80 FR 70885 - Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 220 (November 16, 2015)
Page Range
70885-71386
FR Document
2015-28005
This major final rule with comment period addresses changes to the physician fee schedule, 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.
Federal Register, Volume 80 Issue 220 (Monday, November 16, 2015)
[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)]
[Rules and Regulations]
[Pages 70885-71386]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-28005]
[[Page 70885]]
Vol. 80
Monday,
No. 220
November 16, 2015
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Part 405, 410, 411, et al.
Medicare Program; Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Part B for CY 2016; Final Rule
Federal Register / Vol. 80 , No. 220 / Monday, November 16, 2015 /
Rules and Regulations
[[Page 70886]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 411, 414, 425, and 495
[CMS-1631-FC]
RIN 0938-AS40
Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule and Other Revisions to Part B for CY 2016
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule with comment period.
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SUMMARY: This major final rule with comment period addresses changes to
the physician fee schedule, 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.
DATES: Effective date: The provisions of this final rule with comment
period are effective on January 1, 2016, except the definition of
``ownership or investment interest'' in Sec. 411.362(a), which has an
effective date of January 1, 2017.
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 29, 2015. (See the SUPPLEMENTARY INFORMATION section of
this final rule with comment period for a list of provisions open for
comment.)
ADDRESSES: In commenting, please refer to file code CMS-1631-FC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to www.regulations.gov. Follow the instructions for
``submitting a comment.''
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-1631-FC, P.O. Box 8013,
Baltimore, MD 21244-8013.
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-1631-FC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to either of the following addresses:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD-- Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
please call telephone number (410) 786-7195 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
FOR FURTHER INFORMATION CONTACT:
Donta Henson, (410) 786-1947 for issues related to pathology and
ophthalmology services or any physician payment issues not identified
below.
Abdihakin Abdi, (410) 786-4735, for issues related to portable X-
ray transportation fees.
Gail Addis, (410) 786-4522, for issues related to the refinement
panel.
Lindsey Baldwin, (410) 786-1694, for issues related to valuation of
moderate sedation and colonoscopy services.
Jessica Bruton, (410) 786-5991, for issues related to potentially
misvalued code lists.
Roberta Epps, (410) 786-4503, for issues related to PAMA section
218(a) policy.
Ken Marsalek, (410) 786-4502, for issues related to telehealth
services.
Ann Marshall, (410) 786-3059, for issues related to advance care
planning, and for primary care and care management services.
Geri Mondowney, (410) 786-4584, for issues related to geographic
practice cost indices, malpractice RVUs, target, and phase-in
provisions.
Chava Sheffield, (410) 786-2298, for issues related to the practice
expense methodology, impacts, and conversion factor.
Michael Soracoe, (410) 786-6312, for issues related to the practice
expense methodology and the valuation and coding of the global surgical
packages.
Regina Walker-Wren, (410) 786-9160, for issues related to the
``incident to'' proposals.
Pamela West, (410) 786-2302, for issues related to therapy caps.
Emily Yoder, (410) 786-1804, for issues related to valuation of
radiation treatment services.
Amy Gruber, (410) 786-1542, for issues related to ambulance payment
policy.
Corinne Axelrod, (410) 786-5620, for issues related to rural health
clinics or federally qualified health centers and payment to
grandfathered tribal FQHCs.
Simone Dennis, (410) 786-8409, for issues related to rural health
clinics HCPCS reporting.
Edmund Kasaitis (410) 786-0477, for issues related to Part B drugs,
biologicals, and biosimilars.
Alesia Hovatter, (410) 786-6861, for issues related to Physician
Compare.
Deborah Krauss, (410) 786-5264 and Alexandra Mugge, (410) 786-4457,
for issues related to the physician quality reporting system and the
merit-based incentive payment system.
Alexandra Mugge, (410) 786-4457, for issues related to EHR
Incentive Program.
Sarah Arceo, (410) 786-2356 or Patrice Holtz, (410786-5663 for
issues related to EHR Incentive Program-Comprehensive Primary Care
(CPC) initiative and Medicare EHR Incentive Program aligned reporting.
Rabia Khan or Terri Postma, (410) 786-8084 or [email protected], for
issues related to Medicare Shared Savings Program.
Kimberly Spalding Bush, (410) 786-3232, or Sabrina Ahmed (410) 786-
7499, for issues related to value-based Payment Modifier and Physician
Feedback Program.
Frederick Grabau, (410) 786-0206, for issues related to changes to
opt-out regulations.
Lisa Ohrin Wilson (410) 786-8852, or Matthew Edgar (410) 786-0698,
for issues related to physician self-referral updates.
Christiane LaBonte, (410) 786-7234, for issues related to
Comprehensive Primary Care (CPC) initiative.
JoAnna Baldwin (410) 786-7205, or Sarah Fulton (410) 786-2749, for
issues
[[Page 70887]]
related to appropriate use criteria for advanced diagnostic imaging
services.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
Provisions open for comment: We will consider comments that are
submitted as indicated above in the DATES and ADDRESSES sections on the
following subject areas discussed in this final rule with comment
period: Interim final work, practice expense (PE), and malpractice (MP)
RVUs (including applicable work time, direct PE inputs, and MP
crosswalks) for CY 2016; interim final new, revised, potentially
misvalued HCPCS codes as indicated in the Preamble text and listed in
Addendum C to this final rule with comment period; and the additions
and deletions to the physician self-referral list of HCPCS/CPT codes
found on tables 50 and 51.
Table of Contents
I. Executive Summary and Background
A. Executive Summary
B. Background
II. Provisions of the Final Rule With Comment Period for PFS
A. Determination of Practice Expense (PE) Relative Value Units
(RVUs)
B. Determination of Malpractice Relative Value Units (RVUs)
1. Overview
2. Proposed Annual Update of MP RVUs
3. MP RVU Update for Anesthesia Services
4. MP RVU Methodology Refinements
5. CY 2016 Identification of Potentially Misvalued Services for
Review
6. Valuing Services That Include Moderate Sedation as an
Inherent Part of Furnishing the Procedure
7. Improving the Valuation and Coding of the Global Package
C. Elimination of the Refinement Panel
D. Improving Payment Accuracy for Primary Care and Care
Management Services
E. Target for Relative Value Adjustments for Misvalued Services
F. Phase-In of Significant RVU Reductions
G. Changes for Computed Tomography (CT) Under the Protecting
Access to Medicare Act of 2014 (PAMA)
H. Valuation of Specific Codes
1. Background
2. Process for Valuing New, Revised, and Potentially Misvalued
Codes
3. Methodology for Establishing Work RVUs
4. Methodology for Establishing the Direct PE Inputs Used To
Develop PE RVUs
5. Methodology for Establishing Malpractice RVUs
6. CY 2016 Valuation of Specific Codes
a. Lower GI Endoscopy Services
b. Radiation Treatment and Related Image Guidance Services
c. Advance Care Planning Services
d. Valuation of Other Codes for CY 2016
7. Direct PE Input-Only Recommendations
8. CY 2015 Interim Final Codes
9. CY 2016 Interim Final Codes
I. Medicare Telehealth Services
J. Incident to Proposals: Billing Physician as the Supervising
Physician and Ancillary Personnel Requirements
K. Portable X-Ray: Billing of the Transportation Fee
L. Technical Correction: Waiver of Deductible for Anesthesia
Services Furnished on the Same Date as a Planned Screening
Colorectal Cancer Test
M. Therapy Caps
III. Other Provisions of the Final Rule With Comment Period
A. Provisions Associated With the Ambulance Fee Schedule
B. Chronic Care Management (CCM) Services for Rural Health
Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)
C. Healthcare Common Procedure Coding System (HCPCS) Coding for
Rural Health Clinics (RHCs)
D. Payment to Grandfathered Tribal FQHCs That Were Provider-
Based Clinics on or Before April 7, 2000
E. Part B Drugs--Biosimilars
F. Productivity Adjustment for the Ambulance, Clinical
Laboratory, and DMEPOS Fee Schedules
G. Appropriate Use Criteria for Advanced Diagnostic Imaging
Services
H. Physician Compare Web site
I. Physician Payment, Efficiency, and Quality Improvements--
Physician Quality Reporting System
J. Electronic Clinical Quality Measures (eCQM) and Certification
Criteria and Electronic Health Record (EHR) Incentive Program--
Comprehensive Primary Care (CPC) Initiative and Medicare Meaningful
Use Aligned Reporting
K. Discussion and Acknowledgement of Public Comments Received on
the Potential Expansion of the Comprehensive Primary Care (CPC)
Initiative
L. Medicare Shared Savings Program
M. Value-Based Payment Modifier and Physician Feedback Program
N. Physician Self-Referral Updates
O. Private Contracting/Opt-Out
P. Physician Self-Referral Prohibition: Annual Update to the
List of CPT/HCPCS Codes
IV. Collection of Information Requirements
V. Response to Comments
VI. Waiver of Proposed Rulemaking and Waiver of Delay in Effective
Date
VII. Regulatory Impact Analysis
Acronyms
In addition, because of the many organizations and terms to which
we refer by acronym in this final rule with comment period, we are
listing these acronyms and their corresponding terms in alphabetical
order below:
AAA Abdominal aortic aneurysms
ACO Accountable care organization
AMA American Medical Association
ASC Ambulatory surgical center
ATA American Telehealth Association
ATRA American Taxpayer Relief Act (Pub. L. 112-240)
AWV Annual wellness visit
BBA Balanced Budget Act of 1997 (Pub. L. 105-33)
BBRA [Medicare, Medicaid and State Child Health Insurance Program]
Balanced Budget Refinement Act of 1999 (Pub. L. 106-113)
CAD Coronary artery disease
CAH Critical access hospital
CBSA Core-Based Statistical Area
CCM Chronic care management
CEHRT Certified EHR technology
CF Conversion factor
CG-CAHPS Clinician and Group Consumer Assessment of Healthcare
Providers and Systems
CLFS Clinical Laboratory Fee Schedule
CNM Certified nurse-midwife
CP Clinical psychologist
CPC Comprehensive Primary Care
CPEP Clinical Practice Expert Panel
CPT [Physicians] Current Procedural Terminology (CPT codes,
descriptions and other data only are copyright 2014 American Medical
Association. All rights reserved.)
CQM Clinical quality measure
CSW Clinical social worker
CT Computed tomography
CY Calendar year
DFAR Defense Federal Acquisition Regulations
DHS Designated health services
DM Diabetes mellitus
DSMT Diabetes self-management training
eCQM Electronic clinical quality measures
EHR Electronic health record
E/M Evaluation and management
EP Eligible professional
eRx Electronic prescribing
ESRD End-stage renal disease
FAR Federal Acquisition Regulations
FFS Fee-for-service
FQHC Federally qualified health center
FR Federal Register
GAF Geographic adjustment factor
GAO Government Accountability Office
[[Page 70888]]
GPCI Geographic practice cost index
GPO Group purchasing organization
GPRO Group practice reporting option
GTR Genetic Testing Registry
HCPCS Healthcare Common Procedure Coding System
HHS [Department of] Health and Human Services
HOPD Hospital outpatient department
HPSA Health professional shortage area
IDTF Independent diagnostic testing facility
IPPE Initial preventive physical exam
IPPS Inpatient Prospective Payment System
IQR Inpatient Quality Reporting
ISO Insurance service office
IT Information technology
IWPUT Intensity of work per unit of time
LCD Local coverage determination
MA Medicare Advantage
MAC Medicare Administrative Contractor
MAP Measure Applications Partnership
MAPCP Multi-payer Advanced Primary Care Practice
MAV Measure application validity [process]
MCP Monthly capitation payment
MedPAC Medicare Payment Advisory Commission
MEI Medicare Economic Index
MFP Multi-Factor Productivity
MIPPA Medicare Improvements for Patients and Providers Act (Pub. L.
110-275)
MMA Medicare Prescription Drug, Improvement and Modernization Act of
2003 (Pub. L. 108-173, enacted on December 8, 2003)
MP Malpractice
MPPR Multiple procedure payment reduction
MRA Magnetic resonance angiography
MRI Magnetic resonance imaging
MSA Metropolitan Statistical Areas
MSPB Medicare Spending per Beneficiary
MU Meaningful use
NCD National coverage determination
NCQDIS National Coalition of Quality Diagnostic Imaging Services
NP Nurse practitioner
NPI National Provider Identifier
NPP Nonphysician practitioner
NQS National Quality Strategy
OACT CMS's Office of the Actuary
OBRA '89 Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239)
OBRA '90 Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508)
OES Occupational Employment Statistics
OMB Office of Management and Budget
OPPS Outpatient prospective payment system
OT Occupational therapy
PA Physician assistant
PAMA Protecting Access to Medicare Act of 2014 (Pub. L. 113-93)
PC Professional component
PCIP Primary Care Incentive Payment
PE Practice expense
PE/HR Practice expense per hour
PEAC Practice Expense Advisory Committee
PECOS Provider Enrollment, Chain, and Ownership System
PFS Physician Fee Schedule
PLI Professional Liability Insurance
PMA Premarket approval
PQRS Physician Quality Reporting System
PPIS Physician Practice Expense Information Survey
PT Physical therapy
PY Performance year
QCDR Qualified clinical data registry
QRUR Quality and Resources Use Report
RBRVS Resource-based relative value scale
RFA Regulatory Flexibility Act
RHC Rural health clinic
RIA Regulatory impact analysis
RUC American Medical Association/Specialty Society Relative (Value)
Update Committee
RUCA Rural Urban Commuting Area
RVU Relative value unit
SBA Small Business Administration
SGR Sustainable growth rate
SIM State Innovation Model
SLP Speech-language pathology
SMS Socioeconomic Monitoring System
SNF Skilled nursing facility
TAP Technical Advisory Panel
TC Technical component
TIN Tax identification number
UAF Update adjustment factor
UPIN Unique Physician Identification Number
USPSTF United States Preventive Services Task Force
VBP Value-based purchasing
VM Value-Based Payment Modifier
Addenda Available Only Through the Internet on the CMS Web Site
The PFS Addenda along with other supporting documents and tables
referenced in this final rule with comment period are available through
the Internet on the CMS Web site 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
2016 PFS Final Rule with Comment Period, refer to item CMS-1631-FC.
Readers who experience any problems accessing any of the Addenda or
other documents referenced in this rule and posted on the CMS Web site
identified above should contact Donta Henson at (410) 786-1947.
CPT (Current Procedural Terminology) Copyright Notice
Throughout this final rule with comment period, we use CPT codes
and descriptions to refer to a variety of services. We note that CPT
codes and descriptions are copyright 2015 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 and Background
A. Executive Summary
1. Purpose
This major final rule with comment period revises payment polices
under the Medicare Physician Fee Schedule (PFS) and makes other policy
changes related to Medicare Part B payment. These changes are
applicable to services furnished in CY 2016.
2. Summary of the Major Provisions
The Social Security Act (the Act) 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 Act requires that RVUs be established for three categories of
resources: Work, practice expense (PE); and malpractice (MP) expense;
and, 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 with
comment period, we establish RVUs for CY 2016 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. In addition, this
final rule with comment period includes discussions and proposals
regarding:
Potentially Misvalued PFS Codes.
Telehealth Services.
Advance Care Planning.
Establishing Values for New, Revised, and Misvalued Codes.
Target for Relative Value Adjustments for Misvalued
Services.
Phase-in of Significant RVU Reductions.
``Incident to'' policy.
Portable X-ray Transportation Fee.
Updating the Ambulance Fee Schedule regulations.
Changes in Geographic Area Delineations for Ambulance
Payment.
Chronic Care Management Services for RHCs and FQHCs.
HCPCS Coding for RHCs.
Payment to Grandfathered Tribal FQHCs that were Provider-
Based Clinics on or before April 7, 2000.
Payment for Biosimilars under Medicare Part B.
Physician Compare Web site.
Physician Quality Reporting System.
Medicare Shared Savings Program.
Electronic Health Record (EHR) Incentive Program.
[[Page 70889]]
Value-Based Payment Modifier and the Physician Feedback
Program.
3. Summary of Costs and Benefits
The Act requires that annual adjustments to PFS RVUs may not cause
annual estimated expenditures to differ by more than $20 million from
what they would have been had the adjustments not been made. If
adjustments to RVUs would cause expenditures to change by more than $20
million, we must make adjustments to preserve budget neutrality. These
adjustments can affect the distribution of Medicare expenditures across
specialties. In addition, several changes in this final rule with
comment period will affect the specialty distribution of Medicare
expenditures. When considering the combined impact of work, PE, and MP
RVU changes, the projected payment impacts are small for most
specialties; however, the impact is larger for a few specialties.
We have determined that this major final rule with comment period
is economically significant. For a detailed discussion of the economic
impacts, see section VII. of this final rule with comment period.
B. Background
Since January 1, 1992, Medicare has paid for physicians' services
under section 1848 of the Act, ``Payment for Physicians' Services.''
The system relies on national relative values that are established for
work, PE, and MP, which are adjusted for geographic cost variations.
These values are multiplied by a conversion factor (CF) to convert the
RVUs into payment rates. The concepts and methodology underlying the
PFS were enacted as part of the Omnibus Budget Reconciliation Act of
1989 (Pub. L. 101-239, enacted on December 19, 1989) (OBRA '89), and
the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted
on November 5, 1990) (OBRA '90). The final rule published on November
25, 1991 (56 FR 59502) set forth the first fee schedule used for
payment for physicians' services.
We note that throughout this major final rule with comment period,
unless otherwise noted, the term ``practitioner'' is used to describe
both physicians and nonphysician practitioners (NPPs) who are permitted
to bill Medicare under the PFS for services furnished to Medicare
beneficiaries.
1. Development of the Relative Values
a. Work RVUs
The work RVUs established for the initial fee schedule, which was
implemented on January 1, 1992, were developed with extensive input
from the physician community. A research team at the Harvard School of
Public Health developed the original work RVUs for most codes under a
cooperative agreement with the Department of Health and Human Services
(HHS). In constructing the code-specific vignettes used in determining
the original physician work RVUs, Harvard worked with panels of
experts, both inside and outside the federal government, and obtained
input from numerous physician specialty groups.
As specified in section 1848(c)(1)(A) of the Act, the work
component of physicians' services means the portion of the resources
used in furnishing the service that reflects physician time and
intensity. We establish work RVUs for new, revised and potentially
misvalued codes based on our review of information that generally
includes, but is not limited to, recommendations received from the
American Medical Association/Specialty Society Relative Value Update
Committee (RUC), the Health Care Professionals Advisory Committee
(HCPAC), the Medicare Payment Advisory Commission (MedPAC), and other
public commenters; medical literature and comparative databases; as
well as a comparison of the work for other codes within the Medicare
PFS, and consultation with other physicians and health care
professionals within CMS and the federal government. 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 their
recommendations.
b. Practice Expense RVUs
Initially, only the work RVUs were resource-based, and the PE and
MP RVUs were based on average allowable charges. Section 121 of the
Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on
October 31, 1994), amended section 1848(c)(2)(C)(ii) of the Act and
required us to develop resource-based PE RVUs for each physicians'
service beginning in 1998. We were required to consider general
categories of expenses (such as office rent and wages of personnel, but
excluding malpractice expenses) comprising PEs. The PE RVUs continue to
represent the portion of these resources involved in furnishing PFS
services.
Originally, the resource-based method was to be used beginning in
1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L.
105-33, enacted on August 5, 1997) (BBA) delayed implementation of the
resource-based PE RVU system until January 1, 1999. In addition,
section 4505(b) of the BBA provided for a 4-year transition period from
the charge-based PE RVUs to the resource-based PE RVUs.
We established the resource-based PE RVUs for each physicians'
service in a final rule, published on November 2, 1998 (63 FR 58814),
effective for services furnished in CY 1999. Based on the requirement
to transition to a resource-based system for PE over a 4-year period,
payment rates were not fully based upon resource-based PE RVUs until CY
2002. This resource-based system was based on two significant sources
of actual PE data: the Clinical Practice Expert Panel (CPEP) data and
the AMA's Socioeconomic Monitoring System (SMS) data. (These data
sources are described in greater detail in the CY 2012 final rule with
comment period (76 FR 73033).)
Separate PE RVUs are established for services furnished in facility
settings, such as a hospital outpatient department (HOPD) or an
ambulatory surgical center (ASC), and in nonfacility settings, such as
a physician's office. The nonfacility RVUs reflect all of the direct
and indirect PEs involved in furnishing a service described by a
particular HCPCS code. The difference, if any, in these PE RVUs
generally results in a higher payment in the nonfacility setting
because in the facility settings some costs are borne by the facility.
Medicare's payment to the facility (such as the outpatient prospective
payment system (OPPS) payment to the HOPD) would reflect costs
typically incurred by the facility. Thus, payment associated with those
facility resources is not made under the PFS.
Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L.
106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of
Health and Human Services (the Secretary) to establish a process under
which we accept and use, to the maximum extent practicable and
consistent with sound data practices, data collected or developed by
entities and organizations to supplement the data we normally collect
in determining the PE component. On May 3, 2000, we published the
interim final rule (65 FR 25664) that set forth the criteria for the
submission of these supplemental PE survey data. The criteria were
modified in response to comments received, and published in the Federal
Register (65 FR 65376) as part of a November 1, 2000 final rule. The
PFS final rules published in 2001 and 2003, respectively, (66 FR 55246
and 68 FR 63196) extended the
[[Page 70890]]
period during which we would accept these supplemental data through
March 1, 2005.
In the CY 2007 PFS final rule with comment period (71 FR 69624), we
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for
CY 2010. In the CY 2010 PFS final rule with comment period, we updated
the practice expense per hour (PE/HR) data that are used in the
calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010,
we began a 4-year transition to the new PE RVUs using the updated PE/HR
data, which was completed for CY 2013.
c. Malpractice RVUs
Section 4505(f) of the BBA amended section 1848(c) of the Act to
require that we implement resource-based MP RVUs for services furnished
on or after CY 2000. The resource-based MP RVUs were implemented in the
PFS final rule with comment period published November 2, 1999 (64 FR
59380). The MP RVUs are based on commercial and physician-owned
insurers' malpractice insurance premium data from all the states, the
District of Columbia, and Puerto Rico. For more information on MP RVUs,
see section II.B.2. of this final rule with comment period.
d. Refinements to the RVUs
Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no
less often than every 5 years. Prior to CY 2013, we conducted periodic
reviews of work RVUs and PE RVUs independently. We completed five-year
reviews of work RVUs that were effective for calendar years 1997, 2002,
2007, and 2012.
Although refinements to the direct PE inputs initially relied
heavily on input from the RUC Practice Expense Advisory Committee
(PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to
the use of the updated PE/HR data in CY 2010 have resulted in
significant refinements to the PE RVUs in recent years.
In the CY 2012 PFS final rule with comment period (76 FR 73057), we
finalized a proposal to consolidate reviews of work and PE RVUs under
section 1848(c)(2)(B) of the Act and reviews of potentially misvalued
codes under section 1848(c)(2)(K) of the Act into one annual process.
In addition to the five-year reviews, beginning for CY 2009, CMS,
and the RUC have identified and reviewed a number of potentially
misvalued codes on an annual basis based on various identification
screens. This annual review of work and PE RVUs for potentially
misvalued codes was supplemented by the amendments to section 1848 of
the Act, as enacted by section 3134 of the Affordable Care Act, which
requires the agency to periodically identify, review and adjust values
for potentially misvalued codes.
e. Application of Budget Neutrality to Adjustments of RVUs
As described in section VI.C. of this final rule with comment
period, in accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if
revisions to the RVUs cause expenditures for the year to change by more
than $20 million, we make adjustments to ensure that expenditures did
not increase or decrease by more than $20 million.
2. Calculation of Payments Based on RVUs
To calculate the payment for each service, the components of the
fee schedule (work, PE, and MP RVUs) are adjusted by geographic
practice cost indices (GPCIs) to reflect the variations in the costs of
furnishing the services. The GPCIs reflect the relative costs of work,
PE, and MP in an area compared to the national average costs for each
component.
We received several comments regarding GPCIs that are not within
the scope of proposals in the CY 2016 PFS proposed rule. Many of these
commenters requested adjustments to GPCI values for the Puerto Rico
payment locality. These commenters contend that the data used to
calculate GPCIs do not accurately reflect the cost of medical practice
in Puerto Rico. We have addressed some of these issues in response to
specific comments in prior rulemaking, such as the CY 2014 PFS final
rule with comment period (78 FR 74380 through 74391), and will further
take comments into account when we next propose to update GPCIs.
However, we also note that we anticipate proposing updated GPCIs during
CY 2017 rulemaking, and in the context of that update, we will consider
the concerns expressed by commenters and others regarding the GPCIs for
the Puerto Rico locality.
RVUs are converted to dollar amounts through the application of a
CF, which is calculated based on a statutory formula by CMS's Office of
the Actuary (OACT). The formula for calculating the Medicare fee
schedule payment amount for a given service and fee schedule area can
be expressed as:
Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU MP x GPCI
MP)] x CF.
3. Separate Fee Schedule Methodology for Anesthesia Services
Section 1848(b)(2)(B) of the Act specifies that the fee schedule
amounts for anesthesia services are to be based on a uniform relative
value guide, with appropriate adjustment of an anesthesia conversion
factor, in a manner to assure that fee schedule amounts for anesthesia
services are consistent with those for other services of comparable
value. Therefore, there is a separate fee schedule methodology for
anesthesia services. Specifically, we establish a separate conversion
factor for anesthesia services and we utilize the uniform relative
value guide, or base units, as well as time units, to calculate the fee
schedule amounts for anesthesia services. Since anesthesia services are
not valued using RVUs, a separate methodology for locality adjustments
is also necessary. This involves an adjustment to the national
anesthesia CF for each payment locality.
4. Most Recent Changes to the Fee Schedule
Section 220(d) of the Protecting Access to Medicare Act of 2014
(PAMA) (Pub. L. 113-93, enacted on April 1, 2014) added a new
subparagraph (O) to section 1848(c)(2) of the Act to establish an
annual target for reductions in PFS expenditures resulting from
adjustments to relative values of misvalued codes. If the estimated net
reduction in expenditures for a year is equal to or greater than the
target for that year, the provision specifies that reduced expenditures
attributable to such adjustments shall be redistributed in a budget-
neutral manner within the PFS. The provision specifies that the amount
by which such reduced expenditures exceed the target for a given year
shall be treated as a reduction in expenditures for the subsequent year
for purposes of determining whether the target for the subsequent year
has been met. The provision also specifies that an amount equal to the
difference between the target and the estimated net reduction in
expenditures, called the target recapture amount, shall not be taken
into account when applying the budget neutrality requirements specified
in section 1848(c)(2)(B)(ii)(II) of the Act. The PAMA amendments
originally made the target provisions applicable for CYs 2017 through
2020 and set the target for reduced expenditures at 0.5 percent of
estimated expenditures under the PFS for each of those 4 years.
[[Page 70891]]
Subsequently, section 202 of the Achieving a Better Life Experience
Act of 2014 (ABLE) (Division B of Pub. L. 113-295, enacted December 19,
2014) accelerated the application of the target, amending section
1848(c)(2)(O) of the Act to specify that target provisions apply for
CYs 2016, 2017, and 2018; and setting a 1 percent target for reduced
expenditures for CY 2016 and a 0.5 percent target for CYs 2017 and
2018. The implementation of the target legislation is discussed in
section II.E. of this final rule with comment period.
Section 1848(c)(7) of the Act, as added by section 220(e) of the
PAMA, specified 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. Section 220(e) of the PAMA
required the phase-in of RVU reductions of 20 percent or more to begin
for 2017. Section 1848(c)(7) of the Act was later amended by section
202 of the ABLE Act to require instead that the phase-in must begin in
CY 2016. The implementation of the phase-in legislation is discussed in
section II.F. of this final rule with comment period.
Section 218(a) of the PAMA added a new section 1834(p) of the Act.
Section 1834(p) of the Act requires for certain computed tomography
(CT) services reductions in payment for the technical component (TC)
(and the TC of the global fee) of the PFS service and in the hospital
OPPS payment (5 percent in 2016, and 15 percent in 2017 and subsequent
years). The CT services that are subject to the payment reduction are
services identified as of January 1, 2014 by HCPCS codes 70450-70498,
71250-71275, 72125-72133, 72191-72194, 73200-73206, 73700-73706, 74150-
74178, 74261-74263, and 75571-75574, and succeeding codes, that are
furnished using equipment that does not meet each of the attributes of
the National Electrical Manufacturers Association (NEMA) Standard XR-
29-2013, entitled ``Standard Attributes on CT Equipment Related to Dose
Optimization and Management.'' The implementation of the amendments
made by section 218(a) of the PAMA is discussed in section II.G. of
this final rule with comment period.
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)
(Pub. L. 114-10, enacted on April 16, 2015) makes several changes to
the statute, including but not limited to:
(1) Repealing the sustainable growth rate (SGR) update methodology
for physicians' services.
(2) Revising the PFS update for 2015 and subsequent years.
(3) Requiring that we establish a Merit-based Incentive Payment
System (MIPS) under which MIPS eligible professionals (initially
including physicians, physician assistants, nurse practitioners,
clinical nurse specialists, and certified registered nurse
anesthetists) receive annual payment adjustments (increases or
decreases) based on their performance in a prior period. These and
other MACRA provisions are discussions in various sections of this
final rule with comment period. Please refer to the table of contents
for the location of the various MACRA provision discussions.
II. Provisions of the Final Rule with Comment Period for PFS
A. 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 malpractice 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 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 there are a
number of ongoing Center for Medicare and Medicaid Innovation (CMMI)
initiatives in which pharmacists are making substantial contributions
to redesigning healthcare delivery and financing. The commenters
insisted that pharmacists need to be included in the calculation of
direct PE expenses as an element of the clinical labor variable
relating to physician services, to ensure optimal medication therapy
outcomes for beneficiaries, and the absence of these pharmacists
negatively impacts the health care system.
Response: The direct PE input database contains the service-level
costs in clinical labor based on the typical service furnished to
Medicare beneficiaries. Commenters did not suggest that the labor costs
of pharmacists are a typical resource cost in furnishing any particular
physicians' service. When such costs are typically incurred in
furnishing such 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 many of the CMMI initiatives, payment is
provided for care management and care coordination services, including
services provided by pharmacists. As such, we encourage commenters to
provide information 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 initiatives.
[[Page 70892]]
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 practice expense per hour (PE/HR) by specialty that
was obtained from the AMA's Socioeconomic Monitoring Surveys (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 nonphysician practitioners (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 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 continue previous crosswalks
for specialties that did not participate in the PPIS. However,
beginning in CY 2010 we changed the PE/HR crosswalk for portable X-ray
suppliers from radiology to IDTF, a more appropriate crosswalk because
these specialties are more similar to each other for work time.
For registered dietician services, the resource-based PE RVUs have
been calculated in accordance with the final policy that crosswalks the
specialty to the ``All Physicians'' PE/HR data, as adopted in the CY
2010 PFS final rule with comment period (74 FR 61752) and discussed in
more detail in the CY 2011 PFS final rule with comment period (75 FR
73183).
For CY 2016, we have incorporated the available utilization data
for interventional cardiology, which became a recognized Medicare
specialty during 2014. We proposed to use a proxy PE/HR value for
interventional cardiology, as there are no PPIS data for this
specialty, by crosswalking the PE/HR from Cardiology, since the
specialties furnish similar services in the Medicare claims data. The
change is reflected in the ``PE/HR'' file available on the CMS Web site
under the supporting data files for the CY 2016 PFS proposed rule at
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
Comment: One commenter expressed support for the new proposal to
use a proxy PE per hour for interventional cardiology by crosswalking
to the PE/HR for cardiology.
Response: We appreciate the commenter's support and are finalizing
the crosswalk as proposed.
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
Section II.A.2.b. of this final rule with comment period describes
the current data sources for specialty-specific indirect costs used in
our PE calculations. We allocated the indirect costs to 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 incorporated the survey data described earlier in the PE/HR
discussion. The general approach to developing the indirect portion of
the PE RVUs is as follows:
For a given service, we used 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, represented 25 percent of total costs for the specialties that
furnished 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
[[Page 70893]]
initial indirect allocator would equal 6.00, resulting in a total PE
RVUs of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 percent of
8.00).
Next, we added 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 work RVUs of
4.00 and the clinical labor portion of the direct PE RVUs 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.
(4) Facility and Nonfacility Costs
For procedures that can be furnished in a physician's office, as
well as in a hospital or other facility setting, 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. Because 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 in a facility, the facility PE RVUs are
generally lower than the nonfacility PE RVUs. Medicare makes a separate
payment to the facility for its costs of furnishing a service.
(5) Services With Technical Components (TCs) and Professional
Components (PCs)
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 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.)
(6) 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).
(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. Apply
a scaling adjustment to the direct inputs.
Step 2: Calculate the aggregate pool of direct PE costs for the
current year. Under our current methodology, we first multiply the
current year's conversion factor by the product of the current year's
PE RVUs and utilization for each service to arrive at the aggregate
pool of total PE costs (Step 2a). We then calculate the average direct
percentage of the current pool of PE RVUs (using a weighted average of
the survey data for the specialties that furnish each service (Step
2b).) We then multiply the result of 2a by the result of 2b to arrive
at the aggregate pool of direct PE costs for the current year. For CY
2016, we proposed a technical improvement to step 2a of this
calculation. In place of the step 2a calculation described above, we
proposed to 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 proposed aggregate work RVUs. Historically, in allowing
the current PE RVUs to determine the size of the base PE pool in the PE
methodology, we have assumed that the relationship of PE RVUs to work
RVUs is constant from year to year. Since this is not ordinarily the
case, by not considering the proposed aggregate work RVUs in
determining the size of the base PE pool, we have introduced some minor
instability from year to year in the relative shares of work, PE, and
MP RVUs. Although this modification would result in greater stability
in the relationship among the work and PE RVU components in the
aggregate, we do not anticipate it will affect the distribution of PE
RVUs across specialties. The PE RVUs in addendum B of this final rule
with comment period reflect this refinement to the PE methodology.
We did not receive any comments on this proposed refinement of the
methodology. Therefore, we are finalizing this refinement as proposed.
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, 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 factor to the
direct costs for each service (as calculated in Step 1).
Step 5: Convert the results of Step 4 to an 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 2
and Step 5. Different CFs will result in different direct PE scaling
factors, but this has no effect on the final direct cost PE RVUs since
changes in the CFs and changes in the associated direct scaling factors
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.
Historically, we have used the specialties that furnish the service
in the most recent full year of Medicare claims data (crosswalked to
the current year set of codes) to determine which specialties furnish
individual procedures. For example, for CY 2015 ratesetting, we used
the mix of specialties that
[[Page 70894]]
furnished the services in the CY 2013 claims data to determine the
specialty mix assigned to each code. Although we believe that there are
clear advantages to using the most recent available data in making
these determinations, we have also found that using a single year of
data contributes to greater year-to-year instability in PE RVUs for
individual codes and often creates extreme, annual fluctuations for
low-volume services, as well as delayed fluctuations for some services
described by new codes once claims data for those codes becomes
available. We believe that using an average of the three most recent
years of available data may increase stability of PE RVUs and mitigate
code-level fluctuations for both the full range of PFS codes, and for
new and low-volume codes in particular. Therefore, we proposed to
refine this step of the PE methodology to use an average of the 3 most
recent years of available Medicare claims data to determine the
specialty mix assigned to each code. The PE RVUs in Addendum B of the
CMS Web site reflect this refinement to the PE methodology.
Comment: We received several comments supporting this proposed
refinement of the methodology. Several commenters also urged us to
override the utilization data for low-volume codes using a recommended
list of expected specialty or dominant specialty, consistent with our
previous approach.
Response: We appreciate the support for the use of the 3-year
average of claims utilization for purposes of determining the specialty
mix for individual service. As we stated in our proposal, we believe
that the 3-year average will mitigate the need to use dominant or
expected specialty instead of the claims data. However, we also
understand that the hypothesis will be tested as soon as a new year of
claims data is incorporated into the PFS ratesetting methodology.
Because we anticipate incorporating CY 2015 claims data for use in CY
2017 ratesetting, we believe that the proposed PE RVUs associated with
the CY 2017 PFS proposed rule will provide the best opportunity to
determine whether service-level overrides of claims data are necessary.
Therefore, we are finalizing the policy as proposed for CY 2016 but
will seek comment on the proposed CY 2017 PFS rates and whether or not
the incorporation a new year of utilization data mitigates the need for
service-level overrides. At that time, we would reconsider whether or
not to use a claims-based approach (dominant specialty) or stakeholder-
recommended approach (expected specialty) in the development of PE RVUs
for low-volume codes.
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 will be allocated
using the work RVUs, and for the TC service, indirect PEs will 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 Table 1, 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 2a (as calculated with the proposed
change) 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.
(d) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from Step 6 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 results of
Step 18 to the proposed aggregate work RVUs scaled by the ratio of
current aggregate PE and work RVUs, consistent with the proposed
changes in Steps 2 and 9. This final BN adjustment is required to
redistribute RVUs from step 18 to all PE RVUs in the PFS, and because
certain specialties are excluded from the PE RVU calculation for
ratesetting purposes, but we note that all specialties are included for
purposes of calculating the final BN adjustment. (See ``Specialties
excluded from
[[Page 70895]]
ratesetting calculation'' later in this section.)
(e) Setup File Information
Specialties excluded from ratesetting calculation: For the
purposes of calculating the PE RVUs, we exclude certain specialties,
such as certain nonphysician practitioners 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 1.
Table 1--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.
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 2 details the manner in which the
modifiers are applied.
Table 2--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%.
[[Page 70896]]
53............................ Discontinued Procedure.. 50%.......................... 50%.
54............................ Intraoperative Care only Preoperative + Intraoperative Preoperative +
Percentages on the payment Intraoperative
files used by Medicare portion.
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 with comment period.
The following is a summary of the comments we received regarding PE
RVU methodology.
Comment: We received several comments in response to our proposal
to use the 3 most recent years of Medicare claims data to determine the
specialty mix assigned to each code. All commenters broadly supported
the proposal to use a 3-year average to increase stability of PE RVUs
and mitigate code-level fluctuations. Some commenters, including the
RUC, also stated that for codes which are very low volume in the
Medicare population, the dominant specialty(ies) should be assigned.
These commenters stressed that CMS should continue to utilize the
expertise of the RUC when making these assignments.
Response: For services that are newly created or very low volume,
we will continue to explore different methods to ensure the utilization
of the most accurate specialty mix.
(7) Equipment Cost per Minute
The equipment cost per minute is calculated as:
(1/(minutes per year * usage)) * price * ((interest rate/(1 - (1/((1 +
interest rate)- 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 below.
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 below.
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. We also direct the
reader to section II.H.6.b of this final rule with comment period for a
discussion of our change in the utilization rate assumption for the
linear accelerator used in furnishing radiation treatment services.
Maintenance: This factor for maintenance was proposed and finalized
during rulemaking for CY 1998 PFS (62 FR 33164). Several stakeholders
have suggested that this maintenance factor assumption should be
variable, similar to other assumptions in the equipment cost per minute
calculation. In CY 2015 rulemaking, we solicited comments regarding the
availability of reliable data on maintenance costs that vary for
particular equipment items. We received several comments about variable
maintenance costs, and in reviewing the information offered in those
comments, it is clear that the relationship between maintenance costs
and the price of equipment is not necessarily uniform across equipment.
After reviewing the comments received, we have been unable to identify
a systematic way of varying the maintenance cost assumption relative to
the price or useful life of equipment. Therefore, to accommodate a
variable, as opposed to a standard, maintenance rate within the
equipment cost per minute calculation, we believe we would have to
gather and maintain valid data on the maintenance costs for each
equipment item in the direct PE input database, much like we do for
price and useful life.
Given our longstanding difficulties in acquiring accurate pricing
information for equipment items, we solicited comments on whether
adding another item-specific financial variable for equipment costs
will be likely to increase the accuracy of PE RVUs across the PFS. We
noted that most of the information for maintenance costs we have
received is for capital equipment, and for the most part, this
information has been limited to single invoices. Like the invoices for
the equipment items themselves, we do not believe that very small
numbers of voluntarily submitted invoices are likely to reflect typical
costs for all of the same reasons we have discussed in previous
rulemaking. We noted that some commenters submitted high-level summary
data from informal surveys but we currently have no means to validate
that data. Therefore, we continue to seek a source of publicly
available data on actual maintenance costs for medical equipment to
improve the accuracy of the equipment costs used in developing PE RVUs.
Comment: Many commenters stated that the current 5 percent
equipment maintenance factor does not account for expensive maintenance
contracts on pieces of highly technical equipment. Most commenters were
supportive of the idea of adding an item-specific maintenance variable
for equipment costs, which they stated would likely increase the
accuracy of the PE RVUs across the PFS. These commenters stated that
specialty societies and other stakeholders should be allowed to provide
documentation to CMS, as they
[[Page 70897]]
currently do for pricing new supplies and equipment, to apply for an
increase in maintenance costs. Other commenters requested that if a
fixed maintenance factor remains in place, it should be increased from
5 percent to 10 percent. One commenter expressed concern that CMS would
entertain making a change in this aspect of the equipment cost per
minute formula based on a few invoices when a change would impact every
service in the fee schedule. The commenter expressed concerns with the
possibility that CMS might adopt a variable maintenance factor based on
the submission of individual invoices. Another commenter stated that
without a systematic data collection methodology for determining
maintenance factors, they had concerns that any invoices CMS received
might not accurately capture the true costs of equipment maintenance.
Although most commenters were supportive of adopting a variable
maintenance factor for equipment items, commenters also stated that
they were unaware of any publicly available data source containing this
information. One commenter agreed that there is no comprehensive data
source for the maintenance information and therefore it would be
difficult to implement a variable maintenance formula. Multiple other
commenters concurred that they were unaware of any such public dataset.
Several commenters encouraged CMS to work with stakeholders to define
service contracts/maintenance contracts, collect data on their
associated costs and update the equipment maintenance adjustment factor
as necessary.
Response: We appreciate the submission of extensive comments
regarding the subject of equipment maintenance factor. We agree with
commenters that we do not believe the annual maintenance factor for all
equipment is exactly 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.
However, in the absence of publicly available datasets regarding
equipment maintenance costs or another systematic data collection
methodology for determining maintenance factor, we do not believe that
we have sufficient information at present to adopt a variable
maintenance factor for equipment cost per minute pricing. While we
believe that these costs ideally should be incorporated into the PE
methodology, we also have serious concerns about the problems that
result from incorporating anecdotal data based solely on voluntarily
submitted pricing information. In establishing prices for equipment and
supplies, in many cases we have found that the submitted invoices often
overstate the costs for individual items relative to publically
available prices. We believe that the incentives related to voluntarily
submitted limited invoices for maintenance costs would likely produce
information subject to similar limitations. However, in contrast to
prices, where we have identified no feasible alternative, our
alternative for determining maintenance rates is a long-established
default maintenance rate. We also note that the amount of costs for
maintenance under the current methodology is directly proportional to
the equipment prices, largely determined by the voluntarily submitted
invoices for particular equipment items. Therefore, we believe that
absent an auditable, robust data source, using anecdotal data for
maintenance costs is likely to compound the current problems of pricing
equipment costs accurately, not increase accuracy.
We will continue to investigate potential avenues for determining
equipment maintenance costs across a broad range of equipment items.
Interest Rate: In the CY 2013 final rule with comment period (77 FR
68902), we updated the interest rates used in developing an equipment
cost per minute calculation. 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).
The interest rates are listed in Table 3. (See 77 FR 68902 for a
thorough discussion of this issue.) We did not propose any changes to
these interest rates for CY 2016.
Table 3A--SBA Maximum Interest Rates
------------------------------------------------------------------------
Interest
Price Useful life rate (%)
------------------------------------------------------------------------
<$25K................................ <7 Years 7.50
$25K to $50K......................... <7 Years 6.50
>$50K................................ <7 Years 5.50
<$25K................................ 7+ Years 8.00
$25K to $50K......................... 7+ Years 7.00
>$50K................................ 7+ Years 6.00
------------------------------------------------------------------------
[[Page 70898]]
Table 4--Calculation of PE RVUs Under Methodology for Selected Codes
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
33533
99213 CABG, 71020 Chest 71020-TC 71020-26 93000 ECG, 93005 ECG, 93010 ECG,
Step Source Formula Office arterial, x-ray Chest x- Chest x- complete, tracing report
visit, est single nonfacility ray, ray, nonfacility nonfacility nonfacility
nonfacility facility nonfacility nonfacility
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
(1) Labor cost (Lab)........... Step 1............ AMA............... ................. 13.32 77.52 5.74 5.74 0 5.1 5.1 0
(2) Supply cost (Sup).......... Step 1............ AMA............... ................. 2.98 7.34 0.53 0.53 0 1.19 1.19 0
(3) Equipment cost (Eqp)....... Step 1............ AMA............... ................. 0.17 0.58 7.08 7.08 0 0.09 0.09 0
(4) Direct cost (Dir).......... Step 1............ .................. =(1)+(2)+(3) 16.48 85.45 13.36 13.36 0 6.38 6.38 0
(5) Direct adjustment (Dir. Steps 2-4......... See Footnote*..... ................. 0.5957 0.5957 0.5957 0.5957 0.5957 0.5957 0.5957 0.5957
Adj.).
(6) Adjusted Labor............. Steps 2-4......... .................. =(1)*(5) 7.93 46.18 3.42 3.42 0 3.04 3.04 0
(7) Adjusted Supplies.......... Steps 2-4......... =Eqp * Dir Adj.... =(2)*(5) 1.78 4.37 0.32 0.32 0 0.71 0.71 0
(8) Adjusted Equipment......... Steps 2-4......... =Sup * Dir Adj.... =(3)*(5) 0.1 0.35 4.22 4.22 0 0.05 0.05 0
(9) Adjusted Direct............ Steps 2-4......... .................. =(6)+(7)+(8) 9.82 50.9 7.96 7.96 0 3.8 3.8 0
(10) Conversion Factor (CF).... Step 5............ PFS............... ................. 35.9335 35.9335 35.9335 35.9335 35.9335 35.9335 35.9335 35.9335
(11) Adj. labor cost converted. Step 5............ =(Lab * Dir Adj)/ =(6)/(10) 0.22 1.29 0.1 0.1 0 0.08 0.08 0
CF.
(12) Adj. supply cost converted Step 5............ =(Sup * Dir Adj)/ =(7)/(10) 0.05 0.12 0.01 0.01 0 0.02 0.02 0
CF.
(13) Adj. equipment cost Step 5............ =(Eqp * Dir Adj)/ =(8)/(10) 0 0.01 0.12 0.12 0 0 0 0
converted. CF.
(14) Adj. direct cost converted Step 5............ .................. =(11)+(12)+(13) 0.27 1.42 0.22 0.22 0 0.11 0.11 0
(15) Work RVU.................. Setup File........ PFS............... ................. 0.97 33.75 0.22 0 0.22 0.17 0 0.17
(16) Dir_pct................... Steps 6,7......... Surveys........... ................. 0.25 0.17 0.29 0.29 0.29 0.29 0.29 0.29
(17) Ind_pct................... Steps 6,7......... Surveys........... ................. 0.75 0.83 0.71 0.71 0.71 0.71 0.71 0.71
(18) Ind. Alloc. Formula (1st Step 8............ See Step 8........ ................. 14/ 14/ 14/ 14/ 14/ 14/ 14/ 14/
part). (16)*(17) (16)*(17) (16)*(17) (16)*(17) (16)*(17) (16)*(17) (16)*(17) (16)*(17)
(19) Ind. Alloc.(1st part)..... Step 8............ .................. See 18 0.83 6.7 0.54 0.54 0 0.26 0.26 0
(20) Ind. Alloc. Formula (2nd Step 8............ See Step 8........ ................. (15) (15) (15+11) (11) (15) (15+11) (11) (15)
pt).
(21) Ind. Alloc.(2nd part)..... Step 8............ .................. See 20 0.97 33.75 0.32 0.1 0.22 0.25 0.08 0.17
(22) Indirect Allocator (1st + Step 8............ .................. =(19)+(21) 1.8 40.45 0.85 0.63 0.22 0.52 0.35 0.17
2nd).
(23) Indirect Adjustment (Ind Steps 9-11........ See Footnote**.... ................. 0.3816 0.3816 0.3816 0.3816 0.3816 0.3816 0.3816 0.3816
Adj).
(24) Adjusted Indirect Steps 9-11........ =Ind Alloc * Ind ................. 0.69 15.44 0.33 0.24 0.08 0.2 0.13 0.06
Allocator. Adj.
(25) Ind. Practice Cost Index Steps 12-16....... .................. ................. 1.07 0.76 0.98 0.98 0.98 0.9 0.9 0.9
(IPCI).
(26) Adjusted Indirect......... Step 17........... = Adj.Ind Alloc * =(24)*(25) 0.73 11.71 0.32 0.24 0.08 0.18 0.12 0.06
PCI.
(27) Final PE RVU.............. Step 18........... =(Adj Dir + Adj =((14)+(26)) 1.01 13.16 0.54 0.46 0.08 0.28 0.23 0.06
Ind) * Other Adj. * Other Adj)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
CPT codes and descriptions are copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS apply.
Notes: PE RVUs above (row 27), may not match Addendum B due to rounding.
The use of any particular conversion factor (CF) in the table to illustrate the PE Calculation has no effect on the resulting RVUs.
*The direct adj = [current pe rvus * CF * avg dir pct]/[sum direct inputs] = [step2]/[step3]; **The indirect adj =[current pe rvus * avg ind pct]/[sum of ind allocators]=[step9]/[step10].
[[Page 70899]]
c. Changes to Direct PE Inputs for Specific Services
This section focusses on specific PE inputs that we addressed in
the proposed rule. The direct PE inputs are included in the CY 2016
direct PE input database, which is available on the CMS Web site under
downloads for the CY 2016 PFS final rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(1) PE Inputs for Digital Imaging Services
Prior to CY 2015 rulemaking, the RUC provided a recommendation
regarding the PE inputs for digital imaging services. Specifically, the
RUC recommended that we remove supply and equipment items associated
with film technology from a list of codes since these items are no
longer typical resource inputs. The RUC also recommended that the
Picture Archiving and Communication System (PACS) equipment be included
for these imaging services since these items are now typically used in
furnishing imaging services. However, since we did not receive any
invoices for the PACS system, we were unable to determine the
appropriate pricing to use for the inputs. For CY 2015, we proposed,
and finalized our proposal, to remove the film supply and equipment
items, and to create a new equipment item as a proxy for the PACS
workstation as a direct expense. We used the current price associated
with ED021 (computer, desktop, w-monitor) to price the new item, ED050
(PACS Workstation Proxy), pending receipt of invoices to facilitate
pricing specific to the PACS workstation.
Subsequent to establishing payment rates for CY 2015, we received
information from several stakeholders regarding pricing for items
related to the digital acquisition and storage of images. Some of these
stakeholders submitted information that included prices for items
clearly categorized as indirect costs within the established PE
methodology and equivalent to the storage mechanisms for film.
Additionally, some of the invoices we received included other products
(like training and maintenance costs) in addition to the equipment
items, and there was no distinction on these invoices between the
prices for the equipment items themselves and the related services.
However, we did receive invoices from one stakeholder that facilitated
a proposed price update for the PACS workstation. Therefore, we
proposed to update the price for the PACS workstation to $5,557 from
the current price of $2,501 since the latter price was based on the
proxy item and the former based on submitted invoices. The PE RVUs in
Addendum B on the CMS Web site reflect the updated price.
In addition to the workstation used by the clinical staff acquiring
the images and furnishing the TC of the services, a stakeholder also
submitted more detailed information regarding a workstation used by the
practitioner interpreting the image in furnishing the PC of many of
these services.
As we stated in the CY 2015 final rule with comment period (79 FR
67563), we generally believe that workstations used by these
practitioners are more accurately considered indirect costs associated
with the PC of the service. However, we understand that the
professional workstations for interpretation of digital images are
similar in principle to some of the previous film inputs incorporated
into the global and technical components of the codes. Given that many
of these services are reported globally in the nonfacility setting, we
believe it may be appropriate to include these costs as direct inputs
for the associated HCPCS codes. Based on our established methodology,
these costs would be incorporated into the PE RVUs of the global and
technical component of the HCPCS code.
We solicited comments on whether including the professional
workstation as a direct PE input for these codes would be appropriate,
given that the resulting PE RVUs would be assigned to the global and
technical components of the codes.
Comment: Many commenters supported the equipment price increase to
$5,557 for the PACS workstation. Commenters stated that this is a more
accurate amount than the current price of $2,501. However, many
commenters, including the RUC, stated that this price did not capture
the appropriate pricing for the PC of the PACS workstation. One
commenter expressed concerns with the method that CMS employed to
establish the proposed price for the PACS workstation, disregarded the
invoices and accompanying explanations submitted by several
stakeholders and instead relying on the information submitted by a
single group.
Response: We acknowledge and appreciate that several stakeholders
provided information intended to facilitate our pricing of the
equipment related to PACS. However, much of that submitted information
included costs that are considered indirect PE under the established
methodology. We considered all of the submitted information and used
the submitted prices that were consistent with the principles
established under the PE methodology.
Comment: Many commenters, including the RUC, stated that the
proposed price did not capture the appropriate pricing for the PC of
the PACS workstation. Several commenters indicated that the
professional workstation was a direct PE item due to the fact that it
is used for individual studies (one at a time) in the non-facility
setting, and its use involves a bi-directional exchange between a
technologist and a radiologist while the TC is being provided. These
commenters also suggested that the professional PACS workstation was a
direct proxy for the film alternators, film processors, and view-boxes
previously considered direct PE inputs for many of these services prior
to the film to digital conversion. Several commenters suggested that
the true cost of the PACS workstation was significantly higher than the
proposed $5,557 due to these professional expenses.
Response: We appreciate the extensive feedback regarding the
potential addition of a PC to the PACS workstation. We agree that the
costs of the professional workstation may be analogous to costs
previously incorporated as direct PE inputs for these services.
Therefore, we are seeking comments and recommendations from
stakeholders, including the RUC, regarding which codes would require
the professional PACS workstation and for how many minutes the
professional equipment workstation would be used relative to the work
time or clinical labor tasks associated with individual codes. We would
address any such recommendations in future rulemaking.
Comment: One commenter stated that the CMS' attempt to analogize
elements of a PACS workstation to the historic inputs associated with
film technology was inherently flawed. This commenter stated that CMS
should not characterize critical elements of the PACS workstation as
indirect costs because film technology is fundamentally distinct from
digital technology. The commenter indicated that the PACS workstation
requires specific software to function, and the costs associated with
training, maintenance, and warranties for the PACS workstation have not
been factored into the cost of the equipment. The commenter suggested
that not including these as direct costs reflects a mistaken assumption
that a PACS workstation has functionality for non-imaging services,
such as patient
[[Page 70900]]
scheduling, billing, or electronic medical records capability.
Response: We believe that maintaining consistent treatment of PE
costs is of central importance in the resource-based relative value
system. Since the PE RVUs for individual services are relative to all
other PFS services, we believe that we must categorize typical costs
for individual services into the direct and indirect categories using
the same definitions that apply to all PFS services. We believe it
would be inconsistent with cost-based relative value principles to
change the definition of those categories for particular procedures or
tests, even when technology changes. Centralized record keeping
systems, containing clinical or billing information are considered
indirect expenses across the PFS. Due to technological changes, some of
these systems are well-integrated into equipment items with clinical
functionality, while others remain completely distinct. In pricing and
categorizing these costs, we have aimed to separate these costs where
possible and believe we have maintained relativity among PFS services
to the greatest extent possible. We remind commenters that indirect PE
RVUs are included for every nationally priced PFS service and that
these RVUs contribute to payment for each and every service. We also
note that over time, indirect costs change as direct costs change. For
example, changes in technology might result in particular items using
more or less office space, or using more or less electricity. We do not
believe it would be appropriate to redefine indirect costs as direct
costs whenever we have reason to believe that indirect costs have
changed due to changes in technology. Instead, we acknowledge that
indirect costs change over time for all those who are paid through the
Medicare PFS, making it even more important to follow the established
principles of relativity in establishing direct PE inputs.
After consideration of comments received, we are finalizing our
proposal to update the price for the PACS workstation to $5,557 from
the current price of $2,501.
As we noted in the proposed rule, one commenter expressed concern
about the changes in direct PE inputs for CPT code 76377, (3D
radiographic procedure with computerized image post-processing), that
were proposed and finalized in CY 2015 rulemaking as part of the film
to digital change. Based on a recommendation from the RUC, we removed
the input called ``computer workstation, 3D reconstruction CT-MR'' from
the direct PE input database and assigned the associated minutes to the
proxy for the PACS workstation. Therefore, we sought comment from
stakeholders, including the RUC, about whether or not the PACS
workstation used in imaging codes is the same workstation that is used
in the post-processing described by CPT code 76377, or if a more
specific workstation should be incorporated in the direct PE input
database.
Comment: Multiple commenters indicated that CPT code 76377 requires
image post-processing on an independent workstation. Commenters stated
that the ``computer workstation, 3D reconstruction CT-MR'' equipment
(ED014), which was removed by the RUC from the equipment list for this
procedure, is separate from the PACS workstation and performs a
different function. The commenters requested that ED014 be restored to
the equipment inputs for CPT code 76377 and assigned 38 minutes of
equipment time. The commenters also suggested that the PACS workstation
should remain as a separate direct PE expense as well, since there are
additional PACS related activities specific to the 3-D images after
they have been created on the computer workstation.
Response: We appreciate the additional information regarding the
use of the 3D reconstruction computer workstation for CPT code 76377.
After consideration of comments received, we agree that the ``computer
workstation, 3D reconstruction CT-MR'' equipment (ED014) should be
restored to the equipment list and assigned to CPT code 76377 with an
equipment time of 38 minutes. However, we do not believe that the
typical service for CPT code 76377 would also use the PACS workstation.
Therefore, we substituted ED014 in place of the PACS workstation.
(2) Standardization of Clinical Labor Tasks
As we noted in PFS rulemaking for CY 2015, we continue to work on
revisions 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 pre-service, service, and post-service periods for each code.
In addition to increasing the transparency of the information used to
set PE RVUs, this improvement 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 will facilitate the identification of the
usual numbers of minutes for clinical labor tasks and the
identification of exceptions to the usual values. It will also allow
for greater transparency and consistency in the assignment of equipment
minutes based on clinical labor times. Finally, we believe that the
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 pre-service time packages. We believe such standards will
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 at once for all codes with the
applicable clinical labor tasks, instead of waiting for individual
codes to be reviewed.
Although this work is not yet complete, we anticipate completing it
in the near future. In the following paragraphs, we address a series of
issues related to clinical labor tasks, particularly relevant to
services currently being reviewed under the misvalued code initiative.
(a) Clinical Labor Tasks Associated With Digital Imaging
In PFS rulemaking for CY 2015, we noted that the RUC recommendation
regarding inputs for digital imaging services indicated that, as each
code is reviewed under the misvalued code initiative, the clinical
labor tasks associated with digital technology (instead of film) would
need to be addressed. When we reviewed that recommendation, we did not
have the capability of assigning standard clinical labor times for the
hundreds of individual codes since the direct PE input database did not
previously allow for comprehensive adjustments for clinical labor times
based on particular clinical labor tasks. Therefore, consistent with
the recommendation, we proposed to remove film-based supply and
equipment items but maintain clinical labor minutes that were assigned
based on film technology.
As noted in the paragraphs above, we continue to improve the direct
PE input database by specifying the minutes for each code associated
with each clinical labor task. Once completed, this work would allow
adjustments to be made to minutes assigned to particular clinical labor
tasks related to digital technology, consistent with the changes that
were made to individual supply and equipment items. In the meantime, we
[[Page 70901]]
believe it would be appropriate to establish standard times for
clinical labor tasks associated with all digital imaging for purposes
of reviewing individual services at present, and for possible broad-
based standardization once the changes to the database facilitate our
ability to adjust time for existing services. Therefore, we solicited
comments on the appropriate standard minutes for the clinical labor
tasks associated with services that use digital technology, which are
listed in Table 5. We note that the application of any standardized
times we adopt for clinical labor tasks to codes that are not being
reviewed in this final rule would be considered for possible inclusion
in future notice and comment rulemaking.
Table 5--Clinical Labor Tasks Associated With Digital Technology
------------------------------------------------------------------------
Typical
Clinical labor task minutes
------------------------------------------------------------------------
Availability of prior images confirmed.................. 2
Patient clinical information and questionnaire reviewed 2
by technologist, order from physician confirmed and
exam protocoled by radiologist.........................
Technologist QC's* images in PACS, checking for all 2
images, reformats, and dose page.......................
Review examination with interpreting MD................. 2
Exam documents scanned into PACS. Exam completed in RIS 1
system to generate billing process and to populate
images into Radiologist work queue.....................
------------------------------------------------------------------------
* This clinical labor task is listed as it appears on the ``PE
worksheets.'' QC refers to quality control, which we understand to
mean the verification of the image using the PACS workstation.
The following is a summary of the comments we received regarding
whether these standard times accurately reflect the typical time it
takes to perform these clinical labor tasks associated with digital
imaging.
Comment: Many commenters supported CMS' efforts to recognize the
advances in digital technology and take them into account through
updated RVUs. Several commenters agreed that the clinical labor tasks
outlined in Table 5 reflected the PE Subcommittee's film to digital
workgroup recommendations. The commenters suggested that the staff
types in the tasks should be made more generalized and less specific
(such as technologist to clinical staff or radiologist to physician),
and stated that specialty societies should be afforded the opportunity
to request deviations (that is, increases) from the standard times.
Response: We believe that providing specific guidelines for the
staff types associated with these tasks will aid in determining the
most accurate value for each service. We also agree that specialties
should be afforded the opportunity to request deviations from the
standard times for unusual situations, when supported with the
presentation of additional justification for the added time.
Comment: The RUC commented that it had not supported standard times
for clinical staff activities related to digital imaging in the past,
as the RUC had recommended that the specialties should have an
opportunity to determine the appropriate inputs at the individual
distinct service level and there was too much variability across
imaging modalities to propose standards. While the RUC continued to
hold to its previous position on this subject, it also agreed that four
of the five clinical labor activities proposed by CMS in Table 5 are
representative across imaging and could appropriately be used as
standard times. The one exception was the clinical labor task
``Technologist QC's images in PACS, checking for all images, reformats,
and dose page'', in which the RUC stated the number of minutes would
vary significantly depending on the procedure in question. For example,
a cardiac MR with hundreds of images would require more quality control
time than a single view X-ray of the chest. The RUC recommended that
this line item remain nonstandard, and that specialties should continue
to have the opportunity to make a recommendation on the appropriate
number of minutes based on clinical judgment.
Another commenter also supported standard clinical labor times for
four out of the five tasks associated with digital technology, again
excepting the activity ``Technologist QC's images in PACS, checking for
all images, reformats, and dose page.'' This commenter stated that a
survey of imaging providers had been conducted which suggested that the
median time required to perform this clinical labor task was 10
minutes. The commenter stated that CMS did not have any data to support
its belief in the standard time of 2 minutes, and recommended
considering the commenter's data and information from other
stakeholders regarding the appropriate standard minutes for the
clinical labor tasks associated digital imaging.
Response: With regard to the activity ``Technologist QC's images in
PACS, checking for all images, reformats, and dose page'', we agree
that this task may require a variable length of time depending on the
number of images to be reviewed. We believe that it may be appropriate
to establish several different standard times for this clinical labor
task for a low/medium/high quantity of images to be reviewed, in the
same fashion that the clinical labor assigned to clean a surgical
instrument package has two different standard times depending on the
use of a basic pack (10 minutes) or a medium pack (30 minutes). We are
interested in soliciting public comment and feedback on this subject,
with the anticipation of including a proposal in next year's proposed
rule.
After consideration of comments received, we are finalizing
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.'' We are not finalizing a standard
time for clinical labor task ``Technologist QC's images in PACS,
checking for all images, reformats, and dose page'' at this time,
pending consideration of any additional public comment and future
rulemaking, as described above.
(b) Pathology Clinical Labor Tasks
As with the clinical labor tasks associated with digital imaging,
many of the specialized clinical labor tasks associated with pathology
services do not have consistent times across those
[[Page 70902]]
codes. In reviewing the recommendations for pathology services, we have
not identified information that supports the judgment that the same
tasks take significantly more or less time depending on the individual
service for which they are performed, especially given the specificity
with which they are described.
Therefore, we developed standard times that we have used in
finalizing direct PE inputs. These times are based on our review and
assessment of the current times included for these clinical labor tasks
in the direct PE input database. We have listed these standard times in
Table 6. For services reviewed for CY 2016, in cases where the RUC-
recommended times differed from these standards, we have refined the
time for those tasks to align with the values in Table 6. We solicited
comments on whether these standard times accurately reflect the typical
time it takes to perform these clinical labor tasks when furnishing
pathology services.
Table 6--Standard Times for Clinical Labor Tasks Associated With
Pathology Services
------------------------------------------------------------------------
Standard
Clinical labor task clinical labor
time (minutes)
------------------------------------------------------------------------
Accession specimen/prepare for examination.............. 4
Assemble and deliver slides with paperwork to 0.5
pathologists...........................................
Assemble other light microscopy slides, open nerve 0.5
biopsy slides, and clinical history, and present to
pathologist to prepare clinical pathologic
interpretation.........................................
Assist pathologist with gross specimen examination...... 3
Clean room/equipment following procedure (including any 1
equipment maintenance that must be done after the
procedure).............................................
Dispose of remaining specimens, spent chemicals/other 1
consumables, and hazardous waste.......................
Enter patient data, computational prep for antibody 1
testing, generate and apply bar codes to slides, and
enter data for automated slide stainer.................
Instrument start-up, quality control functions, 13
calibration, centrifugation, maintaining specimen
tracking, logs and labeling............................
Load specimen into flow cytometer, run specimen, monitor 7
data acquisition and data modeling, and unload flow
cytometer..............................................
Preparation: Labeling of blocks and containers and 0.5
document location and processor used...................
Prepare automated stainer with solutions and load 4
microscopic slides.....................................
Prepare specimen containers/preload fixative/label 0.5
containers/distribute requisition form(s) to physician.
Prepare, pack and transport specimens and records for in- 1
house storage and external storage (where applicable)..
Print out histograms, assemble materials with paperwork 2
to pathologists. Review histograms and gating with
pathologist............................................
Receive phone call from referring laboratory/facility 5
with scheduled procedure to arrange special delivery of
specimen procurement kit, including muscle biopsy clamp
as needed. Review with sender instructions for
preservation of specimen integrity and return
arrangements. Contact courier and arrange delivery to
referring laboratory/facility..........................
Register the patient in the information system, 4
including all demographic and billing information......
Stain air dried slides with modified Wright stain. 3
Review slides for malignancy/high cellularity (cross
contamination).........................................
------------------------------------------------------------------------
Comment: Many commenters stated that they did not support the
standardization of clinical labor activities across pathology services.
Commenters stated that a single standard time for each clinical labor
task was infeasible due to the differences in batch size or number of
blocks across different pathology procedures. Several commenters
indicated that it may be possible to standardize across codes with the
same batch sizes, and urged CMS to consider pathology-specific details,
such as batch size and block number, in the creation of any future
standard times for clinical labor tasks. One commenter stated that the
CMS clinical labor times were uniformly too low, and that CMS did not
provide enough information about how it arrived at these revised
standard times. The commenter provided five examples of inadequate
labor times, and stated that CMS should provide stakeholders with
information about the source of its data and why it rejected the RUC
recommendations for these clinical labor tasks.
Response: We appreciate the extensive feedback provided by
commenters on the standard times for clinical labor tasks associated
with pathology services. As we stated in the CY 2016 PFS proposed rule,
we developed the proposed standard times based on our review and
assessment of the current times included for these clinical labor tasks
in the direct PE input database. We believe that clinical labor tasks
with the same work description are comparable across different
pathology procedures. We concur with commenters that accurate clinical
labor times for pathology codes may be dependent on the number of
blocks or batch size typically used for each individual service.
However, we believe that it is possible to establish ``per block''
standards or standards varied by batch size assumptions for many
clinical labor activities that will be comparable across a wide range
of individual services. We have received detailed information regarding
batch size and number of blocks during review of individual pathology
services on an intermittent basis in the past. We request regular
submission of these details on the PE worksheets as part of the review
process for pathology procedures, as a means to assist in the
determination of the most accurate direct PE inputs. Were we to receive
this information as part of standard recommendations, we would include
these assumptions as part of the information open for comment in
proposed revaluations. We are also seeking comment regarding how to
best establish clinical labor standards for pathology services on a
``per block'' or ``per batch size'' basis.
We also believe that many of the clinical labor activities that we
discussed in Table 6 are tasks that do not depend on number of blocks
or batch size. Clinical labor activities such as ``Clean room/equipment
following procedure'' and ``Dispose of remaining specimens'' would
typically remain standard across different services without varying by
block number or batch size, with the understanding of occasional
allowance for additional time for clinical labor tasks of unusual
difficulty.
After consideration of comments received, we are finalizing
standard times for clinical labor tasks associated with pathology
services at 4 minutes for
[[Page 70903]]
``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. For the
rest of the clinical labor tasks associated with pathology services, we
are interested in soliciting further public comment and feedback on
this subject as part of this final rule with comment period, with the
anticipation of including a proposal in next year's proposed rule.
(c) Clinical Labor Task: ``Complete Botox Log''
In the process of improving the level of detail in the direct PE
input database by including the minutes assigned for each clinical
labor task, we noticed that there are several codes with minutes
assigned for the clinical labor task called ``complete botox log.'' We
do not believe the completion of such a log is a direct resource cost
of furnishing a medically reasonable and necessary physician's service
for a Medicare beneficiary. Therefore, we proposed to eliminate the
minutes assigned for the task ``complete botox log'' from the direct PE
input database. The PE RVUs displayed in Addendum B on the CMS Web site
were calculated with the modified inputs displayed in the CY 2016
direct PE input database.
The following is a summary of the comments we received regarding
the clinical labor task ``complete botox log.''
Comment: Several commenters, including the RUC, did not agree with
the proposal to eliminate the minutes associated with this clinical
labor task. Commenters maintained that the clinical labor task of
completing the botox log was a medically reasonable direct resource
cost. One commenter stated that it was critical for clinical staff to
maintain accurate bookkeeping of split botox vials, and that
documentation must reflect the exact dosage of the drug given to
patients and a statement that the unused portion of the drug was
discarded.
Response: We continue to believe that the clinical labor assigned
for the task ``complete botox log'' is a form of indirect PE that is
not allocated to individual services. We believe that this is a quality
control issue for clinical staff. Maintaining accurate administrative
records, even for public safety, is not a task we generally allocate to
individual services, instead we consider these costs as attributable
across a range of services, and therefore, as an indirect PE. After
consideration of comments received, we are finalizing the proposal to
eliminate the minutes assigned for the task ``complete botox log'' from
the direct PE input database.
(3) Clinical Labor Input Inconsistencies
Subsequent to the publication of the CY 2015 PFS final rule with
comment period, stakeholders alerted us to several clerical
inconsistencies in the clinical labor nonfacility intraservice time for
several vertebroplasty codes with interim final values for CY 2015,
based on our understanding of RUC recommended values. We proposed to
correct these inconsistencies in the CY 2016 proposed direct PE input
database to reflect the RUC recommended values, without refinement, as
stated in the CY 2015 PFS final rule with comment period. The CY 2015
interim final direct PE inputs for these codes are displayed on the CMS
Web site under downloads for the CY 2015 PFS final rule with comment
period at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
For CY 2016, we proposed the following adjustments:
For CPT codes 22510 (percutaneous vertebroplasty (bone
biopsy included when performed), 1 vertebral body, unilateral or
bilateral injection, inclusive of all imaging guidance;
cervicothoracic) and 22511 (percutaneous vertebroplasty (bone biopsy
included when performed), 1 vertebral body, unilateral or bilateral
injection, inclusive of all imaging guidance; lumbosacral), a value of
45 minutes for labor code L041B (``Radiologic Technologist'') we
proposed to assign for the ``assist physician'' task and a value of 5
minutes for labor code L037D (``RN/LPN/MTA'') for the ``Check dressings
& wound/home care instructions/coordinate office visits/prescriptions''
task.
For CPT code 22514 (percutaneous vertebral augmentation,
including cavity creation (fracture reduction and bone biopsy included
when performed) using mechanical device (e.g., kyphoplasty), 1
vertebral body, unilateral or bilateral cannulation, inclusive of all
imaging guidance; lumbar), we proposed to adjust the nonfacility
intraservice time to 50 minutes for L041B, 50 minutes for L051A
(``RN''), 38 minutes for a second L041B, and 12 minutes for L037D.
The PE RVUs displayed in Addendum B on the CMS Web site were
calculated with the inputs displayed in the CY 2016 direct PE input
database.
The following is a summary of the comments we received regarding
clinical labor input inconsistencies.
Comment: Two commenters indicated that although they appreciated
CMS' efforts to clean up errors in the direct PE database, they had
specific concerns regarding the proposed changes. The commenters stated
that for CPT code 22510, it appeared that the direct PE clinical time
file had the second technologist listed at 90 minutes for the ``Assist
physician'' task, not 45 minutes as recommended. The commenters
indicated that CMS stated an intention to include 5 minutes for ``Check
dressings & wound'' but this time did not appear to be included in the
direct PE input labor file. The commenters also noted that the
postoperative E/M visit for CPT code 22510 was also not listed in the
CMS file.
The commenters stated that for CPT code 22511, the CMS direct PE
labor file correctly included the 45 minutes of ``Assist physician''
time for the second technologist, however, the 5 minutes for the RN/
LPN/MTA blend (L037D) to ``Check dressings & wound'' was still not
included in the CMS file. The commenter indicated that the
postoperative E/M visit was also not included for this code. The
commenters also stated that for CPT code 22514, CMS was proposing to
include the 5 minutes for ``Check dressings & wound'' in the
intraservice time for this service. The commenters indicated that this
did not appear to be consistent with how CMS was proposing to handle
the same clinical labor task in the prior two codes discussed. The
commenters requested that CMS outline specifically which line items
(from the PE spreadsheet) it proposed to change and the effects these
changes would have on the direct inputs for these three codes.
Response: We appreciate the detailed feedback from the commenters
on the clinical labor inconsistencies in these three codes. We agree
with the commenters that there were remaining clinical labor errors in
these procedures beyond those detailed in the CY 2016 PFS proposed
rule, and appreciate the opportunity to clarify the discrepancies
[[Page 70904]]
in clinical labor for these three procedures.
For CPT code 22510, we agree with the commenters that the clinical
labor assigned to the RadTech (L041B) for ``Assist Physician'' was
incorrectly listed twice in our direct PE input database. The clinical
labor staff type was also incorrectly entered as L041C, which is priced
at the same rate but refers to a second Radiologic Technologist for
Vertebroplasty. We will remove the duplicative clinical labor and
assign type L041B to the ``Assist Physician'' activity. We do not agree
with the commenters that the time for clinical labor task ``Check
dressings & wound'' was missing, as it is present in the database. We
agree with the commenters that the clinical labor time for the office
visit was missing from CPT code 22510, and we will add it to the direct
PE database.
For CPT code 22511, the commenters are correct that the time for
clinical labor task ``Assist physician'' was entered at the correct
value of 45 minutes, and the 5 minutes of clinical labor for ``Check
dressings & wound'' does not appear in the non-facility setting. This
clinical labor time appears to have been incorrectly entered for the
facility setting instead; we will remove this time and add it to its
proper non-facility setting. We agree with the commenters that the
clinical labor time for the office visit was again missing from CPT
code 22511, and we will add it to the direct PE input database.
For CPT code 22514, the time for clinical labor task ``Assist
physician'' has been refined to 50 minutes as detailed in the CY 2016
PFS proposed rule. We agree with the commenters that the 5 minutes of
clinical labor time for ``Check dressings & wound'' is missing from the
direct PE input database. We agree that the clinical labor for this
activity should not be treated differently from the rest of the codes
in the family, and therefore these 5 minutes are included in the direct
PE input database. The postoperative office visit is included in the
direct PE input database for CPT code 22514.
After consideration of comments received, we are finalizing our
proposed changes to clinical labor along with the additional
corrections described above.
(4) Freezer
We identified several pathology codes for which equipment minutes
are assigned to the item EP110 ``Freezer.'' Minutes are only allocated
to particular equipment items when those items cannot be used in
conjunction with furnishing services to another patient at the same
time. We do not believe that minutes should be allocated to items such
as freezers since the storage of any particular specimen or item in a
freezer for any given period of time would be unlikely to make the
freezer unavailable for storing other specimens or items. Instead, we
proposed to classify the freezer as an indirect cost because we believe
that would be most consistent with the principles underlying the PE
methodology since freezers can be used for many specimens at once. The
PE RVUs displayed in Addendum B on the CMS Web site were calculated
with the modified inputs displayed in the CY 2016 direct PE input
database.
We did not receive comments on this proposal, and therefore, we are
finalizing as proposed.
(5) Updates to Price for Existing Direct 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. During 2014, we received
a request to update the price of supply item ``antigen, mite'' (SH006)
from $4.10 per test to $59. In reviewing the request, it is evident
that the requested price update does not apply to the SH006 item but
instead represents a different item than the one currently included as
an input in CPT code 86490 (skin test, coccidioidomycosis). Therefore,
rather than changing the price for SH006 that is included in several
codes, we proposed to create a new supply code for Spherusol, valued at
$590 per 1 ml vial and $59 per test, and to include this new item as a
supply for 86490 instead of the current input, SH006.
Comment: Several commenters strongly supported the CMS proposal to
create a new supply code for Spherusol that reflects the current price
for the antigen and to update the direct inputs for CPT code 86490 to
include this item. However, commenters noted that the public use files
included in the CY 2016 PFS proposed rule continue to reflect the prior
supply code SH006 with a price of $4.10. Commenters asked whether this
was a technical error and urged CMS to correct the input files to be
consistent with the proposal described in the regulation preamble.
Response: We appreciate support for our proposal and acknowledge
our inadvertent omission of this change in the proposed direct PE input
database. After consideration of comments received, we are finalizing
our proposal to create a supply item for Spherusol and it is included
as a direct PE input for CPT code 86490.
We also received a request to update the price for EQ340 (Patient
Worn Telemetry System) used only in CPT code 93229 (External mobile
cardiovascular telemetry with electrocardiographic recording,
concurrent computerized real time data analysis and greater than 24
hours of accessible ECG data storage (retrievable with query) with ECG
triggered and patient selected events transmitted to a remote attended
surveillance center for up to 30 days; technical support for connection
and patient instructions for use, attended surveillance, analysis and
transmission of daily and emergent data reports as prescribed by a
physician or other qualified health care.) The requestor noted that we
had previously proposed and finalized a policy to remove wireless
communication and delivery costs related to the equipment item that had
previously been included in the direct PE input database as supply
items. The requestor asked that we alter the price of the equipment
from $21,575 to $23,537 to account for the equipment costs specific to
the patient-worn telemetry system.
In the proposed rule, we stated that we considered this request in
the context of the unique nature of this particular equipment item.
This equipment item is unique in several ways, including that it is
used continuously 24 hours per day and 7 days per week for an
individual patient over several weeks. It is also unique in that the
equipment is primarily used outside of a healthcare setting. Within our
current methodology, we currently account for these unique properties
by calculating the per minute costs with different assumptions than
those used for most other equipment by increasing the number of hours
the equipment is available for use. Therefore, we also believe it would
be appropriate to incorporate other unique aspects of the operating
costs of this item in our calculation of the equipment cost per minute.
We believe the requestor's suggestion to do so by increasing the price
of the equipment is practicable and appropriate. Therefore, we proposed
to change the price for EQ340 (Patient Worn Telemetry System) to
$23,537. The PE RVUs displayed in Addendum B on the CMS Web site were
calculated with the modified inputs displayed in the CY 2016 direct PE
input database.
Comment: One commenter supported the CMS proposal regarding the
Patient Worn Telemetry System (EQ340). The commenter agreed with the
proposed increase in the price of the equipment
[[Page 70905]]
from $21,757 to $23,537, and the reason for this increase. We did not
receive any comments opposing the proposal.
Response: After consideration of comments received, we are
finalizing our proposal regarding the Patient Worn Telemetry System
equipment.
For CY 2015, we received a request to update the price for supply
item ``kit, HER-2/neu DNA Probe'' (SL196) from $105 to $144.50.
Accordingly, in the CY 2015 proposed rule, we proposed to update the
price to $144.50. In the CY 2015 final rule with comment period, we
indicated that we obtained new information suggesting that further
study of the price of this item was necessary before proceeding to
update the input price. We obtained pricing information readily
available on the Internet that indicated a price of $94 for this item
for a particular hospital. Subsequent to the CY 2015 final rule with
comment period, stakeholders requested that we use the updated price of
$144.50. One stakeholder suggested that the price of $94 likely
reflected discounts for volume purchases not received by the typical
laboratory. We solicited comments on how to consider the higher-priced
invoice, which is 53 percent higher than the price listed, relative to
the price currently in the direct PE database. Specifically, we
solicited information on the price of the disposable supply in the
typical case of the service furnished to a Medicare beneficiary,
including, based on data, whether the typical Medicare case is
furnished by an entity likely to receive a volume discount.
Comment: Several commenters disagreed with the CMS proposal
regarding the updated price for the supply item ``kit, HER-2/neu DNA
Probe'' (SL196). One commenter stated that the price of $94 reflected a
volume discount that could not be obtained by the typical provider. The
lowered price referenced in the CY 2016 PFS proposed rule indicated
that the purchaser may be receiving a competitive contractually
arranged price. The commenter stated that the lowered price referenced
is what might be expected to be acquired by the largest hospitals,
which would be expected to buy supplies in greater volume than a small
community hospital or mid-sized laboratory, and the price indicated
does not reflect the prices for a laboratory of typical size.
Other commenters stated that they were unable to find this pricing
information through publicly available sources, suggesting that it may
not reflect typical transactions. The commenters also stated that it
was unclear as to whether the proposed price referred to FDA-approved
kits, which are more expensive than non-approved kits. The commenters
further indicated that a number of new morphometric analysis, multiplex
quantitative/semi-quantitative ISH tests are in use today with probe
kit costs that are higher than those of HER-2/neu probe kits. The
commenters suggested that CMS should adopt a weighted-average of the
probe kit prices for the probe kits currently used to perform these
procedures.
Response: Without robust, auditable information regarding the
actual prices paid by a range of practitioners that would allow us to
reasonably determine a recommended price to be typical, we believe that
we should assume that the best publicly available price is typical.
Generally speaking, we do not believe vendors are likely to allow
public display of pricing that is not broadly available to potential
customers since that would present significant competitive
disadvantages in the market. Therefore, given the options between the
best publicly available price or prices on invoices selected for the
distinct purpose of pricing individual services, we believe the best
publicly available price is more likely to be typical. Therefore, we
are not making any changes to the price of this supply item at this
time.
Comment: The RUC commented that in the CMS direct PE database the
unit of measure for SL196 is listed as ``kit'', while on the submitted
PE spreadsheet the unit is listed as ``kit assay.'' The RUC recommended
that the unit of measure be changed to ``kit assay'' to correlate
correctly with the cost shown in the database.
Response: We appreciate this additional information, and will
change the unit of measure of SL196 to ``kit assay'' in the direct PE
database.
Comment: Several commenters stated CMS's estimated per-minute labor
cost inputs are too low for laboratory technicians (L033A),
cytotechnologists (L045A) and histotechnologists (L037B). The
commenters stated that the complexity of many laboratory services
demands highly-skilled, highly-trained, certified, and experienced
personnel who typically must be paid higher wages than the current
rates provided by CMS. Commenters stated that CMS has underestimated
the actual labor costs associated with the work that these more
specialized laboratory personnel perform by 20 to 30 percent, after
accounting for costs related to benefits, taxes, and training.
Response: The clinical labor costs per minute are based on data
from the Bureau of Labor Statistics. We believe that it is important to
update that information uniformly among clinical labor types and will
consider updating the clinical labor costs per minute in the direct PE
database in future rulemaking.
(6) Typical Supply and Equipment Inputs for Pathology Services
In reviewing public comments in response to the CY 2015 PFS final
rule with comment period, we re-examined issues around the typical
number of pathology tests furnished at once. In the CY 2013 final rule
with comment period (77 FR 69074), we noted that the number of blocks
assumed for a particular code significantly impacts the assumed
clinical labor, supplies, and equipment for that service. We indicated
that we had concerns that the assumed number of blocks was inaccurate,
and that we sought corroborating, independent evidence that the number
of blocks assumed in the current direct PE input recommendations is
typical. We note that, given the high volume of many pathology
services, these assumptions have a significant impact on the PE RVUs
for all other PFS services. We refer readers to section II.H. where we
detail our concerns about the lack of information regarding typical
batch size and typical block size for many pathology services and
solicit stakeholder input on approaches to obtaining accurate
information that can facilitate our establishing payment rates that
best reflect the relative resources involved in furnishing the typical
service, for both pathology services in particular and more broadly for
services across the PFS.
Comment: Several commenters addressed the number of blocks and
batch size for prostate biopsies in particular. We direct readers to
section II.H. of this final rule with comment period for a more
detailed discussion of the resource costs for these services. We
continue to seek stakeholder input regarding the best sources of
information for typical number of blocks and batch sizes for pathology
services.
d. Developing Nonfacility Rates
We noted that not all PFS services are priced in the nonfacility
setting, but as medical practice changes, we routinely develop
nonfacility prices for particular services when they can be furnished
outside of a facility setting. We noted that the valuation of a service
under the PFS in particular settings does not address whether those
services are medically reasonable and necessary in the case of
individual patients, including being furnished in a setting appropriate
to the patient's medical needs and condition.
[[Page 70906]]
(1) Request for Information on Nonfacility Cataract Surgery
Cataract surgery generally has been performed in an ambulatory
surgery center (ASC) or a hospital outpatient department (HOPD). We
have not assigned nonfacility PE RVUs under the PFS for cataract
surgery. According to Medicare claims data, there are a relatively
small number of these services furnished in nonfacility settings.
Except in unusual circumstances, anesthesia for cataract surgery is
either local or topical/intracameral. Advancements in technology have
significantly reduced operating time and improved both the safety of
the procedure and patient outcomes. As discussed in the proposed rule,
we believe that it now may be possible for cataract surgery to be
furnished in an in-office surgical suite, especially for routine cases.
Cataract surgery patients require a sterile surgical suite with certain
equipment and supplies that we believe could be a part of a
nonfacility-based setting that is properly constructed and maintained
for appropriate infection prevention and control.
We also noted in the proposed rule that we believe there are
potential advantages for all parties to furnishing appropriate cataract
surgery cases in the nonfacility setting. Cataract surgery has been for
many years the highest volume surgical procedure performed on Medicare
beneficiaries. For beneficiaries, cataract surgery in the office
setting might provide the additional convenience of receiving the
preoperative, operative, and post-operative care in one location. It
might also reduce delays associated with registration, processing, and
discharge protocols associated with some facilities. Similarly, it
might provide surgeons with greater flexibility in scheduling patients
at an appropriate site of service depending on the individual patient's
needs. For example, routine cases in patients with no comorbidities
could be performed in the nonfacility surgical suite, while more
complicated cases (for example, pseudoexfoliation) could be scheduled
in the ASC or HOPD. In addition, furnishing cataract surgery in the
nonfacility setting could result in lower Medicare expenditures for
cataract surgery if the nonfacility payment rate were lower than the
sum of the PFS facility payment rate and the payment to either the ASC
or HOPD.
We solicited comments from ophthalmologists and other stakeholders
on office-based surgical suite cataract surgery. In addition, we
solicited comments from the RUC and other stakeholders on the direct PE
inputs involved in furnishing cataract surgery in the nonfacility
setting in conjunction with our consideration of information regarding
the possibility of development of nonfacility cataract surgery PE RVUs.
We received 138 comments from stakeholders including professional
medical societies, the RUC, ambulatory surgical centers (ASCs),
practitioners, and the general public. The RUC deferred to the
specialty societies regarding the appropriateness of performing these
services in the nonfacility setting.
Comment: A few commenters suggested that development of PE RVUs
would allow for greater flexibility regarding scheduling and location
where services are performed. Commenters provided information about
clinical considerations related to furnishing these services in a
nonfacility setting, with many commenters citing safety concerns
involved in furnishing cataract surgery in the office setting.
Response: We will use this information as we consider whether to
proceed with development of nonfacility PE RVUs for cataract surgery.
(2) Direct PE Inputs for Functional Endoscopic Sinus Surgery Services
A stakeholder indicated that due to changes in technology and
technique, several codes that describe endoscopic sinus surgeries can
now be furnished in the nonfacility setting. According to Medicare
claims data, there are a relatively small number of these services
furnished in nonfacility settings. These CPT codes are 31254 (Nasal/
sinus endoscopy, surgical; with ethmoidectomy, partial (anterior)),
31255 (Nasal/sinus endoscopy, surgical; with ethmoidectomy, total
(anterior and posterior)), 31256 (Nasal/sinus endoscopy, surgical, with
maxillary antrostomy), 31267 (Nasal/sinus endoscopy, surgical, with
maxillary antrostomy; with removal of tissue from maxillary sinus),
31276 (Nasal/sinus endoscopy, surgical with frontal sinus exploration,
with or without removal of tissue from frontal sinus), 31287 (Nasal/
sinus endoscopy, surgical, with sphenoidotomy), and 31288 (Nasal/sinus
endoscopy, surgical, with sphenoidotomy; with removal of tissue from
the sphenoid sinus). We solicited input from stakeholders, including
the RUC, about the appropriate direct PE inputs for these services.
We received 53 comments from stakeholders including specialty
societies, device manufacturers, medical centers, and physician
practices (otolaryngology, allergy, facial, and plastics specialists).
Comment: The RUC indicated an intention to review direct PE inputs
at the January 2016 RUC meeting. One specialty society representing
otolaryngology head and neck surgeons indicated that endoscopic sinus
surgery services have been identified by the CPT/RUC workgroup for
development of bundled codes for this code family and inputs will
likely be reviewed as part of this process. Some commenters submitted
information about their respective PEs related to CPT codes 31254,
31255, 31267, 31276, 31287, and 31288. Other commenters limited their
comments to CPT codes 31254 and 31255, noting clinical concerns about
performance of other sinus surgery procedures in the nonfacility
setting. A few commenters did not support development of nonfacility
direct PE RVUs for endoscopic sinus surgery due to clinical
considerations such as patient safety, possible complications, use of
anesthesia, and need for establishment of standards and oversight of
in-office surgical suites.
Response: We appreciate the feedback we received from all
commenters. We will use this information as we consider whether to
proceed with development of nonfacility PE RVUs or functional
endoscopic sinus surgery services.
B. Determination of Malpractice Relative Value Units (RVUs)
1. Overview
Section 1848(c) of the Act requires that 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. Malpractice RVUs for
new codes after 1991 were extrapolated from similar existing codes or
as a percentage of the corresponding work RVU. 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 discussion of the third review and update of MP RVUs see the CY
2015 proposed rule (79 FR 40349 through 40355) and final rule with
comment period (79 FR 67591 through 67596).
As explained in the CY 2011 PFS final rule with comment period (75
FR 73208), MP RVUs for new and revised codes effective before the next
five-year review of MP RVUs were determined either by a direct
crosswalk from a similar source code or by a modified
[[Page 70907]]
crosswalk to account for differences in work RVUs between the new/
revised code and the source code. For the modified crosswalk approach,
we adjust (or ``scale'') the MP RVU for the new/revised code to reflect
the difference in work RVU between the source code and the new/revised
work RVU (or, if greater, the clinical labor portion of the fully
implemented PE RVU) for the new code. For example, if the proposed work
RVU for a revised code is 10 percent higher than the work RVU for its
source code, the MP RVU for the revised code would be increased by 10
percent over the source code MP RVU. Under this approach the same risk
factor is applied for the new/revised code and source code, but the
work RVU for the new/revised code is used to adjust the MP RVUs for
risk.
For CY 2016, we proposed to continue our current approach for
determining MP RVUs for new/revised codes. For the new and revised
codes for which we proposed work RVUs and PE inputs, we also published
the proposed MP crosswalks used to determine their MP RVUs. The MP
crosswalks for those new and revised codes were subject to public
comment and we are responding to comments and finalizing them in
section II.H. of this CY 2016 PFS final rule with comment period. The
MP crosswalks for new and revised codes with interim final values
established in this CY 2016 final rule with comment period will be
implemented for CY 2016 and subject to public comment. We will then
respond to comments and finalize them in the CY 2017 PFS final rule
with comment period.
2. Proposed Annual Update of MP RVUs
In the CY 2012 PFS final rule with comment period (76 FR 73057), we
finalized a process to consolidate the five-year reviews of work and PE
RVUs with our annual review of potentially misvalued codes. We
discussed the exclusion of MP RVUs from this process at the time, and
we stated that, since it is not feasible to obtain updated specialty
level MP insurance premium data on an annual basis, we believe the
comprehensive review of MP RVUs should continue to occur at 5-year
intervals. In the CY 2015 PFS proposed rule (79 FR 40349 through
40355), we stated that there are two main aspects to the update of MP
RVUs: (1) Recalculation of specialty risk factors based upon updated
premium data; and (2) recalculation of service level RVUs based upon
the mix of practitioners providing the service. In the CY 2015 PFS
final rule with comment period (79 FR 67596), in response to several
stakeholders' comments, we stated that we would address potential
changes regarding the frequency of MP RVU updates in a future proposed
rule. For CY 2016, we proposed to begin conducting annual MP RVU
updates to reflect changes in the mix of practitioners providing
services, and to adjust MP RVUs for risk. Under this approach, the
specialty-specific risk factors would continue to be updated every 5
years using updated premium data, but would remain unchanged between
the 5-year reviews. However, in an effort to ensure that MP RVUs are as
current as possible, our proposal would involve recalibrating all MP
RVUs on an annual basis to reflect the specialty mix based on updated
Medicare claims data. Since under this proposal, we would be
recalculating the MP RVUs annually, we also proposed to maintain the
relative pool of MP RVUs from year to year; this will preserve the
relative weight of MP RVUs to work and PE RVUs. We proposed to
calculate the current pool of MP RVUs by using a process parallel to
the one we use in calculating the pool of PE RVUs. (We direct the
reader to section II.2.b.(6) for detailed description of that process,
including a proposed technical revision that we are finalizing for
2016.) To determine the specialty mix assigned to each code, we also
proposed to use the same process used in the PE methodology, described
in section II.2.b.(6) of this final rule with comment period. We note
that for CY 2016, we proposed and are finalizing a policy to modify the
specialty mix assignment methodology to use an average of the 3 most
recent years of available data instead of a single year of data. We
anticipate that this change will increase the stability of PE and MP
RVUs and mitigate code-level fluctuations for all services paid under
the PFS, and for new and low-volume codes in particular. We also
proposed to no longer apply the dominant specialty for low volume
services, because the primary rationale for the policy has been
mitigated by this proposed change in methodology. However, we did not
propose to adjust the code-specific overrides established in prior
rulemaking for codes where the claims data are inconsistent with a
specialty that could be reasonably expected to furnish the service. We
believe that these proposed changes serve to balance the advantages of
using annually updated information with the need for year-to-year
stability in values. We solicited comments on both aspects of the
proposal: Updating the specialty mix for MP RVUs annually (while
continuing to update specialty-specific risk factors every 5 years
using updated premium data); and using the same process to determine
the specialty mix assigned to each code as is used in the PE
methodology, including the proposed modification to use the most recent
3 years of claims data. We also solicited comments on whether this
approach will be helpful in addressing some of the concerns regarding
the calculation of MP RVUs for services with low volume in the Medicare
population, including the possibility of limiting our use of code-
specific overrides of the claims data.
The following is a summary of the comments we received regarding
our current approach for determining malpractice RVUs for new/revised
codes.
Comment: Several commenters, including the RUC, generally supported
CMS' proposal to update the MP RVUs on an annual basis. Commenters,
including the RUC, stated a preference for the annual collection of
professional liability insurance (PLI) premium data to insure the MP
RVUs for every service is accurate, as opposed to only collecting these
data every five years.
Response: We appreciate commenters' support of our proposal to
update the MP RVUs on an annual basis. We also appreciate the comments
from stakeholders regarding the frequency that we currently collect
premium data. We will continue to consider the appropriate frequency
for doing so, and we would address any potential changes in future
rulemaking.
Comment: Commenters, including the RUC, support CMS's proposal to
use the 3 most recent years of available data for the specialty mix
assignment.
Response: We appreciate the commenters' support.
Comment: Commenters supported CMS' proposal to maintain the code-
specific overrides established in previous rulemaking for codes where
the claims data are inconsistent with a specialty that could be
reasonably expected to furnish the service. Commenters also requested
that CMS publish the list of overrides annually to receive stakeholder
feedback related to necessary modification to the list, and in an
effort to be as transparent as possible.
Response: We appreciate the comments and agree that we should
increase the transparency regarding the list of services with MP RVU
overrides. Publication of this list will also allow commenters to alert
us to any discrepancies between MP RVUs developed annually under the
new methodology and previously established overrides. Therefore, we
have posted a public use file containing the overrides.
[[Page 70908]]
The file is available on the CMS Web site under the supporting data
files for the CY 2016 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
Comment: One commenter stated that CMS should be particularly
mindful of using the specialty mix in the Medicare claims data for
services with low Medicare volume but high volume in the United States
health care system more generally, such as pediatric procedures; and
that CMS' MP RVU methodology needs to differentiate between services
that are truly low volume and those that occur frequently, but not
among Medicare beneficiaries.
Response: We believe that the list of overrides we are making
available as a public use file on the CMS Web site will help address
the commenter's concern since the purpose of the code-specific
overrides is to address circumstances where the claims data are
inconsistent with the specialty that could be reasonably expected to
furnish the service. We have previously accepted comment on services
like those identified by the commenter and will continue to consider
comments regarding the need to use overrides for particular services,
especially for high volume services outside the Medicare population.
Comment: One commenter requested that CMS continue to use the
dominant specialty for low volume codes.
Response: We acknowledge the concern about using the dominant
specialty for low volume codes, and will continue to monitor the
resulting RVUs to determine if adjustments become necessary. In
general, we believe the 3-year average mitigates the need to apply the
dominant specialty for low volume services. However, we have a long
history of applying the dominant specialty for low volume services in
instances where the specialty indicated by the claims data is
inconsistent with the specialty that could be reasonably expected to
furnish the service, and we are maintaining that practice.
Comment: Some commenters requested more information on how
specialty impacts were determined. Two commenters expressed concerns
about the estimated impact of the several proposed changes in the MP
methodology on some specialties--particularly gastroenterology, colon
and rectal surgery, and neurosurgery. Those commenters state that they
appreciate the assertion that it may be difficult to obtain premium
data for some specialties, such as neurosurgery, and state that CMS
must thoroughly vet the methodology used by its contractor to determine
MP premiums for such specialties. The commenters urge CMS to review the
data, continue to try to obtain premium data in as many states as
possible, and to share the data with the public for the agency and
specialties to determine its accuracy.
Response: Specialty impacts are determined by comparing the
estimated overall payment for each specialty that would result from the
proposed RVUs and policies to the estimated overall payment for each
specialty under the current year RVUs and policies, using the most
recent year of available claims data as a constant. We note that for MP
RVUs, there were several refinements that resulted in minor impacts to
particular specialties, especially those at the higher end of specialty
risk factors. We believe that these impacts are consistent with the
general tendency of greater change in MP RVUs for specialties with risk
factors of greater magnitude. We agree with the commenters regarding of
the importance of making certain that the collection of premium data
and the methodology of calculating MP RVUs are as accurate as possible.
This is the reason we continue to examine the methodology and develop
technical improvements such as the ones described in this section of
the final rule. Additionally, we believe that annual calibration of MP
RVUs will be likely to reduce the risk of irregularities, since we will
regularly compare MP RVUs for individual codes and for specialties
between consecutive years instead of only comparing MP RVUs update
years.
After consideration of the public comments received, we are
finalizing the policies as proposed. That is, we are finalizing the
proposal to conduct annual MP RVU updates to reflect changes in the mix
of practitioners providing services and to adjust MP RVUs for risk, and
to modify the specialty mix assignment methodology to use an average of
the 3 most recent years of available data instead of a single year. We
note that we will continue to maintain the code-specific overrides
where the claims data are inconsistent with a specialty that would
reasonable be expected to furnish the services.
We also proposed an additional refinement in our process for
assigning MP RVUs to individual codes. Historically, we have used a
floor of 0.01 MP RVUs for all nationally-priced PFS codes. This means
that even when the code-level calculation for the MP RVU falls below
0.005, we have rounded to 0.01. In general, we believe this approach
accounts for the minimum MP costs associated with each service
furnished to a Medicare beneficiary. However, in examining the
calculation of MP RVUs, we do not believe that this floor should apply
to add-on codes. Since add-on codes must be reported with another code,
there is already an MP floor of 0.01 that applies to the base code, and
therefore, to each individual service. By applying the floor to add-on
codes, the current methodology practically creates a 0.02 floor for any
service reported with one add-on code, and 0.03 for those with 2 add-on
codes, etc. Therefore, we proposed to maintain the 0.01 MP RVU floor
for all nationally-priced PFS services that are described by base
codes, but not for add-on codes. We will continue to calculate,
display, and make payments that include MP RVUs for add-on codes that
are calculated to 0.01 or greater, including those that round to 0.01.
We only proposed to allow the MP RVUs for add-on codes to round to 0.00
where the calculated MP RVU is less than 0.005.
Comment: Several commenters, including the RUC, opposed CMS'
proposal to remove the MP RVU floor of 0.01 for add-on services. These
commenters suggested that the incremental risk associated with
performing an additional procedure is not mitigated by the risk
inherent in the base procedure. Another commenter stated that each
service should be considered separately for the purposes of calculating
MP RVUs, and therefore, each service should be given the 0.01 floor
regardless of base or add-on status.
Response: We appreciate commenters' feedback, but note that we do
not believe the comments respond to the rationale for the proposed
refinement. We agree that the incremental risk in procedures described
by add-on codes is not mitigated by the risk inherent in the base
procedure. That is why we did not propose to eliminate MP RVUs for add-
on codes generally. Instead, we believe that when the incremental risk
is calculated to be a number closer to 0.00 than 0.01, we do not
believe that rounding such a number to 0.01 accurately reflects the
risk of the service that is described by two codes (base code and add-
on) relative to the risks associated with other PFS services. We
continue to believe that this refinement is the most appropriate
approach, since we would continue to account for the incremental risk
associated with add-on codes without overestimating the risk in
circumstances where the MP RVU falls below 0.005. Therefore, we are
finalizing the policy as proposed.
[[Page 70909]]
3. MP RVU Update for Anesthesia Services
In the CY 2015 PFS proposed rule (79 FR 40354 through 40355), we
did not include an adjustment under the anesthesia fee schedule to
reflect updated MP premium information, and stated that we intended to
propose an anesthesia adjustment for MP in the CY 2016 PFS proposed
rule. We also solicited comments regarding how to best reflect updated
MP premium amounts under the anesthesiology fee schedule.
As we previously explained, anesthesia services under the PFS are
paid based upon a separate fee schedule, so routine updates must be
calculated in a different way than those for services for which payment
is calculated based upon work, PE, and MP RVUs. To apply budget
neutrality and relativity updates to the anesthesiology fee schedule,
we typically develop proxy RVUs for individual anesthesia services that
are derived from the total portion of PFS payments made through the
anesthesia fee schedule. We then update the proxy RVUs as we would the
RVUs for other PFS services and adjust the anesthesia fee schedule
conversion factor based on the differences between the original proxy
RVUs and those adjusted for relativity and budget neutrality.
We believe that taking the same approach to update the anesthesia
fee schedule based on new MP premium data is appropriate. However,
because work RVUs are integral to the MP RVU methodology and anesthesia
services do not have work RVUs, we decided to seek potential
alternatives prior to implementing our approach in conjunction with the
proposed CY 2015 MP RVUs based on updated premium data. One commenter
supported the delay in proposing to update the MP for anesthesia at the
same time as updating the rest of the PFS, and another commenter
suggested using mean anesthesia MP premiums per provider over a 4- or
5-year period prorated by Medicare utilization to yield the MP expense
for anesthesia services; no commenters offered alternatives to
calculating updated MP for anesthesia services. The latter suggestion
might apply more broadly to the MP methodology for the PFS and does not
address the methodology as much as the data source.
We continue to believe that payment rates for anesthesia should
reflect MP resource costs relative to the rest of the PFS, including
updates to reflect changes over time. Therefore, for CY 2016, to
appropriately update the MP resource costs for anesthesia, we proposed
to make adjustments to the anesthesia conversion factor to reflect the
updated premium information collected for the 5 year review. To
determine the appropriate adjustment, we calculated imputed work RVUs
and MP RVUs for the anesthesiology fee schedule services using the
work, PE, and MP shares of the anesthesia fee schedule. Again, this is
consistent with our longstanding approach to making annual adjustments
to the PE and work RVU portions of the anesthesiology fee schedule. To
reflect differences in the complexity and risk among the anesthesia fee
schedule services, we multiplied the service-specific risk factor for
each anesthesia fee schedule service by the CY 2016 imputed proxy work
RVUs and used the product as the updated raw proxy MP RVUs for each
anesthesia service for CY 2016. We then applied the same scaling
adjustments to these raw proxy MP RVUs that we apply to the remainder
of the PFS MP RVUs. Finally, we calculated the aggregate difference
between the 2015 proxy MP RVUs and the proxy MP RVUs calculated for CY
2016. We then adjusted the portion of the anesthesia conversion factor
attributable to MP proportionately; we refer the reader to section
VI.C. of this final rule with comment period for the Anesthesia Fee
Schedule Conversion Factors for CY 2016. We invited public comments
regarding this proposal.
The following is a summary of the comments we received regarding
this proposal.
Comment: We received few comments with regard to our proposal;
commenters expressed appreciation that CMS recognized the unique
aspects involved in updating the MP component associated with
anesthesia services, and therefore, delayed the anesthesia MP update
until the CY 2016 PFS.
Response: We appreciate the commenters' feedback, and we are
finalizing the policy as proposed.
4. MP RVU Methodology Refinements
In the CY 2015 PFS final rule with comment period (79 FR 67591
through 67596), we finalized updated MP RVUs that were calculated based
on updated MP premium data obtained from state insurance rate filings.
The methodology used in calculating the finalized CY 2015 review and
update of resource-based MP RVUs largely paralleled the process used in
the CY 2010 update. We posted our contractor's report, ``Final Report
on the CY 2015 Update of Malpractice RVUs'' on the CMS Web site. It is
also located under the supporting documents section of the CY 2015 PFS
final rule with comment period located at http://www.cms.gov/PhysicianFeeSched/. A more detailed explanation of the 2015 MP RVU
update can be found in the CY 2015 PFS proposed rule (79 FR 40349
through 40355).
In the CY 2015 PFS proposed rule, we outlined the steps for
calculating MP RVUs. In the process of calculating MP RVUs for purposes
of the CY 2016 PFS proposed rule, we identified a necessary refinement
to way we calculated Step 1, which involves computing a preliminary
national average premium for each specialty, to align the calculations
within the methodology to the calculations described within the
aforementioned contractor's report. Specifically, in the calculation of
the national premium for each specialty (refer to equations 2.3, 2.4,
2.5 in the aforementioned contractor's report), we calculate a weighted
sum of premiums across areas and divide it by a weighted sum of MP
GPCIs across areas. The calculation currently takes the ratio of sums,
rather than the weighted average of the local premiums to the MP GPCI
in that area. Instead, we proposed to update the calculation to use a
price-adjusted premium (that is, the premium divided by the GPCI) in
each area, and then taking a weighted average of those adjusted
premiums. The CY 2016 PFS proposed rule MP RVUs were calculated in this
manner.
Additionally, in the calculation of the national average premium
for each specialty as discussed above, our current methodology used the
total RVUs in each area as the weight in the numerator (that is, for
premiums), and total MP RVUs as the weights in the denominator (that
is, for the MP GPCIs). After further consideration, we believe that the
use of these RVU weights is problematic. Use of weights that are
central to the process at hand presents potential circularity since
both weights incorporate MP RVUs as part of the computation to
calculate MP RVUs. The use of different weights for the numerator and
denominator introduces potential inconsistency. Instead, we believe
that it would be better to use a different measure that is independent
of MP RVUs and better represents the reason for weighting.
Specifically, we proposed to use area population as a share of total
U.S. population as the weight. The premium data are for all MP premium
costs, not just those associated with Medicare patients, so we believe
that the distribution of the population does a better job of capturing
the role of each area's premium in the ``national'' premium for each
specialty than our previous Medicare-specific measure.
[[Page 70910]]
Use of population weights also avoids the potential problems of
circularity and inconsistency.
The CY 2016 PFS final MP RVUs, as displayed in Addendum B of this
final rule with comment period, reflect MP RVUs calculated following
our established methodology, with the inclusion of the proposals and
refinements described above.
Comment: Commenters generally supported the technical changes to
the MP RVU methodology and found them reasonable. One commenter stated
that such refinements will increase stability of MP RVUs and does a
better role of capturing the role of each local area's premium in the
``national'' premium for each specialty.
Response: We appreciate the commenters' support, and we are
finalizing the policy as proposed.
Comment: One commenter stated that the MP RVU for cataract and
other ophthalmic surgeries is deflated significantly because CMS
assumes that optometry is providing the actual surgical portion of the
procedure, when there is no state that allows optometrists to perform
cataract surgery or any other major ophthalmic procedure. The commenter
states that the clinical reality is that optometry is involved only
during the pre- or post- procedure time period, and CMS should not
allow optometric utilization of those codes with co-management
modifiers to be included in the calculations for any major ophthalmic
surgical procedures. The commenter suggested that if CMS does not agree
to remove optometry from the calculation of MP RVUs for ophthalmic
surgery, that CMS should use a much lower percentage of utilization to
accurately reflect the true risk that optometrists encounter during
this limited portion of the service. The commenter also disagreed that
all providers who pay for malpractice insurance should have their
premiums taken into consideration, and stated that when CMS looks at
the dominant specialty for a given service, it must ensure that the
claims reported--particularly by non-physician providers such as
optometrists, are for the surgical portion of the procedure for which
the MP RVU is being considered.
Response: We would clarify for the commenter that we apply the risk
factor(s) of all specialties involved with furnishing services to
calculate the service level risk factors for all PFS codes. Our
methodology already accounts for codes with longer global periods or
codes where two different practitioners report different parts of the
service, weighing the volume differentially among the kinds of
practitioners that report the service depending on which portion of the
service each reports. We also remind commenters that, to determine the
raw MP RVU for a given service, we consider the greater of the work RVU
or clinical labor RVU for the service. Since the time and intensity of
the pre-service and post-service period are incorporated into the work
RVUs for these services and the work RVUs are used in the development
of MP RVUs, we believe it is methodologically consistent to incorporate
the portion of the overall services that is furnished by practitioners
other than those that furnish the procedure itself in the calculation
of MP RVUs. If we were to exclude the risk factors of some specialties
that bill a specific code from the calculation of the service level
risk factor, the resulting MP RVU would not reflect all utilization.
Likewise, we also disagree with the suggestion that the pre- and post-
utilization should be removed from determining MP RVUs for ophthalmic
surgical services. The resources associated with pre- and post-
operative periods for ophthalmic surgery are included in the total RVUs
for the global surgical package. Accordingly, if we did not include the
portion of utilization attributed to pre- and post-operative visits in
the calculation of service level risk factors, the MP RVUs for global
surgery would overstate the relative MP costs.
Comment: One commenter identified three low volume codes typically
performed by cardiac surgery or thoracic surgery that have anomalous MP
RVU values: CPT code 31766 (carinal reconstruction), the commenter
requested that the MP risk factor associated with Thoracic surgery be
assigned; CPT Code 33420 (valvotomy, mitral valve; closed heart), the
commenter requests that the MP risk factor associated with Cardiac
Surgery be assigned; and for 32654 (thorascoscopy, surgical; with
control of traumatic hemorrhage), the commenter requests that the MP
risk factor associated with Thoracic surgery be assigned.
Response: We agree with the commenters and have added these
services to the list of those with specialty overrides for CY 2016. We
hope to identify such anomalies more regularly in the future now that
the public use file listing the overrides is available on the CMS Web
site as indicated above.
5. CY 2016 Identification of Potentially Misvalued Services for Review
a. Public Nomination of Potentially Misvalued Codes
In the CY 2012 PFS final rule with comment period, we finalized a
process for the public to nominate potentially misvalued codes (76 FR
73058). Members of the public including direct stakeholders may
nominate potentially misvalued codes for review by submitting the code
with supporting documentation during the 60-day public comment period
following the release of the annual PFS final rule with comment period.
Supporting documentation for codes nominated for the annual review of
potentially misvalued codes may include, but is not limited to, the
following:
Documentation in the peer reviewed medical literature or
other reliable data that there have been changes in 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 work, that is,
diffusion of technology.
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, Department of Veteran Affairs (VA)
National Surgical Quality Improvement Program (NSQIP), the Society for
Thoracic Surgeons (STS) National Database, and the Physician Quality
Reporting System (PQRS) databases).
National surveys of work time and intensity from
professional and management societies and organizations, such as
hospital associations.
After we receive the nominated codes during the 60-day comment
period following the release of the annual PFS final rule with comment
period, we evaluate the supporting documentation and assess whether the
nominated codes
[[Page 70911]]
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 whether we are
proposing each nominated code as a potentially misvalued code.
During the comment periods for the CY 2015 proposed rule and final
rule with comment period, we received nominations and supporting
documentation for three codes to be considered as potentially misvalued
codes. We evaluated the supporting documentation for each nominated
code to ascertain whether the submitted information demonstrated that
the code should be proposed as potentially misvalued.
CPT code 36516 (Therapeutic apheresis; with extracorporeal
selective adsorption or selective filtration and plasma reinfusion) was
nominated for review as potentially misvalued. The nominator stated
that CPT code 36516 is misvalued because of incorrect direct and
indirect PE inputs and an incorrect work RVU. Specifically, the
nominator stated that the direct supply costs failed to include an $18
disposable bag and the $37 cost for biohazard waste disposal of the
post-treatment bag, and that the labor costs for nursing staff were
inaccurate. The nominator also stated that the overhead expenses
associated with this service were unrealistic and that the current work
RVU undervalues a physician's time and expertise. Based on the
requestor's comment, we proposed this code as a potentially misvalued
code. We also noted that we established a policy in CY 2011 to consider
biohazard bags as an indirect expense, and not as a direct PE input (75
FR 73192).
Comment: Several commenters stated that they do not believe CPT
code 36516 is potentially misvalued because they found no indication
that the clinical staff time, indirect expenses, or work was misvalued.
All commenters requested that this code be removed from the potentially
misvalued list.
Response: We appreciate the comments, but we believe that the
nominator presented some concerns that may have merit, and review of
the code is the best way to determine the validity of the concerns
articulated by the original requestor. Therefore, we are adding CPT
code 36516 to the list of potentially misvalued codes and anticipate
reviewing recommendations from the RUC and other stakeholders.
CPT Codes 52441 (Cystourethroscopy with insertion of permanent
adjustable transprostatic implant; single implant) and 52442
(Cystourethroscopy with insertion of permanent adjustable
transprostatic implant; each additional permanent adjustable
transprostatic implant) were nominated for review as potentially
misvalued. The nominator stated that the costs of the direct PE inputs
were inaccurate, including the cost of the implant. We proposed these
services as potentially misvalued codes.
Comment: Some commenters disagreed that the commenter intended to
nominate CPT codes 52441 and 52442 as potentially misvalued.
Response: After reviewing the original comment, we agree with these
commenters' perspective that the intention was not to nominate the
codes as potentially misvalued. Therefore, we are not finalizing our
proposal to review these codes under the potentially misvalued code
initiative.
b. Electronic Analysis of Implanted Neurostimulator (CPT Codes 95970-
95982)
In the CY 2015 final rule with comment period (79 FR 67670), we
reviewed and valued all of the inputs for the following CPT codes:
95971 (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); simple spinal
cord, or peripheral (i.e., peripheral nerve, sacral nerve,
neuromuscular) neurostimulator pulse generator/transmitter, with
intraoperative or subsequent programming); 95972 (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 spinal cord, or peripheral
(i.e., peripheral nerve, sacral nerve, neuromuscular) (except cranial
nerve) neurostimulator pulse generator/transmitter, with intraoperative
or subsequent programming, up to one hour); and 95973 (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 spinal cord, or
peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular)
(except cranial nerve) neurostimulator pulse generator/transmitter,
with intraoperative or subsequent programming, each additional 30
minutes after first hour (List separately in addition to code for
primary procedure)). Due to significant time changes in the base codes,
we believe the entire family detailed in Table 7 is potentially
misvalued and should be reviewed in a manner consistent with our review
of CPT codes 95971, 95972 and 95973.
Table 7--Potentially Misvalued Codes Identified in the Electronic
Analysis of Implanted Neurostimulator Family
------------------------------------------------------------------------
HCPCS Short descriptor
------------------------------------------------------------------------
95970.............................. Analyze neurostim no prog.
95974.............................. Cranial neurostim complex.
95975.............................. Cranial neurostim complex.
95978.............................. Analyze neurostim brain/1h.
95979.............................. Analyz neurostim brain addon.
95980.............................. Io anal gast n-stim init.
95981.............................. Io anal gast n-stim subsq.
95982.............................. Io ga n-stim subsq w/reprog.
------------------------------------------------------------------------
Comment: One commenter agreed with the review of CPT codes 95970-
95982 as potentially misvalued services.
Response: We are adding CPT codes 95970-95982 to the list of
potentially misvalued codes and anticipate reviewing recommendations
from the AMA RUC and other stakeholders.
[[Page 70912]]
c. Review of High Expenditure Services Across Specialties With Medicare
Allowed Charges of $10,000,000 or More
In the CY 2015 PFS rule, we proposed and finalized the high
expenditure screen as a tool to identify potentially misvalued codes in
the statutory category of ``codes that account for the majority of
spending under the PFS.'' We also identified codes through this screen
and proposed them as potentially misvalued in the CY 2015 PFS proposed
rule (79 FR 40337-40338). However, given the resources required for the
revaluation of codes with 10- and 90-day global periods, we did not
finalize those codes as potentially misvalued codes in the CY 2015 PFS
final rule with comment period. We stated that we would re-run the high
expenditure screen at a future date, and subsequently propose the
specific set of codes that meet the high expenditure criteria as
potentially misvalued codes (79 FR 67578).
As detailed in the CY 2016 PFS proposed rule (80 FR 41706), we
believed that our current resources will not necessitate further delay
in proceeding with the high expenditure screen for CY 2016. Therefore,
we re-ran the screen with the same criteria finalized in last year's
final rule. However, in developing this CY 2016 proposed list, we also
excluded all codes with 10- and 90-day global periods since we believe
these codes should be reviewed as part of the global surgery
revaluation described in section II.B.6. of this final rule with
comment period.
We proposed 118 codes as potentially misvalued codes, identified
using the high expenditure screen under the statutory category, ``codes
that account for the majority of spending under the PFS.'' To develop
the list, we followed the same approach taken last year except we
excluded codes with 10- and 90-day global periods. Specifically, we
identified the top 20 codes by specialty (using the specialties used in
Table 64 in terms of allowed charges. As we did last year, we excluded
codes that we have reviewed since CY 2010, those with fewer than $10
million in allowed charges, and those that described anesthesia or E/M
services. We excluded E/M services from the list of proposed
potentially misvalued codes for the same reasons that we excluded them
in a similar review in CY 2012. These reasons were explained in the CY
2012 final rule with comment period (76 FR 73062 through 73065).
Comment: Some commenters did not believe that high expenditure/high
volume was an appropriate criterion for us to use to identify the codes
for the potentially misvalued codes initiative. These commenters stated
that high expenditure is not an objective gauge of potential
misvaluation. Additionally, commenters believed that selecting codes
that have not been reviewed in the past 5 years insinuates that the
delivery of these services and procedures has changed radically over
that time span, which many doubted. Other commenters believed CMS
should provide justification for the revaluation by providing evidence
and/or data to show how the delivery of a service or procedure has
changed within 5 years. While many disagreed with our use of the high
expenditure screen, some commenters specifically suggested use of
different types of screens; some of which would screen for services for
which volume has increased a certain percentage over a set period or
screen for changes in the predominate site of service.
