1, 2019 through June 30, 2019. This 
election to extend the agreement period would be voluntary and an ACO 
could choose not to extend its agreement period, in which case it would 
conclude its participation in the program with the expiration of its 
current agreement period on December 31, 2018.
    We proposed that the ACO's voluntary election to extend its 
agreement period must be made in the form and manner and according to 
the timeframe established by CMS, and that an ACO executive who has the 
authority to legally bind the ACO must certify the election. We 
explained our expectation that this election process, if finalized, 
would begin in 2018 following the publication of the final rule, as 
part of the annual certification process in advance of 2019 (described 
in section II.A.7.c.(2) of the August 2018 proposed rule (83 FR 
41855)). We noted that this optional 6-month agreement period extension 
would be a one-time exception for ACOs with agreements expiring on 
December 31, 2018, and would not be available to other ACOs that are 
currently participating in a 3-year agreement in the program, or to 
future program entrants.
    In the August 2018 proposed rule, we noted that under the existing 
provision at Sec.  425.210, the ACO must provide a copy of its 
participation agreement with CMS to all ACO participants, ACO 
providers/suppliers, and other individuals and entities involved in ACO 
governance. Further, all contracts or arrangements between or among the 
ACO, ACO participants, ACO providers/suppliers, and other individuals 
or entities performing functions or services related to ACO activities 
must require compliance with the requirements and conditions of the 
program's regulations, including, but not limited to, those specified 
in the participation agreement with CMS. We proposed that an ACO that 
elects to extend its participation agreement by 6 months must notify 
its ACO participants, ACO providers/suppliers and other individuals or 
entities performing functions or services related to ACO activities of 
this continuation of participation and must require their continued 
compliance with the program's requirements for the 6-month performance 
year from January 1, 2019 through June 30, 2019.
    As discussed in section II.A.2. of the August 2018 proposed rule 
(83 FR 41799 through 41800), we proposed modifications to the 
definition of ``agreement period'' in Sec.  425.20 to broaden the 
definition to generally refer to the term of the participation 
agreement. We also proposed to add a provision at Sec.  425.200(b)(2) 
specifying that the term of the participation agreement is 3 years and 
6 months for an ACO that entered an agreement period starting on 
January 1, 2016, that elects to extend its agreement period until June 
30, 2019, and this election is made in the form and manner and 
according to the timeframe established by CMS, and certified by an ACO 
executive who has the authority to legally bind the ACO (83 FR 41849). 
For consistency, we also proposed minor formatting changes to the 
existing provision at Sec.  425.200(b)(2) and (b)(3) to italicize the 
header text.
    We also proposed to revise the definition of ``performance year'' 
in Sec.  425.20 to mean the 12-month period beginning on January 1 of 
each year during the agreement period, unless otherwise specified in 
Sec.  425.200(c) or noted in the participation agreement. We also 
proposed revisions to Sec.  425.200(c) to make necessary formatting 
changes and specify additional exceptions to the definition of 
performance year as a 12-month period. Specifically, we proposed to add 
a provision specifying that for an ACO that entered a first or second 
agreement period with a start date of January 1, 2016, and that elects 
to extend its agreement period by a 6-month period, the ACO's fourth 
performance year is the 6-month period between January 1, 2019, and 
June 30, 2019. Similarly, we proposed to add a provision specifying 
that for an ACO that entered an agreement period with a start date of 
July 1, 2019, the ACO's first performance year of the agreement period 
is defined as the 6-month period between July 1, 2019, and December 31, 
2019 (83 FR 41849).
    In light of the proposed modifications to Sec.  425.200(c) to 
establish two 6-month performance years during CY 2019, we proposed 
revisions to the regulation at Sec.  425.200(d), which reiterates an 
ACO's obligation to submit quality measures in the form and manner 
required by CMS for each performance year of the agreement period, to 
address the quality reporting requirements for ACOs participating in a 
6-month performance year during CY 2019 (83 FR 41849).
    We also considered forgoing an application cycle for a 2019 start 
date altogether and allowing ACOs to enter agreement periods under the 
proposed BASIC track and ENHANCED track for the first time beginning on 
January 1, 2020. This approach would allow ACOs additional time to 
consider the redesign of the program, make organizational and 
operational plans, and implement business and investment decisions, and 
would avoid the complexity of needing to determine performance based on 
6-month performance years during CY 2019. However, we noted that our 
proposed approach of offering an application cycle during 2019 for an 
agreement period start date of July 1, 2019 would allow for a more 
rapid progression of ACOs to the redesigned participation options, 
starting in mid-2019. We further noted that, under this alternative, we 
would also want to offer ACOs that started a first or second agreement 
period on January 1, 2016, a means to continue their participation 
between the conclusion of their current 3-year agreement period 
(December 31, 2018) and the start of their next agreement period 
(January 1, 2020), should the ACO wish to continue in the program. We 
indicated that under that alternative, which would postpone the start 
date for the new participation options to January 1, 2020, we would 
allow ACOs that started a first or second agreement period on January 
1, 2016, to elect a 12-month extension of their current agreement 
period to cover the duration of CY 2019.
    We sought comment on these proposals and the related 
considerations, as well as the alternatives considered.

[[Page 59943]]

    Comment: Regarding the program's application cycles, most 
commenters generally supported CMS' decision to forgo an application 
cycle during CY 2018 for a January 1, 2019 agreement start date. 
Several commenters explained their support for this decision was due to 
the significant revisions to program policies contained in the proposed 
rule.
    Response: We thank commenters for their support of our decision to 
forgo the application cycle that otherwise would take place during CY 
2018 for a January 1, 2019 start date for new Shared Savings Program 
participation agreements.
    Comment: Of the comments addressing the length of the extension for 
ACOs with agreement periods expiring December 31, 2018, a few 
commenters generally supported the proposed participation options for 
agreement periods beginning in 2019, including the proposed 6-month 
extension. Several commenters stated their support for CMS' proposal to 
allow ACOs with agreement periods ending December 31, 2018, to extend 
their agreements through June 30, 2019. Several commenters suggested 
that CMS allow ACOs whose agreement periods expire on December 31, 
2018, an option to extend their current participation agreement by 
either 6 months or 12 months. In addition, many commenters supported 
allowing these ACOs the opportunity to elect a voluntary 12-month 
extension of their current agreement period, for a fourth performance 
year from January 1, 2019 through December 31, 2019. One commenter, 
whose comment was primarily focused on the applicability of policies to 
Track 1 ACOs, specifically recommended that this 12-month extension 
option should be offered for Track 1 ACOs. One commenter suggested that 
CMS permit Track 3 ACOs a 12-month extension for the performance year 
from January 1, 2019 through December 31, 2019, and that CMS apply 
certain aspects of the proposed program redesign, including the use of 
factors based on regional FFS expenditures in establishing, updating 
and adjusting the ACO's historical benchmark and the availability of 
beneficiary incentive programs, during this optional fourth 12-month 
performance year, enabling these Track 3 ACOs to gain experience with 
these policies before deciding whether to continue their participation 
in the Shared Savings Program in the ENHANCED track.
    Some commenters explained that providing a 12-month extension 
option would give ACOs additional time to analyze program changes and 
prepare for the application process. One commenter expressed concern 
that a 6-month extension would provide a limited and inadequate amount 
of time for ACOs to consider participation options under a redesigned 
program, if a final rule establishing a July 1, 2019 start date is not 
issued until later in 2018. This commenter expressed the belief that 
this limited time to consider participation options in advance of a 
July 1, 2019 start date (if finalized) and general uncertainty about 
program policies would result in program attrition, due to ACOs and ACO 
participants electing not to continue in the program at the end of 
their current agreement. One commenter explained a 12-month extension 
would give ACOs additional time to evaluate whether they have the 
appropriate structure in place, implement processes to comply with new 
regulations, and make necessary changes to their ACO participant and 
ACO provider/supplier networks.
    One commenter explained a 12-month extension would provide current 
ACOs with additional time and experience under their current agreement 
periods. Some commenters explained that providing a 12-month extension 
could avoid the complexity and increased burden on providers, 
practices, ACOs, and CMS that could potentially result from ACOs' 
participation in two, 6-month performance years in CY 2019. Other 
commenters raised concerns about making ACO participant list changes, 
and modifying agreements with their ACO participants, to allow for 
participation in two, 6-month performance years during CY 2019, with 
each performance year under a separate participation agreement: The 
first 6-month performance year under their current participation 
agreement (in an extension of their current agreement period); and the 
second 6-month performance year under a new participation agreement 
under one of the proposed redesigned participation options. Some 
commenters requesting a 12-month extension, or the choice between a 6-
month or a 12-month extension, also raised concerns about the 
methodology for determining financial and quality performance for two, 
6-month performance years during CY 2019. We summarize and respond to 
comments related to the methodology for determining performance for the 
6-month performance year from January 1, 2019 through December 31, 
2019, and other program policies applicable to ACOs participating in 
this 6-month performance year, in sections V.B.1.b. and V.B.1.c. of 
this final rule.
    Response: We are not addressing in this final rule, comments on the 
timing for implementing the proposed redesign of the Shared Savings 
Program's participation options. However, we believe it is important to 
allow for continuity in participation for ACOs whose participation 
agreements expire December 31, 2018.
    We appreciate commenters' concerns about preparing to enter a new 
agreement period in light of uncertainty around the participation 
options that may be available. However, we note that, based on the 
proposals in the August 2018 proposed rule, ACOs whose agreement 
periods expire on December 31, 2018, that were interested in continuing 
their participation in the program have had an opportunity to identify 
their likely ACO participants for the proposed 6-month performance year 
from January 1, 2019 through June 30, 2019, and have received 
preliminary feedback from CMS for ACO participant list additions for 
the performance year beginning on January 1, 2019. Moreover, we believe 
these ACOs generally have begun preparing the necessary revisions to 
their agreements with ACO participants and ACO providers/suppliers and, 
if under a two-sided model to extend their repayment mechanism in 
anticipation of the possibility that we would finalize the proposed 6-
month extension period. We believe these ACOs have also been weighing 
their participation options in advance of applying to renew for a 
subsequent agreement period, and will have additional time to make 
these determinations during the 6-month extension (if elected). In 
particular, ACOs reaching the conclusion of their second agreement 
period under Track 1, would have been weighing their participation 
options under two-sided models, given the current requirement that ACOs 
transition to a two-sided model by the start of their third agreement 
period. In fact, the 6-month extension allows ACOs completing their 
second agreement period in Track 1 to continue participation under 
their current agreement period and thereby receive additional time 
under a one-sided model that otherwise would not have been available to 
these ACOs under the program's current regulations.
    We also believe it is important to ensure we retain the flexibility 
to allow ACOs to more rapidly transition, starting as early as July 1, 
2019, to the proposed new participation options, should they be 
finalized, including the participation options that would be Advanced 
APMs that would allow eligible clinicians participating in the ACO to 
qualify for incentive payments

[[Page 59944]]

under the Quality Payment Program. We believe that rapid transition to 
the new participation options would drive more meaningful systematic 
change in ACOs, which have the potential to control their assigned 
beneficiaries' Medicare Parts A and B FFS expenditures by coordinating 
care across care settings, and thus to achieve significant change in 
spending.
    At this time, we believe the proposed 6-month extension for a 6-
month performance year from January 1, 2019 through June 30, 2019, 
strikes an appropriate balance between these factors. To reduce the 
possibility for selective participation bias that could adversely 
affect the Trust Funds, we believe the same option for extending their 
current participation agreement should be made available to all 
eligible ACOs whose agreement periods expire December 31, 2018, as 
opposed to offering ACOs the option to choose between either a 6-month 
or a 12-month extension, or offering extensions of different lengths to 
ACOs based on their current participation track. For example, we 
believe that if we offered a choice regarding the length of the 
extension, only ACOs that would expect to benefit from being rebased 
under new program policies would elect a 6-month extension in order to 
allow the regional rebasing policies to apply sooner.
    We also decline to adopt the commenter's suggestions that we 
finalize certain aspects of the proposed program redesign, such as the 
proposed modifications to the methodology for establishing, adjusting 
and updating an ACO's historical benchmark, and certain payment and 
program flexibilities for eligible ACOs participating under two-sided 
models, and apply these policies to a subset of the ACOs electing the 
voluntary extension. Continuing to apply the current benchmarking 
methodology during the optional fourth performance year maintains ACOs' 
existing historical benchmarks, allowing them to continue to build on 
their experience within their current agreement period and provides a 
more predictable and stable benchmark during the 6-month extension 
period. We also decline to allow only ACOs that are eligible for and 
elect the extension to have access to and make use of additional 
program and payment flexibilities (such as a SNF 3-day rule waiver, 
unless previously approved, or a beneficiary incentive program) as a 
way of allowing these organizations to gain experience with these 
policies in advance of their broader availability (if finalized) to 
eligible ACOs participating in the program. Our proposals to extend the 
availability of a SNF 3-day rule waiver and to give ACOs the 
opportunity to offer beneficiary incentive programs were developed in 
conjunction with our proposed changes to the participation options for 
ACOs participating in the Shared Savings Program. Therefore, we believe 
these proposals need to be considered together as part of a forthcoming 
final rule addressing our proposals for the overall redesign of the 
Shared Savings Program. Further, we believe it would be cumbersome to 
determine ACOs' eligibility for these flexibilities prior to the start 
of the performance year beginning January 1, 2019, particularly given 
the absence of a formal application cycle during CY 2018 during which 
ACOs could elect to apply for such opportunities.
    Comment: One commenter pointed to the Regulatory Impact Analysis of 
the August 2018 proposed rule (83 FR 41926), and our estimate that a 
12-month extension for ACOs whose participation agreements expire on 
December 31, 2018, would reduce overall Federal spending by 
approximately an additional $100 million, as further justification for 
allowing a 12-month rather than a 6-month extension.
    Response: We believe it is important to allow for continuity in 
participation for ACOs whose agreement periods expire on December 31, 
2018. We also believe it is important to ensure ACOs more rapidly 
transition to new participation options in the event we finalize a mid-
year start date for those participation options in 2019. At this time, 
we believe the proposed 6-month extension for a 6-month performance 
year from January 1, 2019 through June 30, 2019, strikes an appropriate 
balance between these factors. The estimated impact of a 12-month 
extension for ACOs whose current agreement periods expire on December 
31, 2018, is not comparable to the impact estimated for a 6-month 
extension for this same group of ACOs. To explain further, the impact 
estimate for a 12-month extension was estimated under a different 
hypothetical baseline. Differences in participation resulting from a 6-
month or a 12-month extension were not a major factor in the impact 
estimate because under the proposed approach, a 12-month extension 
would not have changed the ultimate date that renewing ACOs would be 
required to transition to performance-based risk under the proposed 
redesign. For example, for Track 1 ACOs, a 12-month extension for 
performance year 2019 under Track 1 would result in the Track 1 ACO 
being eligible to participate in proposed BASIC track Level B during 
performance year 2020, whereas with a 6-month extension for a 
performance year from January 1, 2019 through June 30, 2019, under 
Track 1, would permit the ACO up to 1.5 years under proposed BASIC 
track Level B, because the ACO would not automatically transition from 
Level B to Level C at the start of performance year 2020 under the 
policies included in the proposed rule. In either event, however, the 
ACO would be required to participate in performance-based risk under 
Level C, D, or E of the BASIC track by performance year 2021. There 
were also a number of other competing factors working in different 
directions, such as the benchmark the ACO participates under, and the 
availability of Advanced APM incentive payments, which ultimately led 
to our projection that the 12-month extension would result in somewhat 
greater savings over 10 years when compared to the modeling of the 
proposed 6-month extension.
    Comment: One commenter expressed confusion over whether the 
voluntary election for a 6-month performance year from January 1, 2019 
through June 30, 2019, was an option for ACOs within an agreement 
period (such as an ACO that entered an agreement period on January 1, 
2018) as part of the proposed early renewal process.
    Response: The optional 6-month extension is only available for ACOs 
with agreements expiring on December 31, 2018, and would not be 
available to other ACOs that are currently participating in a 3-year 
agreement period in the program because their agreements are not 
expiring. Thus, these ACOs do not require the option of a 6-month 
extension because their current agreement periods will continue during 
2019 and they will not experience a gap in participation as a result of 
our decision to forgo the application cycle in 2018 for an agreement 
start date of January 1, 2019.
    Comment: One commenter suggested that all Track 3 ACOs should be 
offered an extension of their current agreement period, regardless of 
the ACO's agreement period start date.
    Response: We proposed that the one-time, 6-month extension would 
only be available to ACOs whose agreement periods expire on December 
31, 2018, in order to ensure that these ACOs would be able to continue 
participation in the Shared Savings Program without any gap. At this 
time, we decline the commenter's alternative suggestion that we offer a 
similar 6-month extension to ACOs whose agreement periods expire in 
subsequent years. These ACOs would not need a 6-month extension because 
we anticipate a typical, annual application cycle would be available in

[[Page 59945]]

future years so that these ACOs could renew their participation 
agreements and continue their participation in the program without 
interruption.
    Comment: Some commenters urged CMS to provide additional guidance 
and education to ACOs on how ACOs should modify their agreements with 
their ACO participants for the 2019 performance periods. Several ACOs, 
with agreement periods expiring on December 31, 2018, submitted 
comments describing the burden of executing updated participation 
agreements with their ACO participants to account for the 6-month 
extension and the start of a new agreement period under one of the new 
participation options. These commenters explained that expecting the 
program would offer an application cycle in CY 2018 for a January 1, 
2019 agreement start date, their newly executed ACO participant 
agreements were structured according to the program's current policies 
(under the program's regulations and, as applicable, the terms of the 
Track 1+ Model) and do not account for the 6-month extension or 
modified participation options under the proposed redesign of the 
program. One commenter expressed concern that the extension would cause 
some ACO participants to be operating under a different ACO 
participation agreement, depending on whether they started 
participating in the ACO prior to January 1, 2019, or after January 1, 
2019, resulting in different sets of expectations, for example with 
respect to the distribution of shared savings. According to one 
commenter, the time and cost spent on revising agreements with their 
ACO participants would significantly burden the ACO and its 
participants, and delay the execution of many initiatives to reduce 
costs and improve the quality of care as the ACO would spend time 
executing revised agreements with its ACO participants rather than 
focusing on other aspects of its operations. One commenter requested 
that ACOs whose agreement periods expire on December 31, 2018, be given 
ample time to secure extensions to their agreements with ACO 
participants for 2019.
    Response: To prepare for the extension period, ACOs electing to 
extend their participation agreement with CMS must update their ACO 
participant agreements and SNF affiliate agreements, as applicable, 
before the beginning of the next performance year to reflect the 
extension of their current agreement period. As part of the annual 
certification process in advance of 2019, ACOs electing the 6-month 
extension will be required to certify that they have notified their ACO 
participants and SNF affiliates, if applicable, of their continued 
participation in the Shared Savings Program in 2019, and that their ACO 
participant agreements and SNF affiliate agreements, if applicable, 
have been updated. However, ACOs will not be required to submit ACO 
participant agreement or SNF affiliate agreement extensions to CMS.
    ACOs electing the extension would need to extend all current ACO 
participant and/or SNF affiliate agreements on or before December 31, 
2018, so that entities will continue to be ACO participants or SNF 
affiliates, as applicable, for the performance year beginning on 
January 1, 2019. Additionally, the ACO will need to execute ACO 
participant agreements with any new ACO participants to be added to its 
ACO participant list effective January 1, 2019. We also note that these 
ACOs would have been required to revise their ACO participant and SNF 
affiliate agreements, as applicable, if they had been renewing their 
participation agreements for a new agreement period beginning January 
1, 2019. We also note that we now allow ACOs, ACO participants and SNF 
affiliates to digitally sign their agreements, which should help to 
reduce any burden associated with extending agreements. We believe that 
the timing of the issuance of this final rule will permit sufficient 
time for ACOs electing to extend their participation agreements to take 
the necessary steps to extend their ACO participant and SNF affiliate 
agreements, as applicable, before the start of the 6-month performance 
year beginning January 1, 2019.
    In response to the commenter's concern that the extension would 
cause some ACO participants to be operating under different sets of 
expectations (depending on whether they started participating in the 
ACO prior to January 1, 2019 or after January 1, 2019), we note that 
for ACOs that elect the 6-month extension, the payment methodology 
under the ACO's current track would be applicable to determining the 
ACO's shared savings or shared losses, if applicable, for the 6-month 
performance year from January 1, 2019 through June 30, 2019. This is 
the same payment methodology that has applied to the ACO for the 
duration of its agreement period, beginning on January 1, 2016.
    Further, we note that with the exception of the requirements 
specified at Sec.  425.116, the ACO and its ACO participants have 
significant flexibility to determine the contractual terms that would 
apply with respect to all ACO participant agreements, including with 
respect to the use/distribution of shared savings (and payment of 
shared losses).
    Comment: One commenter explained that current and prospective ACOs 
and their leaders are evaluating their options with respect to not only 
the Shared Savings Program start date, but also to participation in 
other potential models such as the Direct Provider Contracting (DPC) 
models anticipated to be tested by CMS' Innovation Center. The 
commenter urged CMS to take the whole payment model landscape into 
account and to take any measures necessary to maximize the level of 
certainty for healthcare providers and to incentivize participation in 
higher-risk models over lower-risk models. For example, the commenter 
recommended that participants in the Shared Savings Program or current 
Innovation Center models should not be excluded from switching to a DPC 
model if and when such a model becomes available, regardless of where 
they are in their current agreement period or the lifecycle of their 
current model.
    Response: We work to align and otherwise create synergies between 
the Shared Savings Program and the payment and service delivery models 
tested by the Innovation Center. We have policies in place to take into 
account overlap between the Shared Savings Program and Innovation 
Center models, which are designed to test new payment and service 
delivery models for the purpose of innovating in the areas of 
healthcare delivery and shared accountability for quality and financial 
performance, whenever possible. We continue to monitor these policies 
and make refinements as we gain experience and lessons learned from 
these interactions. When new models are announced, we encourage ACOs 
and their leaders to engage in dialogue with the Innovation Center and 
Shared Savings Program staff to inform their decision-making regarding 
the participation options.
    After considering the comments received, we are finalizing our 
proposal to allow ACOs that entered a first or second agreement period 
beginning on January 1, 2016, to voluntarily elect a 6-month extension 
of their current agreement period for a fourth performance year from 
January 1, 2019 through June 30, 2019. For the reasons discussed, we 
believe this extension is necessary in order to avoid an involuntary 
gap in participation and to provide ACOs with an opportunity to prepare 
for a more rapid transition to the proposed new participation options, 
including new Advanced APMs that would allow eligible clinicians

[[Page 59946]]

participating in these ACOs to qualify for incentive payments under the 
Quality Payment Program.
    We received no comments on the proposed modifications to the 
definitions of ``agreement period'' and ``performance year'' in Sec.  
425.20 or to the regulation at Sec.  425.200 to establish the 6-month 
extension and to make certain technical and conforming changes. We are 
finalizing as proposed the modifications to the definition of 
``agreement period'' in Sec.  425.20 to broaden the definition to 
generally refer to the term of the participation agreement and the 
revisions to Sec.  425.200(a) to allow for agreement periods greater 
than 3 years. We are also finalizing our proposal to add a provision at 
Sec.  425.200(b)(2) specifying that the term of the participation 
agreement is 3 years and 6 months for an ACO that entered an agreement 
period starting on January 1, 2016, that elects to extend its agreement 
period until June 30, 2019, and this election is made in the form and 
manner and according to the timeframe established by CMS, and certified 
by an ACO executive who has the authority to legally bind the ACO. For 
consistency, we are also finalizing as proposed the minor formatting 
changes to the existing provisions at Sec.  425.200(b)(2) and (b)(3) to 
italicize the header text.
    We are also finalizing as proposed the revision to the definition 
of ``performance year'' in Sec.  425.20 to mean the 12-month period 
beginning on January 1 of each year during the agreement period, unless 
otherwise specified in Sec.  425.200(c) or noted in the participation 
agreement. Therefore, we are also finalizing the proposed revisions to 
Sec.  425.200(c) to make necessary formatting changes and specify an 
additional exception to the definition of performance year as a 12-
month period. Specifically, we are finalizing our proposal to add a 
provision specifying that for an ACO that entered a first or second 
agreement period with a start date of January 1, 2016, and that elects 
to extend its agreement period by a 6-month period, the ACO's fourth 
performance year is the 6-month period between January 1, 2019, and 
June 30, 2019.
    In light of the modifications we are finalizing to Sec.  425.200(c) 
to establish a 6-month performance year during CY 2019, we are also 
finalizing the proposed revisions to the regulation at Sec.  
425.200(d), which reiterates an ACO's obligation to submit quality 
measures in the form and manner required by CMS for each performance 
year of the agreement period, to address the quality reporting 
requirements for ACOs participating in the 6-month performance year 
from January 1, 2019 through June 30, 2019. As described elsewhere in 
this final rule, ACOs electing the voluntary 6-month extension will be 
required to report quality measures for the 2019 reporting period, 
based on CY 2019, consistent with the existing quality reporting 
process and methodology.
b. Methodology for Determining Financial and Quality Performance for 
the 6-Month Performance Year From January 1, 2019 Through June 30, 2019
(1) Background and Description of Methodology
    Under our proposed approach to determining performance for the 6-
month performance year from January 1, 2019 through June 30, 2019, 
after the conclusion of CY 2019, CMS would reconcile the financial and 
quality performance of ACOs that participated in the Shared Savings 
Program during 2019. For ACOs that extended their agreement period for 
the 6-month performance year from January 1, 2019 through June 30, 
2019, CMS would first reconcile the ACO based on its performance during 
the entire 12-month calendar year, and then pro-rate the calendar year 
shared savings or shared losses to reflect the ACO's participation for 
only half of the calendar year. In the August 2018 proposed rule, we 
explained this approach would avoid a more burdensome interim payment 
process that could accompany an alternative proposal to instead 
implement, for example, an 18-month performance year. Consistent with 
the 18- and 21-month performance years offered for the first cohorts of 
Shared Savings Program ACOs, such a policy could require ACOs to 
establish a repayment mechanism that otherwise might not be required, 
create uncertainty over whether the ACO may ultimately need to repay 
CMS based on final results for the extended performance year, and delay 
ACOs seeing a return on their investment in program participation if 
eligible for shared savings.
    We explained our belief that the proposed approach would allow 
continuity in program operations, including operations that occur on a 
calendar year basis. Specifically, the proposed approach would allow 
payment reconciliation to remain on a calendar year basis, which would 
be most consistent with the calendar year-based methodology for 
calculating benchmark expenditures, trend and update factors, risk 
adjustment, county expenditures and regional adjustments. We explained 
that deviating from a 12-month reconciliation calculation by using 
fewer than 12 months of performance year expenditures could interject 
actuarial biases relative to the benchmark expenditures, which are 
based on 12-month benchmark years. As a result, we believed the 
proposed approach of reconciling ACOs based on a 12-month period would 
protect the actuarial soundness of the financial reconciliation 
methodology. We also explained our belief that the alignment of the 
proposed approach with the standard methodology used to perform the 
same calculations for 12-month performance years that correspond to a 
calendar year would make it easier for ACOs and other program 
stakeholders to understand the proposed methodology.
    As is the case with typical calendar year reconciliations in the 
Shared Savings Program, we anticipated results with respect to 
participation during CY 2019 would be made available to ACOs in summer 
2020. We explained that this would allow those ACOs that are eligible 
to share in savings as a result of their participation in the program 
during CY 2019 to receive payment of shared savings following the 
conclusion of the calendar year consistent with the standard process 
and timing for annual payment reconciliation under the program.
    In section II.A.7.b.2 of the August 2018 proposed rule (83 FR 41851 
through 41853), we described in detail our proposed approach to 
determining an ACO's performance for the 6-month performance year from 
January 1, 2019 through June 30, 2019. We also proposed that these 
policies would apply to ACOs that begin a 12-month performance year on 
January 1, 2019, but elect to terminate their participation agreement 
with an effective date of termination of June 30, 2019, in order to 
enter a new agreement period starting on July 1, 2019 (early renewals). 
Our proposed policies addressed the following: (1) The ACO participant 
list that will be used to determine beneficiary assignment; (2) the 
approach to assigning beneficiaries; (3) the quality reporting period; 
(4) the benchmark year assignment methodology and the methodology for 
calculating, adjusting and updating the ACO's historical benchmark; and 
(5) the methodology for determining shared savings and shared losses. 
We proposed to specify these policies for reconciling the 6-month 
period from January 1, 2019 through June 30, 2019, in paragraph (b) of 
a new section of the regulations at Sec.  425.609.
    We proposed to use the ACO participant list for the performance 
year beginning January 1, 2019, to determine

[[Page 59947]]

beneficiary assignment as specified in Sec. Sec.  425.402 and 425.404, 
and according to the ACO's track as specified in Sec.  425.400. As 
discussed in section II.A.7.c. of the August 2018 proposed rule (83 FR 
41855 through 41856), we proposed to allow all ACOs, including ACOs 
entering a 6-month performance year, to make changes to their ACO 
participant list in advance of the performance year beginning January 
1, 2019. Related considerations are discussed in section V.B.1.c.(2) of 
this final rule.
    To determine beneficiary assignment, we proposed to consider the 
allowed charges for primary care services furnished to the beneficiary 
during a 12-month assignment window, allowing for a 3 month claims run 
out. For the 6-month performance year from January 1, 2019 through June 
30, 2019, we proposed to determine the assigned population using the 
following assignment windows:
     For ACOs under preliminary prospective assignment with 
retrospective reconciliation, the assignment window would be CY 2019.
     For ACOs under prospective assignment, Medicare FFS 
beneficiaries would be prospectively assigned to the ACO based on the 
beneficiary's use of primary care services in the most recent 12 months 
for which data are available. For example, in determining prospective 
beneficiary assignment for the January 1, 2019 through June 30, 2019 
performance year we could use an assignment window from October 1, 2017 
through September 30, 2018, to align with the off-set assignment window 
typically used to determine prospective assignment prior to the start 
of a calendar year performance year. Beneficiaries would remain 
prospectively assigned to the ACO at the end of CY 2019 unless they 
meet any of the exclusion criteria under Sec.  425.401(b) during the 
calendar year.
    As discussed in section II.A.7.c.(4) of the August 2018 proposed 
rule (83 FR 41856), to determine ACO performance during a 6-month 
performance year, we proposed to use the ACO's quality performance for 
the 2019 reporting period, and to calculate the ACO's quality 
performance score as provided in Sec.  425.502. We also proposed to use 
a different quality measure sampling methodology depending on whether 
an ACO participates in both a 6-month performance year (or performance 
period) beginning on January 1, 2019, and a 6-month performance year 
beginning on July 1, 2019, or only participates in a 6-month 
performance year from January 1, 2019 through June 30, 2019. As 
described in section V.B.1.c.(4) of this final rule, given the limited 
scope of this final rule, at this time, we are finalizing only our 
proposal to use the ACO's latest certified participant list (the ACO 
participant list effective on January 1, 2019) to determine the quality 
reporting samples for the 2019 reporting period for ACOs that extend 
their prior participation agreement for the 6-month performance year 
from January 1, 2019 to June 30, 2019.
    Consistent with current program policy, we proposed to determine 
assignment for the benchmark years based on the most recent certified 
ACO participant list for the ACO effective for the performance year 
beginning January 1, 2019. This would be the participant list the ACO 
certified prior to the start of its agreement period unless the ACO has 
made changes to its ACO participant list during its agreement period as 
provided in Sec.  425.118(b). If the ACO has made subsequent changes to 
its ACO participant list, we would adjust its historical benchmark to 
reflect the most recent certified ACO participant list. See the 
Medicare Shared Savings Program, ACO Participant List and Participant 
Agreement Guidance (July 2018, version 5), available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/ACO-Participant-List-Agreement.pdf.
    For the 6-month performance year from January 1, 2019 through June 
30, 2019, we proposed to determine the benchmark and calculate 
performance year expenditures for assigned beneficiaries as though the 
performance year were the entire calendar year. The ACO's historical 
benchmark would be determined according to the methodology applicable 
to the ACO based on its agreement period in the program. We would apply 
the methodology for establishing, updating and adjusting the ACO's 
historical benchmark as specified in Sec.  425.602 (for ACOs in a first 
agreement period) or Sec.  425.603 (for ACOs in a second agreement 
period), except that data from CY 2019 would be used in place of data 
for the 6-month performance year in certain calculations, as follows:
     The benchmark would be adjusted for changes in severity 
and case mix between benchmark year 3 and CY 2019 using the methodology 
that accounts separately for newly and continuously assigned 
beneficiaries using prospective HCC risk scores and demographic factors 
as described under Sec. Sec.  425.604(a)(1) through (3), 425.606(a)(1) 
through (3), and 425.610(a)(1) through (3).
     The benchmark would be updated to CY 2019 according to the 
methodology for using growth in national Medicare FFS expenditures for 
assignable beneficiaries described under Sec. Sec.  425.602(b) (for 
ACOs in a first agreement period) and 425.603(b) (for ACOs in a second 
agreement period beginning January 1, 2016).
    For determining financial performance during the 6-month 
performance year from January 1, 2019 through June 30, 2019, we would 
apply the methodology for determining shared savings and shared losses 
according to the approach specified for the ACO's track under the terms 
of the participation agreement that was in effect on January 1, 2019: 
Sec.  425.604 (Track 1), Sec.  425.606 (Track 2) or Sec.  425.610 
(Track 3) and, if applicable, the terms of the ACO's participation 
agreement for the Track 1+ Model authorized under section 1115A of the 
Act. (See discussion in section II.F. of the August 2018 proposed rule 
(83 FR 41912 through 41914) concerning applicability of proposed 
policies to Track 1+ Model ACOs.) However, some exceptions to the 
otherwise applicable methodology were needed because we proposed to 
calculate the expenditures for assigned beneficiaries over the full CY 
2019 for purposes of determining shared savings and shared losses for 
the 6-month performance year from January 1, 2019 through June 30, 
2019. We proposed to use the following steps to calculate shared 
savings and shared losses:
     Average per capita Medicare expenditures for Parts A and B 
services for CY 2019 would be calculated for the ACO's performance year 
assigned beneficiary population.
     We would compare these expenditures to the ACO's updated 
benchmark determined for the calendar year as previously described.
     We would apply the MSR and MLR (as applicable).
    ++ The ACO's assigned beneficiary population for the performance 
year starting on January 1, 2019, would be used to determine the MSR 
for Track 1 ACOs and the variable MSR/MLR for ACOs in a two-sided model 
that selected this option at the start of their agreement period. In 
the event a two-sided model ACO selected a fixed MSR/MLR at the start 
of its agreement period, and the ACO's performance year assigned 
population is below 5,000 beneficiaries, we proposed that the MSR/MLR 
would be determined based on the number of assigned beneficiaries as 
described in section II.A.6.b. of the August 2018 proposed rule (83 FR 
41837 through 41839).

[[Page 59948]]

    ++ To qualify for shared savings, the ACO's average per capita 
Medicare expenditures for its performance year assigned beneficiaries 
during CY 2019 must be below its updated benchmark for the year by at 
least the MSR established for the ACO.
    ++ To be responsible for sharing losses with the Medicare program, 
the ACO's average per capita Medicare expenditures for its performance 
year assigned beneficiaries during CY 2019 must be above its updated 
benchmark for the year by at least the MLR established for the ACO.
     We would determine the shared savings amount if we 
determine the ACO met or exceeded the MSR, and if the ACO met the 
minimum quality performance standards established under Sec.  425.502 
as described in the August 2018 proposed rule and section V.B.1.c.(4) 
of this final rule, and otherwise maintained its eligibility to 
participate in the Shared Savings Program. We would determine the 
shared losses amount if we determine the ACO met or exceeded the MLR. 
To determine these amounts, we would do the following:
    ++ We would apply the final sharing rate or loss sharing rate to 
first dollar savings or losses.
    ++ For ACOs that generated savings that met or exceeded the MSR, we 
would multiply the difference between the updated benchmark 
expenditures and performance year assigned beneficiary expenditures by 
the applicable final sharing rate based on the ACO's track and its 
quality performance as calculated under Sec.  425.502.
    ++ For ACOs that generated losses that met or exceeded the MLR, we 
would multiply the difference between the updated benchmark 
expenditures and performance year assigned beneficiary expenditures by 
the applicable shared loss rate based on the ACO's track and its 
quality performance as calculated under Sec.  425.502 (for ACOs in 
tracks where the loss sharing rate is determined based on the ACO's 
quality performance).
     We would adjust the shared savings amount, if any, for 
sequestration by reducing by 2 percent and compare the sequestration-
adjusted shared savings amount to the applicable performance payment 
limit based on the ACO's track.
     We would compare the shared losses amount, if any, to the 
applicable loss sharing limit based on the ACO's track.
     We would pro-rate any shared savings amount, as adjusted 
for sequestration and the performance payment limit, or any shared 
losses amount, as adjusted for the loss sharing limit, by multiplying 
by one half, which represents the fraction of the calendar year covered 
by the 6-month performance year. This pro-rated amount would be the 
final amount of shared savings that would be paid to the ACO for the 6-
month performance year or the final amount of shared losses that would 
be owed by the ACO for the 6-month performance year.
    We sought comment on these proposals.
    Comment: In general, some commenters supported CMS' proposed 
policies governing how shared savings and shared losses would be 
calculated for the 6-month performance year from January 1, 2019 
through June 30, 2019. Some commenters noted there is significant 
complexity with this approach and urged CMS to clarify and provide 
additional guidance and education to ACOs concerning how certain 
operational details will be addressed. Commenters raised concerns about 
certain aspects of the methodology for determining quality and 
financial performance for a 6-month performance year under the proposed 
approach, and other aspects of program participation affected by a 6-
month performance year, which we summarize elsewhere within section 
V.B.1.b. and V.B.1.c. of this final rule, including (but not limited 
to) the approach to determining beneficiary assignment, flexibilities 
for making ACO participant list changes, quality reporting 
considerations, and interactions with the Quality Payment Program 
policies.
    Response: We appreciate commenters' support for the proposed 
approach for determining financial and quality performance for the 6-
month performance year from January 1, 2019 through June 30, 2019. As 
discussed in the August 2018 proposed rule, we continue to believe in 
the importance of using this approach to maintain alignment with 
program calculations made on a 12-month basis. This approach maintains 
alignment with the program's existing methodology by using 12 months of 
expenditure data (for CY 2019) in determining the ACO's financial 
performance and a 12-month period for quality measure assessment. In 
sections V.B.1.b. and V.B.1.c. of this final rule we respond to 
comments on the specific aspects of the methodology for determining 
financial and quality performance for the 6-month performance year from 
January 1, 2019 through June 30, 2019, and other aspects of program 
participation affected by a 6-month performance year. We acknowledge 
that this approach will add complexity to program policies and certain 
operational processes. To assist ACOs in understanding the operational 
details of participation in a 6-month performance year from January 1, 
2019 through June 30, 2019, we anticipate providing education and 
offering outreach to ACOs on these policies through the various methods 
available, including guidance documents, webinars, FAQs and a weekly 
newsletter.
    Comment: A few commenters expressed support for the proposed 
approach to determining beneficiary assignment for the 6-month 
performance year from January 1, 2019 through June 30, 2019.
    Response: In finalizing the 6-month agreement period extension for 
ACOs that started a first or second agreement period on January 1, 
2016, we believe it is appropriate to finalize our proposed approach to 
determining beneficiary assignment for the performance year from 
January 1, 2019 through June 30, 2019. To determine beneficiary 
assignment for the 6-month performance year, we proposed to consider 
the allowed charges for primary care services furnished to 
beneficiaries during a 12-month assignment window, allowing for a 3-
month claims run out. For ACOs under preliminary prospective assignment 
with retrospective reconciliation, the assignment window would be CY 
2019. For ACOs under prospective assignment, Medicare FFS beneficiaries 
would be prospectively assigned to the ACO based on beneficiaries' use 
of primary care services in the most recent 12 months for which data 
are available. For example, in determining prospective beneficiary 
assignment for the January 1, 2019 through June 30, 2019 performance 
year, we could use an assignment window from October 1, 2017 through 
September 30, 2018, to align with the off-set assignment window 
typically used to determine prospective assignment prior to the start 
of a calendar year performance year. Beneficiaries would remain 
prospectively assigned to the ACO for the performance year unless they 
meet any of the exclusion criteria under Sec.  425.401(b) during the 
calendar year. This approach would maintain alignment with our 
methodology for assigning beneficiaries to ACOs participating in a 12-
month performance year, and allow us to use the same methodology to 
determine beneficiary assignment for all ACOs participating in a 
performance year beginning January 1, 2019. This approach would also be 
consistent with the methodology used to assign beneficiaries for the 
historical benchmark period.

[[Page 59949]]

    Comment: One commenter noted that the proposal to pro-rate shared 
savings and shared losses to reflect the 6-month period of 
participation from January 1, 2019 through June 30, 2019, fails to 
account for habitual behavior of Medicare beneficiaries. The commenter 
explained that most annual wellness visits are performed in the 3rd and 
4th quarters of the calendar year, and quarter 1 and quarter 2 of the 
calendar year typically show lower healthcare utilization. According to 
the commenter, Medicare beneficiaries tend to wait to visit the doctor 
until their deductible is met, which usually occurs towards the end of 
the calendar year. The commenter indicated that this delay occurs even 
for preventive services, like annual wellness visits, that are free at 
the point of delivery. The commenter also seems to have an incorrect 
understanding that we are using only quarter 1 and quarter 2 data to 
determine financial performance for the 6-month performance year from 
January 1, 2019 through June 30, 2019, suggesting that an approach that 
only accounts for 6 months of expenditures would result in quality and 
financial performance determinations that do not fairly reflect the 
ACO's quality of care and expenditures for assigned beneficiaries. 
Another commenter explained that Medicare expenditures demonstrate 
strong and well-known seasonality which would skew performance results 
when comparing performance from the first 6 months of the calendar year 
against a pro-rated benchmark which represents an annual average.
    Response: Under the proposed approach to determining financial and 
quality performance for the 6-month performance year from January 1, 
2019 through June 30, 2019, as restated in this section of this final 
rule, we would continue to determine beneficiary assignment and 
expenditures on a 12-month basis. To determine beneficiary assignment, 
we would consider the allowed charges for primary care services 
furnished to the beneficiary during a 12-month assignment window, 
allowing for a 3-month claims run out. We would maintain the calendar 
year-based methodology for calculating benchmark expenditures, trend 
and update factors, and risk adjustment. To determine shared savings 
and shared losses, we would calculate average per capita Medicare 
expenditures for Parts A and B services for CY 2019 for the ACO's 
performance year assigned beneficiary population and compare this 
amount to the updated historical benchmark. We would then pro-rate any 
shared savings or shared losses by multiplying the amounts by one-half, 
which represents the fraction of the calendar year covered by the 6-
month performance year. We believe this approach addresses the 
commenters' concerns, because we would capture assigned beneficiaries' 
expenditures for the entire CY 2019, which we would compare to a 
benchmark also based on 12 months of expenditures to maintain 
consistency and avoid any seasonality or other variation in 
expenditures that could result from the use of different timeframes. We 
continue to believe that this approach to reconciling ACOs for the 6-
month performance year from January 1, 2019 through June 30, 2019, 
based on expenditures for the 12-month period corresponding to CY 2019 
would protect the actuarial soundness of the financial reconciliation 
methodology.
    Comment: A few commenters urged CMS to apply the regional 
benchmarking methodology in determining the historical benchmark for 
ACOs that first entered the program in 2013 or 2016 that elect a 6-
month extension. One commenter stated that under the program's current 
policies, the regional rebasing methodology would apply to ACOs that 
renew for a second or third agreement period beginning January 1, 2019. 
This commenter also pointed to CMS' proposal in the August 2018 
proposed rule to incorporate regional expenditures in benchmark 
calculations beginning with an ACO's first agreement period for 
agreement periods beginning on July 1, 2019, and in subsequent years to 
underscore the urgency for ACOs that may be entering their seventh 
performance year of program participation without any regional 
adjustment to be under a benchmarking approach that could help to 
sustain their accountable care programs and allow them to drive further 
cost reductions. Several other commenters suggested that CMS rebase the 
historical benchmark for ACOs electing the extension from January 1, 
2019 through June 30, 2019, so that the ACO's historical benchmark 
years would be 2016, 2017, and 2018 (as opposed to 2013, 2014, and 2015 
under the ACO's current agreement period), using a regional rebasing 
methodology. One commenter explained that rebasing these ACOs' 
benchmarks using regional factors would remove the drawback related to 
a delay in agreement period renewal for the organizations on the 
leading edge of the Shared Savings Program. This commenter also 
explained that benchmark rebasing would account for non-claims based 
payments during 2016, 2017, 2018 in the ACO's historical benchmark, and 
would eliminate the delay in aligning the benchmark with the full range 
of services included in calculating performance year expenditures.
    Response: We appreciate the comments, but we decline to accept the 
commenters' suggestions to reset the benchmark for ACOs electing the 6-
month extension to their current agreement period. As proposed, the 6-
month extension allows for continued participation under the ACO's 
current agreement period, which would not meet the conditions for 
applying the program's methodology for rebasing the ACO's historical 
benchmark under Sec.  425.603(a). Accordingly, we would continue to 
update and adjust the benchmarks for ACOs electing this extension using 
the methodology specified under Sec. Sec.  425.602 and 425.603(b), as 
applicable. We also note that for ACOs with second agreement periods 
beginning on January 1, 2016, that elect the voluntary 6-month 
extension, the benchmark rebasing methodology that was used to 
determine their benchmark for their second agreement period accounts 
for a portion of the savings they generated in their prior agreement 
period as an adjustment to their historical benchmark. This adjustment 
coupled with the additional time they will be allowed to participate 
under their existing historical benchmark should continue to provide a 
strong incentive during the extension period.
(2) Use of Authority Under Section 1899(i)(3) of the Act
    In the August 2018 proposed rule (83 FR 41851), we explained our 
belief that the proposal to determine shared savings and shared losses 
for the 6-month performance year starting on January 1, 2019, using 
expenditures for the entire CY 2019 and then pro-rating these amounts 
to reflect the shorter performance year, requires the use of our 
authority under section 1899(i)(3) of the Act to use other payment 
models. Section 1899(d)(1)(B)(i) of the Act specifies that, in each 
year of the agreement period, an ACO is eligible to receive payment for 
shared savings only if the estimated average per capita Medicare 
expenditures under the ACO for Medicare FFS beneficiaries for Parts A 
and B services, adjusted for beneficiary characteristics, is at least 
the percent specified by the Secretary below the applicable benchmark 
under section 1899(d)(1)(B)(ii) of the Act. We explained our belief 
that the proposed approach to calculating the expenditures for assigned 
beneficiaries

[[Page 59950]]

over the full calendar year, comparing this amount to the updated 
benchmark for 2019, and then pro-rating any shared savings (or shared 
losses, which already are implemented using our authority under section 
1899(i)(3) of the Act) for the 6-month performance year involves an 
adjustment to the estimated average per capita Medicare Part A and Part 
B FFS expenditures determined under section 1899(d)(1)(B)(i) of the Act 
that is not based on beneficiary characteristics. Such an adjustment is 
not contemplated under the plain language of section 1899(d)(1)(B)(i) 
of the Act. As a result, we stated it would be necessary to use our 
authority under section 1899(i)(3) of the Act to calculate performance 
year expenditures and determine the final amount of any shared savings 
(or shared losses) for a 6-month performance year during 2019, in the 
proposed manner.
    In order to use our authority under section 1899(i)(3) of the Act 
to adopt an alternative payment methodology to calculate shared savings 
and shared losses for the proposed 6-month performance year from 
January 1, 2019 through June 30, 2019, we must determine that the 
alternative payment methodology will improve the quality and efficiency 
of items and services furnished to Medicare beneficiaries, without 
additional program expenditures. We explained our belief that the 
proposed approach of allowing ACOs that started a first or second 
agreement period on January 1, 2016, to extend their agreement period 
for a 6-month performance year and of allowing entry into the program's 
redesigned participation options beginning on July 1, 2019, if 
finalized, would support continued participation by current ACOs that 
must renew their agreements to continue participating in the program, 
while also resulting in more rapid progression to two-sided risk by 
ACOs within current agreement periods and ACOs entering the program for 
an initial agreement period. As discussed in the Regulatory Impact 
Analysis of the August 2018 proposed rule (83 FR 41915 through 41928), 
we explained our belief that this approach would continue to allow for 
lower growth in Medicare FFS expenditures based on projected 
participation trends. Therefore, we did not believe that the proposed 
methodology for determining shared savings or shared losses for ACOs in 
a 6-month performance year during 2019 would result in an increase in 
spending beyond the expenditures that would otherwise occur under the 
statutory payment methodology in section 1899(d) of the Act. Further, 
we noted that the proposed approach to measuring ACO quality 
performance for a 6-month performance year based on quality data 
reported for CY 2019 would maintain accountability for the quality of 
care ACOs provide to their assigned beneficiaries. Participating ACOs 
would also have an incentive to perform well on the quality measures in 
order to maximize the shared savings they may receive and minimize any 
shared losses they may be required to pay in tracks where the loss 
sharing rate is determined based on the ACO's quality performance. 
Therefore, we noted our expectation that this proposed approach to 
reconciling ACOs for a 6-month performance year during 2019 would 
continue to lead to improvement in the quality of care furnished to 
Medicare FFS beneficiaries.
    As discussed in the Regulatory Impact Analysis section of this 
final rule (section VII.), we believe the approach to determining 
shared savings and shared losses for the 6-month performance year from 
January 1, 2019 through June 30, 2019, for ACOs that elect to 
voluntarily extend their agreement period meets the requirements for 
use of our authority under section 1899(i)(3) of the Act. The 
considerations we described in the August 2018 proposed rule were 
relevant in making this determination. Specifically, we do not believe 
that the methodology for determining shared savings or shared losses 
for ACOs in a 6-month performance year from January 1, 2019 through 
June 30, 2019, (as finalized in this section) will result in an 
increase in spending beyond the expenditures that would otherwise occur 
under the statutory payment methodology in section 1899(d) of the Act. 
Finalizing the voluntary 6-month extension for ACOs whose agreement 
periods expire on December 31, 2018, will support continued 
participation by these ACOs, and therefore, also allow for lower growth 
in Medicare FFS expenditures based on projected participation trends. 
Further, we believe the approach we are finalizing for reconciling ACOs 
for a 6-month performance year from January 1, 2019 through June 30, 
2019, will lead to continued improvement in the quality of care 
furnished to Medicare FFS beneficiaries. As described in section 
V.B.1.c.(4) of this final rule, the approach to measuring ACO quality 
performance for the 6-month performance year from January 1, 2019 
through June 30, 2019, based on quality data reported for CY 2019, will 
maintain accountability for the quality of care ACOs provide to their 
assigned beneficiaries. Participating ACOs will have an incentive to 
perform well on the quality measures in order to maximize the shared 
savings they may receive and minimize any shared losses they may be 
required to pay in two-sided risk tracks where the loss sharing rate is 
determined based on the ACO's quality performance.
(3) Final Policies
    After consideration of the public comments received, we are 
finalizing, with modifications, the proposed approach to determine 
financial and quality performance for ACOs participating in a 6-month 
performance year from January 1, 2019 through June 30, 2019, as 
specified in paragraphs (a) and (b) of a new section of the regulations 
at Sec.  425.609. These modifications are necessary because this final 
rule only addresses the 6-month extension period, and does not address 
our proposal to establish a July 1, 2019 agreement start date. In 
summary, we will do the following to determine an ACO's financial and 
quality performance during the 6-month performance year from January 1, 
2019 through June 30, 2019: We will compare the ACO's historical 
benchmark updated to CY 2019 to the expenditures during CY 2019 for the 
ACO's performance year assigned beneficiaries. If the difference is 
positive and is greater than or equal to the MSR and the ACO has met 
the quality performance standard, the ACO will be eligible for shared 
savings. If the ACO is in a two-sided model and the difference between 
the updated benchmark and assigned beneficiary expenditures is negative 
and is greater than or equal to the MLR (in absolute value terms), the 
ACO will be liable for shared losses. ACOs will share in first dollar 
savings and losses. The amount of any shared savings will be determined 
using the applicable final sharing rate, which is determined based on 
the ACO's track for the applicable agreement period, and taking into 
account the ACO's quality performance for 2019.
    We will adjust the amount of shared savings for sequestration, and 
then cap the amount of shared savings at the applicable performance 
payment limit for the ACO's track. Similarly, the amount of any shared 
losses will be determined using the loss sharing rate for the ACO's 
track and, as applicable, for ACOs in tracks with a loss sharing rate 
that depends upon quality performance, the ACO's quality performance 
for 2019.We will then cap the amount of shared losses at the applicable 
loss sharing limit for the ACO's track. We will then pro-rate any 
shared savings or shared losses by

[[Page 59951]]

multiplying by one-half, which represents the fraction of the calendar 
year covered by the 6-month performance year. This pro-rated amount 
will be the final amount of shared savings earned or shared losses owed 
by the ACO for the 6-month performance year.
    Because we are not addressing the proposed July 1, 2019 agreement 
period start date for the proposed new BASIC track and ENHANCED track 
at this time, we note the following differences between our proposed 
approach (which contemplated that ACOs may be participating in both a 
6-month performance year from January 1, 2019 through June 30, 2019, 
and a 6-month performance year from July 1, 2019 through December 31, 
2019) and our final policies (which are limited to the 6-month 
performance year from January 1, 2019 through June 30, 2019, for 
eligible ACOs that elect to extend their agreement period, which would 
otherwise expire on December 31, 2018):
     We are omitting references that we proposed to include in 
Sec.  425.609(b) in order to establish the applicability of these 
policies to ACOs that begin a 12-month performance year on January 1, 
2019, but elect to terminate their participation agreement with an 
effective date of termination of June 30, 2019, in order to enter a new 
agreement period starting on July 1, 2019 (early renewals). We are also 
making clarifying revisions to the introductory text in Sec.  
425.609(b).
     As described in section V.B.1.c.(4) of this final rule we 
are finalizing a subset of our proposals for identifying the ACO 
participant list used in determining quality reporting samples for ACOs 
participating in a 6-month performance year from January 1, 2019 
through June 30, 2019. We are finalizing our proposal to use the ACO's 
latest certified ACO participant list (the ACO participant list 
effective on January 1, 2019) to determine the quality reporting 
samples for the 2019 reporting period.
     We are not addressing at this time the proposals for 
modifying the MSR/MLR to address small population sizes (83 FR 41837 
through 41839). Therefore, the policies for determining shared savings 
and shared losses in the event the ACO's assigned population falls 
below 5,000, as specified under the program's current regulations at 
Sec.  425.110, would apply to ACOs participating in a 6-month 
performance year from January 1, 2019 through June 30, 2019. Therefore, 
we will specify in Sec.  425.609(b)(3)(ii)(C)(1) that the ACO's 
performance year assigned beneficiary population is used to determine 
the MSR for Track 1 ACOs and the variable MSR/MLR for ACOs in a two-
sided model that selected this option at the start of their agreement 
period. For two-sided model ACOs that selected a fixed MSR/MLR at the 
start of the ACO's agreement period, this fixed MSR/MLR is applied. In 
the event an ACO's performance year assigned population identified in 
Sec.  425.609(b)(1) is below 5,000 beneficiaries, the MSR/MLR is 
determined according to Sec.  425.110(b).
     We are also reserving paragraph (c) of Sec.  425.609 in 
the event that we finalize policies for a second 6-month performance 
year during CY 2019 in the future.
    In section V.B.1.c. of this final rule, we discuss our decision to 
finalize other provisions from the August 2018 proposed rule related to 
determining performance for the 6-month performance year, as specified 
in paragraphs (d) and (e) of Sec.  425.609.
c. Applicability of Program Policies to ACOs Participating in a 6-Month 
Performance Year
    In the August 2018 proposed rule (83 FR 41854), we proposed that 
program requirements under 42 CFR part 425 that are applicable to the 
ACO under the ACO's chosen participation track and based on the ACO's 
agreement start date would be applicable to an ACO participating in a 
6-month performance year, unless otherwise stated. We received no 
comments on this general proposal and we are finalizing this general 
approach as proposed. As we explained in the August 2018 proposed rule, 
this approach will allow routine program operations to continue to 
apply for ACOs participating under a shorter performance year. Further, 
it will ensure consistency in the applicability and implementation of 
our requirements across all program participants, including ACOs 
participating in a 6-month performance year.
    In section V.B.1.b. of this final rule, we describe limited 
exceptions to our general policies for determining financial and 
quality performance which are necessary to ensure calculations can 
continue to be performed on a calendar year basis and using the most 
relevant data.
    In this section, we describe program participation options affected 
by our decision to forgo an application cycle in CY 2018 for a January 
1, 2019 start date, and offer a voluntary extension to allow ACOs whose 
agreement periods expire on December 31, 2018, to continue their 
participation in the program for a 6-month performance year from 
January 1, 2019 through June 30, 2019. We discuss modifications to 
program policies to allow for the 6-month performance year and related 
revisions to the program's regulations. As discussed in section 
II.A.7.c. of the August 2018 proposed rule (83 FR 41854 through 41860), 
these proposals were developed, in part, based on our proposal to offer 
an application cycle in CY 2019 for a July 1, 2019 start date. 
Therefore, we considered that some ACOs would participate in the 
program for both the 6-month performance year (or performance period) 
from January 1, 2019 through June 30, 2019, and the 6-month performance 
year from July 1, 2019 through December 31, 2019, while other ACOs 
would only participate in one of these performance years. In this final 
rule, we do not address the considerations related to the proposed July 
1, 2019 agreement period start date because we are not addressing the 
proposal to offer that start date at this time.
(1) Unavailability of an Application Cycle for Use of a SNF 3-Day Rule 
Waiver Beginning January 1, 2019
    Eligible ACOs may apply for use of a SNF 3-day rule waiver at the 
time of application for an initial agreement or to renew their 
participation. Further, as described in sections II.B.2.a. and II.F. of 
the August 2018 proposed rule (83 FR 41860, 41912), ACOs within a 
current agreement period under Track 3, or the Track 1+ Model may apply 
for a SNF 3-day rule waiver, which, if approved, would begin at the 
start of their next performance year.
    In light of our decision to forgo an application cycle in CY 2018 
for a January 1, 2019 agreement period start date, we are also not 
offering an opportunity for ACOs to apply for a start date of January 
1, 2019, for initial use of a SNF 3-day rule waiver. We proposed that, 
if finalized, the next available application cycle for a SNF 3-day rule 
waiver would occur in advance of a July 1, 2019 start date. Absent 
further rulemaking to establish participation options for a start date 
in 2019 that includes an opportunity for ACOs within existing agreement 
periods in Track 3 or the Track 1+ Model to apply for a SNF 3-day rule 
waiver, these ACOs would not have the opportunity to apply to begin use 
of the waiver until January 1, 2020.
(2) Annual Certifications and ACO Participant List Modifications
    At the end of each performance year, ACOs complete an annual 
certification process. At the same time as this annual certification 
process, CMS also requires ACOs to review, certify and electronically 
sign official program

[[Page 59952]]

documents to support the ACO's participation for the upcoming 
performance year. As we stated in the August 2018 proposed rule (83 FR 
41855), requirements for this annual certification, and other 
certifications that occur on an annual basis, continue to apply to all 
currently participating ACOs in advance of the performance year 
beginning on January 1, 2019.
    Each ACO is required to certify its list of ACO participant TINs 
before the start of its agreement period, before every performance year 
thereafter, and at such other times as specified by CMS in accordance 
with Sec.  425.118(a). A request to add ACO participants must be 
submitted prior to the start of the performance year in which these 
additions would become effective. An ACO must notify CMS no later than 
30 days after termination of an ACO participant agreement, and the 
entity is deleted from the ACO participant list effective as of the 
termination date of the ACO participant agreement. Absent unusual 
circumstances, the ACO participant list that was certified prior to the 
start of the performance year is used to determine beneficiary 
assignment for the performance year and therefore also the ACO's 
quality reporting samples and financial performance. See Sec.  
425.118(b)(3) and see also Medicare Shared Savings Program ACO 
Participant List and Participant Agreement Guidance (July 2018, version 
5), available at https://www.cms.gov/medicare/medicare-fee-for-service-
payment/sharedsavingsprogram/downloads/aco-participant-list-
agreement.pdf. As we explained in the August 2018 proposed rule (83 FR 
41855), these policies would apply for ACOs participating in a 6-month 
performance year consistent with the terms of the existing regulations.
    As we explained in the August 2018 proposed rule (83 FR 41855), 
ACOs that started a first or second agreement period on January 1, 
2016, that extend their agreement period for a 6-month performance year 
beginning on January 1, 2019, would have the opportunity during 2018 to 
make changes to their ACO participant list to be effective for the 6-
month performance year from January 1, 2019, to June 30, 2019. To 
prepare for the possible implementation of this 6-month performance 
year, we allowed ACOs that started a first or second agreement period 
on January 1, 2016, to submit change requests in accordance with usual 
program procedures to indicate additions, updates, and deletions to 
their existing ACO participant lists, and if applicable, SNF affiliate 
lists.
    The program's current regulations prevent duplication of shared 
savings payments; thus, under Sec.  425.114, ACOs may not participate 
in the Shared Savings Program if they include an ACO participant that 
participates in another Medicare initiative that involves shared 
savings. In addition, under Sec.  425.306(b)(2), each ACO participant 
that submits claims for services used to determine the ACO's assigned 
population must be exclusive to one Shared Savings Program ACO. If, 
during a benchmark or performance year (including the 3-month claims 
run out for such benchmark or performance year), an ACO participant 
that participates in more than one ACO submits claims for services used 
in assignment, then CMS will not consider any services billed through 
the TIN of the ACO participant when performing assignment for the 
benchmark or performance year; and the ACO may be subject to the pre-
termination actions set forth in Sec.  425.216, termination under Sec.  
425.218, or both.
    Comment: Some commenters urged CMS to provide ACOs with 
opportunities to add and delete ACO participants throughout the 
performance years (or performance periods) during 2019 and to clarify 
when such opportunities would be available. These commenters urged CMS 
to provide additional guidance and education to ACOs on when 
participant list changes would be permitted. One commenter suggested 
that CMS should provide an additional opportunity for ACOs with 
agreement periods expiring on December 31, 2018, to add ACO 
participants and/or SNF affiliate TINs and CCNs for performance year 
2019 because of the short period of time between the issuance of the 
proposed rule (August 9, 2018) and the final deadline for adding ACO 
participants for performance year 2019 (September 28, 2018). The 
commenter explained that the proposed rule caused confusion and 
uncertainty, and as a result, the commenter believes many ACO 
participants missed the deadline to be added to the ACO participant 
lists of other ACOs. The commenter suggested that we should offer an 
additional opportunity to add ACO participants, with the deadline set 
for 1 month after publication of a final rule.
    Response: During 2018, we allowed ACOs that started a first or 
second agreement period on January 1, 2016, to submit ACO participant 
change requests in accordance with usual program procedures to indicate 
additions, updates, and deletions to their existing ACO participant 
lists and, if applicable, SNF affiliate lists. We noted that the final 
disposition of any change request submitted by an ACO that started a 
first or second agreement period on January 1, 2016, would be 
contingent upon issuance of a final rule establishing an opportunity 
for these ACOs to continue their participation during 2019 without a 
gap in participation. As discussed in section V.B.1. of this final 
rule, we are finalizing the proposed 6-month extension for ACOs whose 
current participation agreement expire on December 31, 2018.
    As a result, all ACOs, including those ACOs that will be eligible 
to elect the voluntary 6-month extension that we are finalizing this 
final rule, had multiple opportunities to submit change requests to add 
ACO participants and/or SNF affiliates for performance years starting 
on January 1, 2019. We also launched a new ACO management system during 
2018 that is more user friendly, provides faster feedback, and 
encourages ACOs to submit change requests to add ACO participants and 
SNF affiliates with fewer errors than the system that was available in 
previous years. We do not believe it is operationally feasible to 
extend the date for ACOs to submit change requests after September 28, 
2018, the date we communicated to ACOs as being the deadline to add ACO 
participants to be effective for performance years beginning on January 
1, 2019. Allowing change requests seeking to add new ACO participants 
to be submitted very close to the end of the calendar year would not 
provide sufficient time to review and screen providers/suppliers for 
program integrity issues and create 2019 assignment list reports, and 
may have other operational impacts (such as on timely production of 
certain other program reports). We note, however, ACO participants can 
be terminated and deleted from the ACO participant list at any time 
during a performance year. The ACO participant is no longer an ACO 
participant as of the termination effective date of the ACO participant 
agreement. Absent unusual circumstances, however, the ACO participant 
data will continue to be utilized for certain operational purposes.
(3) Repayment Mechanism Requirements
    ACOs must demonstrate that they have in place an adequate repayment 
mechanism prior to entering a two-sided model. The repayment mechanism 
must be in effect for the duration of an ACO's participation in a two-
sided model and for a sufficient period of time after the conclusion of 
the agreement period to permit CMS to calculate the amount of

[[Page 59953]]

shared losses owed and to collect this amount from the ACO (Sec.  
425.204(f)(4)). We noted in our ``Repayment Mechanism Arrangements'' 
guidance document that we would consider this standard to be satisfied 
by a repayment mechanism arrangement that remains in effect for 24 
months after the end of the agreement period. See Medicare Shared 
Savings Program & Medicare ACO Track 1+ Model, Repayment Mechanism 
Arrangements, Guidance Document (July 2017, version #6), available at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/Repayment-Mechanism-Guidance.pdf (herein 
Repayment Mechanism Arrangements Guidance).
    In the August 2018 proposed rule (83 FR 41856), we noted that ACOs 
that started a first or second agreement period on January 1, 2016, in 
a two-sided model would have in place under current program policies a 
repayment mechanism arrangement that would cover the 3 years between 
January 1, 2016 and December 31, 2018, plus a 24-month tail period 
until December 31, 2020. We would expect an ACO with an agreement 
period ending December 31, 2018, that extends its agreement for the 6-
month performance year from January 1, 2019 through June 30, 2019, to 
likewise extend the term of its repayment mechanism so that it will be 
in effect for the duration of the ACO's participation in a two-sided 
model plus 24 months following the conclusion of the agreement period 
(that is, until June 30, 2021). This would allow us sufficient time to 
perform financial calculations for the 6-month performance year from 
January 1, 2019 through June 30, 2019, and to use the arrangement to 
collect shared losses for that performance year, if necessary.
    In a forthcoming final rule, we expect to summarize and respond to 
comments on our proposed changes to Sec.  425.204(f) regarding 
repayment mechanism requirements for ACOs that are in a two-sided 
model.
    Comment: One commenter expressed concern over the lack of current 
guidance on the required amount of a repayment mechanism arrangement 
(particularly for Track 1+ Model ACOs) and on how to execute changes to 
an existing repayment mechanism arrangement in order to support an 
ACO's participation during the 6-month performance year from January 1, 
2019 through June 30, 2019. The commenter also indicated that changing 
repayment mechanism amounts mid-year would likely result in extra costs 
to an ACO.
    Response: We appreciate the commenter's concern. We may require a 
Track 1+ Model ACO to adjust its repayment mechanism amount if, during 
the ACO's agreement period, changes in the ACO's participant 
composition occur that result in the application of a relatively higher 
or lower loss sharing limit. For example, if a Track 1+ Model ACO 
reports changes to its composition during the annual certification 
process in advance of the next performance year, and we determine that 
the ACO no longer qualifies for a revenue-based loss sharing limit, we 
may require the ACO to demonstrate that its repayment mechanism is 
sufficient to support losses for a higher amount under a benchmark-
based loss sharing limit (83 FR 41841). We will notify an ACO if there 
is a significant change in its repayment mechanism amount warranting 
modification of its repayment mechanism arrangement and will specify 
the process for submitting to us revised repayment mechanism 
arrangement documentation for review. With regard to ACOs participating 
under Track 2 or Track 3, we clarify that, for the 6-month performance 
year from January 1, 2019 through June 30, 2019, we will not require 
any such ACO that elects to extend its participation agreement for such 
performance year to modify the amount we previously approved for the 
ACO's repayment mechanism arrangement.
    In addition, we have notified ACOs participating under a two-sided 
model that if they elect the 6-month extension from January 1, 2019 
through June 30, 2019 then we expect that they will extend their 
repayment mechanisms in accordance with Sec.  425.204(f)(4). As we 
noted in our Repayment Mechanism Arrangements Guidance, we would 
consider Sec.  425.204(f)(4) to be satisfied by a repayment mechanism 
arrangement that remains in effect for 24 months after the end of the 
agreement period. Accordingly, an ACO participating under a two-sided 
model that elects the 6-month extension from January 1, 2019 through 
June 30, 2019, should extend the term of its repayment mechanism until 
June 30, 2021.
    We acknowledge that amending certain repayment mechanism 
arrangements could come at additional costs to ACOs. However, we 
believe it necessary that the repayment mechanism arrangements comply 
with Shared Savings Program and Track 1+ Model policy to ensure the ACO 
can repay losses for which it may be liable.
(4) Quality Reporting and Quality Measure Sampling
    As described in the August 2018 proposed rule (83 FR 41856 through 
41858), to determine an ACO's quality performance for the 6-month 
performance year from January 1, 2019 through June 30, 2019, we 
proposed to use the ACO's quality performance for the 2019 reporting 
period as determined under Sec.  425.502. Under this proposed approach, 
we would account for the ACO's quality performance using quality 
measure data reported for the 12-month CY 2019.
    As we explained in the August 2018 proposed rule, the following 
considerations support this proposed approach. For one, use of a 12-
month period for quality measure assessment maintains alignment with 
the program's existing quality measurement approach, and aligns with 
the proposed use of 12 months of expenditure data (for CY 2019) in 
determining the ACO's financial performance. Also, this approach would 
continue to align the program's quality reporting period with policies 
under the Quality Payment Program. ACO professionals that are MIPS 
eligible clinicians (not QPs based on their participation in an 
Advanced APM or otherwise excluded from MIPS) would continue to be 
scored under MIPS using the APM scoring standard that covers all of 
2019. Second, the measure specifications for the quality measures used 
under the program require 12 months of data. See for example, the 
Shared Savings Program ACO 2018 Quality Measures Narrative 
Specification Document (January 20, 2018), available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/2018-reporting-year-narrative-specifications.pdf. Third, in light of our proposal to use 12 months of 
expenditures (based on CY 2019) in determining shared savings and 
shared losses for a 6-month performance year, it would also be 
appropriate to hold ACOs accountable for the quality of the care 
furnished to their assigned beneficiaries during this same timeframe. 
Fourth, and lastly, using an annual quality reporting cycle for the 6-
month performance year would avoid the need to introduce new reporting 
requirements, and therefore, potential additional burden on ACOs.
    The ACO participant list is used to determine beneficiary 
assignment for purposes of generating the quality reporting samples. 
Beneficiary assignment is performed using the applicable assignment 
methodology under Sec.  425.400, either preliminary prospective 
assignment or prospective assignment, with excluded beneficiaries 
removed under Sec.  425.401(b), as applicable. The samples for claims-
based measures are typically

[[Page 59954]]

determined based on the assignment list for calendar year quarter 4. 
The sample for quality measures reported through the CMS Web Interface 
is typically determined based on the beneficiary assignment list for 
calendar year quarter 3. The CAHPS for ACOs survey sample is typically 
determined based on the beneficiary assignment list for calendar year 
quarter 2.
    For purposes of determining the quality reporting samples for the 
2019 reporting period, we proposed to use the ACO's most recent 
certified ACO participant list available at the time the quality 
reporting samples are generated, and the assignment methodology most 
recently applicable to the ACO for a 2019 performance year. We 
explained our belief that the use of the ACO's most recent certified 
ACO participant list to assign beneficiaries according to the 
assignment methodology applicable based on the ACO's most recent 
participation in the program during 2019 would result in the most 
relevant beneficiary samples for 2019 quality reporting. Additionally, 
we believed this proposed approach to determining the ACO's quality 
reporting samples was also appropriate for an ACO that participated in 
only one 6-month performance year during 2019 because the most recent 
certified ACO participant list applicable for the performance year 
would also be the certified ACO participant list that is used to 
determine financial performance.
    We proposed two approaches to determine the certified ACO 
participant list, assignment methodology, and assignment window that 
would be used to generate the quality reporting samples for measuring 
quality performance of ACOs participating in the 6-month performance 
year from January 1, 2019 through June 30, 2019. One approach was 
applicable to ACOs that enter a new agreement period under the proposed 
July 1, 2019 agreement start date, including ACOs that extended their 
prior participation agreement for the 6-month performance year from 
January 1, 2019, to June 30, 2019. For ACOs that enter a new agreement 
period beginning on July 1, 2019, we proposed to use the certified ACO 
participant list for the performance year starting on July 1, 2019, to 
determine the quality reporting samples for the 2019 reporting period. 
This most recent certified ACO participant list would therefore be used 
to determine the quality reporting samples for the 2019 reporting year. 
A second approach was proposed for an ACO that extends its 
participation for the first 6 months of 2019, but does not enter a new 
agreement period beginning on the proposed July 1, 2019 agreement start 
date. This second approach is relevant to the policies we are 
finalizing in this final rule, for the 6-month performance year from 
January 1, 2019 through June 30, 2019, for ACOs whose current 
participation agreements expire on December 31, 2018, and that 
voluntarily elect to extend their agreement period for a fourth 
performance year. Under this approach, we proposed to use the ACO's 
latest certified participant list (the ACO participant list effective 
on January 1, 2019) to determine the quality reporting samples for the 
2019 reporting period. Beneficiary assignment for purposes of 
generating the quality reporting samples would be based on the 
assignment methodology applicable to the ACO during its 6-month 
performance year from January 1, 2019 through June 30, 2019, under 
Sec.  425.400, either preliminary prospective assignment or prospective 
assignment, with excluded beneficiaries removed under Sec.  425.401(b), 
as applicable. We anticipated that the assignment windows for the 
quality reporting samples would be as follows, based on our operational 
experience: (1) Samples for claims-based measures would be determined 
based on the assignment list for calendar year quarter 4; (2) the 
sample for CMS Web Interface measures would be determined based on the 
assignment list for calendar year quarter 3; and (3) the sample for the 
CAHPS for ACOs survey would be determined based on the assignment list 
for calendar year quarter 2. We noted that this approach would maintain 
alignment with the assignment windows currently used for establishing 
quality reporting samples for these measures.
    We proposed to specify the certified ACO participant list that 
would be used in determining the quality reporting samples for 
measuring quality performance for the 6-month performance year from 
January 1, 2019 through June 30, 2019, in a new section of the 
regulations at Sec.  425.609(b).
    Comment: Some commenters requested clarification about how quality 
reporting will take place for 6-month performance periods based on 12 
months of data. Specifically, these commenters stated their assumption 
that all ACOs would only be responsible for reporting quality one time, 
during the typical January to March timeframe following the end of 
2019. One commenter expressed concern that the proposed approach for 
two 6-month performance years and two financial reconciliations for 
performance years in CY 2019 would also require two separate quality 
reporting samples for measures reported through the CMS Web Interface. 
The commenter was concerned about the burden that would be imposed on 
ACOs by such a requirement, given that annual quality reporting 
requires a significant amount of ACO resources.
    Response: We proposed to determine quality performance for the 6-
month performance years during 2019 based on an ACO's quality 
performance during the 12-month CY 2019 in order to align with the 
program's existing quality reporting methodology, measure 
specifications which require 12-months of data, and the APM scoring 
standard under MIPS. In addition, because we proposed to use quality 
performance during all of CY 2019, we proposed that ACOs would only 
have to report quality once for CY 2019, regardless of whether they 
complete their participation in the program following the conclusion of 
the 6-month performance year from January 1, 2019 through June 30, 
2019, or they renew for a new agreement period beginning on July 1, 
2019 (if finalized as proposed). Therefore, ACOs participating in the 
6-month performance year from January 1, 2019 through June 30, 2019, 
and the 6-month performance year from July 1, 2019 through December 31, 
2019 (if finalized as proposed), would report quality for one 
beneficiary sample for CY 2019.
    We also note that for the 2019 reporting period, ACOs would be 
required to report quality data through the CMS Web Interface, 
according to the method and timing of submission established by CMS. 
The period for reporting quality data through the CMS Web Interface 
typically occurs for a 12-week period between January and March, 
following the conclusion of the calendar year. Thus, ACOs that 
participate in a 6-month performance year from January 1, 2019 through 
June 30, 2019, along with all other Shared Savings Program ACOs would 
be required to report for the 2019 reporting period, and would report 
quality data through the CMS Web Interface during the designated 
reporting period in early 2020. Further, ACOs participating in the 6-
month performance year from January 1, 201 through June 30, 2019, would 
be required to contract with a CMS-approved vendor to administer the 
CAHPS for ACOs survey for the 2019 reporting period, consistent with 
program-wide policies applicable to all other ACOs. We would apply the 
program's sampling methodology, as we have described in the August 2018 
proposed rule and this section of this final rule, to determine the 
beneficiaries eligible for the samples for claims-based measures (as 
calculated by CMS), CMS

[[Page 59955]]

Web Interface reporting, and the CAHPS for ACOs survey.
    After consideration of the comments, we are finalizing without 
modification our proposal to determine an ACO's quality performance for 
the 6-month performance year from January 1, 2019 through June 30, 
2019, using the ACO's quality performance for the 12-month CY 2019 
(2019 reporting period) as determined under Sec.  425.502. We are also 
finalizing a subset of our proposals for identifying the ACO 
participant list used in determining quality reporting samples for ACOs 
participating in a 6-month performance year from January 1, 2019 
through June 30, 2019. Given the limited scope of this final rule we 
are finalizing our proposal to use an ACO's latest certified ACO 
participant list for the performance year from January 1, 2019 through 
June 30, 2019, (the ACO participant list effective on January 1, 2019) 
to determine the quality reporting samples for the 2019 reporting 
period. We are not addressing at this time our proposals related to the 
proposed July 1, 2019 agreement start date, including the policies for 
determining the quality reporting samples for ACOs that extend their 
participation agreement for the 6-month performance year from January 
1, 2019 through June 30, 2019, and continue their participation in the 
program in a new agreement period beginning on July 1, 2019. We 
anticipate summarizing and responding to comments received on these 
proposals in a forthcoming final rule.
(5) Applicability of Extreme and Uncontrollable Circumstances Policies
    In section II.E.4 of the August 2018 proposed rule (83 FR 41899 
through 41906), we proposed to extend the policies for addressing the 
impact of extreme and uncontrollable circumstances on ACO financial and 
quality performance results for performance year 2017 to performance 
year 2018 and subsequent years. As discussed in section V.B.2.d of this 
final rule, we are finalizing this proposal. In section II.E.4. of the 
August 2018 proposed rule, we indicated that if finalized, these 
policies would apply to ACOs participating in the 6-month performance 
year from January 1, 2019 through June 30, 2019.
    There were no comments directed specifically at our proposals with 
respect to the applicability of these policies for addressing the 
impact of extreme and uncontrollable circumstances on ACOs 
participating in a 6-month performance year from January 1, 2019 
through June 30, 2019. We direct readers to review section V.B.2.d. of 
this final rule, for a more comprehensive discussion of the 
modifications to the program's extreme and uncontrollable circumstances 
policies that we are finalizing with this final rule.
    We are finalizing as proposed the policies for determining the 
financial and quality performance for the 6-month performance year from 
January 1, 2019 through June 30, 2019, for ACOs affected by extreme and 
uncontrollable circumstances during CY 2019. In addition, we are also 
finalizing our proposal to specify, in a new section of the regulations 
at Sec.  425.609(d), the following policies related to determining the 
financial and quality performance for the 6-month performance year from 
January 1, 2019 through June 30, 2019, for an ACO affected by extreme 
and uncontrollable circumstances during CY 2019: (1) In calculating the 
amount of shared losses owed by the ACO, CMS makes adjustments to the 
amount determined under Sec.  425.609(b), as specified in Sec.  
425.606(i) (Track 2) or Sec.  425.610(i) (Track 3), as applicable; and 
(2) in determining the ACO's quality performance score for the 2019 
quality reporting period, CMS uses the alternative scoring methodology 
specified in Sec.  425.502(f).
(6) Payment and Recoupment for 6-Month Performance Years
    In the August 2018 proposed rule (83 FR 41858), we proposed 
policies regarding CMS' notification to ACOs of shared savings and 
shared losses and the timing for ACOs' repayment of shared losses for 
both the 6-month performance year (or performance period) from January 
1, 2019 through June 30, 2019, and the 6-month performance year from 
July 1, 2019 through December 31, 2019.
    In this final rule, we are addressing the proposals specific to the 
6-month performance year from January 1, 2019 through June 30, 2019. In 
a forthcoming final rule, we anticipate discussing comments received on 
the proposals related to payment and recoupment for the 6-month 
performance year from July 1, 2019 through December 31, 2019, and the 
performance period from January 1, 2019 through June 30, 2019, for ACOs 
that terminate their agreement effective June 30, 2019, and enter a new 
agreement period starting on July 1, 2019. We anticipate this final 
rule would include a discussion of our proposal to reduce the shared 
savings payment for one 6-month performance year (or performance 
period) by the amount of any shared losses owed for the other 6-month 
performance year (or performance period).
    In the August 2018 proposed rule, we proposed that the following 
policies would be applicable to ACOs that elect a 6-month extension for 
the performance year from January 1, 2019 through June 30, 2019. 
Because we proposed to perform financial reconciliation for this 6-
month performance year after the end of CY 2019, we anticipated that 
financial performance reports for the 6-month performance year would be 
available in Summer 2020, similar to the expected timeframe for issuing 
financial performance reports for the 12-month 2019 performance year 
(and for 12-month performance years generally).
    We proposed to apply the same policies regarding notification of 
shared savings and shared losses and the timing of repayment of shared 
losses to ACOs in a 6-month performance year that apply under our 
current regulations to ACOs in 12-month performance years. For the 6-
month performance year from January 1, 2019 through June 30, 2019, we 
proposed to specify in a new regulation at Sec.  425.609 that CMS would 
notify the ACO of shared savings or shared losses, consistent with the 
notification requirements specified in Sec.  425.604(f) (Track 1), 
Sec.  425.606(h) (Track 2), and Sec.  425.610(h) (Track 3). 
Specifically, we proposed that the following approach: (1) CMS notifies 
an ACO in writing regarding whether the ACO qualifies for a shared 
savings payment, and if so, the amount of the payment due; (2) CMS 
provides written notification to an ACO of the amount of shared losses, 
if any, that it must repay to the program; (3) if an ACO has shared 
losses, the ACO must make payment in full to CMS within 90 days of 
receipt of notification.
    We proposed to specify policies on payment and recoupment for ACOs 
in a 6-month performance year during CY 2019 in a new section of the 
regulations at Sec.  425.609(e).
    Comment: Some commenters urged CMS to provide additional guidance 
and education to ACOs on whether there will be any disruptions in 
providing performance results to ACOs participating in a 6-month 
performance year in CY 2019.
    Response: We anticipate determining financial and quality 
performance for ACOs participating in the 6-month performance year from 
January 1, 2019 through June 30, 2019, according to the typical annual 
projected timeline for making these determinations, and for issuing 
performance reports to ACOs. The ACO's annual financial reconciliation 
report, quality performance reports, and additional informational 
reports and files, are

[[Page 59956]]

typically made available in the summer following the conclusion of a 
12-month performance year. We also plan to provide ACOs that 
participate in the 6-month performance year from January 1, 2019 
through June 30, 2019, quarterly reports for the third and fourth 
quarter of CY 2019 (see discussion in section V.B.1.c.(8) of this final 
rule). We anticipate that we will make available to ACOs an annual 
schedule for report delivery for 2019. For example, see the 2018 Shared 
Savings Program report schedule included as Table 12 in the Medicare 
Shared Savings Program, Shared Savings and Losses and Assignment 
Methodology Specifications (May 2018, version 6) available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/program-guidance-and-specifications.html.
    We are finalizing without modification our proposal to specify in a 
new section of the regulations at Sec.  425.609(e) that CMS will notify 
the ACO of shared savings or shared losses for the 6-month performance 
year from January 1, 2019 through June 30, 2019, consistent with the 
notification requirements specified in Sec. Sec.  425.604(f), 
425.606(h), and 425.610(h), as applicable. Specifically, we will notify 
an ACO in writing regarding whether the ACO qualifies for a shared 
savings payment, and if so, the amount of the payment due. CMS will 
provide written notification to an ACO of the amount of shared losses, 
if any, that the ACO must repay to the program. If an ACO has shared 
losses, the ACO must make payment in full to CMS within 90 days of 
receipt of notification.
(7) Interactions With the Quality Payment Program
    In the August 2018 proposed rule (83 FR 41859), we took into 
consideration how the proposed July 1, 2019 start date could interact 
with other Medicare initiatives, particularly the Quality Payment 
Program timelines relating to participation in APMs. In the CY 2018 
Quality Payment Program final rule with comment period, we finalized a 
policy for APMs that start or end during the QP Performance Period. 
Specifically, under Sec.  414.1425(c)(7)(i), for Advanced APMs that 
start during the QP Performance Period and are actively tested for at 
least 60 continuous days during a QP Performance Period, CMS will make 
QP determinations and Partial QP determinations for eligible clinicians 
in the Advanced APM using claims data for services furnished during 
those dates on which the Advanced APM is actively tested. CMS performs 
QP determinations for eligible clinicians in an APM entity three times 
during the QP Performance Period using claims data for services 
furnished from January 1 through each of the respective QP 
determination dates: March 31, June 30, and August 31 (Sec.  
414.1425(b)(1)). We explained that this meant that an APM (such as a 
two-sided model of the Shared Savings Program) would need to begin 
operations by July 1 of a given performance year in order to be 
actively tested for at least 60 continuous days before August 31--the 
last date on which QP determinations are made during a QP Performance 
Period (as specified in Sec.  414.1425(b)(1)). Therefore, we believed 
that our proposed July 1, 2019 start date for the proposed new 
participation options under the Shared Savings Program would align with 
Quality Payment Program rules and requirements for participation in 
Advanced APMs. However, we did not address QP determinations for 
eligible clinicians participating in an ACO whose agreement period 
expires on December 31, 2018, that elects a voluntary extension for the 
6-month performance year from January 1, 2019 through June 30, 2019, 
and does not continue in the program past June 30, 2019.
    Further, as described in section II.A.7.c.(4) of the August 2018 
proposed rule (83 FR 41856), our proposal to use a 12-month period for 
quality measure assessment for either 6-month performance year during 
2019 would maintain alignment with the program's existing quality 
measurement approach, and align with the proposed use of 12 months of 
expenditure data (for CY 2019) in determining the ACO's financial 
performance for a 6-month performance year. Also, this approach would 
continue to align the program's quality reporting period with policies 
under the Quality Payment Program (83 FR 41856). We explained that ACO 
professionals that are MIPS eligible clinicians (not QPs based on their 
participation in an Advanced APM or otherwise excluded from MIPS) would 
continue to be scored under MIPS using the APM scoring standard that 
covers all of 2019.
    Comment: One commenter indicated that, as proposed, it appears ACOs 
in a two-sided model may lose Advanced APM Entity status and sought 
clarity on the Advanced APM status for all participating ACOs. This 
commenter was specifically concerned about the Advanced APM status of 
the Track 1+ Model.
    Response: We believe the comment reflects the need for 
clarification about whether eligible clinicians in an ACO that is 
participating in a track that meets the Advanced APM criteria and that 
elects to extend for the 6-month performance year from January 1, 2019 
through June 30, 2019, but does not continue its participation in the 
Shared Savings Program past June 30, 2019, would be eligible to become 
QPs during the 2019 QP Performance Period. Eligible clinicians who 
become QPs will earn the Advanced APM incentive payment and will not be 
subject to the MIPS reporting requirements and payment adjustments for 
the applicable year. The commenter may have been concerned that an 
agreement period that ends prior to the end of the QP performance 
period (August 31, 2019) would be considered an early termination and 
that the ACO would therefore lose its status as participating in an 
Advanced APM, which is not the case under our previously-finalized 
policy for Advanced APMs that start or end during a performance period. 
For an ACO that is in a track that meets the Advanced APM criteria and 
elects to extend for the 6-month performance year from January 1, 2019 
through June 30, 2019, the agreement period would end during the QP 
performance period. However, because the ACO would have been active for 
more than 60 days, it would continue to be an APM entity in an Advanced 
APM in 2019 (Sec.  414.1425(c)(7)). Therefore, clinicians who obtain QP 
status based on the March 31, 2019, or June 30, 2019 snapshot through 
participation in an ACO with a 6-month extension of its agreement 
period will: Maintain QP status, be exempt from MIPS, and receive the 
APM incentive payment, as long as their ACO completes its agreement 
period by remaining in the program through June 30, 2019.
    We also believe there is a need to clarify what happens to an 
eligible clinician's QP status if they are participating in an ACO that 
is in a track that meets the Advanced APM criteria and elects to extend 
for the 6-month performance year from January 1, 2019 through June 30, 
2019, and either voluntarily terminates or is involuntarily terminated 
prior to June 30, 2019. If their ACO terminates or is involuntarily 
terminated any time after March 31, 2019, and before August 31, 2019, 
then eligible clinicians previously determined to have had QP status 
would lose their status as a result of the termination, and would 
instead be scored under MIPS using the APM Scoring Standard (Sec.  
414.1425(c)(5) and (6)). If their ACO terminates before March 31, 2019, 
then the eligible clinicians would not be scored under the APM Scoring 
Standard and will be

[[Page 59957]]

assessed under regular MIPS scoring rules (Sec. Sec.  414.1370(e) and 
414.1425(b)(1)).
    Comment: Some commenters requested clarification on how quality 
reporting for a 6-month performance period based on 12-months of data 
for 2019 will satisfy the MIPS quality reporting requirements for MIPS 
eligible clinicians in ACOs that elect to extend their participation 
agreement for the 6-month performance year from January 1, 2019 through 
June 30, 2019. One commenter indicated there was no discussion of how 
the proposed 6-month extension period would impact scoring under the 
APM scoring standard.
    Response: We believe the comments reflect the need for 
clarification about whether 2019 quality performance for a 6-month 
performance year under the Shared Savings Program will count the same 
as a full year of performance for purposes of the APM scoring standard 
if the ACO ends its current agreement period at the end of the 6-month 
extension and chooses to not renew its agreement with a July 1, 2019 
start date (if finalized as proposed). That is, would the 2019 quality 
reporting for the 6-month performance year count toward the final MIPS 
score in the same way that it would for an ACO that is participating in 
a full 12-month performance year in the program.
    As discussed in this section of this final rule, we are finalizing 
a policy of using a 12-month period for quality performance assessment 
for the 6-month performance year from January 1, 2019 through June 30, 
2019, in order to maintain alignment with the program's existing 
quality measurement approach, and with policies under the Quality 
Payment Program. ACO professionals that are MIPS eligible clinicians 
(not QPs based on their participation in an Advanced APM or otherwise 
excluded from MIPS) participating in an ACO that completes a 6-month 
performance year from January 1, 2019 through June 30, 2019, would 
continue to be scored under MIPS using the APM Scoring Standard, based 
on quality data submitted for all of 2019 during the regular submission 
period in early 2020. Thus, for a Track 1 ACO in a 6-month performance 
year from January 1, 2019 through June 30, 2019, whose agreement period 
expires and the ACO does not renew to continue program participation, 
the ACO would be scored under the MIPS APM scoring rules for quality 
reporting based on the entire CY 2019.
(8) Sharing CY 2019 Aggregate Data With ACOs in 6-Month Performance 
Year From January 1, 2019 Through June 30, 2019
    Under the program's current regulations at Sec.  425.702, we share 
aggregate data with ACOs during the agreement period. This includes 
providing data at the beginning of each performance year, during each 
quarter, and in conjunction with the annual reconciliation. In the 
August 2018 proposed rule (83 FR 41859), for ACOs that started a first 
or second agreement period on January 1, 2016, that extend their 
agreement for an additional 6-month performance year from January 1, 
2019 through June 30, 2019, we proposed to continue to deliver 
aggregate reports for all four quarters of CY 2019 based on the ACO 
participant list in effect for the 6-month performance year. This would 
give ACOs a more complete understanding of the Medicare FFS beneficiary 
population that is the basis for reconciliation for the 6-month 
performance year by allowing them to continue to receive data, 
including demographic characteristics and expenditure/utilization 
trends for their assigned population for the entire calendar year. We 
believed this proposed approach would allow us to maintain transparency 
by providing ACOs with data that relates to the entire period for which 
the expenditures for the beneficiaries assigned to the ACO for the 6-
month performance year would be compared to the ACO's benchmark (before 
pro-rating any shared savings or shared losses to reflect the length of 
the performance year), and maintain consistency with the reports 
delivered to ACOs that participate in a 12-month performance year 2019. 
Otherwise, we could be limited to providing ACOs with aggregate reports 
only for the first and second quarters of 2019, even though under our 
proposed methodology for assessing the financial performance of ACOs in 
a 6-month performance year, the financial reconciliation for the 6-
month performance year would involve consideration of expenditures from 
outside this period during 2019. We proposed to specify this policy in 
revisions to Sec.  425.702.
    Comment: Some commenters urged CMS to provide additional guidance 
and education to ACOs on whether there will be any disruptions in 
sharing claims files with ACOs participating in a 6-month performance 
year in CY 2019.
    Response: In the August 2018 proposed rule, we did not describe in 
detail the applicability of the program's policies on sharing 
beneficiary-identifiable claims data with ACOs under Sec.  425.704. We 
proposed, generally, that unless otherwise stated, program requirements 
under 42 CFR part 425 that are applicable to the ACO under the ACO's 
chosen participation track and based on the ACO's agreement start date 
would be applicable to an ACO participating in a 6-month performance 
year. Therefore, we would continue to provide beneficiary-identifiable 
claims data (referred to as claim and claim line feed files) to ACOs 
only during their participation in the program, including during the 6-
month performance year from January 1, 2019 through June 30, 2019. ACOs 
would receive monthly Part A, B and D claim and claim line feed files 
during the 6-month performance year based on the ACO participant list 
they certify before the start of the performance year. Consistent with 
the program's current data sharing policies, we would discontinue 
delivery of beneficiary-identifiable data to ACOs when their 
participation agreement is no longer in effect.
    After consideration of the comments received, we are finalizing our 
proposal to deliver to ACOs participating in a 6-month performance year 
from January 1, 2019 through June 30, 2019, aggregate reports for all 
four quarters of CY 2019 based on the ACO participant list in effect 
for the performance year. This policy is specified in revisions to 
Sec.  425.702.
(9) Technical or Conforming Changes To Allow for 6-Month Performance 
Years
    In the August 2018 proposed rule (83 FR 41859 through 41860), we 
proposed to make certain technical, conforming changes to certain 
provisions of the regulations, including additional changes to 
provisions discussed elsewhere in the proposed rule, to reflect our 
proposal to add a new provision at Sec.  425.609 to govern the 
calculation of the financial and quality results for the proposed 6-
month performance years within CY 2019.
    In this final rule, we are addressing only the proposals specific 
to the 6-month performance year from January 1, 2019 through June 30, 
2019. In a forthcoming final rule, we anticipate discussing comments 
received on the proposed 6-month performance year from July 1, 2019 
through December 31, 2019, and the proposed 6-month performance period 
from January 1, 2019 through June 30, 2019, for ACOs that terminate 
their agreement effective June 30, 2019, and enter a new agreement 
period starting on July 1, 2019.

[[Page 59958]]

    The following proposals discussed in the August 2018 proposed rule 
would be applicable to ACOs that elect a 6-month extension for the 
performance year from January 1, 2019 through June 30, 2019.
    Our proposal that the policies on reopening determinations of 
shared savings and shared losses to correct financial reconciliation 
calculations (Sec.  425.315) would apply with respect to applicable 
payment determinations for performance years within CY 2019. To 
clarify, we proposed to amend Sec.  425.315 to incorporate a reference 
to the proposed provision for notification of shared savings and shared 
losses for ACOs in a 6-month performance year within CY 2019, as 
specified in Sec.  425.609(e).
    Our proposal to add a reference to Sec.  425.609 in Sec.  425.100 
in order to include ACOs that participate in a 6-month performance year 
during 2019 in the general description of ACOs that are eligible to 
receive payments for shared savings under the program.
    Our proposal to amend Sec.  425.400(a)(1)(ii), which describes the 
step-wise process for determining beneficiary assignment for each 
performance year, to specify that this process would apply to ACOs 
participating in a 6-month performance year within CY 2019, and that 
assignment would be determined based on the beneficiary's utilization 
of primary care services during the entirety of CY 2019, as specified 
in Sec.  425.609.
    Our proposal to further revise Sec.  425.400(c)(1)(iv), on the use 
of certain Current Procedural Terminology (CPT) codes and Healthcare 
Common Procedure Coding System (HCPCS) codes in determining beneficiary 
assignment, to specify that it would be used in determining assignment 
for performance years starting on January 1, 2019, and subsequent 
years. We note that we also proposed certain other revisions to this 
provision in section II.E.3. of the August 2018 proposed rule (83 FR 
41896), as discussed in section V.B.2.c. of this final rule.
    Our proposal to revise Sec.  425.401(b), describing the exclusion 
of beneficiaries from an ACO's prospective assignment list at the end 
of a performance year or benchmark year and quarterly during each 
performance year, to specify that these exclusions would occur at the 
end of CY 2019 for purposes of determining assignment to an ACO in a 6-
month performance year in accordance with Sec. Sec.  425.400(a)(3)(ii) 
and 425.609.
    Our proposal, as part of the proposed revisions to Sec.  
425.402(e)(2), which, as described in section II.E.2. of the August 
2018 proposed rule (83 FR 41894), specifies that beneficiaries who have 
designated a provider or supplier outside the ACO as responsible for 
coordinating their overall care will not be added to the ACO's list of 
assigned beneficiaries for a performance year under the claims-based 
assignment methodology, to allow the same policy to apply to ACOs 
participating in a 6-month performance year during CY 2019. We are 
finalizing our proposed revisions to Sec.  425.402(e)(2), as described 
in section V.B.2.b. of this final rule.
    Our proposal to revise Sec.  425.404(b), on the special assignment 
conditions for ACOs that include FQHCs and RHCs that provide services 
used in determining beneficiary assignment, to specify its 
applicability in determining assignment for performance years starting 
on January 1, 2019, and subsequent performance years.
    We also proposed to incorporate references to Sec.  425.609 in the 
regulations that govern establishing, adjusting, and updating the 
benchmark, including the existing provisions at Sec. Sec.  425.602 and 
425.603, to specify that the annual risk adjustment and update to the 
ACO's historical benchmark for the 6-month performance year from 
January 1, 2019 through June 30, 2019, would use factors based on the 
entirety of CY 2019. For clarity and simplicity, we proposed to add a 
paragraph to each of these sections to explain the following: (1) 
Regarding the annual risk adjustment applied to the historical 
benchmark, when CMS adjusts the benchmark for the 6-month performance 
year from January 1, 2019 through June 30, 2019, the adjustment will 
reflect the change in severity and case mix between benchmark year 3 
and CY 2019; (2) Regarding the annual update to the historical 
benchmark, when CMS updates the benchmark for the 6-month performance 
year from January 1, 2019 through June 30, 2019, the update to the 
benchmark will be based on growth between benchmark year 3 and CY 2019.
    We also proposed to incorporate references to Sec.  425.609 in the 
following provisions regarding the calculation of shared savings and 
shared losses: Sec. Sec.  425.604, 425.606, and 425.610. For clarity 
and simplicity, we proposed to add a paragraph to each of these 
sections explaining that shared savings or shared losses for the 6-
month performance year from January 1, 2019 through June 30, 2019, are 
calculated as described in Sec.  425.609. That is, all calculations 
will be performed using CY 2019 data in place of performance year data.
    There were no comments directed specifically at our proposed 
technical and conforming changes to allow for 6-month performance 
years. We are finalizing as proposed the technical and conforming 
changes to the Shared Savings Program regulations as previously 
described in this section of this final rule, to allow them to apply to 
ACOs participating in a 6-month performance year from January 1, 2019 
through June 30, 2019.
(10) Payment Consequences of Early Termination
    In the August 2018 proposed rule (83 FR 41845 through 41847), we 
proposed policies to govern the payment consequences of early 
termination for performance years beginning in 2019 and subsequent 
years, including for ACOs participating in 6-month performance years 
from January 1, 2019 through June 30, 2019, and July 1, 2019 through 
December 31, 2019, as well as for ACOs participating in 12-month 
performance years. We proposed to impose payment consequences for early 
termination by holding ACOs in two-sided models liable for pro-rated 
shared losses. This approach would apply to ACOs that voluntarily 
terminate their participation more than midway through a 12-month 
performance year and all ACOs that are involuntarily terminated by CMS. 
ACOs would be ineligible to share in savings for a performance year if 
the effective date of their termination from the program is prior to 
the last calendar day of the performance year; but, we would allow an 
exception for ACOs that are participating in a 12-month performance 
year under the program as of January 1, 2019, that terminate their 
agreement with an effective date of June 30, 2019, and enter a new 
agreement period under the proposed BASIC track or ENHANCED track 
beginning July 1, 2019. In these cases, we would perform separate 
reconciliations to determine shared savings and shared losses for the 
ACO's first 6 month period of participation in 2019 and for the ACO's 
6-month performance year from July 1, 2019, to December 31, 2019, under 
the subsequent participation agreement.
    In a forthcoming final rule we anticipate addressing comments 
received on proposals for the payment consequences of early termination 
from 12-month performance years and from 6-month performance years 
beginning on July 1, 2019, should we finalize the proposal to offer a 
July 1, 2019 start date for the new participation options. Therefore, 
in this section of this final rule we focus specifically on the 
proposals regarding the payment consequences of early termination as 
they relate to the 6-month performance

[[Page 59959]]

year from January 1, 2019 through June 30, 2019.
    We proposed that an ACO would be eligible to receive shared savings 
for a 6-month performance year during 2019 if it completes the term of 
the performance year, regardless of whether the ACO chooses to continue 
its participation in the program. That is, we would reconcile ACOs that 
started a first or second agreement period January 1, 2016, that extend 
their agreement period for a fourth performance year, and complete this 
performance year (concluding on June 30, 2019).
    For an ACO that participates for a portion of a 6-month performance 
year during 2019, we proposed the following: (1) If the ACO terminates 
its participation agreement effective before the end of the performance 
year, we would not reconcile the ACO for shared savings or shared 
losses (if a two-sided model ACO); (2) if CMS terminates a two-sided 
model ACO's participation agreement effective before the end of the 
performance year, the ACO would not be eligible for shared savings and 
we would reconcile the ACO for shared losses and pro-rate the amount 
reflecting the number of months during the performance year that the 
ACO was in the program. We proposed to specify these policies in 
amendments to Sec.  425.221(b).
    We also proposed to revise the regulation at Sec.  425.221 to 
streamline and reorganize the provisions in paragraph (b), which we 
believed necessary to incorporate the proposed new requirements. We 
sought comment on these proposals.
    We are not addressing our proposed modifications to program 
policies to impose payment consequences for early termination in this 
final rule. Accordingly, for ACOs participating in a performance year 
starting on January 1, 2019, we will continue to apply the program's 
current policies for payment consequences of early termination. We 
believe that continuing to use the current approach would be simpler, 
both from the standpoint of CMS as the regulatory entity and operator 
of the program, and for ACOs as regulated entities already familiar 
with the current policies. Under this approach, ACOs that terminate 
from a performance year starting on January 1, 2019, with an effective 
date of termination prior to the end of their performance year will not 
be eligible for shared savings or accountable for shared losses.
    At this time, we are finalizing a subset of our proposed policies 
for determining payment consequences of early termination, to account 
for ACOs participating in a 6-month performance year from January 1, 
2019 through June 30, 2019. Specifically, we are finalizing without 
modification our proposal that an ACO participating in a 6-month 
performance year from January 1, 2019 through June 30, 2019, is 
eligible for shared savings if the following conditions are met: CMS 
has designated or approved an effective date of termination that is the 
last calendar day of the performance year (June 30, 2019); the ACO has 
completed all close-out procedures specified in Sec.  425.221(a) by the 
deadline specified by CMS (if applicable); and the ACO has satisfied 
the criteria for sharing in savings for the performance year. 
Consistent with our existing policies, if the participation agreement 
is terminated at any time by CMS under Sec.  425.218, the ACO will not 
be eligible to receive shared savings for the performance year during 
which the termination becomes effective, and will not be accountable 
for any shared losses. Further, for an ACO participating in a 6-month 
performance year from January 1, 2019 through June 30, 2019, that 
elects to terminate early, we will apply the payment consequences of 
early termination consistent with the current regulations, and the ACO 
will not be eligible to receive shared savings for the performance year 
and will not be accountable for any shared losses.
    We are finalizing the proposed revisions to Sec.  425.221 to allow 
us to consistently apply current program policies on the payment 
consequences of early termination or agreement expiration to ACOs in a 
6-month performance year from January 1, 2019 through June 30, 2019. We 
are amending Sec.  425.221(b) to remove references to December 31st of 
a performance year and instead to refer to the last calendar day of the 
performance year, so that the regulatory provisions will apply to ACOs 
regardless of whether they are participating in a 12-month or 6-month 
performance year. We are not addressing at this time the other proposed 
revisions to the regulation at Sec.  425.221, including the proposals 
to streamline and reorganize the provisions in paragraph (b).
2. Updating Program Policies
a. Overview
    This section addresses various proposed revisions described in the 
August 2018 proposed rule (83 FR 41894 through 41911) that are designed 
to update policies under the Shared Savings Program. We proposed to 
revise our regulations governing the assignment process in order to 
align our voluntary alignment policies with the requirements of section 
50331 of the Bipartisan Budget Act of 2018 and to update the definition 
of primary care services. We also proposed to extend the policies that 
we recently adopted for ACOs impacted by extreme and uncontrollable 
circumstances during 2017 to 2018 and subsequent performance years. We 
also solicited comment on considerations related to supporting ACOs' 
activities to address the national opioid crisis and the agency's 
meaningful measures initiative. We proposed to discontinue use of the 
quality performance measure that assesses the level of adoption of 
CEHRT by the eligible clinicians in an ACO and proposed instead that 
ACOs be required to certify upon application to participate in the 
Shared Savings Program and annually thereafter that the percentage of 
eligible clinicians participating in the ACO using CEHRT to document 
and communicate clinical care to their patients or other health care 
providers meets or exceeds certain thresholds.
b. Revisions to Policies on Voluntary Alignment
(1) Background
    Section 50331 of the Bipartisan Budget Act of 2018 amended section 
1899(c) of the Act (42 U.S.C. 1395jjj(c)) to add a new paragraph (2)(B) 
that requires the Secretary, for performance year 2018 and each 
subsequent performance year, to permit a Medicare FFS beneficiary to 
voluntarily identify an ACO professional as the primary care provider 
of the beneficiary for purposes of assigning such beneficiary to an 
ACO, if a system is available for electronic designation. A voluntary 
identification by a Medicare FFS beneficiary under this provision 
supersedes any claims-based assignment otherwise determined by the 
Secretary. Section 50331 also requires the Secretary to establish a 
process under which a Medicare FFS beneficiary is notified of his or 
her ability to designate a primary care provider or subsequently to 
change this designation. An ACO professional is defined under section 
1899(h) of the Act as a physician as defined in section 1861(r)(1) of 
the Act and a practitioner described in section 1842(b)(18)(C)(i) of 
the Act.
    As we stated in the August 2018 proposed rule (83 FR 41894), we 
believe that section 50331 requires certain revisions to our current 
beneficiary voluntary alignment policies in Sec.  425.402(e). Prior to 
enactment of the Bipartisan Budget Act of 2018, section 1899(c) of the 
Act required that beneficiaries be assigned to an ACO based on their 
use of primary care services furnished by a physician as

[[Page 59960]]

defined in section 1861(r)(1) of the Act, and beginning January 1, 
2019, services provided in RHCs/FQHCs. In order to satisfy this 
statutory requirement, we currently require that a beneficiary receive 
at least one primary care service during the beneficiary assignment 
window from an ACO professional in the ACO who is a physician with a 
specialty used in assignment in order to be assigned to the ACO (see 
Sec.  425.402(b)(1)). As currently provided in Sec.  425.404(b), for 
performance year 2019 and subsequent performance years, for purposes of 
the assignment methodology in Sec.  425.402, CMS treats a service 
reported on an FQHC/RHC claim as a primary care service performed by a 
primary care physician. After identifying the beneficiaries who have 
received a primary care service from a physician in the ACO, we use a 
two-step, claims-based methodology to assign beneficiaries to a 
particular ACO for a calendar year (see Sec.  425.402(b)(2) through 
(4)). In the CY 2017 PFS final rule (81 FR 80501 through 80510), we 
augmented this claims-based beneficiary assignment methodology by 
finalizing a policy under which beneficiaries, beginning in 2017 for 
assignment for performance year 2018, may voluntarily align with an ACO 
by designating a ``primary clinician'' they believe is responsible for 
coordinating their overall care using MyMedicare.gov, a secure online 
patient portal. MyMedicare.gov contains a list of all of the Medicare-
enrolled practitioners who appear on the Physician Compare website and 
beneficiaries may choose any practitioner present on Physician Compare 
as their primary clinician.
    Notwithstanding the assignment methodology in Sec.  425.402(b), 
beneficiaries who designate an ACO professional whose services are used 
in assignment as responsible for their overall care will be 
prospectively assigned to the ACO in which that ACO professional 
participates, provided the beneficiary meets the eligibility criteria 
established at Sec.  425.401(a) and is not excluded from assignment by 
the criteria in Sec.  425.401(b), and has had at least one primary care 
service during the assignment window with an ACO professional in the 
ACO who is a primary care physician as defined under Sec.  425.20 or a 
physician with one of the primary specialty designations included in 
Sec.  425.402(c) (see Sec.  425.402(e)). Such beneficiaries will be 
added prospectively to the ACO's list of assigned beneficiaries for the 
subsequent performance year, superseding any assignment that might have 
otherwise occurred under the claims-based methodology. Further, 
beneficiaries may change their designation at any time through 
MyMedicare.gov; the new choice will be incorporated when we perform 
assignment for the subsequent performance year. Beneficiaries who 
designate a provider or supplier outside an ACO, who is a primary care 
physician, a physician with a specialty designation that is considered 
in the assignment methodology, or a nurse practitioner, physician 
assistant, or clinical nurse specialist, as responsible for 
coordinating their overall care will not be added to an ACO's list of 
assigned beneficiaries, even if they would otherwise meet the criteria 
for claims-based assignment.
(2) Summary of Proposed Revisions
    Section 1899(c) of the Act, as amended by section 50331 of the 
Bipartisan Budget Act of 2018, requires the Secretary to permit a 
Medicare FFS beneficiary to voluntarily identify an ACO professional as 
their primary care provider for purposes of assignment to an ACO. Under 
our current methodology, a beneficiary may select any practitioner who 
has a record on the Physician Compare website as their primary 
clinician; however, we will only assign the beneficiary to an ACO if 
they have chosen a practitioner who is a primary care physician (as 
defined at Sec.  425.20), a physician with one of the primary specialty 
designations included in Sec.  425.402(c), or a nurse practitioner, 
physician assistant, or clinical nurse specialist. Therefore, we 
proposed to modify our current voluntary alignment policies at Sec.  
425.402(e)(2)(iii) to provide that we will assign a beneficiary to an 
ACO based upon their selection of any ACO professional, regardless of 
specialty, as their primary clinician. Under this proposal, a 
beneficiary may select a practitioner with any specialty designation, 
for example, a specialty of allergy/immunology or surgery, as their 
primary care provider and be eligible for assignment to the ACO in 
which the practitioner is an ACO professional. Specifically, we 
proposed to revise Sec.  425.402(e)(2)(iii) to remove the requirement 
that the ACO professional designated by the beneficiary be a primary 
care physician as defined at Sec.  425.20, a physician with a specialty 
designation included at Sec.  425.402(c), or a nurse practitioner, 
physician assistant, or clinical nurse specialist. In addition, the 
provision at Sec.  425.402(e)(2)(iv) addresses beneficiary designations 
of clinicians outside the ACO as their primary clinician. The current 
policy at Sec.  425.402(e)(2)(iv) provides that a beneficiary will not 
be assigned to an ACO for a performance year if the beneficiary has 
designated a provider or supplier outside the ACO who is a primary care 
physician as defined at Sec.  425.20, a physician with a specialty 
designation included at Sec.  425.402(c), or a nurse practitioner, 
physician assistant, or clinical nurse specialist as their primary 
clinician responsible for coordinating their overall care. Consistent 
with the proposed revisions to Sec.  425.402(e)(2)(iii) to incorporate 
the requirements of section 50331 of the Bipartisan Budget Act, we 
proposed to revise Sec.  425.402(e)(2)(iv) to indicate that if a 
beneficiary designates any provider or supplier outside the ACO as 
their primary clinician responsible for coordinating their overall 
care, the beneficiary will not be added to the ACO's list of assigned 
beneficiaries for a performance year.
    Section 1899(c) of the Act, as amended by section 50331 of the 
Bipartisan Budget Act of 2018, requires the Secretary to allow a 
beneficiary to voluntarily align with an ACO, and does not impose any 
restriction with respect to whether the beneficiary has received any 
services from an ACO professional (see section 1899(c)(2)(B)(i) of the 
Act). As we explained in the August 2018 proposed rule (83 FR 41895), 
we believe the requirement in section 1899(c)(2)(B)(iii) of the Act 
that a beneficiary's voluntary identification shall supersede any 
claims-based alignment is also consistent with eliminating the 
requirement that the beneficiary have received a service from an ACO 
professional in order to be eligible to be assigned an ACO. Therefore, 
we proposed to remove the requirement at Sec.  425.402(e)(2)(i) that a 
beneficiary must have received at least one primary care service from 
an ACO professional who is either a primary care physician or a 
physician with a specialty designation included in Sec.  425.402(c) 
within the 12-month assignment window in order to be assigned to the 
ACO. Under this proposal, a beneficiary who selects a primary clinician 
who is an ACO professional, but who does not receive any services from 
an ACO participant during the assignment window, will remain eligible 
for assignment to the ACO. We stated that we believe this approach 
would reduce burden on beneficiaries and their practitioners by not 
requiring practitioners to provide unnecessary care during a specified 
period of time in order for a beneficiary to remain eligible for 
assignment to the ACO. Consistent with this proposal, we proposed to 
remove Sec.  425.402(e)(2)(i) in its entirety.