Response: We appreciate commenters' perspective on the proposed
list of potentially misvalued codes based on the high expenditure
screen. It is clear that over time the resources involved in furnishing
particular services can often change and, therefore, many services that
have not recently been evaluated may become potentially misvalued.
Under section 1848(c)(2)(B) of the Act, we are mandated to review
relative values for codes for all physicians' services at least every 5
years. The purpose of specifically identifying potentially misvalued
codes through particular screens established through rulemaking is to
prioritize the review of individual codes since comprehensive, annual
review of all codes for physicians' services is not practical and, due
to the need to maintain relativity, changes in values for individual
services can have an impact across the PFS. We identify potentially
misvalued codes in order to prioritize review of subsets of PFS
services. We prioritize review of individual services based on
indications that a particular code is likely to be misvalued and on the
impact that the potential misvaluation of the code would have on the
valuation of PFS services broadly. Our high expenditure screen is
largely intended to address the latter situation where improved
valuation would have the most significant impact on the valuation of
PFS services more broadly. This approach is also consistent with
another category of codes identified for screening by statute: Codes
with high PE relative value units. In proposing to prioritize this list
of high expenditure codes, we stated that the reason we identified
these codes is because they have significant impact on PFS payment on a
specialty level and have not been recently reviewed.
Comment: A few commenters suggested that E/M services should not be
exempt from review as potentially misvalued codes.
Response: In the CY 2012 final rule (76 FR 73063), we explained the
concerns expressed by commenters that informed our decision to refrain
from finalizing our proposal to review 91 E/M codes as potentially
misvalued. We believe that those concerns remain valid. We also believe
that it is best to exempt E/M codes from our review of potentially
misvalued codes since we are continuously exploring valuations of E/M
services, potential refinements to the PFS, and other options for
policies that may contribute to improved valuation of E/M services.
Comment: Many commenters also stated that the review of codes over
such a short time span puts significant burden on the specialty
societies. Many commenters agreed that high expenditure codes should be
reviewed on a periodic basis over multiple years. Some commenters
specifically suggested that the periodic basis should be 10 years while
others suggested delaying any review of the codes until after the
misvalued code target has been met.
Response: Because of the concerns expressed by commenters about the
burden associated with code reviews, we continue to believe that it is
appropriate to prioritize review of codes to a manageable subset that
also have a high impact on the PFS and work with the specialty society
to spread review of the remaining codes identified as potentially
misvalued over a reasonable timeframe. Therefore, we do not believe it
would be appropriate to remove codes from the high expenditure list
unless we find that we have reviewed both the work RVUs and direct PE
inputs for the code during the specified time period.
Also, we believe that the resources involved in furnishing a
service can evolve over time, including the time and technology used to
furnish the service, and such efficiencies could easily develop in a
time span as short as 5 years. As a result, we continue to believe that
the review of these high expenditure codes is necessary to ensure that
the services are appropriately valued. Additionally, not only do we
believe that regular monitoring of codes with high impact on the PFS
will produce a more accurate and equitable payment system, but we have
a statutory obligation under
[[Page 70913]]
section 1848(c)(2)(B) of the Act to review code values at least every 5
years (although we do not always conduct a review that involves the AMA
RUC). Therefore, we do not agree with the commenter that suggested that
changes in technology and practice can be effectively accounted for
through review of code values every 10 years.
Comment: Commenters stated that the following codes were reviewed
since CY 2010 and, as a result, do not fit the criteria for the high
expenditure screen and should be removed: CPT codes 51728 (Insertion of
electronic device into bladder with voiding pressure studies), 51729
(Insertion of electronic device into bladder with voiding and bladder
canal (urethra) pressure studies), 76536 (Ultrasound of head and neck),
78452 (Nuclear medicine study of vessels of heart using drugs or
exercise multiple studies), 92557 (Air and bone conduction assessment
of hearing loss and speech recognition), 92567 (Eardrum testing using
ear probe), 93350 (Ultrasound examination of the heart performed during
rest, exercise, and/or drug-induced stress with interpretation and
report) and 94010 (Measurement and graphic recording of total and timed
exhaled air capacity).
Response: We agree with commenters that the codes identified do not
fit the criteria for review based on the high expenditure screen.
Therefore, we are not proposing to review CPT codes 51728, 51729,
76536, 78452, 92557, 92567, 93350, and 94010 under the potentially
misvalued code initiative.
Comment: Commenters believed that services that are add-ons to the
excluded 10- and 90-day global services should be removed from the list
of codes identified through the high expenditure screen in order to
maintain relativity. The specific codes suggested for removal were: CPT
codes 22614 (Fusion of spine bones, posterior or posterolateral
approach); 22840 (Insertion of posterior spinal instrumentation at base
of neck for stabilization, 1 interspace); 22842 (Insertion of posterior
spinal instrumentation for spinal stabilization, 3 to 6 vertebral
segments); 22845 (Insertion of anterior spinal instrumentation for
spinal stabilization, 2 to 3 vertebral segments); and 33518 (Combined
multiple vein and artery heart artery bypasses).
Response: We agree with the commenters that the codes identified
should be removed from the list of codes identified for review through
the high expenditure screen due to their relationship to the 10- and
90-day global services that were excluded from our screen. Although we
agree that these codes should be removed from this screen, we think it
is worthwhile to note that for similar reasons, we believe we should
consider these and similar add-on codes in conjunction with efforts to
improve the valuation and the global surgery packages as described in
section II.B.6. of this final rule with comment period. Therefore, we
are not including CPT codes 22614, 22840, 22842, 22845 on the list of
codes identified for review through the high expenditure screen.
Comment: Commenters believed that CPT code 92002 (Eye and medical
examination for diagnosis and treatment, new patient) is considered an
ophthalmological evaluation and management (E/M) service and as a
result, should be excluded for all the same reasons we excluded other
E/M codes.
Response: We agree with commenters that CPT code 92002 is
considered an E/M and, as a result, should be excluded from the screen
as were other E/Ms. Therefore, we are not including CPT code 92002 on
the list of codes identified for review through the high expenditure
screen.
Comment: A few commenters requested that codes with a work RVU
equal to 0.00 (CPT codes 51798 (Ultrasound measurement of bladder
capacity after voiding), 88185 (Flow cytometry technique for DNA or
cell analysis), 93296 (Remote evaluations of single, dual, or multiple
lead pacemaker or cardioverter-defibrillator transmissions, technician
review, support, and distribution of results up to 90 days), 96567
(Application of light to aid destruction of premalignant and/or
malignant skin growths, each session), and 96910 (Skin application of
tar and ultraviolet B or petrolatum and ultraviolet B)) or equal to
0.01 (CPT codes 95004 (Injection of allergenic extracts into skin,
accessed through the skin)) be removed from the list of codes
identified for review through the high expenditure screen. Commenters
stated that historically, services with 0.00 work RVUs were excluded
from screens and that re-reviewing a service with a 0.01 work RVU would
most likely not lower the work component unless work was completely
removed from the code.
Response: We continue to believe that codes with 0.00 work RVUs or
very low work RVUs of 0.01, should still be reviewed and can still be
considered potentially misvalued. As stated earlier, we do not believe
it would be appropriate to remove codes from the high expenditure list
unless we find that we have reviewed both the work RVUs and direct PE
inputs. Therefore, we are maintaining CPT codes 51798, 88185, 93296,
96567, 96910 and 95004 as potentially misvalued codes and anticipate
reviewing recommendations from the AMA RUC and other stakeholders.
Comment: Various commenters objected to the presence of individual
codes that met the high expenditure screen criteria based on absence of
clinical evidence that the individual services are misvalued.
Response: We reviewed each of these comments, and believe that
these kinds of assessments are best addressed through the misvalued
code review process. As we describe in this section, the criteria for
many misvalued code screens, including this one, are designed to
prioritize codes that may be misvalued not to identify codes that are
misvalued. Therefore, we believe that supporting evidence for the
accuracy of current values for particular codes is best considered as
part of the review of individual codes through the misvalued code
process.
Comment: Several commenters believed that codes that are currently
scheduled to be considered by either the CPT Editorial Panel for new
coding or the RUC for revised valuations (for work RVUs and/or PE
inputs) at an upcoming meeting should be removed from the screen.
Commenters also believed that it was best to allow these codes to go
through the RUC code review process rather than identifying the codes
as potentially misvalued through this screen.
Response: Although a number of codes have been or will be
considered through the RUC review process, until we receive
recommendations and review the codes for both work and direct PE
inputs, we will continue to include these codes on the high expenditure
list. We reiterate that we do not believe that the presence of a code
on a misvalued code list signals that a particular code necessarily is
misvalued. Instead, the lists are intended to prioritize codes to be
reviewed under the misvalued code initiative. If any code on the list
finalized here is already being reviewed by the RUC through its
process, we will receive a recommendation regarding valuation for the
code, and the presence or absence of the code in this particular list
is immaterial. However, if subsequent to the removal of a code from the
high expenditure code list, the RUC decides not to review the code, we
would still want to consider the code as potentially misvalued based on
its meeting the criteria established for the screen. Therefore, we do
not agree that we should remove individual codes from a potentially
misvalued code list because the RUC already anticipates
[[Page 70914]]
reviewing the code. However, we want to be clear that when we receive
RUC recommendations regarding a code, we generally remove that code
from misvalued code lists, regardless of whether or not the RUC
reviewed the code on the basis of that particular screen.
Accordingly, we are finalizing the 103 codes in Table 8 as
potentially misvalued services under the high expenditure screen and
seek recommended values for these codes from the RUC and other
interested stakeholders.
Table 8--List of Potentially Misvalued Codes Identified Through High
Expenditure by Specialty Screen
------------------------------------------------------------------------
HCPCS Short descriptor
------------------------------------------------------------------------
10022..................................... Fna w/image.
11100..................................... Biopsy skin lesion.
11101..................................... Biopsy skin add-on.
11730..................................... Removal of nail plate.
20550..................................... Inj tendon sheath/ligament.
20552..................................... Inj trigger point 1/2 muscl.
20553..................................... Inject trigger points 3/>.
27370..................................... Injection for knee x-ray.
29580..................................... Application of paste boot.
31500..................................... Insert emergency airway.
31575..................................... Diagnostic laryngoscopy.
31579..................................... Diagnostic laryngoscopy.
31600..................................... Incision of windpipe.
36215..................................... Place catheter in artery.
36556..................................... Insert non-tunnel cv cath.
36569..................................... Insert picc cath.
36620..................................... Insertion catheter artery.
38221..................................... Bone marrow biopsy.
51700..................................... Irrigation of bladder.
51702..................................... Insert temp bladder cath.
51720..................................... Treatment of bladder lesion.
51784..................................... Anal/urinary muscle study.
51798..................................... Us urine capacity measure.
52000..................................... Cystoscopy.
55700..................................... Biopsy of prostate.
58558..................................... Hysteroscopy biopsy.
67820..................................... Revise eyelashes.
70491..................................... Ct soft tissue neck w/dye.
70543..................................... Mri orbt/fac/nck w/o & w/
dye.
70544..................................... Mr angiography head w/o dye.
70549..................................... Mr angiograph neck w/o & w/
dye.
71010..................................... Chest x-ray 1 view frontal.
71020..................................... Chest x-ray 2vw
frontal&latl.
71260..................................... Ct thorax w/dye.
71270..................................... Ct thorax w/o & w/dye.
72195..................................... Mri pelvis w/o dye.
72197..................................... Mri pelvis w/o & w/dye.
73110..................................... X-ray exam of wrist.
73130..................................... X-ray exam of hand.
73718..................................... Mri lower extremity w/o dye.
73720..................................... Mri lwr extremity w/o & w/
dye.
74000..................................... X-ray exam of abdomen.
74022..................................... X-ray exam series abdomen.
74181..................................... Mri abdomen w/o dye.
74183..................................... Mri abdomen w/o & w/dye.
75635..................................... Ct angio abdominal arteries.
75710..................................... Artery x-rays arm/leg.
75978..................................... Repair venous blockage.
76512..................................... Ophth us b w/non-quant a.
76519..................................... Echo exam of eye.
77059..................................... Mri both breasts.
77263..................................... Radiation therapy planning.
77334..................................... Radiation treatment aid(s).
77470..................................... Special radiation treatment.
78306..................................... Bone imaging whole body.
88185..................................... Flowcytometry/tc add-on.
88189..................................... Flowcytometry/read 16 & >.
88321..................................... Microslide consultation.
88360..................................... Tumor immunohistochem/
manual.
88361..................................... Tumor immunohistochem/
comput.
91110..................................... Gi tract capsule endoscopy.
92136..................................... Ophthalmic biometry.
92240..................................... Icg angiography.
92250..................................... Eye exam with photos.
92275..................................... Electroretinography.
93280..................................... Pm device progr eval dual.
93288..................................... Pm device eval in person.
93293..................................... Pm phone r-strip device
eval.
93294..................................... Pm device interrogate
remote.
93295..................................... Dev interrog remote 1/2/mlt.
93296..................................... Pm/icd remote tech serv.
93306..................................... Tte w/doppler complete.
93351..................................... Stress tte complete.
93503..................................... Insert/place heart catheter.
93613..................................... Electrophys map 3d add-on.
93965..................................... Extremity study.
94620..................................... Pulmonary stress test/
simple.
95004..................................... Percut allergy skin tests.
95165..................................... Antigen therapy services.
95957..................................... Eeg digital analysis.
96101..................................... Psycho testing by psych/
phys.
96116..................................... Neurobehavioral status exam.
96118..................................... Neuropsych tst by psych/
phys.
96360..................................... Hydration iv infusion init.
96372..................................... Ther/proph/diag inj sc/im.
96374..................................... Ther/proph/diag inj iv push.
96375..................................... Tx/pro/dx inj new drug
addon.
96401..................................... Chemo anti-neopl sq/im.
96402..................................... Chemo hormon antineopl sq/
im.
96409..................................... Chemo iv push sngl drug.
96411..................................... Chemo iv push addl drug.
96567..................................... Photodynamic tx skin.
96910..................................... Photochemotherapy with uv-b.
97032..................................... Electrical stimulation.
97035..................................... Ultrasound therapy.
97110..................................... Therapeutic exercises.
97112..................................... Neuromuscular reeducation.
97113..................................... Aquatic therapy/exercises.
97116..................................... Gait training therapy.
97140..................................... Manual therapy 1/regions.
97530..................................... Therapeutic activities.
97535..................................... Self care mngment training.
G0283..................................... Elec stim other than wound.
------------------------------------------------------------------------
6. Valuing Services That Include Moderate Sedation as an Inherent Part
of Furnishing the Procedure
The CPT manual includes more than 400 diagnostic and therapeutic
procedures, listed in Appendix G, for which the CPT Editorial Committee
has determined that moderate sedation is an inherent part of furnishing
the procedure. For these diagnostic and therapeutic procedures, only
the procedure code is reported by the practitioner who conducts the
procedure, without separate billing by the same practitioner for
anesthesia services, and, in developing RVUs for these services, we
include the resource costs associated with moderate sedation in the
valuation. To the extent that moderate sedation is inherent in the
diagnostic or therapeutic service, we believe that the inclusion of
moderate sedation in the valuation of the procedure is appropriate. In
the CY 2015 PFS proposed rule (79 FR 40349), we noted that it appeared
practice patterns for endoscopic procedures were changing, with
anesthesia increasingly being separately reported for these procedures.
Due to the changing nature of medical practice, we noted that we were
considering establishing a uniform approach to valuation for all
Appendix G services. We continue to seek an approach that is based on
using the best available objective, broad-based information about the
provision of moderate sedation, rather than merely addressing this
issue on a code-by-code basis using RUC survey data when individual
procedures are revalued. We sought public comment on approaches to
address the appropriate valuation of these services given that moderate
sedation is no longer inherent for many of these services. To the
extent that Appendix G procedure code values are adjusted to no longer
include moderate sedation, we requested suggestions as to how moderate
sedation should be reported and valued, and how to remove from existing
valuations the RVUs and inputs related to moderate sedation.
To establish an approach to valuation for all Appendix G services
based on the best data about the provision of moderate sedation, we
need to determine the extent to which each code may be misvalued. We
know that there are standard packages for the direct PE inputs
associated with moderate sedation, and we began to develop approaches
to estimate how much of the work involved in these services is
attributable to moderate sedation. However, we believe that we should
seek input from the medical community prior to proposing changes in
values for these services, given the different methodologies used to
develop work RVUs for the hundreds of services in Appendix G.
Therefore, in the CY 2016 PFS proposed rule, we solicited
recommendations from the RUC and other interested stakeholders on the
appropriate valuation of the work associated with moderate sedation
before formally proposing an approach that allows Medicare to adjust
payments based on the resource costs associated with the moderate
sedation or anesthesia services that are being furnished.
The anesthesia procedure codes 00740 (Anesthesia for procedure on
gastrointestinal tract using an endoscope) and 00810 (Anesthesia for
procedure on lower intestine using an endoscope) are used for
anesthesia furnished in conjunction with lower GI
[[Page 70915]]
procedures. In reviewing Medicare claims data, we noted that a separate
anesthesia service is now reported more than 50 percent of the time
that several types of colonoscopy procedures are reported. Given the
significant change in the relative frequency with which anesthesia
codes are reported with colonoscopy services, we believe the relative
values of the anesthesia services should be re-examined. Therefore, in
the CY 2016 PFS proposed rule, we proposed to identify CPT codes 00740
and 00810 as potentially misvalued. We welcomed comments on both of
these issues.
Comment: Several commenters noted that they support CMS' decision
to seek input from the medical community prior to proposing a method
for reporting and valuing moderate sedation as well as adjusting
existing valuations to remove these services. One commenter also
encouraged CMS to seek and consider recommendations from societies that
represent members who provide dialysis vascular access interventional
care, such as the American Society of Diagnostic and Interventional
Nephrology.
Response: We thank the commenters for their support. Through notice
and comment rulemaking, we will review and consider any recommendations
from the public, including those from any interested specialty
societies.
Comment: In response to CMS' proposal to identify anesthesia
procedure codes 00740 and 00810 as potentially misvalued, the RUC
stated that the committee anticipated reviewing CPT codes 00740 and
00810 as potentially misvalued codes.
Response: We appreciate the RUC's responsiveness to the proposal.
Comment: One commenter disagreed that the increase in utilization
of anesthesia is indicative of potential misvaluation of the codes in
Appendix G. This commenter noted that the policy adopted by CMS in the
CY 2015 final rule to eliminate cost-sharing for anesthesia furnished
in conjunction with screening colonoscopies encourages patients to
undergo these screenings. The commenter also noted that use of
anesthesia with upper endoscopy procedures not only decreases patient
discomfort, but also decreases complications and creates more optimal
conditions for efficiency during the procedure as well as reduced
recovery time as compared to the use of narcotics and sedative hypnotic
agents. The commenter believes that this results in savings that offset
the costs of anesthesia services. The commenter also expressed the view
that the work involved in these services has not changed.
Response: We thank the commenters for their input. Since the pool
of beneficiaries that receive anesthesia in conjunction with these
Appendix G services has grown, we believe it is possible that the
typical circumstances under which patients receive these services have
changed since the services were last reviewed. Therefore, we continue
to seek recommendations regarding appropriate approaches to valuation
for these services.
Comment: A few commenters noted that there are a variety of
services in Appendix G and stated their view that practitioners who
furnish services for which there are claims data supporting the
inherent nature of moderate sedation should not have to report moderate
sedation separately, as they believe they would be faced with
administrative burden and costs. They recommended that CMS conduct
ongoing analysis of claims data to determine which codes may require
unbundling of moderate sedation and to refer only those codes as
potentially misvalued. One commenter noted that they opposed the use of
any ``blanket approach'' to valuing moderate sedation such as removing
the standard packages for the direct PE inputs associated with moderate
sedation. The commenter recommended instead that we look at codes by
family or specialty in order to ensure that reimbursements are fair and
accurate. One commenter also noted the difference in the work involved
with moderate sedation when it is furnished by the same physician who
is furnishing the procedure compared with when it is furnished by
another clinician, and requested that this be considered when valuing
the moderate sedation services. Another commenter suggested that CMS
create a modifier to be used by surgeons providing moderate sedation.
They also suggested that CMS consider the expenses involved with using
a registered nurse or CRNA, the medications and delivery systems,
patient monitoring equipment, and lengthened postoperative recovery
period when valuing moderate sedation services.
Response: We thank the commenters for their input. We will consider
input from the medical community on this issue through evaluation of
CPT coding changes and associated RUC recommendations, as well as
feedback received through public comments, as we value these services
through future notice and comment rulemaking.
7. Improving the Valuation and Coding of the Global Package
a. Proposed Transition of 10-Day and 90-Day Global Packages Into 0-Day
Global Packages
In the CY 2015 PFS final rule (79 FR 67582 through 67591) we
finalized a policy to transition all 10-day and 90-day global codes to
0-day global periods in order to improve the accuracy of valuation and
payment for the various components of global surgical packages,
including pre- and postoperative visits and the surgical procedure
itself. Although in previous rulemaking we have marginally addressed
some of the concerns we identified with global packages, we believe
there is still a need to address other fundamental issues with the 10-
and 90-day postoperative global packages. We believe it is critical
that the RVUs we use to develop PFS payment rates reflect the most
accurate resource costs associated with PFS services. We believe that
valuing global codes that package services together without objective,
auditable data on the resource costs associated with the components of
the services contained in the packages may significantly skew
relativity and create unwarranted payment disparities within PFS fee-
for-service payment. We also believe that the resource-based valuation
of individual physicians' services will continue to serve as a critical
foundation for Medicare payment to physicians. Therefore, we believe it
is critical that the RVUs under the PFS be based as closely and
accurately as possible on the actual resources involved in furnishing
the typical occurrence of specific services.
In the rulemaking for CY 2015, we stated our belief that
transforming all 10- and 90-day global codes to 0-day global codes
would:
Increase the accuracy of PFS payment by setting payment
rates for individual services based more closely upon the typical
resources used in furnishing the procedures;
Avoid potentially duplicative or unwarranted payments when
a beneficiary receives postoperative care from a different practitioner
during the global period;
Eliminate disparities between the payment for E/M services
in global periods and those furnished individually;
Maintain the same-day packaging of pre- and postoperative
physicians' services in the 0-day global code; and
Facilitate availability of more accurate data for new
payment models and quality research.
[[Page 70916]]
b. Impact of the Medicare Access and CHIP Reauthorization Act of 2015
The MACRA was enacted into law on April 16, 2015. Section 523 of
the MACRA addresses payment for global surgical packages. Section
523(a) adds a new paragraph at section 1848(c)(8) of the Act. Section
1848(c)(8)(A)(i) of the Act prohibits the Secretary from implementing
the policy established in the CY 2015 PFS final rule with comment
period that would have transitioned all 10-day and 90-day global
surgery packages to 0-day global periods. Section 1848(c)(8)(A)(ii) of
the Act provides that nothing in the previous clause shall be construed
to prevent the Secretary from revaluing misvalued codes for specific
surgical services or assigning values to new or revised codes for
surgical services.
Section 1848(c)(8)(B)(i) of the Act requires CMS to develop,
through rulemaking, a process to gather information needed to value
surgical services from a representative sample of physicians, and
requires that the data collection shall begin no later than January 1,
2017. The collected information must include the number and level of
medical visits furnished during the global period and other items and
services related to the surgery, as appropriate. This information must
be reported on claims at the end of the global period or in another
manner specified by the Secretary. Section 1848(c)(8)(B)(ii) of the Act
requires that, every 4 years, we must reassess the value of this
collected information; and allows us to discontinue the collection if
the Secretary determines that we have adequate information from other
sources in order to accurately value global surgical services. Section
1848(c)(8)(B)(iii) of the Act specifies that the Inspector General will
audit a sample of the collected information to verify its accuracy.
Section 1848(c)(8)(C) of the Act requires that, beginning in CY 2019,
we must use the information collected as appropriate, along with other
available data, to improve the accuracy of valuation of surgical
services under the PFS. Section 523(b) of the MACRA adds a new
paragraph at section 1848(c)(9) of the Act that authorizes the
Secretary, through rulemaking, to delay up to 5 percent of the PFS
payment for services for which a physician is required to report
information under section 1848(c)(8)(B)(i) of the Act until the
required information is reported.
Since section 1848(c)(8)(B)(i) of the Act, as added by section
523(a) of the MACRA, requires us to use rulemaking to develop and
implement the process to gather information needed to value surgical
services no later than January 1, 2017, we sought input from
stakeholders on various aspects of this task. We solicited comments
from the public regarding the kinds of auditable, objective data
(including the number and type of visits and other services furnished
by the practitioner reporting the procedure code during the current
postoperative periods) needed to increase the accuracy of the values
for surgical services. We also solicited comment on the most efficient
means of acquiring these data as accurately and efficiently as
possible. For example, we sought information on the extent to which
individual practitioners or practices may currently maintain their own
data on services, including those furnished during the postoperative
period, and how we might collect and objectively evaluate those data
for use in increasing the accuracy of the values beginning in CY 2019.
We received many comments regarding the kinds of auditable,
objective data needed to increase the accuracy of the values for
surgical services and the most efficient means of acquiring these data.
Commenters had several suggestions for the approach that CMS should
take, including the following:
Collect and examine large group practice data for CPT code
99024 (postoperative follow-up visit).
Review Medicare Part A claims data to determine the length
of stay of surgical services performed in the hospital facility
setting.
Prioritize services that the Agency has identified as high
concern subjects.
Review postoperative visit and length of stay data for
outliers.
In general, commenters were supportive of the need to identify
auditable, objective, representative data, but many were not able to
identify a specific source for such data. We appreciate the comments we
received and we will consider these suggestions for purposes of future
rulemaking.
As noted above, section 1848(c)(8)(C) of the Act mandates that we
use the collected data to improve the accuracy of valuation of surgery
services beginning in 2019. We described in previous rulemaking (79 FR
67582 through 67591) the limitations and difficulties involved in the
appropriate valuation of the global packages, especially when the
values of the component services are not clear. We sought public
comment on potential methods of valuing the individual components of
the global surgical package, including the procedure itself, and the
pre- and postoperative care, including the follow-up care during
postoperative days. We were also interested in stakeholder input on
what other items and services related to the surgery, aside from
postoperative visits, are furnished to beneficiaries during
postoperative care.
We received many comments regarding potential methods of valuing
the individual components of the global surgical package, including the
following:
Use a measured approach to valuing the individual
components of the global surgical package rather than implementing a
blanket data collection policy.
Examine and consider the level of the postoperative E/M
visits, including differences between specialties.
Consider the interaction between the valuing the global
surgery package and the multiple procedure payment reduction (MPPR)
policy.
We will consider these comments regarding the best means to develop
and implement the process to gather information needed to value
surgical services and will provide further opportunity for public
comment through future rulemaking.
Comment: We received many comments expressing strong support for
the CMS proposal to hold an open door forum or town hall meetings with
the public.
Response: We appreciate the extensive comments we received from the
public regarding the global surgical package. We have noted the
positive feedback from commenters about holding potential open forums
or town hall meetings to discuss this process. We will consider these
comments regarding the best means to develop and implement the process
to gather information needed to value surgical services as we develop
proposals for inclusion in next year's PFS proposed rule.
C. Elimination of the Refinement Panel
1. Background
As discussed in the CY 1993 PFS final rule with comment period (57
FR 55938), we adopted a refinement panel process to assist us in
reviewing the public comments on CPT codes with interim final work RVUs
for a year and in developing final work RVUs for the subsequent year.
We decided the panel would be composed of a multispecialty group of
physicians who would review and discuss the work involved in each
procedure under review, and then each panel member would individually
rate the work of the procedure. We believed establishing the panel with
a
[[Page 70917]]
multispecialty group would balance the interests of the specialty
societies who commented on the work RVUs with the budgetary and
redistributive effects that could occur if we accepted extensive
increases in work RVUs across a broad range of services.
Following enactment of section 1848(c)(2)(K) of the Act, which
required the Secretary periodically to identify and review potentially
misvalued codes and make appropriate adjustments to the RVUs, we
reassessed the refinement panel process. As detailed in the CY 2011 PFS
final rule with comment period (75 FR 73306), we continued using the
established refinement panel process with some modifications.
For CY 2015, in light of the changes we made to the process for
valuing new, revised, and potentially misvalued codes (79 FR 67606), we
reassessed the role that the refinement panel process plays in the code
valuation process. We noted that the current refinement panel process
is tied to the review of interim final values. It provides an
opportunity for stakeholders to provide new clinical information that
was not available at the time of the RUC valuation that might affect
work RVU values that are adopted in the interim final value process.
For CY 2015 interim final rates, we stated in the CY 2015 PFS final
rule with comment period that we will use the refinement panel process
as usual for these codes (79 FR 67609).
2. CY 2016 Refinement Panel Proposal
We proposed to permanently eliminate the refinement panel beginning
in CY 2016, and instead, publish the proposed rates for all interim
final codes in the PFS proposed rule for the subsequent year. For
example, we would publish the proposed rates for all CY 2016 interim
final codes in the CY 2017 PFS proposed rule. With the change in the
process for valuing codes adopted in the CY 2015 final rule with
comment period (79 FR 67606), proposed values for most codes that are
being valued for CY 2016 were published in the CY 2016 PFS proposed
rule. As explained in the CY 2015 final rule with comment period, a
smaller number of codes being valued for CY 2016 will be published as
interim final in the 2016 PFS final rule with comment period and be
subject to comment. Under our proposal, we will evaluate the comments
we receive on these code values, and both respond to these comments and
propose values for these codes for CY 2017 in the CY 2017 PFS proposed
rule. Therefore, stakeholders will have two opportunities to comment
and to provide any new clinical information that was not available at
the time of the RUC valuation that might affect work RVU values that
are adopted on an interim final basis. We believe that this proposed
process, which includes two opportunities for public notice and
comment, offers stakeholders a better mechanism and ample opportunity
for providing any additional data for our consideration, and discussing
any concerns with our interim final values, than the current refinement
process. It also provides greater transparency because comments on our
rules are made available to the public at http://www.regulations.gov.
We welcomed comments on this proposed change to eliminate the use of
refinement panels in our process for establishing final values for
interim final codes.
The following is a summary of the comments we received on this
proposed change to eliminate the use of refinement panels in our
process for establishing final values for interim final codes.
Comment: The majority of commenters, including the American Medical
Association/Specialty Society Relative (Value) Update Committee,
opposed the proposal to eliminate the refinement panel. Commenters
expressed concern that the complete elimination of the refinement
process decreases CMS's accountability to its stakeholders who do not
agree with the Agency's decisions. They urged CMS to provide detailed
guidance on how to seek a change in previously finalized RVUs including
the process to initiate a meeting with CMS staff to share and discuss
new information or clarify previously shared information, as well as
any key timelines or dates that may impact CMS's ability to initiate a
change in previously finalized RVUs. Commenters also urged CMS to
maintain a transparent appeal process. Another stated that, as CY 2017
will be the first full year using the new process for establishing
final values for interim final codes, it is possible that unforeseen
needs for the continuation of the refinement panel could arise.
Several commenters agreed with the proposal to eliminate the
refinement panel. One commenter supported the permanent elimination of
the refinement panel since CMS's display of interim final values in the
subsequent year's proposed rule will provide another opportunity for
public input. Another believed the new process will provide more timely
input on the codes and stated that publishing interim final values for
these in the proposed rule versus the final rule should allow adequate
time for public comment and for physicians to prepare for changes that
would have an impact on their practices and patients. Another commenter
welcomed the increased opportunity to review and comment on interim
values, especially given that CMS has not been obligated to accept
recommendations of the refinement panels and has frequently rejected
those recommendations.
Response: We appreciate all of the comments on the proposal. We
understand that commenters have an interest in a transparent process to
review CMS's assignment of RVUs to individual PFS services. We also
understand that some commenters believe that the purpose of the
refinement panel process is to provide for reconsideration of the
agency's previous decisions. However, the refinement panel was
established to assist us in reviewing the public comments on CPT codes
with interim final work RVUs and in balancing the interests of the
specialty societies who commented on the work RVUs with the budgetary
and redistributive effects that could occur if we accepted extensive
increases in work RVUs across a broad range of services. Therefore, we
do not believe that the refinement panel has generally served as the
kind of ``appeals'' or reconsideration process that some stakeholders
envision in their comments. We also have come to believe that the
refinement panel is not achieving its intended purpose. Rather than
providing us with additional information, balanced across specialty
interests, to assist us in establishing work RVUs, the refinement panel
process generally serves to rehash the issues raised and information
already discussed at the RUC meetings and considered by CMS.
We also appreciate commenters' interest in CMS maintaining a
transparent process with public accountability in establishing values
for physicians' services. In contrast to the prior process of
establishing interim final values and using a refinement panel process
that generally is not observed by members of the public, we believe
that the new process of proposing the majority of code values in the
proposed rule and making sure that those proposed values are open for
comment prior to their taking effect for payment inherently represents
greater transparency and accountability. We will also continue to work
towards greater transparency in describing in rulemaking how we develop
our proposed values for individual codes. We believe that focusing our
resources on notice and comment rulemaking would facilitate greater
transparency.
[[Page 70918]]
Given that the timing for valuation of PFS services under the new
process will in large part mitigate the need to establish values on an
interim final basis and will provide two opportunities for notice and
public comment, we do not believe that the refinement panel would
necessarily provide value as an avenue for input, for either CMS or
stakeholders, beyond that intrinsic in the notice and comment
rulemaking process. However, we appreciate commenters' concerns that
the new process has not been fully implemented and there may be
unanticipated needs for additional input like the kind made available
through the refinement panels. We agree that it may be advisable to
preserve existing avenues for public input beyond the rulemaking
process, like the refinement panel.
Therefore, after consideration of all of the comments and the
issues described in this section, we are not finalizing our proposal to
eliminate the refinement panel process at this time. Instead, we will
retain the ability to convene refinement panels for codes with interim
final values under circumstances where additional input provided by the
panel is likely to add value as a supplement to notice and comment
rulemaking. We will make the determination on whether to convene
refinement panels on an annual basis, based on review of comments
received on interim final values. We remind stakeholders that CY 2016
is the final year for which we anticipate establishing interim final
values for existing services.
We also want to remind stakeholders that we have established an
annual process for the public nomination of potentially misvalued
codes. This process, described in the CY 2012 PFS final rule (76 FR
73058), provides an annual means for those who believe that values for
individual services are inaccurate and should be readdressed through
notice and comment rulemaking to bring those codes to our attention.
D. Improving Payment Accuracy for Primary Care and Care Management
Services
In the CY 2016 PFS proposed rule, we sought public comment on a
number of issues regarding payment for primary care and care
coordination under the PFS. We are committed to supporting primary
care, and we have increasingly recognized care management as one of the
critical components of primary care that contributes to better health
for individuals and reduced expenditure growth (77 FR 68978).
Accordingly, we have prioritized the development and implementation of
a series of initiatives designed to improve the accuracy of payment
for, and encourage long-term investment in, care management services.
In addition to the Medicare Shared Savings Program, various
demonstration initiatives including the Pioneer Accountable Care
Organization (ACO) model, the patient-centered medical home model in
the Multi-payer Advanced Primary Care Practice (MAPCP), the Federally
Qualified Health Center (FQHC) Advanced Primary Care Practice
demonstration and the Comprehensive Primary Care (CPC) initiative,
among others (see the CY 2015 PFS final rule (79 FR 67715) for a
discussion of these), we also have continued to explore potential
refinements to the PFS that would appropriately value care management
within Medicare's statutory structure for fee-for-service physician
payment and quality reporting. The payment for some non-face-to-face
care management services is bundled into the payment for face-to-face
evaluation and management (E/M) visits. However, because the current E/
M office/outpatient visit CPT codes were designed with an overall
orientation toward episodic treatment, we have recognized that these E/
M codes may not reflect all the services and resources involved with
furnishing certain kinds of care, particularly comprehensive,
coordinated care management for certain categories of beneficiaries.
Over several years, we have developed proposals and sought
stakeholder input regarding potential PFS refinements to improve the
accuracy of payment for care management services. For example, in the
CY 2013 PFS final rule with comment period, we adopted a policy to pay
separately for transitional care management (TCM) involving the
transition of a beneficiary from care furnished by a treating physician
during an inpatient stay to care furnished by the beneficiary's primary
physician in the community (77 FR 68978 through 68993). In the CY 2014
PFS final rule with comment period, we finalized a policy, beginning in
CY 2015 (78 FR 74414), to pay separately for chronic care management
(CCM) services furnished to Medicare beneficiaries with two or more
qualifying chronic conditions. We believe that these new separately
billable codes more accurately describe, recognize, and make payment
for non-face-to-face care management services furnished by
practitioners and clinical staff to particular patient populations.
We view ongoing refinements to payment for care management services
as part of a broader strategy to incorporate input and information
gathered from research, initiatives, and demonstrations conducted by
CMS and other public and private stakeholders, the work of all parties
involved in the potentially misvalued code initiative, and, more
generally, from the public at large. Based on input and information
gathered from these sources, we are considering several potential
refinements that would continue our efforts to improve the accuracy of
PFS payments. In this section, we discuss our comment solicitation and
the public comments we received regarding these potential refinements.
1. Improved Payment for the Professional Work of Care Management
Services
Although both the TCM and CCM services describe certain aspects of
professional work, some stakeholders have suggested that neither of
these new sets of codes nor the inputs used in their valuations
explicitly account for all of the services and resources associated
with the more extensive cognitive work that primary care physicians and
other practitioners perform in planning and thinking critically about
the individual chronic care needs of particular subsets of Medicare
beneficiaries. Commenters stated that the time and intensity of the
cognitive efforts associated with such planning are in addition to the
work typically required to supervise and manage the clinical staff
associated with the current TCM and CCM codes. Similarly, we continue
to receive requests from a few stakeholders for CMS to lead efforts to
revise the current CPT E/M codes or construct a new set of E/M codes.
The goal of such efforts would be to better describe and value the work
(time and intensity) specific to primary care and other cognitive
specialties in the context of complex care of patients relative to the
time and intensity of the procedure-oriented care physicians and
practitioners, who use the same codes to report E/M services. Some of
these stakeholders have suggested that in current medical practice,
many physicians, in addition to the time spent treating acute
illnesses, spend substantial time working toward optimal outcomes for
patients with chronic conditions and patients they treat episodically,
which can involve additional work not reflected in the codes that
describe E/M services since that work is not typical across the wide
range of practitioners that report the same codes. According to these
groups, this work involves
[[Page 70919]]
medication reconciliation, the assessment and integration of numerous
data points, effective coordination of care among multiple other
clinicians, collaboration with team members, continuous development and
modification of care plans, patient or caregiver education, and the
communication of test results.
We agree with stakeholders that it is important for Medicare to use
codes that accurately describe the services furnished to Medicare
beneficiaries and to accurately reflect the relative resources involved
with furnishing those services. Therefore, in the CY 2016 PFS proposed
rule we solicited public comments on ways to recognize the different
resources (particularly in cognitive work) involved in delivering
broad-based, ongoing treatment, beyond those resources already
incorporated in the codes that describe the broader range of E/M
services. The resource costs of this work may include the time and
intensity related to the management of both long-term and, in some
cases, episodic conditions. To appropriately recognize the different
resource costs for this additional cognitive work within the structure
of PFS resource-based payments, we were particularly interested in
codes that could be used in addition to, not instead of, the current E/
M codes.
In our comment solicitation, we stated that, in principle, these
codes could be similar to the hundreds of existing add-on codes that
describe additional resource costs, such as additional blocks or slides
in pathology services, additional units of repair in dermatologic
procedures, or additional complexity in psychotherapy services. For
example, these codes might allow for the reporting of the additional
time and intensity of the cognitive work often undertaken by primary
care and other cognitive specialties in conjunction with an E/M
service, much like add-on codes for certain procedures or diagnostic
test describe the additional resources sometimes involved in furnishing
those services. Similar to the CCM code, the codes might describe the
increased resources used over a longer period of time than during one
patient visit. For example, the add-on codes could describe the
professional time in excess of 30 minutes and/or a certain set of
furnished services, per one calendar month, for a single patient to
coordinate care, provide patient or caregiver education, reconcile and
manage medications, assess and integrate data, or develop and modify
care plans. Such activity may be particularly relevant for the care of
patients with multiple or complicated chronic or acute conditions, and
should contribute to optimal patient outcomes including more
coordinated, safer care.
Like CCM, we would require that the patient have an established
relationship with the billing professional; and additionally, the use
of an add-on code would require the extended professional resources to
be reported with another separately payable service. However, in
contrast to the CCM code, the new codes might be reported based on the
resources involved in professional work, instead of the resource costs
in terms of clinical staff time. The codes might also apply broadly to
patients in a number of different circumstances, and would not
necessarily make reporting the code(s) contingent on particular
business models or technologies for medical practices. We stated that
we were interested in stakeholder comments on the kinds of services
that involve the type of cognitive work described above and whether or
not the creation of particular codes might improve the accuracy of the
relative values used for such services on the PFS. Finally, we were
interested in receiving information from stakeholders on the overlap
between the kinds of cognitive resource costs discussed above and those
already accounted for through the currently payable codes that describe
CCM and other care management services.
We strongly encouraged stakeholders to comment on this topic to
assist us in developing potential proposals to address these issues
through rulemaking in CY 2016 for implementation in CY 2017. We
anticipated using an approach similar to our multi-year approach for
implementing CCM and TCM services, to facilitate broader input from
stakeholders regarding details of implementing such codes, including
their structure and description, valuation, and any requirements for
reporting.
Comment: We received many comments on these potential policy and
coding refinements that will be useful in the development of potential
future policy proposals. We note that the American Medical Association
and others urged us to make separate Medicare payment for existing CPT
codes that are not separately paid under the PFS, but that describe
similar services and for which we have RUC-recommended values. These
codes describe a broad range of services, some of which involve non
face-to-face care management over a period of time.
Response: We will take the comments into consideration in
developing any potential policy proposals in future PFS rulemaking.
2. Establishing Separate Payment for Collaborative Care
We believe that the care and management for Medicare beneficiaries
with multiple chronic conditions, a particularly complicated disease or
acute condition, or common behavioral health conditions often requires
extensive discussion, information-sharing and planning between a
primary care physician and a specialist (for example, with a
neurologist for a patient with Alzheimer's disease plus other chronic
diseases). We note that for CY 2014, CPT created four codes that
describe interprofessional telephone/internet consultative services
(CPT codes 99446-99449). Because Medicare includes payment for
telephone consultations with or about a beneficiary as a part of other
services furnished to the beneficiary, we currently do not make
separate payment for these services. We note that such
interprofessional consultative services are distinct from the face-to-
face visits previously reported to Medicare using the consultation
codes, and we refer the reader to the CY 2010 PFS final rule for
information regarding Medicare payment policies for those services (74
FR 61767).
However, in considering how to improve the accuracy of our payments
for care coordination, particularly for patients requiring more
extensive care, in the CY 2016 PFS proposed rule we also sought comment
on how Medicare might accurately account for the resource costs of a
more robust interprofessional consultation within the current structure
of PFS payment. For example, we were interested in stakeholders'
perspectives regarding whether there are conditions under which it
might be appropriate to make separate payment for services like those
described by these CPT codes. We expressed interest in stakeholder
input regarding the parameters of, and resources involved in, these
collaborations between a specialist and primary care practitioner,
especially in the context of the structure and valuation of current E/M
services. In particular, we were interested in comments about how these
collaborations could be distinguished from the kind of services
included in other E/M services, how these services could be described
if stakeholders believe the current CPT codes are not adequate, and how
these services should be valued under the PFS. We also expressed
interest in comments on whether we should tie those interprofessional
consultations to a beneficiary encounter, and on
[[Page 70920]]
developing appropriate beneficiary protections to ensure that
beneficiaries are fully aware of the involvement of the specialist in
the beneficiary's care and the associated benefits of the collaboration
between the primary care physician and the specialist physician prior
to being billed for such services.
Additionally, we solicited comments on whether this kind of care
might benefit from inclusion in a CMMI model that would allow Medicare
to test its effectiveness with a waiver of beneficiary financial
liability and/or variation of payment amounts for the consulting and
the primary care practitioners. Without such protections, beneficiaries
could be responsible for coinsurance for services of physicians whose
role in the beneficiary's care is not necessarily understood by the
beneficiary. Finally, we also solicited comments on key technology
supports needed to support collaboration between specialist and primary
care practitioners in support of high quality care management services,
on whether we should consider including technology requirements as part
of any proposed services, and on how such requirements could be
implemented in a way that minimizes burden on providers. We encouraged
stakeholders to comment on this topic to assist us in developing
potential proposals to address these issues through rulemaking in CY
2016 for implementation in CY 2017. We anticipated using an approach
similar to our multi-year approach for implementing CCM and TCM
services, to facilitate broader input from stakeholders regarding
details of implementing such codes, including their structure and
description, valuation, and any requirements for reporting.
Comment: We received many comments on these potential policy and
coding refinements that will be useful in the development of potential
future policy proposals.
Response: We will take the comments into consideration in
developing any potential policy proposals in future PFS rulemaking.
a. Collaborative Care Models for Beneficiaries With Common Behavioral
Health Conditions
In recent years, many randomized controlled trials have established
an evidence base for an approach to caring for patients with common
behavioral health conditions called ``Collaborative Care.''
Collaborative care typically is provided by a primary care team,
consisting of a primary care provider and a care manager, who works in
collaboration with a psychiatric consultant, such as a psychiatrist.
Care is directed by the primary care team and includes structured care
management with regular assessments of clinical status using validated
tools and modification of treatment as appropriate. The psychiatric
consultant provides regular consultations to the primary care team to
review the clinical status and care of patients and to make
recommendations. Several resources have been published that describe
collaborative care models in greater detail and assess their impact,
including pieces from the University of Washington (http://aims.uw.edu/
), the Institute for Clinical and Economic Review (http://ctaf.org/reports/integration-behavioral-health-primary-care), and the Cochrane
Collaboration (http://www.cochrane.org/CD006525/DEPRESSN_collaborative-care-for-people-with-depression-and-anxiety).
Because this particular kind of collaborative care model has been
tested and documented in medical literature, in the proposed rule, we
were particularly interested in comments on how coding under the PFS
might facilitate appropriate valuation of the services furnished under
such a collaborative care model. As these kinds of collaborative models
of care become more prevalent, we would evaluate potential refinements
to the PFS to account for the provision of services through such a
model. We solicited information to assist us in considering refinements
to coding and payment to address this model in particular. We also
sought comments on the potential application of the collaborative care
model for other diagnoses and treatment modalities. For example, we
solicited comments on how a code similar to the CCM code applicable to
multiple diagnoses and treatment plans could be used to describe
collaborative care services, as well as other interprofessional
services, and could be appropriately valued and reported within the
resource-based relative value PFS system, and how the resources
involved in furnishing such services could be incorporated into the
current set of PFS codes without overlap. We also requested input on
whether requirements similar to those used for CCM services should
apply to a new collaborative care code, and whether such a code could
be reported in conjunction with CCM or other E/M services. For example,
we might consider whether the code should describe a minimum amount of
time spent by the psychiatric consultant for a particular patient per
one calendar month and be complemented by either the CCM or other care
management code to support the care management and primary care
elements of the collaborative care model. As with our comment
solicitation on interprofessional consultation, since the patient may
not have direct contact with the psychiatric consultant we solicited
comments on whether and, if so, how written consent for the non-face-
to-face services should be required prior to practitioners reporting
any new interprofessional consultation code or the care management
code.
We also solicited comments on appropriate care delivery
requirements for billing, the appropriateness of CCM technology
requirements or other technology requirements for these services,
necessary qualifications for psychiatric consultants, and whether or
not there are particular conditions for which payment would be more
appropriate than others; as well as how these services may interact
with quality reporting, the resource inputs we might use to value the
services under the PFS (specifically, work RVUs, time, and direct PE
inputs), and whether or not separate codes should be developed for the
psychiatric consultant and the care management components of the
service.
In addition, we solicited comments on whether this kind of care
model should be implemented through a CMMI model that would allow
Medicare to test its effectiveness with a waiver of beneficiary
financial liability and/or variation of payment methodology and amounts
for the psychiatric consultant and the primary care physician. Again,
we encouraged stakeholders to comment on this topic to assist us in
developing potential proposals to address these issues through
rulemaking in CY 2016 for implementation in CY 2017.
Comment: We received many positive comments regarding the
possibility of implementing new payment codes that would allow more
accurate reporting and payment when these services are furnished to
Medicare beneficiaries.
Response: We appreciate commenters' interest in appropriate coding
and payment for these services. We will take all comments into
consideration as we consider the development of proposals in future
rulemaking.
We took particular note that several commenters identified resource
inputs CMS might use to value these services under the PFS, including
defined time elements. As we consider those comments, we encourage
stakeholders to consider whether there are alternatives to time
elements that would account for the range in intensity of services
delivered in accordance with beneficiary need. In addition, since the
[[Page 70921]]
collaborative care models described in the proposed rule include
primary care-based care management, as well as psychiatric consulting,
we encourage further input including comments on this final rule with
comment period, from a broad group of stakeholders, including the
community of primary care providers, who are critical in the successful
provision of these Services.
3. CCM and TCM Services
a. Reducing Administrative Burden for CCM and TCM Services
In CY 2013, we implemented separate payment for TCM services under
CPT codes 99495 and 99496, and in CY 2015, we implemented separate
payment for CCM services under CPT code 99490. We established many
service elements and billing requirements that the physician or
nonphysician practitioner must satisfy to fully furnish these services
and to report these codes (77 FR 68989, 79 FR 67728). Particularly
because of the significant amount of non face-to-face work involved in
CCM and TCM services, these elements and requirements were relatively
extensive and generally exceeded those for other E/M and similar
services. Since the implementation of these services, some
practitioners have stated that the service elements and billing
requirements are too burdensome, and suggested that they interfere with
their ability to provide these care management services to their
patients who could benefit from them. In light of this feedback from
the physician and practitioner community, we solicited comments on
steps that we could take to further improve beneficiary access to TCM
and CCM services. Our aims in implementing separate payment for these
services are that Medicare practitioners are paid appropriately for the
services they furnish, and that beneficiaries receive comprehensive
care management that benefits their long term health outcomes. However,
we understand that excessive requirements on practitioners could
possibly undermine the overall goals of the payment policies. In the CY
2016 PFS proposed rule, we solicited stakeholder input on how we could
best balance access to these services and practitioner burdens such
that Medicare beneficiaries may obtain the full benefit of these
services.
b. Payment for CPT Codes Related to CCM Services
As we stated in the CY 2015 PFS final rule (79 FR 67719), we
believe that Medicare beneficiaries with two or more chronic conditions
as defined under the CCM code can benefit from the care management
services described by that code, and we want to make this service
available to all such beneficiaries. As with most services paid under
the PFS, we recognized that furnishing CCM services to some
beneficiaries will require more resources and some less; but we value
and make payment based upon the typical service. Because CY 2015 is the
first year for which we are making separate payment for CCM services,
we sought information regarding the circumstances under which CCM
services are furnished. This information would include the clinical
status of the beneficiaries receiving the service and the resources
involved in furnishing the service, such as the number of documented
non-face-to-face minutes furnished by clinical staff in the months the
code is reported. We were interested in examining such information to
identify the range of minutes furnished over those months as well as
the distribution of the number of minutes within the total volume of
services. We also solicited objective data regarding the resource costs
associated with furnishing the services described by this code. We
stated that as we review that information, in addition to our own
claims data, we would consider any changes in payment and coding that
may be warranted in the coming years, including the possibility of
establishing separate payment amounts and making Medicare payment for
the related CPT codes, such as the complex care coordination codes, CPT
codes 99487 and 99489.
Comment: We received several comments recommending various changes
in the billing requirements for CCM and TCM services. Some commenters
sought significant changes to the CCM scope of service elements, such
as eliminating the requirement to use certified electronic health
record technology (CEHRT); suspending the electronic care plan sharing
requirement until such time that electronic health records (EHRs) have
the ability to support such capabilities; or having CMS provide a model
patient consent form. Other commenters recommended more minor changes
such as clarifying the application of CCM rules regarding fax
transmission from certified EHRs, and changing the reporting rules for
TCM services (required date of service and when the claim can be
submitted). Many commenters stated the current payment amounts are not
adequate to cover the resources required to furnish CCM or TCM services
and urged CMS to increase payments, for example by creating an add-on
code to CPT code 99490, increasing the clinical labor PE input for CPT
code 99490 to the RUC recommended 60 minutes, and/or paying separately
for the complex CCM codes (CPT codes 99487 and 99489). Commenters also
noted that since CY 2015 is the first year of separate payment for CCM,
there is little utilization data available to assess average time spent
in furnishing CCM services and similar issues. One commenter planned to
share data with CMS next spring upon completion of a study on the cost
and value associated with care management.
Response: We will take these comments into consideration in the
development of potential proposals for future PFS rulemaking. We will
develop subregulatory guidance clarifying the intersection of fax
transmission and CEHRT for purposes of CCM billing. Regarding TCM
services, we are adopting the commenters' suggestions that the required
date of service reported on the claim be the date of the face-to-face
visit, and to allow (but not require) submission of the claim when the
face-to-face visit is completed, consistent with current policy
governing the reporting of global surgery and other bundles of services
under the PFS. We will revise the existing subregulatory guidance for
TCM services accordingly.
E. Target for Relative Value Adjustments for Misvalued Services
Section 220(d) of the Protecting Access to Medicare Act of 2014
(PAMA) (Pub. L. 113-93, enacted on April 1, 2014) added a new
subparagraph at section 1848(c)(2)(O) of the Act to establish an annual
target for reductions in PFS expenditures resulting from adjustments to
relative values of misvalued codes. Under section 1848(c)(2)(O)(ii) of
the Act, if the estimated net reduction in expenditures for a year as a
result of adjustments to the relative values for misvalued codes is
equal to or greater than the target for that year, reduced expenditures
attributable to such adjustments shall be redistributed in a budget-
neutral manner within the PFS in accordance with the existing budget
neutrality requirement under section 1848(c)(2)(B)(ii)(II) of the Act.
The provision also specifies that the amount by which such reduced
expenditures exceeds the target for a given year shall be treated as a
net reduction in expenditures for the succeeding year, for purposes of
determining whether the target has been met for that subsequent year.
Section 1848(c)(2)(O)(iv) of the Act defines a target recapture amount
as the difference between the target for the year and the estimated net
reduction in expenditures under the PFS resulting
[[Page 70922]]
from adjustments to RVUs for misvalued codes. Section
1848(c)(2)(O)(iii) of the Act specifies that, if the estimated net
reduction in PFS expenditures for the year is less than the target for
the year, an amount equal to the target recapture amount shall not be
taken into account when applying the budget neutrality requirements
specified in section 1848(c)(2)(B)(ii)(II) of the Act. Section 220(d)
of the PAMA applies to calendar years (CYs) 2017 through 2020 and sets
the target under section 1848(c)(2)(O)(v) of the Act at 0.5 percent of
the estimated amount of expenditures under the PFS for each of those 4
years.
Section 202 of the Achieving a Better Life Experience Act of 2014
(ABLE) (Division B of Pub. L. 113-295, enacted December 19, 2014)
amended section 1848(c)(2)(O) of the Act to accelerate the application
of the PFS expenditure reduction target to CYs 2016, 2017, and 2018,
and to set a 1 percent target for CY 2016 and 0.5 percent for CYs 2017
and 2018. As a result of these provisions, if the estimated net
reduction for a given year is less than the target for that year,
payments under the fee schedule will be reduced.
In the CY 2016 PFS proposed rule, we proposed a methodology to
implement this statutory provision in a manner consistent with the
broader statutory construct of the PFS. In developing this proposed
methodology, we identified several aspects of our approach for which we
specifically solicited comments. We organized this discussion by
identifying and explaining these aspects in particular but we solicited
comments on all aspects of our proposal.
1. Distinguishing ``Misvalued Code'' Adjustments From Other RVU
Adjustments
The potentially misvalued code initiative has resulted in changes
in PFS payments in several ways. First, potentially misvalued codes
have been identified, reviewed, and revalued through notice and comment
rulemaking. However, in many cases, the identification of particular
codes as potentially misvalued has led to the review and revaluation of
related codes, and frequently, to revisions to the underlying coding
for large sets of related services. Similarly, the review of individual
codes has initiated reviews and proposals to make broader adjustments
to values for codes across the PFS, such as when the review of a series
of imaging codes prompted a RUC recommendation and CMS updated the
direct PE inputs for imaging services to assume digital instead of film
costs. This change, originating through the misvalued code initiative,
resulted in a significant reduction in RVUs for a large set of PFS
services, even though the majority of affected codes were not initially
identified through potentially misvalued code screens. Finally, due to
both the relativity inherent in the PFS ratesetting process and the
budget neutrality requirements specified in section
1848(c)(2)(B)(ii)(II) of the Act, adjustments to the RVUs for
individual services necessarily result in the shifting of RVUs to broad
sets of other services across the PFS.
To implement the PFS expenditure reduction target provisions under
section 1848(c)(2)(O) of the Act, we must identify a subset of the
adjustments in RVUs for a year to reflect an estimated ``net
reduction'' in expenditures. Therefore, we dismissed the possibility of
including all changes in RVUs for a year in calculating the estimated
net reduction in PFS expenditures, even though we believe that the
redistributions in RVUs to other services are an important aspect of
the potentially misvalued code initiative. Conversely, we considered
the possibility of limiting the calculation of the estimated net
reduction in expenditures to reflect RVU adjustments made to the codes
formally identified as ``potentially misvalued.'' We do not believe
that calculation would reflect the significant changes in payments that
have directly resulted from the review and revaluation of misvalued
codes under section 1848(c)(2) of the Act. We further considered
whether to include only those codes that underwent a comprehensive
review (work and PE). As we previously have stated (76 FR 73057), we
believe that a comprehensive review of the work and PE for each code
leads to the more accurate assignment of RVUs and appropriate payments
under the PFS than do fragmentary adjustments for only one component.
However, if we calculated the net reduction in expenditures using
revisions to RVUs only from comprehensive reviews, the calculation
would not include changes in PE RVUs that result from proposals like
the film-to-digital change for imaging services, which not only
originated from the review of potentially misvalued codes, but
substantially improved the accuracy of PFS payments faster and more
efficiently than could have been done through the multiple-year process
required to complete a comprehensive review of all imaging codes.
After considering these options, we believe that the best approach
is to define the reduction in expenditures as a result of adjustments
to RVUs for misvalued codes to include the estimated pool of all
services with revised input values. This would limit the pool of RVU
adjustments used to calculate the net reduction in expenditures to
those for the services for which individual, comprehensive review or
broader proposed adjustments have resulted in changes to service-level
inputs of work RVUs, direct PE inputs, or MP RVUs, as well as services
directly affected by changes to coding for related services. For
example, coding changes in certain codes can sometimes necessitate
revaluations for related codes that have not been reviewed as misvalued
codes, because the coding changes have also affected the scope of the
related services. This definition would incorporate all reduced
expenditures from revaluations for services that are deliberately
addressed as potentially misvalued codes, as well as those for services
with broad-based adjustments like film-to-digital and services that are
redefined through coding changes as a result of the review of misvalued
codes.
Because the annual target is calculated by measuring changes from
one year to the next, we also considered how to account for changes in
values that are best measured over 3 years, instead of 2 years. Under
our current process, the overall change in valuation for many misvalued
codes is measured across values for 3 years: the original value in the
first year, the interim final value in the second year, and the
finalized value in the third year. As we describe in section II.H.2. of
this final rule with comment period, our misvalued code process has
been to establish interim final RVUs for the potentially misvalued,
new, and revised codes 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 accept public comment about those
valuations. For the final rule with comment period for the subsequent
year, we consider and respond to public comments received on the
interim final values, and make any appropriate adjustments to values
based on those comments. However, the calculation of the target would
only compare changes between 2 years and not among 3 years, so the
contribution of a particular change towards the target for any single
year would be measured against only the preceding year without regard
to the overall change that takes place over 3 years.
For recent years, interim final values for misvalued codes (year 2)
have generally reflected reductions relative to original values (year
1), and for most codes, the interim final values (year 2)
[[Page 70923]]
are maintained and finalized (year 3). However, when values for
particular codes have changed between the interim final (year 2) and
final values (year 3) based on public comment, the general tendency has
been that codes increase in the final value (year 3) relative to the
interim final value (year 2), even in cases where the final value (year
3) represents a decrease from the original value (year 1). Therefore,
for these codes, the year 2 changes compared to year 1 would risk over-
representing the overall reduction, while the year 3 to year 2 changes
would represent an increase in value. If there were similar targets in
every PFS year, and a similar number of misvalued code changes made on
an interim final basis, the incongruence in measuring what is really a
3-year change in 2-year increments might not be particularly
problematic since each year's calculation would presumably include a
similar number of codes measured between years 1 and 2 and years 2 and
3.
However, including changes that take place over 3 years generates
challenges in calculating the target for CY 2016 for two reasons.
First, CY 2015 was the final full year of establishing interim final
values for all new, revised, and potentially misvalued codes. Starting
with this final rule with comment period, we are finalizing values for
a significant portion of misvalued codes during one calendar year.
Therefore, CY 2015 will include a significant number of services that
would be measured between years 2 and 3 relative to the services
measured between 1 and 2 years. Second, because there was no target for
CY 2015, any reductions that occurred on an interim final basis for CY
2015 were not counted toward achievement of a target. If we were to
include any upward adjustments made to these codes based on public
comment as ``misvalued code'' changes for CY 2016, we would effectively
be counting the service-level increases for 2016 (year 3) relative to
2015 (year 2) against achievement of the target without any
consideration to the service-level changes relative to 2014 (year 1),
even in cases where the overall change in valuation was negative.
Therefore, we proposed to exclude code-level input changes for CY
2015 interim final values from the calculation of the CY 2016 misvalued
code target since the misvalued change occurred over multiple years,
including years not applicable to the misvalued code target provision.
We note that the impact of interim final values in the calculation
of targets for future years will be diminished as we transition to
proposing values for almost all new, revised, and potentially misvalued
codes in the proposed rule. We anticipate a smaller number of interim
final values for CY 2016 relative to CY 2015. For calculation of the CY
2018 target, we anticipate almost no impact based on misvalued code
adjustments that occur over multiple years.
The list of codes with changes for CY 2016 included under this
definition of ``adjustments to RVUs for misvalued codes'' is available
on the CMS Web site under downloads for the CY 2016 PFS final rule with
comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
The following is a summary of the comments we received regarding
this aspect of the proposal to implement the statutory provision:
Comment: Several commenters, including the RUC, supported CMS'
proposal to include all services that receive revised input values even
if the specific codes were not identified on a misvalued services list
for review; the commenters' stated that this is a reasonable and fair
approach.
Response: We appreciate the commenters' feedback and support.
Comment: A few commenters stated that the selection of codes to be
included for review beyond the codes identified by the screens should
be determined by the pertinent specialty societies as they are the best
determiners of which codes make up a family of codes. Another commenter
stated that CMS should include the E/M services in the list of codes
that are potentially misvalued.
Response: We note that the process for selection of codes to be
reviewed as potentially misvalued is addressed in section II.H. of this
final rule with comment period and has also been addressed in prior
rulemaking. Our proposal to implement section 1848(c)(2)(O) of the Act
does not address how codes are identified to be reviewed under the
misvalued code initiative. Instead, it addresses how to identify the
changes in expenditures that result from such reviews in the
calculation of the target amount.
Comment: Several commenters, including the RUC, also supported CMS'
proposal to exclude code level input changes for CY 2015 interim final
values from the calculation of the target. The commenters concur that
the year 2 and year 3 changes in values represent an incomplete picture
of the redistributive effects for a particular year resulting from the
review of the misvalued services, and the vast majority of
redistribution happens between year 1 and year 2.
Response: We appreciate the commenters' support and feedback.
Comment: One commenter disagreed with CMS' proposal to exclude
code-level input changes for 2015 interim final values stating that it
means organized medicine does not get credit for any net decreases
associated with such codes and is therefore being penalized. The
commenter requested that CMS consider including 2015 interim final
values in the calculation of the 2016 misvalued code target even though
the misvalued change occurred over multiple years. Another commenter
stated that the proposed net reduction in expenditures of 0.25 percent,
as opposed to 1.00, means that the 0.75 percent difference will come
from the conversion factor, and doing so would more than negate the 0.5
percent increase physicians were promised under MACRA, and therefore
the commenter requested that CMS help mitigate this result by including
2015 interim final values in the calculation of the target.
Response: With regard to the commenters who disagreed with the
exclusion of code-level input changes for 2015 interim final values, we
cannot determine if the commenters intended to suggest that CMS was not
including decreases that would help towards the achievement of the
misvalued code target by excluding changes for 2015 interim final
values, or that CMS should include the changes between years 1 and 3.
As stated in the CY 2016 proposed rule (80 FR 41712 through 41713),
when values for particular codes have changed between the interim final
(year 2) and final values (year 3) based on public comment, the general
tendency has been that code values increase in the final value (year 3)
relative to the interim final value (year 2), even in cases where the
final value (year 3) represents a decrease from the original value
(year 1). Additionally, the statute requires comparison between 2
years, and therefore, we do not believe we have the authority to
include changes between year 1 and year 3. Since our remaining options
were to include changes between year 2 and year 3 which, as indicated
above, generally results in an increase, or to exclude code-level input
changes for CY 2015 interim final values, and the commenters express
interest in moving closer to achievement of the target, we do not
believe it would be in the commenters' interest to include the changes
between years 2 and 3.
[[Page 70924]]
With regard to the commenter who stated that the net reduction in
expenditures under the PFS if CMS does not achieve the target reduction
would negate the 0.5 percent increase physicians were promised under
MACRA, we note that both of these provisions continue to apply under
current law.
Comment: Some commenters, including the RUC, suggested that CMS
should be sure to include existing codes that are either being deleted
or will have utilization changes as a result of the misvalued code
project and/or the CPT Editorial Panel process. Another commenter
stated that CMS was excluding existing codes with large volume changes,
and recommended that such codes be included in the calculation of the
target. Some commenters recommended that CMS conduct a procedure-to-
procedure comparison and then calculate the net reduction in RVUs,
including the values of new and deleted CPT codes prompted by the
misvalued code initiative. The commenters stated that this is an area
where the specialty societies and CMS need to work together to
determine the comparisons for calculating the net reduction.
Response: We agree that changes in coding often contribute to
improved valuation of PFS services. We note that we included these
changes in our methodology in the proposed rule and explained that we
would include services directly affected by changes to coding for
related services. We did not propose to exclude existing codes with
large volume changes; changes for such codes have been included. To
clarify, we are including changes in values for any codes for which
changes in coding or policies may result in differences in how a given
service is reported from one year to the next. Under our current
ratesetting methodologies, we already consider how coding revisions
change the way services are reported from one year to the next. The
crosswalk we use to incorporate such changes in our methodology is
based on RUC and specialty society recommendations that explicitly
address the kinds of procedure-to-procedure comparisons suggested by
the commenter. This file is available in the ``downloads'' section of
the PFS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html
under ``Analytic Crosswalk from CY 2015 to CY 2016.'' Since it reflects
the best information available, we used the same crosswalk to account
for coding changes in the calculation of the target. We also refer
readers to the list of HCPCS defined as misvalued for purposes of the
target which is available on the CMS Web site under downloads for the
CY 2016 PFS final rule with comment period.
Comment: One commenter recommended that CMS include the review of
all individual codes and broader adjustments across the PFS, as this
would more accurately represent the total revaluations.
Response: As we explained in the proposed rule, our goal is to
include the review of all individual codes and changes to inputs for
additional codes where changes can be measured between two years.
Because PFS payments are developed under the statutory requirements of
relativity and budget neutrality, including all adjustments to all
codes would necessarily result in a net of zero.
Comment: A few commenters raised objections to the statutory
provision. For example, one commenter stated that the legislation is
penalizing physicians and other healthcare professionals for already
having taken on the task of identifying and revaluating potentially
misvalued codes over the past 10 years. Other commenters stated that
since the RUC and specialty societies have been addressing potentially
misvalued codes since 2006, there should be a way to include
revaluations made back to 2006 in the calculation of the target.
Another commenter stated that CMS should hold primary care and E/M
services harmless in this process, since these services are not over-
valued but rather under-valued. One commenter requested more time to
evaluate the proposed process to identify yearly targets, and
encouraged CMS to work with the AMA to discuss this issue at future RUC
Panel meetings prior to implementing the provision. One commenter
requested that CMS review its approach to determine if there are other
methods that will come closer to reaching the target. One commenter
stated that this new requirement creates a potential incentive to
target codes that offer the greatest likelihood of savings, not those
that are actually misvalued.
Response: We appreciate the commenters' feedback and have
considered these concerns to the extent possible in light of the
requirements of section 1848(c)(2)(O) of the Act.
After consideration of the public comments received, we are
finalizing the approach of defining the reduction in expenditures as a
result of adjustments to RVUs for misvalued codes to include the
estimated pool of all services with revised input values, including any
codes for which changes in coding or policies might result in
differences in how a given service is reported from one year to the
next. We are also finalizing our proposal to exclude code-level input
changes for CY 2015 interim final values from the calculation of the CY
2016 misvalued code target. After considering all comments, we continue
to believe this approach is appropriate and compliant with statutory
directives.
2. Calculating ``Net Reduction''
Once the RVU adjustments attributable to misvalued codes are
identified, estimated net reductions in PFS expenditures resulting from
those adjustments would be calculated by determining the sum of all
decreases and offsetting them against any applicable increases in
valuation within the changes that we defined as misvalued, as described
above. Because section 1848(c)(2)(O)(i) of the Act only explicitly
addresses reductions in expenditures, and we recognize that many
stakeholders will want to maximize the overall magnitude of the
measured reductions in order to prevent an overall reduction to the PFS
conversion factor, we considered the possibility of ignoring the
applicable increases in valuation in the calculation of net reduction.
However, we believe that the requirement to calculate ``net''
reductions implies that we are to take into consideration both
decreases and increases. Additionally, we believe this approach may be
the only practical one due to the presence of new and deleted codes on
an annual basis.
For example, a service that is described by a single code in a
given year, like intensity-modulated radiation therapy (IMRT) treatment
delivery, could be addressed as a misvalued service in a subsequent
year through a coding revision that splits the service into two codes,
``simple'' and ``complex.'' If we counted only the reductions in RVUs,
we would count only the change in value between the single code and the
new code that describes the ``simple'' treatment delivery code. In this
scenario, the change in value from the single code to the new
``complex'' treatment delivery code would be ignored, so that even if
there were an increase in the payment for IMRT treatment delivery
service(s) overall, the mere change in coding would contribute
inappropriately to a ``net reduction in expenditures.'' Therefore, we
proposed to net the increases and decreases in values for services,
including those for which there are coding revisions, in calculating
the estimated net reduction in expenditures as a result of adjustments
to RVUs for misvalued codes.
[[Page 70925]]
The following is a summary of the comments we received regarding
our proposal.
Comment: One commenter stated that the proposal for calculating net
reduction is consistent with the plain reading of the statute.
Response: We appreciate the commenter's feedback and support.
Comment: Several commenters, including the RUC, requested that CMS
use a more transparent process for calculation of the target,
suggesting that the discussion in the CY 2016 PFS proposed rule was not
sufficiently detailed to allow for replication by external
stakeholders. Commenters requested that CMS provide a comprehensive
methodological description of how CMS will calculate the target,
including publication of dollar figure estimates, and information about
individual service level estimated impacts on the net reduction.
Commenters further requested that we provide the impact on the net
reduction either per CPT code, or that we identify a family of services
and publish a combined impact for that family. Another commenter
expressed concern with how CMS will operationalize this policy, noting
that the language in the CY 2016 PFS proposed rule did not outline
where the adjustments would be made. The commenter further questioned
how CMS planned to track the ``savings'' from the revaluation of
services, and requested that CMS clarify how new technology will be
handled, as well as new codes that are a restructuring of existing
codes.
Response: We appreciate the commenters' feedback. In response to
the request for greater transparency, we have posted a public use file
that provides a comprehensive description of how the target is
calculated as well as the estimated impact by code family on the CMS
Web site under the supporting data files for the CY 2016 PFS final rule
at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
In response to the commenter who asked for clarification on how new
technology will be handled, we assume the commenter intends to ask
about how new codes for new services would be addressed under our
proposed methodology. Under our proposal, we would include adjustments
to values for all deleted, new, and revised codes under our
calculations of changes from one year to the next. We would also weight
the changes in the values for those codes by the utilization for those
services in order to calculate the net reduction in expenditures. If a
new code describes a new service (new technology as opposed to recoding
of an existing service), then there would be no utilization for that
code in the calculation. Without utilization, the value for a new
service would have no impact on the calculation of the target. In
response to the commenter who expressed concern about how CMS would
operationalize this policy, and stated that CMS did not explain where
the adjustments would be, we note that if the estimated net reduction
in expenditures is less than the target for the year, then there would
be an overall reduction to the PFS conversion factor as described in
section VI. of this final rule with comment period.
Comment: One commenter disagreed that all increases should be
incorporated into the net reduction calculation and requested that CMS
consider an approach that would maximize the overall magnitude of the
measured reductions in order to prevent an overall reduction to the PFS
conversion factor as a result of failure to achieve the target for
reductions. Specifically, the commenter stated that codes identified as
potentially misvalued for which there is compelling evidence based on
the RUC recommendations to support an increase in RVUs based on a
change in work should not be defined as misvalued for the purposes of
calculating the target.
Response: We believe the requirement that we calculate the net
reduction in expenditures indicates that we must account for
adjustments in values including both increases and decreases and
therefore, believe our proposal comports with the plain reading of the
statute. We recognize that the RUC internal deliberations include rules
that govern under what circumstances individual specialties can request
that the RUC recommend CMS increase values for particular services. As
observers to the RUC process, we appreciate having an understanding of
these rules in the context of our review of RUC-recommended values.
However, we do not believe that the internal RUC standards for
developing recommendations are relevant in determining whether the
statutory provision applies to adjustments to values for individual
codes.
Comment: Some commenters requested that CMS review its
administrative authority to achieve a target recapture amount in a
selective manner, rather than by an across-the-board adjustment to the
conversion factor. A commenter stated that codes already sustaining
reductions in 2016, and consequently contributing to the target, should
not be subjected to additional across-the-board cuts to achieve the
statutory target.
Response: We do not believe that section 1848(c)(2)(O)(iii) of the
Act provides us authority to insulate particular services from the
effects of the budget neutrality adjustment for the target recapture
amount that is required if the estimated net reduction in expenditures
is less than the target for the year. The statute specifies that an
amount equal to the target recapture amount is not to be taken into
account in applying the PFS budget neutrality requirement under section
1848(c)(2)(B)(ii)(II) of the Act. This PFS budget neutrality adjustment
has been in place since the outset of the PFS, and we have consistently
interpreted and implemented it as an adjustment that is made across the
entire PFS. Therefore, we do not believe we can apply the budget
neutrality adjustments in a selective manner.
Comment: Several commenters, including the RUC, stated that when
considering the net impact of service-level input changes in a given
year, it is important for CMS to understand specific scenarios in which
codes under review should not be included in the net reduction target
calculation. The commenters requested that CMS not include particular
payment initiatives, such as Advance Care Planning (ACP), in the target
definition. Instead, since the payment rates for these services require
budget neutrality and relativity adjustments to all other PFS services
and these reductions are not otherwise accounted for in the target
calculation, CMS should count the payments for ACP services as
``redistribution'' (or, in other words, reductions) from other services
for CY 2016. Commenters urged CMS to use the same approach for care
management services valued under the PFS in the future. Generally, the
commenters stated that these and similar new codes could not possibly
be misvalued and therefore, should not only be excluded from the
target, but the reductions to other services due to separate payment
for these services should be counted as net reductions toward
achievement of the misvalued code target.
Response: Because we believe that all of our intended revaluations
of services under the PFS are intended to improve the accuracy of the
relative value units for PFS services, we do not believe we should
exclude increases and decreases to particular services in the target
calculation. Therefore, we do not agree with commenters' suggestions
that codes describing one kind of service (e.g. care management) as
opposed to another (for example, procedures or
[[Page 70926]]
diagnostic tests) should be excluded from the target under the
statutory provision. Similarly, we do not agree that counting the
relativity and budget neutrality redistributions that result from care
management services as part of the net ``reduction'' would be
consistent with a reasonable understanding of ``net reduction'' in
allowed expenditures as a result of changes to misvalued codes.
However, in considering the points raised by commenters, we do
agree that the increases in value for new codes like ACP or Chronic
Care Management (CCM) are not the same as increases to other services.
In general, new codes describe new services that would not have been
reported with particular codes in the previous years or new codes
describe existing services that were reported using other codes in the
prior year. In other cases, however, new codes describe services that
were previously included in the payment for other codes. When those
services become separately payable through new codes, we generally make
adjustments to other relevant codes to adjust for the value of the
services that will be separately reported. In general, new codes
describing care management services fall into this latter category,
since the associated resource costs for these services were previously
bundled into payment for other services. However, unlike many other PFS
services, the resource costs for these kinds of services were bundled
into a set of broadly reported E/M codes and services that include E/M
visits. Since these codes are so broadly reported across nearly all PFS
specialties, to the extent that it would be impracticable to make
adjustments to individual codes, we have not made corresponding
adjustments to E/M visits to account for the status of the new codes as
separately billable. Instead, when unbundling new separately reported
services such as these, we have allowed our general budget neutrality
adjustment to account for these types of changes, since budget
neutrality adjustments apply broadly to the full range of PFS services,
including both codes that specifically describe E/M visits and those
with E/M services as components of the service, such as all codes with
global periods. In terms of calculating the net reduction in
expenditures for purposes of section 1848(c)(2)(O)(i) of the Act, this
means that the shift in payment to these new separately reportable
services, unlike the adjustments to values for other new services, is
not offset by adjustments to any other individual codes. Therefore,
under the methodology we proposed, the increase in payment for these
new separately reportable services would be counted in the net
reduction calculations since the adjustments to values for these
services are reflected in values for individual codes, but the
corresponding decreases would not be counted, since the corresponding
decreases are not attributable to any particular codes. Under the
methodology we proposed, the change to make these types of codes
separately reported would be counted against achievement of the target
even though the increases in value for these codes are fully offset by
budget-neutrality adjustments to all other PFS services.
As we have reflected on the comments and on this particular
circumstance, we do not believe that the change to separate payment for
these kinds of services should be counted as increases that are
included in calculating the ``net reductions'' in expenditures
attributable to adjustments for misvalued codes. Instead, we think that
the adjustments to value these services should be considered in the
context of the budget neutrality adjustments that are applied broadly
to PFS services. This would be consistent with our treatment of the
increase in values for other new codes since the reductions or deletion
of predecessor codes are counted as offsets in our calculation. Since,
under the established ratesetting methodology, the increases in new
separately reportable services and the corresponding budget neutrality
decreases fully offset one another and net to zero, we believe that the
easiest way to account for the adjustments associated with valuing
these services is to exclude altogether the changes for these types of
codes from the list of codes included in the target. This will
effectively make the creation and valuation of such codes neutral in
the calculation of the misvalued code target.
After considering public comments, we are finalizing our policy as
proposed with a modification to exclude from the calculation of the
``net reduction'' in expenditures changes in coding and valuation for
services, such as ACP for CY 2016, that are newly reportable, but for
which no corresponding reduction is made to existing codes and instead
reductions are taken exclusively through a budget neutrality
adjustment.
3. Measuring the Adjustments
The most straightforward method to estimating the net reduction in
expenditures due to adjustments to RVUs for misvalued codes is to
compare the total RVUs of the relevant set of codes (by volume) in the
current year to the update year, and divide that by the total RVUs for
all codes (by volume) for the current year. This approach had the
advantage of being intuitive and readily replicable.
However, there are several issues related to the potential
imprecision of this method. First, and most significantly, the code-
level PE RVUs in the update year include either increases due to the
redistribution of RVUs from other services or reductions due to
increases in PE for other services. Second, because relativity for work
RVUs is maintained through annual adjustments to the CF, the precise
value of a work RVU in any given year is adjusted based on the total
number of work RVUs in that year. Finally, relativity for the MP RVUs
is maintained by both redistribution of MP RVUs and adjustments to the
CF, when necessary (under our proposed methodology this is true
annually; based on our established methodology the redistribution of
the MP RVUs only takes place once every 5 years and the CF is adjusted
otherwise). Therefore, to make a more precise assessment of the net
reduction in expenditures that are the result of adjustments to the
RVUs for misvalued codes, we would need to compare, for the included
codes, the update year's total work RVUs (by volume), direct PE RVUs
(by volume), indirect PE RVUs (by volume), and MP RVUs (by volume) to
the same RVUs in the current year, prior to the application of any
scaling factors or adjustments. This would make for a direct comparison
between years.
However, this approach would mean that the calculation of the net
reduction in expenditures would occur within various steps of the PFS
ratesetting methodology. Although we believe that this approach would
be transparent and external stakeholders could replicate this method,
it might be difficult and time-consuming for stakeholders to do so. We
also noted that when we modeled the interaction of the statutory phase-
in requirement under section 220(e) of the PAMA and the calculation of
the target using this approach during the development of this proposal,
there were methodological challenges in making these calculations. When
we simulated the two approaches using information from prior years, we
found that both approaches generally resulted in similar estimated net
reductions. After considering these options, we proposed to use the
simpler approach of comparing the total RVUs (by volume) for the
relevant set of codes in the current year to the update year, and
divide that result by the total RVUs (by volume) for the current year.
We solicited comments on whether
[[Page 70927]]
comparing the update year's work RVUs, direct PE RVUs, indirect PE
RVUs, and MP RVUs for the relevant set of codes (by volume) prior to
the application of any scaling factors or adjustments to those of the
current year would be a preferable methodology for determining the
estimated net reduction.
The following is a summary of the comments we received regarding
our proposal.
Comment: A few commenters supported CMS' selection of the simpler
formula to calculate the target over the more precise but more complex
formula since it is simpler and easier to understand. One commenter
stated that CMS did not indicate exactly how similar the two proposals
are or which method estimated the larger reduction, and stated that CMS
should make this information available in the final rule and consider
revising the approach in CY 2017 rulemaking and use the method that
results in the larger reduction.
Response: We do not agree that CMS should do both calculations and
determine which to use based solely on which results in the higher
amount. We note that the target for net reductions in expenditures from
adjustments to values for misvalued codes is a multi-year provision and
we believe neither of the two methodologies is assured to produce a
consistently higher result from year to year. Since the majority of
commenters agree that the more intuitive approach to estimating the net
reduction in expenditures is preferable to the more precisely accurate
approach, we are finalizing our approach as proposed.
Comment: One commenter requested that CMS count the full reduction
in payment for codes subject to the phase-in required under section
1848(c)(7) of the Act as discussed in section II.F. of this final rule
with comment period, toward the target in the first year. Another
commenter stated that CMS used the fully reduced RVUs in calculating
the target, not the first year phase-in RVUs, and therefore, CMS should
include the full impact of the change in the equipment utilization rate
for linear accelerators toward the target calculation. Similarly, the
commenter requested that any future multi-year phase-in proposals
should similarly be counted toward the target in the first year.
Response: The target provision requires the calculation of an
estimated net reduction measure between 2 years of PFS expenditures. As
we have detailed in the above paragraphs, we believe that under certain
specific circumstances, changes should be excluded from that estimate;
but we do not believe we can include changes that would occur in future
years based solely on the rulemaking cycle during which policies are
established. Therefore we will not count the full reduction in payment
for codes that are subject to the phase-in toward the calculation of
the net reduction in expenditures for the first year. With regard to
the commenter that stated that CMS used the fully reduced RVUs in
calculating the target, we note that we only used the first year phase-
in RVUs and, for the reasons stated above, believe that we are limited
to including only the changes in the immediate year in the calculation
of the target.
After consideration of the public comments received, we are
finalizing the policy to calculate the net reduction using the simpler
method as proposed.
4. Target Achievement for CY 2016
We refer readers to the regulatory impact analysis section of this
final rule with comment period for our final estimate of the net
reduction in expenditures relative to the 1 percent target for CY 2016,
and the resulting adjustment required to be made to the conversion
factor. Additionally, we refer readers to the public use file that
provides a comprehensive description of how the target is calculated as
well as the estimated impact by code family on the CMS Web site under
the supporting data files for the CY 2016 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
F. Phase-In of Significant RVU Reductions
Section 1848(c)(7) of the Act, as added by section 220(e) of the
PAMA, also 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. Although section
220(e) of the PAMA required the phase-in to begin for 2017, section 202
of the ABLE Act amended section 1848(c)(7) of the Act to require that
the phase-in begin for CY 2016.
In the CY 2016 PFS proposed rule, we proposed a methodology to
implement this statutory provision. In developing this methodology, we
identified several aspects of our approach for which we specifically
solicited comments, given the challenges inherent in implementing this
provision in a manner consistent with the broader statutory construct
of the PFS. We organized this discussion by identifying and explaining
these aspects in particular but we solicited comments on all aspects of
our proposal.
1. Identifying Services That Are Not New or Revised Codes
As described in this final rule with comment period, the statute
specifies that services described by new or revised codes are not
subject to the phase-in of RVUs. We believe this exclusion recognizes
the reality that there is no practical way to phase-in changes to RVUs
that occur as a result of a coding change for a particular service over
2 years because there is no relevant reference code or value on which
to base the transition. To determine which services are described by
new or revised codes for purposes of the phase-in provision, we
proposed to apply the phase-in to all services that are described by
the same, unrevised code in both the current and update year, and to
exclude codes that describe different services in the current and
update year. This approach excludes services described by new codes or
existing codes for which the descriptors were altered substantially for
the update year to change the services that are reported using the
code. We also are excluding as new and revised codes those codes that
describe a different set of services in the update year when compared
to the current year by virtue of changes in other, related codes, or
codes that are part of a family with significant coding revisions. For
example, 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 would also help 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. This application of the phase-in
is also consistent with previous RVU transitions, especially for PE
RVUs, for which we only applied transition values to those codes that
described the same service in both the current and the update years. We
also excluded from the phase-in as new and revised codes those codes
with changes to the global period, since the code in the current year
would not describe the
[[Page 70928]]
same units of service as the code in the update year.
We received few comments regarding this aspect of our proposal, and
some of the comments suggested changes that would require changes to
the statutory provision that requires the phase-in of significant
changes in RVUs. The following is a summary of the comments that we
received.
Comment: One commenter agreed with CMS' broad definition of new or
revised.
Response: We appreciate the commenter's feedback and support.
Comment: One commenter did not agree that new and revised services
should be excluded from the phase-in, and suggested that the phase-in
be applied more broadly.
Response: Section 1848(c)(7) of the Act specifies that services
described by new or revised codes are not subject to the phase-in of
significant reductions in RVUs. Additionally, because RVUs are assigned
to individual codes, we do not believe there would be a straightforward
or transparent way to phase in reductions for services that are
described by new or revised codes between the years for which a phase-
in would apply.
Comment: One commenter urged CMS to include in the phase-in codes
that had interim Final values for CY 2015 and have substantial
reductions of 20 percent or greater as compared to the 2014 values.
Response: We do not believe it would be consistent with the
statutory provision to phase in changes in values between 2015 and 2016
based on 2014 values. Section 1848(c)(7) of the Act, as amended,
specifies that the phase-in of significant reductions in values begins
for fee schedules established beginning with 2016.
Comment: One commenter stated that any code that has a decrease in
value of over 20 percent due to repricing of expensive supplies (for
example, over $500) should be excluded from the phase-in provision.
Response: We appreciate the commenter's feedback and understand the
rationale for the request; however, we do not believe that we have the
discretion to exempt codes from the phase-in, regardless of the reason
for the reduction.
After consideration of the public comments received on this aspect
of our proposal to implement the phase-in of significant changes in
RVUs, we are finalizing the implementation of the phase-in for
significant (20 percent or greater) reductions in RVUs as proposed.
2. Estimating the 20 Percent Threshold
Because the phase-in of significant reductions in RVUs falls within
the budget neutrality requirements specified in section
1848(c)(2)(B)(ii)(II) of the Act, we proposed to estimate total RVUs
for a service prior to the budget-neutrality redistributions that
result from implementing phase-in values. We recognize that the result
of this approach could mean that some codes may not qualify for the
phase-in despite a reduction in RVUs that is ultimately slightly
greater than 20 percent due to budget neutrality adjustments that are
made after identifying the codes that meet the threshold in order to
reflect the phase-in values for other codes. We believe the only
alternative to this approach is not practicable, since it would be
circular, resulting in cyclical iteration.
The following is a summary of the comments we received regarding
this proposal.
Comment: One commenter supported CMS' proposal for estimating the
20 percent threshold.
Response: We appreciate the commenter's support.
Comment: Another commenter did not agree with the proposal to
estimate total RVUs for a service prior to the budget-neutrality
redistributions that result from implementing phase-in values. The
commenter stated that the methodology should not give inequitable
treatment to any particular specialty, and instead it should apply to
all codes that are cut greater than 20 percent in the final analysis.
Response: We appreciate that our proposed methodology could, in the
end, result in no phase-in for some codes that ultimately do have a 20
percent or greater reduction in value after application of required
budget neutrality adjustment. However, we have no reason to believe
that this situation, resulting from using initial unadjusted RVUs to
identify significant RVU reductions, would disadvantage one specialty
more than the next. Therefore, we also do not believe that our proposed
approach is likely to result in unequitable treatment to any one
specialty over another.
After consideration of the public comments received on this aspect
of our proposal, we are finalizing without modification our proposal to
identify significant reductions in RVUs based on a comparison of RVUs
before application of budget neutrality adjustment.
3. RVUs in the First Year of the Phase-In
Section 1848(c)(7) of the Act states that the applicable
adjustments in work, PE, and MP RVUs shall be phased-in over a 2-year
period when the RVU reduction for a code is estimated to be equal to or
greater than 20 percent. We believe that there are two reasonable ways
to determine the portion of the reduction to be phase-in for the first
year. Most recent RVU transitions have distributed the values evenly
across several years. For example, for a 2-year transition we would
estimate the fully implemented value and set a rate approximately 50
percent between the value for the current year and the value for the
update year. We believe that this is the most intuitive approach to the
phase-in and is likely the expectation for many stakeholders. However,
we believe that the 50 percent phase-in in the first year has a
significant drawback. For instance, since the statute establishes a 20
percent threshold as the trigger for phasing in the change in RVUs,
under the 50 percent phase-in approach, a service that is estimated to
be reduced by a total of 19 percent for an update year would be reduced
by a full 19 percent in that update year, while a service that is
estimated to be reduced by 20 percent in an update year would only be
reduced 10 percent in that update year.
The logical alternative approach is to consider a 19 percent
reduction as the maximum 1-year reduction for any service not described
by a new or revised code. This approach would be to reduce the service
by the maximum allowed amount (that is, 19 percent) in the first year,
and then phase in the remainder of the reduction in the second year.
Under this approach, the code that is reduced by 19 percent in a year
and the code that would otherwise have been reduced by 20 percent would
both be reduced by 19 percent in the first year, and the latter code
would see an additional 1 percent reduction in the second year of the
phase-in. For most services, this would likely mean that the majority
of the reduction would take place in the first year of the phase-in.
However, for services with the most drastic reductions (greater than 40
percent), the majority of the reduction would not take place in the
first year of the phase-in.
After considering both of these options, we proposed to consider
the 19 percent reduction as the maximum 1-year reduction and to phase-
in any remaining reduction greater than 19 percent in the second year
of the phase-in. We believe that this approach is
[[Page 70929]]
more equitable for codes with significant reductions but that are less
than 20 percent. We solicited comments on this proposal.
The following is a summary of the comments we received regarding
this proposal.
Comment: Several commenters supported CMS' proposal to consider the
19 percent reduction as the maximum 1-year reduction and to phase in
any remaining reduction greater than 19 percent in the second year of
the phase-in.
Response: We appreciate the commenters' feedback and support.
Comment: Several commenters did not support CMS' proposal, and
instead stated that CMS should spread the transition evenly over both
years--meaning a 50 percent phase-in for year one and year two. One
commenter stated that this would lead to a more equitable payment
system and allow physicians more time to make changes in their
practices to accommodate for reductions. Another commenter acknowledged
that codes with reductions that are less than 20 percent and not
phased-in may experience greater reductions in the first year, however
the commenter stated that a more gradual phase-in for practices facing
steeper cuts should be the paramount principle for any policy to
transition cuts at or greater than 20 percent.
Response: We have considered the comments and understand the
commenters' concerns. We acknowledge some commenters' views that the
gradual phase-in of reductions for services that would experience
reductions above the threshold (20 percent) is an important principle
in determining the best way to implement the phase-in provision.
However, we note that the 19 percent reduction maximum also has the
advantage of applying the most gradual reduction to services with the
greatest reductions (greater than 40 percent). Furthermore, we remain
concerned about several practical problems that could arise from
utilizing the 50 percent approach. The first of these problems would
occur whenever some codes within the same family of services would meet
threshold reductions while others do not. For example if two codes in a
four code family would be reduced by an estimated 20 percent while the
other two were estimated to be reduced by 19 percent, then the first
two would be reduced by 10 percent while the remaining two would be
reduced by 19 percent. Such a scenario could easily create rank order
anomalies within families of codes. The risks of such anomalies is
associated with the financial incentives toward inaccurate downward
coding that could not only jeopardize Medicare claims data as an
accurate source of information, but more directly could have serious
consequences within our ratesetting methodologies for both purposes of
budget neutrality and for allocation of PE and MP RVUs. The second
practical issue with the 50 percent approach would be that the impact
of using the estimated reduction instead of the final reduction to
determine whether or not particular codes qualify for the phase-in
would be significant. Under the 19 percent approach, values for codes
with reductions estimated to be very close to 19 percent would be
similar regardless of whether or not we engage in various iterations of
budget neutrality adjustments to determine whether or not the phase-in
applies. Under the 50 percent approach, determinations that result from
repeated iterations of ratesetting calculations and budget neutrality
adjustments could decide significant changes in the rates for
individual codes (up to 10 percent of the total payment.)
In order to avoid these circumstances and apply the most gradual
phase-in possible to codes with the most significant reductions, we
continue to believe that a 19 percent reduction as the maximum 1-year
reduction is the better approach to determining the phase-in amount.
Comment: One commenter requested that the phase-in period be
extended to a greater number of years when entire code groupings are
impacted, and when multiple codes are identified within a code grouping
and they significantly impact revenue to a specialist or specific
provider.
Response: The statute specifies a 2-year phase-in period and does
not provide authority to extend the phase-in period as described by the
commenter.
After consideration of the comments, we are finalizing the policy
to phase in 19 percent of the reduction in value in the first year, and
the remainder of the reduction in the second year, as proposed.
4. Applicable Adjustments to RVUs
Section 1848(c)(7) of the Act provides that the applicable
adjustments in work, PE, and MP RVUs be phased-in over 2 years for any
service for which total RVUs would otherwise be decreased by an
estimated amount equal to or greater than 20 percent as compared to the
total RVUs for the previous year. However, for several thousand
services, we develop separate RVUs for facility and nonfacility sites
of service. For nearly one thousand other services, we develop separate
RVUs for the professional and technical components of the service, and
sum those RVUs for global billing. Therefore, for individual
practitioners furnishing particular services to Medicare beneficiaries,
the relevant changes in RVUs for a particular code are based on the
total RVUs for a code for a particular setting (facility/nonfacility)
or for a particular professional/technical (PC/TC) component. We
believe the most straightforward and fair approach to addressing both
the site of service differential and the codes with professional and
technical components is to consider the RVUs for the different sites of
service and components independently for purposes of identifying when
and how the phase-in applies. We proposed, therefore, to estimate
whether a particular code met the 20 percent threshold for change in
total RVUs by taking into account the total RVUs that apply to a
particular setting, or to a particular professional or technical
component. This would mean that if the change in total facility RVUs
for a code met the threshold, then that change would be phased in over
2 years, even if the change for the total nonfacility RVUs for the same
code would not be phased in over 2 years. Similarly, if the change in
the total RVUs for the technical component of a service meets the 20
percent threshold, then that change would be phased in over 2 years,
even if the change for the professional component did not meet the
threshold. (Because the global is the sum of the professional and
technical components, the portion of the global attributable to the
technical component would then be phased-in, while the portion
attributable to the professional component would not be.)
However, we note that we create the site of service differential
exclusively by developing independent PE RVUs for each service in the
nonfacility and facility settings. That is, for these codes, we use the
same work RVUs and MP RVUs in both settings and vary only the PE RVUs
to implement the difference in resources depending on the setting.
Similarly, we use the work RVUs assigned to the professional component
codes as the work RVUs for the service when billed globally. Like the
codes with the site of service differential, the PE RVUs for each
component are developed independently. The resulting PE RVUs are then
summed for use as the PE RVUs for the code, billed globally. Since
variation of PE RVUs is the only constant across all individual codes,
[[Page 70930]]
codes with site of service differentials, and codes with professional
and technical components, we are proposing to apply all adjustments for
the phase-in to the PE RVUs.
We considered alternatives to this approach. For example, for codes
with a site of service differential, we considered applying a phase-in
for codes in both settings (and all components) whenever the total RVUs
in either setting reached the 20 percent threshold. However, there are
cases where the total RVUs for a code in one setting (or one component)
may reach the 20 percent reduction threshold, while the total RVUs for
the other setting (or other component) are increasing. In those cases,
applying phase-in values for work or MP RVUs would mean applying an
additional increase in total RVUs for particular services. We also
considered implementing the phase-in of the RVUs for the component
codes billed globally by comparing the global value in the prior year
versus the global value in the current year and applying the phase-in
to the global value for the current year and letting the results flow
through to the PC and TC for each code, irrespective of their
respective changes in value. Similarly, for the codes with site of
service differentials, we considered developing an overall, blended set
of overall PE RVUs using a weighted average of site of service volume
in the Medicare claims data and then comparing that blended value in
the prior year versus the blended value in the current year and
applying the phase-in to the value for the current year before re-
allocating the blended value to the respective PE RVUs in each setting,
regardless of the changes in value for nonfacility or facility values.
We did not pursue this approach for several reasons. First, the
resulting phase-in amounts would not relate logically to the values
paid to any individual practitioner, except those who bill the PC/TC
codes globally. Second, the approach would be so administratively
complicated that it would likely be difficult to replicate or predict.
Therefore, we have concluded that applying the adjustments to the
PE RVUs for all individual codes in order to effect the appropriate
phase-in amount is the most straightforward and fair approach to
implementing the 2-year phase-in of significant reductions of total
RVUs.
The following is a summary of the comments we received regarding
this proposal.
Comment: One commenter requested that CMS confirm that it would
apply all adjustments for the phase-in to the PE RVUs only in
situations in which just one site of service, or just one component is
subject to the phase-in. That is, if both sites of service or both
components of a code were subject to the phase-in, then any adjustments
would be applied to work and malpractice RVUs as well.
Response: As discussed in the proposal, all adjustments for the
phase-in, including for codes with facility and nonfacility RVUs and
PC/TC splits, will be applied to the PE RVUs only. We acknowledge that
for some codes it would be hypothetically possible to phase in the
reductions proportionally across all three RVU components. As we
explained in the proposed rule, it would not be practical to do so for
services with site of service differentials since each of the three RVU
components represent a different proportion of overall nonfacility or
facility RVUs. Therefore, we believe this alternative approach could
only work for codes without site of service differentials and those
without PC/TC splits, which represents a minority of PFS services. We
believe that applying the phase-in for these large categories of codes
differently than for the rest of PFS codes would be confusing to the
public and make adjustments unpredictable since they would be based on
whether or not the service priced in the opposite setting met the
phase-in threshold. Furthermore, we remind commenters that because the
work RVU is an important allocator of indirect PE in the established
methodology, the overall payment impact of any changes in work RVUs is
also automatically reflected in corresponding changes to the PE RVUs,
whereas changes to direct PE inputs do not have a parallel impact on
work RVUs. Therefore, even for individual codes for which it might be
possible to establish phase-in values for work RVUs, the necessary
adjustments would necessarily be weighted more heavily in PE RVUs.
Comment: With regard to CMS' proposal to consider the RVUs for
different sites of service and components independently for the
purposes of identifying when and how the phase-in applies, one
commenter expressed concerns that the proposed approach ignores the
spirit of section 220(e) of the PAMA to benefit physician practices by
dampening the year to year impact of large payment reductions. The
commenter stated that if CMS adjusts only the PE RVUs, then a large
number of codes with greater than 20 percent work RVU reductions could
be excluded. The commenter urged CMS to clarify its intent to dampen
the effects of year to year reductions to both work RVUs and PE RVUs
independently, even for codes with separate facility and non-facility
PE RVUs.
Response: We appreciate the commenter's feedback and we acknowledge
that our proposed approach would not dampen the year to year reductions
in work RVUs. However, our approach would dampen the effect of any
payment reductions for all codes, including those reductions that would
result from reductions to work RVUs when such reductions contributed to
an overall reduction of 20 percent or greater, consistent with the
statutory provision. As a practical matter, we believe that
practitioners reporting services furnished to Medicare beneficiaries
and paid through the PFS would be paid very similar amounts regardless
of which approach we implemented. We also note that the commenter did
not provide any information that would help us to understand how the
suggested phase-in could be applied to services with site of service
differentials.
After consideration of the comments received, we are finalizing
this aspect of the phase-in methodology as proposed.
The list of codes subject to the phase-in and the associated RVUs
that result from this methodology are available on the CMS Web site
under downloads for the CY 2016 PFS final rule with comment period at
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
G. Changes for Computed Tomography (CT) Under the Protecting Access to
Medicare Act of 2014 (PAMA)
Section 218(a)(1) of the Protecting Access to Medicare Act of 2014
(PAMA) (Pub. L. 113-93) amended section 1834 of the Act by establishing
a new subsection 1834(p). Effective for services furnished on or after
January 1, 2016, new section 1834(p) of the Act reduces payment for the
technical component (TC) of applicable CT services paid under the
Medicare PFS and applicable CT services paid under the OPPS (a 5-
percent reduction in 2016 and a 15-percent reduction in 2017 and
subsequent years). The applicable CT services are identified by HCPCS
codes 70450 through 70498; 71250 through 71275; 72125 through 72133;
72191 through 72194; 73200 through 73206; 73700 through 73706; 74150
through 74178; 74261 through 74263; and 75571 through 75574 (and any
succeeding codes). As specified in section 1834(p)(4) of the Act, the
reduction applies for applicable services furnished using equipment
that does not meet
[[Page 70931]]
each of the attributes of the National Electrical Manufacturers
Association (NEMA) Standard XR-29-2013, entitled ``Standard Attributes
on CT Equipment Related to Dose Optimization and Management.'' Section
1834(p)(4) of the Act also specifies that the Secretary may apply
successor standards through rulemaking.
Section 1834(p)(6)(A) of the Act requires that information be
provided and attested to by a supplier and a hospital outpatient
department that indicates whether an applicable CT service was
furnished that was not consistent with the standard set forth in
section 1834(p)(4) of the Act (currently the NEMA CT equipment
standard) and that such information may be included on a claim and may
be a modifier. Section 1834(p)(6)(A) of the Act also provides that such
information must be verified, as appropriate, as part of the periodic
accreditation of suppliers under section 1834(e) of the Act and
hospitals under section 1865(a) of the Act. Section 218(a)(2) of the
PAMA made a conforming amendment to section 1848 (c)(2)(B)(v) of the
Act by adding a new subclause (VIII), which provides that, effective
for fee schedules established beginning with 2016, reduced expenditures
attributable to the application of the quality incentives for computed
tomography under section 1834(p) of the Act shall not be taken into
account for purposes of the budget neutrality calculation under the
PFS.
To implement this provision, in the CY 2016 PFS proposed rule (80
FR 41716), we proposed to establish a new modifier to be used on claims
that describes CT services furnished using equipment that does not meet
each of the attributes of the NEMA Standard XR-29-2013. We proposed
that, beginning January 1, 2016, hospitals and suppliers would be
required to use this modifier on claims for CT scans described by any
of the CPT codes identified in this section (and any successor codes)
that are furnished on non-NEMA Standard XR-29-2013-compliant CT scans.
We stated that the use of this proposed modifier would result in the
applicable payment reduction for the CT service, as specified under
section 1834(p) of the Act. We received the following comments on our
proposal to require the modifier to be used on claims:
Many commenters endorsed the use of quality incentives to improve
patient safety and optimize the use of radiation when providing CT
diagnostic imaging services. Several commenters were supportive of the
proposal to establish the modifier to identify CT services furnished
using equipment that does not meet each of the attributes of the NEMA
Standard XR-29-2013.
Comment: Several commenters requested that we delay implementation
of section 1834(p) of the Act so that they have additional time to
comply before the payment reduction becomes effective.
Response: The statute requires that we apply the payment adjustment
for computed tomography services furnished on or after January 1, 2016.
Given this language, we believe that we must implement this provision
beginning January 1, 2016. Therefore, we are not delaying
implementation of this provision. We note that the payment reduction
for 2016 is 5 percent, and it then increases to 15 percent in
subsequent years. Hospitals and suppliers that furnish services that do
not meet the equipment standard as of January 1, 2016, will receive
this 5 percent payment reduction during 2016, but will have an
opportunity to upgrade their CT scanners before the larger payment
adjustment that takes effect beginning in CY 2017.
Comment: One commenter cited section 1834 (p)(4) of the Act, which
specifies that through rulemaking, the Secretary may apply successor
standards for CT equipment. The commenter indicated that CMS should
develop successor standards that exempt CT scans performed on cone beam
CT (CBCT) scanners that are FDA cleared only for imaging of the head
from the requirement for Automatic Exposure Control (AEC) capability.
This request was based on the AEC capability being unavailable on CBCT
scanners.
Response: Although we agree with the commenter that the Secretary
has authority to apply successor standards for CT equipment through
notice and comment rulemaking, we would like to gain some experience
with the NEMA Standard XR-29-2013 before adopting a successor standard.
Therefore, we are not adopting a successor standard to the NEMA
Standard XR-29-2013 in this final rule with comment period, but may
consider doing so in future rulemaking.
After consideration of the public comments we received, we are
finalizing the establishment of new modifier, ``CT.'' This 2-digit
modifier will be added to the HCPCS annual file as of January 1, 2016,
with the label ``CT,'' and the long descriptor ``Computed tomography
services furnished using equipment that does not meet each of the
attributes of the National Electrical Manufacturers Association (NEMA)
XR-29-2013 standard''.
Beginning January 1, 2016, hospitals and suppliers will be required
to report the modifier ``CT'' on claims for CT scans described by any
of the CPT codes identified in this section (and any successor codes)
that are furnished on non-NEMA Standard XR-29-2013-compliant CT
scanners. The use of this modifier will result in the applicable
payment reduction for the CT service, as specified under section
1834(p) of the Act.
H. Valuation of Specific Codes
1. Background
Establishing valuations for newly created and revised CPT codes is
a routine part of maintaining the PFS. Since inception of the PFS, it
has also been a priority to revalue services regularly to assure 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 five-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. Under the five-year review process, revisions in RVUs were
proposed in a proposed rule and finalized in a final rule. In addition
to the five-year reviews, in each year beginning with CY 2009, CMS and
the RUC have identified a number of potentially misvalued codes using
various identification screens, as discussed in section II.B.5. of this
final rule with comment period. Each year, when we received RUC
recommendations, our process has 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 accept public comment about
those valuations.
For services furnished during the calendar year following the
publication of interim final rates, we pay for services based upon the
interim final values established in the final rule with comment period.
In the final rule with comment period for the subsequent year, we
consider and respond to public comments received on the interim final
values, and make any appropriate adjustments to values based on those
comments. We then typically finalize the values for the codes.
[[Page 70932]]
2. Process for Valuing New, Revised, and Potentially Misvalued Codes
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. CY 2016 represents
a transition year for this new process. For CY 2016, we proposed new
values in the CY 2016 proposed rule for the codes for which we received
complete RUC recommendations by February 10, 2015. For recommendations
regarding any new or revised codes received after the February 10, 2015
deadline, including updated recommendations for codes included in the
CY 2016 proposed rule, we are establishing interim final values in this
final rule with comment period, consistent with previous practice. In
this final rule with comment period, we considered all comments
received in response to proposed values for codes in our proposed rule,
including alternative recommendations to those used in developing the
proposed rule.
Beginning with valuations for CY 2017, the new process will be
applicable to all codes. That is, beginning with rulemaking for CY
2017, we will propose values for the vast majority of new, revised, and
potentially misvalued codes and consider public comments before
establishing final values for the codes; use G-codes as necessary to
facilitate continued payment for certain services for which we do not
receive recommendations in time to propose values; and adopt interim
final values 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 2016, we received RUC recommendations prior to February 10,
2015 for many new, revised and potentially misvalued codes and are
establishing final values for those codes in this final rule with
comment period. However, the RUC recommendations included CPT tracking
codes instead of the actual 2016 CPT codes, which were first made
available to the public subsequent to the publication of the CY 2016
proposed rule with comment period. Because CPT procedure codes are 5
alpha-numeric characters but CPT tracking codes typically have 6 or 7
alpha-numeric characters and CMS systems only utilize 5-character HCPCS
codes, we developed and used alternative 5-character placeholder codes
for use in the proposed rule. The final CPT codes are included and used
for purposes of discussion in this final rule with comment period.
Table 9 lists the CPT tracking codes, the CMS placeholder codes, and
the final CPT codes for all new CPT codes included in the CY 2016 PFS
proposed rule.
Table 9--2016 Final Rule HCPCS Placeholder to CPT Code Numbers
----------------------------------------------------------------------------------------------------------------
CMS
CPT Tracking code Placeholder CPT 2016 Short descriptor
code
----------------------------------------------------------------------------------------------------------------
3160X1........................................ 3160A 31652 Bronch ebus samplng 1/2 node.
3160X2........................................ 3160B 31653 Bronch ebus samplng 3/> node.
3160X3........................................ 3160C 31654 Bronch ebus ivntj perph les.
3347X1........................................ 3347A 33477 Implant tcat pulm vlv perq.
3725X1........................................ 3725A 37252 Intrvasc us noncoronary 1st.
3725X2........................................ 3725B 37253 Intrvasc us noncoronary addl.
3940X1........................................ 3940A 39401 Mediastinoscpy w/medstnl bx.
3940X2........................................ 3940B 39402 Mediastinoscpy w/lmph nod bx.
5039X1........................................ 5039A 50430 Njx px nfrosgrm &/urtrgrm.
5039X2........................................ 5039B 50431 Njx px nfrosgrm &/urtrgrm.
5039X3........................................ 5039C 50432 Plmt nephrostomy catheter.
5039X4........................................ 5039D 50433 Plmt nephroureteral catheter.
5039X13....................................... 5039M 50434 Convert nephrostomy catheter.
5039X5........................................ 5039E 50435 Exchange nephrostomy cath.
5069X7........................................ 5069G 50693 Plmt ureteral stent prq.
5069X8........................................ 5069H 50694 Plmt ureteral stent prq.
5069X9........................................ 5069I 50695 Plmt ureteral stent prq.
5443X1........................................ 5443A 54437 Repair corporeal tear.
5443X2........................................ 5443B 54438 Replantation of penis.
657XX7........................................ 657XG 65785 Impltj ntrstrml crnl rng seg.
692XXX........................................ 692XX 69209 Remove impacted ear wax uni.
7208X1........................................ 7208A 72081 X-ray exam entire spi 1 vw.
7208X2........................................ 7208B 72082 X-ray exam entire spi 2/3 vw.
7208X3........................................ 7208C 72083 X-ray exam entire spi 4/5 vw.
7208X4........................................ 7208D 72084 X-ray exam entire spi 6/> vw.
7778X1........................................ 7778A 77767 Hdr rdncl skn surf brachytx.
7778X2........................................ 7778B 77768 Hdr rdncl skn surf brachytx.
7778X3........................................ 7778C 77770 Hdr rdncl ntrstl/icav brchtx.
7778X4........................................ 7778D 77771 Hdr rdncl ntrstl/icav brchtx.
7778X5........................................ 7778E 77772 Hdr rdncl ntrstl/icav brchtx.
8835X0........................................ 8835X 88350 Immunofluor antb addl stain.
9254X1........................................ 9254A 92537 Caloric vstblr test w/rec.
9254X2........................................ 9254B 92538 Caloric vstblr test w/rec.
99176X........................................ 9917X 99177 Ocular instrumnt screen bil.
9935XX1....................................... 9935A 99415 Prolong clincl staff svc.
9935XX2....................................... 9935B 99416 Prolong clincl staff svc add.
GXXX1......................................... GXXX1 G0296 Visit to determ ldct elig.
GXXX2......................................... GXXX2 G0297 Ldct for lung ca screen.
----------------------------------------------------------------------------------------------------------------
[[Page 70933]]
3. Methodology for Establishing Work RVUs
We conducted a review of each code identified in this section and
reviewed 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 review of recommended work RVUs and time
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 Medicare 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, crosswalk to
key reference or similar codes, and magnitude estimation. More
information on these issues is available in that rule. When referring
to a survey, unless otherwise noted, we mean the surveys conducted by
specialty societies as part of the formal RUC process. The building
block methodology is used to construct, or deconstruct, the work RVU
for a CPT code based on component pieces of the code.
Components used in the building block approach may include
preservice, intraservice, or postservice time and post-procedure
visits. When referring to a bundled CPT code, the building block
components could be the CPT codes that make up the bundled code and the
inputs associated with those codes. 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, CMS has frequently utilized an incremental methodology
in which we value a code based upon its incremental difference between
another code or another family of codes. Since the statute specifically
defines the work component as the resources in time and intensity
required in furnishing the service and the published literature on
valuing work has recognized the key role of time in overall work, we
have also refined the work RVUs for particular codes 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 intra-service time.
Comment: Several commenters objected to CMS' use of these
methodologies as unprecedented and invalid in the context of the
development of PFS RVUs.
Response: We appreciate that many commenters, including the RUC,
have maintained that magnitude estimation, informed by survey results,
is the only appropriate method for valuation of PFS services. However,
we have observed that the approaches used by the RUC in developing
recommended work RVUs have resulted in recommended values that do not
adequately address significant changes in assumptions regarding the
amount of time required to furnish particular PFS services. Since
section 1848(c)(1)(A) of the Act explicitly identifies time as one of
the two kinds of resources that comprise the work component of PFS
payment, we do not believe that our use of the above methodologies is
inconsistent with the statutory requirements related to the maintenance
of work RVUs, and we have regularly used these and other methodologies
in developing values for PFS services. The PFS incorporates cross-
specialty and cross-organ system relativity. Valuing services requires
an assessment of relative value and takes into account the clinical
intensity and time required to furnish a service. In selecting which
methodological approach will best determine the appropriate value for a
service, we consider the current and recommended work and time values,
as well as the intensity of the service, all relative to other
services. In our review of RUC-recommended values, we have noted that
the RUC also uses a variety of methodologies to develop work RVUs for
individual services, and subsequently validates the results of these
approaches through magnitude estimation. We believe that our discrete
use of methodologies that compare the time resources among PFS codes is
fundamentally similar to that approach, but better facilitates our
ability to identify the most accurate work RVU for individual services
by explicitly considering the significance of time in the estimate of
total work.
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 six preservice time packages
for services typically furnished in the facility setting, reflecting
the different combinations of straightforward or difficult procedure,
straightforward or difficult patient, and without or with sedation/
anesthesia. Currently, there are three preservice time packages for
services typically furnished in the nonfacility setting, reflecting
procedures without and with sedation/anesthesia care.
We have 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 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. We believe 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 adjust 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 remove 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 remove a work RVU of
0.09 (4 minutes x 0.0224 IWPUT) if we do not believe the overlap in
time has 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 provided on the
same day as an E/M service.
Table 13 contains a list of codes for which we proposed work RVUs;
this includes all RUC recommendations received by February 10, 2015.
When the proposed work RVUs varied from those recommended by the RUC or
for which we do not have RUC
[[Page 70934]]
recommendations, we address those codes in the portions of this section
that are dedicated to particular codes. The work RVUs and other payment
information for all CY 2016 payable codes are available in Addendum B.
Addendum B is available on the CMS Web site under downloads for the CY
2016 PFS final rule with comment period at http://www.cms.gov/physicianfeesched/downloads/. The time values for all CY 2016 codes are
listed in a file called ``CY 2016 PFS Work Time,'' available on the CMS
Web site under downloads for the CY 2016 PFS final rule with comment
period at http://www.cms.gov/physicianfeesched/downloads/.
4. Methodology for Establishing the Direct PE Inputs Used To Develop PE
RVUs
a. Background
On an annual basis, the RUC provides CMS 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 Medicare PFS, consultation with other
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 recommendations
appropriately estimate the direct PE inputs (clinical labor, disposable
supplies, and medical equipment) required for the typical service,
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 16 details
our refinements of the RUC's direct PE recommendations at the code-
specific level. In this final rule with comment period, 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 $0.32 or less, the refinement has no impact on
the interim final 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
$0.32 threshold and are unlikely to result in a change to the final
RVUs.
We also note that the final direct PE inputs for CY 2016 are
displayed in the final CY 2016 direct PE input database, available on
the CMS Web site under the downloads for the CY 2016 final rule at
www.cms.gov/PhysicianFeeSched/. The inputs displayed there have also
been used in developing the CY 2016 PE RVUs as displayed in Addendum B
of this final rule.
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. Although the direct PE input recommendations
generally correspond to the work time values associated with services,
we believe that in some cases inadvertent discrepancies between work
time values and direct PE inputs should be refined in the establishment
of interim final direct PE inputs. In other cases, CMS refinement of
RUC-recommended work times prompts necessary adjustments in the direct
PE inputs.
We proposed to remove the 6 minutes of clinical labor time allotted
to ``discharge management, same day (0.5 x 99238)'' in the facility
setting from a number of procedures under review. We proposed to align
the clinical labor for discharge day management to align the work time
assigned in the work time file. We made these proposed refinements
under the belief that we should not allocate clinical labor staff time
for discharge day management if there is no discharge visit included in
the procedure's global period.
Comment: Several commenters, including the RUC, disagreed with CMS
and suggested that the clinical staff time in the facility setting may
not conform with work time for discharge day management in a given
code. Commenters stated that the work discharge time reflects the work
involved in discharging from a facility setting. Therefore, if the
service is typically performed in the nonfacility setting, the post-
service time for a CPT code 99238 discharge visit would not be
included. However, since the inputs for PE are differentiated by site
of service, the time for discharge day might be included in the
facility inputs, even if the service is infrequently provided in the
facility setting overall. Although the commenters agreed that there
should not be clinical staff time for discharge management assigned to
0-day global procedures, the commenters requested that this clinical
staff time be restored for the nine 10-day global procedures under
review. Commenters stressed that clinical staff must instruct the
patient regarding home care prior to the post-operative visit and call
in any necessary prescriptions. Commenters also requested that this
clinical labor time be included as two, 3-minute phone calls under the
task ``Conduct phone calls/call in prescriptions.''
Response: We understand and agree that when cases typically
performed in the non-facility setting are performed in the facility
setting, discharge day management may not be typical for the code
overall even if discharge day management activities may be typical when
the service is furnished in the facility setting. However, we also
believe that if a patient's conditions are serious enough to warrant
treatment in the facility setting, then it is likely that the patient
will also be receiving additional services that already include the
resource costs involved with clinical labor tasks associated with
discharge day management. Therefore, we do not believe that it is
appropriate to include the additional time for staff phone calls for
these services generally furnished in the office setting.
We have thus far been addressing the subject of discharge day
management on a code-by-code basis. Based on the comments received, we
believe there is a need for a broader policy concerning the proper
treatment of this issue. We will consider this subject for future
rulemaking.
After consideration of the comments received, we are finalizing our
current
[[Page 70935]]
refinements to discharge day management clinical labor time.
(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 continue to 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 have clarified this
principle, 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 post-operative 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 pre-
service or post-service 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 pre- service or post-service 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. Some stakeholders have objected to this
rationale for our refinement of equipment minutes on this basis and
have reiterated these objections in comments regarding the proposed
direct PE inputs. We are responding to these comments by referring the
commenters to our extensive discussion in response to the same
objections 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 period, 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 are 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, CMS
staff reviews 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 pre-service
clinical labor tasks to avoid duplicative inputs and to reflect the
resource costs of furnishing the typical service.
In general, clinical labor tasks fall into one of the categories on
the PE worksheets. In cases where tasks cannot be attributed to an
existing category, the tasks are labeled ``other clinical activity.''
We believe that continual addition of new and distinct clinical labor
tasks each time a code is reviewed under the misvalued code initiative
is likely to degrade relativity between newly reviewed services and
those with already existing inputs. To mitigate the potential negative
impact of these additions, we review these tasks to determine whether
they are fully distinct from existing clinical labor tasks, typically
included for other clinically similar services under the PFS, and
thoroughly explained in the recommendation. For those tasks that do not
meet these criteria, we do not accept these newly recommended clinical
labor tasks; two examples of such tasks encountered during our review
of the recommendations include ``Enter data into laboratory information
system, multiparameter analyses and field data entry, complete quality
assurance documentation'' and ``Consult with pathologist regarding
representation needed, block selection and appropriate technique.''
In conducting our review of the RUC recommendations for CY 2016, we
noted that several of the recommended times for clinical labor tasks
associated with pathology services differed across codes, both within
the CY 2016 recommendations and in comparison to codes currently in the
direct PE database. We refer readers to Table 16 in section II.A.3. of
this final rule with comment period for a discussion of these
standards.
Comment: Several commenters stated that our standard clinical labor
inputs for digital imaging inputs for many different codes do not
reflect the accurate number of minutes associated with clinical labor
tasks for individual services.
Response: In the CY 2015 PFS final rule with comment period (79 FR
67561), we finalized the transition from film-based to digital direct
PE inputs for imaging services. In the CY 2016 PFS proposed rule, we
sought comment on the appropriate values for the clinical labor tasks
associated with digital imaging. Please see section II.B. of this rule
for a discussion of those policies. We believe that adherence to these
standards produces the most accurate estimate of the resource costs for
these kinds of tasks and supports relativity within the development of
PE RVUs. For these reasons, absent extenuating factors for specific
codes, we are finalizing interim final direct PE inputs that adhere to
these standards.
(4) Recommended Items That Are Not Direct PE Inputs
In some cases, the PE worksheets included with the RUC
recommendations include items that are not clinical labor, disposable
supplies, or medical equipment that cannot be allocated to individual
services or patients. Two examples of such items are ``emergency
service container/safety kit'' and ``service contract.'' We have
addressed these kinds of recommendations in previous rulemaking (78 FR
74242), and we do not use these recommended items as direct PE inputs
in the calculation of PE RVUs.
(5) Moderate Sedation Inputs
Over several rulemaking cycles, we have proposed and finalized a
standard package of direct PE inputs for services where moderate
sedation is considered inherent in the procedure (76 FR 73043 through
73049). Our CY 2016 proposed direct PE inputs conform to these
policies. This includes not
[[Page 70936]]
incorporating the recommended power table (EF031) where it was included
during the intraservice period, since a stretcher is the standard item
in the moderate sedation package. These refinements are reflected in
the final CY 2016 PFS direct PE input database and detailed in Table
16.
Comment: One commenter agreed with CMS' proposal to include the use
of a stretcher in the standard moderate sedation package, and that the
time allocated for the stretcher should be the entire post procedure
recovery period. The commenter recommended that CMS work with the RUC
and specialty groups before removing the power table input from the
service period of any codes.
Response: We appreciate the commenter's support for the standard
moderate sedation package, but we do not believe we should consult with
the RUC prior to implementing the standards in developing or finalizing
direct PE inputs. However, will consider the appropriate direct PE
inputs for each code under review.
(6) 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 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
2016, we received invoices for several new supply and equipment items.
We have accepted the majority of these items and added them to the
direct PE input database. Tables 18 and 19 detail the invoices received
for new and existing items in the direct PE database. As discussed in
section II.A. of this final rule with comment period, we encourage
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 encourage stakeholders to provide
invoices or other information to improve the accuracy of pricing for
these items in the direct PE database. 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 18
and 19 also include the number of invoices received as well as 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. We are concerned
that a single invoice may not be reflective of typical costs and
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 have 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 proposed PE RVU for particular services, it
facilitates our ability to incorporate a price once we obtain
information and are able to do so.
The following is a summary of the comments we received regarding
new supply and equipment items.
Comment: Several commenters stated that they had concerns regarding
the process of pricing new supply and equipment items for the PFS. The
current process requires the submission of recently paid invoices for
CMS to consider pricing a new direct PE item. The commenters asked CMS
to develop a new pathway to submit pricing information that will
protect physicians and vendors, since publishing copies of paid
invoices, even when redacted, does not sufficiently protect private
identities.
Response: We share commenters' concerns about protecting the
privacy of practitioners and vendors during invoice submission. We
welcome and will consider additional feedback and suggestions submitted
by stakeholders regarding alternate avenues to provide updated pricing
information for individual supplies and equipment.
Comment: A commenter stated that although the commenter understands
that CMS cannot accurately value the typical cost of a supply or
equipment if the agency is not provided with sufficient pricing
information, they disagreed with CMS' decision to list the item in
question in the direct PE database without assigning any value to it,
as this can significantly affect the overall PE value for that service.
The commenter requested that CMS highlight those cases where the price
of a supply or equipment item is not being finalized due to inadequate
documentation, so that there is an opportunity to provide additional
resources that might assist in assigning an accurate value.
Response: We agree with the commenter that a lack of sufficient
pricing information can often be problematic in assigning an accurate
value to new supplies and equipment. Although we do not specifically
identify all such items in the preamble to PFS rules, we note that
stakeholders can easily identify items without prices in the direct PE
input database files that are included as downloads with each PFS rule.
We urge the public to submit a comment alerting us to items without a
price that appear to be errors in the database. As detailed above, we
also encourage the submission of invoices to help provide up-to-date,
accurate pricing information for medical supplies and equipment.
Comment: A commenter wrote to express concern with the pricing of
three supplies: Probe, radiofrequency, three array (StarBurstSDE)
(SD109) from $1995 to $353.44; gas, helium (SD079) from 25 cents per
cubic foot to one cent per cubic foot; and gas, argon (SD227) from 25
cents per cubic foot to less than one cent per cubic foot. The
commenter added that there was no evidence that supported lower prices
for these supplies, and urged CMS to retain the existing pricing for
these supply items. The commenter stated that CMS' concerns regarding
the price of these supplies were not addressed in the proposed rule,
which did not allow opportunity for public comment.
Response: The prices of these three supplies were updated in
response to invoices received during the previous calendar year. We
appreciate the commenters' feedback and we recognize that it would have
been easier for stakeholders to identify the prices had they been
included on the Invoices
[[Page 70937]]
Received for Existing Direct PE Inputs table in the proposed rule. We
believe that the commenter may have been mistaken about the pricing of
supplies SD079 and SD227. Both of these supplies have increased in
price, from 25 cents per cubic foot to 57 cents and 32 cents per cubic
foot, respectively. Neither supply has been lowered in price to one
cent per cubic foot. Absent better data sources, we continue to believe
that the supply prices listed in the public use files for the CY 2016
PFS proposed rule are the most accurate values for these items.
Comment: Many commenters wrote to express their concern over the
pricing of the radiofrequency generator (NEURO) (EQ214) equipment
affecting CPT codes 41530, 43228, 43229, 43270, 64633, 64634, 64635 and
64636. Commenters indicated that the invoice for this new equipment
item was submitted in relation to CPT code 41530, and the equipment is
not the same radiofrequency generator used to perform the services
described by CPT codes 64633, 64634, 64635 and 64636. Commenters
requested that the equipment input represented in the invoice be
assigned an equipment code separate from existing code EQ214 and that
CMS maintain the current price of $32,900 for EQ214.
Response: We appreciate the additional information provided by
commenters regarding the pricing of the radiofrequency generator
equipment. After consideration of comments received, we will create a
new equipment code for the radiofrequency generator described in the
submitted invoice, and assign this equipment to CPT codes 41530, 43228,
43229, and 43270. For CPT codes 64633, 64634, 64635, and 64636, we will
maintain the current price of $32,900 for EQ214 and maintain this
equipment.
Comment: One commenter submitted additional invoices regarding the
pricing of the PrePen (SH103) supply. The commenter requested that CMS
update the price of the PrePen to $92 based on an average of the four
invoices submitted.
Response: We appreciate the commenter's submission of additional
pricing information regarding the PrePen supply. We note that three of
the four submitted invoices reported a price of $86 for supply item
``PrePen'' (SH103); we believe that this represents the typical price
of this supply.
Therefore, after consideration of the comments received, we are
increasing the price of supply SH103 from $83 to $86.
(7) Service Period Clinical Labor Time in the Facility Setting
Several of the PE worksheets included in RUC recommendations
contained clinical labor minutes assigned to the service period in the
facility setting. Our proposed inputs did not include these minutes
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 received no general comments that addressed this
issue; we will address code-specific refinements to clinical labor in
the individual code sections.
(8) Duplicative Inputs
Several of the PE worksheets included in the RUC recommendations
contained time for the equipment item ``xenon light source'' (EQ167).
Because there appear to be two special light sources already present
(the fiberoptic headlight and the endoscope itself) in the services for
which this equipment item was recommended by the RUC, we did not
propose to include the time for this equipment item from these
services. In the proposed rule, we solicited comments on whether there
is a rationale for including this additional light source as a direct
PE input for these procedures.
The following is a summary of the comments we received.
Comment: One commenter stated that if CMS believes two light
sources are duplicative for these procedures, the commenter recommended
retaining input EQ167 and removing input EQ170 (the fiberoptic
headlight), as the xenon light source is compatible with various items
and can serve as the light source throughout the procedures.
Response: We appreciate the additional information from the
commenter regarding the appropriate use of these two light sources.
After consideration of comments received, we are restoring input
EQ167 and removing input EQ170 with the same number of equipment
minutes for CPT codes 30300, 31295, 31296, 31297, and 92511.
(9) Identification of Database Errors
Several commenters identified possible errors in the direct PE
database that did not apply to CPT codes under review. The following is
a summary of the comments we received regarding potential database
entry errors.
Comment: A commenter located a potential error for CPT code 33262
(Removal of implantable defibrillator pulse generator with replacement
of implantable defibrillator pulse generator; single lead system) where
the PE RVU dropped from 3.68 in 2015 to 2.35 in the CY 2016 PFS
proposed rule. The commenter pointed out that no changes were made to
the direct PE inputs for the code, and similar codes within the same
family retained the same PE value. The commenter recommended that CMS
review this PE RVU and make a correction in the final rule.
Response: For CPT code 33262, the pre-existing direct PE inputs for
this code were inadvertently not included in the development of the CY
2016 PFS proposed direct PE input database . We believe this was the
result of a data error, and therefore, we are restoring the direct PE
inputs to this service.
Comment: One commenter indicated that the underlying line item
direct inputs for a series of CPT codes were missing from the
individual labor, equipment, and supply public use files. The commenter
provided a list of the ten codes affected by this issue, and asked
whether this was the result of a technical error.
Response: The ten codes in question were all procedures that the
CPT Editorial Panel has assigned for deletion in CY 2016. These codes
appeared in error in our public use files for the CY 2016 PFS proposed
rule. We have identified the technical issue that was causing this
error and corrected it in the CY 2016 final direct PE input database.
Comment: One commenter identified a group of codes where the
calculated clinical labor costs (based on the underlying direct input
labor file) differed from the CMS summary labor findings. The commenter
asked if there were instances where CMS was applying different labor
inputs from those published in the files released with the rule.
Response: We appreciate the commenter bringing this issue regarding
conflicting information in the CY 2016 PFS proposed rule public use
files to our attention. This discrepancy was caused by an error in the
creation of the public use files that undercounted the number of
clinical labor minutes assigned to the postoperative E/M visits
assigned to codes with 10-day and 90-day global periods. This error did
not affect the proposed rates in the proposed rule, only the displayed
values in the ``labor task detail'' public use file. We have corrected
this issue in the public use files for the CY 2016 final direct PE
input database.
Comment: A commenter indicated that for several codes, the CMS file
for work times did not appear to be updated
[[Page 70938]]
with the RUC-approved times. In particular, the pre-evaluation time and
immediate post-service time appeared to be missing from the CMS file.
Response: These incorrect work times have been corrected in the CY
2016 final direct PE input database.
(10) Procedures Subject to the Multiple Procedure Payment Reduction
(MPPR) and the OPPS Cap
We note that services subject to the MPPR lists on diagnostic
cardiovascular services, diagnostic imaging services, diagnostic
ophthalmology services and therapy services, and the list of procedures
that meet the definition of imaging under section 5102(b) of the DRA
and are therefore subject to the OPPS cap for the upcoming calendar
year are displayed in the public use files for the PFS proposed and
final rules for each year. The public use files for CY 2016 are
available on the CMS Web site under downloads for the CY 2016 PFS final
rule with comment period at http://www.cms.gov/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html.
5. Methodology for Establishing Malpractice RVUs
As discussed in section II.B. of this final rule with comment
period, our malpractice methodology uses a crosswalk to establish risk
factors for new services until utilization data becomes available.
Table 10 lists the CY 2016 HCPCS codes and their respective source
codes used to set the CY 2016 MP RVUs. The MP RVUs for these services
are reflected in Addendum B on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/ PhysicianFeeSched/.
TABLE 10--CY 2016 Malpractice Crosswalk
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
CY 2016 new, revised or misvalued coMalpractice risk factor crosswalk code
----------------------------------------------------------------------------------------------------------------
10035.................... Perq Dev Soft Tiss 1St Imag.. 19285................... Perq dev breast 1st us imag
10036.................... Perq Dev Soft Tiss Add Imag.. 19286................... Perq dev breast add us imag
26356.................... Repair finger/hand tendon.... 26356................... Repair finger/hand tendon
26357.................... Repair finger/hand tendon.... 26357................... Repair finger/hand tendon
26358.................... Repair/graft hand tendon..... 26358................... Repair/graft hand tendon
41530.................... Tongue base vol reduction.... 41530................... Tongue base vol reduction
43210.................... Egd esophagogastrc fndoplsty. 43276................... Ercp stent exchange w/dilate
47531.................... Injection For Cholangiogram.. 49450................... Replace g/c tube perc
47540.................... Perq Plmt Bile Duct Stent.... 47556................... Biliary endoscopy thru skin
47541.................... Plmt Access Bil Tree Sm Bwl.. 47500................... Injection for liver x-rays
47542.................... Dilate Biliary Duct/Ampulla.. 47550................... Bile duct endoscopy add-on
47543.................... Endoluminal Bx Biliary Tree.. 47550................... Bile duct endoscopy add-on
47544.................... Removal Duct Glbldr Calculi.. 47630................... Remove bile duct stone
47532.................... Injection For Cholangiogram.. 49407................... Image cath fluid trns/vgnl
47533.................... Plmt Biliary Drainage Cath... 47510................... Insert catheter bile duct
47534.................... Plmt Biliary Drainage Cath... 47511................... Insert bile duct drain
47535.................... Conversion Ext Bil Drg Cath.. 47505................... Injection for liver x-rays
47536.................... Exchange Biliary Drg Cath.... 49452................... Replace g-j tube perc
47537.................... Removal Biliary Drg Cath..... 47505................... Injection for liver x-rays
47538.................... Perq Plmt Bile Duct Stent.... 47556................... Biliary endoscopy thru skin
47539.................... Perq Plmt Bile Duct Stent.... 47556................... Biliary endoscopy thru skin
49185.................... Sclerotx Fluid Collection.... 49407................... Image cath fluid trns/vgnl
50606.................... Endoluminal Bx Urtr Rnl Plvs. 50955................... Ureter endoscopy & biopsy
50705.................... Ureteral Embolization/Occl... 50393................... Insert ureteral tube
50706.................... Balloon Dilate Urtrl Strix... 50395................... Create passage to kidney
55866.................... Laparo radical prostatectomy. 55866................... Laparo radical prostatectomy
61645.................... Perq Art M-Thrombect &/Nfs... 37218................... Stent placemt ante carotid
61650.................... Evasc Prlng Admn Rx Agnt 1St. 37202................... Transcatheter therapy infuse
61651.................... Evasc Prlng Admn Rx Agnt Add. 37202................... Transcatheter therapy infuse
64461.................... Pvb Thoracic Single Inj Site. 64490................... Inj paravert f jnt c/t 1 lev
64462.................... Pvb Thoracic 2Nd+ Inj Site... 64480................... Inj foramen epidural add-on
64463.................... Pvb Thoracic Cont Infusion... 64446................... N blk inj sciatic cont inf
64553.................... Implant neuroelectrodes...... 64553................... Implant neuroelectrodes
64555.................... Implant neuroelectrodes...... 64555................... Implant neuroelectrodes
64566.................... Neuroeltrd stim post tibial.. 64566................... Neuroeltrd stim post tibial
65778.................... Cover eye w/membrane......... 65778................... Cover eye w/membrane
65779.................... Cover eye w/membrane suture.. 65779................... Cover eye w/membrane suture
65780.................... Ocular reconst transplant.... 65780................... Ocular reconst transplant
65855.................... Trabeculoplasty Laser Surg... 65855................... Laser surgery of eye
66170.................... Glaucoma surgery............. 66170................... Glaucoma surgery
66172.................... Incision of eye.............. 66172................... Incision of eye
67107.................... Repair Detached Retina....... 67107................... Repair detached retina
67108.................... Repair Detached Retina....... 67108................... Repair detached retina
67110.................... Repair detached retina....... 67110................... Repair detached retina
67113.................... Repair Retinal Detach Cplx... 67113................... Repair retinal detach cplx
67227.................... Dstrj Extensive Retinopathy.. 67227................... Treatment of retinal lesion
67228.................... Treatment X10Sv Retinopathy.. 67228................... Treatment of retinal lesion
72170.................... X-ray exam of pelvis......... 72170................... X-ray exam of pelvis
73501.................... X-Ray Exam Hip Uni 1 View.... 72170................... X-ray exam of pelvis
73502.................... X-Ray Exam Hip Uni 2-3 Views. 72170................... X-ray exam of pelvis
73503.................... X-Ray Exam Hip Uni 4/> Views. 72170................... X-ray exam of pelvis
73521.................... X-Ray Exam Hips Bi 2 Views... 72170................... X-ray exam of pelvis
73522.................... X-Ray Exam Hips Bi 3-4 Views. 72170................... X-ray exam of pelvis
73523.................... X-Ray Exam Hips Bi 5/> Views. 72170................... X-ray exam of pelvis
73551.................... X-Ray Exam Of Femur 1........ 72170................... X-ray exam of pelvis
73552.................... X-Ray Exam Of Femur 2/>...... 72170................... X-ray exam of pelvis
74712.................... Mri Fetal Sngl/1St Gestation. 72195................... Mri pelvis w/o dye
----------------------------------------------------------------------------------------------------------------
[[Page 70939]]
CY 2016 new, revised or misvalued coMalpractice risk factor crosswalk code
----------------------------------------------------------------------------------------------------------------
74713.................... Mri Fetal Ea Addl Gestation.. 72195................... Mri pelvis w/o dye
77778.................... Apply Interstit Radiat Compl. 77778................... Apply interstit radiat compl
77790.................... Radiation handling........... 77790................... Radiation handling
78264.................... Gastric Emptying Imag Study.. 78264................... Gastric emptying study
78265.................... Gastric Emptying Imag Study.. 78264................... Gastric emptying study
78266.................... Gastric Emptying Imag Study.. 78264................... Gastric emptying study
91200.................... Liver elastography........... 91133................... Electrogastrography w/test
93050.................... Art pressure waveform analys. 93784................... Ambulatory bp monitoring
95971.................... Analyze neurostim simple..... 95971................... Analyze neurostim simple
95972.................... Analyze Neurostim Complex.... 95972................... Analyze neurostim complex
----------------------------------------------------------------------------------------------------------------
6. CY 2016 Valuation of Specific Codes
Table 11--CY 2016 Work RVUs for New, Revised and Potentially Misvalued Codes With Proposed Values in the CY 2016
PFS Proposed Rule
----------------------------------------------------------------------------------------------------------------
Proposed CY Final CY 2016
HCPCS Code Long descriptor CY 2015 WRVU 2016 work RVU work RVU
----------------------------------------------------------------------------------------------------------------
11750........................ Excision of nail and nail matrix, 2.50 1.58 1.58
partial or complete (eg, ingrown
or deformed nail), for permanent
removal;.
20240........................ Biopsy, bone, open; superficial 3.28 2.61 2.61
(eg, ilium, sternum, spinous
process, ribs, trochanter of
femur).
27280........................ Arthrodesis, open, sacroiliac 14.64 20.00 20.00
joint, including obtaining bone
graft, including
instrumentation, when performed.
31652........................ Bronchoscopy, rigid or flexible, NEW 4.71 4.71
including fluoroscopic guidance,
when performed; with
endobronchial ultrasound (EBUS)
guided transtracheal and/or
transbronchial sampling (eg,
aspiration[s]/biopsy[ies]), one
or two mediastinal and/or hilar
lymph node stat.
31653........................ Bronchoscopy, rigid or flexible, NEW 5.21 5.21
including fluoroscopic guidance,
when performed; with
endobronchial ultrasound (EBUS)
guided transtracheal and/or
transbronchial sampling (eg,
aspiration[s]/biopsy[ies]), 3 or
more mediastinal and/or hilar
lymph node stati.
31654........................ Bronchoscopy, rigid or flexible, NEW 1.40 1.40
including fluoroscopic guidance,
when performed; with
transendoscopic endobronchial
ultrasound (EBUS) during
bronchoscopic diagnostic or
therapeutic intervention(s) for
peripheral lesion(s) (List
separately in addition to.
31622........................ Bronchoscopy, rigid or flexible, 2.78 2.78 2.78
including fluoroscopic guidance,
when performed; diagnostic, with
cell washing, when performed
(separate procedure).
31625........................ Bronchoscopy, rigid or flexible, 3.36 3.36 3.36
including fluoroscopic guidance,
when performed; with bronchial
or endobronchial biopsy(s),
single or multiple sites.
31626........................ Bronchoscopy, rigid or flexible, 4.16 4.16 4.16
including fluoroscopic guidance,
when performed; with placement
of fiducial markers, single or
multiple.
31628........................ Bronchoscopy, rigid or flexible, 3.80 3.80 3.80
including fluoroscopic guidance,
when performed; with
transbronchial lung biopsy(s),
single lobe.
31629........................ Bronchoscopy, rigid or flexible, 4.09 4.00 4.00
including fluoroscopic guidance,
when performed; with
transbronchial needle aspiration
biopsy(s), trachea, main stem
and/or lobar bronchus(i).
31632........................ Bronchoscopy, rigid or flexible, 1.03 1.03 1.03
including fluoroscopic guidance,
when performed; with
transbronchial lung biopsy(s),
each additional lobe (List
separately in addition to code
for primary procedure).
31633........................ Bronchoscopy, rigid or flexible, 1.32 1.32 1.32
including fluoroscopic guidance,
when performed; with
transbronchial needle aspiration
biopsy(s), each additional lobe
(List separately in addition to
code for primary procedure).
33477........................ Transcatheter pulmonary valve NEW 25.00 25.00
implantation, percutaneous
approach, including pre-stenting
of the valve delivery site, when
performed.
37215........................ Transcatheter placement of 19.68 18.00 18.00
intravascular stent(s), cervical
carotid artery, open or
percutaneous, including
angioplasty, when performed, and
radiological supervision and
interpretation; with distal
embolic protection.
37252........................ Intravascular ultrasound NEW 1.80 1.80
(noncoronary vessel) during
diagnostic evaluation and/or
therapeutic intervention,
including radiological
supervision and interpretation;
initial non-coronary vessel
(List separately in addition to
code for primary procedure).
37253........................ Intravascular ultrasound NEW 1.44 1.44
(noncoronary vessel) during
diagnostic evaluation and/or
therapeutic intervention,
including radiological
supervision and interpretation;
each additional noncoronary
vessel (List separately in
addition to code for primary
procedure.
38570........................ Laparoscopy, surgical; with 9.34 8.49 8.49
retroperitoneal lymph node
sampling (biopsy), single or
multiple.
[[Page 70940]]
38571........................ Laparoscopy, surgical; with 14.76 12.00 12.00
bilateral total pelvic
lymphadenectomy.
38572........................ Laparoscopy, surgical; with 16.94 15.60 15.60
bilateral total pelvic
lymphadenectomy and peri-aortic
lymph node sampling (biopsy),
single or multiple.
39401........................ Mediastinoscopy; includes NEW 5.44 5.44
biopsy(ies) of mediastinal mass
(eg, lymphoma), when performed.
39402........................ Mediastinoscopy; with lymph node NEW 7.25 7.25
biopsy(ies) (eg, lung cancer
staging).
43775........................ Laparoscopy, surgical, gastric C 20.38 20.38
restrictive procedure;
longitudinal gastrectomy (ie,
sleeve gastrectomy).
44380........................ Ileoscopy, through stoma; 1.05 0.90 0.97
diagnostic, including collection
of specimen(s) by brushing or
washing, when performed
(separate procedure).
44381........................ Ileoscopy, through stoma; with I 1.48 1.48
transendoscopic balloon dilation.
44382........................ Ileoscopy, through stoma; with 1.27 1.20 1.27
biopsy, single or multiple.
44384........................ Ileoscopy, through stoma; with I 2.88 2.95
placement of endoscopic stent
(includes pre- and post-dilation
and guide wire passage, when
performed).
44385........................ Endoscopic evaluation of small 1.82 1.23 1.30
intestinal pouch (e.g., Kock
pouch, ileal reservoir [S or
J]); diagnostic, including
collection of specimen(s) by
brushing or washing, when
performed (separate procedure).
44386........................ Endoscopic evaluation of small 2.12 1.53 1.60
intestinal pouch (eg, Kock
pouch, ileal reservoir [S or
J]); with biopsy, single or
multiple.
44388........................ Colonoscopy through stoma; 2.82 2.75 2.82
diagnostic, including collection
of specimen(s) by brushing or
washing, when performed
(separate procedure).
44389........................ Colonoscopy through stoma; with 3.13 3.05 3.12
biopsy, single or multiple.
44390........................ Colonoscopy through stoma; with 3.82 3.77 3.84
removal of foreign body(s).
44391........................ Colonoscopy through stoma; with 4.31 4.22 4.22
control of bleeding, any method.
44392........................ Colonoscopy through stoma; with 3.81 3.63 3.63
removal of tumor(s), polyp(s),
or other lesion(s) by hot biopsy
forceps.
44394........................ Colonoscopy through stoma; with 4.42 4.13 4.13
removal of tumor(s), polyp(s),
or other lesion(s) by snare
technique.
44401........................ Colonoscopy through stoma; with I 4.44 4.44
ablation of tumor(s), polyp(s),
or other lesion(s) (includes pre-
and post-dilation and guide wire
passage, when performed).
44402........................ Colonoscopy through stoma; with I 4.73 4.80
endoscopic stent placement
(including pre- and post-
dilation and guide wire passage,
when performed).
44403........................ Colonoscopy through stoma; with I 5.53 5.60
endoscopic mucosal resection.
44404........................ Colonoscopy through stoma; with I 3.05 3.12
directed submucosal
injection(s), any substance.
44405........................ Colonoscopy through stoma; with I 3.33 3.33
transendoscopic balloon dilation.
44406........................ Colonoscopy through stoma; with I 4.13 4.20
endoscopic ultrasound
examination, limited to the
sigmoid, descending, transverse,
or ascending colon and cecum and
adjacent structures.
44407........................ Colonoscopy through stoma; with I 5.06 5.06
transendoscopic ultrasound
guided intramural or transmural
fine needle aspiration/
biopsy(s), includes endoscopic
ultrasound examination limited
to the sigmoid, descending,
transverse, or ascending colon
and cecum and adjacent
structures.
44408........................ Colonoscopy through stoma; with I 4.24 4.24
decompression (for pathologic
distention) (eg, volvulus,
megacolon), including placement
of decompression tube, when
performed.
45330........................ Sigmoidoscopy, flexible; 0.96 0.77 0.84
diagnostic, including collection
of specimen(s) by brushing or
washing, when performed
(separate procedure).
45331........................ Sigmoidoscopy, flexible; with 1.15 1.07 1.14
biopsy, single or multiple.
45332........................ Sigmoidoscopy, flexible; with 1.79 1.79 1.86
removal of foreign body(s).
45333........................ Sigmoidoscopy, flexible; with 1.79 1.65 1.65
removal of tumor(s), polyp(s),
or other lesion(s) by hot biopsy
forceps.
45334........................ Sigmoidoscopy, flexible; with 2.73 2.10 2.10
control of bleeding, any method.
45335........................ Sigmoidoscopy, flexible; with 1.46 1.07 1.14
directed submucosal
injection(s), any substance.
45337........................ Sigmoidoscopy, flexible; with 2.36 2.20 2.20
decompression (for pathologic
distention) (e.g., volvulus,
megacolon), including placement
of decompression tube, when
performed.
45338........................ Sigmoidoscopy, flexible; with 2.34 2.15 2.15
removal of tumor(s), polyp(s),
or other lesion(s) by snare
technique.
45340........................ Sigmoidoscopy, flexible; with 1.89 1.35 1.35
transendoscopic balloon dilation.
45341........................ Sigmoidoscopy, flexible; with 2.60 2.15 2.22
endoscopic ultrasound
examination.
45342........................ Sigmoidoscopy, flexible; with 4.05 3.08 3.08
transendoscopic ultrasound
guided intramural or transmural
fine needle aspiration/biopsy(s).
45346........................ Sigmoidoscopy, flexible; with I 2.84 2.91
ablation of tumor(s), polyp(s),
or other lesion(s) (includes pre-
and post-dilation and guide
wire passage, when performed).
45347........................ Sigmoidoscopy, flexible; with I 2.75 2.82
placement of endoscopic stent
(includes pre- and post-dilation
and guide wire passage, when
performed).
[[Page 70941]]
45349........................ Sigmoidoscopy, flexible; with I 3.55 3.62
endoscopic mucosal resection.
45350........................ Sigmoidoscopy, flexible; with I 1.78 1.78
band ligation(s) (e.g.,
hemorrhoids).
45378........................ Colonoscopy, flexible; 3.69 3.29 3.36
diagnostic, including collection
of specimen(s) by brushing or
washing, when performed
(separate procedure).
45379........................ Colonoscopy, flexible; with 4.68 4.31 4.38
removal of foreign body(s).
45380........................ Colonoscopy, flexible; with 4.43 3.59 3.66
biopsy, single or multiple.
45381........................ Colonoscopy, flexible; with 4.19 3.59 3.66
directed submucosal
injection(s), any substance.
45382........................ Colonoscopy, flexible; with 5.68 4.76 4.76
control of bleeding, any method.
45384........................ Colonoscopy, flexible; with 4.69 4.17 4.17
removal of tumor(s), polyp(s),
or other lesion(s) by hot biopsy
forceps.
45385........................ Colonoscopy, flexible; with 5.30 4.67 4.67
removal of tumor(s), polyp(s),
or other lesion(s) by snare
technique.
45386........................ Colonoscopy, flexible; with 4.57 3.87 3.87
transendoscopic balloon dilation.
45388........................ Colonoscopy, flexible; with I 4.98 4.98
ablation of tumor(s), polyp(s),
or other lesion(s) (includes pre-
and post-dilation and guide
wire passage, when performed).
45389........................ Colonoscopy, flexible; with I 5.27 5.34
endoscopic stent placement
(includes pre- and post-dilation
and guide wire passage, when
performed).
45390........................ Colonoscopy, flexible; with I 6.07 6.14
endoscopic mucosal resection.
45391........................ Colonoscopy, flexible; with 5.09 4.67 4.74
endoscopic ultrasound
examination limited to the
rectum, sigmoid, descending,
transverse, or ascending colon
and cecum, and adjacent
structures.
45392........................ Colonoscopy, flexible; with 6.54 5.60 5.60
transendoscopic ultrasound
guided intramural or transmural
fine needle aspiration/
biopsy(s), includes endoscopic
ultrasound examination limited
to the rectum, sigmoid,
descending, transverse, or
ascending colon and cecum, and
adjacent structures.
45393........................ Colonoscopy, flexible; with I 4.78 4.78
decompression (for pathologic
distention) (e.g., volvulus,
megacolon), including placement
of decompression tube, when
performed.
45398........................ Colonoscopy, flexible; with band I 4.30 4.30
ligation(s) (e.g., hemorrhoids).
46500........................ Injection of sclerosing solution, 1.69 1.42 1.42
hemorrhoids.
46601........................ Anoscopy; diagnostic, with high- I 1.60 1.60
resolution magnification (HRA)
(e.g., colposcope, operating
microscope) and chemical agent
enhancement, including
collection of specimen(s) by
brushing or washing, when
performed.
46607........................ Anoscopy; with high-resolution I 2.20 2.20
magnification (HRA) (e.g.,
colposcope, operating
microscope) and chemical agent
enhancement, with biopsy, single
or multiple.
47135........................ Liver allotransplantation; 83.64 90.00 90.00
orthotopic, partial or whole,
from cadaver or living donor,
any age.
50430........................ Injection procedure for antegrade NEW 3.15 3.15
nephrostogram and/or
ureterogram, complete diagnostic
procedure including imaging
guidance (e.g., ultrasound and
fluoroscopy) and all associated
radiological supervision and
interpretation; new access.
50431........................ Injection procedure for antegrade NEW 1.10 1.10
nephrostogram and/or
ureterogram, complete diagnostic
procedure including imaging
guidance (e.g., ultrasound and
fluoroscopy) and all associated
radiological supervision and
interpretation; existing access.
50432........................ Placement of nephrostomy NEW 4.25 4.25
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.
50433........................ Placement of nephroureteral NEW 5.30 5.30
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, new access.
50435........................ Exchange nephrostomy catheter, NEW 1.82 1.82
percutaneous, including
diagnostic nephrostogram and/or
ureterogram when performed,
imaging guidance (e.g.,
ultrasound and/or fluoroscopy)
and all associated radiological
supervision and interpretation.
50434........................ Convert nephrostomy catheter to NEW 4.00 4.00
nephroureteral 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.
50693........................ Placement of ureteral stent, NEW 4.21 4.21
percutaneous, including
diagnostic nephrostogram and/or
ureterogram when performed,
imaging guidance (e.g.,
ultrasound and/or fluoroscopy)
and all associated radiological
supervision and interpretation;
pre-existing nephrostomy.
[[Page 70942]]
50694........................ Placement of ureteral stent, NEW 5.50 5.50
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 separ.
50695........................ Placement of ureteral stent, NEW 7.05 7.05
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.
54437........................ Repair of traumatic corporeal NEW 11.50 11.50
tear(s).
54438........................ Replantation, penis, complete NEW 22.10 24.50
amputation including urethral
repair.
63045........................ Laminectomy, facetectomy and 17.95 17.95 17.95
foraminotomy (unilateral or
bilateral with decompression of
spinal cord, cauda equina and/or
nerve root[s], [eg, spinal or
lateral recess stenosis]),
single vertebral segment;
cervical.
63046........................ Laminectomy, facetectomy and 17.25 17.25 17.25
foraminotomy (unilateral or
bilateral with decompression of
spinal cord, cauda equina and/or
nerve root[s], [eg, spinal or
lateral recess stenosis]),
single vertebral segment;
thoracic.
65785........................ Implantation of intrastromal NEW 5.39 5.39
corneal ring segments.
68801........................ Dilation of lacrimal punctum, 1.00 0.82 0.82
with or without irrigation.
68810........................ Probing of nasolacrimal duct, 2.15 1.54 1.54
with or without irrigation.
68811........................ Probing of nasolacrimal duct, 2.45 1.74 1.74
with or without irrigation;
requiring general anesthesia.
68815........................ Probing of nasolacrimal duct, 3.30 2.70 2.70
with or without irrigation; with
insertion of tube or stent.
68816........................ Probing of nasolacrimal duct, 3.06 2.10 2.10
with or without irrigation; with
transluminal balloon catheter
dilation.
71100........................ Radiologic examination, ribs, 0.22 0.22 0.22
unilateral; 2 views.
72070........................ Radiologic examination, spine; 0.22 0.22 0.22
thoracic, 2 views.
72081........................ Entire spine x ray, one view..... NEW 0.26 0.26
72082........................ Entire spine x-ray; 2 or 3 views. NEW 0.31 0.31
72083........................ Entire spine x-ray; 4 or 5 views. NEW 0.35 0.35
72084........................ Entire spine x-ray; min 6 views.. NEW 0.41 0.41
73060........................ Radiologic examination; humerus, 0.17 0.16 0.16
minimum of 2 views.
73560........................ Radiologic examination, knee; 1 0.17 0.16 0.16
or 2 views.
73562........................ Radiologic examination, knee; 3 0.18 0.18 0.18
views.
73564........................ Radiologic examination, knee; 0.22 0.22 0.22
complete, 4 or more views.
73565........................ Radiologic examination, knee; 0.17 0.16 0.16
both knees, standing,
anteroposterior.
73590........................ Radiologic examination; tibia and 0.17 0.16 0.16
fibula, 2 views.
73600........................ Radiologic examination, ankle; 2 0.16 0.16 0.16
views.
76999........................ Unlisted ultrasound procedure C C C
(e.g., diagnostic,
interventional).
77385........................ Intensity modulated radiation I 0.00 I
treatment delivery (IMRT),
includes guidance and tracking,
when performed; simple.
77386........................ Intensity modulated radiation I 0.00 I
treatment delivery (IMRT),
includes guidance and tracking,
when performed; complex.
77387........................ Guidance for localization of I 0.58 I
target volume for delivery of
radiation treatment delivery,
includes intrafraction tracking,
when performed.
77402........................ Radiation treatment delivery, >= I 0.00 I
1 MeV; simple.
77407........................ Radiation treatment delivery, >= I 0.00 I
1 MeV; intermediate.
77412........................ Radiation treatment delivery, >= I 0.00 I
1 MeV; complex.
77767........................ Remote afterloading high dose NEW 1.05 1.05
rate radionuclide skin surface
brachytherapy, includes basic
dosimetry, when performed;
lesion diameter up to 2.0 cm or
1 channel.
77768........................ Remote afterloading high dose NEW 1.40 1.40
rate radionuclide skin surface
brachytherapy, includes basic
dosimetry, when performed;
lesion diameter over 2.0 cm and
2 or more channels, or multiple
lesions.
77770........................ Remote afterloading high dose NEW 1.95 1.95
rate radionuclide interstitial
or intracavitary brachytherapy,
includes basic dosimetry, when
performed; 1 channel.
77771........................ Remote afterloading high dose NEW 3.80 3.80
rate radionuclide interstitial
or intracavitary brachytherapy,
includes basic dosimetry, when
performed; 2-12 channels.
77772........................ Remote afterloading high dose NEW 5.40 5.40
rate radionuclide interstitial
or intracavitary brachytherapy,
includes basic dosimetry, when
performed; over 12 channels.
88346........................ Immunofluorescent study, each 0.86 0.74 0.74
antibody; direct method.
88350........................ Immunofluorescence, per specimen; NEW 0.56 0.56
each additional single antibody
stain procedure (List separately
in addition to code for primary
procedure).
88367........................ Morphometric analysis, in situ 0.73 0.73 0.73
hybridization (quantitative or
semi-quantitative), using
computer-assisted technology,
per specimen; initial single
probe stain procedure.
88368........................ Morphometric analysis, in situ 0.88 0.88 0.88
hybridization (quantitative or
semi-quantitative), manual, per
specimen; initial single probe
stain procedure.
[[Page 70943]]
91299........................ Unlisted diagnostic C C C
gastroenterology procedure.
92537........................ Caloric vestibular test with NEW 0.60 0.60
recording, bilateral; bithermal
(ie, one warm and one cool
irrigation in each ear for a
total of four irrigations).
92538........................ Caloric vestibular test with NEW 0.30 0.30
recording, bilateral;
monothermal (ie, one irrigation
in each ear for a total of two
irrigations).
99174........................ Instrument-based ocular screening N N N
(e.g., photoscreening, automated-
refraction), bilateral.
99177........................ Instrument-based ocular screening NEW N N
(e.g., photoscreening, automated-
refraction), bilateral; with on-
site analysis.
99497........................ Advance care planning including I 1.50 1.50
the explanation and discussion
of advance directives such as
standard forms (with completion
of such forms, when performed),
by the physician or other
qualified health care
professional; first 30 minutes,
face-to-face with the patient,
family member(s), and/or
surrogate.
99498........................ Advance care planning including I 1.40 1.40
the explanation and discussion
of advance directives such as
standard forms (with completion
of such forms, when performed),
by the physician or other
qualified health care
professional; each additional 30
minutes (List separately in
addition to code for primary
procedure).
G0104........................ Colorectal cancer screening; 0.96 0.77 0.84
flexible sigmoidoscopy.
G0105........................ Colorectal cancer screening; 3.69 3.29 3.36
colonoscopy on individual at
high risk.
G0121........................ Colorectal cancer screening; 3.69 3.29 3.36
colonoscopy on individual not
meeting criteria for high risk.
----------------------------------------------------------------------------------------------------------------
a. Lower GI Endoscopy Services
CPT revised the lower gastrointestinal endoscopy code set for CY
2015 following identification of some of the codes as potentially
misvalued and the affected specialty society's contention that this
code set did not allow for accurate reporting of services based upon
current medical practice. The RUC subsequently provided recommendations
to us for valuing these services. In the CY 2015 PFS final rule with
comment period, we delayed valuing the lower GI codes and indicated
that we would propose values for these codes in the CY 2016 proposed
rule, citing the new process for including proposed values for new,
revised and potentially misvalued codes in the proposed rule as one of
the reasons for the delay.
(1) Gastrointestinal (GI) Endoscopy (CPT Codes 43775, 44380-46607 and
HCPCS Codes G0104, G0105, and G0121)
In the CY 2014 PFS final rule with comment period, we indicated
that we used what we called an ``incremental difference methodology''
in valuing the upper GI codes for that year. We explained that the RUC
made extensive use of a methodology that uses the incremental
difference in codes to determine values for many of these services.
This methodology uses a base code or other comparable code and
considers what the difference should be between that code and another
code by comparing the differentials to those for other sets of similar
codes. As with the esophagoscopy subfamily, many of the procedures
described within the colonoscopy subfamily have identical counterparts
in the esophagogastroduodenoscopy (EGD) subfamily. For instance, the
base colonoscopy CPT code 45378 is described as ``Colonoscopy,
flexible; diagnostic, including collection of specimen(s) by brushing
or washing when performed, (separate procedure).'' The base EGD CPT
code 43235 is described as ``Esophagogastroduodenoscopy, flexible,
transoral; diagnostic, with collection of specimen(s) by brushing or
washing, when performed.'' In valuing other codes within both
subfamilies, the RUC frequently used the difference between these two
base codes as an increment for measuring the difference in work
involved in doing a similar procedure utilizing colonoscopy versus
utilizing EGD. For example, the EGD CPT code 43239 includes a biopsy in
addition to the base diagnostic EGD CPT code 43235. The RUC valued this
by adding the incremental difference in the base colonoscopy code over
the base EGD CPT code to the value it recommended for the esophagoscopy
biopsy, CPT code 43202. With some variations, the RUC used this
incremental difference methodology extensively in valuing subfamilies
of codes. In the CY 2016 PFS proposed rule, we made use of similar
methodologies in establishing the proposed work RVUs for codes in this
family.
We agreed with several of the RUC recommendations for codes in this
family. Where we did not agree, we consistently applied the incremental
difference methodology. Table 12 reflects how we applied this
methodology and the values we proposed. To calculate the base RVU for
the colonoscopy subfamily, we looked at the current intraservice time
for CPT code 45378, which is 30 minutes, and the current work RVU,
which is 3.69. The RUC recommended an intraservice time of 25 minutes
and 3.36 RVUs. We then compared that service to the base EGD CPT code
43235 for which the RUC recommended a work RVU of 2.26, giving an
increment between EGD and colonoscopy of 1.10 RVUs. We added that
increment to our proposed work RVU for CPT code 43235 of 2.19 to arrive
at our proposed work RVU for the base colonoscopy CPT code 45378 of
3.29. We used this value as the base code in the incremental
methodology for establishing the proposed work RVU for the other base
codes in the colonoscopy subfamilies which were then used to value the
other codes in that subfamily.
Comment: Many commenters expressed concerns that the proposed
values for the lower GI code set will hinder efforts to reduce the
incidence of colorectal cancer through detection and treatment by
limiting access to screenings. Comments stated,
[[Page 70944]]
``According to a poll of more than 550 gastroenterologists, more than
half of the respondents plan to limit new Medicare patients if the
proposed cuts are implemented; 55 percent plan to limit procedures to
Medicare patients; and 15 percent are considering opting out of
Medicare entirely. These findings suggest that GI physicians may not be
able to maintain the current mix of Medicare patients and protect the
financial viability of their practices.'' Some commenters specifically
disagreed with CMS' methodology of applying an incremental difference
between the base procedure for upper GI and lower GI, stating they
believe that is a misapplication of the incremental approach and some
noted that they believe that the upper and lower GI services are
clinically distinct. Additionally, many commenters expressed
disappointment that CMS did not consider the survey results, which they
believe are the most reliable indicator of the work involved in
colonoscopy. These commenters suggested that CMS adopt the RUC-
recommended values for the lower GI code set. Additionally, the
affected specialty societies suggested that we accept their original
recommendations (a work RVU of 3.51 for the base colonoscopy code, CPT
code 45378). Some commenters stated that new colorectal cancer
screening protocols have resulted in increased work due to the
attention required to identify and remove precancerous lesions.
Response: In developing the proposed work RVUs, we did consider the
survey data. However, we considered the survey data in the context of
the work RVUs for services within the broader endoscopy family. While
we continue to believe that relativity among families of codes is
important and view the upper and lower endoscopy codes as one code
family, in the context of receiving many comments urging us to accept
the RUC-recommended value for diagnostic colonoscopy (and thus the
screening colonoscopy), we reconsidered the differences between the
RUC-recommended value and our proposed RVUs. We do not believe the
relatively small difference between these two values is itself likely
to present significant issues in PFS relativity. Therefore, we agree
with commenters that the RUC-recommended values generally reflect the
work resources involved in furnishing the service and we are finalizing
the RUC-recommended value of 3.36 RVUs for the base colonoscopy code,
CPT code 45378, and are adjusting the valuation of all the other codes
in the lower GI code set using that base with the incremental
difference methodology. We also note that while we appreciate and share
commenters' interest in maintaining beneficiaries' access to screening
colonoscopies where appropriate under the current benefit, we believe
that establishing RVUs that most accurately reflect the relative
resource costs involved in furnishing services paid under the PFS is
not only required by the statute, but also important to preserve and
promote beneficiary access to all PFS services.
Comment: A few commenters requested that CMS delay finalizing
values for the lower GI codes until codes that are used to report
moderate sedation are separately valued, since implementation of those
codes will require a methodology for removing the work RVUs for
moderate sedation from the endoscopy codes.
Response: We will review and consider recommendations from the
medical community about the work RVUs associated with moderate sedation
and will address the valuation of moderation sedation separately. Since
moderate sedation is a broad, cross-cutting issue that affects many
specialties and code families, we do not believe that it is appropriate
to delay finalizing values for all codes with moderate sedation, and
therefore, will not do so for the GI codes.
Comment: A few commenters stated disagreement with CMS' proposed PE
refinement to remove the mobile instrument table (EF027) from codes
45330 and 45331on the basis that the procedures do not include moderate
sedation. The commenter noted that, ``while the mobile instrument table
is part of the moderate sedation standard package and moderate sedation
is not inherent in the procedure, it is still a necessary part of
flexible sigmoidoscopy codes 45330 and 45331.''
Response: We agree with the commenter that the mobile instrument
table is typically involved in furnishing these services, even though
moderate sedation may not be inherent in the procedure. Therefore, we
have included the mobile instrument table (EF027) in the direct PE
input database for codes 45330 and 45331.
Comment: We received a comment on the proposed PE refinements made
to CPT code 45330, stating that the RUC approved sterile water for CPT
code 43450 instead of distilled water due to the risk of infections and
potential for contamination. The commenter stated an expectation that
all GI endoscopy codes that currently contain distilled water should be
revised to include sterile water instead.
Response: We have considered the comment; however, we re-examined
the RUC-recommended direct PE inputs, and we did not identify the
sterile water as part of that recommendation. Additionally, the
commenter did not provide a detailed rationale for the use of sterile
water over distilled water. Therefore, for CY 2016, we are finalizing
the inputs for code 45330 as proposed. However, we are seeking
additional information regarding these inputs (including rationale and
explanation for the use of the commenter's recommended inputs) and we
will consider this issue for future rulemaking.
Table 12--Application of the Incremental Difference Methodology
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Finalized
WRVU (using
HCPCS Descriptor Current RUC WRVU Base procedure Base RVU Increment Increment Proposed 3.36 RVUs
WRVU value WRVU for the
base)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
44380............................... Ileoscopy, through 1.05 0.97 Colonoscopy............ 3.29 Colonoscopy to -2.39 0.9 0.97
stoma; diagnostic, Ileoscopy.
including collection
of specimen(s) by
brushing or washing,
when performed.
44382............................... Ileoscopy, through 1.27 1.27 Ileoscopy.............. 0.9 Biopsy................. 0.3 1.2 1.27
stoma; with biopsy,
single or multiple.
[[Page 70945]]
44384............................... Ileoscopy, through NA 3.11 Ileoscopy.............. 0.9 Stent.................. 1.98 2.88 2.95
stoma; with placement
of endoscopic stent
(includes pre- and
post-dilation and
guide wire passage,
when performed).
44385............................... Endoscopic evaluation 1.82 1.3 Colonoscopy............ 3.29 Colonoscopy to endo. -2.06 1.23 1.3
of small intestinal eval..
pouch (e.g., Kock
pouch, ileal reservoir
[S or J]); diagnostic,
including collection
of specimen(s) by
brushing or washing,
when performed.
44386............................... Endoscopic evaluation 2.12 1.6 Endo. Eval............. 1.23 Biopsy................. 0.3 1.53 1.6
of small intestinal
pouch (eg, Kock pouch,
ileal reservoir [S or
J]); with biopsy,
single or multiple.
44388............................... Colonoscopy through 2.82 2.82 Colonoscopy............ 3.29 Colonoscopy to -0.54 2.75 2.82
stoma; diagnostic, Colonoscopy through
including collection stoma.
of specimen(s) by
brushing or washing,
when performed
(separate procedure).
44389............................... Colonoscopy through 3.13 3.12 Colonoscopy through 2.75 Biopsy................. 0.3 3.05 3.12
stoma; with biopsy, stoma.
single or multiple.
44390............................... Colonoscopy through 3.82 3.82 Colonoscopy through 2.75 Foreign body........... 1.02 3.77 3.84
stoma; with removal of stoma.
foreign body.
44402............................... Colonoscopy through 4.7 4.96 Colonoscopy through 2.75 Stent.................. 1.98 4.73 4.8
stoma; with endoscopic stoma.
stent placement
(including pre- and
post-dilation and
guidewire passage,
when performed).
44403............................... Colonoscopy through NA 5.81 Colonoscopy through 2.75 Endoscopic mucosal 2.78 5.53 5.6
stoma; with endoscopic stoma. resection.
mucosal resection.
44404............................... Colonoscopy through NA 3.13 Colonoscopy through 2.75 Submucosal injection... 0.3 3.05 3.12
stoma; with directed stoma.
submucosal
injection(s), any
substance.
44406............................... Colonoscopy through NA 4.41 Colonoscopy through 2.75 Endoscopic ultrasound.. 1.38 4.13 4.2
stoma; with endoscopic stoma.
ultrasound
examination, limited
to the sigmoid,
descending,
transverse, or
ascending colon and
cecum and adjacent
structures.
45330............................... Sigmoidoscopy, 0.96 0.84 Colonoscopy............ 3.29 Colonoscopy to -2.52 0.77 0.84
flexible; diagnostic, Sigmoidoscopy.
including collection
of specimen(s) by
brushing or washing
when performed.
45331............................... Sigmoidoscopy, 1.15 1.14 Sigmoidoscopy.......... 0.77 Biopsy................. 0.3 1.07 1.14
flexible; with biopsy,
single or multiple.
45332............................... Sigmoidoscopy, 1.79 1.85 Sigmoidoscopy.......... 0.77 Foreign body........... 1.02 1.79 1.86
flexible; with removal
of foreign body.
[[Page 70946]]
45335............................... Sigmoidoscopy, 1.46 1.15 Sigmoidoscopy.......... 0.77 Submucosal injection... 0.3 1.07 1.14
flexible; with
directed submucosal
injection(s), any
substance.
45341............................... Sigmoidoscopy, 2.6 2.43 Sigmoidoscopy.......... 0.77 Endoscopic ultrasound.. 1.38 2.15 2.22
flexible; with
endoscopic ultrasound
examination.
45346............................... Sigmoidoscopy, NA 2.97 Sigmoidoscopy.......... 0.77 Ablation............... 2.07 2.84 2.91
flexible; with
ablation of tumor(s),
polyp(s), or other
lesion(s) (includes
pre- and post-dilation
and guide wire
passage, when
performed).
45347............................... Sigmoidoscopy, NA 2.98 Sigmoidoscopy.......... 0.77 Stent.................. 1.98 2.75 2.82
flexible; with
placement of
endoscopic stent
(includes pre- and
post-dilation and
guide wire passage,
when performed).
45349............................... Sigmoidoscopy, NA 3.83 Sigmoidoscopy.......... 0.77 Endoscopic mucosal 2.78 3.55 3.62
flexible; with resection.
endoscopic mucosal
resection.
45378............................... Colonoscopy, flexible; 3.69 3.36 Colonoscopy............ 3.29 3.36
diagnostic, including
collection of
specimen(s) by
brushing or washing,
when performed,
(separate procedure).
45379............................... Colonoscopy, flexible; 4.68 4.37 Colonoscopy............ 3.29 Foreign body........... 1.02 4.31 4.38
with removal of
foreign body.
45380............................... Colonoscopy, flexible, 4.43 3.66 Colonoscopy............ 3.29 Biopsy................. 0.3 3.59 3.66
proximal to splenic
flexure; with biopsy,
single or multiple.
45381............................... Colonoscopy, flexible; 4.19 3.67 Colonoscopy............ 3.29 Submucosal injection... 0.3 3.59 3.66
with directed
submucosal
injection(s), any
substance.
45389............................... Colonoscopy, flexible; NA 5.5 Colonoscopy............ 3.29 Stent.................. 1.98 5.27 5.34
with endoscopic stent
placement (includes
pre- and post-dilation
and guide wire
passage, when
performed).
45390............................... Colonoscopy, flexible; NA 6.35 Colonoscopy............ 3.29 Endoscopic mucosal 2.78 6.07 6.14
with endoscopic resection.
mucosal resection.
45391............................... Colonoscopy, flexible; 5.09 4.95 Colonoscopy............ 3.29 Endoscopic ultrasound.. 1.38 4.67 4.74
with endoscopic
ultrasound examination
limited to the rectum,
sigmoid, descending,
transverse, or
ascending colon and
cecum, and adjacent
structures.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
(2) Laparoscopic Sleeve Gastrectomy (CPT Code 43775)
Prior to CY 2013, CPT code 43775 described a non-covered service.
For CY 2013, this service was covered as part of the bariatric surgery
National Coverage Determination (NCD) and has been contractor-priced
since 2013. In the CY 2016 PFS proposed rule, we proposed to establish
national pricing for CPT code 43775. To establish a work RVU, we
crosswalked the work RVUs for this code from CPT code 37217
(Transcatheter placement of an intravascular stent(s), intrathoracic
common carotid artery or innominate artery by retrograde treatment, via
open ipsilateral cervical carotid artery
[[Page 70947]]
exposure, including angioplasty, when performed, and radiological
supervision and interpretation), due to their identical intraservice
times, similar total times, and similar levels of intensity. Therefore,
we proposed a work RVU of 20.38 for CPT code 43775.
Comment: Some commenters noted that CPT code 43775 was reviewed at
the April 2009 RUC meeting and that the RUC submitted recommendations
to CMS for CY 2010, including a recommendation of 21.40 work RVUs for
CPT code 43775. The commenters stated that those recommendations are
still valid and requested that CMS accept the RUC recommended work RVU
of 21.40 for CPT code 43775.
Response: We thank the commenters for pointing out the previous RUC
recommendations from April 2009. We continue to believe that the
proposed work RVU is appropriate based on the reasons stated in the
proposed rule, and therefore, for CY 2016, we are finalizing a work RVU
of 20.38 for CPT code 43775.
Comment: A few commenters noted that they believe the crosswalk
code used by CMS (CPT code 37217) does encourage relativity, but
because it is an endovascular procedural code, does not accurately
capture all aspects of a bariatric surgical patient in the pre-service,
intra-service, or post-service periods. Commenters stated that they
believed a comparison within the code family would provide an
assessment that is more accurate. The commenters urged CMS to accept
the previous valuation of 21.56.
Response: After consideration of the comments, we continue to
believe that the proposed work RVU is appropriate based on the reasons
stated in the proposed rule, and that it maintains relativity within
its family of codes. Therefore, for CY 2016, we are finalizing a work
RVU of 20.38 for CPT code 43775.
(3) Incomplete Colonoscopy (CPT codes 44388, 45378, G0105, and G0121)
Prior to CY 2015, according to CPT instruction, an incomplete
colonoscopy was defined as a colonoscopy that did not evaluate the
colon past the splenic flexure (the distal third of the colon). In
accordance with that definition, the Medicare Claims Processing Manual
(pub. 100-04, chapter 12, section 30.1.B., available at http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items) states that physicians should report an incomplete
colonoscopy with 45378 and append modifier -53, which is paid at the
same rate as a sigmoidoscopy.
In CY 2015, the CPT instruction changed the definition of an
incomplete colonoscopy to a colonoscopy that does not evaluate the
entire colon. The 2015 CPT Manual states when performing a diagnostic
or screening endoscopic procedure on a patient who is scheduled and
prepared for a total colonoscopy, if the physician is unable to advance
the colonoscope to the cecum or colon-small intestine anastomosis due
to unforeseen circumstances, report 45378 (colonoscopy) or 44388
(colonoscopy through stoma) with modifier -53 and provide appropriate
documentation.
Given that the new definition of an incomplete colonoscopy also
includes colonoscopies where the colonoscope is advanced past the
splenic flexure but not to the cecum, we proposed to establish new
values for the incomplete colonoscopies, reported with the -53
modifier. At present, we crosswalk the RVUs for the incomplete
colonoscopies from the values of the corresponding sigmoidoscopy. Given
that the new CPT instructions will reduce the number of reported
complete colonoscopies and increase the number of colonoscopies that
proceeded further toward completion reported with the -53 modifier, we
believe CPT code 45378 reported with the -53 modifier will now describe
a more resource-intensive group of services than were previously
reported. Therefore, we proposed to develop RVUs for these codes
reported with the -53 modifier by using one-half the value of the
inputs for the corresponding codes reported without the -53 modifier.
In addition to this change in input values, we also solicited
comments on how to address the disparity of resource costs among the
broader range of services now described by the colonoscopy codes billed
with the -53 modifier. We believe that it may be appropriate for
practitioners to report the sigmoidoscopy CPT code 45330 under
circumstances when a beneficiary is scheduled and prepared for a total
colonoscopy (diagnostic colonoscopy, screening colonoscopy or
colonoscopy through stoma), but the practitioner is unable to advance
the colonoscope beyond the splenic flexure. We solicited comments and
recommendations on that possibility, as well as more generally, the
typical resource costs of these incomplete colonoscopy services under
CPT's new definition. Finally, we solicited information regarding the
number of colonoscopies that will be considered incomplete under CPT's
new definition relative to the old definition, as well as the number of
incomplete colonoscopies where the practitioner is unable to advance
the colonoscope beyond the splenic flexure. This information will help
us determine whether or not differential payment is required, and if it
is, how to make the appropriate utilization assumptions within our
ratesetting process.
Comment: Some commenters agreed with the proposed policy of using
the-53 modifier to identify the reduced work involved with an
incomplete colonoscopy and a reimbursement that is 50 percent of the
full procedure. However, some noted that instances where the cecum is
not reached immediately would be associated with greater PE than
sigmoidoscopy, noting that the endoscopist will have utilized a
colonoscope for the procedure requiring greater work for staff to clean
and also noted that the endoscopist will commonly obtain a pediatric
endoscope to navigate the narrowed sigmoid. Commenters also stated that
sigmoidoscopy is a procedure commonly performed without moderate
sedation. One commenter recommended that CMS establish a new modifier
for instances in which the colonoscope has passed beyond the splenic
flexure but has not reached the cecum or small bowel--large bowel
anastomosis due to inadequate preparation precluding high-quality
examination of the lumen of the bowel or technical limitations that
preclude the ability of the physician to safely complete the
examination of the colon. The commenter also recommended that payment
for the professional services for colonoscopy in these circumstances be
adjusted to 75 percent of the payment for the colonoscopy procedure,
noting that appending this new modifier to the professional services
for the procedure would allow the same or other physician to bring the
patient back for another colonoscopy examination within 2 months
without triggering the frequency limitation under the Act, and that
facility payment for the procedure would not be adjusted when this
modifier is reported with codes 45378, G0105 or G0121.
Response: We appreciate the commenters' support for the proposed
policy of using the-53 modifier. We also appreciate the additional
feedback regarding the resource costs of incomplete colonoscopies and
will consider whether further changes to valuation or the coding
structure are necessary in future rulemaking.
(4) Malpractice (MP) Crosswalk
We examined the RUC-recommended MP crosswalk for this family of
codes. The MP crosswalks are used to identify the presumed mix of
specialties that
[[Page 70948]]
furnish particular services until there is Medicare claims data for the
new codes. We direct the reader to section II.B.1. of this final rule
with comment period for further explanation regarding these crosswalks.
In reviewing the recommended MP crosswalks for CPT codes 43775, 44407,
44408, 46601, and 46607, we noted that the RUC-recommended MP crosswalk
codes are inconsistent with our analysis of the specialties likely to
furnish the service based on the description of the services and our
review of the RUC-recommended utilization crosswalk. The inconsistency
between the RUC-recommended MP and utilization crosswalks is not
altogether unusual. However when there are discrepancies between the MP
and utilization crosswalk recommendations, they generally reflect the
RUC's expectation that due to changes in coding, there will be a
different mix of specialties reporting a new code than might be
reflected in the claims data for the code previously used to report
that service. This often occurs when the new coding structure for a
particular family of services is either more or less specific than the
old set of codes. In most of these cases, we could identify a rationale
for why the RUC-recommended MP crosswalks for these codes were likely
to be more accurate than the RUC-recommended utilization crosswalk. But
in the case of these codes, the reason for the discrepancies were
neither apparent nor explained as part of the recommendation. Since the
specialty mix in the claims data is used to determine the specialty mix
for each HCPCS code for the purposes of calculating MP RVUs, and those
data will be used to set the MP RVUs once it is available, we believe
using a specialty mix derived from the claims data of the predecessor
codes is more likely to be accurate than the RUC-recommended MP
crosswalk as well as more likely to result in stable MP RVUs for these
services over several years. Therefore, until claims data under the new
set of codes are available, we proposed to use the specialty mix of the
source code(s) in the RUC-recommended utilization crosswalk to
calculate the malpractice risk factor for these services instead of the
RUC-recommended MP crosswalk. Once claims data are available, those
data will be incorporated into the calculation of MP RVUs for these
services under the MP RVU methodology.
Comment: The RUC commented that they support CMS' decision to use
the utilization crosswalk in determining the malpractice crosswalk for
CPT code 43775 given that there are newer data since the RUC last
reviewed this code in 2009. However, the RUC commented that it did not
agree with this proposed decision for the other four services, CPT
codes 44407, 44408, 46601, and 46607, stating that its MP crosswalks
for these codes were based on the intended specialty mix.
Response: We continue to believe that the RUC-recommended MP
crosswalk codes are inconsistent with our analysis of the specialties
likely to furnish the service based on the description of the services
and our review of the RUC recommended utilization crosswalk. Therefore,
for CY 2016, we are finalizing these malpractice crosswalk codes as
proposed.
b. Radiation Treatment and Related Image Guidance Services
For CY 2015, the CPT Editorial Panel revised the set of codes that
describe radiation treatment delivery services based in part on the CMS
identification of these services as potentially misvalued in CY 2012.
We identified these codes as potentially misvalued under a screen
called ``Services with Stand-Alone PE Procedure Time.'' We proposed
this screen following our discovery of significant discrepancies
between the RUC-recommended 60 minute procedure time assumptions for
intensity modulated radiation therapy (IMRT) and information available
to the public suggesting that the procedure typically took between 5
and 30 minutes per treatment.
The CPT Editorial Panel's revisions included the addition and
deletion of several codes and the development of new guidelines and
coding instructions. Four treatment delivery codes (77402, 77403,
77404, and 77406) were condensed into 77402 (Radiation Treatment
Delivery, Simple), three treatment delivery codes (77407, 77408, 77409)
were condensed into 77407 (Radiation treatment delivery, intermediate),
and four treatment codes (77412, 77413, 77414, 77416) were condensed
into 77412 (Radiation treatment delivery, complex). Intensity Modulated
Radiation Therapy (IMRT) treatment delivery, previously reported under
a single code, was split into two codes, 77385 (IMRT treatment
delivery, simple) and 77386 (IMRT treatment delivery, complex). The CPT
Editorial Panel also created a new image guidance code, 77387 (Guidance
for localization of target volume for delivery of treatment, includes
intrafraction tracking when performed) to replace 77014 (computed
tomography guidance for placement of radiation therapy fields), 77421
(stereoscopic X-ray guidance for localization of target volume for the
delivery of radiation therapy,) and 76950 (ultrasonic guidance for
placement of radiation therapy fields) when any of these services were
furnished in conjunction with radiation treatment delivery.
In response to stakeholder concerns regarding the magnitude of the
coding changes and in light of the process changes we adopted for
valuing new and revised codes, we did not implement interim final
values for the new codes and delayed implementing the new code set
until 2016. To address the valuation of the new code set through
proposed rulemaking, and continue making payment based on the previous
valuations even though CPT deleted the prior radiation treatment
delivery codes for CY 2015, we created G-codes that mimic the
predecessor CPT codes (79 FR 67667).
We proposed to establish values for the new codes based on RUC
recommendations, subject to standard CMS refinements. We also note that
because the invoices used to price the capital equipment included ``on-
board imaging,'' and based on our review of the information used to
price the equipment, we considered the costs of that equipment already
to be reflected in the price per minute associated with the capital
equipment. Therefore, we did not propose to include it as a separate
item in the direct PE inputs for these codes, even though it appeared
as a separate item on the PE worksheet included with the RUC
recommendations for these codes. The proposed direct PE inputs for
those codes were displayed the proposed direct PE input database
available on the CMS Web site under the supporting data files for the
CY 2016 PFS proposed rule with comment period at http://www.cms.gov/PhysicianFeeSched/. The RVUs that result from the use of these direct
PE inputs (and work RVUs and work time, as applicable) were displayed
in proposed rule Addendum B on the CMS Web site.
We received many comments regarding various aspects of our proposal
to implement the new CPT codes for radiation treatment services based
on our refinement of RUC-recommended input values. Some commenters
addressed issues for which we explicitly sought comment, while several
commenters brought other issues to our attention. We address these
comments in the following paragraphs.
(1) Image Guidance Services
Under the previous CPT coding structure, image guidance was
separately billable when furnished in
[[Page 70949]]
conjunction with the radiation treatment delivery services. The image
guidance was reported using different CPT codes, depending on which
image guidance modality was used. These codes were split into
professional and/or technical components that allowed practitioners to
report a single component or the global service. The professional
component of each of these codes included the work of the physician
furnishing the image guidance. CPT code 77014, used to report CT
guidance, had a work RVU of 0.85; CPT code 77421, used to report
stereotactic guidance, had a work RVU of 0.39, and CPT code 76950, used
to report ultrasonic guidance, had a work RVU of 0.58. The technical
component of these codes incorporated the resource costs of the image
guidance capital equipment (such as CT, ultrasound, or stereotactic)
and the clinical staff involved in furnishing the image guidance
associated with the radiation treatment. When billed globally, the RVUs
reflected the sum of the professional and technical components. In the
revised coding structure, one new image guidance code is to be reported
regardless of the modality used, and in developing its recommended
values, the RUC assumed that CT guidance would be typical.
However, the 2013 Medicare claims data for separately reported
image guidance indicated that stereotactic guidance for radiation
treatment services was furnished more frequently than CT guidance. The
RUC recommended a work RVU of 0.58 and associated work times of three
pre-service minutes, 10 intraservice minutes, and three post-service
minutes for image guidance CPT code 77387. We reviewed this
recommendation considering the discrepancy between the modality the RUC
assumed to be typical in the vignette and the modality typically
reported in the Medicare claims data. Given that the recommended work
RVU for the new single code is similar to the work RVUs of the
predecessor codes, roughly prorated based on their distribution in
Medicare claims data, we agree with the RUC-recommended work RVU for
the service. However, the RUC also recommended an increase in overall
work time associated with image guidance consistent with the survey
data used to value the new services. If accurate, this increase in time
and maintenance of total work would suggest a decrease in the overall
intensity for image guidance relative to the current codes. We
solicited comments as to the appropriate work time associated with CPT
code 77387.
Comment: Commenters provided feedback that work time of 16 minutes
is accurate for 77387, consistent with the RUC recommendation without
explaining why the work time associated with image guidance has changed
significantly.
Response: We appreciate that commenters responded to our
solicitation but the commenters did not provide a rationale for why the
recommended work time for the new code would be significantly different
than the current work time for the most frequently reported predecessor
code. Absent an explanation, we remain concerned that the aspects of
the recommended values for the new single modality code were developed
based on erroneous assumptions regarding what imaging modality is most
frequently used to provide guidance for radiation treatment services.
Although CPT codes 77421 (stereotactic guidance) and 76950
(ultrasonic guidance) have been deleted, we note that CPT maintained
CPT code 77014 (Computed tomography guidance for placement of radiation
therapy fields). The RUC recommendation stated that the CPT editorial
panel maintained CPT code 77014 based on concerns that without this
option, some practitioners might have no valid CPT alternative than to
use higher valued diagnostic CT codes when they used this CT guidance.
The RUC recommendation also included a statement that utilization of
this code was expected to drop to negligible levels in 2015, assuming
that practitioners would use the new codes that are not differentiated
based on imaging modality. Once all the new codes are implemented for
Medicare, we anticipate that CPT and/or the RUC will address the
continued use of 77014 and, if it continues to be part of the code set,
provide recommendations as to the appropriate values given changes in
utilization.
Comment: Several commenters stated that, while they believe that
the volume for 77014 will fall to negligible levels, they support CMS'
adoption of the decision to continue to monitor and review this code.
Response: We appreciate commenters support and the stakeholder
interest in making certain that the codes accurately describe the
services furnished to Medicare beneficiaries.
Regarding the reporting of the new image guidance codes, CPT
guidance instructs that the technical portion of image guidance is now
bundled into the IMRT and stereotactic radiation treatment delivery
codes, but it is not bundled into the simple, intermediate, and complex
radiation treatment delivery codes. CPT guidance states that the
technical component of the image guidance code can be reported with CPT
codes 77402, 77407, and 77412 (simple, intermediate, and complex
radiation treatment) when furnished, which means that the technical
component of the image guidance code should not be reported with the
IMRT, stereotactic radiosurgery (SRS) or stereotactic body radiation
therapy (SBRT) treatment delivery codes. The RUC recommendation,
however, incorporated the same capital cost of image guidance equipment
(a linear accelerator, or linac), for the conventional radiation
treatment delivery codes and the the codes that describe IMRT treatment
delivery services. The RUC explained that the older lower-dose external
beam radiation machines are no longer manufactured and the image
guidance technology is integrated into the single kind of linear
accelerator used for all the radiation treatment services.
In reviewing the new code structure and the RUC recommendations for
the proposed rule, we assumed that the CPT editorial panel did not
foresee that the RUC would recommend that we develop PE RVUs for all
the radiation treatment delivery codes based on the assumption that the
same capital equipment is typically used in furnishing this range of
external beam radiation treatments. Because the RUC recommendations
incorporate the more extensive capital equipment in the lower dose
treatment codes as well, a portion of the resource costs of the
technical portion of imaging guidance are already allocated into the PE
RVUs for all of the treatment delivery codes, not just the IMRT, SRS,
and SBRT treatment delivery codes as CPT guidance would suggest.
In order to avoid incorporating the cost of this equipment into
both the treatment delivery codes (CPT codes 77402, 77407, and 77412)
and the technical component of the new imaging guidance code (CPT code
77387-TC), we considered valuing CPT code 77387 as a professional
service only and not creating the professional/technical component
splits envisioned by CPT. In the proposed rule we stated that in the
context of the budget neutral PFS, incorporating a duplicative direct
input with a cost of more than six dollars per minute would have
significant impacts on the PE RVUs for all other services. However, we
also noted that the RUC did not address this issue in its
recommendation and proposed that not all of the recommended direct PE
inputs for the
[[Page 70950]]
technical component of CPT code 77387 are capital equipment costs.
Therefore, we proposed to allow for professional and technical
component billing for these services, as reflected in CPT guidance, and
to use the RUC-recommended direct PE inputs for these services (refined
as described in Table 13 of the proposed rule (80 FR 41725-41764). We
solicited comments on the technical component billing for image
guidance in the context of the inclusion of a single linac and the RUC-
recommended integration of imaging guidance technology for all external
beam treatment codes.
Comment: Many commenters stated that it was necessary for CPT code
77387 to include both a technical and professional component because
the current price of the linear accelerator used in radiation treatment
delivery services does not include the additional costs of an
integrated image guidance system. These commenters urged CMS to retain
the technical and professional components for CPT code 77387 on the
basis that there are equipment and labor costs associated with image
guidance that are not reflected in a professional-only code.
Some other commenters were concerned that the new coding structure
for image guidance did not accurately reflect the way that image
guidance is typically furnished. These commenters stated that multiple
modalities of image guidance can be used in a single procedure, and
that this heterogeneity is not reflected through a single image
guidance code.
Response: We appreciate that many commenters addressed the bundling
in the new CPT codes of the technical component of image guidance for
IMRT, SRS, and SBRT, but not for conventional radiation treatment
delivery codes. However, in reviewing the comments, we did not identify
any that address the fundamental issues we identified in the proposed
rule. We understand that commenters generally agreed that image
guidance was not necessarily typically used for conventional radiation
treatment delivery services, so the related costs should not be
embedded in the RVUs for the treatment delivery codes. We also
understand that commenters recommended that we assume that image
guidance costs, while integrated into the functionality of the linear
accelerator, represent additional capital costs and should be used in
the development of PE RVUs for these services. Despite these comments,
we were unable to reconcile the inconsistencies and potential rank
order anomalies associated with including the image guidance costs in
the IMRT treatment delivery codes but not including the image guidance
costs in the conventional radiation treatment delivery codes even
though both use the same capital equipment. Based on the RUC
recommendations and the information from the commenters, we understand
that the same linear accelerator is typically used for all of these
services, and that the image guidance is integrated into the only
linear accelerator that is currently being manufactured and that,
therefore, the image guidance costs should always be included in the
RVUs for the IMRT treatment delivery codes. Based on these comments and
the RUC-recommended values, it appears that when the same machine (with
integrated image guidance) is used for intermediate and complex
conventional treatment, the combination of the treatment costs and
image guidance costs is significantly higher than the technical costs
associated with IMRT treatment delivery furnished with image guidance.
As a result, the PE RVUs for these services include higher overall
payment for intermediate and complex conventional radiation treatment
with imaging guidance than for simple IMRT treatment delivery with
imaging guidance. After review of the comments, we continue to believe
that this creates problematic rank order anomalies, both relative to
the accuracy of the assumed costs and the financial incentives
associated with Medicare paying more overall for conventional radiation
treatment than for IMRT services.
Comment: Many commenters, including equipment manufacturers,
suggested that linacs that include integrated image guidance are
significantly more expensive than the $2.6 million CMS proposed in the
direct practice expense input database. One commenter, a manufacturer
of linear accelerators, submitted several invoices intended to indicate
that the price of a new linear accelerator is significantly higher than
the current price in the direct PE input database. This commenter
suggested that this higher price was due in part to the integrated
image guidance, inherent in all new linear accelerators. The commenter
also submitted invoices intended to illustrate the price of upgrading
an older linear accelerator with image guidance capability.
Response: We appreciate the submission of invoices that indicate
prices for linear accelerators with image guidance and the price
associated with updating existing linacs with image guidance. In our
analysis of these documents, however, we identified several aspects
that make us hesitant to use the documents to change the price of the
equipment in the direct PE input database. First, many of the invoices
listed a total contract value that was distinct from the sum of total
prices listed on the invoice. The documents themselves did not include
any explanation regarding the significant differences in value between
these two prices and whether or not the differences in value represent
costs related to other direct PE input equipment items, factors already
incorporated into the equipment cost per minute calculation, or items
included in the allocation of indirect PE. For example, some line items
included the description of items such as ``travel and lodging,''
``education,'' and treatment planning software or software upgrades
that are already accounted for in the allocation of indirect PE. In
many cases line-item prices were not included, making it difficult to
identify the portion of the total invoice price attributable to direct
equipment costs, which is necessary under the established PE
methodology. Therefore, we will maintain the current equipment price
for CY 2016 while we seek accurate information regarding the price of
this capital equipment.
(2) Equipment Utilization Rate for Linear Accelerators
The cost of the capital equipment is the primary determining factor
in the payment rates for these services. For each CPT code, the
equipment costs are estimated based on multiplying the assumed number
of minutes the equipment is used for that procedure by the per minute
cost of the particular equipment item. Under our PE methodology, we
currently use two default equipment usage assumptions in allocating
capital equipment costs to calculate PE RVUs. The first is that each
equipment item is only available to be used during what are assumed to
be regular business hours for a physician's office: 10 hours per day, 5
days per week (50 hours per week) and 50 weeks per year. The second
assumption is that the equipment is in use only 50 percent of the time
that it is available for use. The current default 50 percent
utilization rate assumption translates into 25 hours per week out of a
50-hour work week.
We have previously addressed the accuracy of these default
assumptions as they apply to particular equipment resources and
particular services. In the CY 2008 PFS proposed rule (72 FR 38132), we
discussed the 50 percent utilization assumption and acknowledged that
the default 50
[[Page 70951]]
percent usage assumption is unlikely to capture the actual usage rates
for all equipment. However, we stated that we did not believe that we
had strong empirical evidence to justify any alternative approaches. We
indicated that we would continue to monitor the appropriateness of the
equipment utilization assumption, and evaluate whether changes should
be proposed in light of the data available.
Subsequently, a 2009 report on equipment utilization by MedPAC
included studies that suggested a higher utilization rate for
diagnostic imaging equipment costing more than $1 million. These
studies cited by MedPAC suggested that for Magnetic Resonance Imaging
equipment, a utilization rate of 92 percent on a 50-hour week would be
most accurate. Similarly, another MedPAC-cited study suggested that for
computed tomography scanners, 45 hours was more accurate, and would be
equivalent to a 90 percent utilization rate on a 50-hour work week. For
the CY 2010 PFS proposed rule, we proposed to increase the equipment
usage rate to 90 percent for all services containing equipment that
cost in excess of $1 million dollars. We stated that the studies cited
by MedPAC suggested that physicians and suppliers would not typically
make huge capital investments in equipment that would only be utilized
50 percent of the time (74 FR 33532).
In response to comments to that proposal, we finalized a 90 percent
utilization rate assumption for MRI and CT to be transitioned over a 4-
year period. Regarding the utilization assumptions for other equipment
priced over $1 million, we stated that we would continue to explore
data sources regarding use of the most accurate utilization rates
possible (74 FR 61755). Congress subsequently specified the utilization
rate to be assumed for MRI and CT by successive amendments to section
1848(b)(4)(C) of the Act. Section 3135(a) of the Affordable Care Act
(Pub. L. 111-148) set the assumed utilization rate for expensive
diagnostic imaging equipment to 75 percent, effective for 2011 and
subsequent years. Section 635 of the American Taxpayer Relief Act
(ATRA) (Pub. L. 112-240) set the assumed equipment utilization rate to
90 percent, effective for 2014 and subsequent years. Both of these
changes were exempted from the budget neutrality requirements described
in section 1848(c)(2)(B)(ii)(II) of the Act.
We have also made other adjustments to the default assumptions
regarding the number of hours for which the equipment is available to
be used. For example, some equipment used in furnishing services to
Medicare beneficiaries is available to be used on a 24-hour/day, 7
days/per week basis. For these items, we develop the rate per minute by
amortizing the cost over the extended period of time the equipment is
in use.
Based on the RUC recommendations for the new codes that describe
radiation treatment services, we do not believe our default assumptions
regarding equipment usage are accurate for the capital equipment used
in radiation treatment services. As we noted above, the RUC
recommendations assume that the same type of linear accelerator is now
typically used to furnish all levels and types of external beam
radiation treatment services because the machines previously used to
furnish these services are no longer manufactured. In valuing the
previous code set and making procedure time assumptions, different
equipment items were assumed to be used to furnish the different levels
and types of radiation treatment. With the current RUC-recommended
inputs, we can then assume that the same equipment item is used to
furnish more services. If we assume the RUC recommendation to include
the same kind of capital equipment for all of these codes is accurate,
we believe that it is illogical to continue to assume that the
equipment is only used for 25 out of a possible 50 hours per week. In
order to estimate the difference between the previous number of minutes
the linear accelerator was assumed to be in use under the previous
valuation and the number of minutes now being recommended by the RUC,
we applied the change in assumptions to the services reported in the
most recent year of Medicare claims data. Under the assumptions
reflected in the previous direct PE inputs, the kind of linear
accelerator used for IMRT made up a total of 44.8 million out of 65
million minutes of external beam treatments furnished to Medicare
beneficiaries. Under the new code set, however, we suggested in the
proposed rule that a single kind of linear accelerator would be used
for all of the 65 million minutes furnished to Medicare beneficiaries.
This represents a 45 percent increase in the aggregate amount of time
that this kind of linac is in use. As we noted in the proposed rule,
the utilization rate that corresponds with that increase in minutes is
not necessarily precise since the current utilization rate only
reflects the default assumption and is not itself rooted in empirical
data. Additionally, in some cases, individual practices that already
use linear accelerators for IMRT may have replaced the now-obsolete
capital equipment with new, additional linear accelerators instead of
increasing the use of capital equipment already owned. However, we do
not believe that the latter scenario is likely to be common in cases
where the linear accelerators had previously been used only 25 hours
per week.
Therefore, we proposed to adjust the equipment utilization rate
assumption for the linear accelerator to account for the significant
increase in usage. Instead of applying our default 50 percent
assumption, we proposed to use a 70 percent assumption based on the
recognition that the item is now being typically used in a
significantly broader range of services, and that would increase how
often the equipment is used in comparison to the previous assumption.
In the proposed rule, we noted that we developed the 70 percent rate
based on a rough reconciliation between the number of minutes the
equipment is being used according to the new recommendations versus the
current number of minutes based on an analysis of claims data.
Comment: Several commenters objected to our analysis specifically
because we described it as a ``rough reconciliation.''
Response: We appreciate commenters' interest in our use of the best
data available in determining what values to assign to necessary
assumptions. We regret the use of the term ``rough reconciliation'' and
clarify that our analysis relied on two somewhat imprecise data points:
The RUC procedure time assumptions for individual services and the
current 50 percent utilization assumption. Because both of these
assumptions directly determine how capital equipment costs are
translated into PE RVUs, they were essential to our analysis. However,
we recognize that these assumptions are round figures, reflecting
assumptions about what is typical. Therefore, when we combined these
numbers with precise Medicare claims data in order to develop a more
accurate assumption, we arrived at a very specific number that might
have appeared to be very precise. Recognizing that the calculation was
based on assumptions as noted above, we subsequently proposed to round
the number to 70 percent instead of using the fractional result of the
calculation. We continue to believe rounding to 70 percent is
appropriate for the reasons stated above.
Given the best available information, we believe that the 70
percent utilization assumption based on the changes in direct PE input
recommendations and Medicare claims
[[Page 70952]]
data is more accurate than the default utilization assumption of 50
percent. However, we have reviewed other information that suggests this
utilization rate may be higher than 70 percent and that the number of
available hours per week is greater than 50.
For example, as part of the 2014 RUC recommendations for the
Radiation Treatment Delivery codes, the RUC submitted a 2011 staffing
survey conducted by the American Society for Radiology Technicians
(ASRT). Using the 2014 version of the same study, we noted that there
are an average of 2.3 linacs per radiation treatment facility and 52.7
patients per day treated per radiation treatment facility. These data
suggest that an average of 22.9 patients are treated on each linac per
day. Using an average of the RUC-recommended procedure times for CPT
codes 77385, 77386, 77402, 77407, and 77412 weighted by the annual
volume of procedures derived from Medicare claims data yielded a total
of 670.39 minutes or 11.2 hours that a single linac is in use per day.
This is in contrast to both the number of hours of use reflected in our
default assumptions (5 of the 10 available business hours per day) and
in our proposed revision to the equipment utilization rate assumptions
(7 hours out of 10 available business hours per day).
For advanced diagnostic imaging services, we finalized a policy for
CY 2010 to change the equipment utilization assumption only by 10
percent per year, in response to suggestions from commenters. Because
capital equipment costs are amortized over several years, we believe it
is reasonable to transition changes to the default assumptions for
particular items over several years. We noted in the proposed rule that
the change from one kind of capital equipment to another is likely to
occur over a number of years, roughly equivalent to the useful life of
particular items as they become obsolete. In the case of most of these
items, we have assumed a 7-year useful life, and therefore, we assumed
that the transition to use of a single kind of capital equipment would
likely take place over seven years as individual pieces of equipment
age into obsolescence. However, in the case of this transition in
capital equipment, we have reason to believe that the transition to the
new capital equipment has already occurred. First, we note that the
specialty societies concluded that the single linear accelerator was
typical for these services at the time that the current recommendations
were developed in 2013. Therefore, we believe it is logical to assume
that, at a minimum, the first several years of the transition to new
capital equipment had already taken place by 2013. This would not be
surprising, given that prior to the 2013 review by the RUC, the codes
describing the non-IMRT external beam radiation treatments had last
been reviewed in 2002. Second, because we proposed to use the 2013
recommendations for the CY 2016 PFS payment rates, we believed it would
be reasonable to assume that in the years between 2013 and 2016, the
majority of the rest of the obsolete machines would have been replaced
with the single linear accelerator.
Nonetheless, we recognized that there would be value in following
precedent to transition changes in utilization assumptions over several
years.
Given the fact that it is likely that the transition to the linear
accelerator began prior to the 2013 revaluation of the radiation
treatment delivery codes by the RUC and that the useful life of the
newest generation of linear accelerator is seven years, we believe a 2-
year transition to the 70 percent utilization rate assumption would
account for any remaining time to transition to the new equipment.
Therefore, in developing PE RVUs for these services, we proposed to use
a 60 percent utilization rate assumption for CY 2016 and a 70 percent
utilization rate assumption for CY 2017. The proposed PE RVUs displayed
in Addendum B on the CMS Web site were calculated using the proposed 60
percent equipment utilization rate for the linac as displayed in the
proposed direct PE input database.
Additionally, we continue to seek empirical data on the capital
equipment costs, including equipment utilization rates, for the linac
and other capital-intensive machines, and seek comment on how to most
accurately address issues surrounding those costs within the PE
methodology.
Comment: Most commenters were opposed to changing the default
utilization assumption for linear accelerators. Many of these
commenters stated that the rationale CMS used to support the change in
default utilization assumption was inadequate and anecdotal. Several
commenters performed and submitted their own data analyses.
Response: We continue to believe a reconciliation of Medicare
claims data with the RUC-recommended procedure times results in the
most accurate equipment utilization rate assumption. We also believe
that whenever possible we should use the Medicare claims data to test
the validity and internal consistency of our ratesetting assumptions.
We do not agree with the commenters that such an approach is anecdotal.
While CMS appreciates the analyses performed by some commenters, no
additional data were submitted to substantiate these analyses.
Comment: One commenter conducted an analysis somewhat similar to
ours, but used three data sets: Medicare claims data, the ASRT staffing
survey CMS referenced in the proposed rule, and data from the CMS
physician billing public use database. Based on this analysis, the
commenter suggested that 50 percent is a more accurate utilization
assumption.
Response: We appreciate the commenter's analysis, and found it to
be very useful in considering whether or not to finalize our proposal.
However, the commenter's conclusion of a 50 percent utilization rate is
entirely dependent on what we believe is an overestimate of the number
of linacs used to deliver radiation treatment. In order to determine
the number of linacs overall, the commenter multiplied the 2.3 linacs
per center statistic cited in the ASRT staffing survey by the number of
individual billing entities reporting treatment services in the
Medicare claims data as a proxy for the number of freestanding centers.
That approach would count two radiation oncologists reporting services
in the same center as if they were practicing in two centers, not one,
and therefore overestimate the number of machines. Were the same
analysis conducted using the number of centers included in the same
ASRT staffing survey, the result of the analysis would be an
approximately 70 percent equipment utilization rate. Therefore, we did
not find the commenter's analysis persuasive.
Comment: Many commenters stated that a 70 percent utilization rate
assumption did not take into account events beyond the control of the
facility that could impact how long any given linear accelerator might
be used over the course of time. These commenters suggested that issues
such as time necessary to warm up the treatment machine, maintenance,
patient preferences, missed appointments, and multiple treatment
devices contributed to a lower utilization rate that CMS proposed to
assume.
Response: We understand that the day-to-day operation and
utilization of capital equipment will vary, and that is precisely why
the equipment cost per minute calculation does not assume that the
equipment is used for the full amount of time possible (100 percent
rate). Instead, the utilization rate assumption is used to allocate the
total cost of the equipment relative to other
[[Page 70953]]
direct PE costs on a per-minute basis. Therefore, the assumptions are
intended to reflect the percentage of total time (assuming a 50-hour
work week) payment is made for services on the machine. In assigning
minutes to individual codes, we generally assign minutes for preparing
and cleaning the equipment; therefore, these minutes would contribute
to the 70 percent portion, or 35 hours per week. In contrast, minutes
for a missed appointment would count toward the 30 percent of the 50
hours, or 15 hours per week, that the equipment is not being used.
Comment: Many commenters were concerned that a higher utilization
rate assumption would have a negative effect on rural treatment centers
and treatment centers in medically disadvantaged areas.
Response: We believe it is important to preserve access to care for
all Medicare beneficiaries. However, we believe we are obligated under
the statute to use accurate assumptions in developing RVUs for
individual services under the PFS. Under the statutory construct of the
PFS, we believe that accurate valuation for all PFS services is
important in maintaining access to care for all Medicare beneficiaries.
Comment: A few commenters suggested that CMS should phase in the
utilization rate change over four years or delay implementing the
change until 2017.
Response: We appreciate the commenters' suggestions. We did
consider these suggested alternatives as part of our rulemaking
process. Although both a longer phase-in and a delay would temporarily
mitigate the payment reductions for these services, especially in the
context of other proposed payment reductions, we did not identify any
persuasive rationale for delaying implementation or phasing in
implementation over more than 2 years.
Comment: Many commenters were concerned that the change in
utilization rate assumption was affecting all equipment items in the
radiation treatment delivery codes, and argued that it should only
apply to the linac. Commenters urged CMS to use a 50 percent
utilization rate assumption for the other equipment items. Some
commenters argued that this was contradictory to the utilization
assumption for advanced diagnostic imaging.
Response: We applied the increased utilization rate assumption
across all equipment items under the assumption that items generally
located in the same room as the linear accelerator could not be used to
furnish other services while the linear accelerator was in use, and
therefore, would be subject to the same utilization assumptions. This
approach is consistent with the application of the equipment
utilization assumption for advanced diagnostic imaging.
Comment: MedPAC expressed support for CMS' proposal to change the
equipment utilization rate assumption for linear accelerators. MedPAC
agreed that CMS should develop a normative standard based on the
assumption that those who purchase an expensive piece of capital
equipment would use it at a higher utilization rate.
Response: We appreciate MedPAC's support for the proposal.
(3) Other Equipment Cost Variables
Comment: A few commenters suggested that CMS update the price for
the radiation treatment vault to approximately $800,000 and reduce the
useful life assumption from 15 to 7 years. Several other commenters
suggested that CMS update the variable maintenance rate from the
default five percent assumption to between 10 and 15 percent.
Response: We appreciate the commenter's feedback, and acknowledge
our longstanding concerns regarding obtaining accurate, objective
information regarding the pricing of direct PE inputs, particularly the
prices for expensive equipment. In the case of the radiation treatment
vault, we believe that at least some portions of the costs associated
with the vault construction are indirect PE under the established
methodology. We will continue to consider this issue, including these
commenters' suggestion to use increased pricing for the item.
Comment: Many commenters disagreed with the classification of
``intercom'' as an indirect PE. These commenters stated that the
intercom is specifically for the practitioner to communicate directly
with the patient and, as such, it constitutes a direct PE.
Response: We remind the commenter that under the established
methodology, direct PE inputs are defined as clinical labor, disposable
supplies, and medical equipment. Other items are incorporated as
indirect costs, regardless of how the items are used.
Comment: Several commenters, including the AMA RUC, stated that CMS
should include 2 minutes for the clinical labor task ``dose output and
verification'' as it is performed on the equipment items associated
with these codes.
Response: ``Dose output and verification'' occurs during the ``pre-
service'' period and pre-service minutes are generally not allocated to
the equipment items, under our established methodology.
(4) Specialty Impacts
Comment: One commenter stated that CMS should no longer display
specialty level impacts for ``radiation therapy centers'' in the
proposed and final rule. The commenter argued that since the PFS
allowed charges associated with ``Radiation Therapy Centers'' represent
only a small portion of radiation oncology services overall, displaying
the impacts separately is misleading to the interested public.
Response: We appreciate the commenter's concerns and agree with
commenters that the PFS allowed charges associated with ``radiation
therapy centers'' is only a small portion of overall payments for
radiation oncology services, including the total amount of those
furnished outside of the hospital setting. Because we think it is
important to maintain a consistent display of specialty-level impacts
between a proposed and final rule, we are not making a change for this
year's final rule. However, we are seeking additional comment regarding
how the impacts for these services should be displayed in future
rulemaking.
(5) Implementation of New Coding
Comment: Several commenters expressed concerns about the two new
treatment delivery codes describing simple and complex IMRT treatment
delivery in contrast to the current single code. Specifically, these
commenters were concerned that that the CPT instruction that requires
treatment for prostate and breast cancer to be reported using the
simple IMRT treatment delivery code would have a negative impact on
overall treatment for patients with prostate and breast cancer. These
commenters suggested that that the new coding structure did not allow
radiation therapy providers to accurately report prostate and breast
cancer treatment services that are more resource intensive than those
described in the simple IMRT code. These commenters also stated that
the coding change including CMS' proposed valuations would have a
widespread negative impact on access to care, including reduction in
the number of freestanding centers offering radiation treatment for
breast and prostate cancer, and therefore limit patients' access to
care outside of the higher cost hospital setting.
Response: We believe that increased specificity in coding for such
a resource-intensive, high-volume group of services is a significant
improvement compared to the use of a single code to describe all IMRT
treatment services, regardless
[[Page 70954]]
of their relative resource costs. However, we understand the
commenters' concerns about the potential negative impact of
implementing the new code set for payment of treatment for breast and
prostate cancers. The primary resource cost for these services is
represented by the capital equipment, so we believe that for purposes
of most accurate payment, the optimal coding for these services would
group them based on how long the capital equipment is being used per
service, so that payment is linked to the resource costs of furnishing
particular services. Under the current set of codes, payment would be
made based on the assumptions regarding the typical resource costs for
the treatment of particular diseases, instead of the resource costs
based on the length of treatment time.
Comment: Several commenters pointed out a rank order anomaly in the
PE RVUs among codes CPT codes 77402, 77407, and 77412 that describe
simple, intermediate, and complex radiation treatment codes,
respectively. The commenters stated that it was illogical for the
intermediate radiation treatment delivery code to have higher PE RVUs
and overall payment compared to the complex radiation treatment
delivery. Commenters suggested that this anomaly may be the result of
the allocation of indirect PE because the specialty reporting the
utilization for the intermediate code is more frequently dermatology
than radiation oncology and dermatology is allocated more indirect PE
within the PE methodology.
Response: We agree with commenters that this rank order anomaly is
due to the difference in the mix of specialties in the utilization for
these services. We also agree with the commenters that such rank order
anomalies within families should be avoided when possible. We believe
these kinds of rank order anomalies generally suggest inaccurate
valuations and present risks to accurate billing and overall
ratesetting. The risks are associated with incentives toward inaccurate
downward coding. For example, in this case, individual practitioners
would have the financial incentive to report radiation treatment
delivery services using the intermediate code, even when the complex
code would be more accurate. If practitioners acted on such an
incentive, there would be serious consequences within our ratesetting
methodologies for both purposes of budget neutrality and for allocation
of PE RVUs. The increased utilization of the higher paying intermediate
code would result in inappropriately low budge neutrality adjustment
across the PFS. The rank order anomaly might also result in cyclical
fluctuations in the year-to-year allocation of PE. This would happen if
the inappropriate reporting of the intermediate code itself resulted in
a concentration of most of the overall volume (including radiation
oncology at a greater volume than dermatology) in the intermediate
code. Then, once the claims data reflecting this concentration were
incorporated into PFS ratesetting, the rank order anomaly would recur
and the cycle would begin again. In considering these comments in the
context of our proposal to implement these codes, we considered how we
might eliminate this anomaly. We concluded that the best approach would
be to maintain the total number of PE RVUs for these services overall,
but to redistribute them among the three codes in order to eliminate
the rank order anomaly. In order to do this, we would calculate the PE
RVUs for these services under the established methodology and multiply
these RVUs by the volume associated with each code. We would then
reallocate the total number of PE RVUs among the three codes based on
the weights of their direct costs included in the direct PE input
database, since the total direct costs for these codes reflect
appropriate valuation. We are seeking comment on this approach or other
possible ways to mitigate the impact of the rank order anomaly among
these codes.
Comment: One commenter stated that, in light of the significant
negative impact of the coding changes and the proposed change in the
default utilization rate assumption, CMS should delay implementation of
the new codes for another year and work with stakeholders to gather
information on the appropriate pricing of equipment items, utilization
of equipment, and coding structure. A few commenters also stated that
CMS should consider pricing radiation treatment delivery through the
OPPS. And finally, several commenters noted that the proliferation of
TC-only codes had a negative impact on the overall allocation of PE
RVUs for radiation oncology services.
Response: We agree with commenters regarding the magnitude of
changes that would result from the new code set. In general, we believe
that significant changes in coding can improve the valuation and
payment for PFS services. In the case of this set of new codes, we
believe increased granularity in IMRT treatment delivery codes would
benefit payment accuracy. We also believe that it is generally
preferable for CMS to use CPT codes to describe physicians' services
paid under the PFS and that, when possible, we should use consistent
coding between the PFS and OPPS.
In consideration of comments from stakeholders and our concerns as
described above, however, we do not believe that, on balance, we should
finalize the new code set for CY 2016. Therefore, for CY 2016, we are
not finalizing our proposal to implement the new set of codes. We will
continue the use of the current G-codes and values for CY 2016 while we
seek more information, including public comments and recommendations
regarding new codes to be developed either through the CPT process or
through future PFS rulemaking. We believe that significant changes to
the codes need to be made before we can develop accurate payment rates
under the PFS for these services. These changes would include:
developing a code set that recognizes the difference in costs between
kinds of imaging guidance modalities; making sure that this code set
facilitates valuation that incorporates the cost of imaging based on
how frequently it is actually provided; and developing treatment
delivery codes that are structured to differentiate payment based on
the equipment resources used.
While we are not finalizing the new code set for these services, we
are finalizing our proposals to include the single linear accelerator
for radiation treatment delivery services as recommended by the RUC,
and to update the default utilization rate assumption for linear
accelerators used in radiation treatment services from 50 to 70
percent, phased in over 2 years. Under either set of codes, it is clear
that the 50 percent utilization assumption is incompatible with the
times used to develop payment rates for individual procedures, given
that the same linear accelerator is used for the services.
Finally, because the costs of capital equipment are the primary
drivers of RVUs and payment amounts for these services, and we
acknowledge significant difficult in obtaining quality information
regarding the actual costs of such equipment across the wide range of
practitioners and suppliers that furnish these services, we will be
engaging in market research to develop independent estimates of
utilization and pricing for linear accelerators and image guidance used
in furnishing radiation treatment services. We will also consider ways
in which data collected from hospitals under the OPPS may be helpful in
establishing rates for these and other technical component services. We
will consider this information, including public comment, as we develop
proposals for inclusion in future notice and comment rulemaking.
[[Page 70955]]
(6) Superficial Radiation Treatment Delivery
In the CY 2015 PFS final rule with comment period, we noted that
changes to the CPT prefatory language modified the services that are
appropriately billed using CPT code 77401 (radiation treatment
delivery, superficial and/or ortho voltage, per day). The changes
effectively meant that many other procedures supporting superficial
radiation therapy were bundled with CPT code 77401. The RUC, however,
did not review the inputs for superficial radiation therapy procedures,
and therefore, did not assess whether changes in its valuation were
appropriate in light of this bundling. Some stakeholders suggested that
the change in the prefatory language precluded them from billing for
codes that were previously frequently billed in addition to this code
and expressed concern that as a result there would be significant
reduction in their overall payments. In the CY 2015 PFS final rule with
comment period, we requested information on whether the new radiation
therapy code set, combined with modifications in prefatory text,
allowed for appropriate reporting of the services associated with
superficial radiation and whether the payment continued to reflect the
relative resources required to furnish superficial radiation therapy
services.
In response to our request, we received a recommendation from a
stakeholder to make adjustments to both the work and PE components for
CPT code 77401. The stakeholder suggested that since crucial aspects of
the service, such as treatment planning and device design and
construction, were not currently reflected in CPT code 77401, and
practitioners were precluded from reporting these activities
separately, additional work should be included for CPT code 77401.
Additionally, the stakeholders suggested that the current inputs used
to value the code are not accurate because the inputs include zero work
and minutes for a radiation therapist to provide the service directly
to the patient. The stakeholders suggested, alternatively, that
physicians, not radiation therapists, typically provide superficial
radiation services directly. Finally, stakeholders also suggested that
we amend the direct PE inputs by including nurse time and updating the
price of the capital equipment used in furnishing the service.
In response, we solicited recommendations from stakeholders,
including the RUC, regarding whether or not it would be appropriate to
add physician work for this service and remove minutes for the
radiation therapists, even though physician work is not included in
other radiation treatment services. We believe it would be appropriate
to address the clinical labor assigned to the code in the context of
the information regarding the work that might be associated with the
service. We also solicited information on the possible inclusion of
nurse time for this service as part of the comments and/or
recommendations regarding work for the service. Lastly, we reviewed the
invoices submitted in response to our request to update the capital
equipment for the service.
We proposed to update the equipment item ER045 ``orthovoltage
radiotherapy system'' by renaming it ``SRT-100 superficial radiation
therapy system'' and update the price from $140,000 to $216,000, on the
basis of the submitted invoices. The proposed PE RVUs displayed in
Addendum B on the CMS Web site were calculated with this proposed
modification that was displayed in the CY 2016 direct PE input
database.
Comment: Multiple commenters from various specialty societies
responded to our request for comment. Several stated that there was
work in 77401, while other commenters stated that there was not. One
commenter suggested that CMS create a G-code to account for work, while
another commenter stated that 77401 should be resurveyed by the RUC.
Response: Given the disagreement among commenters on the work
involved in furnishing CPT code 77401, we are considering the
possibility of creating a code to describe total work associated with
the course of treatment for these services and are seeking additional
information on alternatives descriptions and valuations for a code
describing this work for consideration in future rulemaking.
Comment: A few commenters pointed out that the description of
equipment item ER045 as proposed, ``SRT-100 superficial radiation
therapy system,'' is a particular item that might better be identified
generically as ``superficial radiation therapy system.''
Response: We agree with the commenter's suggestion and have updated
the direct PE input database accordingly.
Comment: A few commenters thanked CMS for updating the price of the
superficial radiation therapy system.
Response: We appreciate the support for our proposal.
After considering the comments, we are finalizing the update to
ER045 as proposed.
c. Advance Care Planning Services
For CY 2015, the CPT Editorial Panel created two new codes
describing advance care planning (ACP) services: CPT code 99497
(Advance care planning including the explanation and discussion of
advance directives such as standard forms (with completion of such
forms, when performed), by the physician or other qualified health
professional; first 30 minutes, face-to-face with the patient, family
member(s) and/or surrogate); and an add-on CPT code 99498 (Advance care
planning including the explanation and discussion of advance directives
such as standard forms (with completion of such forms, when performed),
by the physician or other qualified health professional; each
additional 30 minutes (List separately in addition to code for primary
procedure)). In the CY 2015 PFS final rule with comment period (79 FR
67670-71), we assigned a PFS interim final status indicator of ``I''
(Not valid for Medicare purposes. Medicare uses another code for the
reporting and payment of these services) to CPT codes 99497 and 99498
for CY 2015. We said that we would consider whether to pay for CPT
codes 99497 and 99498 after we had the opportunity to go through notice
and comment rulemaking.
In the CY 2016 PFS proposed rule, for CY 2016 we proposed to assign
CPT codes 99497 and 99498 PFS status indicator ``A,'' which is defined
as: ``Active code. These codes are separately payable under the PFS.
There will be RVUs for codes with this status. The presence of an ``A''
indicator does not mean that Medicare has made a national coverage
determination regarding the service. Contractors remain responsible for
local coverage decisions in the absence of a national Medicare
policy.'' We proposed to adopt the RUC-recommended values (work RVUs,
time, and direct PE inputs) for CPT codes 99497 and 99498 beginning in
CY 2016. The services could be paid on the same day or a different day
as other E/M services. Physicians' services are covered and paid by
Medicare in accordance with section 1862(a)(1)(A) of the Act.
Therefore, under our proposal CPT code 99497 (and CPT code 99498 when
applicable) would be reported when the described service is reasonable
and necessary for the diagnosis or treatment of illness or injury. For
example, this could occur in conjunction with the management or
treatment of a patient's current condition, such as a 68 year old male
with heart failure and diabetes on multiple medications seen by his
physician for the E/M of these two
[[Page 70956]]
diseases, including adjusting medications as appropriate. In addition
to discussing the patient's short-term treatment options, the patient
may express interest in discussing long-term treatment options and
planning, such as the possibility of a heart transplant if his
congestive heart failure worsens and advance care planning including
the patient's desire for care and treatment if he suffers a health
event that adversely affects his decision-making capacity. In this case
the physician would report a standard E/M code for the E/M service and
one or both of the ACP codes depending upon the duration of the ACP
service. However the ACP service as described in this example would not
necessarily have to occur on the same day as the E/M service.
We solicited comment on this proposal, including whether payment is
needed and what type of incentives the proposal might create. In
addition, we solicited comment on whether payment for advance care
planning is appropriate in other circumstances such as an optional
element, at the beneficiary's discretion, of the annual wellness visit
(AWV) under section 1861(hhh)(2)(G) of the Act.
We received approximately 725 public comments to the proposed rule
regarding payment for ACP services. We received comments from
individual citizens; several coalitions; professional associations;
professional and community-based organizations focusing on end-of-life
health care; healthcare systems; major employers; and many individual
healthcare professionals working in primary care, geriatrics, hospice/
palliative medicine, critical care, emergency medicine and other
settings. We also received comments from chaplains, ethicists, advanced
illness counseling companies and other interested parties. The majority
of commenters expressed support for the proposal, providing
recommendations on valuation, the types of professionals who should
able to furnish or bill for the services and the appropriate setting of
care, intersection with existing codes, the establishment of standards
or specialized training, and beneficiary cost sharing and education.
Some commenters opposed or expressed provisional support for the
proposal because they believed it might create perverse financial
incentives relating to termination of patient care. We summarize all of
the comments below.
Valuation
Comment: Many commenters supported the separate identification and
payment for ACP, either by adopting CPT codes 99497 and 99498 or other
unique code(s). Many commenters supported the proposal broadly,
advocating for improved Medicare coverage and payment of ACP. Several
commenters supported our proposal to adopt the RUC-recommended payment
inputs. Several other commenters stated the proposed payment amount was
insufficient, and one of these commenters recommended a payment rate
equal to the payment for CPT code 99215 (Office or other outpatient
visit for the E/M of an established patient) in order to appropriately
account for the physician's time.
Response: We appreciate the commenters' support for separate
identification and payment for voluntary ACP services. We believe the
RUC-recommended inputs accurately reflect the resource costs involved
in furnishing the services described by CPT codes 99497 and 99498, and
therefore, are finalizing our proposal to adopt the RUC-recommended
values for both codes.
Comment: Regarding the time required to furnish ACP services, the
commenters cited times ranging from 10 minutes to several hours over
multiple encounters, depending on the setting and the patient's
condition. Several commenters requested payment for increments of time
of less than 30 minutes (for example, 10-15 minutes). One said the
services typically require 30-45 minutes of face-to-face time with the
patient and family. Several commenters recommended payment for services
lasting less than 30 minutes, for example, by pro-rating the add-on
code.
Response: We believe the CPT codes describe time increments that
are appropriate for furnishing ACP services in various settings.
Therefore we are finalizing our proposal to adopt the CPT codes and CPT
provisions regarding the reporting of timed services.
Comment: Many commenters recommended that CMS issue a national
coverage decision to avoid any local variation in coverage.
Response: We believe it may be advantageous to allow time for
implementation and experience with ACP services, including
identification of any variation in utilization, prior to considering a
controlling national coverage policy through the National Coverage
Determination process (see 78 FR 48164, August 7, 2013). By including
ACP services as an optional element of the AWV (for both the first
visit and subsequent visits), as discussed below, this rule creates an
annual opportunity for beneficiaries to access ACP services should they
elect to do so.
Comment: Many commenters recommended limits on utilization to
prevent abuse, while others recommended no utilization limits in order
to increase access and ensure periodic updates to advance care plans.
Several commenters were concerned that the lack of utilization limits
would lead to practitioners harassing patients.
Response: In general, we do not agree with the commenters who
suggested that this service is more likely to be subject to
overutilization or abuse than other PFS services without our adoption
of explicit frequency limitations. We believe the CPT codes describe
time increments that are appropriate for furnishing ACP services in
various settings. Therefore, we are finalizing our proposal to adopt
the CPT codes and CPT provisions regarding the reporting of timed
services. Since the services are by definition voluntary, Medicare
beneficiaries may decline to receive them. When a beneficiary elects to
receive ACP services, we encourage practitioners to notify the
beneficiary that Part B cost sharing will apply as it does for other
physicians' services (except when ACP is furnished as part of the AWV,
see the discussion below). We plan to monitor utilization of the new
CPT codes over time to ensure that they are used appropriately.
Intersection With Other Services
Comment: Many commenters supported our proposal to pay for ACP
services when furnished either on the same day or a different day than
other E/M services. Several commenters asked CMS to specify whether and
how the ACP codes could be billed in conjunction with E/M visits or
services that span a given time period, such as 10- or 90-day global
codes or Transitional Care Management (TCM) and Chronic Care Management
(CCM) services. One commenter recommended that CMS unbundle ACP
services from critical care services and pay at a higher rate, but did
not suggest an alternative payment amount.
Response: We believe that CPT guidance for these codes is
consistent with the description and recommended valuation of the
described services. When adopting CPT codes for payment, we generally
also adopt CPT coding guidance. In this case, CPT instructs that CPT
codes 99497 and 99498 may be billed on the same day or a different day
as other E/M services, and during the same service period as TCM or CCM
services and within global surgical periods. We are also are adopting
the CPT guidance prohibiting the reporting of CPT codes 99497 and 99498
on the same date of service as certain critical care services including
neonatal and pediatric critical care.
[[Page 70957]]
Who Can Furnish/Setting of Care
Comment: Many commenters who supported the proposal provided
recommendations regarding which practitioners and support staff should
be able to provide or be paid for ACP services. Many commenters sought
clarification regarding who would qualify as the ``other health care
professionals'' described by or able to bill the CPT codes. Many
commenters described ACP services as being routinely provided by a
multidisciplinary team under physician supervision. For example, they
stated that ACP is routinely provided by physicians, non-physician
practitioners and other staff under the order and medical management of
the beneficiary's treating provider. They stated that often a team
approach is used, involving coordination between the beneficiary's
physicians, non-physician practitioners (such as licensed clinical
social workers or clinical nurse specialists) and other licensed and
credentialed hospital staff such as registered nurses.
Similarly, other commenters described social workers, clinical
psychologists, registered nurses, chaplains and other individuals as
appropriate providers of ACP services, either alone or together with a
physician, and recommended payment for the services of these
individuals. For example, one commenter stated that a significant
portion of ACP discussions occur between patients and registered nurses
or allied health professionals functioning as care coordinators, care
navigators or similar roles; that a growing proportion are performed at
home; and that CMS should enable care coordinators and navigators to
bill the ACP codes either by defining them as ``other qualified health
professionals'' or under ``incident to'' provisions.
Some commenters specifically recommended allowing social workers
and chaplains qualified under the hospice benefit to bill the ACP
codes. One community oncologist association stated that best practices
have evolved to include a multi-disciplinary approach utilizing trained
physician, advanced practice provider and social worker skill sets, and
that nearly half of their oncology network's ACP is performed by
licensed clinical social workers. This commenter stated that while it
is typical for a physician to initiate the ACP discussion with
patients, ACP usually occurs with a mid-level provider or social worker
and therefore the association requested that CMS allow clinical social
workers to bill for these services. Another national association stated
that it was working towards the development of new CPT codes for
practitioners such as social workers who the commenter believed would
not be able to directly bill the proposed codes.
Some commenters argued that such non-medically trained individuals
are qualified and have special training and expertise (whether
psychosocial, spiritual or legal) that are needed on ACP care teams.
Some believed that ACP is sometimes appropriate for physicians to
perform, but that physicians do not have enough time to supply all of
the demand for ACP services. Some commenters similarly argued that
inclusion of social workers and other non-medically trained individuals
including Spiritual Directors, Chaplains, Clinical Pastoral Counselors
and others would alleviate concerns about undue influence over patient
decisions. These commenters stated that part of the ACP conversation is
emotional and spiritual and not merely clinical, so it is important to
include individuals who can address the non-clinical aspect of ACP.
Some commenters argued that widening the field of professionals who can
initiate these conversations within their scope of practice will
further encourage appropriate and frequent ACP. Several commenters
stated that physicians should not be paid for ACP services due to an
ethical or financial conflict of interest, and that communities should
take more responsibility for these services.
In contrast, several commenters were concerned that allowing ACP to
be paid to certain trained facilitators would undermine physician
authority in treating patients. These commenters described the use of
trained facilitators in certain community models that offer group
discussions by trained lay and health professionals. These commenters
were concerned that such facilitators would qualify as ``other
qualified professionals'' under the CPT code descriptor and be given
control over ACP, shaping physician behavior. One commenter stated that
to prevent coercion of patients, it would be better if payment was
limited to non-employees of hospitals.
Response: We appreciate the many comments we received on existing
or recommended practice patterns for the provision of ACP services. We
acknowledge the broad range of commenters that stated that the services
described by CPT codes 99497 and 99498 are appropriately provided by
physicians or using a team-based approach provided by physicians, non-
physician practitioners and other staff under the order and medical
management of the beneficiary's treating physician. We note that the
CPT code descriptors describe the services as furnished by physicians
or other qualified health professionals, which for Medicare purposes is
consistent with allowing these codes to be billed by the physicians and
NPPs whose scope of practice and Medicare benefit category include the
services described by the CPT codes and who are authorized to
independently bill Medicare for those services. Therefore only these
practitioners may report CPT codes 99497 or 99498. We note that as a
physicians' service, ``incident to'' rules apply when these services
are furnished incident to the services of the billing practitioner,
including a minimum of direct supervision. We agree with commenters
that advance care planning as described by the proposed CPT codes is
primarily the provenance of patients and physicians. Accordingly we
expect the billing physician or NPP to manage, participate and
meaningfully contribute to the provision of the services, in addition
to providing a minimum of direct supervision. We also note that the
usual PFS payment rules regarding ``incident to'' services apply, so
that all applicable state law and scope of practice requirements must
be met in order to bill ACP services.
Comment: Several commenters recommended that CMS not require direct
supervision for ACP services or allow it to be furnished ``incident
to'' under general supervision.
Response: As discussed above, we understand that the services
described by CPT codes 99497 and 99498 can be provided by physicians or
using a team-based approach where, in addition to providing a minimum
of direct supervision, the billing physician or NPP manages,
participates and meaningfully contributes to the provision of the
services. We note that the ``incident to'' rules apply when these
services are provided incident to the billing practitioner, including
direct supervision. We do not believe it would be appropriate to create
an exception to allow these services to be furnished incident to a
physician or NPP's professional services under less than direct
supervision because the billing practitioner must participate and
meaningfully contribute to the provision of these face-to-face
services.
Comment: Many commenters made recommendations regarding the
settings of care that would be appropriate for payment of ACP services.
Some of these commenters specified that payment should be made in both
ambulatory and inpatient settings. Many commenters stated that ACP is
ideally performed in
[[Page 70958]]
a primary care setting, where the patient has a longstanding
relationship with a physician and can engage in planning prior to
illness, at which time they may be most receptive and most likely to
have full decision making capacity. However many commenters believed
payment was also appropriate in inpatient and other acute care
settings. A few commenters recommended payment for an outpatient code
or a code that would not be payable in the intensive care setting. Some
commenters recommended that ACP should only be payable in clinical
settings and that CMS should explicitly exclude group information
sessions and similar offerings. Commenters stated that patients should
be able to choose any location for ACP services including at home; in
community-based settings; or via telehealth, telephone or other remote
technologies. A few commenters were concerned that CMS might limit
payment to certain specialists and recommended against such a policy.
Response: We agree with commenters that ACP services are
appropriately furnished in a variety of settings, depending on the
condition of the patient. These codes will be separately payable to the
billing physician or practitioner in both facility and non-facility
settings and are not limited to particular physician specialties. We
refer commenters to the CY 2016 hospital outpatient prospective payment
system final rule with comment period for a discussion of how payment
will be made to hospitals for ACP services furnished in hospital
outpatient departments.
Comment: Many commenters supported payment for ACP along the entire
health continuum, in advance of acute illness, and revisiting the
advance care plan with changes in the patient's condition. These
commenters stated ACP is a routine service that should be regularly
performed like preventive services. These commenters responded
affirmatively to our solicitation as to whether or not ACP services
should be included as an optional element, at the beneficiary's
discretion, of the annual wellness visit (AWV) under section
1861(hhh)(2)(G) of the Act. Several of these commenters specified that
ACP should remain separately paid even if included as an optional
element of the AWV.
Response: We appreciate the response of commenters regarding our
request for comment on whether or not we should include ACP as an
optional element, at the beneficiary's discretion, of the annual
wellness visit (AWV) under section 1861(hhh)(2)(G) of the Act. Based on
the commenters' positive response to this solicitation, we are adding
ACP as a voluntary, separately payable element of the AWV. We are
instructing that when ACP is furnished as an optional element of AWV as
part of the same visit with the same date of service, CPT codes 99497
and 99498 should be reported and will be payable in full in addition to
payment that is made for the AWV under HCPCS code G0438 or G0439, when
the parameters for billing those CPT codes are separately met,
including requirements for the duration of the ACP services. Under
these circumstances, ACP should be reported with modifier -33 and there
will be no Part B coinsurance or deductible, consistent with the AWV.
Regarding who can furnish ACP when it is furnished as an optional
element of the AWV, we note that AWV cannot be furnished as an
``incident to'' service since the AWV has a separate, distinct benefit
category from ``incident to'' services. However, the current
regulations for the AWV allow the AWV to be furnished under a team
approach by physicians or other health professionals under direct
supervision. Therefore, the rules that apply to the AWV will also apply
to ACP services when furnished as an optional element of the AWV,
including the requirement for direct supervision.
Comment: We received several comments requesting that ACP be added
as a billable visit for FQHCs, and several comments requesting that we
ensure that Medicare Administrative Contractors (MACs) are aware that a
standalone ACP counseling session with an FQHC billable provider
qualifies as a ``billable visit'' under Medicare's Prospective Payment
System (PPS) for FQHCs.