[[Page 59961]]

    We noted that, under this proposal, if a beneficiary does not 
change their primary clinician designation, the beneficiary will remain 
assigned to the ACO in which that practitioner participates during the 
ACO's entire agreement period and any subsequent agreement periods 
under the Shared Savings Program, even if the beneficiary no longer 
seeks care from any ACO professionals. Because a beneficiary who has 
voluntarily identified a Shared Savings Program ACO professional as 
their primary care provider will remain assigned to the ACO regardless 
of where they seek care, this proposed change could also impact 
assignment under certain Innovation Center models in which overlapping 
beneficiary assignment is not permitted. As we explained in the August 
2018 proposed rule (83 FR 41895), we believe our proposed policy is 
consistent with the requirement under section 1899(c)(2)(B)(iii) of the 
Act that a voluntary identification by a beneficiary shall supersede 
any claims-based assignment. However, we also believe it could be 
appropriate, in limited circumstances, to align a beneficiary to an 
entity participating in certain specialty and disease-specific 
Innovation Center models, such as the Comprehensive ESRD Care (CEC) 
Model. CMS implemented the CEC Model to test a new system of payment 
and service delivery that CMS believes will lead to better health 
outcomes for Medicare beneficiaries living with ESRD, while lowering 
costs to Medicare Parts A and B. Under the model, CMS is working with 
groups of health care providers, dialysis facilities, and other 
suppliers involved in the care of ESRD beneficiaries to improve the 
coordination and quality of care that these individuals receive. We 
believe that an ESRD beneficiary, who is otherwise eligible for 
assignment to an entity participating in the CEC Model, could benefit 
from the focused attention on and increased care coordination for their 
ESRD available under the CEC Model. Such a beneficiary could be 
disadvantaged if they were unable to receive the type of specialized 
care for their ESRD that will be available from an entity participating 
in the CEC Model. Furthermore, we believe it could be difficult for the 
Innovation Center to conduct a viable test of a specialty or disease-
specific model, if we were to require that beneficiaries who have 
previously designated an ACO professional as their primary clinician 
remain assigned to the Shared Savings Program ACO under all 
circumstances. Currently, the CEC Model completes its annual PY 
prospective assignment lists prior to the Shared Savings Program in 
order to identify the beneficiaries who may benefit from receiving 
specialized care from an entity participating in the CEC Model. 
Additionally, on a quarterly basis, a beneficiary may be assigned to 
the CEC Model who was previously assigned to a Track 1 or Track 2 ACO.
    As a result, we believe that in some instances it may be necessary 
for the Innovation Center to use its authority under section 
1115A(d)(1) of the Act to waive the requirements of section 
1899(c)(2)(B) of the Act solely as necessary for purposes of testing a 
particular model. Therefore, we proposed to create an exception to the 
general policy that a beneficiary who has voluntarily identified a 
Shared Savings Program ACO professional as their primary care provider 
will remain assigned to the ACO regardless of where they seek care. 
Specifically, we proposed that we would not assign such a beneficiary 
to the ACO when the beneficiary is also eligible for assignment to an 
entity participating in a model tested or expanded under section 1115A 
of the Act under which claims-based assignment is based solely on 
claims for services other than primary care services and for which 
there has been a determination by the Secretary that a waiver under 
section 1115A(d)(1) of the Act of the requirement in section 
1899(c)(2)(B) of the Act is necessary solely for purposes of testing 
the model. Under this proposal, if a beneficiary selects a primary 
clinician who is a Shared Savings Program ACO professional and the 
beneficiary is also eligible for alignment to a specialty care or 
disease specific model tested or expanded under section 1115A of the 
Act under which claims-based assignment is based solely on claims for 
services other than primary care services and for which there has been 
a determination that a waiver of the requirement in section 
1899(c)(2)(B) is necessary solely for purposes of testing the Model, 
the Innovation Center or its designee would notify the beneficiary of 
their alignment to an entity participating in the model. Additionally, 
although such a beneficiary may still voluntarily identify his or her 
primary clinician and may seek care from any clinician, the beneficiary 
would not be assigned to a Shared Savings Program ACO even if the 
designated primary clinician is an ACO professional in a Shared Savings 
Program ACO.
    In the August 2019 proposed rule (83 FR 41896), we indicated that 
we would include a list of any models that meet these criteria on the 
Shared Savings Program website, to supplement the information already 
included in the beneficiary assignment reports we currently provide to 
ACOs (as described under Sec.  425.702(c)), so that ACOs can know why 
certain beneficiaries, who may have designated an ACO professional as 
their primary clinician, are not assigned to them. Similar information 
would also be shared with 1-800-MEDICARE to ensure that Medicare 
customer service representatives are able to help beneficiaries who may 
be confused as to why they are not aligned to the ACO in which their 
primary clinician is participating.
    Section 1899(c)(2)(B)(ii) of the Act, as amended by section 50331 
of the Bipartisan Budget Act, requires the Secretary to establish a 
process under the Shared Savings Program through which each Medicare 
FFS beneficiary is notified of the ability to identify an ACO 
professional as his or her primary care provider and informed of the 
process that may be used to make and change such identification. In the 
August 2018 proposed rule (83 FR 41896), we stated our intent to 
implement section 1899(c)(2)(B)(ii) of the Act under the beneficiary 
notification process at Sec.  425.312. We are not addressing this topic 
at this time. We will summarize and respond to public comments on this 
proposed policy in a forthcoming final rule.
    We proposed to apply these modifications to our policies under the 
Shared Savings Program regarding voluntary alignment beginning for 
performance years starting on January 1, 2019, and subsequent 
performance years. We proposed to incorporate these new requirements in 
the regulations by redesignating Sec.  425.402(e)(2)(i) through (iv) as 
Sec.  425.402(e)(2)(i)(A) through (D), adding a paragraph heading for 
newly redesignated Sec.  425.402(e)(2)(i), and including a new Sec.  
425.402(e)(2)(ii).
    We noted that as specified in Sec.  425.402(e)(2)(ii) a beneficiary 
who has designated an ACO professional as their primary clinician must 
still be eligible for assignment to an ACO by meeting the criteria 
specified in Sec.  425.401(a). These criteria establish the minimum 
requirements for a beneficiary to be eligible to be assigned to an ACO 
under our existing assignment methodology, and we believe it is 
appropriate to impose the same basic limitations on the assignment of 
beneficiaries on the basis of voluntary alignment. We do not believe it 
would be appropriate, for example, to assign a beneficiary to an ACO if 
the beneficiary does not reside in the United States, or if the other 
eligibility requirements are not met.

[[Page 59962]]

    We requested comments on our proposals to implement the new 
requirements governing voluntary alignment under section 50331 of the 
Bipartisan Budget Act of 2018. We also sought comment on our proposal 
to create a limited exception to our proposed policies on voluntary 
alignment to allow a beneficiary to be assigned to an entity 
participating in a model tested or expanded under section 1115A of the 
Act when certain criteria are met. In addition, we welcomed comments on 
how we might increase beneficiary awareness and further improve the 
electronic process through which a beneficiary may voluntarily identify 
an ACO professional as their primary care provider through 
My.Medicare.gov for purposes of assignment to an ACO.
    Comment: Many commenters supported the proposed policies to 
implement the new requirements governing voluntary alignment under 
section 50331 of the Bipartisan Budget Act of 2018. In particular, many 
commenters supported the proposal to remove the requirement that a 
beneficiary must have received at least one primary care service from 
an ACO professional who is either a primary care physician or a 
physician with a specialty designation included in Sec.  425.402(c) 
within the 12-month assignment window in order to be assigned to the 
ACO. Commenters were in favor of removing this requirement because it 
would allow a beneficiary to select a NP, PA, or CNS, who is 
participating in an ACO, as their primary clinician to voluntarily 
align to the ACO even if they do not receive care from any physicians 
participating in the ACO. Commenters suggested this more inclusive 
policy supports CMS' goals of improving patient access and quality of 
care, and is consistent with patient-centered health care delivery. 
Additionally, some commenters specifically supported the proposal to 
allow a beneficiary to voluntarily designate any ACO professional, 
regardless of specialty, as their primary care provider for purposes of 
assignment to an ACO. In particular, commenters representing 
neurologists and palliative care practitioners were supportive of this 
proposed change. In addition, one commenter agreed that the proposed 
policy would allow ``the opportunity for patients to choose and 
establish a medical home with their clinician.'' The commenter also 
supported voluntary alignment because it results in prospective 
beneficiary attribution, which the commenter preferred over the 
preliminary prospective assignment methodology with retrospective 
reconciliation.
    Response: We appreciate the commenters' support for the proposed 
policies to implement the new requirements governing voluntary 
alignment under section 50331 of the Bipartisan Budget Act of 2018.
    Comment: A few commenters proposed a change to section 
1899(h)(1)(A) of the Act. Section 1899(c) of the Act requires the 
Secretary to determine an appropriate method to assign Medicare FFS 
beneficiaries to an ACO based on their utilization of primary care 
services provided under this title by an ACO professional described in 
subsection (h)(1)(A). Section 1899(h)(1)(A) of the Act constitutes one 
element of the definition of the term ``ACO professional''. 
Specifically, this provision establishes that a physician (as defined 
in section 1861(r)(1)) is an ACO professional for purposes of the 
Shared Savings Program. Section 1861(r)(1) of the Act in turn defines 
the term physician as a doctor of medicine or osteopathy legally 
authorized to practice medicine and surgery by the State in which he 
performs such function or action. One commenter proposed a change to 
allow for ``private NP led practices and NP led clinics'' to be 
included as ACO professionals described in section 1899(h)(1)(A) of the 
Act. The commenter recommended this change in particular for rural 
areas, stating that NPs account for 1 in 4 medical providers in rural 
areas.
    Response: Because commenters are requesting a change to the 
statute, these suggestions are outside the scope of this final rule. 
However, as many commenters noted above, the proposed changes to the 
voluntary alignment methodology will allow a beneficiary to align with 
a NP, PA, or CNS participating in an ACO and ultimately be assigned to 
the ACO regardless of whether they receive care from a physician in the 
ACO. Additionally, we agree these non-physician practitioners play an 
important role in coordinating patient care and providing primary care 
services, as such we have included primary care services furnished by 
NPs, PAs, and CNSs in step 1 of our two-step claims-based assignment 
methodology (see Sec.  425.402(b)).
    Comment: Some commenters opposed the proposed changes to the 
voluntary alignment methodology. One commenter expressed concern about 
beneficiary confusion if their practitioners participate in different 
ACOs or the beneficiary selects a practitioner outside of an ACO as 
their primary care provider. Similarly, one commenter expressed concern 
about an ACO's ability to maintain an assigned population of 5,000 
beneficiaries if beneficiaries can select any ACO professional 
regardless of specialty as their primary care provider. A few 
commenters disagreed with including all practitioner specialties citing 
differences in training, education, knowledge, and experience. Another 
commenter expressed concern about whether specialists are willing to 
take on the role of a primary care physician and manage the overall 
care of beneficiaries assigned to the ACO through voluntary alignment. 
Some commenters disagreed with the proposal to remove the requirement 
that a beneficiary receive a primary care service from an ACO 
professional, with a physician specialty used in assignment, during the 
assignment window. One commenter stated that removing the requirement 
would exacerbate a ``leakage'' problem that they described as a 
scenario where assigned beneficiaries receive some or all of their care 
from providers and suppliers outside the ACO. One commenter suggested 
beneficiaries should be required to renew their selection of their 
primary care clinician one year following the beneficiary's entry into 
a long-term care setting. Another commenter suggested that 
beneficiaries who voluntarily align with an ACO be required to receive 
a minimum number of primary care services from ACO professionals within 
the same ACO in order to remain aligned to the ACO.
    Response: We disagree with these comments. We believe that when a 
beneficiary selects a primary clinician, they are identifying their 
primary care provider, regardless of specialty or whether the 
beneficiary has received a recent primary care service. We believe they 
are informing CMS that they view the practitioner as their primary care 
provider and responsible for managing their overall care. We also 
believe all practitioners, regardless of specialty, play an important 
role in coordinating care for beneficiaries and if a beneficiary 
selects a practitioner as their primary clinician, the beneficiary 
should be treated as having made an informed election. Although we 
understand the concern that an ACO could lose assigned beneficiaries 
due to their voluntary alignment with another ACO, we note that our 
experience to date shows that the majority of beneficiaries who 
voluntarily align to an ACO would have been assigned to the same ACO 
via our two-step claims-based assignment methodology under Sec.  
425.402(b). We

[[Page 59963]]

also believe requiring beneficiaries to renew their primary clinician 
selection would create additional unnecessary burden on beneficiaries. 
Beneficiaries who have designated a primary clinician must have 
established a MyMedicare.gov account, which likely indicates that they 
are actively engaged in reviewing and managing their health 
information. We believe these engaged beneficiaries will also manage 
and update their primary clinician selections as necessary. We also 
disagree with establishing a requirement that a beneficiary receive a 
minimum number of primary care services from ACO providers/suppliers in 
the ACO in order to honor a beneficiary's voluntary alignment 
selection. We believe our proposed approach is in accordance with the 
requirement under section 1899(c) of the Act, as amended by section 
50331 of the Bipartisan Budget Act of 2018, that primary care provider 
selections take precedence over any claims-based assignment.
    Comment: A few commenters suggested CMS simplify the process by 
which a beneficiary selects their primary clinician. Commenters 
suggested that, in addition to the electronic means of voluntary 
alignment, CMS allow beneficiaries to voluntarily align with their 
primary clinician through the ACO, at the point of care, through 1-800 
Medicare, a smart phone application, or Physician Compare. One 
commenter noted they had experienced difficulties with CMS' 
operationalization of the voluntary alignment policy through 
MyMedicare.gov.
    Response: Currently, if beneficiaries need help in designating a 
primary clinician, they can call 1-800 Medicare to have a 
representative walk them through the process or use the ``Empowering 
Patients to Make Decisions About Their Healthcare: Register for 
MyMedicare.gov and Select Your Primary Clinician'' fact sheet available 
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/vol-alignment-bene-fact-sheet.pdf. We 
plan to continue to make refinements to our implementation of voluntary 
alignment in order to improve the user experience for beneficiaries and 
will take the commenters' suggestions into consideration in developing 
future policies regarding voluntary alignment.
    Comment: One commenter disagreed with allowing beneficiaries to 
voluntarily align with an ACO professional. The commenter cited 
difficulty tracking the cost of beneficiaries who are not assigned to 
an ACO through our two-step claims-based assignment methodology. 
Another commenter suggested we not hold an ACO accountable for a 
voluntarily aligned beneficiary for a performance year if the 
beneficiary does not receive any services from their primary clinician 
in the ACO during that performance year. Another commenter opposed 
voluntary alignment because they believe the costs for voluntarily 
aligned beneficiaries are not reflected in an ACO's historical 
benchmark.
    Response: Consistent with section 1899(c)(2)(B)(i) of the Act, we 
are required to allow beneficiaries to voluntarily identify an ACO 
professional as their primary care provider for purposes of assignment 
to an ACO if a system is available for electronic designation. To aid 
ACOs in identifying and tracking costs and Medicare services for 
voluntarily aligned beneficiaries, we provide ACOs with quarterly 
aggregate reports (see Sec.  425.702) that identify beneficiaries who 
have voluntarily aligned with the ACO, as well as monthly claim and 
claim line feed files (see Sec.  425.704) to aid ACOs in their 
operations. Additionally, as previously stated, we have found the 
majority of beneficiaries who voluntarily align to an ACO would have 
been assigned to the same ACO in the applicable performance year based 
on our two-step assignment methodology. As required under section 
1899(b)(2)(A) of the Act and the regulation at Sec.  425.100(a), ACOs 
participating in the Shared Savings Program must agree to become 
accountable for the quality, cost, and overall care of the Medicare 
fee-for-service beneficiaries assigned to the ACO. Beneficiaries who 
voluntarily align to an ACO are prospectively assigned to the ACO for 
the performance year. Under the prospective assignment methodology, 
ACOs are accountable for their assigned beneficiary population 
regardless of where the beneficiaries receive the plurality of their 
primary care services during the performance year. We believe this is 
an appropriate approach when a beneficiary selects a practitioner as 
their primary clinician. As we stated earlier, we believe that when a 
beneficiary selects a primary clinician, the beneficiary is making an 
informed decision and identifying for CMS the provider or supplier whom 
they consider to be responsible for managing their overall care. The 
historical benchmark reflects the beneficiary population who received 
the plurality of their primary care services from the ACO during the 
three benchmark years and, in our experience, there is a high 
correlation between the beneficiaries who are assigned based on our 
two-step claims-based assignment methodology and voluntarily aligned 
beneficiaries. As a result, we believe our current benchmarking 
methodology provides for a population of assigned beneficiaries during 
the benchmark years that is comparable to the population assigned 
during the performance years. We also note, in the future, when an ACO 
renews for a new agreement period and its previous performance years 
become historical benchmark years, beneficiaries who were voluntarily 
aligned to the ACO for those years will then be included in the 
historical benchmark calculations for the ACO's new agreement period.
    Comment: One commenter stated the current voluntary alignment 
process can be confusing and causes unnecessary delays in assigning 
beneficiaries to the ACO in which their primary clinician participates. 
The commenter suggested a rolling voluntary alignment process allowing 
beneficiaries who voluntarily align with an ACO to be added to the 
assignment list for that ACO during a performance year.
    Response: We understand that our policy of performing beneficiary 
assignment annually can cause a delay between when a beneficiary 
selects their primary clinician and when the beneficiary is assigned to 
the ACO. However, we believe this approach reduces complexity and 
burden. For example, ACOs are able to clearly identify a date by which 
to communicate to their beneficiaries regarding the opportunity to 
designate a primary clinician if they would like to align with an ACO 
professional.
    Comment: One commenter expressed concern that physicians with a 
specialty designation not used in assignment would become subject to 
the exclusivity requirements, which would limit an ACO participant to 
participation in a single ACO. The commenter opposed any policy that 
would require an ACO participant to be exclusive to a single Shared 
Savings Program ACO in the event that a beneficiary voluntarily aligns 
to a practitioner billing under the TIN of that ACO participant.
    Response: We agree with the concerns raised by the commenter and 
believe it is important to clarify the operational process we will 
implement if a beneficiary designates a clinician billing under the TIN 
of an ACO participant that participates in more than one Shared Savings 
Program ACO (as permitted under certain circumstances under Sec.  
425.306(b)) as their primary clinician. ACO participants that do not 
bill for services that are considered in assignment will not be 
required to be

[[Page 59964]]

exclusive to a single Shared Savings Program ACO as a result of the 
changes to the voluntary alignment methodology. In the circumstance 
where a beneficiary aligns with a clinician billing under an ACO 
participant TIN that is participating in more than one Shared Savings 
Program ACO, we will determine where the beneficiary received the 
plurality of their primary care services under our claims-based 
assignment methodology under Sec.  425.402(b). If the beneficiary did 
not receive the plurality of their primary care services from ACO 
professionals in either ACO, we will not assign the beneficiary to 
either of the ACOs. However, consistent with Sec.  425.402(c)(2)(iv), 
we will honor the beneficiary's selection of a primary clinician and 
will not align the beneficiary to another ACO in which their primary 
clinician is not participating.
    We did not receive any public comments on the proposal not to 
voluntarily align a beneficiary to the ACO in which their primary 
clinician participates when the beneficiary is also eligible for 
assignment to an entity participating in a model tested or expanded 
under section 1115A of the Act under which claims-based assignment is 
based solely on claims for services other than primary care services 
(for example, CEC).
    After considering the comments received in response to the 
proposals to revise the voluntary alignment methodology, we are 
finalizing the policies as proposed. Specifically, we are finalizing 
the policy to assign a beneficiary to an ACO based upon their selection 
of any ACO professional, regardless of specialty, as their primary 
clinician. We are also finalizing our proposal to remove the 
requirement that a beneficiary must have received at least one primary 
care service from an ACO professional who is either a primary care 
physician or a physician with a specialty designation included in Sec.  
425.402(c) within the 12-month assignment window in order to be 
assigned to the ACO. Lastly, we are finalizing a policy not to 
voluntarily align a beneficiary to an ACO when the beneficiary is also 
eligible for assignment to an entity participating in a model tested or 
expanded under section 1115A of the Act under which claims-based 
assignment is based solely on claims for services other than primary 
care services. Accordingly, we are also finalizing the proposed 
revisions to Sec.  425.402(e)(2) without modification.
c. Revisions to the Definition of Primary Care Services Used in 
Beneficiary Assignment
(1) Background
    Section 1899(c)(1) of the Act, as amended by the 21st Century Cures 
Act and the Bipartisan Budget Act of 2018, provides that for 
performance years beginning on or after January 1, 2019, the Secretary 
shall assign beneficiaries to an ACO based on their utilization of 
primary care services provided by a physician and all services 
furnished by RHCs and FQHCs. However, the statute does not specify 
which kinds of services may be considered primary care services for 
purposes of beneficiary assignment. We established the initial list of 
services that we considered to be primary care services in the November 
2011 final rule (76 FR 67853). In that final rule, we indicated that we 
intended to monitor this issue and would consider making changes to the 
definition of primary care services to add or delete codes used to 
identify primary care services, if there were sufficient evidence that 
revisions were warranted. We have updated the list of primary care 
service codes in subsequent rulemaking to reflect additions or 
modifications to the codes that have been recognized for payment under 
the Medicare PFS, as summarized in the CY 2018 PFS proposed rule (82 FR 
34109 and 34110). Subsequently, in the CY 2018 PFS final rule, we 
revised the definition of primary care services to include three 
additional chronic care management service codes, 99487, 99489, and 
G0506, and four behavioral health integration service codes, G0502, 
G0503, G0504 and G0507 (82 FR 53212 and 53213). These additions are 
effective for purposes of performing beneficiary assignment under Sec.  
425.402 for performance year 2019 and subsequent performance years.
    Accounting for these recent changes, we define primary care 
services in Sec.  425.400(c) for purposes of assigning beneficiaries to 
ACOs under Sec.  425.402 as the set of services identified by the 
following HCPCS/CPT codes:
    CPT codes:
    (1) 99201 through 99215 (codes for office or other outpatient visit 
for the evaluation and management of a patient).
    (2) 99304 through 99318 (codes for professional services furnished 
in a Nursing Facility, excluding services furnished in a SNF which are 
reported on claims with place of service code 31).
    (3) 99319 through 99340 (codes for patient domiciliary, rest home, 
or custodial care visit).
    (4) 99341 through 99350 (codes for evaluation and management 
services furnished in a patients' home).
    (5) 99487, 99489 and 99490 (codes for chronic care management).
    (6) 99495 and 99496 (codes for transitional care management 
services).
    HCPCS codes:
    (1) G0402 (the code for the Welcome to Medicare visit).
    (2) G0438 and G0439 (codes for the Annual Wellness Visits).
    (3) G0463 (code for services furnished in electing teaching 
amendment hospitals).
    (4) G0506 (code for chronic care management).
    (5) G0502, G0503, G0504 and G0507 (codes for behavioral health 
integration).
    As discussed in the CY 2018 PFS final rule (82 FR 53213), a 
commenter recommended that CMS consider including the advance care 
planning codes, CPT codes 99497 and 99498, in the definition of primary 
care services in future rulemaking. We indicated that we would consider 
whether CPT codes 99497 and 99498 or any additional existing HCPCS/CPT 
codes should be added to the definition of primary care services in 
future rulemaking for purposes of assignment of beneficiaries to ACOs 
under the Shared Savings Program. In addition, effective for CY 2018, 
the HCPCS codes for behavioral health integration G0502, G0503, G0504 
and G0507 have been replaced by CPT codes 99492, 99493, 99494, 99484 
(82 FR 53078).
    CPT codes 99304 through 99318 are used for reporting evaluation and 
management (E&M) services furnished by physicians and other 
practitioners in a SNF (reported on claims with POS code 31) or a 
nursing facility (reported on claims with POS code 32). Based on 
stakeholder input, we finalized a policy in the CY 2016 PFS final rule 
(80 FR 71271 through 71272) effective for performance year 2017 and 
subsequent performance years, to exclude services identified by CPT 
codes 99304 through 99318 from the definition of primary care services 
for purposes of the beneficiary assignment methodology when the claim 
includes the POS code 31 modifier designating the services as having 
been furnished in a SNF. We established this policy to recognize that 
SNF patients are shorter stay patients who are generally receiving 
continued acute medical care and rehabilitative services. Although 
their care may be coordinated during their time in the SNF, they are 
then transitioned back into the community to the primary care 
professionals who are typically responsible for providing care to meet 
their true primary care needs. We

[[Page 59965]]

continue to believe that it is appropriate for SNF patients to be 
assigned to ACOs based on care received from primary care professionals 
in the community (including nursing facilities), who are typically 
responsible for providing care to meet the true primary care needs of 
these beneficiaries. As we discussed in the August 2019 proposed rule 
(83 FR 41897), ACOs serving special needs populations, including 
beneficiaries receiving long term care services, and other stakeholders 
have recently suggested that we consider an alternative method for 
determining operationally whether services identified by CPT codes 
99304 through 99318 were furnished in a SNF. Instead of indirectly 
determining whether a beneficiary was a SNF patient when the services 
were furnished based on physician claims data, these stakeholders 
suggest we more directly determine whether a beneficiary was a SNF 
patient based on SNF facility claims data. These commenters recommended 
that CMS use contemporaneous SNF Medicare facility claims to determine 
whether a professional service identified by CPT codes 99304 through 
99318 was furnished in a SNF, and therefore, should not be used for 
purposes of the beneficiary assignment methodology under Sec.  425.402. 
Specifically, these commenters suggested that we determine whether 
services identified by CPT codes 99304 through 99318 were furnished in 
a SNF by determining whether the beneficiary also received SNF facility 
services on the same date of service.
    In the August 2018 proposed rule (83 FR 41897 through 41899), we 
proposed to make changes to the definition of primary care services in 
Sec.  425.400(c) to add new codes and to revise how we determine 
whether services identified by CPT codes 99304 through 99318 were 
furnished in a SNF.
(2) Proposed Revisions
    Based on feedback from ACOs and our further review of the HCPCS and 
CPT codes currently recognized for payment under the PFS, we believe it 
would be appropriate to amend the definition of primary care services 
to include certain additional codes. Specifically, we proposed to 
revise the definition of primary care services in Sec.  425.400(c) to 
include the following HCPCS and CPT codes: (1) Advance care planning 
service codes; CPT codes 99497 and 99498; (2) administration of health 
risk assessment service codes; CPT codes 96160 and 96161; (3) prolonged 
evaluation and management or psychotherapy service(s) beyond the 
typical service time of the primary procedure, CPT codes 99354 and 
99355; (4) annual depression screening service code, HCPCS code G0444; 
(5) alcohol misuse screening service code, HCPCS code G0442; and (6) 
alcohol misuse counseling service code, HCPCS code G0443. In addition, 
in the CY 2019 PFS proposed rule (see 83 FR 35841 through 35844), CMS 
proposed to create three new HCPCS codes to reflect the additional 
resources involved in furnishing certain evaluation and management 
services: (1) GPC1X add-on code, for the visit complexity inherent to 
evaluation and management associated with certain primary care 
services, (2) GCG0X add-on code, for visit complexity inherent to 
evaluation and management associated with endocrinology, rheumatology, 
hematology/oncology, urology, neurology, obstetrics/gynecology, 
allergy/immunology, otolaryngology, or interventional pain management-
centered care, and (3) GPRO1, an additional add-on code for prolonged 
evaluation and management or psychotherapy services beyond the typical 
service time of the primary procedure. As we explained in the August 
2018 proposed rule (83 FR 41897), we believe it would be appropriate to 
include these codes in the definition of primary care services under 
the Shared Savings Program because these codes are used to bill for 
services that are similar to services that are already included in the 
list of primary care codes at Sec.  425.400(c). We also expect that 
primary care physicians, nurse practitioners, physician assistants, and 
clinical nurse specialists frequently furnish these services as part of 
their overall management of a patient. As a result, we believe that 
including these codes would increase the accuracy of the assignment 
process by helping to ensure that beneficiaries are assigned to the ACO 
or other entity that is actually managing the beneficiary's care.
    The following provides additional information about the HCPCS and 
CPT codes that we proposed to add to the definition of primary care 
services:
     Advance care planning (CPT codes 99497 and 99498): 
Effective January 1, 2016, CMS pays for voluntary advance care planning 
under the PFS (80 FR 70955 through 70959). See CMS, Medicare Learning 
Network, ``Advance Care Planning'' (ICN 909289, August 2016), available 
at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/AdvanceCarePlanning.pdf. Advance care 
planning enables Medicare beneficiaries to make important decisions 
that give them control over the type of care they receive and when they 
receive it. Medicare pays for advance care planning either as a 
separate Part B service when it is medically necessary or as an 
optional element of a beneficiary's Annual Wellness Visit. We believe 
it would be appropriate to include both Advance Care Planning codes 
99497 and 99498 in the definition of primary care services under the 
Shared Savings Program because the services provided as part of advance 
care planning include counseling and other evaluation and management 
services similar to the services included in Annual Wellness Visits and 
other evaluation and management service codes that are already included 
in the list of primary care codes.
     Administration of health risk assessment (CPT codes 96160 
and 96161): In the CY 2017 PFS final rule (81 FR 80330 through 80331), 
we added two new CPT codes, 96160 and 96161, to the PFS, effective for 
CY 2017, to be used for payment for the administration of health risk 
assessment. These codes are ``add-on codes'' that describe additional 
resource components of a broader service furnished to the patient that 
are not accounted for in the valuation of the base code. For example, 
if a health risk assessment service were administered during a 
physician office visit, then the physician would bill for both the 
appropriate office visit code and the appropriate health risk 
assessment code. We believe it would be appropriate to include CPT 
codes 96160 and 96161 in the definition of primary care services 
because these add-on codes frequently represent additional practice 
expenses related to office visits for evaluation and management 
services that are already included in the definition of primary care 
services.
     Prolonged evaluation and management or psychotherapy 
service(s) beyond the typical service time of the primary procedure 
(CPT codes 99354 and 99355): These two codes are also ``add-on codes'' 
that describe additional resource components of a broader service 
furnished in the office or other outpatient setting that are not 
accounted for in the valuation of the base codes. Code 99354 is listed 
on a claim to report the first hour of additional face-to-face time 
with a patient and code 99355 is listed separately for each additional 
30 minutes of face-to-face time with a patient beyond the time reported 
under code 99354. Codes 99354 and 99355 would be billed separately in 
addition to the base office or other outpatient evaluation and 
management or

[[Page 59966]]

psychotherapy service. (See Medicare Claims Processing Manual Chapter 
12, Sections 30.6.15.1 Prolonged Services With Direct Face-to-Face 
Patient Contact Service (Codes 99354-99357) available at https://
www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/
clm104c12.pdf; also see CMS, MLN Matters, Prolonged Services (Codes 
99354-99359) (Article Number MM5972, Revised March 7, 2017), available 
at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/mm5972.pdf.) Although we do 
not currently include prolonged services codes CPT codes 99354 and 
99355 on our list of primary care services, based on further review we 
believe it would be appropriate to include them on our list of primary 
care services to more accurately assign beneficiaries to ACOs based on 
all the allowed charges for the primary care services furnished to 
beneficiaries. In the August 2018 proposed rule (83 FR 41898), we noted 
that the definitions of codes 99354 and 99355 also include prolonged 
services for certain psychotherapy services, which are not currently 
included on our list of primary care services. Therefore, we proposed 
to include the allowed charges for CPT codes 99354 and 99355, for 
purposes of assigning beneficiaries to ACOs, only when the base code is 
also on the list of primary care services.
     Annual depression screening (HCPCS code G0444), alcohol 
misuse screening (HCPCS code G0442), and alcohol misuse counseling 
(HCPCS code G0443): Effective October 14, 2011, all Medicare 
beneficiaries are eligible for annual depression screening and alcohol 
misuse screening. (See CMS Manual System, Screening for Depression in 
Adults (Transmittal 2359, November 23, 2011) available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R2359CP.pdf; and see CMS, MLN Matters, Screening and Behavioral 
Counseling Interventions in Primary Care to Reduce Alcohol Misuse 
(Article Number MM7633, Revised June 4, 2012), available at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/mm7633.pdf). Although these three codes 
have been in use since before the implementation of the Shared Savings 
Program in 2012, based on further review of these services, we believe 
that it would be appropriate to consider these services in beneficiary 
assignment. Annual depression screening may be covered if it is 
furnished in a primary care setting that has staff-assisted depression 
care supports in place to assure accurate diagnosis, effective 
treatment, and follow-up. Alcohol misuse screening and counseling are 
screening and behavioral counseling interventions in primary care to 
reduce alcohol misuse. All three of these codes include screening and 
counseling services similar to counseling and other evaluation and 
management services included in the codes already on the list of 
primary care codes.
    In the CY 2019 PFS proposed rule (see 83 FR 35841 through 35844), 
we proposed to create three new HCPCS G-codes as part of a broader 
proposal to simplify the documentation requirements and to more 
accurately pay for services represented by CPT codes 99201 through 
99215 (codes for office or other outpatient visit for the evaluation 
and management of a patient). All three of these codes are ``add-on 
codes'' that describe additional resource components of a broader 
service furnished to the patient that are not accounted for in the 
valuation of the base codes.
    HCPCS code GPC1X is intended to capture the additional resource 
costs, beyond those involved in the base evaluation and management 
codes, of providing face-to-face primary care services for established 
patients. HCPCS code GPC1X would be billed in addition to the base 
evaluation and management code for an established patient when the 
visit includes primary care services. In contrast, new HCPCS code GCG0X 
is an add-on code intended to reflect the complexity inherent to 
evaluation and management services associated with endocrinology, 
rheumatology, hematology/oncology, urology, neurology, obstetrics/
gynecology, allergy/immunology, otolaryngology, cardiology, and 
interventional pain management-centered care. As we stated in the 
August 2018 proposed rule (83 FR 41899), we believe it would be 
appropriate to include both proposed new HCPCS codes GCG0X and GPC1X in 
our definition of primary care services because they represent services 
that are currently included in CPT codes 99201 through 99215, which are 
already included in the list of primary care codes in Sec.  425.400(c).
    Finally, proposed new HCPCS code GPRO1 (prolonged evaluation and 
management or psychotherapy services beyond the typical service time of 
the primary procedure, in the office or other outpatient setting 
requiring direct patient contact beyond the usual service; 30 minutes) 
is modeled on CPT code 99354, a prolonged services code discussed 
earlier in this section which we proposed to add to our list of primary 
care services. HCPCS code GPRO1 is intended to reflect prolonged 
evaluation and management or psychotherapy service(s) of 30 minutes 
duration beyond the typical service time of the primary or base 
service, whereas existing CPT code 99354 reflects prolonged services of 
60 minutes duration. As is the case for code 99354, code GPRO1 would be 
billed separately in addition to the base office or other outpatient 
evaluation and management or psychotherapy service. We stated that we 
believe it would be appropriate to include proposed HCPCS code GPRO1 on 
our list of primary care services for the same reasons we proposed to 
add CPT code 99354 to our list of primary care services. Because the 
proposed definition of HCPCS code GPRO1 also includes prolonged 
services for certain psychotherapy services, which are not currently 
included on our list of primary care services, we proposed to include 
the allowed charges for HCPCS code GPRO1, for purposes of assigning 
beneficiaries to ACOs, only when the base code is also on the list of 
primary care services.
    We proposed to include these codes in the definition of primary 
care services when performing beneficiary assignment under Sec.  
425.402, for performance years starting on January 1, 2019, and 
subsequent years. However, we noted that our proposal to include the 
three proposed new ``add-on codes'', GPC1X, GCG0X, and GPRO1, was 
contingent on CMS finalizing its proposal to create these new codes for 
use starting in 2019.
    As discussed in section V.B.2.c.(1) of this final rule, ACOs and 
other commenters have expressed concerns regarding our current policy 
of identifying services billed under CPT codes 99304 through 99318 
furnished in a SNF by using the POS modifier 31. We continue to believe 
it is appropriate to exclude from assignment services billed under CPT 
codes 99304 through 99318 when such services are furnished in a SNF. 
However, as we explained in the August 2018 proposed rule (83 FR 
41899), we agree with commenters that it might increase the accuracy of 
beneficiary assignment for these vulnerable and generally high cost 
beneficiaries if we were to revise our method for determining whether 
services identified by CPT codes 99304 through 99318 were furnished in 
a SNF to focus on whether the beneficiary also received SNF facility 
services on the same day. We believe it would be feasible for us to 
directly and more precisely determine whether services identified by 
CPT codes 99304 through

[[Page 59967]]

99318 were furnished in a SNF by analyzing our facility claims data 
files rather than by using the POS modifier 31 in our professional 
claims data files. Operationally, we would exclude professional 
services claims billed under CPT codes 99304 through 99318 from use in 
the assignment methodology when there is a SNF facility claim in our 
claims files with dates of service that overlap with the date of 
service for the professional service. Therefore, we proposed to revise 
the regulation at Sec.  425.400(c)(1)(iv)(A)(2), effective for 
performance years starting on January 1, 2019 and subsequent 
performance years, to remove the exclusion of claims including the POS 
code 31 and in its place to indicate more generally that we will 
exclude services billed under CPT codes 99304 through 99318 when such 
services are furnished in a SNF.
    Under our current process, if CMS' HCPCS committee or the American 
Medical Association's CPT Editorial Panel modifies or replaces any of 
the codes that we designate as primary care service codes in Sec.  
425.400(c), we must revise the primary care service codes listed in 
Sec.  425.400(c) as appropriate through further rulemaking before the 
revised codes can be used for purposes of assignment. As noted 
previously, effective for CY 2018, the HCPCS codes for behavioral 
health integration G0502, G0503, G0504 and G0507 have been replaced by 
CPT codes 99492, 99493, 99494 and 99484. Therefore, consistent with our 
current process, we proposed to revise the primary care service codes 
in Sec.  425.400(c)(1)(iv) to replace HCPCS codes G0502, G0503, G0504 
and G0507 with CPT codes 99492, 99493, 99494 and 99484 for performance 
years starting on January 1, 2019, and subsequent performance years.
    We also noted that the regulations text at Sec.  425.400(c)(1)(iv) 
includes brief descriptions for the HCPCS codes that we have designated 
as primary care service codes, but does not include such descriptions 
for the CPT codes that we have designated as primary care service 
codes. For consistency, we proposed a technical change to the 
regulations at Sec.  425.400(c)(1)(iv)(A) to also include descriptions 
for the CPT codes. We also noted that one of the Chronic Care 
Management (CCM) codes, CPT code 99490, is inadvertently listed in the 
regulations text at Sec.  425.400(c)(1)(iv)(A)(6) along with the codes 
for Transitional Care Management (TCM) services. We proposed a 
technical change to the regulations to move CPT code 99490 up to Sec.  
425.400(c)(1)(iv)(A)(5) with the other CCM codes.
    We welcomed comments on the new codes we proposed to add to the 
definition of primary care services used for purposes of assigning 
beneficiaries to Shared Savings Program ACOs. In addition, we sought 
comment on our proposal to revise our method for excluding services 
identified by CPT codes 99304 through 99318 when furnished in a SNF. We 
also sought comment on the other proposed technical changes to Sec.  
425.400(c)(1)(iv). We also welcomed comments on any additional existing 
HCPCS/CPT codes that we should consider adding to the definition of 
primary care services in future rulemaking.
    Comment: Some commenters supported the proposed changes to the 
definition of primary care services. One commenter suggested we include 
the Initial Preventive Physician Examination, or Welcome to Medicare 
Visit, as well as the annual wellness visit CPT codes in the 
definition.
    Response: We appreciate the commenters' support for the proposed 
amendments to the definition of primary care services. We also note we 
currently include the Welcome to Medicare (G0402) and annual wellness 
visit (G0438 and G0439) CPT codes in the definition of primary care 
services under Sec.  425.400(c).
    Comment: Many commenters supported the proposal to modify Sec.  
425.400(c)(1)(iv)(A)(2) to remove the exclusion of claims including the 
POS code 31 and in its place indicate more generally that we will 
exclude services billed under CPT codes 99304 through 99318 from use in 
the assignment methodology when such services are furnished in a SNF, 
as determined based on whether there is a SNF facility claim with dates 
of service that overlap with the date of service for the professional 
service. One commenter supported this proposal because they noted it 
would better identify beneficiaries who have received short-term care 
and appropriately exclude them from assignment.
    Response: We appreciate the commenters' support for the proposal to 
modify Sec.  425.400(c)(1)(iv)(A)(2) to remove the exclusion of claims 
including the POS code 31 modifier and in its place to exclude services 
billed under CPT codes 99304 through 99318 when such services are 
furnished in a SNF. We are finalizing the policy as proposed.
    Comment: Concerning the proposal to remove the exclusion of claims 
including the POS code 31, one commenter suggested we use a longer 
claims run-out period to account for the institutional billing 
practices for SNFs. This commenter also stated they would ``welcome 
transparency related to POS 31 and 32 claims-based attribution'' in the 
claim and claims line feed files we provide to participating ACOs under 
Sec.  425.704.
    Response: As we noted in the 2011 Shared Savings Program final rule 
(76 FR 67837), a 3-month claims run-out results in a completion 
percentage of approximately 98.5 percent for physician services and 98 
percent for Part A services. Additionally, the claim and claim line 
feed files furnished to ACOs under Sec.  425.704 contain Parts A and B 
claims data regarding beneficiaries who are either prospectively 
assigned to the ACO or who may be assigned to the ACO at the end of the 
performance year, depending on the assignment methodology under which 
the ACO participates. As long as the beneficiary has not declined to 
share their claims data, and the claim does not include protected 
health information related to substance use disorder treatment, ACOs 
receive both the claims for physician services and the facility level 
claims that would be used to determine whether a service billed under 
CPT codes 99304 through 99318 was furnished in a SNF.
    Comment: A few commenters suggested we only include the newly 
proposed CPT/HCPCS codes under step 1 of the two-step assignment 
methodology. The commenters stated these codes should be used for 
``assigning beneficiaries on the basis of care furnished specifically 
by primary care physicians and not all ACO professionals.''
    Response: We disagree with these comments. We continue to believe 
our current assignment methodology generally provides an appropriate 
balance between maintaining a strong emphasis on primary care while 
ultimately allowing for assignment of beneficiaries on the basis of how 
they actually receive their primary care services (80 FR 32748). We 
also note that the list of specialty types included in step 1 and step 
2 of the assignment methodology was informed by CMS medical officers 
knowledgeable about the services typically performed by physicians and 
non-physician practitioners (80 FR 32750) as well as comments received 
in response to the 2014 Shared Savings Program proposed rule.
    Comment: One commenter suggested an alternative assignment 
methodology that the commenter believed would be similar to a 
methodology discussed in the CY 2019 PFS proposed rule which would 
distinguish between primary and secondary specialties for practitioners

[[Page 59968]]

billing under the same TIN as part of a multispecialty group. The 
commenter stated this approach would improve the accuracy of the 
assignment methodology by focusing on evaluation and management 
services furnished by primary care providers, rather than specialists. 
Alternatively, this commenter suggested an assignment methodology 
similar to methodologies used by state agencies. According to the 
commenter, this assignment methodology would allow for exclusions, 
attribution, and tie-breaking steps to support a valid beneficiary 
population.
    Response: We encourage the commenter to review our assignment 
methodology under the Shared Savings Program regulations at 42 CFR part 
425, subpart E. Our current assignment methodology emphasizes primary 
care services provided by primary care clinicians in step one, before 
considering primary care services furnished by certain specialists in 
step two. However, we will continue to monitor this issue to determine 
whether there have been any changes or refinements that would allow us 
to more precisely identify both primary and secondary practitioner 
specialties in Medicare claims data and whether those changes should be 
accounted for in the assignment methodology used in the Shared Savings 
Program. Any changes to our assignment methodology would be proposed 
through future rulemaking for the Shared Savings Program.
    As discussed earlier in this final rule, the proposal to create 
three new HCPCS G-codes as part of a broader proposal to simplify the 
documentation requirements and to more accurately pay for the office or 
other outpatient evaluation and management services represented by CPT 
codes 99201 through 99215 is not being finalized. Therefore, the 
proposal to include HCPCS ``add-on codes'', GPC1X, GCG0X, and GPRO1 in 
the definition of ``primary care services'' will not be finalized at 
this time. We will revisit this proposal in future rulemaking and 
continue to monitor the annual rulemaking for the PFS to determine if 
we should propose any changes to the definition of primary care 
services for the Shared Savings Program to reflect proposed HCPCS/CPT 
coding changes.
    We received no comments on the proposed technical changes to Sec.  
425.400(c)(1)(iv). After considering the comments received, we are 
finalizing our proposed revisions to the definition of primary care 
services, with the exception of the proposal to include the three add-
on HCPCS codes GPC1X, GCG0X, and GPRO1. Specifically, we are revising 
the definition of primary care services in Sec.  425.400(c) to add CPT 
codes 99497, 99498, 96160, 96161, 99354, and 99355, and HCPCS codes 
G0444, G0442, and G0443. Additionally, we are finalizing, as proposed, 
the revisions to our method for excluding services identified by CPT 
codes 99304 through 99318 when furnished in a SNF and the proposed 
technical changes to Sec.  425.400(c)(1)(iv).
    Consistent with the approach we have taken in the past when 
implementing changes to the assignment methodology, we will adjust 
ACOs' historical benchmarks for the performance year starting on 
January 1, 2019, to account for the changes to the assignment 
methodology that we are finalizing in this final rule.
d. Extreme and Uncontrollable Circumstances Policies for the Shared 
Savings Program
(1) Background
    Following the 2017 California wildfires and Hurricanes Harvey, 
Irma, Maria, and Nate, stakeholders expressed concerns that the effects 
of these types of disasters on ACO participants, ACO providers/
suppliers, and the assigned beneficiary population could undermine an 
ACO's ability to successfully meet the quality performance standards, 
and adversely affect financial performance, including, in the case of 
ACOs under performance-based risk, increasing shared losses. To address 
these concerns, we published an interim final rule with comment period 
titled Medicare Program; Medicare Shared Savings Program: Extreme and 
Uncontrollable Circumstances Policies for Performance Year 2017 
(hereinafter referred to as the Shared Savings Program IFC) that 
appeared in the December 26, 2017 Federal Register (82 FR 60912). In 
the Shared Savings Program IFC, we established policies for addressing 
ACO quality performance scoring and the determination of the shared 
losses owed by ACOs participating under performance-based risk tracks 
for ACOs that were affected by extreme or uncontrollable circumstances 
during performance year 2017. The policies adopted in the Shared 
Savings Program IFC were effective for performance year 2017, including 
the applicable quality data reporting period for the performance year. 
We have considered the comments received on the Shared Savings Program 
IFC in developing the policies for 2018 and subsequent years.
    The extreme and uncontrollable circumstances policies established 
in the Shared Savings Program for performance year 2017 align with the 
policies established under the Quality Payment Program for the 2017 
MIPS performance period and subsequent MIPS performance periods (see CY 
2018 Quality Payment Program final rule with comment, 82 FR 53780 
through 53783 and Quality Payment Program IFC, 82 FR 53895 through 
53900). In particular, in the Shared Savings Program IFC (82 FR 60914), 
we indicated that we would determine whether an ACO had been affected 
by an extreme and uncontrollable circumstance by determining whether 20 
percent or more of the ACO's assigned beneficiaries resided in counties 
designated as an emergency declared area in performance year 2017 as 
determined under the Quality Payment Program or the ACO's legal entity 
was located in such an area. In the Quality Payment Program IFC (82 FR 
53897), we explained that we anticipated that the types of events that 
could trigger the extreme and uncontrollable circumstances policies 
would be events designated a Federal Emergency Management Agency (FEMA) 
major disaster or a public health emergency declared by the Secretary, 
although we indicated that we would review each situation on a case-by-
case basis.
    Because ACOs may face extreme and uncontrollable circumstances in 
2018 and subsequent years, we proposed to extend the policies adopted 
in the Shared Savings Program IFC for addressing ACO quality 
performance scoring and the determination of the shared losses owed for 
ACOs affected by extreme or uncontrollable circumstances to performance 
year 2018 and subsequent performance years. In addition, in the Shared 
Savings Program IFC, we indicated that we planned to observe the impact 
of the 2017 hurricanes and wildfires on ACOs' expenditures for their 
assigned beneficiaries during performance year 2017, and might revisit 
the need to make adjustments to the methodology for calculating the 
benchmark in future rulemaking. We considered this issue further in the 
August 2018 proposed rule (see 83 FR 41904 through 41906).
(2) Proposed Revisions
    The financial and quality performance of ACOs located in areas 
subject to extreme and uncontrollable circumstances could be 
significantly and adversely affected. Disasters may have several 
possible effects on ACO quality and financial performance. For 
instance, displacement of beneficiaries may make it difficult for ACOs 
to access medical record data required for quality

[[Page 59969]]

reporting, as well as, reduce the beneficiary response rate on survey 
measures. Further, for practices damaged by a disaster, the medical 
records needed for quality reporting may be inaccessible. We also 
believe that disasters may affect the infrastructure of ACO 
participants, ACO providers/suppliers, and potentially the ACO legal 
entity itself, thereby disrupting routine operations related to their 
participation in the Shared Savings Program and achievement of program 
goals. The effects of a disaster could include challenges in 
communication between the ACO and its participating providers and 
suppliers and in implementation of and participation in programmatic 
activities. Catastrophic events outside the ACO's control can also 
increase the difficulty of coordinating care for patient populations, 
and due to the unpredictability of changes in utilization and cost of 
services furnished to beneficiaries, may have a significant impact on 
expenditures for the applicable performance year and the ACO's 
benchmark in the subsequent agreement period. These factors could 
jeopardize ACOs' ability to succeed in the Shared Savings Program, and 
ACOs, especially those in performance-based risk tracks, may reconsider 
whether they are able to continue their participation in the program.
    As we stated in the August 2018 proposed rule (83 FR 41900), 
because widespread disruptions could occur during 2018 or subsequent 
performance years, we believe it is appropriate to have policies in 
place to change the way in which we assess the quality and financial 
performance of Shared Savings Program ACOs in any affected areas. 
Accordingly, we proposed to extend the automatic extreme and 
uncontrollable circumstances policies under the Shared Savings Program 
that were established for performance year 2017 to performance year 
2018 and subsequent performance years. Specifically, we proposed that 
the Shared Savings Program extreme and uncontrollable circumstances 
policies for performance year 2018 and subsequent performance years 
would apply when we determine that an event qualifies as an automatic 
triggering event under the Quality Payment Program. As we discussed in 
the Shared Savings Program IFC (82 FR 60914), we believe it is also 
appropriate to extend these policies to encompass the quality reporting 
period, unless the reporting period is extended, because if an ACO is 
unable to submit its quality data as a result of a disaster occurring 
during the quality data submission window, we would not have the 
quality data necessary to measure the ACO's quality performance for the 
performance year. For example, if an extreme and uncontrollable event 
were to occur in February 2019, which we anticipate would be during the 
quality data reporting period for performance year 2018, then the 
extreme and uncontrollable circumstances policies would apply for 
quality data reporting and quality performance scoring for performance 
year 2018, if the reporting period is not extended. We explained that 
we do not believe it is appropriate to extend this policy to encompass 
the quality data reporting period if the reporting period is extended 
because affected ACOs would have an additional opportunity to submit 
their quality data, enabling us to measure their quality performance in 
the applicable performance year. Accordingly, we also proposed that the 
policies regarding quality reporting would apply with respect to the 
determination of the ACO's quality performance in the event that an 
extreme and uncontrollable event occurs during the applicable quality 
data reporting period for a performance year and the reporting period 
is not extended. However, we noted that, because a disaster that occurs 
after the end of the performance year would have no impact on the 
determination of an ACO's financial performance for that performance 
year, it would not be appropriate to make an adjustment to shared 
losses in the event an extreme or uncontrollable event occurs during 
the quality data reporting period.
    Comment: Commenters overwhelmingly supported adopting permanent 
policies to mitigate the impacts of extreme and uncontrollable 
circumstances. Several commenters supported finalizing the proposals 
without modification; however, the majority of commenters suggested 
modifications to the proposed policies or requested that CMS adopt 
additional means of providing relief to disaster affected ACOs. The 
comments and recommendations are discussed below in sections 
V.B.2.d.(1), (2), and (3) of this final rule.
    Response: We appreciate commenters' support for adopting permanent 
policies to provide relief to ACOs that are affected by extreme and 
uncontrollable circumstances.
    Comment: A few commenters recommended that CMS take into 
consideration whether an ACO has experienced an extreme and 
uncontrollable event during its agreement period when applying certain 
policies proposed in other sections of the August 2018 proposed rule, 
if finalized. These included proposed policies related to monitoring 
for financial performance, repayment mechanism amounts, reconciliation 
after termination and the determination of participant Medicare FFS 
revenue and prior participation for purposes of determining 
participation options.
    Response: We thank commenters for their suggestions on ways to 
further limit the potential negative impacts of extreme and 
uncontrollable circumstances on ACOs affected by such events. We 
believe that these suggestions fall outside the scope of the proposals 
described in section II.E.4 of the August 2018 proposed rule that we 
are addressing in this final rule. We anticipate discussing our 
proposals related to other sections of the August 2018 proposed rule in 
a forthcoming final rule and will address comments related to those 
sections at that time.
(a) Modification of Quality Performance Scores for All ACOs in Affected 
Areas
    As we explained in the Shared Savings Program IFC (82 FR 60914 
through 60916), ACOs and their ACO participants and ACO providers/
suppliers are frequently located across several different geographic 
regions or localities, serving a mix of beneficiaries who may be 
differentially impacted by hurricanes, wildfires, or other triggering 
events. Therefore, for 2017, we established a policy for determining 
when an ACO, which may have ACO participants and ACO providers/
suppliers located in multiple geographic areas, would qualify for the 
automatic extreme and uncontrollable circumstance policies for the 
determination of quality performance. Specifically, we adopted a policy 
for performance year 2017 of determining whether an ACO had been 
affected by extreme and uncontrollable circumstances by determining 
whether 20 percent or more of the ACO's assigned beneficiaries resided 
in counties designated as an emergency declared area in the performance 
year, as determined under the Quality Payment Program as discussed in 
the Quality Payment Program IFC (82 FR 53898) or the ACO's legal entity 
was located in such an area. For 2017, we adopted a policy under which 
the location of an ACO's legal entity was determined based on the 
address on file for the ACO in CMS' ACO application and management 
system. We used 20 percent of the ACO's assigned beneficiary population 
as the minimum threshold to establish an ACO's eligibility for the 
policies regarding quality reporting and quality

[[Page 59970]]

performance scoring for 2017 because, as we stated in the Shared 
Savings Program IFC, we believe the 20 percent threshold provides a 
reasonable way to identify ACOs whose quality performance may have been 
adversely affected by an extreme or uncontrollable circumstance, while 
excluding ACOs whose performance would not likely be significantly 
affected.
    The 20 percent threshold was selected to account for the effect of 
an extreme or uncontrollable circumstance on an ACO that has the 
minimum number of assigned beneficiaries to be eligible for the program 
(5,000 beneficiaries), and in consideration of the average total number 
of unique beneficiaries for whom quality information is required to be 
reported in the combined CAHPS survey sample (860 beneficiaries) and 
the CMS Web Interface sample (approximately 3,500 beneficiaries). 
(There may be some overlap between the CAHPS sample and the CMS Web 
Interface sample.) Therefore, we estimated that an ACO with an assigned 
population of 5,000 beneficiaries typically would be required to report 
quality information on a total of 4,000 beneficiaries. Thus, we 
indicated that we believe the 20 percent threshold ensures that an ACO 
with the minimum number of assigned beneficiaries would have an 
adequate number of beneficiaries across the CAHPS and CMS Web Interface 
samples in order to fully report on these measures. However, we also 
noted that it is possible that some ACOs that have fewer than 20 
percent of their assigned beneficiaries residing in affected areas may 
have a legal entity that is located in an emergency declared area. 
Consequently, their ability to quality report may be equally impacted 
because the ACO legal entity may be unable to collect the necessary 
information from their ACO participants or may experience 
infrastructure issues related to capturing, organizing, and reporting 
the data to CMS. We stated that if less than 20 percent of the ACO's 
assigned beneficiaries reside in an affected area and the ACO's legal 
entity is not located in a county designated as an affected area, then 
we believe that there is unlikely to be a significant impact upon the 
ACO's ability to report or on the representativeness of the quality 
performance score that is determined for the ACO. For performance year 
2017, we determined what percentage of the ACO's performance year 
assigned population was affected by a disaster based on the final list 
of beneficiaries assigned to the ACO for the performance year. Although 
beneficiaries are assigned to ACOs under Track 1 and Track 2 based on 
preliminary prospective assignment with retrospective reconciliation 
after the end of the performance year, these ACOs were able to use 
their quarterly assignment lists, which include beneficiaries' counties 
of residence, for early insight into whether they were likely to meet 
the 20 percent threshold.
    In the Shared Savings Program IFC, we modified the quality 
performance standard specified under Sec.  425.502 by adding a new 
paragraph (f) to address potential adjustments to the quality 
performance scores for performance year 2017 of ACOs determined to be 
affected by extreme and uncontrollable circumstances. We also modified 
Sec.  425.502(e)(4) to specify that an ACO receiving the mean Shared 
Savings Program ACO quality score for performance year 2017 based on 
the extreme and uncontrollable circumstances policies would not be 
eligible for bonus points awarded based on quality improvement in that 
year because quality data would not be available to determine if there 
was improvement from year to year.
    In the Shared Savings Program IFC, we established policies with 
respect to quality reporting and quality performance scoring for the 
2017 performance year. In anticipation of any future extreme and 
uncontrollable events, in the August 2018 proposed rule (83 FR 41901) 
we proposed to extend these policies, with minor modifications, to 
subsequent performance years as well. In order to avoid confusion and 
reduce unnecessary burdens on affected ACOs, we proposed to align our 
policies for 2018 and subsequent years with policies established for 
the Quality Payment Program in the final rule with comment period, 
entitled CY 2018 Updates to the Quality Payment Program (82 FR 53568). 
Specifically, we proposed to apply determinations made under the 
Quality Payment Program with respect to whether an extreme and 
uncontrollable circumstance has occurred and the identification of the 
affected geographic areas and the applicable time periods. Generally, 
in line with the approach taken for 2017 in the Quality Payment Program 
IFC (82 FR 53897), we anticipated that the types of events that would 
be considered an automatic triggering event would be events designated 
as a Federal Emergency Management Agency (FEMA) major disaster or a 
public health emergency declared by the Secretary, but indicated that 
CMS would review each situation on a case-by-case basis. We also 
proposed that CMS would have sole discretion to determine the time 
period during which an extreme and uncontrollable circumstance 
occurred, the percentage of the ACO's assigned beneficiaries residing 
in the affected areas, and the location of the ACO legal entity. 
Additionally, we proposed to determine an ACO's legal entity location 
based on the address on file for the ACO in CMS' ACO application and 
management system.
    In the Shared Savings Program IFC, we established a policy for 
performance year 2017 under which we determined the percentage of the 
ACO's assigned population that was affected by a disaster based on the 
final list of beneficiaries assigned to the ACO for the performance 
year. We begin producing the final list of assigned beneficiaries after 
allowing for 3 months of claims run out following the end of a 
performance year. However, the quality reporting period ends before the 
3-month claims run out period ends. Therefore, in the August 2018 
proposed rule we expressed concern that if, for future performance 
years, we continue to calculate the percentage of affected 
beneficiaries based on the ACO's final list of assigned beneficiaries, 
it would not be operationally feasible for us to notify an ACO as to 
whether it meets the 20 percent threshold prior to the end of the 
quality reporting period because the final list of assigned 
beneficiaries is not available until after the close of the quality 
reporting period. We explained that we now believe it would be 
appropriate to base this calculation on the list of assigned 
beneficiaries used to generate the Web Interface quality reporting 
sample, which would be available with the quarter three program 
reports, generally in November of the applicable performance year. We 
also indicated this report would be available to ACOs participating in 
the proposed 6-month performance year from January 1, 2019 through June 
30, 2019. By basing the calculation on the list of assigned 
beneficiaries used to generate the Web Interface quality reporting 
sample, we would be able to notify ACOs earlier as to whether they 
exceed the 20 percent threshold, and ACOs could then use this 
information to decide whether to report quality data for the 
performance year. Therefore, for performance year 2018 and subsequent 
performance years, we proposed to determine the percentage of an ACO's 
assigned beneficiaries that reside in an area affected by an extreme 
and uncontrollable circumstance using the list of assigned 
beneficiaries used to generate the Web Interface quality reporting 
sample. We indicated that we

[[Page 59971]]

could use this assignment list report regardless of the date(s) the 
natural disaster occurred. The assignment list report provides us with 
a list of beneficiaries who have received the plurality of their 
primary care services from ACO professionals in the ACO at a specific 
point in time. As this is the list that is used to determine the 
quality reporting sample, we believe it is appropriate to use the same 
list to determine how many of the ACO's beneficiaries reside in an area 
affected by a disaster, such that the ACO's ability to report quality 
data could be compromised. We proposed to revise Sec.  425.502(f) to 
reflect this proposal for performance year 2018 and subsequent years.
    In the Shared Savings Program IFC (82 FR 60916), we described the 
policies under the MIPS APM scoring standard that would apply for 
performance year 2017 for MIPS eligible clinicians in an ACO that did 
not completely report quality. The existing tracks of the Shared 
Savings Program (Track 1, Track 2 and Track 3), and the Track 1+ Model 
are all MIPS APMs under the APM scoring standard.\35\ If finalized, we 
expect the BASIC track and ENHANCED track (based on Track 3) proposed 
in the August 2018 proposed rule would similarly be considered MIPS 
APMs under the APM scoring standard. In the August 2018 proposed rule 
(83 FR 41902), we noted, for purposes of the APM scoring standard, MIPS 
eligible clinicians in an ACO that has been affected by an extreme and 
uncontrollable circumstance and does not report quality for a 
performance year, and therefore, receives the mean ACO quality score 
under the Shared Savings Program, would have the MIPS quality 
performance category reweighted to zero percent resulting in MIPS 
performance category weighting of 75 percent for the Promoting 
Interoperability performance category and 25 percent for the 
Improvement Activities performance category under the APM scoring 
standard per our policy at Sec.  414.1370(h)(5)(i)(B). In the event an 
ACO that has been affected by an extreme and uncontrollable 
circumstance is able to completely and accurately report all quality 
measures for a performance year, and therefore receives the higher of 
the ACO's quality performance score or the mean quality performance 
score under the Shared Savings Program, we would not reweight the MIPS 
quality performance category to zero percent under the APM scoring 
standard. Additionally, unless otherwise excepted, the ACO participants 
will receive a Promoting Interoperability (PI) (formerly called 
Advancing Care Information (ACI)) performance category score under the 
APM scoring standard based on their reporting, which could further 
increase their final score under MIPS.
---------------------------------------------------------------------------

    \35\ See, for example Alternative Payment Models in the Quality 
Payment Program as of February 2018, available at https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/Comprehensive-List-of-APMs.pdf.
---------------------------------------------------------------------------

    We proposed to revise Sec.  425.502(f) to extend the policies 
established for performance year 2017 to performance year 2018 and 
subsequent performance years. Specifically, we proposed that for 
performance year 2018 and subsequent performance years, including the 
applicable quality data reporting period for the performance year if 
the reporting period is not extended, in the event that we determine 
that 20 percent or more of an ACO's assigned beneficiaries, as 
determined using the list of beneficiaries used to generate the Web 
Interface quality reporting sample, reside in an area that is affected 
by an extreme and uncontrollable circumstance, as determined under the 
Quality Payment Program, or that the ACO's legal entity is located in 
such an area, we would use the following approach to calculate the 
ACO's quality performance score as specified in proposed revisions to 
paragraphs (e) and (f) of Sec.  425.502.
     The ACO's minimum quality score would be set to equal the 
mean quality performance score for all Shared Savings Program ACOs for 
the applicable performance year.
     If the ACO is able to completely and accurately report all 
quality measures, we would use the higher of the ACO's quality 
performance score or the mean quality performance score for all Shared 
Savings Program ACOs. If the ACO's quality performance score is used, 
the ACO would also be eligible for quality improvement points.
     If the ACO receives the mean Shared Savings Program 
quality performance score, the ACO would not be eligible for bonus 
points awarded based on quality improvement during the applicable 
performance year.
     If an ACO receives the mean Shared Savings Program ACO 
quality performance score for a performance year, in the next 
performance year for which the ACO reports quality data and receives a 
quality performance score based on its own performance, we would 
measure quality improvement based on a comparison between the ACO's 
performance in that year and in the most recently available prior 
performance year in which the ACO reported quality. Under this 
approach, the comparison would continue to be between consecutive years 
of quality reporting, but these years may not be consecutive calendar 
years.
    Additionally, we proposed to address the possibility that ACOs that 
have a 6-month performance year (or performance period) during 2019 may 
be affected by extreme and uncontrollable circumstances. In this final 
rule, we are addressing the proposals specific to the 6-month 
performance year from January 1, 2019 through June 30, 2019. In a 
forthcoming final rule, we anticipate discussing comments received on 
the proposals related to policies for the 6-month performance year from 
July 1, 2019 through December 31, 2019, and the performance period from 
January 1, 2019 through June 30, 2019, for ACOs that terminate their 
agreement effective June 30, 2019, and enter a new agreement period 
starting on July 1, 2019. We anticipate this discussion will include a 
description of the applicability of policies for addressing extreme and 
uncontrollable circumstances.
    As described in section II.A.7 of the August 2018 proposed rule, we 
proposed to use 12 months of data, based on the calendar year, to 
determine quality performance for the 6-month performance year from 
January 2019 through June 2019 (83 FR 41856 through 41858). We 
explained our belief that it is necessary to account for disasters 
occurring in any month(s) of CY 2019 for ACOs participating in a 6-
month performance year during 2019 regardless of whether the ACO is 
actively participating in the Shared Savings Program at the time of the 
disaster. Therefore, for ACOs with a 6-month performance year from 
January 1, 2019 through June 30, 2019, affected by a disaster in any 
month of 2019, we would use the alternative scoring methodology 
specified in Sec.  425.502(f) to determine the quality performance 
score for the 2019 quality reporting period, if the reporting period is 
not extended. For example, assume that an ACO participates in the 
Shared Savings Program for a 6-month performance year from January 1, 
2019 through June 30, 2019, and does not continue its participation in 
the program for a new agreement period beginning July 1, 2019 (as 
proposed). Further assume that we determine that 20 percent or more of 
the ACO's assigned beneficiaries, as determined using the list of 
beneficiaries used to generate the Web Interface quality reporting 
sample, reside in an area that is affected by an extreme and 
uncontrollable circumstance, as determined under the

[[Page 59972]]

Quality Payment Program, in September 2019. The ACO's quality 
performance score for the 2019 reporting period would be adjusted 
according to the policies in Sec.  425.502(f).
    We proposed to specify the applicability of the alternative scoring 
methodology in Sec.  425.502(f) for the 6-month performance year from 
January 1, 2019 through June 30, 2019, in the proposed new section of 
the regulations at Sec.  425.609(d).
    We solicited comments on the proposed policies for assessing the 
quality performance of ACOs affected by an extreme or uncontrollable 
circumstance during performance year 2018 and subsequent years, 
including the applicable quality data reporting period for the 
performance year, unless the reporting period is extended.
    Comment: One commenter incorrectly stated that CMS proposed to 
continue to use a threshold of 25 percent to determine the 
applicability of the proposed alternative quality scoring policies 
(rather than the actual 20 percent proposed) and noted that they agreed 
that this threshold was reasonable. This commenter also suggested that 
CMS consider other percentage thresholds, such as 5 percent or 10 
percent, as test cases. The same commenter also encouraged CMS to look 
at the percentage of an ACO's physicians and other health clinicians 
located in an impacted area as another means of determining which ACOs 
should be automatically eligible for the alternative quality scoring 
policy. This commenter suggested, for example, using a threshold of 50 
percent of NPIs located in an impacted area, based on the practice 
locations listed in the Provider Enrollment, Chain, and Ownership 
System (PECOS).
    Response: We are finalizing our proposal to continue to use 20 
percent of assigned beneficiaries residing in a disaster-affected as 
one of the criteria for determining whether an ACO is eligible for the 
alternative quality scoring methodology. We will continue to monitor 
this criterion as we gain more experience with these policies. However, 
at present we believe that the 20 percent threshold, which was 
influenced by considerations related to ensuring a sufficient 
population size to allow affected ACOs to fully report on quality, 
remains a reasonable level. While we considered the commenter's 
suggestion to expand the criteria for identifying affected ACOs to 
include ACOs for which 50 percent or more of the NPIs billing under the 
ACO participant TINs are located in an impacted area, we believe that 
including this additional criterion would create additional operational 
complexity and less transparency as we do not currently include 
information on the location of ACO providers/suppliers in program 
reports.
    Comment: Several commenters stated that the proposed policy of 
using the higher of an ACO's own quality score in the affected year or 
the national mean score unfairly penalizes ACOs that have had 
historically high quality performance. One commenter also noted that 
this approach could unfairly reward ACOs with historically low quality 
performance to the detriment of the Medicare Trust Funds. These 
commenters recommended that CMS should adopt an approach that considers 
an ACO's own quality score from one or more prior years, if available. 
Some of the commenters explained this approach would be similar to a 
policy used in Medicare Advantage.
    Commenters offered various suggestions on how to implement a policy 
that considers an ACO's historic quality performance. A few commenters 
recommended that CMS use the highest of the ACO's quality score for the 
affected performance year, the ACO's quality score for the prior 
performance year (if available), or the national mean quality score. 
One commenter recommended following this approach for each individual 
quality measure. Suggestions from other commenters included: Using the 
higher of the ACO's average quality score for the prior two years and 
the national mean for ACOs in their third or subsequent year in the 
program and using the national average score for ACOs in their first or 
second year in the program; Using the higher of the affected year 
quality score and the prior year quality score, if one is available, 
and otherwise using the higher of the affected year score and the 
national mean score; Using the ACO's historical quality performance 
instead of the mean when an ACO is in its third or subsequent 
performance year in the program.
    Several commenters also recommended that the proposed policies in 
this section be extended to include all ACOs affected by a natural 
disaster, not just those that cannot report quality data. A few 
commenters provided suggestive evidence that quality outcome measures 
such as readmission measures may be subject to immediate and 
significant impacts in the event of a natural disaster, which could 
have an adverse impact on an ACO's quality score, particularly given 
the non-linear nature of the program's quality scoring methodology 
under which an ACO receives zero points on a measure if it falls below 
the 30th percentile. Several commenters requested that that those ACOs 
whose scores on readmissions measures (ACO-8, all-cause readmissions 
and ACO-35, SNF readmissions) fall below the 30th percentile should be 
eligible to have their quality score adjusted to account for the 
natural disaster.
    Response: We acknowledge that for some ACOs, the mean quality score 
could be lower, or higher, than the score those ACOs would have 
received in the absence of a disaster. However, we have concerns with 
the recommended alternatives which would potentially apply an ACO's 
score from the prior year or apply a score that is an average of prior 
year scores, particularly for ACOs in their early years of 
participation in the Shared Savings Program and for which the prior 
years may have included a higher number of pay-for-reporting measures, 
thus making the quality scores incomparable. Likewise, in section 
III.F.1.b. of this final rule we are finalizing several quality 
measures for use beginning in performance year 2019. These measures 
will be pay-for-reporting for the first 2 years of use (2019 and 2020). 
All else being equal, the addition of these new pay-for-reporting 
measures will increase ACOs' quality scores. Also, we note that ACO 
quality performance can vary from year to year and the fact that an ACO 
had a high quality score in prior years does not necessarily guarantee 
that the ACO would have had an above average score in the affected year 
in the absence of the natural disaster. Lastly, we would remind 
commenters that the national mean quality score includes the quality 
scores of 100 percent earned by ACOs in their first performance year, 
thus increasing the mean.
    For these reasons, we are declining at this time to adopt 
commenters' recommendations that we consider prior year quality scores 
as part of determining the quality performance scores of ACOs affected 
by extreme and uncontrollable circumstances and are finalizing the 
proposed policy. We are also declining to adopt the commenter's 
recommendation to give special consideration to ACOs based on their 
performance on the ACO-8 and ACO-35 readmissions measures. We would 
also like to clarify that both the policy that we finalized for 
performance year 2017 in the Shared Savings Program IFC and the policy 
we are finalizing in this rule for performance year 2018 and subsequent 
performance years would apply to all ACOs deemed to be affected by an 
extreme and uncontrollable circumstance (20 percent or more of assigned 
beneficiaries residing in an

[[Page 59973]]

affected area or legal entity located in such an area), including those 
ACOs that were able to report quality and those for which scores on 
ACO-8 and ACO-35 fell below the 30th percentile. We will continue to 
monitor quality performance among ACOs affected by extreme and 
uncontrollable circumstances, and as we gain more experience will 
consider whether any changes to the finalized policy are warranted.
    Comment: One commenter agreed with setting a disaster-affected 
ACO's quality score to the national mean but opposed using the mean 
score to calculate ``future benchmarks or subsequent year thresholds 
until complete and accurate reporting can be achieved.'' They noted 
that ``setting quality benchmarks to an artificial mean is not a valid 
approach to determine legitimate savings and losses.''
    Response: We clarify that ACOs' quality performance scores are not 
used to calculate quality measure benchmarks. Rather, the quality 
measure benchmarks are calculating using actual ACO performance and all 
other available and applicable Medicare FFS data.
    Comment: One commenter recommended that all affected ACOs should 
receive the higher of the 2018 or 2019 Star Rating for each CAHPS 
measure.
    Response: We note that the Shared Savings Program does not provide 
a Star Rating to ACOs based on their CAHPS performance. Star Ratings 
are used for Medicare Advantage and Medicare Prescription Drug plans to 
provide quality and performance information to Medicare beneficiaries 
to assist them in choosing their health and drug services and, solely 
for Medicare Advantage plans, to implement the quality bonus payment 
adopted by Congress in the Patient Protection and Affordable Care Act. 
We believe that incorporating Star Ratings into the Shared Savings 
Program would need to be part of a larger effort that was not 
contemplated in the August 2018 proposed rule. In contrast, we believe 
our proposal of using the higher of an ACO's own calculated quality 
score or the mean quality score serves as a way to mitigate negative 
impacts for disaster-affected ACOs in manner that can be readily 
incorporated into the existing structure of the Shared Savings Program 
quality scoring methodology.
    Comment: A few commenters recommended that CMS remove claims 
associated with disaster-impacted beneficiaries and time periods or 
claims with disaster payment modifier codes when calculating the 
numerator and denominator of the readmissions measures and other 
claims-based quality measures.
    Response: As we describe in section V.B.2.b. of this final rule, we 
have examined the use of existing disaster payment modifiers during 
2017 and have found their utilization to be low overall and to vary 
across ACOs, including those with comparably high shares of 
beneficiaries residing in disaster affected areas. Therefore, we have 
concerns that these codes would not serve as a useful means for 
comprehensively identifying relevant claims. We also have concerns 
about removing claims for beneficiaries residing in affected areas 
during affected time periods. In addition to adding considerable 
complexity, this approach could lead to the elimination of a large 
number of claims for some ACOs. This could lead to bias if the claims 
removed are systematically different from other claims for reasons 
apart from the natural disaster, such as because they are concentrated 
in a specific geographic area or time period and may also make it more 
difficult for CMS to provide an oversample of beneficiaries to ACOs for 
the CMS Web Interface sample.
    Comment: One commenter requested that CMS provide additional 
clarity before finalizing any of the policies for extreme and 
uncontrollable circumstances proposed in the August 2018 proposed rule. 
In particular, the commenter requested that CMS provide additional 
clarification on how the agency would determine and announce whether 
the extreme and uncontrollable circumstances policies would apply or if 
the reporting period would be extended.
    Response: We intend to make an initial determination about whether 
an ACO meets the criteria for being considered a disaster-affected ACO 
after quarter 3 assignment has been determined and before the start of 
the quality reporting period. We will make the final determination with 
respect to affected ACOs after the end of the calendar year in order to 
capture any additional extreme and uncontrollable circumstances that 
may occur in the remainder of the year or during the quality reporting 
period, if not extended. We will continue to use the quarter 3 
assignment list as the basis for this final determination. In the event 
that CMS decides to extend the quality reporting period, we would 
provide notification to ACOs through existing communication channels 
such as the Shared Savings Program newsletter or an email blast. We 
also note that if an ACO is determined to be an affected ACO as a 
result of an extreme or uncontrollable circumstance during the 
performance year, the alternative quality scoring methodology would 
apply, regardless of whether the quality reporting period is extended.
    Comment: One commenter recommended that CMS adopt the same period 
as any Declaration of Emergency by the Secretary when determining the 
applicable time period for an extreme and uncontrollable circumstance 
instead of an alternative period selected by CMS that may not be as 
well-aligned with the reality of health services instability for areas 
under a declaration of emergency. Another commenter encouraged CMS to 
be transparent regarding the criteria used to determine the applicable 
time period and to work closely with Medicare Administrative 
Contractors and the Federal Emergency Management Agency to communicate 
these policies to ACOs.
    Response: We are finalizing our proposals for extreme and 
uncontrollable circumstances, including our proposal that CMS will have 
the sole discretion to determine the time period during which an 
extreme and uncontrollable circumstance occurred. Although we are not 
adopting fixed criteria for determining the applicable time periods, we 
note that for performance year 2017 we used the time periods associated 
with public health emergencies declared by the Secretary and listed on 
the CMS Emergency Response and Recovery website (now renamed the 
Emergency Preparedness & Response Operations website at https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/EPRO-Home.html). We anticipate continuing this practice, which we believe to 
be transparent, going forward. Furthermore, for events for which the 
public health emergency declaration spans calendar years, we intend to 
treat the portion of the period falling within each year as if it were 
a separate event for purposes of identifying ACOs eligible for the 
alternative quality scoring methodology and for computing any 
adjustment to shared losses.
    Comment: One commenter expressed concerns about what they described 
as CMS' ``one-size-fits-all'' approach for determining the time period 
during which an ACO would be subject to the extreme and uncontrollable 
circumstances policies. They encouraged CMS to allow ACOs an 
opportunity to request relief from shared losses and negative quality 
adjustments over a longer period of time, up to a full performance 
year, to be evaluated by CMS on a case-by-case basis. The commenter 
noted that the impact of a disaster occurring early in the year may 
have a different impact

[[Page 59974]]

than one occurring later in the year and there may be long-lasting 
effects, which should not have counted against affected ACOs. They 
stated that the hardship exemption, which would be approved by CMS on a 
case-by-case basis, would have limited effect on the Trust Funds, but 
would be important for the integrity of the program by establishing a 
formal process for ACOs to request an exemption based on extenuating 
circumstances.
    Response: We have elected to adopt automatic policies to address 
extreme and uncontrollable circumstances in lieu of hardship requests 
that must be considered on a case-by-case basis in order to increase 
certainty and reduce administrative burden for both ACOs and CMS. We 
will continue to monitor the impact of the policies that we are 
finalizing in this rule, and as we gain more experience, if warranted, 
we will propose additional modifications through future notice and 
comment rulemaking.
    After considering the comments received, we are finalizing our 
proposals to extend the policies for determining the quality scores for 
ACOs affected by extreme and uncontrollable circumstances established 
for performance year 2017 to performance year 2018 and subsequent 
performance years. Specifically, we are revising Sec. Sec.  425.502(e) 
and 425.502(f) to state that for performance year 2018 and subsequent 
performance years, including the applicable quality data reporting 
period for the performance year, if the reporting period is not 
extended, in the event that we determine that 20 percent or more of an 
ACO's assigned beneficiaries, as determined using the list of assigned 
beneficiaries used to generate the Web Interface quality reporting 
sample, reside in an area that is affected by an extreme and 
uncontrollable circumstance, as determined under the Quality Payment 
Program, or that the ACO's legal entity is located in such an area, we 
will use the following approach to calculate the ACO's quality 
performance score:
     The ACO's minimum quality score will be set to equal the 
mean quality performance score for all Shared Savings Program ACOs for 
the applicable performance year.
     If the ACO is able to completely and accurately report all 
quality measures, we will use the higher of the ACO's quality 
performance score or the mean quality performance score for all Shared 
Savings Program ACOs. If the ACO's quality performance score is used, 
the ACO will also be eligible for quality improvement points.
     If the ACO receives the mean Shared Savings Program 
quality performance score, the ACO will not be eligible for bonus 
points awarded based on quality improvement during the applicable 
performance year.
     If an ACO receives the mean Shared Savings Program ACO 
quality performance score for a performance year, in the next 
performance year for which the ACO reports quality data and receives a 
quality performance score based on its own performance, we will measure 
quality improvement based on a comparison between the ACO's performance 
in that year and in the most recently available prior performance year 
in which the ACO reported quality.
    We clarify that if an ACO reports quality data in a year in which 
it is affected by an extreme and uncontrollable circumstance, but 
receives the national mean quality score, we will use the ACO's own 
quality performance score to determine quality improvement bonus points 
in the following year. For example, if an ACO reported quality data in 
years 1, 2, and 3 of an agreement period, but received the national 
mean quality score in year 2 as the result of an extreme or 
uncontrollable circumstance, we would determine quality improvement 
bonus points for year 3 by comparing the ACO's year 3 quality score 
with its year 2 score. If the ACO received the mean score in year 2 
because it did not report quality, we would compare year 3 with year 1 
to determine the bonus points for year 3.
    We also want to clarify one point regarding the interaction between 
this alternative quality scoring methodology and MIPS. As we noted 
above, the MIPS quality performance category is reweighted to zero if a 
disaster-affected ACO receives the mean quality score under the Shared 
Savings Program's extreme and uncontrollable circumstance policy, 
because it did not or could not report quality data at the ACO (APM 
Entity) level, regardless of whether or not any of the ACOs participant 
TINs reported quality outside the ACO. This reweighting under MIPS 
results in MIPS performance category weighting of 75 percent for the PI 
performance category and 25 percent for IA performance category. If, 
for any reason, the PI performance category also is reweighted to zero, 
which could be more likely when there is a disaster, there would be 
only one performance category triggering the policy under which the ACO 
in question would receive a neutral (threshold) MIPS score, as per 
Sec.  414.1380(c) (see discussion at 83 FR 53778). If any of the ACO's 
participant TINs do report PI, then the TIN or TINs' PI performance 
category scores will be used to score the ACO under the MIPS scoring 
standard, the PI performance category will not be reweighted, and the 
policy to assign a neutral (threshold) MIPS score will not be 
triggered.
(b) Mitigating Shared Losses for ACOs Participating in a Performance-
Based Risk Track
    In the Shared Savings Program IFC (82 FR 60916) we modified the 
payment methodology for performance year 2017 for performance-based 
risk tracks established under the authority of section 1899(i) of the 
Act, to mitigate shared losses owed by ACOs affected by extreme and 
uncontrollable circumstances during 2017. Under this approach, we 
reduced the ACO's shared losses, if any, determined to be owed for 
performance year 2017 under the existing methodology for calculating 
shared losses in the Shared Savings Program regulations at 42 CFR part 
425 subpart G by an amount determined by multiplying the shared losses 
by two factors: (1) The percentage of the total months in the 
performance year affected by an extreme and uncontrollable 
circumstance; and (2) the percentage of the ACO's assigned 
beneficiaries who resided in an area affected by an extreme and 
uncontrollable circumstance. For performance year 2017, we determined 
the percentage of the ACO's performance year assigned beneficiary 
population that was affected by the disaster based on the final list of 
beneficiaries assigned to the ACO for the performance year. For 
example, assume that an ACO was determined to owe shared losses of 
$100,000 for performance year 2017, a disaster was declared for October 
through December during the performance year, and 25 percent of the 
ACO's assigned beneficiaries resided in the disaster area. In this 
scenario, we would have adjusted the ACO's shared losses in the 
following manner: $100,000-($100,000 x 0.25 x 0.25) = $100,000-$6,250 = 
$93,750. The policies for performance year 2017 are specified in 
paragraph (i) in Sec.  425.606 for ACOs under Track 2 and Sec.  425.610 
for ACOs under Track 3.
    In the August 2018 proposed rule (83 FR 41903), we stated our 
belief that it would be appropriate to continue to apply these policies 
in performance year 2018 and subsequent years to address stakeholders' 
concerns that ACOs participating under a performance-based risk track 
could be held responsible for sharing losses with the Medicare program 
resulting from catastrophic events outside the ACO's control given

[[Page 59975]]

the increase in utilization, difficulty of coordinating care for 
patient populations leaving the impacted areas, and the use of natural 
disaster payment modifiers making it difficult to identify whether a 
claim would otherwise have been denied under normal Medicare FFS rules. 
Absent this relief, we believe that ACOs participating in performance-
based risk tracks might reconsider whether they are able to continue 
their participation in the Shared Savings Program under a performance-
based risk track. The approach we adopted for performance year 2017 in 
the Shared Savings Program IFC, and which we proposed to continue for 
performance year 2018 and subsequent years, balances the need to offer 
relief to affected ACOs with the need to continue to hold those ACOs 
accountable for losses incurred during the months in which there was no 
applicable disaster declaration and for the portion of their final 
assigned beneficiary population that was outside the area affected by 
the disaster. In the August 2018 proposed rule, we explained our belief 
that, consistent with the policy adopted for performance year 2017 in 
the Shared Savings Program IFC, it would be appropriate to continue to 
use the final assignment list report for the performance year for 
purposes of this calculation. This final assignment list report would 
be available at the time we conduct final reconciliation and provides 
the most complete information regarding the extent to which an ACO's 
assigned beneficiary population was affected by a disaster.
    Additionally, we proposed to also address the possibility that ACOs 
that have a 6-month performance year during 2019 may be affected by 
extreme and uncontrollable circumstances. In this final rule, we are 
addressing the proposals specific to the 6-month performance year from 
January 1, 2019 through June 30, 2019. In a forthcoming final rule, we 
anticipate discussing comments received on the proposals related to 
policies for the 6-month performance year from July 1, 2019 through 
December 31, 2019, and the performance period from January 1, 2019 
through June 30, 2019 for ACOs that terminate their agreement effective 
June 30, 2019, and enter a new agreement period starting on July 1, 
2019. We anticipate this discussion will include a description of the 
applicability of policies for determining shared losses for ACOs 
affected by extreme and uncontrollable circumstances.
    As described in section II.A.7. of the August 2018 proposed rule 
(83 FR 41849 through 41853) and the proposed provision at Sec.  
425.609, we proposed to use 12 months of expenditure data, based on the 
calendar year, to perform financial reconciliation for the 6-month 
performance year from January 1, 2019 through June 30, 2019. 
Accordingly, for ACOs participating in a 6-month performance year 
during the first half of 2019, we believed it would be necessary to 
account for disasters occurring in any month(s) of CY 2019, regardless 
of whether the ACO is actively participating in the Shared Savings 
Program at the time of the disaster.
    For ACOs with a 6-month performance year that are affected by an 
extreme or uncontrollable circumstance during CY 2019, we proposed to 
first determine shared losses for the ACO over the full calendar year, 
adjust the shared losses for extreme and uncontrollable circumstances, 
and then determine the portion of shared losses for the 6-month 
performance year according to the methodology proposed under Sec.  
425.609. For example, assume that: A disaster was declared for October 
2019 through December 2019; an ACO is being reconciled for its 
participation during the performance year from January 1, 2019 through 
June 30, 2019; the ACO is determined to have shared losses of $100,000 
for CY 2019; and 25 percent of the ACO's assigned beneficiaries reside 
in the disaster area. In this scenario, we would adjust the ACO's 
losses in the following manner: $100,000-($100,000 x 0.25 x 0.25) = 
$100,000-$6,250 = $93,750, then we would multiply these losses by the 
portion of the year the ACO participated = $93,750 x 0.5 = $46,875.
    Therefore, we proposed to amend Sec. Sec.  425.606(i) and 
425.610(i) to extend the policies regarding extreme and uncontrollable 
circumstances that were established for performance year 2017 to 
performance year 2018 and subsequent years. In addition, we proposed to 
include a provision at Sec.  425.609(d) to provide that the policies on 
extreme and uncontrollable circumstances would apply to the 
determination of shared losses for ACOs participating in a 6-month 
performance year during 2019.
    In the August 2018 proposed rule (83 FR 41904), we noted that to 
the extent that our proposal to extend the policies adopted in the 
Shared Savings Program IFC to 2018 and subsequent performance years 
constitutes a proposal to change the payment methodology for 2018 after 
the start of the performance year, we believe that consistent with 
section 1871(e)(1)(A)(ii) of the Act, and for the reasons discussed in 
section II.E.4 of the August 2018 proposed rule (83 FR 41899 through 
41906), it would be contrary to the public interest not to propose to 
establish a policy under which we would have the authority to adjust 
the shared losses calculated for ACOs in Track 2 and Track 3 for 
performance year 2018 to reflect the impact of any extreme or 
uncontrollable circumstances that may occur during the year.
    We also explained that these proposed policies would not change the 
status of those payment models that meet the criteria to be Advanced 
APMs under the Quality Payment Program (see Sec.  414.1415). Our 
proposed policies would reduce the amount of shared losses owed by ACOs 
affected by a disaster, but the overall financial risk under the 
payment model would not change and participating ACOs would still 
remain at risk for an amount of shared losses in excess of the Advanced 
APM generally applicable nominal amount standard. Additionally, these 
policies would not prevent an eligible clinician from satisfying the 
requirements to become a QP for purposes of the APM Incentive Payment 
(available for payment years through 2024) or higher physician fee 
schedule updates (for payment years beginning in 2026) under the 
Quality Payment Program.
    We also emphasized that all ACOs would continue to be entitled to 
share in any savings they may achieve for a performance year. ACOs in 
all tracks of the program will continue to receive shared savings 
payments, if any, as determined under subpart G of the regulations. The 
calculation of savings and the determination of shared savings payment 
amounts for a performance year would not be affected by the proposed 
policies to address extreme and uncontrollable circumstances, except 
that the quality performance score for an affected ACO may be adjusted 
as described in section II.E.4 of the proposed rule.
    We solicited comments on the proposed policies for assessing the 
financial performance of ACOs affected by an extreme or uncontrollable 
circumstance during performance year 2018 and subsequent years.
    Comment: Several commenters noted that ACOs are likely to 
experience increased expenditures as the result of a natural disaster. 
One commenter noted that studies have shown that natural disasters 
materially increase Medicare costs per beneficiary. A few other 
commenters noted that costs can increase because of the impact of the 
disaster on beneficiaries' health, safety and anxiety causing increased 
utilization of services but also because waivers effected during 
declared Public

[[Page 59976]]

Health Emergencies relax Medicare payment rules allowing more services 
to be covered than usual. Another commenter stated that an ACO may 
experience expenditure increases because its assigned beneficiaries 
migrate to areas with higher FFS payment rates in search of health care 
services in the wake of a natural disaster. This commenter noted that 
ACOs based in Puerto Rico could be significantly affected given that 
after a natural disaster many beneficiaries migrate to the U.S. 
mainland where the FFS payment rates are substantially higher than on 
the island.
    Several commenters shared the opinion that the proposed policy of 
adjusting shared losses adequately addresses the situation of ACOs that 
would have had shared losses in the absence of a natural disaster, but 
had higher shared losses as the result of the disaster. However, they 
expressed concern that the policy does not provide relief to ACOs that 
receive a smaller shared savings payment as a result of the disaster or 
ACOs for which an expenditure increase resulting from a disaster causes 
the ACO to fall short of its MSR (and thus miss out on shared savings 
entirely) or to exceed its MLR (and thus owe shared losses when it 
otherwise would not have had shared losses).
    A few commenters recommended addressing this issue by modifying the 
update that is applied to an ACO's benchmark for a performance year 
that is affected by an extreme and uncontrollable circumstance. For 
example, these commenters recommended that CMS apply a growth rate that 
is the higher of the national growth rate for assignable beneficiaries 
or the regional growth rate for assignable beneficiaries (excluding an 
ACO's own assigned beneficiaries). They suggested that their 
recommendation should be used instead of the ``current policy'' for 
accounting for the impact of disasters on performance year 
expenditures, which they believed relies on the use of natural disaster 
payment modifiers. A few other commenters recommended that CMS use a 
blend of national and regional expenditure growth rates to update the 
benchmark as proposed in the August 2018 rule in ``normal times'' but 
use a purely regional growth rate in the event of an extreme and 
uncontrollable circumstance. The same commenters also suggested that 
CMS remove claims associated with disaster-affected beneficiaries 
during the relevant time periods or claims with a natural disaster 
payment modifier code, pending changes to improve these codes, when 
calculating performance or benchmark year expenditures. It was unclear, 
however, whether they meant for these claims adjustments to be made 
instead of or in addition to their recommended changes to the update 
factors applied to the historical benchmark.
    Several commenters raised concerns about the existing natural 
disaster modifier codes and whether, in their current form, they could 
be used to try to capture the negative impact on an ACO's performance. 
They noted that some health care providers may not be aware of the 
existence of such codes and that the codes may not be used properly due 
to lack of training and competing priorities during an emergency event. 
They also noted that the existing codes do not capture instances of 
``unsafe place of discharge'', which they believe is a common reason 
for lengths of stay to be increased during a disaster and recommended 
that CMS expand existing modifier codes or add a new code to cover this 
circumstance. A few commenters recommended providing proper education 
on the use of such codes, which would allow these codes to serve as a 
more accurate means for identifying the impacts of natural disasters. 
Another commenter recommended that CMS allow an additional 6 to 12 
months for providers to submit such codes to be considered in 
expenditure calculations.
    Response: We are finalizing our proposed approach to mitigate 
shared losses for ACOs affected by extreme and uncontrollable 
circumstances without modification in this final rule. We acknowledge 
commenters' concerns regarding the potential impact of extreme and 
uncontrollable circumstances on the financial performance of ACOs that 
do not owe shared losses and we appreciate the commenters' 
recommendations for how to mitigate these impacts. However, because we 
did not propose to make any adjustments under these circumstances, 
these recommendations are outside the scope of this rulemaking. We will 
continue to monitor the financial performance of ACOs affected by 
extreme and uncontrollable circumstances, and as we gain more 
experience will consider whether any changes to our policies for 
mitigating the effects of extreme and uncontrollable circumstances are 
warranted.
    Furthermore, we note that although we considered the use of natural 
disaster payment modifiers in developing the original extreme and 
uncontrollable circumstances policy for performance year 2017, we did 
not adopt a policy that used such codes in the Shared Savings Program 
IFC, nor did we propose in the August 2018 proposed rule to use such 
codes to adjust benchmark or performance year expenditure calculations 
for performance year 2018 or subsequent years. We have examined the 
existing natural disaster payment modifiers (specifically the ``DR'' 
condition code used on institutional claims and the ``CR'' modifier 
code used on Part B institutional and non-institutional claims) in 2017 
claims for ACO assigned beneficiaries. We found that these codes were 
not widely or consistently used and that there appears to be variation 
in their use among ACOs. For example, among 69 ACOs with 90 percent or 
more of assigned beneficiaries residing in a disaster affected area, we 
found that only 0.01 percent of institutional claims and only 0.0006 
percent of non-institutional claims included such a code. Among this 
same group of ACOs, the total number of claims (institutional or non-
institutional) containing one of these codes ranged from 0 to 155 with 
a mean of 14 and a median of 8. In a separate analysis, we found that 
claims completion rates were comparable in disaster-affected and non-
affected years which suggests that the low levels of modifier usage are 
not necessarily due to delayed claim submission. Based on these 
analyses, as well as the comments offered in response to the August 
2018 proposed rule, we also have concerns that these codes would not 
serve as a useful means for comprehensively identifying relevant 
claims.
    As we described in the August 2018 proposed rule, and have 
recounted in this final rule, we have some concerns about removing 
claims for affected beneficiaries and time periods from benchmark year 
expenditure calculations. As we develop additional experience, we may 
revisit this policy and, if warranted, propose modifications to 
performance or benchmark year expenditure calculations for ACOs 
affected by extreme and uncontrollable circumstances through further 
notice and comment rulemaking.
    We also note that, although the policies regarding extreme and 
uncontrollable circumstances we are finalizing in this final rule do 
not include an explicit adjustment to the shared savings payment of a 
disaster-affected ACO, our alternative methodology for quality scoring 
can indirectly increase an ACO's shared savings payment. In performance 
year 2017, 62 of 117 disaster-affected ACOs received the national mean 
quality score, as it was higher than the score the

[[Page 59977]]

ACO would have received in the absence of the policy.
    After considering the comments received, we are finalizing our 
proposal to extend the policy for mitigating shared losses owed by ACOs 
affected by extreme and uncontrollable circumstances established for 
performance year 2017 to performance year 2018 and subsequent 
performance years. We are revising Sec. Sec.  425.606(i) and 425.610(i) 
to indicate that we will reduce the amount of shared losses calculated 
for the performance year by an amount determined by multiplying (1) the 
percentage of the total months in the performance year affected by an 
extreme and uncontrollable circumstance; and (2) the percentage of the 
ACO's assigned beneficiaries who reside in an area affected by an 
extreme and uncontrollable circumstance. We are also finalizing our 
proposal, through a new provision at Sec.  425.609(d), to adjust shared 
losses for ACOs with a 6-month performance year from January 1, 2019 
through June 30, 2019. For ACOs in a 6-month performance year we will 
first determine shared losses for the ACO over the full calendar year, 
reduce the ACO's shared losses for the calendar year for extreme and 
uncontrollable circumstances, and then determine the portion of shared 
losses for the 6-month performance year.
(c) Determination of Historical Benchmarks for ACOs in Affected Areas
    In the Shared Savings Program IFC, we sought comment on how to 
address the impact of extreme and uncontrollable circumstances on the 
expenditures for an ACO's assigned beneficiary population for purposes 
of determining the benchmark (82 FR 60917). As we explained in the 
Shared Savings Program IFC (82 FR 60913), the impact of disasters on an 
ACO's financial performance could be unpredictable as a result of 
changes in utilization and cost of services furnished to the Medicare 
beneficiaries it serves. In some cases, ACO participants might be 
unable to coordinate care because of migration of patient populations 
leaving the impacted areas. On the other hand, patient populations 
remaining in impacted areas might receive fewer services and have lower 
overall costs to the extent that healthcare providers are unable to 
reopen their offices because they lack power and water or have limited 
access to fuel for operating alternate power generators. Significant 
changes in costs incurred, whether increased or decreased, as a result 
of an extreme or uncontrollable circumstance may impact the benchmark 
determined for the ACO's subsequent agreement period in the Shared 
Savings Program, as performance years of the current agreement period 
become the historical benchmark years for the subsequent agreement 
period. An increase in expenditures for a particular calendar year 
would result in a higher benchmark value when the same calendar year is 
used to determine the ACO's historical benchmark, and in calculating 
adjustments to the rebased benchmark based on regional FFS 
expenditures. Likewise, a decrease in expenditures for a particular 
calendar year would result in a lower benchmark value when the same 
calendar year is used to determine the ACO's historical benchmark.
    While considering options for adjusting ACOs' historical benchmarks 
to account for disasters occurring during a benchmark year, we 
considered the effect that the proposed regional factors, that are 
discussed in section II.D.3. of the August 2018 proposed rule (83 FR 
41886 through 41891), might have on the historical benchmarks for ACOs 
located in a disaster area. After review, we explained that we believe 
that when regional factors are applied to an ACO's historical 
benchmark, the regional factors would inherently adjust for variations 
in expenditures from year to year, and thus would also adjust for 
regional variations in expenditures related to extreme and 
uncontrollable circumstances. For example, assume that an ACO 
experienced a reduction in beneficiary expenditures in performance year 
2017 because a portion of its assigned beneficiaries resided in 
counties that were impacted by a disaster. Then, also assume 
expenditures returned to their previously higher level in 2018 and this 
ACO subsequently renewed its ACO participation agreement in 2020. In 
2020, when the ACO's historical benchmark would be reset (rebased), the 
expenditures for 2017 (now a historical benchmark year) would be 
subject to a higher regional trend factor because expenditures 
increased back to the expected level in 2018, which would increase the 
2017 benchmark year expenditures. Additionally, this ACO could also 
have its historical benchmark increased even further as a result of its 
performance compared to others in its region, as reflected in the 
regional adjustment to the ACO's historical benchmark. In contrast, 
consider an ACO that experienced an increase in beneficiary 
expenditures in performance year 2017 because a portion of its assigned 
beneficiaries resided in counties that were impacted by a disaster. 
Then, assume expenditures returned to their previously lower level in 
2018 and this ACO renewed its ACO participation agreement in 2020. In 
2020, when the ACO's historical benchmark would be reset, the 
expenditures for 2017 would be subject to a lower regional trend factor 
because expenditures decreased back to the expected level in 2018, 
which would decrease the 2017 benchmark year expenditures. 
Additionally, this ACO could also have its historical benchmark 
decreased further as a result of its performance compared to others in 
its region, as reflected in the regional adjustment to the ACO's 
historical benchmark.
    Our expectation that the proposed regional factors that would be 
used to establish an ACO's historical benchmark would also adjust for 
variations in expenditures related to extreme and uncontrollable 
circumstances was supported by a preliminary analysis of data for areas 
that were affected by the disasters that occurred in performance year 
2017. Our analysis of the data showed that, as a result of the 
disasters in these areas, expenditure trends for the performance year 
appeared below projections. For these areas, the expenditures began to 
increase after the disaster incident period ended, but expenditures 
were still below expectations for the year. Based on the expenditure 
trends beginning to return to expected levels after the disaster 
period, it would be reasonable to expect that expenditures would 
continue to increase to expected levels in 2018. This difference 
between the lower than expected levels of expenditures in 2017 and a 
return to expected expenditures in 2018, would result in a higher 
regional trend factor being applied to 2017 expenditures when they are 
used to determine an ACO's historical benchmark. Although our analysis 
for the proposed rule was performed using the proposed regional 
factors, we expect that our existing benchmarking methodology at Sec.  
425.603, which also incorporates regional factors in the determination 
of an ACO's historical benchmark for its second or subsequent agreement 
period beginning in 2017 or later years, would have a similar result.
    In the August 2018 proposed rule (83 FR 41905), in considering 
whether it might be necessary to make an additional adjustment to ACOs' 
historical benchmarks to account for expenditure variations related to 
extreme and uncontrollable circumstances, we considered an approach 
where we would adjust the historical benchmark by reducing the weight 
of expenditures for beneficiaries who resided in a disaster area during 
a

[[Page 59978]]

disaster period and placing a correspondingly larger weight on 
expenditures for beneficiaries residing outside the disaster area 
during the disaster period. Such an approach would be expected to 
proportionally increase the historical benchmark for ACOs that 
experienced a decrease in expenditures, and conversely proportionally 
decrease the historical benchmark for ACOs that experienced an increase 
in expenditures for their assigned beneficiaries who were impacted by a 
disaster. Under this approach, for each of the historical benchmark 
years, we would identify each ACO's assigned beneficiaries who had 
resided in a disaster area during a disaster period. The portion of 
expenditures for these assigned beneficiaries that was impacted by the 
disaster would be removed from the applicable historical benchmark 
year(s). The removal of these expenditures from the historical 
benchmark year(s) would allow the historical benchmark calculations to 
include only expenditures that were not impacted by the disaster. We 
believe this methodology for calculating benchmark expenditures would 
adjust for expenditure increases or decreases that may occur as a 
result of impacts related to a disaster.
    We noted that if we were to implement such an adjustment to the 
historical benchmark, we believed it would be appropriate to avoid 
making minor historical benchmark adjustments for an ACO that was not 
significantly affected by a disaster by establishing a minimum 
threshold for the percentage of an ACO's beneficiaries located in a 
disaster area. Based on data from 2017, quarter 3, over 80 percent of 
ACOs had less than 50 percent of their assigned beneficiaries residing 
in disaster counties, with over 75 percent having less than 10 percent 
of their assigned beneficiaries residing in disaster counties. Based on 
this data, we noted our belief that a minimum threshold of 50 percent 
of assigned beneficiaries residing in disaster counties could be an 
appropriate threshold for the adjustment to historical benchmarks 
because historical benchmarks are calculated based on the ACO's entire 
assigned beneficiary population in each benchmark year, rather than a 
sample as is used for quality reporting.
    However, we were concerned that this methodology for calculating an 
adjustment might not be as accurate as the inherent adjustment that 
would result from applying regional factors when resetting the 
benchmark and may impact other expected expenditure variations 
occurring in the impacted areas. For example, if an additional disaster 
adjustment were to be applied, it might have unintended impacts when 
expenditure truncation is applied, it might inappropriately weight and 
not account for expected variations in expenditures between areas that 
were and were not impacted by the disaster, and it might compound 
effects that have already been offset by the regional adjustment. In 
addition, the expenditures, as adjusted, may not be representative of 
the ACO's actual performance and aggregate assigned beneficiary 
population during the benchmark period.
    In summary, we noted our belief that the regional factors that we 
had proposed to apply as part of the methodology for determining an 
ACO's historical benchmark would reduce the expenditures in a 
historical benchmark year when they are greater than expected (relative 
to other historical benchmark years) as a result of a disaster and 
conversely increase expenditures in a historical benchmark year when 
they are below the expected amount. For these reasons, we believed that 
the proposal in section II.D.3. of the August 2018 proposed rule (83 FR 
41887 through 41888) to apply regional factors when determining ACOs' 
historical benchmarks, starting with an ACO's first agreement period 
for agreement periods starting on July 1, 2019, and in subsequent 
years, would be sufficient to address any changes in expenditures 
during an ACO's historical benchmark years as a result of extreme and 
uncontrollable circumstances, and an additional adjustment, such as the 
method discussed previously in this section would not appear to be 
necessary. However, we noted that we would continue to evaluate the 
impact of the 2017 disasters on ACOs' assigned beneficiary 
expenditures, and that we intended to continue to consider whether it 
might be appropriate to make an additional adjustment to the historical 
benchmark to account for expenditures that may have increased or 
decreased in a historical benchmark year as a result of an extreme or 
uncontrollable circumstance.
    We solicited comments on these issues, including whether it is 
necessary to adjust ACOs' historical benchmarks to account for extreme 
and uncontrollable circumstances that might occur during a benchmark 
year, and appropriate methods for making such benchmark adjustments. We 
also noted that the proposal in section II.D.3. of the August 2018 
proposed rule to apply regional factors to determine ACOs' historical 
benchmarks would apply starting with an ACO's first agreement period 
for agreement periods starting on July 1, 2019, and in subsequent years 
and would therefore have no effect on benchmarks for ACOs in a first 
agreement period starting before July 1, 2019 (see 83 FR 41887). 
Accordingly, we solicited comments on whether and how an adjustment 
should be made for ACOs whose benchmarks do not reflect regional 
factors. We also invited comments on any additional areas where relief 
may be helpful or other ways to mitigate unexpected issues that may 
arise in the event of an extreme and uncontrollable circumstance.
    Comment: A few commenters noted that expenditure increases in a 
performance year due to a natural disaster could lead to unjustly high 
benchmark year expenditures in an ACO's subsequent agreement period 
which could create vulnerabilities for the Trust Funds. As described in 
the prior section V.B.2.d.(2) of this final rule, we received a few 
comments recommending modifications to the update that is applied to an 
ACO's benchmark for a performance year that is affected by an extreme 
and uncontrollable circumstance. Another commenter suggested removing 
claims from benchmark and performance year expenditures that have a 
disaster modifier code or are associated with a beneficiary residing a 
disaster-affected area during an affected time period.
    Response: As discussed in the prior section V.B.2.d.(2) of this 
final rule, we intend to further consider commenters' recommendations 
that we address the financial impacts of extreme and uncontrollable 
circumstances through the update that is applied to the historical 
benchmark and how this approach could mitigate potential negative 
impacts to ACOs or to the Medicare Trust Funds for the performance year 
in which a disaster occurs, performance years for which there was a 
disaster in one or more of the benchmark years, or cases where an ACO 
was affected by disasters in both the benchmark period and the 
performance year.
    As described in the prior section V.B.2.d.(2) of this final rule, 
we have concerns about commenters' recommendation to exclude claims 
with a natural disaster modifier code, or claims associated with 
disaster affected beneficiaries and time periods from benchmark or 
performance year expenditures. As we develop additional experience, we 
may revisit this policy and, if warranted, propose modifications to our 
methodology for calculating performance year or benchmark year 
expenditures through further notice and comment rulemaking.

[[Page 59979]]

    Comment: One commenter opposed using regional factors as currently 
calculated by CMS to address concerns about the effect of extreme and 
uncontrollable circumstances on ACOs' historical benchmarks. This 
commenter disagreed with CMS' current approach, which includes ACO 
assigned beneficiaries when calculating regional expenditures. They 
stated that ``[A]bsent a reform that addresses the underlying issue 
with the regional adjustment factor, applying it to ACOs in a region 
recovering from an extreme or uncontrollable circumstance will 
perpetuate the flaws.''
    Response: We continue to believe that the use of regional factors 
in establishing and updating the benchmark will provide an inherent 
adjustment for regional variations in expenditures related to extreme 
and uncontrollable circumstances. As the commenter notes, and under the 
June 2016 final rule, regional expenditure calculations in the Shared 
Savings Program are based on all assignable beneficiaries in an ACO's 
regional service area including ACO assigned beneficiaries. We have 
detailed in that earlier rule our reasons for not excluding assigned 
beneficiaries from these calculations (see 81 FR 37960). Furthermore, 
we do not believe that inclusion of an ACO's assigned beneficiaries 
would reduce the effectiveness of regional factors to inherently adjust 
for regional variations in expenditures related to extreme and 
uncontrollable circumstances as we have no reason to believe that such 
an event would have a differential impact on expenditures for assigned 
beneficiaries relative to expenditures for assignable beneficiaries 
that are not assigned to an ACO.
    After considering comments we received on the determination of 
historical benchmarks for ACOs in areas affected by extreme and 
uncontrollable circumstances, we are not making any changes to the 
benchmarking methodology to address such events at this time. We will 
continue to monitor the impact of extreme and uncontrollable 
circumstances on benchmark expenditures and, if applicable, the extent 
to which any impact is mitigated by the use of regional factors in 
establishing and updating the benchmark. If warranted, we will propose 
additional modifications to our benchmarking methodology to address the 
effects of extreme and uncontrollable circumstances through future 
notice and comment rulemaking.
e. Program Data and Quality Measures
    In section II.E.5. of the August 2018 proposed rule (41906 through 
41908), we solicited comments on possible changes to the quality 
measure set and modifications to program data shared with ACOs to 
support CMS' Meaningful Measures initiative and respond to the nation's 
opioid misuse epidemic. As part of the Meaningful Measures initiative, 
the agency's efforts are focused on updating quality measures, reducing 
regulatory burden, and promoting innovation (see CMS Press Release, CMS 
Administrator Verma Announces New Meaningful Measures Initiative and 
Addresses Regulatory Reform; Promotes Innovation at LAN Summit, October 
30, 2017, available at https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2017-Press-releases-items/2017-10-30.html). Under the Meaningful Measures initiative, we are working 
towards assessing performance on only those core issues that are most 
vital to providing high-quality care and improving patient outcomes, 
with an emphasis on outcome-based measures, reducing unnecessary burden 
on providers, and putting patients first. When we developed the quality 
reporting requirements under the Shared Savings Program, we considered 
the quality reporting requirements under other initiatives, such as the 
Physician Quality Reporting System (PQRS) and Million Hearts 
Initiative, and consulted with the measures community to ensure that 
the specifications for the measures used under the Shared Savings 
Program are up-to-date and reduce reporting burden.
    Since the Shared Savings Program was first established in 2012, we 
have not only updated the quality measure set to reduce reporting 
burden, but also to focus on more meaningful outcome-based measures. 
The most recent updates to the Shared Savings Program quality measure 
set were made in the CY 2017 PFS Final Rule (81 FR 80484 through 80489) 
to adopt the ACO measure recommendations made by the Core Quality 
Measures Collaborative, a multi-stakeholder group with the goal of 
aligning quality measures for reporting across public and private 
stakeholders in order to reduce provider reporting burden. Currently, 
more than half of the 31 Shared Savings Program quality measures are 
outcome-based, including--
     Patient-reported outcome measures collected through the 
CAHPS for ACOs Survey that strengthen patient and caregiver experience;
     Outcome measures supporting care coordination and 
effective communication, such as unplanned admission and readmission 
measures; and
     Intermediate outcome measures that address the effective 
treatment of chronic disease, such as hemoglobin A1c control for 
patients with diabetes and control of high blood pressure.
    As we explained in the August 2018 proposed rule (83 FR 41906), it 
is important that the quality reporting requirements under the Shared 
Savings Program align with the reporting requirements under other 
Medicare initiatives and those used by other payers in order to 
minimize the need for Shared Savings Program participants to devote 
excessive resources to understanding differences in measure 
specifications or engaging in duplicative reporting. We sought comment, 
including recommendations and input on meaningful measures, on how we 
may be able to further advance the quality measure set for ACO 
reporting, consistent with the requirement under section 1899(b)(3)(C) 
of the Act that the Secretary seek to improve the quality of care 
furnished by ACOs by specifying higher standards, new measures, or 
both.
    One particular area of focus by the Department of Health and Human 
Services is the opioid misuse epidemic. The Centers for Disease Control 
and Prevention (CDC) reports that the number of people experiencing 
chronic pain lasting more than 3 months is estimated to include 11 
percent of the adult population. According to a 2016 CDC publication, 2 
million Americans had opioid use disorder (OUD) associated with 
prescription opioids in 2014 (https://www.cdc.gov/drugoverdose/prescribing/guideline.html). Since the implementation of Medicare Part 
D in 2006 to cover prescription medications, the Medicare program has 
become the largest payer for prescription opioids in the United States 
(Zhou et al., 2016; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4955937/). Safe and effective opioid prescribing for older adults is 
of particular importance because misuse and abuse of opioids can lead 
to increased adverse events in this population (for example, increased 
falls, fractures, hospitalization, ER visits, mortality), especially 
given the high prevalence of polypharmacy in the elderly. Polypharmacy 
is the simultaneous use of multiple drugs by a single patient, for one 
or more conditions, which increases the risk of adverse events. For 
example, a study by MedPAC found that some beneficiaries

[[Page 59980]]

who use opioids fill more than 50 prescriptions among 10 drug classes 
annually (http://www.medpac.gov/docs/default-source/reports/chapter-5-polypharmacy-and-opioid-use-among-medicare-part-d-enrollees-june-2015-report-.pdf?sfvrsn=0, MedPAC, 2015).
    As part of a multifaceted response to address the growing problem 
of overuse and abuse of opioids in the Part D program, CMS adopted a 
policy in 2013 requiring Medicare Part D plan sponsors to implement 
enhanced drug utilization review. Between 2011 through 2014, there was 
a 26 percent decrease or 7,500 fewer Medicare Part D beneficiaries 
identified as potential opioid over-utilizers which may be due, at 
least in part, to these new policies. On January 5, 2017, CMS released 
its Opioid Misuse Strategy. This document outlines CMS' strategy and 
the array of actions underway to address the national opioid misuse 
epidemic and is available at https://www.cms.gov/Outreach-and-Education/Outreach/Partnerships/Downloads/CMS-Opioid-Misuse-Strategy-2016.pdf.
    We aim to align our policies under the Shared Savings Program with 
the priorities identified in the Opioid Misuse Strategy and the 
Department of Health and Human Services Strategy to Combat Opioid 
Abuse, Misuse, and Overdose \36\ and to help ACOs and their 
participating providers and suppliers in responding to and managing 
opioid use, and are therefore considering several actions to improve 
alignment. Specifically, as we described in the August 2018 proposed 
rule, we are considering what information regarding opioid use, 
including information developed using aggregate Medicare Part D data, 
could be shared with ACOs. We are also considering the addition of one 
or more measures specific to opioid use to the ACO quality measures 
set. The potential benefits of such policies would be to focus ACOs on 
the appropriate use of opioids for their assigned beneficiaries and 
support their opioid misuse prevention efforts.
---------------------------------------------------------------------------

    \36\ https://www.hhs.gov/opioids/sites/default/files/2018-09/opioid-fivepoint-strategy-20180917-508compliant.pdf.
---------------------------------------------------------------------------

    First, we are considering what information, including what 
aggregated Medicare Part D data, could be useful to ACOs to combat 
opioid misuse in their assigned beneficiary population. We recognize 
the importance of available and emerging resources regarding the opioid 
epidemic at the federal, state, and local level, and intend to work 
with our federal partners to make relevant resources available in a 
timely manner to support ACOs' goals and activities. We will also 
continue to share information with ACOs highlighting Federal opioid 
initiatives, such as the CDC Guideline for Prescribing Opioids for 
Chronic Pain (https://www.cdc.gov/drugoverdose/prescribing/guideline.html), which reviews the CDC's recommended approach to opioid 
prescribing, and the Surgeon General's report on Substance Use and 
Addiction, Facing Addiction in America: The Surgeon General's Report on 
Alcohol, Drugs, and Health, (https://addiction.surgeongeneral.gov/) 
which focuses on educating and mobilizing prescribers to take action to 
end the opioid epidemic by improving prescribing practices, informing 
patients about the risks of and resources for opioid addiction, and 
encouraging health care professionals to take a pledge to end the 
opioid crisis. We also intend to continue to highlight information 
about the opioid crisis and innovations for opioid treatment and 
prevention strategies in ACO communications and webinars by including 
topics such as innovative uses of health IT for opioid use disorder 
treatment and specifically for electronic clinical decision support 
consistent with the CDC guidelines, as available.
    Although we recognize that not all beneficiaries assigned to Shared 
Savings Program ACOs have Part D coverage, we believe a sufficient 
number do have Part D coverage to make aggregate Part D data regarding 
opioid use helpful for the ACOs. As an example, we have found the 
following information for performance year 2016:
     Approximately 70 percent of beneficiaries assigned to ACOs 
participating in the Shared Savings Program had continuous Part D 
coverage.
     For assigned beneficiaries with continuous Part D 
enrollment, almost 37 percent had at least one opioid prescription. 
This percentage ranged from 10.6 percent to 58.3 percent across ACOs.
     The mean number of opioid medications filled per assigned 
beneficiary (with continuous Part D coverage) varied across ACOs, 
ranging from 0.3 to 4.5 prescriptions filled, with an average of 2.1 
prescriptions filled.
     The number of opioid prescriptions filled for each 
assigned beneficiary with at least one opioid prescription filled 
varied across ACOs and ranged from 2.6 to 8.4 prescriptions, with an 
average of 5.5 opioid prescriptions filled.
    ACOs currently receive, as part of the monthly claims and claims 
line feed data, Part D prescription drug event (PDE) data on prescribed 
opioids for their assigned beneficiaries who have not opted out of data 
sharing. We encourage ACOs to use this beneficiary-level data in their 
care delivery practices.
    In the August 2018 proposed rule (83 FR 41907), we sought 
suggestions for other types of aggregate data related to opioid use 
that could be added for informational purposes to the aggregate 
quarterly and annual reports CMS provides to ACOs. The aim would be for 
ACOs to utilize this additional information to improve population 
health management for assigned beneficiaries, including prevention, 
identifying anomalies, and coordinating care. The type of aggregate 
data should be highly relevant for a population-based program at the 
national level and have demonstrated value in quality improvement 
initiatives. We noted that we are particularly interested in high 
impact aggregate data that would reflect gaps in quality of care, 
patient safety, multiple aspects of care, and drivers of cost. We aim 
to provide aggregate data that have validity for longitudinal analysis 
to enable both ACOs and the Shared Savings Program to trend performance 
across time and monitor for changes. Aggregate data on both processes 
and outcomes are appropriate, provided that the data are readily 
available. Types of aggregate data that we have begun to consider, 
based on the information available from prescription drug event records 
for assigned beneficiaries enrolled in Medicare Part D, include filled 
prescriptions for opioids (percentage of the ACO's assigned 
beneficiaries with any opioid prescription, number of opioid 
prescriptions per opioid user), number of beneficiaries with a 
concurrent prescription of opioids and benzodiazepines; and number of 
beneficiaries with opioid prescriptions above a certain daily Morphine 
Equivalent Dosage threshold. We also sought comments on measures that 
could be added to the quality measure set for the purpose of addressing 
the opioid epidemic and addiction, more generally. We sought comment on 
measures related to various aspects of opioid use, such as prevention, 
pain management, or opioid use disorder treatment, and on measures 
related to addiction. In particular, we noted that we were considering 
the following relevant NQF-endorsed measures, with emphasis on Medicare 
beneficiaries with Part D coverage who are 18 years or older without 
cancer or enrolled in hospice:
     NQF #2940 Use of Opioids at High Dosage in Persons Without 
Cancer: Analyzes the proportion (XX out of 1,000) of Medicare Part D 
beneficiaries

[[Page 59981]]

18 years or older without cancer or enrolled in hospice receiving 
prescriptions for opioids with a daily dosage of morphine milligram 
equivalent (MME) greater than 120 mg for 90 consecutive days or longer.
     NQF #2950 Use of Opioids from Multiple Providers in 
Persons Without Cancer: Analyzes the proportion (XX out of 1,000) of 
Medicare Part D beneficiaries 18 years or older without cancer or 
enrolled in hospice receiving prescriptions for opioids from four (4) 
or more prescribers AND four (4) or more pharmacies.
     NQF #2951 Use of Opioids from Multiple Providers and at 
High Dosage in Persons Without Cancer: Analyzes the proportion (XX out 
of 1,000) of Medicare Part D beneficiaries 18 years or older without 
cancer or enrolled in hospice with a daily dosage of morphine milligram 
equivalent (MME) greater than 120 mg for 90 consecutive days or longer, 
AND who received opioid prescriptions from four (4) or more prescribers 
AND four (4) or more pharmacies.
    In addition, we sought input on potential measures for which data 
are readily available, such as measures that might be appropriately 
calculated using Part D data, and that capture performance on outcomes 
of appropriate opioid management. We requested that comments on 
measures that are not already NQF endorsed include descriptions of 
reliability, validity, benchmarking, the population in which the 
measure was tested, along with the data source that was used, and 
information on whether the measure is endorsed and by what 
organization. We recognized that measures of the various aspects of 
opioid use may involve concepts related to integrated, coordinated, and 
collaborative care, including as applicable for co-occurring and/or 
chronic conditions, as well as measures that reflect the impact of 
interventions on patient outcomes, including direct and indirect 
patient outcome measures. We also sought comment on opioid-related 
measures that would support effective measurement alignment of 
substance use disorders across programs, settings, and varying 
interventions.
    Comment: A majority of commenters supported CMS' focus on burden 
reduction stating that they are encouraged by the administration's 
efforts to reduce reporting burden for healthcare providers. However, 
one commenter cautioned that although decreasing burden is a laudable 
goal, removing process measures could unfairly impact the quality 
scores of healthcare providers who care for vulnerable patients exposed 
to the harshest social determinants of health. Several commenters 
suggested that CMS strive toward a core measure set that identifies and 
harmonizes measures across multiple CMS programs, so that incentives 
and goals are aligned across healthcare providers and care settings.
    Several commenters supported the agency's Meaningful Measures 
Initiative stating that CMS should not only consider whether a measure 
is a process measure, but also whether the measure is considered a low-
value process measure, before removing it from the Shared Savings 
Program quality measure set. In addition, these commenters supported 
CMS' move toward the use of outcome measures, as the emphasis on 
improved health outcomes is an appropriate focus and goal.
    Several commenters suggested future potential refinements to the 
Shared Savings Program measure set. One commenter urged CMS to better 
align the Shared Savings Program with Medicare Advantage, suggesting 
that there should be fewer measures that are included in a roadmap for 
implementation in both programs, because the different measures and the 
differing standards for compliance that are currently used cause 
confusion and require the use of limited provider and staff resources. 
In addition, this commenter stated that with a roadmap of measures, 
organizations would be able to focus their energies on achieving these 
metrics in a systematic and deliberate fashion.
    Another commenter expressed concern with the timing and burden of 
quality measurement and payment, suggesting that we streamline quality 
efforts to include ten specific outcome measures that have a social and 
public health impact and offering a financial incentive in connection 
with each measure to encourage physicians to drive, fund, and sustain 
continued quality efforts.
    A few commenters suggested that CMS should focus on the prevention, 
treatment, and management of behavioral health. They stated that in the 
absence of effective behavioral health assessment tools, the vast 
majority of people with mental health conditions go unidentified in 
primary care settings, which in most cases leads to non-adherent 
patients and higher total medical costs. In addition, they stated that 
behavioral health is central to the prevention, treatment, and 
management of the preventable manifestations of diseases and health 
conditions. They suggested that CMS consider including broader measures 
that would encourage behavioral health and medical providers to work 
collaboratively to provide coordinated care.
    Several commenters suggested that CMS consider developing a quality 
measure set that would evaluate the breadth of chronic conditions 
common in the patient population assigned to Shared Savings Program 
ACOs and use appropriate outcome measures to ensure assigned 
beneficiaries are receiving the necessary care. They noted that the 
proposed Shared Savings Program quality measure set discussed in 
section III.F.1.c. of the CY 2019 PFS proposed rule (83 FR 35876 
through 35878) does not include measures related to respiratory 
conditions, like chronic obstructive pulmonary disease or asthma, 
diabetes, or additional conditions like heart failure. They encouraged 
CMS to include measures that evaluate the quality of care for these 
conditions, such as, measures focused on the delivery of comprehensive 
lower extremity exams for diabetic patients, and rates of complications 
such as amputation. They stated that greater emphasis on management of 
chronic conditions is necessary to promote quality and improve patient 
outcomes. Another commenter suggested CMS should increase the number of 
claims-based measures in the Shared Savings Program measure set and 
provide ACOs with user-friendly, actionable reports that detail the 
ACO-specific data used to calculate specific measure performance. One 
commenter suggested that CMS consider quality measures that reinforce 
shared decision making, as part of treatment plans that align with the 
individual's goals as this is a foundational component of high-quality 
patient-centered care.
    Response: We thank the commenters for their thoughtful input on the 
quality measures used to assess the performance of ACOs under the 
Shared Savings Program. As we plan for future updates and changes to 
the Shared Savings Program quality measure set, we will consider this 
feedback in the development of our proposals.
    Comment: The majority of commenters that addressed the potential 
inclusion of measures related to opioid use in the Shared Savings 
Program quality measure set were supportive of this effort. A few 
commenters noted that continued support and recognition for integration 
of EHRs and electronic sharing of health information, would promote 
improved communication between healthcare providers, which may help 
curb opioid abuse and addiction.

[[Page 59982]]

    Several commenters supported CMS' efforts to consider the possible 
addition of opioid use measures to the Shared Savings Program quality 
measure set in future program years, but some commenters recommended 
that CMS work with the measure developer and NQF to reduce the dosage 
threshold of two of the measures discussed in the August 2018 proposed 
rule to 90 MME per day to align with the CDC guidelines for Prescribing 
Opioids for Chronic Pain. Another commenter agreed that promoting the 
measurement of opioid use and overuse, monitoring, and education 
through quality reporting is an important step in understanding and 
addressing the opioid crisis. A few commenters recommended that CMS 
utilize the Prescription Drug Monitoring Program (PDMP) Query measure, 
as most states have implemented PDMPs, and the PDMP Query measure is a 
reasonable step to improve and measure quality in opioid prescribing.
    Another commenter stated that in general they support CMS' 
considering the addition of opioid use measures to the Shared Savings 
Program measure set; however, they expressed their belief that opioid 
dosage measures are of low-value to the program because, ``. . . since 
the issuance of Centers for Disease Control (CDC) and Prevention 
guidelines, there have been many reports of patients who have been 
successfully managed on opioid analgesics for long periods of time.'' 
This commenter noted that implementing a quality measure that could 
force a health provider to abruptly reduce or discontinue this 
medication regimen could have extreme adverse outcomes such as 
depression, loss of function, or even suicide. The commenter suggested 
CMS consider quality measures other than dosage measures when 
determining the most appropriate metrics to help address and respond to 
the opioid crisis.
    One commenter expressed concern with the specific opioid related 
measures on which CMS sought comment for potential inclusion in the 
Shared Savings Program quality measure set. The commenter stated that 
quality measurement needs to focus on utilization of preventive 
strategies, such as screening and treatment for substance abuse, as 
well as pain management. This commenter disagreed with the potential 
inclusion of NQF #2940: Use of Opioids at Higher Dosage in Persons 
Without Cancer because a measure that focuses only on daily dose and 
duration of therapy involving prescription opioid analgesics, on its 
own is not a good indication of quality patient care. In addition, they 
expressed concerns with the potential inclusion of NQF #2950: Use of 
Opioids from Multiple Providers in Persons Without Cancer and NQF 
#2951: Use of Opioids from Multiple Providers and at High Dosage in 
Persons Without Cancer in the Shared Savings Program measure set, as 
these measures were developed with the intention of determining the 
quality of care provided by prescription drug health plans and because 
of the lack of information on the feasibility of ACOs' collecting and 
reporting pharmacy claims data.
    Another commenter noted that the three opioid measures CMS 
suggested for inclusion in the Shared Savings Program measure set are 
appropriately focused on the right patient population and address the 
major risks associated with opioid misuse--high dosages and multiple 
prescriptions. However, the commenter urged CMS to conduct testing to 
ensure the measures provide accurate, reliable data at the ACO level, 
as they are currently endorsed at the health plan level not the ACO 
level. The commenter suggested that the measures should be reported on 
a voluntary or pay-for-reporting basis rather than as pay-for-
performance measures for the first few years after they are added to 
the measure set.
    Another commenter expressed concern that including measures that 
are so specific will distract ACOs from focusing on what works for them 
and their assigned beneficiary population. As an alternative, the 
commenter suggested CMS provide webinars, education, tools, and data 
for ACOs to incorporate into their current structure for care 
management and patient engagement. Several commenters recommended that 
CMS provide aggregated data to ACOs on opioid use, but they also urged 
CMS to go further and provide aggregated beneficiary data on the use of 
all prescribed medications and their related diagnoses. Similarly, 
another commenter encouraged CMS to continue to add more real-time data 
to the quarterly quality reports so providers can leverage this data to 
improve patient care, address social inequities in health, correct 
inefficiencies to drive down costs, and help to address the nation's 
opioid epidemic and other pressing health crises.
    Response: We thank the commenters for their thoughtful input on the 
possible addition of measures related to opioid use to the quality 
measure set for the Shared Savings Program. As we plan for future 
updates and changes to the Shared Savings Program quality measure set, 
we will consider this feedback from commenters before making any 
proposals with respect to the addition of opioid use measures.
f. Promoting Interoperability
    Consistent with the call in the 21st Century Cures Act for 
interoperable access, exchange, and use of health information, the 
final rule entitled, 2015 Edition Health Information Technology (Health 
IT) Certification Criteria, 2015 Edition Base Electronic Health Record 
(EHR) Definition, and ONC Health IT Certification Program Modifications 
(2015 Edition final rule) (80 FR 62601) under 45 CFR part 170 \37\ 
focused on health IT certification criteria that support patient care, 
patient participation in care delivery, and electronic exchange of 
interoperable health information. The 2015 Edition final rule, which 
was issued on October 16, 2015, aimed to improve interoperability by 
adopting new and updated vocabulary and content standards for the 
structured recording and exchange of health information and to 
facilitate the accessibility and exchange of data by including enhanced 
data export, transitions of care, and application programming interface 
capabilities. These policies are relevant to assessing the use of CEHRT 
under the Quality Payment Program, Shared Savings Program, and other 
value based payment initiatives.
---------------------------------------------------------------------------

    \37\ For more information, see https://www.healthit.gov/sites/default/files/understanding-certified-health-it-2.pdf.
---------------------------------------------------------------------------

    Under the Shared Savings Program, section 1899(b)(2)(G) of the Act 
requires participating ACOs to define processes to report on quality 
measures and coordinate care, such as through the use of telehealth, 
remote patient monitoring, and other such enabling technologies. 
Consistent with the statute, ACOs participating in the Shared Savings 
Program are required to coordinate care across and among primary care 
physicians, specialists, and acute and post-acute providers and 
suppliers and to have a written plan to encourage and promote the use 
of enabling technologies for improving care coordination, including the 
use of electronic health records and electronic exchange of health 
information (Sec.  425.112(b)(4)). Additionally, since the inception of 
the program in 2012, CMS has assessed the level of CEHRT use by certain 
clinicians in the ACO using a double-weighted quality measure (Use of 
Certified EHR Technology, ACO-11) as part of the quality reporting 
requirements for each performance year. Based on previously-finalized 
policies, for the 2018 performance year, we will use data derived from 
the Quality

[[Page 59983]]

Payment Program's Promoting Interoperability performance category to 
calculate the percentage of eligible clinicians participating in an ACO 
who successfully meet the Advancing Care Information Performance 
Category Base Score for purposes of ACO-11. Because the measure is used 
in determining an ACO's quality score and for determining shared 
savings or shared losses under the Shared Savings Program, all eligible 
clinicians participating in Shared Savings Program ACOs must submit 
data for the Quality Payment Program's Advancing Care Information 
performance category for performance year 2018, including those 
eligible clinicians who are participating in Shared Savings Program 
tracks that have been designated as Advanced APMs and who have met the 
QP threshold or are otherwise not subject to the MIPS reporting 
requirements.
    In the August 2018 proposed rule (83 FR 41908), we noted that some 
alternative payment models tested by the Innovation Center, require all 
participants to use CEHRT even though certain tracks within those 
Models do not meet the financial risk standard for designation as 
Advanced APMs. The primary rationale for this requirement is to promote 
CEHRT use by eligible clinicians and organizations participating in 
APMs by requiring them to demonstrate a strong commitment to the 
exchange of health information, regardless of whether they are 
participating in an APM that meets the criteria to be designated as an 
Advanced APM. Under the Quality Payment Program, an incentive payment 
will be made to certain Qualifying APM Participants (QPs) participating 
in Advanced APMs. Beginning in 2017, an eligible clinician can become a 
QP for the year by participating sufficiently in an Advanced APM during 
the QP performance period. Eligible clinicians who are QPs for a year 
receive a lump sum APM incentive payment for payment years from 2019 
through 2024, and are excluded from the MIPS reporting requirements for 
the performance year and the MIPS payment adjustment for the payment 
year. In the CY 2017 Quality Payment Program final rule (81 FR 77408), 
we finalized the criteria that define an Advanced APM based on the 
requirements set forth in sections 1833(z)(3)(C) and (D) of the Act. An 
Advanced APM is an APM that, among other criteria, requires its 
participants to use CEHRT. In the CY 2017 Quality Payment Program final 
rule, we established that Advanced APMs meet this requirement if the 
APM either--(1) requires at least 50 percent of eligible clinicians in 
each participating APM Entity, or for APMs in which hospitals are the 
APM Entities, each hospital, to use CEHRT to document and communicate 
clinical care to their patients or other health care providers; or (2) 
for the Shared Savings Program, applies a penalty or reward to an APM 
Entity based on the degree of the use of CEHRT of the eligible 
clinicians in the APM Entity (Sec.  414.1415(a)(1)(i) and (ii)). In the 
CY 2017 PFS final rule, we updated the title and specifications of the 
EHR quality measure (ACO-11) to align with the Quality Payment Program 
criterion on CEHRT use in order to ensure that certain tracks under the 
Shared Savings Program could meet the criteria to be Advanced APMs. 
Specifically, we revised the ACO-11 measure to assess ACOs on the 
degree of CEHRT use by all eligible clinicians participating in the 
ACO. Performance on the measure is determined by calculating the 
percentage of eligible clinicians participating in the ACO who 
successfully meet the Promoting Interoperability Performance Category 
Base Score.
    In light of our additional experience with the Shared Savings 
Program, our desire to continue to promote and encourage CEHRT use by 
ACOs and their ACO participants and ACO providers/suppliers, and our 
desire to better align with the goals of the Quality Payment Program 
and the criteria for participation in certain alternative payment 
models tested by the Innovation Center, in the August 2018 proposed 
rule, we indicated that we believe it would be appropriate to amend our 
regulations related to CEHRT use and the eligibility requirements for 
ACOs to participate in the Shared Savings Program. Specifically, we 
proposed to add a requirement that all ACOs demonstrate a specified 
level of CEHRT use in order to be eligible to participate in the Shared 
Savings Program. Additionally, we proposed that, as a condition of 
participation in a track, or a payment model within a track, that meets 
the financial risk standard to be an Advanced APM, ACOs must certify 
that the percentage of eligible clinicians participating in the ACO who 
use CEHRT to document and communicate clinical care to their patients 
or other health care providers meets or exceeds the threshold required 
for Advanced APMs as defined under the Quality Payment Program (Sec.  
414.1415(a)(1)(i)). In conjunction with this proposed new eligibility 
requirement, we proposed to retire the EHR quality measure (ACO-11) 
related to CEHRT use, thereby reducing reporting burden, effective for 
quality reporting for performance years starting on January 1, 2019, 
and subsequent performance years. In addition, consistent with our 
proposal to align with the Advanced APM criterion on use of CEHRT, we 
proposed to apply the definition of CEHRT under the Quality Payment 
Program (Sec.  414.1305), including any subsequent updates to this 
definition, for purposes of the Shared Savings Program by adding a 
definition of ``CEHRT'' to Sec.  425.20.
    First, we proposed that for performance years starting on January 
1, 2019, and subsequent performance years, ACOs in a track or a payment 
model within a track that does not meet the financial risk standard to 
be an Advanced APM would have to attest and certify upon application to 
participate in the Shared Savings Program, and subsequently, as part of 
the annual certification process, that at least 50 percent of the 
eligible clinicians participating in the ACO use CEHRT to document and 
communicate clinical care to their patients or other health care 
providers. ACOs would be required to submit this certification in the 
form and manner specified by CMS.
    We stated that our proposed requirement aligned with the 
requirements regarding CEHRT use in many alternative payment models 
being tested by the Innovation Center. Additionally, we noted that at 
the time of application, ACOs must have a written plan to use enabling 
technologies, such as electronic health records and other health IT 
tools, to coordinate care (Sec.  425.112(b)(4)(i)(C)). Over the years, 
successful ACOs have impressed upon us the importance of ``hitting the 
ground running'' on the first day of their participation in the Shared 
Savings Program, rather than spending the first year or two developing 
their care processes. We stated our belief that requiring ACOs that are 
entering a track or a payment model within a track that does not meet 
the financial risk standard to be an Advanced APM to certify that at 
least 50 percent of the eligible clinicians participating in the ACO 
use CEHRT would align with existing requirements under the Shared 
Saving Program and many Innovation Center alternative payment models 
and encourage participation by organizations that are more likely to 
meet the program goals. In addition, we stated that such a requirement 
would also promote greater emphasis on the importance of CEHRT use for 
care coordination. Finally, we noted that in the CY 2019 PFS proposed 
rule, we had proposed to increase the threshold of

[[Page 59984]]

CEHRT use required for APMs to meet criteria for designation as 
Advanced APMs under the Quality Payment Program to 75 percent (see 83 
FR 35990). Given our proposed updates and modifications to the Shared 
Savings Program tracks in the August 2018 proposed rule, as well as the 
proposed changes to the requirements regarding CEHRT use under the 
Quality Payment Program, we explained that we believe it is important 
that only those ACOs that are likely to be able to meet or exceed the 
threshold designated for Advanced APMs should be eligible to enter and 
continue their participation in the Shared Savings Program. Because of 
this, and also our desire to align requirements across the different 
payment models and tracks in Shared Savings Program, as explained in 
more detail later in this section, we also considered whether to 
propose to require all Shared Savings Program ACOs, including ACOs in 
tracks or payment models within tracks that would not meet the 
financial criteria to be designated as Advanced APMs, to meet the 75 
percent threshold proposed under the Quality Payment Program.
    We proposed changes to the regulations at Sec.  425.204(c) (to 
establish the new application requirement) and Sec.  425.302(a)(3)(iii) 
(to establish the new annual certification requirement). We also 
proposed to add a new provision at Sec.  425.506(f)(1) to indicate that 
for performance years starting on January 1, 2019, and subsequent 
performance years, all ACOs in a track or a payment model within a 
track that does not meet the financial risk standard to be an Advanced 
APM must certify that at least 50 percent of their eligible clinicians 
use CEHRT to document and communicate clinical care to their patients 
or other health care providers. We noted that this proposal, if 
finalized, would not affect the previously-finalized requirements for 
MIPS eligible clinicians reporting on the Promoting Interoperability 
(PI) performance category under MIPS. In other words, MIPS eligible 
clinicians who are participating in ACOs would continue to report as 
usual on the Promoting Interoperability performance category. We 
welcomed comment on these proposed changes. We also sought comment on 
whether the percentage of CEHRT use should be set at a level higher 
than 50 percent for ACOs in a track or a payment model within a track 
that does not meet the financial risk standard to be an Advanced APM 
given that average ACO performance on the Use of Certified EHR 
Technology measure (ACO-11) has substantially exceeded 50 percent, with 
ACOs reporting that on average roughly 80 percent of primary care 
physicians in their ACOs meet meaningful use requirements,\38\ 
suggesting that a higher threshold may be warranted now or in the 
future. We noted that a higher threshold percentage (such as 75 
percent) would align with the proposed changes to the CEHRT use 
requirement under the Quality Payment Program that were included in the 
CY 2019 PFS proposed rule.
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    \38\ This estimate is based on calculations of primary care 
physician CEHRT use prior to the changes made to ACO-11 to align 
with the Quality Payment Program, which became effective for quality 
reporting for performance year 2017.
---------------------------------------------------------------------------

    Further, for ACOs in tracks or models that meet the financial risk 
standard to be Advanced APMs under the Quality Payment Program, we 
proposed to align the proposed CEHRT use threshold with the criterion 
on use of CEHRT established for Advanced APMs under the Quality Payment 
Program. We noted that, although it would be ideal for all ACOs to meet 
the same CEHRT thresholds to be eligible for participation in the 
Shared Savings Program, there may be reasons why it may be desirable 
for ACOs in tracks or payment models within a track that do not meet 
the financial risk standard for Advanced APMs to have a different 
threshold requirement for CEHRT use than more sophisticated ACOs that 
are participating in tracks or payment models that qualify as Advanced 
APMs under the Quality Payment Program. For example, we noted that in 
order for an APM to meet the criteria to be an Advanced APM under the 
Quality Payment Program, it must currently require at least 50 percent 
of eligible clinicians in each participating APM entity to use CEHRT to 
document and communicate clinical care to their patients or other 
health care providers (in addition to certain other criteria). However, 
as previously noted, in the CY 2019 PFS proposed rule, we proposed to 
increase this threshold level under the Quality Payment Program to 75 
percent of eligible clinicians in each participating Advanced APM 
entity. Therefore, for performance years starting on January 1, 2019, 
and subsequent performance years for Shared Savings Program tracks (or 
payment models within tracks) that meet the financial risk standard to 
be an Advanced APM, we proposed to align the CEHRT requirement with the 
Quality Payment Program Advanced APM CEHRT use criterion at Sec.  
414.1415(a)(1)(i). Specifically, we proposed that such ACOs would be 
required to certify that they meet the higher of the 50 percent 
threshold proposed for ACOs in a track (or a payment model within a 
track) that does not meet the financial risk standard to be an Advanced 
APM or the CEHRT use criterion for Advanced APMs under the Quality 
Payment Program at Sec.  414.1415(a)(1)(i). We stated that requiring 
these ACOs to meet the higher of the 50 percent threshold proposed for 
ACOs in a track (or a payment model within a track) that does not meet 
the financial risk standard to be an Advanced APM or the CEHRT use 
criterion for Advanced APMs would ensure alignment of eligibility 
requirements across all Shared Savings Program ACOs, while also 
ensuring that if the CEHRT use criterion for Advanced APMs were higher 
than 50 percent, those Shared Savings Program tracks (or payment models 
within a track) that meet the financial risk standard to be an Advanced 
APM would also meet the CEHRT threshold established under the Quality 
Payment Program. We anticipated that for performance years starting on 
January 1, 2019, the tracks (or payment models within tracks) that 
would be required to meet the CEHRT threshold designated at Sec.  
414.1415(a)(1)(i) would include Track 2, Track 3, and the Track 1+ 
Model, and for performance years starting on July 1, 2019, would 
include the proposed BASIC track, Level E, and the proposed ENHANCED 
track. ACOs in these tracks (or a payment model within such a track) 
would be required to attest and certify that the percentage of the 
eligible clinicians in the ACO that use CEHRT to document and 
communicate clinical care to their patients or other health care 
providers meets or exceeds the level of CEHRT use specified under the 
Quality Payment Program regulation at Sec.  414.1415(a)(1)(i). We noted 
that although this proposal might cause Shared Savings Program ACOs in 
different tracks (or different payment models within the same track) to 
be held to different requirements regarding CEHRT use, we believed it 
would be appropriate to ensure not only that ACOs that are still new to 
participation in the Shared Savings Program would not be excluded from 
the program due to a requirement that a high percentage of eligible 
clinicians participating in the ACO use CEHRT, but also that eligible 
clinicians in ACOs further along the risk continuum would have the 
opportunity to participate in an Advanced APM for purposes of the 
Quality Payment Program.
    We proposed to add a new provision to the regulations at Sec.  
425.506(f)(2) to

[[Page 59985]]

establish the CEHRT requirement for performance years starting on 
January 1, 2019, and subsequent performance years for ACOs in a track 
or a payment model within a track that meets the financial risk 
standard to be an Advanced APM under the Quality Payment Program. These 
ACOs would be required to certify that the percentage of eligible 
clinicians participating in the ACO that use CEHRT to document and 
communicate clinical care to their patients or other health care 
providers meets or exceeds the higher of 50 percent or the threshold 
for CEHRT use by Advanced APMs at Sec.  414.1415(a)(1)(i). We sought 
comment on this proposal. We also sought comment on whether we should 
apply the same standard regarding CEHRT use across all Shared Savings 
Program ACOs, including ACOs participating in tracks or payment models 
within tracks that do not meet the financial risk standard to be 
designated as Advanced APMs, specifically Track 1 and the proposed 
BASIC track, Levels A through D, or maintain the proposed 50 percent 
requirement for these ACOs as they gain experience on the glide path to 
performance-based risk.
    We stated that, as a part of these proposals to require ACOs to 
certify that a specified percentage of their eligible clinicians use 
CEHRT, CMS would reserve the right to monitor, assess, and/or audit an 
ACO's compliance with respect to its certification of CEHRT use among 
its participating eligible clinicians, consistent with Sec. Sec.  
425.314 and 425.316, and to take compliance actions (including warning 
letters, corrective action plans, and termination) as set forth at 
Sec. Sec.  425.216 and 425.218 when ACOs fail to meet or exceed the 
required CEHRT use thresholds. Additionally, we proposed to adopt for 
purposes of the Shared Savings Program the same definition of ``CEHRT'' 
as is used under the Quality Payment Program. We proposed to amend 
Sec.  425.20 to incorporate a definition of CEHRT consistent with the 
definition at Sec.  414.1305, including any subsequent updates or 
revisions to that definition. Consistent with this proposal and to 
ensure alignment with the requirements regarding CEHRT use under the 
Quality Payment Program, we also proposed to amend Sec.  425.20 to 
incorporate the definition of ``eligible clinician'' at Sec.  414.1305 
that applies under the Quality Payment Program.
    Additionally, we stated that if the proposal to introduce a 
specified threshold of CEHRT use as an eligibility requirement for 
participation in the Shared Savings Program is finalized, we believed 
this new requirement should replace the current ACO quality measure 
that assesses the Use of Certified EHR Technology (ACO-11). We 
explained that the proposed new eligibility requirement, which would be 
assessed through the application process and annual certification, 
would help to meet the goals of the program and align with the approach 
used in other MIPS APMs. Moreover, the proposed new requirement would 
render reporting on the Use of Certified EHR Technology quality measure 
unnecessary in order for otherwise eligible tracks (and payment models 
within tracks) to meet the Advanced APM criterion regarding required 
use of CEHRT under Sec.  414.1415(a)(1)(i). As a result, continuing to 
require ACOs to report on this measure would impose undue reporting 
burden on eligible clinicians that meet the QP threshold and would 
otherwise not be required to report the Promoting Interoperability 
performance category for purposes of the Quality Payment Program. 
Therefore, we proposed to remove the Use of Certified EHR Technology 
measure (ACO-11) from the Shared Savings Program quality measure set, 
effective with quality reporting for performance years starting on 
January 1, 2019, and subsequent performance years. We proposed 
corresponding changes to the regulation at Sec.  425.506. We also 
reiterated that the removal of the Use of Certified EHR Technology 
measure (ACO-11) from the quality measure set used under the Shared 
Savings Program, if finalized, would not affect policies under MIPS for 
reporting on the Promoting Interoperability performance category and 
scoring under the APM Scoring Standard for MIPS eligible clinicians in 
MIPS APMs. In other words, eligible clinicians subject to MIPS (such as 
eligible clinicians in the proposed BASIC track, Levels A through D, 
Track 1, and other MIPS eligible clinicians who are required to report 
on the Promoting Interoperability performance category for purposes of 
the Quality Payment Program) would continue to report as usual on the 
Promoting Interoperability performance category. However, data reported 
for purposes of the Promoting Interoperability performance category 
under MIPS would not be used to assess the ACO's quality performance 
under the Shared Savings Program. We welcomed public comment on the 
proposal to remove the quality measure on Use of Certified EHR 
Technology (ACO-11) from the Medicare Shared Savings Program measure 
set, effective for quality reporting for performance years starting on 
January 1, 2019, and subsequent performance years.
    Finally, as discussed previously in this section, in the CY 2017 
Quality Payment Program final rule, CMS finalized a separate Advanced 
APM CEHRT use criterion that applies for the Shared Savings Program at 
Sec.  414.1415(a)(1)(ii). To meet the Advanced APM CEHRT use criterion 
under the Shared Savings Program, a penalty or reward must be applied 
to an APM Entity based upon the degree of CEHRT use among its eligible 
clinicians. We believed that this alternative criterion was appropriate 
to assess the Advanced APM CEHRT use requirement under the Shared 
Savings Program because, at the time, a specific level of CEHRT use was 
not required for participation in the program (81 FR 77412).
    As we explained in the August 2018 proposed rule (83 FR 41911), our 
proposal to impose specific CEHRT use requirements on ACOs 
participating in the Shared Savings Program would eliminate the need 
for the separate CEHRT use criterion applicable to the Shared Savings 
Program APMs found at Sec.  414.1415(a)(1)(ii). We noted that if the 
proposal to incorporate specific requirements regarding the use of 
CEHRT by Shared Savings Program ACOs were finalized, ACOs seeking to 
participate in a Shared Savings Program track (or payment model within 
a track) that meets the financial risk standard to be an Advanced APM 
would be required to demonstrate that the percentage of eligible 
clinicians in the ACO using CEHRT to document and communicate clinical 
care to their patients or other health care providers meets or exceeds 
the higher of 50 percent or the percentage specified in the CEHRT use 
criterion for Advanced APMs at Sec.  414.1415(a)(1)(i). As a result, a 
separate CEHRT use criterion for APMs under the Shared Savings Program 
would no longer be necessary.
    Therefore, we proposed to revise the separate Shared Savings 
Program CEHRT use criterion at Sec.  414.1415(a)(1)(ii) so that it 
would apply only for QP Performance Periods under the Quality Payment 
Program prior to 2019. We sought comment on this proposal.
    Comment: Several commenters supported the continued recognition for 
integration of Electronic Medical Records (EMRs) and the sharing of 
health information between providers and suppliers.
    Response: We thank the commenters for their support.
    Comment: A majority of commenters supported our proposal to replace 
ACO-

[[Page 59986]]

11--Use of Certified EHR Technology with a requirement that ACOs 
certify regarding the percentage of eligible clinicians participating 
in the ACO that use CEHRT to document and communicate clinical care to 
their patients or other health care providers. In addition, many 
commenters urged CMS to clarify that MIPS eligible clinician 
participating in Shared Savings Program ACOs would not be required to 
report Promoting Interoperability (PI) and would instead see PI 
performance category weights redistributed equally to the Quality and 
Improvement Activities performance categories.
    Response: As noted in the August 2018 proposed rule (83 FR 41909), 
the proposal to replace ACO-11: Use of Certified EHR Technology with a 
requirement that ACOs certify regarding the level of CEHRT use by 
eligible clinicians in the ACO would not affect any previously 
finalized requirements for MIPS eligible clinicians reporting on the PI 
performance category under MIPS. MIPS eligible clinicians who are 
participating in ACO tracks that are not Advanced APMs and/or who are 
not QPs would continue to report as usual on the PI performance 
category.
    Comment: Several commenters asked CMS to clarify the proposals for 
Promoting Interoperability in the August 2018 proposed rule, in the 
final rule. Specifically, the commenters requested clarification on 
when complete implementation of the 2015 CEHRT edition was required for 
ACOs participating in the Shared Savings Program, as the proposal 
discussed in the August 2018 proposed rule would require an ACO to 
attest to the percentage of eligible clinicians utilizing CEHRT at the 
time of application and annually thereafter. The commenters stated that 
a requirement that they attest to meeting the CEHRT use threshold at 
the time of application would negatively impact ACOs whose participants 
make CEHRT decisions (such as upgrades) based on a minimum consecutive 
90-day reporting period as set forth by the Quality Payment Program The 
commenters stated that clarification of the deadline for implementation 
was needed so healthcare organizations could have a clear understanding 
of the expectations, allowing them to plan accordingly, especially for 
those organizations that participate in more than one regulatory 
program. In addition, several commenters requested that CMS clarify its 
operational expectations with respect to the proposed new certification 
requirement, so that ACOs can confirm that they are able to confidently 
certify with respect to the level of CEHRT use in their ACO.
    Response: We understand that ACOs need to know the deadline by 
which they must meet the proposed new requirements regarding the use of 
CEHRT and have an understanding of how they would be required to 
demonstrate that they have met the requirement. As we explained in the 
August 2018 proposed rule, we believe it is appropriate to ensure that 
ACOs new to participation in the Shared Savings Program not be excluded 
from the program due to a requirement that a high percentage of 
eligible clinicians participating in the ACO use CEHRT. At the same 
time, however, we also sought to align with the CEHRT use requirements 
under the Quality Payment Program to ensure that eligible clinicians in 
ACOs further along the risk continuum would have the opportunity to 
participate in an Advanced APM for purposes of the Quality Payment 
Program. While our proposal was intended to require that ACOs achieve 
the applicable CEHRT use threshold starting in the 2019 performance 
year, we understand from commenters that the requirement that ACOs 
certify that the percentage of eligible clinicians in the ACO that use 
CEHRT meets the applicable threshold at time of application could pose 
an operational challenge. For example, a commenter stated that, ACOs 
not yet operating on 2015 edition CEHRT may have implementation and 
cost barriers related to the upgrade of CEHRT that may place them in a 
non-complaint situation, given the short timeframe between the 
publication of the final rule and the start of performance year 2019.
    Based on the comments received in response to the proposals in the 
August 2018 proposed rule and our desire to align with the Quality 
Payment Program, under which eligible clinicians must certify regarding 
their CEHRT use by the last day of the reporting period, we are not 
finalizing our proposal to require ACOs to certify at the time of 
application that they meet the applicable CEHRT requirements. However, 
we are finalizing our proposal to require ACOs to certify annually that 
the percentage of eligible clinicians participating in the ACO that use 
CEHRT to document and communicate clinical care to their patients or 
other health care providers meets or exceeds the applicable percentage 
during the current performance year. ACOs will be required to submit 
this certification in the form and manner specified by CMS for 
performance years starting on January 1, 2019, and all subsequent 
performance years. For performance years starting on January 1, 2019, 
the annual certification will occur in the spring of 2019 for ACOs 
extending their participation agreement for 6 months, and in the fall 
of 2019 for ACOs that have a 12-month performance year during 2019. We 
believe this final policy is not only responsive to commenters' 
concerns regarding the timing of the certification but also enables 
timely implementation of the requirement starting in 2019. As noted 
above, a majority of commenters supported our proposal to replace ACO-
11--Use of Certified EHR Technology with a requirement that ACOs 
certify regarding the percentage of eligible clinicians participating 
in the ACO that use CEHRT to document and communicate clinical care to 
their patients or other health care providers starting January 1, 2019. 
We also note that this new requirement aligns more closely with the 
requirements regarding CEHRT use imposed under the Next Generation ACO 
Model, which requires that participating ACOs certify compliance with 
the CEHRT use requirement in the fall of each performance year. As 
stated in the August 2018 proposed rule, we currently require that ACOs 
must have in place at the time of application a written plan to use 
enabling technologies, such as electronic health records and other 
health IT tools, to coordinate care (Sec.  425.112(b)(4)(i)(C)). 
Because this policy is already in place, we believe that our decision 
not to finalize the proposal to require ACOs to certify with respect to 
their use of CEHRT at time of application to the Shared Savings Program 
will not undermine the policies under the program designated to promote 
and encourage the use of CEHRT.
    Although the comments requesting clarification of our CEHRT 
proposals were not specific regarding the Shared Savings Program track 
for which they were seeking clarification, in this final rule we are 
clarifying the CEHRT threshold requirement for ACOs participating in an 
Advanced APM. Our intent at the time we proposed this policy was to 
preserve a minimum threshold of 50 percent CEHRT use for all ACOs in 
the Shared Savings Program, even if the requirement at Sec.  
414.1415(a)(1)(i) were revised through future rulemaking to be below 50 
percent. However, we now recognize that this proposed ``higher of'' 
policy generated undue complexity. In the unlikely event that the 
requirement for CEHRT use at Sec.  414.1415(a)(1)(i) were to be reduced 
to below 50 percent in the future, we would have the opportunity

[[Page 59987]]

to revisit the Shared Savings Program threshold through future 
rulemaking. Accordingly, we are revising the proposed regulation at 
Sec.  425.506(f)(2) to remove the reference to the 50 percent threshold 
and to indicate that ACOs participating in a Shared Savings Program 
track that meets the financial risk standard to be an Advanced APM, 
would be required to demonstrate that the percentage of eligible 
clinicians in the ACO using CEHRT to document and communicate clinical 
care to their patients or other health care providers meets or exceeds 
the percentage specified in the CEHRT use criterion for Advanced APMs 
under Sec.  414.1415(a)(1)(i).
    Comment: Several commenters suggested modifications to CMS' 
proposal to require ACOs to certify that the percentage of eligible 
clinicians in the ACO using CEHRT meets the applicable threshold. 
Several commenters suggested that CMS delay the implementation of the 
certification requirement attestation until performance year 2020 to 
avoid inadvertently penalizing Track 1 ACOs that may not have 
sufficient time to meet the new CEHRT requirement. Several other 
commenters expressed concern that meeting the 50 percent CEHRT 
threshold would be a hardship for ACOs in Track 1, especially ACOs 
composed of independent physician practices and rural practices. These 
commenters recommended that CMS not finalize this this new requirement, 
but if CMS were to finalize the 50 percent threshold, these commenters 
believed that CMS should extend exemptions to low-revenue ACOs or those 
ACOs in which the plurality of eligible clinicians qualify for a 
hardship exemption from the Promoting Interoperability performance 
category under the MIPS. Another commenter suggested that CMS require 
ACOs in a track (or payment model within a track) that meets the 
financial risk standard to be an Advanced APM to meet the 50 percent 
CEHRT requirement in the first performance year and then increase to 75 
percent in the second performance year.
    Response: We disagree with the suggestions that we delay 
implementation of the proposed new CEHRT use requirement or impose 
differential requirements for ACOs, depending on their performance year 
or other attributes. Since the inception of the Shared Savings Program 
in 2012, we have assessed the level of CEHRT use by certain clinicians 
in ACOs (ACO-11: Use of Certified EHR Technology) as part of the 
quality reporting requirements for each performance year. In the CY 
2017 PFS final rule, we revised the ACO-11 measure to assess ACOs on 
the degree of CEHRT use by eligible clinicians participating in the ACO 
in order to align with the Quality Payment Program. Starting in 2017, 
performance on this measure has been determined by calculating the 
percentage of eligible clinicians participating in the ACO who 
successfully meet the Promoting Interoperability Category Base Score. 
We believe that this experience offers a foundation on which ACOs can 
build and create processes that allow them to determine the percentage 
of eligible clinicians participating in the ACO that use CEHRT during 
an applicable performance year. As noted in the August 2018 proposed 
rule (83 FR 41909 through 41910), average ACO performance on ACO-11: 
Use of Certified EHR Technology has substantially exceeded 50 percent, 
with ACOs reporting that on average roughly 80 percent of primary care 
physicians in their ACOs meet meaningful use requirements.\39\ As a 
result, we do not believe it is unreasonable to expect Track 1 ACOs to 
meet the requirement that 50 percent or more of the eligible clinicians 
participating in the ACO use CEHRT beginning in the performance year 
starting on January 1, 2019. Furthermore, as noted above, our proposal 
to require ACOs to certify that they meet the applicable CEHRT 
threshold has no impact on the previously-finalized policy that MIPS 
eligible clinicians participating in ACOs will continue to report on 
the PI performance category. Under this policy, MIPS-eligible 
clinicians are required to use the 2015 version of CEHRT for purposes 
of reporting the promoting interoperability performance category (Sec.  
414.1305). Accordingly, we believe our proposal to require this version 
to be used by eligible clinicians participating in Shared Savings 
Program ACOs aligns with existing requirements under the MIPS and does 
not impose a new requirement on ACOs. Further, we believe our decision 
not to finalize the requirement that ACOs certify with respect their 
level of CEHRT use as part of the application process, and to implement 
the requirement solely through the annual certification during the 
performance year, will allow additional time for ACOs to update any 
internal processes as needed in order to meet this requirement during 
the performance year starting on January 1, 2019. In addition, as noted 
above, over the years successful ACOs have provided feedback that it is 
important to ``hit the ground running'' on their first day of 
participation in the Shared Savings Program, rather than spending 
several years developing their care processes. Based on this feedback, 
as well as commenters who supported the CEHRT proposal, we believe it 
is important to implement the proposed CEHRT use thresholds starting 
January 1, 2019. We believe that the use of these thresholds to assess 
CEHRT use by ACOs participating in the Shared Savings Program aligns 
with existing requirements under the program and encourages 
participation by organizations that are more likely to meet the program 
goals.
---------------------------------------------------------------------------

    \39\ This estimate is based on calculations of CEHRT use by 
primary care physicians prior to the changes made to ACO-11 to align 
with the Quality Payment Program, which became effective for quality 
reporting for performance year 2017.
---------------------------------------------------------------------------

    We received no comments on our proposals to change the regulation 
at Sec.  425.204(c) to establish the new application requirement and 
the regulation at Sec.  425.302(a)(3)(iii) to establish the new annual 
certification requirement. We also received no comments on our proposal 
to amend Sec.  425.20 to incorporate a definition of ``CEHRT'' 
consistent with the definition at Sec.  414.1305, including any 
subsequent updates or revisions to that definition, and to incorporate 
the definition of ``eligible clinician'' at Sec.  414.1305 that applies 
under the Quality Payment Program. In addition, we received no comments 
on our proposal to amend the separate Shared Savings Program CEHRT use 
criterion at Sec.  414.1415(a)(1)(ii) so that it applies only for QP 
Performance Periods under the Quality Payment Program prior to 2019. 
Furthermore, we received no comments on our proposal to add a new 
provision to the regulation at Sec.  425.506 to establish the CEHRT 
requirement for performance years starting on January 1, 2019, and 
subsequent performance years for ACOs in a track or payment model 
within a track that does not meet the financial risk standard to be an 
Advanced APM and ACOs in a track or payment model within a track that 
meets the financial risk standard to be an Advanced APM.
    After considering the comments received, we are finalizing with 
modification our proposal that for performance years starting on 
January 1, 2019, and subsequent performance years, ACOs in a track that 
does not meet the financial risk standard to be an Advanced APM must 
certify that at least 50 percent of the eligible clinicians 
participating in the ACO use CEHRT to document and communicate clinical 
care to their patients or other health care providers. Specifically, we 
are finalizing

[[Page 59988]]

the requirement that ACOs make this certification annually in the form 
and manner specified by CMS, but, for the reasons discussed above, we 
are not finalizing the proposal to require ACOs to make this 
certification at the time of application. Accordingly, for performance 
years starting on January 1, 2019, and subsequent performance years, 
ACOs in a track that does not meet the financial risk standard to be an 
Advanced APM must certify annually that at least 50 percent of the 
eligible clinicians participating in the ACO use CEHRT to document and 
communicate clinical care to their patients or other health care 
providers. We reiterate that this final policy does not affect the 
previously finalized requirements for MIPS eligible clinicians 
reporting on the Promoting Interoperability (PI) performance category 
under MIPS. Accordingly, MIPS eligible clinicians who are participating 
in ACOs under a payment track that is not an Advanced APM and/or who 
are not QPs would continue to report as usual on the Promoting 
Interoperability performance category.
    Similarly, after considering the comments received, we are also 
finalizing with modification our proposal with respect to ACOs in 
Shared Savings Program tracks that meet the financial risk standard to 
be an Advanced APM. We proposed that these ACOs would be required to 
certify at the time of application and annually thereafter that they 
meet the higher of the 50 percent threshold proposed for ACOs in a 
track that does not meet the financial risk to be an advanced APM or 
the CEHRT use criterion for Advanced APMs under the Quality Payment 
Program at Sec.  414.1415(a)(1)(i).
    For the reasons discussed previously, we not finalizing the 
requirement that ACOs certify that they meet the higher of the 50 
percent threshold or the applicable threshold under the Quality Payment 
Program. Rather, ACOs will be required to certify only that they meet 
the applicable threshold established under the Quality Payment Program. 
In addition, as also discussed, we are not finalizing our proposal that 
ACOs certify that they meet the CEHRT requirement at the time of 
application. Accordingly, for performance years starting on January 1, 
2019, and subsequent years, ACOs in a track that meets the financial 
risk standard to be an Advanced APM must certify annually that the 
percentage of eligible clinicians participating in the ACO that use 
CEHRT to document and communicate clinical care to their patients or 
other health care providers meets or exceeds the threshold established 
under the Quality Payment Program at Sec.  414.1415(a)(1)(i).
    We are finalizing the proposed new provision at Sec.  425.506(f) 
with conforming modifications to reflect the policies we are finalizing 
in this final rule. As part of these modifications, we are omitting the 
reference to ``a payment model within a track'' because we are not 
addressing the proposal to create the BASIC track, with separate 
payment models at Levels A through E, at this time. We anticipate 
summarizing and responding to comments received on this proposal and 
other proposals related to the participation options under the Shared 
Savings Program in a forthcoming final rule. For the reasons discussed 
previously in this section, we are not finalizing the proposed changes 
to the regulation at Sec.  425.204(c) to establish the new application 
requirement; but, we are finalizing the proposed changes to the 
regulation at Sec.  425.302(a)(3)(iii) to establish the new annual 
certification requirement. In addition, we are finalizing our proposed 
amendments to Sec.  425.20 to incorporate a definition of ``CEHRT'' 
consistent with the definition at Sec.  414.1305, including any 
subsequent updates or revisions to that definition, and to incorporate 
the definition of ``eligible clinician'' at Sec.  414.1305 that applies 
under the Quality Payment Program. We are also finalizing our proposal 
to amend the separate Shared Savings Program CEHRT use criterion at 
Sec.  414.1415(a)(1)(ii) so that it applies only for QP Performance 
Periods under the Quality Payment Program prior to 2019.
    As noted in the August 2018 proposed rule (83 FR 41910), CMS 
reserves the right to monitor, assess, and/or audit an ACO's compliance 
with respect to its certification of CEHRT use among its participating 
eligible clinicians, consistent with Sec. Sec.  425.314 and 425.316, 
and to take compliance actions (including warning letters, corrective 
action plans, and termination) as set forth at Sec. Sec.  425.216 and 
425.218 when ACOs fail to meet or exceed the required CEHRT use 
thresholds.
    Finally, after considering the comments received in response to the 
proposal to remove ACO-11: Use of Certified EHR Technology measure from 
the Shared Savings Program quality measure set, we are finalizing our 
proposal effective with quality reporting for performance years 
starting on January 1, 2019, and subsequent performance years. We are 
also finalizing the corresponding revisions to the regulation at Sec.  
425.506 to reflect this change.
3. Applicability of Final Policies to Track 1+ Model ACOs
a. Background
    In the August 2018 proposed rule (83 FR 41912), we discussed the 
applicability of proposed policies to Track 1+ Model ACOs. We explained 
that the Track 1+ Model was established under the Innovation Center's 
authority at section 1115A of the Act, to test innovative payment and 
service delivery models to reduce program expenditures while preserving 
or enhancing the quality of care for Medicare, Medicaid, and Children's 
Health Insurance Program beneficiaries. We noted that 55 Shared Savings 
Program Track 1 ACOs entered into the Track 1+ Model beginning on 
January 1, 2018. This includes 35 ACOs that entered the model within 
their current agreement period (to complete the remainder of their 
agreement period under the model) and 20 ACOs that entered into a new 
3-year agreement period under the model.
    To enter the Track 1+ Model, ACOs must be approved to participate 
in the model and are required to agree to the terms and conditions of 
the model by executing a Track 1+ Model Participation Agreement 
available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/track-1plus-model-par-agreement.pdf. Track 1+ Model ACOs are also required to have been 
approved to participate in the Shared Savings Program (Track 1) and to 
have executed a Shared Savings Program Participation Agreement. As 
indicated in the Track 1+ Model Participation Agreement, in accordance 
with its authority under section 1115A(d)(1) of the Act, CMS has waived 
certain provisions of law that otherwise would be applicable to ACOs 
participating in Track 1 of the Shared Savings Program, as necessary 
for purposes of testing the Track 1+ Model, and established alternative 
requirements for the ACOs participating in the Track 1+ Model.
    We explained that, unless stated otherwise in the Track 1+ Model 
Participation Agreement, the requirements of the Shared Savings Program 
under 42 CFR part 425 continue to apply. Consistent with Sec.  425.212, 
Track 1+ Model ACOs are subject to all applicable regulatory changes, 
including but not limited to changes to the regulatory provisions 
referenced within the Track 1+ Model Participation Agreement, that 
become effective during the term of the ACO's Shared Savings Program 
Participation Agreement and Track 1+ Model

[[Page 59989]]

Participation Agreement, unless otherwise specified through rulemaking 
or amendment to the Track 1+ Model Participation Agreement. We noted 
that the terms of the Track 1+ Model Participation Agreement permit the 
parties (CMS and the ACO) to amend the agreement at any time by mutual 
written agreement.
b. Unavailability of Application Cycles for Entry Into the Track 1+ 
Model in 2019
    In the August 2018 proposed rule (83 FR 41912 through 41913), we 
discussed the unavailability of application cycles for entry into the 
Track 1+ Model in 2019 and 2020. We explained that an ACO's opportunity 
to join the Track 1+ Model aligns with the Shared Savings Program's 
application cycle. The original design of the Track 1+ Model included 3 
application cycles for ACOs to apply to enter or, if eligible and if 
applicable, to renew their participation in the Track 1+ Model for an 
agreement period start date of 2018, 2019, or 2020. The 2018 
application cycle is closed, and as discussed elsewhere in the August 
2018 proposed rule, 55 ACOs began participating in the Track 1+ Model 
on January 1, 2018. As discussed in section II.A.7 of the August 2018 
proposed rule (83 FR 41847) and section V.B.1.a of this final rule, we 
are not offering an application cycle for a January 1, 2019 start date 
for new agreement periods under the Shared Savings Program. Therefore, 
we similarly are not offering a start date of January 1, 2019, for 
participation in the Track 1+ Model.
    We explained that existing Track 1+ Model ACOs would be able to 
complete the remainder of their current agreement period in the model. 
Additionally, as discussed in section II.A.7.c.(1) of the August 2018 
proposed rule (83 FR 41854 through 41855) and section V.B.1.c.(1) of 
this final rule, ACOs currently participating in the Track 1+ Model 
will not have the opportunity to apply to use a SNF 3-day rule waiver 
starting on January 1, 2019, under our decision to forgo an annual 
application cycle for a January 1, 2019 start date in the Shared 
Savings Program. We proposed that, if finalized, the next available 
application cycle for a SNF 3-day rule waiver would occur in advance of 
a July 1, 2019 start date. We will address proposals related to future 
application cycles in subsequent rulemaking.
c. Applicability of Proposed Policies to Track 1+ Model ACOs Through 
Revised Program Regulations or Revisions to Track 1+ Model 
Participation Agreements
    In section II.F of the August 2018 proposed rule (83 FR 41913 
through 41914), we provided a comprehensive discussion of the 
applicability of the proposed policies to Track 1+ Model ACOs to allow 
these ACOs to better prepare for their future years of participation in 
the program and the Track 1+ Model. We explained that there are two 
ways in which the proposed policies would become applicable to Track 1+ 
Model ACOs: (1) Through revisions to existing regulations that 
currently apply to Track 1+ Model ACOs; and (2) through revisions to 
the ACO's Track 1+ Model Participation Agreement.
    We sought comment on these considerations, and any other issues 
that we may not have discussed related to the effect of the proposed 
policies on ACOs that entered the Track 1+ Model beginning in 2018. We 
note that these ACOs will complete their participation in the Track 1+ 
Model by no later than December 31, 2020 (for ACOs that entered the 
model at the start of a 3-year agreement period), or sooner in the case 
of ACOs that entered the model at the start of their second or third 
performance year within their current 3-year agreement period.
    Generally, comments regarding the application of specific proposals 
to Track 1+ Model ACOs have been addressed as part of the discussion of 
comments in the relevant section of this final rule. Accordingly, in 
this section of this final rule, we are not repeating comments related 
to the applicability of the proposed policies to ACOs participating in 
the Track 1+ Model.
    Therefore, unless specified otherwise, the changes to the program's 
regulations finalized in this final rule that are applicable to Shared 
Savings Program ACOs within a current agreement period will apply to 
ACOs in the Track 1+ Model in the same way that they apply to ACOs in 
Track 1, so long as the applicable regulation has not been waived under 
the Track 1+ Model. Similarly, to the extent that certain requirements 
of the regulations that apply to ACOs under Track 2 or Track 3 have 
been incorporated for ACOs in the Track 1+ Model under the terms of the 
Track 1+ Model Participation Agreement, changes to the regulations as 
finalized in this final rule will also apply to ACOs in the Track 1+ 
Model in the same way that they apply to ACOs in Track 2 or Track 3. 
For example, the following policies apply to Track 1+ Model ACOs:
     Revisions to voluntary alignment policies (section 
V.B.2.b. of this final rule), applicable for the performance year 
beginning on January 1, 2019, and subsequent performance years.
     Revisions to the definition of primary care services used 
in beneficiary assignment (section V.B.2.c. of this final rule), 
applicable for the performance year beginning on January 1, 2019, and 
subsequent performance years.
     Discontinuation of quality measure ACO-11; requirement to 
attest as part of the annual certification that a specified percentage 
of the ACO's eligible clinicians use CEHRT (section V.B.2.f. of this 
final rule), applicable for the performance year beginning on January 
1, 2019, and subsequent performance years.
    We will also apply the following policies finalized in this final 
rule to Track 1+ Model ACOs through an amendment to the Track 1+ Model 
Participation Agreement executed by CMS and the ACO:
     Annual certification that the percentage of eligible 
clinicians participating in the ACO that use CEHRT to document and 
communicate clinical care to their patients or other health care 
providers meets or exceeds the threshold established under Sec.  
414.1415(a)(1)(i) (section V.B.2.f. of this final rule). This 
certification is required to ensure the Track 1+ Model continues to 
meet the CEHRT criterion to qualify as an Advanced APM for purposes of 
the Quality Payment Program.
     For ACOs that started a first or second Shared Savings 
Program participation agreement on January 1, 2016, and entered the 
Track 1+ Model on January 1, 2018, and that elect to extend their 
Shared Savings Program participation agreement for the 6-month 
performance year from January 1, 2019 through June 30, 2019 (as 
described in section V.B.1 of this final rule):
    ++ As described in section V.B.1.c.(3) of this final rule, the ACO 
should extend its repayment mechanism so that it remains in effect for 
24 months after the end of the agreement period (June 30, 2021).
    ++ As described in section V.B.1.c.(10) of this final rule, the ACO 
is eligible for shared savings if the following conditions are met: The 
ACO completed the 6-month performance year starting on January 1, 2019; 
the ACO has completed all close-out procedures specified in Sec.  
425.221(a) by the deadline specified by CMS (if applicable); and the 
ACO has satisfied

[[Page 59990]]

the criteria for sharing in savings for the performance year.
    ++ We will determine performance for the 6-month performance year 
from January 1, 2019 through June 30, 2019, according to the approach 
specified in a new section of the regulations at Sec.  425.609(b), 
applying the financial methodology for calculating shared losses 
specified in the ACO's Track 1+ Model Participation Agreement.
    ++ We will continue to share aggregate report data with the ACO for 
the entire CY 2019, consistent with the approach described in section 
V.B.1.c.(8) of this final rule, and the terms of the ACO's Track 1+ 
Model Participation Agreement.
     Extreme and uncontrollable circumstances policies for 
determining shared losses for performance years 2018 and subsequent 
years, consistent with the policies specified in Sec.  425.610(i) 
(section V.B.2.d. of this final rule) and, for ACOs that elect to 
extend their Shared Savings Program participation agreement for the 6-
month performance year from January 1, 2019 through June 30, 2019, in 
Sec.  425.609(d) (section V.B.1.c.(5) of this final rule).

VI. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. chapter 
35), we are required to publish a 30-day notice in the Federal Register 
and solicit public comment before a collection of information 
requirement is submitted to the Office of Management and Budget (OMB) 
for review and approval.
    We solicited comments in the notice of proposed rulemaking that 
published in the July 27, 2018 Federal Register (83 FR 35704). For the 
purpose of transparency, we are republishing the discussion of the 
information collection requirements along with a reconciliation of the 
public comments we received.

A. Wages

    To derive average costs, we used data from the U.S. Bureau of Labor 
Statistics' May 2017 National Occupational Employment and Wage 
Estimates for all salary estimates (http://www.bls.gov/oes/current/oes_nat.htm). In this regard, Table 60 presents the mean hourly wage, 
the cost of fringe benefits and overhead (calculated at 100 percent of 
salary), and the adjusted hourly wage.
    Private Sector Wages: The adjusted hourly wage is used to calculate 
the labor costs associated with our finalized requirements.

                          Table 60--National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
                                                                                      Fringe
                                                    Occupation      Mean hourly    benefits and      Adjusted
                Occupation title                       code         wage ($/hr)   overhead costs  hourly wage ($/
                                                                                      ($/hr)            hr)
----------------------------------------------------------------------------------------------------------------
All Occupations (for Individuals' Wages)........         00-0000           24.34             n/a             n/a
Billing and Posting Clerks......................         43-3021           18.49           18.49           36.98
Computer Systems Analysts.......................         15-1121           44.59           44.59           89.18
Family and General Practitioner.................         29-1062          100.27          100.27          200.54
Licensed Practical Nurse (LPN)..................         29-2061           21.98           21.98           43.96
Medical Assistant...............................         31-9092           16.15           16.15           32.30
Medical Secretary...............................         43-6013           17.25           17.25           34.50
Physicians......................................         29-1060          103.22          103.22          206.44
Practice Administrator (Medical and Health               11-9111           53.69           53.69          107.38
 Services Managers).............................
Registered Nurse................................         29-1141           35.36           35.36           70.72
----------------------------------------------------------------------------------------------------------------

    As indicated, we adjusted our employee hourly wage estimates by a 
factor of 100 percent. This is necessarily a rough adjustment, both 
because fringe benefits and overhead costs vary significantly from 
employer to employer, and because methods of estimating these costs 
vary widely from study to study. Nonetheless, we believe that doubling 
the hourly wage to estimate total cost is a reasonably accurate 
estimation method.
    Wages for Individuals: For beneficiaries who elect to complete the 
CAHPS for MIPS survey, we believe that the burden will be addressed 
under All Occupations (see Table 60) at $24.34/hr since the group of 
individual respondents varies widely from working and nonworking 
individuals and by respondent age, location, years of employment, and 
educational attainment, etc. Unlike our private sector adjustment to 
the respondent hourly wage, we did not adjust this figure for fringe 
benefits and overhead since the individuals' activities will occur 
outside the scope of their employment.

B. Information Collection Requirements (ICRs)

1. ICRs Regarding the Clinical Laboratory Fee Schedule (CLFS) (Section 
III.A. of This Final Rule)
    Section 1834A of the Act, as established by section 216(a) of the 
Protecting Access to Medicare Act of 2014 (PAMA), required significant 
changes to how Medicare pays for clinical diagnostic laboratory test 
(CDLTs) under the CLFS. The CLFS final rule, titled ``Medicare Clinical 
Diagnostic Laboratory Tests Payment System Final Rule'' (CLFS final 
rule), was published in the Federal Register on June 23, 2016, and 
implemented section 1834A of the Act. Under that rule (81 FR 41036), 
``reporting entities'' must report to CMS during a ``data reporting 
period'' ``applicable information'' (that is, certain private payor 
data) collected during a ``data collection period'' for their component 
``applicable laboratories.'' In general, the payment amount for each 
CDLT on the CLFS furnished beginning January 1, 2018, is based on the 
applicable information collected during the 6-month data collection 
period and reported to us during the 3-month data reporting period, and 
is equal to the weighted median of the private payor rates for the 
CDLT.
    An applicable laboratory is defined at Sec.  414.502, in part, as 
an entity that is a laboratory (as defined under the Clinical 
Laboratory Improvement Amendments (CLIA) definition at Sec.  493.2) 
that bills Medicare Part B under its own National Provider Identifier 
(NPI). In addition, an applicable laboratory is an entity that receives 
more than 50 percent of its Medicare revenues during a data collection 
period from the CLFS and/or the PFS. We refer to this component of the 
applicable laboratory definition as the ``majority of Medicare revenues 
threshold.'' The definition of applicable laboratory also includes a 
``low expenditure threshold'' component, which requires an entity to 
receive at least $12,500 of its Medicare revenues

[[Page 59991]]

from the CLFS during a data collection period for its CDLTs that are 
not advanced diagnostic laboratory tests (ADLTs).
    In determining payment rates under the private payor rate-based 
CLFS, one of our goals is to obtain as much applicable information as 
possible from the broadest possible representation of the national 
laboratory market on which to base CLFS payment amounts, for example, 
from independent laboratories, hospital outreach laboratories, and 
physician office laboratories, without imposing undue burden on those 
entities. We believe it is important to achieve a balance between 
collecting sufficient data to calculate a weighted median that 
appropriately reflects the private market rate for a CDLT, and 
minimizing the reporting burden for entities. In response to 
stakeholder feedback in the proposed rule (see section III.A.3 of this 
final rule for a discussion of this feedback) and in the interest of 
facilitating our goal, we are finalizing the revision to the majority 
of Medicare revenues threshold component of the definition of 
applicable laboratory at Sec.  414.502(3) to exclude Medicare Advantage 
(MA) payments under Medicare Part C from the definition of total 
Medicare revenues (that is, the denominator of the majority of Medicare 
threshold equation). Specifically, this revision could allow additional 
laboratories of all types serving a significant population of 
beneficiaries enrolled in Medicare Part C to meet the majority of 
Medicare revenues threshold and potentially qualify as applicable 
laboratories (provided they meet all other requirements for applicable 
laboratory status) and report data to us.
    In addition, in response to stakeholder feedback (see section 
III.A.4 of this final rule for a discussion of this feedback) in 
response to the comment solicitation in the proposed rule and in the 
interest of obtaining as much applicable information as possible, we 
are finalizing a revision to the definition of applicable laboratory at 
Sec.  414.502 to include a hospital that bills Medicare on the Form 
CMS-1450 14x Type of Bill (OMB control number: 0938-0997) and its 
electronic equivalent.
    As such, we believe the finalized changes may result in more 
applicable information being reported, which we will use to set CLFS 
payment rates. However, with regard to the CLFS-related requirements 
and burden, as we noted in the proposed rule, section 1834A(h)(2) of 
the Act provides that the Paperwork Reduction Act in chapter 35 of 
title 44 of the U.S.C. shall not apply to information collected under 
section 1834A of the Act (which is the new private payor rate-based 
CLFS).
    For a complete discussion of our finalized revisions to the 
definition of applicable laboratory in Sec.  414.502 related to the 
majority of Medicare revenues threshold and use of the Form CMS-1450 
14X TOB, we refer readers to sections III.A.4.a of this final rule.
2. ICRs Regarding Appropriate Use Criteria (AUC) for Advanced 
Diagnostic Imaging Services (Sec.  414.94 and Section III.D. of this 
final rule)
    Consultations: In the CY19 PFS proposed rule, we proposed to revise 
Sec.  414.94(j) to allow the AUC consultation, when not performed 
personally by the ordering professional, to be performed by auxiliary 
personnel (as defined in Sec.  410.26(a)(1)) under the direction of, 
and incident to, the ordering professional's services. In this final 
rule, we did not finalize this proposal but, instead, revised the 
regulation to specify that clinical staff acting under the direction of 
the ordering professional may perform the AUC consultation. The revised 
AUC consultation requirements and burden will be submitted to OMB for 
approval under control number 0938-1345 (CMS-10654).
    General practitioners make up a large group of practitioners who 
order applicable imaging services and will be required to consult AUC 
under this program so we use ``family and general practitioner'' from 
the list of BLS occupation titles (see Table 60) to calculate the 
following cost estimates. While we proposed to modify the consultation 
requirement to allow auxiliary personnel, working under the direction 
of the ordering professional, to interact with the CDSM for AUC 
consultation, in this final rule we changed this estimate from using 
the ``registered nurse'' occupation to using the ``medical assistant'' 
occupation to calculate our revised cost estimates for our final policy 
to allow clinical staff acting under the direction of the ordering 
professional to perform the AUC consultation.
    To derive the burden associated with the requirements under Sec.  
414.94(j), we estimate it will take 2 minutes (0.033 hr) at $70.72/hr 
for auxiliary personnel in the form of a registered nurse to consult 
with a qualified CDSM. The Medicare Benefit Policy Manual (Pub. 100-
02), Chapter 15, Section 60.2 IOM 100-02, requires that an incidental 
service performed by the nonphysician practitioner must have followed 
from a direct, personal, professional service furnished by the 
physician. Therefore, to estimate the percentage of consultations 
available to be performed incident to, we analyzed 2014 Medicare Part B 
claims comparing evaluation and management visits for new (CPT codes 
99201, 99202, 99203, 99204, and 99205) relative to established (CPT 
codes 99211, 99212, 99213, 99214, 99215) patients with place of service 
codes 11 (physician's office). We found that approximately 10 percent 
of all claims incurred were for new patients. Therefore, we also 
estimate that 90 percent or 38,863,636 of the total consultations 
(43,181,818 total consultations x 0.90) will be performed by such 
auxiliary personnel, with the remaining 10 percent (43,181,818 x 0.10) 
performed by the ordering professional. In this final rule and after 
review of public comments (see below), we revised Sec.  414.94(j) to 
allow ordering professionals to delegate the AUC consultation to 
clinical staff acting under the direction of the ordering professional. 
To reflect this change, we updated our burden estimates to reflect the 
final policy and revised our estimates to replace a registered nurse 
with medical assistant to perform the AUC consultation. In aggregate, 
we estimate an annual burden of 1,282,500 hours (38,863,636.2 
consultations x 0.033 hr/consultation) at a cost of $41,424,750 
(1,282,500 hr x $32.30/hr) or $1.07 per consultation performed by 
clinical staff under the direction of the ordering professional. We 
will continue to monitor our burden estimates and, if necessary, adjust 
them for more precision once the program begins.
    Additionally, the CY 2018 Physician Fee Schedule final rule (82 FR 
52976) explicitly discussed and provided a voluntary period for 
ordering professionals to begin to familiarize themselves with 
qualified CDSMs. During the current 18-month voluntary participation 
period, we estimate there may be 10,230,000 consultations based on 
market research from current applicants for the qualification of their 
CDSMs for advanced diagnostic imaging services. Based on feedback from 
CDSMs with experience in AUC consultation, as well as standards 
recommended by the Office of the National Coordinator (ONC) \40\ and 
the Healthcare Information Management Systems Society (HIMSS),\41\ we 
estimate it will take 2 minutes (0.033 hr) at $200.54/hr for a family 
and general practitioner or 2 minutes at $32.30/hr for a medical 
assistant to use a qualified CDSM to consult specified applicable

[[Page 59992]]

AUC. The inclusion of a medical assistant in this calculation is 
reflective of our modifications in the final rule as discussed above. 
As mentioned previously, we estimate that as many as 90-percent of 
practices could use auxiliary personnel working under the direction of 
the ordering professional to interact with the CDSM for AUC 
consultation. Consequently, we estimate a total burden of 337,590 hours 
(10,230,000 consultations x 0.033 hr) at a cost of $16,583,771 
([337,590 hr x 0.10 x $200.54/hr] + [337,590 hr x 0.90 x $32.30/hr]). 
Annually, we estimate 112,530 hours (337,590 hr/3 yr) at a cost of 
$5,527,924 ($16,583,771/3 yr). We are annualizing the one-time burden 
(by dividing our estimates by OMB's 3-year approval period) since we do 
not anticipate any additional burden after the 18-month voluntary 
participation period ends.
---------------------------------------------------------------------------

    \40\ https://ecqi.healthit.gov/cds#quicktabs-tabs_cds3.
    \41\ http://www.himss.org/improving-outcomes-cds-practical-pearls-new-himss-guidebook.
---------------------------------------------------------------------------

    Beginning January 1, 2020, we anticipate 43,181,818 responses in 
the form of consultations based on the aforementioned market research, 
as well as Medicare claims data for advanced diagnostic imaging 
services. As noted earlier, we estimate it will take 2 minutes (0.033 
hr) at $200.54/hr for a family and general practitioner or 2 minutes at 
$32.30/hr for a medical assistant to use a qualified CDSM to consult 
specified applicable AUC. In aggregate, we estimate an annual burden of 
1,425,000 hours (43,181,818 consultations x 0.033 hr/consultation) at a 
cost of $70,001,700 ([0.1 x 1,425,000 hr x $200.54/hr] + [0.9 x 
1,425,000 hr x $32.30/hr]).
    Annual Reporting: Consistent with section 1834(q)(4)(B) of the Act, 
we finalized at Sec.  414.94(k) the reporting requirement of AUC 
consultation information and in the CY 2018 PFS final rule (82 FR 
52976) we estimated the burden of implementing the one-time voluntary 
reporting period beginning in July 2018, and will be implementing the 
mandatory annual reporting requirement beginning January 1, 2020. 
Specifically, Sec.  414.94(k) requires Medicare claims for advanced 
diagnostic imaging services, paid for under an applicable payment 
system (as defined in Sec.  414.94(b)) and ordered on or after January 
1, 2020, to include the following information: (1) Which qualified CDSM 
was consulted by the ordering professional; (2) whether the service 
ordered would adhere to specified applicable AUC, would not adhere to 
specified applicable AUC, or whether specified applicable AUC was not 
applicable to the service ordered; and (3) the NPI of the ordering 
professional (if different from the furnishing professional). The 
reporting requirement will not have any impact on any Medicare claim 
forms because the forms' currently approved data fields, instructions, 
and burden are not expected to change. Consequently, there is no need 
for review by OMB under the authority of the PRA; however, we have 
assessed the impact and include an analysis to this effect in the 
regulatory impact section of this final rule.
    Significant Hardship Exception: We proposed and are finalizing 
revisions to Sec.  414.94(i)(3) that provide for a significant hardship 
exception for ordering professionals who experience a significant 
hardship affecting their consultation of AUC when ordering an advanced 
diagnostic imaging service. The revisions establish a process whereby 
all ordering professionals can self-attest that they are experiencing a 
significant hardship at the time of placing an advanced diagnostic 
imaging order. Although this is not a certification being used as a 
substitute for a collection of AUC consultation information because no 
consultation is required by statute to take place, the significant 
hardship exception process consists of appending to the order for an 
applicable imaging service the significant hardship information for 
inclusion on the Medicare claim in lieu of the AUC consultation 
information. This imposes no burden beyond providing identifying 
information and attesting to the applicable information. In this 
regard, the use of this process is not ``information'' as defined under 
5 CFR 1320.3(h), and therefore, is exempt from requirements of the PRA.
    Recordkeeping: Section 1834(q)(4)(C) of the Act provides for 
certain exceptions to the aforementioned AUC consultation requirement; 
therefore we believe that some claims for advanced diagnostic imaging 
services will not contain AUC consultation information, such as in the 
case of an ordering professional with a significant hardship. However, 
ordering professionals will store documentation supporting the self-
attestation of a significant hardship. Storage of this information 
could involve the use of automated, electronic, or other forms of 
information technology at the discretion of the ordering professional. 
We estimate that the average time for office clerical activities 
associated with this storage of information to be 10 minutes (0.167 hr) 
at $34.50/hr for a medical secretary to perform 6,699 recordkeeping 
actions, since consultation will not take place in the year when a 
hardship is incurred and 2016 data from the Medicare EHR Incentive 
Program and the first 2019 payment year MIPS eligibility and special 
status file suggests this estimate of those seeking hardship (OMB 
control number 0938-1314; CMS-10621). In aggregate we estimate an 
annual burden of 1,119 hours (6,699 recordkeeping activities x 0.167 
hr/activity) at a cost of $38,596 (0.167 hr/activity x 6,699 
recordkeeping activities x $34.50/hr). We solicited comments to inform 
these burden estimates.
    The following is a summary of the comments we received regarding 
these burden estimates.
    Comment: Commenters questioned the assumptions in CMS's 
calculations as part of the proposal to modify the AUC consultation 
requirement to allow auxiliary personnel, working under the direction 
of the ordering professional, to interact with the CDSM for AUC 
consultation. These commenters suggested using the ``medical 
assistant'' rather than the ``registered nurse'' occupation to 
calculate our revised cost estimates.
    Response: As stated in this rule, we have finalized a change in the 
consulting requirement at 414.94(j) to allow ordering professionals to 
delegate the consultation to clinical staff acting under the direction 
of the ordering professional. In aggregate, we update our proposed 
estimate of an annual burden of 1,282,500 hours at a cost of 
$90,698,400 or $2.33 per consultation to an annual burden of 1,282,500 
hours (38,863,636.2 consultations x 0.033 hr/consultation) at a cost of 
$41,424,750 (1,282,500 hr x $32.30/hr) or $1.07 per consultation using 
the medical assistant occupation code 31-9092 with mean hourly wage of 
$16.15 and 100 percent fringe benefits.
    Comment: A few commenters disagreed that the reporting requirement 
will not have any impact on any Medicare claim forms. These commenters 
observed that the electronic claim standard for the institutional 
provider (837i) does not capture or have a placeholder for reporting 
the ordering physician's NPI.
    Response: We appreciate the opportunity to clarify our analysis and 
the distinctions between reporting AUC consultation information and 
standardized communications on Medicare claims forms. The X12N 
insurance subcommittee develops and maintains standards for healthcare 
administrative transactions on professional (837p), institutional 
(837i), and dental (837d) transactions when submitting healthcare 
claims for a service or encounter. The current mandated version of 837 
transactions is 5010\TM\. While we have not finalized a process for 
implementing the reporting requirements at Sec.  414.94(k), we clarify 
that implementation of changes to the

[[Page 59993]]

claim form transactions would not take place outside of the existing 
process we described.
    After considering the comments, we are updating the proposed impact 
estimate of consultations by ordering professionals. First, we modified 
our calculation of the effort by a registered nurse to the effort of a 
2-minute consultation with a qualified CDSM by a medical assistant 
(occupation code 31-9092) with mean hourly wage of $16.15 and 100 
percent fringe benefits for 90 percent of consultations (1,282,500 
hours) to be $41,424,750 (1,282,500 hours x $32.30/hour). Consequently, 
we have updated our estimated total burden during the voluntary period 
to 337,590 hours (10,230,000 consultations x 0.033 hr) at a cost of 
$16,583,771.16 ([337,590 hr x 0.10 x $200.54/hr] + [337,590 hr x 0.90 x 
$32.30/hr]). Annually, this estimate represents 112,530 hours (337,590 
hr/3 yr) at a cost of $5,527,923.72 ($16,583,771.16/3 yr). 
Additionally, we update our aggregate estimate of annual burden 
beginning January 1, 2020 of 1,425,000 hours (43,181,818 consultations 
x 0.033 hr/consultation) at a cost of $70,001,700 ([0.1 x 1,425,000 hr 
x $200.54/hr] + [0.9 x 1,425,000 hr x $32.30/hr]).
3. ICRs Regarding the Medicare Shared Savings Program (Part 425 and 
Section III.F. of This Final Rule)
    Section 1899(e) of the Act provides that chapter 35 of title 44 of 
the U.S. Code, which includes such provisions as the PRA, shall not 
apply to the Shared Savings Program.
4. ICRs Regarding the Physician Self-Referral Law (42 CFR Part 411 and 
Section III.G. of This Final Rule)
    Section 1877 of the Act, also known as the physician self-referral 
law: (1) Prohibits a physician from making referrals for certain 
designated health services (DHS) payable by Medicare to an entity with 
which he or she (or an immediate family member) has a financial 
relationship (ownership or compensation), unless an exception applies; 
and (2) prohibits the entity from filing claims with Medicare (or 
billing another individual, entity, or third party payer) for those 
referred services. The statute establishes a number of specific 
exceptions, and grants the Secretary the authority to create regulatory 
exceptions for financial relationships that pose no risk of program or 
patient abuse. Additionally, the statute mandates refunding any amount 
collected under a bill for an item or service furnished under a 
prohibited referral. Finally, the statute imposes reporting 
requirements and provides for sanctions, including civil monetary 
penalty provisions.
    As discussed in section III.G. of this rule, we are finalizing 
regulatory updates to implement section 50404 of the Bipartisan Budget 
Act of 2018 (Pub. L. 115-123, enacted February 9, 2018), which added 
provisions to section 1877(h)(1) of the Act pertaining to the writing 
and signature requirements in certain compensation arrangement 
exceptions to the physician self-referral law's referral and billing 
prohibitions. Although we believe that the newly enacted provisions in 
section 1877(h)(1) of the Act are principally intended merely to codify 
in statute existing CMS policy and regulations with respect to 
compliance with the writing and signature requirements, we are 
finalizing revisions to our regulations at 42 CFR 411.354(e) and 
411.353(g) to address any actual or perceived difference between the 
statutory and regulatory language, to codify in regulation our 
longstanding policy regarding satisfaction of the writing requirement 
found in many of the exceptions to the physician self-referral law, and 
to make the Bipartisan Budget Act of 2018 policies applicable to 
compensation arrangement exceptions issued using the Secretary's 
authority in section 1877(b)(4) of the Act. The burden associated with 
the writing and signature requirements is the time and effort necessary 
to prepare written documents and obtain signatures of the parties.
    Although the writing and signature requirements are subject to the 
PRA, we believe the associated burden is exempt under 5 CFR 
1320.3(b)(2). We believe that the time, effort, and financial resources 
necessary to comply with the writing and signature requirements will be 
incurred by persons during the normal course of their activities and in 
the absence of federal regulation. Specifically, we believe that, for 
normal business operations purposes, health care providers and 
suppliers document their financial arrangements with physicians and 
others in order to identify and be able to enforce the legal 
obligations of the parties. Therefore, we believe that the writing and 
signature requirements should be considered usual and customary 
business practices.
    We did not receive any public comments regarding our position that 
the burden associated with these requirements is a usual and customary 
business practice that is exempt from the PRA.
5. The Quality Payment Program (Part 414 and Section III.I. of This 
Final Rule)
    Summary: For the PRA, the Quality Payment Program is comprised of a 
series of ICRs associated with MIPS and Advanced APMs. The MIPS ICRs 
consist of registration for virtual groups; qualified registry and QCDR 
self-nomination; CAHPS survey vendor applications; Quality Payment 
Program Identity Management Application Process; quality performance 
category data submission by Medicare Part B claims collection type, 
QCDR and MIPS CQM collection type, eCQM collection type, and CMS web 
interface submission type; CAHPS for MIPS survey beneficiary 
participation; group registration for CMS web interface; group 
registration for CAHPS for MIPS survey; call for quality measures; 
reweighting applications for Promoting Interoperability and other 
performance categories; Promoting Interoperability performance category 
data submission; call for Promoting Interoperability measures; 
improvement activities performance category data submission; nomination 
of improvement activities; and opt-out of Physician Compare for 
voluntary participants. ICRs for Advanced APMs consist of Partial 
Qualifying APM participant (QP) election; Other Payer Advanced APM 
identification: Payer Initiated and Eligible Clinician Initiated 
Processes; and submission of data for All-Payer QP determinations under 
the All-Payer Combination Option.
    The following ICRs reflect this final rule's policies, as well as 
policies in the CY 2017 (81 FR 77008) and CY 2018 (82 FR 53568) Quality 
Payment Program final rules. In discussing each ICR, we reference the 
specific policies and whether they are finalized in this final rule or 
finalized in the CY 2017 or CY 2018 Quality Payment Program final 
rules. As described in this section in more detail, three ICRs 
(Quality: CMS Web Interface, Promoting Interoperability Performance 
Category: Data Submission, and Voluntary Participants Election to Opt-
Out of Performance Data Display on Physician Compare) show a reduction 
in burden due to changes in policies that we are finalizing in this 
final rule. Most of the burden estimates discussed in this section are 
reductions in burden compared to currently approved estimates and 
reflect adjustments due to the use of data from the 2017 MIPS 
performance period or revised per-respondent burden assumptions. 
Finally, we added one ICR to incorporate a collection previously 
mentioned in the CY 2018 Quality

[[Page 59994]]

Payment Program final rule for which collection had not yet started: 
Submission of Data for All-Payer QP Determinations (82 FR 53886). See 
section V.B.5. of this final rule for a summary of the ICRs, the 
overall burden estimates, changes in burden estimates due to policies 
established in this final rule, and a summary of the policy and data 
changes affecting each ICR.
    The revised requirements and burden estimates for all Quality 
Payment Program ICRs (except for CAHPS for MIPS and virtual groups 
election) will be submitted to OMB for approval under control number 
0938-1314 (CMS-10621). The revised CAHPS for MIPS ICRs will be 
submitted to OMB for approval under control number 0938-1222 (CMS-
10450). The Virtual Groups Election is approved under OMB control 
number 0938-1343 (CMS-10652).
    With regard to Quality Payment Program respondents, we selected BLS 
occupations Billing and Postal Clerks, Computer Systems Analysts, 
Physicians, Practice Administrator, and Licensed Practical Nurse (see 
Wage Estimates in section V.A. of this final rule) based on a study 
(Casalino et al., 2016) that collected data on the staff in physician's 
practices involved in the quality data submission process.\42\ To 
calculate the cost for virtual groups to prepare their written formal 
agreements, we used wage estimates for Legal Support Workers, All 
Others.
---------------------------------------------------------------------------

    \42\ Lawrence P. Casalino et al., ``US Physician Practices Spend 
More than $15.4 Billion Annually to Report Quality Measures,'' 
Health Affairs, 35, no. 3 (2016): 401-406.
---------------------------------------------------------------------------

    Respondent estimates for the quality, Promoting Interoperability, 
and improvement activities performance categories are modeled using 
data from the 2017 MIPS performance period with the sole exception of 
286 CMS Web Interface respondents, which is based on the number of 
groups who registered for using the CMS Web Interface during the 2018 
MIPS performance period.
    As discussed in section III.I.3.a. of this final rule, we are 
finalizing with modification our proposal to expand MIPS to additional 
clinician types starting with the 2019 MIPS performance period/2021 
MIPS payment year; these new clinician types include physical 
therapists, occupational therapists, qualified speech-language 
pathologists, qualified audiologists, clinical psychologists, and 
registered dieticians or nutrition professionals. In addition, in 
section III.I.3.c. of this final rule, we are finalizing the low-volume 
threshold in the following manner: If a MIPS eligible clinician meets 
or exceeds one, but not all, of the low-volume threshold criterion, 
including as defined by dollar amount ($90,000), beneficiary count 
(200), or covered professional services to Part-B enrolled individuals 
(minimum threshold of 200) then the clinician may elect to submit data 
and opt-in to MIPS. If a MIPS eligible clinician does not meet at least 
one of these low-volume determinations or meets at least one, but not 
all, of these low-volume determinations and elects not to opt-in, the 
clinician is not eligible and is excluded from MIPS. If the clinician 
is excluded and submits data, the clinician will be a voluntary 
reporter. These policies will expand the number of potential MIPS 
eligible clinicians, but we do not anticipate an incremental increase 
in the burden because the affected clinicians were assumed to be 
voluntary reporters in prior rules. In the CY 2018 Quality Payment 
Program final rule, clinicians who participated in 2016 PQRS, and who 
were not determined to be QPs based on their participation in Advanced 
APMs during CY 2017 and were not MIPS eligible, were assumed to be 
voluntary reporters in MIPS (82 FR 53908) with their burden accounted 
for within our estimates. Therefore, the finalized expansion in MIPS 
eligibility does not change the total number of respondents, but 
instead shifts a certain number of assumed voluntary reporters to MIPS 
eligible clinicians. Additionally, clinicians or groups agreeing to 
opt-in or voluntarily report will simply select the option of opt-in 
participation or to remain excluded and voluntarily report prior to 
submitting data; therefore, we do not believe a commensurate revision 
to the burden hours is necessary for any of our burden estimates. We 
realize that clinicians or groups in small practices who submit quality 
data via Medicare Part B claims do not have to log in the Quality 
Payment Program portal to submit data; however, we assume the 
clinicians or groups electing to opt-in would also submit data for the 
improvement activities performance category as well. Therefore, the 
effort to elect to opt-in is included in the burden estimate for the 
improvement activities performance category. We also note that third 
party intermediaries can be authorized to communicate this opt-in on 
behalf of clinicians.
    Our participation estimates are reflected in Tables 64, 65, and 66 
for the quality performance category, Table 77 for the Promoting 
Interoperability performance category, and Table 79 for the improvement 
activities performance category.
    Due to data limitations, our burden estimates may overstate the 
total burden for data submission under the quality, Promoting 
Interoperability, and improvement activities performance categories. 
This is due to two primary reasons. First, we anticipate the number of 
QPs to increase because of total expected growth in Advanced APM 
participation. The additional QPs will be excluded from MIPS and likely 
not report. Second, it is difficult to predict what eligible clinicians 
who may report voluntarily will do in the 2019 MIPS performance period 
compared to the 2017 MIPS performance period and, therefore, the actual 
number of participants and how they elect to submit data may be 
different than our estimates. However, we believe our estimates are the 
most appropriate given the available data.
    The following is a summary of general public comments received 
regarding our request for comment on our information collections and 
our responses. We received several general comments regarding the 
burden of data collection associated with the Quality Payment Program.
    Comment: One commenter requested CMS provide a table in the 
Collection of Information section of the final rule consistent with the 
summary table provided in previous years' final rules which summarizes 
annual recordkeeping and submission requirements as well as the total 
burden estimate for the cost of reporting to the Quality Payment 
Program. The commenter stated its belief that this information is 
important for policymakers to consider the total cost of pay-for-
performance programs in light of the utility of the information 
collected.
    Response: We have provided total burden summary information by OMB 
control number including the total burden estimate for the cost of 
reporting to the Quality Payment Program in the table notes for Table 
91. For more details, please refer to the Supporting Statement A of the 
Paperwork Reduction Act package for each OMB control number.
    Comment: One commenter noted that based on the burden estimates 
provided in the proposed rule as well as the additional time spent 
analyzing feedback data and implementing care improvements, clinicians 
and their staff are spending too much time and money reporting data and 
not enough time on patient care. Further, the commenter requested that 
CMS continue finalizing policies that will reduce administrative burden 
and make the Quality Payment

[[Page 59995]]

Program more cohesive, holistic, and simplified.
    Response: We will continue refining the Quality Payment Program 
with the goal of reducing administrative, operational, and reporting 
burden while balancing the goal of improving quality of care.
    After consideration of the public comments, we are not making any 
changes to our burden estimate methodology, but have updated the burden 
estimates to reflect the availability of participation data from the 
2017 MIPS performance period.
    Framework for Understanding the Burden of MIPS Data Submission: 
Because of the wide range of information collection requirements under 
MIPS, Table 61 presents a framework for understanding how the 
organizations permitted or required to submit data on behalf of 
clinicians vary across the types of data, and whether the clinician is 
a MIPS eligible clinician or other eligible clinician voluntarily 
submitting data, MIPS APM participant, or an Advanced APM participant. 
As shown in the first row of Table 61, MIPS eligible clinicians that 
are not in MIPS APMs and other clinicians voluntarily submitting data 
will submit data either as individuals, groups, or virtual groups for 
the quality, Promoting Interoperability, and improvement activities 
performance categories. Note that virtual groups are subject to the 
same data submission requirements as groups, and therefore, we will 
refer only to groups for the remainder of this section unless otherwise 
noted. Because MIPS eligible clinicians are not required to submit any 
additional information for assessment under the cost performance 
category, the administrative claims data used for the cost performance 
category is not represented in Table 61.
    For MIPS eligible clinicians participating in MIPS APMs, the 
organizations submitting data on behalf of MIPS eligible clinicians 
will vary between performance categories and, in some instances, 
between MIPS APMs. For the 2019 MIPS performance period, the quality 
data submitted by Shared Savings Program ACOs, Next Generation ACOs, 
and other APM Entities on behalf of their participant MIPS eligible 
clinicians will fulfill any MIPS submission requirements for the 
quality performance category.
    For the Promoting Interoperability performance category, group TINs 
may submit data on behalf of eligible clinicians in MIPS APMs, or 
eligible clinicians in MIPS APMs may submit data individually. For the 
improvement activities performance category, we will assume no 
reporting burden for MIPS APM participants. In the CY 2017 Quality 
Payment Program final rule, we describe that for MIPS APMs, we compare 
the requirements of the specific MIPS APM with the list of activities 
in the Improvement Activities Inventory and score those activities in 
the same manner that they are otherwise scored for MIPS eligible 
clinicians (81 FR 77185). Although the policy allows for the submission 
of additional improvement activities if a MIPS APM receives less than 
the maximum improvement activities performance category score, to date 
all MIPS APM have qualified for the maximum improvement activities 
score. Therefore, we assume that no additional submission will be 
needed.
    Advanced APM participants who are determined to be Partial QPs may 
incur additional burden if they elect to participate in MIPS, which is 
discussed in more detail in the CY 2018 Quality Payment Program final 
rule (82 FR 53841 through 53844), but other than the election to 
participate in MIPS, we do not have data to estimate that burden.

Table 61--Clinicians or Organizations Submitting MIPS Data on Behalf of Clinicians, by Type of Data and Category
                                                 of Clinician *
----------------------------------------------------------------------------------------------------------------
                                                              Type of data submitted
                                --------------------------------------------------------------------------------
                                                                                                  Other data
     Category of clinician             Quality            Promoting           Improvement        submitted on
                                     performance       interoperability       activities        behalf of MIPS
                                      category           performance          performance          eligible
                                                           category            category           clinicians
----------------------------------------------------------------------------------------------------------------
MIPS Eligible Clinicians (not    As group or         As group or          As group or         Groups electing to
 in MIPS APMs) and Other          individual          individual           individual          use a CMS-
 Eligible Clinicians              clinicians.         clinicians.          clinicians.         approved survey
 Voluntarily Submitting Data                          Clinicians who are                       vendor to
 \a\.                                                 hospital-based,                          administer CAHPS
                                                      ambulatory                               must register.
                                                      surgical center-                         Groups electing
                                                      based, non-patient                       to submit via CMS
                                                      facing, physician                        Web Interface for
                                                      assistants, nurse                        the first time
                                                      practitioners,                           must register.
                                                      clinician nurse                          Virtual groups
                                                      specialists,                             must register via
                                                      certified                                email.
                                                      registered nurse
                                                      anesthetists,
                                                      physical
                                                      therapists,
                                                      occupational
                                                      therapists,
                                                      qualified speech-
                                                      language
                                                      pathologists,
                                                      qualified
                                                      audiologists,
                                                      clinical
                                                      psychologists, and
                                                      registered
                                                      dieticians or
                                                      nutrition
                                                      professionals are
                                                      automatically
                                                      eligible for a
                                                      zero percent
                                                      weighting for the
                                                      Promoting
                                                      Interoperability
                                                      performance
                                                      category.
                                                      Clinicians who
                                                      submit an
                                                      application and
                                                      are approved for
                                                      significant
                                                      hardship or other
                                                      exceptions are
                                                      also eligible for
                                                      a zero percent
                                                      weighting.

[[Page 59996]]

 
Eligible Clinicians              ACOs submit to the  Each MIPS eligible   CMS will assign     Advanced APM
 participating in the Shared      CMS Web Interface   clinician in the     the improvement     Entities will
 Savings Program or Next          and CAHPS for       APM Entity reports   activities          make election for
 Generation ACO Model (both       ACOs on behalf of   data for the         performance         participating
 MIPS APMs).                      their               Promoting            category score to   MIPS eligible
                                  participating       Interoperability     each APM Entity     clinicians.
                                  MIPS eligible       performance          group based on
                                  clinicians.         category through     the activities
                                  [These              either group TIN     involved in
                                  submissions are     or individual        participation in
                                  not included in     reporting. [Burden   the Shared
                                  burden estimates    estimates for this   Savings
                                  for this final      final rule assume    Program.\d\ The
                                  rule because        group TIN-level      burden estimates
                                  quality data        reporting].\c\       for this final
                                  submission to                            rule assume no
                                  fulfill                                  improvement
                                  requirements of                          activity
                                  the Shared                               reporting burden
                                  Savings Program                          for APM
                                  and for purposes                         participants
                                  of testing and                           because we assume
                                  evaluating the                           the MIPS APM
                                  Next Generation                          model provides a
                                  ACO Model are not                        maximum
                                  subject to the                           improvement
                                  PRA].\b\                                 activity
                                                                           performance
                                                                           category score.].
Eligible Clinicians              APM Entities        Each MIPS eligible   CMS will assign     Advanced APM
 participating in Other MIPS      submit to MIPS on   clinician in the     the same            Entities will
 APMs.                            behalf of their     APM Entity reports   improvement         make election for
                                  participating       data for the         activities          participating
                                  MIPS eligible       Promoting            performance         eligible
                                  clinicians.         Interoperability     category score to   clinicians.
                                  [These              performance          each APM Entity
                                  submissions are     category through     based on the
                                  not included in     either group TIN     activities
                                  burden estimates    or individual        involved in
                                  for this final      reporting. [The      participation in
                                  rule because        burden estimates     the MIPS APM.
                                  quality data        for this final       [The burden
                                  submission for      rule assume group    estimates for
                                  purposes of         TIN-level            this final rule
                                  testing and         reporting].          assume no
                                  evaluating                               improvement
                                  Innovation Center                        activities
                                  models tested                            performance
                                  under Section                            category
                                  1115A of the                             reporting burden
                                  Social Security                          for APM
                                  Act (or Section                          participants
                                  3021 of the                              because we assume
                                  Affordable Care                          the MIPS APM
                                  Act) are not                             model provides a
                                  subject to the                           maximum
                                  PRA].                                    improvement
                                                                           activity score].
----------------------------------------------------------------------------------------------------------------
* Because the cost performance category relies on administrative claims data, MIPS eligible clinicians are not
  required to provide any additional information, and therefore, the cost performance category is not
  represented in this table.
\a\ Virtual group participation is limited to MIPS eligible clinicians, specifically, solo practitioners and
  groups consisting of 10 eligible clinicians or fewer.
\b\ Sections 1899 and 1115A of the Act (42 U.S.C. 1395jjj and 42 U.S.C. 1315a, respectively) state the Shared
  Savings Program and testing, evaluation, and expansion of Innovation Center models are not subject to the PRA.
\c\ Both group TIN and individual clinician Promoting Interoperability data will be accepted. If both group TIN
  and individual scores are available for the same APM Entity, CMS will use the higher score for each TIN/NPI.
  The TIN/NPI scores are then aggregated for purposes of calculating the APM Entity score.
\d\ APM Entities participating in MIPS APMs do not need to submit improvement activities data unless the CMS-
  assigned improvement activities scores are below the maximum improvement activities score.

    The policies finalized in the CY 2017 and the CY 2018 Quality 
Payment Program final rules and this final rule create some additional 
data collection requirements not listed in Table 61. These additional 
data collections, some of which were previously approved by OMB under 
the control numbers 0938-1314 (Quality Payment Program) and 0938-1222 
(CAHPS for MIPS), are as follows:

Additional approved ICRs related to MIPS third-party intermediaries
     Self-nomination of new and returning QCDRs (81 FR 77507 
through 77508 and 82 FR 53906 through 53908) (OMB 0938-1314).
     Self-nomination of new and returning registries (81 FR 
77507 through 77508 and 82 FR 53906 through 53908) (OMB 0938-1314).
     Approval process for new and returning CAHPS for MIPS 
survey vendors (82 FR 53908) (OMB 0938-1222).

Additional ICRs related to the data submission and the quality 
performance category
     CAHPS for MIPS survey completion by beneficiaries (81 FR 
77509 and 82 FR 53916 through 53917) (OMB 0938-1222).
     Quality Payment Program Identity Management Application 
Process (82 FR 53914).

Additional ICRs related to the Promoting Interoperability performance 
category
     Reweighting Applications for Promoting Interoperability 
and other performance categories (82 FR 53918) (OMB 0938-1314).

Additional ICRs related to call for new MIPS measures and activities
     Nomination of improvement activities (82 FR 53922) (OMB 
0938-1314).

[[Page 59997]]

     Call for new Promoting Interoperability measures (OMB 
0938-1314).
     Call for new quality measures (OMB 0938-1314).

Additional ICRs related to MIPS
     Opt out of performance data display on Physician Compare 
for voluntary reporters under MIPS (82 FR 53924 through 53925) (OMB 
0938-1314).