Response: RHCs and FQHCs furnish Medicare Part B services and are
paid in accordance with the RHC all-inclusive rate system or the FQHC
PPS. Beginning on January 1, 2016, ACP will be a stand-alone billable
visit in a RHC or FQHC, when furnished by a RHC or FQHC practitioner
and all other program requirements are met. If furnished on the same
day as another billable visit, only one visit will be paid. Coinsurance
will be applied for ACP when furnished in an FQHC, and coinsurance and
deductibles will be applied for ACP when furnished in an RHC.
Coinsurance and deductibles will be waived when ACP is furnished as
part of an AWV. Additional information on RHC and FQHC billing of ACP
will be available in sub-regulatory guidance.
Standards/Training
Comment: Many commenters recommended that CMS establish standards
or require specialized training as a condition of payment for ACP
services. Many commenters recommended standards or special training in
relevant state law and advance planning documents; content and time;
communication, representation, counseling, shared decision making and
skills outside the scope of physician training. Several commenters
recommended standards regarding the use of certified electronic health
record technology; contractual or employment relationships with nurses,
social workers and other clinical staff working as part of an ACP team;
use of written protocols and workflows to make ACP part of routine
care; and working with professional societies and other organizations
including the National Quality Forum and the Agency for Healthcare
Research & Quality to establish quality standards for clinician-patient
communication and ACP that would be tied to payment. Many commenters
recommended policies to ensure documentation and transmission of the
results of ACP among health care providers. Some of these commenters
encouraged CMS to use technology to enhance the use and portability of
advance directives across care settings and state lines, or recommended
a universal registry.
Several commenters were concerned about the nature of the services
that would be payable under the proposed codes, noting that ACP should
extend beyond education about advance directives and completing forms.
Several recommended the development of content criteria or quality
measures to ensure that ACP services are meaningful and of value to
patients. Some commenters expressed concern about ensuring appropriate
services were furnished as part of ACP. For example, they expressed
concern that payable services would include mere group information
sessions, filling out forms or similar offerings. One commenter
recommended that CMS require some minimal element like one personal
real-time encounter, whether face-to-face or by phone or telemedicine.
Response: Since CPT codes 99497 and 99498 describe face-to-face
services, we do not believe it would be appropriate at this time to
apply additional payment standards as we have for certain non-face-to-
face services such as CCM services. We will continue to consider
whether additional standards, special training or quality measures may
be appropriate in the future as a condition of Medicare payment for ACP
services. We note that we did not propose to add ACP services to the
list of Medicare telehealth services, so the face-to-face
[[Page 70959]]
services described by the codes need to be furnished in-person in order
to be reported to Medicare.
Comment: Several commenters supported advance care planning between
patients and clinicians, but expressed concern about the potential for
bias against choosing treatment options involving living with
disability, requiring physicians to discuss questionable treatment
options (such as physician assisted suicide or other patient choices
that might violate individual physician ethics) and similar issues.
Some commenters were concerned that patients might change their
decisions once care was actually needed and be unable to override
previous advance directives; or that the government would be making
healthcare decisions instead of patients, physicians, and families.
Response: As discussed above, based on public comments we received,
we believe the services described by CPT codes 99497 and 99498 are
appropriately provided by physicians or using a team-based approach
where ACP is provided by physicians, non-physician practitioners and
other staff under the order and medical management of the beneficiary's
treating physician. We also note that the CPT code descriptors describe
the services as furnished by physicians or other qualified health
professionals, which for Medicare purposes, is consistent with allowing
these codes to be billed by the physicians and NPPs whose scope of
practice and Medicare benefit category include the services described
by the CPT codes and who are authorized to independently bill Medicare
for those services. Therefore only these practitioners may report CPT
codes 99497 or 99498, and ``incident to'' rules apply when these
services are provided incident to the services of the billing
practitioner under a minimum of direct supervision. We agree with
commenters that advance care planning as described by the new CPT codes
is primarily the provenance of patients and physicians. Accordingly we
expect the billing physician or NPP, in addition to providing a minimum
of direct supervision, to manage, participate and meaningfully
contribute to the provision of the services. Also, we note that PFS
payment rules apply when ACP is furnished incident to other physicians'
services, including where applicable, that state law and scope of
practice must be met. Since the ACP services are by definition
voluntary, we believe Medicare beneficiaries should be given a clear
opportunity to decline to receive them. We note that beneficiaries may
receive assistance for completing legal documents from other non-
clinical assisters outside the scope of the Medicare program. Nothing
in this final rule with comment period prohibits beneficiaries from
seeking independent counseling from other individuals outside the
Medicare program--either in addition to, or separately from, their
physician or NPP.
Beneficiary Considerations
Comment: Several commenters suggested that CMS pursue waivers of
cost sharing for ACP services or that cost sharing should vary by the
condition of the patient.
Response: We lack statutory authority to waive beneficiary cost
sharing for ACP services generally because they are not preventive
services assigned a grade of A or B by the United States Preventive
Services Task Force (USPSTF); nor may CMS vary cost sharing according
to the patient's diagnosis. Under current law, the Part B cost sharing
(deductible and coinsurance) will be waived when ACP is provided as
part of the AWV, but we lack authority to waive cost sharing in other
circumstances. We would recommend that practitioners inform
beneficiaries that the ACP service will be subject to separate cost
sharing.
Comment: One commenter recommended beneficiary education through
Medicare & You, partnerships with senior advocacy groups and other
means.
Response: We agree that beneficiary education about ACP services,
especially the voluntary nature of the services, is important. We
welcome such efforts by beneficiary advocacy and community-based
organizations and will consider whether additional material should be
added to the Medicare & You handbook to highlight new payment
provisions for these voluntary services.
In summary, we are finalizing our proposal to assign CPT codes
99497 and 99498 PFS status indicator ``A'' with RVUs developed based on
the RUC-recommended values. We are also adding ACP as an optional
element, at the beneficiary's discretion, of the AWV. We are also
making the conforming changes to our regulations at Sec. 410.15 that
describe the conditions for and limitations on coverage for the AWV.
We note that while some public commenters were opposed to Medicare
paying for ACP services, the vast majority of comments indicate that
most patients desire access to ACP services as they prepare for
important medical decisions.
d. Valuation of Other Codes for CY 2016
(1) Excision of Nail Bed (CPT Code 11750)
CPT code 11750 appeared on the RUC's misvalued code screen of 10-
day global services with greater than 1.5 office visits and utilization
over 1,000. The Health Care Professional Advisory Committee (HCPAC)
reviewed the survey results for valuing this code and determined that
1.99 work RVUs, corresponding to the 25th percentile survey result, was
the appropriate value for this service. As discussed in the proposed
rule, we indicated that we believed the recommendation for this service
overstated the work involved in performing this procedure,
specifically, given the decrease in post-operative visits. Due to
similarity in service and time, we indicated that we believed a direct
crosswalk from the work RVU for CPT code 10140 (Drainage of blood or
fluid accumulation), which is also a 10-day global service with one
post-operative visit, more accurately reflects the time and intensity
of furnishing the service. Therefore, for CY 2016 we proposed a work
RVU of 1.58 for CPT code 11750.
The following is a summary of the comments we received on our
proposal.
Comment: One commenter disagreed with CMS' direct crosswalk of the
work RVU from CPT code 10140 to CPT code 11750. The commenters
suggested that CMS establish the RVU for this procedure consistent with
the recommendation. Additionally, the commenter stated that the HCPAC
recommendation accounted for the removal of one post-operative visit
from the global period. The commenter also stated that CMS' proposed
work RVU would have an intraservice work intensity similar to a level
one E/M visit (99211), which suggests that the value is too low.
Response: In developing our proposed RVUs for this service, we
reviewed codes with similar intra-service and total times, and
identified CPT code 11760 (Repair of nail bed) and CPT code 11765
(Excision of nail fold toe). Since we believe that the crosswalk for
CPT code 11750 has similar intensity, and our proposed RVU is
consistent with these similar services, we do not agree with the
commenter who states that the proposed work RVU is inaccurate.
After consideration of comments received, we are finalizing a work
RVU of 1.58 for CPT code 11750, as proposed.
[[Page 70960]]
(2) Bone Biopsy Excisional (CPT Code 20240)
In its review of 10-day global services, the RUC identified CPT
code 20240 as potentially misvalued. Subsequent to this identification,
the RUC requested that CMS change this code from a 10-day global period
to a 0-day global period for this procedure. Based on survey data, the
RUC recommended a decrease in the intraservice time from 39 to 30
minutes, removal of two postoperative visits (one 99238 and one 99212),
and an increase in the work RVUs for CPT code 20240 from 3.28 to 3.73.
In the proposed rule, we stated that we did not believe the RUC
recommendation accurately reflected the work involved in this
procedure, especially given the decrease in intraservice time and post-
operative visits relative to the previous assumptions used in valuing
the service. Therefore, for CY 2016, we proposed a work RVU of 2.61 for
CPT code 20240 based on the reductions in time for the service.
The following is a summary of the comments we received on our
proposal.
Comment: Several commenters, including the RUC, recommended that
CMS reconsider its decision not to accept the RUC's recommendation for
CPT code 20240. The commenters noted that the service was last valued
by the Harvard study over 20 years ago and the assumptions made at the
time no longer reflect current practice as the survey respondents
included fewer than 10 non-orthopedic surgeons. Commenters stated that
podiatry is currently the dominant provider of the service. Commenters
also stated that deriving a new proposed work RVU based on existing
work RVUs would be misguided in this case.
The commenters also suggested that using a reverse building block
methodology to convert a 10-day global code to 0-day global code by
removing the bundled E/M services is inappropriate since magnitude
estimation was used initially when establishing the work RVUs for
surgical codes. Several commenters indicated that CMS' proposed work
RVU has inappropriately low work intensity and expressed concern about
CMS' approach to global code conversion.
Additionally, the RUC expressed disagreement with CMS' decision to
remove 6 minutes of clinical labor minutes for discharge management
time from 0-day global services stating there is clinical staff time
that needs to be accounted for; the commenter requested we include the
6 minutes of clinical labor time based on the standard clinical labor
task ``conduct phone calls/call in prescriptions.''
Response: In proposing what we believed to be a more accurate value
for CPT code 20240, we considered applying the intra-service ratio,
which yielded a value of 2.52 RVUs; however we believed that value
would have inadequately reflected the work involved in furnishing the
service. Instead, we opted to use the reverse building block
methodology to remove the post-operative visits, acknowledging the
transition from a 10-day to a 0-day global period. We removed the RVUs
associated with the visits (1.12 RVUs) from the RUC-recommended value
of 3.73 RVUs and arrived at an RVU of 2.61, which we continue to
believe accurately accounts for work involved in furnishing the
service. While we generally understand that the work RVUs may not have
been developed using a building-block methodology, and that the reverse
building block methodology may not always be the best approach to
valuing services, we do not agree that significant changes in the post-
operative period should be ignored, especially since we note that the
RUC uses magnitude estimation to develop recommended work RVUs in the
context of survey data regarding the number and level of visits in the
post-operative periods.
In terms of the clinical labor minutes associated with the
discharge day management, we do not agree that the typical discharge
work associated for this service or for others without work time for
discharge day management would typically involve clinical staff
conducting phone calls regarding prescriptions. We are aware that some
codes include the clinical labor minutes for discharge management even
though the work time for these codes do not include time for discharge
management. We are seeking comment on how we might address this
discrepancy in future rulemaking.
After consideration of comments received, we are finalizing the
proposed work RVU of 2.61 for CPT code 20240.
(3) Endobronchial Ultrasound (CPT Codes 31622, 31652, 31653, 31625,
31626, 31628, 31629, 31654, 31632 and 31633)
For CY 2016, the CPT Editorial Panel deleted one code, CPT code
31620 (Ultrasound of lung airways using an endoscope), and created
three new codes, CPT codes 31652-31654, to describe bronchoscopic
procedures that are inherently performed with endobronchial ultrasound
(EBUS).
In their review of the newly revised EBUS family, the RUC
recommended a change in the work RVUs for CPT code 31629 from 4.09 to
4.00. The RUC also recommended maintaining the current work RVUs for
CPT codes 31622, 31625, 31626, 31628, 31632 and 31633. We proposed to
use those work RVUs for CY 2016.
For the newly created codes, the RUC recommended work RVUs of 5.00
for CPT code 31652, 5.50 for CPT code 31653 and 1.70 for CPT code
31654. In the proposed rule, we stated that we believe the RUC-
recommended work RVUs for these services overstate the work involved in
furnishing the procedures. In order to develop proposed work RVUs for
CPT code 31652, we compared the service described by the code
descriptor to deleted CPT codes 31620 and 31629, because this new code
describes a service that combines services described by CPT code 31620
and 31629. Specifically, we took the sum of the current work RVU of CPT
code 31629 (WRVU = 4.09) and the CY 2015 work RVU of CPT code 31620
(WRVU = 1.40) and multiplied it by the quotient of CPT code 31652's
RUC-recommended intraservice time (INTRA = 60 minutes) and the sum of
CPT codes 31620 and 31629's current and CY 2015 intraservice times
(INTRA = 70 minutes), respectively. This resulted in a proposed work
RVU of 4.71. To value CPT code 31653, we used the RUC-recommended
increment of 0.5 work RVUs between this service and CPT code 31652 to
calculate for CPT code 31653 our proposed work RVUs of 5.21. Lastly,
because the service described by new CPT code 31654 is very similar to
deleted CPT code 31620, we stated that we believed a direct crosswalk
of the previous values for CPT code 31620 accurately reflected the time
and intensity of furnishing the service described by CPT code 31654.
Therefore, we proposed a work RVU of 1.40 for CPT code 31654.
The following is a summary of the comments we received on our
proposals.
Comment: Several commenters, including the RUC, stated they did not
agree with CMS' calculations or methodology utilized in valuing these
services. The commenters suggested that CMS' calculations were based on
inconsistent data. One commenter stated the methodology outlined in the
proposed rule had several flaws in the understanding of the new and
deleted bronchoscopy codes and questioned what purpose the creation of
the new bundled codes were designed to address.
Response: As we have addressed more broadly, when we do not believe
that
[[Page 70961]]
the RUC-recommended values adequately address changes in the time
resources required to furnish particular services, we have used several
methodologies to identify potential work RVUs. We examine the results
of such approaches and consider whether or not these results
appropriately account for the total work of the service. We continue to
believe that the methodology used to calculate the proposed work RVU is
the most appropriate methodology to use for these procedures.
Specifically, in considering CPT code 31652 in the context of
similar codes, including CPT code 31638 (Bronchoscopy, rigid or
flexible, including fluoroscopic guidance, when performed; with
revision of tracheal or bronchial stent inserted at previous session
(includes tracheal/bronchial dilation as required)) and CPT code
31661(Bronchoscopy, rigid or flexible, including fluoroscopic guidance,
when performed; with bronchial thermoplasty, 2 or more lobes) both of
which have 60 minutes of intraservice time and RVUs of 4.88 and 4.50,
we continue to believe that a work RVU of 4.71 is the most accurate
valuation. For CPT code 31653, we continue to believe that maintaining
the RUC-recommended 0.5 work RVU increment between 31652 and 31653
yields the most accurate value for CPT code 31653. For CPT code 31654,
we note the direct crosswalk preserves the work RVU of 1.40 from the
previous CPT code 31620, which was also an add-on code, and had more
intraservice time. Therefore, after consideration of comments received,
we are finalizing the work RVUs for CPT codes 31622, 31652, 31653,
31625, 31626, 31628, 31629, 31654, 31632 and 31633 for CY 2016 as
proposed.
Comment: One commenter also expressed appreciation of CMS'
acceptance of the RUC's PE recommendation for several codes in this
family.
Response: We appreciate the support of the commenter.
Comment: In its comment, the RUC indicated that equipment items
ES045 and ES016 were incorrectly included for 31652, 31653, and 31654
and that these items were replaced with new equipment codes. In the CY
2015 Technical Correction Notice (CMS-1612-F2), equipment item ES015
was included in 31654, and the clinical labor direct PE inputs for
31654 were omitted from the direct PE input database. Similarly, for
CPT code 31629, the RUC indicated that CMS proposed 30 minutes for
clinical labor tasks ``assist physician in performing procedure'' and
``assist physician for moderate sedation'', as included in the CY 2016
proposed direct PE input database, while the RUC had recommended 35
minutes. The RUC opined that since the 30 minutes displayed for CPT
code 31629 was incorrect, all of the corresponding equipment times
included discrepancies of 5 minutes. The RUC suggested that all
equipment times should increase by 5 minutes, excluding the stretcher,
which should remain 89 minutes as that equipment is not needed during
the intraservice portion of the procedure. In addition, the RUC
suggested that the calculation of supply item ``gas, oxygen'' (SD084)
would also be affected by the ``assist physician'' time and should be
105 liters, rather than 90 liters as currently indicated in the supply
direct PE input CMS file.
Response: We agree with the RUC's comments regarding the proposed
direct PE inputs for these procedures; the resulting changes appear in
the final direct PE input database for CY 2016.
(4) Intravascular Ultrasound (CPT Codes 37252 and 37253)
In the CY 2015 PFS proposed rule, a stakeholder requested that CMS
establish non-facility PE RVUs for CPT codes 37250 and 37251. CMS
sought comment regarding the setting and valuation of these services.
In September 2014, these codes were referred to the CPT Editorial
Panel. The CPT Editorial Panel deleted CPT codes 37250 and 37251 and
created new bundled codes 37252 and 37253 to describe intravascular
ultrasound (IVUS). The RUC recommended 1.80 RVUs for CPT code 37252 and
1.44 RVUs for CPT code 37253. The RUC also recommended new direct PE
inputs for an IVUS catheter and IVUS system. CMS proposed to accept the
RUC-recommended work RVUs for intravascular ultrasound.
Comment: Commenters expressed support for CMS' proposed work and
time values, as well as for updating the direct PE inputs.
Response: We appreciate commenters' support, and we are finalizing
these values as proposed.
(5) Laparoscopic Lymphadenectomy (CPT Codes 38570, 38571 and 38572).
The RUC identified three laparoscopic lymphadenectomy codes as
potentially misvalued: CPT code 38570 (Laparoscopy, surgical; with
retroperitoneal lymph node sampling (biopsy), single or multiple); CPT
code 38571 (Laparoscopy, surgical; with retroperitoneal lymph node
sampling (biopsy), single or multiple with bilateral total pelvic
lymphadenectomy); and CPT code 38572 (Laparoscopy, surgical; with
retroperitoneal lymph node sampling (biopsy), single or multiple with
bilateral total pelvic lymphadenectomy and periaortic lymph node
sampling (biopsy), single or multiple). Accordingly, the specialty
society surveyed these 10-day global codes, and the survey results
indicated decreases in intraservice and total work times. After
reviewing the survey responses, the RUC recommended that CMS maintain
the current work RVU for CPT code 38570 of 9.34; reduce the work RVU
for CPT code 38571 from 14.76 to 12.00; and reduce the work RVU for CPT
code 38572 from 16.94 to 15.60. We used the RUC recommendations to
propose values for CPT codes 38571 and 38572, since the RUC recommended
reductions in the work RVUs that correspond with marked decreases in
intraservice time and decreases in total time. As discussed in the
proposed rule, we did not agree with the RUC's recommendation to
maintain the current work RVU for CPT code 38570 in spite of similar
changes in intraservice and total times as were shown in the RUC
recommendations for CPT codes 38571 and 38572. Therefore, we proposed a
work RVU for CPT code 38570 of 8.49, which reflects the proportional
reduction in total time for this code and maintains the rank order
among the three codes.
The following is a summary of the comments we received on our
proposals.
Comment: Several commenters, including the RUC, indicated that CMS
should use the recommended work RVU of 9.34 for CPT code 38570.
Commenters stated that CMS used an erroneous calculation to derive the
proposed work RVU of 8.49, with the use of time ratios being
methodologically flawed due to an assumption that the existing time is
correct, that physician intensity would remain constant for a service
over a period of many years, and that different components of total
time consisting of differing levels of physician intensity cannot be
measured together. Commenters stated that using this rationale as the
basis for not accepting the RUC recommendation was unprecedented and
misguided.
Commenters also stated that the recommended work RVU of 9.34 was
based on work time and a comparison to CPT codes 31239 (Nasal/sinus
endoscopy, surgical; with dacryocystorhinostomy) and 50590
(Lithotripsy, extracorporeal shock wave). Commenters indicated that the
comparison to these codes confirmed
[[Page 70962]]
that maintaining the current value for CPT code 38570 would be
appropriate. A different commenter stated that the survey time for this
procedure had increased to 280 minutes and included a hospital
inpatient visit. This commenter also urged CMS to maintain the current
work RVUs of 9.34 for CPT code 38570.
Response: We refer the reader to our earlier discussion about time
ratios. We 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 procedure has changed significantly. In the case of
CPT code 38570, we noted that the intraservice time was reduced by 50
percent, from 120 minutes to 60 minutes, and the total time was also
reduced from 242 minutes to 220 minutes. We also noted that the other
codes in the same family, CPT codes 38571 and 38572, reflected similar
time reductions and consequently had reduced recommended work RVUs. We
believe that in order to maintain relativity, it is appropriate to
apply a similar reduction to the work RVUs of CPT code 38570.
We were unable to find mention of CPT code 31239 in the RUC
recommendations for 38570. Therefore, we considered the values for the
code as a potential rationale for using the RUC-recommended value for
CPT code 38570. We concluded that CPT code 31239 has limited utility as
a comparison, since its values appear to be an outlier among codes with
similar characteristics. For example, all 25 of the other 10-day global
codes with 60 minutes of intraservice time have a lower work RVU than
CPT code 38570, most of them substantially lower, with CPT code 49429
(Removal of peritoneal-venous shunt) having the next highest work RVU
of 7.44. We also do not agree with the comparison to CPT code 50590,
since that code describes all of the work within a 90-day global
period, and we do not believe that relativity between services would be
preserved if we were to make direct work RVU comparisons between 10-day
and 90-day global codes.
After consideration of comments received, we are finalizing our
proposed work RVUs of 8.49 for CPT code 38570, 12.00 for CPT code
38571, and 15.60 for CPT code 38572.
(6) Mediastinoscopy With Biopsy (CPT Codes 39401 and 39402)
The RUC identified CPT code 39400 (Mediastinoscopy, including
biopsy(ies) when performed) as a potentially misvalued code due to an
unusually high preservice time and Medicare utilization over 10,000. In
reviewing the code's history, = the CPT Editorial Panel concluded that
the code had been used to report two distinct procedural variations
although the code was valued using a vignette for only one of them. As
a result, CPT code 39400 is being deleted and replaced with CPT codes
39401 and 39402 to describe each of the two mediastinoscopy procedures.
We proposed to accept the RUC-recommended work RVU of 5.44 for code
39401 and to use the RUC-recommended crosswalk from CPT code 52235
(Cystourethroscopy, with fulguration), which accurately estimates the
overall work for CPT code 39401. In the proposed rule, we disagreed
with the RUC-recommended work RVU of 7.50 for CPT code 39402. We stated
that the work RVU for CPT code 39401 establishes an accurate baseline
for this family of codes, so we proposed to scale the work RVU of CPT
code 39402 in accordance with the change in the intraservice times
between CPT codes 39401 and 39402. We indicated that applying this
ratio in the intraservice time to the work RVU of CPT code 39401
yielded a total work RVU of 7.25 for CPT code 39402. We also noted that
the RUC recommendation for CPT code 39401 represented a decrease in
value by 0.64 work RVUs, which is roughly proportionate to the
reduction from a full hospital discharge visit (99238) to a half
discharge visit assumed to be typical in the post-operative period. The
RUC recommendation for CPT code 39402 had the same reduction in the
post-operative work without a corresponding decrease in its recommended
work RVU. In order to reflect the reduction in post-operative work and
to maintain relativity between the two codes in the family, we proposed
a work RVU of 7.25 for CPT code 39402.
The following is a summary of the comments we received on our
proposals.
Comment: Several commenters stated that the use of intraservice
time ratios was inappropriate for valuation of CPT codes. They
indicated that CMS should instead use the RUC's recommended work RVU of
7.50, due to the difference in technical skill, physical/mental effort,
and additional stress involved in the performance of CPT code 39402
relative to CPT code 39401. Commenters expressed the importance of
using physician survey data and magnitude estimation to arrive at work
RVUs.
Response: We refer the reader to our earlier discussions about the
utility of time ratios in identifying potential work RVUs for PFS
services. We note that when comparing the work RVUs for CPT codes 39401
and 39402, the work RVU for CPT code 39402 was higher than would be
expected based on the difference in time between these two procedures,
even considering the more difficult clinical nature of CPT code 39402.
We continue to believe that the use of intraservice time ratios is one
of several different methods that can be effectively employed for
valuation of CPT codes. For this particular mediastinoscopy family, CPT
codes 39401 and 39402 share identical preservice time, postservice
time, and office visits. Based on this information, we continue to
believe that the intraservice time ratio between the two codes is the
most accurate method for determining the work RVU for this procedure.
Comment: Several commenters suggested that CMS should use the RUC-
recommended work RVU of 7.50 for CPT code 39402 based on the use of a
building block methodology. Commenters stated that the RUC arrived at
this value by adding the work RVU of CPT code 39401 (5.44 RVUs) to one
half of the work RVU of CPT code 32674 (4.12 RVUs). The resulting
calculation of 5.44 plus 2.06 equaled 7.50 RVUs, exactly the same value
recommended by the RUC and a proof of the accuracy of magnitude
estimation.
Response: We believe that the use of the reverse building block
methodology would result in a significantly lower valuation for CPT
code 39402. The current CPT code used for a mediastinoscopy with lymph
node biopsy is 39400, which has a work RVU of 8.05, and includes three
postoperative visits in its global period (a 99231 hospital inpatient
visit, a 99238 hospital discharge visit, and a 99213 office visit). CPT
code 39402 does not include the hospital inpatient visit (0.76 RVUs) or
the office visit (0.97 RVUs), and includes only half of the discharge
visit (0.64 RVUs). If the work of these visits were removed from CPT
code 39400, the result would be a work RVU of 8.05 - 2.37 = 5.68. We
believe that this work RVU understates the work of CPT code 39402,
which is why we believe that a building block methodology would be less
accurate than the use of the intraservice time ratio for this code
family.
After consideration of comments received, we are finalizing our
proposed work RVU of 5.44 for CPT code 39401 and 7.25 for 39402.
[[Page 70963]]
(7) Hemorrhoid(s) Injection (CPT Code 46500)
The RUC identified CPT code 46500 (Injection of sclerosing
solution, hemorrhoids) as potentially misvalued, and the specialty
society resurveyed this 10-day global code. The survey showed a
significant decrease in the reported intraservice and total work times.
After reviewing the survey responses, the RUC recommended that CMS
maintain the current work RVU of 1.69 in spite of the reductions in
intraservice and total times. We proposed to reduce the work RVU to
1.42, which reduces the work RVU by the same ratio as the reduction in
total time.
We also proposed to refine the RUC-recommended direct PE inputs by
removing the inputs associated with cleaning the scope.
The following is a summary of the comments we received on our
proposals.
Comment: The RUC disagreed with the methodology CMS used to develop
the proposed work RVUs stating that CMS' proposed methodology did not
account for differences in pre-service or post-service time. The RUC
also stated that different components of total time (preservice time,
intra-service time, post-service time, and post-operative visits)
consist of differing levels of physician intensity and CMS'
calculations did not appear to have been based on any clinical
information or any measure of physician intensity.
Another commenter supported our efforts to identify and address
such incongruities between work times and work RVUs, stating that when
work time decreases, work RVUs should decrease comparatively, absent a
compelling argument that the intensity of the service has increased
sufficiently to offset the decrease in work time.
One commenter disagreed with CMS' proposed PE refinements for CPT
code 46500 regarding the pre-service clinical labor time for the
facility setting, clinical labor time related to setting up endoscopy
equipment, clinical labor time and supplies related to cleaning
endoscopy equipment, equipment time for item ES002, and clinical labor
time associated with clinical labor task ``follow-up phone calls and
prescriptions''. The commenter also disagreed with CMS' refinement of
not including setup and clean-up time for the scope at the post-
operative visit.
Response: We believe the total time ratio produces an RVU that is
comparable with other 10-day global services. We note that CPT code
41825 (Excision of lesion or tumor (except listed above), dentoalveolar
structures; without repair) and CPT code 10160 (Puncture aspiration of
abscess, hematoma, bulla, or cyst) are similar 10-day global services
that have comparable work RVUs. For CY 2016, we are finalizing our
proposed value of 1.42 RVUs for CPT code 46500.
After reviewing the public comments that were submitted regarding
direct PE inputs, we recognize that we mistakenly believed that a
disposable scope was included as a direct PE input, when a reusable
equipment item was actually included. As a result, we removed the
clinical labor time associated with setting up and cleaning the scope.
Since we made this refinement in error, we will restore the clinical
labor time associated with setting up and cleaning the scope. We also
agree with commenters regarding the time for clinical labor task
``follow-up phone calls and prescriptions''. Therefore, we are
restoring the RUC-recommended clinical labor times for ``follow-up
phone calls & prescriptions'', ``setup scope (non-facility setting
only)'', and ``clean scope''. As a result of including the previously
removed clinical labor time associated with the equipment input ES002
(anoscope with light source), we are increasing the equipment time for
this code from 60 minutes to 70 minutes. We did not add the set-up and
clean scope time to the post-operative visits, however, since the
clinical labor time for post-operative visits across PFS services match
the clinical labor for the associated E/M visits. We are seeking
comment regarding whether or not we should reconsider that practice
broadly before making an exception in this particular case.
(8) Liver Allotransplantation (CPT Code 47135)
The RUC identified CPT code 47135 (Liver allotransplantation;
orthotopic, partial or whole, from cadaver or living donor, any age) as
potentially misvalued, and the specialty society resurveyed this 90-day
global code. The survey results showed a significant decrease in
reported intraservice work time, but a significant increase in total
work time (the number of post-operative visits significantly declined
while the level of visits increased). After reviewing the survey
responses, the RUC recommended an increase in the work RVU from 83.64
to 91.78, which corresponds to the survey median result, as well as the
exact work RVU for CPT code 33935 (Heart-lung transplant with recipient
cardiectomy-pneumonectomy). In the proposed rule, we stated that we did
not believe the RUC-recommended crosswalk was the most accurate from
among the group of transplant codes. We noted that CPT code 32854 (Lung
transplant, double (bilateral sequential or en bloc); with
cardiopulmonary bypass) has intraservice and total times that are
closer to those the RUC recommended for CPT code 47135, and CPT code
32854 has a work RVU of 90.00 which corresponds to the 25th percentile
survey result for CPT code 47135. Therefore, we proposed to increase
the work RVU of CPT code 47135 to 90.00.
The following is a summary of the comments we received on our
proposal.
Comment: The RUC stated that its original reference code is the
most appropriate comparator for this service and revising the work RVU
for CPT code 47135 to 1.9 percent below the RUC's recommendation would
be arbitrary and punitive. Another commenter stated that while they
believed the RUC proposed valuation more accurately reflected the work
involved, they appreciated the proposal to increase the work RVUs
associated with liver transplants, and suggested that CMS accept the
RUC-recommended direct PE valuations.
Response: As we stated in the proposed rule, CPT code 32854(Lung
transplant, double (bilateral sequential or en bloc); with
cardiopulmonary bypass) has very similar intra-service and total times,
in addition to an identical work RVU (90.00) to the 25th percentile
survey result. We continue to believe the proposed direct crosswalk
from CPT code 32854 (Lung transplant, double (bilateral sequential or
en bloc); with cardiopulmonary bypass) to CPT code 47135 results in the
most accurate valuation. Therefore, for CY 2016 we are finalizing
without modification our proposed work RVU of 90.00 for CPT code 47135.
(9) Genitourinary Catheter Procedures (CPT Codes 50430, 50431, 50432,
50433, 50434, 50435, 50693, 50694, and 50695)
For CY 2016, the CPT Editorial Panel deleted six CPT codes (50392,
50393, 50394, 50398, 74475, and 74480) that were commonly reported
together, and created 12 new CPT codes, both to describe these
genitourinary catheter procedures more accurately and to bundle
inherent imaging guidance. Three of these CPT codes (506XF, 507XK, and
507XL) were referred back to CPT to be resurveyed as add-on codes. The
other nine codes were reviewed at the January 2015 RUC meeting and
assigned recommended work RVUs and direct PE inputs.
We proposed to use the RUC-recommended work RVU of 3.15 for CPT
code 50430. We agreed that this is
[[Page 70964]]
an appropriate value and that the code should be used as a basis for
establishing relativity with the rest of the family. We began by making
comparisons between the service times of CPT code 50430 and the other
codes in the family in order to determine the appropriate proposed work
RVU of each procedure.
In our proposal for CPT code 50431, we stated that we disagreed
with the RUC-recommended work RVU of 1.42; we instead proposed a work
RVU of 1.10, based on three separate data points. First, the RUC
recommendation stated that CPT code 50431 describes work previously
described by a combination of CPT codes 50394 and 74425. These two
codes have work RVUs of 0.76 and 0.36, respectively, which sum together
to 1.12. Second, we noted that the work of CPT code 49460 (Mechanical
removal of obstructive material from gastrostomy) is similar, with the
same intraservice time of 15 minutes and same total time of 55 minutes
but a work RVU of 0.96. Finally, we observed that the minimum survey
result had a work RVU of 1.10, and we suggested that this value
reflected the total work for the service. Accordingly, we proposed 1.10
as the work RVU for CPT code 50431.
We employed a similar methodology to develop a proposed work RVU of
4.25 for CPT code 50432. The three previously established codes were
combined in CPT code 50432; these had respective work RVUs of 3.37 (CPT
code 50392), 0.54 (CPT code 74475), and 0.36 (CPT code 74425); together
these sum to 4.27 work RVUs. We also examined the valuation of this
service relative to other codes in the family. The ratio of the
intraservice time of 35 minutes for CPT code 50430 and the intraservice
time of 48 minutes for CPT code 50432, applied to the work RVU of base
code 50430 (3.15), results in a potential work RVU of 4.32. The total
time for CPT code 50432 is higher than CPT code 50430 (107 minutes
relative to 91 minutes); applying this ratio to the base work RVU
results in a work RVU of 3.70. We utilized these data to inform our
proposed crosswalk. In valuing CPT code 50432, we considered CPT code
31660 (Bronchoscopy, rigid or flexible, including fluoroscopic
guidance), which has an intraservice time of 50 minutes, total time of
105 minutes, and a work RVU of 4.25. Therefore, we proposed to
establish the work RVU for CPT code 50432 at the crosswalked value of
4.25 work RVUs.
In the proposed rule, we stated that according to the RUC
recommendations, CPT codes 50432 and 50433 are very similar procedures,
with CPT code 50433 making use of a nephroureteral catheter instead of
a nephrostomy catheter. The RUC valued the added difficulty of CPT code
50433 at 1.05 work RVUs compared to CPT code 50432. We proposed to
maintain the relative difference in work between these two codes by
proposing a work RVU of 5.30 for CPT code 50433 (4.25 + 1.05).
Additionally, we considered CPT code 57155 (Insertion of uterine tandem
and/or vaginal ovoids for clinical brachytherapy), which has a work RVU
of 5.40 and an identical intraservice time of 60 minutes, but 14
additional minutes of total time (133 minutes compared to 119 minutes
for CPT code 50433), which supported the difference of 0.10 RVUs. For
these reasons, we proposed a work RVU of 5.30 for CPT code 50433.
As with the other genitourinary codes, we developed the proposed
work RVU of CPT code 50434 in order to preserve relativity within the
family. In the proposed rule, we stated that CPT code 50434 has 15
fewer minutes of intraservice time compared to CPT code 50433 (45
minutes compared to 60 minutes). We proposed to apply this ratio of
0.75 to the base work RVU of CPT code 50433 (5.30), which resulted in a
potential work RVU of 3.98. We also considered CPT code 50432 as
another similar service within this family of services, with three more
minutes of intraservice time compared to CPT code 50434 (48 minutes of
intraservice time instead of 45 minutes). We noted that applying this
ratio (0.94) to the base work RVU of CPT code 50432 (4.25) resulted in
a potential work RVU of 3.98. Based on this information, we identified
CPT code 31634 (Bronchoscopy, rigid or flexible, with balloon
occlusion) as an appropriate direct crosswalk, and proposed a work RVU
of 4.00 for CPT code 50434. The two codes share an identical
intraservice time of 45 minutes, though the latter possesses a lower
total time of 90 minutes.
For CPT code 50435, we considered how the code and work RVU would
fit within the family in comparison to our proposed values for CPT
codes 50430 and 50432. CPT code 50430 serves as the base code for this
group; it has 35 minutes of intraservice time in comparison to 20
minutes for CPT code 50435. This intraservice time ratio of 0.57 (20/
35) resulted in a potential work RVU of 1.80 for CPT code 50435 when
applied to the work RVU of CPT code 50430 (3.15). Similarly, CPT code
50432 is the most clinically similar procedure to CPT code 50435. CPT
code 50432 has 48 minutes of intraservice time compared to 20 minutes
of intraservice time for CPT code 50435. This ratio of 0.42 (20/48)
applied to the base work RVU of CPT code 50432 (4.25) results in a
potential work RVU of 1.77. We also considered two additional
procedures to determine a proposed value for CPT code 50435. CPT code
64416 (Injection, anesthetic agent; brachial plexus) also includes 20
minutes of intraservice time and has a work RVU of 1.81. CPT code 36569
(Insertion of peripherally inserted central venous catheter) has the
same intraservice and total time as CPT code 50435, with a work RVU of
1.82. Accordingly, we proposed a work RVU of 1.82, a direct crosswalk
from CPT code 36569.
The remaining three codes all utilize ureteral stents and form
their own small subfamily within the larger group of genitourinary
catheter procedures. For CPT code 50693, we proposed a work RVU of
4.21, which corresponds to the 25th percentile survey result. We stated
in the proposed rule that we believed that the work RVU corresponding
to the 25th percentile survey result provided a more accurate value for
CPT code 50693 based on the work involved in the procedure and within
the context of other codes in the family. We also indicated that CPT
code 31648 (Bronchoscopy, rigid or flexible, with removal of bronchial
valve), which shares 45 minutes of intraservice time and has a work RVU
of 4.20, was an accurate crosswalk for CPT code 50693.
For CPT code 50694, we compared its intraservice time to the code
within the family that had the most similar duration, CPT code 50433.
This code has 60 minutes of intraservice time compared to 62 minutes
for CPT code 50694. This is a ratio of 1.03; when applied to the base
work RVU of CPT code 50433 (5.30), we arrived at a potential work RVU
of 5.48. We also looked to procedures with similar times, in particular
CPT code 50382 (Removal and replacement of internally dwelling ureteral
stent), which has 60 minutes of intraservice time, 125 minutes of total
time, and a work RVU of 5.50. We proposed a work RVU of 5.50, a direct
crosswalk from CPT code 50382.
Finally, we developed the proposed work RVU for CPT code 50695
using three related methods. In the proposed rule, we stated that CPT
codes 50694 and 50695 describe very similar procedures, with 50695
adding the use of a nephrostomy tube. The RUC addressed the additional
difficulty of this procedure by recommending 1.55 more work RVUs for
CPT code 50695 than for CPT code 50694. Maintaining the 1.55 work RVUs
increment, we noted that adding 1.55 to our proposed work RVU for CPT
code 50694 (5.50)
[[Page 70965]]
would produce a work RVU of 7.05 for CPT code 50695. We also examined
the ratio of intraservice times for CPT code 50695 (75 minutes) and the
base code in the subfamily, CPT code 50693 (45 minutes). The
intraservice time ratio between these two codes is 1.67; when applied
to the base work RVU of CPT code 50693 (4.21), we calculated a
potential work RVU of 7.02. We also noted that CPT code 36481
(Percutaneous portal vein catheterization by any method) shares the
same intraservice time as CPT code 50695 and has a work RVU of 6.98.
Accordingly, to maintain relativity among this subfamily of codes, we
proposed a work RVU of 7.05 for CPT code 50695 based on an incremental
increase of 1.55 RVUs from CPT code 50694.
In reviewing the direct PE inputs for this family of codes, we
refined a series of the RUC- recommended direct PE inputs in order to
maintain relativity with other codes in the direct PE database. All of
the following refinements refer to the non-facility setting for this
family of codes. Under the clinical labor inputs, we proposed to remove
the RN/LPN/MTA (L037D) (intraservice time for assisting physician in
performing procedure) for CPT codes 50431 and 50435. This amounts to 15
minutes for CPT code 50431 and 20 minutes for CPT code 50435. Moderate
sedation is not inherent in these procedures and, therefore, we
indicated that we did not believe that this clinical labor task would
typically be completed in the course of this procedure. We also reduced
the RadTech (L041B) intraservice time for acquiring images from 47
minutes to 46 minutes for CPT code 50694. This procedure contains 62
minutes of intraservice time, with clinical labor assigned for
acquiring images (75 percent) and a circulator (25 percent). The time
for these clinical labor tasks is 46.5 minutes and 15.5 minutes,
respectively. The RUC recommendation for CPT code 50694 rounded both of
these values upwards, assigning 47 minutes for acquiring images and 16
minutes for the circulator, which together sum to 63 minutes. We
reduced the time for clinical labor tasks ``acquire images'' to 46
minutes to preserve the 62 minutes of total intraservice time for CPT
code 50694.
With respect to the post-service portion of the clinical labor
service period, we proposed to change the labor type for the task
``patient monitoring following service/check tubes, monitors, drains
(not related to moderate sedation)''. There are 45 minutes of clinical
labor time assigned under this category to CPT codes 50430, 50432,
50433, 50434, 50693, 50694, and 50695. Although we agreed that the 45
minutes are accurate for these procedures as part of moderate sedation,
we proposed to change the clinical labor type from the RUC-recommended
RN (L051A) to RN/LPN/MTA (L037D) to reflect the staff that would
typically be doing the monitoring for these procedures. Even though the
CPT Editorial Committee's description of post-service work for CPT code
50435 included a recovery period for sedation, we recognized in our
proposal that according to the RUC recommendation, CPT codes 50431 and
50435 did not use moderate sedation; therefore, we did not propose to
include moderate sedation inputs for these codes.
The RUC recommendation for CPT code 50433 included a nephroureteral
catheter as a new supply input with an included invoice. However, the
RUC recommendation did not discuss the use of a nephroureteral catheter
in the intraservice work description. CPT code 50433 did mention the
use of a nephroureteral stent in this description, but there is no
request for a nephroureteral stent supply item on the PE worksheet for
this code. We asked for feedback from stakeholders regarding the use of
the nephroureteral catheter for CPT code 50433, but did not propose to
add the nephroureteral catheter as a supply item for CPT code 50433
pending this information. We also requested stakeholder feedback
regarding the intraservice work description in for this code to explain
the use, if any, of the nephroureteral catheter in this procedure.
The RUC recommended the inclusion of ``room, angiography'' (EL011)
for this family of codes. In our proposal we stated that we did not
agree with the RUC that an angiography room would be used in the
typical case for these procedures, as there are other rooms available
which can provide fluoroscopic guidance. Most of the codes that make
use of an angiography room are cardiovascular codes, and much of the
equipment listed for this room would not be used for non-cardiovascular
procedures. We therefore proposed to replace equipment item ``room,
angiography'' (EL011) with equipment item ``room, radiographic-
fluoroscopic'' (EL014) for the same number of minutes. We requested
public comment regarding the typical room type used to furnish the
services described by these CPT codes, as well as the more general
question of the typical room type used for GU and GI procedures. In the
past, the RUC has developed broad recommendations regarding the typical
uses of rooms for particular procedures, including the radiographic-
fluoroscopy room. In the proposed rule, we stated that we believed that
such a recommendation from the RUC concerning all of these codes could
be useful in ensuring relativity across the PFS.
The following is a summary of the comments we received on our
proposals.
Comment: Several commenters, including the RUC, stated that the CMS
proposed work RVUs were based on a flawed methodology. Commenters
stated that CMS ignored intensity measures, differences in patient
population, and risk profile considerations between the genitourinary
codes. These commenters indicated that they did not agree with the use
of intraservice time ratios as a methodology for establishing work
RVUs.
Response: We refer the reader to our earlier discussion about the
utility of time ratios in identifying potential work RVUs. For this
particular group of codes, we believe that establishing CPT code 50430
as the baseline value and then using intraservice time ratios to
maintain relativity of work RVUs results in accurate work RVUs for
these services. We note that these refined work RVUs were supported in
all cases by the use of crosswalks to existing CPT codes which we
believe reflect similar intensity, which further supported the refined
work RVUs
Comment: Several commenters indicated that the compelling evidence
standard applied by the RUC for requiring an increase in valuation had
been met for this code family, and therefore increased work RVUs were
acceptable when compared to the previous group of genitourinary
catheter procedures.
Response: We recognize that the RUC internal deliberations include
rules that govern under what circumstances individual specialties can
request that the RUC recommend CMS increase values for particular
services. As observers to the RUC process, we appreciate having an
understanding of these rules in the context of our review of RUC-
recommended values. However, we remind the commenters that we are aware
of such rules when we initially consider RUC recommendations. We are
committed to preserving relativity between services across the entirety
of the PFS, and believe that our proposed values best achieve that aim.
Comment: Several commenters disagreed with the use of crosswalks to
other CPT codes provided by CMS. Commenters stated that the work
[[Page 70966]]
between the codes was not comparable due to clinical differences
between the genitourinary catheter codes and the procedures described
in the crosswalk codes. Commenters specifically referenced the
crosswalk that CMS selected for CPT code 50431 and stated that the CMS
chosen crosswalk code does not have the same infectious considerations
(bacteremia) or the magnitude of diagnostic considerations as CPT code
50431.
Response: In the resource-based relative value system, services do
not have to be clinically similar in order to be comparable. Relative
value units (RVUs) are comparable across services furnished by
different medical specialties. We note as well that the crosswalk codes
referenced by the RUC in its recommendations are frequently not
clinically similar to the CPT code under review. In the case of 50431,
we note that our crosswalk to CPT code 49460 has identical intraservice
time and total time with CPT code 50431, along with similar clinical
intensity, suggesting that it has value as a point of comparison for
this code. Furthermore, we did not establish a direct crosswalk between
the work of these two codes, only using CPT code 49460 (which has a
work RVU of 0.96 RVUs) as one of three separate data points. For our
second data point, we wrote that the recommendation for CPT code 50431
stated that the new code described work previously performed by a
combination of CPT codes 50394 and 74425. These two codes have work
RVUs of 0.76 and 0.36, respectively, which sum together to 1.12. For
our third data point, we observed that the minimum survey result had a
work RVU of 1.10, which we believe accurately reflects the total work
for this service. The survey minimum value of 1.10 RVUs was the method
used to establish our proposed work RVU for this code. We refer readers
to the discussion above in the Methodology for Establishing Work RVUs
section for more information regarding the crosswalks used in
developing values for this procedure.
After consideration of comments received, we are finalizing our
proposed work RVU of 1.10 for CPT code 50431.
Comment: Several commenters disagreed with the CMS proposed work
RVU of 4.25 for CPT code 50432 and suggested that CMS accept the RUC-
recommended RVU of 4.70. They indicated that CMS used a clinically
dissimilar crosswalk, CPT code 31660, which consists of very different
work, patient populations, and potential complications. Commenters also
stated that CMS used a different combination of existing CPT codes in
its building block valuation of the new code 50432, leaving out CPT
code 50390. Commenters indicated that this was a mistake and the use of
CPT code 50390 would be typical.
Response: As we mentioned previously, in the resource-based
relative value system, services do not have to be clinically similar to
be comparable. CPT code 31660 shares intraservice time and total time
values that are nearly identical to CPT code 50432, along with similar
clinical intensity, so we continue to believe that it is an accurate
crosswalk. We also do not believe that the use of CPT code 50390 would
be typical in constructing a building block methodology for CPT code
50432. The new code is assembled through a combination of genitourinary
catheter CPT code 50392 with injection CPT codes 74425 and 74475. We do
not believe that CPT code 50390 would typically be included in this
group as well, since the code descriptors for both 50390 and 50392 also
include drainage and this service would not be performed twice. We
believe that the new CPT code 50432 would be used for either the
previously reported CPT codes 50390 or 50392 service, but not for both
of them at once. In addition, the RUC has recommended that we assume
that most of the procedures previously reported using CPT code 50392
would be reported using new CPT code 50432.
We note as well that our proposed work RVU for CPT code 50432 was
supported by the use of two time ratios with CPT code 50430. Both the
intraservice time ratio and the total time ratio suggested that a value
below the RUC recommendation of 4.70 RVUs would be more accurate. After
consideration of comments received, we are finalizing our proposed work
RVU of 4.25 for CPT code 50432.
Comment: Several commenters stated that CMS should accept the RUC-
recommended work RVU of 5.75 for CPT code 50433. While they agreed with
CMS' use of the RUC-recommended increment of 1.05 RVUs relative to CPT
code 50432, they did not agree with the CMS refined work RVU of CPT
code 50432 itself. Some commenters also did not support the CMS
crosswalk to CPT code 57155, which they stated had very different work,
patient population, and potential complications.
Response: We agree that CPT code 50433 is accurately valued at 1.05
RVUs greater than CPT code 50432, which describes the additional work
performed by placing a nephroureteral catheter relative to the work of
placing a nephrostomy catheter. However, we continue to believe that
our proposed work RVU for CPT code 50432 is an accurate value for the
reasons detailed above. With regard to our crosswalk, we maintain that
relative value units are comparable across different medical
specialties. CPT code 57155 (Insertion of uterine tandem and/or vaginal
ovoids for clinical brachytherapy) has an identical intraservice time
of 60 minutes and 14 additional minutes of total time, along with
similar clinical intensity, which support the difference of 0.10 RVUs
when compared to CPT code 50433. After consideration of the comments
received, we are finalizing a work RVU of 5.30 for CPT code 50433.
Comment: Several commenters requested that CMS adopt the RUC-
recommended work RVU of 4.20 for CPT code 50434. Commenters disagreed
with the methodology that CMS used to arrive at the proposed value of
4.00 RVUs, in particular the use of intraservice time ratios, and
stated that the CMS crosswalk to CPT code 31634 (Bronchoscopy, rigid or
flexible, with balloon occlusion) was inappropriate due to clinical
dissimilarity.
Response: We refer the reader to our earlier discussion about
intraservice time ratios. We found the identical result of 3.98 work
RVUs for CPT code 50434 when we applied the intraservice time ratio to
CPT codes 50432 and 50433. This lent further support to our proposed
work RVU. With regard to our crosswalk, we note that in the resource-
based relative value system, CPT codes do not have to be clinically
similar to be comparable. CPT code 31634 shares the identical
intraservice time with CPT code 50434 and serves as a direct crosswalk.
After consideration of comments received, we are finalizing our
proposed work RVU of 4.00 for CPT code 50434.
Comment: Several commenters made similar statements regarding the
proposed work RVU for CPT code 50435, criticizing the use of
intraservice time ratios with other codes in the genitourinary catheter
family and disagreeing with the crosswalked CPT codes for being
medically dissimilar.
Response: We refer the reader to our earlier discussion about
intraservice time ratios and continue to believe that their use results
in accurate work RVUs for this family of codes. We made use of an
intraservice time ratio with both CPT code 50430 (the base code for the
family) and CPT code 50432 (the most clinically similar code), which
produced results of 1.80 and 1.77 RVUs, respectively. We also found two
different crosswalks with identical intraservice time and very similar
work RVUs, including CPT code 36569, with identical intraservice time,
identical
[[Page 70967]]
total time, and a work RVU of 1.82 RVUs. Although we maintain that
relative value units are comparable across different medical
specialties, CPT code 36569 does in fact describe a medically related
procedure, with the insertion of a central venous catheter. After
consideration of comments received, we are finalizing our proposed work
RVU of 1.82 for CPT code 50435.
Comment: Commenters urged CMS to adopt the RUC-recommended work
RVU, corresponding to the median survey work RVU of 4.60 RVUs for CPT
code 50693. They stated that the placement of a ureteral stent requires
more work than the placement of a nephroureteral catheter, and the 0.21
RVU differential proposed by CMS is insufficient to reflect the
additional work difficulty of CPT code 50693.
Response: We are uncertain about which codes are being compared by
the commenters, since the 0.21 RVU differential referenced by the
commenters does not exist in the codes that appear to be discussed in
the comment (50433). Since the commenters did not include the five
digit CPT designation in their comparison, we are uncertain which code
the commenters intended to discuss.
We continue to believe that a work RVU of 4.21, corresponding to
the 25th percentile survey result, is the most accurate value for CPT
code 50693. We believe that the ureteral stent procedures are
clinically similar to the rest of the genitourinary catheter family,
and the use of intraservice time ratios with these procedures provides
an accurate method for determining relative values. We continue to
believe that the work RVU of 4.21, corresponding to the 25th percentile
survey result, is further supported through our crosswalk to CPT code
31648 (Bronchoscopy, rigid or flexible, with removal of bronchial
valve) which has similar times and a work RVU of 4.20. After
consideration of comments received, we are finalizing our proposed work
RVU of 4.21 for CPT code 50693.
Comment: Several commenters made statements similar to those
mentioned previously regarding the work RVU for CPT code 50694,
criticizing the use of intraservice time ratios with other codes in the
genitourinary catheter family and disagreeing with the crosswalked CPT
codes for being medically dissimilar.
Response: We refer the reader to our earlier discussion about
intraservice time ratios and continue to believe that their use results
in accurate work RVUs for this family of codes. We compared CPT code
50694 with 50433, the code within the family with the most similar
intraservice time, which resulted in a potential work RVU of 5.48. We
also found that CPT code 50382 had nearly identical intraservice time
and total time, and a work RVU of 5.50. While we maintain that relative
value units are comparable across different medical specialties, we do
not agree with the commenters that CPT code 50382 is medically
dissimilar from CPT code 50694. The former refers to the removal and
replacement of a ureteral stent, while the latter refers to the
placement of a ureteral stent. We believe that these codes describe
very similar procedures, share the same patient population, and can
serve as a direct crosswalk for the work RVU of each other. After
consideration of comments received, we are finalizing our proposed work
RVU of 5.50 for CPT code 50694.
Comment: A few commenters stated that their comments on CPT code
50695 are similar to those they had made previously about CPT code
50433. While they agreed that CMS was correct to maintain the RUC-
recommended increment of 1.55 RVUs greater than the value of CPT code
50694, they did not agree with the CMS refined work RVU of 50694
itself. Commenters also did not support the CMS crosswalk to CPT code
36481, which they stated had very different work, patient population,
and potential complications.
Response: We agree that CPT code 50695 is accurately valued at 1.55
RVUs greater than CPT code 50694, which describes the additional work
performed by the use of a nephrostomy tube. However, we continue to
believe that the proposed work RVU for CPT code 50694 is an accurate
value for the reasons detailed above. With regard to our crosswalk, we
continue to believe that relative value units are comparable across
services furnished by different medical specialties. CPT code 36481
(Percutaneous portal vein catheterization by any method) has an
identical intraservice time of 75 minutes and 18 additional minutes of
total time, but a lower work RVU (6.98 RVUs) than the one suggested by
our incremental method. Commenters also did not discuss our use of an
intraservice time ratio with the base code in this subfamily, CPT code
50693, which suggested a work RVU of 7.02. After consideration of
comments received, we are finalizing our proposed work RVU of 7.05 for
CPT code 50695.
Comment: Several commenters disagreed with the CMS proposal to
eliminate the RN/LPN/MTA blend (L037D) of clinical labor for assisting
the physician during procedures 50431 and 50435. The CMS rationale was
based on the lack of moderate sedation taking place in these two
procedures. However, commenters argued that these procedures do require
monitoring for patient stability that the attending physician cannot
provide. They urged that the RN/LPN/MTA blend would be most appropriate
for these procedures.
Response: We are not aware of any other procedures in which there
is a third assistant in the procedure room when moderate sedation is
not being provided. We believe that the standard use of clinical labor
staff would be typical when performing these procedures.
Comment: Commenters also disagreed with the CMS proposal to change
the labor type for patient monitoring following service (not related to
moderate sedation) from the RUC-recommended RN (L051A) to the RN/LPN/
MTA blend (L037D). Commenters stated that although use of the RN/LPN/
MTA blend is standard for this clinical labor task, the RUC allows
specialty groups to use an RN with justification, and that was the case
here for these procedures since they involve invasive percutaneous
solid organ interventions.
Response: After consideration of comments, we agree that the use of
the RN (L051A) clinical labor is typical for patient monitoring
following service (not related to moderate sedation) for these
particular specialty groups. We will restore the recommended L051A
labor type for this clinical labor task for CPT codes 50430, 50432,
50433, 50434, 50693, 50694, and 50695. We will also consider making a
formal proposal regarding the most suitable type of clinical labor
staff for this monitoring in future rulemaking.
Comment: CMS sought clarification regarding the use of the
nephroureteral catheter (SD306) for CPT code 50433. CMS removed this
supply from CPT code 50433 since it was not mentioned in the
information about the survey included in the RUC recommendation.
Commenters wrote to explain that the phrase ``An 8 Fr nephroureteral
stent is inserted with the distal pigtail in the bladder'' is included
in the description of work for CPT code 50433, and in the context of
genitourinary and biliary procedures, the historic term ``stent'' has
been used interchangeably with the term ``catheter''. Commenters
suggested that the nephroureteral catheter should be maintained as a
supply item for this code and for CPT code 50434.
Response: We agree that the nephroureteral catheter should be
maintained as a supply item for CPT codes 50433 and 50434, based on the
presentation of this additional information. However, based on our
analysis of the comments, we believe
[[Page 70968]]
that our review of the RUC recommendations would be facilitated by
consistent use of terminology throughout the information included in
the recommendations.
Comment: Several commenters, including the RUC, disagreed with the
CMS decision to replace the angiography room (EL011) with a
fluoroscopic room (EL014) for the genitourinary catheter family of
codes. Commenters stressed that the fluoroscopic room was incapable of
3-axis rotational imaging, that it would require dangerous movement of
the patient, and that it presented sterility concerns. Commenters
further disagreed that use of the angiography room was typically
limited to cardiovascular procedures. They suggested that looking at
service utilization, rather than number of CPT codes, indicates that
non-vascular interventional procedures together comprise more than 50
percent of utilization of a typical angiography room. Commenters also
provided a list of the equipment found in an angiography room, and
stated that everything other than the ``Injector, Provis'' would be
typically utilized for the genitourinary catheter procedures. As a
result, the commenters urged CMS to reverse the proposed refinement and
restore the use of the angiography room for these codes.
Response: We continue to believe that the use of an angiography
room would not be typical for these genitourinary catheter procedures.
The new genitourinary catheter codes in this family are being
constructed through the bundling of imaging guidance with previously
existing genitourinary catheter procedures. With the exception of CPT
code 50398, the direct PE inputs for the predecessor codes do not
include the use of an angiography room. We do not have reason to
believe the coding changes related to these procedures would
necessitate the use of different technology in furnishing the services.
While it is true that the angiography room was included as a direct PE
input for some of the predecessor imaging services, such as CPT codes
77475, 77480, and 77485, the equipment times for these services were
significantly shorter than the time included for the base procedures,
where use of the room was not considered to be typical. Given the six
fold increase in recommended time and the significantly higher expenses
of the newly recommended equipment versus the equipment costs
associated with the predecessor codes, we are seeking not only a
rationale for the use of the angiography room, but also evidence that
this room is typically used when these services are reported in the
nonfacility setting.
Comment: One commenter disagreed with the CMS decision to refine
the time for clinical labor task ``Clean room/equipment by physician
staff'' (L041B) from 6 minutes to 3 minutes. The commenter stated that
there had been a robust discussion of this topic at the RUC meeting,
and the additional minutes are needed to clean fluids/equipment/etc.
Response: We continue to believe that the standard time of 3
minutes for this clinical labor task is more accurate for the
genitourinary catheter family of codes. We do not believe that these
procedures typically produce enough external fluids to justify 6
minutes for room cleaning.
Comment: Several commenters disagreed with the CMS refinement of
supplies to remove those that were duplicative of the same supplies
found in visit packs (SA048) and sedation packs (SA044). Commenters
stated that the IV starter kit (SA019), endoscope cleaning and
disinfecting pack (SA042), non-sterile gloves (SB022), sterile gloves
(SB024), sterile surgical gown (SB028), and three-way stop cock (SC049)
were not duplicative supplies, as they were used in addition to the
supplies included in the packs. Commenters requested that these
supplies be restored to the direct PE inputs for the genitourinary
catheter codes.
Response: We agree with the commenters that three sets of sterile
garments would typically be used for the three medical professionals
performing the procedure. We are therefore restoring one pair of
sterile gloves, one sterile surgical gown, one IV starter kit, and one
three-way stop cock to these codes, consistent with the RUC
recommendation. We do not believe that the use of two more pairs of
non-sterile gloves (beyond the two pairs already included in the visit
pack) would be typical for these procedures. With regards to the
``endoscope cleaning and disinfecting pack'', our rationale was not
that this supply was duplicative, but rather that its use would not be
typical because the genitourinary catheter codes do not make use of an
endoscope. We did not receive comments that suggested that supply item
``endoscope cleaning and disinfecting pack'' would typically be used.
After consideration of comments received, we are finalizing the
direct PE inputs as proposed, with the addition of the nephroureteral
catheter for CPT code 50433, the change in clinical labor type from
L037D to L051A for patient monitoring following service (not related to
moderate sedation), and the additional four supplies detailed in the
previous paragraph for CPT codes 50430, 50432, 50433, 50434, 50693,
50694, and 50695.
(10) Penile Trauma Repair (CPT Codes 54437 and 54438)
The CPT Editorial Panel created these two new codes because there
are no existing codes to capture penile traumatic injury that includes
penile fracture, also known as traumatic corporal tear, and complete
penile amputation. CPT code 54437 describes a repair of traumatic
corporeal tear(s), while CPT code 54438 describes a replantation,
penis, complete amputation.
In the proposed rule, we stated that we disagreed with the RUC
recommendation of 24.50 work RVUs for CPT code 54438. We indicated that
a work RVU of 22.10, corresponding to the 25th percentile survey
result, was a more accurate value based on the work involved in the
procedure and within the context of other codes in the same family,
since CPT code 54437 was also valued using the 25th percentile. We
found further support for this valuation through a crosswalk to CPT
code 43334 (Repair, paraesophageal hiatal hernia via thoracotomy,
except neonatal), which has an identical intraservice time and a work
RVU of 22.12. Therefore, we proposed a work RVU of 22.10 for CPT code
54438.
Because CPT codes 54437 and 54438 are typically performed on an
emergency basis, in the proposed rule, we questioned the accuracy of
the standard 60 minutes of preservice clinical labor in the facility
setting, as we suggested that the typical procedure would not make use
of office-based clinical labor. We suggested, for example, the typical
case would require 8 minutes to schedule space in the facility for an
emergency procedure, or 20 minutes to obtain consent. We solicited
further public comment on this issue from the RUC and other
stakeholders.
The following is a summary of the comments we received on our
proposals.
Comment: One commenter urged CMS to accept the RUC-recommended
value for CPT code 54438 at 24.50 RVUs. This commenter argued that the
RUC regularly accepts the median survey work RVU for one service and
the 25th percentile survey result work RVU for another when both are in
the same code family, particularly when they diverge in length of time.
The commenter also suggested that reducing the intensity of CPT code
54438 below its RUC-recommended value of 0.071
[[Page 70969]]
was inappropriate for such a complex and difficult procedure, with an
unusual patient population that is often schizophrenic and prone to
self-injury. This commenter emphasized using the RUC-supplied reference
of CPT code 53448 as justification for the RUC-recommended work RVU.
Response: We appreciate the presentation of this additional
information concerning the complexity and intensity of CPT code 54438.
We agree that the unusual patient population for this procedure
justifies a higher work RVU than the proposed value. After
consideration of comments received, we are finalizing our proposed work
RVU of 11.50 for CPT code 54437, and assigning the RUC-recommended work
RVU of 24.50 for CPT code 54438.
(11) Intrastromal Corneal Ring Implantation (CPT Code 65785)
CPT code 65785 is a new code describing insertion of prosthetic
ring segments into the corneal stroma for treatment of keratoconus in
patients whose disease has progressed to a degree that they no longer
tolerate contact lens wear for visual rehabilitation.
In the proposed rule, we stated that we disagreed with the RUC
recommendation of a work RVU of 5.93 for CPT code 65785. Although we
appreciated the extensive list of other codes the RUC provided as
references, we expressed concern that the recommended value for CPT
code 65785 overestimated the work involved in furnishing this service
relative to other PFS services. We did not find any codes with
comparable intraservice and total time that had a higher work RVU. The
recommended crosswalk, CPT code 67917 (Repair of ectropion; extensive),
appears to have the highest work RVU of any 90-day global surgery
service in this range of work time values. It also has longer
intraservice time and total time than the code in question, making a
direct crosswalk unlikely to be accurate.
As a result, we proposed a work RVU for CPT code 65785 based on the
intraservice time ratio in relation to the recommended crosswalk. We
compared the 33 minutes of intraservice time in CPT code 67917 to the
30 minutes of intraservice time in CPT code 65785. The intraservice
time ratio between these two codes is 0.91, and when multiplied by the
work RVU of CPT code 67917 (5.93) resulted in a potential work RVU of
5.39. We also considered CPT code 58605 (Ligation or transection of
fallopian tube(s)), which has the same intraservice time, 7 additional
minutes of total time, and a work RVU of 5.28. In the proposed rule, we
stated that we believed that CPT code 58605 was a more accurate direct
crosswalk because it shares the same intraservice time of 30 minutes
with CPT code 65785. Accordingly, we proposed a work RVU of 5.39 for
CPT code 65785.
The RUC recommendation for CPT code 65785 included a series of
invoices for several new supplies and equipment items. One of these was
the 10-0 nylon suture with two submitted invoice prices of $245.62 per
box of 12, or $20.47 per suture, and another was priced at $350.62 per
box of 12, or $29.22 per suture. Given the range of prices between
these two invoices, we sought publicly available information and
identified numerous sutures that appear to be consistent with those
recommended by the specialty society, at lower prices, which we
believed were more likely to be typical since we assumed that the
typical practitioner would seek the best price. One example is
``Surgical Suture, Black Monofilament, Nylon, Size: 10-0, 12''/30cm,
Needle: DSL6, 12/bx'' for $146. Therefore, we proposed to establish a
new supply code for ``suture, nylon 10-0'' and price that item at
$12.17 each. We welcomed comments from stakeholders regarding this
supply item.
The following is a summary of the comments we received on our
proposals.
Comment: Several commenters indicated that CMS should reconsider
its decision and accept the RUC-recommended work RVU of 5.93. These
commenters stated that the intraservice time ratio used by CMS did not
account for differences in preservice time, postservice time, or levels
of physician intensity. Commenters also disagreed with CMS' statement
that there were no services with a comparable intraservice and total
time that had a higher work RVU than the RUC-recommended value of 5.93
for CPT code 65785. The commenters supplied a list of seven CPT codes
that have a work RVU higher than 5.93 RVUs.
Response: We continue to believe that the use of intraservice time
ratios is one of several different methods that can be used to identify
potential work RVUs. For this particular code, the RUC used a direct
crosswalk to CPT code 67917 (Repair of ectropion; extensive) to set
their recommended work RVU at 5.93 RVUs. We do not believe that that
direct crosswalk was the most accurate way to value CPT code 65785,
since code 67917 has an intraservice time that is 10 percent longer
than the intraservice time of CPT code 65785 (33 minutes to 30
minutes). CPT code 67917 is a clinically similar code which the RUC
used for its own valuation of CPT code 65785, making it an especially
good choice for comparative purposes after applying a ratio to
normalize the intraservice times. We continue to believe that the use
of an intraservice time ratio resulted in the most accurate value,
given the difference in time between the two codes.
As discussed in the proposed rule, all CPT codes with comparable
time values and the same global period had lower work RVUs than the
RUC-recommended work RVU of 5.93. While it is true that the seven codes
provided by the commenters have work RVUs higher than 5.93 RVUs, we do
not agree that these CPT codes are appropriate for comparative purposes
with code 65785. CPT code 33768 is an add-on code (global ZZZ) that
cannot be compared to a code with a 90-day global period such as 65785.
CPT code 59830 is a Harvard-valued code that has not been subject to
RUC review, has low utilization (2013 = 7 reported services), and 20
minutes fewer total time than CPT code 65785. CPT codes 66770 and 67145
are also Harvard codes which have not been RUC reviewed, and both have
different intraservice times than 65785, 5 minutes and 10 minutes,
respectively. CPT codes 67210 and 67220 are the only codes supplied by
the commenters to be recently reviewed by the RUC, but both of them
have only 15 minutes intraservice time, limiting their utility for
comparative purposes with the 30 minutes intraservice time assumed for
CPT code 65785. Although we accept the commenters' point that other
codes with work RVUs above 5.93 RVUs do exist, we do not agree that
codes referenced by commenters have ``comparable intraservice and total
time'' with CPT code 65785. We continue to believe that scaling the
RUC's key reference code of 67917 by the intraservice time ratio
between the two codes provides the most accurate value for CPT code
65785.
After consideration of comments received, we are finalizing the
work RVU and the direct PE inputs for CPT code 65785 as proposed.
(12) Dilation and Probing of Lacrimal and Nasolacrimal Duct (CPT Codes
66801, 68810, 68811, 68815 and 68816)
The RUC reviewed 10-day global services and identified 18 services
with greater than 1.5 office visits and 2012 Medicare utilization data
over 1,000, including CPT codes 66801, 68810, 68811, 68815, and 68816.
The RUC requested surveys and reviews of these services for CY 2016.
As discussed in the proposed rule, the RUC recommended a work RVU
of 1.00
[[Page 70970]]
for CPT code 68801 and a work RVU of 1.54 for CPT code 68810. Although
we proposed to use the RUC-recommended work RVU for CPT code 68810, we
stated that the recommendation for CPT code 68801 did not best reflect
the work involved in the procedure because of a discrepancy between the
post-operative work time and work RVU. Specifically, the RUC
recommendation for the procedure included the removal of a 99211 visit,
but the RUC-recommended work RVU did not reflect any corresponding
adjustment. We proposed to accept the RUC's recommendation to remove
the 99211 visit from the service but proposed to further reduce the
work RVU for CPT code 68801 by removing the RVUs associated with CPT
code 99211. Therefore, for CY 2016, we proposed a work RVUs of 0.82 to
CPT code 68801 and 1.54 to CPT code 68810.
The RUC recommended a work RVU of 2.03, 3.00, and 2.35 for CPT
codes 68811, 68815 and 68816, respectively. In the proposed rule, we
stated that the RUC recommendations for these services do not appear to
best reflect the work involved in performing these procedures. To value
these services for the proposed rule, we calculated a total time ratio
by dividing the code's current total time by the RUC-recommended total
time, and then applying that ratio to the current work RVU. This
produced the proposed work RVUs of 1.74, 2.70, and 2.10 for CPT codes
68811, 68815, and 68816, respectively.
The following is a summary of the comments we received on our
proposals.
Comment: Several commenters, including the RUC, suggested that CMS
reconsider its decision to not accept the RUC recommendations. The
commenters believe that using a reverse building block methodology to
reduce a work RVU for this service is inappropriate since magnitude
estimation was used to establish the recommended work RVUs for this
series of codes. Commenters also believe that CMS did not provide
detailed rationale for the rejection of the RUC-recommended work RVUs
for CPT codes 68811, 68815 and 68816. Finally, commenters noted that
the existing IWPUT for each of these three surgical services is below
0.03, which the commenters believe calls into question the accuracy of
the existing work time and its usage in deriving a new work RVU.
Response: We appreciate the commenters' perspectives, but reiterate
that our proposed values accounted for the changes in the time
resources assumed to be involved in furnishing these services since
they were previously valued. We note that the validity of the IWPUT
alone as a measure of intensity is reliant on the accuracy of the
assumption regarding the number and level of visits for services in the
global period for individual services. Therefore, we do not generally
agree that a low IWPUT itself indicates misvaluation, particularly for
services with global periods. After considering the comments received,
we continue to believe that the work RVUs proposed for these codes
accurately reflect the work involved in furnishing these services.
Therefore, for CY 2016 we are finalizing work RVUs for CPT codes
68801, 68810, 68811, 68815, and 68816, as proposed.
(13) Spinal Instability (CPT Codes 72081, 72082, 72083, and 72084)
For CY 2015, the CPT Editorial Panel deleted codes 72010
(radiologic examination, spine, entire, survey study, anteroposterior
and lateral), 72069 (radiologic examination, spine, thoracolumbar,
standing (scoliosis)), and 72090 (radiological examination, spine;
scoliosis study, including supine and erect studies), revised one code,
72080 (Radiologic examination, spine; thoracolumbar junction, minimum
of 2 views) and created four new codes which cover radiologic
examination of the entire thoracic and lumbar spine, including the
skull, cervical and sacral spine if performed. The new codes were
organized by number of views, ranging from one view in 72081, two to
three views in 72082, four to five views in 72083, and minimum of six
views in 72084.
In the proposed rule, we stated that we did not agree with the
RUC's recommended work RVUs for the four new codes. For 72081, we noted
that the one minute increase in time resulted in a larger work RVU than
would be expected when taking the ratio between time and RVUs in the
source code and comparing that to the time and work RVU ratio in the
new code. Using the relationship between time and RVUs from deleted CPT
code 72069, we proposed a work RVU of 0.26 for CPT code 72081, which
differs from the RUC-recommended value of 0.30. Using an incremental
methodology based on the relationship between work and time in the
first code we proposed to adjust the RUC-recommended work RVUs for CPT
codes 72082, 72083 and 72084 to 0.31, 0.35, and 0.41, respectively.
The following is a summary of the comments we received on our
proposals.
Comment: Many commenters, including the RUC, disagreed with CMS'
proposed crosswalk for 72081 and urged CMS to use the RUC
recommendation. The commenters stated that since CPT code 72069 is
being deleted due to changes in technology and patient population, it
is a poor comparison. Other commenters pointed out that CPT code 72081
typically includes an X-ray of skull, cervical spine, and pelvis and
therefore is by definition more work than CPT code 72069. CPT code
72069 is also noted as ``CMS/other'' code in the RUC's time file and
the times in that file are not divided into time periods as CPT code
72081 is. One commenter suggested that a more accurate crosswalk was
CPT code 74020 (Radiologic examination, abdomen; complete, including
decubitus and/or erect views,) which has a work RVU of 0.30. Using the
same increments, the commenter suggested that the CMS proposed change
for CPT code 72081 to 0.26 RVUs would result in an accurate increase in
work across the family.
Response: We continue to believe that CPT code 72069 is an accurate
crosswalk. While CPT code 72069 may not be divided into time periods,
the ratio between the total time and the RVU adequately reflects the
relationship between time and intensity in CPT code 72081. Although we
used CPT code 72069 as a comparison to CPT code 72081, we note that CPT
code 72081 has a higher work RVU, which accounts for the extra work
associated with imaging the skull, cervical spine, and pelvis. We do
not believe that CPT code 74020 would be an accurate crosswalk because
it describes a radiological examination of the abdomen whereas CPT code
72069 refers to the same anatomical region as CPT code 72081.
Therefore, after considering the comments received, we are
finalizing these work RVUs for 72081, 72082, 72083, and 72084 as
proposed.
(14) Echo Guidance for Ova Aspiration (CPT Code 76948)
In the CY 2014 PFS final rule with comment period, we requested
additional information to assist us in the valuation of ultrasound
guidance codes. We nominated these codes as potentially misvalued based
on the extent to which standalone ultrasound guidance codes were billed
separately from services where ultrasound guidance was an integral part
of the procedure. CPT code 76948 was among the codes considered
potentially misvalued. CPT code 76948 was surveyed by the specialty
societies and the RUC issued a recommendation for CY 2016. In the
proposed rule, we stated that we had concerns about valuation of this
code since it is a guidance code
[[Page 70971]]
used only for a single procedure, CPT code 58970 (aspiration of ova),
and that these two codes are typically billed concurrently. We believe
CPT codes 76948 and 58970 should be bundled to accurately reflect how
the service is furnished.
We proposed to use work times based on refinements of the RUC-
recommended values by removing the 3 minutes of pre and post service
time since these times are reflected in CPT code 58970. We proposed
work and time values for 76948 based on a crosswalk from 76945
(Ultrasonic guidance for chorionic villus sampling, imaging supervision
and interpretation) which has a work time of 30 minutes and an RVU of
0.56. Therefore we proposed to maintain 25 minutes of intraservice time
for CPT code 76948 and proposed a work RVU of 0.56.
The following is a summary of the comments we received on our
proposals.
Comment: Commenters stated that CMS should not have removed the
work from the pre and post service portions of the service period and
should restore the RUC-recommended work RVU of 0.85. The commenters
stated that in the pre service period the physician reviews clinical
history as well as prior imaging studies, and in the post service
period the physician reviews and signs final report. The RUC commented
that CPT codes 58970 and 76945 were billed less than 10 times each in
2014, and were not billed together in any of those instances. The RUC
acknowledged that these codes may be billed together under private
payers and stated they would continue to review codes billed together
75 percent of the time and bundle them when appropriate.
Response: We appreciate the commenters' feedback. However, given
the definition of the codes, we continue to believe that CPT code 76945
is the image guidance code for CPT code 58970, and that these codes
would not typically be billed separately. We acknowledge the anomalies
in the low volume of Medicare claims data but do not believe that data
likely reflects the way the services are intended to be reported.
Therefore, any pre- or post-service work would be accounted for in CPT
code 58970. After considering the comments received, we are finalizing
a work RVU of 0.56 for CPT code 76945 as proposed.
(15) Surface Radionuclide High Dose Radiation Brachytherapy (CPT Codes
77767, 77768, 77770, 77771, and 77772)
In October 2014 the CPT Editorial Panel created five new codes to
describe high dose radiation (HDR) brachytherapy. We proposed the RUC-
recommended work RVUs of 1.05, 1.40, 1.95, 3.80, and 5.40 respectively,
for CPT codes 77767, 77768, 77770, 77771, and 77772. The RUC also
recommended a new PE input, a brachytherapy treatment vault, which we
proposed to include without modification.
Comment: Commenters expressed support for CMS' proposed work and
time values for this family of codes, and for CMS' proposal to add the
brachytherapy vault as a PE input. Many commenters expressed concern
for the overall downward trend in reimbursement for brachytherapy
services, citing a sustained decrease in office-based brachytherapy
procedures since 2009. The commenters encouraged CMS to enact measures
to improve this.
Response: We appreciate commenters' concerns regarding accurate
payment for brachytherapy services. The revaluation of services under
the Potentially Misvalued Code Initiative is aimed at achieving the
most appropriate relative values under the PFS. There is not an
intentional ``downward trend'' for any particular family of services.
We remind commenters and stakeholders that disagree with CMS values,
including those based on RUC recommendations, that in addition to
submitting comments on our proposed rules, they may also nominate codes
as potentially misvalued through the public nomination process. We are
finalizing the values for HDR brachytherapy as proposed.
(16) Immunohistochemistry (CPT Codes 88341, 88342, and 88344)
As discussed in the proposed rule, in establishing CY 2015 interim
final direct PE inputs for CPT codes 88341, 88342, and 88344, we
replaced the RUC-recommended supply item ``UltraView Universal DAB
Detection Kit'' (SL488) with ``Universal Detection Kit'' (SA117), since
the RUC recommendation did not provide an explanation for the required
use of a more expensive kit. We also adjusted the equipment time for
equipment item ``microscope, compound'' (EP024). We reexamined these
codes when valuing the immunofluorescence family of codes for CY 2016,
and reviewed information received by commenters that explained the need
for these supply items. Specifically, commenters explained that the
universal detection kit that CMS included in place of the RUC-
recommended kit was not typically used in these services as it was not
clinically appropriate. We proposed to include the RUC-recommended
supply item SL488 for CPT codes 88341, 88342, and 88344, as well as the
RUC-recommended equipment time for ``microscope, compound'' for CY
2016.
In establishing interim final work RVUs for this family of codes,
we refined the RUC recommendation for CPT code 88341 to 0.42, such that
the work RVU for this add-on code was 60 percent of that of the base
code 88342 (0.70 work RVUs). We noted that for similar procedures in
this family, the RUC had recommended work RVUs for add-on codes that
were 60 percent of the base codes, and that we believed this
methodology would appropriately value this add-on code. In the proposed
rule, we reexamined the work RVU for this service in the context of
reviewing the immunoflurescent studies procedures. In doing so, we
increased the work RVU of this add-on code to 0.53, which reflected 76
percent of 0.70, the base code for this service. We discuss our
rationale for this adjustment in the immunofluorescent studies section
below. However, we inadvertently omitted the rationale for this
revision to the work RVU in the proposed rule.
The following is a summary of the comments we received on our
proposals.
Comment: Several commenters, including the RUC, stated their
appreciation of CMS' reconsideration when reexamining the RUC-
recommended direct PE inputs, ``UltraView Universal DAB Detection Kit''
(SL488) and equipment time for the supply item ``microscope, compound''
(EP024) for CPT codes 88341, 88342, and 88344 following feedback from
the public.
A few commenters also noted that the work RVU for CPT code 88341
(Immunohistochemistry or immunocytochemistry, per specimen; each
additional single antibody stain procedure (List separately in addition
to code for primary procedure) as displayed in Addendum B of the
proposed rule was inconsistent with the CY 2015 work RVU but was not
discussed elsewhere in the proposed rule.
Response: The discussion about the rationale for the increased work
RVU for CPT code 88341 was inadvertently omitted from the proposed
rule. Since the proposed rule did not include this discussion, we will
maintain the interim final status of the CY 2015 work RVU of 0.53 for
CY 2016 and we are seeking comment on this work RVU during the comment
period for this final rule with comment period.
(17) Immunofluorescent Studies (CPT Codes 88346 and 88350)
For CY 2016, the CPT Editorial Panel deleted one code, CPT code
88347
[[Page 70972]]
(Antibody evaluation), created a new add-on service, CPT code 88350,
and revised CPT code 88346 to describe immunofluorescent studies. The
RUC recommended a work RVU of 0.74 for CPT code 88346 and 0.70 for CPT
code 88350. In the proposed rule, we stated that although we proposed
to use the RUC recommendation for CPT code 88346, we did not believe
the recommendation for CPT code 88350 best reflects the work involved
in the procedure due to our concerns with the relationship between the
RUC-recommended intraservice times for the base code and the newly
created add-on code. We examined intraservice time relationships
between other base codes and add-on codes and found that two codes in
the Intravascular ultrasound family, CPT code 37250 (Ultrasound
evaluation of blood vessel during diagnosis or treatment) and CPT code
37251 (Ultrasound evaluation of blood vessel during diagnosis or
treatment), share a similar base code/add-on code intraservice time
relationship, and are also diagnostic in nature, as are CPT codes 88346
and 88350. Due to these similarities, we believed it was appropriate to
apply the relationship, which is a 24 percent difference, between CPT
codes 37250 and 37251 in calculating work RVUs for CPT codes 88346 and
88350. In the proposed rule, we explained that we multiplied the RVU of
CPT code 88346, 0.74, by 24 percent, and then subtracted the product
from 0.74, resulting in a work RVU of 0.56 for CPT code 88350.
Therefore, for CY 2016, we proposed a work RVU of 0.74 for CPT code
88346 and 0.56 for CPT code 88350.
The following is a summary of the comments we received on our
proposals.
Comment: Several commenters stated their disagreement with the
comparison of immunofluorescent studies (CPT codes 88346 and 88350) to
ultrasound evaluation of blood vessels (CPT Codes 37250 and 37251).
Commenters specifically stated the ultrasound services are add-on
services involving initial and additional vessels, whereas CPT codes
88346 and 88350 involve work related to initial and additional single
antibody stain procedures. Commenters maintain that the level of work
required to evaluate the initial stain is nearly identical to the
second and that no efficiency is gained from the initial to the next
and, therefore, a reduction in work RVUs for the additional slide would
be inappropriate.
Response: We continue to believe that the RVUs should reflect a
reduction of overall work in each additional antibody stain slide. We
also note that for CY 2015, we established as interim final a 40
percent reduction for add-on codes, which we subsequently refined to a
24 percent reduction in the CY 2016 proposed rule. We have not received
any alternative recommendations as to the appropriate value for CPT
code 88350. Therefore, we are finalizing our proposed valuation for CPT
codes 88346 and 88350.
(18) Morphometric Analysis (CPT Codes 88364, 88365, 88366, 88367,
88373, 88374, 88377, 88368, and 88369)
The RUC reviewed and developed recommendations regarding CPT codes
88367 and 88368. We reviewed and proposed values based on those
recommended values as discussed in the proposed rule. Subsequently, the
RUC re-reviewed these services for CY 2016 due to the specialty
society's initially low survey response rate. In our review of these
codes, we noticed that the latest RUC recommendation was identical to
the RUC recommendation provided for CY 2015. Therefore, we proposed to
retain the CY 2015 work RVUs and work time for CPT codes 88367 and
88368 for CY 2016.
For CPT codes 88364 and 88369, we refined the RUC recommendations
to 0.67 for both procedures, such that the work RVUs for these add-on
codes was 60 percent of the base codes. We noted that for similar
procedures in this family, the RUC had previously recommended work RVUs
for add-on codes that were 60 percent of the base codes, and that we
believed this methodology would appropriately value these add-on codes.
In the proposed rule, we reexamined the work RVUs for these services in
the context of reviewing the immunofluorescent studies procedures. In
doing so, we increased the work RVUs of these add-on codes to 0.67,
which reflected 76 percent of 0.88, the work RVUs of the base codes for
these services. We discuss our rationale for this adjustment in the
immunofluorescent studies section above. However, we inadvertently
omitted the rationale for this revision to the work RVU in the proposed
rule.
As discussed in the proposed rule, in establishing interim final
direct PE inputs for CY 2015 for CPT codes 88364, 88365, 88366, 88367,
88373, 88374, 88377, 88368, and 88369, we refined the RUC-recommended
direct PE inputs as follows. We refined the units of several supply
items, including ``ethanol, 100%'' (SL189), ``ethanol, 70%'' (SL190),
``ethanol, 85%'' (SL191), ``ethanol, 95%'' (SL248), ``kit, FISH
paraffin pretreatment'' (SL195), ``kit, HER-2/neu DNA Probe'' (SL196),
positive and negative control slides (SL112, SL118, SL119, SL184,
SL185, SL508, SL509, SL510, SL511), ``(EBER) DNA Probe Cocktail''
(SL497),''Kappa probe cocktails'' (SL498) and ``Lambda probe
cocktails'' (SL499), to maintain consistency within the codes in the
family, and adjusted the quantities included in these codes to align
with the code descriptors and better reflect the typical resources used
in furnishing these services. We also adjusted the equipment time for
equipment items ``water bath, FISH procedures (lab)'' (EP054),
``chamber, Hybridization'' (EP045), ``microscope, compound'' (EP024),
``instrument, microdissection (Veritas)'' (EP087), and ``ThermoBrite''
(EP088), to reflect the typical time the equipment is used, among other
common refinements.
For CY 2016, we reexamined these codes when valuing the
immunofluorescence family of codes, and reviewed information received
from commenters during the CY 2015 final rule's comment period that
described the typical batch size for each of these services, which
identified apparent inconsistencies and discrepancies in the quantity
of units among the codes in the family. For CY 2016, we proposed to
include the RUC-recommended quantities for each of these supply items
for the CPT codes 88364, 88365, 88366, 88367, 88373, 88374, 88377,
88368, and 88369. With regard to the equipment items, we received
information explaining that the recommended equipment times already
accounted for the typical batch size, and thus, the recommended times
were already reflective of the typical case. Therefore, we proposed to
adjust the equipment time for equipment items EP054, EP045, and EP087
to align with the RUC-recommended times. We also received comments
explaining the need for equipment item EP088. Therefore, we proposed to
include this equipment item consistent with the RUC recommendations for
CPT code 88366.
In the proposed rule, we noted that the information we received
regarding the typical batch size was critical in determining the
appropriate direct PE inputs for these pathology services. We also
noted that we usually do not have information regarding the typical
batch size or block size when we are reviewing the direct PE inputs for
pathology services. The supply quantity and equipment minutes are often
a direct function of the number of tests processed at once. Given the
importance of the typical number of tests being processed by a
laboratory in determining the direct PE inputs, which often include
expensive supplies, we
[[Page 70973]]
expressed concern that the direct PE inputs included in many pathology
services may not reflect the typical resource costs involved in
furnishing the typical service.
In particular, we noted in the proposed rule that since
laboratories of various sizes furnish pathology tests and that,
depending on the test, a large laboratory may be at least as likely to
have furnished a test to a Medicare beneficiary compared to a small
laboratory, we noted that an equipment item involved in furnishing a
service that is commercially available to a small laboratory may not be
the same equipment item that is used in the typical case. If the
majority of services billed under the PFS for a particular CPT code are
furnished by laboratories that run many of these tests each day, then
assumptions informed by commercially available products may
significantly underestimate the typical number of tests processed
together, and thus the assumptions underlying current valuations for
per-test cost of supplies and equipment may be much higher than the
typical resources used in furnishing the service. We invited
stakeholders to provide us with information about the equipment and
supply inputs used in the typical case for particular pathology
services.
The following is a summary of the comments we received on our
proposals.
Comment: Several commenters, including the RUC, stated their
disagreement with the methodology utilized in valuing CPT code 88367
and urged CMS to use survey data and magnitude estimation when
proposing a work RVU. Commenters also suggested that there should be no
comparison of intravascular ultrasound services to morphometric
analysis, immunohistochemistry, immunofluorescence or any pathology
service. One commenter noted that for CPT code 88374 (Morphometric
analysis, in situ hybridization (quantitative or semi-quantitative),
using computer-assisted technology, per specimen; each multiplex probe
stain procedure), using computer-assisted technology does not replace
the pathologist's work; it merely refers to computer-aided selection of
images for the pathologist to review and that the computer does not
establish the distinction between cancer and non-cancer cells.
Response: As discussed in the CY 2015 final rule with comment
period (79 FR 67669), we do not believe the RUC-recommended work RVU of
0.86 for 88367 (intraservice time = 25 minute) adequately reflects the
difference in time relative to 88368 (RVU = .88, intraservice time = 30
minutes). Commenters did not address our concerns about this change in
time not being reflected in the work RVU for 88367. Therefore, we
continue to believe 0.73 RVUs accurately reflects the work for CPT code
88367. With regard to CPT code 88374, while we acknowledge using
computer-assisted technology does not replace the pathologist's work,
we continue to believe there are some efficiencies gained with the
computer assistance. After considering the comments received, for CY
2016, we are finalizing the values for CPT codes 88367 and 88374 as
proposed.
Comment: A commenter noted that the work RVUs for CPT codes 88364
and 88369 as displayed in Addendum B of the proposed rule were
inconsistent with the CY 2015 work RVUs, but were not discussed
elsewhere in the proposed rule.
Response: As noted above, the discussion about the rationale for
the increased work RVU was inadvertently omitted from the proposed
rule. Since the proposed rule did not include this discussion, we will
maintain the interim final status of the work RVU of 0.76 for CPT codes
88464 and 88369 for CY 2016 and we are seeking comment on these work
RVUs during the comment period for this final rule with comment period.
(19) Vestibular Caloric Irrigation (CPT Codes 92537 and 92538)
For CY 2016, the CPT Editorial Panel deleted CPT code 92543
(Assessment and recording of balance system during irrigation of both
ears) and created two new CPT codes, 92537 and 92538, to report caloric
vestibular testing for bithermal and monothermal testing procedures,
respectively. The RUC recommended a work RVU of 0.80 for CPT code 92537
and a work RVU of 0.55 for CPT code 92538. In the proposed rule, we
stated that we believed that the recommendations for these services
overstate the work involved in performing these procedures. Due to
similarity in service and time, we proposed that a direct crosswalk of
CPT code 97606 (Negative pressure wound therapy, surface area greater
than 50 square centimeters, per session) to CPT code 92537 accurately
reflects the total work involved in furnishing the service. To
establish a proposed value for CPT code 92538, we divided the proposed
work RVU for 92537 in half since the code descriptor for this procedure
describes the service as having two irrigations as opposed to the four
involved in CPT code 92537. Therefore, for CY 2016, we proposed work
RVUs of 0.60 to CPT code 92537 and 0.30 to CPT code 92538.
The following is a summary of the comments we received on our
proposals.
Comment: Several specialty societies stated their disappointment
that CMS did not accept the RUC-recommended work RVUs for CPT codes
92537 and 92538. Commenters stated their objection to the rationale CMS
used, stating that the rationale ignored the cogent, methodical, and
thorough approach utilized by the RUC.
Response: We appreciate the commenters' feedback. However, we
reiterate that CPT code 67606 has nearly identical intra-service and
total times as CPT code 92537 and given the similarity in services we
continue to believe the direct crosswalk from CPT code 97606 to CPT
code 92537 to be the most accurate. Also, CPT code 92538 describes two
irrigations which is half the work involved in furnishing the service
of CPT code 92537. For that reason, we continue to believe it is
appropriate to establish 92538 with half of the work RVUs of 92537.
Therefore, for CY 2016 we are finalizing a work RVU of 0.60 for 92537
and 0.30 for 92538.
(20) Instrument-Based Ocular Screening (CPT Codes 99174 and 99177)
For CY 2015, the CPT Editorial Panel created a new code, CPT code
99177, to describe instrument-based ocular screening with on-site
analysis and also revised existing CPT code 99174, which describes
instrument-based ocular screening with remote analysis and report. In
the proposed rule, we stated that CPT code 99174 was currently assigned
a status indicator of N (non-covered service) which we proposed should
remain unchanged since this is a screening service. After review of CPT
code 99177, we proposed that this service was also a screening service
and should be assigned a status indicator of N (non-covered service).
Therefore, for CY 2016, we proposed to assign a PFS status indicator of
N (non-covered service) for CPT codes 99174 and 99177.
The following is a summary of the comments we received on our
proposals.
Comment: A few commenters, including the RUC, stated their
disagreement with CMS' proposal to assign a status indicator of ``N''
(non-covered service). Commenters stated there is a long-standing
precedent that status indicator ``N,'' codes have had their RUC-
recommended values published in the PFS.
Response: We continue to believe CPT codes 99174 and 99177 are
screening
[[Page 70974]]
services and are therefore non-covered services under the Medicare
program. Therefore, for CY 2016, we are finalizing our proposed
assignment of a PFS status indicator of N (non-covered service) for CPT
codes 99174 and 99177. Because we have not reviewed the recommended
values for these services, we do not believe that we should develop or
display RVUs for these services. In some cases in the past, we have
developed and displayed RVUs for codes not separately payable by
Medicare. However, we note that this practice has not been consistently
applied and we have concerns about this practice since it is not
apparent in the display itself that the resulting RVUs do not reflect
our review or assessment of the recommendations nor do they reflect the
influence of updated Medicare claims data. However, we understand that,
for PFS nonpayable services, displaying RVUs that are based solely on
recommendations may serve an interest for the public. Therefore, we
will consider for the future how we might reconcile that interest with
our interest in maintaining a clear distinction between the RVUs that
result from our established methodology and RVUs that result solely
from recommended input values.
(21) Lung Cancer Screening Counseling and Shared Decision Making Visit
and Lung Cancer Screening With Low Dose Computed Tomography (CPT Codes
G0296 and G0297)
We issued national coverage determination (NCD) for Medicare
coverage of a lung cancer screening counseling and shared decision
making visit, and for appropriate beneficiaries, annual screening with
low dose computed tomography (LDCT), as an additional preventive
benefit, effective February 5, 2015. The American College of Radiology
(ACR) submitted recommendations for work and direct PE inputs.
We proposed to value CPT code G0296 (Counseling visit to discuss
need for lung cancer screening (LDCT) using low dose CT scan (service
is for eligibility determination and shared decision making)) using a
crosswalk from the work RVU for G0443 (Brief face-to-face counseling
for alcohol misuse, 15 minutes) which has a work RVU of 0.45. We added
2 minutes of pre-service time, and one minute post-service time which
we valued at 0.0224 RVU per minute yielding a total of 0.062 additional
RVUs which we then added to 0.45, bringing the total proposed work RVUs
for G0296 to 0.52. The direct PE input recommendations from the ACR
were refined according to CMS standard refinements and appear in the CY
2016 proposed direct PE input database.
For CPT code G0297 (Low dose CT scan (LDCT) for lung cancer
screening), the ACR recommended that CMS crosswalk CPT code G0297 to
CPT code 71250 (computed tomography, thorax; without contrast material)
with additional work added to account for the added intensity of the
service. After reviewing this recommendation, we stated in our proposal
that the work (time and intensity) was identical for both CPT code
G0297 and CPT code 71250. Therefore, we proposed a work RVU of 1.02 for
CPT code G0297. The following is a summary of the comments we received
on our proposals.
Comment: Several commenters stated that the CMS-proposed crosswalk
for G0296 (Counseling visit to discuss need for lung cancer screening
(LDCT) using low dose CT scan (service is for eligibility determination
and shared decision making)) did not accurately reflect the time and
intensity of furnishing this service. Some commenters suggested that 15
minutes is not enough time for the practitioner to engage in a
meaningful conversation with the patient and that the work and time for
the shared decision making visit should reflect this.
Response: Because we continue to believe that the cognitive work
for G0296 is comparable to G0443 and that there is no additional work
associated with fulfilling the requirements of the NCD, we believe that
the work and time for the counseling and shared decision making visit
is included in the values associated with the crosswalk code.
Comment: For CPT code G0297 (Low dose CT scan (LDCT) for lung
cancer screening), a few commenters expressed support for our proposed
work RVUs of 1.02. Several commenters were concerned that the proposed
crosswalks and work valuations did not adequately reflect the time and
intensity involved in furnishing these services. The American College
of Radiology suggested that a lung cancer screening low dose CT
required greater technical skill and mental effort to make the correct
diagnosis, and that the baseline increase of malignancy caused greater
psychological stress for the provider and the additional requirements
of the NCD add to the intensity of performing these services.
Response: Reading radiologists that meet the eligibility
requirements of the NCD have extensive experience interpreting chest
CTs. For example, the NCD states that among other things, an eligible
reading radiologist must have been involved in the supervision and
interpretation of at least 300 chest CT acquisitions in the past 3
years. Therefore, we do not believe that extra work is involved in
furnishing the low-dose CT, as compared to CPT code 71250.
Comment: Several commenters requested CMS clarify that a medically
necessary E/M visit can be billed on the same day as the lung cancer
screening counseling and shared decision making visit. Some commenters
also requested that the shared decision making visit be considered part
of, or complementary to, the annual wellness visit. Several commenters
also asked CMS to clarify that the lung cancer LDCT screening and the
counseling and shared decision making visit are not subject to cost
sharing since they are preventive services.
Response: As long as the NCD requirements for the counseling and
shared decision making visit are met, the counseling visit may be
billed on the same day as a medically necessary E/M visit or an annual
wellness visit with the -25 modifier. Practitioners should refer to the
NCD for information regarding the Medicare coverage requirements for
the counseling and shared decision making visit. Lung cancer screening
with LDCT, including a lung cancer screening counseling and shared
decision making visit, is covered as an additional preventive benefit,
identified for Medicare coverage through the NCD process. Therefore,
this benefit meets the criteria in sections 1833(a)(1) and (b)(1) of
the Act for nonapplication of the deductibles and coinsurance.
Comment: Many commenters were concerned with the fact that,
although the NCD was issued in February of 2015, there are no
instructions for billing services performed prior to 2016.
Response: CMS is in the process of developing claims processing,
coding and billing instructions. This information is forthcoming.
Comment: One commenter asked if the imaging facility would be
subject to recoupment for a CT if a hospital performed a CT believing
that the required counseling had occurred, and later it was determined
that it had not.
Response: We appreciate this comment. While we acknowledge the
commenter's concern, we believe that this comment is outside the scope
of this rulemaking.
Comment: One commenter requested that the shared decision making
visit be added to the list of telehealth services.
Response: We refer readers to section II.I. of this final rule with
comment period, where we discuss the process for adding services to the
list of Medicare
[[Page 70975]]
telehealth services. In addition, we note that information about how to
submit a request to add a service to the telehealth list is available
on the CMS Web site at www.cms.gov/telehealth.
Comment: Commenters were concerned that there was a discrepancy in
reimbursement between the PFS and the OPPS.
Response: Payments made under the PFS and the OPPS are established
under different statutory provisions using different bases and
methodologies, and therefore often result in differential payment
amounts for similar services.
Comment: Several commenters pointed out that there were no
malpractice or PE inputs for G0296 and G0297 in the downloads available
with the proposed rule.
Response: We appreciate commenters' attention to detail and we have
corrected these values in this final rule with comment period.
After consideration of the comments received, we are finalizing the
work RVUs for G0296 and G0297 as proposed.
7. Direct PE Input-Only Recommendations
In CY 2014, we proposed to limit the nonfacility PE RVUs for
individual codes so that the total nonfacility PFS payment amount would
not exceed the total combined amount that Medicare would pay for the
same code in the facility setting. In developing the proposal, we
sought a reliable means for Medicare to set upper payment limits for
office-based procedures given our several longstanding concerns
regarding the accuracy of certain aspects of the direct PE inputs,
including both items and procedure time assumptions, and prices of
individual supplies and equipment (78 FR 74248 through 74250). After
considering the many comments we received regarding our proposal, the
majority of which urged us to withdraw the proposal for a variety of
reasons, we decided not to finalize the policy. However, we continue to
believe that using PE data that are auditable, comprehensive, and
regularly updated would contribute to the accuracy of PE calculations.
Subsequent to our decision not to finalize the proposal, the RUC
forwarded direct PE input recommendations for a subset of codes with
nonfacility PE RVUs that would have been limited by the policy. Some of
these codes also include work RVUs, but the RUC recommendations did not
address the accuracy of those values.
We generally believe that combined reviews of work and PE for each
code under the potentially misvalued codes initiative leads to more
accurate and appropriate assignment of RVUs. We also believe, and have
previously stated, that our standard process for evaluating potentially
misvalued codes is unlikely to be the most effective means of
addressing our concerns regarding the accuracy of some aspects of the
direct PE inputs (79 FR 74248).
However, we also believe it is important to use the most accurate
and up-to-date information available to us when developing PFS RVUs for
individual services. Therefore, we reviewed the RUC-recommended direct
PE inputs for these services and proposed to use them, with the
refinements addressed in this section. However, we also identified
these codes as potentially misvalued because their direct PE inputs
were not reviewed alongside review of their work RVUs and time. We
considered not addressing these recommendations until such time as
comprehensive reviews could occur, but we recognized the public
interest in using the updated recommendations regarding the PE inputs
until such time as the work RVUs and time can be addressed. Therefore,
we noted that while we proposed adjusted PE inputs for these services
based on these recommendations, we would anticipate addressing any
corresponding change to direct PE inputs once the work RVUs and time
are addressed.
a. Repair of Nail Bed (CPT Code 11760)
The RUC recommendation for CPT code 11760 included 22 minutes
assigned to clinical labor task ``Assist physician in performing
procedure.'' Because CPT code 11760 has 33 minutes of work intraservice
time, we believe that this clinical labor input was intended to be
calculated at 67 percent of work time. However, the equipment times
were also calculated based on the 22 minutes of intraservice time. We
proposed to use the RUC-recommended equipment times while we solicited
comments on whether or not it would be appropriate to include the full
33 minutes of work intraservice time for the equipment.
Comment: A commenter clarified that the 22 minutes of time for
clinical labor task ``Assist physician in performing procedure'' was
indeed intended to represent 67 percent of the physician intraservice
time of 33 minutes. The commenter agreed that it is appropriate to
include the full 33 minutes of intraservice time in the equipment time
calculation.
Response: We appreciate the clarification of this issue from the
commenter. After consideration of comments received, we will refine the
equipment times for CPT code 11760 by adding 11 minutes to each item,
to reflect the entire intraservice period of 33 minutes.
Comment: One commenter disagreed with the CMS decision to remove
pre-service clinical labor time in the non-facility setting. The
commenter stated that the service is performed more than 33 percent of
the time in a facility setting, and suggested that CMS should adopt the
RUC recommendation.
Response: We continue to believe that this clinical labor task
would not be performed on a typical basis, as the procedure is most
frequently done on an emergent basis. We also do not believe that time
should be allotted for clinical labor task ``Provide pre-service
education/obtain consent'' in the preservice period, since CPT code
11760 also includes time for the same clinical labor task in the
service period. We note that information about the percentage of time a
service is performed in one setting versus another is not factored into
our assessment of PE inputs for each setting. After consideration of
comments received, we are finalizing the direct PE inputs as proposed
for CPT code 11760, with the additional refinements to equipment time
discussed above.
b. Simple Repair of Superficial Wounds (CPT Codes 12005, 12006, 12007,
12013, 12014, 12015, and 12016)
We refined the time for clinical labor task ``Check dressings &
wound/home care instructions'' to 3 minutes for each code in this
family to reflect the standard time for this clinical labor task.
Comment: One commenter stated that the commenter was unaware that
there was a standard time for this clinical labor task. The commenter
stated that a reduction to 3 minutes was not warranted absent an
identified standard in this regard.
Response: Three minutes is the generally applied number of minutes
assigned to the clinical labor task ``Check dressings & wound/home care
instructions''. In general, we continue to believe that this is the
most accurate time for this clinical labor task.
After consideration of comments received, we are finalizing the
direct PE inputs as proposed for CPT codes 12005, 12006, 12007, 12013,
12014, 12015, and 12016.
c. Intermediate Repair of Wounds (CPT Codes 12041, 12054, 12055, and
12057)
We refined the preservice clinical labor time in the non-facility
setting to zero minutes, and the information in the proposed rule
indicated that this refinement was because these codes are emergent
procedures where certain
[[Page 70976]]
clinical labor tasks would not typically be performed. We also removed
one of the two suture packs (SA054) from the recommended list of
supplies, and adjusted the equipment time formulas to reflect the
established standards.
Comment: A commenter disagreed with the CMS decision to remove the
preservice clinical labor time in the non-facility setting. The
commenter stated that neither the site of service nor the diagnosis
codes for these services indicate that these are emergency procedures,
and they are most commonly performed in a non-emergent setting. The
commenter urged CMS to accept the RUC-recommended times for these
clinical labor tasks.
Response: We appreciate the commenter bringing this issue to our
attention. After reviewing these clinical labor activities again, we
continue to believe that time for these preservice activities should
not be included in the non-facility setting. However, our stated
rationale for this refinement, that this is due to the emergent nature
of these procedures, was incorrectly stated due to a clerical error. We
intended to explain that we refined these preservice activities to zero
minutes because the standard preservice clinical labor for 10-day
global codes in the non-facility setting is zero minutes for all five
preservice activities, and there was no additional justification to
increase the value for this group of codes. We are maintaining this
refinement to zero minutes.
Comment: One commenter indicated that CMS incorrectly reduced the
quantity of suture packs (SA054) from two to one for CPT codes 12055
and 12057 in the facility setting. CMS stated that there was no
rationale for the increase in the quantity of this supply and that
sutures would only be removed one time, but the commenter stated that
suture removal takes place twice for these procedures, with some of the
sutures being removed at each of the two office visits. The commenter
requested that CMS accept the RUC-recommended supply inputs.
Response: We appreciate the additional information regarding the
use of suture packs for this procedure. After consideration of comments
received and based on this presentation of new information, we agree
that the second suture pack would typically be used in these
procedures, and we are restoring the quantity of SA054 to two for CPT
codes 12055 and 12057 in the facility setting.
After consideration of comments received, we are finalizing the
direct PE inputs as proposed for CPT codes 12041, 12054, 12055, and
12057, with the additional refinement to SA054 discussed above.
d. Nasal or Sinus Surgical Endoscopy (CPT Codes 31295, 31296, and
31297)
We refined some of the preservice clinical labor times to align
with standard values, as well as the fact that the decision for surgery
would have been made on the previous day. We also refined the time for
clinical labor task ``Sedate/apply anesthesia'' to reflect the
established standard, refined the quantity of the Afrin nasal spray
(SJ037) to the amount typical for the procedures, and refined the
equipment times to conform to our standard policies.
Comment: A commenter disagreed with the decision by CMS to refine
the time for clinical labor task ``Sedate/apply anesthesia'' from 5
minutes to 2 minutes. The commenter stated that 5 minutes would be
typical for these procedures, since a topical anesthesia requires
additional time to be applied, the staff typically applies a local
anesthetic after the initial topical form, and a second application is
necessary in the majority of patients.
Response: We continue to believe that the established standard of 2
minutes for clinical labor task ``Sedate/apply anesthesia'' is the most
accurate value for these procedures. The RUC recommendations for these
codes did not provide a rationale for anesthesia times in excess of the
standard value.
After consideration of comments received, we are finalizing the
direct PE inputs for CPT codes 31295, 31296, and 31297 as proposed.
e. Removal of Embedded Foreign Body From Mouth and Pharynx (CPT Codes
40804 and 42809)
In the proposed rule, we stated that the ENT suction and pressure
cabinet (EQ234) would not typically be used during an office visit, and
we refined the equipment times to remove the minutes associated with
the office visit. We also refined the quantity of supply item ``suction
canister'' (SD009) from two to one to reflect the amount typically used
during these procedures.
Comment: One commenter indicated that the suction and pressure
cabinet would be standard in ENT rooms, and would be used to store
items and equipment to keep them clean. The commenter urged CMS to
accept the RUC-recommended equipment time for the suction and pressure
cabinet.
Response: We include direct PE inputs for items and services that
are typically involved in furnishing a particular service. The presence
of the suction and pressure cabinet in the same room where the
procedure is being performed does not provide sufficient rationale for
its inclusion in this service since it is not typically used in
furnishing the service. We continue to believe that the suction and
pressure cabinet would only be utilized during the intraservice portion
of CPT codes 40804 and 42809, and not during the follow-up office
visits.
Comment: The same commenter stated that these procedures required
the use of two suction canisters. The commenter explained that one
suction canister would be used during the intraservice portion of the
procedure, and the other suction canister would be used during a
follow-up office visit.
Response: We continue to believe that the use of a suction and
pressure cabinet would not be typical for an office visit, and
therefore there is only a need for one suction canister for these
procedures. Furthermore, the RUC considered this issue in making its
recommendations, and found that no suction canister is needed in the
follow-up visit for the service when furnished in the facility setting.
We therefore do not believe that the suction and pressure cabinet, with
a corresponding suction canister, would be typically used during a
follow-up visit when the procedure is furnished in the non-facility
setting.
After consideration of comments received, we are finalizing the
direct PE inputs as proposed for CPT Codes 40804 and 42809.
f. Cytopathology Fluids, Washings or Brushings and Cytopathology
Smears, Screening, and Interpretation (CPT Codes 88104, 88106, 88108,
88112, 88160, 88161, and 88162)
We proposed to update the price for supply item ``Millipore
filter'' (SL502) based on stakeholder submission of new information
following the RUC's original recommendation. As requested, we proposed
to crosswalk the price of SL502 from the cytology specimen filter
(Transcyst) supply (SL041) and assign a price of $4.15. The proposed
direct PE inputs are included in the proposed CY 2016 direct PE input
database, which is available on the CMS Web site under downloads for
the CY 2016 PFS final rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. We also refined the time for clinical
labor task ``Order, restock, and distribute specimen containers with
requisition forms'' to zero minutes due to our belief that this task
was not allocable to individual services and therefore an
[[Page 70977]]
indirect PE under our established methodology.
As discussed in the proposed rule, we are concerned that there is a
lack of clarity and the possibility for confusion contained in the CPT
descriptors of CPT codes 88160 and 88161. The CPT descriptor for the
first code refers to the ``screening and interpretation'' of
cytopathology smears, while the descriptor for the second code refers
to the ``preparation, screening and interpretation'' of cytopathology
smears. We believe that there is currently the potential for
duplicative counting of direct PE inputs due to the overlapping nature
of these two codes. We are concerned that the same procedure may be
billed multiple times under both CPT code 88160 and 88161. We believe
that these codes are potentially misvalued, and we are seeking a full
review of this family of codes for both work and PE, given the
potential for overlap. We recognize that the ideal solution may involve
revisions by the CPT Editorial Panel.
With regard to the current direct PE input recommendations, we
proposed to remove the clinical labor minutes recommended for ``Stain
air dried slides with modified Wright stain'' for CPT code 88160 since
staining slides would not be a typical clinical labor task if no slide
preparation is taking place, as the descriptor for this code suggests.
We proposed to update supply item ``protease solution'' (SL506)
based on stakeholder submission of new information following the RUC's
original recommendation. As requested, we proposed to change the name
of the supply to ``Protease'', alter the unit of measurement from
milliliters to milligrams, change the quantity assigned to CPT code
88182 from 1 to 1.12, and update the price from $0.47 to $0.4267. These
changes are reflected in the direct PE input database, which is
available on the CMS Web site under downloads for the CY 2016 final
rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Subsequent to receiving these recommendations, we received
additional recommendations from the RUC for this family of procedures
following the publication of the CY 2016 PFS proposed rule. We will
address both recommendations here.
Comment: A commenter provided an invoice for supply item
``Millipore filter'' (SL502) to replace the current supply crosswalk to
the cytology specimen filter (SL041).
Response: We appreciate the submission of this supply invoice.
After consideration of comments received, we will update the price of
supply item ``Millipore filter'' (SL502) in our direct PE inputs
database from the current value of $4.15 to the submitted invoice price
of $0.75.
Comment: A commenter stated that the clinical labor task ``Order,
restock, and distribute specimen containers with requisition forms'' is
a direct PE as it is a variable clinical labor task. The commenter
stated that this task depends on the typical laboratory volume mix for
each service, and any blanket categorization cannot be justified.
Response: We continue to believe that the clinical labor task
``Order, restock, and distribute specimen containers with requisition
forms'' is an indirect PE, as it is not allocated to any individual
service. We have defined direct PE inputs as clinical labor, medical
supplies, or medical equipment that are individually allocable to a
particular patient for a particular service. For a detailed explanation
of the direct PE methodology, including examples, we refer readers to
the CY 2007 PFS final rule with comment period (71 FR 69629).
Therefore, whether a particular cost is fixed or variable does not
determine whether it is a direct PE input under the methodology. We
have removed the recommended 0.5 minutes of time for clinical labor
task ``Order, restock, and distribute specimen containers with
requisition forms'' from all seven of these procedures. However, we
have maintained 0.5 minutes of time for clinical labor task ``Prepare
specimen containers/preload fixative/label containers/distribute
requisition form(s) to physician'' from the previous recommendations
for CPT codes 88160, 88161, and 88162, and added this 0.5 minutes to
the other four codes in the family to conform with the other codes in
the family.
Comment: Several commenters disagreed that there is a lack of
clarity and possibility for confusion within the cytopathology smears,
screening and interpretation family. These commenters stated that in
CPT code 88160, the slide is received in the laboratory typically as a
spray-fixed and air-dried slide that has not been stained. The slide is
then stained in the laboratory with the appropriate stain per fixation
prior to review and interpretation. For CPT code 88161, the laboratory
must first put the patient material on the slide (that is, prepare the
slide) then stain it in the laboratory with the appropriate stain per
fixation prior to review and interpretation. Both codes therefore
include staining, review and interpretation in the laboratory.
Commenters did not agree that there was any provider confusion
concerning these specialized, low volume codes, and stressed that these
codes did not need to be added to the potentially misvalued code list.
Response: We appreciate the additional information clarifying the
nature of the work that takes place during these two procedures.
Comment: The same commenters did not agree with the refinement to
the time for clinical labor task ``Stain air dried slides with modified
Wright stain'' from 5 minutes to 0 minutes for CPT code 88160 and from
5 minutes to 3 minutes for CPT code 88161. Commenters explained that
for CPT code 88160, the slides are received in the laboratory typically
as spray-fixed and air-dried slides that have not been stained. They
must be stained prior to review and interpretation. For CPT code 88161,
the laboratory must put the patient material on the slide, followed by
staining for review and interpretation. Both codes therefore include
staining, review and interpretation in the laboratory.
Response: We appreciate the submission of this additional
information regarding the staining of slides in these procedures. After
consideration of comments received and based on the submission of this
additional information, we agree that there should be time for
allocated for clinical labor task ``Stain air dried slides with
modified Wright stain'' in CPT code 88160. We later received additional
recommendations from the RUC that suggested a time of 2 minutes for the
clinical labor task. We are therefore accepting the time for clinical
labor task ``Stain air dried slides with modified Wright stain'' at the
value of 2 minutes in the most recent set of RUC recommendations for
all seven procedures; we believe that 2 minutes is an accurate standard
for this clinical labor task.
Comment: One commenter disagreed with the CMS refinement to the
clinical labor task ``Prepare automated stainer with solutions and load
microscopic slides.'' The commenter stated that 4 minutes were
recommended for this task, which applied specifically to these
particular CPT codes based on the typical laboratory and efficiency
assumptions.
Response: We agree with the commenter that 4 minutes is an accurate
value for this clinical labor task, but note that we refined the value
to 4 minutes during our initial review.
Comment: A commenter recommended that CMS refine the
[[Page 70978]]
equipment time of the solvent recycling system to 2 minutes. The
commenter expressed the opinion that the use of this equipment is not
dependent on clinical labor time.
Response: We continue to believe that the solvent recycling system
is an indirect PE cost used across numerous services and not
individually allocated to particular procedures. We have removed the
clinical labor time associated with the solvent recycling system from
all seven codes.
In addition, we have removed the time associated with clinical
labor task ``Recycle xylene from stainer'' from all of the codes for
similar reasons. We also noticed what appeared to be an error in the
amount of non-sterile gloves (SB022), impermeable staff gowns (SB027),
and eye shields (SM016) assigned to CPT codes 88108 and 88112. The
recommended value of these supplies was a quantity of 0.2, which we
believe was intended to be a quantity of 2. We are therefore refining
the value of these supplies to 2 for CPT codes 88108 and 88112. After
consideration of comments received, we are finalizing the direct PE
inputs as proposed for CPT Codes 88104, 88106, 88108, 88160, 88161, and
88162 with the exception of the refinements to the clinical labor,
supplies, and equipment described above.
g. Flow Cytometry, Cell Cycle or DNA Analysis (CPT Code 88182)
We refined many of the clinical labor activities in this procedure
to align with the typical times included for other recently reviewed
pathology codes. We requested additional information regarding the use
of the desktop computer with monitor (ED021) since the RUC
recommendation did not specify how it is used.
Comment: One commenter disagreed with the eight refinements that
CMS made to the clinical labor time for CPT code 88182, and with the
rationale of using clinical labor standards for pathology activities in
general. The commenter stated that the time for these clinical labor
tasks varies for each CPT code, and the RUC-recommended times only
reflect the time associated with each particular CPT code. The times
associated with pathology clinical labor activities vary by typical
laboratory-specific efficiencies, such as batch size. The commenter
stated that it was inappropriate for CMS to establish standard clinical
labor times for these clinical labor activities, and urged CMS to
accept the RUC recommendation for these inputs.
Response: We refer the reader to section II.A. of this final rule
for our discussion about clinical labor standards for pathology codes.
We continue to believe that clinical labor tasks with the same
description are comparable across different pathology CPT codes. We
continue to believe that our refinements to clinical labor time ensure
the most accurate values for these activities, based on a comparison
with other pathology codes that share these same clinical labor
activities.
Comment: Several commenters provided additional information
concerning the use of the desktop computer with monitor. These
commenters explained that CPT code 88182 is performed using ploidy
analysis, by comparing the tumor curve to normal cells. These analyses
are performed using a dedicated desktop computer with a monitor, which
is located in the same room and is dedicated to the patient for each
use.
Response: We appreciate the submission of additional information
regarding the use of the desktop computer with monitor. After
consideration of comments received, we believe that the use of this
equipment item is typical during this service and will retain this
equipment item for CPT code 88182. After consideration of comments
received, we are finalizing the direct PE inputs as proposed for CPT
Code 88182.
h.. Flow Cytometry, Cytoplasmic Cell Surface (CPT Codes 88184 and
88185)
We refined many of the clinical labor activities in these
procedures to align with the times typically included in other recently
reviewed pathology codes. We also requested additional information
regarding the specific use of the desktop computer with monitor (ED021)
for CPT codes 88184 and 88185 since the recommendation does not specify
how it is used.
Comment: Many commenters disagreed with the decrease in direct PE
inputs for these codes. Commenters emphasized that the CMS proposal for
these codes reflected reductions in the PE RVUs of 38 percent to CPT
code 88184 and 69 percent to CPT code 88185. Commenters stated that
these reductions are unreasonable and could jeopardize patient access
to care. Several commenters requested that these codes be re-reviewed
by the RUC process because certain inputs were not considered in the
original RUC deliberations.