Additional ICRs related to APMs
     Partial QP Election (81 FR 77512 through 77513 and 82 FR 
53922 through 53923) (OMB 0938-1314).
     Other Payer Advanced APM determinations: Payer Initiated 
Process (82 FR 53923 through 53924) (OMB 0938-1314).
     Other Payer Advanced APM determinations: Eligible 
Clinician Initiated Process (82 FR 53924) (OMB 0938-1314).
     Submission of Data for All-Payer QP Determinations (New 
data collection for the 2019 performance period) (OMB 0938-1314).
6. Quality Payment Program ICRs Regarding the Virtual Group Election 
(Sec.  414.1315)
    This final rule does not include any new or revised reporting, 
recordkeeping, or third-party disclosure requirements related to the 
virtual group election. The virtual group election requirements and 
burden are currently approved by OMB under control number 0938-1343 
(CMS-10652). Consequently, we have not made any virtual group election 
changes under that control number.
7. Quality Payment Program ICRs Regarding Third-Party Intermediaries 
(Sec.  414.1400)
    Under MIPS, the quality, Promoting Interoperability, and 
improvement activities performance category data may be submitted via 
relevant third-party intermediaries, such as qualified registries, 
QCDRs, and health IT vendors. Data on the CAHPS for MIPS survey, which 
counts as one quality performance category measure, or can be used for 
completion of an improvement activity, can be submitted via CMS-
approved survey vendors. In the CY 2018 Quality Payment Program final 
rule, we combined the burden for self-nomination of qualified 
registries and QCDRs (82 FR 53906). For this final rule, we determined 
that requirements for self-nomination for qualified registries were 
sufficiently different from QCDRs that it is necessary to estimate the 
two independently. The change will align the burden more closely to the 
requirements for QCDRs and qualified registries to self-nominate, not 
because of any change in policy in this final rule, but because of 
changes in our initial assumptions. Specifically, while the processes 
for self-nomination are similar, QCDRs have the option to submit QCDR 
measures for the quality performance category. Therefore, differences 
between QCDRs and registries self-nomination are associated with the 
preparation of QCDR measures for approval. The burden associated with 
qualified registry self-nomination, QCDR self-nomination, and the CAHPS 
for MIPS survey vendor applications follow:
    Qualified Registry Self-Nomination: The requirements and burden 
associated with qualified registry self-nomination will be submitted to 
OMB for approval under control number 0938-1314 (CMS-10621).
    Qualified registries interested in submitting MIPS data to us on 
their participants' behalf need to complete a self-nomination process 
to be considered qualified to submit on behalf of MIPS eligible 
clinicians or groups (82 FR 53815).
    In the CY 2018 Quality Payment Program final rule, previously 
approved qualified registries in good standing (that are not on 
probation or disqualified) that wish to self-nominate using the 
simplified process can attest, in whole or in part, that their 
previously approved form is still accurate and applicable (82 FR 
53815). In the same rule, qualified registries in good standing that 
would like to make minimal changes to their previously approved self-
nomination application from the previous year, may submit these 
changes, and attest to no other changes from their previously approved 
qualified registry application for CMS review during the self-
nomination period, from September 1 to November 1 (82 FR 53815). This 
simplified self-nomination process will begin for the 2019 MIPS 
performance period.
    The CY 2017 Quality Payment Program final rule provided the 
definition of a qualified registry to be a medical registry, a 
maintenance of certification program operated by a specialty body of 
the American Board of Medical Specialties or other data intermediary 
that, with respect to a particular performance period, has self-
nominated and successfully completed a vetting process (as specified by 
CMS) to demonstrate its compliance with the MIPS qualification criteria 
specified by CMS for that performance period (81 FR 77382).
    For this final rule, we have adjusted the number of respondents 
(from 120 to 150) based on more recent data and a revised definition of 
``respondent'' to account for self-nomination applications received but 
not approved. We have also adjusted our per respondent time estimate 
(from 10 hours to 3 hours) based on our review of the current burden 
estimates against the existing policy. Finally, we have provided a 
range of time estimates (from 10 hours to 0.5 hours) which reflect the 
availability of a simplified self-nomination process for previously 
approved qualified registries.
    For the 2017 MIPS performance period, we received 138 applications 
for nomination to be a qualified registry and 145 applications for the 
2018 MIPS performance period. In continuance of this trend for the 2019 
MIPS performance period, we estimate 150 nomination applications will 
be received from qualified registries desiring approval to report MIPS 
data, an increase of 30 respondents from our currently approved 
estimate.
    For this final rule, the burden associated with qualified registry 
self-nomination will vary depending on the number of existing qualified 
registries that will elect to use the simplified self-nomination 
process in lieu of the full self-nomination process as described in the 
CY 2018 Quality Payment Program final rule (82 FR 53815). The self-
nomination form is submitted electronically using the web-based tool 
JIRA. For the 2018 MIPS performance period, 141 qualified registries 
were approved to submit MIPS data.
    In section III.I.3.k.(3)(a) of this final rule, we have finalized 
our proposal to modify the definition of a QCDR to be an entity with 
clinical expertise in medicine and in quality measurement development 
that collects medical or clinical data on behalf of a MIPS eligible 
clinician for the purpose of patient and disease tracking to foster 
improvement in the quality of care provided to patients. This revised 
definition of a QCDR may result in previously approved QCDRs who no 
longer meet the new definition to decide to instead seek approval as 
qualified registries. However, we have not received any notifications 
of intent and do not have data to support changing our estimate of 150 
qualified registries who will submit applications during the self-
nomination period for the CY 2020 performance period.
    In the CY 2018 Quality Payment Program final rule, we estimated the 
burden associated with self-nomination of a qualified registry to be 10 
hours, similar to PQRS (82 FR 53907). For this final rule, we reduced 
our estimate to 3 hours because registries no longer provide an XML 
submission, calculated measure, or measure flow as part of the

[[Page 59998]]

self-nomination process and are not subject to a mandatory interview, 
which were done previously as part of the PQRS qualified registry self-
nomination process, upon which the previous assumption of 10 hours was 
based. As described in the CY 2017 Quality Payment Program final rule, 
the full self-nomination process requires the submission of basic 
information, a description of the process the qualified registry will 
use for completion of a randomized audit of a subset of data prior to 
submission, and the provision of a data validation plan along with the 
results of the executed data validation plan by May 31 of the year 
following the performance period (81 FR 77383 through 77384).
    For the simplified self-nomination process, we have estimated 0.5 
hours per qualified registry to submit a nomination, a reduction of 9.5 
hours from currently approved estimates.
    As shown in Table 62, we estimate that the staff involved in the 
qualified registry self-nomination process will be mainly computer 
systems analysts or their equivalent, who have an adjusted labor cost 
of $89.18/hour. Assuming that the time associated with the self-
nomination process ranges from a minimum of 0.5 hours (for the 
simplified self-nomination process) to 3 hours (for the full self-
nomination process) per qualified registry, we estimate that the annual 
burden will range from 97.5 hours ([141 qualified registries x 0.5 hr] 
+ [9 qualified registries x 3 hr]) to 450 hours (150 qualified 
registries x 3 hr) at a cost ranging from $8,695 (97.5 hr x $89.18/hr) 
to $40,131 (450 hr x $89.18/hr), respectively (see Table 62).
    Independent of the change to our per response time estimate, the 
increase in the number of respondents results in an adjustment of 300 
hours and $26,754 (30 registries x 10 hr x $89.18/hr). Accounting for 
the change in the number of qualified registries, the change in time 
per qualified registry to self-nominate results in an adjustment of 
between -1,402.5 hours and -125,075 ([(141 registries x -9.5 hr)] + [(9 
registries x -7 hr)] at $89.18/hr) and -1,050 hours and -$93,639 (150 
registries x -7 hr x $89.18/hr). When these two adjustments are 
combined, the net impact ranges between -1,102.5 (-1,402.5 + 300) and -
750 (-1,050 + 300) hours and -$98,321 (-$125,075 + $26,754) and -
$66,885 (-$93,639 + $26,754).
    Qualified registries must comply with requirements on the 
submission of MIPS data to CMS. The burden associated with the 
qualified registry submission requirements will be the time and effort 
associated with calculating quality measure results from the data 
submitted to the qualified registry by its participants and submitting 
these results, the numerator and denominator data on quality measures, 
the Promoting Interoperability performance category, and improvement 
activities data to us on behalf of their participants. These 
requirements are currently approved by OMB under control number 0938-
1314 (CMS-10621).
    We expect that the time needed for a qualified registry to 
accomplish these tasks will vary along with the number of MIPS eligible 
clinicians submitting data to the qualified registry and the number of 
applicable measures. However, we believe that qualified registries 
already perform many of these activities for their participants. We 
believe the estimates discussed earlier and shown in Table 62 
represents the upper bound of registry burden, with the potential for 
less additional MIPS burden if the registry already provides similar 
data submission services.
    Based on the assumptions previously discussed, we provide an 
estimate of the total annual burden associated with a qualified 
registry self-nominating to be considered ``qualified'' to submit 
quality measures results and numerator and denominator data on MIPS 
eligible clinicians.

    Table 62--Estimated Burden for Qualified Registry Self-Nomination
------------------------------------------------------------------------
                                          Minimum burden  Maximum burden
------------------------------------------------------------------------
Number of Qualified Registry Simplified              141               0
 Self-Nomination Applications submitted
 (a)....................................
Number of Qualified Registry Full Self-                9             150
 Nomination Applications submitted (b)..
Total Annual Hours Per Qualified                     0.5             0.5
 Registry for Simplified Process (c)....
Total Annual Hours Per Qualified                       3               3
 Registry for Full Process (d)..........
                                         -------------------------------
    Total Annual Hours for Qualified                97.5             450
     Registries (e) = (a) * (c) + (b) *
     (d)................................
                                         -------------------------------
Cost Per Simplified Process Per Registry          $44.59          $44.59
 (@computer systems analyst's labor rate
 of $89.18/hr.) (f).....................
Cost Per Full Process Per Registry               $267.54         $267.54
 (@computer systems analyst's labor rate
 of $89.18/hr.) (g).....................
                                         -------------------------------
    Total Annual Cost for Qualified               $8,695         $40,131
     Registries (h) = (a) * (f) + (b) *
     (g)................................
------------------------------------------------------------------------

    Both the minimum and maximum burden shown in Table 62 will be 
submitted for approval to OMB under control number 0938-1314 (CMS-
10621) and reflect adjustments due to review of self-nomination process 
and the number of respondents. For purposes of calculating total burden 
associated with the final rule as shown in Table 89, only the maximum 
burden is used.
    We received no public comments related to the burden estimates for 
qualified registry self-nomination. The burden estimates have not been 
updated from the CY 2019 PFS proposed rule (83 FR 36016 through 36018).
    QCDR Self-Nomination: \43\ The requirements and burden associated 
with QCDR self-nomination will be submitted to OMB for approval under 
control number 0938-1314 (CMS-10621).
---------------------------------------------------------------------------

    \43\ We do not anticipate any changes in the CEHRT process for 
health IT vendors as we transition to MIPS. Hence, health IT vendors 
are not included in the burden estimates for MIPS.
---------------------------------------------------------------------------

    QCDRs interested in submitting quality, Promoting Interoperability, 
and improvement activities performance category data to us on their 
participants' behalf will need to complete a self-nomination process to 
be considered qualified to submit on behalf of MIPS eligible clinicians 
or groups.
    In the CY 2018 Quality Payment Program final rule, previously 
approved QCDRs in good standing (that are not on probation or 
disqualified) that wish to self-nominate using the simplified process 
can attest, in whole or in part, that their previously approved form is 
still accurate and applicable (82 FR 53808). Existing QCDRs in good 
standing that would like to make minimal changes to their previously 
approved self-nomination application

[[Page 59999]]

from the previous year, may submit these changes, and attest to no 
other changes from their previously approved QCDR application, for CMS 
review during the self-nomination period, from September 1 to November 
1 (82 FR 53808). This simplified self-nomination process will begin for 
the 2019 MIPS performance period.
    For this final rule, the burden associated with QCDR self-
nomination will vary depending on the number of existing QCDRs that 
will elect to use the simplified self-nomination process in lieu of the 
full self-nomination process as described in the CY 2018 Quality 
Payment Program final rule (82 FR 53808 through 53813). The self-
nomination form is submitted electronically using the web-based tool 
JIRA. For the 2018 MIPS performance period, 150 QCDRs were approved to 
submit MIPS data.
    For this CY 2019 Quality Payment Program final rule, we have 
adjusted the number of respondents (from 113 to 200) based on more 
recent data and a revised definition of ``respondent'' to account for 
self-nomination applications received but not approved. We have also 
adjusted the time burden estimates per respondent based on our review 
of the current burden estimates against the existing policy as well as 
provided a range of time burden estimates which reflect the 
availability of a simplified self-nomination process for previously 
approved QCDRs.
    For the 2017 MIPS performance period, we received 138 self-
nomination applications from QCDRs and for the 2018 MIPS performance 
period, we received 176 self-nomination applications. In continuance of 
this trend for the 2019 MIPS performance period, we estimate 200 self-
nomination applications will be received from QCDRs desiring approval 
to report MIPS data, an increase of 87 respondents.
    In section III.I.3.k.(3)(a) of this final rule, we have finalized 
our proposal to modify the definition of a QCDR to be an entity with 
clinical expertise in medicine and in quality measurement development 
that collects medical or clinical data on behalf of a MIPS eligible 
clinician for the purpose of patient and disease tracking to foster 
improvement in the quality of care provided to patients. This revised 
definition of a QCDR may result in previously approved QCDRs who no 
longer meet the new definition to decide to instead seek approval as 
qualified registries or collaborate with another previously approved 
QCDR to meet the requirements of the new definition. However, we have 
not received any notifications of intent and do not have data to 
support changing our estimate of 200 QCDRs who will submit applications 
during the self-nomination period for the CY 2020 performance period. 
In addition, we have not accounted for any costs associated with QCDRs 
collaborating to meet the requirements of the new definition as 
electing to do so would be a business decision made by individual 
entities which is not required or endorsed by CMS and considering the 
alternate path of seeking to be a qualified registry would be available 
for entities seeking to continue participating in MIPS.
    We estimate that the self-nomination process for QCDRs to submit on 
behalf of MIPS eligible clinicians or groups for MIPS will involve 
approximately 3 hours per QCDR to submit information required at the 
time of self-nomination as described in the CY 2017 Quality Payment 
Program final rule including basic information about the QCDR, 
describing the process it will use for completion of a randomized audit 
of a subset of data prior to submission, providing a data validation 
plan, and providing results of the executed data validation plan by May 
31 of the year following the performance period (81 FR 77383 through 
77384). However, for the simplified self-nomination process, we 
estimate 0.5 hours per QCDR to submit this information. The 
aforementioned modification to the definition of a QCDR is not expected 
to affect the estimated time for submitting the full or simplified 
self-nomination. The self-nomination form is submitted electronically 
using the web-based tool JIRA.
    In addition, QCDRs calculate their measure results. QCDRs must 
possess benchmarking capabilities (for QCDR measures) that compare the 
quality of care a MIPS eligible clinician provides with other MIPS 
eligible clinicians performing the same quality measures. For QCDR 
measures, the QCDR must provide to us, if available, data from years 
prior (for example, 2017 data for the 2019 MIPS performance period) 
before the start of the performance period. In addition, the QCDR must 
provide to us, if available, the entire distribution of the measure's 
performance broken down by deciles. As an alternative to supplying this 
information to us, the QCDR may post this information on their website 
prior to the start of the performance period, to the extent permitted 
by applicable privacy laws. The time it takes to perform these 
functions may vary depending on the sophistication of the entity, but 
we estimate that a QCDR will spend an additional 1 hour performing 
these activities per measure and assume that each QCDR will submit 
information for 9 QCDR measures, for a total burden of 9 hours per QCDR 
(1 hr per measure x 9 measures). The estimated average of 9 measures 
per QCDR is based on the number of QCDR measure submissions received in 
the 2017 and 2018 MIPS performance periods and is the same for each 
QCDR regardless of whether they elect to use the simplified or full 
self-nomination process.
    In the 2017 MIPS performance period, we received over 1,000 QCDR 
measure submissions. In the 2018 MIPS performance period, we received 
over 1,400 QCDR measure submissions. For the 2019 MIPS performance 
period, we anticipate this trend will continue, and therefore, estimate 
we will receive a total of approximately 1,800 QCDR measure 
submissions, resulting in an average of 9 measure submissions per QCDR 
(1,800 measure submissions/200 QCDRs).
    In the CY 2018 Quality Payment Program final rule, the burden 
associated with self-nomination of a QCDR was estimated to be 10 hours 
(82 FR 53907). For this final rule, we are increasing the burden 
associated with self-nomination to 12 hours. Because QCDRs are no 
longer required to provide an XML submission and are not subject to a 
mandatory interview; both of which were completed as part of the PQRS 
QCDR self-nomination process upon which the previous assumption of 10 
hours was based, we are eliminating 1 hour from our previous burden 
assumption. Simultaneously, we are increasing our burden assumption by 
3 hours to account for an increase in the number of QCDR measure 
submissions being submitted. These two adjustments result in a net 
increase of 2 hours per respondent from our previously approved burden 
estimates.
    As shown in Table 63, we estimate that the staff involved in the 
QCDR self-nomination process will continue to be computer systems 
analysts or their equivalent, who have an average labor cost of $89.18/
hr. Assuming that the hours per QCDR associated with the self-
nomination process ranges from a minimum of 9.5 hours (for the 
simplified self-nomination process) to 12 hours (for the full self-
nomination process), we estimate that the annual burden will range from 
2,025 hours ([150 QCDRs x 9.5 hr] + [50 QCDRs x 12 hr]) to 2,400 hours 
(200 QCDRs x 12 hr) at a cost ranging between $180,590 (2,025 hr x 
$89.18/hr) and $214,032 (2,400 hr x $89.18/hr), respectively (see Table 
63).
    Independent of the change to our per response time estimate, the 
increase in the number of respondents results in an

[[Page 60000]]

adjustment of 870 hours and $77,587 (87 registries x 10 hr x $89.18/
hr). Accounting for the change in the number of qualified registries, 
the change in time per QCDR to self-nominate results in an adjustment 
of between 25 hours and $2,230 ([150 registries x -0.5 hr] + [50 
registries x 2 hr] at $89.18/hr) and 400 hours and $35,672 (200 
registries x 2 hr x $89.18/hr). When these two adjustments are 
combined, the net impact ranges between 895 (870 + 25) hours at $79,817 
($77,587 + $2,230) and 1,270 (870 + 400) hours at $113,259 ($77,587 + 
$35,672).
    QCDRs must comply with requirements on the submission of MIPS data 
to CMS. The burden associated with the QCDR submission requirements 
will be the time and effort associated with calculating quality measure 
results from the data submitted to the QCDR by its participants and 
submitting these results, the numerator and denominator data on quality 
measures, the Promoting Interoperability performance category, and 
improvement activities data to us on behalf of their participants. 
These requirements are currently approved by OMB under control number 
0938-1314 (CMS-10621). We expect that the time needed for a QCDR to 
accomplish these tasks will vary along with the number of MIPS eligible 
clinicians submitting data to the QCDR and the number of applicable 
measures. However, we believe that QCDRs already perform many of these 
activities for their participants. We believe the estimate noted in 
this section represents the upper bound of QCDR burden, with the 
potential for less additional MIPS burden if the QCDR already provides 
similar data submission services.
    We finalized in the CY 2018 Quality Payment Program final rule that 
QCDR vendors may seek permission from another QCDR to use an existing 
measure that is owned by the other QCDR (82 FR 53813). However, some 
QCDR measure stewards charge a fee for the use of their QCDR measures. 
We have not accounted for QCDR measure licensing costs as part of our 
burden estimate due to the election to license a QCDR measure being a 
business decision made by individual QCDRs which is not required or 
endorsed by CMS for participation in MIPS.
    Based on the assumptions previously discussed, we provide an 
estimate of the total annual burden associated with a QCDR self-
nominating to be considered ``qualified'' to submit quality measures 
results and numerator and denominator data on MIPS eligible clinicians.

           Table 63--Estimated Burden for QCDR Self-Nomination
------------------------------------------------------------------------
                                          Minimum burden  Maximum burden
------------------------------------------------------------------------
Number of QCDR Simplified Self-                      150               0
 Nomination Applications submitted (a)..
Number of QCDR Full Self-Nomination                   50             200
 Applications submitted (b).............
Total Annual Hours Per QCDR for                      9.5             9.5
 Simplified Process (c).................
Total Annual Hours Per QCDR for Full                  12              12
 Process (d)............................
                                         -------------------------------
    Total Annual Hours for QCDRs (e) =             2,025           2,400
     (a) * (c) + (b) * (d)..............
                                         -------------------------------
Cost Per Simplified Process Per QCDR             $847.21         $847.21
 (@computer systems analyst's labor rate
 of $89.18/hr.) (f).....................
Cost Per Full Process Per QCDR                 $1,070.16       $1,070.16
 (@computer systems analyst's labor rate
 of $89.18/hr.) (g).....................
                                         -------------------------------
    Total Annual Cost for QCDRs (h) =           $180,590        $214,032
     (a) * (f) + (b) * (g)..............
------------------------------------------------------------------------

    Both the minimum and maximum burden shown in Table 63 will be 
submitted for approval to OMB under control number 0938-1314 (CMS-
10621) and reflect adjustments due to the review of self-nomination 
process and the number of respondents. For purposes of calculating 
total burden associated with the final rule as shown in Table 89, only 
the maximum burden will be used.
    We received no public comments related to the burden estimates for 
QCDR self-nomination. The burden estimates have not been updated from 
the CY 2019 PFS proposed rule (83 FR 36018 through 36019), however we 
have provided additional elaboration on the updated requirements for 
QCDRs electing to self-nominate and our rationale for why the burden 
estimates do not require additional revision.
    CMS-Approved CAHPS for MIPS Survey Vendors: This rule does not 
include any new or revised reporting, recordkeeping, or third-party 
disclosure requirements related to CMS-approved CAHPS for MIPS survey 
vendors. The CMS-approved CAHPS for MIPS survey vendor requirements and 
burden are currently approved by OMB under control number 0938-1222 
(CMS-10450). Consequently, we have not made any MIPS survey vendor 
changes under that control number.
8. Quality Payment Program ICRs Regarding Data Submission (Sec. Sec.  
414.1325 and 414.1335)
    Under our current policies, two groups of clinicians will submit 
quality data under MIPS: Those who submit as MIPS eligible clinicians 
and other eligible clinicians who opt to submit data voluntarily but 
will not be subject to MIPS payment adjustments. Although the finalized 
expansion of the definition of a MIPS eligible clinician to new 
clinician types and the opt-in process for MIPS participation discussed 
in sections III.I.3.a and III.I.3.c.(6) of this final rule could affect 
respondent counts, all of the new potential respondents had the 
opportunity to participate in PQRS and as a voluntary reporter in MIPS. 
Therefore, consistent with our assumptions in the CY 2017 and CY 2018 
Quality Payment Program final rules that PQRS participants that are not 
QPs will have participated in MIPS as voluntary respondents (81 FR 
77501 and 82 FR 53908, respectively), we anticipate that this rule's 
finalized expansion of the definition of a MIPS eligible clinician will 
not have any incremental effect on any of our currently approved burden 
estimates. For the purpose of the following analyses, we assume that 
clinicians who participated in MIPS and who are not QPs in Advanced 
APMs in the 2017 MIPS performance period will continue to submit 
quality data in the 2019 MIPS performance period. We assume that 100 
percent of APM Entities in MIPS APMs will submit quality data to CMS as 
required under their models. We estimate a total of 964,246 clinicians 
participated as individuals or groups in the 2017 MIPS performance 
period; this number differs from the currently approved estimate (OMB 
0938-1314, CMS-10621) of 758,267 due to the availability of updated 
data.

[[Page 60001]]

    As discussed in section III.I.3.h.(1)(b) of this final rule, we are 
replacing the term ``submission mechanism'' with the terms ``collection 
type'' and ``submission type.'' ``Submission mechanism'' is presently 
used to refer not only to the mechanism by which data is submitted, but 
also to certain types of measures and activities on which data are 
submitted to the entities submitting such data in the Quality Payment 
Program.
    We assume that clinicians and groups will continue to submit 
quality data for the same collection types they used during the CY 2017 
performance period. In addition, we assume that the 80 TINs that elect 
to form 16 virtual groups will continue to collect and submit MIPS data 
using the same collection and submission types as they did during the 
2017 MIPS performance period, but the submission will be at the virtual 
group, rather than group level. Our burden estimates for the quality 
performance category do not include the burden for the quality data 
that APM Entities submit to fulfill the requirements of their models. 
The burden is excluded as sections 1899(e) and 1115A(d)(3) of the Act 
(42 U.S.C. 1395jjj(e) and 1315a(d)(3), respectively) state the Shared 
Savings Program and the testing, evaluation, and expansion of 
Innovation Center models tested under section 1115A of the Act (or 
section 3021 of the Affordable Care Act) are not subject to the 
PRA.\44\ Tables 64, 65, and 66 explain our revised estimates of the 
number of organizations (including groups, virtual groups, and 
individual MIPS eligible clinicians) submitting data on behalf of 
clinicians segregated by collection type.
---------------------------------------------------------------------------

    \44\ Our estimates do reflect the burden on MIPS APM 
participants of submitting Promoting Interoperability performance 
category data, which is outside the requirements of their models.
---------------------------------------------------------------------------

    Table 64 provides our estimated counts of clinicians that will 
submit quality performance category data as MIPS individual clinicians 
or groups in the 2019 MIPS performance period based on data from the 
2017 MIPS performance period.
    For the 2019 MIPS performance period, respondents will have the 
option to submit quality performance category data via Medicare Part B 
claims, direct, and log in and upload submission types, and CMS Web 
Interface. At the time of the CY 2019 PFS proposed rule, participation 
data by submission type and user research data to inform burden 
assumptions was not available to estimate burden by submission type. As 
a result, we estimate the burden for collecting data via collection 
type: Claims, QCDR and MIPS CQMs, eCQMs, and the CMS Web Interface. 
While we have more information about MIPS submissions, for this final 
rule, we believe it is important to continue to estimate burden by 
collection type because the public was able to comment on our 
assumptions using this framework. As we gain more experience with the 
program, we may revise this approach through future rulemaking.
    For the Medicare Part B claims collection type, in section 
III.I.3.h.(1)(b) of this rule, we finalized limiting the Medicare Part 
B claims collection type to small practices beginning with the 2021 
MIPS payment year and allowing clinicians in small practices to report 
Medicare Part B claims as a group or as individuals. We assumed in our 
currently approved burden analysis that any clinician that submits 
quality data codes to us for the Medicare Part B claims collection type 
is intending to do so for the Quality Payment Program. We made this 
assumption originally in the CY 2017 Quality Payment Program final rule 
to ensure that we fully accounted for any burden that may have resulted 
from our policies (81 FR 77501 through 77504). In some cases, however, 
clinicians may be submitting quality data codes not only for the 
Medicare Part B claims collection type, but also for MIPS CQM and QCDR 
collection types. Some registries and QCDRs utilize data from claims to 
populate their datasets when submitting on behalf of clinicians. We are 
not able to separate out when a clinician submits a quality data code 
solely for the Medicare Part B claim collection type or when a 
clinician is also submitting these codes for MIPS CQM or QCDR 
collection types. In addition, we see a large number of voluntary 
reporters for the Medicare Part B claims collection type. Approximately 
70 percent of the 257,260 clinicians we estimate will submit quality 
data via Medicare Part B claims (see Table 64) are MIPS eligible 
clinicians while the other 30 percent are voluntary reporters which 
means our burden include estimates for a large number of voluntary 
reporters. Of these clinicians who are not scored as part of an APM, 
approximately 55 percent are in practices with more than 15 clinicians; 
however, over 91 percent of the number in practices larger than 15 
clinicians are either voluntary reporters, group reporters, or are also 
reporting quality data through another collection type. Approximately 
10,700 individual clinicians in non-small practices are both MIPS 
eligible and scored based only on Medicare Part B claims data and of 
these, 52 percent also qualify for facility-based reporting, and 
therefore, will not be required to submit quality data in order to 
receive facility-based quality and cost scores. It is unclear why many 
clinicians are submitting quality data via an alternate collection 
type, and we currently lack data to accurately estimate both the number 
of clinicians who will be impacted by these finalized policies and the 
potential behavioral response of those clinicians who will be required 
to switch to another collection type. As a result, we will continue 
using the assumption that all clinicians (except QPs) who submitted 
data via the Medicare Part B claims collection type in the 2017 MIPS 
performance period will continue to do so for MIPS in order to avoid 
overstating the impact of the change. We intend to update this burden 
estimate with additional data as it becomes available. We solicited 
comment on potential other assumptions for capturing the Medicare Part 
B claims burden, but no comments were received.
    Using our revised terminology, clinicians who used a QCDR or 
Registry will now collect measures via QCDR or MIPS CQM collection 
type; clinicians who used the EHR submission type will elect the eCQM 
collection type, and groups that elected the CMS Web Interface for MIPS 
will continue to elect the CMS Web Interface for MIPS.
    Table 64 shows that in the 2019 MIPS performance period, an 
estimated 257,260 clinicians will submit data as individuals for the 
Medicare Part B claims collection type; 324,693 clinicians will submit 
data as individuals or as part of groups for the MIPS CQM or QCDR 
collection types; 243,062 clinicians will submit data as individuals or 
as part of groups via eCQM collection types; and 139,231 clinicians 
will submit as part of groups via the CMS Web Interface.
    Table 64 provides estimates of the number of clinicians to collect 
quality measures data via each collection type, regardless of whether 
they decide to submit as individual clinicians or as part of groups. 
Because our burden estimates for quality data submission assume that 
burden is reduced when clinicians elect to submit as part of a group, 
we also separately estimate the expected number of clinicians to submit 
as individuals or part of groups.

[[Page 60002]]



    Table 64--Estimated Number of Clinicians Submitting Quality Performance Category Data by Collection Type
----------------------------------------------------------------------------------------------------------------
                                   Medicare Part                                      CMS web
                                     B claims      QCDR/MIPS CQM       eCQM          interface         Total
----------------------------------------------------------------------------------------------------------------
Number of clinicians to collect          257,260         324,693         243,062         139,231         964,246
 data by collection type (as
 individual clinicians or
 groups) in Quality Payment
 Program Year 3 (excludes QPs)
 (a)............................
* Number of clinicians to                278,039         255,228         131,133          93,867         758,267
 collect data by collection type
 (as individual clinicians or
 groups) in Quality Payment
 Program Year 2 (excludes QPs)
 (b)............................
Difference between Year 3 and            -20,779         +69,465        +111,929         +45,364        +205,979
 Year 2 (c) = (a) - (b).........
----------------------------------------------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).

    In the CY 2018 Quality Payment Program final rule (82 FR 53625 
through 53626), beginning with the 2019 MIPS performance period, we 
allowed MIPS eligible clinicians to submit data for multiple collection 
types for a single performance category. Therefore, we captured the 
burden of any eligible clinician that may have historically collected 
via multiple collection types, as we assume they will continue to 
collect via multiple collection types and that our MIPS scoring 
methodology will take the highest score where the same measure is 
submitted via multiple collection types. Hence, the estimated numbers 
of individual clinicians and groups to collect via the various 
collection types are not mutually exclusive and reflect the occurrence 
of individual clinicians or groups that collected data via multiple 
collection types during the MIPS 2017 performance period.
    Table 65 uses methods similar to those described for Table 64 to 
estimate the number of clinicians that will submit data as individual 
clinicians via each collection type in the 2019 MIPS performance 
period. We estimate that approximately 257,260 clinicians will submit 
data as individuals using the Medicare Part B claims collection type; 
approximately 71,439 clinicians will submit data as individuals using 
MIPS CQMs or QCDR collection types; and approximately 47,557 clinicians 
will submit data as individuals using eCQMs collection type.

     Table 65--Estimated Number of Clinicians Submitting Quality Performance Category Data as Individuals by
                                                 Collection Type
----------------------------------------------------------------------------------------------------------------
                                   Medicare Part                                      CMS web
                                     B claims      QCDR/MIPS CQM       eCQM          interface         Total
----------------------------------------------------------------------------------------------------------------
Number of Clinicians to submit           257,260          71,439          47,557               0         376,256
 data as individuals in Quality
 Payment Program Year 3
 (excludes QPs) (a).............
* Number of Clinicians to submit         278,039         104,281          52,709               0         435,029
 data as individuals in Quality
 Payment Program Year 2
 (excludes QPs) (b).............
Difference between Year 3 and            -20,779         -32,842          -5,152               0         -58,773
 Year 2 (c) = (a) - (b).........
----------------------------------------------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).

    To be consistent with the policy in the CY 2018 Quality Payment 
Program final rule that for MIPS eligible clinicians who collect 
measures via Medicare Part B claims, MIPS CQM, eCQM, or QCDR collection 
types and submit more than the required number of measures (82 FR 53735 
through 54736), we will score the clinician on the required measures 
with the highest assigned measure achievement points. Therefore, our 
columns in Table 65 are not mutually exclusive.
    Table 66 provides our estimated counts of groups or virtual groups 
that will submit quality data on behalf of clinicians for each 
collection type in the 2019 MIPS performance period and reflects our 
assumption that the formation of virtual groups will reduce burden. We 
assume that groups that submitted quality data as groups in the 2017 
MIPS performance period will continue to submit quality data either as 
groups or virtual groups for the same collection types as they did as a 
group or TIN within a virtual group for the 2019 MIPS performance 
period. First, we estimated the number of groups or virtual groups that 
will collect data via each collection type during the 2019 MIPS 
performance period using data from the 2017 MIPS performance period. 
The second and third steps in Table 66 reflect our currently approved 
assumption that virtual groups will reduce the burden for quality data 
submission by reducing the number of organizations that will submit 
quality data on behalf of clinicians. We assume that 40 groups that 
previously collected on behalf of clinicians via QCDR or MIPS CQM 
collection types will elect to form 8 virtual groups that will collect 
via QCDR and MIPS CQM collection types. We assume that another 40 
groups that previously collected on behalf of clinicians via eCQM 
collection types will elect to form another 8 virtual groups that will 
collect via eCQM collection types. Hence, the second step in Table 66 
is to subtract out the estimated number of groups under each collection 
type that will elect to form virtual groups, and the third step in 
Table 66 is to add in the estimated number of virtual groups that will 
submit on behalf of clinicians for each collection type.
    Specifically, we assume that 10,542 groups and virtual groups will 
submit data for the QCDR or MIPS CQM collection types on behalf of 
253,254 clinicians; 4,304 groups and virtual groups will submit for 
eCQM collection types on behalf of 195,505 eligible clinicians; and 286 
groups will submit data via the CMS Web Interface on behalf of 139,231 
clinicians. Because we are using 2017 MIPS performance period 
participation data to estimate participation for the 2019 MIPS 
performance period, our estimates do not account for the finalized 
policy to allow only groups that meet the definition of a small 
practice to submit quality data via the Medicare Part B claims 
collection type. Due to a lack of

[[Page 60003]]

historic data identifying which clinicians in small practices would 
want to submit via the Medicare Part B claims collection type and elect 
to be measured as part of a group, we continue to assume these 
clinicians submitting Medicare Part B claims will participate as 
individuals but will review this assumption for future performance 
periods.

     Table 66--Estimated Number of Groups and Virtual Groups Submitting Quality Performance Category Data by
                                     Collection Type on Behalf of Clinicians
----------------------------------------------------------------------------------------------------------------
                                   Medicare Part                                      CMS web
                                     B claims      QCDR/MIPS CQM       eCQM          interface         Total
----------------------------------------------------------------------------------------------------------------
Number of groups to collect data               0          10,574           4,336             286          15,196
 by collection type (on behalf
 of clinicians) in Quality
 Payment Program Year 3
 (excludes QPs) (a).............
Subtract out: Number of groups                 0              40              40               0              80
 to collect data by collection
 type on behalf of clinicians in
 Quality Payment Program Year 3
 that will submit as virtual
 groups in Quality Payment
 Program Year 3 (b).............
Add in: Number of virtual groups               0               8               8               0              16
 to collect data by collection
 type on behalf of clinicians in
 Quality Payment Program Year 3
 (c)............................
Number of groups to collect data               0          10,542           4,304             286          15,132
 by collection type on behalf of
 clinicians in Quality Payment
 Program Year 3 (d) = (a)-(b) +
 (c)............................
* Number of groups to collect                  0           2,936           1,509             296           4,741
 data by collection type on
 behalf of clinicians in Quality
 Payment Program Year 2 (e).....
Difference between Year 3 and                  0          +7,606          +2,795             -10         +10,391
 Year 2 (f) = (d)-(e)...........
----------------------------------------------------------------------------------------------------------------
* Currently approved by OMB under control number 0938-1314 (CMS-10621).

    The burden estimates associated with submission of quality 
performance category data have some limitations. We believe it is 
difficult to quantify the burden accurately because clinicians and 
groups may have different processes for integrating quality data 
submission into their practices' work flows. Moreover, the time needed 
for a clinician to review quality measures and other information, 
select measures applicable to their patients and the services they 
furnish, and incorporate the use of quality measures into the practice 
workflows is expected to vary along with the number of measures that 
are potentially applicable to a given clinician's practice and by the 
collection type. For example, clinicians submitting data via the 
Medicare Part B claims collection type need to integrate the capture of 
quality data codes for each encounter whereas clinicians submitting via 
the eCQM collection types may have quality measures automated as part 
of their EHR implementation.
    We believe the burden associated with submitting quality measures 
data will vary depending on the collection type selected by the 
clinician, group, or third-party. As such, we separately estimated the 
burden for clinicians, groups, and third parties to submit quality 
measures data by the collection type used. For the purposes of our 
burden estimates for the Medicare Part B claims, MIPS CQM and QCDR, and 
eCQM collection types, we also assume that, on average, each clinician 
or group will submit 6 quality measures. In terms of the quality 
measures available for clinicians and groups to report for the 2019 
MIPS performance period, the total number of quality measures will be 
257. These measures are stratified by collection type in Table 67, as 
well as counts of new, removed, and substantively changed measures.

                   Table 67--Summary of Quality Measures for the 2019 MIPS Performance Period
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of
                                                     Number of       Number of       measures        Number of
                 Collection type                     measures        measures     finalized with     measures
                                                   finalized as    finalized for   a substantive   remaining for
                                                        new           removal         change          CY 2019
----------------------------------------------------------------------------------------------------------------
Medicare Part B Claims Specifications...........               0               7               1              64
MIPS CQMs Specifications........................               6              21               0             233
eCQM Specifications.............................               2               6               0              50
Survey--CSV.....................................               0               0               0               1
CMS Web Interface Measure Specifications........               0               1               4              10
Administrative Claims...........................               0               0               0               1
                                                 ---------------------------------------------------------------
    Total.......................................               8            * 26               5           * 257
----------------------------------------------------------------------------------------------------------------
* A measure may be applicable to more than one collection type but will only be counted once in the total.

    For the 2019 MIPS performance period, there is a net reduction of 
18 quality measures across all collection types. We do not anticipate 
that removing these measures will increase or decrease the reporting 
burden on clinicians and groups.
    Quality Payment Program Identity Management Application Process: 
The requirements and burden associated with the application process 
will be

[[Page 60004]]

submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
    In the CY 2018 Quality Payment Program final rule, the time 
associated with the Identity Management Application Process was 
described as ``Obtain Account in CMS-Specified Identity Management 
System'' and included in the ICR for Quality Data Submission by 
Clinicians and Groups: EHR Submission for a total burden of 54,218 
hours (1 hr x 54,218 respondents) (82 FR 53914). After our review of 
the quality data submission process, we determined the burden 
associated with the application process (3,741 hours) should be 
accounted for in a separate ICR. Our per respondent burden estimate 
remains unchanged at 1 hour per response.
    For an individual, group, or third-party to submit MIPS quality, 
improvement activities, or Promoting Interoperability performance 
category data using either the log in and upload or the log in and 
attest submission type or to access feedback reports, the submitter 
must have a CMS Enterprise Portal user account. Once the user account 
is created, registration is not required again for future years.
    Based on the number of new TINs registered in the 2017 MIPS 
performance period, we estimate 3,741 eligible clinicians, groups, or 
third-parties will register for new accounts for the 2019 MIPS 
performance period. As shown in Table 68, it will take 1 hour at 
$89.18/hr for a computer systems analyst (or their equivalent) to 
obtain an account for the CMS Enterprise Portal. In aggregate, we 
estimate an annual burden of 3,741 hours (3,741 registrations x 1 hr/
registration) at a cost of $333,622 (3,741 hr x $89.18/hr) or $89.18 
per registration.

     Table 68--Estimated Burden for Quality Payment Program Identity
                     Management Application Process
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of New TINs completing the Identity Management              3,741
 Application Process (a)................................
                                                         ---------------
Total Hours Per Application (b).........................               1
                                                         ---------------
    Total Annual Hours for completing the Identity                 3,741
     Management Application Process (c) = (a) * (b).....
                                                         ---------------
Cost Per Application @ computer systems analyst's labor           $89.18
 rate of $89.18/hr.) (d)................................
                                                         ---------------
    Total Annual Cost for completing the Identity               $333,622
     Management Application Process (e) = (a) * (d).....
------------------------------------------------------------------------

    We received no public comments related to the burden estimates for 
the Identity Management Application Process. The burden estimates have 
not been updated from the CY 2019 PFS proposed rule (83 FR 36022 
through 36023).
    Quality Data Submission by Clinicians: Medicare Part B Claims-Based 
Collection Type: The requirements and burden associated with 
clinicians' Medicare Part B claims-based data submissions will be 
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
    As noted in Table 64, based on 2017 MIPS performance period data, 
we assume that 257,260 individual clinicians will collect and submit 
quality data via the Medicare Part B claims collection type. We 
continue to anticipate that the Medicare Part B claims submission 
process for MIPS is operationally similar to the way the claims 
submission process functioned under the PQRS. Specifically, clinicians 
will need to gather the required information, select the appropriate 
QDCs, and include the appropriate QDCs on the Medicare Part B claims 
they submit for payment. Clinicians will collect QDCs as additional 
(optional) line items on the CMS-1500 claim form or the electronic 
equivalent HIPAA transaction 837-P, approved by OMB under control 
number 0938-1197. This final rule's provisions do not necessitate the 
revision of either form.
    In this final rule, we have adjusted the number of respondents 
based on more recent data and adjusted our per respondent time 
estimates so that they correctly align with the number of required 
measures for which MIPS data must be submitted (6 measures) in 
comparison to the number of measures previously required under PQRS (9 
measures).
    The total estimated burden of Medicare Part B claims-based 
submission will vary along with the volume of Medicare Part B claims on 
which the submission is based. Based on our experience with PQRS, we 
estimate that the burden for submission of MIPS quality data will range 
from 0.15 to 7.2 hours per clinician, a reduction from the range of 
0.22 to 10.8 hours as set out in the CY 2018 Quality Payment Program 
final rule (82 FR 53912). In the same rule, the 33 percent reduction in 
the number of measures (from 9 to 6) was erroneously omitted from our 
burden calculations; it is reflected in this final rule's burden 
estimates. The wide range of estimates for the time required for a 
clinician to submit quality measures via Medicare Part B claims 
reflects the wide variation in complexity of submission across 
different clinician quality measures. As shown in Table 69, we estimate 
that the cost of quality data submission using Medicare Part B claims 
will range from $13.38 (0.15 hr x $89.18/hr) to $642.10 (7.2 hr x 
$89.18/hr). The burden will involve becoming familiar with MIPS data 
submission requirements. We believe that the start-up cost for a 
clinician's practice to review measure specifications is 7 hours, 
consisting of 3 hours at $107.38/hr for a practice administrator, 1 
hour at $206.44/hr for a clinician, 1 hour at $43.96/hr for an LPN/
medical assistant, 1 hour at $89.18/hr for a computer systems analyst, 
and 1 hour at $36.98/hr for a billing clerk.
    The estimate for reviewing and incorporating measure specifications 
for the claims collection type is higher than that of QCDRs/Registries 
or eCQM collection types due to the more manual, and therefore, more 
burdensome nature of claims measures.
    Considering both data submission and start-up requirements, the 
estimated time (per clinician) ranges from a minimum of 7.15 hours 
(0.15 hr + 7 hr) to a maximum of 14.2 hours (7.2 hr + 7 hr). In this 
regard the total annual burden ranges from 1,819,082 hours (7.15 hr x 
254,417 clinicians) to 3,612,721 hours (14.2 hr x 254,417 clinicians). 
The estimated annual cost (per clinician) ranges from $712.08 ($13.38 + 
$322.14 + $89.18 + $43.96 + $36.98 + $206.44) to a maximum of $1,340.80 
($642.10 + $322.14 + $89.18 + $43.96 + $36.98 + $206.44). The total 
annual burden ranges from a minimum

[[Page 60005]]

of $183,189,701 (257,260 clinicians x $712.08) to a maximum of 
$344,934,208 (257,260 clinicians x $1,340.80).
    Table 69 summarizes the range of total annual burden associated 
with clinicians submitting quality data via Medicare Part B claims.
    Independent of the change in the number of respondents, the change 
in estimated time per clinician results in a burden adjustment of 
between -19,463 hours at -$1,860,081 (278,039 clinicians x -0.07 hr x 
$89.18/hr) and -1,000,941 hours at -$89,261,641 (278,039 clinicians x -
3.6 hr x $89.18/hr). Accounting for the change in the time burden per 
respondent, the decrease in number of respondents results in a total 
adjustment of between -148,713 hours at -$14,810,552 (-20,799 
respondents x $712.08/respondent) and -295,346 hours at -$27,887,299 (-
20,779 respondents x $1,340.80/respondent). When these two adjustments 
are combined, the net adjustment ranges between -168,176 (-19,463 -
148,713) hours at -$16,670,633 (-$1,860,081 -$14,810,552) and -
1,296,287 (-1,000,941 -295,346) hours at -$117,148,940 (-$89,261,641 -
$27,887,299).

    Table 69--Estimated Burden for Quality Performance Category: Clinicians Using the Medicare Part B Claims
                                                 Collection Type
----------------------------------------------------------------------------------------------------------------
                                                                                                  Maximum burden
                                                                  Minimum burden   Median burden     estimate
----------------------------------------------------------------------------------------------------------------
Number of Clinicians (a)........................................         257,260         257,260         257,260
Hours Per Clinician to Submit Quality Data (b)..................            0.15            1.05             7.2
Number of Hours Practice Administrator Review Measure                          3               3               3
 Specifications (c).............................................
Number of Hours Computer Systems Analyst Review Measure                        1               1               1
 Specifications (d).............................................
Number of Hours LPN Review Measure Specifications (e)...........               1               1               1
Number of Hours Billing Clerk Review Measure Specifications (f).               1               1               1
Number of Hours Clinician Review Measure Specifications (g).....               1               1               1
Annual Hours per Clinician (h) = (b) + (c) + (d) + (e) + (f) +              7.15            8.05            14.2
 (g)............................................................
                                                                 -----------------------------------------------
    Total Annual Hours (i) = (a) * (h)..........................       1,839,409       2,070,943       3,653,092
                                                                 -----------------------------------------------
Cost to Submit Quality Data (@ computer systems analyst's labor           $13.38          $93.64         $642.10
 rate of $89.18/hr.) (j)........................................
Cost to Review Measure Specifications (@ practice                        $322.14         $322.14         $322.14
 administrator's labor rate of $107.38/hr.) (k).................
Cost to Review Measure Specifications (@ computer systems                 $89.18          $89.18          $89.18
 analyst's labor rate of $89.18/hr.) (l)........................
Cost to Review Measure Specifications (@ LPN's labor rate of              $43.96          $43.96          $43.96
 $43.96/hr.) (m)................................................
Cost to Review Measure Specifications (@ billing clerk's labor            $36.98          $36.98          $36.98
 rate of $36.98/hr.) (n)........................................
Cost to Review Measure Specifications (@ physician's labor rate          $206.44         $206.44         $206.44
 of $206/44/hr.) (o)............................................
                                                                 -----------------------------------------------
    Total Annual Cost Per Clinician (p) = (j) + (k) + (l) + (m)          $712.08         $792.34       $1,340.80
     + (n) + (o)................................................
                                                                 -----------------------------------------------
        Total Annual Cost (q) = (a) * (p).......................    $183,189,701    $203,837,388    $344,934,208
----------------------------------------------------------------------------------------------------------------

    We received no public comments related to the burden estimates for 
quality performance category: Clinicians using the Medicare Part B 
claims collection type. However, the burden estimates have been updated 
from the CY 2019 PFS proposed rule to reflect availability of data from 
the 2017 MIPS performance period (83 FR 36023 through 36024).
    Quality Data Submission by Individuals and Groups Using MIPS CQM 
and QCDR Collection Types: This final rule does not include any new or 
revised reporting, recordkeeping, or third-party disclosure 
requirements related to this CQM and QCDR collection types. However, we 
have adjusted the number of respondents based on more recent data. The 
adjusted burden will be submitted to OMB for approval under control 
number 0938-1314 (CMS-10621).
    As noted in Tables 64, 65, and 66, and based on 2017 MIPS 
performance period data, we assume that 324,693 clinicians will submit 
quality data as individuals or groups using MIPS CQM or QCDR collection 
types. Of these, we expect 71,439 clinicians, as shown in Table 65, 
will submit as individuals and 10,542 groups, as shown in Table 66, are 
expected to submit on behalf of the remaining 253,254 clinicians. Given 
that the number of measures required is the same for clinicians and 
groups, we expect the burden to be the same for each respondent 
collecting data via MIPS CQM or QCDR, whether the clinician is 
participating in MIPS as an individual or group.
    Under the MIPS CQM and QCDR collection types, the individual 
clinician or group may either submit the quality measures data directly 
to us, log in and upload a file, or utilize a third-party intermediary 
to submit the data to us on the clinician's or group's behalf.
    We estimate that the burden associated with the QCDR collection 
type is similar to the burden associated with the MIPS CQM collection 
type; therefore, we discuss the burden for both together below. For 
MIPS CQM and QCDR collection types, we estimate an additional time for 
respondents (individual clinicians and groups) to become familiar with 
MIPS submission requirements and, in some cases, specialty measure sets 
and QCDR measures. Therefore, we believe that the burden for an 
individual clinician or group to review measure specifications and 
submit quality data total 9.083 hours at $858.86. This consists of 3 
hours at $89.18/hr for a computer systems analyst (or their equivalent) 
to submit quality data along with 2 hours at $107.38/hr for a practice 
administrator, 1 hour at $89.18/hr for a computer systems analyst, 1 
hour at $43.96/hr for a LPN/medical assistant, 1 hour at $36.98/hr for 
a billing clerk, and 1 hour at $206.44/hr for a clinician to review 
measure specifications. Additionally, clinicians and groups will need 
to authorize or instruct the qualified registry or QCDR to submit 
quality measures' results and numerator and denominator data on quality 
measures to us on their behalf. We

[[Page 60006]]

estimate that the time and effort associated with authorizing or 
instructing the quality registry or QCDR to submit this data will be 
approximately 5 minutes (0.083 hours) per clinician or group 
(respondent) for a cost of $7.40 (0.083 hr x $89.18/hr for a computer 
systems analyst).
    In aggregate, we estimate an annual burden of 744,633 hours (9.083 
hr/response x 81,981 groups plus clinicians submitting as individuals) 
at a cost of $71,016,861 (81,981 responses x $866.26/response). The 
decrease in number of respondents results in a total adjustment of -
229,219 hours at -$21,860,937 (-25,236 respondents x $866.26/
respondent). Based on these assumptions, we have estimated in Table 70 
the burden for these submissions.

 Table 70--Estimated Burden for Quality Performance Category: Clinicians
 (Participating Individually or as Part of a Group) Using the MIPS CQM/
                          QCDR Collection Type
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of clinicians submitting as individuals (a)......          71,439
Number of groups submitting via QCDR or MIPS CQM on               10,542
 behalf of individual clinicians (b)....................
Number of Respondents (groups plus clinicians submitting          81,981
 as individuals) (c) = (a) + (b)........................
Hours Per Respondent to Report Quality Data (d).........               3
Number of Hours Practice Administrator Review Measure                  2
 Specifications (e).....................................
Number of Hours Computer Systems Analyst Review Measure                1
 Specifications (f).....................................
Number of Hours LPN Review Measure Specifications (g)...               1
Number of Hours Billing Clerk Review Measure                           1
 Specifications (h).....................................
Number of Hours Clinician Review Measure Specifications                1
 (i)....................................................
Number of Hours Per Respondent to Authorize Qualified              0.083
 Registry to Report on Respondent's Behalf (j)..........
Annual Hours Per Respondent (k) = (d) + (e) + (f) + (g)            9.083
 + (h) + (i) + (j)......................................
                                                         ---------------
    Total Annual Hours (l) = (c) * (k)..................         744,633
                                                         ---------------
Cost Per Respondent to Submit Quality Data (@ computer           $267.54
 systems analyst's labor rate of $89.18/hr.) (m)........
Cost to Review Measure Specifications (@ practice                $214.76
 administrator's labor rate of $107.38/hr.) (n).........
Cost Computer System's Analyst Review Measure                     $89.18
 Specifications (@ computer systems analyst's labor rate
 of $89.18/hr.) (o).....................................
Cost LPN Review Measure Specifications (@ LPN's labor             $43.96
 rate of $43.96/hr.) (p)................................
Cost Billing Clerk Review Measure Specifications (@               $36.98
 clerk's labor rate of $36.98/hr.) (q)..................
Cost Clinician Review Measure Specifications (@                  $206.44
 physician's labor rate of $206.44/hr.) (r).............
Cost for Respondent to Authorize Qualified Registry/QCDR           $7.40
 to Report on Respondent's Behalf (@ computer systems
 analyst's labor rate of $89.18/hr.) (s)................
                                                         ---------------
    Total Annual Cost Per Respondent (t) = (m) + (n) +           $866.26
     (o) + (p) + (q) + (r) + (s)........................
                                                         ---------------
        Total Annual Cost (u) = (c) * (t)...............     $71,016,861
------------------------------------------------------------------------

    We received no public comments related to the burden estimates for 
quality performance category: Clinicians using the MIPS CQM/QCDR 
collection type. However, the burden estimates have been updated from 
the CY 2019 PFS proposed rule to reflect availability of data from the 
2017 MIPS performance period (83 FR 36024 through 36025).
    Quality Data Submission by Clinicians and Groups: eCQM Collection 
Type: This final rule does not include any new or revised reporting, 
recordkeeping, or third-party disclosure requirements related to the 
eCQM collection type. However, we have adjusted the number of 
respondents based on more recent data. The adjusted burden will be 
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
    As noted in Tables 64, 65, and 66, based on 2017 MIPS performance 
period data, we assume that 243,062 clinicians will elect to use the 
eCQM collection type; 47,557 clinicians are expected to submit eCQMs as 
individuals; and 4,304 groups are expected to submit eCQMs on behalf of 
the remaining 195,505 clinicians. We expect the burden to be the same 
for each respondent using the eCQM collection type, whether the 
clinician is participating in MIPS as an individual or group.
    In the CY 2018 Quality Payment Program final rule, the time 
required for users to obtain an account for the CMS Enterprise Portal 
was included in this Quality Data Submission by Clinicians and Groups: 
eCQM Collection Type ICR (82 FR 53914). However, in this final rule, we 
are finalizing a separate ICR for this activity (now described as the 
Quality Payment Program Identity Management Application Process; see 
Table 68) and therefore, reduce (by 1 hour) our per respondent burden 
estimate for this ICR commensurately. We have also adjusted the number 
of respondents based on more recent data.
    Under the eCQM collection type, the individual clinician or group 
may either submit the quality measures data directly to us from their 
eCQM, log in and upload a file, or utilize a health IT vendor to submit 
the data to us on the clinician's or group's behalf.
    To prepare for the eCQM collection type, the clinician or group 
must review the quality measures on which we will be accepting MIPS 
data extracted from eCQMs, select the appropriate quality measures, 
extract the necessary clinical data from their CEHRT, and submit the 
necessary data to the CMS-designated clinical data warehouse or use a 
health IT vendor to submit the data on behalf of the clinician or 
group. We assume the burden for collecting quality measures data via 
eCQM is similar for clinicians and groups who submit their data 
directly to us from their CEHRT and clinicians and groups who use a 
health IT vendor to submit the data on their behalf. This includes 
extracting the necessary clinical data from their CEHRT and submitting 
the necessary data to the CMS-designated clinical data warehouse.
    We continue to estimate that it will take no more than 2 hours at 
$89.18/hr for a computer systems analyst to submit the actual data 
file. The burden

[[Page 60007]]

will also involve becoming familiar with MIPS submission. In this 
regard, we estimate it will take 6 hours for a clinician or group to 
review measure specifications. Of that time, we estimate 2 hours at 
$107.38/hr for a practice administrator, 1 hour at $206.44/hr for a 
clinician, 1 hour at $89.18/hr for a computer systems analyst, 1 hour 
at $43.96/hr for a LPN/medical assistant, and 1 hour at $36.98/hr for a 
billing clerk.
    In aggregate we estimate an annual burden of 414,888 hours (8 hr x 
51,861 groups and clinicians submitting as individuals) at a cost of 
$39,916,374 (51,861 responses x $769.68/response) (see Table 71).
    Independent of the change in the number of respondents, removing 
the time burden associated with completing the Quality Payment Program 
Identity Management Application Process results in an adjustment to the 
total burden of -54,218 hours and -$4,835,161 (54,218 respondents x -1 
hr x $89.18/hr). Accounting for the change in the per respondent time 
estimate, the decrease in number of respondents results in a total 
adjustment of -18,856 hours at -$1,814,136 (-2,357 respondents x 
$769.68/respondent). When these two adjustments are combined, the net 
adjustment is -73,074 (-54,218-18,856) hours at -$6,649,297 (-
$4,835,161-$1,814,136).

 Table 71--Estimated Burden for Quality Performance Category: Clinicians
     (Submitting Individually or as Part of a Group) Using the eCQM
                             Collection Type
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of clinicians submitting as individuals (a)......          47,557
Number of Groups submitting via EHR on behalf of                   4,304
 individual clinicians (b)..............................
Number of Respondents (groups and clinicians submitting           51,861
 as individuals) (c) = (a) + (b)........................
Hours Per Respondent to Submit MIPS Quality Data File to               2
 CMS (d)................................................
Number of Hours Practice Administrator Review Measure                  2
 Specifications (e).....................................
Number of Hours Computer Systems Analyst Review Measure                1
 Specifications (f).....................................
Number of Hours LPN Review Measure Specifications (g)...               1
Number of Hours Billing Clerk Review Measure                           1
 Specifications (h).....................................
Number of Hours Clinicians Review Measure Specifications               1
 (i)....................................................
Annual Hours Per Respondent (j) = (d) + (e) + (f) + (g)                8
 + (h) + (i)............................................
                                                         ---------------
    Total Annual Hours (k) = (c) * (j)..................         414,888
                                                         ---------------
Cost Per Respondent to Submit Quality Data (@ computer           $178.36
 systems analyst's labor rate of $88.10/hr.) (l)........
Cost to Review Measure Specifications (@ practice                $214.76
 administrator's labor rate of $105.16/hr.) (m).........
Cost to Review Measure Specifications (@ computer                 $89.18
 systems analyst's labor rate of $88.10/hr.) (n)........
Cost to Review Measure Specifications (@ LPN's labor              $43.96
 rate of $43.12/hr.) (o)................................
Cost to Review Measure Specifications (@ clerk's labor            $36.98
 rate of $36.12/hr.) (p)................................
Cost to D21Review Measure Specifications (@ physician's          $206.44
 labor rate of $202.08/hr.) (q).........................
                                                         ---------------
    Total Cost Per Respondent (r) = (l) + (m) + (n) +            $769.68
     (o) + (p) + (q)....................................
                                                         ---------------
        Total Annual Cost (s) = (c) * (r)...............     $39,916,374
------------------------------------------------------------------------

    We received no public comments related to the burden estimates for 
quality performance category: Clinicians using the eCQM collection 
type. However, the burden estimates have been updated from the CY 2019 
PFS proposed rule to reflect availability of data from the 2017 MIPS 
performance period (83 FR 36025 through 36026).
    Quality Data Submission via CMS Web Interface: The finalized 
requirements and burden associated with CMS Web Interface data 
submission will be submitted to OMB for approval under control number 
0938-1314 (CMS-10621).
    As discussed in section III.I.3.h.(2)(a)(iii)(A)(bb) of this rule, 
we are finalizing a 33 percent reduction in the number of measures 
(from 15 to 10 measures) for which clinicians are required to submit 
quality data via the CMS Web Interface. To account for the decrease in 
measures, we are also finalizing a decrease to our per respondent time 
estimate.
    We assume that 286 groups will submit quality data via the CMS Web 
Interface based on the number of groups who registered for using the 
CMS Web Interface during the 2018 MIPS performance period. This is a 
decrease of 10 groups from the currently approved number provided in 
the CY 2018 Quality Payment Program final rule (82 FR 53915) due to 
receipt of more current data. We estimate that approximately 91,757 
clinicians will submit via this method.
    The burden associated with the group submission requirements is the 
time and effort associated with submitting data on a sample of the 
organization's beneficiaries that is prepopulated in the CMS Web 
Interface. In the CY 2018 Quality Payment Program final rule, we 
estimated that it would take, on average, 74 hours for each group to 
submit quality measures data via the CMS Web Interface (82 FR 53915). 
Of those hours, approximately half (or 37 hr) are unaffected by the 
number of required measures while the other half (37 hr) are affected 
proportionately by the number of required measures (37 hr x 33 percent 
reduction = 24.67 hr). Accounting for the finalized reduction in 
required measures, our revised estimate for the time to submit data via 
the CMS Web Interface for the 2019 MIPS performance period is 61.67 
hours (37 hr + 24.67 hr), a reduction of 12.33 hours or approximately 
18 percent of the currently approved 74 hour time estimate. Considering 
only the time which varies based on the number of required measures, 
the process of entering or uploading data requires approximately 2.74 
hours of a computer systems analyst's time per measure (24.67 hr/9 
measures). Our estimate for submission includes the time needed for 
each group to populate data fields in the web interface with 
information on approximately 248 eligible assigned Medicare 
beneficiaries and submit the data (we will partially pre-populate the 
CMS Web Interface with claims data

[[Page 60008]]

from their Medicare Part A and B beneficiaries). The patient data 
either can be manually entered, uploaded into the CMS Web Interface via 
a standard file format, which can be populated by CEHRT, or submitted 
directly. Each group must provide data on 248 eligible assigned 
Medicare beneficiaries (or all eligible assigned Medicare beneficiaries 
if the pool of eligible assigned beneficiaries is less than 248) for 
each measure. In aggregate, we estimate an annual burden of 17,637 
hours (286 groups x 61.67 hr) at a cost of $1,572,837 (17,637 hr x 
$89.18/hr).
    Independent of the change in the number of respondents, the 
decrease in total burden resulting from the decrease in required 
measures is -3,650 hours at -$325,566 (296 groups x -12.33 hr x $89.18/
hr). Accounting for the decrease in total time, the decrease in number 
of respondents results in a total adjustment of -616.7 hours at -
$54,994 (-10 respondents x 61.67 hr x $89.18/hr). When these 
adjustments are combined, the net adjustment is -4,267 (-3,650-617) 
hours at -$380,560 (-$325,566-$54,994).
    Based on the assumptions discussed in this section, Table 72 
summarizes the burden for groups submitting to MIPS via the CMS Web 
Interface.

 Table 72--Estimated Burden for Quality Data Submission via the CMS Web
                                Interface
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of Eligible Group Practices (a)..................             286
    Total Annual Hours Per Group to Submit (b)..........           61.67
                                                         ---------------
    Total Annual Hours (c) = (a) * (b)..................          17,637
                                                         ---------------
Cost Per Group to Report (@ computer systems analyst's            $5,499
 labor rate of $89.18/hr.) (d)..........................
                                                         ---------------
    Total Annual Cost (e) = (a) * (d)...................      $1,572,837
------------------------------------------------------------------------

    We received no public comments related to the burden estimates for 
quality data submission via the CMS Web Interface. However, the burden 
estimates have been updated from the CY 2019 PFS proposed rule to 
reflect the change in the number of required measures from 9 in the 
proposed rule to 10 in the final rule (83 FR 36026 through 36027).
    Beneficiary Responses to CAHPS for MIPS Survey: This rule does not 
include any new or revised reporting, recordkeeping, or third-party 
disclosure requirements related to the CAHPS for MIPS survey. However, 
we have adjusted our currently approved burden estimates based on more 
recent data. The adjusted burden will be submitted to OMB for approval 
under control number 0938-1222 (CMS-10450).
    In this final rule, we have adjusted the number of groups electing 
to report on the CAHPS for MIPS survey as well as the average number of 
beneficiaries per group based on more recent data.
    Under MIPS, groups of 25 or more clinicians can elect to contract 
with a CMS-approved survey vendor and use the CAHPS for MIPS survey as 
one of their 6 required quality measures. Beneficiaries that choose to 
respond to the CAHPS for MIPS survey will experience burden.
    The usual practice in estimating the burden on public respondents 
to surveys such as CAHPS is to assume that respondent time is valued, 
on average, at civilian wage rates. As explained in section V.A. of 
this final rule, BLS data sets out an average hourly wage for civilians 
in all occupations at $24.34/hr. Although most Medicare beneficiaries 
are retired, we believe that their time value is unlikely to depart 
significantly from prior earnings expense, and we have used the average 
hourly wage to compute our cost estimate for the beneficiaries' time.
    For the 2019 MIPS performance period, we assume that 143 groups 
will elect to report on the CAHPS for MIPS survey, which is equal to 
the number of groups that have registered and have a sufficient 
beneficiary sample size to conduct the CAHPS for MIPS survey in the 
2018 MIPS performance period; a decrease of 318 from the 461 groups 
currently approved by OMB. Table 73 shows the estimated annual burden 
for beneficiaries to participate in the CAHPS for MIPS Survey. Based on 
the number of complete and partially complete surveys for groups 
participating in CAHPS for MIPS survey administration for the 2018 MIPS 
performance period, we assume that an average of 273 beneficiaries will 
respond per group for the 2019 MIPS performance period. Therefore, the 
CAHPS for MIPS survey will be administered to approximately 39,039 
beneficiaries per year (143 groups x an average of 273 beneficiaries 
per group responding). This is a decrease of 93,268 from our currently 
approved 132,307 beneficiary estimate.
    The CAHPS for MIPS survey that will be administered in the 2019 
MIPS performance period is unchanged from the survey administered in 
the 2018 MIPS performance period. In that regard, we continue to 
estimate an average administration time of 12.9 minutes (or 0.215 hr) 
at a pace of 4.5 items per minute for the English version of the 
survey. For the Spanish version, we estimate an average administration 
time of 15.5 minutes (assuming 20 percent more words in the Spanish 
translation). However, since less than 1 percent of surveys were 
administered in Spanish for reporting year 2016, our burden estimate 
reflects the time for administering the English version of the survey.
    Given that we expect approximately 39,039 respondents, we estimate 
an annual burden of 8,393 hours (39,039 respondents x 0.215 hr/
respondent) at a cost of $204,286 (8,393 hr x $24.34/hr).
    The decrease in the number of beneficiaries responding to the CAHPS 
for MIPS survey results in an adjustment to the total time burden of -
20,715 hours and -$503,556 (-93,268 beneficiaries x 0.215 hr x $24.34/
hr).

[[Page 60009]]



  Table 73--Estimated Burden for Beneficiary Participation in CAHPS for
                               MIPS Survey
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of Eligible Group Practices Administering CAHPS               143
 for MIPS (a)...........................................
Number of Beneficiaries Per Group Responding to Survey               273
 (b)....................................................
Number of Total Beneficiary Respondents (c) = (a) * (b).          39,039
Number of Hours Per Beneficiary Respondent (d)..........           0.215
Cost (@ labor rate of $24.34/hr.) (e)...................       $24.34/hr
                                                         ---------------
    Total Annual Hours (f) = (c) * (d)..................           8,393
                                                         ---------------
        Total Annual Cost for Beneficiaries Responding          $204,286
         to CAHPS for MIPS (g) = (c) * (e)..............
------------------------------------------------------------------------

    We received no public comments related to the burden estimates for 
beneficiary participation in CAHPS for MIPS survey. However, the burden 
estimates have been updated from the CY 2019 PFS proposed rule to 
reflect availability of data from the 2018 MIPS performance period (83 
FR 36027).
    Group Registration for CMS Web Interface: This rule does not 
include any new or revised reporting, recordkeeping, or third-party 
disclosure requirements related to the group registration for CMS Web 
Interface. However, we have adjusted our currently approved burden 
estimates based on more recent data. The adjusted burden will be 
submitted to OMB for approval under control number 0938-1222 (CMS-
10450).
    In this final rule, we have adjusted the number of respondents 
based on more recent data and adjusted our per response time estimate 
based on our review of the currently approved estimates against the 
existing registration process.
    Groups interested in participating in MIPS using the CMS Web 
Interface for the first time must complete an on-line registration 
process. After first time registration, groups will only need to opt 
out if they are not going to continue to submit via the CMS Web 
Interface. In Table 74, we estimate that the registration process for 
groups under MIPS involves approximately 0.25 hours at $89.18/hr for a 
computer systems analyst (or their equivalent) to register the group. 
Although the registration process remains unchanged from the CY 2018 
Quality Payment Program final rule, a review of the steps required for 
registration warranted a reduction of 0.75 hours in estimated burden 
per group (82 FR 53917).
    We assume that approximately 67 groups will elect to use the CMS 
Web Interface for the first time during the 2019 MIPS performance 
period based on the number of new registrations received during the CY 
2018 registration period; an increase of 57 compared to the number of 
groups currently approved by OMB under control number 0938-1314 (CMS-
10621). In aggregate, we estimate a burden of 16.75 hours (67 new 
registrations x 0.25 hr/registration) at a cost of $1,494 (16.75 hr x 
$89.18/hr).
    Independent of the decrease in time burden per group, the increase 
in the number of groups registering to submit MIPS data via the CMS Web 
Interface results in an adjustment to the total time burden of 57 hours 
at $5,083 (57 groups x 1 hr x $89.18/hr). Accounting for the increase 
in the number of groups, the decrease in time burden per group to 
register results in an adjustment to the total burden of -50.25 hours 
at -$4,481 (67 groups x -0.75 hrs x $89.18/hr). When these adjustments 
are combined, the net adjustment is 6.75 hours (57-50.25) at $602 
($5,083-$4,481).

 Table 74--Estimated Burden for Group Registration for CMS Web Interface
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of New Groups Registering for CMS Web Interface                67
 (a)....................................................
Annual Hours Per Group (b)..............................            0.25
                                                         ---------------
    Total Annual Hours (c) = (a) * (b)..................           16.75
                                                         ---------------
Labor Rate to Register for CMS Web Interface @ computer        $89.18/hr
 systems analyst's labor rate) (d)......................
                                                         ---------------
    Total Annual Cost for CMS Web Interface Group                 $1,494
     Registration (e) = (a) * (d).......................
------------------------------------------------------------------------

    We received no public comments related to the burden estimates for 
group registration for the CMS Web Interface. The burden estimates have 
not been updated from the CY 2019 PFS proposed rule (83 FR 36027 
through 36028).
    Group Registration for CAHPS for MIPS Survey: This rule does not 
include any new or revised reporting, recordkeeping, or third-party 
disclosure requirements related to the group registration for the CAHPS 
for MIPS Survey. However, we have adjusted our currently approved 
burden estimates based on more recent data. The adjusted burden will be 
submitted to OMB for approval under control number 0938-1222 (CMS-
10450).
    In this final rule, we have adjusted our currently approved number 
of respondents based on more recent data and adjusted our per 
respondent time estimate based on our review of the current burden 
estimates against the existing registration process.
    Under MIPS, the CAHPS for MIPS survey counts for 1 measure toward 
the MIPS quality performance category and, as a patient experience 
measure, it also fulfills the requirement to submit at least one high 
priority measure in the absence of an applicable outcome measure. 
Groups that wish to administer the CAHPS for MIPS survey must register 
by June of the applicable 12-month performance period, and 
electronically notify CMS of which vendor they have selected to 
administer

[[Page 60010]]

the survey on their behalf. For the 2019 MIPS performance period, we 
assume that 282 groups will enroll in the MIPS for CAHPS survey based 
on the number of groups which elected to register during the CY 2018 
registration period; a decrease of 179 compared to the number of groups 
currently approved by OMB under the aforementioned control number (82 
FR 53917).
    As shown in Table 75, we assume that the staff involved in the 
group registration for CAHPS for MIPS Survey will mainly be computer 
systems analysts (or their equivalent) who have an average labor cost 
of $89.18/hr. We assume the CAHPS for MIPS Survey registration burden 
consists of 0.25 hours to register for the survey as well as 0.5 hours 
to select the CAHPS for MIPS Survey vendor that will be used and 
electronically notifying CMS of this selection. In this regard, the 
total time for CAHPS for MIPS registration is 0.75 hours. Although the 
registration process remains unchanged from the CY 2018 Quality Payment 
Program final rule, after we reviewed the steps required for 
registration more thoroughly, we believe that the burden was less than 
we had originally estimated. Therefore, we have adjusted the estimated 
burden from 1.5 hours to 0.75 hours per respondent.
    In aggregate, we estimate an annual burden of 211.50 hours (282 
groups x 0.75 hr per group) at a cost of $18,862 (211.50 hr x $89.18/
hr).
    Independent of the change in time per group, the decrease in the 
number of groups registering results is an adjustment to the total 
burden of -268.5 hours at -$23,945 (-179 groups x 1.5 hrs x $89.18/hr). 
Accounting for the decrease in the number of groups registering, the 
decrease in time per group to register results in an adjustment to the 
total burden of -211.5 hours at -$18,862 (282 groups x -0.75 hr x 
$89.18/hr). When these adjustments are combined, the net adjustment is 
-480 hours (-268.5-211.5) at -$42,807 (-$23,945-$18,862).

  Table 75--Estimated Burden for Group Registration for CAHPS for MIPS
                                 Survey
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of Groups Registering for CAHPS (a)...................             282
Total Annual Hours for CAHPS Registration (b)...........            0.75
                                                         ---------------
    Total Annual Hours for CAHPS Registration (c) = (a)            211.5
     * (b)..............................................
                                                         ---------------
Labor Rate to Register for CAHPS (computer systems             $89.18/hr
 analyst) (d)...........................................
                                                         ---------------
    Total Annual Cost for CAHPS Registration (e) = (a) *         $18,862
     (d)................................................
------------------------------------------------------------------------

    We received no public comments related to the burden estimates for 
group registration for the CAHPS for MIPS survey. However, the burden 
estimates have been updated from the CY 2019 PFS proposed rule to 
reflect availability of data from the 2018 MIPS performance period (83 
FR 36028 through 36029).
9. Quality Payment Program ICRs Regarding the Nomination of Quality 
Measures
    This rule does not include any new or revised reporting, 
recordkeeping, or third-party disclosure requirements related to the 
nomination of quality measures. However, we have adjusted our currently 
approved burden estimates based on more recent data. We have also 
accounted for burden associated with policies that have been finalized 
but whose burden were erroneously excluded from our estimates. The new 
and adjusted burden will be submitted to OMB for approval under control 
number 0938-1314 (CMS-10621).
    As discussed in section III.I.3.h.(2)(b)(i) of this final rule, 
quality measures are selected annually through a call for quality 
measures under consideration, with a final list of quality measures 
being published in the Federal Register by November 1 of each year. 
Under section 1848(q)(2)(D)(ii) of the Act, the Secretary must solicit 
a ``Call for Quality Measures'' each year. Specifically, the Secretary 
must request that eligible clinician organizations and other relevant 
stakeholders identify and submit quality measures to be considered for 
selection in the annual list of MIPS quality measures, as well as 
updates to the measures. Under section 1848(q)(2)(D)(ii) of the Act, 
eligible clinician organizations are professional organizations as 
defined by nationally recognized specialty boards of certification or 
equivalent certification boards.
    As we described in the CY 2017 Quality Payment Program final rule 
(81 FR 77137), we will accept quality measures submissions at any time, 
but only measures submitted during the timeframe provided by us through 
the pre-rulemaking process of each year will be considered for 
inclusion in the annual list of MIPS quality measures for the 
performance period beginning 2 years after the measure is submitted. 
This process is consistent with the pre-rulemaking process and the 
annual call for measures, which are further described at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Pre-Rule-Making.html.
    To identify and submit a quality measure, eligible clinician 
organizations and other relevant stakeholders use a one-page online 
form that requests information on background, a gap analysis which 
includes evidence for the measure, reliability, validity, endorsement 
and a summary which includes how the proposed measure relates to the 
Quality Payment Program and the rationale for the measure. In addition, 
proposed measures must be accompanied by a completed Peer Review 
Journal Article form.
    As shown in Table 76, we estimate that approximately 140 
organizations, including clinicians, CEHRT developers, and vendors, 
will submit measures for the Call for Quality Measures process; an 
increase of 100 compared to the number of organizations currently 
approved by OMB. In keeping with the focus on clinicians as the primary 
source for recommending new quality measures, we are using practice 
administrators and clinician time for our burden estimates. We also 
estimate it will take 0.5 hours per organization to submit an activity 
to us, consisting of 0.3 hours at $107.38/hr for a practice 
administrator to make a strategic decision to nominate and submit a 
measure and 0.2 hours at $206.44/hr for clinician review time.
    The 0.5 hour estimate assumes that submitters will have the 
necessary information to complete the nomination form readily 
available, which we believe is a reasonable assumption. Additionally, 
some submitters familiar

[[Page 60011]]

with the process or who are submitting multiple measures may require 
significantly less time, while other submitters may require more if the 
opposite is true; on average we believe 0.5 hours is a reasonable 
average across all submitters.
    Consistent with the CY 2017 Quality Payment Program final rule, we 
also estimate it will take 4 hours at $206.44/hr for a clinician (or 
equivalent) to complete the Peer Review Journal Article Form (81 FR 
77153 through 77155). This assumes that measure information is 
available and testing is complete in order to have the necessary 
information to complete the form, which we believe is a reasonable 
assumption. Although the requirement for completing the Peer Review 
Journal Article was previously included in the CY 2017 Quality Payment 
Program final rule, the time required for completing the form was 
erroneously excluded from our burden estimates.
    As shown in Table 76, in aggregate we estimate an annual burden of 
630 hours (140 organizations x 4.5 hr/response) at a cost of $125,896 
(140 x [(0.3 hr x $107.38/hr) + (4.2 hr x $206.44/hr)].
    Independent of the change in time per organization, the change in 
the number of organizations nominating new quality measures results in 
an adjustment of 50 hours at $7,350 (100 organizations x [(0.3 hr x 
$107.38/hr) + (0.2 hr x $206.44/hr)]). When accounting for the change 
in respondents, the change in burden to nominate a quality measure 
results in an adjustment of 560 hours at $115,606 (140 organizations x 
4 hr x $206.44/hr). When these adjustments are combined, the total 
adjustment is 610 hours (560 + 50) at $122,956 ($7,350 + $115,606).

        Table 76--Estimated Burden for Call for Quality Measures
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of Organizations Nominating New Quality Measures (a)..             140
# of Hours Per Practice Administrator to Identify and               0.30
 Propose Measure (b)....................................
# of Hours Per Clinician to Identify Measure (c)........            0.20
# of Hours Per Clinician to Complete Peer Review Article            4.00
 Form (d)...............................................
Annual Hours Per Response (e) = (b) + (c) + (d).........            4.50
                                                         ---------------
        Total Annual Hours (f) = (a) * (e)..............             630
                                                         ---------------
Cost to Identify and Submit Measure (@ practice                   $32.21
 administrator's labor rate of $107.38/hr.) (g).........
Cost to Identify Quality Measure and Complete Peer               $867.05
 Review Article Form (@ physician's labor rate of
 $206.44/hr.) (h).......................................
                                                         ---------------
        Total Annual Cost Per Respondent (i) = (g) + (h)         $899.26
                                                         ---------------
        Total Annual Cost (j) = (a) * (i)...............        $125,896
------------------------------------------------------------------------

    We received no public comments related to the burden estimates for 
the Call for Quality Measures. The burden estimates have not been 
updated from the CY 2019 PFS proposed rule (83 FR 36029 through 36030).
10. Quality Payment Program ICRs Regarding Promoting Interoperability 
Data (Sec. Sec.  414.1375 and 414.1380)
    The finalized requirements and burden discussed under this section 
will be submitted to OMB for approval under control number 0938-1314 
(CMS-10621).
    For the 2019 MIPS performance period, clinicians and groups can 
submit Promoting Interoperability data through direct, log in and 
upload, or log in and attest submission types. We have worked to 
further align the Promoting Interoperability performance category with 
other MIPS performance categories. With the exception of submitters who 
elect to use the log in and attest submission type for the Promoting 
Interoperability performance category which is not available for the 
quality performance category, we anticipate that most organizations 
will use the same data submission type for the both of these 
performance categories and that the clinicians, practice managers, and 
computer systems analysts involved in supporting the quality data 
submission will also support the Promoting Interoperability data 
submission process. Hence, the following burden estimates show only 
incremental hours required above and beyond the time already accounted 
for in the quality data submission process. Although this analysis 
assesses burden by performance category and submission type, we 
emphasize that MIPS is a consolidated program and submission analysis 
and decisions are expected to be made for the program as a whole.
    Reweighting Applications for Promoting Interoperability and Other 
Performance Categories: As established in the CY 2017 and CY 2018 
Quality Payment Program final rules, MIPS eligible clinicians who meet 
the criteria for a significant hardship or other type of exception may 
submit an application requesting a zero percent weighting for the 
Promoting Interoperability performance category in the following 
circumstances: insufficient internet connectivity, extreme and 
uncontrollable circumstances, lack of control over the availability of 
CEHRT, clinicians who are in a small practice, and decertified EHR 
technology (81 FR 77240 through 77243 and 82 FR 53680 through 53686). 
In addition, as finalized in the CY 2018 Quality Payment Program final 
rule, MIPS eligible clinicians and groups citing extreme and 
uncontrollable circumstances may also apply for a reweighting of the 
quality, cost, and/or improvement activities performance categories (82 
FR 53783 through 53785). Respondents who apply for a reweighting for 
any of these performance categories have the option of applying for 
reweighting for the Promoting Interoperability performance category on 
the same online form. Since we do not have data on the number of 
reweighting applications submitted for the 2018 MIPS performance period 
for this rule, we assume that respondents applying for a reweighting of 
the Promoting Interoperability performance category due to extreme and 
uncontrollable circumstances will also request a reweighting of at 
least one of the other performance categories simultaneously and not 
submit multiple reweighting applications. As data availability allows, 
we will estimate the reporting burden for each reweighting application 
under separate ICRs in future rulemaking.
    Table 77 summarizes the burden for clinicians to apply for 
reweighting the

[[Page 60012]]

Promoting Interoperability performance category to zero percent due to 
a significant hardship exception (including a significant hardship 
exception for small practices) or as a result of a decertification of 
an EHR. Based on the number of reweighting applications received for 
the 2017 MIPS performance period, we assume 6,041 respondents (eligible 
clinicians or groups) will submit a request to reweight the Promoting 
Interoperability performance category to zero percent due to a 
significant hardship (including clinicians in small practices) or EHR 
decertification. We estimate that 3,344 respondents (eligible 
clinicians or groups) will submit a request for reweighting the 
Promoting Interoperability performance category to zero percent due to 
extreme and uncontrollable circumstances, insufficient internet 
connectivity, lack of control over the availability of CEHRT, or as a 
result of a decertification of an EHR. An additional 2,697 respondents 
will submit a request for reweighting the Promoting Interoperability 
performance category to zero percent as a small practice experiencing a 
significant hardship. In total, this represents a decrease of 34,604 
from the number of respondents currently approved by OMB. In the CY 
2019 PFS proposed rule, we lacked the detailed data necessary to 
independently estimate the number of reweighting applications submitted 
by clinicians in a small practice who were of an eligible clinician 
type and are not eligible to have the Promoting Interoperability 
performance category reweighted for any other reason (for example, 
because they are hospital-based, ASC-based, or non-patient facing), and 
therefore, assumed all clinicians in small practices that met these 
criteria would apply for reweighting of the Promoting Interoperability 
performance category. Data from the 2017 MIPS performance period has 
sufficient detail to allow for this analysis, resulting in a decrease 
of 78,573 from the estimate of 81,270 clinicians in a small practice 
cited in the CY 2019 PFS proposed rule (83 FR 36030).
    The total of 6,041 respondents represents a decrease of 34,604 from 
the number of respondents currently approved by OMB. The application to 
request a reweighting to zero percent only for the Promoting 
Interoperability performance category is a short online form that 
requires identifying the type of hardship experienced or whether 
decertification of an EHR has occurred and a description of how the 
circumstances impair the clinician or group's ability to submit 
Promoting Interoperability data, as well as some proof of circumstances 
beyond the clinician's control. The application for reweighting of the 
quality, cost, Promoting Interoperability, and/or improvement 
activities performance categories due to extreme and uncontrollable 
circumstances requires the same information with the exception of there 
being only one option for the type of hardship experienced. We estimate 
it will take 0.25 hours at $89.18/hr for a computer system analyst to 
submit the application. This is a reduction from the 0.5 hours 
estimated in the CY 2018 Quality Payment Program final rule due to a 
revised assessment of the application process (82 FR 53918). As shown 
in Table 77, in aggregate, we estimate an annual burden of 1,510.25 
hours (6,041 applications x 0.25 hr/application) at a cost of $134,684 
(1,510.25 hr x $89.18/hr).
    Independent of the change to the number of respondents, the 
decrease in the amount of time to submit a reweighting application 
results in an adjustment of -10,161.25 hours at -$906,180 (40,645 
respondents x -0.25 hr x $89.18/hr). Accounting for the decrease in 
time per respondent, the decrease in the number of respondents 
submitting reweighting applications results in an adjustment of -8,651 
hours at -$771,496 (-34,604 respondents x 0.25 hr x $89.18hr). When 
these adjustments are combined, the total adjustment is -18,812.25 
hours (-10,161.25-8,651) at $1,677,676 (-$906,180-$771,496).

  Table 77--Estimated Burden for Reweighting Applications for Promoting
            Interoperability and Other Performance Categories
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of Eligible Clinicians or Groups Applying Due to                 3,344
 Significant Hardship and Other Exceptions (a)..........
# of Eligible Clinicians or Groups Applying Due to                 2,697
 Significant Hardship for Small Practice (b)............
                                                         ---------------
    Total Respondents Due to Hardships, Other Exceptions           6,041
     and Hardships for Small Practices (c)..............
                                                         ---------------
Hours Per Applicant per application submission (d)......            0.25
                                                         ---------------
    Total Annual Hours (e) = (a) * (c)..................        1,510.25
Labor Rate for a computer systems analyst (f)...........       $89.18/hr
                                                         ---------------
    Total Annual Cost (g) = (a) * (f)...................        $134,684
------------------------------------------------------------------------

    The following is a summary of the public comments received on the 
Quality Payment Program ICRs regarding reweighting applications for 
Promoting Interoperability and other performance categories:
    Comment: One commenter noted that CMS's estimate of 15 minutes to 
complete and submit the Promoting Interoperability reweighting 
application is low and should be increased to an estimate of between 30 
minutes and 1 hour.
    Response: We understand that some respondents may require 
additional time to submit a reweighting application above the 15 
minutes we estimate, but we believe this estimate is a reasonable 
average across all respondents as the application process requires 
limited basic information about the clinician or submitter, a small 
number of check boxes and drop-down selections, and a free text field 
to provide justification for the requested application. In addition, we 
believe increased familiarity with the process in its second year also 
reduces the average time across all respondents.
    After consideration of public comments, we are making no changes to 
our estimates as a result of public comments received. However, the 
burden estimates have been updated from the CY 2019 PFS proposed rule 
to reflect availability of data from the 2017 MIPS performance period 
(83 FR 36030 through 36031).

[[Page 60013]]

    Submitting Promoting Interoperability Data: In this final rule, we 
have adjusted the estimated number of respondents based on data from 
the 2017 MIPS performance period and the estimated per respondent time 
due to the net reduction of 3 measures (6 removed measures and 3 new 
measures) for which clinicians are required to submit data, which we 
are finalizing as discussed in section III.I.3.h.(5)(f) of this final 
rule.
    A variety of organizations will submit Promoting Interoperability 
data on behalf of clinicians. Clinicians not participating in a MIPS 
APM may submit data as individuals or as part of a group. In the CY 
2017 Quality Payment Program final rule (81 FR 77258 through 77260, 
77262 through 77264), we established that eligible clinicians in MIPS 
APMS other than the Shared Savings Program may submit data for the 
Promoting Interoperability performance category as individuals or as 
part of a group, whereas eligible clinicians participating in the 
Shared Savings Program are limited to submitting data through the ACO 
participant TIN. In section III.I.3.h.(6)(d)(ii) of this final rule, we 
are finalizing our proposal to extend this flexibility to allow for 
both individual and group reporting by eligible clinicians 
participating in the Shared Savings Program.
    As shown in Table 78, based on data from the 2017 MIPS performance 
period, we estimate that a total of 93,933 respondents consisting of 
81,456 individual MIPS eligible clinicians and 12,413 groups will 
submit Promoting Interoperability data. Similar to the process shown in 
Table 66 for groups reporting via QCDR/MIPS CQM and eCQM collection 
types, we have adjusted the group reporting data from the 2017 MIPS 
performance period to account for virtual groups, as the option to 
submit data as a virtual group was not available until the 2018 MIPS 
performance period. These estimates reflect that under the policies in 
the CY 2017 Quality Payment Program final rule and in the CY 2018 
Quality Payment Program final rule, certain MIPS eligible clinicians 
will be eligible for automatic reweighting of the Promoting 
Interoperability performance category to zero percent, including MIPS 
eligible clinicians that are hospital-based, ambulatory surgical 
center-based, non-patient facing clinicians, physician assistants, 
nurse practitioners, clinician nurse specialists, and certified 
registered nurse anesthetists (81 FR 77238 through 77245 and 82 FR 
53680 through 53687). As discussed in section III.I.3.h.(5)(h)(ii) of 
this final rule, starting with the 2021 MIPS payment year, we are 
finalizing a policy to automatically reweight the Promoting 
Interoperability performance category for clinician types new to MIPS: 
Physical therapists; occupational therapists; qualified speech-language 
pathologists or qualified audiologist; clinical psychologists; and 
registered dieticians or nutrition professionals. These estimates also 
account for the reweighting policies finalized in the CY 2017 and CY 
2018 Quality Payment Program final rules, including exceptions for MIPS 
eligible clinicians who have experienced a significant hardship 
(including clinicians who are in small practices), as well as 
exceptions due to decertification of an EHR.
    Further, we assume that Shared Savings Program Track 1 ACOs will 
submit data at the ACO participant TIN-level, APM Entities electing the 
one-sided track in the CEC model will submit data at the group TIN-
level, and APM Entities in the OCM (one-sided risk arrangement) will 
submit data at APM Entity level; these entities are included in our 
estimate of the number of groups submitting data. Our respondent 
estimate is based on existing data and does not consider policies 
finalized in section V of this final rule, as well as additional 
policies that were proposed in the August 2018 proposed rule and may be 
finalized in a future rule, which may change the number of Shared 
Saving Program ACOs that are required to submit Promoting 
Interoperability data for future years.\45\
---------------------------------------------------------------------------

    \45\ https://www.thefederalregister.org/fdsys/pkg/FR-2018-08-17/pdf/2018-17101.pdf.

      Table 78--Estimated Number of Respondents To Submit Promoting
        Interoperability Performance Data on Behalf of Clinicians
------------------------------------------------------------------------
                                                             Number of
                                                            respondents
------------------------------------------------------------------------
Number of individual clinicians to submit Promoting               81,456
 Interoperability (a)...................................
Number of groups to submit Promoting Interoperability(b)          12,477
Subtract: Number of groups to submit Promoting                        80
 Interoperability on behalf of clinicians in Quality
 Payment Program Year 3 that will submit as virtual
 groups in Quality Payment Program Year 3 (c)...........
Add in: Number of virtual groups to submit Promoting                  16
 Interoperability on behalf of clinicians in Quality
 Payment Program Year 3 (d).............................
Number of groups to submit Promoting Interoperability on          12,413
 behalf of clinicians in Quality Payment Program Year 3
 (e) = (b)-(c) + (d)....................................
                                                         ---------------
    Total (f) = (a) + (e)...............................          93,869
------------------------------------------------------------------------

    In the CY 2018 Quality Payment Program final rule, we estimated it 
takes 3 hours for a computer system analyst to collect and submit 
Promoting Interoperability performance category data (82 FR 53920). For 
this final rule, we estimate the time required to submit such data 
should be reduced by 20 minutes to 2.67 hours due to the reduction in 
the number of measures for which clinicians are required to submit 
data, which we are finalizing as discussed in section III.I.3.h.(5)(f) 
of this final rule. As shown in Table 78, the total time for an 
organization to submit data on the specified Promoting Interoperability 
objectives and measures is estimated to be 250,317 hours (93,869 
respondents x 2.67 incremental hours for a computer analyst's time 
above and beyond the clinician, practice manager, and computer system's 
analyst time required to submit quality data) at a cost of $22,323,300 
(250,317 hr x $89.18/hr).
    Independent of the change in the number of respondents, the 
reduction in estimated time to submit Promoting Interoperability data 
results in a decrease in burden of -72,738.33 hours at -$6,486,805 
(218,215 respondents x -0.33 hr x $89.18/hr). Accounting for the 
decreased per respondent time, the decrease in the number of 
respondents

[[Page 60014]]

results in an adjustment to the total burden of -331,589.33 hours at -
$29,571,137 (-124,346 respondents x 2.67 hrs x $89.18/hr). When these 
adjustments are combined, the total adjustment is -404,327.67 hours (-
72,738.33 -331,589.33) at -$36,057,941 (-$6,486,805 -$29,571,137).

  Table 79--Estimated Burden for Promoting Interoperability Performance
                        Category Data Submission
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of individual clinicians to submit Promoting               81,456
 Interoperability (a)...................................
Number of groups to submit Promoting Interoperability             12,413
 (b)....................................................
                                                         ---------------
    Total (c) = (a) + (b)...............................          93,869
                                                         ---------------
    Total Annual Hours Per Respondent (b)...............            2.67
                                                         ---------------
Total Annual Hours (c) = (a) * (b)......................         250,317
                                                         ---------------
Labor rate for a computer systems analyst to submit            $89.18/hr
 Promoting Interoperability data/hr.) (d)...............
                                                         ---------------
    Total Annual Cost (e) = (a) * (d)...................     $22,323,300
------------------------------------------------------------------------

    The following is a summary of the public comments received on the 
Quality Payment Program ICRs regarding Promoting Interoperability Data:
    Comment: One commenter noted that CMS should consider and reduce 
the operational burden imposed on clinicians and medical practice staff 
by the required measures and reporting processes associated with the 
Quality Payment Program specifically and all quality reporting programs 
in general. The commenter cited the 20 minute reduction in burden 
associated with the proposed reduction in Promoting Interoperability 
measures as evidence of its belief that reducing the number of measures 
is not enough to reduce the total burden on respondents. The commenter 
also noted its belief that frustration and clinician burnout are 
increased due to the documentation requirements and workflow 
modifications associated with quality reporting programs.
    Response: We thank the commenter for its input. We recognize there 
is additional burden on clinicians and practice staff beyond the 
reporting burden estimated in the Collection of Information section of 
this policy which only accounts for the time required for record 
keeping, reporting, and third-party disclosures associated with the 
policy. CMS does consider the operational burden imposed on clinicians 
and practice staff and weighs it against the goal of improving quality 
of care prior to finalizing policy decisions. On balance, we believe 
that any potential additional burden is outweighed by increased quality 
and improved patient outcomes. We will continue to monitor this balance 
and will continue to propose efficiencies and policies that will help 
to further reduce burden.
    After consideration of public comments, we are making no changes to 
our estimates as a result of public comments received. However, the 
burden estimates have been updated from the CY 2019 PFS proposed rule 
to reflect availability of data from the 2017 MIPS performance period 
(83 FR 36031 through 36032).
11. Quality Payment Program ICRs Regarding the Nomination of Promoting 
Interoperability (PI) Measures
    This rule does not include any new or revised reporting, 
recordkeeping, or third-party disclosure requirements related to the 
nomination of Promoting Interoperability measures. However, we have 
adjusted our currently approved burden estimates based data from the 
2017 MIPS performance period. The adjusted burden will be submitted to 
OMB for approval under control number 0938-1314 (CMS-10621).
    Consistent with our requests for stakeholder input on quality 
measures and improvement activities, we also request potential measures 
for the Promoting Interoperability performance category that measure 
patient outcomes, emphasize patient safety, support improvement 
activities and the quality performance category, and build on the 
advanced use of CEHRT using 2015 Edition standards and certification 
criteria. Promoting Interoperability measures may be submitted via a 
designated submission form that includes the measure description, 
measure type (if applicable), reporting requirement, and CEHRT 
functionality used (if applicable).
    We estimate 47 organizations will submit Promoting Interoperability 
measures, based on the number of organizations submitting measures 
during the CY 2017 nomination period. This is an increase of 7 from the 
estimate currently approved by OMB under the aforementioned control 
number. We estimate it will take 0.5 hours per organization to submit 
an activity to us, consisting of 0.3 hours at $107.38/hr for a practice 
administrator to make a strategic decision to nominate that activity 
and submit an activity to us via email and 0.2 hours at $206.44/hr for 
a clinician to review the nomination. As shown in Table 80, in 
aggregate, we estimate an annual burden of 235 hours (47 organizations 
x 0.5 hr/response) at a cost of $3,455 (47 x [(0.3 h x $107.38/hr) + 
(0.2 hr x $206.44/hr)]. The increase in the number of respondents 
results in an adjustment of 3.5 hours and $514.50 (7 respondents x 0.5 
hrs x $73.50 per respondent).

   Table 80--Estimated Burden for Call for Promoting Interoperability
                                Measures
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of Organizations Nominating New Promoting                           47
 Interoperability Measures (a)..........................
# of Hours Per Practice Administrator to Identify and               0.30
 Propose Measure (b)....................................
# of Hours Per Clinician to Identify Measure (c)........            0.20

[[Page 60015]]

 
Annual Hours Per Respondent (d) = (b) + (c).............            0.50
                                                         ---------------
    Total Annual Hours (e) = (a) * (d)..................           23.50
                                                         ---------------
Cost to Identify and Submit Measure (@practice                    $32.21
 administrator's labor rate of $107.38/hr.) (f).........
Cost to Identify Improvement Measure (@physician's labor          $41.29
 rate of $206.44/hr.) (g)...............................
                                                         ---------------
    Total Annual Cost Per Respondent (h) = (f) + (g)....          $73.50
    Total Annual Cost (i) = (a) * (h)...................          $3,455
------------------------------------------------------------------------

    We received no public comments related to the burden estimates for 
the Call for Promoting Interoperability Measures. The burden estimates 
have not been updated from the CY 2019 PFS proposed rule (83 FR 36032 
through 36033).
12. Quality Payment Program ICRs Regarding Improvement Activities 
Submission (Sec. Sec.  414.1305, 414.1355, 414.1360, and 414.1365)
    This rule does not include any new or revised reporting, 
recordkeeping, or third-party disclosure requirements related to the 
submission of Improvement Activities data. However, we have adjusted 
our currently approved burden estimates based on more recent data. The 
adjusted burden will be submitted to OMB for approval under control 
number 0938-1314 (CMS-10621).
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77511 through 77512) and the CY 2018 Quality Payment Program 
final rule (82 FR 53920 through 53922) for our previous burden 
estimates for improvement activities under the Quality Payment Program.
    The CY 2018 Quality Payment Program final rule provides: (1) That 
for activities that are performed for at least a continuous 90 days 
during the performance period, MIPS eligible clinicians must submit a 
``yes'' response for activities within the Improvement Activities 
Inventory (82 FR 53651); (2) that the term ``recognized'' is accepted 
as equivalent to the term ``certified'' when referring to the 
requirements for a patient-centered medical home to receive full credit 
for the improvement activities performance category for MIPS (82 FR 
53649); and (3) that for the 2020 MIPS payment year and future years, 
to receive full credit as a certified or recognized patient-centered 
medical home or comparable specialty practice, at least 50 percent of 
the practice sites within the TIN must be recognized as a patient-
centered medical home or comparable specialty practice (82 FR 53655).
    In the CY 2017 Quality Payment Program final rule, we describe how 
we determine MIPS APM scores (81 FR 77185). We compare the requirements 
of the specific MIPS APM with the list of activities in the Improvement 
Activities Inventory and score those activities in the same manner that 
they are otherwise scored for MIPS eligible clinicians (81 FR 77817 
through 77831). If, by our assessment, the MIPS APM does not receive 
the maximum improvement activities performance category score, then the 
APM Entity can submit additional improvement activities, although, as 
we noted, we anticipate that MIPS APMs in the 2019 MIPS performance 
period will not need to submit additional improvement activities as the 
models will already meet the maximum improvement activities performance 
category score (81 FR 77185).
    A variety of organizations and in some cases, individual 
clinicians, will submit improvement activity performance category data. 
For clinicians who are not part of APMs, we assume that clinicians 
submitting quality data as part of a group through direct, log in and 
upload submission types, and CMS Web Interface will also submit 
improvement activities data. As finalized in the CY 2017 Quality 
Payment Program final rule (81 FR 77264), APM Entities only need to 
report improvement activities data if the CMS-assigned improvement 
activities score is below the maximum improvement activities score. Our 
CY 2018 Quality Payment Program final rule burden estimates assumed 
that all APM Entities will receive the maximum CMS-assigned improvement 
activities score (82 FR 53921 through 53922).
    As represented in Table 81, based on 2017 MIPS performance period 
data, we estimate that 125,713 clinicians will submit improvement 
activities as individuals during the 2019 MIPS performance period and 
16,478 groups will submit improvement activities on behalf of 
clinicians. Similar to the process shown in Table 77 for groups 
submitting Promoting Interoperability data, we have adjusted the group 
reporting data from the 2017 MIPS performance period to account for 
virtual groups, as the option to submit data as a virtual group was not 
available until the 2018 MIPS performance period.
    Our burden estimates assume there will be no improvement activities 
burden for MIPS APM participants. We will assign the improvement 
activities performance category score at the APM level. We also assume 
that the MIPS APM models for the 2019 MIPS performance period will 
qualify for the maximum improvement activities performance category 
score and the APM Entities will not need to submit any additional 
improvement activities.

[[Page 60016]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.078

    As described in section III.I.3.h.(4)(b) of this final rule, for 
purposes of the 2021 MIPS payment year, we have finalized Sec.  
414.1360(a)(1) to more accurately reflect the data submission process 
for the improvement activities performance category. In particular, 
instead of ``via qualified registries; EHR submission mechanisms; QCDR, 
CMS Web Interface; or attestation,'' as currently stated, we have 
revised the first sentence to state that data will be submitted ``via 
direct, log in and upload, and log in and attest.'' The revision will 
more closely align with the actual submission experience users have.
    In the CY 2018 Quality Payment Program final rule, we estimated it 
would take 1 hour for a computer system analyst to submit data on the 
specified improvement activities (82 FR 53922). We are finalizing to 
decrease this burden estimate since the actual submission experience of 
the user is such that improvement activities data is submitted as part 
of the process for submitting quality and Promoting Interoperability 
data, resulting in less additional required time to submit improvement 
activities data. As a result, we estimate that the per response time 
required per individual or group is 5 minutes at $89.18/hr for a 
computer system analyst to submit by logging in and manually attesting 
that certain activities were performed in the form and manner specified 
by CMS with a set of authenticated credentials. Additionally, as stated 
in the CY 2018 Quality Payment Program final rule, the same improvement 
activity may be reported across multiple performance periods so many 
MIPS eligible clinicians will not have any additional information to 
submit for the 2019 MIPS performance period (82 FR 53921).
    As discussed in section III.I.3.h.(4)(d)(ii) of this final rule, we 
are also finalizing for CY 2019 and future years to: Add 6 new 
improvement activities; modify 5 existing improvement activities; and 
remove 1 existing improvement activity. Because MIPS eligible 
clinicians are still required to submit the same number of activities, 
we do not expect these provisions to affect our collection of 
information burden estimates. In addition, in order for an eligible 
clinician or group to receive credit for being a patient-centered 
medical home or comparable specialty practice, the eligible clinician 
or group must attest in the same manner as any other improvement 
activity.
    As shown in Table 82, we estimate an annual burden of 11,333.7 
hours (136,004 responses x 5 minutes/60) at a cost of $1,010,736 
(11,333.7 hr x $89.18/hr).
    Independent of the change to our per response time estimate, the 
decrease in the number of respondents results in an adjustment of -
303,782 hours at -$27,091,279 (-303,782 respondents x 1 hr x $89.18/
hr). Accounting for the change in number of respondents, the decrease 
in the time to submit improvement activities data results in an 
adjustment of -124,670.33 hours at -$11,118,100.33 (136,004 respondents 
x 55 minutes/60 x $89.18/hr). When these adjustments are combined, the 
total adjustment is -428,452.33 hours (-303,782-124,670.33) hours at -
$38,209,379.33 (-$27,091,279-$11,118,100.33).

    Table 82--Estimated Burden for Improvement Activities Submission
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Total Number of Respondents (Groups, Virtual Groups, and         136,004
 Individual Clinicians) to submit improvement activities
 data on behalf of clinicians during the 2019 MIPS
 performance period (a).................................
Total Annual Hours Per Respondent (b)...................       5 minutes
    Total Annual Hours (c)..............................        11,333.7
Labor rate for a computer systems analyst to submit            $89.18/hr
 improvement activities (d).............................
                                                         ---------------
    Total Annual Cost (e) = (a) * (d)...................      $1,010,736
------------------------------------------------------------------------


[[Page 60017]]

    The following is a summary of the public comments received on the 
Quality Payment Program ICRs regarding Improvement Activities 
Submission:
    Comment: One commenter noted that CMS's estimate of 5 minutes to 
submit data for the Improvement Activities performance category is low 
and should be increased to an estimate of between 15 and 30 minutes.
    Response: We thank the commenter for its input. We understand that 
some respondents may require additional time to submit improvement 
activities data above the 5 minutes we estimate, but we believe this 
estimate is a reasonable average across all respondents as it reflects 
the actual submission experience of the user. User experiences from the 
2017 MIPS performance period reflect that the majority of users submit 
improvement activities data as part of the login and upload or direct 
submission types which allow multiple performance categories (i.e., 
quality and promoting interoperability) worth of data to be submitted 
at once. This results in less additional required time to submit 
improvement activities data which consists of manually attesting that 
certain activities were performed. In addition, as previously stated in 
the CY 2018 Quality Payment Program final rule, the same improvement 
activity may be reported across multiple performance periods so many 
MIPS eligible clinicians will not have any additional information to 
submit for the 2019 MIPS performance period, further reducing the 
average time spent reporting improvement activities data across all 
MIPS eligible clinicians (82 FR 53921).
    After consideration of public comments, we are making no changes to 
our estimates as a result of public comments received. However, the 
burden estimates have been updated from the CY 2019 PFS proposed rule 
to reflect availability of data from the 2017 MIPS performance period 
(83 FR 36033 through 36034).
13. Quality Payment Program ICRs Regarding the Nomination of 
Improvement Activities (Sec.  414.1360)
    The finalized requirements and burden discussed under this section 
will be submitted to OMB for approval under control number 0938-1314 
(CMS-10621). We refer readers to the CY 2018 Quality Payment Program 
final rule for our previous burden estimates for nomination of 
improvement activities under the Quality Payment Program (82 FR 53922). 
In this final rule, we have adjusted the number of respondents based on 
more recent data and adjusted our per response time estimate based on 
our review of our currently approved burden estimates against the 
existing process for nomination of improvement activities. As discussed 
in section III.I.3.h.(4)(d)(i)(A) of this final rule, we are also 
finalizing to adopt one new criteria and remove one existing criteria 
for nominating new improvement activities beginning with the CY 2019 
performance period and future years. Furthermore, we have made 
clarifications to: (1) Considerations for selecting improvement 
activities for the CY 2019 performance period and future years; and (2) 
the weighting of improvement activities. We believe these policy 
changes will not affect our currently approved burden estimates since 
they do not substantively impact the level of effort previously 
estimated to nominate an Improvement Activity.
    As discussed in section III.I.3.h.(4)(d)(i)(D) of this final rule, 
we are finalizing changing the performance year for which the 
nominations will apply, such that improvement activities nominations 
received in a particular year will be vetted and considered for the 
next year's rulemaking cycle for possible implementation in the 
following year. Also, as discussed in section III.I.3.h.(4)(d)(i)(D) of 
this final rule, we are finalizing changing the submission timeframe 
for the Call for Activities from February 1st through March 1st to 
February 1st through June 30th, providing approximately four additional 
months for stakeholders to submit nominations. We believe these policy 
changes will not affect our currently approved burden estimates since 
we believe that the number of nominations is unlikely to change, but 
the quality of the nominations is likely to increase given the 
additional time provided.
    For the 2018 MIPS performance period, we provided opportunity for 
stakeholders to propose new activities formally via the Annual Call for 
Activities nomination form that was posted on the CMS website (82 FR 
53657). The 2018 Annual Call for Activities lasted from March 2, 2017 
through March 1, 2018, for which we received 72 nominations consisting 
of a total of 125 activities which were evaluated for the Improvement 
Activities Under Consideration (IAUC) list for possible inclusion in 
the CY 2019 Improvement Activities Inventory. Based on the number of 
activities being evaluated during the 2018 Annual Call for Activities 
(125 activities), we estimate that the total number of nominations we 
will receive for the 2019 Annual Call for Activities will continue to 
be 125, unchanged from the number of activities evaluated in CY 2018, 
which is a decrease from the 150 nominations currently approved by OMB.
    In the CY 2018 Quality Payment Program final rule, we estimated 
that it takes 0.5 hours to nominate an improvement activity (82 FR 
53922). As shown in Table 83, due to a review of the nomination process 
including the criteria required to nominate an improvement activity, we 
now estimate it will take 2 hours (per organization) to submit an 
activity to us. Of those hours, we estimate it will take 1.2 hours at 
$107.38/hr for a practice administrator or equivalent to make a 
strategic decision to nominate and submit that activity and 0.8 hours 
at $206.44/hr for a clinician's review. In aggregate, we estimate an 
annual burden of 250 hours (125 nominations x 2 hr/nomination) at a 
cost of $36,751 (125 x [(1.2 hr x $107.38/hr) + (0.8 hr x $206.44/
hr)]).
    The percentage of practice administrator and clinician labor in 
relation to the total is unchanged from the CY 2018 Quality Payment 
Program final rule (82 FR 53922).
    Independent of the change to our per response time estimate, the 
decrease in the number of nominations results in an adjustment of -12.5 
hours and -$1,837 (-25 activities x [(0.3 hr x $107.38/hr) + (0.2 hr x 
$206.44/hr)]). Accounting for the decrease in the number of nominated 
improvement activities, the increase in time per nominated improvement 
activity results in an adjustment of 187.5 hours and $27,563 (125 
activities x [(0.9 hr x $107.38/hr) + (0.6 hr x $206.44/hr)]). When 
these adjustments are combined, the total adjustment is 175 hours 
(187.5-12.5) and $25,726 ($27,563-$1,837).

[[Page 60018]]



   Table 83--Estimated Burden for Nomination of Improvement Activities
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of Organizations Nominating New Improvement                   125
 Activities (a).........................................
Number of Hours Per Practice Administrator to Identify               1.2
 and Propose Activity (b)...............................
Number of Hours Per Clinician to Identify Activity (c)..             0.8
                                                         ---------------
Annual Hours Per Respondent (d) = (b) + (c).............               2
                                                         ---------------
    Total Annual Hours (e) = (a) * (d)..................             250
                                                         ---------------
Cost to Identify and Submit Activity (@practice                  $128.86
 administrator's labor rate of $107.38/hr.) (f).........
Cost to Identify Improvement Activity (@physician's              $165.15
 labor rate of $206.44/hr.) (g).........................
Total Annual Cost Per Respondent (h) = (f) + (g)........         $294.01
                                                         ---------------
    Total Annual Cost (i) = (a) * (h)...................         $36,751
------------------------------------------------------------------------

    The following is a summary of the public comments received on the 
Quality Payment Program ICRs regarding Improvement Activities 
Submission:
    Comment: One commenter noted that the burden estimate of 2 hours 
for nomination of Improvement Activities is low due to the time needed 
by clinicians and their staff to assess a need in their practice 
situation, formulate a creative solution, and determine how they would 
implement it in their practice in addition to documenting and 
submitting the improvement activity to CMS.
    Response: We recognize there is additional burden on respondents 
associated with development of a new improvement activity beyond the 
reporting burden estimated in the Collection of Information section of 
this policy which only accounts for the time required for record 
keeping, reporting, and third-party disclosures associated with the 
policy. We understand that some respondents may require additional time 
above the 2 hours we estimate for completing the process for nominating 
an improvement activity, but given that we do not include development 
of an improvement activity in our burden estimate, we believe this 
estimate is a reasonable average across all respondents based on our 
review of the nomination process, the information required to complete 
the nomination form, and the criteria required to nominate an 
improvement activity.
    After consideration of public comments, we are making no changes to 
our estimates as a result of public comments received. The burden 
estimates have not been updated from the CY 2019 PFS proposed rule (83 
FR 36034 through 36035).
14. Quality Payment Program ICRs Regarding CMS Study on Factors 
Associated With Reporting Quality Measures
    During each performance year, eligible clinicians are recruited to 
participate in the CMS study on the burden associated with reporting 
quality measures. Eligible clinicians who are interested in 
participating can sign up whereby an adequate sample size is then 
selected by CMS from this group of potential participants. This study 
is ongoing, and participants are recruited on a yearly basis. Current 
participants can sign up when the study year ends.
    Section 1848(s)(7) of the Act, as added by section 102 of the MACRA 
(Pub. L. 114-10) states that Chapter 35 of title 44, United States 
Code, shall not apply to the collection of information for the 
development of quality measures. Consequently, we are not setting out 
such burden since the study shall inform us (and our contractors) on 
the root causes of clinicians' performance measure data collection and 
data submission burdens and challenges that hinders accurate and timely 
quality measurement activities. We refer readers to the discussion of 
this policy in section VII.F.7 of this final rule.
15. Quality Payment Program ICRs Regarding the Cost Performance 
Category (Sec.  414.1350)
    The cost performance category relies on administrative claims data. 
The Medicare Parts A and B claims submission process (OMB control 
number 0938-1197) is used to collect data on cost measures from MIPS 
eligible clinicians. MIPS eligible clinicians are not required to 
provide any documentation by CD or hardcopy. Moreover, the provisions 
of this final rule do not result in the need to add or revise or delete 
any claims data fields. Therefore, we do not anticipate any new or 
additional submission requirements and/or burden for MIPS eligible 
clinicians resulting from the cost performance category.
    We received no public comments related to burden for the cost 
performance category.
16. Quality Payment Program ICRs Regarding Partial QP Elections (Sec.  
414.1430)
    This rule does not include any new or revised reporting, 
recordkeeping, or third-party disclosure requirements related to QP 
elections. However, we have adjusted our currently approved burden 
estimates based on more recent data. The adjusted burden will be 
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
    APM Entities may face a data submission burden under MIPS related 
to Partial QP elections. Advanced APM participants will be notified 
about their QP or Partial QP status as soon as possible after each QP 
determination. Where Partial QP status is earned at the APM Entity 
level, the burden of Partial QP election will be incurred by a 
representative of the participating APM Entity. Where Partial QP status 
is earned at the eligible clinician level, the burden of Partial QP 
election will be incurred by the eligible clinician. For the purposes 
of this burden estimate, we assume that all MIPS eligible clinicians 
determined to be Partial QPs will participate in MIPS.
    Based on our predictive QP analysis for the 2019 QP performance 
period, we estimate that 6 APM Entities and 75 eligible clinicians will 
make the election to participate as a Partial QP in MIPS (see Table 
84), an increase of 64 from the 17 elections currently approved by OMB 
under the aforementioned control number. We estimate it will take the 
APM Entity representative or eligible clinician 15 minutes (0.25 hr) to 
make this election. In aggregate, we estimate

[[Page 60019]]

an annual burden of 20.25 hours (81 respondents x .25 hr/election) at a 
cost of $1,805.90 (20.25 hours x $89.18/hr). The increase in the number 
of Partial QP elections results in an adjustment of 16 hours and $1,431 
(64 elections x 0.25 hrs x $89.18/hr).

           Table 84--Estimated Burden for Partial QP Election
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of respondents making Partial QP election (6 APM               81
 Entities, 75 eligible clinicians) (a)..................
Total Hours Per Respondent to Elect to Participate as         0.25 hours
 Partial QP (b).........................................
Total Annual Hours (c) = (a) * (b)......................     20.25 hours
Labor rate for computer systems analyst (d).............       $89.18/hr
                                                         ---------------
    Total Annual Cost (d) = (c) * (d)...................       $1,805.90
------------------------------------------------------------------------

    We received no public comments related to the burden estimates for 
Partial QP Election. The burden estimates have not been updated from 
the CY 2019 PFS proposed rule (83 FR 36036).
17. Quality Payment Program ICRs Regarding Other Payer Advanced APM 
Determinations: Payer-Initiated Process (Sec.  414.1440) and Eligible 
Clinician Initiated Process (Sec.  414.1445)
    As indicated below, the finalized requirements and burden discussed 
under this section will be submitted to OMB for approval under control 
number 0938-1314 (CMS-10621).
    Payer Initiated Process (Sec.  414.1440): This rule does not 
include any new or revised reporting, recordkeeping, or third-party 
disclosure requirements related to the Payer Initiated Process. 
However, we have adjusted our currently approved burden estimates based 
on more recent data. The adjusted burden will be submitted to OMB for 
approval under control number 0938-1314 (CMS-10621).
    Beginning in Quality Payment Program Year 3, the All-Payer 
Combination Option will be an available pathway to QP status for 
eligible clinicians participating sufficiently in Advanced APMs and 
Other Payer Advanced APMs. The All-Payer Combination Option allows for 
eligible clinicians to achieve QP status through their participation in 
both Advanced APMs and Other Payer Advanced APMs. In order to include 
an eligible clinician's participation in Other Payer Advanced APMs in 
their QP threshold score, we will need to determine if certain payment 
arrangements with other payers meet the criteria to be Other Payer 
Advanced APMs. To provide eligible clinicians with advance notice prior 
to the start of a given performance period, and to allow other payers 
to be involved prospectively in the process, the 2018 CY Quality 
Payment Program final rule established a payer-initiated process for 
identifying payment arrangements that qualify as Other Payer Advanced 
APMs (82 FR 53844). The payer-initiated process for Other Payer 
Advanced APM determinations began in CY 2018 for Medicaid, Medicare 
Health Plans, and payers participating in CMS multi-payer models. 
Payers seeking to submit payment arrangement information for Other 
Payer Advanced APM determination through the payer-initiated process 
are required to complete a Payer Initiated Submission Form, 
instructions for which is available at https://qpp.cms.gov/. 
Determinations made in 2018 are applicable for the Quality Payment 
Program Year 3.
    Also in the CY 2018 Quality Payment Program final rule we 
established our intent to finalize that the remaining other payers, 
including commercial and other private payers, may request that we 
determine whether other payer arrangements are Other Payer Advanced 
APMs starting prior to the 2020 QP performance period and each 
performance period thereafter (82 FR 53867). As a result, in this final 
rule, we finalized our proposal to eliminate the Payer Initiated 
Process that is specifically for CMS Multi-Payer Models. We believe 
that payers aligned with CMS Multi-Payer Models can submit their 
arrangements through the Payer Initiated Process for Remaining Other 
Payers in section III.I.4.e.(4)(c) of this final rule, or through the 
Medicaid or Medicare Health Plan payment arrangement submission 
processes.
    As shown in Table 85, we estimate that in 2019 for the 2020 QP 
performance period 215 payer-initiated requests for Other Payer 
Advanced APM determinations will be submitted (15 Medicaid payers, 100 
Medicare Advantage Organizations, and 100 remaining other payers), a 
decrease of 85 from the 300 total requests currently approved by OMB 
under the aforementioned control number. We estimate it will take 10 
hours at $89.18/hr for a computer system analyst per arrangement 
submission. In aggregate, we estimate an annual burden of 2,150 hours 
(215 submissions x 10 hr/submission) at a cost of $191,737 (2,150 hr x 
$89.18/hr). The decrease in the number of payer-initiated requests 
results in an adjustment of -850 hours and -$75,803 (-85 requests x 10 
hr x $89.18/hr).

 Table 85--Estimated Burden for Other Payer Advanced APM Identification
                 Determinations: Payer-Initiated Process
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of other payer payment arrangements (15 Medicaid,             215
 100 Medicare Advantage Organizations, 100 remaining
 other payers) (a)......................................
Total Annual Hours Per other payer payment arrangement                10
 (b)....................................................
                                                         ---------------
    Total Annual Hours (c) = (a) * (b)..................           2,150
                                                         ---------------
Labor rate for a computer systems analyst (d)...........       $89.18/hr
                                                         ---------------

[[Page 60020]]

 
    Total Annual Cost for Other Payer Advanced APM              $191,737
     determinations (e) = (a) * (d).....................
------------------------------------------------------------------------

    We received no public comments related to the burden estimates for 
Other Payer Advanced APM Identification Determinations: Payer-Initiated 
Process. The burden estimates have been updated from the CY 2019 PFS 
proposed rule to reflect updated respondent estimates (83 FR 36036 
through 36037).
    Eligible Clinician Initiated Process (Sec.  414.1445): This rule 
does not include any new or revised reporting, recordkeeping, or third-
party disclosure requirements related to the Eligible Clinician 
Initiated Process. However, we have adjusted our currently approved 
burden estimates based on more recent data. The adjusted burden will be 
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
    Beginning in Quality Payment Program Year 3, the All-Payer 
Combination Option will be an available pathway to QP status for 
eligible clinicians participating sufficiently in Advanced APMs and 
Other Payer Advanced APMs. The All-Payer Combination Option allows for 
eligible clinicians to achieve QP status through their participation in 
both Advanced APMs and Other Payer Advanced APMs. In order to include 
an eligible clinician's participation in Other Payer Advanced APMs in 
their QP threshold score, we will need to determine if certain payment 
arrangements with other payers meet the criteria to be Other Payer 
Advanced APMs. To provide eligible clinicians with advanced notice 
prior to the start of a given performance period, and to allow other 
payers to be involved prospectively in the process, the CY 2018 Quality 
Payment Program final rule provided a payer-initiated identification 
process for identifying payment arrangements that qualify as Other 
Payer Advanced APMs (82 FR 53854). In the same rule, under the Eligible 
Clinician Initiated Process, APM Entities and eligible clinicians 
participating in other payer arrangements will have an opportunity to 
request that we determine for the year whether those other payer 
arrangements are Other Payer Advanced APMs (82 FR 53857--53858). 
However, to appropriately implement the statutory requirement to 
exclude from the All Payer Combination Option QP threshold calculations 
certain Title XIX payments and patients, we determined it will be 
problematic to allow APM Entities and eligible clinicians to request 
determinations for Title XIX payment arrangements after the conclusion 
of the QP performance period because any late-identified Medicaid APM 
or Medicaid Medical Home Model that meets the Other Payer Advanced APM 
criteria could unexpectedly affect QP threshold calculations for every 
other clinician in that state (or county). Thus, the CY 2018 Quality 
Payment Program final rule provided that APM Entities and eligible 
clinicians may request determinations for any Medicaid payment 
arrangements in which they are participating at an earlier point, prior 
to the start of a given QP performance period (82 FR 53858). This will 
allow all clinicians in a given state or county to know before the 
beginning of the performance period whether their Title XIX payments 
and patients will be excluded from the all-payer calculations that are 
used for QP determinations for the year under the All-Payer Combination 
Option. This Medicaid specific eligible clinician-initiated 
determination process for Other Payer Advanced APMs also began in CY 
2018, and determinations made in 2018 are applicable for the Quality 
Payment Program Year 3. Eligible clinicians or APM Entities seeking to 
submit payment arrangement information for Other Payer Advanced APM 
determination through the Eligible Clinician-Initiated process are 
required to complete an Eligible Clinician Initiated Submission Form, 
instructions for which is available at https://qpp.cms.gov/.
    As shown in Table 86, we estimate that 150 other payer arrangements 
will be submitted by APM Entities and eligible Other Payer Advanced APM 
determinations, an increase of 75 from the 75 total requests currently 
approved by OMB under the aforementioned control number.
    We estimate it will take 10 hours at $89.18/hr for a computer 
system analyst per arrangement submission to submit this data. In 
aggregate, we estimate an annual burden of 1,500 hours (150 submissions 
x 10 hr/submission) at a cost of $133,770 (1,500 hr x $89.18/hr). The 
increase in the number of clinician-initiated requests results in an 
adjustment of 750 hours and $66,885 (75 requests x 10 hr x $89.18/hr).

 Table 86--Estimated Burden for Other Payer Advanced APM Determinations:
                  Eligible Clinician Initiated Process
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
Number of other payer payment arrangements from APM                  150
 Entities and eligible clinicians.......................
Total Annual Hours Per other payer payment arrangement                10
 (b)....................................................
                                                         ---------------
    Total Annual Hours (c) = (a) * (b)..................           1,500
                                                         ---------------
Labor rate for a computer systems analyst (d)...........       $89.18/hr
                                                         ---------------
    Estimated Total Annual Cost for Other Payer Advanced        $133,770
     APM determinations (e) = (a) * (d).................
------------------------------------------------------------------------

    We received no public comments related to the burden estimates for 
Other Payer Advanced APM Identification Determinations: Eligible 
Clinician Initiated Process. The burden estimates have not been updated 
from the CY

[[Page 60021]]

2019 PFS proposed rule (83 FR 36037 through 36038).
    Submission of Data for QP Determinations under the All-Payer 
Combination Option (Sec.  414.1440): The following reflects the burden 
associated with the first year of data collection resulting from 
policies set out in the CY 2018 Quality Payment Program final rule. 
Because no collection of data was required prior to the CY 2019 
performance period, the requirements and burden were not submitted to 
OMB for approval. However, by virtue of this rulemaking, the 
requirements and burden will be submitted to OMB for approval under 
control number 0938-1314 (CMS-10621).
    The CY 2017 Quality Payment Program final rule provided that either 
APM Entities or individual eligible clinicians must submit by a date 
and in a manner determined by us: (1) Payment arrangement information 
necessary to assess whether each other payer arrangement is an Other 
Payer Advanced APM, including information on financial risk 
arrangements, use of CEHRT, and payment tied to quality measures; (2) 
for each payment arrangement, the amounts of payments for services 
furnished through the arrangement, the total payments from the payer, 
the numbers of patients furnished any service through the arrangement 
(that is, patients for whom the eligible clinician is at risk if actual 
expenditures exceed expected expenditures), and (3) the total number of 
patients furnished any service through the arrangement (81 FR 77480). 
The rule also specified that if we do not receive sufficient 
information to complete our evaluation of another payer arrangement and 
to make QP determinations for an eligible clinician using the All-Payer 
Combination Option, we will not assess the eligible clinicians under 
the All-Payer Combination Option (81 FR 77480).
    In the CY 2018 Quality Payment Program final rule, we explained 
that in order for us to make QP determinations under the All-Payer 
Combination Option using either the payment amount or patient count 
method, we will need to receive all of the payment amount and patient 
count information: (1) Attributable to the eligible clinician or APM 
Entity through every Other Payer Advanced APM; and (2) for all other 
payments or patients, except from excluded payers, made or attributed 
to the eligible clinician during the QP performance period (82 FR 
53885). We also finalized that eligible clinicians and APM Entities 
will not need to submit Medicare payment or patient information for QP 
determinations under the All-Payer Combination Option (82 FR 53885).
    The CY 2018 Quality Payment Program final rule noted that we will 
need this payment amount and patient count information for the periods 
January 1 through March 31, January 1 through June 30, and January 1 
through August 31 (82 FR 53885). We noted that the timing may be 
challenging for APM Entities or eligible clinicians to submit 
information for the August 31 snapshot date. If we receive information 
for either the March 31 or June 30 snapshots, but not the August 31 
snapshot, we will use that information to make QP determinations under 
the All-Payer Combination Option. This payment amount and patient count 
information is to be submitted in a way that allows us to distinguish 
information from January 1 through March 31, January 1 through June 30, 
and January 1 through August 31 so that we can make QP determinations 
based on the two finalized snapshot dates (82 FR 30203 through 30204).
    The CY 2018 Quality Payment Program final rule specified that APM 
Entities or eligible clinicians must submit all of the required 
information about the Other Payer Advanced APMs in which they 
participate, including those for which there is a pending request for 
an Other Payer Advanced APM determination, as well as the payment 
amount and patient count information sufficient for us to make QP 
determinations by December 1 of the calendar year that is 2 years to 
prior to the payment year, which we refer to as the QP Determination 
Submission Deadline (82 FR 53886).
    In section III.I.4.e.(5)(b) of this final rule, we are finalizing 
the addition of a third alternative to allow QP determinations at the 
TIN level in instances where all clinicians who have reassigned billing 
rights to the TIN participate in a single (the same) APM Entity. This 
option will therefore be available to all TINs participating in Full 
TIN APMs, such as the Medicare Shared Savings Program. It will also be 
available to any other TIN for which all clinicians who have reassigned 
billing rights to the TIN participating in a single APM Entity. To make 
QP determinations under the All-Payer Combination Option at the TIN 
level as finalized using either the payment amount or patient count 
method, we will need to receive, by December 1 of the calendar year 
that is 2 years to prior to the payment year, all of the payment amount 
and patient count information: (1) Attributable to the eligible 
clinician, TIN, or APM Entity through every Other Payer Advanced APM; 
and (2) for all other payments or patients, except from excluded 
payers, made or attributed to the eligible clinician(s) during the QP 
performance period for the periods January 1 through March 31, January 
1 through June 30, and January 1 through August 31.
    As shown in Table 87, we assume that 4 APM Entities, 225 TINs, and 
80 eligible clinicians will submit data for QP determinations under the 
All-Payer Combination Option in 2019. We estimate it will take the APM 
Entity representative, TIN representative, or eligible clinician 5 
hours at $107.38/hr for a practice administrator to complete this 
submission. In aggregate, we estimate an annual burden of 1,545 hours 
(309 respondents x 5 hr) at a cost of $165,902 (1,545 hr x $107.38/hr).

 Table 87--Estimated Burden for the Submission of Data for All-Payer QP
                             Determinations
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of APM Entities submitting data for All-Payer QP                     4
 Determinations (a).....................................
# of TINs submitting data for All-Payer QP                           225
 Determinations (b).....................................
# of eligible submitting data for All-Payer QP                        80
 Determinations (c).....................................
Hours Per respondent QP Determinations (d)..............               5
                                                         ---------------
    Total Hours (g) = [(a) * (d)] + [(b) * (d)] + [(c) *           1,545
     (d)]...............................................
                                                         ---------------
Labor rate for a Practice Administrator ($107.38) (h)...      $107.38/hr
                                                         ---------------
    Total Annual Cost for Submission of Data for All-           $165,902
     Payer QP Determinations (i) = (g) * (h)............
------------------------------------------------------------------------


[[Page 60022]]

    We received no public comments related to the burden estimates for 
the Submission of Data for All-Payer QP Determinations. The burden 
estimates have been updated from the CY 2019 PFS proposed rule to 
reflect updated respondent estimates (83 FR 36038 through 36039).
18. Quality Payment Program ICRs Regarding Voluntary Participants 
Election To Opt-Out of Performance Data Display on Physician Compare 
(Sec.  414.1395)
    This rule does not include any new or revised reporting, 
recordkeeping, or third-party disclosure requirements related to the 
election by voluntary participants to opt-out of public reporting on 
Physician Compare. However, we have adjusted our currently approved 
burden estimates based on more recent data. The adjusted burden will be 
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
    We estimate that 10 percent of the total clinicians and groups who 
will voluntarily participate in MIPS will also elect not to participate 
in public reporting. This results in a total of 11,617 (10 percent x 
116,174 voluntary MIPS participants), a decrease of 10,783 from the 
total respondents currently approved by OMB under the aforementioned 
control number due to the reduction in voluntary participation in MIPS 
overall. As we discussed earlier in this section of the final rule, 
voluntary respondents are clinicians that are not QPs and are expected 
to be excluded from MIPS after applying the eligibility requirements 
discussed in section III.I.3.a. of this final rule, but have elected to 
submit data to MIPS. In implementing the finalized opt-in policy, we 
estimate that 33 percent of clinicians that exceed 1 of the low-volume 
criteria, but not all 3, will elect to opt-in to MIPS, become MIPS 
eligible, and no longer be considered a voluntary reporter. This logic 
was also applied in the regulatory impact analysis of this rule. Table 
88 shows that for these voluntary participants, we estimate it will 
take 0.25 hours at $89.18/hr for a computer system analyst to submit a 
request to opt-out. In aggregate, we estimate an annual burden of 
2,904.25 hours (11,617 requests x 0.25 hr/request) at a cost of 
$259,001 (2,904.25 hr x $89.18/hr).
    The decrease in the number of respondents due to policies finalized 
in this rule results in a decrease of -2,695.75 hours (-10,783 
respondents x 0.25 hr) and -$240,407 (-2,695.75 hours x $89.18/hr).

 Table 88--Estimated Burden for Voluntary Participants To Elect Opt Out
            of Performance Data Display on Physician Compare
------------------------------------------------------------------------
                                                              Burden
                                                             estimate
------------------------------------------------------------------------
# of Voluntary Participants Opting Out of Physician               11,617
 Compare (a)............................................
Total Annual Hours Per Opt-out Requester (b)............            0.25
                                                         ---------------
    Total Annual Hours for Opt-out Requester (c) = (a) *        2,904.25
     (b)................................................
                                                         ---------------
Labor rate for a computer systems analyst (d)...........       $89.18/hr
                                                         ---------------
    Total Annual Cost for Opt-out Requests (e) = (a) *          $259,001
     (d)................................................
------------------------------------------------------------------------

    We received no public comments related to the burden estimates for 
voluntary participants to elect to opt out of performance data display 
on Physician Compare. However, the burden estimates have not been 
updated from the CY 2019 PFS proposed rule to reflect availability of 
data from the 2017 MIPS performance period (83 FR 36039).
19. Summary of Annual Quality Payment Program Burden Estimates
    Table 89 summarizes this final rule's burden estimates for the 
Quality Payment Program. To understand the burden implications of the 
policies finalized in this rule, we have also estimated a baseline 
burden of continuing the policies and information collections set forth 
in the CY 2018 Quality Payment Program final rule into the 2019 MIPS 
performance period. Our baseline burden estimates reflect the recent 
availability of data sources to more accurately reflect the number of 
the respondents for the quality, Promoting Interoperability, and 
improvement activities performance categories and the number of 
organizations exempt from the Promoting Interoperability performance 
category.
BILLING CODE 4120-01-P

[[Page 60023]]

[GRAPHIC] [TIFF OMITTED] TR23NO18.079

BILLING CODE 4120-01-C
    Table 90 provides the reasons for changes in the estimated burden 
for information collections in this final rule. We have divided the 
reasons for

[[Page 60024]]

our change in burden into those related to new policies and those 
related to changes in the baseline burden of continued Quality Payment 
Program Year 2 policies that reflect updated data and methods.

    Table 90--Reasons for Change in Burden Compared to the Currently
             Approved CY 2018 Information Collection Burdens
------------------------------------------------------------------------
                                                         Changes to
                                                      ``baseline'' of
                                Changes in burden  burden continued Year
    Table in collection of       due to finalized  2 policy (italics are
          information            Year 3 policies    changes in number of
                                                    respondents' due to
                                                       updated data)
------------------------------------------------------------------------
Table 62: Qualified Registry    None.............  After a review of the
 Self-Nomination.                                   self-nomination
                                                    process, we
                                                    determined it is
                                                    more accurate to
                                                    separately assess
                                                    the burden of
                                                    Qualified Registry
                                                    and QCDR self-
                                                    nomination rather
                                                    than aggregate them
                                                    in the same ICR.
                                                   Review of self-
                                                    nomination process
                                                    resulted in a
                                                    decrease in
                                                    estimated time
                                                    needed to complete
                                                    simplified self-
                                                    nomination (-9.5 hr.
                                                    computer system
                                                    analyst time) and
                                                    full self-nomination
                                                    (-7 hr. computer
                                                    system analyst
                                                    time).
                                                   Increase in the
                                                    number of
                                                    respondents as the
                                                    number of qualified
                                                    registries enrolling
                                                    increases and the
                                                    basis for estimating
                                                    the number of
                                                    respondents is
                                                    updated to reflect
                                                    the number of self-
                                                    nomination
                                                    applications
                                                    received in place of
                                                    the number of
                                                    qualified registries
                                                    being approved.
Table 63: QCDR Self-Nomination  None.............  After a review of the
                                                    self-nomination
                                                    process, we
                                                    determined it is
                                                    more accurate to
                                                    separately assess
                                                    the burden of
                                                    Qualified Registry
                                                    and QCDR self-
                                                    nomination rather
                                                    than aggregate them
                                                    in the same ICR.
                                                   Review of self-
                                                    nomination process
                                                    resulted in an
                                                    increase in
                                                    estimated time
                                                    needed to complete
                                                    simplified self-
                                                    nomination (-0.5 hr.
                                                    computer system
                                                    analyst time) and
                                                    full self-nomination
                                                    (+2 hr. computer
                                                    system analyst
                                                    time).
                                                   Increase in the
                                                    number of
                                                    respondents as the
                                                    number of QCDRs
                                                    enrolling increases
                                                    and the basis for
                                                    estimating the
                                                    number of
                                                    respondents is
                                                    updated to reflect
                                                    the number of self-
                                                    nomination
                                                    applications
                                                    received in place of
                                                    the number of QCDRs
                                                    being approved.
Table 68: Quality Payment       None.............  Decreased number of
 Program Identity Management                        respondents due to
 Application Process.                               updates to the
                                                    identity management
                                                    system being used
                                                    for data submission
                                                    in the 2018 MIPS
                                                    performance period;
                                                    only new respondents
                                                    submitting quality
                                                    data using the CMS
                                                    Enterprise Portal
                                                    need to create a new
                                                    account, versus
                                                    system where all
                                                    respondents
                                                    submitting via EHR
                                                    needed to register
                                                    for user account
                                                    annually.
Table 69: Quality Performance   None.............  Decreased number of
 Category Medicare Part B                           respondents due to
 Claims Collection Type.                            updated data from
                                                    2017 MIPS
                                                    performance period.
                                                   Correction to
                                                    estimate to account
                                                    for reduced number
                                                    of required measures
                                                    compared to PQRS (6
                                                    in MIPS; 9 in PQRS)
                                                    reduced estimated
                                                    time to submit data.
Table 70: Quality Performance   None.............  Decreased number of
 Category QCDR/MIPS CQM                             respondents due to
 Collection Type.                                   updated data from
                                                    2017 MIPS
                                                    performance period.
Table 71: Quality Performance   None.............  Decreased number of
 Category eCQM Collection Type.                     respondents due to
                                                    updated data from
                                                    2017 MIPS
                                                    performance period.
Table 72: Quality Performance   Decrease in        Decrease in the
 Category CMS Web Interface.     number of          number of
                                 required           respondents due to
                                 measures           updated data from
                                 resulted in        the 2018 MIPS
                                 reduction in       performance period
                                 estimated time     as fewer eligible
                                 needed to submit   group practices
                                 data (-12.33 hrs   elected to submit
                                 computer system    data using the CMS
                                 analyst time).     Web Interface.
Table 73: Beneficiary           None.............  Decrease in the
 Responses to CAHPS for MIPS                        number of
 Survey.                                            respondents due to
                                                    updated data from
                                                    the 2018 MIPS
                                                    performance period
                                                    as fewer eligible
                                                    group practices
                                                    elect to have
                                                    vendors administer
                                                    the CAHPS for MIPS
                                                    survey and fewer
                                                    beneficiaries per
                                                    group respond to the
                                                    survey, on average.
Table 74: Registration for CMS  None.............  Increase in the
 Web Interface.                                     number of
                                                    respondents due to
                                                    updated data from
                                                    the 2018 MIPS
                                                    performance period
                                                    as more groups
                                                    register to submit
                                                    data using the CMS
                                                    Web Interface.
                                                   Review of
                                                    registration process
                                                    resulted in decrease
                                                    in estimated time to
                                                    register. (-0.75 hr.
                                                    computer system
                                                    analyst time).
Table 75: Registration for      None.............  Decrease in the
 CAHPS for MIPS Survey.                             number of
                                                    respondents due to
                                                    updated data from
                                                    the 2018 MIPS
                                                    performance period
                                                    as fewer eligible
                                                    group practices
                                                    elect to have
                                                    vendors administer
                                                    the CAHPS for MIPS
                                                    survey.
                                                   Review of
                                                    registration process
                                                    resulted in decrease
                                                    in estimated time to
                                                    register. (-0.75 hr.
                                                    computer system
                                                    analyst time).
Table 76: Call for Quality      None.............  Increase in the
 Measures.                                          number of new
                                                    quality measures
                                                    being nominated.
                                                   Inclusion of time
                                                    required to complete
                                                    Peer Review Journal
                                                    Article Form
                                                    resulted in increase
                                                    in time to nominate
                                                    a quality measure.
                                                    This was a
                                                    requirement in the
                                                    CY 2017 Quality
                                                    Payment Program
                                                    final rule (81 FR
                                                    77153 through 77155)
                                                    but was not included
                                                    in burden estimates.
                                                    (+4 hrs Physician
                                                    time).
Table 77: Reweighting           None.............  Decrease in the
 Applications for Promoting                         number of
 Interoperability and Other                         respondents due to
 Performance Categories.                            updated data from
                                                    2017 MIPS
                                                    performance period.
                                                   Review of application
                                                    process resulted in
                                                    decrease in
                                                    estimated time to
                                                    apply (-0.25 hr
                                                    computer system
                                                    analyst time).
Table 79: Promoting             Decrease in        Decrease in the
 Interoperability Performance    number of          number of
 Category Data Submission.       required           respondents due to
                                 measures           updated data from
                                 resulted in        2017 MIPS
                                 reduction in       performance period.
                                 estimated time
                                 needed to submit
                                 data (-.33 hr
                                 computer system
                                 analyst time).
Table 80: Call for Promoting    None.............  Increase in the
 Interoperability Measures.                         number of new
                                                    Promoting
                                                    Interoperability
                                                    measures being
                                                    nominated.
Table 82: Improvement           None.............  Decrease in the
 Activities Submission.                             number of
                                                    respondents due to
                                                    updated data from
                                                    2017 MIPS
                                                    performance period.

[[Page 60025]]

 
                                                   Review of submission
                                                    process resulted in
                                                    decrease in
                                                    estimated to submit
                                                    (-0.92 hr computer
                                                    system analyst
                                                    time).
Table 83: Nomination of         None.............  Review of nomination
 Improvement Activities.                            process resulted in
                                                    increase in
                                                    estimated time to
                                                    nominate a new
                                                    improvement activity
                                                    (+0.9 hrs Practice
                                                    Administrator time;
                                                    +0.6 hrs Physician
                                                    time).
Table 84: Partial QP Election.  None.............  Increase in the
                                                    number of
                                                    respondents due to
                                                    additional APM
                                                    Entities and
                                                    eligible clinicians
                                                    electing to
                                                    participate as a
                                                    Partial QP in MIPS.
Table 85: Other Payer Advanced  None.............  Decrease in the
 APM Identification: Other                          number of
 Payer Initiated Process.                           anticipated other
                                                    payer arrangements
                                                    submitted for
                                                    identification as
                                                    Other Payer Advanced
                                                    APMs.
Table 86: Other Payer Advanced  None.............  Increase in the
 APM Identification: Eligible                       number of
 Clinician Initiated Process.                       anticipated other
                                                    payer arrangements
                                                    submitted by APM
                                                    Entities and
                                                    eligible clinicians
                                                    for identification
                                                    as Other Payer
                                                    Advanced APMs.
Table 87: Submission of Data    Reflects new       None.
 for All-Payer QP                policy in this
 Determinations under the All-   final rule..
 Payer Combination Option.
Table 88: Voluntary             Decrease in the    None.
 Participants to Elect to Opt    number of
 Out of Performance Data         respondents due
 Display on Physician Compare.   to updated data
                                 from 2017 MIPS
                                 performance
                                 period.
------------------------------------------------------------------------

C. Summary of Annual Burden Estimates for Finalized Requirements

                                                        Table 91--Annual Requirements and Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Total annual
Regulation section(s) under Title   OMB control   Respondents    Responses    Burden per  response     burden         Labor cost of      Total cost  ($)
          42 of the CFR               No. ***                                       (hours)            (hours)      reporting  ($/hr)           *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   414.94(j) (AUC                 0938-1345    10,230,000     3,410,000  0.033................       112,530  Varies...............        5,527,924
 consultations) Voluntary period.                                            (2 min)..............
Sec.   414.94(j) (AUC                 0938-1345       586,386    43,181,818  0.033................     1,425,000  Varies...............       70,001,700
 consultations) Beginning Jan 1,                                             (2 min)..............
 2020.
Sec.   414.94 (AUC recordkeeping)     0938-1345       586,386         6,699  0.167................         1,119  34.50................           38,596
                                                                             (10 min).............
Quality Payment Program (See          0938-1314          (**)     (517,537)  varies...............   (2,450,334)  varies...............    (221,510,118)
 Subtotal Under Table 89).
Quality Payment Program (See          0938-1222      (93,447)      (93,447)  varies...............      (21,195)  varies...............        (546,362)
 Subtotal Under Table 89).
                                  ----------------------------------------------------------------------------------------------------------------------
    Total........................  ............    10,722,939    45,987,533  Varies...............     (932,880)  Varies...............    (146,488,260)
--------------------------------------------------------------------------------------------------------------------------------------------------------
* For the PRA, this rule will not impose any non-labor costs.
** We are unable to accurately calculate a total number of respondents for the Quality Payment Program. In many cases, individuals, groups, and entities
  have responded to multiple data collections and there is no unified way to identify unique respondents.
*** OMB and CMS' PRA package ID numbers: OMB 0938-1345 (CMS-10654), OMB 0938-1314 (CMS-10621), and OMB 0938-1222 (CMS-10450).
**** For OMB 0938-1314 (CMS-10621), the estimated total number of respondents across all ICRs for the CY 2019 performance period is 644,144 while
  estimated total burden hours are 5,109,042 at a cost of $482,416,597. (CMS-10450), the estimated total number of respondents across all ICRs for the
  CY 2019 performance period is 39,336 while estimated total burden hours are 8,755 at a cost of $236,525. For OMB 0938-1343 (CMS-10652), the estimated
  total number of respondents across all ICRs for the CY 2019 performance period is 16 while estimated total burden hours are 160 at a cost of $13,506.

VII. Regulatory Impact Analysis

A. Statement of Need

    This final rule makes payment and policy changes under the Medicare 
PFS and implements required statutory changes under the Medicare Access 
and CHIP Reauthorization Act of 2015 (MACRA), the Achieving a Better 
Life Experience Act (ABLE), the Protecting Access to Medicare Act of 
2014 (PAMA), section 603 of the Bipartisan Budget Act of 2015, the 
Consolidated Appropriations Act of 2016, the Bipartisan Budget Act of 
2018, and section 2001(a) of the SUPPORT for Patients and Communities 
Act of 2018. This final rule also makes changes to payment policy and 
other related policies for Medicare Part B.
    This final rule is necessary to make policy changes under Medicare 
fee-for-service. Therefore, we included a detailed regulatory impact 
analysis (RIA) to assess all costs and benefits of available regulatory 
alternatives and explained the selection of these regulatory approaches 
that we believe adhere to section 1834(q) of the Act and, to the extent 
feasible, maximize net benefits.
    This final rule also makes payment and policy changes under the 
Medicare PFS and makes required statutory changes under the MACRA, as 
amended by section 51003 of the Bipartisan Budget Act of 2018.
    The new policies for CY 2019 are detailed throughout this final 
rule. For example, the policies associated with modernizing Medicare 
physician payment by recognizing communication technology-based 
services are described in section II.D. of this final rule, while the 
policies associated with E/M visits are described in section II.I. of 
this final rule. Several policies addressing the use of innovative 
technology that enables remote services will expand access to care and 
create more opportunities for patients to access more personalized care 
management, as well as connect with their physicians more quickly. 
These policies support access to care using telecommunications 
technology by paying clinicians for virtual check-ins (brief, non-face-
to-face appointments via communications technology), paying clinicians 
for evaluation of patient-submitted photos or videos, and

[[Page 60026]]

expanding Medicare-covered telehealth services to include prolonged 
preventive services.
    Several policies in the final rule will also give physicians more 
time to spend with their patients, especially those with complex needs, 
rather than on paperwork. Specifically, there are provisions that 
simplify certain documentation requirements for E/M visits, which make 
up about 40 percent of allowed charges under the PFS and consume much 
of clinicians' time; reduce supervision requirements for radiologist 
assistants during diagnostic test services; and remove burdensome and 
overly complex functional reporting requirements for outpatient 
therapy. In addition, section VII.H. of this final rule, the RIA, 
details the economic effect of these policies on Medicare providers and 
beneficiaries.

B. Overall Impact

    We examined the impact of this rule as required by Executive Order 
12866 on Regulatory Planning and Review (September 30, 1993), Executive 
Order 13563 on Improving Regulation and Regulatory Review (February 2, 
2013), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. 
L. 96-354), section 1102(b) of the Social Security Act, section 202 of 
the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-
4), Executive Order 13132 on Federalism (August 4, 1999), the 
Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 
on Reducing Regulation and Controlling Regulatory Costs (January 30, 
2017).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). An RIA 
must be prepared for major rules with economically significant effects 
($100 million or more in any 1 year). We estimated, as discussed in 
this section, that the PFS policies included in this final rule would 
redistribute more than $100 million in 1 year. Therefore, we estimate 
that this rulemaking is ``economically significant'' as measured by the 
$100 million threshold, and hence also a major rule under the 
Congressional Review Act. Accordingly, we prepared an RIA that, to the 
best of our ability, presents the costs and benefits of the rulemaking. 
The RFA requires agencies to analyze options for regulatory relief of 
small entities. For purposes of the RFA, small entities include small 
businesses, nonprofit organizations, and small governmental 
jurisdictions. Most hospitals, practitioners and most other providers 
and suppliers are small entities, either by nonprofit status or by 
having annual revenues that qualify for small business status under the 
Small Business Administration standards. (For details see the SBA's 
website at http://www.sba.gov/content/table-small-business-size-standards (refer to the 620000 series)). Individuals and states are not 
included in the definition of a small entity.
    The RFA requires that we analyze regulatory options for small 
businesses and other entities. We prepare a regulatory flexibility 
analysis unless we certify that a rule would not have a significant 
economic impact on a substantial number of small entities. The analysis 
must include a justification concerning the reason action is being 
taken, the kinds and number of small entities the rule affects, and an 
explanation of any meaningful options that achieve the objectives with 
less significant adverse economic impact on the small entities.
    Approximately 95 percent of practitioners, other providers, and 
suppliers are considered to be small entities, based upon the SBA 
standards. There are over 1 million physicians, other practitioners, 
and medical suppliers that receive Medicare payment under the PFS. 
Because many of the affected entities are small entities, the analysis 
and discussion provided in this section, as well as elsewhere in this 
final rule is intended to comply with the RFA requirements regarding 
significant impact on a substantial number of small entities.
    For example, the effects of changes to payment rates for 
practitioners, other providers, and suppliers are discussed in VII.C. 
of this final rule. Alternative options considered to the payment rates 
are discussed generally in section VII.F. of this final rule.
    In addition, section 1102(b) of the Act requires us to prepare an 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. This analysis must conform 
to the provisions of section 604 of the RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a Metropolitan Statistical Area for Medicare 
payment regulations and has fewer than 100 beds. The PFS does not 
reimburse for services provided by rural hospitals; the PFS pays for 
physicians' services, which can be furnished by physicians and non-
physician practitioners in a variety of settings, including rural 
hospitals. We did not prepare an analysis for section 1102(b) of the 
Act because we determined, and the Secretary certified, that this final 
rule would not have a significant impact on the operations of a 
substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits on state, 
local, or tribal governments or on the private sector before issuing 
any rule whose mandates require spending in any 1 year of $100 million 
in 1995 dollars, updated annually for inflation. In 2018, that 
threshold is approximately $150 million. This final rule will impose no 
mandates on state, local, or tribal governments or on the private 
sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it issues a proposed rule (and subsequent final 
rule) that imposes substantial direct requirement costs on state and 
local governments, preempts state law, or otherwise has Federalism 
implications. Since this regulation does not impose any costs on state 
or local governments, the requirements of Executive Order 13132 are not 
applicable.
    Executive Order 13771, entitled Reducing Regulation and Controlling 
Regulatory Costs (82 FR 9339), was issued on January 30, 2017. This 
final rule is considered an E.O. 13771 deregulatory action because it 
is expected to result in regulatory cost savings. The estimated impact 
would be $71 million in cost savings in 2019, $3.986 billion in costs 
in 2020, $387 million in cost savings in 2021, $450 million cost 
savings in 2022, and $557 million in cost savings in 2023 and 
thereafter. Annualizing these costs and cost savings in perpetuity and 
discounting at 7 percent back to 2016, we estimated that this rule 
would generate $190 million in annualized net cost savings for E.O. 
13771 accounting purposes. Details on the estimated cost savings of 
this rule can be found in the following analyses.
    We prepared the following analysis, which together with the 
information provided in the rest of this preamble, meets all assessment 
requirements. The analysis explains the rationale for and purposes of 
this final rule; details the costs and benefits of the rule; analyzes 
alternatives; and presents the measures we would use to minimize the 
burden on small entities. As indicated elsewhere in this final rule, we 
are implementing a variety of changes to our regulations, payments, or 
payment policies to ensure that our payment

[[Page 60027]]

systems reflect changes in medical practice and the relative value of 
services, and implementing statutory provisions. We provided 
information for each of the policy changes in the relevant sections of 
this final rule. We are unaware of any relevant federal rules that 
duplicate, overlap, or conflict with this final rule. The relevant 
sections of this final rule contain a description of significant 
alternatives if applicable.

C. Changes in Relative Value Unit (RVU) Impacts

1. Resource-Based Work, PE, and MP RVUs
    Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or 
decreases in RVUs may not cause the amount of expenditures for the year 
to differ by more than $20 million from what expenditures would have 
been in the absence of these changes. If this threshold is exceeded, we 
make adjustments to preserve budget neutrality.
    Our estimates of changes in Medicare expenditures for PFS services 
compared payment rates for CY 2018 with payment rates for CY 2019 using 
CY 2017 Medicare utilization. The payment impacts in this final rule 
reflect averages by specialty based on Medicare utilization. The 
payment impact for an individual practitioner could vary from the 
average and would depend on the mix of services he or she furnishes. 
The average percentage change in total revenues will be less than the 
impact displayed here because practitioners and other entities 
generally furnish services to both Medicare and non-Medicare patients. 
In addition, practitioners and other entities may receive substantial 
Medicare revenues for services under other Medicare payment systems. 
For instance, independent laboratories receive approximately 83 percent 
of their Medicare revenues from clinical laboratory services that are 
paid under the Clinical Laboratory Fee Schedule (CLFS).
    The annual update to the PFS conversion factor (CF) was previously 
calculated based on a statutory formula; for details about this 
formula, we refer readers to the CY 2015 PFS final rule with comment 
period (79 FR 67741 through 67742). Section 101(a) of the MACRA 
repealed the previous statutory update formula and amended section 
1848(d) of the Act to specify the update adjustment factors for CY 2015 
and beyond. The update adjustment factor for CY 2019, as required by 
section 53106 of the Bipartisan Budget Act of 2018, is 0.25 percent 
before applying other adjustments.
    To calculate the CF for this year, we multiplied the product of the 
current year CF and the update adjustment factor by the budget 
neutrality adjustment described in the preceding paragraphs. We 
estimated the CY 2019 PFS CF to be 36.0391 which reflects the budget 
neutrality adjustment under section 1848(c)(2)(B)(ii)(II) and the 0.25 
percent update adjustment factor specified under section 1848(d)(18) of 
the Act. We estimate the CY 2019 anesthesia CF to be 22.2730, which 
reflects the same overall PFS adjustments with the addition of 
anesthesia-specific PE and MP adjustments.

    Table 92--Calculation of the Final CY 2019 PFS Conversion Factor
------------------------------------------------------------------------
 
------------------------------------------------------------------------
CY 2018 Conversion Factor.........  ....................         35.9996
    Statutory Update Factor.......  0.25 percent          ..............
                                     (1.0025).
    CY 2019 RVU Budget Neutrality   -0.14 percent         ..............
     Adjustment.                     (0.9986).
CY 2019 Conversion Factor.........  ....................         36.0391
------------------------------------------------------------------------


 Table 93--Calculation of the Final CY 2019 Anesthesia Conversion Factor
------------------------------------------------------------------------
 
------------------------------------------------------------------------
CY 2018 National Average            ....................         22.1887
 Anesthesia Conversion Factor.
    Statutory Update Factor.......  0.25 percent          ..............
                                     (1.0025).
    CY 2019 RVU Budget Neutrality   -0.14 percent         ..............
     Adjustment.                     (0.9986).
    CY 2019 Anesthesia Fee          0.27 percent          ..............
     Schedule Practice Expense and   (1.0027).
     Malpractice Adjustment.
CY 2019 Conversion Factor.........  ....................         22.2730
------------------------------------------------------------------------

    Table 94 shows the payment impact on PFS services of the policies 
contained in this final rule. To the extent that there are year-to-year 
changes in the volume and mix of services provided by practitioners, 
the actual impact on total Medicare revenues would be different from 
those shown in Table 94 (CY 2019 PFS Estimated Impact on Total Allowed 
Charges by Specialty). The following is an explanation of the 
information represented in Table 94.
     Column A (Specialty): Identifies the specialty for which 
data are shown.
     Column B (Allowed Charges): The aggregate estimated PFS 
allowed charges for the specialty based on CY 2017 utilization and CY 
2018 rates. That is, allowed charges are the PFS amounts for covered 
services and include coinsurance and deductibles (which are the 
financial responsibility of the beneficiary). These amounts have been 
summed across all services furnished by physicians, practitioners, and 
suppliers within a specialty to arrive at the total allowed charges for 
the specialty.
     Column C (Impact of Work RVU Changes): This column shows 
the estimated CY 2019 impact on total allowed charges of the changes in 
the work RVUs, including the impact of changes due to potentially 
misvalued codes.
     Column D (Impact of PE RVU Changes): This column shows the 
estimated CY 2019 impact on total allowed charges of the changes in the 
PE RVUs.
     Column E (Impact of MP RVU Changes): This column shows the 
estimated CY 2019 impact on total allowed charges of the changes in the 
MP RVUs.
     Column F (Combined Impact): This column shows the 
estimated CY 2019 combined impact on total allowed charges of all the 
changes in the previous columns. Column F may not equal the sum of 
columns C, D, and E due to rounding.

[[Page 60028]]



                  Table 94--CY 2019 PFS Estimated Impact on Total Allowed Charges by Specialty
----------------------------------------------------------------------------------------------------------------
                                                  Impact of work   Impact of PE    Impact of MP
            Specialty                 Allowed       RVU changes     RVU changes     RVU changes      Combined
                                   charges (mil)        (%)             (%)             (%)         impact (%)
(A)                                          (B)             (C)             (D)             (E)             (F)
----------------------------------------------------------------------------------------------------------------
Allergy/Immunology..............            $239               0              -1               0              -1
Anesthesiology..................           1,982               0               0               0               0
Audiologist.....................              68               0               1               0               1
Cardiac Surgery.................             293               0               0               0               0
Cardiology......................           6,616               0               0               0               0
Chiropractor....................             754               0              -1               0              -1
Clinical Psychologist...........             776               0               3               0               3
Clinical Social Worker..........             728               0               3               0               2
Colon and Rectal Surgery........             166               0               1               0               1
Critical Care...................             342               0              -1               0              -1
Dermatology.....................           3,489               0               1               0               1
Diagnostic Testing Facility.....             734               0              -5               0              -5
Emergency Medicine..............           3,121               0               0               0               0
Endocrinology...................             482               0               0               0               0
Family Practice.................           6,207               0               0               0               0
Gastroenterology................           1,754               0               0               0               0
General Practice................             428               0               0               0               0
General Surgery.................           2,090               0               0               0               0
Geriatrics......................             197               0               0               0               0
Hand Surgery....................             214               0               0               0               0
Hematology/Oncology.............           1,741               0              -1               0              -1
Independent Laboratory..........             646               0              -2               0              -2
Infectious Disease..............             649               0               0               0              -1
Internal Medicine...............          10,766               0               0               0               0
Interventional Pain Mgmt........             868               0               1               0               1
Interventional Radiology........             384               1               1               0               2
Multispecialty Clinic/Other Phys             149               0               0               0               0
Nephrology......................           2,188               0               0               0               0
Neurology.......................           1,529               0               0               0               0
Neurosurgery....................             802               0               0               0               0
Nuclear Medicine................              50               0              -1               0              -1
Nurse Anes/Anes Asst............           1,242               0               0               0               0
Nurse Practitioner..............           4,060               0               0               0               0
Obstetrics/Gynecology...........             637               0               0               0               0
Ophthalmology...................           5,451               0              -1               0              -1
Optometry.......................           1,309               0              -1               0              -1
Oral/Maxillofacial Surgery......              67               0               0               0               0
Orthopedic Surgery..............           3,741               0               0               0               0
Other...........................              31               0               4               0               4
Otolarngology...................           1,222               0               0               0               0
Pathology.......................           1,165               0              -1               0              -2
Pediatrics......................              61               0               0               0               0
Physical Medicine...............           1,107               0               0               0               0
Physical/Occupational Therapy...           3,950               0              -1               0              -1
Physician Assistant.............           2,438               0               0               0               0
Plastic Surgery.................             376               0               0               0               0
Podiatry........................           1,974               0               2               0               2
Portable X-Ray Supplier.........              99               0               1               0               1
Psychiatry......................           1,187               0               1               0               1
Pulmonary Disease...............           1,714               0               0               0               0
Radiation Oncology and Radiation           1,765               0               0               0              -1
 Therapy Centers................
Radiology.......................           4,907               0               0               0               0
Rheumatology....................             541               0               0               0               0
Thoracic Surgery................             357               0               0               0               0
Urology.........................           1,738               0               1               0               1
Vascular Surgery................           1,141               0               2               0               2
                                 -------------------------------------------------------------------------------
    Total.......................          92,733               0               0               0               0
----------------------------------------------------------------------------------------------------------------
* Column F may not equal the sum of columns C, D, and E due to rounding.

2. CY 2019 PFS Impact Discussion
a. Changes in RVUs
    The most widespread specialty impacts of the RVU changes are 
generally related to the changes to RVUs for specific services 
resulting from the misvalued code initiative, including RVUs for new 
and revised codes. The estimated impacts for some specialties, 
including clinical psychologists, vascular surgery, interventional 
radiology, and podiatry, reflect increases relative to other physician 
specialties. These increases can largely be attributed to finalized 
increases in

[[Page 60029]]

value for particular services following the recommendations from the 
American Medical Association (AMA)'s Relative Value Scale Update 
Committee (RUC) and CMS review, increased payments as a result of 
finalized updates to supply and equipment pricing, and the 
implementation of new payment policies associated with communication 
technology-based services.
    The estimated impacts for several specialties, including diagnostic 
testing facilities, independent labs, pathology, and ophthalmology, 
reflect decreases in payments relative to payment to other physician 
specialties. These decreases can largely be attributed to revaluation 
of individual procedures reviewed by the AMA's committee and CMS, 
decreased payments as a result of finalized updates to supply and 
equipment pricing, and continued implementation of previously finalized 
code-level reductions that are being phased-in over several years. We 
note that the estimated impacts for many specialties differ 
significantly relative to the estimates included in the proposed rule. 
These changes reflect changes between the proposed and final policies 
based on our consideration of public comments. We note that the most 
significant of these changes relates to the various elements of the 
proposed changes in coding and payment for office/outpatient E/M 
visits, none of which are being finalized for CY 2019. For independent 
laboratories, it is important to note that these entities receive 
approximately 83 percent of their Medicare revenues from services that 
are paid under the CLFS. As a result, the estimated 2 percent reduction 
for CY 2019 is only applicable to approximately 17 percent of the 
Medicare payment to these entities.
    We often receive comments regarding the changes in RVUs displayed 
on the specialty impact table (Table 94), including comments received 
in response to the proposed rates. We remind stakeholders that although 
the estimated impacts are displayed at the specialty level, typically 
the changes are driven by the valuation of a relatively small number of 
new and/or potentially misvalued codes. The percentages in Table 94 are 
based upon aggregate estimated PFS allowed charges summed across all 
services furnished by physicians, practitioners, and suppliers within a 
specialty to arrive at the total allowed charges for the specialty, and 
compared to the same summed total from the previous calendar year. 
Therefore, they are averages, and may not necessarily be representative 
of what is happening to the particular services furnished by a single 
practitioner within any given specialty.
b. Impact
    Column F of Table 94 displays the estimated CY 2019 impact on total 
allowed charges, by specialty, of all the RVU changes. A table showing 
the estimated impact of all of the changes on total payments for 
selected high volume procedures is available under ``downloads'' on the 
CY 2019 PFS final rule website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/. We selected these 
procedures for sake of illustration from among the procedures most 
commonly furnished by a broad spectrum of specialties. The change in 
both facility rates and the nonfacility rates are shown. For an 
explanation of facility and nonfacility PE, we refer readers to 
Addendum A on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
c. Estimated Impacts of Implementing the Payment and Coding Changes for 
Office/Outpatient E/M Services for CY 2021
    Although we are not finalizing changes to E/M coding and payment 
for CY 2019, we are finalizing certain changes for CY 2021. We provide 
the following impact estimate only for illustrative purposes. Table 95 
illustrates the estimated specialty level impacts associated with 
implementing our finalized policies for E/M coding and payment in CY 
2019, rather than delaying until CY 2021. Table 24C shows the estimated 
impacts of adopting single payment rates for new and established 
patient E/M visit levels 2-4 (with the rates determined using input 
values that reflect the weighted average of 2018 inputs for codes 
describing those visit levels), keeping separate rates for new and 
established patient E/M visit level 5 (with the rates determined using 
the 2018 input values for level 5 visits), and adopting add-on codes 
with equal rates to adjust for the inherent visit complexity of primary 
care and non-procedural specialty care (with the rates determined using 
the input values from the proposed rule for the non-procedural 
specialty care complexity code).

  TABLE 95--Estimated Specialty Level Impacts of Final E/M Payment and Coding Policies If Implemented for 2019
----------------------------------------------------------------------------------------------------------------
                                      Allowed     Impact of work   Impact of PE    Impact of MP      Combined
            Specialty              charges (mil)  RVU changes  %  RVU changes  %  RVU changes  %     impact  %
(A)                                          (B)             (C)             (D)             (E)             (F)
----------------------------------------------------------------------------------------------------------------
Allergy/Immunology..............            $239               0               0               0               0
Anesthesiology..................           1,981              -1               0               0              -2
Audiologist.....................              68              -1               1               0               0
Cardiac Surgery.................             294              -1              -1               0              -2
Cardiology......................           6,618              -1              -1               0              -2
Chiropractor....................             754              -1               0               0              -1
Clinical Psychologist...........             776              -1               1               0               0
Clinical Social Worker..........             728              -2               2               0               0
Colon and Rectal Surgery........             166               0               1               0               0
Critical Care...................             342              -2              -1               0              -3
Dermatology.....................           3,486               1               3               0               4
Diagnostic Testing Facility.....             733               0              -5               0              -5
Emergency Medicine..............          $3,121              -2              -1               0              -2
Endocrinology...................             482              -1              -1               0              -2
Family Practice.................           6,208               1               1               0               2
Gastroenterology................           1,757              -2              -1               0              -3
General Practice................             429               2               1               0               3
General Surgery.................           2,093               0               0               0              -1

[[Page 60030]]

 
Geriatrics......................             197              -1              -1               0              -1
Hand Surgery....................             214               1               1               0               3
Hematology/Oncology.............           1,741               0              -1               0               0
Independent Laboratory..........             646              -1               3               0               3
Infectious Disease..............             649              -1              -1               0              -1
Internal Medicine...............          10,767               0               0               0               0
Interventional Pain Mgmt........             868               1               2               0               3
Interventional Radiology........             386               0              -2               0              -2
Multispecialty Clinic/Other Phys             149              -1              -1               0              -2
Nephrology......................           2,190              -1              -1               0              -2
Neurology.......................           1,529              -1               0               0              -1
Neurosurgery....................             804              -1              -1               0              -1
Nuclear Medicine................              50              -1              -1               0              -3
Nurse Anes/Anes Asst............           1,242              -2               0               0              -2
Nurse Practitioner..............           4,065               2               1               0               3
Obstetrics/Gynecology...........             638               2               2               0               5
Ophthalmology...................           5,448              -1              -2               0              -3
Optometry.......................          $1,309               0              -1               0              -1
Oral/Maxillofacial Surgery......              68               0               0               0               1
Orthopedic Surgery..............           3,743               0               1               0               1
Other...........................              31              -1               3               0               2
Otolarngology...................           1,210               3               3               0               5
Pathology.......................           1,165              -1              -1               0              -2
Pediatrics......................              61               1               0               0               1
Physical Medicine...............           1,107              -1               0               0              -2
Physical/Occupational Therapy...           3,950              -1              -2               0              -3
Physician Assistant.............           2,457               2               1               0               4
Plastic Surgery.................             377               0               0               0               1
Podiatry........................           1,974               4               6               0              10
Portable X-Ray Supplier.........              99               0               0               0               0
Psychiatry......................           1,187               3               2               0               5
Pulmonary Disease...............           1,715              -1              -1               0              -2
Radiation Oncology and Radiation           1,766              -1              -1               0              -1
 Therapy Centers................
Radiology.......................           4,911              -1              -1               0              -2
Rheumatology....................             541               0              -1               0              -1
Thoracic Surgery................             358              -1              -1               0              -2
Urology.........................           1,738               2               3               0               4
Vascular Surgery................           1,148               0              -2               0              -2
                                 -------------------------------------------------------------------------------
    Total.......................          92,771               0               0               0               0
----------------------------------------------------------------------------------------------------------------

    Under our finalized policies, specialties that disproportionately 
report lower level visits, such as podiatry, and specialties that 
report office/outpatient visits in conjunction with minor procedures, 
such as dermatology, would see significant increases. Specialties that 
predominantly furnish higher level visits would have their negative 
redistribution significantly mitigated by the maintenance of the level 
5 visit and the add-on codes for inherent visit complexity for primary 
and non-procedural specialty care.
    We note that our original proposal was developed more generally to 
maintain overall RVUs within the codes describing office/outpatient 
visits, but, after consideration of public comments, we are not 
finalizing several elements of those proposals, including and 
especially the multiple procedure payment reduction. As a result, 
implementation with the values and policies as altered, would require 
off-setting reductions in overall PFS payments. Following our current 
methodology, these reductions, required by statute, would be applied 
through a budget neutrality adjustment in the PFS CF, consistent with 
our established methodology. As a result of such an adjustment, 
specialties that do not furnish office/outpatient visits generally 
would see overall reductions in payment of approximately 2.0 percent, 
as generally reflected in the Table 95. Given that overall payment for 
the office/outpatient E/M codes would increase, and because these 
services are reported by most specialities, the overall changes for 
most specialties are generally offsetting. However, for physician 
specialties and suppliers that do not report office/outpatient E/M 
services, the reduction would be approximately -2.0 percent.
    As discussed in section II.H., of this final rule, based on the 
statements by commenters that the medical community, through the CPT 
process, has committed itself to considering revisions to the office/
outpatient visit codes and given the history of collaboration between 
CMS and the medical community, we expect to consider any possible 
changes in CPT coding, as well as recommendations regarding valuation 
for services, from the RUC and other stakeholders, through our annual 
rulemaking process, between now and implementation for

[[Page 60031]]

CY 2021. We note that any potential coding changes, and recommendations 
in overall valuation for new or existing codes, could have significant 
impact on the actual change in overall RVUs for office/outpatient 
visits relative to the rest of the PFS. Given the various factors that 
will be considered by the variety of stakeholders involved in the CPT 
and RUC processes, we do not believe we can estimate with any degree of 
certainty what the impact of potential changes might be. We also, note, 
however, that any changes in coding and payment for these services 
would be subject to notice and comment rulemaking.
    With regard to the documentation policies we are finalizing for CY 
2021, our intent is to allow clinicians a choice in how levels 2 
through 5 visits are documented--using current framework, MDM or time. 
Assuming the current code set for E/M office/outpatient visits is 
maintained for CY 2021, when a level 2 through 4 visit (which comprises 
the majority of visits currently furnished) is documented using the 
current framework or MDM, documentation will be simplified by applying 
a minimum level 2 documentation standard to level 2 through 4 visits. 
When a level 2 through 4 visit is documented using time, practitioners 
should report the appropriate code based on the time defined as typical 
under the CPT code descriptors for office/outpatient E/M visits. 
Practitioners will be required to document that the visit was medically 
necessary and the billing practitioner spent at least the amount of 
time included in the CPT as typical face-to-face with the patient. The 
extended visit code can be reported with a level 2 through 4 visit when 
the time of the overall visit is between 34 and 69 minutes (for 
established patients) and between 38 and 89 minutes (for new patients) 
of face-to-face time with the billing practitioner. (See section II.I. 
of this final rule. For example, a level 2 through 4 extended visit 
will require the billing practitioner to spend and document that he or 
she spent at least 35 minutes face-to-face with the patient. We are 
also finalizing a policy to require minimal documentation to support 
reporting of the add-on codes that we are finalizing for use with the 
level 2 through 4 visit codes. These add-on codes are to reflect the 
inherent complexity in E/M services for primary care, and for other 
non-procedural specialty care, and for extended visits).
    For level 5 E/M visits, again assuming the current code set remains 
in place for CY 2021, we will allow the visit to be documented using 
the current framework, MDM or time. When documenting using MDM, the 
current definition of level 5 MDM will apply. When documenting a level 
5 visit using time, we will require the billing practitioner to 
document that they spent at least the typical time for the reported 
level 5 CPT code, face-to-face with the patient (currently 40 minutes 
for an established patient and 60 minutes for a new patient). The add-
on codes that we are finalizing for use with the level 2 through 4 
visits (the inherent complexity add-on codes for primary care and other 
non-procedural specialty care and extended visits) will not be 
reportable with level 5 visits. We note that the current coding for 
prolonged visits would continue to be reportable with level 5 visits.
    As discussed elsewhere in this section of the final rule, we 
estimate this approach would lead to significant burden reduction for 
practitioners, while allowing preparatory time and time for potential 
refinement over the next few years as we take into account any feedback 
from stakeholders on these changes, as well as any potential revisions 
to the E/M code set.

D. Effect of Changes Related to Telehealth

    As discussed in section II.D. of this final rule, we are adding two 
new codes, HCPCS codes G0513 and G0514, to the list of Medicare 
telehealth services. Although we expect these changes to have the 
potential to increase access to care in rural areas, based on recent 
telehealth utilization of services already on the list, including 
services similar to the proposed additions, we estimate there will only 
be a negligible impact on PFS expenditures from these additions. For 
example, for services already on the list, they are furnished via 
telehealth, on average, less than 0.1 percent of the time they are 
reported overall. This addition was responsive to longstanding 
stakeholder interest in expanding Medicare payment for telehealth 
services. The restrictions placed on Medicare telehealth by the statute 
limit the magnitude of utilization; however, we believe there is value 
in allowing physicians and patients the greatest flexibility when 
appropriate.

E. Effect of Changes to Payment to Provider-Based Departments (PBDs) of 
Hospitals Paid Under the PFS

    As discussed in section II.G. of this final rule, we are finalizing 
a PFS Relativity Adjuster of 40 percent for CY 2019, meaning that 
nonexcepted items and services furnished by nonexcepted off-campus PBDs 
will be paid under the PFS at a rate that is 40 percent of the OPPS 
rate. In finalizing our policy to maintain the PFS Relativity Adjuster 
at 40 percent, we updated our analysis to include a full year of claims 
data. We estimated site-specific PFS rates for the technical component 
of a service for the entire range of HCPCS codes furnished in 
nonexcepted off campus PBDs. Next we compared the sum of the site-
specific payment rates under the PFS, weighted by OPPS claims volume, 
to the sum of payment rates under the OPPS, also weighted by OPPS 
claims volume. This calculation resulted in a relative rate of 
approximately 40 percent, supporting our policy to maintain the PFS 
Relativity Adjuster at 40 percent. We are finalizing the PFS Relativity 
Adjuster of 40 percent, as proposed. There will be no additional 
savings for CY 2019 relative to CY 2018 because we are maintaining the 
current PFS Relativity Adjuster of 40 percent, which was finalized for 
CY 2018.

F. Other Provisions of the Final Regulation

1. Part B Drugs: Application of an Add-On Percentage for Certain 
Wholesale Acquisition Cost (WAC)-Based Payments
    In section II.M. of this final rule, we finalized the following 
policy: Effective January 1, 2019, Wholesale Acquisition Cost (WAC)-
based payments for Part B drugs made under section 1847A(c)(4) of the 
Act will utilize a 3 percent add-on in place of the 6 percent add-on 
that is currently being used. We also will permit Medicare 
Administrative Contractors (MACs) to use an add-on percentage of up to 
3 percent for WAC-based payments for new drugs.
    We anticipate that the reduction to the add-on payment made for a 
subset of Part B drugs will result in savings to the Medicare program. 
The 3 percent add-on is consistent with MedPAC's analysis and 
recommendations, as well as discounts observed by MedPAC in their June 
2017 Report to the Congress. We have also considered how CMS' 
experience with WAC-based pricing for recently marketed new drugs and 
biologicals compares to MedPAC's findings. Although the number of new 
drugs that are priced using WAC is very limited, the average difference 
between WAC and Average Sales Price (ASP)-based payment limits for a 
group of 3 recently approved drugs and biologicals that appeared on the 
ASP Drug Pricing Files (including one biosimilar biological product) 
was 9.0 percent. Excluding the biosimilar biological product results in 
a difference of 3.5 percent. The difference was determined by comparing 
a partial quarter WAC-based payment amount determined

[[Page 60032]]

under section 1847A(c)(4) of the Act to the next quarter's ASP-based 
payment amount. These findings are in general agreement with MedPAC's 
findings.
    Although we are able to provide examples of the relative 
differences between ASP and WAC based payment limits, and we anticipate 
some savings from the change in policy, we cannot estimate the 
magnitude of savings over time because we cannot determine how many new 
drugs and biologicals subject to partial quarter pricing will appear on 
the ASP Drug Pricing files in the future or how many Part B claims for 
these products will be paid. This limitation also applies to 
contractor-priced drugs and biologicals that have HCPCS codes and are 
in their first quarter of sales. Finally, the claims volume for 
contractor-priced drugs and biologicals that are billed using 
miscellaneous or Not Otherwise Classified codes, such as J3490 and 
J3590, cannot be quantified. We would like to note that for the three 
drugs discussed in the preceding paragraph, Medicare Part B payments 
for individual doses of each drug range from approximately $3,000 to 
$10,000. The payment changes finalized in this rule would result in a 
little less than $100 to $300 savings in Medicare allowed charges for 
each dose.
    Although we cannot estimate the overall savings to the Medicare 
Program or to beneficiaries, we would like to note that this change in 
policy is likely to decrease copayments for individual beneficiaries 
who are prescribed new drugs. Given that launch prices for single doses 
for some new drugs may range from tens to hundreds of thousands of 
dollars, a 3 percentage point reduction in the total payment allowance 
will reduce a patient's 20 percent Medicare Part B copayment. This 
reduction can result in savings to an individual beneficiary and can 
help Medicare beneficiaries particularly those without supplementary 
insurance, afford to pay for new drugs by reducing out of pocket 
expenses.
    The 3 percent add-on is expected to reduce the difference between 
acquisition cost and certain WAC-based Part B drug payments. Based on 
MedPAC's June 2017 Report to Congress, and for reasons discussed in 
section II.M. of this rule, we do not anticipate that this change will 
result in payments amounts that are below acquisition cost or that the 
new policy will impair providers or patients' access to Part B drugs.
2. Changes to the Regulations Associated With the Ambulance Fee 
Schedule
    As discussed in section III B.2. of this final rule, section 
50203(a) of the Bipartisan Budget Act of 2018 amended section 
1834(l)(12)(A) and (l)(13)(A) of the Act to extend the payment add-ons 
set forth in those subsections through December 31, 2022. The ambulance 
extender provisions are enacted through legislation that is self-
implementing. A plain reading of the statute requires only a 
ministerial application of the mandated rate increase and does not 
require any substantive exercise of discretion on the part of the 
Secretary. As a result, there were no policy proposals associated with 
these legislative provisions or associated impact in this rule. We are 
finalizing our proposal without modification to revise the dates in 
Sec.  414.610(c)(1)(ii) and (c)(5)(ii) to conform the regulations to 
these self-implementing statutory requirements.
    In addition, as discussed in section III.B.3. of this final rule, 
section 53108 of the BBA amended section 1834(l)(15) of the Act to 
increase the payment reduction from 10 percent to 23 percent effective 
for ambulance services furnished on or after October 1, 2018 consisting 
of non-emergency basic life support services involving transports of an 
individual with end stage renal disease for renal dialysis services 
furnished other than on an emergency basis by a provider of services or 
a renal dialysis facility. The 10 percent reduction applies for such 
ambulance services furnished during the period beginning on October 1, 
2013 and ending on September 30, 2018.
    This statutory requirement is self-implementing. A plain reading of 
the statute requires only a ministerial application of the mandated 
rate decrease and does not require any substantive exercise of 
discretion on the part of the Secretary. As a result, there were no 
policy proposals associated with these legislative provisions or 
associated impact in this rule. We are finalizing our proposal without 
modification to revise Sec.  414.610(c)(8) to conform the regulations 
to this self-implementing statutory requirement.
3. Clinical Laboratory Fee Schedule: Change to the Majority of Medicare 
Revenues Threshold in Definition of Applicable Laboratory
    As discussed in section III. A. of this final rule, section 1834A 
of the Act, as established by section 216(a) of the Protecting Access 
to Medicare Act of 2014 (PAMA), required significant changes to how 
Medicare pays for Clinical Diagnostic Laboratory Tests (CDLTs) under 
the Clinical Laboratory Fee Schedule (CLFS). The CLFS final rule 
titled, Medicare Clinical Diagnostic Laboratory Tests Payment System 
final rule, published in the Federal Register on June 23, 2016, 
implemented section 1834A of the Act. Under the CLFS final rule (81 FR 
41036), ``reporting entities'' must report to CMS during a ``data 
reporting period'' ``applicable information'' (that is, certain private 
payor data) collected during a ``data collection period'' for their 
component ``applicable laboratories.'' In general, the payment amount 
for each CDLT on the CLFS furnished beginning January 1, 2018, is based 
on the applicable information collected during the 6-month data 
collection period and reported to us during the 3-month data reporting 
period, and is equal to the weighted median of the private payor rates 
for the CDLT.
    An applicable laboratory is defined at Sec.  414.502, in part, as 
an entity that is a laboratory (as defined under the Clinical 
Laboratory Improvement Amendments (CLIA) definition at Sec.  493.2) 
that bills Medicare Part B under its own National Provider Identifier 
(NPI). In addition, an applicable laboratory is an entity that receives 
more than 50 percent of its Medicare revenues during a data collection 
period from the CLFS and/or the PFS. We refer to this component of the 
applicable laboratory definition as the ``majority of Medicare revenues 
threshold.'' The definition of applicable laboratory also includes a 
``low expenditure threshold'' component which requires an entity to 
receive at least $12,500 of its Medicare revenues from the CLFS during 
a data collection period, for its CDLTs that are not advanced 
diagnostic laboratory tests (ADLTs).
    In determining payment rates under the private payor rate-based 
CLFS, one of our objectives is to obtain as much applicable information 
as possible from the broadest possible representation of the national 
laboratory market on which to base CLFS payment amounts, for example, 
from independent laboratories, hospital outreach laboratories, and 
physician office laboratories, without imposing undue burden on those 
entities. We believe it is important to achieve a balance between 
collecting sufficient data to calculate a weighted median that 
appropriately reflects the private market rate for a CDLT, and 
minimizing the reporting burden for entities. In response to 
stakeholder feedback and in the interest of facilitating this 
objective, we are finalizing the revision to the majority of

[[Page 60033]]

Medicare revenues threshold component in the third paragraph of the 
definition of applicable laboratory at Sec.  414.502 to exclude 
Medicare Advantage (MA) payments under Medicare Part C from the 
definition of total Medicare revenues (that is, the denominator of the 
majority of Medicare threshold equation). We believe this change would 
increase the opportunity for laboratories with a significant Medicare 
Part C revenue component to meet the majority of Medicare revenues 
threshold and qualify as an applicable laboratory (provided all other 
requirements for applicable laboratory status are met). We believe this 
will result in a broader representation of the laboratory industry 
reporting applicable information from which to determine payment rates 
under the CLFS. For a complete discussion of this revision to the 
majority of Medicare revenues threshold component of the definition of 
applicable laboratory under the Medicare CLFS, we refer readers to 
section III A. of this final rule.
    Therefore, in response to stakeholder feedback and in the interest 
of obtaining as much applicable information as possible, we are 
finalizing the revision of the definition of applicable laboratory at 
Sec.  414.502 to include a hospital laboratory that bills Medicare on 
the Form CMS-1450 14x bill type and its electronic equivalent. For a 
complete discussion of this revision to the definition of applicable 
laboratory under the Medicare CLFS, we refer readers to section III.A. 
of this final rule.
a. Estimation of Increased Reporting
    To estimate the potential impact of excluding MA plan payments from 
total Medicare revenues (that is, the denominator of the low 
expenditure threshold) on the number of laboratories meeting the 
majority of Medicare revenues threshold, using CY 2017 Medicare claims 
data, we compared the number of billing NPIs that would have met the 
majority of Medicare revenues threshold with MA plan revenues included 
in total Medicare revenues (which is the current requirement) versus 
the number of billing NPIs that would meet the majority of Medicare 
revenues threshold had MA plan payments been excluded from total 
Medicare revenues. We found that excluding MA plan payments from total 
Medicare revenues increased the level of laboratories meeting the 
majority of Medicare revenues threshold by approximately 49 percent. In 
other words, we estimate that excluding MA plan payments from total 
Medicare revenues (the denominator) of the majority of Medicare 
revenues threshold, and keeping the numerator constant (that is 
revenues from only the CLFS and or PFS) yields an increase of 49 
percent in the number of laboratories meeting the majority of Medicare 
revenues threshold.
    Our summary analysis of data reporting from the initial data 
reporting period under the Medicare CLFS private payor rate-based 
payment system, indicates that we received applicable information from 
1,942 applicable laboratories and they reported over 4.9 million 
records. Applying the projected 49 percent increase to the number of 
applicable laboratories from the first data reporting period (1,942 x 
1.49) yields an estimated 2,893 laboratories that would meet the 
majority of Medicare revenues threshold, which reflects an additional 
951 laboratories. Provided all other requirements for applicable 
laboratory status are met (including the low expenditure threshold of 
receiving at least $12,500 in CLFS revenues during a data collection 
period) a laboratory would report applicable information for the next 
data reporting period.
    To determine the estimated reporting burden for an applicable 
laboratory, we looked at the distribution of reported records that 
occurred for the first data reporting period. The average number of 
records reported for an applicable laboratory for the first data 
reporting period was 2,573. The largest amount of records reported for 
an applicable laboratory was 457,585 while the smallest amount reported 
was 1 record. A summary of the distribution of reported records from 
the first data collection period is illustrated in the Table 96.

                                          TABLE 96--Summary of Records Reported for First Data Reporting Period
                                                               [By applicable laboratory]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     Percentile distribution of records
             Total  records                  Average    Min  records  Max  records ---------------------------------------------------------------------
                                             records                                    10th          25th          50th          75th          90th
--------------------------------------------------------------------------------------------------------------------------------------------------------
4,995,877...............................        2,573             1       457,585            23            79           294         1,345         4,884
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Presuming that all of the additional laboratories that are 
projected to meet the majority of Medicare revenues threshold, that is 
approximately 951, also meet all of the criteria necessary to receive 
applicable laboratory status, as defined at Sec.  414.502, they would 
be an applicable laboratory and report applicable information for the 
next data reporting period, January 1, 2020 through March 31, 2020. 
Using the mid-point of the percentile distribution of reported records 
from the initial data reporting period, that is approximately 300 
records reported per applicable laboratory (50th percentile for the 
first data reporting period was 294), we estimate an additional 285,300 
records would be reported for the next data reporting period (951 
laboratories x 300 records per laboratory = 285,300). This represents 
an increase in data reporting of about 5 percent over the number of 
records reported for the initial data reporting period (285,300 
additional records/4,995,877 = 0.05). In other words, using the 
approximate mid-point of reported records for the first data reporting 
period, we estimate that our proposed change to the majority of 
Medicare revenues threshold would increase the total amount of records 
reported by approximately 5 percent. As illustrated in Table 96, the 
number of records reported varies greatly, depending on the volume of 
services performed by a given laboratory. Laboratories with larger test 
volumes, for instance at the 90th percentile, should expect to report 
more records as compared to the midpoint used for this analysis. 
Laboratories with smaller test volume, for instance at the 10th 
percentile, should expect to report fewer records as compared to the 
midpoint.
    We estimate that the inclusion of 14X type of bills would yield an 
increase of 39 percent in the total number of laboratories meeting the 
majority of Medicare revenues threshold. Applying the projected 39 
percent increase to the number of applicable laboratories from the 
first data reporting period (1,942 x 1.39) yielded an estimated 2,699 
laboratories that would meet the majority of Medicare revenues 
threshold, which reflects approximately

[[Page 60034]]

757 additional laboratories. Provided all other required criteria for 
applicable laboratory status are met (including the low expenditure 
threshold of receiving at least $12,500 in CLFS revenues during a data 
collection period) a laboratory would report applicable information for 
the next data reporting period. Using the mid-point of the percentile 
distribution of reported records from the initial data reporting 
period, that is approximately 300 records reported per applicable 
laboratory (50th percentile for the first data reporting period was 
294), we estimated an additional 221,100 records would be reported for 
the next data reporting period (757 laboratories x 300 records per 
laboratory = 227,100). This represents an increase in data reporting of 
about 5 percent over the number of records reported for the initial 
data reporting period (227,100 additional records/4,995,877 = 0.05).
b. Minimal Impact Expected on CLFS Rates
    We note that there would only be an associated Medicare cost or 
savings to the extent that the additional applicable laboratories are 
paid at a higher or lower private payor rate, as compared to other 
laboratories that reported previously, and only to the extent that the 
volume of services performed by these ``additional'' applicable 
laboratories is significant enough to make an impact on the weighted 
median of private payor rates. We have no reason to believe that 
increasing the level of participation, either by excluding MA plan 
payments from total Medicare revenues or including laboratories that 
bill Medicare Part B on the Form CMS-1450 14x bill type would result in 
a measurable cost difference under the CLFS. Given that the largest 
laboratories with the highest test volumes, by definition, dominate the 
weighted median of private payor rates, and that the largest 
laboratories reported data for the determination of CY 2018 CLFS rates 
and are expected to report again, we do not expect the additional 
reported data resulting from our proposed change to the majority of 
Medicare revenues threshold to have a predictable, direct impact on 
CLFS rates because of the reasons stated above. However, we believe 
that this proposal responds directly to stakeholder concerns regarding 
the number of applicable laboratories reporting applicable information 
for the initial data reporting period. Therefore, in an effort to 
increase the number of laboratories qualifying for applicable 
laboratory status, we are finalizing a change to the majority of 
Medicare revenues threshold so that laboratories furnishing tests to a 
significant level of Medicare Part C enrollees may qualify as 
applicable laboratories and report data to us. In addition, as part of 
the same effort to increase the number of laboratories qualifying for 
applicable laboratory status, we are finalizing a change in the 
definition of applicable laboratory to include an entity that bills 
Medicare Part B on the Form CMS-1450 14x bill type. We note that other 
laboratory types, such as independent laboratories and physician office 
laboratories, are required under the current definition of an 
applicable laboratory to determine applicable laboratory status and 
must report applicable information. The use of Form CMS-1450 14x TOB to 
define an applicable laboratory would assist hospital outreach 
laboratories to comply with their obligation to assess applicable 
laboratory status for any outreach laboratories and report applicable 
information if they meet the requirements to be an applicable 
laboratory. As such, the hospital could use the revenues from the CLFS 
and PFS as the numerator compared to the total revenues for the 14X TOB 
to determine applicable laboratory status. Alternatively, a hospital 
could get an NPI for its outreach laboratory.
    Comment: One commenter disagreed with our using the number of 
laboratories reporting applicable information during the first data 
reporting period as a baseline for estimating the number of additional 
laboratories that would report applicable information as a result of 
excluding MA plan payments under Part C from total Medicare revenues. 
The commenter stated that because the OIG estimated that 5 percent of 
all laboratories paid under Medicare Part B, or about 12,500 
laboratories, would qualify as applicable laboratories and would be 
required to report applicable information to CMS. The commenter stated 
that because the OIG's estimate is far greater than the number of 
laboratories that actually reported (that is 1,942), we should not have 
used the number of laboratories reporting applicable information during 
the first data reporting period as a baseline.
    Response: We believe that it is more appropriate to use the actual 
reporting levels (1,942 laboratories) from the initial data reporting 
period as a baseline for projecting increased data reporting under our 
final policy rather than an estimation of laboratories determined as 
applicable. We acknowledge that the OIG estimated that 5 percent of all 
laboratories paid under Medicare Part B, or about 12,500 laboratories, 
would qualify as applicable laboratories. It is important to note that 
individual laboratories determine whether they meet the requirements to 
be an applicable laboratory and that neither OIG nor CMS had the 
benefit of experience with collecting private payor data before those 
estimates were made. We believe that using the actual number of 
laboratories that reported is the more reliable method to develop our 
estimates of future potential applicable laboratories. We believe that 
it is would be inappropriate here to estimate future changes using an 
estimate as a baseline when there is actual experience (for example, 
number of reporters) that can base used as a baseline.
4. Appropriate Use Criteria for Advanced Diagnostic Imaging Services
    Section 1834(q)(2) of the Act, as added by section 218(b) of the 
PAMA, established a program to promote the use of AUC for applicable 
imaging services furnished in an applicable setting. The CY 2016 PFS 
final rule with comment period established an evidence-based process 
and transparency requirements for the development of AUC and stated 
that the AUC development process requirements, as well as the 
application process that organizations must comply with to become 
qualified provider-led entities (PLEs) did not impact CY 2016 physician 
payments under the PFS (80 FR 71362). The CY 2017 PFS final rule 
identified the requirements clinical decision support mechanisms 
(CDSMs) must meet for qualification and stated that the CDSM 
requirements, as well as the application process that CDSM developers 
must comply with for their mechanisms to be specified as qualified 
under this program, did not impact CY 2017 physician payments under the 
PFS (81 FR 80546). The CY 2018 PFS final rule established the effective 
date of January 1, 2020, on which the AUC consulting and reporting 
requirements will begin, and extended the voluntary consulting and 
reporting period to 18 months. Therefore, we stated these proposals did 
not impact CY 2018 physician payments under the PFS (82 FR 53349) and 
noted we would provide an impact statement when applicable in future 
rulemaking.
    This final rule modifies the Medicare AUC Program and addresses the 
impacts related to the actions taken by ordering professionals who 
order advanced diagnostic imaging services and those who furnish the 
advanced diagnostic imaging services, including the professional and 
technical portions of the services. We finalized a modification to the 
AUC consultation requirement for ordering professionals

[[Page 60035]]

specified in our regulation at Sec.  414.94(j) to allow clinical staff 
under the direction of the ordering professional to perform the AUC 
consultation; therefore, this analysis estimates the impact of AUC 
consultations. We also clarified the requirement that reporting AUC 
consultation information across claims for both the furnishing 
professional and furnishing facility is required in Sec.  414.94(k), 
and this analysis estimates the impact of the statutorily required 
reporting AUC consultation information. In addition, we modified the 
significant hardship exceptions in Sec.  414.94(i) as proposed, 
therefore this analysis estimates the impact of a self-attestation 
process for ordering professionals. We also estimated the further 
reaching impacts of the AUC program in the detailed analysis that 
follows, assuming that some ordering professionals will voluntarily 
choose to purchase a qualified CDSM integrated within their existing 
electronic health record (EHR) and others may voluntarily choose to 
purchase an EHR system in order to obtain an integrated qualified CDSM. 
We believe that in the beginning of this program due to the additional 
action required on the part of the ordering professional, it may take 
longer for a Medicare beneficiary to obtain an order for an advanced 
diagnostic imaging service, and therefore, we have calculated an 
estimated impact to Medicare beneficiaries.
    This final rule includes a discussion of the proposed options along 
with the final policy to report the required claims-based AUC 
consultation information in the form of G-codes and HCPCS modifiers. We 
estimated the impact to use existing coding methods (G-codes and HCPCS 
modifiers) to report that information. Finally, we measured the 
estimated impact on furnishing professionals and facilities of the 
finalized proposal to include independent diagnostic testing facilities 
(IDTFs) as an applicable setting in Sec.  414.94(b). While the AUC 
consultation and reporting requirements of this program are effective 
beginning January 1, 2020 with an educational and operations testing 
period, we attempt in this analysis to identify areas of potential 
qualitative benefits to both Medicare beneficiaries and the Medicare 
program.
a. Impact of Required AUC Consultations by Ordering Professionals
    In this final rule, we modified the AUC program largely in response 
to public comments and recommendations as we believe these 
modifications are also important in minimizing burden of the AUC 
program on ordering professionals, furnishing professionals, and 
facilities. Specifically, we included a proposal regarding who, other 
than the ordering professional, may conduct the AUC consultation 
through a qualified CDSM and still meet the requirements of our 
regulations. In the CY 2018 PFS final rule (82 FR 53349), we based our 
estimate for the AUC consultation requirement on the 2 minute effort of 
a family and general practitioner resulting in an annual burden of 
1,425,000 hours (43,181,818 consultations (Part B analytics 2014 claims 
data) x 0.033 hr/consultation) at a cost of $275,139,000.
    An important difference from last year's analysis is that this 
year's analysis includes estimates for non-physician practitioners that 
order advanced diagnostic imaging services. For the purposes of this 
analysis, we assumed that orders for advanced diagnostic imaging 
services will be placed by ordering professionals that are non-
physician practitioners in the same percent as the numbers of non-
physician practitioners are relative to the total number of non-
institutional providers. Therefore, this analysis assumed that 40 
percent of all advanced diagnostic imaging services will be ordered by 
non-physician practitioners. While non-physician practitioners may not 
order advanced diagnostic imaging services in the same proportion as 
their numbers, we did not have other data to use for this estimate. We 
specifically solicited comment and data on alternative assumptions 
about the number of non-physician practitioners who order advanced 
imaging services. We did not receive comments on this aspect of our 
estimate.
    In addition, we had proposed, but did not finalize, that auxiliary 
personnel may perform the AUC consultation when under the direction of, 
and incident to, the ordering professional's services. We finalized 
that the AUC consultation task may be delegated by the ordering 
professional to clinical staff under the direction of the ordering 
professional. The final estimate below, after taking into account 
public comments, is applicable given the change in policy from proposed 
rule to final rule. In the CY 2019 PFS proposed rule, we estimated that 
the majority, or as many as 90 percent, of practices will employ the 
use of auxiliary personnel, working under the direction of the ordering 
professional, to interact with the CDSM for AUC consultation for 
advanced diagnostic imaging orders. We also considered leaving the 
policy unchanged, and smaller modifications to that could expand who 
performs the consultation to a single type of non-physician 
practitioner. We originally proposed this modification because we 
believed it maximized burden reduction effort as illustrated in the 
following updated estimate of consultation burden.
    To estimate the burden of this proposed policy, we calculated the 
effort of a 2-minute consultation with a qualified CDSM by a registered 
nurse (occupation code 29-1141) with mean hourly wage of $35.36 and 100 
percent fringe benefits to be $2.33/consultation ($35.36/hour x 2 x 
0.033 hour). If 90 percent of AUC consultations (1,282,500 hours) are 
performed by auxiliary personnel as proposed then annually the burden 
estimate would be $90,698,400 (1,282,500 hours x $70.72/hour) to 
consult. We acknowledged that some AUC consultations will be performed 
by the ordering professional, therefore the remaining total annual 
burden we estimated was $28,576,950 for the consultation requirement as 
it was proposed. As a result of these assumptions and calculations, we 
estimated a reduction in the burden of the statutorily required AUC 
consultation burden from $275,139,000 (as fully discussed in the CY 
2018 PFS final rule) to $122,508,675, which resulted in a net burden 
reduction of $152,630,325.
    The following is a summary of the comments we received on the 
proposed estimated impact of consultations by ordering professionals.
    Comment: In general, several commenters found CMS' proposed 
estimate of the burden of the Medicare AUC program to be sensible. A 
few commenters disagreed with the proposed burden estimate of 2 minutes 
to consult a qualified CDSM. One commenter suggested the time was too 
short and noted that the Medicare Imaging Demonstration Evaluation 
Report to Congress \46\ indicated 3.3 additional minutes to order an 
advanced diagnostic imaging service, while another commenter questioned 
whether the estimate of burden included calculations for the time and 
effort of the ordering professional to look up the CDSM username and 
password, wait for web pages to load, conduct the AUC consultation, and 
record the results. Additionally, a few commenters stated that more 
complex clinical situations will require additional time to perform an 
AUC consultation, as well as consultations involving new patients with 
new clinical scenarios. In contrast, a few other commenters suggested 
that

[[Page 60036]]

the 2 minute estimate to perform AUC consultation overestimated the 
time and effort, stating that accessing one no fee website for a 
qualified CDSM to perform an AUC consultation takes a healthcare 
provider less than 50 seconds.
---------------------------------------------------------------------------

    \46\ Timbie JW, Hussey PS, Burgette L, et al. Medicare imaging 
demonstration evaluation report for the report to congress. April 
2014. RR-706-CMMS.
---------------------------------------------------------------------------

    Response: Based on the average of two estimates provided ([3.3 min 
+ 0.8 min]/2 = 2.1 min), we continue to believe that 2 minutes is a 
reasonable estimate of the time and effort to consult one of the 
currently qualified clinical decision support mechanisms available 
under this program. We will continue to supplement these estimates with 
published evidence as the AUC consultation and reporting requirements 
are implemented beginning January 1, 2020.
    Comment: A few commenters agreed with our estimates that as many as 
90 percent of practices would use other personnel working under the 
direction of the ordering professional to interact with the CDSM. One 
commenter noted that most family physicians and general practitioners 
would not employ a registered nurse for the purpose of AUC consultation 
and instead would rely upon a licensed practical nurse or medical 
assistant. The commenter also noted that we are likely overestimating 
the costs in question because if CMS anticipates a registered nurse is 
needed, then such a professional would be cost prohibitive for most 
family medicine practices.
    Response: As a result of the finalized policy at Sec.  414.94(j) 
and after reading the public comments, we have updated our estimate to 
account for the $16.15 mean hourly wage and fringe benefits of a 
medical assistant (BLS #31-9092) to perform the AUC consultation. If 90 
percent of consultations (1,282,500 hours) are performed by such an 
individual then annually the burden estimate would be $41,424,750 
(1,282,500 hours x $32.30/hour) to consult.
    Comment: One commenter suggested that not all clinical situations 
will require the ordering professional to consult a CDSM and report the 
AUC adherence, but rather noted that first the ordering professional 
must determine if the patient's clinical scenario is within a priority 
clinical area. Additionally, one commenter stated that additional time 
and effort should be considered to estimate the interaction that will 
likely be required between the ordering professional and auxiliary 
personnel to complete the AUC consultation within the CDSM. Finally, 
one commenter suggested that CMS also estimate the time and effort for 
the furnishing professional to perform the AUC consultation on behalf 
of the ordering professional.
    Response: We remind all commenters that an AUC consultation must 
take place for any applicable imaging service furnished in an 
applicable setting and paid for under an applicable payment system, 
regardless of whether the patient's clinical scenario falls within a 
priority clinical area. Therefore, we believe that there is not 
additional time and effort needed to make this determination as it does 
not change the estimation of burden for the AUC consultation 
requirement at Sec.  414.94(j). As a result of the finalized policy at 
Sec.  414.94(j), the furnishing professional cannot perform the AUC 
consultation on behalf of the ordering professional; therefore, we did 
not include this additional estimate. When the consultation and 
reporting requirements are implemented beginning January 1, 2020, we 
may have data to support additional time for other supportive 
consultations, such as that between clinical staff and the ordering 
professional. However, at this time we have no experience or data to 
suggest the type or time of these interactions, and did not receive 
estimates or experience from commenters to suggest the level of effort 
required to change this AUC consultation burden estimate further.
    Comment: A few commenters requested that CMS consider situations 
where multiple consultations occur for the same advanced diagnostic 
imaging service for the same Medicare beneficiary, such as in the case 
of obtaining a second opinion. One commenter expected that the estimate 
of burden would include calculations for the time and effort required 
of the ordering professional to consult more than one CDSM. Another 
commenter noted situations resulting in the Medicare beneficiary being 
unable to receive an order during the encounter and forced to return to 
the practice such as in the case of technical issues with a CDSM. 
Finally, one commenter asked that CMS consider an assumption that some 
ordering professionals will decide not to use a qualified CDSM and 
instead refer the patient to a specialist for AUC consultation.
    Response: If we can consider that a patient is referred to a 
specialist in lieu of receiving an order from their general 
practitioner, then we recognize that no second consultation would occur 
and that a specialist acting as an ordering professional may choose to 
delegate the AUC consultation to another individual such as someone on 
their clinical staff. If there are technical difficulties that result 
in a significant hardship for the ordering professional to consult 
specified applicable AUC, then no consultation is required and no 
additional time and effort to perform the consultation would take 
place. While multiple consultations may take place, such as in the case 
of consulting more than one CDSM, it is not a requirement. We will 
continue to look for published evidence on these experiences after the 
AUC consultation and reporting requirements are implemented beginning 
January 1, 2020.
    Comment: A few commenters noted that additional costs should be 
considered on the part of the ordering professional and/or personnel 
under their supervision. One commenter asked that CMS consider the time 
and effort to educate ordering professionals and auxiliary personnel on 
how to use a CDSM.
    Response: We agree with the commenter that we unintentionally 
excluded the time and effort to undertake educational training 
activities related to performing an AUC consultation. As a result we 
have included the time and effort of a general practitioner (occupation 
code 29-1062) with mean hourly wage of $100.27 plus 100-percent to 
account for fringe benefits to attend a one-time, 1.0 hour training. 
The hour is representative of training incurred by physicians for a 
single topic as part of the process of maintaining credentials. Some 
physicians may not need to undertake educational training activities 
related to this program. Others may undertake training activities in 
lieu of an alternative continuing education training resulting in no 
net increase to their training costs. If all 579,687 ordering 
professionals subject to this program attend a one-time, 1.0 hour 
training, then we estimate the total burden to be $116,250,431 ($100.27 
x 2 x 1.0 hour x 579,687). We recognize that some ordering 
professionals may be specialists with higher mean hourly wage and other 
ordering professionals are not physicians (for example, nurse 
practitioners, physician assistants) with lower mean hourly wage, 
however without any additional evidence or specific estimates from 
commenters, we could not inform this burden estimate further.
    After considering the comments, we are updating the proposed impact 
estimate of consultations by ordering professionals. First, we modified 
our calculation of the effort by a registered nurse to the effort of a 
2-minute consultation with a qualified CDSM by a medical assistant 
(occupation code 31-9092) with mean hourly wage of $16.15 and 100 
percent fringe benefits

[[Page 60037]]

for 90 percent of consultations (1,282,500 hours) to be $41,424,750 
(1,282,500 hours x $32.30/hour). We acknowledged that some AUC 
consultations will not be performed by these individuals, therefore the 
remaining total annual burden we estimate is $28,576,950 (142,500 hours 
x $200.54/hour) for this proposed consultation requirement. As a result 
of these assumptions and calculations, we estimated a reduction in 
burden of the statutorily required consultation from cost of 
$275,139,000 to $70,001,700, which results in a net burden reduction of 
$205,137,300.
    In section VII.G. of this RIA, Alternatives Considered, we provide 
a detailed estimate of the burden of an ordering professional 
voluntarily choosing to consult a second, free CDSM for 300,717 
services annually. If 90 percent of those consultations (300,717 
services x 90 percent x 0.033 hr/service) for 8,931.285 total hours 
were performed by a medical assistant at a rate of $32.30/hour for a 
total of $288,480.50 (8,931.285 x $32.30/hour) and 10 percent of 
consultations (300,717 services x 10 percent x 0.033 hr/service) for 
992.376 total hours were performed by the ordering professional at a 
rate of $200.54/hour for a total of $199,011.08 then annually the 
burden estimate would be 9,923.661 total hours (8,931.285 hours + 
992.376 hours) and $487,491.58 ($288,480.50 + $199,011.08) to perform 
the second consultation.
    We also estimated the burden of this one-time effort to undertake 
educational training activities related to the impact of consultations 
by ordering professionals. As a result we have included the time and 
effort of a general practitioner (occupation code 29-1062) with mean 
hourly wage of $100.27 plus 100-percent to account for fringe benefits 
to attend a one-time, 1.0 hour training. Based on our proposed estimate 
in section VII.F.4.b. of this RIA, if 579,687 ordering professionals 
are subject to this program, and all attend training for the same 
amount of time, then we estimate the total one-time burden of education 
and training to be $116,250,431 ($200.54/hr x 1.0 hour x 579,687). 
Since not all physicians would undertake educational training 
activities, this estimate should be considered an upper bound.
b. Impact of Significant Hardship Exceptions for Ordering Professionals
    We previously identified significant hardship exceptions to the 
requirement that ordering professionals consult specified applicable 
AUC when ordering applicable imaging services (81 FR 80170). Our 
original intention was to design the AUC hardship exception process in 
alignment with the EHR Incentive Program and then the MIPS ACI 
performance category (now Promoting Interoperability). However, in this 
final rule, we modified the significant hardship exception criteria 
under Sec.  414.94(i)(3) to be specific to the Medicare AUC program and 
independent of other Medicare programs both in policy and process. 
Specifically, we finalized the policy that all ordering professionals 
self-attest if they are experiencing a significant hardship at the time 
of placing an advanced diagnostic imaging order. Since the Medicare EHR 
Incentive Program has ended and we are unable to continue referring to 
a regulation that is no longer in effect, we did not consider leaving 
this policy unchanged. We also considered using a significant hardship 
application submission process. However, we believe that the self-
attestation process maximizes burden reduction effort as illustrated in 
the following updated estimate of ordering professionals subject to an 
AUC consultation burden.
    To estimate the impact of our modification and create a hardship 
exception specific to this program we attempted to identify how many 
ordering professionals would be subject to this program.
    Medicare non-institutional Part B claims for the first 6 months of 
2014 shows that for claims for an advanced diagnostic imaging service 
that listed an NPI for the ordering/referring provider, up to 90-
percent of claims include only 18 different provider specialties. These 
specialties include: Emergency Medicine; Internal Medicine; Family 
Practice; Cardiology; Hematology/Oncology; Orthopedic Surgery; 
Neurology; Urology; Physician Assistant; Nurse Practitioner; Pulmonary 
Disease; General Surgery; Neurosurgery; Medical Oncology; 
Gastroenterology; Radiation Oncology; Otolaryngology; and Diagnostic 
Radiology. We then used CMS data that served to create Table II.8 of 
the 2014 Medicare Statistics Book and were able to identify how many 
practitioners in each of those specialties were participating in 
Medicare program. Table II.8 of the 2014 Medicare Statistics Book 
combines many of these specialties into higher level groupings and 
displays the total number of practitioners participating in the 
Medicare program. However, we used more granular information that 
identifies the number of practitioners participating in the Medicare 
program by an individual specialty rather than higher level groupings 
(table available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/CMSProgramStatistics/2016/Downloads/PROVIDERS/2016_CPS_MDCR_PROVIDERS_6.pdf). For example, Table 
II.8 of the 2014 Medicare Statistics Book combines all surgeons into 
one category whereas we used detailed information for the individual 
surgical specialties of general surgery and orthopedic surgery for this 
estimate.
    Using this more specific data for the 18 specialties, we estimate 
the count of practitioners that will be ordering professionals under 
the AUC program to be 586,386. There are limitations as we do not have 
data on the actual number of practitioners who order advanced 
diagnostic imaging services because information about the ordering 
professional is not currently required to be included on the Medicare 
claim form for advanced diagnostic imaging services.
    In the absence of data on the breadth of professionals who would be 
required to consult AUC, we assumed that all professionals in the 
specialties listed earlier could potentially be subject to these 
requirements because some professionals within a specialty may order 
these imaging services. We specifically requested comments and data on 
the numbers of professionals in the specialties that actually order 
advanced imaging services. We did not receive comments on this 
estimate.
    With respect to the significant hardship exceptions, based on 2016 
data from the Medicare EHR Incentive Program and the 2019 payment year 
MIPS eligibility and special status file, we estimated that 6,699 
respondents in the form of eligible clinicians, groups, or virtual 
groups will submit a request for a reweighting to zero for the 
advancing care information performance category due to extreme and 
uncontrollable circumstances or as a result of a decertification of an 
EHR. For the purposes of this analysis, we cautiously estimated that 
each of the 6,699 respondents represents a unique ordering professional 
and that all respondents who experience extreme and uncontrollable 
circumstances or have an EHR that is decertified are ordering 
professionals who would self-attest to a significant hardship exception 
under the AUC program. Nevertheless, we have used this information to 
update our estimate that there are 579,687 ordering professionals 
subject to this program.
    We believe that the proposed significant hardship exception at

[[Page 60038]]

Sec.  414.94(i) would further reduce the burden of this program as 
finalized for four reasons. First, due to the availability of a 
significant hardship exception there will likely be fewer ordering 
professionals consulting specified applicable AUC. Second, the self-
attestation process is a less burdensome proposal when compared to the 
alternative of a hardship application process that may have both 
regulatory impact and information collection requirements. We estimate 
the impact of a significant hardship exception application in section 
VII.G. of this RIA, Alternatives Considered.
    Third, any application or case-by-case determination would 
necessitate immediate infrastructure development by CMS directly or 
through one or more MACs, which adds burden and impact to this program. 
Finally, the proposed self-attestation process requires no verification 
on the part of the furnishing professional or facility required to 
report AUC consultation information on the Medicare claim, thus 
minimizing burden for both ordering professionals, furnishing 
professionals and facilities. While some of the efficiencies gained 
from a self-attestation process are qualitative in nature and difficult 
to measure, such as the streamlined reporting, we believe that relative 
to other regulatory approaches this proposal uses a least burdensome 
approach.
    We recognize that ordering professionals would store documentation 
supporting the self-attestation of a significant hardship. Storage of 
this information could involve the use of automated, electronic, or 
other forms of information technology at the discretion of the ordering 
professional. We estimated that the average time for office clerical 
activities associated with this task to be 10 minutes. To estimate the 
burden of this storage, we expected that a Bureau of Labor Statistics 
(BLS) occupation title 43-6013 Medical Secretary with a mean hourly 
rate of $17.25 and 100-percent fringe benefits would result in a 
calculated effort of 10 minutes of clerical work to be $5.76 ($17.25/
hour x 2 x 0.167 hour). If 6,699 separate ordering professionals 
require that a Medical Secretary perform the same clerical activity on 
an annual basis, then this equates to a cost of approximately $38,596 
per year. We solicited comment to inform these burden estimates. We did 
not receive comments on these burden estimates and have finalized these 
estimates as proposed.
c. Impact of Consultations Beyond the Impact To Ordering Professionals
    Although we have already discussed the time and effort to consult 
specified applicable AUC through a qualified CDSM here and in previous 
rulemaking (81 FR 80170), we believe the impact of this program is 
extensive as it will apply to every advanced diagnostic imaging service 
(for example, magnetic resonance imaging (MRI), computed tomography 
(CT) or positron emission tomography (PET)). Therefore, we also have 
described in this detailed analysis the estimated impacts of AUC 
consultation beyond the act of consulting specified applicable AUC 
which would be an upper bound.
(1) Transfers From Ordering Professionals to Qualified CDSMs and EHR 
Systems
    The first additional impact we identified is upstream in the 
workflow of the AUC consultation and represents the acquisition cost, 
training, and maintenance of a qualified CDSM. These tools may be 
modules within or available through certified EHR technology (as 
defined in section 1848(o)(4)) of the Act or private sector mechanisms 
independent from certified EHR technology or established by the 
Secretary. Currently, none are established by the Secretary. 
Additionally, for the purposes of this program, as required by statute, 
one or more of such mechanisms is available free of charge. For this 
impact analysis we will illustrate three potential scenarios as low, 
medium, and higher burden assessments of this consultation requirement. 
First, we assume that some number of ordering professionals consults a 
qualified CDSM available free of charge. Second, we assume that some 
number purchase a qualified CDSM to integrate within an existing EHR 
system. Third, we assume that some do not currently have an EHR system 
and, as a result of the statutory requirement to consult with AUC, 
would purchase an EHR system with an integrated qualified CDSM to 
consult specified applicable AUC for the purposes of this program.
    In the lowest estimate of burden, every AUC consultation would take 
place using a qualified CDSM available free of charge integrated into 
an EHR system and add no additional cost to the requirement in Sec.  
414.94(j) of this final rule. While we did not base this estimate on 
absolute behaviors by all those who have ordered advanced diagnostic 
imaging services, we believe it is reasonable to estimate that as many 
as 75 percent of an assumed annual 40,000,000 orders for advanced 
diagnostic imaging services could occur at no additional cost beyond 
the time and effort to perform the consultation. This may be an 
underestimate of orders that occur at no additional cost beyond time 
and effort because multiple free qualified CDSMs are available.
    In contrast, some ordering professionals may voluntarily choose to 
purchase a qualified CDSM that is integrated within their EHR. To 
estimate how many ordering professionals may choose to purchase an 
integrated qualified CDSM, we consulted the 2015 National Electronic 
Health Records Survey \47\ (NEHRS), which is conducted by the National 
Center for Health Statistics (NCHS) and sponsored by the Office of the 
National Coordinator for Health Information Technology (ONC). NEHRS is 
a nationally representative mixed mode survey of office-based 
physicians that collects information on physician and practice 
characteristics, including the adoption and use of EHR systems. In the 
United States in 2015, 86.9 percent of office-based physicians used any 
EHR/EMR, with significantly higher adoption by general or family 
practice physicians (92.7 percent, p-value <0.05), and slightly lower 
for medical non-primary care physicians (84.4 percent). Given that 
approximately 87 percent of office-based physicians have adopted EHR 
systems, we believe it is likely that the majority will prefer a 
qualified CDSM integrated with EHR. While we note that qualified CDSMs 
available free of charge are also integrated within one or more EHR 
systems, the following illustrative exercise estimates the time and 
effort to purchase, install, train, and maintain a qualified CDSM 
integrated into an EHR system. Since section 1834(q)(1)(c)(iii) 
requires that one or more free CDSMs be available, this is an 
illustrative exercise rather than an estimate of the burden of the 
statutory requirement.
---------------------------------------------------------------------------

    \47\ Jamoom E, Yang N. Table of Electronic Health Record 
Adoption and Use among Office-based Physicians in the U.S., by 
State: 2015 National Electronic Health Records Survey. 2016.
---------------------------------------------------------------------------

    Again, as stated above, we do not have data on the number of 
clinicians who order advanced diagnostic imaging services, and we have 
made overarching assumptions to look at particular specialty areas that 
in our claims analysis order these advanced diagnostic imaging 
services. We assumed all individual clinicians in these specialty areas 
could potentially be subject to these requirements. Adding the number 
of clinicians in each of the specialty areas results in 586,386 
ordering professionals. We also did not make a distinction between 
individual

[[Page 60039]]

professionals and groups, as further explained below.
    To calculate the impact of a single purchase, we believe based on 
market research that ordering professionals, either in groups or 
individually, would spend an estimated $15,000 for a one-time purchase 
of an integrated qualified CDSM, including installation and training. 
We assume that all of these costs are based on market research and 
incurred over the course of 5 years. We also assume that the $15,000 
purchase would be made by each ordering professional and did not take 
into account the potential that a group practice might incur a 
discounted price per user based on the number of ordering professionals 
in the practice. These assumptions could significantly alter the impact 
estimate and we sought comment on such assumptions. Given the difficult 
nature of deriving these illustrative estimates based on limited data, 
we solicited comment and information on the preference that physicians 
and practitioners might have for using an integrated qualified CDSM--a 
free CDSM or a CDSM that is not free but integrated within an existing 
EHR system. Also, if purchased, whether this would be purchased at the 
group practice level to be made available to all clinicians in the 
practice for the same cost that would be incurred by a single 
practitioner purchasing the same qualified CDSM, and whether the cost 
of purchasing a CDSM would be incurred in a single year or over 
multiple years.
    For the purposes of estimating the transfer of costs from ordering 
professionals to qualified CDSM developers, of the estimated 579,687 
practitioners that are likely subject to this program, we excluded 
181,653 ordering professionals with specialties whose practitioners 
order on average fewer than 20 advanced diagnostic imaging services per 
year (physician assistant, nurse practitioner, and diagnostic 
radiology). The assumption is that lower volume ordering professionals 
would select a qualified CDSM that is free of charge. This updates the 
estimate to consider 398,034 ordering professionals who may purchase an 
integrated qualified CDSM. To this end, if we assume 346,290 (398,034 
ordering professionals x 87 percent) ordering professionals already 
have an EHR system and 30 percent of these ordering professionals 
(346,290 x 30 percent, or 103,887) make this purchase for $15,000 and 
spend $1,000 annually to maintain their system for 5 years (initial 
acquisition cost in year 1 and maintenance costs in years 2-5), then 
the total annual cost is estimated to be $394,770,600 ((103,887 x 
$19,000)/5 years)).
    It is also reasonable to assume that some ordering professionals 
may not need additional training in using a qualified CDSM because the 
EHR Incentive Program required CDS as a core measure. In addition, the 
EHR Incentive Program incentivized use of computerized provider order 
entry (CPOE)--an electronic submission of pharmacy, laboratory, or 
radiology orders. To determine readiness among Medicare practitioners 
for these and other measures, the 2011 Meaningful Use Census \48\ (RTI 
International, 2012) observed that those participating in the EHR 
Incentive Program in 2011 on average met and exceeded the established 
30 percent threshold for meaningful use of CPOE in Stage 1. Analysis of 
the distribution of performance on these measures shows that 86 percent 
of eligible participants were well over the established thresholds. It 
is important to note that the CPOE measure had a higher threshold in 
Stage 2, and 60 percent of eligible participants in 2011 attested to 
meaningful use are already meeting this higher threshold. This report 
suggests that some ordering professionals may be well prepared to adopt 
a qualified clinical decision support mechanism, as this experience 
offset may yield lower costs and burden to learn to incorporate 
decision support into the ordering workflow through shorter training 
times.
---------------------------------------------------------------------------

    \48\ Vincent, A. EHR Incentive Program: 2011 Meaningful Use 
Census. RTI Internatoinal. November 2012.
---------------------------------------------------------------------------

    Additionally, some ordering professionals may voluntarily choose to 
purchase a certified EHR system to use a qualified CDSM already 
integrated within the EHR. The first estimate of capital costs for 
certified EHR system was identified in the first year of the EHR 
incentive program as an estimated cost of approximately $54,000 (75 FR 
44518), which adjusted for inflation using the Consumer Price Index for 
All Urban Consumers (CPI-U) U.S. city average series for all items, not 
seasonally adjusted, represents $62,050.40 in 2018. If we assume that 
346,290 ordering professionals subject to this program have adopted 
EHR, then we will also assume that 51,744 ordering professionals 
(398,034 ordering professionals x 13 percent) have not adopted an EHR 
system.
    Most physicians who have not yet invested in the hardware, 
software, testing, and training to implement EHRs may continue to work 
outside the EHR for a number of reasons--lack of standards, lack of 
interoperability, limited physician acceptance among their peers, 
maintenance costs, and lack of capital. Adoption of EHR technology 
necessitates major changes in business processes and practices 
throughout a provider's office or facility. Business process 
reengineering on such a scale is not undertaken lightly. Therefore, 
while we cannot estimate the business decisions of all ordering 
professionals, we assume for the purposes of this analysis that as a 
result of this program some ordering professionals will purchase an EHR 
system in order to access a qualified CDSM that is integrated into that 
EHR system for the purposes of acquiring long-term process efficiencies 
in consulting specified applicable AUC.
    We do not have data on the characteristics of physicians who have 
not purchased an EHR system. However, for the purpose of estimating the 
transfer of costs from ordering professionals to EHR systems, we will 
assume based on research from business advisors \49\ that 30 percent, 
or 15,523 ordering professionals (51,744 ordering professionals x 30 
percent) will seek to purchase an EHR system at an estimated cost of 
$62,050.40 for a total one-time cost of $963,208,359.20 in EHR system 
and integrated qualified CDSM infrastructure. As we believe not every 
ordering professional in this example would purchase such 
infrastructure immediately, for the purposes of this estimate, we 
annualized this cost over 5 years to $192,641,671.84/year. We recognize 
that qualified CDSMs may be modules within or available through 
certified EHR technology (as defined in section 1848(o)(4) of the Act) 
or private sector mechanisms independent from certified EHR technology 
or established by the Secretary.
---------------------------------------------------------------------------

    \49\ McCormack M, ``EHR Software Buyer Report--2014'' available 
at https://www.softwareadvice.com/resources/ehr-buyer-report-2014/.
---------------------------------------------------------------------------

    We recognize that due to the limited data available to make these 
assumptions our estimates are likely high and we sought comment and 
information about these assumptions. These estimates might be viewed as 
an upper bound of the impact of this program beyond consultation with a 
free tool and note that at the time of publication there were three 
free tools available as indicated on the CMS website at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM.html.