Response: We agree with the commenters that there were major
changes to the direct PE inputs for these two procedures. We note that
almost all of the change in direct PE inputs resulted from RUC
recommendations. With the exception of the equipment time for the dye
sublimation color photo printer and the clinical labor activities that
we refined to bring into accordance with pathology standards, we used
the RUC-recommended values to develop proposed PE inputs for these
codes and we believe that they provide the most accurate valuation for
these services.
Comment: Several commenters indicated that the pathology
specialties inadvertently left an equipment item out of their
recommendation, Flow Cytometry Analytics Software. The commenters
stated that this software is typically used for both CPT codes 88184
and 88185, and recommended adding 10 minutes of equipment time to CPT
code 88184 along with 2 minutes of equipment time for CPT code 88185.
Response: Equipment time for flow cytometry analytics software is
not currently included in CPT codes 88184 and 88185, and equipment time
for this software was not included in the RUC recommendation for these
procedures. We believe that if there are new direct PE inputs for these
procedures, the commenter should publicly nominate CPT codes 88184 and
88185 for further review through the potentially misvalued code
initiative.
Comment: Multiple commenters disagreed with the CMS decision to
refine the time for clinical labor task ``Other Clinical Activity: Load
specimen into flow cytometer, run specimen, monitor data acquisition,
and data modeling, and unload flow cytometer.'' The commenters
requested adding 10 minutes to this clinical labor task for CPT code
88184 and 2 minutes for CPT code 88185. This additional time would
reflect the Cytotechnician's time spent using the Cytometry Analytics
Software to analyze the data generated from the service on a designated
desktop computer, w-monitor (ED021). The commenters also requested
adding these additional minutes to the equipment time for the desktop
computer.
Response: We continue to believe that 7 minutes is the most
accurate time for this clinical labor task for CPT code 88184 based on
a comparison with CPT code 88182, which is another flow cytometry code
in the same family where we included the recommended 7 minutes of time
for the same clinical labor task. Since we do not believe that this
clinical labor time would be typical, we also do not believe that an
additional 10 minutes would be typical for use of the desktop computer
with monitor. We continue to believe that the recommended 20 minutes of
equipment time for the desktop computer with monitor, which is shared
by CPT code
[[Page 70979]]
88182, is the most accurate value for CPT code 88184.
Comment: Several commenters stated that the pathology specialties
inadvertently miscalculated the amount of supply item ``antibody, flow
cytometry'' (SL186) that are necessary for CPT codes 88184 and 88185.
The commenters recommended a revised supply quantity of 1.6 for both
codes instead of the quantity of 1 included in the RUC recommendation.
Response: CPT codes 88184 and 88185 currently use 1 unit of supply
SL186, and the recommendation for these procedures also indicated that
1 unit of supply SL186 is typical. We continue to agree with the RUC
recommendation that 1 unit of supply SL186 is the most accurate amount
for these procedures. If the commenter believes that these codes are
potentially misvalued, then we suggest the submission of a public
comment following the publication of the CY2016 final rule with comment
period to nominate CPT codes 88184 and 88185 as a potentially misvalued
code that could facilitate development of new recommended values.
Comment: A commenter explained that the equipment time for the dye
sublimation color photo printer (ED031) is independent of clinical
labor time. The commenter suggested that CMS should therefore accept
the RUC recommendation of 5 minutes of equipment time for CPT code
88184 and 2 minutes for CPT code 88185, instead of the CMS refinement
of 1 minute chosen to reflect the clinical labor time assigned to
printing in each procedure.
Response: We appreciate the commenter bringing this issue to our
attention. Although we agree with the general principle that equipment
time for printers may not align with clinical labor time assigned to
printing, we do not agree that 5 minutes of equipment time would be the
most accurate value for the dye sublimation color photo printer
assigned to CPT code 88184. However, we did notice that we
inadvertently set the equipment time of this printer to 1 minute, when
it should have been 2 minutes to align with the time for clinical labor
task ``Print out histograms.'' After consideration of comments
received, we are refining the equipment time of the dye sublimation
color photo printer to 2 minutes for CPT code 88184, and maintaining an
equipment time of 1 minute for the dye sublimation color photo printer
for CPT code 88185.
Comment: Several commenters disagreed with the CMS refinement to
the time for clinical labor task ``Enter data into laboratory
information system, multiparameter analyses and field data entry,
complete quality assurance documentation.'' The commenters stated that
entering this information takes additional time, that these are
extremely important tasks that require technical skill, and assigning
zero minutes to this clinical labor task is illogical for a service
like flow cytometry.
Response: We have not recognized the laboratory information system
as an equipment item that can be allocated to an individual service. We
continue to believe that this is a form of indirect PE, and therefore
we do not recognize the laboratory information system as a direct PE
input, as we do not believe this task is typically performed by
clinical labor for each service.
Comment: One commenter stated that CMS should accept the RUC
recommendation of 5 minutes of clinical labor for ``Print out
histograms, assemble materials with paperwork to pathologists, review
histograms and gating with pathologists.'' The commenter stated that it
is not reasonable to expect a cytotechnologist to print out histograms,
assemble the documents and deliver them to a pathologist, and review
the histograms with a pathologist, all in the span of 2 minutes. The
commenter stated that a technologist would not be able to produce a
high quality product and ensure its accuracy in the clinical labor time
assigned to this task by CMS.
Response: We believe that in order to maintain relativity, it is
important to apply standards to ensure consistency in the time for the
same clinical labor task among similar procedures. In refining the time
for this clinical labor task, we examined procedures that included the
same task, such CPT code 88182, which include 2 minutes for this task.
Therefore, we continue to believe that 2 minutes is the appropriate
value for this clinical labor task.
Comment: A commenter requested that CMS maintain the current
quantity of supply item ``lysing reagent'' (SL089). The commenter
indicated that there are increased supply costs associated with the
newer, more automated flow cytometers, such as additional costs for
tandem conjugates and other fluorochromes. Although the commenter
agreed that the new technology may require less lysing reagent
supplies, they urged CMS to maintain the current supply quantity of
SL089.
Response: We believe that the increasing use of new technology
reduces the need for the same quantity of lysing reagent used in the
past for these procedures. Since the commenter did not provide a
rationale for us to maintain the current quantity for supply item SL089
relative to the actual use of that quantity in furnishing the service,
we continue to agree that the RUC-recommended quantities of 5 ml for
CPT code 88184 and 2 ml for CPT code 88185 are the most accurate
amounts of lysing reagent typically required for these procedures.
After consideration of comments received, we are finalizing the
direct PE inputs as proposed for CPT codes 88184 and 88185, with the
additional refinements to equipment time discussed above.
i. Consultation on Referred Slides and Materials (CPT Codes 88321,
88323, and 88325)
We proposed to remove the time for clinical labor task ``Accession
specimen/prepare for examination'' for CPT codes 88321 and 88325. These
codes do not involve the preparation of slides, so this clinical labor
task is duplicative with the labor carried out under ``Open shipping
package, remove and sort slides based on outside number.'' We proposed
to maintain the recommended 4 minutes for this clinical labor task for
CPT code 88323, since it does require slide preparation.
We proposed to refine the time for clinical labor task ``Register
the patient in the information system, including all demographic and
billing information'' from 13 minutes to 5 minutes for all three codes.
As indicated in Table 6, our standard time for clinical labor task
``entering patient data'' is 4 minutes for pathology codes, and we
believe that the extra tasks involving label preparation described in
this clinical labor task would typically require an additional 1 minute
to complete. We also believe that the additional recommended time
likely reflects administrative tasks that are appropriately accounted
for in the allocation of indirect PE under our established methodology.
We proposed to refine the time for clinical labor task ``Receive
phone call from referring laboratory/facility with scheduled procedure
to arrange special delivery of specimen procurement kit, including
muscle biopsy clamp as needed. Review with sender instructions for
preservation of specimen integrity and return arrangements. Contact
courier and arrange delivery to referring laboratory/facility'' from 7
minutes to 5 minutes. Based on the description of this task, we
indicated that we believe that this task would typically take 5 minutes
to be performed by the Lab Technician.
We proposed to remove supply item ``eosin solution'' (SL063) from
CPT code
[[Page 70980]]
88323. We do not agree that this supply would typically be used in this
procedure, since the eosin solution is redundant when used together
with supply item ``hematoxylin stain supply'' (SL135). We also refined
the quantity of SL135 from 32 to 8 for CPT code 88323, to be consistent
with its use in related procedures.
We proposed to remove many of the inputs for clinical labor,
supplies, and equipment for CPT code 88325. The descriptor for this
code indicates that it does not involve slide preparation, and
therefore we proposed to refine the labor, supplies, and equipment
inputs to align with the inputs recommended for CPT code 88321, which
also does not include the preparation of slides.
Comment: One commenter disagreed with the CMS refinements and urged
CMS to accept the RUC recommendations. The commenter stated that the
clinical labor task ``Accession specimen/prepare for examination'' is
actually far more time consuming for outside cases than accessioning
inside cases, due to the need to individually identify and enter each
slide and block. The commenter disagreed with the CMS proposal to
remove this clinical labor time for CPT codes 88321 and 88325.
Response: According to the code descriptors, there is no slide
preparation taking place in CPT codes 88321 and 88325. These services
consist of the consultation and review of specimens prepared by another
practitioner. We continue to believe that accession of specimens would
not be typical for these procedures, and we therefore maintain that
time should not be allocated for this clinical labor task. In addition,
any clinical labor required for preparation of the referred slides is
already included in the descriptions for other clinical labor tasks
included for these codes, such as:
Register the patient in the information system, including
all demographic and billing information. In addition to standard
accessioning, enter contributing physician name and address, number of
slides and the outside case number, etc., into the laboratory
information system. Print labels for slides, and affix labels to
slides.
Print label for outside block and affix to block.
List and label all accompanying material (imaging on a
disk, portion of chart, etc.)
Comment: The commenter also disagreed with the CMS refinement to
the time for clinical labor task ``Register the patient in the
information system, including all demographic and billing
information.'' The commenter stated that these tasks are performed in
addition to accessioning the specimen and preparing for examination.
Response: We continue to believe that the typical time for the
clinical labor task ``accession of specimen'' is 4 minutes, based on
comparison to other pathology services. We refined the time for this
clinical labor task to 5 minutes based on our belief that the
additional tasks involving label preparation would typically take 1
minute. We also continue to believe that the additional recommended
time for CPT codes 88321, 88323, and 88325 likely reflects
administrative tasks that are appropriately accounted for in the
indirect PE methodology.
Comment: A commenter disagreed with the proposal to remove the time
for clinical labor tasks ``Assemble and deliver slides with paperwork
to pathologists'' and ``Clean equipment while performing service'' for
CPT code 88323. The commenter stated that the assembling of slides in
this task was a separate task from the clinical labor associated with
preparation of materials associated with the non-frozen section
processing of the specimen. The commenter also stated that for the
typical laboratory setting, specific equipment must be cleaned and
maintained immediately after use.
Response: We continue to believe that these are duplicative
clinical labor activities. CPT code 88323 already includes time for
clinical labor task ``Complete workload recording logs. Collate slides
and paperwork. Deliver to pathologist'' and ``Clean room/equipment
following procedure.'' We do not believe that there it would be typical
to assemble slides or clean the room twice.
Comment: The commenter disagreed with the removal of the eosin
solution (SL063) from CPT code 88323. The commenter stated that the
eosin solution would be used for the hematoxylin stain (SL135), and
elimination of this supply item would likely compromise patient care.
The commenter also indicated that 32 ml of the hematoxylin stain is
typical for these services in the typical laboratory setting.
Response: We appreciate the additional information regarding this
supply and its importance for staining in this procedure. After
consideration of comments received, we believe that this is the most
accurate type of eosin supply for use in this type of slide staining
because it is most similar to the eosin supply previously used in CPT
code 88323. Therefore, we are replacing supply SL063 with supply SL201
(stain, eosin) and restoring a quantity of 8 ml for CPT code 88323. We
are also refining our proposed quantity of 8 ml of the hematoxylin
stain to 16 ml for CPT code 88323. The current supply inputs for CPT
code 88323 have twice the amount of hematoxylin stain compared to
eosin, 4.8 compared to 2.4, and we are maintaining the same 2:1 ratio.
Comment: The commenter disagreed with the removal of time for many
clinical labor tasks in CPT code 88325, such as ``Dispose of remaining
specimens'', ``Prepare, pack and transport specimens and records for
in-house storage and external storage'', and several other activities
related to slide preparation. The commenter objected to the
standardization of clinical labor tasks across differing pathology
codes, and stated that these are necessary and integral tasks for this
service that cannot be eliminated without compromising standards of
care.
Response: As the code descriptor indicates for CPT code 88325, we
continue to believe that there is no slide preparation taking place in
this procedure. Therefore, we do not believe that clinical labor tasks
related to the preparation of slides or the disposal of hazardous waste
materials would typically be performed.
Comment: The commenter also disagreed with the CMS decision to
remove supplies and equipment unassociated with slide preparation from
CPT code 88325. The commenter wrote to indicate that when hematoxylin
and eosin (H&E) slides are prepared from referred blocks, all technical
services are performed. The commenter urged that the recommended
supplies and equipment be restored to CPT code 88325.
Response: We do not agree that referred materials require the same
clinical labor, supplies, and equipment as materials prepared locally.
The vignette for CPT code 88325 states that the pathologist performing
the service is receiving prepared slides from another laboratory;
therefore, we do not believe that the use of these supplies and
equipment associated with slide preparation would be typical for the
second pathologist performing this consultation.
After consideration of comments received, we are finalizing the
direct PE inputs as proposed for CPT Codes 88321, 88323, and 88325,
with the additional refinement to the eosin stain and hematoxylin stain
supplies discussed above in CPT code 88323.
[[Page 70981]]
j. Pathology Consultation During Surgery (CPT Codes 88329, 88331,
88332, 88333, and 88334)
We refined many of the clinical labor activities in these
procedures to align with the typical times included in recently
reviewed pathology codes, in particular the clinical labor times for
CPT code 88305. We also removed supply item ``H&E stain kit supply''
(SL231) and replaced it with supply item ``H&E frozen section stain
supply'' (SL134) and refined the quantity of the microscope slides
(SL122) for CPT codes 88333 and 88334.
Comment: A commenter disagreed with the CMS refinement of these
clinical labor activities. The commenter stated that clinical labor
times should not be standardized for pathology services, and that
although standards may be used as a starting point, the work for
pathology codes varies depending on the pathology task that is being
done.
Response: We refer the reader to our earlier discussion about
clinical labor standards for pathology codes. We continue to believe
that clinical labor tasks with the same description are comparable
across different pathology CPT codes. For these pathology consultation
codes, we have refined the clinical labor times to bring them into
accordance with other similar codes, in particular CPT code 88305. For
example, we do not believe that the time for clinical labor task
``Assist pathologist with gross specimen examination'' for a
consultation procedure (as in CPT code 88331) should require more
clinical labor time than the identical clinical labor task in a tissue
biopsy procedure (as in CPT code 88305).
Comment: The same commenter stated that 3 minutes of time for
clinical labor task ``Clean room/equipment following procedure'' is the
standard for surgical procedures, and the same clinical labor time
should be applied to pathology procedures.
Response: We do not believe that clinical labor times for surgical
procedures are typically applicable to pathology procedures. We believe
that it is more accurate to compare clinical labor times for pathology
procedures to other pathology procedures that utilize the same clinical
labor tasks. In the case of the clinical labor for ``Clean room/
equipment following procedure'', we continue to believe that 1 minute
is the standard time for these services, based on a comparison to other
recently reviewed pathology codes.
Comment: The commenter stated that the H&E stain supply kit removed
by CMS is needed to perform the procedure for CPT codes 88331 and
88332, as the kit is needed to prepare the slides (that is, xylene,
alcohol, bluing agent, etc). The commenter also stated that the
preamble text in the CY 2016 PFS proposed rule did not state anything
specific about this substitution, and that CMS must supply a better
rational for this proposed change.
Response: We appreciate the opportunity to clarify our position
regarding the replacement of the H&E stain supply kit with an H&E
frozen section stain. We noticed that these procedures had previously
been performed using 1 H&E frozen section stain, which was removed by
the RUC in favor of a quantity of 0.1 of supply item ``H&E stain supply
kit''. Because the RUC recommendation did not explain why the use of an
H&E stain supply kit would be typical, we believed that it would be
more accurate to maintain the quantity of 1 for supply item ``H&E
frozen section stain'' as is currently included in these codes. We
believe that this maintains relativity with other codes in the family,
and maintains consistency with other related pathology procedures.
Comment: A different commenter disagreed with the CMS decision to
remove the time for clinical labor task ``Prepare room. Filter and
replenish stains and supplies.'' The commenter stated that this
dedicated room must be prepared for the next immediate consultation
after each service; stains must be filtered and changed, while
cryostats and chucks must be cleaned. The commenter requested the
restoration of the RUC recommended clinical labor time.
Response: We continue to believe that the preparation in this
clinical labor task is duplicative with the clinical labor assigned for
``Clean room/equipment following procedure.'' We also continue to
believe that the labor involved in replenishing stains and supplies is
not allocated to an individual service, and therefore comprises an
indirect PE.
After consideration of comments received, we are finalizing the
direct PE inputs as proposed for CPT Codes 88329, 88331, 88332, 88333,
and 88334.
k. Morphometric Analysis (CPT Code 88355)
We refined many of the clinical labor activities in these
procedures to align with the standard times used by other recently
reviewed pathology codes, in particular the clinical labor times for
CPT code 88305. We also removed the equipment time for the ultradeep
freezer (EP046), as we believe that items used for storage such as
freezers are more accurately classified as indirect PE.
Comment: One commenter disagreed with the CMS removal of the
equipment time for the ultradeep freezer. The commenter stated that the
use of the ultradeep freezer is specific to CPT code 88355. While other
specimens may be stored in the same freezer, freezer space is
unavailable for other specimens or items during storage. Freezer space
is therefore a variable direct expense dependent upon patient specimen
caseloads, and should be considered a direct expense for pathology
services.
Response: As we stated in the CY 2016 PFS proposed rule (80FR
41699), we do not believe that minutes should be allocated to items
such as freezers since the storage of any particular specimen in a
freezer for any given length of time would be unlikely to make the
freezer unavailable for storing other specimens. We continue to believe
that the ultradeep freezer is most accurately classified as an indirect
PE since freezers can be used for many specimens at once. We refer
readers to our discussion of direct PE inputs earlier in this section.
Comment: The same commenter objected to the CMS refinements to
standard pathology times for clinical labor tasks ``Assemble and
deliver slides with paperwork to pathologist'', ``Clean room/equipment
following procedure,'' and ``Receive phone call from referring
laboratory/facility with scheduled procedure to arrange special
delivery of specimen procurement kit.'' The commenter indicated their
disagreement with these refinements and the standardization of
pathology clinical labor tasks more generally, as the time for these
tasks varies for each unique service.
Response: We refer the reader to our earlier discussion about
clinical labor standards for pathology codes. We continue to believe
that clinical labor tasks with the same description are comparable
across different pathology CPT codes. For this morphometric analysis of
the skeletal muscle procedure, we have refined the clinical labor times
to bring them into accordance with other similar procedures.
Comment: The commenter disagreed with the CMS refinement to the
time for clinical labor task ``Prepare specimen containers/preload
fixative/label containers/distribute requisition form(s) to
physician.'' The commenter explained that nerves and muscle typically
arrive in the laboratory on saline soaked gauze held in a clamp, and
the tissue requires specialized knowledge to further prepare and
[[Page 70982]]
process it. The commenter stressed that the specimen preparation for
these services is vastly different than for routine surgical pathology
specimens where large numbers of specimen containers are prepared at
one time, and therefore the typical batch size for this type of
specimen would be one, necessitating the increased time.
Response: We appreciate the additional description of the clinical
labor tasks taking place in CPT code 88355 provided by the commenter.
Based on this presentation of further clinical information and after
consideration of comments, we believe that additional time for clinical
labor task ``Prepare specimen containers/preload fixative/label
containers/distribute requisition form(s) to physician.'' is
appropriate. We note that the original RUC recommendation included 9
minutes for this clinical labor task. However, this clinical labor task
is related to clinical labor task ``Accession specimen/prepare for
examination''. To avoid duplicative preparation labor, we have assigned
an additional 4.5 minutes relative to our proposal, for a total of 5
minutes, of time for clinical labor task ``Prepare specimen containers/
preload fixative/label containers/distribute requisition form(s) to
physician'' for CPT code 88355.
Comment: The commenter requested that CMS adopt the RUC-recommended
time of 4 minutes for clinical labor task for ``Prepare, pack and
transport specimens and records for storage.'' The commenter explained
that these specimens are quite unique and require special care and
handling and the time allocated to this task is typically longer than
other pathology specimens.
Response: We appreciate the commenter submission of additional
information regarding this clinical labor task. After consideration of
comments received, we believe that it would be more accurate to
increase the time for this clinical labor task to 3 minutes for CPT
code 88355, to reflect the additional preparation taking place over the
typical storage of specimens in other pathology procedures.
Comment: The commenter disagreed with the CMS decision to remove
the recommended time for clinical labor task ``Prepare specimen for -70
degree storage.'' The commenter stated that this task was not on the
table of standard times for clinical labor tasks associated with
pathology services included in the CY 2016 PFS proposed rule, and this
specimen preparation task is unique to CPT code 88355.
Response: We believe that the resource costs associated with
storage preparation are accurately accounted for under the minutes
assigned to the clinical labor tasks ``Prepare, pack and transport
specimens and records for storage'' for CPT code 88355. We believe that
the clinical labor associated with preparation for -70 degree storage
would be duplicative of this clinical labor task. We have also added
additional time for clinical labor task ``slide storage preparation''
under the clinical labor task ``Prepare, pack and transport specimens
and records for storage'' to reflect the extra storage requirements of
this procedure.
Comment: The commenter also disagreed with the CMS decision to
refine the time for clinical labor task ``Assist pathologist with gross
examination.'' The commenter wrote that specialty knowledge is required
to further process the tissue. The tag of nerve or muscle outside the
clamp must be carefully trimmed by hand with the trimmings going to
formalin containers. Clinical labor staff is needed to collaborate with
the pathologist often to prepare the specimen and process the specimen.
Tissue must be examined and, if too thick, must be further trimmed to
allow penetration by glutaraldehyde. The properly trimmed, clamped
tissue can then be transferred to a glutaraldehyde container, which is
then transferred to a refrigerator for at least 24 hours when it can
then be processed with further consultation with the pathologist.
Response: We appreciate the submission of additional clinical
information regarding the clinical labor utilized in the performance of
CPT code 88355. However, we do not agree that all of this labor would
take place during the ``Assist pathologist with gross examination''
task. We believe that the information provided by the commenter
describes several other steps in the procedure, such as ``Measure
specimen and fix on muscle/nerve clamp'' and ``Process specimen for
slide preparation'', each task having its own respective clinical labor
time. In order to avoid the potential for duplicative clinical labor,
we are maintaining the CMS refinement to 3 minutes for clinical labor
task for ``Assist pathologist with gross examination'' for CPT code
88355.
After consideration of comments received, we are finalizing the
direct PE inputs as proposed for CPT code 88355, with the additional
clinical labor refinements discussed above.
l. Morphometric Analysis, Tumor Immunohistochemistry (CPT Codes 88360
and 88361)
We refined many of the clinical labor activities in these
procedures to align with the typical times included in recently
reviewed pathology codes. We also proposed to update the pricing for
the Benchmark ULTRA automated slide preparation system (EP112) and the
E-Bar II Barcode Slide Label System (EP113). Based on stakeholder
submission of information subsequent to the original RUC
recommendation, we proposed to reclassify these two pieces of equipment
as a single item with a price of $150,000, which will use equipment
code EP112. CPT codes 88360 and 88361 have been valued using this new
price. The equipment minutes remain unchanged.
The RUC recommendation for CPT codes 88360 and 88361 included an
invoice for supply item ``Antibody Estrogen Receptor monoclonal''
(SL493). The submitted invoice had a price of $694.70 per box of 50, or
$13.89 per test. We sought publicly available information regarding
this supply and identified numerous monoclonal antibody estrogen
receptors that appear to be consistent with those recommended by the
specialty society, at publicly available lower prices, which we believe
are more likely to be typical since we assume that the practitioner
would seek the best price available to the public. One example is
Estrogen Receptor Antibody (h-151) [DyLight 405], priced at 100 tests
per box for $319. Therefore, we proposed to establish a new supply code
for ``Antibody Estrogen Receptor monoclonal'' and price that item at
$3.19 each. We welcomed comments from stakeholders regarding this
supply item.
Comment: Several commenters disagreed with the CMS refinements to
the time for clinical labor task ``Enter patient data, computational
prep for antibody testing, generate and apply bar codes to slides, and
enter data for automated slide stainer'', ``Verify results and complete
work load recording logs'', and ``Recycle xylene from tissue processor
and stainer.'' The commenters stated that entering patient data
requires far longer than the 1 minute proposed by CMS, and that
removing the time for clinical labor tasks related to verifying results
and recycling xylene could result in laboratory disaccreditation or
errors that are harmful to patients.
Response: We refer the reader to our earlier discussion about
clinical labor standards for pathology codes. We continue to believe
that clinical labor
[[Page 70983]]
tasks with the same description are comparable across different
pathology CPT codes. We continue to believe it is most accurate to
allocate zero minutes of time for the task ``Verify results and
complete work load recording logs'', and ``Recycle xylene from tissue
processor and stainer'', as we believe that these are indirect PE tasks
not allocated to any individual service.
Comment: One commenter provided a list of eight additional clinical
labor activities for CPT code 88360 and one additional clinical labor
task for CPT code 88361. The commenter suggested that CMS should
consider adding these tasks, which were not included in the RUC
recommendations, into its labor estimates for the two procedures.
Response: We appreciate the suggestion from the commenter of
additional tasks that can aid in the performance of IHC special stains.
We believe that the tasks associated with furnishing particular PFS
services could be described and categorized in various ways. We believe
that particular tasks should be considered in the context of
comprehensive review that allows for an assessment of overall number of
minutes involved in furnishing the service. If the commenter examines
the list of clinical labor tasks used by the RUC to develop
recommendations for these services and finds that many tasks are
missing, then we believe that the commenter may want to consider
submitting the codes through the public nomination process of the
misvalued code initiative to improve the accuracy of the valuations.
Comment: Another commenter disagreed with CMS' refinement to the
equipment time of the compound microscope (EP024). The commenter stated
that this refinement was not discussed in the preamble text, and that
the time involves 35 minutes of work time plus 1 minute of clinical
labor time, as described in the RUC recommendation. The commenter asked
for CMS to accept the RUC recommended equipment time of 36 minutes.
Response: We note that we did not fully explain our rationale for
the refinement of equipment time for the compound microscope equipment
time. We observed that the description of the intraservice work for the
physician includes many tasks that do not use the microscope. As a
result, we do not believe that use of the compound microscope would be
typical for the entire intraservice period. We continue to believe that
the most accurate equipment time for the compound microscope is 25
minutes: 24 Minutes for the work time (66 percent of 35 minutes) plus 1
minute for the technician.
Comment: Many commenters disagreed with the CMS proposal to price
supply item ``monoclonal antibody estrogen receptor'' (SL493) at $3.19.
Commenters stated that this was substantially lower than the submitted
invoice of $13.89; CMS instead referenced the Estrogen Receptor
Antibody (h-151) [DyLight 405] for its price of $3.19. Commenters
stated that this supply is for research use only, and that it is not
approved for use in humans or in clinical diagnosis. According to the
commenters, this item is not an alternate reagent for CPT codes 88360
and 88361, and would not be used for these services.
Response: We appreciate all of the additional information provided
by the commenter. The only pricing information that we received for
SL493 was an invoice that included a hand-written price over redacted
information. We were unable to verify the accuracy of this invoice. In
order to price SL493 appropriately, we believe that we need additional
information. We will use the publicly available price of $3.19 as a
proxy value pending the submission of additional pricing information.
We welcome the submission of updated pricing information regarding
SL493 through valid invoices from commenters and other stakeholders.
After consideration of comments received, we are finalizing the
direct PE inputs as proposed for CPT Codes 88360 and 88361.
m. Nerve Teasing Preparations (CPT Code 88362)
We proposed to refine the recommended time for clinical labor task
``Assist pathologist with gross specimen examination including the
following; Selection of fresh unfixed tissue sample; selection of
tissue for formulant fixation for paraffin blocking and epon blocking.
Reserve some specimen for additional analysis'' from 10 minutes to 5
minutes. We noted that the 5 minutes includes 3 minutes for assisting
the pathologist with the gross specimen examination (as listed in Table
6 of the proposed rule (80 FR 41698) and an additional 2 minutes for
the additional tasks due to the work taking place on a fresh specimen.
Comment: Several commenters disagreed with the CMS decision to
refine the time for clinical labor task ``Assist pathologist with gross
specimen examination'' from 10 minutes to 5 minutes. The commenters
stated that the pathologist must work together with clinical labor
staff during the gross specimen work, and the clinical labor could not
be performed in 5 minutes due to the number of specimens involved.
Response: We continue to believe that the 5 minutes for this
clinical labor task included 3 minutes for assisting the pathologist
with the gross specimen examination and an additional 2 minutes for the
additional tasks due to the work taking place on a fresh specimen. We
also continue to believe that this is the most accurate value for this
clinical labor task in the absence of additional data supporting an
increase in the time for this clinical labor task.
Comment: These commenters also expressed their disagreement with
the CMS removal of the recommended time for clinical labor task
``Consult with pathologist regarding representation needed, block
selection and appropriate technique.'' Commenters stated that clinical
labor staff must collaborate with the pathologist in the preservice
time, and the unique technical protocols required for nerve teasing
pathology services requires the clinical labor staff to have a complete
understanding of what is necessary for each individual specimen case.
Commenters emphasized that nerve teasing pathology services cannot be
batched as they are complex, low volume unusual studies requiring
special handling, preparation, and storage.
Response: We continue to believe that the clinical labor described
in this clinical labor task constitutes basic knowledge for a
practicing Histotechnologist. We noted that this clinical labor task
appears to be unique to CPT code 88362, and does not appear in other
pathology services. We do not believe it maintains relativity to
include increasingly specialized clinical labor tasks that are not
included in similar procedures. We also do not believe that it would be
typical for the Histotechnologist to require this kind of extensive
consultation with the pathologist before performing each individual
procedure, since the technician would have prior knowledge of what he
or she will be doing.
Comment: One commenter disagreed with the CMS refinements to
clinical labor tasks associated with slide preparation. For the
clinical labor tasks ``Assemble and deliver cedar mounted slides with
paperwork to pathologists'', ``Assemble other light microscopy slides,
epon nerve biopsy slides, and clinical history, and present to
pathologist to prepare clinical pathologic interpretation'', and
``Dispose of remaining specimens, spent chemicals/other consumables,
and hazardous waste'', the commenter indicated that there are less
batch size
[[Page 70984]]
efficiencies with these specimens compared to other typical surgical
pathology services, and the recommendation for extra clinical labor
time reflected the need for careful handling of materials.
Response: We refer the reader to our earlier discussion about
clinical labor standards for pathology codes. We continue to believe
that clinical labor tasks with the same description are comparable
across different pathology CPT codes. The proposed refinement to 0.5
minutes for these clinical labor tasks reflects the time typically
included for slide preparation established across many different
pathology procedures.
Comment: The same commenter disagreed with the CMS refinement to
the time for clinical labor tasks ``Preparation: labeling of blocks and
containers and document location and processor used'' and ``Accession
specimen and prepare for examination.'' The commenter stated that
although they agreed with the reduction in time, they disagreed with
the refinement rationale and the standardization of pathology clinical
labor tasks, as the time for each task varies for each CPT code.
Response: We appreciate that the commenter's support for our
proposal to reduce the clinical labor for these activities. We continue
to believe that clinical labor tasks with the same description are
comparable across different pathology CPT codes assuming similar batch
sizes, and we appreciate further comments as we work to establish
clinical labor standards across pathology services.
Comment: The commenter did not agree with the CMS refinement to the
time for clinical labor task ``Prepare specimen containers preload
fixative label containers distribute requisition form(s) to
physician.'' The commenter explained that nerves and muscle typically
arrive in the laboratory on saline soaked gauze for this procedure.
Specialty knowledge is required to further prepare and process the
tissue, and as a result the specimen preparation for CPT code 88362 is
different from routine surgical pathology specimens where large numbers
of specimen containers are prepared at one time. The commenter stated
that the typical batch size for this type of specimen would be one,
which necessitates the increased time.
Response: We appreciate the additional description of the clinical
labor taking place in CPT code 88362 provided by the commenter. Based
on this presentation of further clinical information, and in order to
maintain consistency with our refinements to CPT code 88355, we believe
that additional clinical labor time is appropriate. Since this is the
same clinical labor task taking place in CPT code 88355, we will also
assign 5 minutes for ``Prepare specimen containers/preload fixative/
label containers/distribute requisition form(s) to physician'' for CPT
code 88362 using the same rationale as described for 88355.
Comment: The commenter also disagreed with the CMS refinements to
the time for clinical labor task ``Prepare, pack and transport
specimens and records for in-house storage and external storage'' and
``Prepare, pack and transport cedar oiled glass slides and records for
in-house special storage.'' The commenter stressed that the specimens
used in these labor tasks were unique to CPT code 88362, and therefore
they cannot be standardized as part of a wider set of clinical labor
activities for the field of pathology. However, the commenter did agree
that the clinical labor task ``Prepare, pack and transport specimens
and records for in-house storage and external storage'' would typically
take 1 minute, although the typical time in the commenter's specialized
laboratory would be higher.
Response: We appreciate the commenter's support for our proposal to
refine the time for clinical labor task ``Prepare, pack and transport
specimens and records for in-house storage and external storage''. We
continue to believe that this and other pathology clinical labor tasks
more generally, can be standardized across different services. We do
not believe that there should be time allocated for clinical labor task
``Prepare, pack and transport cedar oiled glass slides and records for
in-house special storage'' for this procedure, since there is already
time for clinical labor tasks related to preparing, packing, and
transportation of materials.
Comment: The commenter also did not agree with the CMS removal of
the recommended time for clinical labor task ``Storage remaining
specimen. (Osmicated nerve strands, potential for additional teased
specimens).'' The commenter stated that this clinical labor task was
not listed anywhere in the proposed rule to explain why CMS believes
this is a standard clinical labor task. This storage clinical labor
task is unique to CPT code 88362 and its removal could potentially
compromise patient care.
Response: We appreciate this opportunity to clarify our rationale
regarding the refinement to this clinical labor task. We believe that
the clinical labor described in this clinical labor task is duplicative
of the clinical labor described in the task ``Prepare, pack and
transport specimens and records for in-house storage and external
storage.'' We do not believe that the use of three different clinical
labor activities for storage of specimens would be typical for CPT code
88362.
After consideration of comments received, we are finalizing the
direct PE inputs as proposed for CPT code 88362, with the additional
clinical labor refinements discussed above.
n. Nasopharyngoscopy With Endoscope (CPT Code 92511)
We proposed to remove the endosheath (SD070) from this procedure,
because we indicated that we do not believe it would be typically used
and it was not included in the recommendations for any of the other
related codes in the same tab. If the endosheath were included as a
supply with the presentation of additional clinical information, then
we stated we believed it would be appropriate to remove all of the
clinical labor and equipment time currently assigned to cleaning the
scope. We sought public comment regarding the proper use of the
endosheath supply and the clinical labor associated with scope
cleaning.
Comment: Several commenters agreed that the endosheath is not
typically used for CPT code 92511 and was inadvertently included from
past direct PE inputs for the service. The commenters stated that after
removing the endosheath, it was appropriate to retain all the clinical
labor and equipment time assigned to cleaning the scope. In addition,
in order to clean the equipment and to be consistent with other codes
in the family, commenters requested adding four supplies to the code
associated with scope cleaning, which were excluded previously because
the endosheath was retained.
Response: We appreciate the additional clarification from the
commenters regarding the use of supply item ``endosheath'' for this
procedure. After consideration of comments received, we agree that it
is appropriate to retain the clinical labor and equipment time assigned
to cleaning the scope, as well as include the additional requested
cleaning supplies. Based on this additional information, we are
refining the direct PE inputs to include the following supply items: 2
Endoscope cleaning brushes (SM010), 4 oz. of enzymatic detergent
(SM015), 4 oz. of glutaraldehyde 3.4% (SM018), and 1 glutaraldehyde
test strip (SM019).
Comment: One commenter disagreed with the CMS decision to remove
the recommended surgical masks,
[[Page 70985]]
impervious staff gowns, and non-sterile drape sheet from the procedure.
The commenter stated that these supplies were necessary, with one mask
and gown needed for the physician and one mask and gown needed for the
staff, since the procedure produces a lot of secretion transmission.
Therefore, these were not duplicative supplies.
Response: We appreciate the additional clarification regarding the
use of these supplies. After consideration of comments received, we are
restoring these supplies and adding 2 surgical masks (SB033), 2
impervious staff gowns (SB027), and 1 non-sterile sheet drape (SB006)
to CPT code 92511 in the non-facility setting.
After consideration of comments received, we are finalizing the
direct PE inputs for CPT code 92511, with the additional supply
refinements described above.
o. EEG Extended Monitoring (CPT Codes 95812 and 95813)
We refined several of the clinical labor times for CPT codes 95812
and 95813 to align them with our proposed standards, including refining
the time for clinical labor task ``Assist physician in performing
procedure'' to align with the intraservice time of each procedure. We
also removed the service period time for clinical labor task ``Provide
pre-service education/obtain consent'' to avoid duplicative clinical
labor with the same task in the preservice period, and refined several
of the equipment times to align with the standard equipment times for
non-highly technical equipment.
Comment: Some commenters did not agree with the CMS refinement of
the time for clinical labor task ``Assist physician in performing
procedure.'' The commenters stated that the practitioner reads the
patient record subsequently without the technologist present, and that
the intraservice work time is not temporally equivalent with the tech's
assist physician clinical labor time. The line ``Assist physician in
performing procedure'' was used as a surrogate data entry line for
where to place the technologist's service in performing the testing,
and it was not meant to be taken literally. The commenter therefore
requested that CMS adopt the RUC-recommended time for both procedures.
Response: The RUC recommendation for these procedures explicitly
stated that CPT code 95812 requires 50 minutes of time for clinical
labor task ``EEG recording'', and CPT code 95813 requires 80 minutes of
clinical labor time for the same clinical labor task. We do not believe
that existing clinical labor tasks should be used as data entry
surrogates for other tasks, and we do not believe that clinical labor
time should be allocated to tasks that are not described in the
submitted recommendations. We continue to believe that this represents
the clinical labor time which would be spent assisting the physician in
performing the procedure.
After consideration of comments received, we are finalizing the
direct PE inputs as proposed for CPT codes 95812 and 95813.
p. Testing of Autonomic Nervous System Function (CPT Code 95923)
We proposed to reduce the quantity of supply item ``iontophoresis
electrode kit'' (SA014) from 4 to 3. According to the description of
this code, the procedure typically uses 2-4 electrodes, and we
indicated that we therefore believe that a supply quantity of 3 would
better reflect the typical case. We requested further information
regarding the typical number of electrodes used in this procedure; if
the maximum of 4 electrodes is in fact typical for the procedure, then
we recommended that the code descriptor be referred to CPT for further
clarification.
Comment: Several commenters pointed out that CMS incorrectly
labeled this section of the CY 2016 PFS proposed rule under the heading
of ``Needle Electromyography'' with associated CPT codes 95863, 95864,
95869, and 95870. Commenters inferred that CMS intended to reference
CPT code 95923 instead of the needle electromyography procedures.
Response: The commenters are correct, and we agree that we included
the wrong heading for this part of the CY 2016 PFS proposed rule (80 FR
41781). We apologize for any confusion caused by this error.
Comment: The commenters also explained that the use of 4
iontophoresis electrode kits would be typical for CPT code 95923.
According to the commenters, several experts in the field of autonomic
testing confirmed that when providing this service they always, without
exception, used at least 4 sites of iontophoresis: forearm, proximal
leg, distal leg, and foot. The commenters therefore maintained that 4
units of the iontophoresis electrode kit would be the appropriate
quantity.
Response: We appreciate the submission of this additional clinical
information regarding the use of the iontophoresis electrodes. After
consideration of comments received, we are increasing the quantity of
the iontophoresis electrode kit (SA014) to 4 for CPT code 95923 in line
with the recommended value.
After consideration of comments received, we are finalizing the
direct PE inputs as proposed for CPT Code 95923, with the additional
refinement to SA014 discussed above.
q. Central Motor Evoked Study (CPT Codes 95928 and 95929)
We refined portions of the clinical labor time for CPT codes 95928
and 95929 as duplicative with other tasks, and refined the time for
clinical labor task ``Assist physician in performing procedure'' to
align with the intraservice work duration. We also removed a minimum
multi-specialty visit pack (SA048) from CPT code 95928 due to the fact
that it is typically billed with a same-day E/M service, and we refined
some of the equipment times for both procedures to conform to the
standard equipment formulas.
Comment: One commenter disagreed with the CMS decision to refine
the time for clinical labor task ``Assist physician in performing
procedure'' to align with the intraservice work time. This commenter
stated that the technologist sets up the service without the physician
present, after which the physician enters the room for the main portion
of the testing. Afterwards, the physician leaves the room and the
technologist completes the last portion of the procedure without the
physician present. The commenter indicated that the time for clinical
labor task ``Assist physician in performing procedure'' and the
physician intraservice work time were not temporally equivalent, and
that this clinical labor task was only used as a surrogate data entry
line for where to place the technologist's service in performing the
testing, not meant to be taken literally.
Response: The RUC recommendation for CPT codes 95928 and 95929
states that the technologist will ``Assist physician in conducting the
test.'' As a result, we do not believe that the clinical labor assigned
to ``Assist physician in performing procedure'' was merely a surrogate
data entry line that was not meant to be taken literally. We do not
agree that existing clinical labor tasks should be used as data entry
surrogates for other tasks, and we do not believe that clinical labor
time should be allocated to tasks that are not described in the
submitted recommendations. We continue to believe that this clinical
labor task should align with the intraservice work time, and we are
maintaining durations of 40 minutes for CPT code 95928 and 95929.
[[Page 70986]]
After consideration of comments received, we are finalizing the
direct PE inputs as proposed for CPT codes 95928 and 95929.
r. Blink Reflex Test (CPT Code 95933)
We added 2 minutes of time for clinical labor task ``Prepare room,
equipment, supplies'' to CPT code 95933 and refined the time for
clinical labor task ``Clean room/equipment by physician staff'' to 3
minutes, in both cases conforming to the established standards for
these clinical labor tasks.
Comment: One commenter indicated that the CY 2016 PFS proposed rule
summary showed a net reduction in PE relative value units for CPT code
95933, from a 2015 PE RVU of 1.75 to a proposed 2016 PE RVU of 1.50.
The commenter disagreed with this reduction and stated that they were
unable identify the source for the proposed reductions.
Response: To clarify the proposed change in PE for CPT code 95933,
we note that we believe this reduction is due to two changes in the
recommended values. We accepted the RUC recommendation to reduce the
time for clinical labor task ``Assist physician in cleaning area,
relaxing patient. Take notes from physician'' from 30 minutes to 25
minutes. We also accepted the RUC recommendation to reduce the quantity
of supply item ``electrode skin prep gel (NuPrep)'' (SJ022) from 100 ml
to 10 ml. These two reductions likely account for the reduction in PE
RVUs.
After consideration of comments received, we are finalizing the
direct PE inputs as proposed for CPT code 95933.
8. CY 2015 Interim Final Codes
In this section, we discuss each code for which we received a
comment on the CY 2015 interim final work RVU or work time during the
comment period for the CY 2015 final rule or for which we are modifying
the CY 2015 interim final work RVU, work time or procedure status
indicator for CY 2016. If a code in Table 15 is not discussed in this
section, we did not receive any comments on that code or received only
comment(s) in support of the CY 2015 interim final status; for those,
we are finalizing the interim final work RVU and time without
modification for CY 2016.
A comprehensive list of all interim final values for which public
comments were sought in the comment period for the CY 2015 PFS final
rule is contained in Addendum C to the CY 2015 PFS final rule with
comment period. We note that the values for some codes with interim
final values were addressed in the CY 2016 PFS proposed rule (see:
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html), and therefore, are addressed in section
II.H. of this final rule with comment period. A comprehensive list of
all CY 2016 RVUs is in Addendum B. All Addenda to the PFS final rule
with comment period are available on the CMS Web site under downloads
at http://www.cms.gov/physicianfeesched/PFSFederalRegulationNotices.html/. The time values and direct PE inputs
for all codes are listed files called ``CY 2016 PFS Work Time,'' and
``CY 2016 Direct PE Inputs,'' available on the CMS Web site under
downloads for the CY 2016 PFS final rule with comment period at http://www.cms.gov/physicianfeesched/downloads/.
Table 13--CY 2016 Actions on Codes With CY 2015 Interim Final RVUs
----------------------------------------------------------------------------------------------------------------
CY 2015 interim CY 2016 work
HCPCS code Long descriptor final work RVU RVU CY 2016 action
----------------------------------------------------------------------------------------------------------------
11980........................ Subcutaneous hormone 1.10 1.10 Finalize.
pellet implantation
(implantation of
estradiol and/or
testosterone pellets
beneath the skin).
20604........................ Arthrocentesis, aspiration 0.89 0.89 Finalize.
and/or injection, small
joint or bursa (e.g.,
fingers, toes); with
ultrasound guidance, with
permanent recording and
reporting.
20606........................ Arthrocentesis, aspiration 1.00 1.00 Finalize.
and/or injection,
intermediate joint or
bursa (e.g.,
temporomandibular,
acromioclavicular, wrist,
elbow or ankle, olecranon
bursa); with ultrasound
guidance, with permanent
recording and reporting.
20611........................ Arthrocentesis, aspiration 1.10 1.10 Finalize.
and/or injection, major
joint or bursa (e.g.,
shoulder, hip, knee,
subacromial bursa); with
ultrasound guidance, with
permanent recording and
reporting.
20983........................ Ablation therapy for 7.13 7.13 Finalize.
reduction or eradication
of 1 or more bone tumors
(e.g., metastasis)
including adjacent soft
tissue when involved by
tumor extension,
percutaneous, including
imaging guidance when
performed; cryoablation.
21811........................ Open treatment of rib 10.79 10.79 Finalize.
fracture(s) with internal
fixation, includes
thoracoscopic
visualization when
performed, unilateral; 1-
3 ribs.
21812........................ Open treatment of rib 13.00 13.00 Finalize.
fracture(s) with internal
fixation, includes
thoracoscopic
visualization when
performed, unilateral; 4-
6 ribs.
21813........................ Open treatment of rib 17.61 17.61 Finalize.
fracture(s) with internal
fixation, includes
thoracoscopic
visualization when
performed, unilateral; 7
or more ribs.
22510........................ Percutaneous 8.15 8.15 Finalize.
vertebroplasty (bone
biopsy included when
performed), 1 vertebral
body, unilateral or
bilateral injection,
inclusive of all imaging
guidance; cervicothoracic.
22511........................ Percutaneous 7.58 7.58 Finalize.
vertebroplasty (bone
biopsy included when
performed), 1 vertebral
body, unilateral or
bilateral injection,
inclusive of all imaging
guidance; lumbosacral.
22512........................ Percutaneous 4.00 4.00 Finalize.
vertebroplasty (bone
biopsy included when
performed), 1 vertebral
body, unilateral or
bilateral injection,
inclusive of all imaging
guidance; each additional
cervicothoracic or
lumbosacral vertebral
body (List separately in
addition to code for
primary procedure).
22513........................ Percutaneous vertebral 8.90 8.90 Finalize.
augmentation, including
cavity creation (fracture
reduction and bone biopsy
included when performed)
using mechanical device
(e.g., kyphoplasty), 1
vertebral body,
unilateral or bilateral
cannulation, inclusive of
all imaging guidance;
thoracic.
[[Page 70987]]
22514........................ Percutaneous vertebral 8.24 8.24 Finalize.
augmentation, including
cavity creation (fracture
reduction and bone biopsy
included when performed)
using mechanical device
(e.g., kyphoplasty), 1
vertebral body,
unilateral or bilateral
cannulation, inclusive of
all imaging guidance;
lumbar.
22515........................ Percutaneous vertebral 4.00 4.00 Finalize.
augmentation, including
cavity creation (fracture
reduction and bone biopsy
included when performed)
using mechanical device
(e.g., kyphoplasty), 1
vertebral body,
unilateral or bilateral
cannulation, inclusive of
all imaging guidance;
each additional thoracic
or lumbar vertebral body
(List separately in
addition to code for
primary procedure).
22856........................ Total disc arthroplasty 24.05 24.05 Finalize.
(artificial disc),
anterior approach,
including discectomy with
end plate preparation
(includes osteophytectomy
for nerve root or spinal
cord decompression and
microdissection); single
interspace, cervical.
22858........................ Total disc arthroplasty 8.40 8.40 Finalize.
(artificial disc),
anterior approach,
including discectomy with
end plate preparation
(includes osteophytectomy
for nerve root or spinal
cord decompression and
microdissection); second
level, cervical (List
separately in addition to
code for primary
procedure).
27279........................ Arthrodesis, sacroiliac 9.03 9.03 See II.J.5.a.
joint, percutaneous or
minimally invasive
(indirect visualization),
with image guidance,
includes obtaining bone
graft when performed, and
placement of transfixing
device.
29200........................ Strapping; thorax......... 0.39 0.39 Finalize.
29240........................ Strapping; shoulder (e.g., 0.39 0.39 Finalize.
Velpeau).
29260........................ Strapping; elbow or wrist. 0.39 0.39 Finalize.
29280........................ Strapping; hand or finger. 0.39 0.39 Finalize.
29520........................ Strapping; hip............ 0.39 0.39 Finalize.
29530........................ Strapping; knee........... 0.39 0.39 Finalize.
31620........................ Endobronchial ultrasound 1.40 ............... Deleted.
(EBUS) during
bronchoscopic diagnostic
or therapeutic
intervention(s) (List
separately in addition to
code for primary
procedure[s]).
33215........................ Repositioning of 4.92 4.92 Finalize.
previously implanted
transvenous pacemaker or
implantable defibrillator
(right atrial or right
ventricular) electrode.
33216........................ Insertion of a single 5.87 5.87 Finalize.
transvenous electrode,
permanent pacemaker or
implantable defibrillator.
33217........................ Insertion of 2 transvenous 5.84 5.84 Finalize.
electrodes, permanent
pacemaker or implantable
defibrillator.
33218........................ Repair of single 6.07 6.07 Finalize.
transvenous electrode,
permanent pacemaker or
implantable defibrillator.
33220........................ Repair of 2 transvenous 6.15 6.15 Finalize.
electrodes for permanent
pacemaker or implantable
defibrillator.
33223........................ Relocation of skin pocket 6.55 6.55 Finalize.
for implantable
defibrillator.
33224........................ Insertion of pacing 9.04 9.04 Finalize.
electrode, cardiac venous
system, for left
ventricular pacing, with
attachment to previously
placed pacemaker or
implantable defibrillator
pulse generator
(including revision of
pocket, removal,
insertion, and/or
replacement of existing
generator).
33225........................ Insertion of pacing 8.33 8.33 Finalize.
electrode, cardiac venous
system, for left
ventricular pacing, at
time of insertion of
implantable defibrillator
or pacemaker pulse
generator (e.g., for
upgrade to dual chamber
system) (List separately
in addition to code for
primary procedure).
33240........................ Insertion of implantable 6.05 6.05 Finalize.
defibrillator pulse
generator only; with
existing single lead.
33241........................ Removal of implantable 3.29 3.29 Finalize.
defibrillator pulse
generator only.
33243........................ Removal of single or dual 23.57 23.57 Finalize.
chamber implantable
defibrillator
electrode(s); by
thoracotomy.
33244........................ Removal of single or dual 13.99 13.99 Finalize.
chamber implantable
defibrillator
electrode(s); by
transvenous extraction.
33249........................ Insertion or replacement 15.17 15.17 Finalize.
of permanent implantable
defibrillator system,
with transvenous lead(s),
single or dual chamber.
33262........................ Removal of implantable 6.06 6.06 Finalize.
defibrillator pulse
generator with
replacement of
implantable defibrillator
pulse generator; single
lead system.
33263........................ Removal of implantable 6.33 6.33 Finalize.
defibrillator pulse
generator with
replacement of
implantable defibrillator
pulse generator; dual
lead system.
33270........................ Insertion or replacement 9.10 9.10 Finalize.
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.
33271........................ Insertion of subcutaneous 7.50 7.50 Finalize.
implantable defibrillator
electrode.
33272........................ Removal of subcutaneous 5.42 5.42 Finalize.
implantable defibrillator
electrode.
[[Page 70988]]
33273........................ Repositioning of 6.50 6.50 Finalize.
previously implanted
subcutaneous implantable
defibrillator electrode.
33418........................ Transcatheter mitral valve 32.25 32.25 Finalize.
repair, percutaneous
approach, including
transseptal puncture when
performed; initial
prosthesis.
33419........................ Transcatheter mitral valve 7.93 7.93 Finalize.
repair, percutaneous
approach, including
transseptal puncture when
performed; additional
prosthesis(es) during
same session (List
separately in addition to
code for primary
procedure).
33946........................ Extracorporeal membrane 6.00 6.00 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; initiation,
veno-venous.
33947........................ Extracorporeal membrane 6.63 6.63 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; initiation,
veno-arterial.
33949........................ Extracorporeal membrane 4.60 4.60 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; daily
management, each day,
veno-arterial.
33951........................ Extracorporeal membrane 8.15 8.15 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; insertion
of peripheral (arterial
and/or venous)
cannula(e), percutaneous,
birth through 5 years of
age (includes
fluoroscopic guidance,
when performed).
33952........................ Extracorporeal membrane 8.15 8.15 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; insertion
of peripheral (arterial
and/or venous)
cannula(e), percutaneous,
6 years and older
(includes fluoroscopic
guidance, when performed).
33953........................ Extracorporeal membrane 9.11 9.11 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; insertion
of peripheral (arterial
and/or venous)
cannula(e), open, birth
through 5 years of age.
33954........................ Extracorporeal membrane 9.11 9.11 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; insertion
of peripheral (arterial
and/or venous)
cannula(e), open, 6 years
and older.
33955........................ Extracorporeal membrane 16.00 16.00 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; insertion
of central cannula(e) by
sternotomy or
thoracotomy, birth
through 5 years of age.
33956........................ Extracorporeal membrane 16.00 16.00 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; insertion
of central cannula(e) by
sternotomy or
thoracotomy, 6 years and
older.
33957........................ Extracorporeal membrane 3.51 3.51 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; reposition
peripheral (arterial and/
or venous) cannula(e),
percutaneous, birth
through 5 years of age
(includes fluoroscopic
guidance, when performed).
33958........................ Extracorporeal membrane 3.51 3.51 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; reposition
peripheral (arterial and/
or venous) cannula(e),
percutaneous, 6 years and
older (includes
fluoroscopic guidance,
when performed).
33959........................ Extracorporeal membrane 4.47 4.47 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; reposition
peripheral (arterial and/
or venous) cannula(e),
open, birth through 5
years of age (includes
fluoroscopic guidance,
when performed).
33962........................ Extracorporeal membrane 4.47 4.47 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; reposition
peripheral (arterial and/
or venous) cannula(e),
open, 6 years and older
(includes fluoroscopic
guidance, when performed).
33963........................ Extracorporeal membrane 9.00 9.00 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; reposition
of central cannula(e) by
sternotomy or
thoracotomy, birth
through 5 years of age
(includes fluoroscopic
guidance, when performed).
33964........................ Extracorporeal membrane 9.50 9.50 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; reposition
central cannula(e) by
sternotomy or
thoracotomy, 6 years and
older (includes
fluoroscopic guidance,
when performed).
33965........................ Extracorporeal membrane 3.51 3.51 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; removal of
peripheral (arterial and/
or venous) cannula(e),
percutaneous, birth
through 5 years of age.
33966........................ Extracorporeal membrane 4.50 4.50 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; removal of
peripheral (arterial and/
or venous) cannula(e),
percutaneous, 6 years and
older.
33969........................ Extracorporeal membrane 5.22 5.22 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; removal of
peripheral (arterial and/
or venous) cannula(e),
open, birth through 5
years of age.
[[Page 70989]]
33984........................ Extracorporeal membrane 5.46 5.46 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; removal of
peripheral (arterial and/
or venous) cannula(e),
open, 6 years and older.
33985........................ Extracorporeal membrane 9.89 9.89 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; removal of
central cannula(e) by
sternotomy or
thoracotomy, birth
through 5 years of age.
33986........................ Extracorporeal membrane 10.00 10.00 Finalize.
oxygenation (ECMO)/
extracorporeal life
support (ECLS) provided
by physician; removal of
central cannula(e) by
sternotomy or
thoracotomy, 6 years and
older.
33987........................ Arterial exposure with 4.04 4.04 Finalize.
creation of graft conduit
(e.g., chimney graft) to
facilitate arterial
perfusion for ECMO/ECLS
(List separately in
addition to code for
primary procedure).
33988........................ Insertion of left heart 15.00 15.00 Finalize.
vent by thoracic incision
(e.g., sternotomy,
thoracotomy) for ECMO/
ECLS.
33989........................ Removal of left heart vent 9.50 9.50 Finalize.
by thoracic incision
(e.g., sternotomy,
thoracotomy) for ECMO/
ECLS.
34839........................ Physician planning of a B B Finalize.
patient-specific
fenestrated visceral
aortic endograft
requiring a minimum of 90
minutes of physician time.
34841........................ Endovascular repair of C C Finalize.
visceral aorta (e.g.,
aneurysm, pseudoaneurysm,
dissection, penetrating
ulcer, intramural
hematoma, or traumatic
disruption) by deployment
of a fenestrated visceral
aortic endograft and all
associated radiological
supervision and
interpretation, including
target zone angioplasty,
when performed; including
one visceral artery
endoprosthesis (superior
mesenteric, celiac or
renal artery).
34842........................ Endovascular repair of C C Finalize.
visceral aorta (e.g.,
aneurysm, pseudoaneurysm,
dissection, penetrating
ulcer, intramural
hematoma, or traumatic
disruption) by deployment
of a fenestrated visceral
aortic endograft and all
associated radiological
supervision and
interpretation, including
target zone angioplasty,
when performed; including
two visceral artery
endoprostheses (superior
mesenteric, celiac and/or
renal artery[s]).
34843........................ Endovascular repair of C C Finalize.
visceral aorta (e.g.,
aneurysm, pseudoaneurysm,
dissection, penetrating
ulcer, intramural
hematoma, or traumatic
disruption) by deployment
of a fenestrated visceral
aortic endograft and all
associated radiological
supervision and
interpretation, including
target zone angioplasty,
when performed; including
three visceral artery
endoprostheses (superior
mesenteric, celiac and/or
renal artery[s]).
34844........................ Endovascular repair of C C Finalize.
visceral aorta (e.g.,
aneurysm, pseudoaneurysm,
dissection, penetrating
ulcer, intramural
hematoma, or traumatic
disruption) by deployment
of a fenestrated visceral
aortic endograft and all
associated radiological
supervision and
interpretation, including
target zone angioplasty,
when performed; including
four or more visceral
artery endoprostheses
(superior mesenteric,
celiac and/or renal
artery[s]).
34845........................ Endovascular repair of C C Finalize.
visceral aorta and
infrarenal abdominal
aorta (e.g., aneurysm,
pseudoaneurysm,
dissection, penetrating
ulcer, intramural
hematoma, or traumatic
disruption) with a
fenestrated visceral
aortic endograft and
concomitant unibody or
modular infrarenal aortic
endograft and all
associated radiological
supervision and
interpretation, including
target zone angioplasty,
when performed; including
one visceral artery
endoprosthesis (superior
mesenteric, celiac or
renal artery).
34846........................ Endovascular repair of C C Finalize.
visceral aorta and
infrarenal abdominal
aorta (e.g., aneurysm,
pseudoaneurysm,
dissection, penetrating
ulcer, intramural
hematoma, or traumatic
disruption) with a
fenestrated visceral
aortic endograft and
concomitant unibody or
modular infrarenal aortic
endograft and all
associated radiological
supervision and
interpretation, including
target zone angioplasty,
when performed; including
two visceral artery
endoprostheses (superior
mesenteric, celiac and/or
renal artery[s]).
34847........................ Endovascular repair of C C Finalize.
visceral aorta and
infrarenal abdominal
aorta (e.g., aneurysm,
pseudoaneurysm,
dissection, penetrating
ulcer, intramural
hematoma, or traumatic
disruption) with a
fenestrated visceral
aortic endograft and
concomitant unibody or
modular infrarenal aortic
endograft and all
associated radiological
supervision and
interpretation, including
target zone angioplasty,
when performed; including
three visceral artery
endoprostheses (superior
mesenteric, celiac and/or
renal artery[s]).
[[Page 70990]]
34848........................ Endovascular repair of C C Finalize.
visceral aorta and
infrarenal abdominal
aorta (e.g., aneurysm,
pseudoaneurysm,
dissection, penetrating
ulcer, intramural
hematoma, or traumatic
disruption) with a
fenestrated visceral
aortic endograft and
concomitant unibody or
modular infrarenal aortic
endograft and all
associated radiological
supervision and
interpretation, including
target zone angioplasty,
when performed; including
four or more visceral
artery endoprostheses
(superior mesenteric,
celiac and/or renal
artery[s]).
36475........................ Endovenous ablation 5.30 5.30 See II.J.5.a
therapy of incompetent
vein, extremity,
inclusive of all imaging
guidance and monitoring,
percutaneous,
radiofrequency; first
vein treated.
36476........................ Endovenous ablation 2.65 2.65 See II.J.5.a
therapy of incompetent
vein, extremity,
inclusive of all imaging
guidance and monitoring,
percutaneous,
radiofrequency; second
and subsequent veins
treated in a single
extremity, each through
separate access sites
(List separately in
addition to code for
primary procedure).
36478........................ Endovenous ablation 5.30 5.30 See II.J.5.a.
therapy of incompetent
vein, extremity,
inclusive of all imaging
guidance and monitoring,
percutaneous, laser;
first vein treated.
36479........................ Endovenous ablation 2.65 2.65 See II.J.5.a.
therapy of incompetent
vein, extremity,
inclusive of all imaging
guidance and monitoring,
percutaneous, laser;
second and subsequent
veins treated in a single
extremity, each through
separate access sites
(List separately in
addition to code for
primary procedure).
36818........................ Arteriovenous anastomosis, 12.39 12.39 Finalize.
open; by upper arm
cephalic vein
transposition.
36819........................ Arteriovenous anastomosis, 13.29 13.29 Finalize.
open; by upper arm
basilic vein
transposition.
36820........................ Arteriovenous anastomosis, 13.07 13.07 Finalize.
open; by forearm vein
transposition.
36821........................ Arteriovenous anastomosis, 11.90 11.90 Finalize.
open; direct, any site
(e.g., Cimino type)
(separate procedure).
36825........................ Creation of arteriovenous 14.17 14.17 Finalize.
fistula by other than
direct arteriovenous
anastomosis (separate
procedure); autogenous
graft.
36830........................ Creation of arteriovenous 12.03 12.03 Finalize.
fistula by other than
direct arteriovenous
anastomosis (separate
procedure); nonautogenous
graft (e.g., biological
collagen, thermoplastic
graft).
36831........................ Thrombectomy, open, 11.00 11.00 Finalize.
arteriovenous fistula
without revision,
autogenous or
nonautogenous dialysis
graft (separate
procedure).
36832........................ Revision, open, 13.50 13.50 Finalize.
arteriovenous fistula;
without thrombectomy,
autogenous or
nonautogenous dialysis
graft (separate
procedure).
36833........................ Revision, open, 14.50 14.50 Finalize.
arteriovenous fistula;
with thrombectomy,
autogenous or
nonautogenous dialysis
graft (separate
procedure).
37218........................ Transcatheter placement of 15.00 15.00 Finalize.
intravascular stent(s),
intrathoracic common
carotid artery or
innominate artery, open
or percutaneous antegrade
approach, including
angioplasty, when
performed, and
radiological supervision
and interpretation.
43180........................ Esophagoscopy, rigid, 9.03 9.03 Finalize.
transoral with
diverticulectomy of
hypopharynx or cervical
esophagus (e.g., Zenker's
diverticulum), with
cricopharyngeal myotomy,
includes use of telescope
or operating microscope
and repair, when
performed.
45399........................ Unlisted procedure, colon. I C Finalize.
47383........................ Ablation, 1 or more liver 9.13 9.13 Finalize.
tumor(s), percutaneous,
cryoablation.
52441........................ Cystourethroscopy, with 4.50 4.50 Finalize.
insertion of permanent
adjustable transprostatic
implant; single implant.
52442........................ Cystourethroscopy, with 1.20 1.20 Finalize.
insertion of permanent
adjustable transprostatic
implant; each additional
permanent adjustable
transprostatic implant
(List separately in
addition to code for
primary procedure).
55840........................ Prostatectomy, retropubic 21.36 21.36 Finalize.
radical, with or without
nerve sparing.
55842........................ Prostatectomy, retropubic 21.36 21.36 Finalize.
radical, with or without
nerve sparing; with lymph
node biopsy(s) (limited
pelvic lymphadenectomy).
55845........................ Prostatectomy, retropubic 25.18 25.18 Finalize.
radical, with or without
nerve sparing; with
bilateral pelvic
lymphadenectomy,
including external iliac,
hypogastric, and
obturator nodes.
58541........................ Laparoscopy, surgical, 12.29 12.29 Finalize.
supracervical
hysterectomy, for uterus
250 g or less.
58542........................ Laparoscopy, surgical, 14.16 14.16 Finalize.
supracervical
hysterectomy, for uterus
250 g or less; with
removal of tube(s) and/or
ovary(s).
58543........................ Laparoscopy, surgical, 14.39 14.39 Finalize.
supracervical
hysterectomy, for uterus
greater than 250 g.
58544........................ Laparoscopy, surgical, 15.60 15.60 Finalize.
supracervical
hysterectomy, for uterus
greater than 250 g; with
removal of tube(s) and/or
ovary(s).
58570........................ Laparoscopy, surgical, 13.36 13.36 Finalize.
with total hysterectomy,
for uterus 250 g or less.
[[Page 70991]]
58571........................ Laparoscopy, surgical, 15.00 15.00 Finalize.
with total hysterectomy,
for uterus 250 g or less;
with removal of tube(s)
and/or ovary(s).
58572........................ Laparoscopy, surgical, 17.71 17.71 Finalize.
with total hysterectomy,
for uterus greater than
250 g.
58573........................ Laparoscopy, surgical, 20.79 20.79 Finalize.
with total hysterectomy,
for uterus greater than
250 g; with removal of
tube(s) and/or ovary(s).
62284........................ Injection procedure for 1.54 1.54 Finalize.
myelography and/or
computed tomography,
lumbar (other than C1-C2
and posterior fossa).
62302........................ Myelography via lumbar 2.29 2.29 Finalize.
injection, including
radiological supervision
and interpretation;
cervical.
62303........................ Myelography via lumbar 2.29 2.29 Finalize.
injection, including
radiological supervision
and interpretation;
thoracic.
62304........................ Myelography via lumbar 2.25 2.25 Finalize.
injection, including
radiological supervision
and interpretation;
lumbosacral.
62305........................ Myelography via lumbar 2.35 2.35 Finalize.
injection, including
radiological supervision
and interpretation; 2 or
more regions (e.g.,
lumbar/thoracic, cervical/
thoracic, lumbar/
cervical, lumbar/thoracic/
cervical).
62310........................ Injection(s), of 1.91 1.91 Finalize.
diagnostic or therapeutic
substance(s) (including
anesthetic,
antispasmodic, opioid,
steroid, other solution),
not including neurolytic
substances, including
needle or catheter
placement, includes
contrast for localization
when performed, epidural
or subarachnoid; cervical
or thoracic.
62311........................ Injection(s), of 1.54 1.54 Finalize.
diagnostic or therapeutic
substance(s) (including
anesthetic,
antispasmodic, opioid,
steroid, other solution),
not including neurolytic
substances, including
needle or catheter
placement, includes
contrast for localization
when performed, epidural
or subarachnoid; lumbar
or sacral (caudal).
62318........................ Injection(s), including 2.04 2.04 Finalize.
indwelling catheter
placement, continuous
infusion or intermittent
bolus, of diagnostic or
therapeutic substance(s)
(including anesthetic,
antispasmodic, opioid,
steroid, other solution),
not including neurolytic
substances, includes
contrast for localization
when performed, epidural
or subarachnoid; cervical
or thoracic.
62319........................ Injection(s), including 1.87 1.87 Finalize.
indwelling catheter
placement, continuous
infusion or intermittent
bolus, of diagnostic or
therapeutic substance(s)
(including anesthetic,
antispasmodic, opioid,
steroid, other solution),
not including neurolytic
substances, includes
contrast for localization
when performed, epidural
or subarachnoid; lumbar
or sacral (caudal).
64486........................ Transversus abdominis 1.27 1.27 Finalize.
plane (TAP) block
(abdominal plane block,
rectus sheath block)
unilateral; by
injection(s) (includes
imaging guidance, when
performed).
64487........................ Transversus abdominis 1.48 1.48 Finalize.
plane (TAP) block
(abdominal plane block,
rectus sheath block)
unilateral; by continuous
infusion(s) (includes
imaging guidance, when
performed).
64488........................ Transversus abdominis 1.60 1.60 Finalize.
plane (TAP) block
(abdominal plane block,
rectus sheath block)
bilateral; by injections
(includes imaging
guidance, when performed).
64489........................ Transversus abdominis 1.80 1.80 Finalize.
plane (TAP) block
(abdominal plane block,
rectus sheath block)
bilateral; by continuous
infusions (includes
imaging guidance, when
performed).
64561........................ Percutaneous implantation 5.44 5.44 Finalize.
of neurostimulator
electrode array; sacral
nerve (transforaminal
placement) including
image guidance, if
performed.
66179........................ Aqueous shunt to 14.00 14.00 Finalize.
extraocular equatorial
plate reservoir, external
approach; without graft.
66180........................ Aqueous shunt to 15.00 15.00 Finalize.
extraocular equatorial
plate reservoir, external
approach; with graft.
66184........................ Revision of aqueous shunt 9.58 9.58 Finalize.
to extraocular equatorial
plate reservoir; without
graft.
66185........................ Revision of aqueous shunt 10.58 10.58 Finalize.
to extraocular equatorial
plate reservoir; with
graft.
67036........................ Vitrectomy, mechanical, 12.13 12.13 Finalize.
pars plana approach;.
67039........................ Vitrectomy, mechanical, 13.20 13.20 Finalize.
pars plana approach; with
focal endolaser
photocoagulation.
67040........................ Vitrectomy, mechanical, 14.50 14.50 Finalize.
pars plana approach; with
endolaser panretinal
photocoagulation.
67041........................ Vitrectomy, mechanical, 16.33 16.33 Finalize.
pars plana approach; with
removal of preretinal
cellular membrane (e.g.,
macular pucker).
[[Page 70992]]
67042........................ Vitrectomy, mechanical, 16.33 16.33 Finalize.
pars plana approach; with
removal of internal
limiting membrane of
retina (e.g., for repair
of macular hole, diabetic
macular edema), includes,
if performed, intraocular
tamponade (i.e., air, gas
or silicone oil).
67043........................ Vitrectomy, mechanical, 17.40 17.40 Finalize.
pars plana approach; with
removal of subretinal
membrane (e.g., choroidal
neovascularization),
includes, if performed,
intraocular tamponade
(i.e., air, gas or
silicone oil) and laser
photocoagulation.
67255........................ Scleral reinforcement 8.38 8.38 Finalize.
(separate procedure);
with graft.
70486........................ Computed tomography, 0.85 0.85 See II.J.5.a.
maxillofacial area;
without contrast material.
70487........................ Computed tomography, 1.13 1.13 See II.J.5.a.
maxillofacial area; with
contrast material(s).
70488........................ Computed tomography, 1.27 1.27 See II.J.5.a.
maxillofacial area;
without contrast
material, followed by
contrast material(s) and
further sections.
70496........................ Computed tomographic 1.75 1.75 Finalize.
angiography, head, with
contrast material(s),
including noncontrast
images, if performed, and
image postprocessing.
70498........................ Computed tomographic 1.75 1.75 Finalize.
angiography, neck, with
contrast material(s),
including noncontrast
images, if performed, and
image postprocessing.
71275........................ Computed tomographic 1.82 1.82 Finalize.
angiography, chest
(noncoronary), with
contrast material(s),
including noncontrast
images, if performed, and
image postprocessing.
72191........................ Computed tomographic 1.81 1.81 Finalize.
angiography, pelvis, with
contrast material(s),
including noncontrast
images, if performed, and
image postprocessing.
72240........................ Myelography, cervical, 0.91 0.91 Finalize.
radiological supervision
and interpretation.
72255........................ Myelography, thoracic, 0.91 0.91 Finalize.
radiological supervision
and interpretation.
72265........................ Myelography, lumbosacral, 0.83 0.83 Finalize.
radiological supervision
and interpretation.
72270........................ Myelography, 2 or more 1.33 1.33 Finalize.
regions (e.g., lumbar/
thoracic, cervical/
thoracic, lumbar/
cervical, lumbar/thoracic/
cervical), radiological
supervision and
interpretation.
74174........................ Computed tomographic 2.20 2.20 Finalize.
angiography, abdomen and
pelvis, with contrast
material(s), including
noncontrast images, if
performed, and image
postprocessing.
74175........................ Computed tomographic 1.82 1.82 Finalize.
angiography, abdomen,
with contrast
material(s), including
noncontrast images, if
performed, and image
postprocessing.
74230........................ Swallowing function, with 0.53 0.53 Finalize.
cineradiography/
videoradiography.
76641........................ Ultrasound, breast, 0.73 0.73 Finalize.
unilateral, real time
with image documentation,
including axilla when
performed; complete.
76642........................ Ultrasound, breast, 0.68 0.68 Finalize.
unilateral, real time
with image documentation,
including axilla when
performed; limited.
76700........................ Ultrasound, abdominal, 0.81 0.81 Finalize.
real time with image
documentation; complete.
76705........................ Ultrasound, abdominal, 0.59 0.59 Finalize.
real time with image
documentation; limited
(e.g., single organ,
quadrant, follow-up).
76770........................ Ultrasound, 0.74 0.74 Finalize.
retroperitoneal (e.g.,
renal, aorta, nodes),
real time with image
documentation; complete.
76775........................ Ultrasound, 0.58 0.58 Finalize.
retroperitoneal (e.g.,
renal, aorta, nodes),
real time with image
documentation; limited.
76856........................ Ultrasound, pelvic 0.69 0.69 Finalize.
(nonobstetric), real time
with image documentation;
complete.
76857........................ Ultrasound, pelvic 0.50 0.50 Finalize.
(nonobstetric), real time
with image documentation;
limited or follow-up
(e.g., for follicles).
76930........................ Ultrasonic guidance for 0.67 0.67 Finalize.
pericardiocentesis,
imaging supervision and
interpretation.
76932........................ Ultrasonic guidance for 0.85 0.67 Finalize.
endomyocardial biopsy,
imaging supervision and
interpretation.
76942........................ Ultrasonic guidance for 0.67 0.67 Finalize.
needle placement (e.g.,
biopsy, aspiration,
injection, localization
device), imaging
supervision and
interpretation.
76948........................ Ultrasonic guidance for 0.38 0.38 Finalize.
aspiration of ova,
imaging supervision and
interpretation.
77055........................ Mammography; unilateral... 0.7 0.70 Finalize.
77056........................ Mammography; bilateral.... 0.87 0.87 Finalize.
77057........................ Screening mammography, 0.7 0.70 Finalize.
bilateral (2-view film
study of each breast).
77061........................ Digital breast I I Finalize.
tomosynthesis; unilateral.
77062........................ Digital breast I I Finalize.
tomosynthesis; bilateral.
77063........................ Screening digital breast 0.60 0.60 Finalize.
tomosynthesis, bilateral
(List separately in
addition to code for
primary procedure).
77080........................ Dual-energy X-ray 0.20 0.20 Finalize.
absorptiometry (DXA),
bone density study, 1 or
more sites; axial
skeleton (e.g., hips,
pelvis, spine).
77085........................ Dual-energy X-ray 0.30 0.30 Finalize.
absorptiometry (DXA),
bone density study, 1 or
more sites; axial
skeleton (e.g., hips,
pelvis, spine), including
vertebral fracture
assessment.
[[Page 70993]]
77086........................ Vertebral fracture 0.17 0.17 Finalize.
assessment via dual-
energy X-ray
absorptiometry (DXA).
77300........................ Basic radiation dosimetry 0.62 0.62 See II.J.5.a.
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.
77306........................ Teletherapy isodose plan; 1.40 1.40 See II.J.5.a.
simple (1 or 2 unmodified
ports directed to a
single area of interest),
includes basic dosimetry
calculation(s).
77307........................ Teletherapy isodose plan; 2.90 2.90 See II.J.5.a.
complex (multiple
treatment areas,
tangential ports, the use
of wedges, blocking,
rotational beam, or
special beam
considerations), includes
basic dosimetry
calculation(s).
77316........................ Brachytherapy isodose 1.40 1.40 Finalize.
plan; simple
(calculation[s] made from
1 to 4 sources, or remote
afterloading
brachytherapy, 1
channel), includes basic
dosimetry calculation(s).
77317........................ Brachytherapy isodose 1.83 1.83 Finalize.
plan; intermediate
(calculation[s] made from
5 to 10 sources, or
remote afterloading
brachytherapy, 2-12
channels), includes basic
dosimetry calculation(s).
77318........................ Brachytherapy isodose 2.90 2.90 Finalize.
plan; complex
(calculation[s] made from
over 10 sources, or
remote afterloading
brachytherapy, over 12
channels), includes basic
dosimetry calculation(s).
88341........................ Immunohistochemistry or 0.53 0.53 See II.I.5.d.
immunocytochemistry, per
specimen; each additional
single antibody stain
procedure (List
separately in addition to
code for primary
procedure).
88342........................ Immunohistochemistry or 0.70 0.70 Finalize.
immunocytochemistry, per
specimen; initial single
antibody stain procedure.
88344........................ Immunohistochemistry or 0.77 0.77 Finalize.
immunocytochemistry, per
specimen; each multiplex
antibody stain procedure.
88348........................ Electron microscopy, 1.51 1.51 Finalize.
diagnostic.
88356........................ Morphometric analysis; 2.80 2.80 Finalize.
nerve.
88364........................ In situ hybridization 0.67 0.67 See II.I.5.d
(e.g., FISH), per
specimen; each additional
single probe stain
procedure (List
separately in addition to
code for primary
procedure).
88365........................ In situ hybridization 0.88 0.88 Finalize.
(e.g., FISH), per
specimen; initial single
probe stain procedure.
88366........................ In situ hybridization 1.24 1.24 Finalize.
(e.g., FISH), per
specimen; each multiplex
probe stain procedure.
88369........................ Morphometric analysis, in 0.67 0.67 See II.I.5.d.
situ hybridization
(quantitative or semi-
quantitative), manual,
per specimen; each
additional single probe
stain procedure (List
separately in addition to
code for primary
procedure).
88373........................ Morphometric analysis, in 0.43 0.43 Finalize.
situ hybridization
(quantitative or semi-
quantitative), using
computer-assisted
technology, per specimen;
each additional single
probe stain procedure
(List separately in
addition to code for
primary procedure).
88374........................ Morphometric analysis, in 0.93 0.93 See II.I.5.d.
situ hybridization
(quantitative or semi-
quantitative), using
computer-assisted
technology, per specimen;
each multiplex probe
stain procedure.
88377........................ Morphometric analysis, in 1.40 1.40 Finalize.
situ hybridization
(quantitative or semi-
quantitative), manual,
per specimen; each
multiplex probe stain
procedure.
88380........................ Microdissection (i.e., 1.14 1.14 See II.J.5.a.
sample preparation of
microscopically
identified target); laser
capture.
88381........................ Microdissection (i.e., 0.53 0.53 See II.J.5.a.
sample preparation of
microscopically
identified target);
manual.
91200........................ Liver elastography, 0.30 0.27 See II.J.5.a.
mechanically induced
shear wave (e.g.,
vibration), without
imaging, with
interpretation and report.
92145........................ Corneal hysteresis 0.17 0.17 Finalize.
determination, by air
impulse stimulation,
unilateral or bilateral,
with interpretation and
report.
92540........................ Basic vestibular 1.50 1.50 Finalize.
evaluation, includes
spontaneous nystagmus
test with eccentric gaze
fixation nystagmus, with
recording, positional
nystagmus test, minimum
of 4 positions, with
recording, optokinetic
nystagmus test,
bidirectional foveal and
peripheral stimulation,
with recording, and
oscillating tracking
test, with recording.
92541........................ Spontaneous nystagmus 0.40 0.40 Finalize.
test, including gaze and
fixation nystagmus, with
recording.
92542........................ Positional nystagmus test, 0.48 0.48 Finalize.
minimum of 4 positions,
with recording.
92543........................ Caloric vestibular test, 0.10 ............... Deleted.
each irrigation
(binaural, bithermal
stimulation constitutes 4
tests), with recording.
92544........................ Optokinetic nystagmus 0.27 0.27 Finalize.
test, bidirectional,
foveal or peripheral
stimulation, with
recording.
92545........................ Oscillating tracking test, 0.25 0.25 Finalize.
with recording.
[[Page 70994]]
93260........................ Programming device 0.85 0.85 Finalize.
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.
93261........................ Interrogation device 0.74 0.74 Finalize.
evaluation (in person)
with analysis, review and
report by a physician or
other qualified health
care professional,
includes connection,
recording and
disconnection per patient
encounter; implantable
subcutaneous lead
defibrillator system.
93282........................ Programming device 0.85 0.85 Finalize.
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; single
lead transvenous
implantable defibrillator
system.
93283........................ Programming device 1.15 1.15 Finalize.
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; dual
lead transvenous
implantable defibrillator
system.
93284........................ Programming device 1.25 1.25 Finalize.
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.
93287........................ Peri-procedural device 0.45 0.45 Finalize.
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 implantable
defibrillator system.
93289........................ Interrogation device 0.92 0.92 Finalize.
evaluation (in person)
with analysis, review and
report by a physician or
other qualified health
care professional,
includes connection,
recording and
disconnection per patient
encounter; single, dual,
or multiple lead
transvenous implantable
defibrillator system,
including analysis of
heart rhythm derived data
elements.
93312........................ Echocardiography, 2.55 2.55 Finalize.
transesophageal, real-
time with image
documentation (2D) (with
or without M-mode
recording); including
probe placement, image
acquisition,
interpretation and report.
93313........................ Echocardiography, 0.51 0.51 Finalize.
transesophageal, real-
time with image
documentation (2D) (with
or without M-mode
recording); placement of
transesophageal probe
only.
93314........................ Echocardiography, 2.10 2.10 Finalize.
transesophageal, real-
time with image
documentation (2D) (with
or without M-mode
recording); image
acquisition,
interpretation and report
only.
93315........................ Transesophageal 2.94 2.94 Finalize.
echocardiography for
congenital cardiac
anomalies; including
probe placement, image
acquisition,
interpretation and report.
93316........................ Transesophageal 0.85 0.85 Finalize.
echocardiography for
congenital cardiac
anomalies; placement of
transesophageal probe
only.
93317........................ Transesophageal 2.09 2.09 Finalize.
echocardiography for
congenital cardiac
anomalies; image
acquisition,
interpretation and report
only.
93318........................ Echocardiography, 2.40 2.40 Finalize.
transesophageal (TEE) for
monitoring purposes,
including probe
placement, real time 2-
dimensional image
acquisition and
interpretation leading to
ongoing (continuous)
assessment of
(dynamically changing)
cardiac pumping function
and to therapeutic
measures on an immediate
time basis.
93320........................ Doppler echocardiography, 0.38 0.38 Finalize.
pulsed wave and/or
continuous wave with
spectral display (List
separately in addition to
codes for
echocardiographic
imaging); complete.
93321........................ Doppler echocardiography, 0.15 0.15 Finalize.
pulsed wave and/or
continuous wave with
spectral display (List
separately in addition to
codes for
echocardiographic
imaging); follow-up or
limited study (List
separately in addition to
codes for
echocardiographic
imaging).
93325........................ Doppler echocardiography 0.07 0.07 Finalize.
color flow velocity
mapping (List separately
in addition to codes for
echocardiography).
[[Page 70995]]
93355........................ Echocardiography, 4.66 4.66 Finalize.
transesophageal (TEE) for
guidance of a
transcatheter
intracardiac or great
vessel(s) structural
intervention(s) (e.g.,
TAVR, transcatheter
pulmonary valve
replacement, mitral valve
repair, paravalvular
regurgitation repair,
left atrial appendage
occlusion/closure,
ventricular septal defect
closure) (peri-and intra-
procedural), real-time
image acquisition and
documentation, guidance
with quantitative
measurements, probe
manipulation,
interpretation, and
report, including
diagnostic
transesophageal
echocardiography and,
when performed,
administration of
ultrasound contrast,
Doppler, color flow, and
3D.
93644........................ Electrophysiologic 3.29 3.29 Finalize.
evaluation of
subcutaneous implantable
defibrillator (includes
defibrillation threshold
evaluation, induction of
arrhythmia, evaluation of
sensing for arrhythmia
termination, and
programming or
reprogramming of sensing
or therapeutic
parameters).
93880........................ Duplex scan of 0.80 0.80 Finalize.
extracranial arteries;
complete bilateral study.
93882........................ Duplex scan of 0.50 0.50 Finalize.
extracranial arteries;
unilateral or limited
study.
93886........................ Transcranial Doppler study 0.91 0.91 Finalize.
of the intracranial
arteries; complete study.
93888........................ Transcranial Doppler study 0.50 0.50 Finalize.
of the intracranial
arteries; limited study.
93895........................ Quantitative carotid N N Finalize.
intima media thickness
and carotid atheroma
evaluation, bilateral.
93925........................ Duplex scan of lower 0.80 0.80 Finalize.
extremity arteries or
arterial bypass grafts;
complete bilateral study.
93926........................ Duplex scan of lower 0.50 0.50 Finalize.
extremity arteries or
arterial bypass grafts;
unilateral or limited
study.
93930........................ Duplex scan of upper 0.80 0.80 Finalize.
extremity arteries or
arterial bypass grafts;
complete bilateral study.
93931........................ Duplex scan of upper 0.50 0.50 Finalize.
extremity arteries or
arterial bypass grafts;
unilateral or limited
study.
93970........................ Duplex scan of extremity 0.70 0.70 Finalize.
veins including responses
to compression and other
maneuvers; complete
bilateral study.
93971........................ Duplex scan of extremity 0.45 0.45 Finalize.
veins including responses
to compression and other
maneuvers; unilateral or
limited study.
93975........................ Duplex scan of arterial 1.16 1.16 Finalize.
inflow and venous outflow
of abdominal, pelvic,
scrotal contents and/or
retroperitoneal organs;
complete study.
93976........................ Duplex scan of arterial 0.80 0.80 Finalize.
inflow and venous outflow
of abdominal, pelvic,
scrotal contents and/or
retroperitoneal organs;
limited study.
93978........................ Duplex scan of aorta, 0.80 0.80 Finalize.
inferior vena cava, iliac
vasculature, or bypass
grafts; complete study.
93979........................ Duplex scan of aorta, 0.50 0.50 Finalize.
inferior vena cava, iliac
vasculature, or bypass
grafts; unilateral or
limited study.
93990........................ Duplex scan of 0.50 0.50 Finalize.
hemodialysis access
(including arterial
inflow, body of access
and venous outflow).
95971........................ Electronic analysis of 0.78 0.78 Finalize.
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);
simple spinal cord, or
peripheral (i.e.,
peripheral nerve, sacral
nerve, neuromuscular)
neurostimulator pulse
generator/transmitter,
with intraoperative or
subsequent programming.
95972........................ Electronic analysis of 0.80 0.80 Finalize.
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 spinal cord, or
peripheral (i.e.,
peripheral nerve, sacral
nerve, neuromuscular)
(except cranial nerve)
neurostimulator pulse
generator/transmitter,
with intraoperative or
subsequent programming,
up to 1 hour.
95973........................ Electronic analysis of 0.49 ............... Deleted.
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 spinal cord, or
peripheral (i.e.,
peripheral nerve, sacral
nerve, neuromuscular)
(except cranial nerve)
neurostimulator pulse
generator/transmitter,
with intraoperative or
subsequent programming,
each additional 30
minutes after first hour
(List separately in
addition to code for
primary procedure).
97605........................ Negative pressure wound 0.55 0.55 Finalize.
therapy (e.g., vacuum
assisted drainage
collection), utilizing
durable medical equipment
(DME), including topical
application(s), wound
assessment, and
instruction(s) for
ongoing care, per
session; total wound(s)
surface area less than or
equal to 50 square
centimeters.
[[Page 70996]]
97606........................ Negative pressure wound 0.60 0.60 Finalize.
therapy (e.g., vacuum
assisted drainage
collection), utilizing
durable medical equipment
(DME), including topical
application(s), wound
assessment, and
instruction(s) for
ongoing care, per
session; total wound(s)
surface area greater than
50 square centimeters.
97607........................ Negative pressure wound C C Finalize.
therapy, (e.g., vacuum
assisted drainage
collection), utilizing
disposable, non-durable
medical equipment
including provision of
exudate management
collection system,
topical application(s),
wound assessment, and
instructions for ongoing
care, per session; total
wound(s) surface area
less than or equal to 50
square centimeters.
97608........................ Negative pressure wound C C Finalize.
therapy, (e.g., vacuum
assisted drainage
collection), utilizing
disposable, non-durable
medical equipment
including provision of
exudate management
collection system,
topical application(s),
wound assessment, and
instructions for ongoing
care, per session; total
wound(s) surface area
greater than 50 square
centimeters.
97610........................ Low frequency, non- 0.35 0.35 Finalize.
contact, non-thermal
ultrasound, including
topical application(s),
when performed, wound
assessment, and
instruction(s) for
ongoing care, per day.
99183........................ Physician or other 2.11 2.11 Finalize.
qualified health care
professional attendance
and supervision of
hyperbaric oxygen
therapy, per session.
99184........................ Initiation of selective 4.50 4.50 Finalize.
head or total body
hypothermia in the
critically ill neonate,
includes appropriate
patient selection by
review of clinical,
imaging and laboratory
data, confirmation of
esophageal temperature
probe location,
evaluation of amplitude
EEG, supervision of
controlled hypothermia,
and assessment of patient
tolerance of cooling.
99188........................ Application of topical N N Finalize.
fluoride varnish by a
physician or other
qualified health care
professional.
99487........................ Complex chronic care B B Finalize.
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.
99490........................ Chronic care management 0.61 0.61 Finalize.
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.
G0277........................ Hyperbaric oxygen under 0.00 0.00 Finalize.
pressure, full body
chamber, per 30 minute
interval.
G0279........................ Diagnostic digital breast 0.60 0.60 Finalize.
tomosynthesis, unilateral
or bilateral (list
separately in addition to
G0204 or G0206).
G0389........................ Ultrasound b-scan and/or 0.58 0.58 Finalize.
real time with image
documentation; for
abdominal aortic aneurysm
(AAA) screening.
G0473........................ Face-to-face behavioral 0.23 0.23 Finalize.
counseling for obesity,
group (2-10), 30 minutes.
----------------------------------------------------------------------------------------------------------------
a. Specific Issues for Codes With CY 2015 Interim Final Values
(1) Ablation Therapy (CPT Code 20983)
In CY 2015 we established the RUC-recommended work RVU for CPT code
20983 and made minor refinements to the RUC-recommended direct PE
inputs.
Comment: A commenter stated that the total clinical labor times in
the direct PE input database are inconsistent with the RUC-recommended
values. The commenter mentioned that some of the service period
activity time was assigned to the total post-service clinical labor
time.
Response: We reviewed the direct PE input database and confirmed
the time for clinical labor task ``Assist Physician'' was missing for
labor type L046A. We will restore the missing labor time as we intended
to establish as interim final the RUC recommendation for the clinical
labor times without refinement.
(2) Automatic Fixation of Rib Fracture (CPT Codes 21811, 21812, and
21813)
For CY 2015, the CPT Editorial Panel deleted CPT code 21810
(Treatment of rib fracture requiring external fixation) and replaced it
with CPT codes 21811, 21812, and 21813 to address internal fixation of
rib fracture. As described in the CY 2015 PFS final rule with comment
period, the RUC recommended that we value these procedures with 90-day
global periods. We indicated that we believed it would be more
appropriate to value these
[[Page 70997]]
procedures with 0-day global periods. We valued each of these services
by subtracting the work RVU related to postoperative care from the
total work RVU. We also refined the RUC-recommended time by subtracting
the time associated with the postoperative visits, and removed direct
PE inputs associated with the postoperative visits.
In the CY 2015 PFS final rule with comment period, we considered
whether certain pre-service clinical labor tasks would typically be
performed given that these procedures are frequently furnished on an
emergency basis. We reviewed other emergency procedures valued under
the PFS to determine whether pre-service clinical labor activities were
typically included in the PE worksheets and found that the
recommendations for these procedures were inconsistent. Therefore, in
the CY 2015 PFS final rule with comment period, we did not remove the
time allocated for certain clinical labor activities, but sought public
comment on this issue.
Comment: One commenter expressed concerns with the methodology
employed by CMS. The commenter stated that CMS staff had attended the
RUC meeting where these codes were reviewed and were aware that a
building block methodology (BBM) was not used to build the work RVUs
for these codes. Therefore, the commenter suggested it was incorrect
for CMS to use a reverse BBM to calculate a new value.
Response: We are committed to establishing the most accurate
valuation possible for each procedure. In this case, we examined the
results of the reverse BBM and determined that it was the most
appropriate approach to value these services. Due to the emergency
nature of these procedures, we believe that they are more accurately
valued using a 0-day global period.
Comment: Another commenter reminded CMS that the specialty
societies surveyed these three codes based on a 90-day global period
and that CMS had ample opportunity to inform the RUC and the
specialties of an impending change in the global assignment prior to
the development of recommended RVUs.
Response: We understand that the specialties surveyed the codes
under the assumption that they would be valued with a 90-day global
period, prior to our determination that these services would be more
accurately valued as 0-day globals due to their emergency nature. We
believe that in the case of these emergent services, it may not be
typical for the individual performing the initial procedure to be
responsible for providing the follow-up care. Therefore, we believe
that the 0-day global period to more accurately reflect the care
furnished. This is precisely why it was necessary for us to account for
the change in global period when establishing interim final work RVUs
for the codes. To do so, we employed a reverse BBM to establish
separate work RVUs for the individual procedure in each case. As we
have previously stated, we believe that the best way to improve the
valuation of codes that describe multiple services over long periods of
time (for example, 90 days) is to develop discrete values for the
component services. We agree that survey results are likely to be most
useful when there is consistency between the global period as surveyed
and the global period in the final valuation of the code. However,
because we did not have such survey data in this case, we used another
established methodology to develop a potential work RVUs. In this case,
we believe that the reverse building block methodology establishes the
most accurate value for this group of codes. Although the RUC
recommends global periods for individual services and often consults
with CMS staff regarding the typical global periods for such services,
we believe that it is appropriate to establish global period for
particular codes through rulemaking. If stakeholders are concerned
about the final values for services surveyed based on a presumed global
period that is not ultimately applied to the individual code, then we
encourage stakeholders to consider nominating such codes as potentially
misvalued through the public nomination process.
Comment: One commenter suggested that CMS did not provide reference
codes with 0-day global periods to support the new interim final work
RVUs. The commenter disagreed with the work RVUs established by CMS and
suggested that all three of the codes in question were undervalued. The
commenter provided information about other codes with 0-day global
periods that had similar work time. The commenter urged CMS to
reinstate the 90-day global period and accept the RUC recommendations
for work RVUs, similar to other trauma codes.
Response: After reviewing the codes provided by the commenter, we
believe that the values of other existing codes support our valuation
of these procedures. For CPT code 21811, we note that CPT code 93650
(Intracardiac catheter ablation of atrioventricular node function)
shares the same intraservice time of 120 minutes and has a higher total
time (240 minutes compared to 220 minutes for CPT code 21811), but a
lower work RVU of 10.49. We believe that the work RVU assigned to CPT
code 21811 fits well within the work RVUs for the group of codes that
have 0-day global periods and 120 intraservice minutes. For CPT code
21812, we note that 92997 (Percutaneous transluminal pulmonary artery
balloon angioplasty), which has 5 additional minutes of intraservice
time (155 minutes compared to 150 minutes for 21812) and a higher total
time (275 minutes compared to 250 minutes for 21812), has a lower work
RVU of 11.98. We believe that our valuation of CPT code 21812 maintains
relativity within this group of 0-day global codes with times of
approximately 150 intraservice minutes.
For CPT code 21813, we agree with the commenter that there is a
lack of 0-day global codes with comparable intraservice times. We also
agree with the commenter's suggestion that CPT codes 93654 and 93656
provide the best references available. These codes share an
intraservice time of 240 minutes compared to the 210 minutes of
intraservice time for CPT code 21813. However, we disagree with the
commenter that CPT code 21813 is undervalued based on a comparison of
these intraservice times. Applying the ratio between the 210 minutes
for CPT code 21813 and the 240 minutes for the reference CPT code 93654
(0.875) to the work RVU of 20.00 for CPT code 93654, results in a work
RVU of 17.50. This is similar to our valuation for CPT code 21813 of
17.61. We believe that this intraservice time ratio further supports
our valuation of CPT code 21813, which maintains relativity with
similar 0-day global codes. After consideration of comments received,
we are finalizing the interim final work RVUs for CPT codes 21811,
21812, and 21813 for CY 2016.
(3) Percutaneous Vertebroplasty and Augmentation (CPT Codes 22510,
22511, 22512, 22513, 22514, and 22515)
In CY 2015, we established the RUC-recommended work RVUs as interim
final for all of the codes in this family except CPT code 22511 because
we did not agree with its RUC-recommended crosswalk. To value this
code, we took the difference between the work RVUs for the predecessor
codes for CPT codes 22510 and 22511, CPT codes 22520 (Percutaneous
vertebroplasty (bone biopsy included when performed), one vertebral
body, unilateral or bilateral injection; thoracic)) and 22521
(Percutaneous vertebroplasty (bone biopsy included when performed), one
vertebral body, unilateral or bilateral injection; thoracic; lumbar))
and applied
[[Page 70998]]
that to the work RVU we established for CPT code 22510. We believed
that increment established the appropriate rank order in the family,
and thus, assigned an interim final work RVU of 7.58 for CPT code
22511.
Comment: A commenter disagreed with the methodology CMS used for
valuing CPT code 22511 because they believed CMS' approach was
arbitrary and invalidated the RUC process of using new survey data. The
commenter urged CMS to accept the RUC-recommended work RVU of 8.05 for
this code.
Another commenter requested that CMS reconsider the RVUs for these
codes. The commenter believed that, due to the bundling of these
imaging codes for CY 2015, additional PE costs were added to the
service. The commenter expressed concerns that practitioners might find
it infeasible to furnish these services in the non-facility setting if
payment continues to be based on the interim final values we adopted
for CY 2015.
Additionally, several commenters alerted CMS to missing clinical
labor times for ``assist physician'' for all of the codes in this
family. Some commenters also stated that clinical labor time was
missing for the post-operative visit in CPT codes 22510, 22511, 22513,
and 22514.
Response: Unlike other codes in this family for which the RUC-
recommended work RVU was based on the 25th percentile in the survey,
the RUC established its recommended work RVU for CPT code 22511 by
crosswalking the service to CPT code 39400 (Mediastinoscopy, includes
biopsy(ies), when performed), which has a work RVU of 8.05. Because the
level of work performed by a practitioner in the two services differs,
we continue to believe that this crosswalk is inaccurate. We maintain
that a more accurate comparison is found in the difference between the
work RVUs for the predecessor codes for CPT codes 22510 and 22511 and
that applying this differential leads to appropriate valuation.
We agree with the commenters that there were inconsistencies in the
clinical labor times for these codes as entered in our direct PE
database. We direct the reader to section II.B. of this final rule with
comment period for a discussion of these clinical labor input
inconsistencies.
Therefore, we are finalizing our CY 2015 work valuation for CPT
codes 22510, 22511, 22512, 22513, 22514, and 22515.
(4) Total Disc Arthroplasty (CPT code 22856)
In the CY 2015 PFS final rule with comment period, we maintained
the CY 2014 work RVU for CPT code 22856, consistent with the RUC
recommendation.
Comment: One commenter suggested that CPT code 22856 has been
undervalued since 2009. The commenter believed CMS should value this
service relative to several other codes that together comprise standard
anterior cervical discectomy and fusion which the commenter believes is
appropriately valued. The commenter stated that a higher valuation
would be consistent with higher procedure operating room time included
for CPT code 22856 in six clinical trials.
Response: We appreciate the submission of this additional
information about the current practice of cervical disc replacement
from the commenter. However, for the purpose of valuation, we typically
compare a procedure against a broad range of other procedures across
the PFS to help maintain relativity, rather than a single related
procedure. In addition to intraservice operating time, other resource
costs are included in the work RVU, such as the clinical intensity of
the procedure and the time and intensity of the pre- and post-work,
including post-operative visits.
After consideration of comments received, we are finalizing the CY
2015 interim final work RVU for CY 2016 without modification,
consistent with the RUC recommendation.
(5) Sacroiliac Joint Fusion (CPT code 27279)
In the CY 2015 PFS final rule with comment period, we maintained
the CY 2014 work RVU for CPT code 27279, consistent with the RUC
recommendation.
Comment: Several commenters stated that the RUC survey data were
not reliable because the reference service (CPT code 62287,
Percutaneous discectomy) with a work RVU of 9.03 is not comparable. One
of the commenters, a professional association, recommended a work RVU
of 14.36 based upon its own survey or a work RVU of 13.18 based on a
comparison with CPT code 63030 (Low back disk surgery). This commenter
requested that CMS refer CPT code 27279 to the multispecialty
refinement panel.
Response: CPT code 27279 was referred to the CY 2015 Multi-
Specialty Refinement Panel per the commenter's request. The outcome of
the refinement panel was a median of 9.03 work RVUs. After
consideration of the comments and the results of the refinement panel,
we are finalizing our interim final work RVU of 9.03 for CPT code
27279.
(6) Subcutaneous Implantable Defibrillator Procedures (CPT Codes 33270,
33271, 33272, 33273, 93260, 93261 and 93644)
For CY 2015, the CPT Editorial Panel added the word ``implantable''
to the descriptors for several codes in this family and created several
new codes (CPT codes 33270, 33271, 33272, 33273, 93260, 93261, and
93644). We established as interim final the RUC-recommended work RVUs
for all of the codes in this family except CPT code 93644. The RUC-
recommended times for CPT code 93644 included an intraservice time of
20 minutes and a total time of 84 minutes. We disagreed with the RUC-
recommended direct crosswalk for CPT code 93644 because the code that
serves as the source for the crosswalk had greater intraservice time
(29 minutes) and total time (115 minutes). We believed that a crosswalk
to CPT code 32551 was more accurate since the intraservice time for CPT
code 32551 was 20 minutes, total time was 83 minutes, and intensity was
comparable. Therefore, we established a CY 2015 interim final work RVU
of 3.29 for CPT code 93644.
Comment: Two commenters expressed disappointment that CMS did not
accept the RUC recommendation for CPT code 93644. The commenters
disagreed with the decision to crosswalk the work RVU for CPT code
93644 from CPT code 32551 because they believed that the services were
not similar in nature. Commenters suggested that CMS accept the RUC
recommendation with a crosswalk from CPT code 15002, due to a similar
intraservice time. The commenters also requested that CPT code 93644 be
referred to the multispecialty refinement panel.
Response: We continue to believe that crosswalking the value for
CPT code 93644 from CPT code 32551 is the best way to value this
service due to the codes' similar intraservice and total times and
similar intensity. We believe that the difference in time values for
the RUC-recommended crosswalk is too great to serve as a direct
crosswalk for overall work. We did not receive any new clinical
information needed for referral of this code to the multispecialty
refinement panel. Therefore, we are finalizing our CY 2015 valuation.
[[Page 70999]]
(7) Fenestrated Endovascular Repair (FEVAR) Endograft Planning (CPT
Codes 34839-34848)
For CY 2015, we examined several FEVAR codes. CPT code 34839 was
created to report the planning that occurs prior to the work included
in the global period for a FEVAR. We accepted the RUC recommendation
for all of the codes in this family except CPT code 34839. We believed
the planning that occurs prior to the work was included in the global
period for FEVAR and should be bundled with the underlying service. We
did not believe bundling was inappropriate in this case. Accordingly,
we assigned a PFS procedure status indicator of B (Bundled Code) to CPT
code 34839.
Comment: One commenter requested that CMS issue coding guidance
regarding with which codes the FEVAR co-surgeon modifier can be used.
Response: We appreciate the commenter's feedback. We will take this
comment into consideration in developing guidance for use of the co-
surgeon modifier.
(8) Endovenous Ablation Therapy (CPT Codes 36475-36479)
For CY 2015, we examined several endovenous ablation therapy codes
and used the RUC-recommended work RVUs to establish interim final work
RVUs. We made minor refinements to the RUC recommended direct PE inputs
to establish interim final direct PE inputs for this family of codes.
Comment: A commenter requested that CMS review the difference in PE
inputs between CPT codes 36475 and 36478. The commenter stated that
they believed CPT code 36478 was missing supplies which are commonly
used in the procedure, and that this difference in reimbursement could
only be explained by errors in the supply and staff inputs. The
commenter also provided clinical information suggesting that the laser
technique of endovenous ablation therapy described in CPT code 36478 is
more effective than the radiofrequency treatment described in CPT code
36475.
Response: We thank the commenter for bringing this issue to our
attention. We agree that there are errors in the direct PE database
regarding these two codes. After consideration of comments received, we
are making the following refinements. For CPT code 36475, we are adding
one unit of supply item ``needle, spinal 18-26g'' (SC028) and one unit
of supply item ``syringe 20 ml'' (SC053). For CPT code 36478, we are
adding 5 minutes of clinical labor time of staff type L037D for ``Apply
multi-layer comprehensive dressing'' and adding 3 minutes of clinical
labor time of the same type for ``Check dressings & wounds.'' We are
also removing 2 minutes of clinical labor time of staff type L054A for
``Patient clinical information and questionnaire reviewed by
technologist'', as this time was inadvertently included in the direct
PE database. This results in identical clinical labor inputs for the
two procedures, as the commenter correctly pointed out should be the
case.
With regards to the commenter's feedback regarding the supplies
allocated to CPT codes 36475 and 36478, we reviewed the direct PE
inputs as recommended by the RUC and agree that they represent the
typical inputs used in furnishing these procedures.
Comment: One commenter disagreed with all of the PE refinements
made in this family. The commenter stated that 30 minutes was typical
recovery time for input code EF019 (stretcher chair) and that 32
minutes is the time the room is unavailable to other patients for input
codes EL015 (room, ultrasound, general), EQ215 (radiofrequency
generator (vascular)), and EQ160 (laser, endovascular ablation (ELVS)).
The commenter also stated that additional images are inherent to the
add-on codes which justify the extra minute in input code L054A
(vascular technologist). Another commenter expressed support for CMS'
acceptance of the RUC-recommended RVUs and times for these services.
Response: In establishing interim final times for the direct
equipment inputs, we followed our standard methodologies that resulted
in the allocated equipment times for EL015, EL215, and EQ160 for these
codes in the direct PE input database. We believe that adherence to
these standard methodologies maintains relativity within the
development of PE RVUs and is likely to reflect the typical case. We
disagree with commenters regarding the equipment times for EL015,
El215, and EQ160. However, we agree additional images are inherent in
the add-on codes, which supports the additional minute of clinical
labor time. Therefore, we are finalizing the interim final values for
these services, with the exception of the refinements to the clinical
labor, supplies, and equipment described above.
(9) Cryoablation of Liver Tumor (CPT Code 47383)
For CY 2015, we proposed the RUC-recommended work RVU of 9.13 for
CPT code 47383 and made several refinements to the recommended clinical
labor and equipment times.
Comment: A commenter stated that the clinical labor time associated
with the 99212 postoperative visit did not appear in the CMS direct PE
public use files.
Response: We appreciate the assistance from the commenter in
bringing this issue to our attention. We have corrected this error in
the CMS direct PE public use files; we note that this issue was limited
to the public use files and had no impact on the calculation of PE
RVUs. For further information, please see the Identification of
Database Errors in section II.H. of this final rule with comment
period.
After consideration of comments received, we are finalizing the CY
2015 interim final work RVU and direct PE inputs as proposed for CPT
code 47383.
(10) Transprostatic Implant Procedures (TIP) (CPT Codes 52441 and
52442)
In CY 2015, we established the RUC-recommended work RVUs and direct
PE inputs as interim final for CPT codes 52441 and 52442.
Comment: One commenter agreed with the list and total cost of
direct PE supplies established by CMS.
Response: We appreciate the commenter's supportive comments. We are
finalizing our CY 2015 valuation for CPT codes 52441 and 52442.
(11) Laparoscopic Hysterectomy (CPT codes 58541, 58542, 58543, 58544,
58570, 58571, 58572, and 58573)
In the CY 2015 final rule with comment period, we established as
interim final the RUC-recommended work RVUs and direct PE inputs for
these codes.
Comment: Two commenters requested that these codes be sent to the
multispecialty refinement panel prior to finalizing their work RVUs for
CY 2016. Commenters stated that gynecologic oncologists were not
offered the chance to participate in the RUC surveys for these
procedures. As a result, the survey results did not reflect the typical
patients that receive these procedures from practitioners of that
specialty, who have complex medical needs with co-morbid conditions and
complications. Commenters also indicated that the Food and Drug
Administration (FDA) recently discouraged the use of morcellation
during these procedures, which increases the amount of time it takes to
perform the procedure and remove the fibroids prior to removing the
uterus. The commenters stated that these changes need to be taken into
account with new data prior to finalizing these work RVUs.
[[Page 71000]]
Response: We received and granted a request for multispecialty
refinement panel review based on the presentation of new clinical
information. However, the specialty groups making the original request
later chose not to present these procedures at the 2015 Multi-Specialty
Refinement Panel. After consideration of comments received and the lack
of review by the multispecialty refinement panel, we are finalizing the
CY 2015 interim final work RVUs for CPT codes 58541, 58542, 58543,
58544, 58570, 58571, 58572, and 58573 for CY 2016.
(12) Myelography (CPT Codes 62284, 62302, 62303, 62304, 62305, 72240,
72255, 72265, and 72270)
In the CY 2015 PFS final rule with comment period, we accepted the
RUC-recommended work RVU for these nine codes on an interim final
basis. We made refinements to the clinical labor and equipment time for
the non-radiological codes in the family.
Comment: A commenter stated that the RUC recommended only a single
staff type for the myelography codes, with clinical labor L041B for the
radiological codes and L037D for the non-radiological ones. The
commenter stated that they did not believe it would be typical to have
two staff types involved in the procedure, and suggest allocating all
minutes for the non-radiological codes to L037D.
Response: We agree with the commenter that assigning all of the
clinical labor to a single staff type for each of the two types of
procedure in the myelography family would be more typical for these
services. Therefore we are changing the clinical labor type from L041B
to L037D for the clinical labor activities ``Availability of prior
images confirmed'', ``Patient clinical information and questionnaire
reviewed by technologist, order from physician confirmed and exam
protocoled by radiologist'' and ``Assist physician in performing
procedure'' for CPT codes 62302, 62303, 62304, and 62305. This ensures
a single staff type for each of the nine codes in this family.
After consideration of comments received, we are finalizing these
codes as proposed, with the change in clinical staff type detailed
above.
(13) Maxillofacial Computed Tomography (CT) (CPT Codes 70486, 70487 and
70488)
In the CY 2015 PFS final rule with comment period, we used the RUC-
recommended work RVU to establish an interim final work RVU of 0.85 for
CPT code 70486 (Computed tomography, maxillofacial area; without
contrast material). The RUC arrived at this value by crosswalking CPT
code 70486 to CPT code 70460 (Computed tomography, head or brain; with
contrast material(s)), which is the equivalent code in the head and
brain CT family. To maintain rank order within and across CT families,
we crosswalked the work RVU for CPT code 70487 (Computed tomography,
maxillofacial area; with contrast material(s)) from CPT code 70460
(Computed tomography, head or brain; with contrast material(s)). We
also crosswalked the work RVU for CPT code 70488 (Computed tomography,
maxillofacial area; without contrast material, followed by contrast
material(s) and further sections) from CPT code 70470 (Computed
tomography, head or brain; without contrast material, followed by
contrast material(s) and further sections). Therefore, we established
interim final work RVUs of 1.13 for CPT code 70487 and 1.27 for CPT
code 70488.
Comment: For CPT codes 70487 and 70488, commenters suggested that
the CMS crosswalks did not accurately reflect the intensity of
maxillofacial CT. Commenters suggested that CPT codes 70487 and 70488
require a thinner CT slice technique than the CMS crosswalks of CPT
codes 70460 and 70470, and that the volume of images to be interpreted
is greater. Commenters suggested that maxillofacial CTs were
instrumental in imaging potentially dangerous conduits, which could be
damaged due to maxillofacial disease.
Response: We continue to believe that since the lowest of the brain
CT code family was an accurate crosswalk for CPT code 70486, the other
two codes in the brain CT family are also accurate crosswalks for CPT
codes 70487 and 70488. The procedures are similar in terms of both
intraservice time and complexity of the anatomical region. While
commenters requested that these codes be addressed by the
multispecialty refinement panel, the request did not include
information reflecting new clinical evidence, and therefore, did not
meet the established criteria for review by the multispecialty
refinement panel.
Comment: For CPT codes 70487 and 70488, commenters requested 3
minutes for the clinical labor task ``Provide pre-service education and
obtain consent.''
Response: Upon review of the task ``provide pre-service education
and obtain consent,'' we agree with commenters that 3 minutes is an
accurate estimate for the amount of time required to discuss the risks
involved in these procedures. Three minutes also maintains consistency
within the code family. Therefore, we are including 3 minutes for
``provide pre-service education and obtain consent in the direct PE
input database.
(14) Abdominal Ultrasound (CPT Codes 76700, 76705, 76770, 76775, 76856,
and 76857)
For CY 2015, we used the RUC-recommended work RVUs and PE inputs to
establish interim final values for six codes in the abdominal
ultrasound family.
Comment: Commenters noted that CPT codes 76700 and 76705 were
missing from the direct PE input database.
Response: We appreciate the commenters' attention to detail and we
have included these codes in the updated direct PE input database.
(15) Breast Ultrasound (CPT Codes 76641 and 76642)
For CY 2015, the CPT Editorial Panel replaced CPT code 76645
(Ultrasound, breast(s) (unilateral or bilateral), real time with image
documentation) with two codes: CPT codes 76641 (Ultrasound, breast,
unilateral, real time with image documentation, including axilla when
performed; complete) and 76642 (Ultrasound, breast, unilateral, real
time with image documentation, including axilla when performed;
limited). We used the RUC-recommended work RVUs of 0.73 and 0.68 to
establish interim final work RVUs for CPT codes 76641 and 76642,
respectively.
Comment: A few commenters encouraged CMS to refine the input for
ultrasound room from 27 minutes to 29 minutes for CPT code 76641 and
from 20 to 22 minutes for CPT code 76642 because ultrasound uses
distinctive imaging equipment. All clinical labor tasks require usage
of the machine, making the room unavailable during that time.
Response: The number of minutes assigned to the ultrasound room for
both codes conforms to established times for highly technical
equipment. We believe that adherence to these standard methodologies
maintains relativity within the development of PE RVUs. Therefore, we
are finalizing the interim final direct PE inputs for these services.
(16) CT Angiography (CTA) Head (CPT Codes 70496 and 70498)
In the CY 2015 PFS final rule with comment period, we used the RUC-
recommended work and direct PE input recommendations without refinement
to establish interim final values for these codes.
Comment: Some stakeholders stated that clinical staff time for
confirming prior images and reviewing patient
[[Page 71001]]
clinical information was erroneously allocated to Rad Tech (L041B)
instead of CT tech (L046A) and that CMS removed 2 minutes from clinical
labor task ``technologist QC''. Commenters suggested that both actions
were inconsistent with other codes in the CTA family.
Response: We reviewed the interim final direct PE inputs as well as
the ``PE worksheet'' that accompanied the RUC recommendation. We noted
that the values in ``CMS code'' and ``staff type'' columns were
discrepant for the two clinical labor tasks noted by the commenters.
While the CMS code indicated L041B, the Staff Type indicated CT Tech.
We have therefore corrected the CMS code from L041B to L046A to
correspond to the clinical staff type. We reviewed the direct PE
database and confirmed that clinical labor task ``Technologist QC's
images in PACS, checking for all images, reformats, and dose page'' is
included for these codes. We are finalizing the interim final values
for these services, with the additional correction of the staff type
discrepancy.
(17) Breast Tomosynthesis (CPT Codes 77061, 77062, and 77063)
In the CY 2015 PFS final rule with comment period, we assigned a
PFS indicator of ``I'' to CPT codes 77061 and 77062 on an interim basis
while awaiting recommendations from the RUC for all mammography
services. Since CPT code 77063 is an add-on code and did not have an
equivalent CY 2014 code, we believed it was appropriate to value it on
an interim final basis in advance of receiving the RUC recommendations
for other mammography services. We assigned it a CY 2015 interim final
work RVU of 0.60 as recommended by the RUC. We also removed the
equipment time for the PACS Workstation proxy from all three codes, and
removed the time for task ``Federally Mandated MQSA Activities
Allocated To Each Mammogram'' from CPT code 77063.
Comment: A commenter indicated that the direct PE input files
included a PACS Workstation proxy for CPT code 77063, but did not
allocate clinical staff time to this proxy.
Response: We removed the 4 minutes of clinical labor associated
with ``Federally Mandated MQSA Activities Allocated To Each Mammogram''
due to the fact that CPT code 77063 is an add-on code, and this task
would already have been performed previously with another mammography
service. We did not assign equipment time for the PACS Workstation as
we do not believe that its use would be typical for this procedure.
After consideration of comments received, we are finalizing the PFS
indicator ``I'' for CPT codes 77061 and 77062, the interim final work
RVU of 0.60 for CPT code 77063, and the interim final direct PE inputs
for all three codes.
(18) Dosimetry (CPT Codes 77300, 77306, and 77307)
To establish interim final RVUs for these codes, we used the RUC-
recommend work and direct PE inputs for these codes with PE
refinements, with the refinement of consideration of the ``record and
verify system'' as an indirect PE.
Comment: A few commenters expressed support for CMS' adoption of
the RUC-recommended work RVUs for CPT codes 77306 and 77307. Other
commenters requested that CMS consider equipment item ED011 (record and
verify) as a direct PE input because it is typically used during the
procedures.
Response: We appreciate the commenters' feedback related to these
services. We reviewed the ``record and verify'' equipment item and
agree with commenters that ``record and verify'' should be included as
a direct PE to maintain consistency with other services in the direct
PE database, and have updated the direct PE input database accordingly.
(19) Brachytherapy Isodose Plan (CPT Codes 77316, 77317, and 77318)
For CY 2015, the CPT Editorial Panel replaced six CPT codes (77305,
77310, 77315, 77326, 77327, and 77328) with five new CPT codes to
bundle basic dosimetry calculation(s) with teletherapy and
brachytherapy isodose planning. We established interim final work RVUs
based on the RUC-recommended work RVUs for CY 2015 for all of the codes
in this family except CPT code 77316. Instead of using the RUC-
recommended work RVU for CPT code 77316, a simple isodose planning
code, we developed an interim final work RVU based on a direct
crosswalk from the corresponding simple isodose planning code in the
same family, CPT code 77306. Therefore, for CY 2015 we established an
interim final work RVU of 1.40 for CPT code 77316. This approach is
similar to the crosswalk the RUC used to develop the recommended work
RVUs for CPT code 77318.
Comment: Commenters disagreed with CMS' refinements to CPT code
77316 and stated that although CPT code 77316 is the simple isodose
planning code in the family, the CMS-recommended crosswalk to CPT code
77306 does not accurately capture the intensity of the procedure.