[[Page 60040]]

(2) Impact to Medicare Beneficiaries
    Additionally, we believe that the additional 2-minute consultation 
will impact the Medicare beneficiary when their advanced diagnostic 
imaging service is ordered by the ordering professional by introducing 
additional time to their office visit. To estimate this annual cost, we 
multiplied the annual burden of 1,425,000 hours by the BLS occupation 
code that represents all occupations in the BLS (00-0000) as mean 
hourly wage plus 100 percent fringe ($47.72/hr) for a total estimate of 
$68,001,000 per year. Over time, there may be process efficiencies 
implemented in one or more practices similar to the benefits of 
deploying CDS \50\ (Berner, 2009; Karsh, 2009) that decrease this 
estimate. For example, we will assume that every time an advanced 
diagnostic imaging service is ordered, it is the result of a visit by a 
Medicare beneficiary for evaluation and management. Then, let us assume 
that 50 percent of practices implemented an improvement process that 
streamlined the AUC consultation such that Medicare beneficiaries who 
visited those practices spent the same amount of time in the 
physician's office regardless of whether an advanced diagnostic imaging 
service was ordered. As a result of this improvement process in 
practice we could estimate such efficiency would offset the estimated 
burden by $34,000,500 annually. Although we could not at the time of 
the proposed rule identify a concrete solution, we sought comment on 
this detailed analysis to inform future rulemaking.
---------------------------------------------------------------------------

    \50\ Berner ES. Clinical decision support systems: State of the 
Art. AHRQ Publication No. 09-0069-EF. Rockville, Maryland: Agency 
for Healthcare Research and Quality. June 2009. Karsh B-T. Clinical 
practice improvement and redesign: How change in workflow can be 
supported by clinical decision support. AHRQ Publication No. 09-
0054-EF. Rockville, Maryland: Agency for Healthcare Research and 
Quality. June 2009.
---------------------------------------------------------------------------

    The following is a summary of the comments we received on the 
proposed estimated impact of consultations beyond ordering 
professionals.
    Comment: Commenters responded to our solicitation for comment and 
information on the preference that physicians and practitioners might 
have for purchasing an integrated qualified CDSM. One commenter 
suggested that CMS did not reasonably estimate the percentage of 
practices that would purchase an integrated CDSM relative to using a 
free qualified CDSM. This commenter noted that most health systems 
prefer to go with a commercial product for accountability, attempted 
standardization, and support when a system goes down or requires 
updating. To this end, the commenter also asked that CMS estimate the 
cost of maintenance to a CDSM. In contrast, another commenter asked 
that CMS provide additional information in the final rule as to how it 
arrived at the maintenance estimate of $1,000 per year for an 
integrated CDSM.
    Response: We appreciate these comments acknowledging the challenges 
with determining the percentage of practices that would purchase an 
integrated CDSM relative to using a free and non-integrated CDSM. While 
we did not receive any more precise information to change the estimated 
percent of practitioners that would purchase an integrated CDSM, we 
will continue to evaluate these estimates as information and published 
evidence becomes available once the AUC consultation and reporting 
requirements are implemented beginning January 1, 2020. To clarify our 
estimate of maintenance, we performed market research by gathering 
information from IT experts suggesting annualized costs between 5 
percent and 10 percent of initial purchase cost.
    Comment: A few commenters questioned the lack of ancillary costs 
attributed to the estimation of using a free qualified CDSM. One 
commenter cited the need for internet access to use the free tool. 
Another commenter cited AUC conferences, town hall meetings, as well as 
other forms of professional education to learn about CDSM consultation.
    Response: We continue to believe that a free tool is a qualified 
CDSM available free of charge. Any ordering professional without 
internet access would continue to remain eligible for a significant 
hardship exception from performing an AUC consultation and would 
instead communicate to the furnishing professional their hardship. We 
have included updates to our estimate in this final rule to account for 
education and training of all ordering professionals that we estimated 
would be subject to this program irrespective of what qualified CDSM is 
used to perform the AUC consultation.
    After reviewing all comments, for purposes of this RIA we are 
finalizing our proposed estimate representing the acquisition cost, and 
maintenance of a qualified CDSM. However, we note that these estimates 
are based on multiple assumptions, which could change the estimate in 
significant ways, and as such may be an overestimate of burden as a 
free qualified CDSM is required by law.
d. Considering the Impact of Claims-Based Reporting
    In the CY 2018 PFS proposed rule (82 FR 34094), we discussed using 
a combination of G-codes and modifiers to report the AUC consultation 
information on the Medicare claim. We received numerous public comments 
objecting to this potential solution. In the 2018 PFS final rule, we 
agreed with many of the commenters that additional approaches to 
reporting AUC consultation information on Medicare claims should be 
considered, and in the opinion of some commenters, reporting unique 
consultation identifiers (UCIs) would be a less burdensome and 
preferred approach. We had the opportunity to engage some stakeholders 
and we understand that some commenters from the previous rule continue 
to be in favor of a UCI. Practically examining the workflow of an order 
for an advanced diagnostic imaging service before and after 
implementation of the Medicare AUC program, we see that in general the 
process remains largely unchanged. Before and after the implementation 
of this program, an ordering professional could employ support staff to 
transmit an order for an advanced diagnostic imaging service from his 
or her office to an imaging facility, physician office, or hospital 
that furnishes advanced diagnostic imaging services. After 
implementation of this program, the ordering professionals, furnishing 
professionals and facilities must adapt this existing workflow to 
accommodate new information not previously required on orders for 
advanced diagnostic imaging services.
    We considered leaving the policy unchanged, and we also considered 
writing new regulations requiring larger modifications to the form and 
manner by which AUC consultation information is communicated from the 
ordering professional to the furnishing professional or facility. 
However, we believe this final rule minimizes burden and maximizes 
efficiency by reporting through established coding methods, to include 
G-codes and modifiers, to report the required AUC information on 
Medicare claims.
(1) Impact on Transmitting Order for Advanced Diagnostic Imaging 
Services
    We estimate that including AUC consultation information on the 
order to the furnishing professional or facility is estimated as the 
additional 5 minutes spent by a medical secretary (BLS #43-6013) at a 
mean hourly rate of $17.25 plus 100 percent fringe to transmit the 
order for the advanced diagnostic

[[Page 60041]]

imaging service. Taking into account transmissions through an EHR that 
could occur on the order of seconds, a facsimile transmission that 
could occur on the order of few minutes, or a telephone call that occur 
on the order of several minutes, we believe the estimate of 5 minutes 
is an estimate that accounts for different transmittal methods, such as 
through an integrated EHR system, by facsimile, or via telephone call 
directly to the office of the furnishing professional or facility. In 
aggregate, if we assume that 40,000,000 advanced diagnostic imaging 
services are ordered annually, then the total annual burden to 
communicate additional information in the order is estimated as 
$114,540,000 ($17.25/hr x 2 x 0.083 hr x 40,000,000 orders).
(2) Impact on CDSM Developers
    While we did not finalize use of a UCI to report AUC consultation 
information, the following section remains important to understanding 
the impact of standardizing the UCI should we move forward with such 
additional modifications in the future.
    We believe that in considering a distinct UCI we also considered 
updating the requirements of a qualified CDSM in Sec.  
414.94(g)(1)(vi)(B). This would incur additional costs for the 
developers of these mechanisms to accommodate formatting changes if 
instructed by CMS. We continue to believe that participation by CDSM 
developers in this program is voluntary, that any considerations of 
proposed changes to this policy maximize benefits and minimize burden 
to ordering professionals and furnishing professionals and facilities. 
Internally, CMS has explored the possibility of using a UCI to 
determine feasibility, and provide a detailed estimate of costs to 
develop, test, and implement an update in the form and manner of the 
UCI generated by the CDSM.
    To estimate the costs to develop, test, and implement this update, 
we will provide a relevant case study. In 1998, the Year 2000 
Information and Readiness Disclosure Act (Pub. L. 105-271, enacted 
October 19, 1998) was passed to ensure continuity of operations in the 
year 2000. At the time of passage, millions of information technology 
computer systems, software programs, and semiconductors were not 
capable of recognizing certain dates after December 31, 1999, and 
without modification would read dates in the year 2000 and thereafter 
as if those dates represented the year 1900 or thereafter, or would 
have failed to process those dates entirely. The federal government had 
budgeted $8,300,000,000 to continue processing dates in 2000 and beyond 
(Department of Commerce, 1999). Additional estimates to repair the date 
in a form and manner accommodating the year 2000 varied, but one 
estimate \51\ from analysis of the 1998-99 budget bill of the state of 
California estimated $241,000,000 to repair 3,000 systems, or 
$80,333.33 per system, which adjusted for inflation using the CPI-U, 
U.S. city average series for all items, not seasonally adjusted, 
represents $123,775.95 per system in 2018. If all 16 qualified CDSMs 
performed an update to the formatting of the UCI to appear on 
certification or documentation of every AUC consultation, then the one-
time total cost incurred by all CDSM developers would be $1,980,415.20. 
Although this does not represent a direct transfer of costs from CDSM 
developers to savings and efficiencies for ordering professionals, 
furnishing professionals and facilities, we do believe that as a result 
of such a policy modification that the ordering professional could 
directly communicate a single AUC UCI, and furnishing professionals and 
facilities can report UCI in place of identifying each individual CDSM 
qualified for the purposes of this program.
---------------------------------------------------------------------------

    \51\ LAO Analysis of the 1998-99 Budget Bill Information 
Technology Issues. Information Technology Issues Analysis of the 
1998-99 Budget Bill. The Year 2000 (``Y2K'') Computer Problem. 
Published February 18, 1998. Accessed March 25, 2018 at http://www.lao.ca.gov/analysis_1998/info_tech_anl98.html.
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    The following is a summary of the comments we received on the 
proposed estimated impact of claims-based reporting.
    Comment: One commenter noted that there is no standardized form and 
manner for submitting the AUC consultation information with the order 
for an advanced diagnostic imaging service. This commenter observed 
that each imaging facility has its own way of accepting an imaging 
order, therefore, the commenter stated it will be burdensome for the 
imaging facility to coordinate accurate information for one, let alone 
multiple imaging services with the many ordering clinicians from whom 
they receive imaging orders. The commenter also stated that facilities 
would need to invest considerable resources to develop an appropriate 
workflow to comply with this policy, such as additional staff time to 
translate AUC consultation information into appropriate codes and 
modifiers for billing.
    Response: We appreciate this experience of order transmission as we 
included in the proposed rule burden estimates for the communication 
between staff of the ordering professional to those furnishing the 
applicable imaging service ordered in section VII.F.4.d.(1) of this 
RIA. We also included in section VII.F.4.e. of the proposed rule a 
burden estimate to account for the potential of updates to billing 
software to accommodate possible changes in workflow that would 
accommodate this policy. As we did not require in this final rule a 
specific form and manner standardized to transmit AUC consultation 
information, we did not update this area of our burden estimate in this 
final rule.
    Comment: A few commenters expected additional time estimated for 
communication between ordering and furnishing professionals. For 
example, one commenter provided the scenario of a furnishing 
professional or facility receiving an order for an applicable imaging 
service but the order does not contain AUC consultation information. In 
another example, a patient obtains an advanced diagnostic imaging 
service as part of a clinical trial protocol that does not adhere to 
the AUC consulted. To this end, a few commenters requested that CMS 
allow the work associated with the additional consultation and 
communication time between the ordering and furnishing physicians and 
their teams be separately billable for the purposes of the AUC 
requirement.
    Response: We disagree that additional time for communication 
between ordering professionals and those furnishing advanced diagnostic 
imaging services should be included for instances where AUC 
consultation information was not initially communicated. We remind the 
commenters that the estimated burden included communicating AUC 
consultation information for all advanced diagnostic imaging services. 
In other words, whether the information was initially communicated or 
whether there was an initial failure and the information was then 
subsequently communicated, that communication has been accounted in our 
5 minute estimate per service. We did not propose to authorize a 
separately billable service by ordering or furnishing professionals or 
their teams to communicate and therefore cannot estimate the cost of 
billing Medicare for time to transmit AUC consultation information.
    After reviewing the comments, we are finalizing the proposed 
estimate of impact of claims based reporting. We note that before and 
after the implementation of this program, an ordering professional 
could employ support staff to transmit an order for an advanced 
diagnostic imaging service

[[Page 60042]]

from his or her office to an imaging facility, physician office, or 
hospital that furnishes advanced diagnostic imaging services. As a 
result of the flexibility afforded to the means of order communication 
and transmission, there are many market-based solutions available to 
adapt this existing workflow to accommodate new information not 
previously required on orders for advanced diagnostic imaging services.
e. Impact on Furnishing Professionals and Facilities
    We expect that an AUC consultation must take place for every 
applicable imaging service furnished in an applicable setting and paid 
for under an applicable payment system. In the CY 2017 PFS final rule 
(81 FR 80170), we codified the definition of applicable setting in 
Sec.  414.94(b) to include a physician's office, a hospital outpatient 
department (including an emergency department), an ambulatory surgical 
center, and any other provider-led outpatient setting determined 
appropriate by the Secretary. In this final rule, we finalize as 
proposed adding IDTFs to the definition of applicable settings under 
this program. This was based on the following factors from 2016 CMS 
Statistics: (1) An IDTF is independent both of an attending or 
consulting physician's office and of a hospital; (2) diagnostic 
procedures when performed by an IDTF are paid under the PFS; (3) 
independent facilities have increased 5,120 percent from 4,828 in 1990 
to 252,044 in 2015; (4) Of those facilities, 1,125 received total 
payments in excess of $100,000 in 2015; (5) there were 37,038 radiology 
non-institutional providers utilized by fee-for-service Medicare 
beneficiaries for all Part B non-institutional provider services in 
2015, of which 14,341 received total payments in excess of $100,000 in 
2015. Taken together, we believe this will result in a more even 
application of the Medicare AUC program.
    To estimate this impact, we assume based on data derived from the 
CCW's 2014 Part B non-institutional claim line file, which includes 
services covered by the Part B benefit that were furnished during CY 
2014, that approximately 40,000,000 advanced diagnostic imaging 
services are furnished annually, but questioned whether for the 
purposes of this estimate we should attribute equal weight for these 
services furnished by each of the following places: (1) A physician's 
office; (2) a hospital outpatient department; (3) an ambulatory 
surgical center; and (4) an IDTF. Therefore, we sought to determine the 
frequency of advanced diagnostic imaging services furnished by each 
setting.
    For this estimation, we analyzed 2014 Medicare Part B claims data 
to weight the various applicable settings subject to this program. For 
this estimate, we analyzed a count of total services furnished for the 
following 7 Current Procedural Terminology (CPT) codes for advanced 
diagnostic imaging studies: 70450--computed tomography, head or brain, 
without contrast material; 74177--computed tomography, abdomen and 
pelvis, without contrast material; 70553--magnetic resonance (e.g., 
proton) imaging, brain (including brain stem), without contrast 
material, followed by contrast material(s) and further sequences; 
72148--magnetic resonance (e.g., proton) imaging, spinal canal and 
contents, lumbar, without contrast material; 78452--Myocardial 
perfusion imaging, tomographic single-photon emission computed 
tomography (SPECT) including attenuation correction, qualitative or 
quantitative wall motion, ejection fraction by first pass or gated 
technique, additional quantification, when performed, multiple studies, 
at rest and/or stress (exercise or pharmacologic) and/or redistribution 
and/or rest reinjection; 78492--myocardial imaging, positron emission 
tomography (PET), perfusion, multiple studies at rest and/or stress; 
78803--radiopharmaceutical localization of tumor or distribution of 
radiopharmaceutical agent(s), tomographic SPECT; which represented 
10,000,000 total services or approximately a 25 percent sample of the 
40,000,000 total advanced diagnostic imaging services furnished under 
Part B in 2014.
    In this sample, we found the following total services and percent 
of total services for each of the following settings: (1) Physician's 
office, 2,997,460 total services, 28.5 percent; (2) hospital outpatient 
department, 7,465,279 total services, 70.9 percent; (3) ambulatory 
surgical center, 1,062 total services, 0.01 percent; (4) IDTF, 58,900 
total services, 0.6 percent. We also examined whether the total 
services furnished in 2015 for each setting increased more than 10 
percent from 2014. We found the following total services and percent 
change from 2014 for each of the following settings: (1) Physician's 
office, 2,944,144 total services, 2 percent decrease; (2) hospital 
outpatient department, 7,854,997 total services, 5 percent increase; 
(3) ambulatory surgical center, 2,900 total services, 173 percent 
increase; (4) IDTF, 65,479 total services, 11 percent increase. Taken 
together, we believe these estimates that attribute 70 percent of all 
advanced diagnostic imaging services to outpatient, 28 percent to 
physician's office, and 1 percent each to ambulatory surgical centers 
and independent diagnostic testing facilities, respectively is 
generalizable to the total number of visits by Medicare beneficiaries 
to each of those applicable settings, respectively.
    We do not expect that for the purposes of this program furnishing 
professionals and facilities will need to create new billing practices; 
however, we assume that the majority of furnishing professionals and 
facilities will work to alter billing practices through automation 
processes that accommodate AUC consultation information when furnishing 
advanced diagnostic imaging services to Medicare beneficiaries. 
Therefore, we believe a transfer of costs and benefits will be made 
from furnishing professionals and facilities to medical billing 
companies to create, test, and implement changes in billing practice 
for all affected furnishing professionals and facilities.
    As mentioned earlier, the 2016 CMS Statistics identified 37,038 
radiology non-institutional providers (Table II.8), and 5,470 
ambulatory surgical centers (Table II.5) as of December 31, 2015. 
Because the classification of independent facilities includes both 
diagnostic radiology and diagnostic laboratory tests, we will assume 
that 50 percent of the 252,044 facilities existing in 2015 according to 
2016 CMS Statistics (126,022 facilities) furnish advanced diagnostic 
imaging services. The American Hospital Association (AHA) Hospital 
Statistics published in 2018 by Health Forum, an affiliate of the AHA, 
identifies the total number of all U.S. registered hospitals to be 
5,534. Taken together, we have identified an estimated 174,064 
furnishing professionals (37,038 radiologists + 5,470 ASCs + 126,022 
independent diagnostic testing facilities + 5,534 hospitals). We will 
assume for the purposes of this calculation that every identified 
furnishing professional and facility will choose to update their 
processes for the purposes of this program in the same way by 
purchasing an automated solution to reporting AUC consultation 
information.
    The effective date of January 1, 2020 provides some but not 
extensive time to prepare to update billing processes to accept and 
report AUC consultation information. Requirements at Sec.  414.94(k) 
include the following additional information that must be reported: (1) 
The qualified CDSM consulted by the ordering professional; (2) 
information indicating whether the service ordered would or would not

[[Page 60043]]

adhere to specified applicable AUC, or whether the specified applicable 
AUC consulted was not applicable to the service ordered; (3) the NPI of 
the ordering professional who consulted specified applicable AUC as 
required in paragraph (j) of this section, if different from the 
furnishing professional. Although we are not familiar with any 
automated billing solution currently available that accommodates this 
new information, we based our estimate on medical billing and coding 
for experienced professionals (http://www.mb-guide.org/), which 
provides estimates ranging from $1,000 to $50,000 for medical billing 
software. For example,\52\ the basic Medisoft software program costs 
around $1300 while a premium can cost $11,900 for an unlimited amount 
of users. In another example,\7\ a simple claims processing interface 
through McKesson's Relay Health Clearinghouse costs $200 for 
preliminary set up, and added monthly service fees that were not 
described explicitly. Therefore, for the purposes of this calculation 
such a solution will be estimated to cost each furnishing professional 
or facility an estimated $10,000. This estimate is based on the 
assumption that the number of available furnishing professionals and 
facilities does not equal the number of professionals and facilities 
furnishing advanced diagnostic imaging services in the Medicare program 
and although we recognize that more than one furnishing professional or 
facility may use the same billing service, the combined effectiveness 
for an automated solution may decrease overall cost. Although we note 
that this estimate is based on certain assumptions, we estimate that 
the one-time update will cost $1,740,640,000 (174,064 x $10,000).
---------------------------------------------------------------------------

    \52\ http://www.mb-guide.org/medical-billing-software-prices.html.
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    The Congressional Budget Office estimates that section 218 of the 
PAMA would save approximately $200,000,000 in benefit dollars over 10 
years from FY 2014 through 2024, which could be the result of 
identification of outlier ordering professionals and also includes 
section 218(a) of the PAMA--a payment deduction for computed tomography 
equipment that is not up to a current technology standard. Because we 
have not yet proposed a mechanism or calculation for outlier ordering 
professional identification and prior authorization, we are unable to 
quantify the impact of prior authorization at this time.
    The following is a summary of the comments we received on the 
proposed estimated impact on furnishing professionals and facilities.
    Comment: A few commenters noted that the Medicare claim form would 
change as a result of the Medicare AUC program. These commenters 
observed that the electronic claim standard for the institutional 
provider (837i) does not capture or have a placeholder for reporting 
the ordering physician's NPI. These commenters stated that hospitals 
and health systems would need to make sweeping and costly system 
changes to interface with a modified 837i as a result.
    Response: We appreciate the opportunity to clarify our sentence and 
recognize the overlap between reporting AUC consultation information 
and standardized communications on Medicare claims forms. The X12N 
insurance subcommittee develops and maintains standards for healthcare 
administrative transactions on professional (837p), institutional 
(837i), and dental (837d) transactions when submitting healthcare 
claims for a service or encounter. The current mandated version of 837 
transactions is 5010TM. While we have not finalized a 
process for implementing the reporting requirements at Sec.  414.94(k), 
we clarify that implementation of changes to the claim form 
transactions would not take place outside of the existing process we 
described.
    After reviewing all comments, we are finalizing our proposed 
estimate without modification. However, we note that these estimates 
are based on multiple assumptions and as such may be an overestimate of 
burden.
f. Appropriate Use Criteria for Advanced Diagnostic Imaging Services
    We believe that the first 5 years of this program will be dedicated 
to implementation activities, from installation of the technology to 
training to operational and behavioral changes. Information on the 
benefits of adopting qualified CDSMs or automating billing practices 
specifically meeting the requirements in this final rule does not yet 
exist--and information on benefits overall is limited. Nonetheless, we 
believe there are benefits that can be obtained by ordering 
professionals, furnishing professionals and facilities, beneficiaries 
and technology infrastructure developers including qualified CDSM 
developers, EHR systems developers, and medical billing practices. We 
describe these estimated benefits in more detail in the following 
sections.
(1) Estimates of Savings
    It has been suggested that one-third of imaging procedures are 
inappropriate, costing the United States between $3 billion and $10 
billion annually \53\ (Stein, 2003). Data derived from the CCW 2014 
Part B non-institutional claim line file, which includes services 
covered by the Part B benefit that were furnished during CY 2014, 
identified approximately $3,300,000,000 in total payments for advanced 
diagnostic imaging services. For illustrative purposes, if 
implementation of this program were to lead to a 30 percent decrease in 
total payments, then we could potentially expect $990,000,000 in fewer 
payments annually. To address this suggestion, the insertion of a pause 
in the ordering workflow to introduce AUC is a potentially beneficial 
and cost-effective solution. Some believe that savings could be 
achieved through the reduction of inappropriate orders, and expenses 
associated with radiology benefit managers.\54\ Indeed, the Institute 
for Clinical Systems Improvement in Bloomington, Minnesota, performed a 
clinical decision support pilot project \55\ to (1) improve the utility 
of diagnostic radiology tests ordered, (2) reduce radiation exposure, 
(3) increase efficiency, (4) aid in shared decision making, and (5) 
save Minnesota $84,000,000 in 3 years. While not directly tested in 
Miliard et al., we believe this estimate may be generalizable on a 
national level and applicable to the Medicare AUC program, as both 
activities seek to achieve improvements in quality and decrease costs. 
Therefore, if savings estimated in Minnesota were a general 
representation of the nation, and on average a single state achieved 
50-percent of that representative savings, annualized over 3 years this 
estimate could be extrapolated to account for $700,000,000 savings per 
year (($84,000,000/3 years) x 50-percent x 50 states). It is 
hypothesized \56\ that these benefits are the result of educating 
ordering professionals on the appropriate test for a set of clinical 
symptoms, rather than just adding time and electronic obstacles between

[[Page 60044]]

ordering physicians and advanced diagnostic imaging services as such 
transfer of knowledge can alter clinical practice. The Center for 
Health Care Solutions at Virginia Mason Medical Center in Seattle, 
Washington examined approaches to control imaging utilization, 
including external authorization methods and clinical decision support 
systems. A retrospective cohort study \57\ was performed by Blackmore 
and colleagues in 2011 of the staged implementation of evidence-based 
clinical decision support for the following advanced diagnostic imaging 
services: Lumbar MRI; brain MRI; and sinus CT. Brain CT was included as 
a control. The number of patients imaged as a proportion of patients 
with selected clinical conditions before and after the decision support 
interventions were determined from billing data from a regional health 
plan and from institutional radiology information systems. The imaging 
utilization rates after the implementation of clinical decision support 
resulted in decreases for lumbar MRI (p-value = 0.001), head MRI (p-
value = 0.05), and sinus CT (p-value = 0.003), while a decrease in 
control service head CT was not statistically significant (p-value = 
0.88). Although there are limitations to this retrospective claims data 
analysis, the authors concluded that clinical decision support is 
associated with large decreases in the inappropriate utilization of 
advanced diagnostic imaging services.
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    \53\ Stein C. Code red: partners program aims to rein in 
skyrocketing costs of diagnostic imaging. Boston Globe, 2003.
    \54\ Hardy, K. Decision Support for Rad Reports. Radiology 
Today. Vol. 11, No. 1, p. 16., 2010.
    \55\ Miliard, M. Nuance, ICSI aim to prevent unnecessary imaging 
tests. Healthcare IT News. November 10, 2010.
    \56\ Sistrom CL, Dang PA, Weilburg JB, et al., Effect of 
Computerized Order Entry with Integrated Decision Support on the 
Growth of Outpatient Procedure Volumes: Seven-year Time Series 
Analysis. Radiology. 251(1), 2009.
    \57\ Blackmore, CC; Mecklenburg, RS; Kaplan GS. Effectiveness of 
Clinical Decision Support in Controlling Inappropriate Imaging. 
Journal of the American College of Radiology. 8(1) 2011.
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    It seems reasonable from this and other studies \58\ of local 
implementation of clinical decision support to assume that there may be 
some savings when regulations become effective January 1, 2020; 
however, there are also a few hesitations to extrapolating these and 
other findings broadly to the Medicare population. First, ordering 
professionals in this program are aware that CMS will pay for advanced 
diagnostic imaging services that do not adhere to the specified 
applicable AUC consulted. This awareness may impact the level of 
interest or extent of behavior modification from exposing ordering 
professionals to a qualified CDSM. Second, the statute distinguishes 
between the ordering professional, furnishing professional and 
facility, recognizing that the professional who orders an applicable 
imaging service is usually not the same professional or facility 
reporting to Medicare for that service when furnished. As a result, 
some ordering professionals may believe that since they are not 
required to submit AUC consultation information directly to CMS, there 
are no direct consequences of adhering to specified applicable AUC. 
Third, many advanced diagnostic imaging services may not have relevant 
or applicable AUC. Indeed a recent study \59\ implementing CDS was only 
able to prospectively generate a score for 26 percent and 30 percent of 
requests for advanced diagnostic imaging services before and after 
implementation of decision support, respectively. Without AUC 
available, there can be no decision support intervention into the 
workflow of the ordering professional. Fourth, even when an ordering 
professional identifies an advanced diagnostic imaging service 
recognized as adhering to specified applicable AUC from one qualified 
PLE, discordance between AUC from different specialty societies has 
been reported,\60\ suggesting that full benefits and savings cannot be 
realized without standard levels of appropriateness. Taken together, 
these concerns will form the basis for our continued examination of the 
impact of this and future rulemaking to maximize the benefits of this 
program.
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    \58\ Curry, L. and Reed, M.H. Electronic decision support for 
diagnostic imaging in a primary care setting. J Am Med Inform Assoc. 
2011; 18: 267-270; Ip, I.K., Schneider, L.I., Hanson, R. et al. 
Adoption and meaningful use of computerized physician order entry 
with an integrated clinical decision support system for radiology: 
ten-year analysis in an urban teaching hospital. J Am Coll Radiol. 
2012; 9: 129-136.
    \59\ Moriarity, AK, Klochko C, O'Brien M, Halabi S. The Effect 
of Clinical Decision Support for Advanced Inpatient Imaging. Journal 
of American College of Radiology. 12(4) 2015.
    \60\ Winchester DE et al., Discordance Between Appropriate Use 
Criteria for Nuclear Myocardial Perfusion Imaging from Different 
Specialty Societies: a potential concern for health policy. JAMA 
Cardiol. 1(2) 2016:207-210.
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(2) Benefits to Medicare Beneficiaries
    Although qualified CDSMs are not required to demonstrate that their 
tools provide measurable benefits, we believe that as a result of 
installation and use, some ordering professionals may find benefits to 
the patients they serve. For example, if a qualified CDSM creates a 
flag or alert to obsolete tests, then the patient will benefit from 
avoiding unnecessary testing. The same outcome would be likely if a 
qualified CDSM implemented algorithms that recognize advanced 
diagnostic imaging services that may produce inaccurate results because 
of medications being taken by the patient. In addition, if the CDSM 
provides standardized processes for advanced diagnostic imaging orders 
or clarification for confusing test names, then the patient benefits 
from a potential decrease in medical errors and less exposure. Finally, 
we believe it is reasonable to assume that some improvements in shared 
decision making could result from use of a qualified CDSM, because some 
CDSMs could provide cost information associated with advanced 
diagnostic imaging services and/or identify situations of repeated 
testing.
    The following is a summary of the comments we received on the 
proposed estimated benefits that can be obtained by ordering 
professionals, furnishing professionals and facilities, beneficiaries 
and technology infrastructure developers including qualified CDSM 
developers, EHR systems developers, and medical billing practices.
    Comment: A few commenters disagreed that there are any benefits to 
the Medicare AUC program. As an example, one commenter submitted their 
experience with a CDSM and found that a change in utilization was not 
significant. Additionally, a few commenters indicated that every dollar 
spent on this program is a dollar that cannot be used elsewhere, more 
specifically, for patient care. One commenter disagreed with these 
comments, citing a published study \61\ that exposing ordering 
professionals to evidence based medicine improves quality and reduces 
inappropriate utilization. Another commenter cited several evidence-
based studies 15 62 63 that demonstrate the improvement in 
the quality of clinical outcomes and reduction of cost resulting from 
engagement using AUC.
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    \61\ Huber TC, Krishmaraj A, Patrie J, et al. Impact of a 
commercially available clinical decision support program on provider 
ordering habits. J Am Coll Radiol. 2018:15:951-7.
    \62\ Bunt CW, Burke HB, Towbin AJ, et al. Point-of-care 
estimated radiation exposure and imaging guidelines can reduce 
pediatric radiation burden. J Am Board Fam Med. 2015:28:343-50.
    \63\ Tajmir S, Raja AS, Ip IK, et al. Impact of clinical 
decision support on radiography for acute ankle injuries: a 
randomized trial. West J Emerg Med. 2017:18(3):487-95.
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    Response: We thank the commenters for sharing their experience, and 
experiences cited in peer-reviewed published literature. This RIA is 
presented in conjunction with statutory AUC program requirements. We 
provide these estimates in addition to policies that are consistent 
with statute and finalized in this rule. However, we note that these 
estimates are based on multiple assumptions and as such may be an 
overestimate of burden as a free qualified CDSM is available and 
required by law.

[[Page 60045]]

5. Medicaid Promoting Interoperability Program Requirements for 
Eligible Professionals (EPs) Medicaid Promoting Interoperability 
Program Requirements for Eligible Professionals (EPs)
    In the Medicaid Promoting Interoperability Program, to keep 
electronic clinical quality measure (eCQM) specifications current and 
minimize complexity, we proposed to align the eCQMs available for 
Medicaid EPs in 2019 with those available for MIPS eligible clinicians 
for the CY 2019 performance period. We explained that we anticipated 
that this proposal would reduce burden for Medicaid EPs by aligning the 
requirements for multiple reporting programs, and that the system 
changes required for EPs to implement this change would not be 
significant, as many EPs are expected to report eCQMs to meet the 
quality performance category of MIPS and therefore should be prepared 
to report on those eCQMs for 2019. We explained that we expected that 
this proposal would have only a minimal impact on states, by requiring 
minor adjustments to state systems for 2019 to maintain current eCQM 
lists and specifications. State expenditures to make any systems 
changes required as a result of this proposal would be eligible for 
ninety percent enhanced Federal financial participation. After careful 
consideration of the comments received on this proposal, we are 
finalizing it without change. See discussion of comments in section 
III.E. of this final rule.
    For 2019, we proposed that Medicaid EPs would report on any six 
eCQMs that are relevant to the EP's scope of practice, including at 
least one outcome measure, or if no applicable outcome measure is 
available or relevant, at least one high priority measure, regardless 
of whether they report via attestation or electronically. This policy 
would generally align with the MIPS data submission requirement for 
eligible clinicians using the eCQM collection type for the quality 
performance category, which is established in Sec.  414.1335(a)(1). 
After careful consideration of the comments received on this proposal, 
we are finalizing it without change, and also explain that if no 
outcome or high priority measure is relevant to a Medicaid EP's scope 
of practice, he or she may report on any six eCQMs that are relevant. 
We also proposed that the eCQM reporting period for EPs in the Medicaid 
Promoting Interoperability Program would be a full CY in 2019 for EPs 
who have demonstrated meaningful use in a prior year, in order to align 
with the corresponding performance period for the quality performance 
category in MIPS. This proposal is also finalized without change, after 
careful consideration of comments received. (See discussion of comments 
in section III.E. of this final rule.) We continue to align Medicaid 
Promoting Interoperability Program requirements with requirements for 
other CMS quality programs, such as MIPS, to the extent practicable, to 
reduce the burden of reporting different data for separate programs.
    In order to help states to make incentive payments to Medicaid EPs 
by December 31, 2021, consistent with section 1903(t)(4)(A)(iii) of the 
Act, we proposed to amend Sec.  495.4 to provide that the EHR reporting 
period in 2021 for all EPs in the Medicaid Promoting Interoperability 
Program would be a minimum of any continuous 90-day period within CY 
2021, provided that the end date for this period falls before October 
31, 2021, to help ensure that the state can issue all Medicaid 
Promoting Interoperability Program payments on or before December 31, 
2021. Similarly, we proposed to change the eCQM reporting period in 
2021 for EPs in the Medicaid Promoting Interoperability Program to a 
minimum of any continuous 90-day period within CY 2021, provided that 
the end date for this period falls before October 31, 2021, to help 
ensure that the state can issue all Medicaid Promoting Interoperability 
Program payments on or before December 31, 2021.
    We proposed to allow states the flexibility to set alternative, 
earlier final deadlines for EHR or eCQM reporting periods for Medicaid 
EPs in CY 2021, with prior approval from CMS, through their State 
Medicaid HIT Plans (SMHP). Providing states with the flexibility to set 
an alternative, earlier last possible date for the EHR or eCQM 
reporting period for Medicaid EPs in 2021 would make it easier for 
states to ensure that all payments are made by the December 31, 2021 
deadline, especially for states whose prepayment process may take 
longer than the 61 days provided for by an October 31, 2021 deadline. 
We explained that we expect that this proposal would have only a 
minimal impact on states, by requiring minor adjustments to state 
systems to meet specifications for the proposed reporting periods, 
especially because we are also proposed to permit states to set a 
different end date for all EHR and eCQM reporting periods for Medicaid 
EPs in 2021. As previously noted, state expenditures for any systems 
changes required as a result of this proposal would be eligible for 90 
percent enhanced Federal financial participation. After careful 
consideration of the comments received on this proposal, as discussed 
above in section III.E. of this final rule, we are finalizing it 
without change. However, in light of comments received from EPs, we are 
also considering whether to propose in future rulemaking that no state 
may set a reporting period deadline for CY 2021 that is earlier than 
June 30, 2021, or an attestation deadline for CY 2021 that is earlier 
than July 1, 2021.
    Finally, we proposed changes to the EP Meaningful Use Objective 6, 
(Coordination of care through patient engagement) Measure 1 (View, 
Download, or Transmit) and Measure 2 (Secure Electronic Messaging), and 
to EP Meaningful Use Objective 8, Measure 2 (Syndromic surveillance 
reporting). We proposed to amend these measures in response to feedback 
about the burdens they create for EPs seeking to demonstrate meaningful 
use, and about how they may not be fully aligned with how states and 
public health agencies collect syndromic surveillance data. These 
proposed amendments were expected to reduce EP burden. Again, we 
expected that any changes these proposals might require to state 
systems would be minimal and that state expenditures to make any such 
changes would also be eligible for 90 percent enhanced federal 
financial participation. After careful consideration of the comments 
received on these proposals, as discussed in section III.E. of this 
final rule, we are finalizing them without change.
6. Medicare Shared Savings Program
    In section III.F.1.b. of this final rule, we summarize the proposed 
certain modifications to the quality measure set used to assess the 
quality of performance of ACOs participating in the Shared Savings 
Program. Specifically we proposed: (1) The addition of two Patient 
Experience of Care Survey measures, and (2) the removal of four claims-
based outcome measures. After consideration of the comments received, 
we are finalizing these proposed modifications to the quality measure 
set for the Shared Savings Program in sections III.F. of this final 
rule.
    The modifications to the Shared Savings Program quality measure set 
reduce the number of measures in the Shared Savings Program quality 
measure set from 31 to 23 measures, making the quality measure set more 
outcome oriented. This reduction in the number of measure is expected 
to reduce ACO reporting burden and

[[Page 60046]]

improve quality outcomes for beneficiaries.
7. Physician Self-Referral Law
    The physician self-referral law provisions are discussed in section 
III.G. of this final rule. We are finalizing regulatory updates to 
implement the provisions of section 50404 of the Bipartisan Budget Act 
of 2018 pertaining to the writing and signature requirements in certain 
compensation arrangement exceptions to the statute's referral and 
billing prohibitions. The regulatory language for the writing 
requirement reflects current policy, so we do not anticipate that it 
will have an impact. We expect that the update regarding temporary non-
compliance with signature arrangements will reduce burden by giving 
parties additional time to obtain all required signatures.
8. Changes Due to Updates to the Quality Payment Program
    In section III.I. of this final rule, we included our finalized 
policies for the Quality Payment Program. In this section of the final 
rule, we present the overall and incremental impacts to the number of 
expected QPs and associated APM incentive payments. In MIPS, we analyze 
the total impact and incremental impact of statutory changes to 
eligibility from the Bipartisan Budget Act of 2018, as well as final 
policies to expand MIPS eligibility by expanding the MIPS eligible 
clinician definition and adding a third criterion for the low-volume 
threshold and an opt-in policy option for any clinician that exceeds at 
least one, but not all, of the low-volume threshold criteria. Finally, 
we estimate the payment impacts by practice size based on various final 
policies to modify the MIPS final score, such as the new Promoting 
Interoperability performance category policies, for the performance 
threshold and additional performance threshold, and as required by the 
Bipartisan Budget Act of 2018, the impact of applying the MIPS payment 
adjustments to covered professional services (services for which 
payment is made under, or is based on, the PFS and that are furnished 
by an eligible clinician) rather than items and services covered under 
Part B.
    The submission period for the first MIPS performance period ended 
in early 2018; however, the final data sets were not available in time 
to incorporate into the CY 2019 PFS proposed rule analysis (83 FR 
36057). We stated in the proposed rule that if technically feasible, we 
intended to use data from the CY 2017 MIPS performance period for the 
final rule. In this analysis, we have updated our analyses from the 
proposed rule to consider data submitted for the 2017 MIPS performance 
period (which we refer to in this section as Quality Payment Program 
Year 1 data). In section VII.F.8.b. of this final rule, we summarize 
the high level findings of updating our model with Quality Payment 
Program Year 1 data.
a. Estimated Incentive Payments to QPs in Advanced APMs and Other Payer 
Advanced APMs
    From 2019 through 2024, through the Medicare Option, eligible 
clinicians receiving a sufficient portion of Medicare Part B payments 
for covered professional services or seeing a sufficient number of 
Medicare patients through Advanced APMs as required to become QPs, for 
the applicable performance period, will receive a lump-sum APM 
Incentive Payment equal to 5 percent of their estimated aggregate 
payment amounts for Medicare covered professional services in the 
preceding year. In addition, beginning in payment year 2021, in 
addition to the Medicare Option, eligible clinicians may become QPs 
through the All-Payer Combination Option. The All-Payer Combination 
Option will allow eligible clinicians to become QPs by meeting the QP 
thresholds through a pair of calculations that assess a combination of 
both Medicare Part B covered professional services furnished through 
Advanced APMs and services furnished through Other Payer Advanced APMs.
    The APM Incentive Payment is separate from and in addition to the 
payment for covered professional services furnished by an eligible 
clinician during that year. Eligible clinicians who become QPs for a 
year would not need to report to MIPS and would not receive a MIPS 
payment adjustment to their Part B PFS payments. Eligible clinicians 
who do not become QPs, but meet a slightly lower threshold to become 
Partial QPs for the year, may elect to report to MIPS and, if they 
elect to report, would then be scored under MIPS and receive a MIPS 
payment adjustment, but will not receive the APM Incentive Payment. For 
the 2019 Medicare QP Performance Period, we define Partial QPs to be 
eligible clinicians in Advanced APMs who collectively have at least 40 
percent, but less than 50 percent, of their payments for Part B covered 
professional services through an APM Entity, or collectively furnish 
Part B covered professional services to at least 20 percent, but less 
than 35 percent, of their Medicare beneficiaries through an APM Entity. 
If the Partial QP elects to be scored under MIPS, they would be subject 
to all MIPS requirements and would receive a MIPS payment adjustment. 
This adjustment may be positive, negative or neutral. If an eligible 
clinician does not meet either the QP or Partial QP standards, and does 
not meet any another exemption category, the eligible clinician would 
be subject to MIPS, would report to MIPS, and would receive the 
corresponding MIPS payment adjustment.
    Beginning in payment year 2026, payment rates for services 
furnished by clinicians who achieve QP status for a year would be 
increased each year by 0.75 percent for the year, while payment rates 
for services furnished by clinicians who do not achieve QP status for 
the year would be increased by 0.25 percent. In addition, MIPS eligible 
clinicians would receive positive, neutral, or negative MIPS payment 
adjustments to payment for their Part B PFS services in a payment year 
based on performance during a prior performance period. Although MACRA 
amendments established overall payment rate and procedure parameters 
until 2026 and beyond, this impact analysis covers only the third 
payment year (2021 MIPS payment year) of the Quality Payment Program in 
detail.
    In section III.I.4.g.(4)(b) of this final rule, we summarized our 
finalized policy to add a third alternative to allow requests for QP 
determinations at the TIN level in instances where all clinicians who 
have reassigned billing rights under the TIN participate in a single 
APM Entity. This option will therefore be available to all TINs 
participating in Full TIN APMs, such as the Medicare Shared Savings 
Program. It will also be available to any other TIN for whom all 
clinicians who have reassigned billing rights to the TIN are 
participating in a single APM Entity. We also finalized that this third 
alternative will only be available to eligible clinicians who meet the 
Medicare threshold at the APM Entity level; it will not be available 
for eligible clinicians who meet the Medicare threshold individually.
    In section III.I.4.g.(4)(c)(ii) of this final rule, we also 
discussed our finalized policy to extend the same weighting methodology 
to TIN level Medicare Threshold Scores in situations where a TIN is 
assessed under the Medicare Option as part of an APM Entity group, and 
receives a Medicare Threshold Score at the APM Entity group level. In 
this scenario, we believe that the Medicare portion of the TIN's All-
Payer Combination Option Threshold Score should not be lower than the 
Medicare Threshold Score that they received by

[[Page 60047]]

participating in an APM Entity group (82 FR 53881 through 53882). We 
note this extension of the weighting methodology will only apply to a 
TIN when that TIN represents a subset of the eligible clinicians in the 
APM Entity, because when the TIN and the APM Entity are the same there 
is no need for this weighted methodology. We finalized our proposal to 
calculate the TIN's QP Threshold Scores both on its own and with this 
weighted methodology, and then use the most advantageous score when 
making a QP determination. We believe that, as it does for QP 
determinations made at the APM Entity level, this approach promotes 
consistency between the Medicare Option and the All-Payer Combination 
Option to the extent possible. Additionally, the application of this 
weighting approach in the case of a TIN level QP determination is 
consistent with our established policy.
    These finalized policies affect the estimated number of QPs for the 
2021 payment year. We estimate that approximately 8,100 eligible 
clinicians in 8 APM Entities representing approximately 225 TINs will 
become QPs due to these finalized policies representing TIN level QP 
determinations under the All-Payer Combination Option. Therefore, they 
will be excluded from MIPS, and qualify for the lump sum incentive 
payment based on 5 percent of their Part B allowable charges for 
covered professional services, which are estimated to be approximately 
$545 million in the 2019 performance year. We also estimated the 
corresponding increase of the APM incentive payment of 5 percent of 
Part B allowed charges for these QPs will be approximately $27 million 
for the 2021 payment year. However, we note that the majority, if not 
all, of the 8,100 eligible clinicians that would become QPs if these 
policies are finalized, had already attained QP status in the 2018 QP 
performance period. Therefore, the associated APM incentive payments 
for these 8,100 would not be additional impacts in comparison to 
previous performance years, only additional impacts in the absence of 
finalizing these proposed policies.
    Overall, we estimated that between 165,000 and 220,000 eligible 
clinicians will become QPs, therefore be excluded from MIPS, and 
qualify for the lump sum incentive payment based on 5 percent of their 
Part B allowable charges for covered professional services in the 
preceding year, which are estimated to be between approximately $12,000 
million and $16,000 million in total for the 2019 performance year. We 
estimated that the aggregate total of the APM incentive payment of 5 
percent of Part B allowed charges for QPs will be between approximately 
$600 and $800 million for the 2021 payment year. The estimated number 
of QPs in this final rule is slightly higher than the estimates of 
160,000 and 215,000 clinicians included in the proposed rule due to 
more updated information being available for the final rule. The 
proposed rule used the APM Participation Lists on the most recent MDM 
provider extract for the Predictive QP determination file for 2018, 
whereas this final rule uses the APM Participation Lists on the most 
recent MDM provider extract for the Second QP determination file for 
the 2018 performance period. This more updated information did not 
significantly change the estimated amount of total Part B allowed 
charges and the amount of total APM incentive payments.
    We projected the number of eligible clinicians that will be QPs, 
and thus excluded from MIPS, using several sources of information. 
First, the projections are anchored in the most recently available 
public information on Advanced APMs. The projections reflect Advanced 
APMs that will be operating during the 2019 QP performance period, as 
well as Advanced APMs anticipated to be operational during the 2019 QP 
performance period. The projections also reflect an estimated number of 
eligible clinicians that would attain QP status through the All-Payer 
Combination Option. The following APMs are expected to be Advanced APMs 
in performance year 2019: Next Generation ACO Model, Comprehensive 
Primary Care Plus (CPC+) Model, Comprehensive ESRD Care (CEC) Model 
(Two-Sided Risk Arrangement), Vermont All-Payer ACO Model (Vermont 
Medicare ACO Initiative),\64\ Comprehensive Care for Joint Replacement 
Payment Model (CEHRT Track), Oncology Care Model (Two-Sided Risk 
Arrangements), Medicare ACO Track 1+ Model, Bundled Payments for Care 
Improvement Advanced, Maryland Total Cost of Care Model (Maryland Care 
Redesign Program; Maryland Primary Care Program), and the Shared 
Savings Program Tracks 2 and 3. We used the APM Participant Lists (see 
81 FR 77444 through 77445 for information on the APM participant lists 
and QP determination) on the most recent MDM provider extract for the 
Second QP determination file for 2018 QP performance period to estimate 
QPs, total Part B allowed charges for covered professional services, 
and the aggregate total of APM incentive payments for the 2019 QP 
performance period. We examine the extent to which Advanced APM 
participants would meet the QP thresholds of having at least 50 percent 
of their Part B covered professional services or at least 35 percent of 
their Medicare beneficiaries furnished Part B covered professional 
services through the APM Entity.
---------------------------------------------------------------------------

    \64\ Vermont ACOs are participating in an Advanced APM during 
2018 through a version of the Next Generation ACO Model. The Vermont 
Medicare ACO Initiative is expected to be an Advanced APM beginning 
in CY 2019.
---------------------------------------------------------------------------

b. Updates to MIPS Estimates Using Quality Payment Program Year 1 Data
    In the CY 2019 PFS proposed rule (83 FR 36058 through 36068), the 
RIA modeled MIPS eligibility and performance using data from the 
Physician Quality Reporting System (PQRS), the Value Modifier, and the 
Medicare/Medicaid EHR Incentive programs to account for the absence of 
MIPS performance data. We indicated, that if feasible, we would 
integrate performance data from the CY 2017 MIPS performance period 
(which we refer to in this section of the final rule as Quality Payment 
Program Year 1 data). The model in the 2019 PFS proposed rule had 
several assumptions to proxy MIPS performance and we noted the 
limitations of the model (83 FR 36067).
    In this final rule, we integrated Quality Payment Program Year 1 
data into our model estimates and we chose to summarize in this section 
important differences or findings that are needed for context when 
interpreting the RIA in this final rule. It should be noted that 
although we are using Quality Payment Program Year 1 data, the 
estimates described in this RIA reflect the impact of the finalized 
policies in this final rule and do not reflect actual CY 2017 MIPS 
performance period/2019 MIPS payment year results.
    First, the Quality Payment Program Year 1 data had more complete 
group and individual participation and performance data. In the CY 2019 
PFS proposed rule (83 FR 36053 through 36061), we estimated group 
reporting solely based on the submission of quality data as a group to 
2016 PQRS. For this final rule, we were able to identify group 
reporting through submissions to quality, improvement activities or 
Promoting Interoperability performance categories. As a result, we 
observed higher group reporting than was previously estimated using 
PQRS performance data. This finding led to a 42 percent increase (from 
approximately 390,000 in the CY 2019 PFS proposed

[[Page 60048]]

rule to 553,000 in this final rule) in group reporters who otherwise 
would not have been MIPS eligible clinicians. (See section VII.F.8.c. 
for more details on eligibility.) The second benefit of group and 
individual level data through the Quality Payment Program Year 1 data 
led to our improved ability to better estimate group and individual 
scores and to appropriately apply scoring policies at the group and 
individual level. (See section VII.F.8.d.(2) for more details on 
methodologies for estimating the performance category scores.)
    Second, we observed an increase in participation among small 
practices than previously estimated in the CY 2019 PFS proposed rule. 
The number of clinicians in small practices (who we believe are 
estimated to be in MIPS year 3) estimated to submit data increased from 
79.7 percent to 89.9 percent. We believe this is related to our 
policies for the 2017 MIPS performance period which was designed to 
encourage participation, engage clinicians and help them transition 
smoothly into MIPS. (See section VII.F.8.d.(3) for more details.)
    Third, the Quality Payment Program Year 1 data allowed for the 
direct observation of performance for the MIPS performance categories. 
With the availability of actual advancing care information and 
improvement activities performance category data from the Quality 
Payment Program Year 1, we improved our estimates for the Promoting 
Interoperability and improvement activities performance category scores 
at the individual and group level for the 2019 MIPS performance period/
2021 MIPS payment year. This led to more variation in performance at 
the individual and group level for these performance categories 
compared to the model in the 2019 PFS proposed rule and to the ability 
to accurately assess which clinicians are measured on Promoting 
Interoperability or are reweighted (see section III.I.3.h.(5) of this 
final rule for more details).
    Finally, the Quality Payment Program Year 1 data improved our 
ability to estimate who is excluded from MIPS, such as newly enrolled 
clinicians. We found that the previous proxy for the CY 2019 PFS 
proposed rule overestimated the number of newly enrolled clinicians 
than the observed with the Quality Payment Program Year 1 data. As a 
result, fewer clinicians were excluded from MIPS compared to the CY 
2019 PFS proposed rule. (See section VII.F.8.c.(2) of this final rule 
for more details.)
    In summary, the estimates presented in the RIA of this final rule 
differ from the CY 2019 PFS proposed rule due to our ability to improve 
our estimates of eligibility and performance in MIPS. As a result of 
data source and methodology changes for the final policies of this 
final rule, we observe a slight decrease in final scores. For example, 
the mean and median final scores in the CY 2019 PFS proposed rule 
analysis were 73.41 and 82.41 respectively,\65\ and the mean and median 
in this final rule are 69.53 and 78.72, respectively. As a result, a 
higher percentage of clinicians submitting data have scores below the 
final performance threshold of 30 points for this final rule (8.8 
percent) compared to the CY 2019 PFS proposed rule (3.9 percent). Given 
the increase in participation, we are not surprised by these changes. 
However, it should be noted we are still using historic data to predict 
future performance. Therefore, behaviors due to policies in MIPS Year 1 
may not reflect behaviors in Year 3. For example, MIPS eligible 
clinicians had to earn 3 out of 100 points to receive at least a 
neutral payment adjustment in CY 2017 MIPS performance period/CY 2021 
MIPS payment year and therefore may have only submitted a limited 
amount of information. As the performance threshold increases in Year 
3, we anticipate clinicians will continue to participate and will 
likely increase their performance to meet the higher performance 
threshold. Therefore, the results presented in this final rule may not 
accurately reflect performance for CY 2019 performance period/CY 2021 
payment year, which is an important limitation of our findings. See 
section VII.F.8.f. for more limitations of this rule.
---------------------------------------------------------------------------

    \65\ The mean and median was not published in the CY 2019 PFS 
proposed rule RIA, but the methodology is summarized in the CY 2019 
PFS proposed rule (83 FR 36058 through 36066).
---------------------------------------------------------------------------

c. Estimated Number of Clinicians Eligible for MIPS Eligibility
(1) Summary of Final Policies Related to MIPS Eligibility and 
Application of MIPS Payment Adjustments
    In section III.I.3 of this final rule, we finalized three sets of 
policy changes that would impact the number of MIPS eligible clinicians 
starting with CY 2019 MIPS performance period and the associated CY 
2021 MIPS payment year. Two of the changes were finalized as proposed 
and affect the low-volume threshold. The third policy affects the 
definition of a MIPS eligible clinician and was finalized with 
modifications.
    In section III.I.3.c.(2) of this final rule, we finalized as 
proposed changes to our policy to comply with the Bipartisan Budget Act 
of 2018. Specifically, we updated the low-volume threshold starting 
with the 2020 MIPS payment year to be based on covered professional 
services (services for which payment is made under, or is based on the 
PFS and that are furnished by an eligible clinician) rather than items 
and services covered under Part B, as provided in section 1848(q)(1)(B) 
as amended by section 51003(a)(1)(A)(i) of the Bipartisan Budget Act of 
2018. This finalized policy may affect the previously finalized 
calculation for the low-volume threshold for certain clinicians because 
payment for items, such as Part B drugs, which were previously 
considered in the low-volume determination, are now excluded. In 
addition, section 51003(a)(1)(E) of the Bipartisan Budget Act of 2018 
revised section 1848(q)(6)(E) to apply the MIPS payment adjustments to 
covered professional services rather than to items and services covered 
under Part B. This change is effective with the 2019 MIPS payment year. 
Its effect on the amount of payment adjustments under MIPS is included 
in this analysis.
    Second, in section III.I.3.a. of this final rule, beginning with 
the 2021 MIPS payment year, we finalized with modification the 
expansion of the definition of MIPS eligible clinicians to include 
physical therapists, occupational therapists, speech-language 
pathologists, audiologists, clinical psychologists, and registered 
dietitians or nutrition professionals. This finalized list differs from 
the proposed list of physical therapists, occupational therapists, 
clinical social workers, and clinical psychologists (83 FR 36058). 
Specifically, we finalized the definition of MIPS eligible clinician, 
as identified by a unique billing TIN and NPI combination used to 
assess performance, as any of the following: A physician (as defined in 
section 1861(r) of the Act); a physician assistant, nurse practitioner, 
and clinical nurse specialist (as such terms are defined in section 
1861(aa)(5) of the Act); a certified registered nurse anesthetist (as 
defined in section 1861(bb)(2) of the Act), physical therapist, 
occupational therapist, speech-language pathologist, audiologist, 
clinical psychologist, and registered dietitian or nutrition 
professional; and a group that includes such clinicians.
    Third, as discussed in sections III.I.3.c.(4) and III.I.3.c.(5) of 
this final rule, in addition to the amendments to comply with 
Bipartisan Budget Act of 2018, we finalized as proposed our definition 
of the low-volume threshold by adding a third criterion (for ``covered

[[Page 60049]]

professional services''). The low-volume threshold now includes a third 
criterion: Set at 200 covered professional services to Part B-enrolled 
individuals. Taken together, the low-volume threshold is as follows: 
(1) Those with $90,000 or less in allowed charges for covered 
professional services; or (2) 200 or fewer Part B-enrolled individuals 
who are furnished Medicare PFS services; or (3) 200 or fewer covered 
professional services. The low volume threshold assessment is applied 
at the TIN/NPI level for individual reporting, the TIN level for group 
reporting, or the APM Entity Level for reporting under the APM scoring 
standard. We also finalized as proposed for any clinician who exceeds 
the low-volume threshold on at least one, but not all three, low-volume 
threshold criteria may elect to opt-in to MIPS to be measured on 
performance, thereby qualifying to receive a positive, neutral, or 
negative MIPS payment adjustment based on performance. The absence of 
the opt-in election within this cohort means they are not MIPS eligible 
clinicians. If a MIPS eligible clinician does not meet at least one of 
these low-volume criteria, they are excluded from MIPS. For purposes of 
this impact analysis we refer to these revisions to the low-volume 
threshold and its application collectively as the ``opt-in policy''.
    We discuss how the three finalized policy changes impact MIPS 
eligibility and payments, later in this section.
(2) Methodology To Assess MIPS Eligibility
(a) Clinicians Included in the Model Prior to Applying the Low-Volume 
Threshold Exclusion
    To estimate the number of MIPS eligible clinicians for the CY 2019 
performance period in this final rule, our scoring model used the first 
determination period from CY 2020 MIPS payment year eligibility file as 
described in the CY 2018 Quality Payment Program Final Rule (82 FR 
53587 through 53592). The first determination period from the CY 2020 
MIPS payment year eligibility file was selected to maximize the overlap 
with the performance period data used in the model. In addition, the 
low-volume threshold for with the 2020 MIPS payment year was originally 
finalized in the CY 2018 Quality Payment Program final rule (82 FR 
53587 through 53592) as using Part B items and services, but was later 
finalized in section III.I.3.c of this final rule to be based on 
covered professional services (services for which payment is made 
under, or is based on the PFS and that are furnished by an eligible 
clinician). Therefore, this data file provided the information to 
calculate a baseline as well as understand the incremental impact of 
basing the low-volume threshold on covered professional services rather 
than all items and services under Part B. We included 1.5 million 
clinicians (see Table 97) who had PFS claims from September 1, 2016 to 
August 31, 2017 and included a 30-day claim run-out.We excluded 
individual clinicians who were affected by the automatic extreme and 
uncontrollable policy finalized for the 2017 MIPS performance period/
2019 MIPS payment year in section III.I.3.i.(2)(b)(ii)(B) of this final 
rule as we are unable to predict how these clinicians would perform in 
a year where there was no extreme and uncontrollable event.
    Clinicians are ineligible for MIPS (and are excluded from MIPS 
payment adjustment) if they are newly enrolled to Medicare; are QPs; 
are partial QPs who elect to not participate in MIPS; are not one of 
the clinician types included in the definition for MIPS eligible 
clinician; or do not exceed the low-volume threshold. Therefore, we 
excluded these clinicians when calculating those clinicians eligible 
for MIPS.
    For our baseline population, we restricted to clinicians who are a 
physician (as defined in section 1861(r) of the Act); a physician 
assistant, nurse practitioner, and clinical nurse specialist (as such 
terms are defined in section 1861(aa)(5) of the Act); a certified 
registered nurse anesthetist (as defined in section 1861(bb)(2) of the 
Act). For the estimated MIPS eligible population for the CY 2021 MIPS 
payment year, we added in clinicians who are physical therapists, 
occupational therapists, speech-language pathologist, audiologist, 
clinical psychologist, and registered dietitian or nutrition 
professional.
    As noted previously, we excluded QPs from our scoring model, since 
these clinicians are not eligible for MIPS. To determine which QPs 
should be excluded, we used the QP List for the first snapshot date of 
the 2018 QP performance period because these data were available by TIN 
and NPI and could be merged into our model. This data also included 
participants in APMs, such as the Medicare ACO Track 1+ Model, which 
were not available models in the 2017 QP performance period. From this 
data, we calculated the QP determinations as described in the 
Qualifying APM Participant definition at Sec.  414.1305 for the 2019 QP 
performance period. We assumed that all partial QPs would participate 
in MIPS and included them in our scoring model and eligibility counts. 
The estimated number of QPs excluded from our model is lower than the 
projected number of QPs (165,000 to 220,000) for the 2019 QP 
performance period due to the expected growth in APM participation. Due 
to data limitations, we could not identify specific clinicians who may 
become QPs in the 2019 Medicare QP Performance Period; hence, our model 
may overestimate the fraction of clinicians and allowed charges for 
covered professional services that will remain subject to MIPS after 
the exclusions.
    We also excluded newly enrolled Medicare clinicians from our model. 
To identify newly enrolled Medicare clinicians, we used the indicator 
that was used for the 2017 MIPS performance period/2019 MIPS payment 
year. The number of newly enrolled clinicians identified using this 
approach and data source was approximately one third the estimated 
number of newly enrolled clinicians estimated in the proposed rule 
which indicates we overestimated the number of newly enrolled 
clinicians in the CY 2019 PFS proposed rule impact analysis and that 
more clinicians are eligible for MIPS.
    In section III.I.3.j.(4)(c) of this final rule, we finalized that 
beginning with the 2019 MIPS payment year the MIPS payment adjustment 
factors would not apply to certain model-specific payments for the 
duration of a section 1115A model's testing. Due to the aggregated data 
in our analysis, we were not able to incorporate this policy into our 
estimate.
    In section III.I.3.j.(4)(d) of the final rule, we finalized the 
proposal to waive the payment consequences (positive, negative or 
neutral adjustments) of MIPS and to waive the associated MIPS reporting 
requirements adopted to implement the payment consequences for certain 
participating clinicians in the MAQI Demonstration subject to 
conditions outlined in the Demonstration, starting with the 2020 MIPS 
payment period. Removing eligible clinicians from MIPS may affect the 
payment adjustments for other MIPS eligible clinicians in each year the 
waiver is offered. At this time we are unable to identify specific 
clinicians that would be affected by this proposal (that is, removed 
from the MIPS payment adjustments), but estimate the first year number 
of clinicians to be less than 0.1 percent of all MIPS eligible 
clinicians. We plan to monitor the impact of the MAQI Demonstration on 
payments received by MIPS eligible

[[Page 60050]]

clinicians to whom the waivers do not apply; however, we note that it 
may be challenging to draw significant conclusions from such monitoring 
as there are many variables that may impact and influence a clinician's 
final MIPS adjustment. Due to the lack of information currently 
available we are unable to account for this proposal in the eligibility 
or payment adjustment tables.
(b) Assumptions Related to Applying the Low-Volume Threshold Exclusion
    The low-volume threshold policy may be applied at the individual 
(that is, TIN/NPI) or group (that is, TIN or APM entity) levels based 
on how data are submitted. If no data are submitted, then the low-
volume threshold is applied at the TIN/NPI level. A clinician or group 
that exceeds at least one but not all three low-volume threshold 
criteria may become MIPS eligible by electing to opt-in and 
subsequently submitting data to MIPS, thereby getting measured on 
performance and receiving a MIPS payment adjustment.
    Table 97 compares the MIPS eligibility status and the associated 
PFS allowed charges from the CY 2019 PFS proposed rule (83 FR 36060) 
with the estimates of MIPS eligibility and the associated PFS allowed 
charges after using Quality Payment Program Year 1 data and applying 
the finalized policies for the CY 2019 MIPS performance period.
    For the purposes of modeling, we made assumptions on group 
reporting to apply the low-volume threshold. One extreme and unlikely 
assumption is that no practices elect group reporting and the low-
volume threshold would always be applied at the individual level. 
Although we believe a scenario in which only these clinicians would 
participate as individuals is unlikely, this assumption is important 
because it quantifies the minimum number of MIPS eligible clinicians. 
For final rule model, we estimate there are approximately 217,000 
clinicians \66\ who would be MIPS eligible because they exceed the low 
volume threshold as individuals and are not otherwise excluded. In 
Table 97,\67\ we identify clinicians under this assumption as having 
``required eligibility.'' Using this assumption, the number of 
clinicians with required eligibility in this final rule and their 
associated PFS allowed charges are very similar to the estimate in the 
CY 2019 PFS proposed rule (approximately 218,000 clinicians).
---------------------------------------------------------------------------

    \66\ The count of 216,612 MIPS eligible clinicians for required 
eligibility includes those who participated in MIPS (196,236 MIPS 
eligible clinicians) as well as those who did not participate 
(17,376 MIPS eligible clinicians).
    \67\ Estimates for the proposed rule available at 83 FR 36060.
---------------------------------------------------------------------------

    Based on CY 2017 Quality Payment Program Year 1 data, we anticipate 
that group and APM Entities that submitted to MIPS as a group and APM 
Entity will continue to do so for the CY 2019 MIPS performance period. 
Therefore, if we revise our model's group reporting assumption such 
that all clinicians that were participating in ACOs in 2017 (including 
ACOs participating under the Shared Savings Program or Next Generation 
ACO Model) or who reported to the Quality Payment Program Year 1 as a 
group would continue to do so in MIPS, then the MIPS eligible clinician 
population would be approximately 770,000 clinicians if we only include 
the 218,000 required clinicians and the 553,000 clinicians who are only 
eligible because of group reporting. In Table 97, we identify these 
clinicians who do not meet the low-volume threshold individually but 
are anticipated to submit to MIPS as a group based on Quality Payment 
Program Year 1 data as having ``group eligibility.'' Updating the data 
source for identifying group reporting led to a 42 percent increase 
(from approximately 390,000 in the proposed rule to 553,000 in this 
final rule) in clinicians in the ``group eligibility'' category. We 
also observed a 33 percent increase in the PFS allowed charges in MIPS 
from $10,262 million in the proposed rule to $13,662 million in this 
final rule for the clinicians in the ``group eligibility'' category. 
The previous estimate presented in the proposed rule likely 
underestimated the number of clinicians using group reporting since 
previously group reporting could only be identified through the 
submission of quality data to PQRS. With the availability of CY 2017 
Quality Payment Program Year 1 data, we can identify group reporting 
through the submission of improvement activities, Promoting 
Interoperability, or quality performance category data.To model the 
proposed opt-in policy, we assumed that 33 percent of the clinicians 
who exceed at least one low-volume threshold and submitted data to CY 
2017 MIPS performance period would elect to opt-in to MIPS. We selected 
a random sample of 33 percent of clinicians without accounting for 
performance. We believe this assumption of 33 percent is reasonable 
because some clinicians may choose not to submit data due to 
performance, practice size, or resources or alternatively, some may 
submit data, but elect to be a voluntary reporter and not be subject to 
a MIPS payment adjustment based on their performance. Similar to the 
proposed rule (83 FR 36060), we applied a 33 percent opt-in assumption 
to estimate opt-in eligibility in this final rule. We sought comment on 
these assumptions in the proposed rule, including whether modeling 
eligibility only among clinicians or groups who submitted at least 6 
quality measures to PQRS would be more appropriate. As we describe in 
more detail below, we also explored an alternate opt-in assumption 
where only high-performers would opt-in to MIPS. In the alternate 
model, we saw a difference in the maximum payment adjustment of 
approximately one-tenth of a percent. Given the minimal differences 
between the two alternatives, we elected to continue the assumption 
from the CY 2019 PFS proposed rule and present results with the 33 
percent random opt-in for this impact analysis. This 33 percent 
participation assumption is identified in Table 97 as ``Opt-In 
eligibility''. In the final rule analysis, we estimate an additional 
28,000 clinicians would be eligible through this policy for a total 
MIPS eligible population of approximately 798,000. The leads to an 
associated $66.6 billion allowed PFS charges estimated to be included 
in the 2019 MIPS performance period.
    We observed a decrease of approximately 14,000 clinicians compared 
to the proposed rule in the ``opt-in eligibility'' category after 
updating the data source and applying the finalized policies. This 
observed decrease in the number of clinicians that would elect to opt-
in to MIPS is because there were fewer clinicians from which to 
randomly select for opt-in eligibility due to the increase in group 
reporting.

[[Page 60051]]



 Table 97--Description of MIPS Eligibility Status for CY 2021 MIPS Payment Year Using the Proposed and Finalized
                                                 Assumptions ***
----------------------------------------------------------------------------------------------------------------
                                                      Proposed rule estimates      Final Rule estimates [dagger]
                                    Predicted    ---------------------------------------------------------------
                                  participation            Legacy data *                  QPP Year 1 data
      Eligibility status         status in MIPS  ---------------------------------------------------------------
                                among clinicians                    PFS allowed                     PFS allowed
                                        *            Number of     charges ($ in     Number of     charges ($ in
                                                    clinicians       mil) ****      clinicians       mil) ****
----------------------------------------------------------------------------------------------------------------
Required eligibility (always    Participate in           186,549          43,546         199,236          47,653
 subject to a MIPS payment       MIPS.                    31,921           7,605          17,376           3,916
 adjustment because individual  Do not
 clinicians exceed the low-      participate in
 volume threshold in all 3       MIPS.
 criteria).
Group eligibility (only         Submit data as a         389,670          10,262         553,475          13,662
 subject to payment adjustment   group.
 because clinicians' groups
 exceed low-volume threshold
 in all 3 criteria and submit
 as a group).
Opt-In eligibility assumptions  Elect to opt-in           42,025           2,099          27,903           1,380
 (only subject to a positive,    and submit data.
 neutral, or negative
 adjustment because the
 individual or group exceeds
 the low-volume threshold in
 at least 1 criterion but not
 all 3, and they elect to opt-
 in to MIPS and submit data).
                                                 ---------------------------------------------------------------
    Total Number of MIPS        ................         650,165          63,512      ** 797,990          66,611
     Eligible Clinicians.
Not MIPS eligible:
    Potentially MIPS eligible   Do not opt-in;           482,574          11,695         390,244           9,290
     (not subject to payment     or.
     adjustment for non-        Do not submit as
     participation; could be     a group.
     eligible for one of two
     reasons: 1) meet group
     eligibility or 2) opt-in
     eligibility criteria).
    Below the low-volume        Not applicable..          88,070             690          77,617             404
     threshold (never subject
     to payment adjustment;
     both individual and group
     is below all 3 low-volume
     threshold criteria).
    Excluded for other reasons  Not applicable..         302,172          13,688         209,403           9,735
     (Non-eligible clinician
     type, newly enrolled, QP).
                                                 ---------------------------------------------------------------
        Total Number of         ................         872,816          26,073         677,264          19,429
         Clinicians Not MIPS
         Eligible.
                                                 ---------------------------------------------------------------
        Total Number of         ................       1,522,981          89,585       1,475,254          86,040
         Clinicians (MIPS and
         Not MIPS Eligible).
----------------------------------------------------------------------------------------------------------------
* Participation in MIPS defined as previously submitting quality or EHR data for PQRS. Group reporting based on
  2016 PQRS group reporting.
** Updated Estimated MIPS Eligible Population.
*** Facility-based eligible clinicians are not modeled separately in this table and are captured in the
  individual eligible category. This table does not consider the impact of the MAQI Demonstration waiver. This
  table also does not include clinicians impacted by the automatic extreme and uncontrollable policy
  (approximately 22,000 clinicians and $3.7 billion in PFS allowed charges).
[dagger] These estimates reflect the finalized policies, which differ from the proposed rule (that is, change in
  MIPS eligible clinician types and those identified as QPs).
**** Allowed charges estimated using 2016 and 2017 dollars. Low-volume threshold is calculated using allowed
  charges. MIPS payment adjustments are applied to the paid amount.

    There are approximately 390,000 clinicians who are not MIPS 
eligible, but could be if their practice decides to participate. We 
describe this group as ``Potentially MIPS eligible.'' This is the 
unlikely scenario in which all group practices elect to submit data as 
a group and all clinicians that could elect to opt-into MIPS do elect 
to opt-in. This assumption is important because it quantifies the 
maximum number of MIPS eligible clinicians. When this unlikely scenario 
is modeled, we estimate that the MIPS eligible clinician population 
could be as high as 1.2 million clinicians. We observed a decrease of 
approximately 92,000 clinicians compared to the model in the proposed 
rule after updating the data source and applying the finalized 
policies. This observed decrease is due to the increase in group 
reporting.
    Finally, there are some clinicians who would not be MIPS eligible 
either because they are below the low-volume threshold on all three 
criteria (approximately 78,000) or because they are excluded for other 
reasons (approximately 209,000). We observed a decrease of 
approximately 93,000 clinicians after updating the data source and 
applying the finalized policies. This observed decrease is due to much 
lower estimated number of newly enrolled clinicians but slightly higher 
number of QPs in the 2017 Quality Payment Program Year 1 data.
    Since eligibility among some clinicians is contingent on submission 
to MIPS as a group or election to opt-in, we will not know the exact 
number of MIPS eligible clinicians until the submission period for the 
CY 2019 MIPS performance period is closed. For this impact analysis, we 
are using the estimated population of 797,990 MIPS eligible clinicians 
described above.
    We received the following comments on our methodology:
    Comment: One commenter requested CMS explain how the number of 
clinicians affected by the proposed MIPS opt-in policy for the 2021

[[Page 60052]]

payment year was estimated. The commenter supported the proposed MIPS 
opt-in policy starting in 2019 but would like to know how CMS estimated 
the number of clinicians that would be impacted by the policy.
    Response: For the proposed rule, to estimate the number of 
clinicians that may elect to opt-in to MIPS, we randomly selected 33 
percent of clinicians that met at least one but not all the low-volume 
criteria and submitted data to 2016 PQRS. This led to an estimated 
42,025 number of clinicians that will opt-in to MIPS.
    For this final rule, we randomly selected 33 percent of clinicians 
that met at least one but not all the low-volume criteria and submitted 
to CY 2017 MIPS performance period. This led to an estimated 27,903 
number of clinicians that will opt-in to MIPS. We also estimated the 
impact if we had assumed only those who expect to perform well would 
elect to opt-in. In the alternate model assumption where only high 
performers would opt-in to MIPS, we assumed 100 percent of clinicians 
with final scores above the additional performance threshold would opt-
in and 50 percent of clinicians above the performance threshold but 
below the additional performance threshold would opt-in. We observed a 
decrease in the budget neutral pool from $310 million to $296 comparing 
the model with the 33 percent random opt-in to the model where only 
high-performers opt-in. We observed a minimal impact to the maximum 
payment adjustment compared to the model with 33 percent random opt-in 
(4.7 percent versus 4.6 percent). We refer readers to section 
III.I.3.c.(5) of this final rule for additional results on that 
analysis. Because we did not see much difference in results, we present 
the model with the 33 percent random opt-in this impact analysis.
    Comment: One commenter recommended CMS present specialty-specific 
data for exemption criteria. Specifically, the commenter recommended 
CMS present specialty specific information on the number of clinicians 
exempt from MIPS because they are newly enrolled in Medicare and/or 
Qualified Participants (QPs) or Partial QPs in Advanced APMs, and the 
number of clinicians assigned to certain special categories (for 
example, non-patient facing, hospital-based, facility-based, and ASC-
based for the purposes of the ACI exemption). The commenter noted the 
provision of this information will allow for the assessment of how many 
clinicians are exempt by specialty and for member education activities.
    Response: We appreciate that some stakeholders would like specialty 
specific information; however, given the numerous assumptions for group 
reporting and opt-in participation, we believe presenting the overall 
number of MIPS eligible clinicians is the most transparent way to 
present the information.
    After consideration of the public comments, we have updated our 
methodology to estimate the number of MIPS eligible clinicians for the 
2019 MIPS performance period/2021 MIPS payment year to account for the 
Quality Payment Program Year 1 data and the policies finalized in this 
final rule.
(3) Impact of MIPS Eligibility Finalized Policies
    We illustrate in Table 98 \68\ how each finalized policy for the CY 
2021 payment year affects the estimated number of MIPS eligible 
clinicians. The baseline is the number of individuals that would have 
been MIPS eligible clinicians for the 2019 MIPS performance period/2021 
MIPS payment year if this regulation did not exist. In the CY 2019 PFS 
proposed rule (83 FR 36060), we estimated the baseline was 591,010. 
After updating the model to reflect the updated data sources, the new 
baseline population is 751,498. All incremental impact estimates are 
relative to this baseline.
---------------------------------------------------------------------------

    \68\ Estimates for the proposed rule available at 83 FR 36061.

                                  Table 98--Incremental Change Table for Finalized Policies for 2021 MIPS Payment Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Estimated       Estimated
                                                          number of MIPS     effect of                    Estimated Part   Estimated PFS
                                                             eligible     policy changes    Estimated %      B allowed        allowed       Estimated %
                    Policy changes *                        clinicians     on number of     change from    charges (mil)   charges (mil)   change in PFS
                                                            impacted by    MIPS eligible     baseline           ***             ***        from baseline
                                                           policy change    clinicians
--------------------------------------------------------------------------------------------------------------------------------------------------------
Baseline: Applying previously finalized policy for the               N/A         751,498             N/A          79,375          64,382             N/A
 2021 payment year if this regulation did not exist.....
Policy Change 1: Low-volume threshold (LVT)                       -1,651         749,847            -0.2          79,160          64,266           -0.2%
 determination based on covered professional services
 (as required by Bipartisan Budget Act of 2018).........
Policy Change 2: Expansion of eligible clinician types            20,240         770,087             2.5             N/A          65,231            1.3%
 to include physical therapists, occupational
 therapists, qualified speech-language pathologist, or
 qualified audiologist, clinical psychologist, and
 registered dietician or nutrition professional based
 with policy change 1...................................
Policy Change 3: Cumulative change of Opt-in Policy with          27,903         797,990             6.2             N/A          66,611            3.5%
 policy changes 1 and 2 **..............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
* This table does not consider the impact of the MAQI Demonstration waiver and does not include clinicians impacted by the extreme and uncontrollable
  policy.
** Model assumption is 33 percent clinicians who are eligible will elect to opt-in.
*** Allowed charges estimated using 2016 and 2017 dollars. Low-volume threshold is calculated using allowed charges. MIPS payment adjustments are
  applied to the paid amount.


[[Page 60053]]

    First, as shown in Table 98, the first row shows the effect of 
changing the application of the MIPS payment adjustments, as required 
by section 51003(a)(1)(E) of the Bipartisan Budget Act of 2018 to apply 
them to covered professional services (services for which payment is 
made under, or is based on, the Medicare PFS and are furnished by an 
eligible clinician) rather than to items and services covered under 
Part B. As shown, the baseline allowed charges for Part B is $79.4 
billion, compared with $64.4 billion in covered professional services, 
which is a difference of almost $15 billion. Beginning in the 2019 MIPS 
payment year, payment adjustments will only be applied to the total 
paid amount for covered professional services.
    In Table 98, under the first policy change, basing the low-volume 
threshold on covered professional services (services provided under the 
PFS rather than items and services covered under Part B) has minimal 
impact in terms of clinicians (less than half of one percent decrease).
    When the second policy change, to expand the definition of MIPS 
eligible clinician types, was added to the first policy change, the 
total effect is small. The change in the potential MIPS eligible 
clinician population increased by less than 3 percent and the allowed 
charges in the PFS increased by 1.3 percent.
    When the third policy change, which implements the opt-in policy, 
is added to the other two policies, the estimated number of MIPS 
eligible clinicians increases by 6.2 percent. The estimated increase in 
the allowed charges in the PFS is 3.5 percent.
d. Estimated Impacts on Payments to MIPS Eligible Clinicians
(1) Summary of Approach
    In sections III.I.3.h., III.I.3.i. and III.I.3.j. of this final 
rule, we finalized several proposals which impact the measures and 
activities that impact the performance category scores, final score 
calculation, and the MIPS payment adjustment. We discuss these changes 
in more detail in section VII.F.8.d.(2) of this RIA as we describe our 
methodology to estimate MIPS payments for the 2021 MIPS payment year. 
We note that many of the MIPS policies from the CY 2018 Quality Payment 
Program final rule were only defined for the 2018 MIPS performance 
period and 2020 MIPS payment year (including the performance threshold, 
the additional performance threshold, the policy for redistributing the 
weights of the performance categories, and many scoring policies for 
the quality performance category) which precludes us from developing a 
baseline for the 2019 MIPS performance period and 2021 MIPS payment 
year if there was no new regulatory action. Therefore, our impact 
analysis looks at the total effect of the finalized MIPS policy changes 
on the MIPS final score and payment adjustment for CY 2019 MIPS 
performance period/CY 2021 MIPS payment year.
    The payment impact for a MIPS eligible clinician is based on the 
clinician's final score, which is a value determined by their 
performance in the four MIPS performance categories: Quality, cost, 
improvement activities, and Promoting Interoperability. As described in 
the CY 2019 PFS proposed rule (83 FR 36061), the performance and 
participation data submitted for the 2017 MIPS performance period were 
not available to estimate the final score and the projected payment 
adjustments for MIPS eligible clinicians. This analysis has been 
updated with the Quality Payment Program Year 1 data and those results 
are presented in this final rule. We refer readers to CY 2019 PFS 
proposed rule (83 FR 36061 through 36066) for additional details on how 
we estimated the final scores and payment adjustments in the proposed 
rule.
    The estimated payment impacts presented in this final rule reflect 
averages by practice size based on Medicare utilization. The payment 
impact for a MIPS eligible clinician could vary from the average and 
would depend on the combination of services that the MIPS eligible 
clinician furnishes. The average percentage change in total revenues 
would be less than the impact displayed here because MIPS eligible 
clinicians generally furnish services to both Medicare and non-Medicare 
patients; this program does not impact payment from non-Medicare 
patients. In addition, MIPS eligible clinicians may receive Medicare 
revenues for services under other Medicare payment systems, such as the 
Medicare Federally Qualified Health Center Prospective Payment System 
or Medicare Advantage that would not be affected by MIPS payment 
adjustment factors.
(2) Methodology To Assess Impact
    To estimate participation in MIPS for the CY 2019 Quality Payment 
Program for this final rule, we used CY 2017 Quality Payment Program 
Year 1 performance period data. Our scoring model includes the 797,990 
estimated number of MIPS eligible clinicians as described in section 
VII.F.8.c of this RIA.
    To estimate the impact of MIPS on eligible clinicians, we used the 
Quality Payment Program Year 1 submission data, including data 
submitted for the quality, improvement activities, and advancing care 
information performance categories, CAHPS for MIPS and CAHPS for ACOs, 
the total per capita cost measure, Medicare Spending Per Beneficiary 
(MSPB) measures and other data sets.\69\ We calculated a hypothetical 
final score for the 2019 MIPS performance period/2021 MIPS payment year 
for each MIPS eligible clinician based on quality, cost, Promoting 
Interoperability, and improvement activities performance categories.
---------------------------------------------------------------------------

    \69\ 2016 PQRS and Value Modifier data was used for the 
improvement score for the quality performance category.
---------------------------------------------------------------------------

    Starting in CY 2018 MIPS performance period, solo practitioner or a 
group of 10 or fewer eligible clinicians may elect to participate in 
MIPS as a virtual group (82 FR 53604). We had two virtual groups 
register for the 2018 performance period, of which one had all its 
participants participating in a MIPS APM for the 2018 performance 
period. While we anticipate an increase in the number of virtual groups 
for the 2019 MIPS performance period, we did not attempt to model 
virtual groups in this model as the participants in one virtual group 
who are in a MIPS APM would receive the MIPS APM score which left just 
one virtual group to measure.
(a) Methodology To Estimate the Quality Performance Category Score
    We estimated the quality performance category score using measures 
submitted to MIPS for the 2017 performance period. For the quality 
measures, we started with the assigned measure achievement points 
assigned for the 2017 MIPS performance period. As finalized as proposed 
in III.I.3.i.(1)(b)(iii)(A) of this final rule, we applied a 3-point 
floor for measures that cannot be reliably scored against a baseline 
benchmark in the 2019 MIPS performance period. As described in section 
III.I.3.h.(2)(b)(iii) of this final rule, we finalized the proposal to 
remove many measures that were previously able to be reported in PQRS 
and in previous MIPS performance periods. For our estimates, we assumed 
that clinicians who reported Medicare Part B claims, eCQM, MIPS CQM and 
QCDR measures that are removed would find alternate measures; 
therefore, we assigned points to these measures and included them in 
our scoring model. For CY 2019, we maintained the policies for

[[Page 60054]]

scoring measures that do not meet the quality category requirements 
(case minimum, benchmark, and data completeness) as described in the CY 
2018 Quality Payment Program final rule (82 FR 53727 through 53730). As 
finalized in the CY 2018 Quality Payment Program final rule, we also 
applied a 7-point cap for measures that are topped out for two or more 
years (82 FR 53721 through 53727).
    As stated in section III.I.3.h.(2)(a)(iii)(A)(bb) of this final 
rule, we finalized the proposal to remove several Web Interface 
measures. For that collection type, which has a standard set of 
measures, we estimated performance on the measures that we propose to 
continue.
    As finalized in sections III.I.3.i.(1)(b)(ix) and (x) of this final 
rule, we maintained the cap on bonus points for high-priority measures 
and end-to-end electronic bonus points at 10 percent of the denominator 
and, beginning with the 2019 MIPS performance period, discontinue high 
priority bonus points for CMS Web Interface Reporters. Because we are 
able to use MIPS performance data in our models, we assigned 1 point 
for each measure that was submitted with end-to-end electronic 
reporting with a cap of 10 percent of the total possible measure 
achievement points. To be consistent with our small practice bonus 
finalized policy in section III.I.3.i.(1)(b)(viii) of this final rule, 
we added 6 measure achievement points to the quality performance 
category score for small practices that had a quality performance 
category score greater than 0 points.
    As finalized in the CY 2018 Quality Payment Program final rule (82 
FR 53625 through 52626) and further discussed in III.I.3.h.(2)(a)(iii) 
of this final rule, we are allowing MIPS eligible clinicians and groups 
to submit data collected via multiple collection types within a 
performance category beginning with the 2019 performance period. The 
requirements for the performance categories remain the same regardless 
of the number of collection types used. We do not apply the validation 
process that is discussed in section III.I.3.i.(1)(b)(vii) of this 
final rule.
    To estimate the impact of improvement for the quality performance 
category, we estimated a quality performance category percent score 
using 2019 MIPS data, 2015 and 2018 CAHPS for ACOs and MIPS data, and 
2016 PQRS VM data. For MIPS eligible clinicians with an estimated 
quality performance category score less than or equal to a 30 percent 
score in the previous year, we compared 2019 performance to an assumed 
2018 quality score of 30 percent for their improvement score as 
described in III.I.3.i.(1)(b)(xiii) of this final rule.
    Due to data limitations, we are unable to model all the finalized 
policies in this rule. We are not able to incorporate the policy to 
reduce the denominator for the quality performance category score by 10 
points for groups that registered for CAHPS for MIPS but were unable to 
report due to insufficient sample size as discussed in section 
III.I.3.i.(1)(b)(iii)(B) of this final rule. We also did not apply the 
finalized scoring policy for measures that are significantly impacted 
by clinical guideline or other changes discussed in section 
III.I.3.i.(1)(b)(vi) of this final rule.
    Our model applied the MIPS APM scoring standards finalized in 
section III.I.3.h.(6) of this final rule to quality data from MIPS 
eligible clinicians that participated in the Shared Savings Program, 
and the Next Generation ACO Model in 2017.
(b) Methodology To Estimate the Cost Performance Category Score
    In section III.I.3.h.(3)(b)(ii) of this final rule, we finalized 
the proposal to add 8 episode-based measures to the cost performance 
category beginning with the 2019 performance period. For the episode-
based measures, we used the episode specifications proposed in the CY 
2019 PFS proposed rule (83 FR 35902 through 35903) and claims data from 
June 2016 through May 2017. As discussed in section 
III.I.3.h.(3)(b)(ii) of this final rule, we made updates to the 
specifications for three episode measures. Due to timing constraints we 
were not able to incorporate the updated specifications into this 
impact analysis; however, we anticipate that the updates will only have 
a marginal effect on the cost measure scores.
    We estimated the cost performance category score using the total 
per capita cost measure and Medicare Spending Per Beneficiary (MSPB) 
measures from the CY 2017 Quality Payment Period Year 1 data that was 
presented in the MIPS feedback reports. Cost measure scores were used 
only when the associated case size met or exceeded the previously 
finalized or newly finalized case minimum: 20 for the total per capita 
cost measure, 35 for MSPB, 10 for procedural episodes, and 20 for acute 
medical inpatient medical condition episodes. The cost measures are 
computed for both the TIN/NPI and the TIN. For clinicians participating 
as individuals, the TIN/NPI level score was used if available and if 
the minimum case size was met. For clinicians participating as groups, 
the TIN level score was used, if available, and if the minimum case 
size was met. For clinicians with no measures meeting the minimum case 
requirement, we did not estimate a score for the cost performance 
category, and the weight for the cost performance category was 
reassigned to the quality performance category. The raw cost measure 
scores were mapped to scores on the scale of 1-10, using benchmarks 
based on all measures that met the case minimum during the relevant 
performance period. For the episode-based cost measures, separate 
benchmarks were developed for TIN/NPI level scores and TIN level 
scores. For each clinician, a cost performance category score was 
computed as the average of the measure scores available for the 
clinician.
(c) Methodology To Estimate the Facility-Based Measurement Scoring
    As discussed in section III.I.3.i.(1)(d) of this final rule, we are 
implementing facility-based measurement for the 2019 MIPS performance 
period. In facility-based measurement, we determine the eligible 
clinician's MIPS score based on Hospital VBP Total Performance Score 
for eligible clinicians or groups who meet the eligibility criteria, 
which we designed to identify those who primarily furnish services 
within a hospital. Given that we are not requiring eligible clinicians 
to opt-in to facility-based measurement, it is possible that a MIPS 
eligible clinician or a group is automatically eligible for facility-
based measurement but they participate in MIPS as an individual or a 
group. In these cases, we use the higher combined quality and cost 
performance category score from facility-based scoring compared to the 
combined quality and cost performance category score from MIPS 
submission based scoring.
    Data was not available to attribute specific Hospital VBP Total 
Performance Score to MIPS eligible clinicians, hence we made the 
following assumptions. For MIPS eligible clinicians and groups who are 
eligible for facility-based measurement and who submitted quality data 
to the Quality Payment Program for the 2017 MIPS performance period, we 
did not estimate a facility-based score. We instead calculated a MIPS 
quality and cost score based on the available quality measures and cost 
data. Some clinicians who submitted Quality Payment Program quality 
data may receive a higher combined quality and cost score through 
facility-based measurement, but we are unable to identify those 
clinicians due to data limitations and therefore believe the score 
based on

[[Page 60055]]

their submitted data is more likely to reflect their performance.
    For MIPS eligible clinicians that did not submit data to the 
Quality Payment Program for the 2017 MIPS performance period and were 
eligible for facility-based measurement, we estimated a facility-based 
score by taking the median MIPS quality and cost performance score. We 
believe it is important to develop an estimate for this cohort because 
we would have otherwise assigned this group a quality performance 
category percent score of zero percent which we believe would 
underestimate their MIPS final score. Given the data limitations in 
assigning a specific hospital score to a clinician, we selected the 
median MIPS quality and cost performance scores as that represents the 
quality and cost performance category scores that a clinician working 
in a hospital with median performance would receive.
(d) Methodology To Estimate the Promoting Interoperability Performance 
Category Score
    As discussed in section III.I.3.h.(5)(d)(ii) of this final rule, we 
finalized the proposal to modify the measures and scoring for the 
Promoting Interoperability performance category score. We simplified 
scoring by eliminating the concept of base and performance scores and 
focusing on a smaller set of measures which are scored on performance. 
We estimated Promoting Interoperability performance category scores 
using the advancing care information performance category data from the 
CY 2017 Quality Payment Period Year 1 data. The Promoting 
Interoperability performance category scores were based on the 
individual level for individual submissions and on the group level for 
clinicians that were part of a group submission or part of an APM 
entity.
    For the e-Prescribing objective, we only estimated the e-
Prescribing measure and did not assume any bonus points for the Query 
of Prescription Drug Monitoring Program (PDMP) or the Verify Opioid 
Treatment Agreement measures. To estimate the e-Prescribing measure, we 
used the reported numerator and denominator values for the e-
Prescribing measure for the advancing care information performance 
category, unless a measure exclusion applied.
    For the Health Information Exchange objective, we used the required 
measures in the Health Information Exchange objective from the 
advancing care information performance category to proxy performance 
for the two finalized measures in the Promoting Interoperability 
objective. We used the Send Summary of Care measure and the Health 
Information Exchange transition measure for the Support Electronic 
Referral Loops by Sending Health Information measure. For MIPS eligible 
clinicians that reported data using 2015 CEHRT, we used the Request/
Accept Summary of Care measure for the Support Electronic Referral 
Loops by Receiving and Incorporating Health Information. If this 
information was not available, then we used just the Send Summary of 
Care measure. If there was an exclusion for the Send Summary of Care 
measure or the Health Information Exchange transition measure, then for 
purpose of this model, we reweighted the measure to the Patient 
Electronic Access objective.
    For the Provider to Patient Exchange objective, we used the Provide 
Patient Access measure to estimate performance for the finalized 
Provide Patients Electronic Access to Their Health Information measure.
    For the Public Health and Clinical Data Exchange objective, we 
estimated the score by using the reported responses for the following 
advancing care information measures: Immunization Registry Reporting, 
Syndromic Surveillance Reporting, Electronic Case Reporting, Public 
Health Registry Reporting, Clinical Data Registry Reporting and 
Specialized Registry Reporting.
    To calculate the Promoting Interoperability performance category, 
we summed the performance category measure scores and divided the total 
sum by the total number of possible points (100), as described in 
section III.I.3.i.(1)(d) of this final rule. As discussed in section 
III.I.3.i.(1)(d) of this final rule, a TIN/NPI must report on all 
required measures in the Promoting Interoperability performance 
category and complete all actions included in the Security Risk 
Analysis measure during the year to receive a non-zero performance 
category score. For APM Entities, we aggregated the scores of the 
participants consistent with the requirements for the 2017 MIPS 
performance period.
    For eligible clinicians who did not submit a required Promoting 
Interoperability measure and did not complete all actions included in 
the Security Risk Analysis measure, we evaluated whether the MIPS 
eligible clinician could have their Promoting Interoperability 
performance category reweighted and applied the reweighting policies 
described in section III.I.3.h.(5)(d) of this final rule. For the 
Registry Reporting measures, which did not have an exclusion defined 
for the 2017 MIPS performance period, we assumed that failure to submit 
data or submissions with all ``No'' answers implied a request for 
exclusion. A group was only reweighted for the Promoting 
Interoperability performance category if all the TIN/NPIs were eligible 
for reweighting, thereby reweighting only applying to 24 percent of 
MIPS eligible clinicians as opposed to 62 percent of MIPS eligible 
clinicians scores in the CY 2019 PFS proposed rule (83 FR 36063) in 
which Promoting Interoperability was always assessed at the individual 
level.
    As finalized in the CY 2017 (81 FR 77069 through 77070) and CY 2018 
(82 FR 53625 through 52626) Quality Payment Program final rules, the 
Promoting Interoperability performance category weight is set equal to 
0 percent, and the weight is redistributed to the quality or 
improvement activities performance category for non-patient facing MIPS 
eligible clinicians, hospital-based MIPS eligible clinicians, ASC-based 
MIPS eligible clinicians, or those who request and are approved for a 
significant hardship or other type of exception, including a 
significant hardship exception for small practices, or clinicians who 
are granted an exception based on decertified EHR technology (82 FR 
53780 through 53786). We also finalized in section III.I.3.h.(5)(h) of 
this final rule to continue automatic reweighting for NPs, PAs, CNSs 
and CRNAs and to add an automatic reweighting policy for physical 
therapists, occupational therapist, speech-language pathologists, 
audiologists, clinical psychologists, and registered dietitians or 
nutrition professionals, which we have incorporated into our model. We 
used the non-patient facing and hospital-based indicators and specialty 
and small practice indicators as calculated in the initial MIPS 
eligibility run for the 2017 MIPS performance period (81 FR 77069 
through 77070). For significant hardship exceptions, we used the 
approved significant hardship file for the 2017 MIPS performance 
period.
    If a TIN/NPI did not report on all required measures and did not 
qualify for reweighting for a required measure, then their Promoting 
Interoperability performance category score was set to zero percent.
(e) Methodology To Estimate the Improvement Activities Performance 
Category Score
    We modeled the improvement activities performance category score 
based on CY 2017 Quality Payment Period Year 1 data and APMs 
participation in the 2017 MIPS performance period. We did not make

[[Page 60056]]

any policy changes that impact scoring for the improvement activities 
performance category. Our model identified participants in APMs during 
the 2017 performance period, including but not limited to those in the 
Shared Savings Program, Next Generation ACO Model, and assigned them an 
improvement activity score of 100 percent, consistent with our policy 
to assign an improvement activities score of 100 percent to ACO 
participants who were not excluded due to being QPs.
    Clinicians and groups not participating in a MIPS APM were assigned 
their CY 2017 Quality Payment Period Year 1 improvement activities 
performance category score.
(f) Methodology To Estimate the Complex Patient Bonus
    In sections III.I.3.i.(2)(a)(ii) of this final rule, we finalized 
the proposed policy to continue the complex patient bonus. Consistent 
with the policy to define complex patients as those with high medical 
risk or with dual eligibility, our scoring model calculated the bonus 
by using the average Hierarchical Condition Category (HCC) risk score, 
as well as the MIPS eligible clinician's patients dual eligible 
proportion calculated for each NPI in the 2016 Physician and Other 
Supplier Public Use File. The dual eligible proportion for each MIPS 
eligible clinician was multiplied by 5. We also generated a group 
average HCC risk score by weighing the scores for individual clinicians 
in each group by the number of beneficiaries they have seen. We 
generated group dual eligible proportions using the weighted average 
dual eligible patient ratio for all MIPS eligible clinicians in the 
groups, which was then multiplied by 5. The complex patient bonus was 
calculated by adding together the average HCC risk score and the 
percent of dual eligible patients multiplied by 5, with a 5-point cap.
(g) Methodology To Estimate the Final Score
    As finalized in sections III.I.3.h.(2)(a)(ii), III.I.3.h.(3)(a), 
III.I.3.h.(4)(a), III.I.3.h.(5)(d)(i) and summarized in section 
III.I.3.i.(2)(b) of this final rule, our model assigns a final score 
for each TIN/NPI by multiplying each performance category score by the 
corresponding performance category weight, adding the products 
together, multiplying the sum by 100 points, and adding the complex 
patient bonus. After adding any applicable bonus for complex patients, 
we reset any final scores that exceeded 100 points equal to 100 points. 
For MIPS eligible clinicians who were assigned a weight of zero percent 
for the Promoting Interoperability due to a significant hardship or 
other type of exception, the weight for the Promoting Interoperability 
performance category was redistributed to the quality performance 
category. For MIPS eligible clinicians who did not have a cost 
performance category score, the weight for the cost performance 
category was redistributed to the quality performance category. In our 
scoring model, we did not address scenarios where a zero percent weight 
would be assigned to the quality performance category or the 
improvement activities performance category.
(h) Methodology To Estimate the MIPS Payment Adjustment
    As described in the CY 2018 Quality Payment Program final rule (82 
FR 53785 through 53787), we applied a hierarchy to determine which 
final score should be used for the payment adjustment for each MIPS 
eligible clinician when more than one final score is available (for 
example if a clinician qualifies for a score for an APM entity and a 
group score, we select the APM entity score).
    We then calculated the parameters of an exchange function in 
accordance with the statutory requirements related to the linear 
sliding scale, budget neutrality, minimum and maximum adjustment 
percentages and additional payment adjustment for exceptional 
performance (as finalized under Sec.  414.1405), using a performance 
threshold of 30 points and the additional performance threshold of 75 
points (as finalized in sections III.I.3.j.(2) and III.I.3.j.(3) of 
this final rule). We used these resulting parameters to estimate the 
positive or negative MIPS payment adjustment based on the estimated 
final score and the PFS paid amount. We considered other performance 
thresholds which are discussed in section VII.G. of this RIA.
(3) Impact of Payments by Practice Size
    Using the assumptions provided above, our model estimates that $310 
million would be redistributed through budget neutrality and that the 
maximum positive payment adjustments are 4.7 percent after considering 
the MIPS payment adjustment and the additional MIPS payment adjustment 
for exceptional performance. The observed decrease in the funds 
available for redistribution and the maximum positive payment 
adjustment from the proposed rule to the final rule is due to the 
change in the data sources used to estimate final scores for MIPS 
eligible clinicians and the decrease in the additional performance 
threshold.
    The use of 2017 Quality Payment Program Year 1 data to estimate the 
impact of the 2019 Quality Payment Program Year 3 finalized policies 
led to lower average final scores compared to the proposed rule. The 
main contributors to the lower estimated final scores were the changes 
in the estimated quality and Promoting Interoperability performance 
categories scores. The average quality scores were lower because some 
of the group reporters did not have quality data. As described in 
section VII.F.8.c.(2) of this final rule, we previously identified 
group reporters based on the submission of quality data submitted to 
PQRS; therefore, all group reporters submitted quality data and had a 
quality score. As a result of the 2017 Quality Payment Program Year 1 
data, we can identify group reporters through submissions for the 
improvement activities or the Promoting Interoperability performance 
category who may not have submitted quality data. Therefore, these new 
groups in the estimated MIPS population received a zero (or close to 
zero) quality performance category score for not submitting quality 
data.
    Table 99 shows the impact of the payments by practice size and 
whether clinicians are expected to submit data to MIPS.\70\ We estimate 
that a smaller proportion of clinicians in small practices (1-15 
clinicians) who participate in MIPS will receive a positive or neutral 
payment adjustment compared to larger size practices. Overall, 
clinicians in small practices participating in MIPS would receive a 1.2 
percent increase in their paid amount, which is similar to the payment 
amount received by MIPS eligible clinicians in practices with 16 to 24 
and 25 to 99 clinicians. After considering the positive adjustments and 
subtracting the negative adjustments, eligible clinicians in small 
practices would have an increase in funds which is consistent with all 
MIPS eligible clinicians. Table 99 also shows that 91.2 percent of MIPS 
eligible clinicians that participate in MIPS are expected to receive 
positive or neutral payment adjustments. The combined impact of 
negative and positive adjustments and exceptional performance payment 
as percent of paid

[[Page 60057]]

amount among those that do not submit data to MIPS was not the maximum 
negative payment adjustment possible because not all MIPS eligible 
clinicians that do not submit to MIPS receive a final score of zero. 
Indeed, some MIPS eligible clinicians that do not submit data to MIPS 
may receive final scores above zero through the cost performance 
category, which does not require submission to MIPS. Among those who we 
estimate would not submit data to MIPS, 90 percent are in small 
practices (15,680 out of 17,376 clinicians). To address participation 
concerns, we have policies targeted towards small practices including 
technical assistance and special scoring policies to minimize burden 
and facilitate small practice participation in MIPS or APMs.
---------------------------------------------------------------------------

    \70\ The proposed rule estimated MIPS participation and 
performance using historical PQRS and EHR data because MIPS CY 2017 
performance period data were not available in time for analysis in 
the proposed rule (83 36058 through 36066). This final rule presents 
the results from analysis of MIPS CY 2019 performance period data. 
Previous estimates are available in the proposed (83 FR 36066).

             Table 99--MIPS Estimated Payment Year 2021 Impact on Total Estimated Paid Amount by Participation Status and Practice Size * a
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                        Combined  Impact
                                                                                                   Percent  MIPS                        of  negative and
                                                                                Percent  MIPS         eligible        Percent  MIPS         positive
                                                                                   eligible      clinicians with a       eligible       adjustments  and
                                                            Number of  MIPS    clinicians with        positive       clinicians with      exceptional
                     Practice size *                            eligible         positive or      adjustment with    negative payment     performance
                                                               clinicians      neutral  payment     exceptional         adjustment        payment  as
                                                                                  adjustment          payment           (percent)       percent  of paid
                                                                                  (percent)          adjustment                            amount * *
                                                                                                     (percent)                             (percent)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Among those submitting data * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) 1-15.................................................            140,251               80.1               47.2               19.9                1.2
(2) 16-24................................................             41,226               86.1               41.4               13.9                1.1
(3) 25-99................................................            185,140               89.8               48.6               10.2                1.3
(4) 100+.................................................            413,997               96.1               69.0                3.9                2.0
    Overall..............................................            780,614               91.2               58.8                8.8                1.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Among those not submitting data
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) 1-15.................................................             15,680                0.0                0.0              100.0               -6.3
(2) 16-24................................................                629                0.0                0.0              100.0               -6.6
(3) 25-99................................................                860                0.0                0.0              100.0               -6.6
(4) 100+.................................................                207                0.0                0.0              100.0               -6.9
    Overall..............................................             17,376                0.0                0.0              100.0               -6.4
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Practice size is the total number of TIN/NPIs in a TIN.
** 2016 and 2017 data used to estimate 2019 performance period payment adjustments. Payments estimated using 2016 and 2017 dollars.
*** Includes facility-based clinicians whose quality data is submitted through hospital programs.
\a\ This table does not account for clinicians that are in the MAQI Demonstration waiver.