Commenters suggested that CPT code 77316 is typically used for HDR
brachytherapy with a single channel and more than four dwell positions.
This requires more work than CPT code 77306, which is for external beam
radiation planning. Commenters requested that CPT code 77316 be
referred to the multispecialty refinement panel.
Response: Commenters did not provide new clinical information and,
therefore we did not refer the codes to the multispecialty refinement
panel. The RUC recommended a crosswalk for CPT code 77318 to CPT code
77307. We believe that if the work resources for the complex isodose
planning codes are comparable between the two families, then the work
resources between the simple isodose planning codes are also
comparable. Therefore, we believe that the most accurate work RVU for
CPT code 77316 is 1.40, based on a crosswalk to CPT code 77306.
Comment: Several commenters thanked CMS for adopting the RUC-
recommended work RVUs for CPT codes 77317 and 77318.
Response: We appreciate the commenters' support. We are finalizing
the CY 2015 interim final work RVUs as established.
(20) Electron Microscopy (CPT Code 88348)
We received PE-only recommendations for CPT code 88348 following
the October 2013 RUC meeting. After reviewing these recommendations, we
used the RUC recommendations without refinement to establish interim
final values for CY 2015.
Comment: One commenter wrote to express their disagreement with the
79 percent reduction in the technical component of the procedure
following the publication of the CY 2015 final rule. The commenter
suggested that there was an error in evaluating the value and cost of
this service, and provided additional information regarding the direct
costs associated with providing electron microscopy to patients. The
commenter stated that continued reduction in the value for CPT code
88348 will result in a reduction in the availability of tests which
will provide impaired service to many patients with treatable
conditions and salvageable kidney function.
Response: We concur with the commenter on the importance of
providing patient access to quality testing. However, we do not believe
that there was an error in evaluating the value and cost of this
service. We agreed with the RUC recommendations for
[[Page 71002]]
direct PE inputs for CPT code 88348, and we continue to believe that
these represent the most accurate values for this procedure.
(21) Microdissection (CPT Codes 88380 and 88381)
In reviewing the RUC recommendations for CPT code 88380, the work
vignette indicated that the microdissection is performed by the
pathologist. However, the PE worksheet also included several subtasks
of ``Microdissect each stained slide sequentially while reviewing H and
E stained slide'' that are performed by the cytotechnologist. Since we
did not believe that both the pathologist and the cytotechnologist were
completing these tasks, we did not allocate clinical labor time for the
specific tasks we believe are completed by the pathologist. Table 31 of
the CY 2015 final rule (FR 79 67697-67698) detailed our refinements to
these clinical labor tasks. We accepted the RUC-recommended work RVU of
1.14 for CPT code 88380 and 0.53 for CPT code 88381 on an interim final
basis for CY 2015.
Comment: A commenter urged CMS to accept and implement the practice
expense inputs recommended by the RUC for CPT code 88380. For the
clinical labor task ``Dispose of razor blade, Cap tube and vortex
specimens'', the commenter stated that the recommended 3 minutes for
blade disposal tube capping is part of the processing of the individual
specimen. The commenter suggested that the word ``blade disposal'' may
have been confusing since it is not a cleaning function. The commenter
requested that CMS restore the RUC-recommended 3 minutes for this task.
Response: We do not believe that clinical labor time should be
assigned for this task, as CPT code 88380 uses a laser to perform the
same activity. We do not believe that the use of a razor blade, and
associated clinical labor, would be typical for this procedure.
Comment: One commenter stated that the RUC recommended 18 minutes
for the clinical labor task ``Turn on dissecting microscope, place
slide on scope, remove razor blade from box. Microdissect tissue within
etched area, while viewing slide under dissecting scope, place tissue
into cap of collection tube with blade. Repeat this step for seven
other slides.'' The commenter indicated that the cytotechnologist and
pathologist are working together during this task, and the assistance
of the cytotechnologist is necessary during these ancillary tasks for
the efficiency of the dissection process. The work survey results
indicated that some of the work time has shifted to the clinical labor
time for this particular task.
Response: We continue to believe that the pathologist is the
individual performing this clinical labor task, not the
cytotechnologist.
Comment: One commenter disagreed with the CMS refinement to the
equipment time for the Veritas microdissection instrument (EP087). The
commenter stated that the equipment time associated with EP087 is the
sum of time to prepare the instrument for use, plus the time the
pathologist and cytotechnologist are using it, plus the time the room
and equipment are cleaned. The commenter suggested that while
microdissection is taking place, the equipment cannot be used for any
other purpose. The commenter indicated that the sum of these time
increments equals 34 minutes, not the 32 minutes as refined by CMS.
Response: We appreciate the commenter's assistance in providing
clarification regarding the appropriate equipment time for EP087. After
consideration of comments received, we agree that the Veritas
microdissection instrument would typically be in use for 33 minutes of
intraservice time, plus 3 minutes for laser preparation, plus one
minute for room cleaning following equipment use. Therefore, we are
refining the equipment time for EP087 to 37 minutes for CPT code 88380,
to match the standard equipment time formula, and finalizing all other
direct PE inputs as established as interim final.
(22) Electro-Oculography (EOG VNG) (CPT Code 92543)
We established a work RVU of 0.10 for CPT code 92543 as interim
final for CY 2015. Several commenters disagreed with our interim final
values. However, the CPT Editorial Panel deleted CPT code 92543 for CY
2016; we refer readers to section II.H. of this final rule with comment
period, where we discuss CPT codes 9254A and 9254B, used to report
related services.
(23) Doppler Echocardiography (CPT Codes 93320, 93321 and 93325)
As detailed in the CY 2015 PFS final rule with comment period, we
maintained the CY 2014 work RVUs for CPT codes 93320, 93321 and 93325,
based upon the RUC-recommended work RVUs. In establishing interim final
direct PE inputs for CY 2015, we refined the RUC's recommendations for
CPT codes 93320, 93321 and 93325 by removing the minutes associated
with equipment item ED021 (computer, desktop, w/monitor) since a
computer is included in the other equipment inputs associated with
codes.
Comment: One commenter supported CMS' adopting the work RVUs and
times recommended by the RUC for these services (CPT codes 93320,
93321, and 93325).
Response: We appreciate the commenters support. We are finalizing
the CY 2015 interim final work RVUs as established.
Comment: One commenter stated that ED021 is not included in the
room.
Response: We disagree that ``computer, desktop w/monitor'' (ED021)
is not included in the equipment room ``room, vascular ultrasound.''
The PE reference materials submitted by the RUC indicate that
``ultrasound room, vascular'' includes a computer (Vascoguard II, main
station with cart, keyboard, LCD monitor, deskjet printer, Doppler, and
probe holder). Therefore, we are finalizing the direct PE inputs for
CPT codes 93320, 93321, and 93225 as established as interim final.
(24) Interventional Transesophageal Echocardiography (TEE) (CPT Codes
93312, 93313, 93314, 93315, 93316, 93317, 93318 and 93355)
For CY 2015, we used the RUC-recommended work RVU of 2.40 to
establish an interim final value for CPT code 93318 and 4.66 for CPT
code 93355. Based on a crosswalk from CPT code 75573, we assigned CPT
code 93312 a CY 2015 interim final work RVU of 2.55. We noted that
based on the CPT descriptor for CPT code 93315, we believed that the
appropriate work for this service was reflected in the combined work of
CPT codes 93316 and 93317, resulting in a CY 2015 interim final work
RVU of 2.94. For CPT codes 93313, 93314, 93316 and 93317, we assigned
CY 2015 interim final work RVUs that corresponded to the 25th
percentile survey result. Each of these codes had a significant
reduction in intraservice time since the last valuation. We noted that
we believe the 25th percentile survey values better describe the work
and time involved in these procedures than the RUC recommendations, and
that it helps maintain appropriate relativity in the family.
Additionally, we refined the preservice and intraservice times for CPT
codes 93314 and 93317 to 10 and 20 minutes, respectively, to maintain
relativity among the interim final work RVUs and times.
Comment: Some commenters disagreed with CMS' decision to value the
work RVU for CPT code 93312 by crosswalking it from CPT code 75573,
rather than the RUC-recommended work
[[Page 71003]]
RVU based on a crosswalk from CPT code 43247
(Esophagogastroduodenoscopy).
Response: The RUC-recommended crosswalk code, CPT code 43247, is a
0-day global service, whereas CPT code 75573 has no global period.
Since CPT code 75573 and CPT code 93312 do not have global periods,
while 43247 has a global period, we do not believe that the latter code
can serve as an appropriate crosswalk. Therefore, we are finalizing the
CY 2015 work RVUs as established for CPT code 93312.
Comment: A few commenters disagreed with CMS' refinement of the
work RVUs for CPT codes 93313 and 93314. The commenters stated that the
work RVU that corresponds to the 25th percentile survey result fails to
account for changes in technique, technology, and knowledge.
Response: After review of the comments, we continue to believe that
the RUC-recommended work RVUs do not adequately reflect the significant
reduction in intraservice time, and that our corresponding refinements
to the work RVUs are appropriate. We do not believe that the work RVUs
corresponding to the survey 25th percentile result fail to account for
typical changes in technique, technology, and knowledge. Therefore, we
are finalizing the CY 2015 work RVUs as established for CPT codes 93313
and 93314.
Comment: A few commenters disagreed with the time refinement made
to CPT codes 93314 and 93317.
Response: To maintain consistency with the work RVUs, we continue
to believe that these time refinements are appropriate. Therefore, we
are finalizing the times for CPT codes 93314 and 93317 as established
for CY 2015.
Comment: Some commenters disagreed with CMS' use of the BBM to
determine a work RVU for CPT code 93315, suggesting that it did not
incorporate updated service times and changes in technique, technology,
and knowledge.
Response: After consideration of the comments received, we continue
to believe that the appropriate work RVU for CPT code 93315 is
reflected in the combined work of CPT codes 93316 and 93317, resulting
in a CY 2015 interim final work RVU of 2.94. We are finalizing the
interim final work RVUs for these codes as established.
Comment: A commenter requested that this family of codes be
referred to the multispecialty refinement panel.
Response: The request for referral to the multispecialty refinement
panel did not include new clinical information; therefore, the request
did not meet the criteria for review by the multispecialty refinement
panel.
Commen One commenter questioned why the TC codes within the
congenital TEE family are contractor-priced.
Response: We did not receive recommendations for the direct PE
inputs for CPT codes 93315, 93317, and 93318. Without such
recommendations, we did not have sufficient information about the
resource costs necessary to establish national pricing and we therefore
assigned a contractor-priced status to the technical component of these
codes. We are finalizing the contractor-priced status for the technical
component of CPT codes 93315, 93317, and 93318.
Comment: One commenter supported CMS' proposal to adopt the RUC-
recommended work RVU and times for CPT code 93355.
Response: We appreciate the commenter's feedback, and we are
finalizing the CY 2015 work RVUs and direct PE inputs as established as
interim final.
(25) Duplex Scans (CPT Codes 93880, 93882, 93886, 93888, 93926, 93975,
93976, 93977, 93978, and 93979)
For CY 2014, we maintained the CY 2013 RVUs for CPT codes 93880 and
93882. As we stated in the CY 2014 PFS final rule with comment period
(78 FR 74342), we were concerned that the RUC-recommended work RVUs for
CPT codes 93880 and 93882, as well as our final work RVUs for CPT codes
93925 (Duplex scan of lower extremity arteries or arterial bypass
grafts; complete bilateral study) and 93926 (Duplex scan of lower
extremity arteries or arterial bypass grafts; unilateral or limited
study) did not maintain the appropriate relativity within the family.
We referred the entire family to the RUC to assess relativity among the
codes and to recommend appropriate work RVUs. We also requested that
the RUC consider CPT codes 93886 (Transcranial Doppler study of the
intracranial arteries; complete study) and 93888 (Transcranial Doppler
study of the intracranial arteries; limited study) in conjunction with
the duplex scan codes to assess the relativity between and among the
codes. In the CY 2015 PFS final rule with comment period, we used the
RUC-recommended work RVUs for CPT codes 93880, 93882, 93925, and 93926
while making several standard PE refinements consistent with standard
inputs for digital imaging and our policies for not allocating quality
assurance documentation to individual services as a direct expense.
Comment: Some commenters stated that quality assurance (QA)
documentation is an integral part of the procedure, so it should be
included as a direct PE input clinical labor task.
Response: We consider QA documentation to be an indirect PE since
it is not generally allocated to a single patient during an individual
procedure. Instead, we believe QA activities are undertaken through
different means across a wide range of practices.
Comment: One commenter disagreed with the minutes assigned to the
vascular ultrasound room (EL016) for CPT code 93880. The commenter
disagreed with the CMS refinement from 68 minutes of equipment time to
51 minutes, and objected to the removal of equipment time for
preservice tasks not typically associated with highly technical
equipment. The commenter stated that there was no data to support the
CMS rationale, and presented survey data suggesting that preservice
activities are routinely carried out in the vascular ultrasound room.
Response: We continue to believe that certain highly technical
pieces of equipment and equipment rooms are less likely to be used
during all of the pre-service or post-service tasks performed by
clinical labor staff on the day of the procedure and are typically
available for other patients even when one member of the clinical staff
may be occupied with a pre-service or post-service task related to the
procedure. We refer readers to our extensive discussion in response to
those objections 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).
Comment: A few commenters stated that a desktop computer is a
necessary PE input for these codes.
Response: We believe that computer processing functionality is
inherent in the ultrasound system included in the general ultrasound
room. We refer readers to Table 14 for the items and associated prices
that constitute the ultrasound rooms.
Table 14--Items That Constitute the Ultrasound Rooms
------------------------------------------------------------------------
------------------------------------------------------------------------
$369,945........................... General Ultrasound Room, General.
[[Page 71004]]
$220,000....................... GE Logic 9 ultrasound system
(H4902SG).
$18,000........................ transducer, 3-8MHz matrix array
convex (H40412LC).
$650........................... probe starter kit for H40412LD:
bracket, needle guides, probe
covers (E8385RF).
$18,000........................ transducer, 5-13MHz linear
matrix array (H40412LD).
$650........................... probe starter kit for H40412LD:
bracket, needle guides, probe
covers (E8385RF).
$12,000........................ transducer, 4-10MH micro convex
probe (H40412LE).
$11,000........................ transducer, 4-10MHz probe
(H40412LG).
$10,000........................ transducer, 2-5MHz probe
(H4901PE).
$12,500........................ software, B-flow (H4901BF).
$5,500......................... software, DICOM (H4901DM).
$8,000......................... software, LOGIQ View (h4901LW).
$4,900......................... VHS video recorder (Sony SVO-
9500MD/2).
$6,500......................... digital printer (Sony UPD21).
$1,995......................... monochrome thermal printer (Sony
UPD895).
$5,250......................... ultrasound table (E8375F).
$35,000........................ compound imaging.
$466,492....................... Ultrasound Room, Vascular.
General Ultrasound Room,
General.
Nicojet VasoGuard P84 (PPG &
lower extremity):
Nicolet Pioneer TC 8080
(transcranial).
Atrium Medical Vaslab--
software add-on for data
collection, database
maintenance, and
accreditation processing.
------------------------------------------------------------------------
In the CY 2014 PFS final rule with comment period (78 FR 74342), we
requested that the RUC assess the relativity among the entire family of
duplex scans codes and recommend appropriate work RVUs. We also
requested that the RUC consider CPT codes 93886 (Transcranial Doppler
study of the intracranial arteries; complete study) and 93888
(Transcranial Doppler study of the intracranial arteries; limited
study) in conjunction with the duplex scan codes to assess the
relativity between and among those codes. For CY 2015, we established
the RUC-recommended work RVUs as interim final for all of the codes in
the family except CPT codes 93886, 93888, 93926, 93975, 93976, 93977,
93978, and 93979. For several codes in this family with 10 minutes of
intraservice time, the RUC recommended 0.50 work RVUs. CPT code 93926
(Duplex scan of lower extremity arteries or arterial bypass grafts;
unilateral or limited study), CPT code 93979 (Duplex scan of aorta,
inferior vena cava, iliac vasculature, or bypass grafts; unilateral or
limited study,) and CPT code 93888 all have 10 minutes intraservice
time and we assigned them an interim final work RVU of 0.50. For
several codes in this family with 15 minutes of intraservice time, the
RUC recommended work RVUs that corresponded to the 25th percentile
survey result. We found this to appropriately reflect the work involved
and applied the same logic to other codes with 15 minutes of
intraservice time. We established the work RVUs for CPT codes 93975,
93976, and 93978 that corresponded to the 25th percentile survey
result, which all have 15 minutes of intraservice time. Therefore, for
CY 2015 we established the following interim final work RVUs: 1.16 for
CPT code 93975; 0.80 for CPT code 93976; 0.80 for CPT code 93978; and
0.50 for CPT code 93979.
Comment: Several commenters disagreed with the allocation of 0.50
RVUs to codes with 10 minutes of intraservice time across the Doppler/
duplex code family. The commenters suggested that 0.50 RVUs does not
reflect the relationship between the codes based on their time,
intensity, rank order, and complexity. Commenters stated that
transcranial Doppler studies are more intense than Doppler studies of
other body parts and thus should be valued with higher RVUs. Commenters
requested that CPT codes 93886 and 93888 be referred to the
multispecialty refinement panel.
Response: When valuing these codes, we used the RUC recommendation
of 0.80 RVUs for CPT code 93880, which has an intraservice time of 15
minutes. Applying the work RVU-to-time ratio of CPT code 93880 to CPT
code 93886, which has an intraservice time of 17 minutes, results in
our interim final work RVU of 0.91 for CPT code 93886. For CPT code
93888, we noted that it had an identical time and similar intensity to
code 93882; therefore, we found an RVU of 0.50 to be appropriate. The
commenters did not include any new clinical information in their
requests for referral of CPT codes 93886 and 93888. Therefore, the
requests did not meet the criteria for referral to the multispecialty
refinement panel.
Comment: Several commenters encouraged CMS to adopt the RUC
recommendation for CPT code 93926, stating that, although CPT code
93926 has 10 minutes of intraservice time, the intensity is greater
than 0.50 RVUs.
Response: We appreciate the commenters' feedback. However, we
believe that 0.50 is the accurate work RVU for CPT code 93926 based on
a crosswalk from CPT code 93880. We believe that because the intensity
is similar and the overall time is the same, the overall work is
comparable.
Comment: Several commenters pointed out that CPT code 93975 has 20
minutes of intraservice time, and should not have the same RVU as a
code with 15 minutes of intraservice time. A few commenters suggested
that CPT code 93976 involves arterial and venous blood flow and is
therefore more intense than other procedures in the code family.
Commenters requested that CPT codes 93975 and 93976 be referred to the
multispecialty refinement panel.
Response: When valuing code 93965, we noted that we did not think
the RVU that resulted in application of the intraservice ratio to 93880
accurately reflected the work involved in furnishing the procedure.
Therefore, we used the work RVU that corresponded to the 25th
percentile survey result to establish the RVU. For code 93976, we noted
that the intraservice time is identical to CPT code 93880, which has a
work RVU of 0.50. This value also corresponds to the 25th percentile
survey result.
Comment: A commenter commended CMS for accepting the RUC-
recommended work RVU for CPT code 93931.
Response: We appreciate the commenter's feedback and support.
After considering these comments, we are finalizing the CY 2015
interim final values as established.
(26) Carotid Intima-Media Thickness Ultrasound (CPT Code 93895)
For CY 2015, the CPT Editorial Panel created new CPT code 93895 to
describe the work of using carotid ultrasound to measure
atherosclerosis and quantify the intima-media thickness. After review
of this code, we determined that
[[Page 71005]]
it was used only for screening, and therefore, we assigned a PFS
procedure status indicator of N (Noncovered service) to CPT code 93895.
Comment: Two commenters were dissatisfied with our designation of
this service as a noncovered screening tool. One commenter stated that
``other methods for atherosclerosis imaging are already approved for
coverage under Medicare local coverage determination policies and are
directly comparable to carotid atherosclerosis imaging in terms of
their purpose and clinical application.'' Another commenter suggested
that the test was ``designed to be used in patients with cardiovascular
risk to enhance care and assist physicians in selection and intensity
of risk reducing therapies.'' All commenters encouraged CMS to
reconsider its decision to classify CPT code 93895 as a noncovered
screening service.
Response: While we appreciate the commenter's feedback, we are
unaware of other carotid atherosclerosis imaging services for which we
provide payment when used for patients without signs or symptoms of
disease. Information that we received from the RUC and specialty
societies indicated that the typical patient would be one without signs
or symptoms of carotid disease. Therefore, this test does not meet the
statutory definition of a diagnostic test and as such, is not covered
under Medicare.
(27) Negative Pressure Wound Therapy (CPT Codes 97605, 97606, 97607 and
97608)
Prior to CY 2013, CPT codes 97605 and 97606 were both used to
report negative pressure wound therapy, which were typically reported
in conjunction with durable medical equipment that was separately
payable. In the CY 2013 final rule with comment period, we created two
HCPCS codes to provide a payment mechanism for negative pressure wound
therapy services furnished to beneficiaries using equipment that is not
paid for as durable medical equipment: G0456 (Negative pressure wound
therapy, (for example, vacuum assisted drainage collection) using a
mechanically powered device, not durable medical equipment, including
provision of cartridge and dressing(s), topical application(s), wound
assessment, and instructions for ongoing care, per session; total
wound(s) surface area less than or equal to 50 square centimeters) and
G0457 (Negative pressure wound therapy, (for example, vacuum assisted
drainage collection) using a mechanically-powered device, not durable
medical equipment, including provision of cartridge and dressing(s),
topical application(s), wound assessment, and instructions for ongoing
care, per session; total wound(s) surface area greater than 50 sq. cm).
For CY 2015, the CPT Editorial Panel created CPT codes 97607 and
97608 to describe negative pressure wound therapy with the use of a
disposable system. In addition, CPT codes 97605 and 97606 were revised
to specify the use of durable medical equipment. Based upon the revised
coding scheme for negative pressure wound therapy, we deleted the G-
codes. We contractor-priced CPT codes 97607 and 97608 for CY 2015 and
the CPT codes were designated ``Sometimes Therapy'' on our Therapy Code
List, consistent with the G-codes.
Comment: One commenter was disappointed with CMS' decision to
contractor price CPT Codes 97607 and 97608, since CMS originally
created G-codes to provide a payment mechanism for negative pressure
wound therapy services furnished to beneficiaries through means
unrelated to the durable medical equipment benefit. They expressed
concern that practitioners who utilize the new disposable device will
be paid amounts derived from crosswalks from the DME-related codes (CPT
codes 97605 and 97606), which include more work time and work.
Response: We agree that the codes are intended to provide a payment
mechanism for negative pressure wound therapy services furnished to a
beneficiary using equipment that is not paid for as durable medical
equipment. However, we do not agree that contractor pricing the codes
is unlikely to result in accurate payment amounts for the services.
There are several obstacles to developing accurate payment rates for
these services within the PE RVU methodology, including the indirect PE
allocation for the typical practitioners who furnish these services and
the diversity of the products used in furnishing these services. Since
our methodology values services based on the typical case, and the cost
structure differs among a variety of products, we believe that
contractor pricing allows for more accurate payment than national
prices that would be based on the cost structure of a single product.
Thus, contractor pricing these codes allows for flexibility in the
products used, pending additional information about what product is
typically involved in furnishing these services.
Comment: One commenter expressed disappointment that CMS had
adjusted the equipment and staff time downward for CPT codes 97605 and
97606. The commenter expressed that the timing of the publication of
this rule does not allow adequate time to evaluate the impact these
changes will have on operating expenses and noted that the complicated
nature of the formula used to calculate PE RVUs limits their ability to
predict the impact of these changes.
Response: The intraservice clinical labor time already included
time for wound checking. As a result, the 5 minutes in the post-service
period were refined to 2 minutes. Accordingly, equipment times were
refined to conform to the changes in clinical labor time. After
consideration of the comment, we are finalizing the direct PE inputs
for CPT codes 97605 and 97606 as established. In response to the
commenter's concerns regarding the timing of changes in values for
particular PFS services, we note that beginning in rulemaking for CY
2017, we anticipate that most changes in payment based on review of
individual codes will be proposed in the annual PFS proposed rule
instead of established as interim final in the annual final rule. We
also note that we display the resulting PE RVUs for each code in
Addendum B for each proposed and final rule. This allows stakeholders
to see the PE RVUs that result from any changes in input assumptions
for particular codes.
(28) Hyperbaric Oxygen Therapy (HBOT) (CPT Code 99183 and HCPCS Code
G0277)
For CY 2015, we received RUC recommendations for CPT code 99183
that included significant increases to the direct PE inputs, which
assumed a treatment time of 120 minutes. Prior to CY 2015, CPT code
99183 was used to report both the professional attendance and
supervision, and the costs associated with treatment delivery were
included in nonfacility direct PE inputs for the code. We created HCPCS
code G0277 to be used to report the treatment delivery separately,
consistent with the OPPS coding mechanism, to allow the use of the same
coding structure across settings. In establishing interim final direct
PE inputs for HCPCS code G0277, we used the RUC-recommended direct PE
inputs for CPT code 99183 and adjusted them to align with the 30-minute
treatment interval. We observed that the quantity of oxygen increased
significantly relative to the previous value. To better understand this
change, we reviewed the instruction manual for the most commonly used
HBOT chamber, which provided guidance regarding the quantity of oxygen
used. Based on our review, we determined that 12,000, rather than
47,000, was the typical number of units. Therefore, in
[[Page 71006]]
aligning the direct PE inputs as described above, we first adjusted the
units of oxygen to 12,000 for the recommended 120-minute time, and
subsequently adjusted it to align with the 30 minute G-code.
Comment: Several commenters disagreed with the volume of oxygen
consumed for a 120 minute treatment time cited in the final rule and
some recommended adopting 42,000-47,000 liters or units for a typical
120-minute HBO2 profile. We also received a few additional comments on
these services during the comment period for the proposed rule. The
commenters reiterated that they support the change from C1300 to G0277
as the 30 minute interval for hyperbaric oxygen therapy; however, they
suggested that the methodology used by the RUC more accurately reflects
the amount of oxygen that is used in a hyperbaric oxygen treatment.
They stated, ``the provision of a hyperbaric oxygen treatment requires
a pressure of greater than 1.4 ATA and a therapeutic dose of as close
to 100 percent oxygen as can be achieved in the monoplace environment.
This level of oxygen delivery must be reached and maintained for the
duration of the designated treatment time. Therefore, a treatment of
2.4 ATA for 120 minutes will require that the target chamber oxygen
concentration must be achieved at the same time as the designated
pressure.'' The commenter additionally requested that CMS not finalize
the proposed CY 2016 reduction in PE RVUs.
Response: We thank the commenters for their feedback and have
considered the materials submitted. We agree that a high purge flow
rate is needed in order to reach maximum pressure/O2; however, we still
have not seen data that demonstrates the need to continue a maximum
flow rate throughout the entire session. The RUC forwarded an invoice
for the Sechrist Model 3600E Hyperbaric Chamber for use in pricing the
capital equipment for this service. According to the manufacturer's
manual for this model, ``once the nitrogen has been purged from the
chamber and the internal oxygen concentration has exceeded 95 percent,
high flows are no longer needed to maintain the patient's saturation
level.'' The manual also states that ``the plateau purge flow can be
set to 80 lpm.'' We calculated that 13 minutes at 400 lpm plus 120
minutes at 80 lpm equals 14,800 liters of oxygen. Based on the current
publicly available information in the manufacturer's manual, we believe
that this represents the typical usage for a 120 minute treatment. This
amount represents an increase from the interim final amount of 12,000.
As we described in the CY 2015 final rule, we aligned this total oxygen
requirement to the 30 minute G-code. Following that principle here, we
are updating the direct PE inputs to 3,700 liters of oxygen for HCPCS
code G0277. In response to the commenter's request regarding a
reduction in the PE RVUs in the CY 2016 PFS proposed rule, any changes
from the CY 2015 PE RVUs for HCPCS code G0277 to values displayed in
association with the CY 2016 proposed rule resulted from overall
changes in PE relativity and PFS budget neutrality and did not result
from a change in the direct PE inputs.
9. CY 2016 Interim Final Codes
For recommendations regarding any new or revised codes received
after the February 10, 2015 deadline, including updated recommendations
for codes included in the CY 2016 proposed rule, we are establishing
interim final values in this final rule with comment period, consistent
with previous practice.
We note that in the CY 2016 PFS proposed rule, we inadvertently
published work RVUs for several CPT codes in Addendum B that were not
explicitly discussed in the text. Those CPT codes include 88341, 88364,
and 88369; these codes had previously been proposed on an interim basis
in the CY 2015 PFS final rule with comment period. While these codes
were not discussed in the proposed rule because our files displayed
incorrect work RVUs for these codes due to the data error, some
commenters raised questions about these codes' displayed work RVUs. To
allow public comment on the correct valuations, we are therefore
establishing interim final work RVUs for these codes for CY 2016 and
requesting comment on those interim final values in this final rule. We
will respond to comments on these values in CY 2017 rulemaking.
Table 15--CY 2016 Interim Final Work RVUs for New/Revised or Potentially Misvalued Codes
----------------------------------------------------------------------------------------------------------------
RUC/HCPAC
HCPCS Code Long descriptor CY 2015 recommended CMS 2016 CMS time
WRVU work RVU work RVU refinement
----------------------------------------------------------------------------------------------------------------
10035........................... Placement of soft NEW 1.70 1.70 No.
tissue
localization
device(s) (e.g.,
clip, metallic
pellet, wire/
needle,
radioactive
seeds),
percutaneous,
including imaging
guidance; first
lesion.
10036........................... Placement of soft NEW 0.85 0.85 No.
tissue
localization
device(s) (e.g.,
clip, metallic
pellet, wire/
needle,
radioactive
seeds),
percutaneous,
including imaging
guidance; each
additional lesion.
26356........................... Repair or 10.62 10.03 9.56 No.
advancement,
flexor tendon, in
zone 2 digital
flexor tendon
sheath (e.g., no
man's land);
primary, without
free graft, each
tendon.
26357........................... Repair or 8.77 11.50 10.53 No.
advancement,
flexor tendon, in
zone 2 digital
flexor tendon
sheath (e.g., no
man's land);
secondary,
without free
graft, each
tendon.
26358........................... Repair or 9.36 13.10 12.13 No.
advancement,
flexor tendon, in
zone 2 digital
flexor tendon
sheath (e.g., no
man's land);
secondary, with
free graft
(includes
obtaining graft),
each tendon.
41530........................... Submucosal 4.51 3.50 3.50 No.
ablation of the
tongue base,
radiofrequency, 1
or more sites,
per session.
43210........................... Esophagogastroduod NEW 9.00 7.75 Yes.
enoscopy,
flexible,
transoral; with
esophagogastric
fundoplasty,
partial or
complete,
includes
duodenoscopy when
performed.
47531........................... Injection NEW 1.80 1.80 No.
procedure for
cholangiography,
percutaneous,
complete
diagnostic
procedure
including imaging
guidance (e.g.,
ultrasound and/or
fluoroscopy) and
all associated
radiological
supervision and
interpretation;
existing access.
[[Page 71007]]
47532........................... Injection NEW 4.25 4.25 No.
procedure for
cholangiography,
percutaneous,
complete
diagnostic
procedure
including imaging
guidance (e.g.,
ultrasound and/or
fluoroscopy) and
all associated
radiological
supervision and
interpretation;
new access (e.g.,
percutaneous
transhepatic
cholangiogram).
47533........................... Placement of NEW 6.00 6.00 No.
biliary drainage
catheter,
percutaneous,
including
diagnostic
cholangiography
when performed,
imaging guidance
(e.g., ultrasound
and/or
fluoroscopy) and
all associated
radiological
supervision and
interpretation;
external.
47534........................... Placement of NEW 8.03 8.03 No.
biliary drainage
catheter,
percutaneous,
including
diagnostic
cholangiography
when performed,
imaging guidance
(e.g., ultrasound
and/or
fluoroscopy) and
all associated
radiological
supervision and
interpretation;
internal-external.
47535........................... Placement of NEW 4.50 4.50 No.
biliary drainage
catheter,
percutaneous,
including
diagnostic
cholangiography
when performed,
imaging guidance
(e.g., ultrasound
and/or
fluoroscopy) and
all associated
radiological
supervision and
interpretation;
internal-external.
47536........................... Exchange of NEW 2.88 2.88 No.
biliary drainage
catheter (e.g.,
external,
internal-
external, or
conversion of
internal-external
to external
only),
percutaneous,
including
diagnostic
cholangiography
when performed,
imaging guidance
(e.g.,
fluoroscopy) and
all associated
radiological
supervision and
interpretation.
47537........................... Removal of biliary NEW 1.83 1.83 No.
drainage
catheter,
percutaneous,
requiring
fluoroscopic
guidance (e.g.,
with concurrent
indwelling
biliary stents),
including
diagnostic
cholangiography
when performed,
imaging guidance
(e.g.,
fluoroscopy) and
all associated
radiological
supervision and
interpretation.
47538........................... Placement of NEW 6.60 6.60 No.
stent(s) into a
bile duct,
percutaneous,
including
diagnostic
cholangiography,
imaging guidance
(e.g.,
fluoroscopy and/
or ultrasound),
balloon dilation,
catheter exchange
or removal when
performed, and
all associated
radiological
supervision and
interpretation,
each stent;
existing access.
47539........................... Placement of NEW 9.00 9.00 No.
stent(s) into a
bile duct,
percutaneous,
including
diagnostic
cholangiography,
imaging guidance
(e.g.,
fluoroscopy and/
or ultrasound),
balloon dilation,
catheter exchange
or removal when
performed, and
all associated
radiological
supervision and
interpretation,
each stent; new
access, without
placement of
separate biliary
drainage catheter.
47540........................... Placement of NEW 12.00 10.75 No.
stent(s) into a
bile duct,
percutaneous,
including
diagnostic
cholangiography,
imaging guidance
(e.g.,
fluoroscopy and/
or ultrasound),
balloon dilation,
catheter exchange
or removal when
performed, and
all associated
radiological
supervision and
interpretation,
each stent; new
access, with
placement of
separate biliary
drainage catheter
(e.g., external
or internal-
external ).
47541........................... Placement of NEW 5.61 5.61 No.
access through
the biliary tree
and into small
bowel to assist
with an
endoscopic
biliary procedure
(e.g., rendezvous
procedure),
percutaneous,
including
diagnostic
cholangiography
when performed,
imaging guidance
(e.g., ultrasound
and/or
fluoroscopy) and
all associated
radiological
supervision and
interpretation;
new access.
47542........................... Balloon dilation NEW 3.28 2.50 No.
of biliary
duct(s) or of
ampulla
(sphincteroplasty
), percutaneous,
including imaging
guidance (e.g.,
fluoroscopy) and
all associated
radiological
supervision and
interpretation,
each duct.
47543........................... Endoluminal NEW 3.51 3.07 No.
biopsy(ies) of
biliary tree,
percutaneous, any
method(s) (e.g.,
brush, forceps
and/or needle),
including imaging
guidance (e.g.,
fluoroscopy) and
all associated
radiological
supervision and
interpretation,
single or
multiple.
47544........................... Removal of calculi/ NEW 4.74 4.29 No.
debris from
biliary duct(s)
and/or
gallbladder,
percutaneous,
including
destruction of
calculi by any
method (e.g.,
mechanical,
electrohydraulic,
lithotripsy) when
performed,
imaging guidance
(e.g.,
fluoroscopy) and
all associated
radiological
supervision and
interpretation
(List separately
in addition to
code for primary
procedure).
49185........................... Sclerotherapy of a NEW 2.78 2.35 No.
fluid collection
(e.g.,
lymphocele, cyst,
or seroma),
percutaneous,
including
contrast
injection(s),
sclerosant
injection(s),
diagnostic study,
imaging guidance
(e.g.,
ultrasound,
fluoroscopy) and
radiological
supervision and
interpretation
when performed.
[[Page 71008]]
50606........................... Endoluminal biopsy NEW 3.16 3.16 No.
of ureter and/or
renal pelvis, non-
endoscopic,
including imaging
guidance (e.g.,
ultrasound and/or
fluoroscopy) and
all associated
radiological
supervision and
interpretation.
50705........................... Ureteral NEW 4.03 4.03 No.
embolization or
occlusion,
including imaging
guidance (e.g.,
ultrasound and/or
fluoroscopy) and
all associated
radiological
supervision and
interpretation.
50706........................... Balloon dilation, NEW 3.80 3.80 No.
ureteral
stricture,
including imaging
guidance (e.g.,
ultrasound and/or
fluoroscopy) and
all associated
radiological
supervision and
interpretation.
55866........................... Laparoscopy, 32.06 26.80 21.36 No.
surgical
prostatectomy,
retropubic
radical,
including nerve
sparing, includes
robotic
assistance, when
performed.
61645........................... Percutaneous NEW 17.00 15.00 Yes.
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).
61650........................... Endovascular NEW 12.00 10.00 Yes.
intracranial
prolonged
administration of
pharmacologic
agent(s) other
than for
thrombolysis,
arterial,
including
catheter
placement,
diagnostic
angiography, and
imaging guidance;
initial vascular
territory.
61651........................... Endovascular NEW 5.50 4.25 No.
intracranial
prolonged
administration of
pharmacologic
agent(s) other
than for
thrombolysis,
arterial,
including
catheter
placement,
diagnostic
angiography, and
imaging guidance;
each additional
vascular
territory (List
separately in
addition to the
primary code).
64461........................... Paravertebral NEW 1.75 1.75 No.
block (PVB)
(paraspinous
block), thoracic;
single injection
site (includes
imaging guidance,
when performed).
64462........................... Paravertebral NEW 1.10 1.10 No.
block (PVB)
(paraspinous
block), thoracic;
second and any
additional
injection
site(s),
(includes imaging
guidance, when
performed).
64463........................... Paravertebral NEW 1.90 1.81 No.
block (PVB)
(paraspinous
block), thoracic;
continuous
infusion by
catheter
(includes imaging
guidance, when
performed).
64553........................... Percutaneous 2.36 2.36 2.36 No.
implantation of
neurostimulator
electrode array;
cranial nerve.
64555........................... Percutaneous 2.32 2.32 2.32 No.
implantation of
neurostimulator
electrode array;
peripheral nerve
(excludes sacral
nerve).
64566........................... Posterior tibial 0.60 0.60 0.60 No.
neurostimulation,
percutaneous
needle electrode,
single treatment,
includes
programming.
65778........................... Placement of 1.19 1.00 1.00 No.
amniotic membrane
on the ocular
surface; without
sutures.
65779........................... Placement of 3.92 2.50 2.50 Yes.
amniotic membrane
on the ocular
surface; single
layer, sutured.
65780........................... Ocular surface 10.73 8.80 7.81 No.
reconstruction;
amniotic membrane
transplantation,
multiple layers.
65855........................... Trabeculoplasty by 3.99 3.00 2.66 No.
laser surgery.
66170........................... Fistulization of 15.02 13.94 11.27 No.
sclera for
glaucoma;
trabeculectomy ab
externo in
absence of
previous surgery.
66172........................... Fistulization of 18.86 14.81 12.57 No.
sclera for
glaucoma;
trabeculectomy ab
externo with
scarring from
previous ocular
surgery or trauma
(includes
injection of
antifibrotic
agents).
67107........................... Repair of retinal 16.71 16.00 14.06 No.
detachment;
scleral buckling
(such as lamellar
scleral
dissection,
imbrication or
encircling
procedure),
including, when
performed,
implant,
cryotherapy,
photocoagulation,
and drainage of
subretinal fluid.
67108........................... Repair of retinal 22.89 17.13 15.19 No.
detachment; with
vitrectomy, any
method,
including, when
performed, air or
gas tamponade,
focal endolaser
photocoagulation,
cryotherapy,
drainage of
subretinal fluid,
scleral buckling,
and/or removal of
lens by same
technique.
67110........................... Repair of retinal 10.25 10.25 8.31 No.
detachment; by
injection of air
or other gas
(e.g., pneumatic
retinopexy).
67113........................... Repair of complex 25.35 19.00 19.00 No.
retinal
detachment (e.g.,
proliferative
vitreoretinopathy
, stage C-1 or
greater, diabetic
traction retinal
detachment,
retinopathy of
prematurity,
retinal tear of
greater than 90
degrees), with
vitrectomy and
membrane peeling,
including, when
performed, air,
gas, or silicone
oil tamponade,
cryotherapy,
endolaser
photocoagulation,
drainage of
subretinal fluid,
scleral buckling,
and/or removal of
lens.
[[Page 71009]]
67227........................... Destruction of 7.53 3.50 3.50 No.
extensive or
progressive
retinopathy
(e.g., diabetic
retinopathy),
cryotherapy,
diathermy.
67228........................... Treatment of 13.82 4.39 4.39 No.
extensive or
progressive
retinopathy
(e.g., diabetic
retinopathy),
photocoagulation.
72170........................... Radiologic 0.17 0.17 0.17 No.
examination,
pelvis; 1 or 2
views.
73501........................... Radiologic NEW 0.18 0.18 No.
examination, hip,
unilateral, with
pelvis when
performed; 1 view.
73502........................... Radiologic NEW 0.22 0.22 No.
examination, hip,
unilateral, with
pelvis when
performed; 2-3
views.
73503........................... Radiologic NEW 0.27 0.27 No.
examination, hip,
unilateral, with
pelvis when
performed;
minimum of 4
views.
73521........................... Radiologic NEW 0.22 0.22 No.
examination,
hips, bilateral,
with pelvis when
performed; 2
views.
73522........................... Radiologic NEW 0.29 0.29 No.
examination,
hips, bilateral,
with pelvis when
performed; 3-4
views.
73523........................... Radiologic NEW 0.31 0.31 No.
examination,
hips, bilateral,
with pelvis when
performed;
minimum of 5
views.
73551........................... Radiologic NEW 0.16 0.16 No.
examination,
femur; 1 view.
73552........................... Radiologic NEW 0.18 0.18 No.
examination,
femur; minimum 2
views.
74712........................... Magnetic resonance NEW 3.00 3.00 No.
(e.g., proton)
imaging, fetal,
including
placental and
maternal pelvic
imaging when
performed; single
or first
gestation.
74713........................... Magnetic resonance NEW 1.85 1.78 No.
(e.g., proton)
imaging, fetal,
including
placental and
maternal pelvic
imaging when
performed; each
additional
gestation.
77778........................... Interstitial 11.32 8.78 8.00 No.
radiation source
application,
complex, includes
supervision,
handling, loading
of radiation
source, when
performed.
77790........................... Supervision, 1.05 0.00 0.00 No.
handling, loading
of radiation.
78264........................... Gastric emptying 0.80 0.80 0.74 No.
imaging study
(e.g., solid,
liquid, or both).
78265........................... Gastric emptying NEW 0.98 0.98 No.
imaging study
(e.g., solid,
liquid, or both);
with small bowel
transit, up to 24
hours.
78266........................... Gastric emptying NEW 1.08 1.08 No.
imaging study
(e.g., solid,
liquid, or both);
with small bowel
and colon
transit, multiple
days.
88104........................... Cytopathology, 0.56 0.56 0.56 No.
fluids, washings
or brushings,
except cervical
or vaginal;
smears with
interpretation.
88106........................... Cytopathology, 0.37 0.37 0.37 No.
fluids, washings
or brushings,
except cervical
or vaginal;
simple filter
method with
interpretation.
88108........................... Cytopathology, 0.44 0.44 0.44 No.
concentration
technique, smears
and
interpretation
(e.g., Saccomanno
technique).
88112........................... Cytopathology, 0.56 0.56 0.56 No.
selective
cellular
enhancement
technique with
interpretation
(e.g., liquid
based slide
preparation
method), except
cervical or
vaginal.
88160........................... Cytopathology, 0.50 0.50 0.50 No.
smears, any other
source; screening
and
interpretation.
88161........................... Cytopathology, 0.50 0.50 0.50 No.
smears, any other
source;
preparation,
screening and
interpretation.
88162........................... Cytopathology, 0.76 0.76 0.76 No.
smears, any other
source; extended
study involving
over 5 slides and/
or multiple
stains.
91200........................... Liver 0.30 0.27 0.27 No.
elastography,
mechanically
induced shear
wave (e.g.,
vibration),
without imaging,
with
interpretation
and report.
93050........................... Arterial pressure NEW 0.17 0.17 No.
waveform analysis
for assessment of
central arterial
pressures,
includes
obtaining
waveform(s),
digitization and
application of
nonlinear
mathematical
transformations
to determine
central arterial
pressures and
augmentation
index, with
interpretation
and report, upper
extremity artery,
non-invasive.
95971........................... Electronic 0.78 0.78 0.78 No.
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);
simple spinal
cord, or
peripheral (i.e.,
peripheral nerve,
sacral nerve,
neuromuscular)
neurostimulator
pulse generator/
transmitter, with
intraoperative or
subsequent
programming.
[[Page 71010]]
95972........................... Electronic 0.80 0.80 0.80 No.
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 spinal
cord, or
peripheral (i.e.,
peripheral nerve,
sacral nerve,
neuromuscular)
(except cranial
nerve)
neurostimulator
pulse generator/
transmitter, with
intraoperative or
subsequent
programming.
G0416........................... Surgical 3.09 3.09 3.09 No.
pathology, gross
and microscopic
examinations, for
prostate needle
biopsy, any
method.
----------------------------------------------------------------------------------------------------------------
[[Page 71011]]
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[[Page 71038]]
[GRAPHIC] [TIFF OMITTED] TR16NO15.027
[[Page 71039]]
[GRAPHIC] [TIFF OMITTED] TR16NO15.028
[[Page 71040]]
[GRAPHIC] [TIFF OMITTED] TR16NO15.029
[[Page 71041]]
[GRAPHIC] [TIFF OMITTED] TR16NO15.030
[[Page 71042]]
[GRAPHIC] [TIFF OMITTED] TR16NO15.031
[[Page 71043]]
[GRAPHIC] [TIFF OMITTED] TR16NO15.032
[[Page 71044]]
[GRAPHIC] [TIFF OMITTED] TR16NO15.033
[[Page 71045]]
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[[Page 71047]]
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[[Page 71048]]
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[[Page 71049]]
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[[Page 71050]]
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[[Page 71051]]
Table 17--CY 2016 Interim Final Codes With Direct PE Input
Recommendations Accepted Without Refinements
------------------------------------------------------------------------
HCPCS code Description
------------------------------------------------------------------------
26356........................... Repair finger/hand tendon.
26357........................... Repair finger/hand tendon.
26358........................... Repair/graft hand tendon.
43210........................... Egd esophagogastrc fndoplsty.
47543........................... Endoluminal bx biliary tree.
55866........................... Laparo radical prostatectomy.
64461........................... Pvb thoracic single inj site.
64462........................... Pvb thoracic 2nd+ inj site.
64463........................... Pvb thoracic cont infusion.
64566........................... Neuroeltrd stim post tibial.
65778........................... Cover eye w/membrane.
65780........................... Ocular reconst transplant.
65855........................... Trabeculoplasty laser surg.
66172........................... Incision of eye.
67107........................... Repair detached retina.
67108........................... Repair detached retina.
67227........................... Dstrj extensive retinopathy.
72170........................... X-ray exam of pelvis.
73501........................... X-ray exam hip uni 1 view.
73502........................... X-ray exam hip uni 2-3 views.
73503........................... X-ray exam hip uni 4/> views.
73521........................... X-ray exam hips bi 2 views.
73522........................... X-ray exam hips bi 3-4 views.
73551........................... X-ray exam of femur 1.
73552........................... X-ray exam of femur 2.
74712........................... Mri fetal sngl/1st gestation.
74713........................... Mri fetal ea addl gestation.
77778........................... Apply interstit radiat compl.
77790........................... Radiation handling.
88104........................... Cytopath fl nongyn smears.
91200........................... Liver elastography.
93050........................... Art pressure waveform analys.
95971........................... Analyze neurostim simple.
95972........................... Analyze neurostim complex.
G0416........................... Prostate biopsy, any mthd.
------------------------------------------------------------------------
Table 18--Invoices Received for New Direct PE Inputs for CY 2016 Interim Final Codes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated non-
facility
allowed
CPT/HCPCS codes Item name CMS code Average price Number of services for
invoices HCPCS codes
using this
item
--------------------------------------------------------------------------------------------------------------------------------------------------------
41530, 43229, 43270...................... radiofrequency generator (Gyrus EQ374..................... $10,000.00 1 2,932
ENT G3 workstation).
47534, 47535, 47536, 47538, 47539, 47540. internal/external biliary SD312..................... 162.80 1 220
catheter.
47538, 47539, 47540...................... Viabil covered biliary stent..... SD313..................... 2,721.00 2 26
47543.................................... Radial Jaw....................... SD314..................... 94.20 1 0
47543.................................... stone basket..................... SD315..................... 417.00 1 0
64463.................................... Catheter securement device....... SD316..................... .............. 0 514
76377.................................... computer workstation, 3D ED014..................... 45,926.00 1 67,296
reconstruction CT-MR.
77778.................................... Applicator (TPV-200)/Kit......... EQ373..................... 9,770.00 1 517
77778.................................... reentrant well ionization chamber EP117..................... 5,180.00 2 517
77778, 77790............................. L-block (needle loading shield).. EP118..................... 1,195.00 1 1,848
78264, 78265, 78266...................... Bread............................ SK121..................... 0.16 1 9,735
78264, 78265, 78266...................... Egg Whites....................... SK122..................... 0.16 1 9,735
78264, 78265, 78266...................... Jelly............................ SK123..................... 0.06 1 9,735
78264, 78265, 78266...................... paper plate...................... SK124..................... 0.17 1 9,735
93050.................................... Central Blood Pressure Monitoring EP119..................... 14,700.00 2 25,000
Equipment (XCEL PWA & PWV
System).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 19--Invoices Received for Existing Direct PE Inputs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated non-
facility
allowed
CPT/HCPCS codes Item name CMS code Current price Updated price % Change services for
HCPCS codes
using this
item
--------------------------------------------------------------------------------------------------------------------------------------------------------
10035, 10036, 19081, 19082, 19083, 19084, clip, tissue marker......... SD037 $75.00 $98.20 31 58,640
19085, 19086, 19285, 19286, 19287, 19288.
20982, 32998, 50592, 64600, 64605, 64610, radiofrequency generator EQ214 $ 10,000.00 $32,900.00 229 262,846
64633, 64634, 64635, 64636. (NEURO).
65778..................................... human amniotic membrane SD248 $895.00 $949.00 6 8,807
allograft mounted on a non-
absorbable self-retaining
ring.
65779..................................... human amniotic membrane SD247 $595.00 $670.00 13 104
allograft.
88106..................................... Millipore filter............ SL502 $4.15 $0.75 -82 1,204
[[Page 71052]]
95018..................................... benzylpenicilloyl polylysine SH103 $83.00 $86.00 4 60,683
(e.g., PrePen) 0.25ml uou.
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) Repair Flexor Tendon (CPT Codes 26356, 26357, and 26358)
The RUC recommended a work RVU of 10.03 for CPT code 26356.
Although the RUC-recommended work RVU represents a reduction from the
current work RVU of 10.62, we believe that the decrease in resource
costs as reflected in the survey data (specifically in the intraservice
time, the total time, and the change in the office visits) are not
adequately reflected in the recommended work RVU. The intraservice time
decreased from 90 minutes to 60 minutes (33 percent) while the RUC-
recommended work RVU decreased from 10.62 to 10.03, a reduction of less
than 6 percent. The total time and the number of office visits were
also reduced by about 25 percent in each case, which is significantly
greater than the 6 percent decrease in the recommended work RVU. We
examined CPT code 25607 (Open treatment of distal radial extra-
articular fracture), which has an intraservice time of 60 minutes and a
total time of 275 minutes, which closely approximates the 60 minutes
and 277 minutes reflected in the survey results for CPT code 26356. We
also believe that these procedures have similar intensity based on
their clinical profiles. We are therefore establishing an interim final
work RVU of 9.56 for CPT code 26356 after considering both its
similarity in time to CPT code 25607 and the reduction in time relative
to the current times included for this procedure.
The RUC recommended a work RVU of 11.50 for CPT code 26357. We
refined the RUC-recommended work RVU, employing a similar methodology
to the one we used in valuing CPT code 26356. While we agree that the
value of this code should increase from its current work RVU of 8.77,
we believe that the RUC-recommended work RVU of 11.50 does not
accurately reflect the change in time for this code. The RUC-
recommended work RVU is an increase of 31 percent from the current work
RVU of the code, while the total time increases from 256 minutes to 302
minutes, an increase of only 18 percent. The intraservice time for CPT
code 26357 decreases from 89 minutes to 85 minutes, which does not
suggest that a significant increase to the work RVU is accurate.
Therefore, we considered CPT code 27654, (Repair, secondary, Achilles
tendon, with or without graft) which has a similar intraservice time of
90 minutes, a total time of 283 minutes, a similar intensity, and a
work RVU of 10.53. We are establishing an interim final work RVU of
10.53 for CPT code 26357 based on this direct crosswalk from CPT code
27654, as we believe this work RVU better reflects the changes in time
for this procedure.
The RUC recommended a work RVU of 13.10 for CPT code 26358. We do
not believe that this value accurately reflects the change in the
intraservice time and the total time for this code. The RUC-recommended
work RVU is an increase of 40 percent over the current work RVU of
9.36, while the total time only increases from 286 minutes to 327
minutes, an increase of 14 percent, and the intraservice time only
increases from 108 minutes to 110 minutes, an increase of 2 percent. We
do not believe that the RUC-recommended work RVU of 13.10, which
corresponds to the survey median result, accurately reflects the
increase in time. In the interest of preserving relativity among the
codes in this family, we are maintaining the RUC-recommended increment
of 1.6 work RVUs between CPT codes 26257 and 26358. Therefore, we are
establishing an interim final work RVU of 12.13 for CPT code 26358,
based on an increase of 1.6 work RVUs relative to CPT code 26357.
(2) Submucosal Ablation of Tongue Base (CPT Code 41530)
In the proposed rule, we proposed CPT code 41530 as potentially
misvalued based on a public nomination. The nominator stated that CPT
code 41530 is misvalued because there have been changes in the direct
PE inputs used in furnishing the service. In the CY 2015 PFS Final Rule
(79 FR 67575), we noted that the RUC submitted PE recommendations and
stated that, under our usual process, we value work and PE at the same
time and would expect to receive RUC recommendations for both before we
revalued this service. Subsequently, the RUC submitted recommendations
for both. The RUC recommended a work RVU of 3.50 for CPT code 41530,
which we are establishing as the interim final work RVU for the code.
To address the concerns raised by CMS in the CY 2015 PFS Final Rule,
the PE Subcommittee reviewed minor revisions submitted by the specialty
society. The RUC determined that this service should not be performed
in the office setting and recommended removing the nonfacility direct
PE inputs from the direct PE input database. However, 2014 Medicare
claims data indicate that this service is furnished in the office
setting 95 percent of the time, and that this service is frequently
furnished multiple times to a beneficiary. Due to this discrepancy, we
are seeking comment about the typical site of service and whether
changes to the coding are needed to clarify this issue. For CY 2016, we
have established interim final nonfacility direct PE inputs based on
the current direct PE inputs for the code.
(3) Esophagogastric Fundoplasty Trans-Oral Approach (CPT Code 43210)
The CPT Editorial Panel established CPT code 43210 to describe
trans-oral esophagogastric fundoplasty. The RUC recommended a work RVU
of 9.00 for CPT code 43210. We were unable to identify CPT codes with
an intraservice time of 60 minutes that have an RVU of 9.00 or greater.
We were also unable to identify esophago gastro duoden os copy (EGD)
codes with an RVU of 9.00 or greater. We compared this code to CPT code
43240 (Drainage of cyst of the esophagus, stomach, and/or upper small
bowel using an endoscope), which has similar total work time and a work
RVU of 7.25. We believe a work RVU of 7.75, which corresponds to the
25th percentile survey result, more accurately reflects the resources
used in furnishing the service. Therefore, for CY 2016 we are
establishing an interim final work RVU of 7.75 for CPT code
[[Page 71053]]
43210. Additionally, in accordance with our established policy, as
described in the CY 2012 PFS Final Rule (76 FR 73119), we removed the
subsequent observation visit (99224) included in the RUC recommended
value for this code and adjusted the total work time accordingly, by
including the intraservice time of the inpatient hospital visit in the
immediate post-service time of the code.
(4) Percutaneous Biliary Procedures (CPT Codes 47531, 47532, 47533,
47534, 47535, 47536, 47537, 47538, 47539, 47540, 47541, 47542, 47543,
and 47544)
Several percutaneous biliary catheter and related image guidance
procedures were identified through a misvalued code screen of codes
reported together more than 75 percent of the time. For CY 2016, the
CPT Editorial Panel deleted six existing biliary catheter codes (47500,
47505, 47510, 47511, 47525, and 47530) and five related image-guidance
codes (74305, 74320, 74327, 75980, and 75982) and created 14 new codes,
CPT codes 47531 through 47544, to describe percutaneous biliary
procedures and to bundle inherent imaging services. We are establishing
the RUC recommended work RVUs as interim final for CY 2016 for all of
the percutaneous biliary procedures with the exception of CPT codes
47540, 47542, 47543, and 47544.
The RUC recommended a work RVU of 12.00 for CPT code 47540
(Placement of stent(s) into a bile duct, percutaneous, including
diagnostic cholangiography, imaging guidance (e.g., fluoroscopy and/or
ultrasound), balloon dilation, catheter exchange or removal when
performed, and all associated radiological supervision and
interpretation, each stent; new access, with placement of separate
biliary drainage catheter (e.g., external or internal-external))
corresponding to the survey median result. We believe that a work RVU
of 10.75, which corresponds to the 25th percentile survey result, more
accurately reflects the work associated with this service. The RUC used
magnitude estimation to value CPT code 47540, considering reference
codes CPT code 37226 (Revascularization, endovascular, open or
percutaneous, femoral, popliteal artery(s), unilateral; with
transluminal stent placement(s), includes angioplasty within the same
vessel, when performed) and CPT code 37228 (Revascularization,
endovascular, open or percutaneous, tibial, peroneal artery,
unilateral, initial vessel; with transluminal angioplasty). These codes
have work RVUs of 10.49 and 11.00 RVUs respectively; both less than the
RUC-recommended work RVU of 12.00 for CPT code 47540. In reviewing CPT
codes with 90 minutes of intraservice times and a 0-day global period,
we found that the majority of codes had a work RVU of less than 12.00.
As such, we believe that a work RVU of 10.75 better aligns this service
with other 0 day global codes with similar intraservice times and
maintains appropriate relativity among the codes in this family. We are
establishing a CY 2016 interim final work RVU of 10.75 for CPT code
47540.
The RUC recommended a work RVU of 3.28 for 47542. We believe that a
work RVU of 2.50 more accurately reflects the work associated with this
service. In valuing CPT code 47542, the RUC used a direct crosswalk
from CPT code 37185 (Primary percutaneous transluminal mechanical
thrombectomy, noncoronary, arterial or arterial bypass graft, including
fluoroscopic guidance and intraprocedural pharmacological thrombolytic
injection(s); second and all subsequent vessel(s) within the same
vascular family), which has an intraservice time of 40 minutes. We
believe that a more appropriate direct crosswalk is CPT code 15116
(Epidermal autograft, face, scalp, eyelids, mouth, neck, ears, orbits,
genitalia, hands, feet, or multiple digits) because it shares an
intraservice time of 35 minutes. Therefore, we are establishing an
interim final work RVU of 2.50 for CPT code 47542 for CY 2016.
The RUC recommended work RVUs of 3.51 and 4.74 for CPT codes 47543
and 47544, respectively. We do not believe the RUC-recommended work
RVUs accurately reflect the work involved in furnishing these
procedures. To value the work described in these procedures, we used
the intraservice time ratio to identify values. We used CPT code 47542
as the base code, and calculated an intraservice time ratio by dividing
the intraservice time of CPT code 47543 (43 minutes) by the
intraservice time of CPT code 47542 (35 minutes); we then applied that
ratio (1.228) to the interim final work RVU of 2.50 for CPT code 47542.
This resulted in a work RVU of 3.07 for CPT code 47543. We used the
same intraservice time ratio approach to calculate the interim final
work RVU for CPT code 47544. We divided the intraservice time for CPT
code 47544 (60 minutes) by the intraservice time for CPT code 47542 (35
minutes), and then applied that ratio (1.714) to the interim final work
RVU of 2.50 for CPT code 47542, which results in a work RVU of 4.29. We
are establishing an interim final work RVU of 3.07 for CPT code 47543
and 4.29 for CPT code 47544 for CY 2016.
We also refined a series of RUC-recommended direct PE inputs. We
are replacing supply item ``catheter, balloon, PTA'' (SD152) with
supply item ``catheter, balloon ureteral (Dowd)'' (SD150) on an interim
final basis. We believe that the use of this balloon catheter, which is
specifically designed for catheter and image guidance procedures, would
be more typical than the use of a PTA balloon catheter.
We are also refining the RUC-recommended malpractice crosswalks for
most of the codes in this family to align with the specialty mix that
furnishes these procedures; we believe that these better reflect the
malpractice risk associated with these procedures. We are establishing
as interim final the malpractice crosswalks listed in Table 20.
Table 20--MP Crosswalks for Biliary and Catheter Procedures
------------------------------------------------------------------------
CMS interim
HCPCS code RUC recommended final MP
MP crosswalk crosswalk
------------------------------------------------------------------------
47531............................... 49450 49450
47532............................... 49407 49407
47533............................... 37191 47510
47534............................... 36247 47511
47535............................... 36247 47505
47536............................... 49452 49452
47537............................... 49451 47505
47538............................... 37191 47556
47539............................... 37226 47556
47540............................... 37226 47556
[[Page 71054]]
47541............................... 36247 47500
47542............................... 37222 47550
47543............................... 22515 47550
47544............................... 37235 47630
------------------------------------------------------------------------
(5) Percutaneous Image Guided Sclerotherapy (CPT Code 49185)
The CPT Editorial Panel created CPT code 49185 (Sclerotherapy of a
fluid collection (eg, lymphocele, cyst, or seroma), percutaneous,
including contrast injection(s), sclerosant injection(s)) to describe
percutaneous image-guided sclerotherapy of fluid collections. These
services were previously reported using CPT code 20500 (Injection of
sinus tract; therapeutic (separate procedure)). To develop recommended
work RVUs for CPT code 49185, the RUC used a direct crosswalk from
reference code 31622 (Bronchoscopy, rigid or flexible, including
fluoroscopic guidance, when performed; diagnostic, with cell washing,
when performed), which has an intraservice time of 30 minutes and work
RVU of 2.78. Although CPT code 31622 is clinically similar to CPT code
49185, we do not believe CPT code 31622 has a similar intensity to CPT
code 49185. To establish the CY 2016 interim final work RVU for CPT
code 49185, we instead used a direct crosswalk from CPT code 62305
(injection, radiologic supervision and interpretation), which shares an
intraservice time of 30 minutes and is clinically similar, as it also
includes an injection, radiologic supervision, and interpretation. We
are establishing an interim final work RVU of 2.35 for CPT code 49185.
The RUC recommended including 300 ml of supply item ``sclerosing
solution injection'' (SHO62) for CPT code 49185, which is priced at
$2.29 per millimeter. The predecessor code included supply item
``obupivacaine (0.25% inj (Marcaine)'' (SH021)), which is priced at
25.4 cents per millimeter. We are concerned that supply item SH062 may
not be used in the typical case for this procedure. We note that other
CPT codes that include supply item SH062 include between 1 and 10 ml.
We request that stakeholders review this supply item and provide
invoices to improve the accuracy of pricing. We are also requesting
information regarding the price of supply item SH062 given the
significant increase in volume used in this procedure relative to other
procedures.
(6) Genitourinary Catheter Procedures (CPT Codes 50606, 50705, and
50706)
We are establishing as interim final the RUC-recommended work RVUs
for all three codes.
For CPT code 50706, we are replacing the RUC-recommended supply
item ``catheter, balloon, PTA'' (SD152) with a ``catheter, balloon,
ureteral-GI (strictures)'' (SD019) in the nonfacility setting. We
believe that the latter balloon catheter, which is specifically
designed for ureteral procedures, would be more typically used for
these procedures than a PTA balloon catheter. We welcome further
comment regarding the appropriate catheter supply for CPT code 50706,
including any objective data regarding which supply item is more
typically used for these procedures.
The RUC recommended the inclusion of ``room, angiography'' (EL011)
for this family of codes. As discussed in section II.H.d.8. of this
final rule with comment period, we do not believe that an angiography
room would be used in the typical case for these procedures, and are
therefore replacing the recommended equipment item ``room,
angiography'' with equipment item ``room, radiographic-fluoroscopic''
(EL014) for all three codes on an interim final basis. Since the
predecessor procedure codes generally did not include an angiography
room and we do not have a reason to believe that the procedure would
have shifted to an angiography room in the course of this coding
change, we do not believe that the use of an angiography room would be
typical for these procedures.
We are refining the RUC-recommended MP crosswalks for the codes in
this family, as we do not believe that the source codes, which are
cardiovascular services, are representative of the specialty mix that
would typically furnish the genitourinary catheter procedures. Instead,
we are establishing interim final MP crosswalks from codes with a
specialty mix similar to the expected mix of those furnishing the
services described by the new codes. We are therefore establishing the
following MP crosswalks as interim final for 2016: CPT code 50606 from
50955, CPT code 50705 from 50393, and CPT code 50706 from 50395.
(7) Laparoscopic Radical Prostatectomy (CPT Code 55866)
For CPT code 55866, the RUC recommended a work RVU of 26.80. This
is significantly higher than the work RVU for CPT code 55840
(Prostatectomy, retropubic radical, with or without nerve sparing), the
key reference code selected by the specialty society's survey
participants. This reference code shares an intraservice time of 180
minutes as well as similar total time (442 minutes for CPT code 55866,
relative to 448 minutes for CPT code 55840). We believe that these
codes are medically similar and would require similar work resources,
and CPT code 55840 was recently reviewed in CY 2014. However, CPT code
55840 has a work RVU of 21.36 while the RUC-recommended work RVU for
CPT code 55866 is 26.80. We do not believe that difference in intensity
between CPT code 55840 and CPT code 55866 is significant enough to
warrant the difference of 5.50 work RVUs.
In addition to CPT code 55840, we also examined CPT code 55845 as
another medically similar and recently RUC-reviewed procedure. CPT code
55845 is an open procedure that involves a lymphadenectomy, while CPT
code 55866 is a laparoscopic procedure without a lymphadenectomy. In
the CY 2014 PFS Final Rule with Comment Period, CMS requested review of
CPT codes 55845 and 55866 as potentially misvalued because the work RVU
for the laparoscopic procedure (55866) was higher than for the open
procedure (55845). In general, we do not believe that a laparoscopic
procedure would require greater resources than the open procedure.
However, the RUC-recommended work RVU for CPT code 55866 is 26.80,
which is still higher than the work RVU of 25.18 for CPT code 55845. We
do not believe that the rank order of these work RVUs accurately
reflects the relative resources
[[Page 71055]]
typically required to furnish these procedures, and believe that the
work RVU for CPT code 55866 should be lower than that of CPT code
55845. Therefore, we are establishing an interim final work RVU of
21.36 for CPT code 55866 based on a crosswalk from CPT code 55840.We
believe that this is an appropriate valuation based on the procedure
time and the resources typically used to furnish the procedure.
(8) Intracranial Endovascular Intervention (CPT Codes 61645, 61650 and
61651)
The CPT Editorial Panel created three new codes to describe
percutaneous intracranial endovascular intervention procedures and to
bundle inherent imaging services. These services were previously
reported using CPT codes 61640-61642 (Balloon dilatation of
intracranial vasospasm). In establishing interim final values for these
services, we are refining the RUC-recommended work RVUs for all of the
codes in this family. The RUC recommended a work RVU of 17.00 for CPT
code 61645 (Percutaneous arterial transluminal mechanical thrombectomy
and/or infusion for thrombolysis, intracranial), referencing CPT code
37231 (Revascularization, endovascular, open or percutaneous, tibial,
peroneal artery, unilateral, initial vessel; with transluminal stent
placement(s) and atherectomy, includes angioplasty within the same
vessel, when performed) and CPT code 37182 (Insertion of transvenous
intrahepatic portosystemic shunt(s) (TIPS)). We believe that CPT code
37231 is an appropriate direct crosswalk because the overall work is
similar to that of CPT code 61645. Therefore, we are establishing an
interim final work RVU of 15.00 for CPT code 61645. Additionally, in
reviewing the work time for CPT code 61645, we noted that it includes
postservice work time associated with postoperative visit CPT code
99233 (level 3 subsequent hospital care, per day). As we stated in the
CY 2010 PFS proposed rule (74 FR 33557) and affirmed in the CY 2011 PFS
proposed rule (75 FR 40072), we believe that for the typical patient,
these services would be considered hospital outpatient services, not
inpatient services. We believe that we should treat the valuation of
the work time in the same manner as discussed previously, that is, by
valuing the intraservice time of the hospital observation care service
in the immediate post service time of the 23-hour stay code being
valued. Therefore, we refined the work time for CPT code 61645 by
removing the 55 minutes of work time associated with CPT code 99233
(subsequent hospital care) and instead included the 30 minutes of
intraservice time from CPT code 99233 in the immediate postservice time
of the procedure. This reduces the total work time from 266 minutes to
241 minutes and increases the immediate post service time from 53
minutes to 83 minutes.
The RUC recommended a work RVU of 12.00 for CPT code 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). We believe the RUC-recommended work RVU
overestimates the work involved in furnishing this procedure. To
establish an interim final work RVU for CPT code 61650, we are using a
direct crosswalk from CPT code 37221 (Revascularization, endovascular,
open or percutaneous, iliac artery, unilateral, initial vessel; with
transluminal stent placement(s), includes angioplasty within the same
vessel, when performed), which shares an intraservice time of 90
minutes with similar intensity. Therefore, we are establishing an
interim final work RVU of 10.00 for CPT code 61650.
For CY 2016, we are also establishing interim final work time by
removing the 55 minutes total time associated with CPT code 99233
(subsequent hospital care) as recommended by the RUC and instead
allocating the intraservice time of 30 minutes to the immediate
postservice time of the procedure. This reduces the total time from 231
minutes to 206 minutes and the immediate post service time from 45
minutes to 75 minutes.
The RUC recommended a work RVU of 5.50 for CPT code 61651
(Endovascular intracranial prolonged administration of pharmacologic
agent(s) other than for thrombolysis, arterial, including catheter
placement, diagnostic angiography, and imaging guidance; each
additional vascular territory (List separately in addition to the
primary code)). We believe that a direct crosswalk from CPT code 37223
(Revascularization, endovascular, open or percutaneous, iliac artery,
each additional ipsilateral iliac vessel; with transluminal stent
placement(s), includes angioplasty within the same vessel, when
performed (List separately in addition to code for primary procedure)),
more accurately reflects the work described by CPT code 61651. We
believe that CPT code 37223 is an appropriate crosswalk because it
shares intraservice time, has similar intensity, and is clinically
similar to CPT code 61651. Therefore, we are establishing an interim
final work RVU of 4.25 for CPT code 61651.
We have also refined the RUC-recommended malpractice crosswalks for
this family of codes to align with the specialty mix that furnish the
services in this family. We are establishing the following interim
final malpractice crosswalks in place of the RUC-recommended
malpractice crosswalks: CPT code 37218 to CPT code 61645; and CPT code
37202 to CPT codes 61650 and 61651.
(9) Paravertebral Block Injection (CPT Codes 64461, 64462, and 64463)
In CY 2015, the CPT Editorial Panel created three new codes to
describe paravertebral block injections at single or multiple levels,
as well as for continuous infusion for the administration of local
anesthetic for post-operative pain control and thoracic and abdominal
wall analgesia. We are establishing as interim final the RUC-
recommended work RVUs for CPT codes 64461 and 64462. For CPT code 64463
(Paravertebral block (PVB) (paraspinous block), thoracic continuous
infusion by catheter (includes imaging guidance, when performed) the
RUC recommended a work RVU of 1.90, which corresponds to the 25th
percentile survey result. After considering similar injection codes
with identical intra-service time and longer total times, we believe
the RUC recommendation for CPT code 64463 overestimates the work
involved in furnishing the service. We believe a direct crosswalk from
three other injection codes which all have a work RVU of 1.81 (CPT
codes 64461, 64446, and 64449) more accurately reflects the work
involved in furnishing this service. Therefore, for CY 2016, we are
establishing an interim final work RVU of 1.81 for CPT code 64463.
(10) Ocular Surface Membrane Placement (CPT Codes 65778 and 65779)
These services were identified through the New Technology/New
Services List in February 2010. For CY 2015, the RUC's Relativity
Assessment Workgroup noted there may have been diffusion in technology
for these services and requested that the specialty society survey
these codes for work and direct PE inputs. While we are establishing
the RUC-recommended work RVUs for CPT code 65778 and 65779 as interim
final, we removed the work time associated with the half-day discharge
management from CPT code 65779.
[[Page 71056]]
(11) Ocular Reconstruction Transplant (CPT Code 65780)
The RUC identified 65780 as potentially misvalued through a
misvalued code screen of 90-day global services (based on 2012 Medicare
utilization data) reported at least 1,000 times per year that included
more than 6 office visits. The RUC recommended a direct work RVU
crosswalk from CPT code 27829 (Open treatment of distal tibiofibular
joint (syndesmosis) disruption, includes internal fixation, when
performed). After examining comparable codes, we believe the RUC-
recommended work RVU of 8.80 for CPT code 65780 overstates the work
involved in the procedures given the reduction in intraservice and
total times. We believe that the ratio of the total times (230/316)
applied to the work RVU (10.73) more accurately reflects the work
involved in this procedure. Therefore, we are establishing an interim
final work RVU of 7.81 to CPT code 65780.
(12) Trabeculoplasty by Laser Surgery (CPT Code 65855)
The RUC identified CPT code 65855 (Trabeculoplasty by laser
surgery, 1 or more sessions (defined treatment series)) as potentially
misvalued through the review of 10-day global services with more than
1.5 postoperative visits. The RUC noted that the code was changed from
a 90-day to a 10-day global period when it was last valued in 2000.
However, the descriptor was not updated to reflect that change. CPT
code 65855 describes multiple laser applications to the trabecular
meshwork through a contact lens to reduce intraocular pressure. The
current practice is to perform only one treatment session of the laser
for glaucoma during a 10-day period and then wait for the effect on the
intraocular pressure. The descriptor for CPT code 65855 has been
revised and removes the language ``1 or more sessions'' to clarify this
change in practice.
The RUC recommended a work RVU of 3.00. While the RUC-recommended
value represents a reduction from the CY 2015 work RVU of 3.99, we
believe that significant reductions in the intraservice time, the total
time, and the change in the office visits represent a more significant
change in the work resources involved in furnishing the typical
service. The intraservice and total times were decreased by
approximately 33 percent while the elimination of two post-operative
visits (CPT code 99212) alone would reduce the overall work RVU by at
least 24 percent under the reverse BBM. However, the recommended work
RVU only represents a 25 percent reduction relative to the previous
value. To develop an interim final work RVU for this service, we
calculated an intraservice time ratio between the CY 2015 intraservice
time, 15 minutes, and the RUC-recommended intraservice time, 10
minutes, and applied this ratio to the current work RVU of 3.99 to
arrive at a work RVU of 2.66 for CPT code 65855. Therefore, for CY
2016, we are establishing an interim final work RVU of 2.66 for CPT
code 65855.
(13) Glaucoma Surgery (CPT Codes 66170 and 66172)
The RUC identified CPT codes 66170 and 66172 as potentially
misvalued through a 90-day global post-operative visits screen
(services reported at least 1,000 times per year that included more
than 6 office visits). We believe the RUC-recommended work RVU of 13.94
for CPT code 66170 (fistulization of sclera for glaucoma;
trabeculectomy ab externo in absence of previous surgery) does not
accurately account for the reductions in time. Specifically, the survey
results indicated reductions of 25 percent in intraservice time and 28
percent in total time. These reductions suggest that the RUC-
recommended work RVU for CPT code 66170 overstates the work involved in
furnishing the service, since the recommended value only represents a
reduction of approximately seven percent. We believe that applying the
intraservice time ratio, as described above, to the current work RVU
results in a more appropriate work RVU. Therefore, for CY 2016, we are
establishing an interim final work RVU of 11.27 for CPT code 66170.
For CPT code 66172 (fistulization of sclera for glaucoma;
trabeculectomy ab externo with scarring from previous ocular surgery or
trauma (includes injection of antifibrotic agents)), the RUC
recommended a work RVU of 14.81. After comparing the RUC-recommended
work RVUs for this code to the work RVUs of similar codes (for example,
CPT code 44900 (Incision and drainage of appendiceal abscess, open) and
CPT code 59100 (Hysterotomy, abdominal (eg, for hydatidiform mole,
abortion)), we believe the RUC-recommended work RVU of 14.81 overstates
the work involved in this procedure. For the same reasons and following
the same valuation methodology utilized above, we applied the
intraservice time ratio between the CY 2015 intraservice time and the
survey intraservice time, 60/90, to the CY 2015 work RVU of 18.86. This
results in a work RVU of 12.57 for CPT code 66172. Therefore, for CY
2016, we are establishing an interim final work RVU of 12.57 for CPT
code 66172.
(14) Retinal Detachment Repair (CPT Codes 67107, 67108, 67110, and
67113)
CPT codes 67107, 67108, 67110 and 67113 were identified as
potentially misvalued through the 90-day global post-operative visit
screen (either directly or indirectly as being part of the same
family). The RUC recommended a work RVU of 16.00 for CPT code 67107,
which corresponds to the 25th percentile survey result. While the RUC
recommendation represents a 5 percent reduction from the current work
RVU of 16.71, we believe the RUC recommendation still overvalues the
service given the 15 percent reduction in intraservice time and 25
percent reduction in total time. Using the methodology previously
described, we used the intraservice time ratio to arrive at an interim
final work RVU of 14.06. We believe this value more accurately reflects
the work involved in this service and is comparable to other codes that
have the same global period and similar intraservice time and total
time. For CY 2016, we are establishing an interim final work RVU of
14.06 for CPT code 67107.
For CPT code 67108, the RUC recommended a work RVU of 17.13 based
on the 25th percentile survey result, which reflects a 25 percent
reduction from the current work RVU. The survey results reflect a 53
percent reduction in intraservice time and a 42 percent reduction in
total time. We believe the RUC-recommended work RVU overstates the
work, given the significant reductions in intraservice time and total
time and does not maintain relativity among the codes in this family.
To determine the appropriate value for this code and maintain
relativity within the family, we preserved the 1.13 increment
recommended by the RUC, between this code and CPT code 67107, and
applied that increment to the interim final work RVU of 14.06 for CPT
code 67107. Therefore, we are establishing an interim final work RVU of
15.19 for CPT code 67108.
For CPT code 67110, the RUC recommended maintaining the current
work RVU of 10.25. To maintain appropriate relativity with the work
RVUs established for the other services within this family, we are
using the RUC-recommended -5.75 RVU differential between CPT code 67107
and CPT code 67110 to establish the CY 2016 interim final work RVU of
8.31 for CPT code 67110.
[[Page 71057]]
(15) Fetal MRI (CPT Codes 74712 and 74713)
For CY 2016, the CPT Editorial Panel established two new codes to
describe fetal MRI services, which were previously billed using CPT
codes 72195 (Magnetic resonance (eg, proton) imaging, pelvis; without
contrast material(s)), 72196 (with contrast material(s)) and 72197
(without contrast material(s), followed by contrast material(s) and
further sequences). For CY 2016, we are establishing as interim final
the RUC-recommended work RVU of 3.00 for 74712. The RUC recommended a
work RVU of 1.85 for add-on code 74713, with an intra-service time of
35 minutes. Based on the ratio of work to time for these codes, we
believe that the add-on code should approximate the relationship
between work and time in the base code; therefore, we are establishing
as interim final a work RVU of 1.78 for CPT code 74713, which
corresponds to the 25th percentile survey result.
(16) Interstitial Radiation Source Codes (CPT Codes 77778 and 77790)
The RUC identified CPT code 77778 (interstitial radiation source
application, complex, includes supervision, handling, loading of
radiation source, when performed) and CPT code 77790 (supervision,
handling, loading of radiation source) through a misvalued code screen
of codes reported together more than 75 percent of the time. After
reviewing the entire code family (CPT codes 77776, 77777, 77778, and
77790), the CPT Editorial Panel deleted the interstitial radiation
source codes (CPT codes 77776 and 77777) and revised CPT code 77778 to
incorporate the supervision and handling of brachytherapy sources
previously reported with CPT code 77790. The RUC recommended that CPT
code 77790 be valued without work, and recommended a work RVU of 8.78
for CPT code 77778. We are establishing an interim final value for CPT
code 77790 without a work RVU, consistent with the RUC's
recommendation.
The specialty society's survey indicated that the total service
time for CPT code 77778 was 220 minutes and the median work RVU was
8.78; however, the RUC recommended a total work time of 145 minutes. In
reviewing that recommendation, we cannot reconcile how the RUC
determined that the same survey results that overestimated the time by
over 50 percent at the same time accurately estimated the work, given
that time is a component of overall work. We believe that the 25th
percentile survey result is more likely to represent the typical
overall work in a survey in which time is overestimated. Therefore, we
are establishing an interim final work RVU of 8.00 for CPT code 77778
based on the 25th percentile survey. However, we are also seeking
comment regarding the accuracy of the survey results given the
significant disparity between the survey results and the considered
judgment of the RUC regarding the amount of overall time required to
furnish this service.
(17) Colon Transit Imaging (CPT Codes 78264, 78265, and 78266)
For CY 2016, the CPT Editorial Panel revised CPT code 78264
(gastric emptying study) to describe gastric emptying procedure, and
also created two new add-on codes, CPT code 78265 (gastric emptying
imaging study (eg, liquid, solid, or both); with small bowel transit up
to 24 hours) and CPT code 78266 (gastric emptying study (eg, liquid,
solid, or both with small bowel and colon transit for multiple days)).
The RUC recommendation indicates that the base CPT code 78264 was
previously used to report three distinct procedural variations. The new
codes were created to describe the services in the procedures.
We are establishing as interim final the RUC-recommended work RVUs
for CPT codes 78265 and 78266. However, we believe the RUC-recommended
work RVU of 0.80 overstates the work involved in CPT code 78264. We
note that CPT code 78264 has a higher recommended work RVU and a
shorter intraservice time relative to the other codes in the family.
Additionally, the CY 2016 RUC survey result showed a two minute
decrease, from 12 to 10 minutes, in the intraservice time for CPT code
78264. We considered reference CPT code 78226 (Hepatobiliary system
imaging, including gallbladder when present), as it shares the same
intraservice time of 10 minutes and has similar intensity, and we are
using a direct crosswalk from the work RVU of 0.74. We are establishing
an interim final work RVU of 0.74 for CPT code 78264.
We received invoices for several new supply and equipment items for
colon transit imaging services, as listed in Table 21. We have accepted
the invoices for these items and added them to the direct PE input
database. However, we are concerned that these invoice prices may not
be reflective of the typical costs associated with the submitted supply
items. We request that stakeholders review these prices and provide
invoices or other information to improve the accuracy of pricing for
these and other items in the direct PE database. Additionally, as
discussed in section II.A of the proposed rule, 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.
(18) Liver Elastography (CPT Code 91200)
For CY 2015, we used the RUC recommendation of 0.30 RVUs and direct
PE inputs without refinement to establish interim final values for CPT
code 91200. For CY 2016, we received an updated RUC recommendation of
0.27 RVUs; we have established the RUC-recommended work RVU and direct
PE inputs as interim final.
Comment: One commenter stated a concern about the assumption that
CMS used regarding the proportion of the total Medicare utilization
furnished in nonfacility and facility settings. The commenter suggested
that the assumption CMS used had a significant negative impact on the
PE RVUs so drastic as to not allow for the procedure to be furnished in
nonfacility settings.
Another commenter requested reconsideration for the nonfacility
payment rates stating the PE RVUs for the comparison codes CPT code
76700 (Ultrasound, abdominal, real time with image documentation;
complete) and CPT code 76102 (Radiologic examination, complex motion
(ie, hypercycloidal) body section (eg, mastoid polytomography), other
than with urography; bilateral) are significantly higher than CPT code
91200. The commenter also stated the nonfacility payment was lower than
the OPPS rate while the equipment costs are the same.
Response: We note that the proportion of services in the non-
facility setting versus the facility setting in our utilization has no
direct impact on the development of PE RVUs for each setting. We also
note that the comparison codes, CPT code 76700 and CPT code 76102 have
higher work RVUs; 0.81 for 76700 and 0.58 for 76102; since work is a
portion of the indirect PE allocator, the comparison codes would be
expected to have higher PE RVUs. Also, the capital equipment included
as a direct PE input for CPT code 76700 is more expensive and is used
for twice as long. While we agree with commenters that 76102 includes
similarly priced equipment to 91200, we note that this equipment is
used for more than 6 times as long (104 minutes vs. 16 minutes), and
the clinical labor staff time is also 6 times as long. These
differences in direct PE inputs and work result in a PE RVUs for the
comparison
[[Page 71058]]
codes suggested by the commenter that are far higher than the PE RVU
for 91200.
With respect to the commenter's statement about the comparison of
the PFS payment amount to the OPPS payment amount, we note that OPPS
payments for individual services are grouped into rates that reflect
the cost of a range of services. We also note that for services newly
priced under the OPPS, the APC assignment is based on that of the
predecessor codes and clinical similarity to other services. As such,
the payment rates for newly priced services may not be reflective of
the rates that will be assigned once claims data for these services
becomes available.
As stated above, we are establishing an interim final work RVU and
direct PE inputs; we will accept comments during the comment period for
this final rule with comment period.
(19) Electronic Analysis of Implanted Neurostimulator (CPT Codes 95971
and 95972)
For CY 2015, the RUC reviewed CPT codes 95971 and 95972 because
they were identified by the High Volume Growth Services Screen which
identifies services in which Medicare utilization increased by at least
100 percent from 2006 to 2011 screen. In the CY 2015 final rule with
comment period, we stated that the lack of survey data for CPT code
95973, along with the confusing descriptor language and intraservice
time for CPT code 95972, suggested the need for these services to be
described through revised codes. However, to facilitate more accurate
payment for these services pending such revisions, we adopted the RUC-
recommended intraservice time of 20 minutes and work RVU of 0.78 for
CPT code 95971. For CPT code 95972, we refined the RUC-recommended work
RVU of 0.90 to establish an interim final value of 0.80 and adopted the
RUC-recommended intraservice time of 23 minutes.
Comment: A commenter was disappointed that CMS did not accept the
RUC recommendation for CPT code 95972. The commenter stated support for
the RUC's determination of the work of CPT code 95972, based on its
similarity to CPT code 62370. The commenter also stated that the CMS
valuation for these services was arbitrary because CMS did not fully
detail its methodology. The commenter recommended that CMS adopt the
RUC recommendation for CPT code 95972 and continue to use the work RVU
value of 0.92 for 95973 until the RUC is able to conduct a survey of
95973 and provide an updated recommendation of the work RVU value for
this code.
Response: We appreciate the commenter's feedback and will consider
it in finalizing values for these codes. We note that in the CY 2015
final rule with comment period (79 FR 67670), we described our use of
the instraservice time ratio methodology to develop the work RVU for
95972. Additionally, we note that for CY 2016 the RUC recommended work
RVU is the same as the work RVU CMS established in the CY 2015 final
rule with comment period.
For CY 2016, the CPT Editorial Panel deleted CPT code 95973 and
modified the descriptor for CPT code 95972. The RUC again reviewed CPT
codes 95971 and 95972 and recommended no change to the work RVU of 0.78
with an intraservice time of 20 minutes for CPT code 95971. Because the
survey for CPT code 95972 had used the older descriptor, the RUC
recommended that the code be resurveyed with the correct descriptor and
that the current RVU of 0.80 with an intraservice time of 23 minutes be
maintained until the new survey is complete. We agree with the RUC that
we should use these values for these codes on an interim final basis
pending new recommendations from the RUC for the CY 2017 rule based on
a new survey for CPT code 95972. We look forward to receiving
recommendations from the AMA RUC, and intend to consider both codes
using the most recent survey data available.
(20) Prostate Biopsy, Any Method (HCPCS Code G0416)
For CY 2014, we finalized interim final work RVUs and direct PE
inputs for the surgical pathology services described by CPT codes
88300-88309 (Surgical Pathology, Levels I through VI). In conjunction
with the revaluation of these procedures, we modified the code
descriptors of G0416 through G0419 so that they described any method of
prostate needle biopsy services, rather than only saturation biopsies.
To simplify the coding, for CY 2014, we revised the descriptor for
G0416 on an interim final basis to reflect all prostate biopsies,
regardless of the number of specimens taken or the method used, and we
deleted the remaining G-codes. We also maintained the existing RVUs for
G0416, pending additional information, including recommendations from
the RUC, about the typical resource costs associated with prostate
biopsies. For CY 2016, we received and will be establishing as interim
final, the RUC's recommended direct PE inputs to use in valuing G0416.
However, we also received comments suggesting that the typical number
of blocks used in these services can be significantly lower than what
is assumed in the RUC recommendations. Given our consideration of those
comments and our anticipation of a RUC-recommended work RVU for CY 2017
rulemaking, we emphasize that we are seeking evidence of the typical
batch and block size used in furnishing this service.
We also note that the RUC recommended that, for purposes of
calculating overall PFS budget neutrality, we assume that more
practitioners will report these services accurately in the future than
did so in prior years. For purposes of calculating budget neutrality,
we generally assume that the Medicare utilization data reflect the
accurate reporting of PFS services in compliance with Medicare payment
rules. Therefore, we did not incorporate an anticipated shift toward
compliant coding as recommended by the RUC. The utilization crosswalk
used in setting rates for CY 2016 is available on the CMS Web site
under downloads for the CY 2016 PFS Final Rule at http://www.cms.gov/physicianfeesched/PFSFederalRegulationNotices.html/.
Table 21--Invoices Received for New Direct PE Inputs
----------------------------------------------------------------------------------------------------------------
Estimated non-
facility
allowed
CPT/HCPCS codes Item name CMS code Average price Number of services for
invoices HCPCS codes
using this
item
----------------------------------------------------------------------------------------------------------------
41530, 43229, 43270............. radiofrequency EQ374 $ 10,000.00 1 2,932
generator (Gyrus
ENT G3
workstation).
[[Page 71059]]
47534, 47535, 47536, 47538, internal/external SD312 162.80 1 220
47539, 47540. biliary catheter.
47538, 47539, 47540............. Viabil covered SD313 2,721.00 2 26
biliary stent.
47543........................... Radial Jaw......... SD314 94.20 1 0
47543........................... stone basket....... SD315 417.00 1 0
64463........................... Catheter securement SD316 .............. 0 514
device.
76377........................... computer ED014 45,926.00 1 67,296
workstation, 3D
reconstruction CT-
MR.
77778........................... Applicator (TPV- EQ373 9,770.00 1 517
200)/Kit.
77778........................... reentrant well EP117 5,180.00 2 517
ionization chamber.
77778, 77790.................... L-block (needle EP118 1,195.00 1 1,848
loading shield).
78264, 78265, 78266............. Bread.............. SK121 0.16 1 9,735
78264, 78265, 78266............. Egg Whites......... SK122 0.16 1 9,735
78264, 78265, 78266............. Jelly.............. SK123 0.06 1 9,735
78264, 78265, 78266............. paper plate........ SK124 0.17 1 9,735
93050........................... Central Blood EP119 14,700.00 2 25,000
Pressure
Monitoring
Equipment (XCEL
PWA & PWV System).
----------------------------------------------------------------------------------------------------------------
I. Medicare Telehealth Services
1. Billing and Payment for Telehealth Services
Several conditions must be met for Medicare to make payments for
telehealth services under the PFS. The service must be on the list of
Medicare telehealth services and meet all of the following additional
requirements:
The service must be furnished via an interactive
telecommunications system.
The service must be furnished by a physician or other
authorized practitioner.
The service must be furnished to an eligible telehealth
individual.
The individual receiving the service must be located in a
telehealth originating site.
When all of these conditions are met, Medicare pays a facility fee
to the originating site and makes a separate payment to the distant
site practitioner furnishing the service.
Section 1834(m)(4)(F)(i) of the Act defines Medicare telehealth
services to include consultations, office visits, office psychiatry
services, and any additional service specified by the Secretary, when
furnished via a telecommunications system. We first implemented this
statutory provision, which was effective October 1, 2001, in the CY
2002 PFS final rule with comment period (66 FR 55246). We established a
process for annual updates to the list of Medicare telehealth services
as required by section 1834(m)(4)(F)(ii) of the Act in the CY 2003 PFS
final rule with comment period (67 FR 79988).
As specified at Sec. 410.78(b), we generally require that a
telehealth service be furnished via an interactive telecommunications
system. Under Sec. 410.78(a)(3), an interactive telecommunications
system is defined as multimedia communications equipment that includes,
at a minimum, audio and video equipment permitting two-way, real-time
interactive communication between the patient and distant site
physician or practitioner.
Telephones, facsimile machines, and stand-alone electronic mail
systems that are not integrated into an electronic health record system
do not meet the definition of an interactive telecommunications system.
An interactive telecommunications system is generally required as a
condition of payment; however, section 1834(m)(1) of the Act allows the
use of asynchronous ``store-and-forward'' technology when the
originating site is part of a federal telemedicine demonstration
program in Alaska or Hawaii. As specified in Sec. 410.78(a)(1),
asynchronous store-and-forward is the transmission of medical
information from an originating site for review by the distant site
physician or practitioner at a later time.
Medicare telehealth services may be furnished to an eligible
telehealth individual notwithstanding the fact that the practitioner
furnishing the telehealth service is not at the same location as the
beneficiary. An eligible telehealth individual is an individual
enrolled under Part B who receives a telehealth service furnished at a
telehealth originating site.
Practitioners furnishing Medicare telehealth services are reminded
that these services are subject to the same non-discrimination laws as
other services, including the effective communication requirements for
persons with disabilities of section 504 of the Rehabilitation Act and
language access for persons with limited English proficiency, as
required under Title VI of the Civil Rights Act of 1964. For more
information, see http://www.hhs.gov/ocr/civilrights/resources/specialtopics/hospitalcommunication.
Practitioners furnishing Medicare telehealth services submit claims
for telehealth services to the MACs that process claims for the service
area where their distant site is located. Section 1834(m)(2)(A) of the
Act requires that a practitioner who furnishes a telehealth service to
an eligible telehealth individual be paid an amount equal to the amount
that the practitioner would have been paid if the service had been
furnished without the use of a telecommunications system.
Originating sites, which can be one of several types of sites
specified in the statute where an eligible telehealth individual is
located at the time the service is being furnished via a
telecommunications system, are paid a facility fee under the PFS for
each Medicare telehealth service. The statute specifies both the types
of entities that can serve as originating sites and the geographic
qualifications for originating sites. With regard to geographic
qualifications, Sec. 410.78(b)(4) limits originating sites to those
located in rural health professional shortage areas (HPSAs) or in a
county that is not included in a metropolitan statistical area (MSA).
[[Page 71060]]
Historically, we have defined rural HPSAs to be those located
outside of MSAs. Effective January 1, 2014, we modified the regulations
regarding originating sites to define rural HPSAs as those located in
rural census tracts as determined by the Office of Rural Health Policy
(ORHP) of the Health Resources and Services Administration (HRSA) (78
FR 74811). Defining ``rural'' to include geographic areas located in
rural census tracts within MSAs allows for broader inclusion of sites
within HPSAs as telehealth originating sites. Adopting the more precise
definition of ``rural'' for this purpose expands access to health care
services for Medicare beneficiaries located in rural areas. HRSA has
developed a Web site tool to provide assistance to potential
originating sites to determine their geographic status. To access this
tool, see the CMS Web site at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
An entity participating in a federal telemedicine demonstration
project that has been approved by, or received funding from, the
Secretary as of December 31, 2000 is eligible to be an originating site
regardless of its geographic location.
Effective January 1, 2014, we also changed our policy so that
geographic status for an originating site would be established and
maintained on an annual basis, consistent with other telehealth payment
policies (78 FR 74400). Geographic status for Medicare telehealth
originating sites for each calendar year is now based upon the status
of the area as of December 31 of the prior calendar year.
For a detailed history of telehealth payment policy, see 78 FR
74399.
2. Adding Services to the List of Medicare Telehealth Services
As noted previously, in the December 31, 2002 Federal Register (67
FR 79988), we established a process for adding services to or deleting
services from the list of Medicare telehealth services. This process
provides the public with an ongoing opportunity to submit requests for
adding services. Under this process, we assign any qualifying request
to make additions to the list of telehealth services to one of two
categories. Revisions to criteria that we use to review requests in the
second category were finalized in the November 28, 2011 Federal
Register (76 FR 73102). The two categories are:
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
proposed service; for example, the use of interactive audio and video
equipment.
Category 2: Services that are not similar to 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 deliver 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.
For the list of telehealth services, see the CMS Web site at
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
Requests to add services to the list of Medicare telehealth
services must be submitted and received no later than December 31 of
each calendar year to be considered for the next rulemaking cycle. For
example, qualifying requests submitted before the end of CY 2015 will
be considered for the CY 2017 proposed rule. 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
a vehicle for making changes to the list of Medicare telehealth
services, requestors should be advised that any information submitted
is subject to public disclosure for this purpose. For more information
on submitting a request for an addition to the list of Medicare
telehealth services, including where to mail these requests, see the
CMS Web site at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
3. Submitted Requests to the List of Telehealth Services for CY 2016
Under our existing 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 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, the criteria
also expedite our ability to identify codes for the telehealth list
that resemble those services already on this list.
a. Submitted Requests
We received several requests in CY 2014 to add various services as
Medicare telehealth services effective for CY 2016. The following
presents a discussion of these requests, and our proposals for
additions to the CY 2016 telehealth list. Of the requests received, we
found that the following services were sufficiently similar to
psychiatric diagnostic procedures or office/outpatient visits currently
on the telehealth list to qualify on a category 1 basis. Therefore, we
proposed to add the following services to the telehealth list on a
category 1 basis for CY 2016:
CPT code 99356 (prolonged service in the inpatient or
observation setting, requiring unit/floor time beyond the usual
service; first hour (list separately in addition to code for inpatient
evaluation and management service)); and 99357 (prolonged service in
the inpatient or observation setting, requiring unit/floor time beyond
the
[[Page 71061]]
usual service; each additional 30 minutes (list separately in addition
to code for prolonged service)).
The prolonged service codes can only be billed in conjunction with
hospital inpatient and skilled nursing facility evaluation & management
(E/M) codes, and of these, only subsequent hospital and subsequent
nursing facility visit codes are on list of Medicare telehealth
services. Therefore, CPT codes 99356 and 99357 would only be reportable
with codes for which limits of one subsequent hospital visit every
three days via telehealth, and one subsequent nursing facility visit
every 30 days, would continue to apply.
CPT codes 90963 (end-stage renal disease (ESRD) related
services for home dialysis per full month, for patients younger than 2
years of age to include monitoring for the adequacy of nutrition,
assessment of growth and development, and counseling of parents); 90964
(end-stage renal disease (ESRD) related services for home dialysis per
full month, for patients 2-11 years of age to include monitoring for
the adequacy of nutrition, assessment of growth and development, and
counseling of parents); 90965 (end-stage renal disease (ESRD) related
services for home dialysis per full month, for patients 12-19 years of
age to include monitoring for the adequacy of nutrition, assessment of
growth and development, and counseling of parents); and 90966 (end-
stage renal disease (ESRD) related services for home dialysis per full
month, for patients 20 years of age and older).
Although these services are for home-based dialysis, and a
patient's home is not an authorized originating site for telehealth, we
recognize that many components of these services could be furnished
when a patient is located at a telehealth originating site and,
therefore, can be furnished via telehealth.
The required clinical examination of the catheter access site must
be furnished face-to-face ``hands on'' (without the use of an
interactive telecommunications system) by a physician, certified nurse
specialist (CNS), nurse practitioner (NP), or physician's assistant
(PA). An interactive telecommunications system may be used to provide
additional visits required under the 2-to-3 visit Monthly Capitation
Payment (MCP) code and the 4-or-more visit MCP code. See the final rule
for CY 2005 (69 FR 66276) for further information on furnishing ESRD
services via telehealth.
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 the following procedures for the reasons noted:
All E/M services; telerehabilitation services; and
palliative care, pain management and patient navigation services for
cancer patients.
None of these requests identified the specific codes that were
being requested for addition as telehealth services, and two of the
requests did not include evidence of any clinical benefit when the
services are furnished via telehealth. Since we did not have
information on the specific codes requested for addition or evidence of
clinical benefit for these requests, we cannot evaluate whether the
services are appropriate for addition to the Medicare telehealth
services list.
CPT codes 99291 (critical care, evaluation and management
of the critically ill or critically injured patient; first 30-74
minutes); and 99292 (critical care, evaluation and management of the
critically ill or critically injured patient; each additional 30
minutes (list separately in addition to code for primary service).
We previously considered and rejected adding these codes to the
list of Medicare telehealth services in the CY 2009 PFS final rule (74
FR 69744) on a category 1 basis because, due to the acuity of
critically ill patients, we did not consider critical care services
similar to any services on the current list of Medicare telehealth
services. In that rule, we said that critical care services must be
evaluated as category 2 services. Because we would consider critical
care services under category 2, we needed to evaluate whether these are
services for which telehealth can be an adequate substitute for a face-
to-face encounter, based on the category 2 criteria at the time of that
request. We had no evidence suggesting that the use of telehealth could
be a reasonable surrogate for the face-to-face delivery of this type of
care.
The American Telemedicine Association (ATA) submitted a new request
for CY 2016, which cited several studies to support adding these
services on a category 2 basis. To qualify under category 2, we would
need evidence that the service produces a clinical benefit for the
patient. However, in reviewing the information provided by the ATA and
a study entitled, ``Impact of an Intensive Care Unit Telemedicine
Program on Patient Outcomes in an Integrated Health Care System,''
published July 2014 in JAMA Internal Medicine, which found no evidence
that the implementation of ICU telemedicine significantly reduced
mortality rates or hospital length of stay, we do not believe that the
submitted evidence demonstrates a clinical benefit to patients.
Therefore, we did not propose to add these services on a category 2
basis to the list of Medicare telehealth services for CY 2016.
CPT code 99358 (prolonged evaluation and management
service before and/or after direct patient care; first hour) and 99359
(prolonged evaluation and management service before and/or after direct
patient care; each additional 30 minutes (list separately in addition
to code for prolonged service)).
As we indicated in the CY 2015 PFS final rule with comment period
(79 FR 67600), these services are not separately payable by Medicare.
It would be inappropriate to include a service as a telehealth service
when Medicare does not otherwise make a separate payment for it.
Therefore, we did not propose to add these nonpayable services to the
list of Medicare telehealth services for CY 2016.
CPT code 99444 (online evaluation and management service
provided by a physician or other qualified health care professional who
may report an evaluation and management service provided to an
established patient or guardian, not originating from a related E/M
service provided within the previous 7 days, using the internet or
similar electronic communications network).
As we indicated in the CY 2014 PFS final rule with comment period
(78 FR 74403), we assigned a status indicator of ``N'' (Noncovered
service) to this service because: (1) This service is non-face-to-face;
and (2) the code descriptor includes language that recognizes the
provision of services to parties other than the beneficiary and for
whom Medicare does not provide coverage (for example, a guardian).
Under section 1834(m)(2)(A) of the Act, Medicare pays the physician or
practitioner furnishing a telehealth service an amount equal to the
amount that would have been paid if the service was furnished without
the use of a telecommunications system. Because CPT code 99444 is
currently noncovered, there would be no Medicare payment if this
service was furnished without the use of a telecommunications system.
Since this service is noncovered under Medicare, we are not proposing
to add it to the list of Medicare telehealth services for CY 2016.
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
[[Page 71062]]
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).
This service is one that can be furnished without the beneficiary's
face-to-face presence, and using any number of non-face-to-face means
of communication. Therefore, the service is not appropriate for
consideration as a Medicare telehealth service. It is unnecessary to
add this service to the list of Medicare telehealth services.
Therefore, we did not propose to add it to the list of Medicare
telehealth services for CY 2016.
CPT codes 99605 (medication therapy management service(s)
provided by a pharmacist, individual, face-to-face with patient, with
assessment and intervention if provided; initial 15 minutes, new
patient); 99606 (medication therapy management service(s) provided by a
pharmacist, individual, face-to-face with patient, with assessment and
intervention if provided; initial 15 minutes, established patient); and
99607 (medication therapy management service(s) provided by a
pharmacist, individual, face-to-face with patient, with assessment and
intervention if provided; each additional 15 minutes (list separately
in addition to code for primary service)).
These codes are noncovered services for which no payment may be
made under the PFS. Therefore, we did not propose to add these services
to the list of Medicare telehealth services for CY 2016.
In summary, we proposed to add the following codes to the list of
Medicare telehealth services beginning in CY 2016 on a category 1
basis: Prolonged service inpatient CPT codes 99356 and 99357 and ESRD-
related services 90963 through 90966. As indicated above, the prolonged
service codes can only be billed in conjunction with subsequent
hospital and subsequent nursing facility codes. Limits of one
subsequent hospital visit every three days, and one subsequent nursing
facility visit every 30 days, would continue to apply when the services
are furnished as telehealth services. For the ESRD-related services,
the required clinical examination of the catheter access site must be
furnished face-to-face ``hands on'' (without the use of an interactive
telecommunications system) by a physician, CNS, NP, or PA.
4. Proposal to amend Sec. 410.78 to Include Certified Registered Nurse
Anesthetists as Practitioners for Telehealth Services
Under section 1834(m)(1) of the Act, Medicare makes payment for
telehealth services furnished by physicians and practitioners. Section
1834(m)(4)(E) of the Act specifies that, for purposes of furnishing
Medicare telehealth services, the term ``practitioner'' has the meaning
given that term in section 1842(b)(18)(C) of the Act, which includes a
certified registered nurse anesthetist (CRNA) as defined in section
1861(bb)(2) of the Act.
We initially omitted CRNAs from the list of distant site
practitioners for telehealth services in the regulation because we did
not believe these practitioners would furnish any of the service on the
list of Medicare telehealth services. However, CRNAs in some states are
licensed to furnish certain services on the telehealth list, including
E/M services. Therefore, we proposed to revise the regulation at Sec.
410.78(b)(2) to include a CRNA, as described under Sec. 410.69, to the
list of distant site practitioners who can furnish Medicare telehealth
services.
The following is a summary of the comments we received on proposals
related to telehealth services.
Comment: All commenters supported one or more of our proposals to
add prolonged service inpatient procedures (CPT codes 99356 and 99357)
and ESRD-related services for home dialysis procedures (CPT codes
90963, 90964, 90965 and 90966) to the list of Medicare telehealth
services for CY 2016.
Response: We appreciate the commenters' support for the proposed
additions to the list of Medicare telehealth services. After
consideration of the public comments received, we are finalizing our CY
2016 proposal to add these services to the list of telehealth services
for CY 2016 on a category 1 basis.
Comment: Concerning our proposal to add prolonged services in the
inpatient or observation setting (CPT codes 99356 and 99357) to the
telehealth list, a few commenters questioned the need for CMS to
establish a limit on the frequency with which these services can be
provided, since there is no such limit when they are provided in-
person. The commenter suggested that the criteria should be whether the
services are reasonable and necessary, safe and effective, medically
appropriate, and provided in accordance with accepted standards of
medical practice. The commenter concluded that care provided via
telemedicine should be paid as other physician services and that the
technology used to deliver the services should not be the primary
consideration.
Response: In the PFS final rule for CY 2011 (75 FR 73317), we
concluded that subsequent hospital care visits by a patient's admitting
practitioner may sufficiently resemble follow-up inpatient consultation
services to add these subsequent hospital care services on a category 1
basis for the telehealth list. Although we still believed the potential
acuity of hospital inpatients is greater than those patients likely to
receive currently approved Medicare telehealth services, we also
believed that it would be appropriate to permit some subsequent
hospital care services to be furnished through telehealth to ensure
that hospitalized patients have frequent encounters with their
admitting practitioner. However, we also believed 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.
Therefore, we added subsequent hospital care services, specifically
CPT codes 99231, 99232, and 99233, to the list of telehealth services
on a category 1 basis in CY 2011, but with some limitations on the
frequency with which these services may be furnished through
telehealth. Because of our concerns regarding the potential acuity of
hospital inpatients, we limited the provision of subsequent hospital
care services through telehealth to once every 3 days. We were
confident that admitting practitioners would continue to make
appropriate in-person visits to all patients who need such care during
their hospitalization.
Likewise, for CY 2011, we concluded that subsequent nursing
facility visits by a patient's admitting practitioner sufficiently
resemble follow-up inpatient consultation services to consider them on
a category 1 basis for the telehealth list. We concluded that 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, although we continued to believe that the federally
mandated visits should be in-person to facilitate the comprehensive,
coordinated, and personal care that these complex patients require on
an ongoing basis.
Therefore, we added subsequent nursing facility care services,
specifically CPT codes 99307, 99308, 99309, and 99310, to the list of
Medicare telehealth services on a
[[Page 71063]]
category 1 basis in CY 2011, with some limitations on furnishing these
services through telehealth. 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.
We believe the concerns that we addressed in the cases discussed in
this section continues to hold for CPT codes 99356 and 99357, and that
frequency limits are appropriate to ensure that patients continue to
receive appropriate and high-quality care.
We note that section 1834(m) of the Act requires Medicare to make
the same payment for services furnished via telehealth as is made for
face-to-face services. In addition, it provides for payment of an
originating site facility fee. However, the statute does not require
that all conditions for payment for telehealth services be the same as
for the services when furnished without the use of an interactive
telecommunications system. We continue to believe the established
frequency limits are appropriate and will leave them in place for these
services.
Comment: Some commenters supported and others disagreed with our
decision not to add critical care services (CPT codes 99291 and 99292)
to the list of telehealth services. One commenter questioned why
intensive care unit (ICU) telemedicine (TM) must demonstrate
significantly reduced mortality rates or hospital length of stay for
Medicare coverage. The commenter further noted that CMS covers new
codes and procedures routinely without any evidence that they
significantly reduce mortality rates or hospital length of stay. The
commenter suggested that the criteria should be whether the proposed
telehealth services are reasonable and necessary, safe and effective,
medically appropriate, and provided in accordance with accepted
standards of medical practice. The commenter believes CMS is applying a
comparative effectiveness standard to coverage of telehealth services
that it does not apply elsewhere in its coverage and payment for
physician services, resulting in a double standard for coverage.
Another commenter questioned our statement that there is ``no
evidence that the implementation of ICU TM significantly reduce[s]
mortality rates or hospital length of stay,'' noting that these are not
category 2 criteria and that telemedicine for critical care services
clearly meets the following three criteria for adding services on a
category 2 basis:
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.
The commenter maintained that telemedicine is safe and feasible for
all patients. The commenter further maintained that advances in today's
technology enable health care providers to deliver a focused, critical
intervention no matter where the patient may be situated and/or what
services are delivered.
Another commenter questioned the relevance of the ``JAMA Internal
Medicine Study'' we cited because it involved VA hospitals whose
patients do not represent the Medicare patient population. Finally, a
commenter indicated that adding these services to the telehealth list
would support the clinical stabilization of such patients awaiting
critical care and/or surgical intervention or transport, in which a
specialist may not be available to support the immediate clinical needs
of the patient.
Response: We disagree that we have applied a comparative
effectiveness standard to the coverage of telehealth. As noted, in
reviewing requests to add services on a category 2 basis, we look for
evidence indicating that the use of a telecommunications system in
furnishing the candidate telehealth service produces clinical benefit
to the patient. In this circumstance of ICU critical care, we did not
review the evidence to determine if the evidence demonstrated that the
benefit of in-person ICU critical care was greater than in a
telemedicine setting. We limited our review to the evidence of benefit
of telemedicine in ICU critical care.
As noted in the proposed rule (80 FR 41783), we reviewed the
information provided by the ATA. We also reviewed a study entitled,
``Impact of an Intensive Care Unit Telemedicine Program on Patient
Outcomes in an Integrated Health Care System,'' published July 2014 in
JAMA Internal Medicine that addressed potential clinical benefits of
these kinds of services furnished via telehealth. The two studies had
contradictory conclusions. In any evidentiary review, valid conclusions
must be made based upon the totality of the available evidence. One
must look at the quality of the study, the study hypothesis,
appropriate study design, appropriate inclusion/exclusion factors,
appropriate statistical analyses, and many other factors to adequately
address the validity of the data. These factors are then used to draw
conclusions about the totality of the evidence. In doing so for this
service, we concluded that the totality of the evidence did not
demonstrate a benefit for ICU telemedicine. This conclusion does not
mean that a benefit does not exist. This conclusion only states that
the totality of the evidence is not sufficient to reach a conclusion
that a benefit exists. Although our proposal not to add these codes to
the telehealth list did not specifically address whether or not the
critical care service is accurately described by the requested codes
when furnished via telehealth, we also reconsidered that portion of the
category 2 criteria when we reconsidered our assessment in the context
of the comments on the proposed rule. Based on our review of the code
descriptors and CPT prefatory language, we do not believe that the
services described by the critical care codes accurately describe the
full range of services required by patients in need of that level of
care. Instead, we believe that the kinds of services furnished to these
patients via telehealth are more accurately described by the inpatient/
emergency department telehealth consultation codes, which are already
on the list of Medicare telehealth services. Specifically, we believe
that the kinds of telehealth services commenters describe as effective
in the clinical stabilization of patients awaiting critical care and/or
surgical intervention or transport, and in which a specialist may not
be available to support the immediate clinical needs of the patient,
are more accurately described and paid through the telehealth g-codes
than through the critical care E/M CPT codes that describe in-person
services.
In Response to commenters who suggested that we are applying a
``double standard'' for coverage of telehealth services, we note that
section 1834(m)(4)(F) of the Act initially provided a payment mechanism
for services furnished via telehealth for professional consultations,
office visits, and office psychiatry services. The statute further
required the Secretary to establish a process for annual additions or
deletions to the telehealth list to be paid under particular
circumstances. The statute does not suggest that any service that
potentially could be furnished via telehealth should be included.
Rather, the statute specifies a consideration process by CMS before
making changes to the list of Medicare telehealth services. Since
establishing the process in 2002, we have added codes to the telehealth
list on a regular
[[Page 71064]]
basis and we will continue to do so, as appropriate, using the
established process.
Comment: A few commenters objected to our decision not to add
online E/M service, chronic care management services, and medication
therapy management services to the telehealth services list.
Response: As noted, online E/M service (CPT code 99444) is
currently noncovered; there would be no Medicare payment if this
service was furnished without the use of a telecommunications system.
Chronic care management services (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. Therefore, it is unnecessary
to add this service to the list of Medicare telehealth services. The
chronic care management service can inherently be furnished using a
wide range of remote communication technologies. Medication therapy
management services (CPT codes 99605-99607) are noncovered services for
which no payment may be made under the PFS. Therefore, we did not
propose to add these services to the list of Medicare telehealth
services for CY 2016.
Comment: Concerning our decision to add ESRD services (CPT codes
90963 through 90764) which includes counseling of parents, a commenter
requested adding counseling of caregiver and family as all patients may
not have parents as their only caregiver.
Response: Although the CPT code descriptor specifies only parents,
we believe that legal guardians would be recognized in lieu of parents.
Comment: Commenters requested that:
A patient's home, a dialysis facility, and an assisted
living facility serve as originating sites for telehealth services.
Originating site restrictions to rural areas be
eliminated.
Home health providers, registered nurses (RNs), Certified
Pediatric Nurse Practitioners (CPNPs) and Certified Family Nurse
Practitioners (CFNPs) be included in the list of eligible providers
telehealth.
The ability of NPs and PAs in a retail clinic setting to
furnish telehealth services be clarified and that payment be
commensurate with furnishing an in-person service.
Response: Section 1834(m)(4)(C) of the Act does not include a
patient's home, a dialysis facility, or an assisted living facility as
an originating site. Additionally, an originating site must be in a
rural HPSA; in a county that is not in an MSA; or a participant in a
federal telemedicine demonstration project approved as of December 31,
2000.
Section 1834(m)(4)(E) of the Act defines a practitioner for
telehealth services per section 1842(b)(18)(C), which does not include
home health providers or RNs. CPNPs or CFNPS are authorized to furnish
telehealth services if they meet the conditions for NPs in section
1861(a)(a)(5) of the Act. NPs and PAs can furnish telehealth service as
distant site practitioners. There are no specific criteria for a
distant site. Therefore, there are no telehealth rules that would
prohibit eligible distant site practitioners from furnishing telehealth
services from a retail clinic, assuming the telehealth individual
(beneficiary) is located at a telehealth originating site. Section
1834(m)(2)(A) of the Act provides that payment for a service furnished
via telehealth equals the payment that would be made for an in-person
service. Because these requirements are specified in the statute, we do
not have discretion to revise the telehealth rules as desired by the
commenters.
Comment: Many commenters supported, and one commenter opposed, our
proposal to revise Sec. 410.78(b)(2) to include a CRNA, as described
under Sec. 410.69, to the list of distant site practitioners who can
furnish Medicare telehealth services. One commenter expressed concern
that CRNAs furnish only services they are qualified to furnish.
Response: We appreciate the commenters' support for the proposal to
revise the regulation. We note that section 1834(m)(4)(E) of the Act
defines a practitioner for telehealth services per section
1842((b)(18)(C) of the Act, which includes CRNAs. We also note that
CRNAs can only furnish services they are legally authorized to perform
in the state in which the services are performed. After consideration
of the public comments received, we are finalizing our proposal to
revise Sec. 410.78(b)(2) to include a CRNA.
We wish to inform stakeholders of the following initiatives to
promote telehealth:
The CMS Innovation Center is responsible for developing and testing
new payment and service delivery models to lower costs and improve
quality for Medicare, Medicaid, and CHIP beneficiaries. As part of that
authority, the CMS Innovation Center can consider potential new payment
and service delivery models to test changes to Medicare's telehealth
payment policies. For example, the Next Generation Accountable Care
Organization (ACO) Model is an Innovation Center initiative for ACOs
that are experienced in coordinating care for populations of patients.
It will allow these provider groups to assume higher levels of
financial risk and reward than are available under the current Pioneer
ACO Model and Medicare Shared Savings Program (Shared Savings Program).
The goal of the Model is to test whether strong financial incentives
for ACOs, coupled with tools to support better patient engagement and
care management, can improve health outcomes and lower expenditures for
Medicare fee-for-service (FFS) beneficiaries. Central to the Next
Generation ACO Model are several benefit enhancement tools to help ACOs
improve engagement with beneficiaries. ACOs participating in this Model
have the opportunity to provide aligned beneficiaries with access to
home visits and telehealth services that exceed what is currently
covered under the Medicare program, and CMS will make reward payments
to aligned beneficiaries who receive a high percentage of their care
from the ACO and from certain providers and suppliers that have agreed
to participate in the ACO's network as ACO Participants or Preferred
Providers under this Model.
The Fed-Tel Committee is comprised of employees from various
federal agencies whose purpose is to facilitate telehealth education
and information sharing, as well as coordinate funding opportunity
announcements and other programmatic materials.
We reminded all interested stakeholders that we are currently
soliciting public requests to add services to the list of Medicare
telehealth services. To be considered during PFS rulemaking for CY
2017, these requests must be submitted and received by December 31,
2015. 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. For more information on
submitting a request for an addition to the list of Medicare telehealth
services, including where to mail these requests, we refer readers to
the CMS Web site at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
5. Telehealth Originating Site Facility Fee Payment Amount Update
Section 1834(m)(2)(B) of the Act establishes 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
[[Page 71065]]
calendar year, the telehealth originating site facility fee is
increased by the percentage increase in the MEI as defined in section
1842(i)(3) of the Act. The MEI increase for 2016 is 1.1 percent.
Therefore, for CY 2016, the payment amount for HCPCS code Q3014
(Telehealth originating site facility fee) is 80 percent of the lesser
of the actual charge or $25.10. The Medicare telehealth originating
site facility fee and the MEI increase by the applicable time period is
shown in Table 22.