    The following is a summary of the public comments received 
regarding the estimated impact on payments for MIPS eligible 
clinicians:
    Comment: A few commenters encouraged CMS to use Year 1 MIPS 
participation data to inform changes to the program, citing that actual 
QPP data is needed for assessing the best ways to improve the program 
and how these changes will impact clinicians financially.
    Response: We thank the commenter for this suggestion. As described 
in this RIA for this final rule, the 2017 Quality Payment Program Year 
1 data were available in time to assess impact of the finalize policies 
and are now presented in this final rule.
    Comment: A few commenters recommended CMS present specialty 
specific tables. Specifically, they requested the estimated payment 
impact table by specialty as presented in previous years and additional 
performance data by specialty on each performance category (Data on 
reporting and performance rates for quality measures (similar to what 
was released via the PQRS Experience Reports); Statistics on clinical 
improvement activities reported; Statistics on clinician attribution to 
cost measures and performance on cost measures.). This would allow for 
better understanding of MIPS for their stakeholders.
    Response: We chose to only present the payment impact by practice 
size in this final rule; however, we may provide additional analyses 
via the Quality Payment Program website or other forums.
    After consideration of public comments, we have updated our 
analyses to incorporate the Quality Payment Program Year 1 data and the 
final policies.
e. Potential Costs of Compliance With the Promoting Interoperability 
and Improvement Activities Performance Categories for Eligible 
Clinicians
(1) Potential Costs of Compliance With Promoting Interoperability 
Performance Category
    In section III.I.3.h.(5)(c) of this final rule, we discussed the 
requirement to use EHR technology certified to the 2015 Edition 
beginning with the 2019 MIPS performance period for the Promoting 
Interoperability performance category. As discussed in section V.B.3 of 
this final rule, we assumed a slight decrease in overall information 
collection burden costs for the Promoting Interoperability performance 
category related to having fewer measures to submit.
    With respect to any costs unrelated to data submission, although 
this final rule would require some investment in systems updates, our 
policy prior to this regulation as reflected in Sec.  414.1305, is that 
2015 Edition CEHRT will be required beginning with the 2019 MIPS

[[Page 60058]]

performance period/2021 MIPS payment year (82 FR 53671). Therefore, we 
do not anticipate any additional costs due to this regulation.
    The following is a summary of the public comments received 
regarding these assumptions:
    Comment: A few commenters stated that complying with Promoting 
Interoperability performance category is a financial burden for many 
clinicians due to their practice size and their administrative 
capability, and the costs required by the EMR and EHR vendors. One 
commenter suggested that state and federal legislation ought to take 
these challenges into account, while another commenter suggested CMS 
work with stakeholders to establish mechanisms for providers to be 
compensated for creating interoperable data.
    Response: We reiterate that this policy was finalized in the CY 
2018 Quality Payment Program final rule (82 FR 53671) and thus this is 
not a new obligation for this final rule. We do have policies that 
recognize challenges, such as significant hardship exceptions for small 
practices.
    After consideration of public comments, we are not making any 
modifications on our potential cost for compliance with Promoting 
Interoperability performance category.
(2) Potential Costs of Compliance With Improvement Activities 
Performance Category
    Under the policies established in the CY 2017 Quality Payment 
Program final rule, the costs for complying with the improvement 
activities performance category requirements could have potentially led 
to higher expenses for MIPS eligible clinicians. Costs per full-time 
equivalent primary care clinician for improvement activities will vary 
across practices, including for some activities or certified patient-
centered medical home practices, in incremental costs per encounter, 
and in estimated costs per (patient) member per month.
    Costs for compliance with previously finalized policies may vary 
based on panel size (number of patients assigned to each care team) and 
location of practice among other variables. For example, Magill (2015) 
conducted a study of certified patient-centered medical home practices 
in two states.\71\ That study found that costs associated with a full-
time equivalent primary care clinician, who was associated with 
certified patient-centered medical home practices, varied across 
practices. Specifically, the study found an average cost of $7,691 per 
month in Utah practices, and an average of $9,658 in Colorado 
practices. Consequently, incremental costs per encounter were $32.71 
for certified patient-centered medical home practices in Utah and 
$36.68 in Colorado (Magill, 2015). The study also found that the 
average estimated cost per patient member, per month, for an assumed 
panel of 2,000 patients was $3.85 in Utah and $4.83 in Colorado. 
However, given the lack of comprehensive historical data for 
improvement activities, we are unable to quantify those costs in detail 
at this time. The findings presented in these papers have not changed. 
We have improvement activities information from the 2017 performance 
period, but additional analysis would be required before using that 
data to report the costs and benefits of implementing the improvement 
activities; and we are not able to do this in time for publication of 
this final rule. We have considered factors that also contribute to the 
difficulty of identifying compliance costs for the improvement 
activities performance category in the CY 2018 Quality Payment Program 
final rule (82 FR 53845).
---------------------------------------------------------------------------

    \71\ Magill et al. ``The Cost of Sustaining a Patient-Centered 
Medical Home: Experience from 2 States.'' Annals of Family Medicine, 
2015; 13:429-435.
---------------------------------------------------------------------------

    We believe that because we finalized an opt-in policy (as described 
in section II.C.2.c of this final rule), we would add approximately 
28,000 additional clinicians to the MIPS eligible clinicians. In 
section V.B.4 of this final rule, we assumed that those who have 
elected to opt-in have already been voluntary reporters in MIPS and 
would not have additional compliance costs as a result of this 
regulation. Thus, we believe the overall potential cost of compliance 
would not increase because of this final rule.
    Further, we anticipate that the vast majority of clinicians 
submitting improvement activities data to comply with existing MIPS 
policies could continue to submit the same activities under the 
policies established in this final rule. Previously finalized 
improvement activities continue to apply for the current and future 
years unless otherwise modified per rule-making (82 FR 54175). We refer 
readers to Table H in the Appendix of the CY 2017 Quality Payment 
Program final rule (81 FR 77177 through 77199) and Tables F and G in 
the Appendix of the CY 2018 Quality Payment Program final rule (82 FR 
54175 through 54229) for our previously finalized 112 improvement 
activities established in the Improvement Activities Inventory. In 
section III.I.3.h.(4)(d)(ii) of this final rule, we finalized 6 new 
improvement activities, 5 modifications, and 1 removal of an existing 
activity.
    Similarly, we believe that third parties who submit data on behalf 
of clinicians who prepared to submit data in the transition year will 
not incur additional costs as a result of this final rule. We requested 
comments that provide additional information that would enable us to 
quantify the costs, costs savings, and benefits associated with 
implementation of improvement activities in the inventory, but did not 
receive comments with information that would enable us to quantify the 
costs, costs savings, and benefits associated with the implementation 
and compliance with the requirements of the improvement activities 
performance category: In section III.I.3.h.(4)(e) of this final rule, 
we discuss how eligible clinicians can participate in the CMS study on 
burdens associated with reporting quality measures for each MIPS 
performance period. Eligible clinicians who are interested in 
participating can sign up and an adequate sample size is then selected 
by CMS from these potential participants. In the CY 2018 Quality 
Payment Program final rule, the sample size for the CY 2018 performance 
period was set at a minimum of 102 MIPS eligible clinicians (81 FR 
77196). Each study participant is required to complete a survey prior 
to submitting MIPS data and another survey after submitting MIPS data. 
In section III.I.3.h.(4)(e) of this final rule, for the CY 2019 
performance period, we finalized the increase to the sample size to a 
minimum of 200 MIPS eligible clinicians.
    However, we made the focus group a requirement only for a selected 
subset of the study participants, using purposive sampling and random 
sampling methods, beginning with the CY 2019 performance period and 
future years. Completing each survey is estimated to require 
approximately 15 minutes; therefore, the annual hourly burden per 
participant is approximately 30 minutes. The annual hourly burden 
associated with the increase in sample size by 98 clinicians (from 102 
clinicians to 200) is estimated to be 49 hours (98 clinicians x 0.5 
hours). Using the hourly rate for physicians in section V.A of this 
final rule, the total estimated annual cost burden is estimated to be 
$10,116 ($206.44/hour x 49 hours). While the sample size of the study 
is increasing, we did not make a change to the sample size of MIPS 
eligible clinicians participating in the focus group, so no burden is 
estimated for participating in that activity. We did

[[Page 60059]]

receive a comment on the burden associated with the study.
f. Assumptions & Limitations
    We note several limitations to our estimates of MIPS eligible 
clinicians' eligibility and participation, negative MIPS payment 
adjustments, and positive payment adjustments for the 2021 MIPS payment 
year. We based our analyses on the data prepared to support the 2018 
performance period initial determination of clinician and special 
status eligibility (available via the NPI lookup on qpp.cms.gov),\72\ 
participant lists using the APM Participation List for the first 
snapshot date of the 2018 QP performance period, CY 2017 Quality 
Payment Program Year 1 data and CAHPS for ACOs. The scoring model 
results presented in this final rule assume that CY 2017 Quality 
Payment Program Year 1 data submissions and performance are 
representative of CY 2017 Quality Payment Program Year 3 data 
submissions and performance. The scoring model does not reflect the 
growth in Advanced APM participation between 2018 and 2019 (Quality 
Payment Program Years 2 and 3) because that data is not available at 
the detailed level needed for our scoring analysis. The estimated 
performance for CY 2019 MIPS performance period using Quality Payment 
Program Year 1 data may be underestimated because the performance 
threshold to avoid a negative payment adjustment for the 2017 MIPS 
performance period/2019 MIPS payment year was significantly lower (3 
out of 100 points) than the performance threshold for the 2019 MIPS 
performance period/2021 MIPS payment year (30 out of 100). We 
anticipate clinicians may submit more performance categories to meet 
the higher performance threshold to avoid a negative payment 
adjustment.
---------------------------------------------------------------------------

    \72\ The time period for this eligibility file (September 1, 
2016 to August 31, 2017) maximizes the overlap with the performance 
data in our model.
---------------------------------------------------------------------------

    In our MIPS eligible clinician assumptions, we assumed that 33 
percent of the opt-in eligible clinicians that participated in the CY 
2017 Quality Payment Program Year 1 would elect to opt-in to the MIPS 
program. It is difficult to predict whether clinicians will elect to 
opt-in to participate in MIPS with the finalized policy.
    There are additional limitations to our estimates: (1) We only 
estimated the potential impact of facility-based scoring for MIPS 
eligible clinicians that are eligible for facility-based measurement 
and would have a quality performance category score of zero from 
failure to submit quality data; (2) because we used historic data, we 
assumed participation in the three performance categories in MIPS Year 
1 would be similar to MIPS Year 3 performance; and (3) to the extent 
that there are year-to-year changes in the data submission, volume and 
mix of services provided by MIPS eligible clinicians, the actual impact 
on total Medicare revenues will be different from those shown in Table 
99. Due to the limitations described, there is considerable uncertainty 
around our estimates that is difficult to quantify in detail.
9. Medicare Shared Savings Program; Accountable Care Organizations--
Pathways to Success
    This final rule includes certain provisions originally proposed for 
the Medicare Shared Savings Program (Shared Savings Program) in a 
proposed rule titled ``Medicare Program; Medicare Shared Savings 
Program; Accountable Care Organizations--Pathways to Success'' 
(hereinafter referred to as the ``August 2018 proposed rule'') that 
appeared in the Federal Register on August 17, 2018 (83 FR 41786). As 
described in section V. of this final rule, certain provisions of the 
August 2018 proposed rule are being finalized in this final rule in 
order to ensure that certain payment and policy changes for the 
Medicare Shared Savings Program are in place prior to the start of 
performance years under the program that begin on January 1, 2019. In a 
forthcoming final rule, we anticipate summarizing and responding to 
public comments on the remaining proposals in the August 2018 proposed 
rule that are not addressed in this final rule.
    The most consequential of the changes to the Medicare Shared 
Savings Program being finalized in this final rule is the option for 
existing ACOs whose agreement periods expire on December 31, 2018, to 
elect an extension to their current agreement period for a fourth 
performance year, defined as the period from January 1, 2019, through 
June 30, 2019. Absent the voluntary 6-month extension as finalized in 
this rule, approximately 203 ACOs would be required to leave the 
program at least temporarily until the availability of an opportunity 
to enter a new agreement period for program participation. We estimate 
that up to 200 ACOs would elect the extension for the first 6 months of 
2019, and therefore, would continue to improve care coordination and 
efficiency, and have the opportunity to receive shared savings for such 
period estimated to total approximately $170 million. As noted in the 
August 2018 proposed rule (83 FR 41922), we assumed that ACOs dropping 
out of the program may continue to produce residual savings in certain 
years following their exit from the program because of efficient 
practices put in place that may continue even after participation in 
the program ends. Therefore, while we estimate that ACOs electing the 
extension would produce additional savings on claims exceeding the cost 
of the anticipated $170 million in shared savings payments for the 
extension period, we note that lesser residual claims savings would 
also be expected for the baseline where such ACOs are not allowed to 
extend their participation in the program in the first 6 months of 2019 
and therefore would not earn shared savings payments for that period. 
However, when considering the residual difference in savings on claims 
attributable to the 6-month extension period over the 12 months 
following the end of the extension we estimate that the $170 million in 
shared savings payments for the extension period would be fully offset 
by the effect of the extension on preserving a higher savings 
trajectory than the up to 200 ACOs that are expected to elect the 
extension would have exhibited absent the extension.
    Lastly, we note that the modifications to the Shared Savings 
Program finalized in this rule that rely on the authority of section 
1899(i)(3) of the Act, including most notably the methodology for 
determining the financial performance for the 6-month performance year 
from January 1, 2019, through June 30, 2019, for ACOs that voluntarily 
elect the extension, based on the entire 12-month CY 2019 and pro-
rating the amount of any shared savings or shared losses to reflect the 
ACO's participation during a 6-month period, comply with requirements 
of section 1899(i)(3)(B). The considerations we described in the August 
2018 proposed rule (83 FR 41851) (as well as those considerations 
discussed in section V.B.1. of this final rule) were relevant in making 
this determination. Specifically, we do not believe that the 
methodology for determining the financial performance of ACOs in a 6-
month performance year from January 1, 2019, through June 30, 2019, 
would result in an increase in spending beyond the expenditures that 
would otherwise occur under the statutory payment methodology 
prescribed in section 1899(d) of the Act.
    Finalizing the voluntary 6-month extension for ACOs whose agreement 
periods expire on December 31, 2018, supports continued participation 
by these ACOs, and therefore also allows

[[Page 60060]]

for lower growth in Medicare FFS expenditures based on projected 
participation trends. The extension is estimated to produce net savings 
over the baseline non-extension scenario when considering the residual 
benefit to savings on claims for Parts A and B services over a period 
of one or more years after the end of the 6-month extension period. 
Further, we believe the approach we are finalizing for determining the 
performance of ACOs for the 6-month performance year from January 1, 
2019, through June 30, 2019, would continue to lead to improvement in 
the quality of care furnished to Medicare FFS beneficiaries. As 
described in section V.B.1.c.4. of this final rule, the approach to 
measuring ACO quality performance for the 6-month performance year from 
January 1, 2019, through June 30, 2019, based on quality data reported 
for CY 2019, would maintain accountability for the quality of care ACOs 
provide to their assigned beneficiaries. Participating ACOs would have 
an incentive to perform well on the quality measures in order to 
maximize any shared savings they may receive and minimize any shared 
losses they must pay in tracks where the loss sharing rate is 
determined based on the ACO's quality performance.
    The anticipated forthcoming final rule will provide a detailed 
estimate of the impact of all other changes that may be finalized from 
the August 2018 proposed rule.

G. Alternatives Considered

    This final rule contains a range of policies, including some 
provisions related to specific statutory provisions. The preceding 
preamble provides descriptions of the statutory provisions that are 
addressed, identifies those policies when discretion has been 
exercised, presents rationale for our proposed policies and, where 
relevant, alternatives that were considered. For purposes of the 
payment impact on PFS services of the policies contained in this final 
rule, we presented the estimated impact on total allowed charges by 
specialty. The alternatives we considered, as discussed in the 
preceding preamble sections, would result in different payment rates, 
and therefore, result in different estimates than those shown in Table 
94 (CY 2019 PFS Estimated Impact on Total Allowed Charges by 
Specialty).
1. E/M Coding and Payment Alternatives Considered
    For the CY 2019 PFS proposed rule, we considered a number of other 
options for simplifying coding and payment for E/M services to align 
with the proposed reduction in documentation requirements and better 
account for the resources associated with inherent complexity, visit 
complexity, and visits furnished on the same day as a 0-day global 
procedure. For example, as we noted in the proposed rule, we considered 
establishing single payment rates for new and established patients for 
combined E/M visit levels 2 through 4, as opposed to combined E/M visit 
levels 2 through 5, as we proposed. We considered the potential impacts 
of making this change in isolation.

Table 100--Unadjusted Estimated Specialty Impacts of Single PFS Rate for
                Office/Outpatient E/M Levels 2 Through 4
             [As displayed in the CY 2019 PFS proposed rule]
------------------------------------------------------------------------
                                              Allowed
                Specialty                     charges         Impact
                                            (millions)       (percent)
------------------------------------------------------------------------
Podiatry................................          $2,022              10
Dermatology.............................           3,525               6
Hand Surgery............................             202               5
Oral/Maxillofacial Surgery..............              57               4
Otolaryngology..........................           1,220               4
Cardiology..............................           6,723              -3
Hematology/Oncology.....................           1,813              -3
Neurology...............................           1,565              -3
Rheumatology............................             559              -6
Endocrinology...........................             482              -8
------------------------------------------------------------------------
Note: All other specialty level impacts were within +/-3%.

    Table 100 shows the specialties that would experience the greatest 
increase or decrease by establishing single payment rates for E/M visit 
levels 2 through 4, while maintaining the value of the level 1 and the 
level 5 E/M visits. We note that this alternative is similar to the 
policy we are finalizing for CY 2021. However, we are also finalizing 
the inherent visit complexity add-on codes that will likely result in 
mitigating some of the more significant estimated specialty-level 
impacts of establishing a single rate for the level 2-4 visits.
    While considering whether to finalize a single payment rate for new 
and established office/outpatient E/M visit levels 2-5, we explored a 
number of alternative scenarios based on commenters' varied responses 
to aspects of our proposal. For example, we considered the potential 
impacts on finalizing all elements of the proposal except for the MPPR 
and the single PE/hr value across the office/outpatient E/M code set.

[[Page 60061]]



      Table 101--Specialty Level Impacts of Finalizing as Proposed With the Exception of the MPPR and PE/hr
                                                   Adjustments
----------------------------------------------------------------------------------------------------------------
                                                  Impact of work   Impact of PE    Impact of MP
            Specialty                 Allowed       RVU changes     RVU changes     RVU changes      Combined
                                   charges (mil)        (%)             (%)             (%)         impact (%)
(A)                                          (B)             (C)             (D)             (E)             (F)
----------------------------------------------------------------------------------------------------------------
Allergy/Immunology..............            $239               1               1               0               2
Anesthesiology..................           1,981               0               0               0              -1
Audiologist.....................              68               0               1               0               1
Cardiac Surgery.................             294              -1              -1               0              -2
Cardiology......................           6,618               0              -1               0              -1
Chiropractor....................             754               0               0               0              -1
Clinical Psychologist...........             776               0               2               0               1
Clinical Social Worker..........             728              -1               2               0               2
Colon And Rectal Surgery........             166               0               1               0               2
Critical Care...................             342              -1              -1               0              -2
Dermatology.....................           3,486               3               4               0               7
Diagnostic Testing Facility.....             733               0              -4               0              -5
Emergency Medicine..............           3,121              -1               0               0              -1
Endocrinology...................             482               0              -1               0              -1
Family Practice.................           6,208               0               0               0               0
Gastroenterology................           1,757              -1               0               0              -1
General Practice................             429               0               0               0               0
General Surgery.................           2,093               0               0               0               1
Geriatrics......................             197              -2              -1               0              -4
Hand Surgery....................             214               3               2               0               5
Hematology/Oncology.............           1,741              -1              -1               0              -2
Independent Laboratory..........             646               0               4               0               3
Infectious Disease..............             649              -1              -1               0              -2
Internal Medicine...............          10,767              -1               0               0              -1
Interventional Pain Mgmt........             868               2               3               0               5
Interventional Radiology........             386               0              -1               0              -1
Multispecialty Clinic/Other Phys             149              -1              -1               0              -2
Nephrology......................           2,190              -2              -1               0              -3
Neurology.......................           1,529              -1              -1               0              -2
Neurosurgery....................             804               0               0               0               0
Nuclear Medicine................              50              -1              -1               0              -2
Nurse Anes/Anes Asst............           1,242              -1               0               0              -1
Nurse Practitioner..............           4,065               1               1               0               1
Obstetrics/Gynecology...........             638               3               3               0               6
Ophthalmology...................           5,448               0              -1               0              -1
Optometry.......................           1,309               1               0               0               1
Oral/Maxillofacial Surgery......              68               1               1               0               2
Orthopedic Surgery..............           3,743               1               2               0               3
Other...........................              31              -1               3               0               3
Otolarngology...................           1,210               4               4               0               8
Pathology.......................           1,165               0              -1               0              -1
Pediatrics......................              61              -1               0               0              -1
Physical Medicine...............           1,107              -1               0               0              -1
Physical/Occupational Therapy...           3,950               0              -2               0              -2
Physician Assistant.............           2,457               1               2               0               3
Plastic Surgery.................             377               1               1               0               3
Podiatry........................           1,974               0              -3               0              -4
Portable X-Ray Supplier.........              99               0               0               0               0
Psychiatry......................           1,187               0               1               0               1
Pulmonary Disease...............           1,715              -2              -2               0              -4
Radiation Oncology And Radiation           1,766              -1              -1               0              -2
 Therapy Centers................
Radiology.......................           4,911               0              -1               0              -1
Rheumatology....................             541               0               0               0               0
Thoracic Surgery................             358              -1              -1               0              -2
Urology.........................           1,738               3               3               0               6
Vascular Surgery................           1,148               0              -2               0              -1
                                 -------------------------------------------------------------------------------
    Total.......................          92,771               0               0               0               0
----------------------------------------------------------------------------------------------------------------

    We also explored an alternative of finalizing all elements of the 
proposal except for separate coding for podiatric E/M visits and the 
application of a single PE/hr across the office/outpatient E/M codes.

[[Page 60062]]



   Table 102--Specialty Level Impacts of Finalizing as Proposed With the Exception of the Separate Podiatric G
                                           codes and PE/hr Adjustments
----------------------------------------------------------------------------------------------------------------
                                                     Impact of     Impact of  PE   Impact of  MP
            Specialty                 Allowed        work RVU      RVU  changes    RVU  changes      Combined
                                  charges  (mil)    changes (%)         (%)             (%)         impact (%)
(A)                                          (B)             (C)             (D)             (E)             (F)
----------------------------------------------------------------------------------------------------------------
Allergy/Immunology..............            $239               1               1               0               2
Anesthesiology..................           1,981               0               0               0               0
Audiologist.....................              68               0               2               0               1
Cardiac Surgery.................             294              -1              -1               0              -2
Cardiology......................           6,618               0              -1               0              -1
Chiropractor....................             754               0               1               0               0
Clinical Psychologist...........             776               0               2               0               1
Clinical Social Worker..........             728               0               2               0               2
Colon And Rectal Surgery........             166               0               0               0               0
Critical Care...................             342              -1              -1               0              -2
Dermatology.....................           3,486               1               1               0               2
Diagnostic Testing Facility.....             733               0              -4               0              -4
Emergency Medicine..............           3,121               0               0               0              -1
Endocrinology...................             482               0              -1               0              -1
Family Practice.................           6,208               0               0               0               0
Gastroenterology................           1,757              -1               0               0              -1
General Practice................             429               0               0               0               0
General Surgery.................           2,093               0               0               0               0
Geriatrics......................             197              -2              -1               0              -3
Hand Surgery....................             214               1               1               0               2
Hematology/Oncology.............           1,741              -1              -1               0              -2
Independent Laboratory..........             646               0               4               0               4
Infectious Disease..............             649              -1              -1               0              -2
Internal Medicine...............          10,767              -1               0               0              -1
Interventional Pain Mgmt........             868               2               2               0               4
Interventional Radiology........             386               1              -1               0               0
Multispecialty Clinic/Other Phys             149              -1              -1               0              -2
Nephrology......................           2,190              -1              -1               0              -2
Neurology.......................           1,529              -1              -1               0              -2
Neurosurgery....................             804               0               0               0               0
Nuclear Medicine................              50              -1              -1               0              -2
Nurse Anes/Anes Asst............           1,242               0               0               0               0
Nurse Practitioner..............           4,065               0               1               0               1
Obstetrics/Gynecology...........             638               3               2               0               5
Ophthalmology...................           5,448               0              -1               0              -1
Optometry.......................           1,309               1               0               0               1
Oral/Maxillofacial Surgery......              68               1               1               0               2
Orthopedic Surgery..............           3,743               1               1               0               1
Other...........................              31              -1               4               0               3
Otolarngology...................           1,210               2               2               0               4
Pathology.......................           1,165               0              -1               0              -1
Pediatrics......................              61              -1               0               0              -1
Physical Medicine...............           1,107              -1               0               0              -1
Physical/Occupational Therapy...           3,950               0              -1               0              -1
Physician Assistant.............           2,457               0               1               0               1
Plastic Surgery.................             377               1               1               0               2
Podiatry........................           1,974               5               5               0              10
Portable X-Ray Supplier.........              99               0               0               0               1
Psychiatry......................           1,187               0               1               0               1
Pulmonary Disease...............           1,715              -2              -1               0              -4
Radiation Oncology And Radiation           1,766               0               0               0              -1
 Therapy Centers................
Radiology.......................           4,911               0              -1               0               0
Rheumatology....................             541              -1              -1               0              -2
Thoracic Surgery................             358              -1              -1               0              -2
Urology.........................           1,738               2               3               0               5
Vascular Surgery................           1,148               0              -1               0              -1
                                 -------------------------------------------------------------------------------
    Total.......................          92,771               0               0               0               0
----------------------------------------------------------------------------------------------------------------

    We considered alternatives that included finalizing all elements of 
the proposal, except for the PE/hr change and separate coding for 
podiatric E/M visits and establishing a single payment rate for office/
outpatient new and established E/M visit levels 2 through 4, rather 
than a single payment rate for office/outpatient E/M levels 2 through 5 
as proposed. Table 103 illustrates the specialty level impacts of this 
alternative.

[[Page 60063]]



  Table 103--Specialty Level Impact of Finalizing Single PFS Rates for Office/Outpatient E/M Levels 2 Through 4
     and Other Proposed Elements With the Exception of PE/hr Adjustment and the G-Codes for Podiatric Visits
----------------------------------------------------------------------------------------------------------------
                                                     Impact of     Impact of  PE   Impact of  MP
            Specialty                 Allowed        work RVU      RVU  changes    RVU  changes      Combined
                                  charges  (mil)    changes (%)         (%)             (%)         impact (%)
(A)                                          (B)             (C)             (D)             (E)             (F)
----------------------------------------------------------------------------------------------------------------
Allergy/Immunology..............            $239               1               1               0               1
Anesthesiology..................           1,981              -1               0               0              -1
Audiologist.....................              68              -1               1               0               1
Cardiac Surgery.................             294              -1              -1               0              -1
Cardiology......................           6,618               0              -1               0              -1
Chiropractor....................             754              -1               0               0              -1
Clinical Psychologist...........             776              -1               1               0               1
Clinical Social Worker..........             728              -1               2               0               1
Colon And Rectal Surgery........             166              -1               0               0              -1
Critical Care...................             342              -1              -1               0              -2
Dermatology.....................           3,486               0               0               0               0
Diagnostic Testing Facility.....             733               0              -4               0              -4
Emergency Medicine..............           3,121              -1               0               0              -1
Endocrinology...................             482               0              -1               0              -1
Family Practice.................           6,208               1               1               0               2
Gastroenterology................           1,757              -1               0               0              -2
General Practice................             429              -1               0               0              -1
General Surgery.................           2,093               0               0               0               0
Geriatrics......................             197               0               0               0              -1
Hand Surgery....................             214               0               0               0               0
Hematology/Oncology.............           1,741               1               0               0               1
Independent Laboratory..........             646               0               4               0               4
Infectious Disease..............             649              -1              -1               0              -2
Internal Medicine...............          10,767               0               0               0               1
Interventional Pain Mgmt........             868               1               2               0               3
Interventional Radiology........             386               0              -1               0              -1
Multispecialty Clinic/Other Phys             149              -1              -1               0              -2
Nephrology......................           2,190              -2              -1               0              -2
Neurology.......................           1,529               0               0               0               0
Neurosurgery....................             804              -1               0               0              -1
Nuclear Medicine................              50              -1              -1               0              -2
Nurse Anes/Anes Asst............           1,242              -1               0               0              -1
Nurse Practitioner..............           4,065               2               1               0               3
Obstetrics/Gynecology...........             638               2               2               0               4
Ophthalmology...................           5,448              -1              -1               0              -2
Optometry.......................           1,309               0              -1               0               0
Oral/Maxillofacial Surgery......              68               0               1               0               1
Orthopedic Surgery..............           3,743               0               0               0               0
Other...........................              31              -1               4               0               3
Otolarngology...................           1,210               1               1               0               2
Pathology.......................           1,165              -1              -1               0              -2
Pediatrics......................              61               1               0               0               1
Physical Medicine...............           1,107              -1               0               0              -2
Physical/Occupational Therapy...           3,950              -1              -1               0              -2
Physician Assistant.............           2,457               1               1               0               2
Plastic Surgery.................             377               0               0               0               1
Podiatry........................           1,974               3               4               0               8
Portable X-Ray Supplier.........              99               0               1               0               1
Psychiatry......................           1,187               0               1               0               1
Pulmonary Disease...............           1,715              -2              -1               0              -3
Radiation Oncology And Radiation           1,766               0               0               0              -1
 Therapy Centers................
Radiology.......................           4,911               0              -1               0              -1
Rheumatology....................             541              -1              -1               0              -2
Thoracic Surgery................             358              -1               0               0              -1
Urology.........................           1,738               1               2               0               4
Vascular Surgery................           1,148               0              -1               0              -1
                                 -------------------------------------------------------------------------------
    Total.......................          92,771               0               0               0               0
----------------------------------------------------------------------------------------------------------------

    In this scenario, specialties that furnish a large volume of 
standalone office/outpatient E/M visits in conjunction with minor 
procedures see decreases in overall impacts, while specialties who tend 
to only bill E/M office/outpatient visits see minor increases and in 
many instances, the application of the MPPR adjustment is

[[Page 60064]]

not enough to overcome the negative impacts of the single payment rate 
on specialties that bill a higher volume of level 4 visits relative to 
their overall allowed services.
    We also modeled the specialty level impacts associated with 
finalizing all elements of the proposal with the exception of the PE/hr 
adjustment and the MPPR, but establishing a single payment rate for 
office/outpatient new and established E/M visit levels 2-4, rather than 
a single payment rate for office/outpatient E/M levels 2-5 as proposed. 
Table 104 illustrates the specialty level impacts for this alternative.

  Table 104--Specialty Level Impact of Finalizing Single PFS Rates for Office/Outpatient E/M Levels 2 Through 4
                                         and Other Elements as Proposed
----------------------------------------------------------------------------------------------------------------
                                                  Impact of work   Impact of PE    Impact of MP
            Specialty                 Allowed       RVU changes     RVU changes     RVU changes      Combined
                                  charges  (mil)        (%)             (%)             (%)         impact (%)
(A)                                          (B)             (C)             (D)             (E)             (F)
----------------------------------------------------------------------------------------------------------------
Allergy/Immunology..............            $239               0               0               0               1
Anesthesiology..................           1,981              -1               0               0              -2
Audiologist.....................              68              -1               1               0               0
Cardiac Surgery.................             294              -1              -1               0              -2
Cardiology......................           6,618              -1              -1               0              -2
Chiropractor....................             754              -1              -1               0              -2
Clinical Psychologist...........             776              -1               1               0               0
Clinical Social Worker..........             728              -1               2               0               1
Colon And Rectal Surgery........             166               0               1               0               1
Critical Care...................             342              -2              -1               0              -3
Dermatology.....................           3,486               2               3               0               5
Diagnostic Testing Facility.....             733               0              -5               0              -5
Emergency Medicine..............           3,121              -1               0               0              -2
Endocrinology...................             482              -1              -1               0              -1
Family Practice.................           6,208               1               1               0               3
Gastroenterology................           1,757              -2               0               0              -2
General Practice................             429               2               1               0               4
General Surgery.................           2,093               0               0               0               0
Geriatrics......................             197              -1               0               0              -1
Hand Surgery....................             214               1               2               0               3
Hematology/Oncology.............           1,741               0               0               0               0
Independent Laboratory..........             646              -1               3               0               3
Infectious Disease..............             649              -1               0               0              -1
Internal Medicine...............          10,767               0               0               0               0
Interventional Pain Mgmt........             868               1               2               0               3
Interventional Radiology........             386               0              -1               0              -1
Multispecialty Clinic/Other Phys             149              -1              -1               0              -2
Nephrology......................           2,190              -1               0               0              -1
Neurology.......................           1,529               0               0               0              -1
Neurosurgery....................             804              -1               0               0              -1
Nuclear Medicine................              50              -1              -1               0              -2
Nurse Anes/Anes Asst............           1,242              -1               0               0              -2
Nurse Practitioner..............           4,065               2               1               0               3
Obstetrics/Gynecology...........             638               2               2               0               5
Ophthalmology...................           5,448              -1              -1               0              -2
Optometry.......................           1,309               0              -1               0              -1
Oral/Maxillofacial Surgery......              68               1               1               0               1
Orthopedic Surgery..............           3,743               0               1               0               1
Other...........................              31              -1               3               0               2
Otolarngology...................           1,210               3               3               0               6
Pathology.......................           1,165              -1              -1               0              -2
Pediatrics......................              61               1               0               0               1
Physical Medicine...............           1,107              -1               0               0              -2
Physical/Occupational Therapy...           3,950              -1              -2               0              -3
Physician Assistant.............           2,457               2               2               0               4
Plastic Surgery.................             377               0               1               0               1
Podiatry........................           1,974              -1              -4               0              -5
Portable X-Ray Supplier.........              99               0               0               0               0
Psychiatry......................           1,187               3               2               0               5
Pulmonary Disease...............           1,715              -1              -1               0              -1
Radiation Oncology And Radiation           1,766               0              -1               0              -1
 Therapy Centers................
Radiology.......................           4,911              -1              -1               0              -2
Rheumatology....................             541               0               0               0               0
Thoracic Surgery................             358              -1              -1               0              -2
Urology.........................           1,738               2               3               0               5
Vascular Surgery................           1,148               0              -2               0              -2
                                 -------------------------------------------------------------------------------
    Total.......................          92,771               0               0               0               0
----------------------------------------------------------------------------------------------------------------


[[Page 60065]]

2. E/M Documentation Alternatives Considered
    We considered several alternatives to our final policies on 
documentation of E/M office/outpatient visits. Under all of these 
alternatives, we would finalize the documentation proposals that are 
not associated with coding and payment changes (the documentation 
proposals for home visits and avoiding redundant data recording that we 
are finalizing for January 1, 2019 as proposed).
    Regarding the rest of the documentation policies, one alternative 
we considered was to maintain all five current E/M office/outpatient 
visit levels and eliminate additional documentation requirements. Under 
this option, there would be no minimum documentation standard because 
payment rates for multiple code levels would not be combined, but we 
could still have allowed choice in documentation methodology (current 
framework, MDM or time). Overall payments would likely change due to 
increased ability to use different key components to reach different 
code levels relative to the status quo. There would be no new add-on 
codes for primary care, other non-procedural specialty care or 
prolonged services, since the current code set would continue to 
differentiate levels of complexity. We estimate that this alternative 
would have reduced the documentation burden for office/outpatient 
visits by approximately 5 percent or 0.32 minutes per impacted visit. 
However, this alternative could result in significant and unpredictable 
redistributive effects as there would be a financial incentive to code 
to the highest possible visit level. Given that possibility, we chose 
not to finalize this alternative.
    Another alternative was our proposed policies, which in the 
proposed rule we estimated would have reduced administrative burden by 
approximately 1.6 minutes per impacted visit. A large part of this time 
savings was attributed to the associated application of the minimum 
level 2 visit documentation standard to most visits (levels 2 through 
5). We did not finalize this proposal because we were persuaded by 
public comments (detailed elsewhere in this final rule), indicating 
that Medicare should continue to recognize distinctions in visit 
complexity among the current level 2 through 5 visits.
3. Modernizing Medicare Physician Payment by Recognizing Communication 
Technology-Based Services Alternatives Considered
    We considered not finalizing our proposal in the CY 2019 PFS 
proposed rule to recognize a discrete set of services that are defined 
by and inherently involve the use of communication technology. If we 
had not finalized making separate coding and payment for HCPCS codes 
G2010 ((Remote evaluation of recorded video and/or images submitted by 
an established patient (e.g., store and forward), including 
interpretation with follow-up with the patient within 24 business 
hours, not originating from a related E/M service provided within the 
previous 7 days nor leading to an E/M service or procedure within the 
next 24 hours or soonest available appointment) and G2012 ((Brief 
communication technology-based service, e.g. virtual check-in, by a 
physician or other qualified health care professional who can report 
evaluation and management services, provided to an established patient, 
not originating from a related E/M service provided within the previous 
7 days nor leading to an E/M service or procedure within the next 24 
hours or soonest available appointment; 5-10 minutes of medical 
discussion) for CY 2019, we estimate that there would have been a 0.2 
percent increase to the CF, based on our estimate that usage of these 
services will result in fewer than 1 million visits in the first year 
but will eventually result in more than 19 million visits per year, 
ultimately increasing payments under the PFS by about 0.2 percent.
4. Alternatives Considered for the AUC Program
    For the purposes of estimating potential alternatives to the 
proposals in the CY 2019 PFS proposed rule for the AUC program, we 
considered the alternative scenarios below.
a. Consultation With More Than One Qualified CDSM
    We considered an alternative scenario that would result in ordering 
professionals or auxiliary staff consulting more than one qualified 
CDSM prior to ordering advanced diagnostic imaging. In this scenario, 
we assumed a goal of decreasing the frequency that a ``not applicable'' 
consultation result would be reported on Medicare claims. One outcome 
of reducing ``not applicable'' responses is the potential to improve 
the quality and quantity of claims-based data available for calculating 
outlier ordering professionals. In future rulemaking the agency will 
establish the methodology to identifying outlier ordering 
professionals. Reducing ``not applicable'' responses will increase 
responses for adherence or non-adherence thereby increasing the total 
number of responses that can be used to calculate outlier ordering 
professionals. Additionally, according to the Medicare Imaging 
Demonstration Evaluation Report,\1\ clinicians were conceptually 
interested in learning about how to improve ordering patterns. Ordering 
professionals receiving ``not applicable'' responses for some of their 
orders may not be able to achieve desired learning directly through the 
CDSM and may have to seek information elsewhere. Therefore reducing the 
number of ``not applicable'' responses may allow ordering professionals 
to achieve more of their learning within the CDSM.
    In this assumption, the ordering professional or auxiliary 
personnel would consult their primary, qualified CDSM to find that such 
AUC were not available. For example, a consultation using CDSM 1 for a 
patient with unspecified abdominal pain results in no specified 
applicable AUC being available, and therefore, provides a ``not 
applicable'' result. In this clinical scenario, we know that specified 
applicable AUC are available (https://acsearch.acr.org/docs/69467/Narrative/) in qualified CDSM 2 and that CDSM 2 is available free of 
charge. Second, we assumed that additional requirements to reduce ``not 
applicable'' consultation outcomes, through tighter stipulations on AUC 
consultation, would change behavior in that a second consultation would 
occur (qualified CDSM 2). For example, we know that all CDSMs are 
required, consistent with Sec.  414.94(g)(1)(iii) of our regulations to 
make available, at a minimum, specified applicable AUC that reasonably 
address common and important clinical scenarios within all priority 
clinical areas. Therefore, there may be clinical scenarios (for 
example, unspecified abdominal pain) outside of priority clinical areas 
that are not addressed within all qualified CDSMs. However, tighter 
requirements on AUC consultation--to consult a second CDSM when a ``not 
applicable'' response is the result of the first consultation in 
specific clinical scenarios--would reduce ``not applicable'' reporting 
on Medicare claims and would motivate ordering professionals to access 
a secondary CDSM that is qualified and available free of charge. CMS 
did not propose to require any ordering professional to

[[Page 60066]]

perform any additional AUC consultation if the initial consultation 
yields a result of ``not applicable.'' Rather, the ordering 
professional would have completely satisfied their AUC consultation 
requirement under Sec.  414.94(j) with the first AUC consultation, 
regardless of the determination of the qualified CDSM.
    Based on these assumptions, we identified examples of the advanced 
diagnostic imaging services that are outside the priority clinical 
areas yet have AUC available for a specific clinical scenario in a 
qualified, free CDSM. We focused our analysis on abdominal pain (any 
locations and flank pain). In addition, we identified the top five 
advanced diagnostic imaging services from data derived from the CCW's 
2014 Part B non-institutional claim line file, which includes services 
covered by the Part B benefit that were furnished during calendar year 
2014. These data are available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/data.html.
    We estimated the burden of consulting a second, free CDSM to reduce 
the frequency of ``not applicable'' responses, which we did not 
propose. We did this by calculating the number of advanced diagnostic 
imaging services for unspecified abdominal pain based on 2014 claims 
data (Computed tomography of abdomen & pelvis with contrast--CPT 
74177--299,644 services; Computed tomography of abdomen & pelvis with 
and without contrast--CPT 74176--233,088 services; Computed tomography 
of abdomen and pelvis; without contrast material in one or both body 
regions, followed by contrast material(s) and further sections in one 
or both body regions--CPT 74178--36,992 services; Diagnostic nuclear 
medicine procedures on the gastrointestinal system with pharmacologic 
intervention--CPT 78227--20,997 services; Diagnostic nuclear medicine 
procedures on the gastrointestinal system--CPT 78226-10,713 services). 
According to the Medicare Imaging Demonstration Evaluation Report,\1\ 
clinicians were conceptually interested in learning about how to 
improve ordering patterns, and in the context of clinical practice, 
most clinician focus group participants noted that they expected that a 
clinical decision support tool would provide more detailed feedback 
that would help clinicians reduce the number of inappropriately rated 
orders. Unfortunately, data compiled \73\ as of 2002 suggested that 
appropriateness criteria could not be applied to 41-percent of MRI 
imaging requests. These gaps in appropriateness criteria often prompt 
local providers to augment the criteria produced by professional 
societies with their own decisions on appropriateness. One study \74\ 
has shown that clinicians use appropriateness criteria far less often 
than other resources, such as specialist consults and UpToDate (Wolters 
Kluwer Health), to guide the management of their patients. In order to 
meet the expressed needs of ordering professionals, and direct ordering 
behaviors towards qualified CDSMs with specific applicable AUC, we 
considered pursuing tighter requirements in the context of the 
following impact estimate.
---------------------------------------------------------------------------

    \73\ Levy, G et al. 2006. Nonradiologist utilization of American 
College of Radiology appropriateness criteria in apreauthorization 
center for MRI requests: Applicability and effects. AJR Am J 
Roentgenol, 187(4), 855-858. doi: 10.2214/AJR.05.1055.
    \74\ Bautista, AB et al. 2009. Do clinicians use the American 
College of Radiology appropriateness criteria in the management of 
their patients? AJR Am J Roentgenol, 192(6), 1581-1585. doi: 
10.2214/AJR.08.1622.
---------------------------------------------------------------------------

    If we assume that 50 percent of these 601,434 total services 
required a second consultation because the specified applicable AUC 
were available in CDSM 1 then this estimate would be the time and 
effort for a 2-minute repeat consultation with another qualified CDSM 
available free of charge for 300,717 services annually (601,434 
services x 50 percent). If 90 percent of those consultations (300,717 
services x 90 percent x 0.033 hr/service) for 8,931.285 total hours 
were performed by a medical assistant (occupation code 31-9092) at a 
rate of $32.30/hour for a total of $288,480.50 and 10 percent of 
consultations (300,717 services x 10 percent x 0.033 hr/service) for 
992.376 total hours were performed by the ordering professional at a 
rate of $200.54/hour for a total of $199,011.08 then annually the 
burden estimate would be 9,923.661 total hours (8,931.285 hours + 
992.376 hours) and $487,491.58 ($288,480.50 + $199,011.08) to perform 
the second consultations. This analysis was limited to abdominal pain 
because that is one example of a clinical scenario that falls outside 
of the priority clinical areas. In the proposed rule we did not propose 
tighter requirements on the frequency to which ordering professionals 
or applicable staff would be required to consult at this time this was 
due to the agency's efforts to minimize burden whereas a second 
consultation would result in added time and cost to the ordering 
professional.
b. Significant Hardship Application Process
    To illustrate the consideration that a self-attestation of a 
significant hardship exception is a less burdensome approach, we 
compared this to the alternative consideration of requiring a 
significant hardship exception application process to review and 
approve applicants in near real-time. We recognize that there are some 
benefits to a significant hardship exception application that could not 
be directly quantified. For instance, some ordering professionals may 
gain confidence knowing that they have documentation confirming that a 
significant hardship exception application was submitted and/or 
received by CMS. Those same ordering professionals and others may 
appreciate a process that includes receipt of a determination from CMS 
as to the acceptance of their application for significant hardship 
exception. Finally some furnishing professionals and facilities that 
provide advanced diagnostic imaging services as a result of orders 
placed by ordering professionals could have reassurance knowing that 
such ordering professionals have a significant hardship exception 
granted by CMS and confirmed for 1 year.
    As a basis for comparison of the significant hardship exception 
application to self-attestation, we estimate that such an application 
would be similar to the existing application (CMS-10621, OCN 0938-1314) 
to request a reweighting to zero for the advancing care information 
performance category (renamed the promoting interoperability 
performance category) due to significant hardship. This is a short 
online form that requires identifying which type of hardship applies, 
and a description of how the circumstances impair the ability to submit 
advancing care information data, as well as some proof of 
circumstances. The estimate for the $44.59 mean hourly wage and 100-
percent fringe benefits of a computer system analyst (BLS #15-1121) to 
submit this application is 0.5 hours. Given that we would expect 6,699 
AUC hardship applications per year, the annual total burden hours are 
estimated to be 3349.50 hours (6,699 respondents x 0.5 burden hours per 
respondent). The estimated total annual burden is $298,708.41 (3349.50 
hours x $89.18 per hour). Based in part on the cost and burden 
estimates, we did not propose the use of a significant hardship 
exception application.

[[Page 60067]]

5. Alternatives Considered for the Quality Payment Program
    For purposes of the payment impact on the Quality Payment Program, 
we view the performance threshold and the additional performance 
threshold, as the critical factors affecting the distribution of 
payment adjustments. We ran two separate models with performance 
thresholds of 25 and 35 respectively (as an alternative to the 
finalized performance threshold of 30) to estimate the impact of a 
moderate and aggressive increase in the performance threshold. A lower 
performance threshold would be a more gradual transition and could 
potentially allow more clinicians to meet or exceed the performance 
threshold. The lower performance threshold would lower the amount of 
budget neutral dollars to redistribute and increase the number of 
clinicians with a positive payment adjustment but the scaling factor 
would be lower. In contrast, a more aggressive increase would likely 
lead to higher positive payment adjustments for clinicians that exceed 
the performance threshold because the budget neutral pool would be 
redistributed among fewer clinicians. We ran each of these models using 
the finalized additional performance threshold of 75. In the model with 
a performance threshold of 25, we estimate that $271 million would be 
redistributed through budget neutrality. There would be a maximum 
payment adjustment of 4.5 percent after considering the MIPS payment 
adjustment and the additional MIPS payment adjustment for exceptional 
performance. In addition, 7.2 percent of MIPS eligible clinicians would 
receive a negative payment adjustment among those that submit data. In 
the model with a performance threshold of 35, we estimate that $349 
million would be redistributed through budget neutrality, and that 
there would be a maximum payment adjustment of 4.9 percent after 
considering the MIPS payment adjustment and the additional MIPS payment 
adjustment for exceptional performance. In addition, 10.5 percent of 
MIPS eligible clinicians would receive a negative payment adjustment 
among those that submit data. We finalized a performance threshold of 
30 because we believe increasing the performance threshold to 30 points 
was not unreasonable or too steep, but rather a moderate step that 
encourages clinicians to gain experience with all MIPS performance 
categories. We refer readers to section III.I.3.j.(2) of this final 
rule for additional rationale on the selection of performance 
threshold.
    To evaluate the impact of modifying the additional performance 
threshold, we ran two models with additional performance thresholds of 
70 and 80 as an alternative to the finalized 75 points. We ran each of 
these models using a performance threshold of 30. The benefit of the 
model with the additional performance threshold of 70 would maintain 
the additional performance threshold that was in years 2 and 3. In the 
model with the additional performance threshold of 70, we estimate that 
$310 million would be redistributed through budget neutrality, and 
there would be a maximum payment adjustment of 3.9 percent after 
considering the MIPS payment adjustment and the additional MIPS payment 
adjustment for exceptional performance. In addition, 8.8 percent of 
MIPS eligible clinicians would receive a negative payment adjustment 
among those that submit data. In the model with an additional 
performance threshold of 80, for which the benefit was to assess the 
impact of the proposed additional performance threshold in the 2019 PFS 
proposed rule, we estimate that $310 million would be redistributed 
through budget neutrality, and that there would be a maximum payment 
adjustment of 6.1 percent after considering the MIPS payment adjustment 
and the additional MIPS payment adjustment for exceptional performance 
among those that submit data. Also, that 8.8 percent of MIPS eligible 
clinicians will receive a negative payment adjustment. We finalized the 
additional performance threshold at 75 points, which is halfway between 
our proposal of 80 and the CY 2018 MIPS performance period additional 
performance threshold at 70 because we believe raising the additional 
performance threshold, but for less than the original amount proposed, 
would incentivize continued improved performance while accounting for 
policy changes in the third year of the program. We refer readers to 
section III.I.3.j.(3) of this final rule for additional rationale on 
the selection of additional performance threshold.
    To examine the impact of changes to the low-volume threshold on the 
number of MIPS eligible clinicians, we ran estimates for three 
different low-volume threshold criteria. As we discuss in section 
III.I.3.c of this final rule, we analyzed the impact of alternate low-
volume thresholds because the low-volume threshold can affect the 
number of MIPS eligible clinicians and some public commenters were 
concerned about the associated impacts of the exclusions on the MIPS 
payment adjustments. When we set the third low volume threshold at 100 
as an alternative to 200 covered professional services, we estimate 
that 32,828 clinicians would elect to opt-in for a total population of 
802,915. When we apply the opt-in policy without adding the third 
finalized low-volume criterion at 200 covered professional services, we 
estimate that 12,242 clinicians would elect to opt-in for a total 
population of 782,329. When we lower the low-volume threshold criteria 
to $30,000 or fewer allowed charges for covered professional services; 
100 or fewer Part B-enrolled individuals; and 100 or fewer furnished 
covered professional services to Medicare Part B-enrolled 
beneficiaries, we estimate a total of 871,238 MIPS eligible clinicians. 
To assess the impact of the number of MIPS eligible clinicians on 
payment adjustments, we ran a model with the lowest low-volume 
threshold and, therefore, highest number of MIPS eligible clinicians 
(871,238). We estimate that $440 million would be redistributed through 
budget neutrality. There would be a maximum payment adjustment of 5.0 
percent after considering the MIPS payment adjustment and the 
additional MIPS payment adjustment for exceptional performance. In 
addition, 9.7 percent of MIPS eligible clinicians would receive a 
negative payment adjustment among those that submit data. These 
alternative low-volume thresholds were not selected because we did not 
observe a meaningful difference on the maximum payment adjustment from 
the finalized low-volume threshold in this final rule. As we stated in 
section III.I.3.c.(4) of this final rule, we will continue to strike a 
balance between ensuring sufficient participation in MIPS while also 
addressing the needs of small practices that may find it difficult to 
meet the program requirements. We refer readers to section 
III.I.3.c.(4) of this final rule for additional rationale on the 
selection of the low-volume threshold.

H. Impact on Beneficiaries

    There are a number of changes in this final rule that will have an 
effect on beneficiaries. In general, we believe that many of these 
changes, including those intended to improve accuracy in payment 
through regular updates to the inputs used to calculate payments under 
the PFS, will have a positive impact and improve the quality and value 
of care provided to Medicare providers and beneficiaries.

[[Page 60068]]

I. Burden Reduction Estimates

1. Evaluation and Management Documentation
    All health care practitioners, as part of their routine record 
keeping activities, create and maintain documentation in the patient 
medical record for clinical and payment purposes. It is standard 
industry practice that when healthcare practitioners bill insurers, 
payers and health plans, such as Medicare, state plans under Title XIX, 
and commercial or other third party payers, for office and outpatient 
E/M services, that health care practitioners report the services using 
the common coding framework and definitions developed and maintained by 
the AMA CPT Editorial Panel. The 1995/1997 E/M services documentation 
guidelines provide guidance to medical practitioners regarding medical 
record documentation of E/M services based on the AMA CPT coding 
framework and definitions. In response to comments received from RFIs 
released to the public under our Patients Over Paperwork Initiative, we 
proposed to address medical documentation by simplifying the payment 
framework for E/M services and allowing greater flexibility on the 
components practitioners could choose to document when billing Medicare 
for E/M visits.
    We estimate that the E/M visit documentation changes finalized in 
section II.I. of this final rule may significantly reduce the amount of 
time practitioners spend documenting office/outpatient E/M visits. 
Although little research is available on exactly how much time 
physicians and non-physician practitioners (NPPs) spend specifically 
documenting E/M visits, according to one recent estimate, primary care 
physicians spend on average, 84 minutes or 1.4 hours per day (24 
percent of the time that they spend working within an EHR) documenting 
progress notes.\75\ Another study found that primary care physicians 
spend an average of 2.1 hours per day writing progress notes (both in-
clinic and remote access).\76\ Assuming an average of 20 patient visits 
per day, one E/M visit per patient, and using the higher figure of 2.1 
hours per day spent documenting these visits, in our proposed rule we 
estimated that documentation of an average outpatient/office E/M visit 
takes 6.3 minutes.\77\
---------------------------------------------------------------------------

    \75\ Arndt BG, Beasley JW, Watkinson MD, et al. Tethered to the 
EHR: Primary care physician workload assessment using EHR event log 
data and time-motion observations. Ann Fam Med. 2017;15:427-33.
    \76\ Tai-Seale M, Olson CW, Li J, et al. Electronic health 
record logs indicate that physicians split time evenly between 
seeing patients and desktop medicine. Health Aff (Milwood). 
2017;36:655-62.
    \77\ 20 patient visits per day based on the average number 
reported in the Physicians Foundation 2016 Survey of America's 
Physicians, available online at https://physiciansfoundation.org/wp-content/uploads/2018/01/Biennial_Physician_Survey_2016.pdf.
---------------------------------------------------------------------------

    We stated our belief that our proposals to reduce redundancy in 
visit documentation, to allow auxiliary staff and the beneficiary to 
enter certain information in the medical record that would be verified 
but not required to be re-documented by the billing practitioner, to 
allow the choice of visit level and documentation based on MDM or time 
as alternatives to the current framework, and to require only minimum 
documentation (the amount required for a level 2 visit) for all visits 
except level 1 visits may reduce the documentation time by one quarter 
of the current time for the average office/outpatient visit. Under this 
assumption, we estimated these proposals would save clinicians 
approximately 1.6 minutes of time per office/outpatient E/M visit 
billed to Medicare. For a full-time practitioner whose panel of 
patients is 40 percent Medicare (60 percent other payers), this would 
translate to approximately 51 hours saved per year.\78\
---------------------------------------------------------------------------

    \78\ Forty percent of 20 total patients per day = 8 Medicare 
vists per day. (8 visits per day)*(1.6 minutes per visit)*(240 days 
per year) = 51.2 hours.
---------------------------------------------------------------------------

    We noted that stakeholders had emphasized to us in public comments 
that whatever reductions may be made to the E/M documentation 
guidelines for purposes of Medicare payment, physicians and non-
physician practitioners will still need to document substantial 
information in their progress notes for clinical, legal, operational, 
quality reporting and other purposes, as well as potentially for other 
payers. Furthermore, we recognized that there may be a ramp-up period 
for physicians and non-physician practitioners to implement the 
proposed documentation changes in their clinical workflow and EHR such 
that the effects of mitigating documentation burden may not be 
immediately realized. Accordingly, we believed the total amount of time 
practitioners spend on E/M visit documentation may remain high, despite 
the time savings that we estimated in our proposed rule could result 
from our E/M documentation proposals. These and all other improvements 
to payment accuracy that we proposed for CY 2019 were described in 
greater detail in section II.I. of the proposed rule. We welcomed 
public comments on our assumptions for the estimated reduction in 
documentation burden related to our E/M visit proposals.
    Comment: We received many public comments on our assumptions 
regarding the potential burden reduction associated with our E/M 
proposals. The commenters stated that CMS overestimated how much the 
proposals would reduce burden, and noted they would reduce burden less 
than CMS estimated or, according to some commenters, might increase 
burden overall. Some commenters stated that the time and labor saved on 
documentation would be time currently spent after hours and on 
weekends, so it would not translate into additional ``work time'' or 
availability to see more patients. They stated that documentation time, 
in general, would remain high, due to the need to continue documenting 
for clinical, legal and many other purposes such as risk adjustment, 
quality reporting and other payers. Many of the commenters stated 
concerns that other payers including Medicaid and secondary payers 
might not adopt the same policies as Medicare, and that incongruities 
in documentation rules between payers would necessitate extra effort by 
practices to assess the best or required documentation method, among so 
many choices, for different patients. They noted that which payer(s) a 
given patient has is not always known at the outset of the visit.
    Many commenters stated there would be significant burden and cost 
to update EHRs and educate and train coders, staff and auditors. Also, 
they noted that without appropriate medical documentation for each 
visit, the proposals might result in insufficient documentation by one 
member of the care team that another member might have to make up for, 
and that fractured care from incomplete or insufficient documentation 
might inadvertently create additional burdens, as well as impact 
quality of care. While many commenters supported allowing a choice in 
documentation methodology (current framework, medical decision-making, 
or time), other commenters noted such a policy would increase burden 
due to increased variation in how visits would be documented, and the 
need to restructure EHR templates to accommodate different options and 
decide which method was best for a given patient or practice. Most of 
the commenters noted our proposals regarding billing eligibility and 
supporting documentation for the proposed add-on codes for primary 
care, other specialty care, prolonged services, and documenting using 
time were unclear and might create new burdens that would equal or 
exceed the current

[[Page 60069]]

burden. Some commenters stated that our proposals layered on complexity 
that would counteract the goal of reducing administrative burden, and 
that the negative impacts of the payment proposals would outweigh 
positive impacts of documentation changes.
    Other commenters were concerned about impacts on MA plan payments, 
plan quality, and provider access. Some commenters were concerned that 
paying for visits based on a single rate would not allow an 
understanding of the complexity of care being delivered and might lead 
to abuse. Another commenter noted that the proposed add-on codes to 
account for care complexity would increase complexity and result in a 
need for perpetual fixes from unanticipated consequences. Similar to 
other commenters, this commenter was concerned that a single payment 
rate would redistribute payments without reducing the burden associated 
with determining the right codes, because the coding structure would 
remain the same. The commenter also expressed concern that 
practitioners would be less willing to see complex patients, and that 
the proposal would incentivize gaming by certain specialties to make up 
for lost revenue. The commenter's preferred approach was to simplify 
the current guidelines and rather than implement a single payment rate, 
CMS should wait for the AMA/CPT's E/M workgroup results. Finally, the 
commenter recommended that if CMS finalized as proposed, CMS should 
phase implementation and create a monitoring process.
    Response: We understand that practitioners would continue to need 
to document substantial information in the medical record for clinical, 
legal and many other purposes such as risk adjustment, quality 
reporting, productivity measures and potentially other payers. In 
making our proposal, we did not aim to eliminate the need to document 
any history, exam, and/or MDM, but rather, we ocused on eliminating 
unnecessary, and outdated requirements that are associated with payment 
for visit ``levels.'' This would allow the practitioner to document 
what is clinically relevant and needed to support the service within 
whatever framework they chose to apply--along with medical necessity--
rather than outdated aspects of the current guidelines. We understand 
that other payers might not adopt the same approach, at least not in 
the short term. The AMA/CPT has stated an intention to revise the E/M 
code set by 2020 or 2021, which would help to establish uniformity 
among payers. However, we agree with the commenters that it would be 
critical to allow time for education, changing workflows and billing 
systems. We understand that particularly in the initial year(s) of any 
changes, there would be a cost to these activities for practitioners 
and providers, including a cost to update EHRs. We are reducing our 
estimate of burden reduction to account for these issues.
    We note that we believe that time physicians spend fulfilling 
current documentation requirements on evenings and weekends are 
burdensome, and that even if that additional time would not necessarily 
be spent seeing additional patients, that time is a quantifiable 
resource cost to physicians and other practitioners.
    After considering the comments, we adjusted our proposed burden 
reduction estimate, including our estimates on the documentation of an 
average outpatient/office E/M. We are still assuming an average of 20 
patient visits per day, one E/M visit per patient, but instead are 
using the more conservative figure of 1.4 hours per day spent 
documenting E/M visits that we identified in our review of available 
research. As a result, we estimate that documentation of an average 
outpatient/office E/M visit takes 4.2 minutes versus our initial 
estimate of 6.3 minutes. The final rule estimated time savings is 
monetized into practitioner wages and summarized as follows.

                                       Table 105--Estimated Burden Reduction for E/M Documentation Final Policies
                                                                  [Practitioner wages]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                       2023 and annually
                                                                  2019               2020               2021               2022            thereafter
--------------------------------------------------------------------------------------------------------------------------------------------------------
Grand Total..............................................    $84,059,794.68     $84,059,794.68    $298,522,913.92    $405,754,473.54    $512,986,033.15
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We calculated the time savings associated with documentation 
changes annually, and converted this time to practitioner wages using 
2016 hourly wage data from the Bureau of Labor Statistics (BLS) \79\ 
multiplied by two to adjust for overhead and benefits. We adjusted for 
the estimated proportion of impacted visits furnished by NPPs earning 
lower wages than physicians, which we acknowledge is unclear due to the 
ability to report services as ``incident to'' a physician when they are 
furnished directly by an NPP. We approximated the portion attributable 
to NPP wages using the number of visits directly reported by NPPs 
(reported with a specialty of NP, PA, CNS or CNM).
---------------------------------------------------------------------------

    \79\ https://www.bls.gov/oes/2016/may/oes_nat.htm.
---------------------------------------------------------------------------

    The estimated savings for 2019 and 2020 are for the initial changes 
to documentation in these years (those not impacted by coding and 
payment changes, including provisions to no longer require 
documentation of the medical necessity of a home visit in lieu of an 
office visit and to expand current policy reducing the need to re-
document prior data in the medical record). These savings would impact 
levels 2 through 5 visits, and are estimated to save 0.11 minutes \80\ 
per impacted visit, which translates into approximately $84 million in 
wages across all impacted visits.
---------------------------------------------------------------------------

    \80\ 2.5% of the 4.2 minutes we estimate that it currently takes 
to document an office/outpatient E/M visit.
---------------------------------------------------------------------------

    Additional savings are estimated annually starting in 2021 for the 
finalized payment and coding-related changes. These savings would 
impact levels 3 and 4 visits, and are estimated to save 0.63 minutes 
\81\ per impacted visit, which translates into approximately $513 
million annually in wages across all impacted visits. We assume half of 
these estimated savings in year 1 (2021), 75 percent in year 2 (2022) 
and 100 percent each subsequent year (2023 and each year thereafter) to 
account for information provided in the public comments that there is

[[Page 60070]]

potentially off-setting burden associated with the continued need to 
document for MA and potentially other payers, quality reporting, and 
clinical, legal and other purposes, as well as ramp-up costs to update 
EHRs and conduct training and education. The estimate assumes very 
minimal burden associated with use and documentation of the add-on 
codes for primary care and other specialty care, as well as the 
extended visit add-on code and otherwise documenting using time, as we 
are clarifying these policies and establishing minimal documentation 
rules discussed in section II.I. of this final rule. We intend to allow 
flexibility in how office/outpatient visits are documented and to allow 
a choice in using the current framework, medical decision-making or 
time, though we will take into consideration any changes in the code 
set that may impact these options in future years.
---------------------------------------------------------------------------

    \81\ We reduced the final rule time savings estimate of 25% (1.1 
minutes) to 15 percent (0.63 minutes). We reduced it by 10 
percentage points to account for the burden of documenting level 5 
visits, as well as the level 2-4 combined visit. This is to account 
for the uncertainty of the future code structure/definitions, as 
well as public comments that introducing variation in documentation 
choices and methods and providing for a bare bones minimum standard 
could increase burden).
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2. Modernizing Medicare Physician Payment by Recognizing Communication 
Technology-Based Services
    As noted in section II.D. of this final rule, for CY 2019, we aimed 
to increase access for Medicare beneficiaries to physicians' services 
that are routinely furnished via communication technology by clearly 
recognizing a discrete set of services that are defined by and 
inherently involve the use of communication technology. Accordingly, we 
made several proposals for modernizing Medicare physician payment for 
communication technology-based services.
    The use of communication technology-based services will provide new 
options for physicians to treat patients. These services could help to 
avoid unnecessary office visits, could consist of services that are 
already occurring but are not being separately paid, or could 
constitute new services. Medicare would pay $14 per visit in the first 
year for these communication technology-based services, compared with 
$92 per visit for the corresponding established patient visits.
    Practitioners have a choice of when to use the communication 
technology-based services. Because of the low payment rate relative to 
that for an office visit, we are assuming that usage of these services 
will be relatively low. In addition, we expect that the number of new 
or newly billable visits and subsequent treatments will outweigh the 
number of times that communication technology-based services will be 
used instead of more costly services. As a result, we expect that the 
financial impact of paying for the communication technology-based 
services will be an increase in Medicare costs. We estimate that usage 
of these services will result in fewer than 1 million visits in the 
first year but will eventually result in more than 19 million visits 
per year, ultimately increasing payments under the PFS by about 0.2 
percent. In order to maintain budget neutrality in setting proposed 
rates for CY 2019, we assumed the number of services that would result 
in a 0.2 percent reduction in the CF.
    As with all estimates, and particularly those for new separately 
billable services, this outcome is highly uncertain. Because 
recognition of communication technology-based services is a new area 
for healthcare coverage, the available information on which to base 
estimates is limited and is usually not directly applicable, 
particularly to a new Medicare payment. The cost and utilization 
estimates are based on Medicare claims data together with a study 
published in Health Affairs,\82\ which examined the cost and 
utilization of telehealth in the private sector. While this study was 
the most applicable for an estimate, we note that the results from this 
program may be different because Medicare experience may differ from 
private sector behavior and because the study was limited to acute 
respiratory infection visits. We also note that the study cites the use 
of direct-to-consumer telehealth companies, many of which provide 
access to care 24 hours per day, 7 days per week, 365 days per year, 
whereas the services described by HCPCS codes G2010 and G2012 are 
limited to only established patients.
---------------------------------------------------------------------------

    \82\ Ashwood, J.S. (2017 March) Direct-To-Consumer Telehealth 
May Increase Access To Care But Does Not Decrease Spending. Health 
Affairs.
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    We proposed to make separate payment for these services when 
furnished by RHCs and FQHCs. A potential estimate of utilization and 
overall cost of these services by RHCs and FQHCs could be derived by 
comparing their use of chronic care management and other care 
management services to the same services furnished by practitioners 
paid under the PFS, since these care management services are also 
separately billable and do not take place in-person. Based on this 
comparison, and without considering potential variables and issues 
specific to these services, the impact the finalized policy would be 
less than $1 million in additional Medicare spending in the first year 
and could eventually result in up to $20 million in spending per year 
in future years. These estimates are uncertain and could change after 
further consideration of the potential variables and issues specific to 
these services.
3. Outpatient Therapy Services
    As noted in section II.M. of this final rule, we are finalizing our 
proposal to end functional reporting for outpatient therapy services as 
part of our burden reduction efforts in response to the RFI on CMS 
Flexibilities and Efficiencies that was issued in the CY 2018 PFS 
proposed rule (82 FR 34172 through 34173). Under our functional 
reporting system therapy practitioners and providers are required to 
report, whenever functional reporting is required, non-payable HCPCS G-
codes and modifiers--typically in pairs--to convey information about 
the beneficiary's functional limitation category and functional status 
throughout the PT, OT, or SLP episode of care. In addition, each time 
functional reporting is required on the claim, the therapy provider 
must also document the functional reporting G-codes and their modifiers 
in the medical record. In this final rule, we are finalizing our 
proposal to eliminate this requirement that therapy practitioners and 
providers report HCPCS G-codes and modifiers or document in the medical 
record to convey functional reporting status for PT, OT or SLP episode 
of care.
    To quantify the amount of burden reduction, we estimated the total 
amount of time that therapy practitioners spend doing functional 
reporting. To do this, we first looked at our data for CY 2017 for 
professional claims by the type of plan of care reported primarily by 
therapists in private practice (TPPs), including physical therapists, 
occupational therapists, and speech-language pathologists. We found 
that the overall utilization of the 42 functional reporting HCPCS G-
codes totaled 15,456,421 single units, or 7,728,211 pairs.
    We then considered the time, on average, it might take to report on 
the claim and document in the medical record each pair of HCPCS G-
codes. We noted this includes the time it takes to make the initial 
determination of the HCPCS G-code functional limitation category, as 
well as the time needed to make each initial and/or subsequent 
assignments for the applicable severity modifiers in order to define 
the patient's functional status. We then made the assumption that it 
would take between 1 minute and 1.5 minutes, on average, to report the 
HCPCS G-code and modifier pair each time functional reporting is 
required. Using the total utilization of G-code pairs and the range of 
1 minute to 1.5 minutes, we

[[Page 60071]]

calculated that TPPs would have saved between 128,804 and 193,206 hours 
(or 7,728,211 to 11,592,317 minutes) collectively in CY 2017 if the 
functional reporting requirements had not been in place. We continue to 
believe this is a reasonable projection for the potential savings to 
TPPs, physicians and certain nonphysician practitioners in future years 
with the finalization of our proposal to end functional reporting 
effective January 1, 2019.
    Because therapy services are also furnished by providers of 
outpatient therapy services such as hospitals, SNFs and rehabilitation 
agencies that submit institutional claims, typically representing a 
greater amount of expenditures than practitioners submitting 
professional claims, we calculated additional savings for these 
providers using the same time assumptions of 1 to 1.5 minutes to report 
the HCPCS G-code and modifier pair each time functional reporting is 
required. Our 2017 data showed a total utilization of the functional 
reporting HCPCS G-codes is 29,053,921 single units, or 14,526,961 
pairs, indicating that therapy providers would collectively save 
between 242,116 to 363,174 hours (or 14,526,961 to 21,790,442 minutes) 
for CY 2017 if the functional reporting requirements had not been 
effective during that year.
    As discussed in section II.M. of this final rule, we received many 
comments on our burden reduction proposal to eliminate our functional 
reporting requirements, and nearly all comments were supportive. We 
believe it is reasonable to estimate that in CY 2019 TPPs and other 
practitioners submitting professional claims and therapists working for 
providers submitting institutional claims will collectively save, at a 
minimum, the same number of collective hours we calculated they would 
save for CY 2017, as specified previously in this RIA, with dates of 
service on and after January 1, 2019.
4. Physician Supervision of Diagnostic Imaging Procedures
    We believe that the changes to the physician supervision 
requirements for RAs furnishing diagnostic imaging procedures as 
described in section II.F. of this final rule will significantly reduce 
burden for physicians. While approximately 215,000 diagnostic imaging 
services per year are currently performed that require personal 
supervision, we are not able to determine the number of these services 
that are performed by an RA due to limitations in the claims data. As a 
result, we are not able to quantify the amount of time potentially 
saved by physicians and practitioners under the policy we are 
finalizing to require direct supervision of diagnostic imaging 
procedures done by RAs in cases where personal supervision would 
ordinarily be required. That said, stakeholders representing the 
practitioner community have indicated that changing the required 
supervision level for RAs will result in a redistribution of workload 
from radiologists to RAs, potentially resulting in improved practice 
efficiency and patient satisfaction. Stakeholders have stated that 
practitioners that utilize RAs have experienced improvements in 
practice efficiency, as use of RAs allows radiologists more time for 
professional services such as interpretation of images, and these 
practitioners cite greater flexibility that results in reduced wait 
times. Furthermore, stakeholders contend that the Medicare supervision 
requirements currently create disincentives to use RAs, as 
practitioners cannot make full use of them for Medicare patients, and 
the change to the supervision requirement would allow RAs to be more 
fully utilized. For these reasons, we believe the change in supervision 
requirements we are finalizing for RAs will contribute to burden 
reduction for physicians and practitioners providing diagnostic imaging 
procedures for Medicare beneficiaries.
5. Beneficiary Liability
    Many proposed policy changes could result in a change in 
beneficiary liability as it relates to coinsurance (which is 20 percent 
of the fee schedule amount, if applicable for the particular provision 
after the beneficiary has met the deductible). To illustrate this 
point, as shown in our public use file Impact on Payment for Selected 
Procedures available on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/, the CY 2018 
national payment amount in the nonfacility setting for CPT code 99203 
(Office/outpatient visit, new) was $109.80, which means that in CY 
2018, a beneficiary would be responsible for 20 percent of this amount, 
or $21.96. Based on this final rule, using the CY 2019 CF, the CY 2019 
national payment amount in the nonfacility setting for CPT code 99203, 
as shown in the Impact on Payment for Selected Procedures public use 
file, is $109.92, which means that, in CY 2019, the final beneficiary 
coinsurance for this service would be $21.98.

J. Impact on Beneficiaries in the Quality Payment Program

    There are several changes in this rule that would have an effect on 
beneficiaries. In general, we believe that many of these changes, 
including those intended to improve accuracy in payment through regular 
updates to the inputs used to calculate payments under the PFS, would 
have a positive impact and improve the quality and value of care 
provided to Medicare beneficiaries. For example, several of the new 
proposed measures include patient-reported outcomes, which may be used 
to help patients make more informed decisions about treatment options. 
Patient-reported outcome measures provide information on a patient's 
health status from the patient's point of view and may also provide 
valuable insights on factors such as quality of life, functional 
status, and overall disease experience, which may not otherwise be 
available through routine clinical data collection. Patient-reported 
outcomes are factors frequently of interest to patients when making 
decisions about treatment.\83\ Further, the proposed policy changes in 
the Promoting Interoperability performance category shifts the focus to 
the interoperable, seamless exchange of electronic information. With 
the requirement that program participants use 2015 Edition CEHRT, the 
interoperable exchange of patient health information should be easier 
because the certification criteria are designed to facilitate 
information exchange. In combination with the newly proposed Promoting 
Interoperability measure to receive and incorporate health information, 
beneficiaries should begin to experience improved care coordination and 
care transitions because clinicians have improved access to the 
beneficiaries' health information across the spectrum of care.
---------------------------------------------------------------------------

    \83\ Institute of Medicine. 2013. Delivering High-Quality Cancer 
Care: Charting a New Course for a System in Crisis. Washington, DC: 
The National Academies Press. https://doi.org/10.17226/18359.
---------------------------------------------------------------------------

Impact on Other Health Care Programs and Providers
    We estimate that CY 2019 Quality Payment Program will not have a 
significant economic effect on eligible clinicians and groups and 
believe that MIPS policies, along with increasing participation in APMs 
over time may succeed in improving quality and reducing costs. This may 
in turn result in beneficial effects on both patients and some 
clinicians, and we intend to continue focusing on clinician-driven, 
patient-centered care.

[[Page 60072]]

K. Estimating Regulatory Familiarization Costs

    If regulations impose administrative costs on private entities, 
such as the time needed to read and interpret this rule, we should 
estimate the cost associated with regulatory review. Due to the 
uncertainty involved with accurately quantifying the number of entities 
that will review the rule, we assume that the total number of unique 
commenters on last year's rule will be the number of reviewers of this 
rule. We acknowledge that this assumption may understate or overstate 
the costs of reviewing this rule. It is possible that not all 
commenters reviewed last year's rule in detail, and it is also possible 
that some reviewers chose not to comment on the rule. For these reasons 
we thought that the number of past commenters would be a fair estimate 
of the number of reviewers of this rule. We welcomed any comments on 
the approach in estimating the number of entities which will review 
this rule.
    We also recognize that different types of entities are in many 
cases affected by mutually exclusive sections of this rule, and 
therefore for the purposes of our estimate we assume that each reviewer 
reads approximately 50 percent of the rule. We sought comments on this 
assumption.
    Using the wage information from the BLS for medical and health 
service managers (Code 11-9111), we estimate that the cost of reviewing 
this rule is $107.38 per hour, including overhead and fringe benefits 
https://www.bls.gov/oes/current/oes_nat.htm. Assuming an average 
reading speed, we estimate that it would take approximately 8.0 hours 
for the staff to review half of this rule. For each facility that 
reviews the rule, the estimated cost is $859.04 (8.0 hours x $107.38). 
Therefore, we estimated that the total cost of reviewing this 
regulation is $5,105,275 ($859.04 x 5,943 reviewers).

L. Accounting Statement

    As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in Tables 106 and 107 
(Accounting Statements), we have prepared an accounting statement. This 
estimate includes growth in incurred benefits from CY 2018 to CY 2019 
based on the FY 2019 President's Budget baseline.

      Table 106--Accounting Statement: Classification of Estimated
                              Expenditures
------------------------------------------------------------------------
                Category                            Transfers
------------------------------------------------------------------------
CY 2019 Annualized Monetized Transfers.  Estimated increase in
                                          expenditures of $0.3 billion
                                          for PFS CF update.
From Whom To Whom?.....................  Federal Government to
                                          physicians, other
                                          practitioners and providers
                                          and suppliers who receive
                                          payment under Medicare.
------------------------------------------------------------------------


   Table 107--Accounting Statement: Classification of Estimated Costs,
                          Transfer, and Savings
------------------------------------------------------------------------
                Category                             Transfer
------------------------------------------------------------------------
CY 2019 Annualized Monetized Transfers   $0.1 billion.
 of beneficiary cost coinsurance.
From Whom to Whom?.....................  Beneficiaries to Federal
                                          Government.
------------------------------------------------------------------------

M. Conclusion

    The analysis in the previous sections, together with the remainder 
of this preamble, provided an initial Regulatory Flexibility Analysis. 
The previous analysis, together with the preceding portion of this 
preamble, provides an RIA. In accordance with the provisions of 
Executive Order 12866, this regulation was reviewed by the Office of 
Management and Budget.

List of Subjects

42 CFR Part 405

    Administrative practice and procedure, Diseases, Health facilities, 
Health professions, Medical devices, Medicare, Reporting and 
recordkeeping requirements, Rural areas, X-rays.

42 CFR Part 410

    Health facilities, Health professions, Kidney diseases, 
Laboratories, Medicare, Reporting and recordkeeping requirements, Rural 
areas, X-rays.

42 CFR Part 411

    Diseases, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 414

    Administrative practice and procedure, Biologics, Drugs, Health 
facilities, Health professions, Kidney diseases, Medicare, Reporting 
and recordkeeping requirements.

42 CFR Part 415

    Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 425

    Administrative practice and procedure, Health facilities, Health 
professions, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 495

    Administrative practice and procedure, Health facilities, Health 
maintenance organizations (HMO), Health professions, Health records, 
Medicaid, Medicare, Penalties, Reporting and recordkeeping 
requirements.
    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

0
1. The authority citation for part 405 is revised to read as follows:

    Authority:  42 U.S.C. 405(a), 1302, 1320b-12, 1395x, 1395y(a), 
1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k)) and 42 U.S.C. 263a.

0
2. Section 405.2401 is amended in paragraph (b) by--
0
a. Revising the introductory text of the definition of ``Federally 
qualified health center''; and
0
b. Revising the definition of ``Secretary''.
    The revisions read as follows:


Sec.  405.2401   Scope and definitions.

* * * * *
    (b) * * *
    Federally qualified health center (FQHC) means an entity that has 
entered into an agreement with CMS to meet Medicare program 
requirements under Sec.  405.2434 and--
* * * * *

[[Page 60073]]

    Secretary means the Secretary of Health and Human Services or his 
or her delegate.
* * * * *

0
3. Section 405.2462 is amended by revising paragraph (g) introductory 
text to read as follows:


Sec.  405.2462  Payment for RHC and FQHC services.

* * * * *
    (g) To receive payment, the RHC or FQHC must do all of the 
following:
* * * * *

0
4. Section 405.2464 is amended by--
0
a. Revising paragraphs (a)(1), (b) heading, (b)(1), (c), and (d); and
0
b. Adding a new paragraph (e)
    The revisions and additions read as follows:


Sec.  405.2464  Payment rate.

    (a) * * *
    (1) Except as specified in paragraphs (d) and (e) of this section, 
an RHC that is authorized to bill under the reasonable cost system is 
paid an all-inclusive rate that is determined by the MAC at the 
beginning of the cost reporting period.
* * * * *
    (b) Payment rate for FQHCs that are authorized to bill under the 
prospective payment system. (1) Except as specified in paragraphs (d) 
and (e) of this section, a per diem rate is calculated by CMS by 
dividing total FQHC costs by total FQHC daily encounters to establish 
an average per diem cost.
* * * * *
    (c) Payment for care management services. For chronic care 
management services furnished between January 1, 2016 and December 31, 
2017, payment to RHCs and FQHCs is at the physician fee schedule 
national non-facility payment rate. For care management services 
furnished on or after January 1, 2018, payment to RHCs and FQHCs is at 
the rate set for each of the RHC and FQHC payment codes for care 
management services.
    (d) Payment for FQHCs that are authorized to bill as grandfathered 
tribal FQHCs. Grandfathered tribal FQHCs are paid at the outpatient per 
visit rate for Medicare as set annually by the Indian Health Service 
for each beneficiary visit for covered services. There are no 
adjustments to this rate.
    (e) Payment for communication technology-based and remote 
evaluation services. For communication technology-based and remote 
evaluation services furnished on or after January 1, 2019, payment to 
RHCs and FQHCs is at the rate set for each of the RHC and FQHC payment 
codes for communication technology-based and remote evaluation 
services.

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0
5. The authority citation for part 410 is revised to read as follows:

    Authority:  42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.

0
6. Section 410.32 is amended by adding paragraph (b)(4) to read as 
follows:


Sec.  410.32  Diagnostic x-ray tests, diagnostic laboratory tests, and 
other diagnostic tests: Conditions.

* * * * *
    (b) * * *
    (4) Supervision requirement for RRA or RPA. Diagnostic tests that 
are performed by a registered radiologist assistant (RRA) who is 
certified and registered by the American Registry of Radiologic 
Technologists or a radiology practitioner assistant (RPA) who is 
certified by the Certification Board for Radiology Practitioner 
Assistants, and that would otherwise require a personal level of 
supervision as specified in paragraph (b)(3) of this section, may be 
furnished under a direct level of physician supervision to the extent 
permitted by state law and state scope of practice regulations.
* * * * *


Sec.  410.59  [Amended]

0
7. Section 410.59 is amended by removing paragraph (a)(4).


Sec.  410.60  [Amended]

0
8. Section 410.60 is amended by removing paragraph (a)(4).

0
9. Section 410.61 is amended by revising paragraph (c) to read as 
follows:


Sec.  410.61  Plan of treatment requirements for outpatient 
rehabilitation services.

* * * * *
    (c) Content of the plan. The plan prescribes the type, amount, 
frequency, and duration of the physical therapy, occupational therapy, 
or speech-language pathology services to be furnished to the 
individual, and indicates the diagnosis and anticipated goals.
* * * * *


Sec.  410.62  [Amended]

0
10. Section 410.62 is amended by removing paragraph (a)(4).

0
11. Section 410.78 is amended by--
0
a. Adding paragraphs (b)(3)(ix), (x), (xi), and (xii);
0
b. Revising paragraph (b)(4) introductory text, and
0
c. Adding paragraph (b)(4)(iv).
    The additions and revision read as follows:


Sec.  410.78  Telehealth services.

* * * * *
    (b) * * *
    (3) * * *
    (ix) A renal dialysis facility (only for purposes of the home 
dialysis monthly ESRD-related clinical assessment in section 
1881(b)(3)(B) of the Act);
    (x) The home of an individual (only for purposes of the home 
dialysis ESRD-related clinical assessment in section 1881(b)(3)(B) of 
the Act).
    (xi) A mobile stroke unit (only for purposes of diagnosis, 
evaluation, or treatment of symptoms of an acute stroke provided in 
accordance with section 1834(m)(6) of the Act).
    (xii) The home of an individual (only for purposes of treatment of 
a substance use disorder or a co-occurring mental health disorder, 
furnished on or after July 1, 2019, to an individual with a substance 
use disorder diagnosis.
    (4) Except as provided in paragraph (b)(4)(iv) of this section, 
originating sites must be:
* * * * *
    (iv) The geographic requirements specified in paragraph (b)(4) of 
this section do not apply to the following telehealth services:
    (A) Home dialysis monthly ESRD-related clinical assessment services 
furnished on or after January 1, 2019, at an originating site described 
in paragraphs (b)(3)(vi), (ix) or (x) of this section, in accordance 
with section 1881(b)(3)(B) of the Act; and
    (B) Services furnished on or after January 1, 2019, for purposes of 
diagnosis, evaluation, or treatment of symptoms of an acute stroke.
    (C) Services furnished on or after July 1, 2019 to an individual 
with a substance use disorder diagnosis, for purposes of treatment of a 
substance use disorder or a co-occurring mental health disorder.
* * * * *


Sec.  410.105  [Amended]

0
12. Section 410.105 is amended--
0
a. In paragraph (c)(1)(ii) by removing the phrase ``that are consistent 
with the patient function reporting on the claims for services''; and
0
b. By removing paragraph (d).

PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE 
PAYMENT

0
13. The authority citation for part 411 is revised to read as follows:

    Authority: 42 U.S.C. 1302, 1395w-101 through 1395w-152, 1395hh, 
and 1395nn.

[[Page 60074]]


0
14. Section 411.353 is amended by--
0
a. Revising paragraph (g)(1); and
0
b. Removing and reserving paragraph (g)(2).
    The revision reads as follows:


Sec.  411.353  Prohibition on certain referrals by physicians and 
limitations on billing.

* * * * *
    (g) * * *
    (1) An entity may submit a claim or bill and payment may be made to 
an entity that submits a claim or bill for a designated health service 
if--
    (i) The compensation arrangement between the entity and the 
referring physician fully complies with an applicable exception in this 
subpart except with respect to the signature requirement of the 
exception; and
    (ii) The parties obtain the required signature(s) within 90 
consecutive calendar days immediately following the date on which the 
compensation arrangement became noncompliant and the compensation 
arrangement otherwise complies with all criteria of the applicable 
exception.
    (2) [Reserved]

0
15. Section 411.354 is amended by adding paragraph (e) to read as 
follows:


Sec.  411.354  Financial relationship, compensation, and ownership or 
investment interest.

* * * * *
    (e) Special rule on compensation arrangements--(1) Application. 
This paragraph (e) applies only to compensation arrangements as defined 
in section 1877 of the Act and this subpart.
    (2) Writing requirement. In the case of any requirement in this 
subpart for a compensation arrangement to be in writing, such 
requirement may be satisfied by a collection of documents, including 
contemporaneous documents evidencing the course of conduct between the 
parties.

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

0
16. The authority citation for part 414 is revised to read as follows:

    Authority:  42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).

0
17. Section 414.65 is amended by--
0
a. Revising paragraph (a) introductory text;
0
b. Removing paragraph (a)(1);
0
c. Redesignating paragraphs (a)(2) and (3), as paragraphs (a)(1) and 
(2), respectively; and
0
d. Adding paragraph (b)(3).
    The revision and addition reads as follows:


Sec.  414.65  Payment for telehealth services.

    (a) Professional service. The Medicare payment amount for 
telehealth services described under Sec.  410.78 of this chapter is 
equal to the current fee schedule amount applicable for the service of 
the physician or practitioner, subject to paragraphs (a)(1) and (2) of 
this section, but must be made in accordance with the following 
limitations:
* * * * *
    (b) * * *
    (3) No originating site facility fee payment is made to an 
originating site described in Sec.  410.78(b)(3)(x), (xi), or (xii); or 
to an originating site for services furnished under the exception at 
Sec.  410.78(b)(4)(iv)(A) or (B) of this chapter.
* * * * *

0
18. Section 414.94 is amended--
0
a. In paragraph (b), by revising the definition of ``Applicable 
setting''; and
0
b. By revising paragraphs (i)(3), (j), and (k) introductory text.
    The revisions read as follows:


Sec.  414.94   Appropriate use criteria for advanced diagnostic imaging 
services.

* * * * *
    (b) * * *
    Applicable setting means a physician's office, a hospital 
outpatient department (including an emergency department), an 
ambulatory surgical center, an independent diagnostic testing facility, 
and any other provider-led outpatient setting determined appropriate by 
the Secretary.
* * * * *
    (i) * * *
    (3) Significant hardships for ordering professionals who experience 
any of the following:
    (i) Insufficient internet access.
    (ii) EHR or CDSM vendor issues.
    (iii) Extreme and uncontrollable circumstances.
    (j) Consulting. (1) Except as specified in paragraphs (i) and 
(j)(2) of this section, ordering professionals must consult specified 
applicable AUC through qualified CDSMs for applicable imaging services 
furnished in an applicable setting, paid for under an applicable 
payment system, and ordered on or after January 1, 2020.
    (2) Ordering professionals may delegate the consultation with 
specified applicable AUC required under paragraph (j)(1) of this 
section to clinical staff acting under the direction of the ordering 
professional.
    (k) Reporting. The following information must be reported on 
Medicare claims for advanced diagnostic imaging services furnished in 
an applicable setting, paid for under an applicable payment system 
defined in paragraph (b) of this section, and ordered on or after 
January 1, 2020:
* * * * *

0
19. Section 414.502 is amended in the definition of ``Applicable 
laboratory'' by adding paragraph (2)(i), adding and reserving paragraph 
(2)(ii), and revising paragraph (3) introductory text to read as 
follows:


Sec.  414.502  Definitions.

* * * * *
    Applicable laboratory * * *
    (2) * * *
    (i) For hospital outreach laboratories--bills Medicare Part B on 
the CMS 1450 under bill type 14x;
    (ii) [Reserved]
    (3) In a data collection period, receives more than 50 percent of 
its Medicare revenues, which includes fee-for-service payments under 
Medicare Parts A and B, prescription drug payments under Medicare Part 
D, and any associated Medicare beneficiary deductible or coinsurance 
for services furnished during the data collection period from one or a 
combination of the following sources:
* * * * *

0
20. Section 414.610 is amended--
0
a. In paragraphs (c)(1)(ii) introductory text and (c)(5)(ii) by 
removing the date ``December 31, 2017'' and adding in its place the 
date ``December 31, 2022''; and
0
b. By revising paragraph (c)(8).
    The revision reads as follows:


Sec.  414.610  Basis of payment.

* * * * *
    (c) * * *
    (8) Transport of an individual with end-stage renal disease for 
renal dialysis services. For ambulance services furnished during the 
period October 1, 2013 through September 30, 2018, consisting of non-
emergency basic life support (BLS) services involving transport of an 
individual with end-stage renal disease for renal dialysis services (as 
described in section 1881(b)(14)(B) of the Act) furnished other than on 
an emergency basis by a provider of services or a renal dialysis 
facility, the fee schedule amount otherwise applicable (both base rate 
and mileage) is reduced by 10 percent. For such services furnished on 
or after October 1, 2018, the fee schedule amount otherwise applicable 
(both base rate and mileage) is reduced by 23 percent.
* * * * *


Sec.  414.904  [Amended]

0
21. Section 414.904 is amended in paragraph (e)(4) by removing the 
phrase

[[Page 60075]]

``acquisition cost or the applicable Medicare Part B drug payment'' and 
adding in its place the phrase ``acquisition cost or the Medicare Part 
B drug payment''.

0
22. Section 414.1305 is amended by--
0
a. Revising the definition of ``Ambulatory Surgical Center (ASC)-based 
MIPS eligible clinician'';
0
b. Adding in alphabetical order definitions for ``Collection type'' and 
``Health IT vendor'';
0
c. Revising the definitions of ``High priority measure'', ``Hospital-
based MIPS eligible clinician'', and ``Low-volume threshold'';
0
d. Adding in alphabetical order a definition for ``MIPS determination 
period'';
0
e. Revising the definitions of ``MIPS eligible clinician'', ``Non-
patient facing MIPS eligible clinician'', ``Qualified Clinical Data 
Registry (QCDR)'', ``Qualifying APM Participant (QP)'', and ``Small 
practice''; and
0
f. Adding in alphabetical order a definition for ``Submission type'', 
``Submitter type'', and ``Third party intermediary''.
    The revisions and additions read as follows:


Sec.  414.1305  Definitions.

* * * * *
    Ambulatory Surgical Center (ASC)-based MIPS eligible clinician 
means:
    (1) For the 2019 and 2020 MIPS payment years, a MIPS eligible 
clinician who furnishes 75 percent or more of his or her covered 
professional services in sites of service identified by the Place of 
Service (POS) codes used in the HIPAA standard transaction as an 
ambulatory surgical center setting based on claims for a period prior 
to the performance period as specified by CMS; and
    (2) Beginning with the 2021 MIPS payment year, a MIPS eligible 
clinician who furnishes 75 percent or more of his or her covered 
professional services in sites of service identified by the POS codes 
used in the HIPAA standard transaction as an ambulatory surgical center 
setting based on claims for the MIPS determination period.
* * * * *
    Collection type means a set of quality measures with comparable 
specifications and data completeness criteria, as applicable, 
including, but not limited to: electronic clinical quality measures 
(eCQMs); MIPS Clinical Quality Measures (MIPS CQMs), QCDR measures, 
Medicare Part B claims measures, CMS Web Interface measures, the CAHPS 
for MIPS survey, and administrative claims measures.
* * * * *
    Health IT vendor means an entity that supports the health IT 
requirements on behalf of a MIPS eligible clinician (including 
obtaining data from a MIPS eligible clinician's CEHRT).
* * * * *
    High priority measure means:
    (1) For the 2019 and 2020 MIPS payment years, an outcome (including 
intermediate-outcome and patient-reported outcome), appropriate use, 
patient safety, efficiency, patient experience, or care coordination 
quality measure.
    (2) Beginning with the 2021 MIPS payment year, an outcome 
(including intermediate-outcome and patient-reported outcome), 
appropriate use, patient safety, efficiency, patient experience, care 
coordination, or opioid-related quality measure.
    Hospital-based MIPS eligible clinician means:
    (1) For the 2019 and 2020 MIPS payment years, a MIPS eligible 
clinician who furnishes 75 percent or more of his or her covered 
professional services in sites of service identified by the Place of 
Service (POS) codes used in the HIPAA standard transaction as an 
inpatient hospital, on-campus outpatient hospital, off campus-
outpatient hospital, or emergency room setting based on claims for a 
period prior to the performance period as specified by CMS; and
    (2) Beginning with the 2021 MIPS payment year, a MIPS eligible 
clinician who furnishes 75 percent or more of his or her covered 
professional services in sites of service identified by the POS codes 
used in the HIPAA standard transaction as an inpatient hospital, on-
campus outpatient hospital, off campus outpatient hospital, or 
emergency room setting based on claims for the MIPS determination 
period.
* * * * *
    Low-volume threshold means:
    (1) For the 2019 MIPS payment year, the low-volume threshold that 
applies to an individual eligible clinician, group, or APM Entity group 
that, during the low-volume threshold determination period described in 
paragraph (4) of this definition, has Medicare Part B allowed charges 
less than or equal to $30,000 or provides care for 100 or fewer 
Medicare Part B-enrolled individuals.
    (2) For the 2020 MIPS payment year, the low-volume threshold that 
applies to an individual eligible clinician, group, or APM Entity group 
that, during the low-volume threshold determination period described in 
paragraph (4) of this definition, has allowed charges for covered 
professional services less than or equal to $90,000 or furnishes 
covered professional services to 200 or fewer Medicare Part B-enrolled 
individuals.
    (3) Beginning with the 2021 MIPS payment year, the low-volume 
threshold that applies to an individual eligible clinician, group, or 
APM Entity group that, during the MIPS determination period, has 
allowed charges for covered professional services less than or equal to 
$90,000, furnishes covered professional services to 200 or fewer 
Medicare Part B-enrolled individuals, or furnishes 200 or fewer covered 
professional services to Medicare Part B-enrolled individuals.
    (4) For the 2019 and 2020 MIPS payment years, the low-volume 
threshold determination period is a 24-month assessment period 
consisting of:
    (i) An initial 12-month segment that spans from the last 4 months 
of the calendar year 2 years prior to the performance period through 
the first 8 months of the calendar year preceding to the performance 
period; and
    (ii) A second 12-month segment that spans from the last 4 months of 
the calendar year 1 year prior to the performance period through the 
first 8 months of the calendar year performance period. An individual 
eligible clinician, group, or APM Entity group that is identified as 
not exceeding the low-volume threshold during the initial 12-month 
segment will continue to be excluded under Sec.  414.1310(b)(1)(iii) 
for the applicable year regardless of the results of the second 12-
month segment analysis. For the 2019 MIPS payment year, each segment of 
the low-volume threshold determination period includes a 60-day claims 
run out. For the 2020 MIPS payment year, each segment of the low-volume 
threshold determination period includes a 30-day claims run out.
* * * * *
    MIPS determination period means:
    (1) Beginning with the 2021 MIPS payment year, a 24-month 
assessment period consisting of:
    (i) An initial 12-month segment beginning on October 1 of the 
calendar year 2 years prior to the applicable performance period and 
ending on September 30 of the calendar year preceding the applicable 
performance period, and that includes a 30-day claims run out; and
    (ii) A second 12-month segment beginning on October 1 of the 
calendar year preceding the applicable performance period and ending on 
September 30 of the calendar year in which the applicable performance 
period occurs.
    (2) Subject to Sec.  414.1310(b)(1)(iii), an individual eligible 
clinician, group, or APM Entity group that is identified as not 
exceeding the low-volume threshold

[[Page 60076]]

or as having special status during the first segment of the MIPS 
determination period will be identified as such for the applicable MIPS 
payment year regardless of the results of the second segment of the 
MIPS determination period. An individual eligible clinician, group, or 
APM Entity group for which the unique billing TIN and NPI combination 
is established during the second segment of the MIPS determination 
period will be assessed based solely on the results of such segment.
    MIPS eligible clinician as identified by a unique billing TIN and 
NPI combination used to assess performance, means any of the following 
(except as excluded under Sec.  414.1310(b)):
    (1) For the 2019 and 2020 MIPS payment years:
    (i) A physician (as defined in section 1861(r) of the Act);
    (ii) A physician assistant, a nurse practitioner, and clinical 
nurse specialist (as such terms are defined in section 1861(aa)(5) of 
the Act);
    (iii) A certified registered nurse anesthetist (as defined in 
section 1861(bb)(2) of the Act); and
    (iv) A group that includes such clinicians.
    (2) For the 2021 MIPS payment year and future years:
    (i) A clinician described in paragraph (1) of this definition;
    (ii) A physical therapist or occupational therapist;
    (iii) A qualified speech-language pathologist;
    (iv) A qualified audiologist (as defined in section 1861(ll)(3)(B) 
of the Act);
    (v) A clinical psychologist (as defined by the Secretary for 
purposes of section 1861(ii) of the Act);
    (vi) A registered dietician or nutrition professional; and
    (vii) A group that includes such clinicians.
* * * * *
    Non-patient facing MIPS eligible clinician means:
    (1) For the 2019 and 2020 MIPS payment year, an individual MIPS 
eligible clinician who bills 100 or fewer patient facing encounters 
(including Medicare telehealth services defined in section 1834(m) of 
the Act), as described in paragraph (3) of this definition, during the 
non-patient facing determination period described in paragraph (4) of 
this definition, and a group or virtual group provided that more than 
75 percent of the NPIs billing under the group's TIN or virtual group's 
TINs, as applicable, meet the definition of a non-patient facing 
individual MIPS eligible clinician.
    (2) Beginning with the 2021 MIPS payment year, an individual MIPS 
eligible clinician who bills 100 or fewer patient facing encounters 
(including Medicare telehealth services defined in section 1834(m) of 
the Act), as described in paragraph (3) of this definition, during the 
MIPS determination period, and a group or virtual group provided that 
more than 75 percent of the NPIs billing under the group's TIN or 
virtual group's TINs, as applicable, meet the definition of a non-
patient facing individual MIPS eligible clinician.
    (3) For purposes of this definition, a patient-facing encounter is 
an instance in which the individual MIPS eligible clinician or group 
bills for items and services furnished such as general office visits, 
outpatient visits, and procedure codes under the PFS, as specified by 
CMS.
    (4) For the 2019 and 2020 MIPS payment year, the non-patient facing 
determination period is a 24-month assessment period consisting of:
    (i) An initial 12-month segment that spans from the last 4 months 
of the calendar year 2 years prior to the performance period through 
the first 8 months of the calendar year preceding the performance 
period; and
    (ii) A second 12-month segment that spans from the last 4 months of 
the calendar year 1 year prior to the performance period through the 
first 8 months of the calendar year performance period. An individual 
eligible MIPS clinician, group, or virtual group that is identified as 
non-patient facing during the initial 12-month segment will continue to 
be considered non-patient facing for the applicable year regardless of 
the results of the second 12-month segment analysis. For the 2019 MIPS 
payment year, each segment of the non-patient facing determination 
period includes a 60-day claims run out. For the 2020 MIPS payment year 
and future years, each segment of the non-patient facing determination 
period includes a 30-day claims run out.
* * * * *
    Qualified clinical data registry (QCDR) means:
    (1) For the 2019, 2020 and 2021 MIPS payment year, a CMS-approved 
entity that has self-nominated and successfully completed a 
qualification process to determine whether the entity may collect 
medical or clinical data for the purpose of patient and disease 
tracking to foster improvement in the quality of care provided to 
patients.
    (2) Beginning with the 2022 MIPS payment year, an entity that 
demonstrates clinical expertise in medicine and quality measurement 
development experience and collects medical or clinical data on behalf 
of a MIPS eligible clinician for the purpose of patient and disease 
tracking to foster improvement in the quality of care provided to 
patients.
* * * * *
    Qualifying APM participant (QP) means an eligible clinician 
determined by CMS to have met or exceeded the relevant QP payment 
amount or QP patient count threshold under Sec.  414.1430(a)(1), 
(a)(3), (b)(1), or (b)(3) for a year based on participation in an APM 
Entity that is also participating in an Advanced APM.
* * * * *
    Small practice means:
    (1) For the 2019 MIPS payment year, a TIN consisting of 15 or fewer 
eligible clinicians.
    (2) For the 2020 MIPS payment year, a TIN consisting of 15 or fewer 
eligible clinicians during a 12-month assessment period that spans from 
the last 4 months of the calendar year 2 years prior to the performance 
period through the first 8 months of the calendar year preceding the 
performance period and includes a 30-day claims run out.
    (3) Beginning with the 2021 MIPS payment year, a TIN consisting of 
15 or fewer eligible clinicians during the MIPS determination period.
* * * * *
    Submission type means the mechanism by which the submitter type 
submits data to CMS, including, but not limited to: Direct, log in and 
upload, log in and attest, Medicare Part B claims and the CMS Web 
Interface.
    Submitter type means the MIPS eligible clinician, group, virtual 
group, or third party intermediary acting on behalf of a MIPS eligible 
clinician, group, or virtual group, as applicable, that submits data on 
measures and activities under MIPS.
    Third party intermediary means an entity that has been approved 
under Sec.  414.1400 to submit data on behalf of a MIPS eligible 
clinician, group, or virtual group for one or more of the quality, 
improvement activities, and promoting interoperability performance 
categories.
* * * * *

0
23. Section 414.1310 is amended by revising paragraphs (a), (b)(1)(ii), 
(iii), (d), (e)(1) and (2) to read as follows:


Sec.  414.1310  Applicability.

    (a) Program implementation. Except as specified in paragraph (b) of 
this section, MIPS applies to payments for

[[Page 60077]]

covered professional services furnished by MIPS eligible clinicians on 
or after January 1, 2019.
    (b) * * *
    (1) * * *
    (ii) Is a Partial Qualifying APM Participant and does not elect to 
participate in MIPS as a MIPS eligible clinician; or
    (iii) Does not exceed the low-volume threshold. Beginning with the 
2021 MIPS payment year, if an individual eligible clinician, group, or 
APM Entity group in a MIPS APM exceeds at least one, but not all, of 
the low-volume threshold criteria and elects to participate in MIPS as 
a MIPS eligible clinician, the individual eligible clinician, group, or 
APM Entity group is treated as a MIPS eligible clinician for the 
applicable MIPS payment year. For such solo practitioners and groups 
that elect to participate in MIPS as a virtual group (except for APM 
Entity groups in MIPS APMs), the virtual group election under Sec.  
414.1315 constitutes an election under this paragraph and results in 
the solo practitioners and groups being treated as MIPS eligible 
clinicians for the applicable MIPS payment year. For such APM Entity 
groups in MIPS APMs, only the APM Entity group election can result in 
the APM Entity group being treated as MIPS eligible clinicians for the 
applicable MIPS payment year.
* * * * *
    (d) Clarification. In no case will a MIPS payment adjustment factor 
(or additional MIPS payment adjustment factor) apply to payments for 
items and services furnished during a year by a eligible clinician, 
including an eligible clinician described in paragraph (b) or (c) of 
this section, who is not a MIPS eligible clinician, including an 
eligible clinician who voluntarily reports on applicable measures and 
activities under MIPS.
    (e) * * *
    (1) Except as provided under Sec.  414.1370(f)(2), each MIPS 
eligible clinician in the group will receive a MIPS payment adjustment 
factor (or additional MIPS payment adjustment factor) based on the 
group's combined performance assessment.
    (2) For individual MIPS eligible clinicians to participate in MIPS 
as a group, all of the following requirements must be met:
    (i) Groups must meet the definition of a group at all times during 
the applicable performance period.
    (ii) Individual eligible clinicians that elect to participate in 
MIPS as a group must aggregate their performance data across the 
group's TIN.
    (iii) Individual eligible clinicians that elect to participate in 
MIPS as a group will have their performance assessed at the group level 
across all four MIPS performance categories.
    (iv) Groups must adhere to an election process established by CMS, 
as applicable.
* * * * *

0
24. Section 414.1315 is revised to read as follows:


Sec.  414.1315  Virtual groups.

    (a) Eligibility. (1) For a MIPS payment year, a solo practitioner 
or a group of 10 or fewer eligible clinicians may elect to participate 
in MIPS as a virtual group with at least one other such solo 
practitioner or group. The election must be made prior to the start of 
the applicable performance period and cannot be changed during the 
performance period. A solo practitioner or group may elect to be in no 
more than one virtual group for a performance period, and, in the case 
of a group, the election applies to all MIPS eligible clinicians in the 
group.
    (2) Except as provided under Sec.  414.1370(f)(2), each MIPS 
eligible clinician in the virtual group receives a MIPS payment 
adjustment factor and, if applicable, an additional MIPS payment 
adjustment factor based on the virtual group's combined performance 
assessment.
    (b) Election deadline. The election deadline is December 31 of the 
calendar year preceding the applicable performance period.
    (c) Election process. For the 2020 MIPS payment year and future 
years, the virtual group election process is as follows:
    (1) Stage 1: Virtual group eligibility determination. (i) For the 
2020 MIPS payment year, the virtual group eligibility determination 
period is an assessment period of up to 5 months beginning on July 1 
and ending as late as November 30 of the calendar year preceding the 
applicable performance period, and that includes a 30-day claims run 
out.
    (ii) Beginning with the 2021 MIPS payment year, the virtual group 
eligibility determination period is the first segment of the MIPS 
determination period.
    (2) Stage 2: Virtual group formation. (i) Solo practitioners and 
groups that elect to participate in MIPS as a virtual group must 
establish a formal written agreement that satisfies paragraph (c)(3) of 
this section prior to the election.
    (ii) A designated virtual group representative must submit an 
election, on behalf of the solo practitioners and groups that compose a 
virtual group, to participate in MIPS as a virtual group for a 
performance period in a form and manner specified by CMS by the 
election deadline specified in paragraph (b) of this section. The 
virtual group election must include each TIN and NPI associated with 
the virtual group and contact information for the virtual group 
representative.
    (iii) After an election is made, the virtual group representative 
must contact their designated CMS contact to update any election 
information that changed during a performance period at least one time 
prior to the start of data submission.
    (3) Virtual group agreement. The virtual group arrangement must be 
set forth in a formal written agreement among the parties, consisting 
of each solo practitioner and group that composes a virtual group. The 
agreement must comply with the following requirements:
    (i) Identifies each party by name, TIN, and each NPI under the TIN, 
and includes as parties only the solo practitioners and groups that 
compose the virtual group.
    (ii) Is for a term of at least one performance period.
    (iii) Requires each party to notify each NPI under the party's TIN 
regarding their participation in the MIPS as a virtual group.
    (iv) Sets forth each NPI's rights and obligations in, and 
representation by, the virtual group, including, but not limited to, 
the reporting requirements and how participation in the MIPS as a 
virtual group affects the NPI's ability to participate in the MIPS 
outside of the virtual group.
    (v) Describes how the opportunity to receive payment adjustments 
will encourage each member of the virtual group (and each NPI under 
each TIN in the virtual group) to adhere to quality assurance and 
improvement.
    (vi) Requires each party to update its Medicare enrollment 
information, including the addition or removal of NPIs billing under 
its TIN, on a timely basis in accordance with Medicare program 
requirements and to notify the other parties of any such changes within 
30 days of the change.
    (vii) Requires completion of a close-out process upon termination 
or expiration of the agreement that requires each party to furnish all 
data necessary for the parties to aggregate their data across the 
virtual group's TINs.
    (viii) Expressly requires each party to participate in the MIPS as 
a virtual group and comply with the requirements of the MIPS and all 
other applicable laws (including, but not limited to, Federal criminal 
law, the Federal False Claims Act, the Federal

[[Page 60078]]

anti-kickback statute, the Federal civil monetary penalties law, the 
Federal physician self-referral law, and the Health Insurance 
Portability and Accountability Act of 1996).
    (ix) Is executed on behalf of each party by an individual who is 
authorized to bind the party.
    (d) Virtual group reporting requirements. For solo practitioners 
and groups of 10 or fewer eligible clinicians to participate in MIPS as 
a virtual group, all of the following requirements must be met:
    (1) Virtual groups must meet the definition of a virtual group at 
all times during the applicable performance period.
    (2) Solo practitioners and groups of 10 or fewer eligible 
clinicians that elect to participate in MIPS as a virtual group must 
aggregate their performance data across the virtual group's TINs.
    (3) Solo practitioners and groups of 10 or fewer eligible 
clinicians that elect to participate in MIPS as a virtual group will 
have their performance assessed at the virtual group level across all 
four MIPS performance categories.
    (4) Virtual groups must adhere to the election process described in 
paragraph (c) of this section.

0
25. Section 414.1320 is amended by revising paragraphs (b)(2) and 
(c)(2) and adding paragraphs (d) and (e) to read as follows:


Sec.  414.1320  MIPS performance period.

* * * * *
    (b) * * *
    (2) Promoting Interoperability and improvement activities 
performance categories is a minimum of a continuous 90-day period 
within CY 2018, up to and including the full CY 2018 (January 1, 2018 
through December 31, 2018).
    (c) * * *
    (2) Promoting Interoperability and improvement activities 
performance categories is a minimum of a continuous 90-day period 
within CY 2019, up to and including the full CY 2019 (January 1, 2019 
through December 31, 2019).
    (d) Beginning with the 2022 MIPS payment year, the performance 
period for:
    (1) The quality and cost performance categories is the full 
calendar year (January 1 through December 31) that occurs 2 years prior 
to the applicable MIPS payment year.
    (2) The improvement activities performance categories is a minimum 
of a continuous 90-day period within the calendar year that occurs 2 
years prior to the applicable MIPS payment year, up to and including 
the full calendar year.
    (e) For purposes of the 2022 MIPS payment year, the performance 
period for:
    (1) The Promoting Interoperability performance category is a 
minimum of a continuous 90-day period within the calendar year that 
occurs 2 years prior to the applicable MIPS payment year, up to and 
including the full calendar year.
    (2) [Reserved]

0
26. Section 414.1325 is revised to read as follows:


Sec.  414.1325  Data submission requirements.

    (a) Applicable performance categories. (1) Except as provided in 
paragraph (a)(2) of this section or under Sec.  414.1370, as 
applicable, individual MIPS eligible clinicians and groups must submit 
data on measures and activities for the quality, improvement 
activities, and Promoting Interoperability performance categories in 
accordance with this section. Except for the Medicare Part B claims 
submission type, the data may also be submitted on behalf of the 
individual MIPS eligible clinician or group by a third party 
intermediary described at Sec.  414.1400.
    (2) There are no data submission requirements for:
    (i) The cost performance category or administrative claims-based 
quality measures. Performance in the cost performance category and on 
such measures is calculated by CMS using administrative claims data, 
which includes claims submitted with dates of service during the 
applicable performance period that are processed no later than 60 days 
following the close of the applicable performance period.
    (ii) The quality and cost performance categories, as applicable, 
for MIPS eligible clinicians and groups that are scored under the 
facility-based measurement scoring methodology described in Sec.  
414.1380(e).
    (b) Data submission types for individual MIPS eligible clinicians. 
An individual MIPS eligible clinician may submit their MIPS data using:
    (1) For the quality performance category, the direct, login and 
upload, and Medicare Part B claims (beginning with the 2021 MIPS 
payment year for small practices only) submission types.
    (2) For the improvement activities or Promoting Interoperability 
performance categories, the direct, login and upload, or login and 
attest submission types.
    (c) Data submission types for groups. Groups may submit their MIPS 
data using:
    (1) For the quality performance category, the direct, login and 
upload, Medicare Part B claims (beginning with the 2021 MIPS payment 
year, for small practices only), and CMS Web Interface (for groups 
consisting of 25 or more eligible clinicians or a third party 
intermediary submitting on behalf of a group) submission types.
    (2) For the improvement activities or Promoting Interoperability 
performance categories, the direct, login and upload, or login and 
attest submission types.
    (d) Use of multiple data submission types. Beginning with the 2021 
MIPS payment year, MIPS eligible clinicians, groups, and virtual groups 
may submit their MIPS data using multiple data submission types for any 
performance category described in paragraph (a)(1) of this section, as 
applicable; provided, however, that the MIPS eligible clinician, group, 
or virtual group uses the same identifier for all performance 
categories and all data submissions.
    (e) Data submission deadlines. The data submission deadlines are as 
follows:
    (1) For the direct, login and upload, login and attest, and CMS Web 
Interface submission types, March 31 following the close of the 
applicable performance period or a later date as specified by CMS.
    (2) For the Medicare Part B claims submission type, data must be 
submitted on claims with dates of service during the applicable 
performance period that must be processed no later than 60 days 
following the close of the applicable performance period.

0
27. Section 414.1330 is revised to read as follows:


Sec.  414.1330  Quality performance category.

    (a) For a MIPS payment year, CMS uses the following quality 
measures, as applicable, to assess performance in the quality 
performance category:
    (1) Measures included in the MIPS final list of quality measures 
established by CMS through rulemaking;
    (2) QCDR measures approved by CMS under Sec.  414.1400;
    (3) Facility-based measures described in Sec.  414.1380; and
    (4) MIPS APM measures described in Sec.  414.1370.
    (b) Unless a different scoring weight is assigned by CMS, 
performance in the quality performance category comprises:
    (1) 60 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2019.
    (2) 50 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2020.
    (3) 45 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2021.

[[Page 60079]]


0
28. Section 414.1335 is amended by revising paragraphs (a)(1) through 
(3) to read as follows:


Sec.  414.1335  Data submission criteria for the quality performance 
category.

    (a) * * *
    (1) For Medicare Part B claims measures, MIPS CQMs, eCQMs, or QCDR 
measures. (i) Except as provided in paragraph (a)(1)(ii) of this 
section, submit data on at least six measures, including at least one 
outcome measure. If an applicable outcome measure is not available, 
report one other high priority measure. If fewer than six measures 
apply to the MIPS eligible clinician or group, report on each measure 
that is applicable.
    (ii) MIPS eligible clinicians and groups that report on a specialty 
or subspecialty measure set, as designated in the MIPS final list of 
quality measures established by CMS through rulemaking, must submit 
data on at least six measures within that set, including at least one 
outcome measure. If an applicable outcome measure is not available, 
report one other high priority measure. If the set contains fewer than 
six measures or if fewer than six measures within the set apply to the 
MIPS eligible clinician or group, report on each measure that is 
applicable.
    (2) For CMS Web Interface measures. (i) Report on all measures 
included in the CMS Web Interface. The group is required to report on 
at least one measure for which there is Medicare patient data.
    (ii) [Reserved]
    (3) For the CAHPS for MIPS survey. (i) For the 12-month performance 
period, a group that wishes to voluntarily elect to participate in the 
CAHPS for MIPS survey must use a survey vendor that is approved by CMS 
for the applicable performance period to transmit survey measures data 
to CMS.
    (ii) [Reserved]
* * * * *

0
29. Section 414.1340 is amended by revising paragraphs (a) introductory 
text, (b) introductory text, and (c) to read as follows:


Sec.  414.1340  Data completeness criteria for the quality performance 
category.

    (a) MIPS eligible clinicians and groups submitting quality measures 
data on QCDR measures, MIPS CQMs, or eCQMs must submit data on:
* * * * *
    (b) MIPS eligible clinicians and groups submitting quality measure 
data on Medicare Part B claims measures must submit data on:
* * * * *
    (c) Groups submitting quality measures data on CMS Web Interface 
measures or the CAHPS for MIPS survey must submit data on the sample of 
the Medicare Part B patients CMS provides, as applicable.
    (1) For CMS Web Interface measures. (i) The group must report on 
the first 248 consecutively ranked beneficiaries in the sample for each 
measure or module. If the sample of eligible assigned beneficiaries is 
less than 248, then the group must report on 100 percent of assigned 
beneficiaries.
    (ii) [Reserved]
    (2) [Reserved]

0
30. Section 414.1350 is revised to read as follows:


Sec.  414.1350  Cost performance category.

    (a) Specification of cost measures. For purposes of assessing 
performance of MIPS eligible clinicians on the cost performance 
category, CMS specifies cost measures for a performance period.
    (b) Attribution. (1) Cost measures are attributed at the TIN/NPI 
level.
    (2) For the total per capita cost measure, beneficiaries are 
attributed using a method generally consistent with the method of 
assignment of beneficiaries under Sec.  425.402 of this chapter.
    (3) For the Medicare Spending per Beneficiary (MSPB) measure, an 
episode is attributed to the MIPS eligible clinician who submitted the 
plurality of claims (as measured by allowed charges) for Medicare Part 
B services rendered during an inpatient hospitalization that is an 
index admission for the MSPB measure during the applicable performance 
period.
    (4) For the acute condition episode-based measures specified for 
the 2017 performance period, an episode is attributed to each MIPS 
eligible clinician who bills at least 30 percent of inpatient 
evaluation and management (E&M) visits during the trigger event for the 
episode.
    (5) For the procedural episode-based measures specified for the 
2017 performance period, an episode is attributed to each MIPS eligible 
clinician who bills a Medicare Part B claim with a trigger code during 
the trigger event for the episode.
    (6) For the acute inpatient medical condition episode-based 
measures specified beginning with the 2019 performance period, an 
episode is attributed to each MIPS eligible clinician who bills 
inpatient E&M claim lines during a trigger inpatient hospitalization 
under a TIN that renders at least 30 percent of the inpatient E&M claim 
lines in that hospitalization.
    (7) For the procedural episode-based measures specified beginning 
with the 2019 performance period, an episode is attributed to each MIPS 
eligible clinician who renders a trigger service as identified by 
HCPCS/CPT procedure codes.
    (c) Case minimums. (1) For the total per capita cost measure, the 
case minimum is 20.
    (2) For the Medicare spending per beneficiary measure, the case 
minimum is 35.
    (3) For the episode-based measures specified for the 2017 
performance period, the case minimum is 20.
    (4) For the procedural episode-based measures specified beginning 
with the 2019 performance period, the case minimum is 10.
    (5) For the acute inpatient medical condition episode-based 
measures specified beginning with the 2019 performance period, the case 
minimum is 20.
    (d) Scoring weight. Unless a different scoring weight is assigned 
by CMS under section 1848(q)(5)(F) of the Act, performance in the cost 
performance category comprises:
    (1) Zero percent of a MIPS eligible clinician's final score for 
MIPS payment year 2019.
    (2) 10 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2020.
    (3) 15 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2021.

0
31. Section 414.1355 is amended by revising paragraphs (a), (b) 
introductory text, and (c) to read as follows:


Sec.  414.1355  Improvement activities performance category.

    (a) For a MIPS payment year, CMS uses improvement activities 
included in the MIPS final inventory of improvement activities 
established by CMS through rulemaking to assess performance in the 
improvement activities performance category.
    (b) Unless a different scoring weight is assigned by CMS under 
section 1848(q)(5)(F) of the Act, performance in the improvement 
activities performance category comprises:
* * * * *
    (c) The following are the list of subcategories, of which, with the 
exception of Participation in an APM, include activities for selection 
by a MIPS eligible clinician or group:
    (1) Expanded practice access, such as same day appointments for 
urgent needs and after-hours access to clinician advice.
    (2) Population management, such as monitoring health conditions of

[[Page 60080]]

individuals to provide timely health care interventions or 
participation in a QCDR.
    (3) Care coordination, such as timely communication of test 
results, timely exchange of clinical information to patients or other 
clinicians, and use of remote monitoring or telehealth.
    (4) Beneficiary engagement, such as the establishment of care plans 
for individuals with complex care needs, beneficiary self-management 
assessment and training, and using shared decision making mechanisms.
    (5) Patient safety and practice assessment, such as through the use 
of clinical or surgical checklists and practice assessments related to 
maintaining certification.
    (6) Participation in an APM.
    (7) Achieving health equity, such as for MIPS eligible clinicians 
that achieve high quality for underserved populations, including 
persons with behavioral health conditions, racial and ethnic 
minorities, sexual and gender minorities, people with disabilities, 
people living in rural areas, and people in geographic HPSAs.
    (8) Emergency preparedness and response, such as measuring MIPS 
eligible clinician participation in the Medical Reserve Corps, 
measuring registration in the Emergency System for Advance Registration 
of Volunteer Health Professionals, measuring relevant reserve and 
active duty uniformed services MIPS eligible clinician activities, and 
measuring MIPS eligible clinician volunteer participation in domestic 
or international humanitarian medical relief work.
    (9) Integrated behavioral and mental health, such as measuring or 
evaluating such practices as: Co-location of behavioral health and 
primary care services; shared/integrated behavioral health and primary 
care records; cross training of MIPS eligible clinicians, and 
integrating behavioral health with primary care to address substance 
use disorders or other behavioral health conditions, as well as 
integrating mental health with primary care.

0
32. Section 414.1360 is amended by revising paragraph (a)(1) to read as 
follows:


Sec.  414.1360   Data submission criteria for the improvement 
activities performance category.

    (a) * * *
    (1) Via direct, login and upload, and login and attest. For the 
applicable performance period, submit a yes response for each 
improvement activity that is performed for at least a continuous 90-day 
period during the applicable performance period.
* * * * *


Sec.  414.1365  [Removed]

0
33. Section 414.1365 is removed.

0
34. Section 414.1370 is amended by revising paragraphs (b)(3), (f)(2), 
(g)(4), (h)(4) introductory heading, (h)(5)(i)(A) and (B), and 
(h)(5)(ii) introductory text.
    The revisions read as follows:


Sec.  414.1370   APM scoring standard under MIPS.

* * * * *
    (b) * * *
    (3) The APM bases payment on quality measures and cost/utilization; 
and
* * * * *
    (f) * * *
    (2) MIPS eligible clinicians who participate in a group or have 
elected to participate in a virtual group and who are also on a MIPS 
APM Participation List will be included in the assessment under MIPS 
for purposes of producing a group or virtual group score and under the 
APM scoring standard for purposes of producing an APM Entity score. The 
MIPS payment adjustment for these eligible clinicians is based solely 
on their APM Entity score; if the APM Entity group is exempt from MIPS 
all eligible clinicians within that APM Entity group are also exempt 
from MIPS.
    (g) * * *
    (4) Promoting Interoperability. (i) For the 2019 and 2020 MIPS 
payment years, each Shared Savings Program ACO participant TIN must 
report data on the Promoting Interoperability performance category 
separately from the ACO, as specified in Sec.  414.1375(b)(2). The ACO 
participant TIN scores are weighted according to the number of MIPS 
eligible clinicians in each TIN as a proportion of the total number of 
MIPS eligible clinicians in the APM Entity group, and then aggregated 
to determine an APM Entity score for the ACI performance category.
    (ii) For the 2019 and 2020 MIPS payment years, for APM Entities in 
MIPS APMs other than the Shared Savings Program, CMS uses one score for 
each MIPS eligible clinician in the APM Entity group to derive a single 
average APM Entity score for the Promoting Interoperability performance 
category. Beginning with the 2021 MIPS payment year, for APM Entities 
in MIPS APMs including the Shared Savings Program, CMS uses one score 
for each MIPS eligible clinician in the APM Entity group to derive a 
single average APM Entity score for the Promoting Interoperability 
performance category. The score for each MIPS eligible clinician is the 
higher of either:
    (A) A group score based on the measure data for the Promoting 
Interoperability performance category reported by a TIN for the MIPS 
eligible clinician according to MIPS submission and reporting 
requirements for groups; or
    (B) An individual score based on the measure data for the Promoting 
Interoperability performance category reported by the MIPS eligible 
clinician according to MIPS submission and reporting requirements for 
individuals.
    (iii) In the event that a MIPS eligible clinician participating in 
a MIPS APM receives an exception from the Promoting Interoperability 
performance category reporting requirements, such eligible clinician 
will be assigned a null score when CMS calculates the APM Entity's 
Promoting Interoperability performance category score under the APM 
scoring standard.
    (A) If all MIPS eligible clinicians in an APM Entity have been 
excepted from reporting the Promoting Interoperability performance 
category, the performance category weight will be reweighted to zero 
for the APM Entity for that MIPS performance period.
    (B) [Reserved]
    (h) * * *
    (4) Promoting Interoperability. * * *
    (5) * * *
    (i) * * *
    (A) In 2017, the improvement activities performance category is 
reweighted to 25 percent and the Promoting Interoperability performance 
category is reweighted to 75 percent; and
    (B) Beginning in 2018, the Promoting Interoperability performance 
category is reweighted to 75 percent and the improvement activities 
performance category is reweighted to 25 percent.
    (ii) If CMS reweights the Promoting Interoperability performance 
category to zero percent:
* * * * *

0
35. Section 414.1375 is amended by revising the section heading, 
paragraphs (a), (b) introductory text, and (b)(2) to read as follows:


Sec.  414.1375   Promoting Interoperability (PI) performance category.

    (a) Final score. Unless a different scoring weight is assigned by 
CMS under sections 1848(o)(2)(D), 1848(q)(5)(E)(ii), or 1848(q)(5)(F) 
of the Act, performance in the Promoting Interoperability performance 
category comprises 25 percent of a MIPS eligible clinician's final 
score for each MIPS payment year.

[[Page 60081]]

    (b) Reporting for the Promoting Interoperability performance 
category. To earn a performance category score for the Promoting 
Interoperability performance category for inclusion in the final score, 
a MIPS eligible clinician must:
* * * * *
    (2) Report MIPS--Promoting Interoperability objectives and 
measures. Report on the objectives and associated measures as specified 
by CMS for the Promoting Interoperability performance category for the 
performance period as follows:
    (i) For the 2019 and 2020 MIPS payment years: For each base score 
measure, as applicable, report the numerator (of at least one) and 
denominator, or yes/no statement, or claim an exclusion for each 
measure that includes an option for an exclusion; and
    (ii) For the 2021 and 2022 MIPS payment years:
    (A) Report that the MIPS eligible clinician completed the actions 
included in the Security Risk Analysis measure during the year in which 
the performance period occurs; and
    (B) For each required measure, as applicable, report the numerator 
(of at least one) and denominator, or yes/no statement, or an exclusion 
for each measure that includes an option for an exclusion.
* * * * *

0
36. Section 414.1380 is revised to read as follows:


Sec.  414.1380  Scoring.

    (a) General. MIPS eligible clinicians are scored under MIPS based 
on their performance on measures and activities in four performance 
categories. MIPS eligible clinicians are scored against performance 
standards for each performance category and receive a final score, 
composed of their performance category scores, and calculated according 
to the final score methodology.
    (1) Performance standards. (i) For the quality performance 
category, measures are scored between zero and 10 measure achievement 
points. Performance is measured against benchmarks. Measure bonus 
points are available for submitting high-priority measures, submitting 
measures using end-to-end electronic reporting, and in small practices 
that submit data on at least 1 quality measure. Beginning with the 2020 
MIPS payment year, improvement scoring is available in the quality 
performance category.
    (ii) For the cost performance category, measures are scored between 
1 and 10 points. Performance is measured against a benchmark. Starting 
with the 2024 MIPS payment year, improvement scoring is available in 
the cost performance category.
    (iii) For the improvement activities performance category, each 
improvement activity is assigned a certain number of points. The points 
for all submitted activities are summed and scored against a total 
potential performance category score of 40 points.
    (iv) For the Promoting Interoperability performance category, each 
measure is scored against a maximum number of points. The points for 
all submitted measures are summed and scored against a total potential 
performance category score of 100 points.
    (2) [Reserved]
    (b) Performance categories. MIPS eligible clinicians are scored 
under MIPS in four performance categories.
    (1) Quality performance category. (i) Measure achievement points. 
For the 2019, 2020, and 2021 MIPS payment years, MIPS eligible 
clinicians receive between 3 and 10 measure achievement points 
(including partial points) for each measure required under Sec.  
414.1335 on which data is submitted in accordance with Sec.  414.1325 
that has a benchmark at paragraph (b)(1)(ii) of this section, meets the 
case minimum requirement at paragraph (b)(1)(iii) of this section, and 
meets the data completeness requirement at Sec.  414.1340. The number 
of measure achievement points received for each such measure is 
determined based on the applicable benchmark decile category and the 
percentile distribution. MIPS eligible clinicians receive zero measure 
achievement points for each measure required under Sec.  414.1335 on 
which no data is submitted in accordance with Sec.  414.1325. MIPS 
eligible clinicians that submit data in accordance with Sec.  414.1325 
on a greater number of measures than required under Sec.  414.1335 are 
scored only on the required measures with the greatest number of 
measure achievement points. Beginning with the 2021 MIPS payment year, 
MIPS eligible clinicians that submit data in accordance with Sec.  
414.1325 on a single measure via multiple collection types are scored 
only on the data submission with the greatest number of measure 
achievement points.
    (A) Lack of benchmark or case minimum. (1) Except as provided in 
paragraph (b)(1)(i)(A)(2) of this section, for the 2019, 2020, and 2021 
MIPS payment years, MIPS eligible clinicians receive 3 measure 
achievement points for each submitted measure that meets the data 
completeness requirement, but does not have a benchmark or meet the 
case minimum requirement.
    (2) The following measures are excluded from a MIPS eligible 
clinician's total measure achievement points and total available 
measure achievement points:
    (i) Each submitted CMS Web Interface-based measure that meets the 
data completeness requirement, but does not have a benchmark or meet 
the case minimum requirement, or is redesignated as pay-for-reporting 
for all Shared Savings Program accountable care organizations by the 
Shared Savings Program; and
    (ii) Each administrative claims-based measure that does not have a 
benchmark or meet the case minimum requirement.
    (B) Lack of complete data. (1) Except as provided in paragraph 
(b)(1)(i)(B)(2) of this section, for each submitted measure that does 
not meet the data completeness requirement:
    (i) For the 2019 MIPS payment year, MIPS eligible clinicians 
receive 3 measure achievement points;
    (ii) For the 2020 and 2021 MIPS payment years, MIPS eligible 
clinicians other than small practices receive 1 measure achievement 
point, and small practices receive 3 measure achievement points; and
    (iii) Beginning with the 2022 MIPS payment year, MIPS eligible 
clinicians other than small practices receive zero measure achievement 
points, and small practices receive 3 measure achievement points.
    (2) MIPS eligible clinicians receive zero measure achievement 
points for each submitted CMS Web Interface-based measure that does not 
meet the data completeness requirement.
    (ii) Benchmarks. Benchmarks will be based on collection type, from 
all available sources, including MIPS eligible clinicians and APMs, to 
the extent feasible, during the applicable baseline or performance 
period.
    (A) Each benchmark must have a minimum of 20 individual clinicians 
or groups who reported the measure meeting the case minimum requirement 
at paragraph (b)(1)(iii) of this section and the data completeness 
requirement at Sec.  414.1340 and having a performance rate that is 
greater than zero.
    (B) CMS Web Interface collection type uses benchmarks from the 
corresponding reporting year of the Shared Savings Program.
    (iii) Minimum case requirements. Except for the all-cause hospital 
readmission measure, the minimum case requirement is 20 cases. For the 
all-cause hospital readmission measure, the minimum case requirement is 
200 cases.

[[Page 60082]]

    (iv) Topped out measures. CMS will identify topped out measures in 
the benchmarks published for each Quality Payment Program year.
    (A) For the 2020 MIPS payment year, each topped out measure 
specified by CMS through rulemaking receives no more than 7 measure 
achievement points, provided that the benchmark for the applicable 
collection type is identified as topped out in the benchmarks published 
for the 2018 MIPS performance period.
    (B) Beginning with the 2021 MIPS payment year, each measure (except 
for measures in the CMS Web Interface) for which the benchmark for the 
applicable collection type is identified as topped out for 2 or more 
consecutive years receives no more than 7 measure achievement points in 
the second consecutive year it is identified as topped out, and beyond.
    (v) Measure bonus points. MIPS eligible clinicians receive measure 
bonus points for the following measures, except as otherwise required 
under Sec.  414.1335, regardless of whether the measure is included in 
the MIPS eligible clinician's total measure achievement points.
    (A) High priority measures. Subject to paragraph (b)(1)(v)(A)(1) of 
this section, MIPS eligible clinicians receive 2 measure bonus points 
for each outcome and patient experience measure and 1 measure bonus 
point for each other high priority measure. Beginning with the 2021 
MIPS payment year, MIPS eligible clinicians do not receive such measure 
bonus points for CMS Web Interface measures.
    (1) Limitations. (i) Each high priority measure must have a 
benchmark at paragraph (b)(1)(ii) of this section, meet the case 
minimum requirement at (b)(1)(iii) of this section, meet the data 
completeness requirement at Sec.  414.1340, and have a performance rate 
that is greater than zero.
    (ii) For the 2019, 2020, and 2021 MIPS payment years, the total 
measure bonus points for high priority measures cannot exceed 10 
percent of the total available measure achievement points.
    (iii) Beginning with the 2021 MIPS payment year, MIPS eligible 
clinicians that collect data in accordance with Sec.  414.1325 on a 
single measure via multiple collection types receive measure bonus 
points only once.
    (B) End-to-end electronic reporting. Subject to paragraph 
(b)(1)(v)(B)(1) of this section, MIPS eligible clinicians receive 1 
measure bonus point for each measure (except claims-based measures) 
submitted with end-to-end electronic reporting for a quality measure 
under certain criteria determined by the Secretary.
    (1) Limitations. (i) For the 2019, 2020, and 2021 MIPS payment 
years, the total measure bonus points for measures submitted with end-
to-end electronic reporting cannot exceed 10 percent of the total 
available measure achievement points.
    (ii) Beginning with the 2021 MIPS payment year, MIPS eligible 
clinicians that collect data in accordance with Sec.  414.1325 on a 
single measure via multiple collection types receive measure bonus 
points only once.
    (C) Small practices. Beginning with the 2021 MIPS payment year, 
MIPS eligible clinicians in small practices receive 6 measure bonus 
points if they submit data to MIPS on at least 1 quality measure.
    (vi) Improvement scoring. Improvement scoring is available to MIPS 
eligible clinicians that demonstrate improvement in performance in the 
current MIPS performance period compared to performance in the 
performance period immediately prior to the current MIPS performance 
period based on measure achievement points.
    (A) Improvement scoring is available when the data sufficiency 
standard is met, which means when data are available and a MIPS 
eligible clinician has a quality performance category achievement 
percent score for the previous performance period and the current 
performance period.
    (1) Data must be comparable to meet the requirement of data 
sufficiency which means that the quality performance category 
achievement percent score is available for the current performance 
period and the previous performance period and quality performance 
category achievement percent scores can be compared.
    (2) Quality performance category achievement percent scores are 
comparable when submissions are received from the same identifier for 
two consecutive performance periods.
    (3) If the identifier is not the same for 2 consecutive performance 
periods, then for individual submissions, the comparable quality 
performance category achievement percent score is the highest available 
quality performance category achievement percent score associated with 
the final score from the prior performance period that will be used for 
payment for the individual. For group, virtual group, and APM Entity 
submissions, the comparable quality performance category achievement 
percent score is the average of the quality performance category 
achievement percent score associated with the final score from the 
prior performance period that will be used for payment for each of the 
individuals in the group.
    (4) Improvement scoring is not available for clinicians who were 
scored under facility-based measurement in the performance period 
immediately prior to the current MIPS performance period.
    (B) The improvement percent score may not total more than 10 
percentage points.
    (C) The improvement percent score is assessed at the performance 
category level for the quality performance category and included in the 
calculation of the quality performance category percent score as 
described in paragraph (b)(1)(vii) of this section.
    (1) The improvement percent score is awarded based on the rate of 
increase in the quality performance category achievement percent score 
of MIPS eligible clinicians from the previous performance period to the 
current performance period.
    (2) An improvement percent score is calculated by dividing the 
increase in the quality performance category achievement percent score 
from the prior performance period to the current performance period by 
the prior performance period quality performance category achievement 
percent score multiplied by 10 percent.
    (3) An improvement percent score cannot be lower than zero 
percentage points.
    (4) For the 2020 and 2021 MIPS payment year, we will assume a 
quality performance category achievement percent score of 30 percent if 
a MIPS eligible clinician earned a quality performance category score 
less than or equal to 30 percent in the previous year.
    (5) The improvement percent score is zero if the MIPS eligible 
clinician did not fully participate in the quality performance category 
for the current performance period.
    (D) For the purpose of improvement scoring methodology, the term 
``quality performance category achievement percent score'' means the 
total measure achievement points divided by the total available measure 
achievement points, without consideration of measure bonus points or 
improvement percent score.
    (E) For the purpose of improvement scoring methodology, the term 
``improvement percent score'' means the score that represents 
improvement for the purposes of calculating the quality performance 
category percent score as described in paragraph (b)(1)(vii) of this 
section.
    (F) For the purpose of improvement scoring methodology, the term 
``fully participate'' means the MIPS eligible

[[Page 60083]]

clinician met all requirements in Sec. Sec.  414.1335 and 414.1340.
    (vii) Quality performance category score. A MIPS eligible 
clinician's quality performance category percent score is the sum of 
all the measure achievement points assigned for the measures required 
for the quality performance category criteria plus the measure bonus 
points in paragraph (b)(1)(v) of this section. The sum is divided by 
the sum of total available measure achievement points. The improvement 
percent score in paragraph (b)(1)(vi) of this section is added to that 
result. The quality performance category percent score cannot exceed 
100 percentage points.
    (A) Beginning with the 2021 MIPS payment year, for each measure 
that a MIPS eligible clinician submits that is significantly impacted 
by clinical guideline changes or other changes that CMS believes may 
result in patient harm or misleading results, the total available 
measure achievement points are reduced by 10 points.
    (B) Beginning with the 2021 MIPS payment year, for groups that 
submit 5 or fewer measures and register for the CAHPS for MIPS survey 
but do not meet the minimum beneficiary sampling requirements, the 
total available measure achievement points are reduced by 10 points.
    (viii) ICD-10 updates. Beginning with the 2018 MIPS performance 
period, measures significantly impacted by ICD-10 updates, as 
determined by CMS, will be assessed based only on the first 9 months of 
the 12-month performance period. For purposes of this paragraph 
(b)(1)(viii), CMS will make a determination as to whether a measure is 
significantly impacted by ICD-10 coding changes during the performance 
period. CMS will publish on the CMS website which measures require a 9-
month assessment process by October 1st of the performance period if 
technically feasible, but by no later than the beginning of the data 
submission period at Sec.  414.1325(f)(1).
    (2) Cost performance category. For each cost measure attributed to 
a MIPS eligible clinician, the clinician receives one to ten 
achievement points based on the clinician's performance on the measure 
during the performance period compared to the measure's benchmark. 
Achievement points are awarded based on which benchmark decile range 
the MIPS eligible clinician's performance on the measure is between. 
CMS assigns partial points based on the percentile distribution.
    (i) Cost measure benchmarks are determined by CMS based on cost 
measure performance during the performance period. At least 20 MIPS 
eligible clinicians or groups must meet the minimum case volume 
specified under Sec.  414.1350(c) for a cost measure in order for a 
benchmark to be determined for the measure. If a benchmark is not 
determined for a cost measure, the measure will not be scored.
    (ii) A MIPS eligible clinician must meet the minimum case volume 
specified under Sec.  414.1350(c) to be scored on a cost measure.
    (iii) The cost performance category percent score is the sum of the 
following, not to exceed 100 percent:
    (A) The total number of achievement points earned by the MIPS 
eligible clinician divided by the total number of available achievement 
points; and
    (B) The cost improvement score, as determined under paragraph 
(b)(2)(iv) of this section.
    (iv) The cost improvement score is determined for a MIPS eligible 
clinician that demonstrates improvement in performance in the current 
MIPS performance period compared to their performance in the 
immediately preceding MIPS performance period.
    (A) The cost improvement score is determined at the measure level 
for the cost performance category.
    (B) The cost improvement score is calculated only when data 
sufficient to measure improvement is available. Sufficient data is 
available when a MIPS eligible clinician or group participates in MIPS 
using the same identifier in 2 consecutive performance periods and is 
scored on the same cost measure(s) for 2 consecutive performance 
periods. If the cost improvement score cannot be calculated because 
sufficient data is not available, then the cost improvement score is 
zero.
    (C) The cost improvement score is determined by comparing the 
number of measures with a statistically significant change (improvement 
or decline) in performance; a change is determined to be significant 
based on application of a t-test. The number of cost measures with a 
significant decline is subtracted from the number of cost measures with 
a significant improvement, with the result divided by the number of 
cost measures for which the MIPS eligible clinician or group was scored 
for 2 consecutive performance periods. The resulting fraction is then 
multiplied by the maximum cost improvement score.
    (D) The cost improvement score cannot be lower than zero percentage 
points.
    (E) The maximum cost improvement score for the 2020, 2021, 2022, 
and 2023 MIPS payment years is zero percentage points.
    (v) A cost performance category percent score is not calculated if 
a MIPS eligible clinician or group is not attributed any cost measures 
for the performance period because the clinician or group has not met 
the minimum case volume specified by CMS for any of the cost measures 
or a benchmark has not been created for any of the cost measures that 
would otherwise be attributed to the clinician or group.
    (3) Improvement activities performance category. Subject to 
paragraphs (b)(3)(i) and (ii) of this section, the improvement 
activities performance category score equals the total points for all 
submitted improvement activities divided by 40 points, multiplied by 
100 percent. MIPS eligible clinicians (except for non-patient facing 
MIPS eligible clinicians, small practices, and practices located in 
rural areas and geographic HPSAs) receive 10 points for each medium-
weighted improvement activity and 20 points for each high-weighted 
improvement activity required under Sec.  414.1360 on which data is 
submitted in accordance with Sec.  414.1325. Non-patient facing MIPS 
eligible clinicians, small practices, and practices located in rural 
areas and geographic HPSAs receive 20 points for each medium-weighted 
improvement activity and 40 points for each high-weighted improvement 
activity required under Sec.  414.1360 on which data is submitted in 
accordance with Sec.  414.1325.
    (i) For MIPS eligible clinicians participating in APMs, the 
improvement activities performance category score is at least 50 
percent.
    (ii) For MIPS eligible clinicians in a practice that is certified 
or recognized as a patient-centered medical home or comparable 
specialty practice, as determined by the Secretary, the improvement 
activities performance category score is 100 percent. For the 2019 MIPS 
payment year, at least one practice site within a group's TIN must be 
certified or recognized as a patient-centered medical home or 
comparable specialty practice. For the 2020 MIPS payment year and 
future years, at least 50 percent of the practice sites within a 
group's TIN must be recognized as a patient-centered medical home or 
comparable specialty practice. MIPS eligible clinicians that wish to 
claim this status for purposes of receiving full credit in the 
improvement activities performance category must attest to their status 
as a patient-centered medical home or comparable specialty practice in 
order to receive this credit. A practice is certified or recognized as

[[Page 60084]]

a patient-centered medical home if it meets any of the following 
criteria:
    (A) The practice has received accreditation from one of four 
accreditation organizations that are nationally recognized;
    (1) The Accreditation Association for Ambulatory Health Care;
    (2) The National Committee for Quality Assurance (NCQA);
    (3) The Joint Commission; or
    (4) The Utilization Review Accreditation Commission (URAC).
    (B) The practice is participating in a Medicaid Medical Home Model 
or Medical Home Model.
    (C) The practice is a comparable specialty practice that has 
received the NCQA Patient-Centered Specialty Recognition.
    (D) The practice has received accreditation from other certifying 
bodies that have certified a large number of medical organizations and 
meet national guidelines, as determined by the Secretary. The Secretary 
must determine that these certifying bodies must have 500 or more 
certified member practices, and require practices to include the 
following:
    (1) Have a personal physician/clinician in a team-based practice.
    (2) Have a whole-person orientation.
    (3) Provide coordination or integrated care.
    (4) Focus on quality and safety.
    (5) Provide enhanced access.
    (4) Promoting Interoperability performance category. (i) For the 
2019 and 2020 MIPS payment years, a MIPS eligible clinician's Promoting 
Interoperability performance category score equals the sum of the base 
score, performance score, and any applicable bonus scores, not to 
exceed 100 percentage points. A MIPS eligible clinician cannot earn a 
performance score or bonus score unless they have earned a base score.
    (A) A MIPS eligible clinician earns a base score by reporting for 
each base score measure, as applicable: The numerator (of at least one) 
and denominator, or a yes/no statement, or an exclusion.
    (B) A MIPS eligible clinician earns a performance score by 
reporting on the performance score measures specified by CMS. A MIPS 
eligible clinician may earn up to 10 or 20 percentage points as 
specified by CMS for each performance score measure reported.
    (C) A MIPS eligible clinician may earn the following bonus scores:
    (1) A bonus score of 5 percentage points for reporting to one or 
more additional public health agencies or clinical data registries.
    (2) A bonus score of 10 percentage points for attesting to 
completing one or more improvement activities specified by CMS using 
CEHRT.
    (3) For the 2020 MIPS payment year, a bonus score of 10 percentage 
points for submitting data for the measures for the base score and the 
performance score generated solely from CEHRT as defined in Sec.  
414.1305 for 2019 and subsequent years.
    (ii) For the 2021 and 2022 MIPS payment years, a MIPS eligible 
clinician's Promoting Interoperability performance category score 
equals the sum of the scores for each of the six required measures and 
any applicable bonus scores, not to exceed 100 points.
    (A) A MIPS eligible clinician earns a score for each measure by 
reporting, as applicable: the numerator (of at least one) and 
denominator, or a yes/no statement. If an exclusion is reported for a 
measure, the points available for that measure are redistributed to 
another measure(s).
    (B) Each required measure is worth 10, 20, or 40 points, as 
specified by CMS.
    (C) Each optional measure is worth five bonus points.
    (c) Final score calculation. Each MIPS eligible clinician receives 
a final score of 0 to 100 points for a performance period for a MIPS 
payment year calculated as follows. If a MIPS eligible clinician is 
scored on fewer than 2 performance categories, he or she receives a 
final score equal to the performance threshold.

------------------------------------------------------------------------
 
-------------------------------------------------------------------------
For the 2019 MIPS payment year:
    Final score = [(quality performance category percent score x quality
     performance category weight) + (cost performance category percent
     score x cost performance category weight) + (improvement activities
     performance category score x improvement activities performance
     category weight) + (Promoting Interoperability performance category
     score x Promoting Interoperability performance category weight)],
     not to exceed 100 points.
For the 2020 MIPS payment year:
    Final score = [(quality performance category percent score x quality
     performance category weight) + (cost performance category percent
     score x cost performance category weight) + (improvement activities
     performance category score x improvement activities performance
     category weight) + (Promoting Interoperability performance category
     score x Promoting Interoperability performance category weight)] x
     100 + [the complex patient bonus + the small practice bonus], not
     to exceed 100 points.
Beginning with the 2021 MIPS payment year:
    Final score = [(quality performance category percent score x quality
     performance category weight) + (cost performance category percent
     score x cost performance category weight) + (improvement activities
     performance category score x improvement activities performance
     category weight) + (Promoting Interoperability performance category
     score x Promoting Interoperability performance category weight)] x
     100 + the complex patient bonus, not to exceed 100 points.
------------------------------------------------------------------------

    (1) Performance category weights. The weights of the performance 
categories in the final score are as follows, unless a different 
scoring weight is assigned under paragraph (c)(2) of this section:
    (i) Quality performance category weight is defined under Sec.  
414.1330(b).
    (ii) Cost performance category weight is defined under Sec.  
414.1350(d).
    (iii) Improvement activities performance category weight is defined 
under Sec.  414.1355(b).
    (iv) Promoting Interoperability performance category weight is 
defined under Sec.  414.1375(a).
    (2) Reweighting the performance categories. (i) In accordance with 
paragraph (c)(2)(ii) of this section, a scoring weight different from 
the weights specified in paragraph (c)(1) of this section will be 
assigned to a performance category, and its weight as specified in 
paragraph (c)(1) of this section will be redistributed to another 
performance category or categories, in the following circumstances:
    (A) CMS determines based on the following circumstances that there 
are not sufficient measures and activities applicable and available 
under section 1848(q)(5)(F) of the Act.
    (1) For the quality performance category, CMS cannot calculate a 
score for the MIPS eligible clinician because there is not at least one 
quality measure applicable and available to the clinician.
    (2) For the cost performance category, CMS cannot reliably 
calculate a score for the cost measures that adequately captures and 
reflects the performance of the MIPS eligible clinician.
    (3) Beginning with the 2021 MIPS payment year, for the quality, 
cost, improvement activities, and Promoting

[[Page 60085]]

Interoperability performance categories, the MIPS eligible clinician 
joins an existing practice during the final 3 months of the performance 
period year that is not participating in MIPS as a group or joins a 
practice that is newly formed during the final 3 months of the 
performance period year.
    (4) For the Promoting Interoperability performance category 
beginning with the 2021 MIPS payment year, the MIPS eligible clinician 
is a physical therapist, occupational therapist, clinical psychologist, 
qualified audiologist, qualified speech-language pathologist, or a 
registered dietitian or nutrition professional. In the event that a 
MIPS eligible clinician submits data for the Promoting Interoperability 
performance category, the scoring weight specified in paragraph (c)(1) 
of this section will be applied and its weight will not be 
redistributed.
    (5) For the Promoting Interoperability performance category for the 
2019, 2020, and 2021 MIPS payment years, the MIPS eligible clinician is 
a nurse practitioner, physician assistant, clinical nurse specialist, 
or certified registered nurse anesthetist. In the event that a MIPS 
eligible clinician submits data for the Promoting Interoperability 
performance category, the scoring weight specified in paragraph (c)(1) 
of this section will be applied and its weight will not be 
redistributed.
    (6) Beginning with the 2020 MIPS payment year, for the quality, 
cost, and improvement activities performance categories, the MIPS 
eligible clinician demonstrates through an application submitted to CMS 
that they were subject to extreme and uncontrollable circumstances that 
prevented the clinician from collecting information that the clinician 
would submit for a performance category or submitting information that 
would be used to score a performance category for an extended period of 
time. Beginning with the 2021 MIPS payment year, in the event that a 
MIPS eligible clinician submits data for the quality, cost, or 
improvement activities performance categories, the scoring weight 
specified in paragraph (c)(1) of this section will be applied and its 
weight will not be redistributed.
    (7) For the 2019 MIPS payment year, for the quality and improvement 
activities performance categories, the MIPS eligible clinician was 
located in an area affected by extreme and uncontrollable circumstances 
as identified by CMS. In the event that a MIPS eligible clinician 
submits data for a performance category, the scoring weight specified 
in paragraph (c)(1) of this section will be applied and its weight will 
not be redistributed.
    (8) Beginning with the 2020 MIPS payment year, for the quality, 
cost, and improvement activities performance categories, the MIPS 
eligible clinician was located in an area affected by extreme and 
uncontrollable circumstances as identified by CMS. In the event that a 
MIPS eligible clinician submits data for the quality or improvement 
activities performance categories, the scoring weight specified in 
paragraph (c)(1) of this section will be applied and its weight will 
not be redistributed.
    (B) Under section 1848(q)(5)(E)(ii) of the Act, CMS estimates that 
the proportion of MIPS eligible clinicians who are physicians as 
defined in section 1861(r) of the Act and earn a Promoting 
Interoperability performance category score of at least 75 percent is 
75 percent or greater. The estimation is based on data from the 
performance period that occurs four years before the MIPS payment year 
and does not include physicians for whom the Promoting Interoperability 
performance category is weighted at zero percent.
    (C) Under section 1848(o)(2)(D) of the Act, a significant hardship 
exception or other type of exception is granted to a MIPS eligible 
clinician based on the following circumstances for the Promoting 
Interoperability performance category. In the event that a MIPS 
eligible clinician submits data for the Promoting Interoperability 
performance category, the scoring weight specified in paragraph (c)(1) 
of this section will be applied and its weight will not be 
redistributed.
    (1) The MIPS eligible clinician demonstrates through an application 
submitted to CMS that they lacked sufficient internet access during the 
performance period, and insurmountable barriers prevented the clinician 
from obtaining sufficient internet access.
    (2) The MIPS eligible clinician demonstrates through an application 
submitted to CMS that they were subject to extreme and uncontrollable 
circumstances that caused their CEHRT to be unavailable.
    (3) The MIPS eligible clinician was located in an area affected by 
extreme and uncontrollable circumstances as identified by CMS.
    (4) The MIPS eligible clinician demonstrates through an application 
submitted to CMS that 50 percent or more of their outpatient encounters 
occurred in practice locations where they had no control over the 
availability of CEHRT.
    (5) The MIPS eligible clinician is a non-patient facing MIPS 
eligible clinician as defined in Sec.  414.1305.
    (6) The MIPS eligible clinician is a hospital-based MIPS eligible 
clinician as defined in Sec.  414.1305.
    (7) The MIPS eligible clinician is an ASC-based MIPS eligible 
clinician as defined in Sec.  414.1305.
    (8) Beginning with the 2020 MIPS payment year, the MIPS eligible 
clinician demonstrates through an application submitted to CMS that 
their CEHRT was decertified either during the performance period for 
the MIPS payment year or during the calendar year preceding the 
performance period for the MIPS payment year, and the MIPS eligible 
clinician made a good faith effort to adopt and implement another CEHRT 
in advance of the performance period. In no case may a MIPS eligible 
clinician be granted this exception for more than 5 years.
    (9) Beginning with the 2020 MIPS payment year, the MIPS eligible 
clinician demonstrates through an application submitted to CMS that 
they are in a small practice as defined in Sec.  414.1305, and 
overwhelming barriers prevent them from complying with the requirements 
for the Promoting Interoperability performance category.
    (ii) A scoring weight different from the weights specified in 
paragraph (c)(1) of this section will be assigned to a performance 
category, and its weight as specified in paragraph (c)(1) of this 
section will be redistributed to another performance category or 
categories, as follows:
    (A) For the 2019 MIPS payment year:

----------------------------------------------------------------------------------------------------------------
                                                                    Reweight         Reweight        Reweight
                                                                 scenario if no   scenario if no  scenario if no
                                                 Weighting for      promoting         quality       improvement
           Performance category (%)              the 2019 MIPS  interoperability    performance     activities
                                                 payment year      performance       category       performance
                                                      (%)        category score    percent score  category score
                                                                       (%)              (%)             (%)
----------------------------------------------------------------------------------------------------------------
Quality.......................................              60               85                0              75
Cost..........................................               0                0                0               0
Improvement Activities........................              15               15               50               0

[[Page 60086]]

 
Promoting Interoperability....................              25                0               50              25
----------------------------------------------------------------------------------------------------------------

    (B) For the 2020 MIPS payment year:

----------------------------------------------------------------------------------------------------------------
                                                                                                    Promoting
             Reweighting scenario                 Quality (%)      Cost (%)       Improvement   interoperability
                                                                                activities (%)         (%)
----------------------------------------------------------------------------------------------------------------
No Reweighting Needed:
    --Scores for all four performance                       50              10              15               25
     categories...............................
Reweight One Performance Category:
    --No Cost.................................              60               0              15               25
    --No Promoting Interoperability...........              75              10              15                0
    --No Quality..............................               0              10              45               45
    --No Improvement Activities...............              65              10               0               25
Reweight Two Performance Categories:
    --No Cost and no Promoting                              85               0              15                0
     Interoperability.........................
    --No Cost and no Quality..................               0               0              50               50
    --No Cost and no Improvement Activities...              75               0               0               25
    --No Promoting Interoperability and no                   0              10              90                0
     Quality..................................
    --No Promoting Interoperability and no                  90              10               0                0
     Improvement Activities...................
    --No Quality and no Improvement Activities               0              10               0               90
----------------------------------------------------------------------------------------------------------------

    (C) For the 2021 MIPS payment year:

----------------------------------------------------------------------------------------------------------------
                                                                                                    Promoting
             Reweighting scenario                 Quality (%)      Cost (%)       Improvement   interoperability
                                                                                activities (%)         (%)
----------------------------------------------------------------------------------------------------------------
No Reweighting Needed:
    --Scores for all four performance                       45              15              15               25
     categories...............................
Reweight One Performance Category:
    --No Cost.................................              60               0              15               25
    --No Promoting Interoperability...........              70              15              15                0
    --No Quality..............................               0              15              40               45
    --No Improvement Activities...............              60              15               0               25
Reweight Two Performance Categories:
    --No Cost and no Promoting                              85               0              15                0
     Interoperability.........................
    --No Cost and no Quality..................               0               0              50               50
    --No Cost and no Improvement Activities...              75               0               0               25
    --No Promoting Interoperability and no                   0              15              85                0
     Quality..................................
    --No Promoting Interoperability and no                  85              15               0                0
     Improvement Activities...................
    --No Quality and no Improvement Activities               0              15               0               85
----------------------------------------------------------------------------------------------------------------

    (iii) For MIPS eligible clinicians submitting data as a group or 
virtual group, in order for the Promoting Interoperability performance 
category to be reweighted in accordance with paragraph (c)(2)(ii) of 
this section, all of the MIPS eligible clinicians in the group must 
qualify for reweighting based on the circumstances described in 
paragraph (c)(2)(i) of this section.
    (3) Complex patient bonus. For the 2020 and 2021 MIPS payment 
years, provided that a MIPS eligible clinician, group, virtual group or 
APM entity submits data for at least one MIPS performance category for 
the applicable performance period for the MIPS payment year, a complex 
patient bonus will be added to the final score for the MIPS payment 
year, as follows:
    (i) For MIPS eligible clinicians and groups, the complex patient 
bonus is calculated as follows: [The average HCC risk score assigned to 
beneficiaries (pursuant to the HCC risk adjustment model established by 
CMS pursuant to section 1853(a)(1) of the Act) seen by the MIPS 
eligible clinician or seen by clinicians in a group] + [the dual 
eligible ratio x 5].
    (ii) For APM entities and virtual groups, the complex patient bonus 
is calculated as follows: [The beneficiary weighted average HCC risk 
score for all MIPS eligible clinicians, and if technically feasible, 
TINs for models and virtual groups which rely on complete TIN 
participation within the APM entity or virtual group, respectively] + 
[the average dual eligible ratio for all MIPS eligible clinicians, and 
if technically feasible, TINs for models and virtual groups which rely 
on complete TIN participation, within the APM entity or virtual group, 
respectively, x 5].
    (iii) The complex patient bonus cannot exceed 5.0.
    (4) Small practice bonus. A small practice bonus of 5 points will 
be added to the final score for the 2020 MIPS payment year for MIPS 
eligible clinicians, groups, virtual groups, and APM Entities that meet 
the definition of a small practice as defined at Sec.  414.1305 and 
participate in MIPS by submitting

[[Page 60087]]

data on at least one performance category in the 2018 MIPS performance 
period.
    (d) Scoring for APM Entities. MIPS eligible clinicians in APM 
Entities that are subject to the APM scoring standard are scored using 
the methodology under Sec.  414.1370.
    (e) Scoring for facility-based measurement. For the payment in 2021 
MIPS payment year and subsequent years and subject to paragraph 
(e)(6)(vi) of this section, a MIPS eligible clinician or group will be 
scored under the quality and cost performance categories using the 
methodology described in this paragraph (e).
    (1) General. The facility-based measurement scoring standard is the 
MIPS scoring methodology applicable for MIPS eligible clinicians 
identified as meeting the requirements in paragraph (e)(2) of this 
section.
    (i) The measures used for facility-based measurement are the 
measure set finalized for the fiscal year value-based purchasing 
program for which payment begins during the applicable MIPS performance 
period.
    (ii) Beginning with the 2021 MIPS payment year, the scoring 
methodology applicable for MIPS eligible clinicians scored with 
facility-based measurement is the Total Performance Score methodology 
adopted for the Hospital VBP Program, for the fiscal year for which 
payment begins during the applicable MIPS performance period.
    (2) Eligibility for facility-based measurement. MIPS eligible 
clinicians are eligible for facility-based measurement for a MIPS 
payment year if they are determined to be facility-based as an 
individual clinician or as part of a group, as follows:
    (i) Facility-based individual determination. A MIPS eligible 
clinician is facility-based if the clinician meets all of the following 
criteria:
    (A) Furnishes 75 percent or more of his or her covered professional 
services in sites of service identified by the place of service codes 
used in the HIPAA standard transaction as an inpatient hospital, on-
campus outpatient hospital, or emergency room setting based on claims 
for a 12-month segment beginning on October 1 of the calendar year 2 
years prior to the applicable performance period and ending on 
September 30 of the calendar year preceding the performance period with 
a 30-day claims run out.
    (B) Furnishes at least 1 covered professional service in sites of 
service identified by the place of service codes used in the HIPAA 
standard transaction as an inpatient hospital, or emergency room 
setting.
    (C) Can be attributed, under the methodology specified in paragraph 
(e)(5) of this section, to a facility with a value-based purchasing 
score for the applicable period.
    (ii) Facility-based group determination. A facility-based group is 
a group in which 75 percent or more of its eligible clinician NPIs 
billing under the group's TIN meet the requirements under paragraph 
(e)(2)(i) of this section.
    (3) [Reserved]
    (4) Data submission for facility-based measurement. There are no 
data submission requirements for individual clinicians to be scored 
under facility-based measurement. A group must submit data in the 
improvement activities or Promoting Interoperability performance 
categories in order to be scored as a facility-based group.
    (5) Determination of applicable facility score. (i) A facility-
based clinician is scored with facility-based measurement using the 
score derived from the value-based purchasing score for the facility at 
which the clinician provided services to the most Medicare 
beneficiaries during the period the claims are drawn from in paragraph 
(e)(2) of this section. If there is an equal number of Medicare 
beneficiaries treated at more than one facility, the value-based 
purchasing score for the highest scoring facility is used.
    (ii) A facility-based group is scored with facility-based 
measurement using the score derived from the value-based purchasing 
score for the facility at which the plurality of clinicians identified 
as facility-based would have had their score determined under paragraph 
(e)(5)(i) of this section.
    (6) MIPS performance category scoring under the facility-based 
measurement scoring standard--(i) Measures. The quality and cost 
measures are those adopted under the value-based purchasing program of 
the facility for the year described in paragraph (e)(1)(i) of this 
section.
    (ii) Benchmarks. The benchmarks are those adopted under the value-
based purchasing program of the facility program for the year described 
in paragraph (e)(1) of this section.
    (iii) Performance period. The performance period for facility-based 
measurement is the performance period for the measures adopted under 
the value-based purchasing program of the facility program for the year 
described in paragraph (e)(1) of this section.
    (iv) Quality. The quality performance category percent score is 
established by determining the percentile performance of the facility 
in the value-based purchasing program for the specified year as 
described in paragraph (e)(1) of this section and awarding a score 
associated with that same percentile performance in the MIPS quality 
performance category percent score for those MIPS-eligible clinicians 
who are not eligible to be scored using facility-based measurement for 
the MIPS payment year. A clinician or group receiving a facility-based 
performance score will not earn improvement points based on prior 
performance in the MIPS quality performance category
    (v) Cost. The cost performance category percent score is 
established by determining the percentile performance of the facility 
in the value-based purchasing program for the specified year as 
described in paragraph (e)(1) of this section and awarding a score 
associated with that same percentile performance in the MIPS cost 
performance category percent score for those MIPS eligible clinicians 
who are not eligible to be scored using facility-based measurement for 
the MIPS payment year. A clinician or group receiving a facility-based 
performance score will not earn improvement points based on prior 
performance in the MIPS cost category.
    (A) Other cost measures. MIPS eligible clinicians who are scored 
under facility-based measurement are not scored on cost measures 
described in paragraph (b)(2) of this section.
    (B) [Reserved]
    (vi) Use of score from facility-based measurement. The MIPS quality 
and cost performance category scores will be based on the facility-
based measurement scoring methodology described in paragraph (e)(6) of 
this section unless a clinician or group receives a higher combined 
MIPS quality and cost performance category score through another MIPS 
submission.

0
37. Section 414.1395 is amended by revising paragraphs (b) and (c) to 
read as follows:


Sec.  414.1395  Public reporting.

* * * * *
    (b) Maintain existing public reporting standards. With the 
exception of data that must be mandatorily reported on Physician 
Compare, for each program year, CMS relies on established public 
reporting standards to guide the information available for inclusion on 
Physician Compare. The public reporting standards require data included 
on Physician Compare to be statistically valid, reliable, and accurate; 
comparable across collection types; and meet the reliability threshold. 
And, to be included on the public facing profile pages, the data must 
also resonate with website users, as determined by CMS.

[[Page 60088]]

    (c) First year measures. For each program year, CMS does not 
publicly report any first year measure for the first 2 years, meaning 
any measure in its first 2 years of use in the quality and cost 
performance categories. After the first 2 years, CMS reevaluates 
measures to determine when and if they are suitable for public 
reporting.
* * * * *

0
38. Section 414.1400 is revised to read as follows:


Sec.  414.1400  Third party intermediaries.

    (a) General. (1) MIPS data may be submitted on behalf of a MIPS 
eligible clinician, group, or virtual group by any of the following 
third party intermediaries:
    (i) A QCDR;
    (ii) A qualified registry;
    (iii) A health IT vendor; or
    (iv) A CMS-approved survey vendor.
    (2) QCDRs, qualified registries, and health IT vendors may submit 
MIPS data for any of the following MIPS performance categories:
    (i) Quality, except for data on the CAHPS for MIPS survey;
    (ii) Improvement activities; or
    (iii) Promoting Interoperability, if the MIPS eligible clinician, 
group, or virtual group is using CEHRT.
    (3) CMS-approved survey vendors may submit data on the CAHPS for 
MIPS survey for the MIPS quality performance category.
    (4) To be approved as a third party intermediary, an entity must 
agree to meet the applicable requirements of this section, including, 
but not limited to, the following:
    (i) A third party intermediary's principle place of business and 
retention of any data must be based in the U.S.
    (ii) If the data is derived from CEHRT, a QCDR, qualified registry, 
or health IT vendor must be able to indicate its data source.
    (iii) All data must be submitted in the form and manner specified 
by CMS.
    (iv) If the clinician chooses to opt-in in accordance with Sec.  
414.1310, the third party intermediary must be able to transmit that 
decision to CMS.
    (5) All data submitted to CMS by a third party intermediary on 
behalf of a MIPS eligible clinician, group or virtual group must be 
certified by the third party intermediary as true, accurate, and 
complete to the best of its knowledge. Such certification must be made 
in a form and manner and at such time as specified by CMS.
    (b) QCDR approval criteria--(1) QCDR self-nomination. For the 2020 
and 2021 MIPS payment years, entities seeking to qualify as a QCDR must 
self-nominate September 1 until November 1 of the CY preceding the 
applicable performance period. For the 2022 MIPS payment year and 
future years, entities seeking to qualify as a QCDR must self-nominate 
during a 60-day period during the CY preceding the applicable 
performance period (beginning no earlier than July 1 and ending no 
later than September 1). Entities seeking to qualify as a QCDR for a 
performance period must provide all information required by CMS at the 
time of self-nomination and must provide any additional information 
requested by CMS during the review process. For the 2021 MIPS payment 
year and future years, existing QCDRs that are in good standing may 
attest that certain aspects of their previous year's approved self-
nomination have not changed and will be used for the applicable 
performance period.
    (2) Establishment of a QCDR entity. (i) Beginning with the 2022 
MIPS Payment Year, the QCDR must have at least 25 participants by 
January 1 of the year prior to the applicable performance period.
    (ii) If the entity uses an external organization for purposes of 
data collection, calculation, or transmission, it must have a signed, 
written agreement with the external organization that specifically 
details the responsibilities of the entity and the external 
organization. The written agreement must be effective as of September 1 
of the year preceding the applicable performance period.
    (3) QCDR measures for the quality performance category. (i) For 
purposes of QCDRs submitting data for the MIPS quality performance 
category, CMS considers the following types of quality measures to be 
QCDR measures:
    (A) Measures that are not included in the MIPS final list of 
quality measures described in Sec.  414.1330(a)(1) for the applicable 
MIPS payment year; and
    (B) Measures that are included in the MIPS final list of quality 
measures described in Sec.  414.1330(a)(1) for the applicable MIPS 
payment year, but have undergone substantive changes, as determined by 
CMS.
    (ii) For the 2020 MIPS payment year and future years, an entity 
seeking to become a QCDR must submit specifications for each measure, 
activity, and objective that the entity intends to submit to for MIPS 
(including the information described in paragraphs (b)(3)(ii)(A) and 
(B) of this section) at the time of self-nomination. In addition, no 
later than 15 calendar days following CMS approval of any QCDR measure 
specifications, the entity must publicly post the measure 
specifications for each QCDR measure (including the CMS-assigned QCDR 
measure ID) and provide CMS with a link to where this information is 
posted.
    (A) For QCDR measures, the entity must submit the measure 
specifications for each QCDR measure, including: Name/title of 
measures, NQF number (if NQF-endorsed), descriptions of the 
denominator, numerator, and when applicable, denominator exceptions, 
denominator exclusions, risk adjustment variables, and risk adjustment 
algorithms.
    (B) For MIPS quality measures, the entity must submit the MIPS 
measure IDs and specialty-specific measure sets, as applicable.
    (iii) A QCDR must include the CMS-assigned QCDR measure ID when 
submitting data on any QCDR measure to CMS.
    (c) Qualified registry approval criteria--(1) Qualified registry 
self-nomination. For the 2020 and 2021 MIPS payment years, entities 
seeking to qualify as a qualified registry must self-nominate from 
September 1 until November 1 of the CY preceding the applicable 
performance period. For the 2022 MIPS payment year and future years, 
entities seeking to qualify as a qualified registry must self-nominate 
during a 60-day period during the CY preceding the applicable 
performance period (beginning no earlier than July 1 and ending no 
later than September 1). Entities seeking to qualify as a qualified 
registry for a performance period must provide all information required 
by CMS at the time of self-nomination and must provide any additional 
information requested by CMS during the review process. For the 2021 
MIPS payment year and future years, existing qualified registries that 
are in good standing may attest that certain aspects of their previous 
year's approved self-nomination have not changed and will be used for 
the applicable performance period.
    (2) Establishment of a qualified registry entity. Beginning with 
the 2022 MIPS Payment Year, the qualified registry must have at least 
25 participants by January 1 of the year prior to the applicable 
performance period.
    (d) Health IT vendor approval criteria. Health IT vendors must meet 
the criteria specified at paragraph (a)(4) of this section.
    (e) CMS-approved survey vendor approval criteria. Entities seeking 
to be a CMS-approved survey vendor for any MIPS performance period must 
submit a survey vendor application to CMS in a form and manner 
specified by CMS for each MIPS performance period for

[[Page 60089]]

which it wishes to transmit such data. The application and any 
supplemental information requested by CMS must be submitted by 
deadlines specified by CMS. For an entity to be a CMS-approved survey 
vendor, it must meet the following criteria:
    (1) The entity must have sufficient experience, capability, and 
capacity to accurately report CAHPS data, including:
    (i) At least 3 years of experience administering mixed-mode surveys 
(that is, surveys that employ multiple modes to collect date), 
including mail survey administration followed by survey administration 
via Computer Assisted Telephone Interview (CATI);
    (ii) At least 3 years of experience administering surveys to a 
Medicare population;
    (iii) At least 3 years of experience administering CAHPS surveys 
within the past 5 years;
    (iv) Experience administering surveys in English and at least one 
other language for which a translation of the CAHPS for MIPS survey is 
available;
    (v) Use equipment, software, computer programs, systems, and 
facilities that can verify addresses and phone numbers of sampled 
beneficiaries, monitor interviewers, collect data via CATI, 
electronically administer the survey and schedule call-backs to 
beneficiaries at varying times of the day and week, track fielded 
surveys, assign final disposition codes to reflect the outcome of data 
collection of each sampled case, and track cases from mail surveys 
through telephone follow-up activities; and
    (vi) Employment of a program manager, information systems 
specialist, call center supervisor and mail center supervisor to 
administer the survey.
    (2) The entity has certified that it has the ability to maintain 
and transmit quality data in a manner that preserves the security and 
integrity of the data.
    (3) The entity has successfully completed, and has required its 
subcontractors to successfully complete, vendor training(s) 
administered by CMS or its contractors.
    (4) The entity has submitted a quality assurance plan and other 
materials relevant to survey administration, as determined by CMS, 
including cover letters, questionnaires and telephone scripts.
    (5) The entity has agreed to participate and cooperate, and has 
required its subcontractors to participate and cooperate, in all 
oversight activities related to survey administration conducted by CMS 
or its contractors.
    (6) The entity has sent an interim survey data file to CMS that 
establishes the entity's ability to accurately report CAHPS data.
    (f) Remedial action and termination of third party intermediaries. 
(1) If CMS determines that a third party intermediary has ceased to 
meet one or more of the applicable criteria for approval, or has 
submitted data that is inaccurate, unusable, or otherwise compromised, 
CMS may take one or more of the following remedial actions after 
providing written notice to the third party intermediary:
    (i) Require the third party intermediary to submit a corrective 
action plan (CAP) to CMS to address the identified deficiencies or data 
issue, including the actions it will take to prevent the deficiencies 
or data issues from recurring. The CAP must be submitted to CMS by a 
date specified by CMS.
    (ii) Publicly disclose the entity's data error rate on the CMS 
website until the data error rate falls below 3 percent.
    (2) CMS may immediately or with advance notice terminate the 
ability of a third party intermediary to submit MIPS data on behalf of 
a MIPS eligible clinician, group, or virtual group for one or more of 
the following reasons:
    (i) CMS has grounds to impose remedial action;
    (ii) CMS has not received a CAP within the specified time period or 
the CAP is not accepted by CMS; or
    (iii) The third party intermediary fails to correct the 
deficiencies or data errors by the date specified by CMS.
    (3) For purposes of paragraph (f) of this section, CMS may 
determine that submitted data is inaccurate, unusable, or otherwise 
compromised if the submitted data:
    (i) Includes, without limitation, TIN/NPI mismatches, formatting 
issues, calculation errors, or data audit discrepancies; and
    (ii) Affects more than 3 percent of the total number of MIPS 
eligible clinicians or group for which data was submitted by the third 
party intermediary.
    (g) Auditing of entities submitting MIPS data. Any third party 
intermediary must comply with the following procedures as a condition 
of its qualification and approval to participate in MIPS as a third 
party intermediary.
    (1) The entity must make available to CMS the contact information 
of each MIPS eligible clinician or group on behalf of whom it submits 
data. The contact information must include, at a minimum, the MIPS 
eligible clinician or group's practice phone number, address, and, if 
available, email.
    (2) The entity must retain all data submitted to CMS for purposes 
of MIPS for 6 years from the end of the MIPS performance period.
    (3) For the purposes of auditing, CMS may request any records or 
data retained for the purposes of MIPS for up to 6 years from the end 
of the MIPS performance period.

0
39. Section 414.1405 is amended by--
0
a. Adding paragraphs (b)(6) and (d)(5);
0
b. Revising paragraph (e); and
0
c. Adding paragraph (f).
    The additions and revision read as follows:


Sec.  414.1405  Payment.

* * * * *
    (b) * * *
    (6) The performance threshold for the 2021 MIPS payment year is 30 
points.
* * * * *
    (d) * * *
    (5) The additional performance threshold for the 2021 MIPS payment 
year is 75 points.
    (e) Application of adjustments to payments. Except as specified in 
paragraph (f) of this section, in the case of covered professional 
services (as defined in section 1848(k)(3)(A) of the Act) furnished by 
a MIPS eligible clinician during a MIPS payment year beginning with 
2019, the amount otherwise paid under Part B with respect to such 
covered professional services and MIPS eligible clinician for such 
year, is multiplied by 1, plus the sum of the MIPS payment adjustment 
factor divided by 100, and as applicable, the additional MIPS payment 
adjustment factor divided by 100.
    (f) Exception to application of MIPS payment adjustment factors to 
model-specific payments under section 1115A APMs. Effective for the 
2019 MIPS payment year, the payment adjustment factors specified under 
paragraph (e) of this section are not applicable to payments that meet 
all of the following conditions:
    (1) Are made only to participants in a model tested under section 
1115A of the Act;
    (2) Would otherwise be subject to the requirement to apply the MIPS 
payment adjustment factors if the payment is made with respect to a 
MIPS eligible clinician participating in a section 1115A model; and
    (3) Either have a specified payment amount or are paid according to 
a methodology for calculating a model-specific payment that is applied 
in a consistent manner to all model participants, such that application 
of the MIPS payment adjustment factors would potentially interfere with 
CMS's ability to effectively evaluate the impact of the APM.

[[Page 60090]]


0
40. Section 414.1415 is amended, effective January 1, 2019, by revising 
paragraphs (a)(1)(i) and (ii), (b)(1), (c) introductory text, 
(c)(3)(i)(A), and (c)(6) to read as follows:


Sec.  414.1415  Advanced APM criteria.

    (a) * * *
    (1) * * *
    (i) Require at least 50 percent, or for QP Performance Periods 
beginning in 2019, 75 percent of eligible clinicians in each 
participating APM Entity group, or for APMs in which hospitals are the 
APM Entities, each hospital, to use CEHRT to document and communicate 
clinical care to their patients or health care providers; or
    (ii) For QP Performance Periods prior to 2019, for the Shared 
Savings Program, apply a penalty or reward to an APM Entity based on 
the degree of the use of CEHRT of the eligible clinicians in the APM 
Entity.
    (b) * * *
    (1) To be an Advanced APM, an APM must include quality measure 
performance as a factor when determining payment to participants for 
covered professional services under the terms of the APM.
* * * * *
    (c) Financial risk. To be an Advanced APM, except as described in 
paragraph (c)(6) of this section, an APM must either meet the financial 
risk standard under paragraph (c)(1) or (2) of this section and the 
nominal amount standard under paragraph (c)(3) or (4) of this section 
or be an expanded Medical Home Model under section 1115A(c) of the Act.
* * * * *
    (3) * * *
    (i) * * *
    (A) For QP Performance Periods beginning in 2017, through 2024, 8 
percent of the average estimated total Medicare Parts A and B revenue 
of all providers and suppliers in participating APM Entities; or
* * * * *
    (6) Capitation. A full capitation arrangement meets this Advanced 
APM criterion. For purposes of this part, a full capitation arrangement 
means a payment arrangement in which a per capita or otherwise 
predetermined payment is made under the APM for all items and services 
furnished to a population of beneficiaries during a fixed period of 
time, and no settlement is performed to reconcile or share losses 
incurred or savings earned by the APM Entity. Arrangements between CMS 
and Medicare Advantage Organizations under the Medicare Advantage 
program (42 U.S.C. 422) are not considered capitation arrangements for 
purposes of this paragraph (c)(6).
* * * * *

0
41. Section 414.1415 is further amended (effective January 1, 2010) by 
revising paragraphs (b)(2) and (3) to read as follows:


Sec.  414.1415  Advanced APM criteria.

* * * * *
    (b) * * *
    (2) At least one of the quality measures used in the payment 
arrangement as specified in paragraph (b)(1) of this section must:
    (i) For QP Performance Periods before January 1, 2020, have an 
evidence-based focus, be reliable and valid, and meet at least one of 
the following criteria:
    (A) Used in the MIPS quality performance category, as described in 
Sec.  414.1330;
    (B) Endorsed by a consensus-based entity;
    (C) Developed under section 1848(s) of the Act;
    (D) Submitted in response to the MIPS Call for Quality Measures 
under section 1848(q)(2)(D)(ii) of the Act; or
    (E) Any other quality measures that CMS determines to have an 
evidence-based focus and to be reliable and valid; and
    (ii) For QP Performance Periods beginning on or after January1, 
2020, be:
    (A) Finalized on the MIPS final list of measures, as described in 
Sec.  414.1330;
    (B) Endorsed by a consensus-based entity; or
    (C) Determined by CMS to be evidenced-based, reliable, and valid.
    (3) In addition to the quality measure described under paragraph 
(b)(2) of this section, the quality measures upon which an Advanced APM 
bases the payment in paragraph (b)(1) of this section must include at 
least one additional measure that is an outcome measure unless CMS 
determines that there are no available or applicable outcome measures 
included in the MIPS final quality measures list for the Advanced APM's 
first QP Performance Period. Beginning January 1, 2020, the included 
outcome measure must satisfy the criteria in paragraph (b)(2) of this 
section.
* * * * *

0
42. Section 414.1420 is amended effective January 1, 2019, by revising 
paragraphs (d) introductory text, (d)(3)(i), and (d)(7) to read as 
follows:


Sec.  414.1420   Other payer advanced APM criteria.

* * * * *
    (d) Financial risk. To be an Other Payer Advanced APM, except as 
described in paragraph (d)(7) of this section, a payment arrangement 
must meet either the financial risk standard under paragraph (d)(1) or 
(2) of this section and the nominal amount standard under paragraph 
(d)(3) or (4) of this section, or be a Medicaid Medical Home Model with 
criteria comparable to an expanded Medical Home Model under section 
1115A(c) of the Act.
* * * * *
    (3) * * *
    (i) For QP Performance Periods 2019 through 2024, 8 percent of the 
total combined revenues from the payer to providers and other entities 
under the payment arrangement if financial risk is expressly defined in 
terms of revenue; or, 3 percent of the expected expenditures for which 
an APM Entity is responsible under the payment arrangement.
* * * * *
    (7) Capitation. A full capitation arrangement meets this Other 
Payer Advanced APM criterion. For purposes of paragraph (d)(3) of this 
section, a full capitation arrangement means a payment arrangement in 
which a per capita or otherwise predetermined payment is made under the 
payment arrangement for all items and services furnished to a 
population of beneficiaries during a fixed period of time, and no 
settlement is performed for the purpose of reconciling or sharing 
losses incurred or savings earned by the participant. Arrangements made 
directly between CMS and Medicare Advantage Organizations under the 
Medicare Advantage program (42 U.S.C. 422) are not considered 
capitation arrangements for purposes of this paragraph (c)(7).
* * * * *

0
43. Section 414.1420 is further amended (effective January 1, 2020) by 
revising paragraphs (b), (c)(2) and (3) to read as follows:


Sec.  414.1420   Other payer advanced APM criteria.

* * * * *
    (b) Use of CEHRT. To be an Other Payer Advanced APM, CEHRT must be 
used by at least 50 percent, or for QP Performance Periods on or after 
January 1, 2020, 75 percent of participants in each participating APM 
Entity group, or each hospital if hospitals are the APM Entities, in 
the other payer arrangement to document and communicate clinical care.
    (c) * * *
    (2) At least one of the quality measures used in the payment 
arrangement as specified in paragraph (c)(1) of this section must:

[[Page 60091]]

    (i) For QP Performance Period before January 1, 2020, have an 
evidence-based focus, be reliable and valid, and meet at least one of 
the following criteria:
    (A) Used in the MIPS quality performance category, as described in 
Sec.  414.1330;
    (B) Endorsed by a consensus-based entity;
    (C) Developed under section 1848(s) of the Act;
    (D) Submitted in response to the MIPS Call for Quality Measures 
under section 1848(q)(2)(D)(ii) of the Act; or
    (E) Any other quality measures that CMS determines to have an 
evidence-based focus and to be reliable and valid; and
    (ii) For QP Performance Periods beginning on or after January 1, 
2020, be:
    (A) Finalized on the MIPS final list of measures, as described in 
Sec.  414.1330;
    (B) Endorsed by a consensus-based entity; or
    (C) Determined by CMS to be evidenced-based, reliable, and valid.
    (3) To meet the quality measure use criterion under paragraph 
(c)(1) of this section, a payment arrangement must:
    (i) For QP Performance Periods before January 1, 2020, use an 
outcome measure if there is an applicable outcome measure on the MIPS 
quality measure list. This criterion also applies for payment 
arrangements determined to be Other Payer Advanced APMs on or before 
January 1, 2020, but only for the Other Payer Advanced APM 
determination made with respect to the arrangement for the CY 2020 QP 
Performance Period (regardless of whether that determination is a 
single- or multi-year determination).
    (ii) For QP Performance Periods on or after January 1, 2020, in 
addition to the quality measure described under paragraph (c)(2) of 
this section, use at least one additional measure that is an outcome 
measure and meets the criteria in paragraph (c)(2)(ii) of this section 
if there is such an applicable outcome measure on the MIPS quality 
measure list.
* * * * *

0
44. Section 414.1440 is amended by revising paragraphs (d)(1) through 
(3) to read as follows:


Sec.  414.1440   Qualifying APM participant determination: All-payer 
combination option.

* * * * *
    (d) * * *
    (1) CMS performs QP determinations following the QP Performance 
Period using payment amount and/or patient count information submitted 
from January 1 through each of the respective QP determination dates: 
March 31, June 30, and August 31. CMS will use data for the same time 
periods for the Medicare and other payer portions of Threshold Score 
calculations under the All-Payer Combination Option. CMS will use the 
payment amount or patient count method, applying the more advantageous 
of the two for both the Medicare and other payer portions of the 
Threshold score calculation, regardless of the method used for the 
Medicare Threshold Score calculation.
    (2) An APM Entity may request that CMS make QP determinations at 
the APM Entity level, an eligible clinician may request that CMS make 
QP determinations at the eligible clinician level, and an eligible 
clinician or an APM Entity may request that CMS makes QP determinations 
at the TIN-level in instances where all clinicians who reassigned 
billing rights to the TIN are participating in a single APM Entity. CMS 
makes QP determinations at either the APM Entity, eligible clinician, 
or TIN level. Eligible clinicians assessed at the eligible clinician 
level under the Medicare Option at Sec.  414.1425(b)(2) will be 
assessed at the eligible clinician level only under the All-Payer 
Combination Option. Eligible Clinicians may meet the Medicare and the 
All-Payer Combination Option thresholds using the payment amount method 
for both thresholds, the patient account method for both thresholds, or 
the payment amount method for one threshold and the patient account 
method for the other threshold.
    (3) CMS uses data at the same level for the Medicare and other 
payer portions of Threshold Score calculations under the All-Payer 
Combination Option. When QP determinations are made at the eligible 
clinician or, at the TIN level when all clinicians who have reassigned 
billing rights to the TIN are included in a single APM Entity; and if 
the Medicare Threshold score for the APM Entity group is higher than 
when calculated for the eligible clinician or TIN, CMS makes QP 
determinations using a weighted Medicare Threshold Score that is 
factored into an All-Payer Combination Option Threshold Score.
* * * * *

0
45. Section 414.1445 is amended by revising paragraph (b)(1), adding 
paragraph (c)(2)(i), and reserving paragraph (c)(2)(ii) to read as 
follows:


Sec.  414.1445   Determination of other payer advanced APMs.

* * * * *
    (b) * * *
    (1) Payer initiated Other Payer Advanced APM determination process. 
Beginning in 2018, and each year thereafter, at a time determined by 
CMS a payer with a Medicare Health Plan payment arrangement may 
request, in a form and manner specified by CMS, that CMS determine 
whether a Medicare Health Plan payment arrangement meets the Other 
Payer Advanced APM criteria set forth in Sec.  414.1420. A payer with a 
Medicare Health Plan payment arrangement must submit its requests by 
the annual Medicare Advantage bid deadline of the year prior to the 
relevant QP Performance Period. A Medicare Health Plan is a Medicare 
Advantage plan, a section 1876 cost plan, a PACE organization operated 
under section 1894, and any similar plan which provides Medicare 
benefits under demonstration or waiver authority (other than an APM as 
defined in section 1833(z)(3)(C) of the Act).
* * * * *
    (c) * * *
    (2) * * *
    (i) Based on the submission by an eligible clinician or payer of 
evidence that CMS determines sufficiently demonstrates that CEHRT is 
used as specified in Sec.  414.1420(b) by participants in the payment 
arrangement, CMS will consider the CEHRT criterion in Sec.  414.1420(b) 
is satisfied for that payment arrangement.
    (ii) [Reserved]
* * * * *

PART 415--SERVICES FURNISHED BY PHYSICIANS IN PROVIDERS, 
SUPERVISING PHYSICIANS IN TEACHING SETTINGS, AND RESIDENTS IN 
CERTAIN SETTINGS

0
46. The authority citation for part 415 is revised to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh.

0
47. Section 415.172 is amended by revising paragraph (b) to read as 
follows:


Sec.  415.172  Physician fee schedule payment for services of teaching 
physicians.

* * * * *
    (b) Documentation. Except for services furnished as set forth in 
Sec. Sec.  415.174 (concerning an exception for services furnished in 
hospital outpatient and certain other ambulatory settings), 415.176 
(concerning renal dialysis services), and 415.184 (concerning 
psychiatric services), the medical records must document the teaching 
physician was present at the time the service is furnished. The 
presence of the teaching physician during procedures and evaluation and 
management services may be demonstrated by the notes in the medical 
records made by a physician, resident, or nurse.
* * * * *

[[Page 60092]]


0
48. Section 415.174 is amended--
0
a. In paragraph (a)(3)(iii) by removing ``;'' and adding in its place 
``; and'';
0
b. In paragraph (a)(3)(iv) by removing ``; and'' and adding in its 
place ``.'';
0
c. By removing paragraph (a)(3)(v); and
0
d. By adding paragraph (a)(6).
    The addition reads as follows:


Sec.  415.174  Exception: Evaluation and management services furnished 
in certain centers.

    (a) * * *
    (6) The medical records must document the extent of the teaching 
physician's participation in the review and direction of services 
furnished to each beneficiary. The extent of the teaching physician's 
participation may be demonstrated by the notes in the medical records 
made by a physician, resident, or nurse.
* * * * *

PART 425--MEDICARE SHARED SAVINGS PROGRAM

0
49. The authority citation for part 425 is revised to read as follows:

    Authority:  42 U.S.C. 1302, 1306, 1395hh, and 1395jjj.

0
50. Section 425.20 is amended--
0
a. By revising the definition of ``Agreement period'';
0
b. By adding in alphabetical order definitions for ``Certified 
Electronic Health Record Technology (CEHRT)'' and ``Eligible 
clinician''; and
0
c. By revising the definition of ``Performance year''.
    The revisions and additions read as follows:


Sec.  425.20  Definitions.

* * * * *
    Agreement period means the term of the participation agreement.
* * * * *
    Certified Electronic Health Record Technology (CEHRT) has the same 
meaning given this term under Sec.  414.1305 of this chapter.
* * * * *
    Eligible clinician has the same meaning given this term under Sec.  
414.1305 of this chapter.
* * * * *
    Performance year means the 12-month period beginning on January 1 
of each year during the agreement period, unless otherwise specified in 
Sec.  425.200(c) or noted in the participation agreement.
* * * * *


Sec.  425.100  [Amended]

0
51. Section 425.100 is amended--
0
a. In paragraph (b) by removing the phrase ``under Sec.  425.604, Sec.  
425.606 or Sec.  425.610'' and adding in its place the phrase ``under 
Sec.  425.604, Sec.  425.606, Sec.  425.609 or Sec.  425.610''; and
0
b. In paragraph (c) by removing the phrase ``under Sec.  425.606 or 
Sec.  425.610'' and adding in its place the phrase ``under Sec.  
425.606, Sec.  425.609 or Sec.  425.610''.

0
52. Section 425.200 is amended--
0
a. By revising paragraph (a);
0
b. By revising the heading of paragraph (b);
0
c. By removing paragraph (b)(2) introductory text, adding a heading for 
paragraph (b)(2), and revising paragraph (b)(2)(ii); and
0
d. By removing paragraph (b)(3) introductory text, adding a heading for 
paragraph (b)(3); and
0
e. By revising paragraphs (c) and (d).
    The revisions and additions read as follows:


Sec.  425.200  Participation agreement with CMS.

    (a) General. In order to participate in the Shared Savings Program, 
an ACO must enter into a participation agreement with CMS for a period 
of not less than the number of years specified in this section.
    (b) Agreement period.* * *
    (2) For 2013 and through 2016.* * *
    (ii) The term of the participation agreement is 3 years unless all 
of the following conditions are met to extend the participation 
agreement by 6 months:
    (A) The ACO entered an agreement period starting on January 1, 
2016.
    (B) The ACO elects to extend its agreement period until June 30, 
2019.
    (1) The ACO's election to extend its agreement period is made in 
the form and manner and according to the timeframe established by CMS; 
and
    (2) An ACO executive who has the authority to legally bind the ACO 
must certify the election described in paragraph (b)(2)(ii)(B) of this 
section.
    (3) For 2017 and all subsequent years. * * *
    (c) Performance year. The ACO's performance year under the 
participation agreement is the 12 month period beginning on January 1 
of each year during the term of the participation agreement unless 
otherwise noted in its participation agreement, and except as follows:
    (1) For an ACO with a start date of April 1, 2012, or July 1, 2012, 
the ACO's first performance year is defined as 21 months or 18 months, 
respectively.
    (2) For an ACO that entered a first or second agreement period with 
a start date of January 1, 2016, and that elects to extend its 
agreement period by a 6-month period under paragraph (b)(2)(ii)(B) of 
this section, the ACO's fourth performance year is the 6-month period 
between January 1, 2019, and June 30, 2019.
    (d) Submission of measures. For each performance year of the 
agreement period, ACOs must submit measures in the form and manner 
required by CMS according to Sec.  425.500(c), and as applicable 
according to Sec. Sec.  425.608 and 425.609.
* * * * *


Sec.  425.221  [Amended]

0
53. Section 425.221 is amended--
0
a. In paragraph (b)(1)(i) by removing the phrase ``December 31st of 
such performance year'' and adding in its place the phrase ``the last 
calendar day of the performance year''; and
0
b. In paragraph (b)(2) by removing the phrase ``December 31 of a 
performance year'' and adding in its place the phrase ``the last 
calendar day of a performance year''.

0
54. Section 425.302 is amended--
0
a. In paragraph (a)(3)(i) by removing the phrase ``requirements; and'' 
and adding in its place the phrase ``requirements;'';
0
b. In paragraph (a)(3)(ii) by removing the phrase ``owed to CMS.'' and 
adding in its place the phrase ``owed to CMS; and''; and
0
c. Adding paragraph (a)(3)(iii).
    The addition reads as follows:


Sec.  425.302   Program requirements for data submission and 
certifications.

    (a) * * *
    (3) * * *
    (iii) That the percentage of eligible clinicians participating in 
the ACO that use CEHRT to document and communicate clinical care to 
their patients or other health care providers meets or exceeds the 
applicable percentage specified by CMS at Sec.  425.506(f).
* * * * *


Sec.  425.315   [Amended]

0
55. Section 425.315 is amended in paragraph (a)(1)(ii) by removing the 
phrase ``Sec.  425.604(f), Sec.  425.606(h) or Sec.  425.610(h)'' and 
adding in its place the phrase ``Sec.  425.604(f), Sec.  425.606(h), 
Sec.  425.609(e) or Sec.  425.610(h)''.

0
56. Section 425.400 is amended by--
0
a. Revising paragraph (a)(1)(ii);
0
b. Revising paragraphs (c)(1)(iv) introductory text, (c)(1)(iv)(A), 
(c)(1)(iv)(B) introductory text, and (c)(1)(iv)(B)(5); and
0
c. Adding paragraphs (c)(1)(iv)(B)(6) and (7).

[[Page 60093]]

    The revisions and additions read as follows:


Sec.  425.400   General.

    (a)(1) * * *
    (ii) CMS applies a step-wise process based on the beneficiary's 
utilization of primary care services provided under Title XVIII by a 
physician who is an ACO professional during each performance year for 
which shared savings are to be determined and, with respect to ACOs 
participating in a 6-month performance year during CY 2019, during the 
entirety of CY 2019 as specified in Sec.  425.609.
* * * * *
    (c) * * *
    (1) * * *
    (iv) For performance years starting on January 1, 2019, and 
subsequent performance years as follows:
    (A) CPT codes:
    (1) 99201 through 99215 (codes for office or other outpatient visit 
for the evaluation and management of a patient).
    (2) 99304 through 99318 (codes for professional services furnished 
in a nursing facility; services identified by these codes furnished in 
a SNF are excluded).
    (3) 99319 through 99340 (codes for patient domiciliary, rest home, 
or custodial care visit).
    (4) 99341 through 99350 (codes for evaluation and management 
services furnished in a patients' home for claims identified by place 
of service modifier 12).
    (5) 99487, 99489 and 99490 (codes for chronic care management).
    (6) 99495 and 99496 (codes for transitional care management 
services).
    (7) 99497 and 99498 (codes for advance care planning).
    (8) 96160 and 96161 (codes for administration of health risk 
assessment).
    (9) 99354 and 99355 (add-on codes, for prolonged evaluation and 
management or psychotherapy services beyond the typical service time of 
the primary procedure; when the base code is also a primary care 
service code under this paragraph (c)(1)).
    (10) 99484, 99492, 99493 and 99494 (codes for behavioral health 
integration services).
    (B) HCPCS codes:
* * * * *
    (5) G0444 (codes for annual depression screening service).
    (6) G0442 (code for alcohol misuse screening service).
    (7) G0443 (code for alcohol misuse counseling service).

0
57. Section 425.401 is amended by revising paragraph (b) introductory 
text to read as follows:


Sec.  425.401   Criteria for a beneficiary to be assigned to an ACO.

* * * * *
    (b) A beneficiary is excluded from the prospective assignment list 
of an ACO that is participating under prospective assignment under 
Sec.  425.400(a)(3) at the end of a performance or benchmark year and 
quarterly during each performance year consistent with Sec.  
425.400(a)(3)(ii), or at the end of CY 2019 as specified in Sec.  
425.609(b)(1)(ii), if the beneficiary meets any of the following 
criteria during the performance or benchmark year:
* * * * *

0
58. Section 425.402 is amended by revising paragraph (e)(2) to read as 
follows:


Sec.  425.402   Basic assignment methodology.

* * * * *
    (e) * * *
    (2) Beneficiaries are added to the ACO's list of assigned 
beneficiaries if all of the following conditions are satisfied:
    (i) For performance year 2018:
    (A) The beneficiary must have had at least one primary care service 
during the assignment window as defined under Sec.  425.20 with a 
physician who is an ACO professional in the ACO who is a primary care 
physician as defined under Sec.  425.20 or who has one of the primary 
specialty designations included in paragraph (c) of this section.
    (B) The beneficiary meets the eligibility criteria established at 
Sec.  425.401(a) and must not be excluded by the criteria at Sec.  
425.401(b). The exclusion criteria at Sec.  425.401(b) apply for 
purposes of determining beneficiary eligibility for alignment to ACOs 
under all tracks based on the beneficiary's designation of an ACO 
professional as responsible for coordinating their overall care under 
paragraph (e) of this section.
    (C) The beneficiary must have designated an ACO professional who is 
a primary care physician as defined at Sec.  425.20, a physician with a 
specialty designation included at paragraph (c) of this section, or a 
nurse practitioner, physician assistant, or clinical nurse specialist 
as responsible for coordinating their overall care.
    (D) If a beneficiary has designated a provider or supplier outside 
the ACO who is a primary care physician as defined at Sec.  425.20, a 
physician with a specialty designation included at paragraph (c) of 
this section, or a nurse practitioner, physician assistant, or clinical 
nurse specialist, as responsible for coordinating their overall care, 
the beneficiary is not added to the ACO's list of assigned 
beneficiaries under the assignment methodology in paragraph (b) of this 
section.
    (ii) For performance years starting on January 1, 2019, and 
subsequent performance years:
    (A) The beneficiary meets the eligibility criteria established at 
Sec.  425.401(a) and must not be excluded by the criteria at Sec.  
425.401(b). The exclusion criteria at Sec.  425.401(b) apply for 
purposes of determining beneficiary eligibility for alignment to an ACO 
based on the beneficiary's designation of an ACO professional as 
responsible for coordinating their overall care under paragraph (e) of 
this section, regardless of the ACO's assignment methodology selection 
under Sec.  425.400(a)(4)(ii).
    (B) The beneficiary must have designated an ACO professional as 
responsible for coordinating their overall care.
    (C) If a beneficiary has designated a provider or supplier outside 
the ACO as responsible for coordinating their overall care, the 
beneficiary is not added under the assignment methodology in paragraph 
(b) of this section to the ACO's list of assigned beneficiaries for a 
12-month performance year or the ACO's list of assigned beneficiaries 
for a 6-month performance year, which is based on the entire CY 2019 as 
provided in Sec.  425.609.
    (D) The beneficiary is not assigned to an entity participating in a 
model tested or expanded under section 1115A of the Act under which 
claims-based assignment is based solely on claims for services other 
than primary care services and for which there has been a determination 
by the Secretary that waiver of the requirement in section 
1899(c)(2)(B) of the Act is necessary solely for purposes of testing 
the model.
* * * * *


Sec.  425.404   [Amended]

0
59. Section 425.404 is amended in paragraph (b) by removing the phrase 
``For performance year 2019 and subsequent performance years'' and 
adding in its place the phrase ``For performance years starting on 
January 1, 2019, and subsequent performance years''.

0
60. Section 425.502 is amended--
0
a. In paragraph (e)(4)(vi) by removing the phrase ``For performance 
year 2017'' and adding in its place the phrase ``For performance year 
2017 and subsequent performance years'';
0
b. By adding a new paragraph (e)(4)(vii);
0
c. By revising paragraph (f) introductory text;

[[Page 60094]]

0
d. By redesignating paragraphs (f)(1) and (2) as paragraphs (f)(2)(i) 
and (ii);
0
e. By adding a new paragraph (f)(1);
0
f. By adding a new paragraph (f)(2) introductory text;
0
g. In newly redesignated paragraph (f)(2)(i) by removing the phrase 
``for performance year 2017'' and adding in its place the phrase ``for 
the relevant performance year'';
0
h. By removing paragraph (f)(4); and
0
i. By redesignating paragraph (f)(5) as paragraph (f)(4).
    The revisions and additions read as follows:


Sec.  425.502   Calculating the ACO quality performance score.

* * * * *
    (e) * * *
    (4) * * *
    (vii) For performance year 2017 and subsequent performance years, 
if an ACO receives the mean Shared Savings Program ACO quality score 
under paragraph (f) of this section, in the next performance year for 
which the ACO receives a quality performance score based on its own 
quality reporting, quality improvement is measured based on a 
comparison between the performance in that year and the most recently 
available prior performance year in which the ACO reported quality.
    (f) Extreme and uncontrollable circumstances. For performance year 
2017 and subsequent performance years, including the applicable quality 
data reporting period for the performance year if the quality reporting 
period is not extended, CMS uses an alternative approach to calculating 
the quality score for ACOs affected by extreme and uncontrollable 
circumstances instead of the methodology specified in paragraphs (a) 
through (e) of this section as follows:
    (1) CMS determines the ACO was affected by an extreme and 
uncontrollable circumstance based on either of the following:
    (i) Twenty percent or more of the ACO's assigned beneficiaries 
reside in an area identified under the Quality Payment Program as being 
affected by an extreme and uncontrollable circumstance.
    (A) Assignment is determined under subpart E of this part.
    (B) In making this determination for performance year 2017, CMS 
uses the final list of beneficiaries assigned to the ACO for the 
performance year. For performance year 2018 and subsequent performance 
years, CMS uses the list of assigned beneficiaries used to generate the 
Web Interface quality reporting sample.
    (ii) The ACO's legal entity is located in an area identified under 
the Quality Payment Program as being affected by an extreme and 
uncontrollable circumstance. An ACO's legal entity location is based on 
the address on file for the ACO in CMS' ACO application and management 
system.
    (2) If CMS determines the ACO meets the requirements of paragraph 
(f)(1) of this section, CMS calculates the ACO's quality score as 
follows:
* * * * *

0
61. Section 425.506 is amended--
0
a. In paragraph (b) by removing the phrase ``As part of the quality 
performance score'' and adding in its place the phrase ``For 
performance years 2012 through 2018, as part of the quality performance 
score'';
0
b. In paragraph (c) by removing the phrase ``Performance on this 
measure'' and adding in its place the phrase ``For performance years 
2012 through 2018, performance on this measure'';
0
c. In paragraph (e) introductory text by removing the phrase ``For 2017 
and subsequent years'' and adding in its place the phrase ``For 2017 
and 2018''; and
0
d. By adding paragraph (f).
    The addition reads as follows:


Sec.  425.506   Incorporating reporting requirements related to 
adoption of certified electronic health record technology.

* * * * *
    (f) For performance years starting on January 1, 2019, and 
subsequent performance years, ACOs in a track that--
    (1) Does not meet the financial risk standard to be an Advanced APM 
must certify annually that the percentage of eligible clinicians 
participating in the ACO that use CEHRT to document and communicate 
clinical care to their patients or other health care providers meets or 
exceeds 50 percent; or
    (2) Meets the financial risk standard to be an Advanced APM must 
certify annually that the percentage of eligible clinicians 
participating in the ACO that use CEHRT to document and communicate 
clinical care to their patients or other health care providers meets or 
exceeds the threshold established under Sec.  414.1415(a)(1)(i) of this 
chapter.

0
62. Section 425.602 is amended by adding paragraph (c) to read as 
follows:


Sec.  425.602  Establishing, adjusting, and updating the benchmark for 
an ACO's first agreement period.

* * * * *
    (c) January 1, 2019 through June 30, 2019 performance year. In 
determining performance for the January 1, 2019 through June 30, 2019 
performance year described in Sec.  425.609(b) CMS does all of the 
following:
    (1) When adjusting the benchmark using the methodology set forth in 
paragraph (a)(9) of this section and Sec.  425.609(b), CMS adjusts for 
severity and case mix between BY3 and CY 2019.
    (2) When updating the benchmark using the methodology set forth in 
paragraph (b) of this section and Sec.  425.609(b), CMS updates the 
benchmark based on growth between BY3 and CY 2019.

0
63. Section 425.603 is amended by adding paragraph (g) to read as 
follows:


Sec.  425.603   Resetting, adjusting, and updating the benchmark for a 
subsequent agreement period.

* * * * *
    (g) In determining performance for the January 1, 2019 through June 
30, 2019 performance year described in Sec.  425.609(b) CMS does all of 
the following:
    (1) When adjusting the benchmark using the methodology set forth in 
paragraph (c)(10) of this section and Sec.  425.609(b), CMS adjusts for 
severity and case mix between BY3 and CY 2019.
    (2) When updating the benchmark using the methodology set forth in 
paragraph (d) of this section and Sec.  425.609(b), CMS updates the 
benchmark based on growth between BY3 and CY 2019.

0
64. Section 425.604 is amended by adding paragraph (g) to read as 
follows:


Sec.  425.604  Calculation of savings under the one-sided model.

* * * * *
    (g) January 1, 2019 through June 30, 2019 performance year. Shared 
savings for the January 1, 2019 through June 30, 2019 performance year 
are calculated as described in Sec.  425.609.

0
 65. Section 425.606 is amended--
0
a. In paragraph (i) introductory text by removing the phrase ``For 
performance year 2017'' and adding in its place the phrase ``For 
performance year 2017 and subsequent performance years'';
0
b. In paragraph (i)(1) remove the phrase ``2017''; and
0
c. By adding paragraph (j).
    The addition reads as follows:


Sec.  425.606  Calculation of shared savings and losses under Track 2.

* * * * *
    (j) January 1, 2019 through June 30, 2019. Shared savings or shared 
losses for the January 1, 2019 through June 30, 2019 performance year 
are calculated as described in Sec.  425.609.

0
66. Section 425.609 is added to read as follows:

[[Page 60095]]

Sec.  425.609  Determining performance for a 6-month performance year 
during CY 2019.

    (a) General. An ACO's financial and quality performance for a 6-
month performance year during 2019 are determined as described in this 
section.
    (b) January 2019 through June 2019. For ACOs participating in a 6-
month performance year from January 1, 2019, through June 30, 2019, 
under Sec.  425.200(b)(2)(ii)(B), CMS reconciles the ACO for the period 
from January 1, 2019, through June 30, 2019, after the conclusion of CY 
2019, based on the 12-month calendar year and pro-rates shared savings 
or shared losses to reflect the ACO's participation from January 1, 
2019, through June 30, 2019. CMS does all of the following to determine 
financial and quality performance:
    (1) Uses the ACO participant list in effect for the performance 
year beginning January 1, 2019, to determine beneficiary assignment, 
using claims for the entire calendar year, as specified in Sec. Sec.  
425.402 and 425.404, and according to the ACO's track as specified in 
Sec.  425.400.
    (i) For ACOs under preliminary prospective assignment with 
retrospective reconciliation the assignment window is CY 2019.
    (ii) For ACOs under prospective assignment--
    (A) Medicare fee-for-service beneficiaries are prospectively 
assigned to the ACO based on the beneficiary's use of primary care 
services in the most recent 12 months for which data are available; and
    (B) Beneficiaries remain prospectively assigned to the ACO at the 
end of CY 2019 if they do not meet any of the exclusion criteria under 
Sec.  425.401(b) during the calendar year.
    (2) Uses the ACO's quality performance for the 2019 reporting 
period to determine the ACO's quality performance score as specified in 
Sec.  425.502. The ACO's latest certified ACO participant list is used 
to determine the quality reporting samples for the 2019 reporting year 
for an ACO that extends its participation agreement for the 6-month 
performance year from January 1, 2019, through June 30, 2019, under 
Sec.  425.200(b)(2)(ii)(B).
    (3) Uses the methodology for calculating shared savings or shared 
losses applicable to the ACO under the terms of the participation 
agreement that was in effect on January 1, 2019.
    (i) The ACO's historical benchmark is determined according to 
either Sec.  425.602 (first agreement period) or Sec.  425.603 (second 
agreement period) except as follows:
    (A) The benchmark is adjusted for changes in severity and case mix 
between BY3 and CY 2019 using the methodology that accounts separately 
for newly and continuously assigned beneficiaries using prospective HCC 
risk scores and demographic factors as described under Sec. Sec.  
425.604(a)(1) through (3), 425.606(a)(1) through (3), and 425.610(a)(1) 
through (3).
    (B) The benchmark is updated to CY 2019 according to the 
methodology described under Sec.  425.602(b), Sec.  425.603(b), or 
Sec.  425.603(d), based on whether the ACO is in its first or second 
agreement period, and for an ACO in a second agreement period, the date 
on which that agreement period began.
    (ii) The ACO's financial performance is determined based on the 
track the ACO is participating under during the performance year 
starting on January 1, 2019 (Sec.  425.604, Sec.  425.606 or Sec.  
425.610), unless otherwise specified. In determining ACO financial 
performance, CMS does all of the following:
    (A) Average per capita Medicare Parts A and B fee-for-service 
expenditures for CY 2019 are calculated for the ACO's performance year 
assigned beneficiary population identified in paragraph (b)(1) of this 
section.
    (B) Expenditures calculated in paragraph (b)(3)(ii)(A) of this 
section are compared to the ACO's updated benchmark determined 
according to paragraph (b)(3)(i) of this section.
    (C)(1) The ACO's performance year assigned beneficiary population 
identified in paragraph (b)(1) of this section is used to determine the 
MSR for Track 1 ACOs and the variable MSR/MLR for ACOs in a two-sided 
model that selected this option at the start of their agreement period. 
For two-sided model ACOs that selected a fixed MSR/MLR at the start of 
the ACO's agreement period, this fixed MSR/MLR is applied. In the event 
an ACO's performance year assigned population identified in paragraph 
(b)(1) of this section is below 5,000 beneficiaries, the MSR/MLR is 
determined according to Sec.  425.110(b).
    (2) To qualify for shared savings an ACO must do all of the 
following:
    (i) Have average per capita Medicare Parts A and B fee-for-service 
expenditures for its assigned beneficiary population for CY 2019 below 
its updated benchmark costs for the year by at least the MSR 
established for the ACO based on the track the ACO is participating 
under during the performance year starting on January 1, 2019 (Sec.  
425.604, Sec.  425.606 or Sec.  425.610) and paragraph (b)(3)(ii)(C)(1) 
of this section.
    (ii) Meet the minimum quality performance standards established 
under Sec.  425.502 and according to paragraph (b)(2) of this section.
    (iii) Otherwise maintain its eligibility to participate in the 
Shared Savings Program under this part.
    (3) To be responsible for sharing losses with the Medicare program, 
an ACO's average per capita Medicare Parts A and B fee-for-service 
expenditures for its assigned beneficiary population for CY 2019 must 
be above its updated benchmark costs for the year by at least the MLR 
established for the ACO based on the track the ACO is participating 
under during the performance year starting on January 1, 2019 (Sec.  
425.606 or Sec.  425.610) and paragraph (b)(3)(ii)(C)(1) of this 
section.
    (D) For an ACO that meets all the requirements to receive a shared 
savings payment under paragraph (b)(3)(ii)(C)(2) of this section--
    (1) The final sharing rate, determined based on the track the ACO 
is participating under during the performance year starting on January 
1, 2019 (Sec.  425.604, Sec.  425.606 or Sec.  425.610), is applied to 
all savings under the updated benchmark specified under paragraph 
(b)(3)(i) of this section, not to exceed the performance payment limit 
for the ACO based on its track; and
    (2) After applying the applicable performance payment limit, CMS 
pro-rates any shared savings amount determined under paragraph 
(b)(3)(ii)(D)(1) of this section by multiplying the amount by one-half, 
which represents the fraction of the calendar year covered by the 
period from January 1, 2019, through June 30, 2019.
    (E) For an ACO responsible for shared losses under paragraph 
(b)(3)(ii)(C)(3) of this section--
    (1) The shared loss rate, determined based on the track the ACO is 
participating under during the performance year starting on January 1, 
2019 (Sec.  425.606 or Sec.  425.610), is applied to all losses under 
the updated benchmark specified under paragraph (b)(3)(i) of this 
section, not to exceed the loss recoupment limit for the ACO based on 
its track; and
    (2) After applying the applicable loss recoupment limit, CMS pro-
rates any shared losses amount determined under paragraph 
(b)(3)(ii)(E)(1) of this section by multiplying the amount by one-half, 
which represents the fraction of the calendar year covered by the 
period from January 1, 2019, through June 30, 2019.
    (c) [Reserved]
    (d) Extreme and uncontrollable circumstances. For ACOs affected by 
extreme and uncontrollable circumstances during CY 2019--

[[Page 60096]]

    (1) In calculating the amount of shared losses owed, CMS makes 
adjustments to the amount determined in paragraph (b)(3)(ii)(E)(1) of 
this section, as specified in Sec.  425.606(i) or Sec.  425.610(i), as 
applicable; and
    (2) In determining the ACO's quality performance score for the 2019 
quality reporting period, CMS uses the alternative scoring methodology 
specified in Sec.  425.502(f).
    (e) Notification of savings and losses. CMS notifies the ACO of 
shared savings or shared losses for the January 1, 2019 through June 
30, 2019 performance year, consistent with the notification 
requirements specified in Sec. Sec.  425.604(f), 425.606(h), and 
425.610(h), as applicable:
    (1) CMS notifies an ACO in writing regarding whether the ACO 
qualifies for a shared savings payment, and if so, the amount of the 
payment due.
    (2) CMS provides written notification to an ACO of the amount of 
shared losses, if any, that it must repay to the program.
    (3) If an ACO has shared losses, the ACO must make payment in full 
to CMS within 90 days of receipt of notification.

0
67. Section 425.610 is amended--
0
a. In paragraph (i) introductory text by removing the phrase ``For 
performance year 2017'' and adding in its place the phrase ``For 
performance year 2017 and subsequent performance years'';
0
b. In paragraph (i)(1) by removing the phrase ``2017''; and
0
c. By adding paragraph (j).
    The addition reads as follows:


Sec.  425.610   Calculation of shared savings and losses under Track 3.

* * * * *
    (j) January 1, 2019 through June 30, 2019 performance year. Shared 
savings or shared losses for the January 1, 2019 through June 30, 2019 
performance year are calculated as described in Sec.  425.609.

0
68. Section 425.702 is amended by adding paragraph (d) to read as 
follows:


Sec.  425.702   Aggregate reports.

* * * * *
    (d) For an ACO eligible to be reconciled under Sec.  425.609(b), 
CMS shares with the ACO quarterly aggregate reports as provided in 
paragraphs (b) and (c)(1)(ii) of this section for CY 2019.

PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY 
INCENTIVE PROGRAM

0
69. The authority citation for part 495 is revised to read as follows:

    Authority: 42 U.S.C. 1302 and 1395hh.


0
70. Section 495.4 is amended in the definition of ``EHR reporting 
period'' by adding paragraph (1)(v) to read as follows:


Sec.  495.4   Definitions.

* * * * *
    EHR reporting period. * * *
    (1) * * *
    (v) Under the Medicaid Promoting Interoperability Program, for the 
CY 2021 payment year:
    (A) For the EP first demonstrating he or she is a meaningful EHR 
user, any continuous 90-day period within CY 2021 that ends before 
October 31, 2021, or that ends before an earlier date in CY 2021 that 
is specified by the state and approved by CMS in the State Medicaid HIT 
plan described at Sec.  495.332.
    (B) For the EP who has successfully demonstrated he or she is a 
meaningful EHR user in any prior year, any continuous 90-day period 
within CY 2021 that ends before October 31, 2021, or that ends before 
an earlier date in CY 2021 that is specified by the state and approved 
by CMS in the State Medicaid HIT plan described at Sec.  495.332.
* * * * *

0
71. Section 495.24 is amended by revising paragraphs (d)(6)(i)(B) and 
(d)(8)(i)(B)(2) to read as follows:


Sec.  495.24   Stage 3 meaningful use objectives and measures for EPs, 
eligible hospitals and CAHs for 2019 and subsequent years.

* * * * *
    (d) * * *
    (6) * * *
    (i) * * *
    (B) Measures. In accordance with paragraph (a)(2) of this section, 
an EP must satisfy 2 out of the 3 following measures in paragraphs 
(d)(6)(i)(B)(1) through (3) of this section except those measures for 
which an EP qualifies for an exclusion under paragraph (a)(3) of this 
section.
    (1) During the EHR reporting period, more than 5 percent of all 
unique patients (or their authorized representatives) seen by the EP 
actively engage with the electronic health record made accessible by 
the provider and do either of the following:
    (i) View, download or transmit to a third party their health 
information;
    (ii) Access their health information through the use of an API that 
can be used by applications chosen by the patient and configured to the 
API in the provider's CEHRT; or
    (iii) A combination of paragraphs (d)(6)(i)(B)(1)(i) and (ii) of 
this section.
    (2) A secure message was sent using the electronic messaging 
function of CEHRT to the patient (or their authorized representatives), 
or in response to a secure message sent by the patient, for more than 5 
percent of all unique patients seen by the EP during the EHR reporting 
period.
    (3) Patient generated health data or data from a nonclinical 
setting is incorporated into the CEHRT for more than 5 percent of all 
unique patients seen by the EP during the EHR reporting period.
* * * * *
    (8) * * *
    (i) * * *
    (B) * * *
    (2) Syndromic surveillance reporting. The EP is in active 
engagement with a public health agency to submit syndromic surveillance 
data from an urgent care setting, or from any other setting from which 
ambulatory syndromic surveillance data are collected by the state or a 
local public health agency.
* * * * *

0
72. Section 495.332 is amended by adding paragraphs (f)(3), (4), and 
(5) to read as follows:


Sec.  495.332  State Medicaid health information technology (HIT) plan 
requirements.

* * * * *
    (f) * * *
    (3) An alternative date within CY 2021 by which all ``EHR reporting 
periods'' (as defined under Sec.  495.4) for the CY 2021 payment year 
for Medicaid EPs demonstrating they are meaningful EHR users must end. 
The alternative date selected by the state must be earlier than October 
31, 2021, and must not be any earlier than the day prior to the 
attestation deadline for Medicaid EPs attesting to that state.
    (4) An alternative date within CY 2021 by which all clinical 
quality measure reporting periods for the CY 2021 payment year for 
Medicaid EPs demonstrating they are meaningful EHR users must end. The 
alternative date selected by the state must be earlier than October 31, 
2021, and must not be any earlier than the day prior to the attestation 
deadline for Medicaid EPs attesting to that state.
    (5) For the CY 2019 payment year and beyond, a state-specific 
listing of which clinical quality measures selected by CMS are 
considered to be high priority measures for purposes of Medicaid EP 
clinical quality measure reporting.
* * * * *


[[Page 60097]]


    Dated: October 26, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: October 30, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.

Appendix 1: Finalized MIPS Quality Measures

    Note:  Except as otherwise finalized in this final rule, 
previously finalized measures and specialty measure sets will 
continue to apply for the 2021 MIPS payment year and future years.

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[FR Doc. 2018-24170 Filed 11-1-18; 4:15 pm]
BILLING CODE 4120-01-C