Table 22--The Medicare Telehealth Originating Site Facility Fee and MEI
Increase by the Applicable Time Period
------------------------------------------------------------------------
Time period MEI increase Facility fee
------------------------------------------------------------------------
10/01/2001-12/31/2002................... N/A $20.00
01/01/2003-12/31/2003................... 3 20.60
01/01/2004-12/31/2004................... 2.9 21.20
01/01/2005-12/31/2005................... 3.0 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
------------------------------------------------------------------------
J. Incident to Proposals: Billing Physician as the Supervising
Physician and Ancillary Personnel Requirements
1. Background
Section 1861(s)(2)(A) of the Act establishes the benefit category
for services and supplies furnished as ``incident to'' the professional
services of a physician. The statute specifies that services and
supplies furnished as an incident to a physician's professional service
(hereinafter ``incident to services'') are ``of kinds which are
commonly furnished in physicians' offices and are commonly either
rendered without charge or included in physicians' bills.'' In addition
to the requirements of the statute, the regulation at Sec. 410.26 sets
forth specific requirements that must be met for physicians and other
practitioners to bill Medicare for incident to services. Section
410.26(a)(7) limits ``incident to'' services to those included under
section 1861(s)(2)(A) of the Act and that are not covered under another
benefit category. Section 410.26(b) specifies (in part) that for
services and supplies to be paid as incident to services under Medicare
Part B, the services or supplies must be:
Furnished in a noninstitutional setting to
noninstitutional patients.
An integral, though incidental, part of the service of a
physician (or other practitioner) in the course of diagnosis or
treatment of an injury or illness.
Furnished under supervision (as specified under Sec.
410.26(a)(2) and Sec. 410.26(b)(5)) of a physician or other
practitioner eligible to bill and directly receive Medicare payment.
Furnished by a physician, a practitioner with an incident
to benefit, or auxiliary personnel.
In addition to Sec. 410.26, there are regulations specific to each
type of practitioner who is allowed to bill for incident to services as
specified in Sec. 410.71(a)(2) (clinical psychologist services), Sec.
410.74(b) (PAs' services), Sec. 410.75(d) (NPs' services), Sec.
410.76(d) (CNSs' services), and Sec. 410.77(c) (certified nurse-
midwives' services). Incident to services are treated as if they were
furnished by the billing physician or other practitioner for purposes
of Medicare billing and payment. Consistent with this terminology, when
referring in this discussion to the physician or other practitioner
furnishing the service, we are referring to the physician or other
practitioner who is billing for the incident to service. When we refer
to the ``auxiliary personnel'' or the person who ``provides'' the
service, we are referring to an individual who is personally performing
the service or some aspect of it as distinguished from the physician or
other practitioner who bills for the incident to service.
Since we treat incident to services as services furnished by the
billing physician or other practitioner for purposes of Medicare
billing and payment, payment is made to the billing physician or other
practitioner under the PFS, and all relevant Medicare rules apply
including, but not limited to, requirements regarding medical
necessity, documentation, and billing. Those practitioners who can bill
Medicare for incident to services are paid at their applicable Medicare
payment rate as if they personally furnished the service. For example,
when incident to services are billed by a physician, they are paid at
100 percent of the fee schedule amount, and when the services are
billed by a nurse practitioner or clinical nurse specialist, they are
paid at 85 percent of the fee schedule amount. Payments are subject to
the usual deductible and coinsurance amounts.
In the CY 2014 PFS final rule with comment period, we amended Sec.
410.26 by adding a paragraph (b)(7) to require that, as a condition for
Medicare Part B payment, all incident to services must be furnished in
accordance with applicable state law. Additionally, we amended the
definition of auxiliary personnel at Sec. 410.26(a)(1) to require that
the individual who provides the incident to services must meet any
applicable requirements to provide such services (including licensure)
imposed by the state in which the services are furnished. These
requirements for compliance with applicable state laws apply to any
individual providing incident to services as a means to protect the
health and safety of Medicare beneficiaries in the delivery of health
care services, and to provide the Medicare program with additional
recourse for denying or recovering Part B payment for incident to
services that are not furnished in compliance with state law (78 FR
74410). Revisions to Sec. 410.26(a)(1) and (b)(7) were intended to
clarify the longstanding payment policy of paying only for services
that are furnished in compliance with any
[[Page 71066]]
applicable state or federal requirements. The amended regulations also
provide the Medicare program with additional recourse for denying or
recovering Part B payment for incident to services that are not
furnished in compliance with applicable requirements.
2. Billing Physician as the Supervising Physician
In addition to the CY 2014 revisions to the regulations for
incident to services, we believe that additional requirements for
incident to services should be explicitly and unambiguously stated in
the regulations. As described in this final rule with comment period,
incident to a physician's or other practitioner's professional services
means that the services or supplies are furnished as an integral,
although incidental, part of the physician's or other practitioner's
personal professional services in the course of diagnosis or treatment
of an injury or illness (Sec. 410.26(b)(2)). Incident to services
require direct supervision of the auxiliary personnel providing the
service by the physician or other practitioner (Sec. 410.26(b)(5))
with the exception that allows care management services and
transitional care management services (other than the required face-to-
face visit) to be furnished under the general supervision of the
physician (or other practitioner).)
We proposed to revise the regulations specifying the requirements
for which physicians or other practitioners can bill for incident to
services. In the CY 2002 PFS final rule (66 FR 55267), in response to a
comment seeking clarification regarding what physician billing number
should be used on the claim form for an incident to service, we stated
that when a claim is submitted to Medicare under the billing number of
a physician or other practitioner for an incident to service, the
physician or other practitioner is stating that he or she performed the
service or directly supervised the auxiliary personnel performing the
service. Additionally, in Transmittal 148, which was published on April
23, 2004, effective May 24, 2004, we specifically instructed
practitioners as to how claim forms should be completed to account for
the fact that the supervising physician or other practitioner is
responsible for the incident to service. Section 410.26(b)(5) currently
states that the physician (or other practitioner) supervising the
auxiliary personnel need not be the same physician (or other
practitioner) upon whose professional service the incident to service
is based. To be certain that the incident to services furnished to a
beneficiary are in fact an integral, although incidental, part of the
physician's or other practitioner's personal professional service that
is billed to Medicare, we believe that the physician or other
practitioner who bills for the incident to service must also be the
physician or other practitioner who directly supervises the service. It
has been our position that billing practitioners should have a personal
role in, and responsibility for, furnishing services for which they are
billing and receiving payment as an incident to their own professional
services. This is consistent with the requirements that all physicians
and billing practitioners attest on each Medicare claim that he or she
``personally furnished'' the services for which he or she is billing.
Without this requirement, there could be an insufficient nexus with the
physician's or other practitioner's services being billed on a claim to
Medicare as incident to services and the actual services being
furnished to the Medicare beneficiary by the auxiliary personnel.
Therefore, we proposed to amend Sec. 410.26(b)(5), consistent with
previous preamble discussion and subregulatory guidance, that the
physician or other practitioner who bills for incident to services must
also be the physician or other practitioner who directly supervises the
auxiliary personnel who provide the incident to services. Also, to
further clarify the meaning of the proposed amendment to this
regulation, we proposed to remove the last sentence from Sec.
410.26(b)(5), which specified that the physician (or other
practitioner) supervising the auxiliary personnel need not be the same
physician (or other practitioner) upon whose professional service the
incident to service is based.
3. Auxiliary Personnel Who Have Been Excluded or Revoked From Medicare
As a condition of Medicare payment, auxiliary personnel who, under
the direct supervision of a physician or other practitioner, provide
incident to services to Medicare beneficiaries must comply with all
applicable federal and state laws. This includes not having been
excluded from Medicare, Medicaid and all other federally funded health
care programs. We proposed to amend the regulation to explicitly
prohibit auxiliary personnel from providing incident to services who
have either been excluded from Medicare, Medicaid and all other
federally funded health care programs by the Office of Inspector
General (OIG) or who have had their enrollment revoked for any reason.
These excluded or revoked individuals are already prohibited from
providing services to Medicare beneficiaries, so this proposed revision
is an additional safeguard to ensure that these excluded or revoked
individuals are not providing incident to services and supplies under
the direct supervision of a physician or other authorized supervising
practitioner. These proposed revisions to the incident to regulations
will provide the Medicare program with additional recourse for denying
or recovering Part B payment for incident to services and supplies that
are not furnished in compliance with our program requirements.
4. Compliance and Oversight
We recognize that there are many ways in which compliance with
these requirements could be consistently and fairly assured across the
Medicare program. In considering implementation of these proposals, we
wish to be mindful of the need to minimize or eliminate any
practitioner administrative burden while at the same time ensuring that
practitioners are not subjected to unnecessary audits or placed at risk
of being inadvertently deemed non-compliant. Therefore, while we
believe that the initial responsibility of compliance rests with the
practitioner, we invited comments through this final rule with comment
period about possible approaches we could take to improve our ability
to ensure that incident to services are provided to beneficiaries by
qualified individuals in a manner consistent with Medicare statute and
regulations. We invited commenters to consider the options we
considered, such as creating new categories of enrollment, implementing
a mechanism for registration short of full enrollment, requiring the
use of claim elements such as modifiers to identify the types of
individuals providing services, or relying on post-payment audits,
investigations and recoupments by CMS contractors such as Recovery
Auditors or Program Integrity Contractors. We considered these comments
in the course of finalizing proposals for CY 2016, and will continue to
consider these comments should we decide in the future that additional
regulations or guidance will be necessary to monitor compliance with
these or other requirements surrounding incident to services.
The following is a summary of the comments we received regarding
our proposals on ``incident to'' services.
Comment: Many commenters sought clarification on whether CMS's
proposal requires that a physician or other practitioner who furnishes
the initial care and/or orders or refers incident to services must also
be the same
[[Page 71067]]
individual who also directly supervises and bills Medicare for incident
to services. These commenters urged CMS to clarify that the proposed
change would not require that the physician or other practitioner who
orders, refers, develops a treatment plan, or initiates treatment must
also directly supervise all incident to services.
Response: We understand these comments, and in making our proposal,
we intended to amend the current incident to regulations to state
explicitly that only the physician or other practitioner who directly
supervises the auxiliary personnel who provide the incident to services
may bill Medicare for the incident to services. The proposed policy was
not intended to require that the supervising physician or other
practitioner must be the same individual as the physician or other
practitioner who orders or refers the beneficiary for the services, or
who initiates treatment. Rather, we intended to clarify that under
circumstances where the supervising practitioner is not the same as the
referring, ordering, or treating practitioner, only the supervising
practitioner may bill Medicare for the incident to service. As stated
in the CY 2002 PFS final rule at 66 FR 55267 in response to a comment
seeking clarification regarding what physician billing number should be
used on the claim form for an incident to service, we stated that the
Medicare billing number of the ordering physician or other practitioner
should not be used if that person did not directly supervise the
auxiliary personnel. When the billing number of the physician or other
practitioner is reported on the claim form, the physician or
practitioner is stating that he or she directly performed the service,
or supervised the auxiliary personnel performing the service consistent
with the required level of supervision. Accordingly, we believe that an
explicit statement in the regulations text further strengthens our
intent that only the physician or other practitioner directly
supervising the incident to services may bill Medicare for the incident
to services.
Comment: While some commenters supported our proposal to amend
regulatory text regarding incident to services, the majority of
commenters opposed our proposal to remove the last sentence from Sec.
410.26(b)(5) to clarify our proposal to require that the billing
physician or other practitioner for incident to services must have
directly supervised the auxiliary personnel who provided incident to
services. This sentence in the current incident to regulations states
that the physician (or other practitioner) supervising the auxiliary
personnel need not be the same physician (or other practitioner) upon
whose professional service the incident to service is based. Most of
these commenters believe that the removal of this sentence represents a
change in longstanding policy regarding how incident to services are
furnished and billed, especially by group practices and multispecialty
clinics, rather than a clarification about who the program requires to
bill for incident to services. Other commenters stated that we should
maintain the final sentence of Sec. 410.26(b)(5), in current
regulations because they believe the policy, as expressed in the
sentence allows for situations where incident to services may be
furnished during an extended course of care under the supervision of a
different physician or other practitioner than the one that is
ordering, referring, diagnosing, or initially treating the patient.
Still other commenters suggested that our proposal to remove the
sentence will severely impact patient care in terms of access, creating
delays in care and in some cases restricting care for patients--
particularly those in rural areas and low-income populations, when the
same physician or other practitioner who orders services and/or
initiates care is not also available and present to directly supervise
the incident to services. Additionally, many of these commenters urged
us to restore the sentence that we proposed to remove, or to not
finalize the proposal, because they believe it would be overly
burdensome to group practices and multispecialty clinics to impose the
proposed billing and supervision requirements. These commenters
indicated that, for these types of practices or for anything other than
a solo practice, our proposal creates a financial burden, requires
extensive restructuring, and imposes operational and staff coverage
difficulties particularly in locum tenens situations, scheduling
vacations and, in situations where the same physician or other
practitioner does not practice daily at the same location.
Response: We appreciate the concerns of commenters who urged us not
to delete the final sentence in regulation at Sec. 410.26(b)(5). Since
we believe the incident to services provided by auxiliary personnel are
based on the professional services of the directly supervising
physician or other practitioner (who has a personal role in, and
responsibility for, furnishing services for which they are billing and
receiving payment), we thought our regulations would be made clearer by
removing the final sentence of the regulation at Sec. 410.26(b)(5). We
have considered the extensive and insightful comments expressing
concern about how the removal of the subject sentence might be
construed to be a change in policy that would require that the
physician (or other practitioner) supervising the auxiliary personnel
must be the same physician (or other practitioner) who is treating the
patient more generally. We also considered the comments from
stakeholders who suggested the change in the regulatory language would
adversely impact the physician community, particularly group practices
and multispecialty clinics. Given the concerns that have been
expressed, we are not finalizing our proposal to delete the final
sentence of the regulatory language. Instead, we will revise this
sentence to reflect our policy that the physician (or other
practitioner) supervising the auxiliary personnel need not be the same
physician (or other practitioner) treating the patient more broadly. In
addition to this revised sentence, we will add clarifying regulation
text specifying that only the physician or other practitioner under
whose supervision the incident to service(s) are being provided is
permitted to bill the Medicare program for the incident to services.
Comment: One commenter disagreed with our proposal to specify that
only the directly supervising physician or other practitioner is
permitted to bill for incident to services. The commenter advised that,
in single specialty groups, to require that incident to services must
be billed by the directly supervising physician or other practitioner
who is present at the time the incident to services are furnished,
rather than the ordering physician or other practitioner who is also
present, creates an unnecessary tracking, accounting, and scheduling
burden on the practice. The commenter suggested that in situations
where the ordering physician or other practitioner and the directly
supervising physician or other practitioner are in the same single
specialty group, and both are present at the time that auxiliary
personnel are providing incident to services, either the ordering or
supervising physician or other practitioner should be permitted to bill
for the incident to services.
Response: Although the physician or practitioner who orders or
refers a beneficiary for a service has a connection to the services, we
believe the physician or other practitioner directly supervising the
incident to service assumes responsibility and accountability for the
care of the patient that is provided by auxiliary personnel.
[[Page 71068]]
Hence, we maintain that it is appropriate to limit billing for incident
to services to the physician or practitioner who supervises the
provision of those services. Although we understand that individual
practitioners or practices may need to improve the tracking and
accounting regarding the supervision and billing of incident to
services, we do not agree with the commenter that such tracking or
accounting is unnecessary. Instead, we believe that such tracking and
accounting is necessary to ensure that practitioners bill appropriately
for services furnished incident to their professional services.
Comment: Some commenters supported our proposal to amend the
current regulations to state explicitly that only the directly
supervising physician or other practitioner can bill the program for
incident to services, and to remove the sentence under current
regulations indicating that the physician or other practitioner
directly supervising the auxiliary personnel need not be the same
physician or other practitioner upon whose professional service the
incident to service is based. These commenters interpreted our proposal
to promote clear direction on the appropriate billing practices for
incident to services in that the proposals are transparent and impose
accountability. Additionally, one of these commenters characterized our
proposals as clarifications that will allow small primary care
practices to continue providing high quality and coordinated care.
Response: We appreciate these comments, which indicate that the
commenters understood the intent of our proposals and did not interpret
them as requiring changes in the way incident to services are furnished
and billed.
Comment: Most commenters that addressed our proposal regarding
auxiliary personnel who have been excluded or revoked from the Medicare
program supported our approach. The commenters stated that since
excluded or revoked individuals are already prohibited from furnishing
incident to services to Medicare patients, our proposal will provide
the Medicare program with additional recourse for denying or recovering
Part B payment for incident to services that are not furnished in
compliance with program requirements. The commenters believe that our
proposed prohibition will improve the quality of incident to services
overall because it offers an additional safeguard against the
possibility of auxiliary personnel who have been excluded or revoked
from the Medicare program continuing to provide services to
beneficiaries by obscuring them as incident to the services of another
practitioner. However, one commenter opposed the proposal because the
commenter believed that it would prevent marriage and family therapists
from providing incident to services as auxiliary personnel since the
commenter believed these therapists are excluded from the Medicare
program.
Response: We appreciate the support for our proposal and are
finalizing our proposal. We clarify that the term ``excluded'' in this
context does not refer to the kinds of practitioners who do not have a
benefit, and are not permitted to bill independently for their services
under Medicare law.
Comment: In addition to the comments discussed above that are
specifically related to our proposals, we received several comments in
response to our solicitation of comments regarding future potential
compliance and oversight considerations for incident to services. We
also received several comments on the incident to benefit that are
outside the scope of our specific proposal or solicitation. These
comments addressed issues such as: Developing a list of CPT codes to
distinguish therapeutic services that can be billed on an incident to
basis from diagnostic tests that cannot be billed incident to; an
explicit determination about whether CPT codes representing services
that contain both a technical component and a professional component
can be billed incident to; or whether CPT codes representing services
with only a technical component can be billed incident to; and how
transition care management and chronic care management services are
affected by incident to requirements.
Response: We thank commenters for their feedback. We will consider
these comments in the context of developing future improvements to
guidance regarding incident to services.
After considering the comments that we received on incident to
services under our proposed rule, we are finalizing the changes to our
regulation at Sec. 410.26(a)(1) without modification, and we are
finalizing the proposed change to the regulation at Sec. 410.26(b)(5)
with a clarifying modification. Specifically, we are amending the
definition of the term, ``auxiliary personnel'' at Sec. 410.26(a)(1)
that are permitted to provide ``incident to'' services to exclude
individuals who have been excluded from the Medicare program or have
had their Medicare enrollment revoked. Additionally, we are amending
Sec. 410.26(b)(5) by revising the final sentence to make clear that
the physician (or other practitioner) directly supervising the
auxiliary personnel need not be the same physician (or other
practitioner) that is treating the patient more broadly, and adding a
sentence to specify that only the physician (or other practitioner)
that supervises the auxiliary personnel that provide incident to
services may bill Medicare Part B for those incident to services.
K . Portable X-Ray: Billing of the Transportation Fee
Part B's payment to portable X-ray suppliers includes a
transportation fee for transporting portable X-ray equipment to the
location where portable X-rays are taken. If more than one patient at
the same location is X-rayed during the course of the visit, the
portable X-ray transportation fee is prorated to reflect this. We have
received feedback that some portable X-ray suppliers have been
operating under the assumption that when multiple patients receive
portable X-ray services in this manner, the transportation fee would
only be prorated among a subset of those patients. The Medicare Claims
Processing Manual (Pub. 100-4, Chapter 13, Section 90.3) currently
states:
Carriers shall allow only a single transportation payment for
each trip the portable X-ray supplier makes to a particular
location. When more than one Medicare patient is X-rayed at the same
location, e.g., a nursing home, prorate the single fee schedule
transportation payment among all patients receiving the services.
For example, if two patients at the same location receive X-rays,
make one-half of the transportation payment for each.
In some jurisdictions, Medicare contractors have been allowing the
portable X-ray transportation fee to be allocated only among Medicare
Part B beneficiaries. In other jurisdictions, Medicare contractors have
required the transportation fee to be allocated among all Medicare
patients (Parts A and B). We believe it would be more appropriate to
determine the transportation fee attributable to Medicare Part B by
allocating it among all patients who receive portable X-ray services in
a single trip. Medicare Part B should not pay for more than its share
of the transportation costs for portable X-ray services.
For CY 2016, we proposed to revise the Medicare Claims Processing
Manual (Pub. 100-4, Chapter 13, Section 90.3) to remove the word
``Medicare'' before ``patient'' in section 90.3. We also proposed to
clarify that this subregulatory guidance means that, when more than one
patient is X-rayed at the same location, the transportation payment
under the PFS for the Part B
[[Page 71069]]
patient(s) is to be prorated by allocating the trip among all patients
(Medicare Parts A and B, and non-Medicare) receiving portable X-ray
services during that trip, regardless of their insurance status. For
example, for portable X-ray services furnished during a single trip to
a skilled nursing facility (SNF), we believe that the transportation
fee should be allocated among all patients receiving services during
the trip, irrespective of whether the patient is in a Part A stay, a
Part B patient, or not a Medicare beneficiary at all. Thus, for a
Medicare Part B patient, the prorated transportation fee made under
Part B would appropriately reflect the share of the trip that is
actually attributable to that patient. The following is a summary of
the comments we received on our proposal to clarify the subregulatory
guidelines to determine Medicare Part B's portion of the portable X-ray
services' transportation fee.
Comment: Some commenters supported our proposal to clarify the
current subregulatory guidance for the portable X-ray transportation
fee. The commenters believe that this proposal will ensure consistent
treatment of the payment for transportation among the different MACs
and will eliminate the overpayment of portable X-ray transportation
services. Other commenters supported our proposal, but advised CMS not
to implement the proposal without also including a transportation fee
proration policy for payers under Medicare Part A, Medicare Advantage,
and Medicaid to pay an amount for transportation that is equal to the
proportion of their covered patients receiving an X-ray on that trip to
the facility. If CMS implements the proration of the transportation fee
for Medicare Part B only, the commenters stated that the result will be
reduced payment to the portable X-ray transportation suppliers.
Response: We appreciate the commenters' support for our proposal.
With regard to the commenters that asked CMS to consider requiring
Medicare Part A and non-Medicare payers to pay a prorated
transportation fee amount for their covered patients receiving portable
X-ray services during the same trip, we note that such requirements
generally are beyond the scope of this rule. However, with regard to
payment under Medicare Part A, as we noted in the SNF prospective
payment system (PPS) final rule for CY 2016 (80 FR 46408, August 4,
2015), under the SNF PPS, a SNF's global per diem payment for its
resident's covered Part A stay specifically includes the portable X-
ray's transportation and setup. Further guidance on arrangements
between SNFs and their suppliers is contained in CY 2016 SNF
prospective payment system (PPS) final rule with comment period, which
is available online at http://www.thefederalregister.org/fdsys/pkg/FR-2015-08-04/pdf/2015-18950.pdf.
Comment: Another commenter disagreed with the proposal and
indicated that the proration among Part B patients may discourage
community-based services if portable X-ray suppliers reduce their
services in light of the potential reduction in the payment they
previously received for the transportation fee. The commenter is
concerned that if portable X-ray suppliers do not provide X-ray
services in SNFs or other places where Medicare Part B beneficiaries
reside, that the beneficiaries would be required to receive X-ray
services in a hospital or other facility. The commenter suggested CMS
consider the negative impact of the proposal in the context of the
improved care and lowered cost of services in the community as compared
to facility-based care. The commenter also expressed concern about how
this would affect non-Medicare patients since third party payers often
end up paying more to offset reduced Medicare payments levels.
Response: We appreciate the commenter's feedback, and understand
the concerns raised regarding the implications of our proposal. We
agree that Medicare payment for services should encourage access to
care for Medicare beneficiaries. However, we do not believe that the
consistent application of payment policies that permit Medicare Part B
to make payment only for costs attributable to services furnished to
Medicare Part B patients is likely to discourage community-based care
such as portable X-ray services provided to individuals residing in a
SNF.
After consideration of the comments we received, we are finalizing
our proposed change to the subregulatory guidance in the Medicare
Claims Processing Manual (Pub. 100-4, Chapter 13, Section 90.3) to
clarify the portable X-ray transportation fee proration policy,
effective January 1, 2016. We believe the revision to the Manual
provides consistent direction to all MACs in the payment of portable X-
ray transportation for Medicare Part B claims. In addition, we believe
the revision strengthens program integrity under Medicare Part B
because Medicare will no longer pay for more than its share of the
portable X-ray transportation costs.
We received several comments that are not within the scope of our
proposal to clarify the subregulatory guidance in Sec. 90.3 of the
Medicare Claims Processing Manual, which pertains to portable X-ray
transportation fee proration policy. The topics addressed by commenters
included recommendations that CMS:
Update regulations which govern conditions for coverage of
portable x-ray services.
Consider allowing certain services to be performed in a
mobile setting.
Clarify and/or change the consolidated billing payment
policy of diagnostic tests including portable X-ray.
Use multiple transportation codes that describe costs
attributable to different imaging modalities.
Response: We appreciate these comments, but they are beyond the
scope of this rule. However, we will review all recommendations
provided and consider them in the development of future policy.
L. Technical Correction: Waiver of Deductible for Anesthesia Services
Furnished on the Same Date as a Planned Screening Colorectal Cancer
Test
Section 1833(b)(1) of the Act waives the deductible for colorectal
cancer screening tests regardless of the code that is billed for the
establishment of a diagnosis as a result of the test, or the removal of
tissue or other matter or other procedure that is furnished in
connection with, as a result of, and in the same clinical encounter as
the screening test. To implement this statutory provision, we amended
Sec. 410.160 to add to the list of services to which the deductible
does not apply, beginning January 1, 2011, a surgical service furnished
in connection with, as a result of, and in the same clinical encounter
as a planned colorectal cancer screening test. A surgical service
furnished in connection with, as a result of, and in the same clinical
encounter as a colorectal cancer screening test means a surgical
service furnished on the same date as a planned colorectal cancer
screening test as described in Sec. 410.37.
In the CY 2015 PFS final rule with comment period, we modified the
regulatory definition of colorectal cancer screening test with regard
to colonoscopies to include anesthesia services whether billed as part
of the colonoscopy service or separately. (See Sec. 410.37(a)(1)(iii))
In the preamble to the final rule, we stated that the statutory waiver
of deductible would apply to anesthesia services furnished in
conjunction with a colorectal cancer screening test even when a polyp
or other tissue is removed during a
[[Page 71070]]
colonoscopy (79 FR 67731). We also indicated that practitioners should
report anesthesia services with the PT modifier in such circumstances.
The final policy was implemented for services furnished during CY 2015.
Although we modified the definition of colorectal cancer screening
services in Sec. 410.37(a)(1)(iii) to include anesthesia furnished
with a screening colonoscopy, we did not make a conforming change to
our regulations to expressly reflect the inapplicability of the
deductible to those anesthesia services.
To better reflect our policy in the regulations, we proposed a
technical correction to amend Sec. 410.160(b)(8) to expressly
recognize anesthesia services. Specifically, we proposed to amend Sec.
410.160(b)(8) to add ``and beginning January 1, 2015, for an anesthesia
service,'' following the first use of the phrase ``a surgical service''
and to add ``or anesthesia'' following the word ``surgical'' each time
it is used in the second sentence of Sec. 410.160(b)(8). This
amendment to our regulation will ensure that both surgical or
anesthesia services furnished in connection with, as a result of, and
in the same clinical encounter as a colorectal cancer screening test
will be exempt from the deductible requirement when furnished on the
same date as a planned colorectal cancer screening test as described in
Sec. 410.37.
Comment: A few commenters thanked us for modifying the definition
of colorectal cancer screening services to include anesthesia care and
for making the conforming change to regulations, noting that this will
help to increase access to screening colonoscopies. The commenters also
stated that the coinsurance should be waived in instances where the
screening becomes diagnostic, but noted that they understand that CMS
may not have the statutory authority to make this change. Commenters
also stated that if CMS were to receive such authority, they hope CMS
would make the associated regulatory change as quickly as possible so
that beneficiaries would be further encouraged to seek the screening.
One commenter urged CMS to identify a way a way under the existing
authority to redefine colorectal cancer screening to include
colonoscopy with removal of polyp or abnormal growth during the
screening encounter. The commenter stated that nearly half of all
patients who undergo screening colonoscopy have a polyp or other tissue
removed, and believed that the current policy is unfair and
disproportionately affects lower income beneficiaries. The commenter
also stated that there are various types of colorectal cancer
screenings, including fecal occult blood test, double contrast barium
enema, and CT colonography, and urged CMS to cover these other
screening tests without cost-sharing obligations for the beneficiary.
Response: We thank the commenters for their feedback and will
consider the issues that are within our authority for future
rulemaking. After consideration of these comments, we are finalizing
our proposed technical correction to amend Sec. 410.160(b)(8).
M. Therapy Caps
1. Outpatient Therapy Caps for CY 2016
Section 1833(g) of the Act requires application of annual per
beneficiary limitations on the amount of expenses that can be
considered as incurred expenses for outpatient therapy services under
Medicare Part B, commonly referred to as ``therapy caps.'' There is one
therapy cap for outpatient occupational therapy (OT) services and
another separate therapy cap for physical therapy (PT) and speech-
language pathology (SLP) services combined.
The therapy caps apply to outpatient therapy services furnished in
all settings, including the previously exempted hospital setting
(effective October 1, 2012) and critical access hospitals (CAHs)
(effective January 1, 2014).
The therapy cap amounts under section 1833(g) of the Act are
updated each year based on the Medicare Economic Index (MEI).
Specifically, the annual caps are calculated by updating the previous
year's cap by the MEI for the upcoming calendar year and rounding to
the nearest $10.00. Increasing the CY 2015 therapy cap of $1,940 by the
CY 2016 MEI of 1.1 percent and rounding to the nearest $10.00 results
in a CY 2016 therapy cap amount of $1,960.
An exceptions process for the therapy caps has been in effect since
January 1, 2006. Originally required by section 5107 of the Deficit
Reduction Act of 2005 (DRA), which amended section 1833(g)(5) of the
Act, the exceptions process for the therapy caps has been extended
multiple times through subsequent legislation as described in the CY
2015 PFS final rule with comment period (79 FR 67730) and most recently
extended by the Medicare Access and CHIP Reauthorization Act of 2015
(MACRA) (Pub. L. 114-10). The Agency's current authority to provide an
exceptions process for therapy caps expires on December 31, 2017.
CMS tracks each beneficiary's incurred expenses annually and counts
them towards the therapy caps by applying the PFS rate for each service
less any applicable multiple procedure payment reduction (MPPR) amount.
As required by section 1833(g)(6)(B), added by section 603(b) of the
American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-240) and
extended by subsequent legislation, the PFS-rate accrual process is
applied to outpatient therapy services furnished by CAHs even though
they are paid on a cost basis. After expenses incurred for the
beneficiary's outpatient therapy services for the year have exceeded
one or both of the therapy caps, therapy suppliers and providers use
the KX modifier on claims for subsequent services to request an
exception to the therapy caps. By use of the KX modifier, the therapist
is attesting that the services above the therapy caps 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 over the caps without the KX modifier are denied.
Since October 1, 2012, under section 1833(g)(5)(C) of the Act, we
have been required to apply a manual medical review process to therapy
claims when a beneficiary's incurred expenses for outpatient therapy
services exceed a threshold amount of $3,700. There are two separate
thresholds of $3,700, just as there are two separate therapy caps, one
for OT services and one for PT and SLP services combined; and incurred
expenses are counted towards the thresholds in the same manner as the
caps. Now, under section 1833(g)(5) of the Act as amended by section
202(b) of the MACRA, claims exceeding the therapy thresholds are no
longer automatically subject to a manual medical review process as they
were before. Rather, CMS is permitted to do a more targeted medical
review on these claims using factors specified in section
1833(g)(5)(E)(ii) of the Act as amended by section 202(b) of the MACRA,
including targeting those therapy providers with a high claims denial
rate for therapy services or with aberrant billing practices compared
to their peers. The statutorily-required manual medical review process
required under section 1833(g)(5)(C) of the Act expires at the same
time as the exceptions process for therapy caps on December 31, 2017.
For information on the 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.
[[Page 71071]]
2. Applying Therapy Caps to Maryland Hospitals
Since October 1, 2012, the therapy caps and related provisions have
applied to the outpatient therapy services furnished by hospitals as
recognized under section 1833(a)(8)(B) of the Act. Before then,
outpatient therapy services furnished by hospitals had been exempted
from the statutory therapy caps. Since 1999, hospitals have been paid
for the outpatient therapy services they furnish at PFS rates--the
applicable fee schedule established under section 1834(k)(3) of the
Act.
Beginning October 1, 2012, CMS has been required to apply the
therapy caps and related provisions to outpatient therapy services
under section 1833(g) of the Act furnished in hospitals. As with other
statutory provisions on therapy caps, this provision has been extended
several times by additional legislation. Most recently, section 202(a)
of the MACRA extended this broadened application of the therapy caps to
include outpatient therapy services furnished by hospitals through
December 31, 2017.
When we first implemented the statutory provision that extended
application of the therapy caps to outpatient therapy services
furnished by hospitals, we did not apply the therapy caps to most
hospitals in Maryland. Originally, this omission was linked to our
longstanding waiver policy under section 1814(b) of the Act, which
allowed Maryland to set the payment rates for hospital services,
including those for the outpatient therapy services they furnish. Since
2014, most hospitals in Maryland are paid at rates determined under the
Maryland All-Payer Model, which is being tested under the authority of
section 1115A of the Act.
To correct this oversight, we recently issued instructions through
Change Request 9223 (available online at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3367CP.pdf)
to our Maryland MAC to revise our systems to ensure the application of
the therapy caps and related provisions to the outpatient therapy
services provided in all Maryland hospitals. These instructions
included the direction to use the rates established under the Maryland
All-Payer Model rather than the PFS rates to accrue towards the per-
beneficiary therapy caps and thresholds. We believe using the Maryland
All-Payer Model rates rather than the PFS rates is consistent with the
statute at sections 1833(g)(1) and (3) of the Act that requires us to
count the actual expenses incurred in any calendar year towards the
beneficiary's therapy caps. These instructions will become effective
January 1, 2016.
III. Other Provisions of the Final Rule With Comment Period
A. Provisions 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 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
Our 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. 410.40 and Sec. 410.41. Part 414, subpart H, describes how
payment is made for ambulance services covered by Medicare.
2. Ambulance Extender Provisions
a. Amendment to Section 1834(l)(13) of the Act
Section 146(a) of the MIPPA 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 203(a) of the
Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-10,
enacted on April 16, 2015) amended section 1834(l)(13)(A) of the Act to
extend the payment add-ons through December 31, 2017. Thus, these
payment add-ons apply to covered ground ambulance transports furnished
before January 1, 2018. We proposed to revise Sec. 414.610(c)(1)(ii)
to conform the regulations to this statutory requirement. (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) and the CY 2015 PFS final rule with comment period
(79 FR 67743)).
[[Page 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 several comments
regarding this proposal. The following is a summary of the comments we
received and our response.
Comment: Several commenters supported the implementation of the
extension of the ambulance payment add-ons. These commenters also
agreed that these provisions are self-implementing. One commenter
encouraged CMS to seek to make these add-on payments permanent.
Response: We appreciate the commenters' support of these
provisions, but we do not have the authority to make these provisions
permanent.
After consideration of the public comments received, we are
finalizing our proposal 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 on 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 203(b) of the Medicare
Access and CHIP Reauthorization Act of 2015 amended section
1834(l)(12)(A) of the Act to extend this rural bonus through December
31, 2017. 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, 2018 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 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) and the CY 2015 PFS final rule with comment period
(79 FR 67743 through 67744)).
This statutory provision is self-implementing. It requires an
extension of this rural bonus (which was previously established by the
Secretary) through December 31, 2017, and does not require any
substantive exercise of discretion on the part of the Secretary. We
received several comments regarding this proposal. The following is a
summary of the comments we received and our response.
Comment: Several commenters supported the continued implementation
of the percent increase in the base rate of the fee schedule for
transports in areas defined as super rural. These commenters also
agreed with CMS that these provisions are self-implementing. One
commenter encouraged CMS to seek to make these add-on payments
permanent.
Response: We appreciate the commenters' support of these
provisions, but we do not have the authority to make these provisions
permanent.
After consideration of the public comments received, we are
finalizing our proposal to revise Sec. 414.610(c)(5)(ii) to conform
the regulations to this statutory requirement.
3. Changes in Geographic Area Delineations for Ambulance Payment
a. Background
In the CY 2015 PFS final rule with comment period (79 FR 67744
through 67750) as amended by the correction issued December 31, 2014
(79 FR 78716 through 78719), we adopted, beginning in CY 2015, the
revised OMB delineations as set forth in OMB's February 28, 2013
bulletin (No. 13-01) and the most recent modifications of the Rural-
Urban Commuting Area (RUCA) codes for purposes of payment under the
ambulance fee schedule. With respect to the updated RUCA codes, we
designated any census tracts falling at or above RUCA level 4.0 as
rural areas. In addition, we stated that none of the super rural areas
would lose their status upon implementation of the revised OMB
delineations and updated RUCA codes. After publication of the CY 2015
PFS final rule with comment period and the correction, we received
feedback from stakeholders expressing concerns about the implementation
of the new geographic area delineations finalized in that rule (as
corrected). In response to these concerns, in the CY 2016 PFS proposed
rule (80 FR 41788 through 41792), we clarified our implementation of
the revised OMB delineations and the updated RUCA codes in CY 2015, and
reproposed the implementation of the revised OMB delineations and
updated RUCA codes for CY 2016 and subsequent calendar years. We
requested public comment on our proposals, which comments are further
discussed in section III A.3.b. of this final rule with comment period.
b. Provisions of the Final Rule With Comment Period
Under section 1834(l)(2)(C) of the Act, the Secretary is required
to consider appropriate regional and operational differences in
establishing the ambulance fee schedule. Historically, the Medicare
ambulance fee schedule has used the same geographic area designations
as the acute care hospital inpatient prospective payment system (IPPS)
and other Medicare payment systems to take into account appropriate
regional (urban and rural) differences. This use of consistent
geographic standards for Medicare payment purposes provides for
consistency across the Medicare program.
The geographic areas used under the ambulance fee schedule
effective in CY 2007 were based on OMB standards published on December
27, 2000 (65 FR 82228 through 82238), Census 2000 data, and Census
Bureau population estimates for 2007 and 2008 (OMB Bulletin No. 10-02).
For a discussion of OMB's delineation of Core-Based Statistical Areas
(CBSAs) and our implementation of the CBSA definitions under the
ambulance fee schedule, we refer readers to the preamble of the CY
[[Page 71073]]
2007 Ambulance Fee Schedule proposed rule (71 FR 30358 through 30361)
and the CY 2007 PFS final rule with comment period (71 FR 69712 through
69716). On February 28, 2013, OMB issued OMB Bulletin No. 13-01, which
established revised delineations for Metropolitan Statistical Areas
(MSAs), Micropolitan Statistical Areas, and Combined Statistical Areas,
and provided guidance on the use of the delineations of these
statistical areas. A copy of this bulletin may be obtained at http://www.whitehouse.gov/sites/default/files/omb/bulletins/2013/b-13-01.pdf.
According to OMB, this bulletin provides the delineations of all
Metropolitan Statistical Areas, Metropolitan Divisions, Micropolitan
Statistical Areas, Combined Statistical Areas, and New England City and
Town Areas in the United States and Puerto Rico based on the standards
published in the June 28, 2010 Federal Register (75 FR 37246-37252) and
Census Bureau data. OMB defines an MSA as a CBSA associated with at
least one urbanized area that has a population of at least 50,000, and
a Micropolitan Statistical Area (referred to in this discussion as a
Micropolitan Area) as a CBSA associated with at least one urban cluster
that has a population of at least 10,000 but less than 50,000 (75 FR
37252). Counties that do not qualify for inclusion in a CBSA are deemed
``Outside CBSAs.'' We note that, when referencing the new OMB
geographic boundaries of statistical areas, we are using the term
``delineations'' consistent with OMB's use of the term (75 FR 37249).
Although the revisions OMB published on February 28, 2013 were not
as sweeping as the changes made when we adopted the CBSA geographic
designations for CY 2007, the February 28, 2013 OMB bulletin did
contain a number of significant changes. For example, there are new
CBSAs, urban counties that became rural, rural counties that became
urban, and existing CBSAs that were split apart. As we stated in the CY
2015 PFS final rule with comment period (79 FR 67745), we reviewed our
findings and impacts relating to the new OMB delineations, and found no
compelling reason to further delay implementation. We stated in the CY
2015 final rule with comment period, and in the CY 2016 PFS proposed
rule (80 FR 41788), that it is important for the ambulance fee schedule
to use the latest labor market area delineations available as soon as
reasonably possible to maintain a more accurate and up-to-date payment
system that reflects the reality of population shifts.
Additionally, in the FY 2015 IPPS/LTCH PPS final rule (79 FR
49952), we adopted OMB's revised delineations to identify urban areas
and rural areas for purposes of the IPPS wage index. For the reasons
discussed in this section, we believe that it was appropriate to adopt
the same geographic area delineations for use under the ambulance fee
schedule as are used under the IPPS and other Medicare payment systems.
Thus, in the CY 2016 PFS proposed rule (80 FR 41788), we proposed to
continue implementation of the new OMB delineations as described in the
February 28, 2013 OMB Bulletin No. 13-01 for CY 2016 and subsequent CYs
to more accurately identify urban and rural areas for ambulance fee
schedule payment purposes. We stated in the CY 2016 PFS proposed rule
(80 FR 41788) that we continue to believe that the updated OMB
delineations more realistically reflect rural and urban populations,
and that the use of such delineations under the ambulance fee schedule
would result in more accurate payment. Under the ambulance fee
schedule, consistent with our current definitions of urban and rural
areas (Sec. 414.605), in CY 2016 and subsequent CYs, MSAs would
continue to be recognized as urban areas, while Micropolitan and other
areas outside MSAs, and rural census tracts within MSAs (as discussed
below in this section), would continue to be recognized as rural areas.
We invited public comments on this proposal.
In addition to the OMB's statistical area delineations, the current
geographic areas used in the ambulance fee schedule also are based on
rural census tracts determined under the most recent version of the
Goldsmith Modification. These rural census tracts within MSAs are
considered rural areas under the ambulance fee schedule (see Sec.
414.605). For certain rural add-on payments, section 1834(l) of the Act
requires that we use the most recent version of the Goldsmith
Modification to determine rural census tracts within MSAs. In the CY
2007 PFS final rule with comment period (71 FR 69714 through 69716), we
adopted the most recent (at that time) version of the Goldsmith
Modification, designated as RUCA codes. RUCA codes use urbanization,
population density, and daily commuting data to categorize every census
tract in the country. For a discussion about RUCA codes, we refer the
reader to the CY 2007 PFS final rule with comment period (71 FR 69714
through 69716), the CY 2015 PFS final rule with comment period (79 FR
67745 through 67746) and the CY 2016 PFS proposed rule (80 FR 41788
through 41789). As stated previously, on February 28, 2013, OMB issued
OMB Bulletin No. 13-01, which established revised delineations for
MSAs, Micropolitan Statistical Areas, and Combined Statistical Areas,
and provided guidance on the use of the delineations of these
statistical areas. Several modifications of the RUCA codes were
necessary to take into account updated commuting data and the revised
OMB delineations. We refer readers to the U.S. Department of
Agriculture's Economic Research Service Web site for a detailed listing
of updated RUCA codes found at http://www.ers.usda.gov/data-products/rural-urban-commuting-area-codes.aspx. The updated RUCA code
definitions were introduced in late 2013 and are based on data from the
2010 decennial census and the 2006-2010 American Community Survey.
Information regarding the American Community Survey can be found at
http://www.ers.usda.gov/data-products/rural-urban-commuting-area-codes.aspx and at http://www.census.gov/programs-surveys/acs/guidance/training-presentations/acs-basics.html. We stated in the CY 2016 PFS
proposed rule (80 FR 41789) that we believe the most recent RUCA codes
provide more accurate and up-to-date information regarding the rurality
of census tracts throughout the country. Accordingly, we proposed to
continue to use the most recent modifications of the RUCA codes for CY
2016 and subsequent CYs, to recognize levels of rurality in census
tracts located in every county across the nation, for purposes of
payment under the ambulance fee schedule. We stated that if we continue
to use the most recent RUCA codes, many counties that are designated as
urban at the county level based on population would continue to have
rural census tracts within them that would be recognized as rural areas
through our use of RUCA codes.
As we stated in the CY 2015 PFS final rule with comment period (79
FR 67745) and in the CY 2016 PFS proposed rule (80 FR 41789), the 2010
Primary RUCA codes are as follows:
(1) Metropolitan area core: Primary flow with an urbanized area
(UA).
(2) Metropolitan area high commuting: Primary flow 30 percent or
more to a UA.
(3) Metropolitan area low commuting: Primary flow 10 to 30 percent
to a UA.
(4) Micropolitan area core: Primary flow within an Urban Cluster of
10,000 to 49,999 (large UC).
[[Page 71074]]
(5) Micropolitan high commuting: Primary flow 30 percent or more to
a large UC.
(6) Micropolitan low commuting: Primary flow 10 to 30 percent to a
large UC.
(7) Small town core: Primary flow within an Urban Cluster of 2,500
to 9,999 (small UC).
(8) Small town high commuting: Primary flow 30 percent or more to a
small UC.
(9) Small town low commuting: Primary flow 10 to 30 percent to a
small UC.
(10) Rural areas: Primary flow to a tract outside a UA or UC.
Based on this classification, and consistent with our current
policy as set forth in the CY 2015 PFS final rule with comment period
(79 FR 67745), we proposed to continue to designate any census tracts
falling at or above RUCA level 4.0 as rural areas for purposes of
payment for ambulance services under the ambulance fee schedule. As
discussed in the CY 2007 PFS final rule with comment period (71 FR
69715), the CY 2015 PFS final rule with comment period (79 FR 67745),
and the CY 2016 PFS proposed rule (80 FR 41789), the Office of Rural
Health Policy within the Health Resources and Services Administration
(HRSA) determines eligibility for its rural grant programs through the
use of the RUCA code methodology. Under this methodology, HRSA
designates any census tract that falls in RUCA level 4.0 or higher as a
rural census tract. In addition to designating any census tracts
falling at or above RUCA level 4.0 as rural areas, under the updated
RUCA code definitions, HRSA has also designated as rural census tracts
those census tracts with RUCA codes 2 or 3 that are at least 400 square
miles in area with a population density of no more than 35 people. We
refer readers to HRSA's Web site at ftp://ftp.hrsa.gov/ruralhealth/Eligibility2005.pdf for additional information. Consistent with the
HRSA guidelines discussed above and the policy we adopted in the CY
2015 PFS final rule with comment period (79 FR 67750), we proposed for
CY 2016 and subsequent CYs, to designate as rural areas those census
tracts that fall at or above RUCA level 4.0. We stated that we continue
to believe that this HRSA guideline accurately identifies rural census
tracts throughout the country, and thus, would be appropriate to apply
for ambulance fee schedule payment purposes.
Also, consistent with the policy we finalized in the CY 2015 PFS
final rule with comment period (79 FR 67749), we did not propose in the
CY 2016 PFS proposed rule (80 FR 41789) to designate as rural areas
those census tracts that fall in RUCA levels 2 or 3 that are at least
400 square miles in area with a population density of no more than 35
people. We stated in the CY 2016 PFS proposed rule (80 FR 41789) that
it is not feasible to implement this guideline due to the complexities
of identifying these areas at the ZIP code level. We stated that we do
not have sufficient information available to identify the ZIP codes
that fall in these specific census tracts. Also, payment under the
ambulance fee schedule is based on ZIP codes; therefore, if the ZIP
code is predominantly metropolitan but has some rural census tracts, we
do not split the ZIP code areas to distinguish further granularity to
provide different payments within the same ZIP code. We stated that we
believe payment for all ambulance transportation services at the ZIP
code level provides for a more consistent and administratively feasible
payment system. For example, there are circumstances where ZIP codes
cross county or census tract borders and where counties or census
tracts cross ZIP code borders. Such overlaps in geographic designations
would complicate our ability to appropriately assign ambulance
transportation services to geographic areas for payment under the
ambulance fee schedule if we were to pay based on ZIP codes for some
areas and counties or census tracts for other areas. Therefore, we
stated in the proposed rule (80 FR 41789) that, under the ambulance fee
schedule, we would not designate as rural areas those census tracts
that fall in RUCA levels 2 or 3 that are at least 400 square miles in
area with a population density of no more than 35 people.
We invited public comments on our proposals, as discussed in in the
CY 2016 PFS proposed rule, to continue to use the revised OMB
delineations and updated RUCA codes under the ambulance fee schedule
for CY 2016 and subsequent CYs.
As we stated in the CY 2015 PFS final rule with comment period (79
FR 67746) and the CY 2016 PFS proposed rule (80 FR 41789 through
41790), the adoption of the most current OMB delineations and the
updated RUCA codes would affect whether certain areas are recognized as
rural or urban. The distinction between urban and rural is important
for ambulance payment purposes because urban and rural transports are
paid differently. The determination of whether a transport is urban or
rural is based on the point of pick-up for the transport; thus, a
transport is paid differently depending on whether the point of pick-up
is in an urban or a rural area. During claims processing, a geographic
designation of urban, rural, or super rural is assigned to each claim
for an ambulance transport based on the point of pick-up ZIP code that
is indicated on the claim.
The continued implementation of the revised OMB delineations and
the updated RUCA codes would continue to affect whether or not
transports would be eligible for rural adjustments under the ambulance
fee schedule statute and regulations. For ground ambulance transports
where the point of pick-up is in a rural area, the mileage rate is
increased by 50 percent for each of the first 17 miles (Sec.
414.610(c)(5)(i)). For air ambulance services where the point of pick-
up is in a rural area, the total payment (base rate and mileage rate)
is increased by 50 percent (Sec. 414.610(c)(5)(i)).
Section 1834(l)(12) of the Act (as amended most recently by section
203(b) of the Medicare Access and CHIP Reauthorization Act of 2015)
specifies that, for services furnished during the period July 1, 2004
through December 31, 2017, the payment amount for the ground ambulance
base rate is increased by a ``percent increase'' (Super Rural Bonus)
where the ambulance transport originates in a ``qualified rural area,''
which is a rural area that we determine to be in the lowest 25th
percentile of all rural populations arrayed by population density (also
known as a ``super rural area''). We implement this Super Rural Bonus
in Sec. 414.610(c)(5)(ii). As discussed in section III.A.2.b. of this
final rule with comment period, we are revising Sec. 414.610(c)(5)(ii)
to conform the regulations to this statutory requirement. As we stated
in the CY 2015 PFS final rule with comment period (79 FR 67746) and the
CY 2016 PFS proposed rule (80 FR 41790), adoption of the revised OMB
delineations and the updated RUCA codes would have no negative impact
on ambulance transports in super rural areas, as none of the current
super rural areas would lose their status due to the revised OMB
delineations and the updated RUCA codes. Furthermore, under section
1834(l)(13) of the Act (as amended most recently by section 203(a) of
the Medicare Access and CHIP Reauthorization Act of 2015), for ground
ambulance transports furnished through December 31, 2017, transports
originating in rural areas are paid based on a rate (both base rate and
mileage rate) that is 3 percent higher than otherwise is applicable.
(See also Sec. 414.610(c)(1)(ii)). As discussed in section III.A.2.a.
of this final rule with comment period, we are revising Sec.
414.610(c)(1)(ii) to conform the
[[Page 71075]]
regulations to this statutory requirement.
Similar to our discussion in the CY 2015 PFS final rule with
comment period (79 FR 67746) and the CY 2016 PFS proposed rule (80 FR
41790), if we continue to use OMB's revised delineations and the
updated RUCA codes for CY 2016 and subsequent CYs, ambulance providers
and suppliers that pick up Medicare beneficiaries in areas that would
be Micropolitan or otherwise outside of MSAs based on OMB's revised
delineations or in a rural census tract of an MSA based on the updated
RUCA codes (but were within urban areas under the geographic
delineations in effect in CY 2014) would continue to experience
increases in payment for such transports (as compared to the CY 2014
geographic delineations) because they may be eligible for the rural
adjustment factors discussed in this section. In addition, those
ambulance providers and suppliers that pick up Medicare beneficiaries
in areas that would be urban based on OMB's revised delineations and
the updated RUCA codes (but were previously in Micropolitan Areas or
otherwise outside of MSAs, or in a rural census tract of an MSA under
the geographic delineations in effect in CY 2014) would continue to
experience decreases in payment for such transports (as compared to the
CY 2014 geographic delineations) because they would no longer be
eligible for the rural adjustment factors discussed in this section.
The continued use of the revised OMB delineations and the updated
RUCA codes for CY 2016 and subsequent CYs would mean the continued
recognition of urban and rural boundaries based on the population
migration that occurred over a 10-year period, between 2000 and 2010.
As discussed in this section, we proposed to continue to use the
updated RUCA codes to identify rural census tracts within MSAs, such
that any census tracts falling at or above RUCA level 4.0 would
continue to be designated as rural areas. To determine which ZIP codes
are included in each such rural census tract, we proposed to continue
to use the ZIP code approximation file developed by HRSA. This file
includes the 2010 RUCA code designation for each ZIP code and can be
found at http://www.ers.usda.gov/data-products/rural-urban-commuting-area-codes.aspx. If ZIP codes are added over time to the USPS ZIP code
file (and thus are not included in the 2010 ZIP code approximation file
provided to us by HRSA) or if ZIP codes are revised over time, we
stated that we would determine the appropriate urban/rural designation
for such ZIP code based on any updates provided on the HRSA and OMB Web
sites, located at http://www.ers.usda.gov/data-products/rural-urban-commuting-area-codes.aspx and http://www.whitehouse.gov/sites/default/files/omb/bulletins/2013/b-13-01.pdf.
Based on the August 2015 USPS ZIP code file that we are using in
this final rule with comment period to assess the impacts of the
revised geographic delineations, there are a total of 42,927 ZIP codes
in the U.S. Table 23 sets forth an analysis of the number of ZIP codes
that changed urban/rural status in each U.S. state and territory after
CY 2014 due to our implementation of the revised OMB delineations and
the updated RUCA codes beginning in CY 2015, using the August 2015 USPS
ZIP code file, the revised OMB delineations, and the updated RUCA codes
(including the RUCA ZIP code approximation file discussed above). Based
on this data, the geographic designations for approximately 95.22
percent of ZIP codes are unchanged by OMB's revised delineations and
the updated RUCA codes. Similar to the analysis set forth in the CY
2015 PFS final rule with comment period, as corrected (79 FR 78716
through 78719), and the CY 2016 PFS proposed rule (80 FR 41790 through
41791), as reflected in Table 23, more ZIP codes have changed from
rural to urban (1,600 or 3.73 percent) than from urban to rural (451 or
1.05 percent). In general, it is expected that ambulance providers and
suppliers in 451 ZIP codes within 42 states may continue to experience
payment increases under the revised OMB delineations and the updated
RUCA codes, as these areas have been redesignated from urban to rural.
The state of Ohio has the most ZIP codes that changed from urban to
rural with a total of 54, or 3.63 percent of all zip codes in the
state. Ambulance providers and suppliers in 1,600 ZIP codes within 44
states and Puerto Rico may continue to experience payment decreases
under the revised OMB delineations and the updated RUCA codes, as these
areas have been redesignated from rural to urban. The state of West
Virginia has the most ZIP codes that changed from rural to urban (149
or 15.92 percent of all zip codes in the state). As discussed in this
section, these findings are illustrated in Table 23.
Table 23--ZIP Code Analysis Based on OMB's Revised Delineations and Updated RUCA Codes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percentage of
Total ZIP Total ZIP Percentage of Total ZIP Percentage of Total ZIP total ZIP
State/ territory * Codes Codes changed total ZIP Codes changed total ZIP Codes not Codes not
rural to urban Codes urban to rural Codes changed changed
--------------------------------------------------------------------------------------------------------------------------------------------------------
AK...................................... 276 0 0.00 0 0.00 276 100.00
AL...................................... 854 43 5.04 8 0.94 803 94.03
AR...................................... 725 19 2.62 9 1.24 697 96.14
AS...................................... 1 0 0.00 0 0.00 1 100.00
AZ...................................... 569 21 3.69 7 1.23 541 95.08
CA...................................... 2,723 85 3.12 43 1.58 2,595 95.30
CO...................................... 677 4 0.59 9 1.33 664 98.08
CT...................................... 445 37 8.31 0 0.00 408 91.69
DC...................................... 303 0 0.00 0 0.00 303 100.00
DE...................................... 99 6 6.06 0 0.00 93 93.94
EK...................................... 63 0 0.00 0 0.00 63 100.00
EM...................................... 857 35 4.08 4 0.47 818 95.45
FL...................................... 1,513 69 4.56 9 0.59 1,435 94.84
FM...................................... 4 0 0.00 0 0.00 4 100.00
GA...................................... 1,032 47 4.55 4 0.39 981 95.06
GU...................................... 21 0 0.00 0 0.00 21 100.00
HI...................................... 143 9 6.29 3 2.10 131 91.61
IA...................................... 1,080 20 1.85 3 0.28 1,057 97.87
ID...................................... 335 0 0.00 0 0.00 335 100.00
IL...................................... 1,629 68 4.17 7 0.43 1,554 95.40
[[Page 71076]]
IN...................................... 1,000 33 3.30 20 2.00 947 94.70
KY...................................... 1,030 30 2.91 5 0.49 995 96.60
LA...................................... 739 69 9.34 1 0.14 669 90.53
MA...................................... 751 8 1.07 9 1.20 734 97.74
MD...................................... 630 69 10.95 0 0.00 561 89.05
ME...................................... 505 5 0.99 12 2.38 488 96.63
MH...................................... 2 0 0.00 0 0.00 2 100.00
MI...................................... 1,185 22 1.86 21 1.77 1,142 96.37
MN...................................... 1,043 31 2.97 7 0.67 1,005 96.36
MP...................................... 3 0 0.00 0 0.00 3 100.00
MS...................................... 541 14 2.59 1 0.18 526 97.23
MT...................................... 411 0 0.00 3 0.73 408 99.27
NC...................................... 1,102 87 7.89 10 0.91 1,005 91.20
ND...................................... 419 2 0.48 0 0.00 417 99.52
NE...................................... 632 7 1.11 6 0.95 619 97.94
NH...................................... 292 0 0.00 2 0.68 290 99.32
NJ...................................... 748 1 0.13 2 0.27 745 99.60
NM...................................... 438 4 0.91 2 0.46 432 98.63
NV...................................... 257 1 0.39 2 0.78 254 98.83
NY...................................... 2,246 84 3.74 42 1.87 2,120 94.39
OH...................................... 1,487 23 1.55 54 3.63 1,410 94.82
OK...................................... 791 5 0.63 7 0.88 779 98.48
OR...................................... 496 26 5.24 9 1.81 461 92.94
PA...................................... 2,244 129 5.75 38 1.69 2,077 92.56
PR...................................... 177 21 11.86 0 0.00 156 88.14
PW...................................... 2 0 0.00 0 0.00 2 100.00
RI...................................... 91 2 2.20 1 1.10 88 96.70
SC...................................... 544 47 8.64 2 0.37 495 90.99
SD...................................... 418 0 0.00 1 0.24 417 99.76
TN...................................... 814 52 6.39 12 1.47 750 92.14
TX...................................... 2,726 64 2.35 32 1.17 2,630 96.48
UT...................................... 360 2 0.56 0 0.00 358 99.44
VA...................................... 1,277 98 7.67 19 1.49 1,160 90.84
VI...................................... 16 0 0.00 0 0.00 16 100.00
VT...................................... 309 3 0.97 0 0.00 306 99.03
WA...................................... 744 17 2.28 6 0.81 721 96.91
WI...................................... 919 19 2.07 5 0.54 895 97.39
WK...................................... 711 11 1.55 7 0.98 693 97.47
WM...................................... 342 2 0.58 3 0.88 337 98.54
WV...................................... 936 149 15.92 3 0.32 784 83.76
WY...................................... 198 0 0.00 1 0.51 197 99.49
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Totals.............................. 42,927 1,600 3.73 451 1.05 40,876 95.22
--------------------------------------------------------------------------------------------------------------------------------------------------------
* ZIP code analysis includes U.S. States and Territories (FM--Federated States of Micronesia, GU--Guam, MH--Marshall Islands, MP--Northern Mariana
Islands, PW--Palau, AS--American Samoa; VI--Virgin Islands; PR--Puerto Rico). Missouri is divided into east and west regions due to work distribution
of the Medicare Administrative Contractors (MACs): EM--East Missouri, WM--West Missouri. Johnson and Wyandotte counties in Kansas were changed as of
January 2010 to East Kansas (EK) and the rest of the state is West Kansas (WK).
For more detail on the impact of these changes, in addition to
Table 23, the following files are available through the Internet on the
Ambulance Fee Schedule Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule/index.html,
Downloads, CY 2016 Final Rule; ZIP Codes By State Changed From Urban To
Rural; ZIP Codes By State Changed From Rural To Urban; List of ZIP
Codes With RUCA Code Designations; and Complete List of ZIP Codes.
We stated in the CY 2015 PFS final rule with comment period (79 FR
67750) and in the CY 2016 PFS proposed rule (80 FR 41792) that we
believe the most current OMB statistical area delineations, coupled
with the updated RUCA codes, more accurately reflect the contemporary
urban and rural nature of areas across the country, and thus we believe
the use of the most current OMB delineations and RUCA codes under the
ambulance fee schedule will enhance the accuracy of ambulance fee
schedule payments. As we discussed in the CY 2015 PFS final rule with
comment period (79 FR 67750), we considered, as alternatives, whether
it would be appropriate to delay the implementation of the revised OMB
delineations and the updated RUCA codes, or to phase in the
implementation of the new geographic delineations over a transition
period for those ZIP codes losing rural status. We determined that it
would not be appropriate to implement a delay or a transition period
for the revised geographic delineations for the reasons set forth in
the CY 2015 PFS final rule. Similarly, we considered whether a delay in
implementation or a transition period would be appropriate for CY 2016
and subsequent CYs. We stated in the CY 2016 PFS proposed rule (80 FR
41792) that we continue to believe it is important to use the most
current OMB delineations and RUCA codes available as soon as reasonably
possible to maintain a more accurate and up-to-date payment system that
reflects the reality
[[Page 71077]]
of population shifts. Because we believe the revised OMB delineations
and updated RUCA codes more accurately identify urban and rural areas
and enhance the accuracy of the Medicare ambulance fee schedule, we
stated that we do not believe a delay in implementation or a transition
period would be appropriate for CY 2016 and subsequent CYs. Areas that
have lost their rural status and become urban have become urban because
of recent population shifts. We believe it is important to base payment
on the most accurate and up-to-date geographic area delineations
available. Furthermore, we stated in the proposed rule that a delay in
implementation of the revised OMB delineations and the updated RUCA
codes would be a disadvantage to the ambulance providers or suppliers
experiencing payment increases based on these updated and more accurate
OMB delineations and RUCA codes. Thus, we did not propose a delay in
implementation or a transition period for the revised OMB delineations
and updated RUCA codes for CY 2016 and subsequent CYs.
We invited public comments on our proposals to continue
implementation of the revised OMB delineations as set forth in OMB's
February 28, 2013 bulletin (No. 13-01) and the most recent
modifications of the RUCA codes as discussed above for CY 2016 and
subsequent CYs for purposes of payment under the ambulance fee
schedule. In addition, we invited public comments on any alternative
methods for implementing the revised OMB delineations and the updated
RUCA codes.
We received several comments from ambulance providers and suppliers
and associations representing ambulance providers and suppliers on our
proposals to continue implementation of the revised OMB delineations
and the most recent modifications of the RUCA codes as discussed above
for CY 2016 and subsequent CYs. The following is a summary of those
comments along with our responses.
Comment: A commenter supported our proposal to continue
implementation of the new OMB delineations for CY 2016 and subsequent
CYs to more accurately identify urban and rural areas for ambulance fee
schedule payment purposes.
Response: We appreciate the commenter's support of our proposal.
Comment: Several commenters agreed with CMS that it is appropriate
to adjust the geographic area designations periodically so that the
ambulance fee schedule reflects population shifts. These commenters
remain concerned, however, because they contend that the modifications
finalized last year have led to some rural ZIP codes being designated
as urban. Several commenters urged CMS to refine the modified
geographic area designations to restore rural status to those ZIP codes
the commenters contended were improperly classified as urban last year.
Specifically, commenters urged CMS to adopt HRSA's rural designations
of 132 census tracts with RUCA codes of 2 and 3 that are at least 400
square miles in area with a population density of no more than 35
people per square mile. According to the commenters, the discrepancy
between CMS and HRSA in the application of RUCA codes appears to result
from the fact that HRSA designates rural areas for its programs by
focusing on the Census tract, while CMS focuses on a U.S. Department of
Agriculture (USDA) ZIP code list. The commenters stated that it is
important for these 132 Census tract areas to be taken into account for
making geographic designations. The commenters suggested that CMS adopt
a methodology to adjust the RUCA code status for the 132 census tracts
recognized by HRSA as rural to RUCA code status 4 before cross walking
the ZIP codes. According to the commenters, when the analysis is re-
run, the resulting ZIP codes would be appropriately designated as
rural. The commenters stated that by recognizing the 132 census tracts
as rural, CMS's policy would align with HRSA's policy and address the
concerns raised by ambulance providers and suppliers. According to the
commenters, this approach would avoid the concerns that CMS has raised
about splitting ZIP codes.
Response: We appreciate the commenters' support for adjusting the
geographic area designations periodically to reflect population shifts.
As discussed in this section and in the CY 2016 PFS proposed rule (80
FR 41788 through 41792), we believe that the most current OMB
delineations, coupled with the updated RUCA codes, more accurately
reflect the urban and rural nature of areas across the country, and
thus we believe the use of the most current OMB delineations and RUCA
codes under the ambulance fee schedule enhances the accuracy of
ambulance fee schedule payments. Further, as discussed previously, we
believe that our methodology of designating rural geographic areas by
using OMB's delineations, and by using RUCA codes of 4 and above to
identify rural census tracts within MSAs, is appropriate for ambulance
fee schedule payment purposes.
We have concerns with the methodology proposed by the commenters to
identify as rural certain census tracts with RUCA codes of 2 and 3. The
132 census tracts recognized as rural by HRSA have RUCA code
designations of 2 or 3, indicating that the census tracts are
predominantly urban. To assign these entire census tracts a RUCA code
of 4 before cross walking the ZIP codes could result in inappropriate
classifications of urban areas as rural. Payment under the ambulance
fee schedule is based on ZIP codes (Sec. 414.610(e)). We would require
a list of ZIP codes assigned to the 132 census tracts with RUCA codes
of 2 and 3 that are at least 400 square miles in area with a population
density of no more than 35 people per square mile to appropriately
identify these areas as rural. As we previously discussed, we do not
have sufficient information available to identify the ZIP codes that
fall in these specific census tracts. We do not believe it would be
prudent at this time to implement the commenters' suggested methodology
absent the data and methodology to precisely identify the ZIP codes for
the census tracts with RUCA codes of 2 and 3 that are at least 400
square miles in area with a population density of no more than 35
people per square mile. We will consider further evaluating for CY 2017
these additional census tracts that HRSA has designated as rural and
the feasibility of identifying the ZIP codes that are assigned to those
areas.
Comment: Several commenters requested that CMS issue an Advanced
Notice of Proposed Rulemaking (ANPRM) prior to the CY 2017 rulemaking
cycle to seek input from all interested stakeholders about whether a
new urban-rural data set should be used or other policy modifications
should be adopted to apply the RUCA designations. According to the
commenters, the data to determine the levels for RUCAs are no longer
collected through the long-form census, which had a high response rate.
The commenters contend that the RUCA data are now based on a response
rate in the single digits which is not high enough to accurately
identify urban-rural areas when it comes to access to vital ambulance
services. The commenters stated that an ANPRM would allow CMS to hear
from all interested parties at an early stage in the process and
provide CMS with the information it needs to fully evaluate the current
policy and to identify options for addressing the issues that have been
raised by commenters with
[[Page 71078]]
RUCA being used as the data set for identifying rural census tracts
within urban areas.
Response: The updated RUCA code definitions are based on data from
the 2010 decennial census and the 2006-2010 American Community Survey
(ACS). According to the United States Census Bureau's Web site, http://www.census.gov/programs-surveys/acs/guidance/training-presentations/acs-basics.html, ACS is a nationwide survey that provides
characteristics of the population and housing throughout the country,
similar to the long-form questionnaire used in Census 2000. The ACS
produces estimates of these characteristics for small areas and small
population groups throughout the country.
According to the Census Bureau's Web site, the content collected by
the ACS can be grouped into four main types of characteristics--social,
economic, demographic, and housing. For example, economic
characteristics include such topics as health insurance coverage,
income, benefits, employment status, occupation, industry, commuting to
work, and place of work. This is the same information that was
collected by the 2010 Census.
The ACS is a continuous survey, in which, each month, a sample of
housing unit addresses receives a questionnaire. For the ACS, the
Census Bureau selects a random sample of addresses where workers reside
to be included in the survey, and the sample is designed to ensure good
geographic coverage. About 3.5 million addresses are surveyed each
year. The ACS collects data from the 50 states, the District of
Columbia, and Puerto Rico. The survey had the following response rates
at the state level for 2006-2010: 91.1 percent to 99.0 percent in 2006,
91.7 percent to 99.3 percent in 2007, 91.4 percent to 99.4 percent in
2008, 94.9 percent to 99.4 percent in 2009, and 95.3 percent to 99.0
percent in 2010. The ACS collects survey information continuously and
then aggregates the results over a specific period of time--1 year, 3
years, or 5 years. The ACS period estimates describe the average
characteristics of the population or housing over a specified period of
time. For smaller geographic areas, such as the census tracts, 5 year
estimates are used. As mentioned in this section, the most recent
update of the RUCA codes was developed using data collected from the
2006, 2007, 2008, 2009, and 2010 ACS. According to the Census Bureau,
the estimates that they published based on the ACS had a 90 percent
confidence interval.
According to the USDA's Web site, http://www.ers.usda.gov/data-products/rural-urban-commuting-area-codes.aspx, the RUCA codes were
based on a special tabulation for the Department of Transportation,
Census Transportation Planning Products, Part 3, Worker Home-to-Work
Flow Tables (http://www.fhwa.dot.gov/planning/census_issues/ctpp/data_products/2006-2010_table_list/sheet04.cfm). According to the USDA,
as with all survey data, ACS estimates are not exact because they are
based on a sample. Nevertheless, we believe that the ACS provides the
most recent comprehensive source of data on the population and is
robust enough for use for purposes of determining the rural status of
census tracts throughout the country.
We do not believe it is necessary to issue an ANPRM prior to the CY
2017 rulemaking cycle. In the CY 2016 PFS proposed rule and in past
rules, we have discussed the implementation of the OMB delineations and
the RUCA codes for purposes of payment under the ambulance fee
schedule, and we believe that the public has had ample opportunity to
provide comments and suggestions about other methodologies for
designating geographic areas or other policy modifications that should
be adopted to apply the RUCA code designations. We note that the public
did not provide any suggestions for any alternative data sources for
designating rural geographic areas.
We note that we utilize the ACS data in other Medicare payment
systems as well. In the FY 2016 IPPS/LTCH PPS final rule (80 FR 49501),
we finalized our proposal that the out-migration adjustments be based
on commuting data compiled by the Census Bureau that were derived from
a custom tabulation of the ACS, an official Census Bureau survey,
utilizing 2008 through 2012 (5-Year) Microdata. (See also the FY 2016
IPPS/LTCH PPS proposed rule (80 FR 24471)). Furthermore, the physician
fee schedule uses the 2008-2010 ACS data for calculating the office
rent component of the PE of the geographic practice cost index (78 FR
74390).
After consideration of the public comments received and for the
reasons discussed in this section and in the CY 2016 PFS proposed rule,
we are finalizing without modification our proposal to continue
implementation of the revised OMB delineations as set forth in OMB's
February 28, 2013 bulletin (No. 13-01) and the most recent
modifications of the RUCA codes, as discussed in this section, for CY
2016 and subsequent CYs for purposes of payment under the ambulance fee
schedule. As we proposed, using the updated RUCA code definitions, we
will continue to designate any census tracts falling at or above RUCA
code 4.0 as rural areas. In addition, as discussed in this section,
none of the current super rural areas will lose their super rural
status upon implementation of the revised OMB delineations and the
updated RUCA codes.
4. Proposed Changes to the Ambulance Staffing Requirements
Under section 1861(s)(7) of the Act, Medicare Part B covers
ambulance services when the use of other methods of transportation is
contraindicated by the individual's medical condition, but only to the
extent provided in regulations. Section 410.41(b)(1) requires that a
vehicle furnishing ambulance services at the Basic Life Support (BLS)
level must be staffed by at least two people, one of whom must meet the
following requirements: (1) Be certified as an emergency medical
technician by the state or local authority where the services are
furnished; and (2) be legally authorized to operate all lifesaving and
life-sustaining equipment on board the vehicle.
Section 410.41(b)(2) states that, for vehicles furnishing ambulance
services at the Advanced Life Support (ALS) level, ambulance providers
and suppliers must meet the staffing requirements for vehicles
furnishing services at the BLS level, and, additionally, that one of
the two staff members must be certified as a paramedic or an emergency
medical technician, by the state or local authority where the services
are being furnished, to perform one or more ALS services. These
staffing requirements are further explained in the Medicare Benefit
Policy Manual (Pub. No. 100-02), Chapter 10 (see sections 10.1.2 and
30.1.1)
In its July 24, 2014 Management Implication Report, 13-0006,
entitled ``Medicare Requirements for Ambulance Crew Certification,''
the Office of Inspector General (OIG) discussed its investigation of
ambulance suppliers in a state that requires a higher level of training
than Medicare requires for ambulance staff. In some instances, OIG
found that second crew members: (1) Possessed a lower level of training
than required by state law, or (2) had purchased or falsified
documentation to establish their credentials. The OIG expressed its
concern that our current regulations and manual provisions do not set
forth licensure or certification requirements for the second crew
member. The OIG was informed by federal prosecutors that prosecuting
[[Page 71079]]
individuals who had purchased or falsified documentation to establish
their credentials would be difficult because Medicare had no
requirements regarding the second ambulance staff member and the
ambulance transports complied with the relevant Medicare regulations
and manual provisions for ambulance staffing.
As we stated in the CY 2016 PFS proposed rule (80 FR 41792), the
OIG recommended that Medicare revise its regulations and manual
provisions related to ambulance staffing to parallel the standard used
for vehicle requirements at Sec. 410.41(a), which requires that
ambulances be equipped in ways that comply with state and local laws.
Specifically, the OIG recommended that our regulation and manual
provisions addressing ambulance vehicle staffing should indicate that,
for Medicare to cover ambulance services furnished to a Medicare
beneficiary, the ambulance crew must meet the requirements currently
set forth in Sec. 410.41(b) or the state and local requirements,
whichever are more stringent. Currently, Sec. 410.41(b) does not
require that ambulance vehicle staff comply with all applicable state
and local laws. In the CY 2016 PFS proposed rule, we stated that we
agree with OIG's concerns and believe that requiring ambulance staff to
also comply with state and local requirements would enhance the quality
and safety of ambulance services furnished to Medicare beneficiaries.
Accordingly, in the CY 2016 PFS proposed rule (80 FR 41792), we
proposed to revise Sec. 410.41(b) to require that all Medicare-covered
ambulance transports must be staffed by at least two people who meet
both the requirements of applicable state and local laws where the
services are being furnished, and the current Medicare requirements
under Sec. 410.41(b). We believe that this would, in effect, require
both of the required ambulance vehicle staff to also satisfy any
applicable state and local requirements that may be more stringent than
those currently set forth at Sec. 410.41(b), consistent with OIG's
recommendation. In addition, we proposed to revise the definition of
Basic Life Support (BLS) in Sec. 414.605 to include the proposed
revised staffing requirements discussed above for Sec. 410.41(b) (80
FR 41793). We stated that these revisions to Sec. 410.41(b) and Sec.
414.605 would account for differences in individual state or local
staffing and licensure requirements, better accommodating state or
local laws enacted to ensure beneficiaries' health and safety.
Likewise, these revisions would strengthen the federal government's
ability to prosecute violations associated with such requirements and
recover inappropriately or fraudulently received funds from ambulance
companies found to be operating in violation of state or local laws.
Furthermore, we stated in the proposed rule that we believe these
proposals would enhance the quality and safety of ambulance services
provided to Medicare beneficiaries.
In addition, we proposed to revise Sec. 410.41(b) and the
definition of Basic Life Support (BLS) in Sec. 414.605 to clarify
that, for BLS vehicles, at least one of the staff members must be
certified, at a minimum, as an emergency medical technician--basic
(EMT-Basic), which we believe would more clearly state our current
policy (80 FR 41793). Currently, these regulations require that, for
BLS vehicles, one staff member be certified as an EMT (Sec. 410.41(b))
or EMT-Basic (Sec. 414.605). These revisions to the regulations do not
change our current policy, but clarify that one of the BLS vehicle
staff members must be certified at the minimum level of EMT-Basic, but
may also be certified at a higher level, for example, EMT-intermediate
or EMT paramedic.
Finally, we proposed to revise the definition of Basic Life Support
(BLS) in Sec. 414.605 to delete the last sentence, which sets forth
examples of certain state law provisions (80 FR 41793). This sentence
has been included in the definition of BLS since the ambulance fee
schedule was finalized in 2002 (67 FR 9100, Feb. 27, 2002). Because
state laws may change over the course of time, we are concerned that
this sentence may not accurately reflect the status of the relevant
state laws over time. Therefore, we proposed to delete the last
sentence of this definition. Furthermore, we do not believe that the
examples set forth in this sentence are necessary to convey the
definition of BLS for Medicare coverage and payment purposes.
We invited public comments on our proposals to revise the ambulance
vehicle staffing requirements in Sec. 410.41(b) and the definition of
Basic Life Support (BLS) in Sec. 414.605, as discussed in this
section. We also stated that, if we finalized these proposals, we would
revise our manual provisions addressing ambulance vehicle staffing as
appropriate, consistent with our finalized policy.
We received approximately 21 comments from ambulance providers and
suppliers and associations representing such entities. The following is
a summary of the comments we received along with our responses.
Comment: Several commenters supported the proposed changes to the
ambulance staffing requirements. Commenters also requested that CMS
support efforts to designate ambulance services as providers under the
Medicare program (rather than having some designated as suppliers).
Response: We appreciate the commenters' support of our proposals.
Comments requesting us to support efforts to designate ambulance
services as providers are outside the scope of this final rule with
comment period.
Comment: One commenter requested additional clarification on
whether the proposed revision would require both ambulance medical
technicians to be certified by the state as EMTs. This same commenter
requested clarification on whether both technicians would need to be
legally authorized to operate lifesaving and life-sustaining equipment
on board the vehicle.
Two commenters opposed the proposed changes to the ambulance
staffing requirements, expressing concern that the proposed changes
would require both crew members to be certified as EMTs, a change they
believed would negatively impact ambulance services in rural
communities. One of these commenters stated that such a change would
(1) not increase the level of care provided to the patient being
transported, and (2) make it more difficult for volunteer Emergency
Medical Services (EMS) providers to be properly reimbursed for their
work. The commenters also stated that this requirement would limit
access in rural communities, and that it would be difficult for
volunteer EMS staff to meet such requirements.
Response: We believe that these commenters misinterpreted our
proposal. We did not propose to require that both ambulance crew
members be certified as EMTs or that both ambulance crew members be
legally authorized to operate all lifesaving and life-sustaining
equipment on board the vehicle. The only change we proposed to our
current policy was to require both ambulance vehicle staff to meet the
requirements of state and local laws where the services are being
furnished. Thus, our proposed policy would require that both ambulance
vehicle staff be certified as EMTs only when this is required by the
state or local laws where the services are being furnished. As we
stated in the CY 2016 PFS proposed rule (80 FR 41942), because we
expect that ambulance providers and suppliers already comply with their
state and local laws, we expect that this requirement would have a
minimal
[[Page 71080]]
impact on ambulance providers and suppliers.
Comment: Several commenters supported the proposed revision to the
definition of Basic Life Support (BLS) in Sec. 414.605 to delete the
last sentence, which sets forth examples of certain state law
provisions.
Response: We appreciate the commenters' support for our proposed
revision to the definition of Basic Life Support (BLS) in Sec.
414.605.
After consideration of the public comments received, and for the
reasons discussed in this section, we are finalizing without
modification our proposals to revise (1) Sec. 410.41(b) and the
definition of Basic Life Support (BLS) in Sec. 414.605, as discussed
in this section, to require that all Medicare-covered ambulance
transports be staffed by at least two people who meet both the
requirements of state and local laws where the services are being
furnished, and the current Medicare requirements, (2) Sec. 410.41(b)
and the definition of Basic Life Support (BLS) in Sec. 414.605 to
clarify that for BLS vehicles, one of the staff members must be
certified at a minimum as an EMT-Basic, and (3) the definition of Basic
Life Support (BLS) in Sec. 414.605 to delete the last sentence, which
sets forth examples of certain state law provisions. We will also
revise our manual provisions addressing ambulance vehicle staffing, as
appropriate, to be consistent with these finalized policies.
B. Chronic Care Management (CCM) Services for Rural Health Clinics
(RHCs) and Federally Qualified Health Centers (FQHCs)
1. Background
a. Primary Care and Care Coordination
Over the last several years, we have been increasing our focus on
primary care, and have explored ways in which care coordination can
improve health outcomes and reduce expenditures.
In the CY 2012 PFS proposed rule (76 FR 42793 through 42794, and
42917 through 42920), and the CY 2012 PFS final rule (76 FR 73063
through 73064), we discussed how primary care services have evolved to
focus on preventing and managing chronic disease, and how refinements
for payment for post-discharge care management services could improve
care management for a beneficiary's transition from the hospital to the
community setting. We acknowledged that the care coordination included
in services such as office visits does not always describe adequately
the non-face-to-face care management work involved in primary care, and
may not reflect all the services and resources required to furnish
comprehensive, coordinated care management for certain categories of
beneficiaries, such as those who are returning to a community setting
following discharge from a hospital or skilled nursing facility (SNF)
stay. We initiated a public discussion on primary care and care
coordination services, and stated that we would consider payment
enhancements in future rulemaking as part of a multiple year strategy
exploring the best means to encourage primary care and care
coordination services.
In the CY 2013 PFS proposed rule (77 FR 44774 through 44775), we
noted several initiatives and programs designed to improve payment for,
and encourage long-term investment in, care management services. These
include the Medicare Shared Savings Program; testing of the Pioneer
Accountable Care Organization (ACO) model and the Advance Payment ACO
model; the Primary Care Incentive Payment (PCIP) Program; the patient-
centered medical home model in the Multi-payer Advanced Primary Care
Practice (MAPCP) Demonstration; the Federally Qualified Health Center
(FQHC) Advanced Primary Care Practice demonstration; the Comprehensive
Primary Care (CPC) initiative; and the HHS Strategic Framework on
Multiple Chronic Conditions. We also noted that we were monitoring the
progress of the AMA Chronic Care Coordination Workgroup in developing
codes to describe care transition and care coordination activities, and
proposed refinement of the PFS payment for post discharge care
management services.
In the CY 2013 PFS final rule (77 FR 68978 through 68994), we
finalized policies for payment of Transitional Care Management (TCM)
services, effective January 1, 2013. We adopted two CPT codes (99495
and 99496) to report physician or qualifying nonphysician practitioner
care management services for a patient following a discharge from an
inpatient hospital or SNF, an outpatient hospital stay for observation
or partial hospitalization services, or partial hospitalization in a
community mental health center. As a condition for receiving TCM
payment, a face-to-face visit was required.
In the CY 2014 PFS proposed rule (78 FR 43337 through 43343), we
proposed to establish separate payment under the PFS for chronic care
management (CCM) services and proposed a scope of services and
requirements for billing and supervision. In the CY 2014 PFS final rule
(78 74414 through 74427), we finalized policies to establish separate
payment under the PFS for CCM services furnished to patients with
multiple chronic conditions that are expected to last at least 12
months or until the death of the patient, and that place the patient at
significant risk of death, acute exacerbation/decompensation, or
functional decline. In the CY 2015 PFS final rule (79 FR 67715 through
67730), additional billing requirements were finalized, including the
requirement to furnish CCM services using a certified electronic health
record or other electronic technology. Payment for CCM services was
effective beginning on January 1, 2015, for physicians billing under
the PFS.
b. RHC and FQHC Payment Methodologies
A RHC or FQHC visit must be a face-to-face encounter between the
patient and a RHC or FQHC practitioner (physician, nurse practitioner,
physician assistant, certified nurse midwife, clinical psychologist, or
clinical social worker, and under certain conditions, an RN or LPN
furnishing care to a homebound RHC or FQHC patient) during which time
one or more RHC or FQHC services are furnished. A TCM service can also
be a 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 a FQHC visit.
RHCs are paid an all-inclusive rate (AIR) for medically-necessary
medical and mental health services, and qualified preventive health
services furnished on the same day (with some exceptions). In general,
the A/B MAC calculates the AIR for each RHC by dividing total allowable
costs by the total number of visits for all patients. Productivity,
payment limits, and other factors are also considered in the
calculation. Allowable costs must be reasonable and necessary and may
include practitioner compensation, overhead, equipment, space,
supplies, personnel, and other costs incident to the delivery of RHC
services. The AIR is subject to a payment limit, except for those RHCs
that have an exception to the payment limit. Services furnished
incident to a RHC professional service are included in the per-visit
payment and are not billed separately.
FQHCs have also been paid under the AIR methodology; however, on
October 1, 2014, FQHCs began to transition to a FQHC PPS system in
which they are paid based on the lesser of a national encounter-based
rate or their total adjusted charges. The FQHC PPS rate is adjusted for
geographic differences in the cost of services by the FQHC
[[Page 71081]]
geographic adjustment factor. It is also increased by 34 percent when a
FQHC furnishes care to a patient that is new to the FQHC or to a
beneficiary receiving an Initial Preventive Physical Examination (IPPE)
or an Annual Wellness Visit (AWV). Both the AIR and FQHC PPS payment
rates were designed to reflect all the services that a RHC or FQHC
furnishes in a single day, regardless of the length or complexity of
the visit or the number or type of practitioners seen.
c. Payment for CCM Services
To address the concern that the non-face-to-face care management
work involved in furnishing comprehensive, coordinated care management
for certain categories of beneficiaries is not adequately paid for as
part of an office visit, beginning on January 1, 2015, practitioners
billing under the PFS are paid separately for CCM services under CPT
code 99490 when CCM service requirements are met.
RHCs and FQHCs cannot bill under the PFS for RHC or FQHC services
and individual practitioners working at RHCs and FQHCs cannot bill
under the PFS for RHC or FQHC services while working at the RHC or
FQHC. Although many RHCs and FQHCs coordinate services within their own
facilities, and may sometimes help to coordinate services outside their
facilities, the type of structured care management services that are
now payable under the PFS for patients with multiple chronic
conditions, particularly for those who are transitioning from a
hospital or SNF back into their communities, are generally not included
in the RHC or FQHC payment. We proposed to provide an additional
payment for the costs of CCM services that are not already captured in
the RHC AIR or the FQHC PPS payment, beginning on January 1, 2016.
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.
d. Solicitation of Comments on Payment for CCM Services in RHCs and
FQHCs
In the May 2, 2014 final rule, ``Medicare Program: Prospective
Payment System for Federally Qualified Health Centers; Changes to
Contracting Policies for Rural Health Clinics; and Changes to Clinical
Laboratory Improvement Amendments of 1988 Enforcement Actions for
Proficiency Testing Referral Final Rule'' (79 FR 25447), we discussed
ways to achieve the Affordable Care Act goal of furnishing integrated
and coordinated services, and specifically noted the CCM services
program beginning in 2015 for physicians billing under the PFS. We
encouraged RHCs and FQHCs to review the CCM services information in the
CY 2014 PFS final rule with comment period and submit comments to us on
how the CCM services payment could be adapted for RHCs and FQHCs to
promote integrated and coordinated care in RHCs and FQHCs.
All of the comments we received in response to this request were
strongly supportive of payment to RHCs and FQHCs for CCM services. Some
commenters were concerned that the requirements for electronic exchange
of information and interoperability with other providers would be
difficult for some entities, and that some patients do not have the
resources to receive secure messages via the internet. One commenter
suggested that the additional G-codes for CCM services should be
sufficient to cover the associated costs of documenting care
coordination in FQHCs, and another commenter suggested that we develop
a risk-adjusted CCM services fee. We also received subsequent
recommendations from the National Association of Rural Health Clinics
on various payment options for CCM services in RHCs. These comments
were very helpful in forming the basis for this proposal, and we thank
the commenters for their comments.
2. Payment Methodology and Billing for CCM Services in RHCs and FQHCs
a. Payment Methodology and Billing Requirements
The requirements we proposed for RHCs and FQHCs to receive payment
for CCM services are consistent with those finalized in the CY 2015 PFS
final rule with comment period for practitioners billing under the PFS
and are summarized in Table 24. We proposed to establish payment,
beginning on January 1, 2016, for RHCs and FQHCs that furnish a minimum
of 20 minutes of qualifying CCM services during a calendar month to
patients with multiple (two or more) chronic conditions that would be
expected to last at least 12 months or until the death of the patient,
and that would place the patient at significant risk of death, acute
exacerbation/decompensation, or functional decline. The CPT code
descriptor sets forth the eligibility guidelines for CCM services and
would serve as the basis for potential medical review. In accordance
with both the CPT instructions and Medicare policy, only one
practitioner can bill this code per month, and there are restrictions
regarding the billing of other overlapping care management services
during the same service period. The following section discusses these
aspects of our proposal in more detail and additional information will
be communicated in sub-regulatory guidance.
We proposed that a RHC or FQHC could bill for CCM services
furnished by, or incident to, the services of a RHC or FQHC physician,
NP, PA, or certified nurse midwife (CNM) for a RHC or FQHC patient once
per month, and that only one CCM payment per beneficiary per month
could be paid. If another practice furnishes CCM services to a
beneficiary, the RHC or FQHC could not bill for CCM services for the
same beneficiary for the same service period. We also proposed that TCM
and any other program that provided additional payment for care
management services (outside of the RHC AIR or FQHC PPS payment) cannot
be billed during the same service period.
For purposes of meeting the minimum 20-minute requirement, the RHC
or FQHC could count the time of only one practitioner or auxiliary
staff (for example, a nurse, medical assistant, or other individual
working under the supervision of a RHC or FQHC physician or other
practitioner) at a time, and could not count overlapping intervals such
as when two or more RHC or FQHC practitioners are meeting about the
patient. Only conversations that fall under the scope of CCM services
would be included towards the time requirement.
We noted that for billing under the PFS, the care coordination
included in services such as office visits do not always describe
adequately the non-face-to-face care management work involved in
primary care. We also noted that payment for office visits may not
reflect all the services and resources required to furnish
comprehensive, coordinated care management for certain categories of
beneficiaries, such as those who are returning to a community setting
following discharge from a hospital or SNF stay. We proposed CCM
payment for RHCs and FQHCs because we believe that the non-face-to-face
time required to coordinate care is not captured in the RHC AIR or the
FQHC PPS payment, particularly for the rural and/or low-income
populations served by RHCs and FQHCs. Allowing separate payment for CCM
services in RHCs and FQHCs is intended to reflect the additional
resources necessary for the unique components of CCM services.
[[Page 71082]]
We proposed that payment for CCM services be based on the PFS
national average non-facility payment rate when CPT code 99490 is
billed alone or with other payable services on a RHC or FQHC claim.
(For the first quarter of 2015, the national average payment rate was
$42.91 per beneficiary per calendar month.) This rate would not be
subject to a geographic adjustment. CCM payment to RHCs and FQHCs would
be based on the PFS amount, but would be paid as part of the RHC and
FQHC benefit, using the CPT code to identify that the requirements for
payment are met and a separate payment should be made. We also proposed
to waive the RHC and FQHC face-to-face requirements when CCM services
are furnished to a RHC or FQHC patient. Coinsurance would be applied as
applicable to FQHC claims, and coinsurance and deductibles would apply
to RHC claims as applicable. RHCs and FQHCs would continue to be
required to meet the RHC and FQHC Conditions of Participation and any
additional RHC or FQHC payment requirements.
b. Other Options Considered
We considered adding CCM services as a RHC or FQHC covered stand-
alone service and removing the RHC/FQHC policy requiring a face-to-face
visit requirement for this service. Under this option, payment for RHCs
would be at the AIR, payment for FQHCs would be the lesser of total
charges or the PPS rate, and if CCM services are furnished on the same
day as another payable medical visit, only one visit would be paid. We
did not propose this payment option because it would result in a
significant overpayment if no other services were furnished on the same
day, and would result in no additional payment if furnished on the same
day as another medical visit.
We also considered allowing RHCs and FQHCs to carve out CCM
services and bill them separately to the PFS. We did not propose this
payment option because CCM services are a RHC and FQHC service and only
non-RHC/FQHC services can be billed through the PFS.
We also considered developing a modifier that could be added to the
claim for additional payment when CCM services are furnished. We did
not propose this option because it would require that payment for CCM
services be made only when furnished along with a billable service that
qualifies as an RHC or FQHC service.
We also considered establishing payment for CCM costs on a
reasonable cost basis through the cost report. We did not propose this
option because payment for CCM services through the cost report would
complicate coinsurance and/or deductible accountability, whereas it is
more administratively feasible to apply coinsurance and/or deductible
on a RHC/FQHC claim, as applicable. For example, section 1833(a)(3) of
the Act specifies that influenza and pneumococcal vaccines and their
administration are exempt from payment at 80 percent of reasonable
costs and payment to RHCs and FQHCs for such services is at 100 percent
of reasonable cost. Since influenza and pneumococcal vaccines and their
administration are not subject to copayment, it is administratively
feasible to pay these services through the cost report.
3. Requirements for CCM Payment in RHCs and FQHCs
a. Beneficiary Eligibility for CCM Services
Consistent with beneficiary eligibility requirements under the PFS,
we proposed that RHCs and FQHCs receive payment for furnishing CCM
services to patients with multiple chronic conditions that are expected
to last at least 12 months or until the death of the patient, as
determined by the RHC or FQHC practitioner, and that place the patient
at significant risk of death, acute exacerbation/decompensation, or
functional decline. We encouraged RHCs and FQHCs to focus on patients
with high acuity and high risk when furnishing CCM services to eligible
patients, including those who would be returning to a community setting
following discharge from a hospital or SNF.
b. Beneficiary Agreement Requirements
Not all patients who are eligible for separately payable CCM
services may necessarily want these services to be provided, and some
patients who receive CCM services may wish to discontinue them. A
beneficiary who declines to receive CCM services from the RHC or FQHC,
or who accepts the services and then chooses to revoke his/her
agreement, would continue to be able to receive care from the RHC or
FQHC and receive any care management services that were being furnished
under the RHC AIR or FQHC PPS payment system.
Consistent with beneficiary notification and consent requirements
under the PFS, we proposed that the following requirements be met
before the RHC or FQHC can furnish or bill for CCM services:
The eligible beneficiary must be informed about the
availability of CCM services from the RHC or FQHC and provide his or
her written agreement to have the services provided, including the
electronic communication of the patient's information with other
treating providers as part of care coordination. This would include a
discussion with the patient about what CCM services are, how they
differ from any care management services the RHC or FQHC currently
offers, how these services are accessed, how the patient's information
will be shared among others, that a non RHC or FQHC cannot furnish or
bill for CCM services during the same calendar month that the RHC or
FQHC furnishes CCM services, the applicability of coinsurance even when
CCM services are not delivered face-to-face in the RHC or FQHC, and
that any care management services that are currently provided will
continue even if the patient does not agree to have CCM services
provided.
The RHC or FQHC must document in the patient's medical
record that all of the CCM services were explained and offered to the
patient, and note the patient's decision to accept these services.
At the time the agreement is obtained, the eligible
beneficiary must be informed that the agreement for CCM services could
be revoked by the beneficiary at any time either verbally or in
writing, and the RHC or FQHC practitioner must explain the effect of a
revocation of the agreement for CCM services. If the revocation occurs
during a CCM calendar month, the revocation would be effective at the
end of that period. The eligible beneficiary must also be informed that
the RHC or FQHC is able to be separately paid for these services during
the 30-day period only if no other practitioner or eligible entity,
including another RHC or FQHC that is not part of the RHC's or FQHC's
organization, has already billed for this service. Since only one CCM
payment can be paid per beneficiary per month, the RHC or FQHC would
need to ask the patient if they are already receiving CCM services from
another practitioner. Revocation by the beneficiary of the agreement
must also be noted by recording the date of the revocation in the
beneficiary's medical record and by providing the beneficiary with
written confirmation that the RHC or FQHC would not be providing CCM
services beyond the current 30-day period. A beneficiary who has
revoked the agreement for CCM services from a RHC or FQHC may choose
instead to receive these services from a different practitioner
(including another RHC or
[[Page 71083]]
FQHC), beginning at the conclusion of the 30-day period.
The RHC or FQHC must provide a written or electronic copy
of the care plan to the beneficiary and record this in the
beneficiary's electronic medical record.
c. Scope of CCM Services in RHCs and FQHCs
We proposed that all of the following scope of service requirements
must be met to bill for CCM services:
Initiation of CCM services during a comprehensive
Evaluation/Management (E/M), AWV, or IPPE visit. The time spent
furnishing these services would not be included in the 20 minute
monthly minimum required for CCM billing.
Continuity of care with a designated RHC or FQHC
practitioner with whom the patient is able to get successive routine
appointments.
Care management for chronic conditions, including
systematic assessment of a patient's medical, functional, and
psychosocial needs; system-based approaches to ensure timely receipt of
all recommended preventive care services; medication reconciliation
with review of adherence and potential interactions; and oversight of
patient self-management of medications.
A patient-centered plan of care document created by the
RHC or FQHC practitioner furnishing CCM services in consultation with
the patient, caregiver, and other key practitioners treating the
patient to assure that care is provided in a way that is congruent with
patient choices and values. The plan would be a comprehensive plan of
care for all health issues based on a physical, mental, cognitive,
psychosocial, functional and environmental (re)assessment and an
inventory of resources and supports. It would typically include, but
not be limited to, the following elements: Problem list, expected
outcome and prognosis, measurable treatment goals, symptom management,
planned interventions, medication management, community/social services
ordered, how the services of agencies and specialists unconnected to
the practice will be directed/coordinated, the individuals responsible
for each intervention, requirements for periodic review and, when
applicable, revision, of the care plan. A complete list of problems,
medications, and medication allergies would be in the electronic health
record to inform the care plan, care coordination, and ongoing clinical
care.
The electronic care plan would be available 24 hours a day
and 7 days a week to all practitioners within the RHC or FQHC who are
furnishing CCM services whose time counts towards the time requirement
for billing the CCM code, and to other practitioners and providers, as
appropriate, who are furnishing care to the beneficiary, to address a
patient's urgent chronic care needs. No specific electronic solution or
format is required to meet this scope of service element. However, we
encourage RHCs and FQHCs to review the care plan criterion for health
information technology (IT) finalized in the 2015 Edition of Health
Information Technology Certification Criteria, 2015 Edition Base
Electronic Health Record (EHR) Definition, and ONC Health IT
Certification Program Modifications final rule (80 FR 62648), which
aims to enable users of certified health IT to create and receive care
plan information in accordance with the C-CDA Release 2.1 standard.
Management of care transitions within health care
including referrals to other clinicians, visits following a patient
visit to an emergency department, and visits following discharges from
hospitals and SNFs. The RHC or FQHC must be able to facilitate
communication of relevant patient information through electronic
exchange of a summary care record with other health care providers
regarding these transitions. The RHC or FQHC must also have qualified
personnel who are available to deliver transitional care services to a
patient in a timely way to reduce the need for repeat visits to
emergency departments and readmissions to hospitals and SNFs.
Coordination with home and community based clinical
service providers required to support a patient's psychosocial needs
and functional deficits. Such communication to and from home- and
community-based providers regarding these clinical patient needs must
be documented in the RHC's or FQHC's medical record system.
Secure messaging, internet or other asynchronous non-face-
to-face consultation methods for a patient and caregiver to communicate
with the provider regarding the patient's care in addition to the use
of the telephone. We would note that the faxing of information would
not meet this requirement. These methods would be required to be
available, but would not be required to be used by every practitioner
or for every patient receiving CCM services.
d. Electronic Health Records (EHR) Requirements
We believe that the use of EHR technology that allows data sharing
is necessary to assure that RHCs and FQHCs can effectively coordinate
services with other practitioners for patients with multiple chronic
conditions. Therefore, we proposed the following requirements:
Certified health IT must be used for the recording of
demographic information, health-related problems, medications, and
medication allergies; a clinical summary record; and other scope of
service requirements that reference a health or medical record.
RHCs and FQHCs must use technology certified to the
edition(s) of certification criteria that is, at a minimum, acceptable
for the EHR Incentive Programs as of December 31st of the year
preceding each CCM payment year to meet the following core technology
capabilities: Structured recording of demographics, problems,
medications, medication allergies, and the creation of a structured
clinical summary. For example, technology used to furnish CCM services
beginning on January 1, 2016, would be required to meet, at a minimum,
the requirements included in the 2014 Edition certification criteria.
For the purposes of the scope of services, we refer to technology
meeting these requirements as ``CCM Certified Technology.''
Applicable HIPAA standards would apply to electronic
sharing of patient information.
[[Page 71084]]
Table 24--Summary of CCM Scope of Service Elements and Billing
Requirements
------------------------------------------------------------------------
CCM scope of service/billing
requirements Health IT requirements
------------------------------------------------------------------------
Initiation of CCM services at an AWV, None.
IPPE, or a comprehensive E/M visit.
Structured recording of demographics, Structured recording of
problems, medications, medication demographics, problems,
allergies, and the creation of a medications, medication
structured clinical summary record. A allergies, and creation of
full list of problems, medications and structured clinical summary
medication allergies in the EHR must records using CCM certified
inform the care plan, care technology.
coordination, and ongoing clinical
care.
Access to CCM services 24/7 (providing None.
the beneficiary with a means to make
timely contact with the RHC or FQHC to
address his or her urgent chronic care
needs regardless of the time of day or
day of the week).
Continuity of care with a designated None.
RHC or FQHC practitioner with whom the
beneficiary is able to get successive
routine appointments.
CCM services for chronic conditions None.
including systematic assessment of the
beneficiary's medical, functional, and
psychosocial needs; system-based
approaches to ensure timely receipt of
all recommended preventive care
services; medication reconciliation
with review of adherence and potential
interactions; and oversight of
beneficiary self-management of
medications.
Creation of a patient-centered care Must at least electronically
plan based on a physical, mental, capture care plan information;
cognitive, psychosocial, functional make this information
and environmental (re)assessment and available on a 24/7 basis to
an inventory of resources and all practitioners within the
supports; a comprehensive care plan RHC or FQHC whose time counts
for all health issues. Share the care towards the time requirement
plan as appropriate with other for the practice to bill for
practitioners and providers. CCM services; and share care
plan information
electronically (other than by
fax) as appropriate with other
practitioners, providers, and
caregivers.
Provide the beneficiary with a written Document provision of the care
or electronic copy of the care plan plan as required to the
and document its provision in the beneficiary in the EHR using
electronic medical record. CCM certified technology.
Management of care transitions between Format clinical summaries
and among health care providers and according to CCM certified
settings, including referrals to other technology. Not required to
clinicians; follow-up after an use a specific tool or service
emergency department visit; and follow- to exchange/transmit clinical
up after discharges from hospitals, summaries, as long as they are
skilled nursing facilities or other transmitted electronically
health care facilities. (other than by fax).
Coordination with home and community Communication to and from home
based clinical service providers. and community based providers
regarding the patient's
psychosocial needs and
functional deficits must be
documented in the patient's
medical record using CCM
certified technology.
Enhanced opportunities for the None.
beneficiary and any caregiver to
communicate with the RHC or FQHC
regarding the beneficiary's care
through not only telephone access, but
also through the use of secure
messaging, internet or other
asynchronous non face-to-face
consultation methods.
Beneficiary consent--Inform the ...............................
beneficiary of the availability of CCM
services and obtain his or her written
agreement to have the services
provided, including authorization for
the electronic communication of his or
her medical information with other
treating providers.
Document in the beneficiary's medical ...............................
record that all of the CCM services
were explained and offered, and note
the beneficiary's decision to accept
or decline these services.
Document the beneficiary's written Document the beneficiary's
consent and authorization in the EHR written consent and
using CCM certified technology. authorization in the EHR using
CCM certified technology.
Beneficiary consent--Inform the None.
beneficiary of the right to stop the
CCM services at any time (effective at
the end of the calendar month) and the
effect of a revocation of the
agreement on CCM services.
Beneficiary consent--Inform the None.
beneficiary that only one practitioner
can furnish and be paid for these
services during a calendar month.
------------------------------------------------------------------------
We invited public comments on all aspects of the proposed payment
methodology and billing for CCM services in RHCs and FQHCs, the
proposed CCM requirements for RHCs and FQHCs, and any other aspect of
our proposal. The following is a summary of the comments we received
and our responses.
Most of the comments we received were very supportive of our
proposal to establish payment for CCM services in RHCs and FQHCs.
Several commenters agreed that allowing separate payment for CCM
services in RHCs and FQHCs will better reflect the additional resources
necessary for the unique services that are required to furnish CCM
services to the populations served by RHCs and FQHCs. Many commenters
appreciated that the proposed methodology would enable RHCs and FQHCs
to be paid for these services even if there was no billable visit. A
few commenters had concerns regarding health information technology
requirements or beneficiary copayment requirements. One commenter had
concerns about potential duplication in payment and increased Medicare
spending. Several commenters requested clarification on specific
aspects of the program. A few commenters asked questions that were
beyond the scope of the proposal.
[[Page 71085]]
Comment: One commenter noted that in a few instances, our proposal
alternately used ``a CCM 30-day period'' and ``only one CCM payment can
be paid per beneficiary per month.'' The commenter stated that under
the Medicare PFS and the definition of CPT code 99490, CCM services are
based on a calendar month, not a 30-day period.
Response: The commenter is correct that the CCM period is based on
a calendar month, not a 30-day period.
Comment: A few commenters were concerned that charging a
beneficiary coinsurance for non-face-to-face services will be confusing
to the beneficiary and create a barrier to receiving care. One
commenter recommended that we waive coinsurance for CCM services, and
another recommended that we waive the applicable coinsurance and
deductible through CMMI's waiver authority.
Response: We do not have the statutory authority to waive
coinsurance for CCM services, and CMMI waiver authority is only
applicable to CMMI demonstration programs. Although there may be
potential for confusion on the part of the beneficiary who receives a
bill for services that were conducted on their behalf but not furnished
directly to them, this should be fully explained to the beneficiary
during the consent process and in subsequent patient interactions as
necessary. We suggest that when practitioners explain the benefits of
receiving CCM, they include the possibility that it may help the
beneficiary to avoid the need for more costly face-to-face visits that
would entail greater cost sharing.
Comment: A commenter was concerned that many beneficiaries and
their caregivers will not fully understand the beneficiary consent for
CCM services requirements, including what they are being asked to
accept or decline, or why they are being asked to approve in writing
the provision of certain services and not others. The commenter
recommended that CMS take steps to ensure that beneficiaries will have
a proper understanding of CCM and its value, as well as their right to
decline enrollment in CCM, and that family caregivers be included in
these conversations, whenever possible.
Response: We agree with the commenter regarding the importance of
the beneficiary's understanding of CCM services and their right to
accept or decline this service. Beneficiary education on CCM services,
including information on the value of this service and the
beneficiary's right to accept or decline it, is a required component of
CCM services and must be provided to beneficiaries as part of the
consent process. We also agree that these discussions should include
the caregiver, when applicable.
Comment: A commenter urged CMS to ensure that communication methods
are conducted in a culturally and linguistically appropriate manner.
The commenter suggested that notices and agreements regarding CCM
services should be written in plain language and in their patients'
preferred languages, and be accessible to those with visual, hearing,
cognitive, and communication impairments.
Response: RHCs and FQHCs serve diverse populations, and we thank
the commenter for this important reminder that written and oral
communication materials should be accessible and understandable to the
patient population being served.
Comment: Some commenters expressed concerns with the proposed
technological requirements for CCM services. They noted that
interoperability and electronic exchange of medical information is
costly and there are technological barriers that may prevent the
seamless transmission and recording of patient information. One
commenter stated that since RHCs and FQHCs were not eligible for
Meaningful Use incentives, they may not have the health information
technology in place to support some of the requirements, and that those
RHCs and FQHCs that cannot meet the health information technology
requirements will be excluded from payment for CCM services. Other
commenters were concerned that some patients served by RHCs and FQHCs
may not have the resources to receive secure messages via the Internet.
These commenters recommended that the electronic health record
requirements, and the electronic exchange of information and
interoperability with other providers, be encouraged but not required
for CCM payment.
Response: We appreciate the concern regarding the cost and
challenges inherent in adopting new technological requirements and
understand that not all RHCs or FQHCs may be able to meet the
technological requirements at this time. RHCs and FQHCs that do not
have an EHR system in place, or are not able to meet the CCM
interoperability requirements, will not be able to furnish and bill for
CCM services. However, based on recent surveys, we believe that many,
if not most, RHCs and FQHCs have the capability to meet the
technological requirements now or in the near future. For example, a
recent survey showed that nearly 72 percent of RHCs have an operational
EHR system, with 63 percent indicating use by 90 percent or more of
their staff. The same study showed that slightly over 17 percent of
RHCs without an EHR plan to implement one within 6 months, and 27
percent plan to do so within 7 to 12 months.\1\ A 2014 study showed
that 93 percent of FQHCs have an EHR system, and that 76 percent
reported meeting the criteria to qualify for meaningful use incentive
payments.\2\ We would also note that eligible professionals working in
RHCs and FQHCs are eligible to receive payment under the EHR Incentive
Programs.
---------------------------------------------------------------------------
\1\ Adoption and Use of Electronic Health Recoreds by Rural
Health Clinics Results of a National Survey; Maine Rural Health
Research Center, Research and Policy Brief, September 2015.
\2\ The Adoption and Use of Health Information Technology by
Community Health Centers, 2009-2013; The Commonwealth Fund; Issue
Brief; May 2014.
---------------------------------------------------------------------------
We are aware that not all patients, particularly those served by
RHCs and FQHCs, may be able to receive secure messages via the
Internet, and they are not required to do so. However, to furnish and
bill for CCM services, RHCs and FQHCs must have the capability to
communicate with the beneficiary and any caregiver, not only through
telephone access, but also through the use of secure messaging,
Internet, or other asynchronous non face-to-face consultation methods.
Beneficiaries are not required to have this capability to receive CCM
services.
Comment: One commenter disagreed with the proposed requirement that
an electronic care plan be made available 24 hours a day, 7 days a
week, and believes that this unrealistically fails to account for
``system maintenance, down-time, change in EHR vendor, or the event of
technological glitches and cyber-attacks''. The commenter recommended
that at a minimum, CMS should provide for exceptions in the event of
any of these circumstances.
Response: RHCs and FQHCs that choose to furnish and bill CCM
services must have a system that supports 24 hours a day, 7 days a
week, access to the electronic care plan. We understand that there may
be times when the system is not operable, but we expect that this will
not be a frequent occurrence.
Comment: A commenter stated that they were worried that adding very
prescriptive technological requirements may stifle innovation and
prevent the use of technology that is more appropriate and tailored for
chronically ill patients. The commenter recommended that any
technological requirements for CCM services should be broadly drafted
to allow for future changes and advancements over time.
[[Page 71086]]
Response: We appreciate the commenter's concerns about the need to
avoid stifling innovation. In including these technology requirements,
we are seeking to ensure that all RHCs and FQHCs furnishing CCM
services have the technological capabilities that are needed to deliver
high-quality services while allowing the flexibility needed to adopt
appropriate technology solutions. By proposing the adoption of a
minimal set of certified health IT capabilities, and allowing
flexibility around more advanced capabilities such as shared care
planning, we believe that these goals will be met.
Comment: A commenter stated that physicians have significant
problems and usability concerns with the clinical care summaries, and
recommended that these summaries not be required for CCM services.
Response: We respectfully disagree with this commenter's
recommendation that clinical care summaries not be required for CCM
services. We believe that the transmission of clinical care summaries
is an important component of supporting effective care transitions and
should be available electronically to effectively furnish CCM services.
Comment: A commenter stated that the proposed care plan for CCM
services in RHCs and FQHCs, which includes the patient's medical,
functional, and psychosocial needs and has system-based approaches for
receipt of services, provides a comprehensive definition of care
management that should be used in other CPT codes to assure consistency
across programs and settings.
Response: We appreciate the comment, but the description of ``care
management'' utilized in other CPT codes is outside the scope of this
rule.
Comment: A commenter requested that CMS provide an optional
patient-centered plan of care document template that can be used as an
example to create a comprehensive care plan that is compliant with CCM
requirements. Another commenter asked for clarification on the
documentation requirements for billing CCM services, and another stated
that physicians are likely to need assistance from CMS in providing
educational materials for their patients regarding CCM. A commenter
urged CMS to expand the use of CCM codes to all Medicare beneficiaries.
Response: While we have not provided a template for RHCs and FQHCs
to use in developing care plans, we would refer these commenters to the
CMS Web site at https://www.cms.gov/Outreach-and-Education/Outreach/NPC/National-Provider-Calls-and-Events-Items/2015-02-18-Chronic-Care-Management-new.html for general information on CCM, including
educational materials.
Comment: A commenter requested that auxiliary personnel, including
pharmacists, be allowed to provide CCM services in RHCs and FQHCs,
including furnishing the AWV. Another commenter asked for clarification
of what positions qualify as auxiliary staff.
Response: The CMS Benefit Policy Manual, Chapter 9, describes
auxiliary personnel in RHCs and FQHCs as a nurse, medical assistant, or
anyone acting under the supervision of the physician. Auxiliary
personnel are not RHC or FQHC practitioners and cannot bill for a visit
in a RHC or FQHC. However, the time spent by auxiliary personnel in
furnishing CCM services could be counted towards meeting the 20 minute
minimum requirement for billing a CCM visit.
Comment: A commenter urged CMS to recognize occupational therapy
practitioners as RHC and FQHC practitioners, and to include
occupational therapy in all CMS's efforts to ensure beneficiary care is
appropriately provided and managed. The commenter states that this
would assist in promoting patient self-management, reduce caregiver
burden, decrease hospitalizations, increase effective resource
utilization, and contribute to improved beneficiary and population
health.
Response: We agree that occupational therapists can be a valuable
and important part of the health care team and can contribute to
improved outcomes and reduced costs. The full list of statutorily-
defined RHC and FQHC practitioners is set out at section 1861(aa)(2) of
the Act, and includes physicians, NPs, PAs, CNMs, CPs, or CSWs. Other
qualified practitioners, such as occupational therapists, may furnish
services incident to a RHC or FQHC practitioner's services. For
additional information on the provision of occupational therapy in RHCs
and FQHCs, see the CMS Benefit Policy Manual, Chapter 13, on the CMS
Web site at https://www.cms.gov/Center/Provider-Type/Rural-Health-Clinics-Center.html, or https://www.cms.gov/Center/Provider-Type/Federally-Qualified-Health-Centers-FQHC-Center.html.
Comment: A commenter questioned what specific tasks can be counted
toward the 20 minute CCM requirement.
Response: The tasks comprising CCM services are described in the
scope of service requirements in section III.B. of this final rule with
comment period.
Comment: A commenter urged CMS to emphasize and reiterate the scope
of services that are expected, including 24-7 access to care
management, continuity with a designated provider, and creation of a
patient-centered care plan document.
Response: The scope of services that are required for CCM payment,
including 24-7 access to care management, continuity of care with a
designated provider, and creation of a patient-centered care plan
document, are all required components of CCM services.
Comment: A commenter asked what would be considered the date of
service for CCM if multiple days per month are used to get to the 20-
minute mark.
Response: The service period for billing CCM services is one
calendar month, and we expect the RHC or FQHC to continue furnishing
services during a given month as applicable even after the 20-minute
time threshold to bill the service is met. The RHC or FQHC could bill
for the CCM service after completion of at least 20 minutes of
qualifying CCM services during the service period, or any time after
that until the end of the month. Additional billing information will be
provided in subregulatory guidance.
Comment: A commenter was concerned that CMS's proposed
reimbursement level for CCM services in RHCs and FQHCs is low, and
asked that we re-evaluate the time and effort needed for the
appropriate provision of these important services.
Response: We proposed that payment for CCM services be based on the
PFS national average non-facility payment rate when CPT code 99490 is
billed alone or with other payable services on a RHC or FQHC claim.
Since the commenter did not provide any rationale or additional data
supporting an increase in the payment rate for RHCs or FQHCs, we cannot
address this comment.
Comment: A commenter was concerned that separate payment for CCM
services in RHCs and FQHCs may lead to duplicative payments because the
FQHC PPS payment reflects the costs for all services associated with a
comprehensive primary care visit, even if not all the services occur on
the same day. The commenter also suggested that separate payment for
CCM services could lead to duplicative payment for FQHCs that receive a
Public Health Service grant because the grant already requires the
provision of health services that are available and accessible promptly
and in a manner which will assure continuity of service to the
residents of the center's catchment area.
Response: We would like to alleviate any concerns that separate
payment for CCM services is a duplication of RHC
[[Page 71087]]
and FQHC payment. Although the FQHC PPS payment, and the RHC AIR, do
reflect the costs for all services associated with a comprehensive
primary care visit, even if not all the services occur on the same day,
it does not generally include the costs of the services required for
CCM payment. For example, FQHCs are required to provide case management
that includes an assessment of factors affecting health (for example,
medical, social, housing, or educational), counseling and referrals to
address identified needs and periodic follow-up of services. They are
not required to create a structured recording of demographics,
problems, medications, medication allergies, and structured clinical
summary records using CCM certified technology, or to share the care
plan as appropriate with other practitioners and providers. FQHCs are
required to have an on-call provider for after-hours care, but they are
not required to have the 24/7 case management services that the CCM
billing code requires. RHCs do not have these requirements for primary
care visits.
In general, although a few of the services required for CCM payment
may be provided by some RHCs and FQHCs on occasion, the systematic
provision of care management, the level and intensity of care
coordination, and the interoperability of care plans with external
providers is not typically found in RHCs or FQHCs.
Comment: A commenter noted that the increase Medicare expenditures
for CCM services in RHCs and FQHCs would not trigger a budget-
neutrality adjustment, even though the estimated increase in spending
is material.
Response: The commenter is correct that payment for RHC and FQHC
services is not subject to budget neutrality. We believe that the
additional cost for furnishing CCM services in RHCs and FQHCs is an
investment in comprehensive and coordinated care that is likely to be
offset by reduced hospitalizations and readmissions. We would also note
that, based on the current utilization under the PFS, we have revised
our original estimate to reflect the expected phased in rate of CCM
utilization.
Comment: A commenter stated that FQHCs should not be required to
exclude any activities related to CCM from their Medicare cost reports.
Response: Any cost incurred as a result of the provision of CCM
services (as defined in the task list in section III.B.) is an
allowable cost and should be included in the Medicare cost report.
Comment: A commenter requested that CMS clarify in the final rule
that Medicare Advantage (MA) enrollees are entitled to the same CCM
services as non-MA enrollees, and that MA-contracted FQHCs are entitled
to the same payment for CCM services as FQHCs providing qualifying CCM
services to non-MA enrollees.
Response: In addition to Medicare Part A and Part B services, MA
organizations (MAOs) are required to furnish care coordination services
that are substantially similar to the Original Medicare CCM services.
They have flexibility in terms of how to furnish care coordination
services to ensure ongoing continuity of care and care management for
all enrollees. MA regulations at Sec. 422.256(a)(2)(ii) expressly
preclude CMS from interfering in payment rates agreed to by an MA plan
and its contracted providers. Whether or not a MAO pays its providers
for furnishing care coordination services through use of the CPT code
or some other mechanism can vary depending on the contract agreement in
place. Thus, the amount the MA plan will pay the contracted FQHC
depends on the terms of the contract. We note that MA PPO enrollees
have the option to obtain covered services from non-contracted
providers. Thus, if a PPO enrollee chooses an out-of-network provider
to furnish chronic care management services and all criteria for
billing the CCM code is met, the MAO must pay for those services
consistent with Original Medicare payment rules. In this scenario,
enrollees are responsible for any plan established out-of-network cost
sharing. Additionally, although not coordinated care plans, Medicare
PACE Organizations, MA private fee-for-service plans and MA Medicare
Savings Account plans are required to cover Medicare Part A and Part B
services, which include coverage of the CCM services consistent with
Medicare coverage and payment rules.
Comment: A commenter stated that RHCs and FQHCs cannot bill for an
IPPE or AWV visit in addition to the AIR and that RHCs and FQHCs are
doing this work at their own expense and without compensation. The
commenters stated that CMS has proposed the ability for RHCs to bill
for CCM in addition to the AIR in the CY 2016 PFS, and asked that this
RHCs and FQHCs also be allowed to bill separately for the IPPE and AWV.
Response: It is unclear why the commenter stated that the IPPE and
AWV are uncompensated, since these services are billable visits.
Although we do not agree that RHCs and FQHCs are furnishing IPPEs and
AWVs at their own expense and without compensation, payment for IPPEs
and AWVs in RHCs and FQHCs is outside of the scope of this proposal.
Comment: A commenter expressed concern that the unique RHC and FQHC
billing structures may preclude them from receiving payment for newly
developed care coordination payment codes, and suggested that RHCs and
FQHCs be guaranteed care coordination payments. The commenter stated
that including RHCs and FQHCs in ensuring better care coordination is
vital, and suggested that CMS make payments for care coordination
services available to RHCs and FQHCs through ``crosswalk'' procedures
or similar technical allowances,
Response: We agree that care coordination in RHCs and FQHCs is
extremely important, and would note that the payment methodology
proposed for RHCs and FQHCs is due to the non-face-to-face nature of
this benefit. As the commenter did not provide any specific suggestions
on ``crosswalk procedures or similar technical allowances,'' we cannot
address this comment.
Comment: A commenter requested that PAs in RHCs be allowed to bill
for laboratory, X-rays, and other services using a methodology similar
to what was proposed for CCM services.
Response: This comment is outside the scope of this rule.
Comment: A few commenters requested that an exception to the direct
supervision requirements be made for CCM and TCM services that are
furnished incident to physician services in RHCs and FQHCs. The
commenters suggested that the regulatory language be amended to be
consistent with the provisions in Sec. 410.26(b)(5), which state that
CCM and TCM services (other than the required face-to-face visit) can
be furnished under general supervision of the physician (or other
practitioner) when they are provided by clinical staff incident to the
services of a physician (or other practitioner). The physician (or
other practitioner) supervising the auxiliary personnel need not be the
same physician (or other practitioner) upon whose professional service
the incident to service is based.
Response: We believe that due to their different model of care and
payment structure, requiring direct supervision for ``incident to''
services is appropriate for RHCs and FQHCs at this time. However, we
will consider this for future rulemaking if RHCs and FQHCs find that
requiring direct supervision presents a barrier to furnishing CCM
services.
Comment: A commenter stated that the limitation of one CCM payment
per month per beneficiary does not support
[[Page 71088]]
the scope of services that beneficiaries often need.
Response: We are not sure if this commenter is suggesting that CCM
payments be made more frequently to the same RHC or FQHC (or other
practitioner), or if more than one entity (for example, RHC, FQHC, a
physician's office, etc.) should be able to bill for CCM services
within the month. For either of these situations, we respectfully
disagree with this commenter. We believe that a minimum of 20 minutes
of CCM services over a one-month period is required to achieve the
benefits of CCM services, and that there should be a single and
consistent point of contact for these services.
Comment: A commenter recommended the creation of a modifier for
services furnished by a specialist to establish a link between a
primary care referral and the specialist for CCM.
Response: Since services furnished directly by a primary care
practitioner or a specialist are separately billable services, we
believe this commenter may be suggesting a way to document referrals to
specialist services that result from CCM services. We thank the
commenter for the suggestion but do not believe this would be necessary
or beneficial.
As a result of the comments, we are finalizing these provisions as
proposed, except to change ``30-day period'' to ``calendar month''
wherever it was used in the proposed rule.
C. Healthcare Common Procedure Coding System (HCPCS) Coding for Rural
Health Clinics (RHCs)
1. RHC Payment Methodology and Billing Requirements
RHCs are paid an all-inclusive rate (AIR) per visit for medically
necessary primary health services and qualified preventive health
services furnished face-to-face by a RHC practitioner to a Medicare
beneficiary. The all-inclusive payment system was designed to minimize
reporting requirements, and as such, the rate includes all costs
associated with the services that a RHC furnishes in a single day to a
Medicare beneficiary, regardless of the length or complexity of the
visit or the number or type of RHC practitioners seen. Except for
certain preventive services that are not subject to coinsurance
requirements, it has not been necessary for RHCs to report medical and
procedure codes, such as level I and level II of the HCPCS, on claims
for services that were furnished during the visit to determine Medicare
payment. Generally, the services reported using the appropriate site of
service revenue code on a RHC claim receives payment under the AIR,
with coinsurance and deductible applied based upon the associated
charges on that line, notwithstanding other Medicare requirements.
Historically, billing instructions for RHCs and Federally Qualified
Health Centers (FQHCs) have been similar. Beginning on April 1, 2005,
through December 31, 2010, RHCs and FQHCs were no longer required to
report HCPCS when billing for RHC and FQHC services rendered during an
encounter, absent a few exceptions. CMS Transmittal 371, dated November
19, 2004, eliminated HCPCS coding for FQHCs and eliminated the
additional line item reporting of preventive services for RHCs and
FQHCs for claims with dates of service on or after April 1, 2005. CMS
Transmittal 1719, dated April 24, 2009, effective October 1, 2009,
required RHCs and FQHCs to report HCPCS codes for a few services, such
as certain preventive services eligible for a waiver of deductible,
services subject to frequency limits, and services eligible for
payments in addition to the all-inclusive rate.
Section 1834(o)(1)(B) of the Act, as added by the Affordable Care
Act, required that FQHCs begin reporting services using HCPCS codes to
develop and implement the FQHC PPS. Since January 1, 2011, FQHCs have
been required to report all services furnished during an encounter by
specifically listing the appropriate HCPCS code(s) for each line item,
along with the site of service revenue code(s), when billing Medicare.
As of October 1, 2014, HCPCS coding is used to calculate payment for
FQHCs that are paid under the FQHC PPS.
Section 4104 of the Affordable Care Act waived the coinsurance and
deductible for the initial preventive physical examination (IPPE), the
annual wellness visit (AWV), and other Medicare covered preventive
services recommended by the United States Preventive Services Task
Force (USPSTF) with a grade of A or B. Since January 1, 2011, RHCs have
been required to report HCPCS coding for these preventive services, for
which coinsurance and deductible are waived. When billing for an
approved preventive service, RHCs must report an additional line with
the appropriate site of service revenue code with the approved
preventive service HCPCS code and the associated charges. Although
HCPCS coding is currently required for approved preventive services on
RHC claims, HCPCS coding is not used to determine RHC payment.
2. Requirement for Reporting of HCPCS Coding for All Services Furnished
by RHCs during a Medicare Visit
For payment under Medicare Part B, the statute requires health
transactions to be exchanged electronically, subject to certain
exceptions, using standards specified by the Secretary. Specifically,
section 1862(a)(22) of the Act requires that no payment may be made
under part A or part B for any expenses incurred for items or services,
subject to exceptions under section 1862(h), for which a claim is
submitted other than in an electronic form specified by the Secretary.
Further, section 1173(1)(a) of the Act, added by section 262 of the
Health Insurance Portability and Accountability Act of 1996 (HIPAA),
requires the Secretary to adopt standards for transactions, and data
elements for such transactions, to enable health information to be
exchanged electronically, that are appropriate for transactions. These
include but are not limited to health claims or equivalent encounter
information. As a result of the HIPAA amendments, HHS adopted
regulations pertaining to data standards for health care related
transactions. The regulations at 45 CFR 160.103 define a covered entity
to include a provider of medical or health services (as defined in
section 1861(s) of the Act), and define the types of standard
transactions. When conducting a transaction, under 45 CFR 162.1000, a
covered entity must use the applicable medical data code sets described
in Sec. 162.1002 that are valid at the time the health care is
furnished, and these regulations define the standard medical data code
sets adopted by the Secretary as HCPCS and CPT (Current Procedural
Terminology--Fourth Edition) for physician services and other health
care services.
Under section 1861(s)(2)(E) of the Act, a RHC is a supplier of
medical or health services. As such, our regulations require these
covered entities to report a standard medical code set for electronic
health care transactions, although our program instructions have
directed RHCs to submit HCPCS codes only for preventive services. We
believe reporting of HCPCS coding for all services furnished by a RHC
would be consistent with the health transactions requirements, and
would provide useful information on RHC patient characteristics, such
as level of acuity and frequency of services furnished, and the types
of services being furnished by RHCs. This information would also allow
greater oversight of the program and inform policy decisions.
We proposed that all RHCs must report all services furnished during
an
[[Page 71089]]
encounter using standardized coding systems, such as level I and level
II of the HCPCS, for dates of service on or after January 1, 2016. In
accordance with section 1862(h) of the Act, in limited situations RHCs
that are unable to submit electronic claims and RHCs with fewer than 10
full time equivalent employees are exempt from submitting claims
electronically. We proposed that RHCs exempt from electronic reporting
under section 1862(h) of the Act must also report all services
furnished during an encounter using HCPCS coding via paper claims for
dates of services on or after January 1, 2016. This proposal would
necessitate new billing practices for such RHCs, but we believe there
would be no significant burden for the limited number of RHCs exempt
from electronic billing.
Under this proposal, a HCPCS code would be reported along with the
presently required Medicare revenue code for each service furnished by
the RHC to a Medicare patient. Although HCPCS coding is currently used
to determine FQHC payment under the FQHC PPS, under this proposal, RHCs
would continue to be paid under the AIR and there would be no change in
their payment methodology.
Accordingly, we proposed to remove the requirement at Sec.
405.2467(b) pertaining to HCPCS coding for FQHCs and redesignate
paragraphs (c) and (d) as paragraphs (b) and (c), respectively. We also
proposed to add a new paragraph (g)(3) to Sec. 405.2462 to require
FQHCs and RHCs, whether or not exempt from electronic reporting under
Sec. 424.32(d)(3), to report on Medicare claims all service(s)
furnished during each FQHC and RHC visit (as defined in Sec. 405.2463)
using HCPCS and other codes as required.
We proposed to require reporting of HCPCS coding for all services
furnished by RHCs to Medicare beneficiaries effective for dates of
service on or after January 1, 2016. We are aware that many RHCs
already record this information through their billing software or
electronic health record systems; however, we recognize there may be
some RHCs that need to make changes in their systems. We invited RHCs
to submit comments on the feasibility of updating their billing systems
to meet this implementation date of January 1, 2016.
As part of the implementation of the HCPCS coding requirement, we
plan to provide instructions on how RHCs are to report HCPCS and other
coding and clarify other appropriate billing procedures through program
instruction.
The following is a summary of the comments we received and our
responses.
Comment: We received a few comments on our proposal and all were
supportive of requiring RHCs to report HCPCS for all services
furnished. Most commenters agreed with our assertions that the data
could potentially inform future policy decisions by providing useful
information on individual patient attributes and the types of services/
procedures furnished by RHCs. One commenter supported this proposal
because currently all other providers such as hospitals, physicians,
and FQHCs report HCPCS on claims to Medicare. Another commenter
expressed interest in reporting HCPCS to enable participation in PQRS
and other quality reporting programs. A commenter stated that HCPCS
could be determined from the services recorded in the electronic
medical record system and office systems that generate claim forms
could be modified easily to bill all services furnished. A commenter
believed that the majority of RHCs would experience minimal burden
fulfilling this requirement. Although all commenters supported the
requirement, a few commenters raised concerns about operational
challenges of the requirement. One commenter stated, ``The operational
challenge for providers will be capturing the appropriate charge for
`all' services provided.'' Another commenter was concerned about
whether CMS and the MACs would be ready by January 1, 2016 to process
RHC claims under the proposed requirement.
Response: We appreciate the support for our proposal to require
RHCs to report HCPCS on RHC claims for Medicare services. We want to
clarify that the reporting of HCPCS does not necessarily convey
eligibility to participate in PQRS and other value-based payments since
these programs have additional eligibility requirements that RHCs may
be unable to meet. We do not believe there will be an operational
challenge for providers to capture the charge for all services
provided. There is no change to the methodology for reporting charges
under this requirement. We acknowledge the commenter's concerns about
the system's readiness to process claims under the requirement and we
have been working with the MACs to implement the required updates. We
are finalizing the reporting requirement as proposed with an effective
date of April 1, 2016 to allow the MACs additional time to implement
the necessary claims processing systems changes completely.
D. Payment to Grandfathered Tribal FQHCs That Were Provider-Based
Clinics on or Before April 7, 2000
1. Background
a. Health Services to American Indians and Alaskan Natives (AI/AN)
There is a special government-to-government relationship between
the federal government and federally recognized tribes based on U.S.
treaties, laws, Supreme Court decisions, Executive Orders and the U.S.
Constitution. This government-to-government relationship forms the
basis for federal health services to American Indians/Alaska Natives
(AI/AN) in the U.S.
In 1976, the Indian Health Care Improvement Act (IHCIA, Pub. L. 94-
437) amended the statute to permit payment by Medicare and Medicaid for
services provided to AI/ANs in Indian Health Service (IHS) and tribal
health care facilities that meet the applicable requirements. Under
this authority, Medicare services to AI/ANs may be furnished by IHS
operated facilities and programs and tribally-operated facilities and
programs under Title I or Title V of the Indian Self Determination
Education Assistance Act, as amended (ISDEAA, Pub. L 93-638).
According to the IHS Year 2015 Profile, the IHS healthcare delivery
system currently consists of 46 hospitals, with 28 of those hospitals
operated by the IHS and 18 of them operated by tribes under the ISDEAA.
Payment rates for inpatient and outpatient medical care furnished
by the IHS and tribal facilities is set annually by the IHS under the
authority of sections 321(a) and 322(b) of the Public Health Service
(PHS) Act (42 U.S.C. 248 and 249(b)), Pub. L. 83-568 (42 U.S.C.
2001(a)), and the IHCIA, based on the previous year's cost reports from
federal and tribal hospitals. The 1976 IHCIA provided the authority for
CMS (then HCFA) to pay IHS for its hospital services to Medicare
eligible patients, and in 1978 CMS agreed to use a Medicare all-
inclusive payment rate for IHS hospitals and IHS hospital-based
clinics.
There is an outpatient visit rate for Medicare visits in Alaska and
an outpatient visit rate for Medicare visits in the lower 48 States.
The Medicare outpatient rate is only applicable for those IHS or tribal
facilities that meet the definition of a provider-based department as
described at Sec. 413.65(a), or a ``grandfathered'' facility as
described at Sec. 413.65(m). For CY 2015, the Medicare outpatient
encounter rate is $564 for Alaska and $307 for the rest
[[Page 71090]]
of the country (80 FR 18639, April 7, 2015).
b. Provider-Based Entities and the ``Grandfathering'' Provision
In 2000, we adopted regulations at Sec. 413.65 that established
criteria for facilities to be considered provider-based to a hospital
for Medicare payment purposes. The provider-based rules apply to
facilities located both on and off the main hospital campus for which
provider-based status is sought.
In the CY 2001 Hospital Outpatient PPS final rule with comment
period (65 FR 18507), we addressed comments on the proposed provider-
based rules. In regard to IHS facilities, commenters expressed concern
that the proposed rule would undermine the ISDEAA contracting and
compacting relationships between the IHS and tribes because provider-
based clinics must be clinically and administratively integrated into
the hospital, and a tribe that assumes the operation of a provider-
based clinic but not the operation of the hospital would not be able to
meet this requirement. Commenters were also concerned that the proposed
proximity requirements would threaten the status of many IHS and tribal
facilities that frequently were located in distant remote areas.
In response to these comments and the special provisions of law
referenced above governing health care for IHS and the tribes, we
recognized the special relationship between tribes and the United
States government, and did not apply the general provider-based
criteria to IHS and tribally-operated facilities. The regulations
currently include a grandfathering provision at Sec. 413.65(m) for IHS
and tribal facilities that were provider-based to a hospital on or
prior to April 7, 2000. This section states that facilities and
organizations operated by the IHS or tribes will be considered to be
departments of hospitals operated by the IHS or tribes if, on or before
April 7, 2000, they furnished only services that were billed as if they
had been furnished by a department of a hospital operated by the IHS or
a tribe and they are:
Owned and operated by the IHS;
Owned by the tribe but leased from the tribe by the IHS
under the ISDEAA in accordance with applicable regulations and policies
of the IHS in consultation with tribes; or
Owned by the IHS but leased and operated by the tribe
under the ISDEAA in accordance with applicable regulations and policies
of the IHS in consultation with tribes.
Under the authority of the ISDEAA, a tribe may assume control of an
IHS hospital and the provider-based clinics affiliated with the
hospital, or may only assume responsibility of the provider-based
clinic. On August 11, 2003, we issued a letter to Trailblazer Health
Enterprises, LLC, stating that changes in the status of a hospital or
facility from IHS to tribal operation, or vice versa, or the
realignment of a facility from one IHS or tribal hospital to another
IHS or tribal hospital, would not affect the facility's grandfathered
status if the resulting configuration is one which would have qualified
for grandfathering under Sec. 413.65(m) if it had been in effect on
April 7, 2000.
However, the Medicare Conditions of Participation (CoPs) for
Medicare-participating hospitals at Sec. 482.12 require administrative
and clinical integration between a hospital and its provider-based
clinics, departments, and locations. A tribal clinic billing under an
IHS hospital's CMS Certification Number (CCN), without any additional
administrative or clinical relationship with the IHS hospital, could
put that hospital at risk for non-compliance with the CoPs.
Consequently, it became apparent that a different structure was
needed to maintain access to care for AI/AN populations served by these
hospitals and clinics, while also ensuring that these facilities are in
compliance with our health and safety rules. We believed that the FQHC
program may provide an alternative structure that met the needs of
these tribal clinics and the populations they served, while also
ensuring the IHS hospitals were not at risk of being cited for non-
compliance with the requirements in their CoPs.
c. Federally Qualified Health Centers (FQHCs)
FQHCs were established in 1990 by section 4161 of the Omnibus
Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted on November
5, 1990) (OBRA 90), and were effective beginning on October 1, 1991.
They are facilities that furnish services that are typically furnished
in an outpatient clinic setting.
The statutory requirements that FQHCs must meet to qualify for the
Medicare benefit are in section 1861(aa)(4) of the Act. All FQHCs are
subject to Medicare regulations at 42 CFR part 405, subpart X, and 42
CFR part 491. Based on these provisions, the following three types of
organizations that are eligible to enroll in Medicare as FQHCs:
Health Center Program grantees: Organizations receiving
grants under section 330 of the PHS Act (42 U.S.C. 254b).
Health Center Program ``look-alikes'': Organizations that
have been identified by the Health Resources and Services
Administration as meeting the requirements to receive a grant under
section 330 of the PHS Act, but which do not receive section 330 grant
funding.
Outpatient health programs or facilities operated by a
tribe or tribal organization under the ISDEAA, or by an urban Indian
organization receiving funds under Title V of the IHCIA.
FQHCs are also entities that were treated by the Secretary for
purposes of Medicare Part B as a comprehensive federally funded health
center as of January 1, 1990 (see section 1861(aa)(4)(C) of the Act).
Section 1834 of the Act was amended by section 10501(i)(3)(A) of
the Affordable Care Act by adding a new subsection (o), ``Development
and Implementation of Prospective Payment System'' for FQHCs. Section
1834(o)(1)(A) of the Act requires that the system include a process for
appropriately describing the services furnished by FQHCs, and establish
payment rates based on such descriptions of services, taking into
account the type, intensity, and duration of services furnished by
FQHCs. It also stated that the new system may include adjustments (such
as geographic adjustments) as determined appropriate by the Secretary.
Section 1833(a)(1)(Z), as added by the Affordable Care Act, requires
that Medicare payment for FQHC services under section 1834(o) of the
Act be 80 percent of the lesser of the actual charge or the PPS amount
determined under section 1834(o) of the Act.
In accordance with the requirements in the statute, as amended by
the Affordable Care Act, beginning on October 1, 2014, payment to FQHCs
is based on the lesser of the national encounter-based FQHC PPS rate,
or the FQHC's total charges, for primary health services and qualified
preventive health services furnished to Medicare beneficiaries. The
FQHC PPS rate is adjusted by the FQHC geographic adjustment factor
(GAF), which is based on the Geographic Practice Cost Index used under
the PFS. The FQHC PPS rate is also adjusted when the FQHC furnishes
services to a patient that is new to the FQHC, and when the FQHC
furnishes an IPPE or an AWV. The FQHC PPS base rate for the period from
October 1, 2014, to December 31, 2015 is $158.85. The rate will be
adjusted in CY 2016 by the MEI, as defined at section 1842(i)(3) of the
Act, and subsequently by either the MEI or a
[[Page 71091]]
FQHC market basket (which would be determined under CMS regulations).
To assure that FQHCs receive appropriate payment for services
furnished, we established a new set of five HCPCS G-codes for FQHCs to
report Medicare visits. These G-codes include all the services in a
typical bundle of services that would be furnished per diem to a
Medicare patient at the FQHC. The five FQHC G-codes are:
G0466-FQHC visit, new patient.
G0467-FQHC visit, established patient.
G0468-FQHC visit, IPPE or AWV.
G0469-FQHC visit, mental health, new patient.
G0470-FQHC visit, mental health, established patient.
FQHCs establish charges for the services they furnish to FQHC
patients, including Medicare beneficiaries, and charges must be uniform
for all patients, regardless of insurance status. The FQHC would
determine the services that are included in each of the 5 FQHC G-codes,
and the sum of the charges for each of the services associated with the
G-code would be the G-code payment amount. Payment to the FQHC for a
Medicare visit is the lesser of the FQHC's charges (as established by
the G-code), or the PPS rate.
2. Payment Methodology and Requirements
We proposed that IHS and tribal facilities and organizations that
met the conditions of Sec. 413.65(m) on or before April 7, 2000, and
have a change in their status on or after April 7, 2000 from IHS to
tribal operation, or vice versa, or the realignment of a facility from
one IHS or tribal hospital to another IHS or tribal hospital such that
the organization no longer meets the CoPs, may seek to become certified
as grandfathered tribal FQHCs. To help avoid any confusion, we referred
to these tribal FQHCs as ``grandfathered tribal FQHCs'' to distinguish
them from freestanding tribal FQHCs that are currently being paid the
lesser of their charges or the adjusted national FQHC PPS rate of
$158.85, and from provider-based tribal clinics that may have begun
operations subsequent to April 7, 2000.
Under the authority in 1834(o) of the Affordable Care Act to
include adjustments determined appropriate by the Secretary, we
proposed that these grandfathered tribal FQHCs be paid the lesser of
their charges or a grandfathered tribal FQHC PPS rate of $307, which
equals the Medicare outpatient per visit payment rate paid to them as a
provider-based department, as set annually by the IHS, rather than the
FQHC PPS per visit base rate of $158.85, and that coinsurance would be
20 percent of the lesser of the actual charge or the grandfathered
tribal FQHC PPS rate. These grandfathered tribal FQHCs would be
required to meet all FQHC certification and payment requirements. This
FQHC PPS adjustment for grandfathered tribal clinics would not apply to
a currently certified tribal FQHC, a tribal clinic that was not
provider-based as of April 7, 2000, or an IHS-operated clinic that is
no longer provider-based to a tribally operated hospital. This
provision would also not apply in those instances where both the
hospital and its provider-based clinic(s) are operated by the tribe or
tribal organization.
Since we proposed that these grandfathered tribal FQHCs would be
paid based on the IHS payment rates and not the FQHC PPS payment rates,
we also proposed that the payment rate would not be adjusted by the
FQHC PPS GAF, or be eligible for the special payment adjustments under
the FQHC PPS for new patients, patients receiving an IPPE or an AWV.
They would also not be eligible for the exceptions to the single per
diem payment that is available to FQHCs paid under the FQHC PPS. As the
IHS outpatient rate for Medicare is set annually, we also proposed not
to apply the MEI or a FQHC market basket adjustment that is applied
annually to the FQHC PPS base rate. We proposed that these adjustments
not be applied because we believe that the special status of these
grandfathered tribal clinics, and the enhanced payment they would
receive under the FQHC PPS system, would make further adjustments
unnecessary and/or duplicative of adjustments already made by IHS in
deriving the rate. We will monitor future costs and claims data of
these tribal clinics and reconsider options as appropriate.
Grandfathered tribal FQHCs would be paid for services included in
the FQHC benefit, even if those services are not included in the IHS
Medicare outpatient all-inclusive rate. Services that are included in
the IHS outpatient all-inclusive rate but not in the FQHC benefit would
not be paid. Information on the FQHC benefit is available in Chapter 13
of the Medicare Benefit Policy Manual. Grandfathered tribal FQHCs will
be subject to Medicare regulations at part 405, subpart X, and part
491, except as noted in section III.D.2. of this final rule with
comment period. Therefore, we proposed to revise Sec. 405.2462, Sec.
405.2463, Sec. 405.2464, and Sec. 405.2469 to specify the
requirements for payment as a grandfathered tribal FQHC, and to specify
payment provisions, adjustments, rates, and other requirements for
grandfathered tribal FQHCs.
3. Transition
To become certified as a FQHC, an eligible tribe or tribal
organization must submit a Form 855A and all required accompanied
documentation, including an attestation of compliance with the Medicare
FQHC Conditions for Coverage at part 491, to the Jurisdiction H
Medicare Administrative Contractor (A/B MAC). After reviewing the
application and determining that it was complete and approvable, the
MAC would forward the application with its recommendation for approval
to the CMS Regional Office (RO) that has responsibility for the
geographic area in which the tribal clinic is located. The RO would
issue a Medicare FQHC participation agreement to the tribal FQHC,
including a CCN, and would advise the MAC of the CCN number, to
facilitate the MAC's processing of FQHC claims submitted by the tribal
FQHC. Payment to grandfathered tribal FQHCs would begin on the first
day of the month in the first quarter of the year subsequent to receipt
of a Medicare CCN.
4. Conforming Changes
In addition, to the changes proposed in Sec. 405.2462, Sec.
405.2463, Sec. 405.2464, and Sec. 405.2469, we proposed to remove
obsolete language from Sec. 405.2410 regarding FQHCs that bill on the
basis of the reasonable cost system, add a section heading to Sec.
405.2415, and remove obsolete language from Sec. 405.2448 regarding
employment requirements.
We invited public comments on all aspects of our proposal to allow
IHS and tribal facilities and organizations that met the conditions of
Sec. 413.65(m) on or before April 7, 2000, and have a change in their
status on or after April 7, 2000 from IHS to tribal operation, or vice
versa, or the realignment of a facility from one IHS or tribal hospital
to another IHS or tribal hospital such that the organization no longer
meets the CoPs, to become certified as grandfathered tribal FQHCs.
We received comments on this proposal from the Alaska Native Health
Board, Alaska Native Tribal Health Consortium, Citizen Potawatomi
Nation, Southern Ute Indian Tribe, Southcentral Foundation, and the
Tribal Technical Advisory Group (TTAG). All the commenters were
strongly opposed to the proposal and requested that it be either
withdrawn or revised.
The following is a summary of the comments we received and our
responses.
[[Page 71092]]
Comment: Commenters questioned the necessity of changing the
payment system for grandfathered tribal outpatient clinics that are no
longer provider-based to a hospital, and cited our history of
interpreting and applying the provider-based regulations in a manner
which granted provider-based status to these clinics even though they
do not meet the provider-based requirements.
Response: In the proposed rule, we stated several reasons for
proposing that these grandfathered tribal outpatient clinics transition
to grandfathered tribal FQHC status. First, a grandfathered tribal
outpatient clinic billing under an IHS hospital's CCN, without any
administrative or clinical relationship with the IHS hospital, violates
our hospital CoPs, which as noted, requires a hospital to function as
one integrated entity, no matter how many off campus locations it may
have. This would include having one governing body, one organized
medical staff, one organized nursing department, one quality assessment
and improvement program, and so forth. Non-compliance with any CoP
requirement is cited as non-compliance for the entire hospital (Sec.
482.12). Serious noncompliance in any part of the hospital puts the
entire hospital at risk for termination of its Medicare agreement,
which would impact not just the hospital, but also the community it
serves.
Second, a hospital may be legally liable for actions that occur by
any part of their organization, which would include a clinic that is
billing for Medicare services under the hospital's CCN, even if the
hospital exercises no control over the clinic. We believe this puts a
hospital in the untenable position of being legally responsible for
actions over which it has no control.
Finally, under the current practice, grandfathered tribal
outpatient clinics receive Medicare payment for services to Medicare
beneficiaries and are subject to the hospital's CoPs. The Medicare CoPs
are sets of requirements for acceptable quality in the operation of
health care entities that must be met in order to bill Medicare, and an
entity cannot participate in Medicare unless it meets every Condition.
Because the facility would no longer be associated with a hospital, we
believe that the FQHC CoPs would be an appropriate standard that all of
these clinics would be able to meet.
For these reasons, we believe it is prudent for grandfathered
tribal outpatient clinics to be directly responsible for their
operations and held to Medicare CoPs that are reasonable and
achievable, and that the option to become grandfathered tribal FQHCs
will achieve these goals.
Comment: Commenters stated that provider-based status is already
guaranteed under existing law and does not jeopardize the Medicare
certification of IHS hospitals.
Response: As discussed in the previous response, a hospital that is
not in compliance with its Medicare hospital CoPs is at risk for
termination of its Medicare certification. The CoPs at Sec. 482.12 and
Sec. 485.627, as applicable, require that each hospital have a
governing body legally responsible for its operations, and do not
provide an exception where a tribal clinic is billing as an outpatient
department of the hospital but otherwise has no clinical or
administrative relationship with that hospital. As we discussed in the
proposed rule, a letter was issued to Trailblazer Health Enterprises,
LLC, on August 11, 2003, stating that changes in the status of a
hospital or facility from IHS to tribal operation, or vice versa, or
the realignment of a facility from one IHS or tribal hospital to
another IHS or tribal hospital, would not affect the facility's
grandfathered status if the resulting configuration is one which would
have qualified for grandfathering under Sec. 413.65(m) if it had been
in effect on April 7, 2000. This letter has been interpreted by some as
the basis for allowing tribal clinics that no longer meet the provider-
based requirements to maintain their provider-based status and continue
to be paid as an outpatient department of a hospital. We would note
that although this letter acknowledged the continued provider-based
status of some tribal clinics, no statute guarantees provider-based
status to outpatient departments of hospitals that have changed their
status such that they are no longer integrated with the hospital under
whose Medicare CCN they are billing.
Comment: Commenters stated although they believe no clarification
is needed, CMS could amend the regulations to state that (1) IHS and
tribal facilities qualify for grandfathered provider-based status
solely by virtue of satisfying Sec. 413.65(m) and that (2) changes in
the IHS or tribal status of a hospital or facility's operation will not
lead to the loss of provider-based status, or jeopardize the associated
hospital's Medicare certification, if the resulting configuration would
have qualified as a grandfathered provider-based tribal facility as of
April 7, 2000. Alternately, CMS could reaffirm its longstanding reading
of the regulations as stated in the preamble to the CY 2000 PFS final
rule.
Response: We appreciate the suggestion, but neither of these
approaches would relieve the hospital from liability for CoP violations
found in a grandfathered tribal provider-based clinic using the
hospital's CCN, or, in the alternative, address the lack of applicable
CoPs for tribal clinics claiming to operate as outpatient departments
of a hospital with which they do not otherwise have an administrative
or clinical relationship.
Comment: Commenters requested that CMS withdraw the proposed rule,
or make the grandfathered tribal FQHC status optional for eligible
tribal facilities and allow them time to compare the alternatives and
make an informed choice.
Response: We stated in the proposal that IHS and tribal facilities
and organizations that met the conditions of Sec. 413.65(m) on or
before April 7, 2000, and have a change in their status on or after
April 7, 2000, from IHS to tribal operation, or vice versa, or the
realignment of a facility from one IHS or tribal hospital to another
IHS or tribal hospital such that the organization no longer meets the
CoPs, may seek to become certified as grandfathered tribal FQHCs.
Although we would encourage all facilities that qualify for this status
to become certified as grandfathered tribal FQHCs as soon as possible,
they are not required to do so. We do, note, however, that CMS has an
obligation to enforce compliance with the hospital CoPs at Sec.
482.12. Thus, if CMS were to survey a hospital, and find Medicare being
billed for hospital outpatient services by a provider-based department
that was not in compliance with the hospital CoPs, the hospital would
have to submit an acceptable plan of correction consistent with
provisions of Sec. 488.28 and demonstrate compliance via an on-site
survey or risk termination of its Medicare certification. Such an
action could potentially lead to an interruption in Medicare Part B
payments for the tribal facility. It is for this reason that we would
encourage all facilities that meet the requirements to be grandfathered
tribal FQHCs to transition to this status at the soonest possible time.
Comment: Commenters stated that the proposed change would disrupt
operations at the affected tribal facilities and potentially disqualify
them from receiving any Medicare payments between the time they lose
their grandfathered provider-based status and the time they qualify for
the grandfathered tribal FQHC certification. Commenters stated that CMS
has not indicated when a currently grandfathered tribal provider-based
[[Page 71093]]
clinic will be deemed to lose that status, or how they should bill and
be paid during the interim period between submitting the Form 855A and
ultimately receiving their first payment as a grandfathered tribal
FQHC.
Response: We recognize that any change, especially one as
significant as a change in a payment system, can be disruptive. We have
taken numerous steps to assure that there would be no gap in Medicare
payments between the time that one of these clinics ceases billing as a
grandfathered tribal outpatient clinic and begins billing as a
grandfathered tribal FQHC. We contacted the tribal clinics that would
be eligible for grandfathered tribal FQHC certification and held
several training calls to explain the proposed changes. We pledged to
work closely with the tribes and affected clinics throughout the
process to assure that the transition proceeds as smoothly as possible.
We also note that other clinics have gone through similar transitions
in payment systems, and we expect that this one would also be
implemented with minimum disruption.
Comment: Commenters expressed concern regarding tribal preparedness
to transition to a new payment system and the lack of technical
assistance to date. The commenters noted that tribal facilities are
unfamiliar with the FQHC rules and are apprehensive about what this
change will entail in terms of reimbursement rates and covered
services, as well as the legal and technical costs associated with the
transition. Commenters stated that the lack of technical assistance
will discourage tribes from transitioning to grandfathered tribal FQHC
status. The commenters requested that CMS provide extensive and ongoing
technical assistance to facilitate this transition, including practical
training for tribal billing offices and financial officers and
associated legal analysis for tribal attorneys and technical advisors.
Commenters also requested a ``reasonable transition period'' and a
``generous grace period'' for any facility that must change to
grandfathered tribal FQHC status, and suggested that these clinics be
allowed twelve months before they are required to submit an application
to become a grandfathered tribal FQHC.
Response: We understand the apprehension associated with changes
that may impact the financial operations of a clinic. Following the
issuance of the CY 2016 PFS proposed rule, we held several public calls
to further explain the grandfathered tribal FQHC proposal. An ``All
Tribes Call'' was held on July 29, 2015, to review the proposed rule,
including eligibility, certification and billing requirements, and
transitioning to the new system for grandfathered tribal FQHCs. This
was followed by an August 12, 2015, call with the Northeast Tribal
Health Consortium, and an August 26, 2015, call with the Osage Nation,
and a call on September 30 with the Southern Ute and Alaska tribes.
Members of and advisors to the TTAG also participated on all of these
calls. A slide presentation was provided to outline key components of
the proposed rule and we were available to answer any questions. During
these calls, we reaffirmed our commitment to assisting these clinics in
the transition and providing technical assistance as appropriate and
necessary.
We also held calls with the CMS Regional Office Survey and
Certification staff in the regions that have clinics eligible for this
transition, and with the MAC responsible for the processing of claims
and payment to these clinics, to ensure that they are aware of the
proposal and are prepared to assist clinics as necessary in the
transition. Subregulatory guidance on payment policies and claims
processing will be available following publication of the final rule
with comment period.
We intend to continue to provide technical assistance to affected
clinics to facilitate the transition to grandfathered tribal FQHC, but
we cannot provide training for financial officers or legal analysis.
Comment: Commenters were concerned that once a clinic self-attests
or is informed by CMS that it no longer satisfies grandfathered
provider-based tribal clinic status, it would not be able to bill
Medicare at all until the clinic receives its Medicare CCN as new
grandfathered tribal FQHC. Commenters also requested assurance that
Medicare payments made to a grandfathered provider-based tribal clinic
for services it provides between the date CMS determines it has lost
provider-based status, and the date it begins billing as a
grandfathered tribal FQHC, will not be treated as overpayments.
Response: We will assist eligible tribal outpatient departments
with the transition to status as grandfathered tribal FQHCs so that
there will be no overlap or gap in Medicare certification or payment.
Further instructions on billing and claims processing will be provided
in subregulatory guidance.
Comment: Commenters stated that the proposed change would
dramatically lower their reimbursement rates.
Response: We respectfully disagree with this comment. We proposed
to set the grandfathered tribal FQHC PPS rate at the same rate that the
clinics are currently billing as grandfathered tribal outpatient
clinics, subject to the FQHC PPS statutory requirement of paying 80
percent of the lesser of actual charges or the PPS rate. We note that
this rate is significantly higher than the FQHC PPS rate and higher
than payments made under the PFS. Although we have designed the
proposal such that it continues to pay the same rate per encounter, we
also note that services covered under the FQHC benefit differ from
those covered under the hospital outpatient benefit, so an exact
comparison is not possible. For example, the IHS hospital outpatient
department's AIR includes technical services such as lab and X-rays.
Under the FQHC PPS, these services are separately billable by the
facility. The FQHC's per-diem payment includes practitioner services,
and these services are separately billable under the IHS hospital
outpatient department's AIR. The final payment under both systems is a
result of the clinic's charges and the mix of services that are
furnished by the particular clinic. Both IHS hospital outpatient
departments and grandfathered tribal FQHCs are paid a single per diem
visit for Medicare beneficiaries.
Comment: Commenters stated that grandfathered tribal FQHCs would
see a reduction in their Medicare reimbursement because they would be
paid ``the lesser of'' their charges or the grandfathered tribal FQHC
PPS rate, and because the FQHC PPS rates include the professional
services for which provider-based tribal facilities receive separate
reimbursement in addition to their Medicare outpatient per-visit
payment. Commenters stated that the grandfathered tribal FQHC will only
be paid at the IHS hospital outpatient department's AIR if the G-code-
based charges are higher than the AIR, and that this will result in a
cap on their payment instead of a floor or a guarantee, as it is under
the provider-based payment methodology. The commenters also stated that
the proposed payment methodology will result in lost revenue for
facilities assumed by tribes under the ISDEAA and would hamper the
financial feasibility of tribes assuming the responsibility to carry
out IHS programs. The commenters believe that this would contradict
congressional intent to encourage self-determination and self-
governance by tribes through the exercise of their rights under the
ISDEAA.
Response: Grandfathered tribal FQHCs, like all FQHCs, would be paid
the lesser of their charges or the grandfathered tribal FQHC PPS rate.
[[Page 71094]]
This is in accordance with section 1833(a)(1)(Z) of the Affordable Care
Act, which requires that Medicare payment for FQHC services under
section 1834(o) of the Act shall be 80 percent of the lesser of the
actual charge or the PPS amount determined under section 1834(o) of the
Act.
As noted in the previous response, the services included in the
FQHC benefit are different than the services included in the IHS
hospital outpatient department AIR, and a direct comparison in Medicare
payments cannot be made without factoring in the clinic's charges and
the mix of services that are furnished. We have no reason to believe
that there will be a significant increase or decrease in Medicare
payments to those clinics that become grandfathered tribal FQHCs.
We fully support the rights of tribes to take over IHS facilities
under the ISDEAA, and believe that the proposed payment system will
enable tribes to continue to exercise self-determination and self-
governance of their health care services. These clinics currently have
the option of billing for Medicare services as a standard FQHC which
has a 2015 PPS payment rate of $158.85, or billing for Medicare
services separately under the PFS. We believe the proposed
grandfathered tribal FQHC PPS rate, with an adjusted 2015 PPS rate of
$307, will enable these clinics to provide Medicare services and bill
at approximately the same rate.
Comment: Commenters stated that the proposed G code system is
vague, and that little guidance has been provided as to how tribal
health programs should go about determining the charge levels for their
G codes. The commenters cited a July 29, 2015 ``All Tribes Call'' where
CMS explained that charges must be ``reasonable'' and ``uniform for all
patients, regardless of insurance status.'' The commenters stated that
what constitutes a ``reasonable medical charge'' is highly context-
specific, and usually includes some combination of analyzing the
relevant market for hospital services, the usual and customary rate the
hospital charges, the hospital's internal cost structure, the nature of
the services provided, the average payment the provider would have
accepted as full payment from third-parties, and the price an average
patient would agree to pay for the service at issue. Commenters stated
that it would be difficult for tribal facilities to know whether or not
they are devising charge rates that would withstand judicial scrutiny
if challenged as unreasonable, that tribes will have to devote
additional time, resources, and legal analysis to devising G codes, and
the G codes will likely vary from tribe to tribe for providing
identical services to the same patient population. Commenters requested
consultation to develop uniform standards as to what constitutes
reasonable charges for the purposes of grandfathered tribal FQHC
payments. The commenters also noted their preference to eliminate the
charge-based ``lesser of'' G-code standard and instead authorize
grandfathered tribal FQHCs to be paid as if they were provider-based
outpatient hospital departments.
Response: Eliminating the charge-based ``lesser of'' G-code
standard and instead authorizing grandfathered tribal FQHCs to bill as
if they were provider-based hospital outpatient departments is not
legally permissible. As previously noted, section 1833(a)(1)(Z) of the
Affordable Care Act requires that Medicare payment for FQHC services
under section 1834(o) of the Act shall be 80 percent of the lesser of
the actual charge or the PPS amount determined under section 1834(o) of
the Act.
As discussed in the proposed rule, there are five FQHC G codes
(G0466-FQHC visit, new patient; G0467-FQHC visit, established patient;
G0468-FQHC visit, IPPE or AWV; G0469-FQHC visit, mental health, new
patient, and G0470-FQHC visit, mental health, established patient).
Each grandfathered tribal FQHC would determine which services to
include in each G code, based on the services typically furnished per
diem by that grandfathered tribal FQHC to their Medicare patients. Once
the typical bundle of services in each G code is established, the
grandfathered tribal FQHC would total their normal charges for those
services. The sum of the charges for the services included in the
bundle of services is the G code amount. Since grandfathered tribal
outpatient clinics already have established charges for their services,
it should not be difficult for them to establish their G codes.
Consistent with longstanding policy, the use of these payment codes
does not dictate to providers how to set their charges. A grandfathered
tribal FQHC would set the charge for a specific payment code pursuant
to its own determination of what would be appropriate for the services
normally provided and the population served at that grandfathered
tribal FQHC, based on the description of services associated with the G
code. The charge for a specific payment code would reflect the sum of
regular rates charged to both beneficiaries and other paying patients
for a typical bundle of services that would be furnished per diem to a
Medicare beneficiary.
In setting its charges, a grandfathered tribal FQHC would have to
comply with established cost reporting rules in Sec. 413.53 which
specify that charges must reflect the regular rates for various
services that are charged to both beneficiaries and other paying
patients who receive the services. Each grandfathered tribal FQHC would
establish charges for Medicare visits that reflect the sum of regular
rates charged to both beneficiaries and other paying patients for a
typical bundle of services that the FQHC would furnish per diem to a
Medicare beneficiary. We note that establishing Medicare per diem rates
that are substantially in excess of the usual rates charged to other
paying patients for a similar bundle of services could be subject to
section 1128(b)(6) of the Act, as codified at 42 CFR 1001.701.
Comment: Commenters objected to withdrawing grandfathered provider-
based status for certain tribal facilities and replacing it with a new
status that is untested and poorly understood and may not fit their
administrative and clinical operations.
Response: FQHCs began transitioning from an AIR payment system to
the FQHC PPS on October 1, 2014. The system was thoroughly tested prior
to implementation, and FQHCs have been submitting claims and receiving
payment under this system without disruption. The proposed
grandfathered tribal FQHC payment is an adjustment under the FQHC PPS
to maintain the same payment rate that these clinics previously billed
Medicare. Therefore, we do not agree that the system is untested or
poorly understood, although we understand that it would be new for
those clinics that choose to transition to become grandfathered tribal
FQHCs. We created this option because we believe that the FQHC model
most closely aligns with the operations of tribal outpatient clinics,
and being included in this benefit category would enable these tribal
clinics to continue their services and meet the Medicare CoPs.
Comment: Commenters requested that CMS extend grandfathered
provider-based status to certain tribal facilities in Oklahoma, and
perhaps other locations, which were denied that status because of
errors committed by federal agencies.
Response: This comment is beyond the scope of this rule.
Comment: Commenters stated that the proposed rule is unclear
whether Alaska clinics that become grandfathered tribal FQHCs would be
paid at the $564 Alaska Medicare outpatient rate, or at the $307 rate
that applies in the lower 48 states, and stated that if the proposal is
finalized, Alaska facilities should be paid at the higher Medicare
outpatient
[[Page 71095]]
hospital rate that reflects their higher cost of services.
Response: At this time, it is our understanding that there are no
IHS or tribal facilities in Alaska that are eligible to become
grandfathered tribal FQHCs. However, it is our intention that the
reference to the payment rate in Sec. 405.2462(d)(4) would include the
rates specific to facilities in Alaska pursuant to the IHS
reimbursement rates. In the event that any Alaska facilities are
eligible and convert to a grandfathered tribal FQHC, the specific rates
for facilities in Alaska would apply.
Comment: Some commenters were concerned that CMS might propose
further reimbursement reductions for these clinics because the proposed
rule states that CMS ``will monitor future costs and claims data of
these tribal clinics and reconsider options as appropriate.''
Response: We have a responsibility to assure that Medicare Trust
funds are utilized in accordance with Congressional intent and make
adjustments to payments as necessary. Any changes to the payment
methodology would be made through notice and rulemaking and with
appropriate tribal consultation.
Comment: A commenter was concerned that the proposed regulation may
impose more stringent physician supervision requirements than those
that apply to provider-based clinics under the Medicare Part A and B
rules and that it may be difficult or impossible for some affected
clinics to meet these more stringent requirements, particularly those
in remote locations where there are few or no physicians and services
are provided primarily by mid-level practitioners or through the use of
telemedicine. The commenter requested that grandfathered tribal FQHCs
be exempt from physician supervision and other clinical requirements
that are more stringent than those that apply to grandfathered
provider-based programs.
Response: Grandfathered tribal outpatient clinics that choose to
transition to become a grandfathered tribal FQHC will be required to be
in compliance with the Medicare CoPs and other Medicare FQHC
requirements and policies, unless such provisions are in conflict with
applicable Federal law. Medicare requires most hospital outpatient
services to be furnished under direct supervision as a condition of
payment, including services furnished in a location that is a provider-
based department of the hospital. FQHC practitioners practice under
general supervision requirements and in accordance with state licensure
requirements. However, state-specific licensure requirements are
exempted for IHS and tribal programs under section 25 U.S.C. 1647a of
the IHCIA. General supervision means the procedure is furnished under
the physician's overall direction and control, but the physician's
presence is not required during the furnishing of the service. We also
note that the FQHC conditions for coverage generally impose
significantly fewer regulatory burdens on facilities than the hospital
CoPs that would otherwise apply.
Further instructions on Medicare CoPs for participation for
grandfathered tribal outpatient clinics will be provided in
subregulatory guidance.
Comment: A commenter requested confirmation that the governing
board exception for tribes under section 330 of the PHS Act (42 U.S.C.
254b) would apply to grandfathered tribal FQHCs.
Response: We believe that the commenter is referring to section
330(k)(3)(H) of the PHS Act, and specifically to the exception to the
requirements in section 330(k)(3)(H)(i)-(iii) of the PHS Act for
entities operated by an Indian tribe or tribal or Indian organization
under the ISDEAA or an urban Indian organization under the IHCIA. A
grandfathered tribal FQHC that is operated by one of the aforementioned
entities would not be required to meet the governing board requirements
in section 330(k)(3)(H) of the PHS Act. The governing board exemption
would not apply to an IHS clinic operating as a FQHC look-alike that
meets the requirements for a grandfathered tribal FQHC.
Comment: Commenters expressed disappointment with the extent and
quality of tribal consultation that has occurred and believe that CMS
should have consulted with the TTAG prior to issuing the proposed rule.
The commenters referenced a letter sent to CMS on July 9, 2015, in
response to a request for more information regarding the grandfathered
provider-based status of tribal clinics and why their associated
hospitals maintain Medicare certification absent administrative or
clinical integration. Commenters stated that they expected CMS to study
the letter and give it due consideration before issuing a proposed
rule, but CMS released the proposed rule without prior tribal
consultation or consideration of the TTAG's analysis, despite their
request for further discussion prior to any action.
Response: On February 18, 2015, CMS representatives met with the
TTAG to discuss the concerns regarding outpatient tribal clinics
billing Medicare as provider-based clinics to IHS hospitals. In
response to comments made during the discussion, we requested that the
TTAG send additional information that explains the TTAG's understanding
of the provider-based rules and how they apply to these clinics.
We appreciate the detailed and thoughtful information that was
provided by the TTAG in their July 9, 2015 letter. We regret that the
letter was not provided in time to be addressed in the CY 2016 PFS
proposed rule that was issued on July 8, 2015.
Comment: Commenters stated that CMS should have consulted with the
TTAG and tribes nationwide prior to issuing the proposed rule.
Commenters requested that CMS withdraw the proposal and engage in
further tribal consultation before releasing a proposal. The commenters
requested that CMS consult with the TTAG and other tribal stakeholders
in the future before issuing proposed changes to regulations that
affect tribes.
Response: We have a long history of tribal consultation on issues
pertaining to tribes, and the discussions that have occurred have had a
significant and beneficial influence on our policies. We believe that
the tribal consultation that occurred prior to the publication of the
proposed rule was both adequate and informative. We are subject to the
provisions of the Administrative Procedure Act (APA) (5 U.S.C.), and
external discussions on the development of proposed rules are limited
during the regulatory process. We met with the TTAG before developing
the proposed rule, and have had several national calls (as noted above)
since the proposed rule became public. We look forward to continuing
our dialogue with the TTAG and the tribes regarding this and any other
Medicare issue that affects tribes.
Comment: Commenters requested the formation of a Tribal-CMS
provider-based status workgroup prior to CMS issuing a final rule, as
well as nationwide tribal consultation concerning CMS's interpretation
of the proposed rule and applicable requirements. The commenters stated
that consultation must go beyond providing comments on a proposed rule.
Response: Formation of a Tribal-CMS workgroup is not in the purview
of this final rule. We suggest that the commenters make this request
through the CMS Division of Tribal Affairs. As noted above, the process
for regulatory notice and comment is in accordance with the APA.
Comment: Commenters requested that the proposed revisions at Sec.
405.2462(d)(1)(ii) that defines a
[[Page 71096]]
grandfathered tribal FQHC be revised to ensure that grandfathered
provider-based tribal facilities qualify for the new tribal FQHC status
so long as they fulfilled the applicable grandfathering requirements as
of the relevant date.
They also suggested that because eligibility for becoming a
grandfathered tribal FQHC applies to clinics that had provider-based
status on or before April 7, 2000, tribal clinics that were provider-
based before but not on April 7, 2000, should be eligible for
grandfathered tribal FQHC status.
Response: The proposed rule stated that grandfathered tribal FQHC
status would not apply to a currently certified tribal FQHC, a tribal
clinic that was not provider-based on or before April 7, 2000, or an
IHS-operated clinic that is no longer provider-based to a tribally
operated hospital, and that this provision would also not apply in
those instances where both the hospital and its provider-based
clinic(s) are operated by the tribe or tribal organization. We believe
the eligibility criteria are clear and no revisions are needed.
As a result of the comments, we are finalizing this rule as
proposed.
E. Part B Drugs
1. Payment for Biosimilar Biological Products Under Section 1847A of
the Act
Section 3139 of the Affordable Care Act amended section 1847A of
the Act to define a biosimilar biological product and a reference
biological product, and to provide for Medicare payment of biosimilar
biological products using the average sale price (ASP) methodology.
Section 1847A(c)(6)(H) of the Act, as added by section 3139 of the
Affordable Care Act, defines a biosimilar biological product as a
biological product approved under an abbreviated application for a
license of a biological product that relies in part on data or
information in an application for another biological product licensed
under section 351 of the Public Health Service Act (PHSA). Section
1847A(c)(6)(I) of the Act, also added by section 3139 of the Affordable
Care Act, defines the reference biological product for a biosimilar
biological product as the biological product licensed under such
section 351 of the PHSA that is referred to in the application of the
biosimilar biological product.
Section 3139 of the Affordable Care Act also amended section
1847A(b) of the Act by adding a new paragraph (8) to specify that the
payment amount for a biosimilar biological product will be the sum of
the following two amounts: (1) The ASP as determined using the
methodology described under section 1847A(b)(6) of the Act applied to a
biosimilar biological product for all National Drug Codes (NDCs)
assigned to such product in the same manner as such paragraph is
applied to drugs described in such paragraph; and (2) 6 percent of the
payment amount determined using the methodology in section 1847A(b)(4)
of the Act for the corresponding reference biological product. The
effective date for section 3139 of the Affordable Care Act regarding
payment for biosimilars under the ASP system was July 1, 2010. Separate
sections of the Affordable Care Act also established a licensing
pathway for biosimilar biological products.
To implement these provisions, we published the CY 2011 PFS final
rule with comment period (75 FR 73393 and 73394) in the November 29,
2010 Federal Register. The relevant regulation text is found at Sec.
414.902 and Sec. 414.904. At the time that the CY 2011 PFS final rule
with comment period was published, it was not apparent when biosimilar
products would be approved for marketing in the United States. The FDA
approved the first biosimilar product under the new biosimilar approval
pathway required by the Affordable Care Act on March 6, 2015.
Since 2010, we have continued to monitor the implementation of the
FDA biosimilar approval process and the emerging biosimilar
marketplace. As biosimilars now begin to enter the marketplace, we have
also reviewed the existing guidance on Medicare payment for these
products. Our review has revealed a potential inconsistency between our
interpretation of the statutory language at section 1847A(b)(8) of the
Act and regulation text at Sec. 414.904(j). To make the regulation
text more consistent with our interpretation of the statutory language,
we proposed to amend Sec. 414.904(j) to make clear that the payment
amount for a biosimilar biological product is based on the ASP of all
NDCs assigned to the biosimilar biological products included within the
same billing and payment code consistent with section 1847A(b)(8) of
the Act), which directs the Secretary to use the weighted average
payment methodology that is applied to drugs. We also proposed to amend
Sec. 414.914(j) to update the effective date of this provision from
July 1, 2010 to January 1, 2016, the anticipated effective date of the
CY 2016 PFS final rule with comment period. We welcomed comments about
these proposals.
We also took this opportunity to discuss and clarify some other
details of Part B biosimilar payment policy. First, we plan to use a
single ASP payment limit for biosimilar products that are assigned to a
specific HCPCS code. In general, this means that products that rely on
a common reference product's biologics license application (BLA) will
be grouped into the same payment calculation for determining the single
ASP payment limit. This approach, which is similar to the ASP
calculation for multiple source drugs, is authorized by section
1847A(b)(8)(A) of the Act, which states that the payment for a
biosimilar biological product is determined using the methodology in
section 1847A(b)(6) of the Act applied to a biosimilar biological
product for all NDCs assigned to such product in the same manner as
such paragraph is applied to drugs described in such paragraph.
Second, we described how payment for newly approved biosimilars
will be determined. As we stated in the CY 2011 PFS final rule with
comment period (75 FR 73393 and 73394), we anticipate that as
subsequent biosimilar biological products are approved, we will receive
manufacturers' ASP sales data through the ASP data submission process
and publish national payment amounts in a manner that is consistent
with our current approach to other drugs and biologicals that are paid
under section 1847A of the Act and set forth in 42 CFR part 414,
subpart J. Until we have collected sufficient sales data as reported by
manufacturers, payment limits will be determined in accordance with the
provisions in section 1847A(c)(4) of the Act. If no manufacturer data
is collected, prices will be determined by local contractors using any
available pricing information, including provider invoices. As with
newly approved drugs and biologicals (including biosimilars), Medicare
Part B payment would be available once the product is approved by the
FDA. Payment for biosimilars (and other drugs and biologicals that are
paid under Part B) may be made before a HCPCS code has been released,
provided that the claim is reasonable and necessary, and meets
applicable coverage and claims submission criteria.
We also clarified how wholesale acquisition cost (WAC) data may be
used by CMS for Medicare payment of biosimilars in accordance with the
provisions in section 1847A(c)(4) of the Act. Section 1847A(c)(4) of
the Act authorizes the use of a WAC-based payment amount in cases where
the ASP during the first quarter of sales is not sufficiently available
from the manufacturer to compute an ASP-based payment amount. Once the
WAC data is available from the pharmaceutical
[[Page 71097]]
pricing compendia and when WAC-based payment amounts are utilized by
CMS to determine the national payment limit for a biosimilar product,
the payment limit will be 106 percent of the WAC of the biosimilar
product; the reference biological product will not be factored into the
WAC-based payment limit determination. This approach is consistent with
partial quarter pricing that was discussed in rulemaking in the CY 2011
PFS final rule with comment period (75 FR 73465 and 73466) and with
statutory language at section 1847A(c)(4) of the Act. Once ASP
information is available for a biosimilar product, and when partial
quarter pricing requirements no longer apply, the Medicare payment
limit for a biosimilar product will be determined based on ASP data.
The following is a summary of the comments we received regarding
our proposals and related discussion in the proposed rule. In general,
a number of commenters opposed a single payment amount for all
biosimilars that rely on a common reference product. Commenters
included individuals, pharmaceutical manufacturers, patient advocate
groups, providers, and members of the House of Representatives. Most of
these commenters stated that the CMS proposal will create access
issues, and that grouping payment for biosimilar biological products is
inconsistent with the statute. Other concerns included a belief that as
a result of the proposal, prescribers' choices will be limited, that
tracking or pharmacovigilance activities will be impaired, and that
innovation and product development will be harmed, leading to increased
costs for biosimilar products. Many of these commenters suggested that
CMS determine a payment amount for each biosimilar. However, several
commenters also supported CMS's proposal to amend the regulation text
effective January 1, 2016. Commenters who supported the proposal also
suggested that CMS remain mindful of its policy as the biosimilar
marketplace evolves. However, several commenters asked that policy
decisions be delayed while issues such as naming conventions and
interchangeability standards are finalized by the FDA.
We would also like to remind readers about the scope of CMS's
proposals. The proposals and additional discussion encompass payment
policy under Medicare Part B; they do not encompass claims processing
instructions, coverage policies, clinical decision making and the
clinical use of biosimilars, FDA policies, or payments made by other
payers. However, some of these issues overlap with payment policy and
we have mentioned them as they pertain to payment policy or specific
comments in the more detailed comment responses below.
Comment: Some commenters stated that the proposed rule did not
include sufficient explanation of the reasoning behind the proposed
change to the regulation text.
Response: Our proposal would amend Sec. 414.904(j) to be
consistent with a biosimilar payment approach that groups biosimilars
with a common reference product. We believe that the proposed change to
Sec. 414.904(j) would more accurately reflect our interpretation of
section 1847A(b)(8)(A) of the Act, which states that the payment for a
biosimilar biological product is determined using the methodology in
section 1847A(b)(6) of the Act applied to a biosimilar biological
product for all NDCs assigned to such product in the same manner as
such paragraph is applied to the multiple source drugs described in
such paragraph.
Our rationale for this clarification arises from our understanding
of both the abbreviated approval pathway for biosimilars and the
amendments to section 1847A of the Act to address payment for
biosimilars. As further explained below, we believe the approach we are
finalizing in this rule is consistent with our statutory authority.
The Affordable Care Act contains two provisions for biosimilars:
one setting forth a Medicare Part B payment methodology (section 3139);
and one setting forth an approval pathway (section 7002). Our proposal
addressed Part B payment policy, and therefore, focused on section
3139, but section 7002 is also relevant.
Section 3139 of the Affordable Care Act amends section 1847A of the
Act to define the term ``biosimilar biological product'' to mean ``a
biological product approved under an abbreviated application for a
license of a biological product that relies in part on data or
information in an application for another biological product licensed
under section 351 of the Public Health Service Act (PHSA).'' Section
7002 of the Affordable Care Act defines the terms biosimilar and
biosimilarity for purposes of section 351 of the PHSA to mean (A) that
the biological product is highly similar to the reference product
notwithstanding minor differences in clinically inactive components;
and (B) there are no clinically meaningful differences between the
biological product and the reference product in terms of the safety,
purity, and potency of the product.
This statutory definition establishes that biosimilar products and
their corresponding reference products share a number of significant
similarities. That is, the biosimilar biological product and reference
product must rely on data from a single biologics license application
(BLA)--the BLA of the reference product; they share high degree of
similarity in the active component; and have no clinically meaningful
differences in safety, purity, and potency. While we have not stated,
nor are we suggesting now, that these similarities must (or even
should) drive clinical decision making for an individual patient, they
persuade us that our proposed payment policy approach is reasonable.
Because of the degree of similarity that biosimilars share with
their reference products, we believe it is appropriate to price
biosimilar products in groups in a manner similar to how we price
multiple source or generic drugs. In other words, it is reasonable to
look to our payment policy for multiple source drugs to guide our
policy on payment for biosimilars because multiple source drugs are
biosimilars' closest analogues compared to the other categories of
drugs and biologicals for which we make payment under section 1847A of
the Act, such as single source drugs. Of course, we acknowledge the
comparison between biosimilars and multiple source drugs is not a
perfect one because of the distinct approval processes, statutory
definitions, and potentially, the differences in molecular complexity
between drugs and biologicals. From the perspective of part B drug
payment policy, however, we believe that, the abbreviated pathway for
biosimilar approval and the abbreviated pathway for generic drug
approval have relevant parallels--such as the approval of a predecessor
product (a reference product for biosimilars; an innovator product for
drugs) and the comparison of a product that is being approved through
an abbreviated pathway to the predecessor. Further, we believe that
biosimilar products and multiple source drugs will have similar
marketplace attributes. Although lack of statutory authority prevents
us from pricing a biosimilar reference product with biosimilar
products, like multiple source drugs, we see biosimilars competing for
market share with each other, as well as competing with the reference
or innovator product.
Finally, how the payment provision in section 3139 of the
Affordable Care Act addresses interchangeability also supports the
position that biosimilars
[[Page 71098]]
can be treated like multiple source drugs. Under section 1847A of the
Act, the potential for interchangeability does not factor into how
payment is determined for a biosimilar. Neither the definitions in
section 1847A, nor the requirements for how payment amounts are
calculated treat biosimilars that are interchangeable (and could be
potentially be substituted much like generic drugs) differently from
other biosimilars. This suggests that Congress contemplated that we
should group all biosimilars with a common reference product (in a
manner that is similar to multiple source drugs).
Thus, in light of our belief that biosimilars with a common
reference product are--for payment policy purposes--analogous to
multiple source drugs, we believe that our biosimilars payment policy
should mirror payment policy for multiple source drugs to the extent
possible. We further believe, as described below, that the statute
supports such an approach. We would like to make clear that although
our payment policy approach for biosimilars is analogous to our payment
policy for multiple source drugs as described in this response, we take
no position on whether a biosimilar is completely or partially
analogous to its biologic reference product as a clinical matter.
Comment: Many commenters believe that the proposal is inconsistent
with the statute and with the regulation text at Sec. 414.904(j). Most
commenters who provided specific concerns believe that that the use of
the singular form of ``product'' when used to describe payment for
biosimilars in section 1847A of the Act requires that CMS determine
separate ASP-based payment amounts for each manufacturer's biosimilar
product. Commenters who provided specific concerns quoted some or all
of section 1847A(b)(8) of the Act to support their argument that the
statute requires that there be a single billing code and payment rate
for each biosimilar product. The commenters focused use of the singular
form of ``product,'' and said they believe it is a clear indication
that the statute requires separate payment for each individual
biosimilar product.
Response: We disagree with the commenters and believe that the
proposed biosimilar payment approach is consistent with section 1847A
of the Act.
We do not believe the use of the singular is dispositive of the
issue. The statute directs CMS to apply the payment approach for a
given biosimilar biological product in the same manner as such
paragraph is applied to drugs described in such paragraph. ``Such
paragraph'' is paragraph (b)(6) of section 1847A of the Act. Section
1847A(b)(6)(A) of the Act states that it applies to all drug products
included within the same multiple source drug billing and payment code
before setting forth the methodology for determining a volume weighted
average sales price for multiple source drugs. The statute also
specifies the use of this methodology for determining the average sales
prices for single source drugs (under section 1847A(b)(4) of the Act)
and biosimilars (under section 1847A(b)(8) of the Act). However,
sections 1847A(b)(4) and 1847A(b)(8) of the Act differ in one
significant respect; namely, that only section 1847A(b)(8) of the Act
includes language that directs the payment determination in paragraph
(b)(6) to be carried out in the same manner as paragraph (b)(6) is
applied to drugs that are described in paragraph (b)(6). Because all
drugs and biologicals paid for under section 1847A of the Act have
their ASP-based payment allowances calculated using the methodology set
forth in section 1847A(b)(6) of the Act, to give meaning to the phrase
that directs that the payment determination be made in the same manner
as paragraph (b)(6) is applied to drugs described in paragraph (b)(6),
we concluded that the statute authorizes us to develop coding and
pricing for biosimilars in the same manner as for multiple source
drugs. Our conclusion is based on the language in section
1847A(b)(6)(A) of the Act, which clearly refers to drug products that
are within the same multiple source drug billing code. The paragraph
also states that the amount specified (or determined by this approach)
is the amount determined using the mathematical calculation in section
1847A(b)(6) of the Act that is applied to all drugs and biologicals
paid for under section 1847A of the Act.
We further note that the commenters have emphasized use of the
singular form ``biosimilar product'' to support their statutory
interpretation. However, we do not believe whether ``product'' is used
in the singular or plural is the critical point for determining coding
and pricing of biosimilars. Rather, we believe the critical point is
that Congress is directing us to use the methodology specified in
section 1847A(b)(6) of the Act for all drug products that are included
with the same multiple source drug billing and payment code to
determine coding and pricing for biosimilars.
We believe it is reasonable to interpret the phrase that directs
the pricing to be carried out in the same manner as such paragraph
(that is, paragraph (b)(6)) is applied to drugs described in paragraph
(b)(6), to mean that we have the discretion to calculate an ASP-based
payment methodology for grouped biosimilars in the same way that we
have discretion to calculate an ASP-based payment methodology for
grouped multiple source drugs. CMS's historical practices have been to
develop coding and pricing for programmatic purposes. This approach is
consistent with the provisions of the Health Insurance Portability and
Accountability Act of 1996 (HIPAA), which required CMS to adopt
standards for coding systems that are used for reporting health care
transactions, and in October of 2003, the Secretary of HHS delegated
authority under the HIPAA legislation to CMS to maintain and distribute
HCPCS Level II Codes (the alphanumeric codes that are typically used in
part B drug claims) (Source: https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/HCPCSLevelIICodingProcedures7-2011.pdf. We
believe it is reasonable to believe that Congress is aware of this
longstanding policy and that the policy would apply for the pricing and
payment of biosimilars. Indeed, had Congress intended a specific and
different result than the one we proposed, it could have required a
separate payment allowance for each biosimilar biological product.
Section 3139 of the Affordable Care Act could have explicitly stated
that payment for a biosimilar biological product be determined as
provided in section 1847A(b)(4) of the Act. We note that Congress did
not specify in the statute how CMS must assign biosimilars to a HCPCS
billing and payment code other than direct us to section 1847A(b)(6) of
the Act and do so in the same manner as we do for all drug products
included with the same multiple source drug billing and payment code.
For these reasons, we disagree with commenters that a proposal to
group biosimilar products together for Part B payment purposes and the
associated coding approach are inconsistent with the statute. While
other interpretations of the statute may be possible, we believe our
interpretation is consistent with the statute. We also note that the
proposed revised regulation text would not preclude CMS from separating
some, or all, of a group of biosimilars for payment (and the creation
of one or more separate HCPCS codes) should a program need to do so
arise.
Comment: One commenter stated that if Congress had intended that
the multiple source drug approach could be used to pay for biosimilars,
it would have so specified. This commenter further stated that the
detailed direction
[[Page 71099]]
in the statute that describes the payment for multiple source drugs,
including the use of Therapeutic Equivalency ratings, suggests that
Congress would have included the same amount of detail for biosimilars
had Congress intended for payment to be grouped.
Response: We disagree with this comment. Therapeutic equivalency
ratings for drugs have been published by the FDA in the ``Orange Book''
since 1980 (source: http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm). The Medicare Modernization Act, which authorized the
use of the ASP payment methodology and defined multiple source drugs
for purposes of the ASP payment methodology, was enacted in 2003. We
believe that the level of detail in statutory provisions for the
payment of multiple source drugs reflects 23 years of experience that
Congress could draw on as it carefully crafted a payment approach.
Also, the ``Orange Book'' limits its scope to approved drug products;
we would not expect ratings for biological products to be included in
this publication.
In contrast, the Affordable Care Act was enacted in 2010, when
there was no interchangeability or equivalency pathway available for
biosimilar biological products. The ``Purple Book'', a list of
biosimilar and interchangeable biological products licensed by FDA, was
published in 2014. However, no interchangeable products are currently
on the market, nor are any expected to enter the marketplace in the
next year, and interchangeability standards have not yet been
finalized.
We attribute this contrast to the fact that there is insufficient
experience or information at this time to create an approach for
biosimilars that is as specific as that which exists for multiple
source drugs, and therefore, do not believe that the lack of
specificity upon which the commenter relies is indicative of
Congressional intent to limit CMS's ability to group biosimilars
together for coding and payment purposes.
Comment: Several commenters also cited Senate Committee language
that they believe indicates clear Congressional intent to pay for
biosimilars separately. (See Senate Committee Report 111-089, pages
225-226 located at http://www.thefederalregister.org/fdsys/pkg/CRPT-111srpt89/pdf/CRPT-111srpt89.pdf.) Commenters focused on the final paragraph of the
Committee language as the basis for their opinion about Congressional
intent. Specifically, commenters noted that the committee report states
that the Committee Bill would allow a Part B biosimilar product
approved by the Food and Drug Administration and assigned a separate
billing code to be reimbursed at the ASP of the biosimilar plus 6
percent of the ASP of the reference product. A biosimilar biological
product would mean a product approved under an abbreviated application
for a license of a biological product that relies in part on data or
information in an application for another biological product licensed
under the Public Health Service Act. The term reference biological
product means the licensed biological product that is referred to in
the application for the biosimilar product.
Commenters contended that this report's reference to assigning a
separate billing code for a biosimilar biological product shows that
Congress intended that CMS make separate payment for each biosimilar
biological product.
Response: We disagree with these comments for two reasons. First,
we believe that the statements commenters characterize as inconsistent
with our interpretation of the statute are actually consistent with our
interpretation. Second, although commenters focused on one statement in
particular, a review of the entire relevant section of the report
further indicates our interpretation seems to be consistent with the
committee's views.
As noted above, commenters believe that the report indicates that
Congress intended biosimilar biological products each to have their own
ASP-based payment allowance. However, a closer look at the relevant
language indicates that instead, Congress was acknowledging CMS's
current coding discretion: ``The Committee Bill would allow a Part B
biosimilar product approved by the Food and Drug Administration and
assigned a separate billing code to be reimbursed at the ASP of the
biosimilar plus 6 percent of the ASP of the reference product''
(emphasis added). This statement's use of the phrase ``would allow''
(as opposed to ``would require'') indicates that CMS has discretion,
rather than the obligation, to price biosimilars separately. Moreover,
the statement appears to acknowledge that such separate payment would
occur only when the biosimilar is assigned its own billing and payment
code.
Similarly, the rest of this section of the report supports the
notion that biosimilars are analogous to multiple source drugs. The
report indicates the committee's view that the approval pathway to be
enacted for biosimilars would be comparable to the approval process for
generic drugs, stating:
[t]he new [abbreviated biological] regulatory pathway would be
analogous to the FDA's existing authority for approving generic
chemical drugs under the Drug Price Competition and Patent Term
Restoration Act of 1984 (P.L. 98-417). Often referred to as the
Hatch-Waxman Act, this law allows the generic company to establish
that its drug product is chemically the same as the already approved
innovator drug, and thereby its application for FDA approval relies
on FDA's previous finding of safety and effectiveness for the
approved drug.
For these reasons, we believe that contrary to commenters'
assertions, our proposed approach to coding and payment for biosimilar
biological products is consistent with the Senate Committee report.
Comment: One commenter also suggested that the proposal would be
contrary to a 2009 court decision (Hays v. Sebelius) which does not
allow Medicare drug payments to be based on the least costly item in a
group.
Response: We do not believe that the proposed approach is
inconsistent with the Hays v Sebelius ruling on least costly
alternatives. In that case, the Court ruled that the Secretary could
not rely on section 1862(a)(1)(A) of the Act to pay for one drug
product in a given HCPCS code using the lower price for a drug product
in a different HCPCS code because it was the ``least costly
alternative.'' Instead, the court ruled that the Secretary must either
cover or deny payment altogether if the service or item is not
reasonable and necessary. As we have explained earlier, we believe that
the statutory authority to group biosimilars for payment exists in
section 1847A of the Act. Payment for groups of biosimilars will be
made under the statutory provision that requires the determination of a
weighted average price. Since the approach is consistent with statutory
authority for grouping biosimilars and the use of a weighted average
calculation (not a partial payment), we believe that our approach is
consistent with Hays v. Sebelius.
Comment: Several commenters stated that the proposed Part B payment
policy is not consistent with Medicare Part D and particularly Medicaid
requirements. Some commenters also stated that the inconsistencies
would impact rebate calculations.
Response: Medicare Part B groups and pays for drugs and biologicals
differently from Medicare Part D and Medicaid. Drug payment under these
programs is authorized by three different parts of the statute, and
although they share some similarities, for the most part these payment
approaches do not overlap. The different statutory and operational
[[Page 71100]]
requirements of each program can lead to differences between how drugs
and biologicals are treated under each program. The biosimilar payment
policies we are finalizing in this rule relate only to the Part B
payment requirements described in section 1847A of the Act.
Comment: Some commenters stated that blending of biosimilar product
payment amounts is an indication that CMS believes that biosimilars are
generic drugs. Commenters expressed concerns about a range of issues
related to this position. These concerns focused on provider impact,
including negative effects on prescribers' choice, medical record
keeping and billing. Some commenters also mentioned that effects on
prescribers' choice would include a greater emphasis on cost rather
than clinical considerations. Other commenters expressed concerns that
brands of biosimilars that may be approved for fewer than all
indications approved for the reference product would lead to confusion
about the identity of which product was administered to the patient,
and make adherence to billing and coverage requirements difficult.
Response: We appreciate that there are differences between multiple
source small molecule drugs and biosimilar biological products. The
proposals and related discussion in the proposed rule relate only to
payment and coding for biosimilar biological products. Thus, although
our payment policy for biosimilars is analogous to our payment policy
for multiple source drugs, we take no position on whether a biosimilar
is completely or partially analogous to its biologic reference product
as a clinical matter.
Issues such as the clinical use of drugs and medical recordkeeping
are outside the scope of this rule.
We are aware of situations where products with different
indications share a HCPCS code; \3\ however, we are not aware of
significant instances of provider confusion resulting from these
groupings and therefore, we do not believe that this concern should
drive the current policy approach for biosimilars.
---------------------------------------------------------------------------
\3\ For examples: J3489 zoledronic acid injection includes
Reclast[supreg] (indicated for osteoporosis and Paget's disease of
the bone), Zometa[supreg] (indicated for hypercalcemia of
malignancy, and the treatment of multiple myeloma and bone
metastases of solid tumors) and generic versions of both zoledronic
acid products; J0153 adenosine injection includes Adenocard[supreg]
(indicated for the treatment of certain types of supraventricular
tachycardia), Adenoscan[supreg] (indicated as an adjunct to thallium
stress tests for patients who cannot exercise adequately) and
generic versions of both adenosine products. Also, certain
lyophilized versions of intravenous immunoglobulins (IVIG) have been
paid using the HCPCS code J1566 (and its predecessor codes); at this
time, the biological products in this HCPCS code do not have the
same indications.
---------------------------------------------------------------------------
Comment: Many commenters discussed how CMS could approach
interchangeability between biosimilar products. Positions varied; for
example, some commenters suggested grouping interchangeable biosimilars
together, others suggested paying interchangeable biosimilars
separately. Some commenters also asked that CMS consider blending the
biosimilar payment calculation so that the reference product is
included in the ASP calculation.
Response: CMS' proposals and related discussion about how
biosimilar product ASPs would be grouped did not encompass clinical
interchangeability, substitution of biosimilar products or clinical
decision making when prescribing these products. While section 7002 of
the Affordable Care Act (the Biologics Price Competition and Innovation
Act of 2009) outlines specific criteria for a determination of
interchangeability, at this point, there are no interchangeable
biosimilars products on the market. Thus, we are not addressing whether
a product's interchangeability status should be the basis for a
different approach to Part B payment in this rule at this time. To the
contrary, our proposed approach, which we are finalizing in this rule,
would preserve our discretion to group interchangeable biosimilars
together for payment purposes in the same manner we will code and pay
for biosimilars that do not have a designation of interchangeability
under section 7002 of the Affordable Care Act. However, given that no
interchangeable biosimilars are currently available, we will consider
whether further refinements to our biosimilar payment policy may be
necessary as the market develops in the future.
In response to comments recommending that CMS include the reference
product in the ASP payment calculation for biosimilars, we note that
such an approach is not consistent with section 1847A of the Act.
Comment: Some commenters stated that the payment policy approach
may encourage inappropriate interchange between biosimilar products.
Response: We disagree with this comment. We understand that groups
of biosimilar products may not have all of the same indications as the
reference product in common, all the same indications as other
biosimilars within that group, or may have other clinical differences
such as fewer than all routes of administration as the reference
product. We are not aware of situations where providers have assumed
that biological products grouped together for payment purposes are
clinically equivalent, or that confusion regarding coverage, billing,
coding, or medical records has been a problem.
Comment: A number of commenters also expressed concern about how
grouping biosimilar products for payment purposes when they have a
common reference product would affect the marketplace. Commenters
stated that CMS's proposal would discourage product development and
innovation and would affect this new segment for the drug and
biological marketplace in a negative manner. Commenters also cited the
high risk for biosimilar product manufacturers because of factors such
as high product development costs and long product development
timelines for biosimilars (compared to small molecule drugs), and
suggested that grouping biosimilar products into a single payment code
could lead to a competitive environment that decreases profit margin,
forcing manufacturers to leave the marketplace, resulting in less
competition, access problems for patients and higher prices. Some of
this information appears to have been extrapolated from experience with
(small molecule) Part B drugs. However, several commenters who
discussed potential differences between biosimilars and drugs suggested
that assessing the proposed policy's impact as the market develops and
actual experience with this new category of products is gained is a
reasonable approach. One commenter believed that the size of the
biosimilar marketplace and the regulatory environment created less risk
for biosimilar manufacturers than for reference product manufacturers
and that CMS's proposed approach would be an incentive for price
competition. One commenter suggested that separate pricing of
biosimilars was comparable to price protection and that separate
pricing is not supported by actual facts. Another commenter stated that
separate pricing would reduce competition and would result in a market
where biosimilars were sold as branded drugs with small discounts.
Response: We do not agree that our approach to Medicare Part B
payment policy will stifle or damage the marketplace. Biological
products are heavily utilized in Part B and account for a significant
share of spending compared to drugs. According to a GAO report dated
October 12, 2012 (GAO-13-46R High Expenditure Part B Drugs, http://www.gao.gov/products/GAO-13-46R, pages 6 and 7), Medicare and its
beneficiaries spent $19.5 billion on Part
[[Page 71101]]
B drugs and biologicals in 2010. The 10 most expensive products
accounted for about $9.1 billion of that amount and 8 of 10 of the
highest expenditure Part B drugs were biologicals. Given the robust
marketplace for biologicals, we do not believe that a payment policy
that encourages greater competition will drive manufacturers out of the
market. To the contrary, we believe there is a strong need for lower
cost alternatives to high cost biologicals, and the statute provides an
incentive for the development of the biosimilars market by providing
for reimbursement that includes a 6 percent add-on of the more
expensive reference product's ASP. Competition fosters innovations that
redefine markets. Overall, the availability of generic drugs, in
competition with each other and with branded products, has improved
price and availability of drugs. Competition among biosimilars can do
the same for Medicare beneficiaries--improving the quality, price, and
access. We agree that it is desirable to have fair reimbursement in a
healthy marketplace that encourages product development, and we agree
with commenters who support future refinements to policy as needed
based on actual experience with this new segment of the market.
Comment: Several commenters suggested that CMS consider delaying
action on the proposals to allow for FDA policies on issues like naming
and interchangeability standards to be developed, and to allow the
marketplace to develop.
Response: We disagree with this comment. Issues such as the naming
convention and specific interchangeability standards are complicated,
may require some time to finalize, and are not directly relevant to
Medicare Part B payment policy. Rather, we believe it is important to
implement a payment policy for biosimilars now, before the second
biosimilar for any reference product becomes available, in order to
provide certainty for providers and suppliers who will be billing
Medicare for these products in the near term.
Comment: Several commenters stated that the proposed approach is
consistent with savings for the beneficiary and sustainability of the
Medicare program.
Response: We thank the commenters for their support.
Comment: Commenters stated that the proposed approach would
negatively impact tracking and safety monitoring because products could
not be distinguished on claims. Commenters stated that separate codes
are necessary to track the safety of biosimilars and to conduct
effective pharmacovigilance efforts, and a few commenters also
expressed concerns that clinical outcomes studies would be difficult to
conduct. These commenters expressed concern that obtaining data about
potential differences in safety and efficacy would be difficult if
Medicare paid for all biosimilars that are related to a common
reference product the same amount and used a single HCPCS billing code
to indicate that a biosimilar product was administered. However,
several commenters suggested other possible mechanisms for using claims
data to track biosimilar products, including the use of modifiers.
Response: Pharmacovigilance and the postmarketing assessment of the
safety and efficacy of drugs and biologicals are frequently conducted
by the FDA. Coding determinations, including the assignment of HCPCS
codes, are a part of Medicare payment policy. The FDA's determinations
are outside the scope of this rule. However, we agree that it is
desirable to have the ability to track biosimilars. We also agree with
commenters who suggested that alternative means of tracking biosimilar
are possible. We will provide guidance on mechanisms for tracking drug
use through information on claims in the near future. Specifically, we
are developing an approach for using manufacturer-specific modifiers on
claims to assist with pharmacovigilance.
Final Decision: After considering the comments, we are finalizing
our proposal to amend the regulation text at Sec. 414.904(j) to make
clear that the payment amount for a biosimilar biological product is
based on the ASP of all NDCs assigned to the biosimilar biological
products included within the same billing and payment code. We are also
finalizing the proposal's effective date: January 1, 2016.
Comment: Several commenters also acknowledged or agreed with the
use of WAC-based pricing during the initial period of sales while an
ASP is not available. One commenter understood CMS' discussion to mean
that a greater reliance on invoice pricing would result.
Response: We are not changing how pricing determinations by
contractors (MACs) are made in situations where national pricing data
is not available. We appreciate the comments on our discussion about
how biosimilar products will be paid before an ASP is available.
In addition to the comments on biosimilars discussed, we received
comments about specific issues pertaining to HCPCS coding and
descriptor development such as the use of J codes and Q codes, claims
submission and medical record keeping (including the use of NDCs on
Medicare Part B claims), notification of substitution to providers and
pharmacy dispensing and substitution activities, coverage policies for
biosimilars, effects on other payers, Therapeutic Equivalency
determinations based on either the Orange Book or interchangeability
determinations based on the Purple Book, and the FDA approval process
for biosimilars. Comments on these issues are outside the scope of this
rule. Therefore, these comments are not addressed in this final rule
with comment period.
F. Productivity Adjustment for the Ambulance, Clinical Laboratory, and
DMEPOS Fee Schedules
Section 3401 of the Affordable Care Act requires that the update
factor under certain payment systems be annually adjusted by changes in
economy-wide productivity. The year that the productivity adjustment is
effective varies by payment system. Specifically, section 3401 of the
Affordable Care Act requires that in CY 2011 (and in subsequent years)
update factors under the ambulance fee schedule (AFS), the clinical
laboratory fee schedule (CLFS) and the DMEPOS fee schedule be adjusted
by changes in economy-wide productivity. Section 3401(a) of the
Affordable Care Act amends section 1886(b)(3)(B) of the Act to add
clause (xi)(II), which sets forth the definition of this productivity
adjustment. The statute defines the productivity adjustment to be equal
to the 10-year moving average of changes in annual economy-wide private
nonfarm business multifactor productivity (MFP) (as projected by the
Secretary for the 10-year period ending with the applicable fiscal
year, year, cost reporting period, or other annual period). Historical
published data on the measure of MFP is available on the Bureau of
Labor Statistics (BLS) Web site at http://www.bls.gov/mfp.
MFP is derived by subtracting the contribution of labor and capital
inputs growth from output growth. The projection of the components of
MFP are currently produced by IHS Global Insight, Inc. (IGI), a
nationally recognized economic forecasting firm with which we contract
to forecast the components of MFP. To generate a forecast of MFP, IGI
replicates the MFP measure calculated by the BLS using a series of
proxy variables derived from IGI's U.S. macroeconomic models. In the CY
2011 and CY 2012 PFS final rules with comment period (75 FR 73394
through 73396, 76 FR 73300 through 73301), we set forth the current
[[Page 71102]]
methodology to generate a forecast of MFP. We identified each of the
major MFP component series employed by the BLS to measure MFP as well
as provided the corresponding concepts determined to be the best
available proxies for the BLS series. Beginning with CY 2016, for the
AFS, CLFS and DMEPOS fee schedule, the MFP adjustment is calculated
using a revised series developed by IGI to proxy the aggregate capital
inputs. Specifically, IGI has replaced the Real Effective Capital Stock
used for Full Employment GDP with a forecast of BLS aggregate capital
inputs recently developed by IGI using a regression model. This series
provides a better fit to the BLS capital inputs, as measured by the
differences between the actual BLS capital input growth rates and the
estimated model growth rates over the historical time period.
Therefore, we are using IGI's most recent forecast of the BLS capital
inputs series in the MFP calculations beginning with CY 2016. A
complete description of the MFP projection methodology is available on
our Web site at http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareProgramRatesStats/MarketBasketResearch.html. Although we discussed the IGI changes to the
MFP proxy series in the CY 2016 PFS proposed rule (80 FR 41802) and in
this final rule with comment period, in the future, when IGI makes
changes to the MFP methodology, we will announce them on our Web site
rather than in the annual rulemaking.
G. Appropriate Use Criteria for Advanced Diagnostic Imaging Services
Section 218(b) of the PAMA amended Title XVIII of the Act to add
section 1834(q) directing us to establish a program to promote the use
of appropriate use criteria (AUC) for advanced diagnostic imaging
services. This rule outlines the initial component of the new Medicare
AUC program and our plan for implementing the remaining components.
1. Background
In general, AUC are a set of individual criteria that 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 context.
We believe the goal of this statutory AUC program is to promote the
evidence-based use of advanced diagnostic imaging to improve quality of
care and reduce inappropriate imaging services. Professional medical
societies, health systems, and academic institutions have been
designing and implementing AUC for decades. Experience and published
studies alike show that results are best when AUC are built on an
evidence base that considers patient health outcomes, weighing the
benefits and harms of alternative care options, and are integrated into
broader care management and continuous quality improvement (QI)
programs. Successful QI programs in turn have provider-led
multidisciplinary teams that collectively identify key clinical
processes and then develop bottom-up, evidence-based AUC or guidelines
that are embedded into clinical workflows, and become the organizing
principle of care delivery (Aspen 2013). Feedback loops, an essential
component, compare provider performance and patient health outcomes to
individual, regional and national benchmarks.
There is also consensus that AUC programs built on evidence-based
medicine and applied in a QI context are the best method to identify
appropriate care and eliminate inappropriate care, and are preferable
to across-the-board payment reductions that do not differentiate
interventions that add value from those that cause harm or add no
value.
2. Previous AUC Experience
The first CMS experience with AUC, the Medicare Imaging
Demonstration (MID), was required by section 135(b) of the Medicare
Improvements for Patients and Providers Act of 2008 (MIPPA). Designed
as an alternative to prior authorization, the MID's purpose was to
examine whether provider exposure to appropriateness guidelines would
reduce inappropriate utilization of advanced imaging services. In the
2-year demonstration which began in October 2011, nearly 4,000
physicians, grouped into one of five conveners across geographically
and organizationally diverse practice settings, ordered a total of
nearly 50,000 imaging studies.\4\
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\4\ Timbie J, Hussey P, Burgette L, et al. Medicare Imaging
Demonstration Final Evaluation: Report to Congress. 2014 The Rand
Corporation.
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In addition to the outcomes of the MID (http://www.rand.org/content/dam/rand/pubs/research_reports/RR700/RR706/RAND_RR706.pdf), we
considered others' experiences and results from implementation of
imaging AUC and other evidence-based clinical guidelines at healthcare
organizations such as Brigham & Women's, Intermountain Healthcare,
Kaiser, Massachusetts General Hospital, and Mayo, and in states such as
Minnesota. From these experiences, and analyses of them by medical
societies and others, general agreement on at least two key points has
emerged. First, AUC, and the clinical decision support (CDS) mechanisms
through which providers access AUC, must be integrated into the
clinical workflow and facilitate, not obstruct, evidence-based care
delivery. Second, the ideal AUC is an evidence-based guide that starts
with a patient's specific clinical condition or presentation (symptoms)
and assists the provider in the overall patient workup, treatment and
follow-up. Imaging would appear as key nodes within the clinical
management decision tree. The end goal of using AUC is to improve
patient health outcomes. In reality, however, many providers may
encounter AUC through a CDS mechanism for the first time at the point
of image ordering. The CDS would ideally bring the provider back to
that specific clinical condition and work-up scenario to ensure and
simultaneously document the appropriateness of the imaging test.
However, there are different views about how best to roll out AUC
into clinical practice. One opinion is that it is best to start with as
comprehensive a library of individual AUC as possible to avoid the
frustration, experienced and voiced by many practitioners participating
in the MID, of spending time navigating the CDS tool only to find that,
about 40 percent of the time, no AUC for their patient's specific
clinical condition existed. A second opinion is that, based on decades
of experience rolling out AUC in the context of robust QI programs, it
is best to focus on a few priority clinical areas (for example, low
back pain) at a time, to ensure that providers fully understand the AUC
they are using, including when they do not apply to a particular
patient. This same group also believes, based on experience with the
MID, that too many low-evidence alerts or rules simply create ``alert
fatigue.'' They envision that, rather than navigating through a CDS to
find relevant AUC, providers would simply enter the patient's condition
and a message would pop up stating whether AUC existed for that
condition.
We believe there is merit to both approaches, and it has been
suggested to us that the best approach may depend on the particular
care setting. The second, ``focused'' approach may work better for a
large health system that produces and uses its own AUC. The first,
``comprehensive'' approach may in turn work better for a smaller
practice with broad image ordering patterns and
[[Page 71103]]
fewer resources that wants to simply adopt and start using from day one
a complete AUC system developed elsewhere. We believe a successful
program would allow flexibility, and under section 1834(q) of the Act,
we foresee a number of sets of AUC developed by different provider-led
entities, and an array of CDS mechanisms, from which providers may
choose.
3. Statutory Authority
Section 218(b) of the PAMA amended Title XVIII of the Act by adding
a new section 1834(q) entitled, ``Recognizing Appropriate Use Criteria
for Certain Imaging Services,'' which directs us to establish a new
program to promote the use of AUC. In section 1834(q)(1)(B) of the Act,
AUC are defined as criteria that are evidence-based (to the extent
feasible) and assist professionals who order and furnish applicable
imaging services to make the most appropriate treatment decision for a
specific clinical condition for an individual.
4. Discussion of Statutory Requirements
There are four major components of the AUC program under section
1834(q) of the Act, each with its own implementation date: (1)
Establishment of AUC by November 15, 2015 (section 1834(q)(2)); (2)
mechanisms for consultation with AUC by April 1, 2016 (section
1834(q)(3)); (3) AUC consultation by ordering professionals and
reporting on AUC consultation by furnishing professionals by January 1,
2017 (section 1834(q)(4)); and (4) annual identification of outlier
ordering professionals for services furnished after January 1, 2017
(section 1834(q)(5)). In the proposed rule, we primarily addressed the
first component under section 1834(q)(2)--the process for establishment
of AUC, along with relevant aspects of the definitions under section
1834(q)(1).
Section 1834(q)(1) of the Act describes the program and provides
definitions of terms. The program is required to promote the use of AUC
for applicable imaging services furnished in an applicable setting by
ordering professionals and furnishing professionals. Section 1834(q)(1)
of the Act provides definitions for AUC, applicable imaging service,
applicable setting, ordering professional, and furnishing professional.
An ``applicable imaging service'' under section 1834(q)(1)(C) of the
Act must be an advanced imaging service as defined in section
1834(e)(1)(B) of the Act, which defines ``advanced diagnostic imaging
services'' to include diagnostic magnetic resonance imaging, computed
tomography, and nuclear medicine (including positron emission
tomography); and other diagnostic imaging services we may specify in
consultation with physician specialty organizations and other
stakeholders, but excluding x-ray, ultrasound and fluoroscopy services.
Section 1834(q)(2)(A) of the Act requires the Secretary to specify
applicable AUC for applicable imaging services, through rulemaking and
in consultation with physicians, practitioners and other stakeholders,
by November 15, 2015. Applicable AUC may be specified only from among
AUC developed or endorsed by national professional medical specialty
societies or other provider-led entities. Section 1834(q)(2)(B) of the
Act identifies certain considerations the Secretary must take into
account when specifying applicable AUC including whether the AUC have
stakeholder consensus, are scientifically valid and evidence-based, and
are based on studies that are published and reviewable by stakeholders.
Section 1834(q)(2)(C) of the Act requires the Secretary to review the
specified applicable AUC each year to determine whether there is a need
to update or revise them, and to make any needed updates or revisions
through rulemaking. Section 1834(q)(2)(D) of the Act specifies that, if
the Secretary determines that more than one AUC applies for an
applicable imaging service, the Secretary shall apply one or more AUC
for the service.
The PAMA was enacted into law on April 1, 2014. Implementation of
many aspects of the amendments made by section 218(b) of the PAMA
requires consultation with physicians, practitioners, and other
stakeholders, and notice and comment rulemaking. We believe the PFS
calendar year rulemaking process is the most appropriate and
administratively feasible implementation vehicle. Given the timing of
the PFS rulemaking process, we were not able to include proposals in
the PFS proposed rule to begin implementation in the same year the PAMA
was enacted. The PFS proposed rule is published in late June or early
July each year. For the new Medicare AUC program to have been a part of
last year's rule (CY 2015), we would have had to interpret and analyze
the new statutory language, and develop proposed plans for
implementation in under one month. Additionally, given the complexity
of the program to promote the use of AUC for advanced imaging services
established under section 1834(q) of the Act, we believed it was
imperative to consult with physicians, practitioners and other
stakeholders in advance of developing proposals to implement the
program. In the time since the legislation was enacted, we have met
extensively with stakeholders to gain insight and hear their comments
and concerns about the AUC program. Having this open door with
stakeholders has greatly informed our proposed policy. In addition,
before AUC can be specified as directed by section 1834(q)(2)(A) of the
Act, there is first the need to define what AUC are and to specify the
process for developing them. To ensure transparency and meet the
requirements of the statute, we proposed to implement section
1834(q)(2) of the Act by first establishing through rulemaking a
process for specifying applicable AUC and proposing the requirements
for AUC development. Under our proposal, the specification of AUC under
section 1834(q)(2)(A) of the Act will flow from this process.
We also proposed to define the term, ``provider-led entity,'' which
is included in section 1834(q)(1)(B) of the Act so that the public had
an opportunity to comment, and entities meeting the definition are
aware of the process by which they may become qualified under Medicare
to develop or endorse AUC. Under our proposed process, once a provider-
led entity (PLE) is qualified (which includes rigorous AUC development
requirements involving evidence evaluation, as provided in section
1834(q)(2)(B) of the Act and proposed in the CY 2016 PFS proposed rule)
the AUC that are developed or endorsed by the entity would be
considered to be specified applicable AUC under section 1834(q)(2)(A)
of the Act.
[[Page 71104]]
The second major component of the Medicare AUC program is the
identification of qualified CDS mechanisms that could be used by
ordering professionals for consultation with applicable AUC under
section 1834(q)(3) of the Act. We envision a CDS mechanism for
consultation with AUC as an interactive tool that communicates AUC
information to the user. The ordering professional would input
information regarding the clinical presentation of the patient into the
CDS tool, which may be a feature of or accessible through an existing
system, and the tool would provide immediate feedback to the ordering
professional on the appropriateness of one or more imaging services.
Ideally, multiple CDS mechanisms would be available that could
integrate directly into, or be seamlessly interoperable with, existing
health information technology (IT) systems. This would minimize burden
on provider teams and avoid duplicate documentation.
Section 1834(q)(3)(A) of the Act states that the Secretary must
specify qualified CDS mechanisms in consultation with physicians,
practitioners, health care technology experts, and other stakeholders.
This paragraph authorizes the Secretary to specify mechanisms that
could include: CDS modules within certified EHR technology; private
sector CDS mechanisms that are independent of certified EHR technology;
and a CDS mechanism established by the Secretary.
However, all CDS mechanisms must meet the requirements under
section 1834(q)(3)(B) of the Act which specifies that a mechanism must:
Make available to the ordering professional applicable AUC and the
supporting documentation for the applicable imaging service that is
ordered; where there is more than one applicable AUC specified for an
applicable imaging service, indicate the criteria it uses for the
service; determine the extent to which an applicable imaging service
that is ordered is consistent with the applicable AUC; generate and
provide to the ordering professional documentation to demonstrate that
the qualified CDS was consulted by the ordering professional; be
updated on a timely basis to reflect revisions to the specification of
applicable AUC; meet applicable privacy and security standards; and
perform such other functions as specified by the Secretary (which may
include a requirement to provide aggregate feedback to the ordering
professional). Section 1834(q)(3)(C) of the Act specifies that the
Secretary must publish an initial list of specified mechanisms no later
than April 1, 2016, and that the Secretary must identify on an annual
basis the list of specified qualified CDS mechanisms.
We did not include proposals to implement section 1834(q)(3) of the
Act in the CY 2016 PFS proposed rule. We needed to first establish,
through notice and comment rulemaking, the process for specifying
applicable AUC. Specified applicable AUC would serve as the inputs to
any qualified CDS mechanism; therefore, these must first be identified
so that prospective tool developers are able to establish relationships
with AUC developers. In addition, we intend that in PFS rulemaking for
CY 2017, we will provide clarifications, develop definitions, and
establish the process by which we will specify qualified CDS
mechanisms. The requirements for qualified CDS mechanisms set forth in
section 1834(q)(3)(B) of the Act will also be vetted through PFS
rulemaking for CY 2017 so that mechanism developers have a clear
understanding and notice regarding the requirements for their tools.
The CY 2017 proposed rule would be published at the end of June or in
early July of 2016, be open for a period of public comment, and then
the final rule would be published by November 1, 2016. We anticipate
that the initial list of specified applicable CDS mechanisms will be
published sometime after the CY 2017 PFS final rule. If we were to
follow a similar process for CDS as we have for specifying AUC, the
initial list of CDS mechanisms would be available in the summer of
2017. In advance of these actions, we will continue to work with
stakeholders to understand how to ensure that appropriate mechanisms
are available, particularly with respect to standards for certified
health IT, including EHRs, that can enable interoperability of AUC
across systems.
The third major component of the AUC program is in section
1834(q)(4) of the Act, Consultation with Applicable Appropriate Use
Criteria. This section establishes, beginning January 1, 2017, the
requirement for an ordering professional to consult with a listed
qualified CDS mechanism when ordering an applicable imaging service
that would be furnished in an applicable setting and paid for under an
applicable payment system; and for the furnishing professional to
include on the Medicare claim information about the ordering
professional's consultation with a qualified CDS mechanism. The statute
distinguishes between the ordering and furnishing professional,
recognizing that the professional who orders the imaging service is
usually not the same professional who bills Medicare for the test when
furnished. Section 1834(q)(4)(C) of the Act provides for certain
exceptions to the AUC consultation and reporting requirements including
in the case of certain emergency services, inpatient services paid
under Medicare Part A, and ordering professionals who obtain a hardship
exemption. Section 1834(q)(4)(D) of the Act specifies that the
applicable payment systems for the AUC consultation and reporting
requirements are the PFS, hospital outpatient prospective payment
system, and the ambulatory surgical center payment system.
We did not include proposals to implement section 1834(q)(4) of the
Act in the CY 2016 PFS proposed rule. Again, it is important that we
first establish through notice and comment rulemaking the process by
which applicable AUC will be specified as well as the CDS mechanisms
through which ordering providers would access them. We anticipate
including further discussion and adopting policies regarding claims-
based reporting requirements in the CY 2017 and CY 2018 rulemaking
cycles. Therefore, we do not intend to require that ordering
professionals meet this requirement by January 1, 2017.
The fourth component of the AUC program is 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 for outlier professionals
beginning January 1, 2020, as specified under section 1834(q)(6) of the
Act. Although, we did not include proposals to implement these sections
in the CY 2016 PFS proposed rule, we proposed to identify outlier
ordering professionals from within priority clinical areas. Prior
clinical areas will be identified through subsequent rulemaking.
The concept of priority clinical areas allows CMS to implement an
AUC program that combines two approaches to implementation. Under our
proposed policy, while potentially large volumes of AUC (as some
eligible PLEs have large libraries of AUC) would become specified
across clinical conditions and advanced imaging technologies, we
believe this rapid roll out of specified AUC should be balanced with a
more focused approach to identifying outlier ordering professionals. We
believe this will provide an opportunity for physicians and
practitioners to become familiar with AUC in identified priority
clinical areas prior to Medicare claims for those services being part
of the input for calculating outlier ordering professionals.
[[Page 71105]]
In the CY 2017 PFS rulemaking process, with the benefit of public
comments, we will begin to identify priority clinical areas and expand
them over time. Also in future rulemaking, we will develop and clarify
our policy to identify outlier ordering professionals.
5. Proposals for Implementation
We proposed to amend our regulations to add a new Sec. 414.94,
``Appropriate Use Criteria for Certain Imaging Services.''
a. Definitions
In Sec. 414.94(b), we proposed to codify and add language to
clarify some of the definitions provided in section 1834(q)(1) of the
Act as well as define terms that were not defined in statute but for
which a definition would be helpful for program implementation. In this
section we provide a description of the terms we proposed to codify to
facilitate understanding and encourage public comment on the AUC
program.
Due to circumstances unique to imaging, it is important to note
that there is an ordering professional (the physician or practitioner
that orders that the imaging service be furnished) and a furnishing
professional (the physician or practitioner that actually performs the
imaging service and provides the interpretation of the imaging study)
involved in imaging services. In some cases the ordering professional
and the furnishing professional are the same.
This AUC program only applies in applicable settings as defined in
section 1834(q)(1)(D) of the Act. An applicable setting would include a
physician's office, a hospital outpatient department (including an
emergency department), an ambulatory surgical center, and any provider-
led outpatient setting determined appropriate by the Secretary. The
inpatient hospital setting, for example, is not an applicable setting.
Further, the program only applies to applicable imaging services as
defined in section 1834(q)(1)(C) of the Act. These are advanced
diagnostic imaging services for which one or more applicable AUC apply,
one or more qualified CDS mechanisms is available, and one of those
mechanisms is available free of charge.
We proposed to clarify the definition for appropriate use criteria,
which is defined in section 1834(q)(2)(B) of the Act to include only
criteria developed or endorsed by national professional medical
specialty societies or other PLEs, to assist ordering professionals and
furnishing professionals in making the most appropriate treatment
decision for a specific clinical condition for an individual. To the
extent feasible, such criteria shall be evidence-based. To further
describe AUC, we proposed to add the following language to this
definition: AUC are a collection of individual appropriate use
criteria. Individual criteria are information presented 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).
For the purposes of implementing this program, we proposed to
define new terms in Sec. 414.94(b). A PLE would include national
professional medical specialty societies (for example the American
College of Radiology and the American Academy of Family Physicians) or
an organization that is comprised primarily of providers and is
actively engaged in the practice and delivery of healthcare (for
example hospitals and health systems).
Applicable AUC become specified when they are developed or modified
by a qualified PLE, or when a qualified PLE endorses AUC developed by
another qualified PLE. A PLE is not considered qualified until CMS
makes a determination via the qualification process finalized in this
CY 2016 PFS final rule with comment period. We introduced priority
clinical areas to inform ordering professionals and furnishing
professionals of the clinical topics alone, clinical topics and imaging
modalities combined or imaging modalities alone that may be identified
by the agency through annual rulemaking and in consultation with
stakeholders which may be used in the identification of outlier
ordering professionals.
The definitions in Sec. 414.94 are important in understanding
implementation of the program. Only AUC developed, modified or endorsed
by organizations meeting the definition of PLE would be considered
specified applicable AUC. As required by the statute, specified
applicable AUC must be consulted and such consultation must be reported
on the claim for applicable imaging services. To assist in
identification of outlier ordering professionals, we proposed to focus
on priority clinical areas. Priority clinical areas would be associated
with a subset of specified AUC.
b. AUC Development by Provider-Led Entities
In Sec. 414.94, we proposed to include regulations to implement
the first component of the Medicare AUC program--specification of
applicable AUC. We first proposed a process by which PLEs (including
national professional medical specialty societies) become qualified by
Medicare to develop or endorse AUC. The cornerstone of this process is
for PLEs to demonstrate that they engage in a rigorous evidence-based
process for developing, modifying, or endorsing AUC. It is through this
demonstration that we proposed to meet the requirements of section
1834(q)(2)(B) of the Act to take into account certain considerations
for specifying AUC. Section 1834(q)(2)(B) specifies that the Secretary
must consider whether AUC have stakeholder consensus, are
scientifically valid and evidence-based, and are based on studies that
are published and reviewable by stakeholders. It is not feasible for us
to review every individual criterion of an AUC. Rather, we proposed to
establish a qualification process and requirements for qualified PLEs
to ensure that the AUC development or endorsement processes used by a
PLE result in high quality, evidence-based AUC in accordance with
section 1834(q)(2)(B). Therefore, we proposed that AUC developed,
modified, or endorsed by qualified PLEs will constitute the specified
applicable AUC that ordering professionals would be required to consult
when ordering applicable imaging services.
To become and remain a qualified PLE, we proposed to require a PLE
to demonstrate adherence to specific requirements when developing,
modifying or endorsing AUC. The first proposed requirement is related
to the evidentiary review process for individual criteria. Entities
must engage in a systematic literature review of the clinical topic and
relevant imaging studies. We would expect the literature review to
include evidence on analytical validity, clinical validity, and
clinical utility of the specific imaging study. In addition, the PLE
must assess the evidence using a formal, published, and widely
recognized methodology for grading evidence. Consideration of relevant
published evidence-based guidelines and consensus statements by
professional medical specialty societies must be part of the evidence
assessment. Published consensus statements may form part of the
evidence base of AUC and would be subject to the evidentiary grading
methodology as any other evidence identified as part of a systematic
review.
In addition, we proposed that the PLE's AUC development process
must be led by at least one multidisciplinary team with autonomous
governance that is accountable for developing, modifying, or endorsing
AUC. At a minimum, the team must be composed of three members including
one with
[[Page 71106]]
expertise in the clinical topic related to the criterion and one with
expertise in imaging studies related to the criterion. We encourage
such teams to be larger, and include experts in each of the following
domains: Statistical analysis (such as biostatics, epidemiology, and
applied mathematics); clinical trial design; medical informatics; and
quality improvement. A given team member may be the team's expert in
more than one domain. These experts should contribute substantial work
to the development of the criterion, not simply review the team's work.
Another important area to address that provides additional
assurance regarding quality and evidence-based AUC development is the
disclosure of conflicts of interest. We believe it is appropriate to
impose relatively stringent requirements for public transparency and
disclosure of potential conflicts of interest for anyone participating
with a PLE in the development of AUC. We proposed that the PLE must
have a publicly transparent process for identifying and disclosing
potential conflicts of interest of members on the multidisciplinary AUC
development team. The PLE must disclose any direct or indirect
relationships, as well as ownership or investment interests, among the
multidisciplinary team members or immediate family members and
organizations that may financially benefit from the AUC that are being
considered for development, modification or endorsement. In addition,
the information must be made available to the public, if requested, in
a timely manner.
For individual criteria to be available for practitioners to review
prior to incorporation into a CDS mechanism, we proposed that the PLE
must maintain on its Web site each criterion that is part of the AUC
that the entity has considered or is considering for development,
modification, or endorsement. This public transparency of individual
criteria is critical not only to ordering and furnishing professionals,
but also to patients and other health care providers who may wish to
view all available AUC.
Although evidence should be the foundation for the development,
modification, and endorsement of AUC, we recognized that not all
aspects of a criterion will be evidence-based, and that a criterion
does not exist for every clinical scenario. We believe it is important
for AUC users to understand which aspects of a criterion are evidence-
based and which are consensus-based. Therefore, we proposed that key
decision points in individual criteria be graded in terms of strength
of evidence using a formal, published, and widely recognized
methodology. This level of detail must be part of each AUC posted to
the entity's Web site.
It is critical that as PLEs develop large collections of AUC, they
have a transparent process for the timely and continual review of each
criterion, as there are sometimes rapid changes in the evidence base
for certain clinical conditions and imaging studies.
Finally, we proposed that a PLE's process for developing,
modifying, or endorsing AUC (which would be inclusive of the
requirements being proposed in this rule) must be publicly posted on
the entity's Web site.
We believe it is important to fit AUC to local circumstances and
populations, while also ensuring a rigorous due process for doing so.
Under our AUC program, local adaptation of AUC will happen in three
ways. First, compatibility with local practice is something that
ordering professionals can assess when selecting AUC for consultation.
Second, professional medical societies (many of which have state
chapters) and large health systems (which incorporate diverse practice
settings, both urban and rural) that become qualified PLEs can get
local feedback at the outset and build alternative options into the
design of their AUC. Third, local PLEs can themselves become qualified
to develop, modify, or endorse AUC.
c. Process for Provider-Led Entities To Become Qualified To Develop,
Endorse, or Modify AUC
We proposed that PLEs must apply to CMS to become qualified. We
proposed that entities that believed they met the definition of
provider-led, submit applications to us that document adherence to each
of the qualification requirements. The application must include a
statement as to how the entity meets the definition of a PLE.
Applications will be accepted each year but must be received by January
1. A list of all applicants that we determine to be qualified PLEs will
be posted to our Web site by the following June 30 at which time all
AUC developed or endorsed by that PLE will be considered to be
specified AUC. We proposed all qualified PLEs must re-apply every 6
years and their applications must be received by January 1 during the
5th year of their approval. Note that the application is not a CMS
form; rather it is created by the applicant entity.
d. Identifying Priority Clinical Areas
Section 1834(q)(4) of the Act requires that, beginning January 1,
2017, ordering professionals must consult applicable AUC using a
qualified CDS mechanism when ordering applicable imaging services for
which payment is made under applicable payment systems and provide
information about the CDS mechanism consultation to the furnishing
professional, and that furnishing professionals must report the results
of this consultation on Medicare claims. Section 1834(q)(5) of the Act
further provides for the identification of outlier ordering
professionals based on a low adherence to applicable AUC. We proposed
to identify priority clinical areas of AUC that we will use in
identifying outlier ordering professionals. Although there is no
consequence to being identified as an outlier ordering professional
until January 2020, it is important to allow ordering and furnishing
professionals as much time as possible to use and familiarize
themselves with the specified applicable AUC that will eventually
become the basis for identifying outlier ordering professionals.
To identify these priority clinical areas, we may consider
incidence and prevalence of diseases, as well as the volume,
variability of utilization, and strength of evidence for imaging
services. We may also consider applicability of the clinical area to a
variety of care settings, and to the Medicare population. We proposed
to annually solicit public comment and finalize clinical priority areas
through the PFS rulemaking process beginning in CY 2017. To further
assist us in developing the list of proposed priority clinical areas,
we proposed to convene the Medicare Evidence Development and Coverage
Advisory Committee (MEDCAC), a CMS FACA compliant committee, as needed
to examine the evidence surrounding certain clinical areas.
Specified applicable AUC falling within priority clinical areas may
factor into the low-adherence calculation when identifying outlier
ordering professionals for the prior authorization component of this
statute, which is slated to begin in 2020. Future rulemaking will
address further details.
e. Identification of Non-Evidence-Based AUC
Despite our proposed PLE qualification process that should ensure
evidence-based AUC development, we remain concerned that non-evidence-
based criteria may be developed or
[[Page 71107]]
endorsed by qualified PLEs. Therefore, we proposed a process by which
we would identify and review potentially non-evidence-based criteria
that fall within one of our identified priority clinical areas. We
proposed to accept public comment through annual PFS rulemaking so that
the public can assist in identifying AUC that potentially are not
evidence-based. We foresee this being a standing request for comments
in all future rules regarding AUC. We proposed to use the MEDCAC to
further review the evidentiary basis of these identified AUC, as
needed. The MEDCAC has extensive experience in reviewing, interpreting,
and translating evidence. If through this process, a number of criteria
from an AUC library are identified as being insufficiently evidence-
based, and the PLE that produced the library does not make a good faith
attempt to correct these in a timely fashion, this information could be
considered when the PLE applies for re-qualification.
6. Summary
Section 1834(q) of the Act includes rapid timelines for
establishing a new Medicare AUC program for advanced imaging services.
The number of clinicians impacted by the scope of this program is
massive as it will apply to every physician and practitioner who orders
applicable diagnostic imaging services. This crosses almost every
medical specialty and could have a particular impact on primary care
physicians since their scope of practice can be quite vast.
We believe the best implementation approach is one that is
diligent, maximizes the opportunity for public comment and stakeholder
engagement, and allows for adequate advance notice to physicians and
practitioners, beneficiaries, AUC developers, and CDS mechanism
developers. It is for these reasons we proposed a stepwise approach,
adopted through rulemaking, to first define and lay out the process for
the Medicare AUC program. However, we also recognize the importance of
moving expeditiously to accomplish a fully implemented program.
In summary, we proposed definitions of terms necessary to implement
the AUC program. We were particularly seeking comment on the proposed
definition of PLE as these are the organizations that have the
opportunity to become qualified to develop, modify, or endorse
specified AUC. We also proposed an AUC development process which allows
some flexibility for PLEs but sets standards including an evidence-
based development process and transparency. In addition, we proposed
the concept and definition of priority clinical areas and how they may
contribute to the identification of outlier ordering professionals.
Lastly, we proposed to develop a process by which non-evidence-based
AUC will be identified and discussed in the public domain. We invited
the public to submit comments on these proposals.
The following is a summary of the comments we received regarding
our proposals.
Comment: There was disagreement among commenters regarding the
proposed definition of PLE. Numerous commenters supported finalization
of the proposed definition for PLE. One commenter noted that national
professional medical specialty societies were specified in PAMA as an
example of a PLE and therefore the definition should encompass such
societies. Another commenter requested the agency provide a definition
of national professional medical specialty societies. Some commenters
requested the definition ensure that provider groups, physicians, and
alliances of provider organizations are included. Some commenters
requested that the definition of PLE be expanded to include radiology
benefit management (RBM) or similar companies, health plans and
manufacturers. These commenters stated that providers, physicians and
other practitioners are integrally involved if not in control of their
AUC development processes. They stated that by including these entities
in the definition of PLE, there would be more AUC available in the
market (which they believe would yield healthy competition). They also
indicated that these entities can move more quickly to update AUCs.
Commenters in support of RBMs stated that national professional medical
specialty societies had potential conflicts of interest when developing
AUC for use by their own medical specialty as some specialties are paid
by performing imaging services. Commenters in support of national
professional medical specialty societies state that RBMs had potential
conflicts of interest and were incentivized to control costs.
Commenters also expressed conflicting opinions regarding the intent of
the term ``provider-led entities'' as used in section 218(b) of the
PAMA.
Response: We agree with the commenter that national professional
medical societies were identified in the statute as an example of the
entities that should fall within the definition of PLE. The proposed
definition of PLE explicitly included national professional medical
specialty societies, as well as organizations comprised primarily of
providers and actively engaged in the practice and delivery of health
care. The way that national professional medical societies and other
similar organizations are structured, many would not have been
considered ``actively engaged in the practice and delivery of
healthcare'' under the proposed definition. This is because national
professional medical specialty societies and other similar entities do
not, as an organization, deliver care to patients. Therefore, we are
modifying the proposed definition of PLE to finalize a definition that
focuses on the practitioners and providers that comprise an
organization and not on whether the organization, as an entity,
delivers care. This approach subsumes national professional medical
specialty societies whose members are actively engaged in delivering
care in the community and eliminates the need to establish a separate
definition for national professional medical specialty societies as
they are now an example of a PLE. This will also include alliances and
collaboratives of hospitals and hospital system.
Some commenters suggested that physicians and other practitioners
are involved in the AUC development process and, therefore, should be
considered PLEs. However, we believe the AUC development process
typically would be embedded within a larger organization, and the
organization as a whole may not be primarily comprised of
practitioners. We continue to believe that the statute is intended to
focus on the structure of the entire organization, and to require that
it be ``provider-led.'' We believe that the PLE definition must apply
to the organization as a whole, as processes that are embedded within
the organization are not the same as a separately identifiable entity.
We do not believe the modified definition of PLE that we are finalizing
will limit the AUC market or the participation of third parties (such
as RBMs) in the AUC development process. There may be opportunity for
third parties to collaborate with PLEs to develop AUC.
Comment: Some commenters expressed concerns that the process to
become a qualified PLE is more restrictive than section 218(b) of the
PAMA requires and could prohibit some organizations with evidence-based
AUC from participating in the program, which could limit physician and
practitioner choice for AUC consultation.
Response: Section 1834(q)(2)(A) of the Act, as added by section
218(b) of the PAMA, requires that we specify AUC for applicable imaging
services only from among AUC developed or endorsed by
[[Page 71108]]
national professional medical specialty societies or other PLEs.
Section 1834(q)(2)(B) of the Act requires that, in specifying these
AUC, we must take into account whether the AUC have stakeholder
consensus, are scientifically valid and evidence-based, and are based
on published studies that are reviewable by stakeholders. We believe
the process we proposed to identify qualified PLEs is essential to
ensuring that we take into account the factors described in the
statute.
Comment: Regarding our proposal to require that, in order to be
considered a qualified PLE, the PLE's AUC development process be led by
a multidisciplinary team with specific characteristics, some commenters
requested that the multidisciplinary team should include more than the
minimum three members we had proposed, with some commenters suggesting
upwards of 15 members. Other commenters suggested the requirements for
the team should not restrict the participation of any qualified
participants; in other words, expertise should not be dictated entirely
by CMS and teams should have the option to add whomever they determine
appropriate. Still other commenters suggested that CMS should require
representation on the multidisciplinary team from primary care,
industry, patient advocates and insurers and experts on the imaging
study and clinical topic.
Response: We agree that the multidisciplinary team would benefit
from additional representation and, more specifically, from
representation by primary care practitioners, because a large
proportion of imaging orders will be made by primary care
practitioners. In response to these comments, we are modifying our
proposal to instead require that the multidisciplinary team must have
at least seven members including a primary care practitioner. We are
also modifying the requirements to clearly state that the required
expertise in the clinical topic and imaging service related to the AUC
that are being developed must be provided by practicing physicians.
These modifications to the multidisciplinary team requirements align
with many of the commenters' support for more representation from
practitioners in the field.
We agree with the commenters' suggestions that the team should be
required to include more members, and that the types of experts
required on the team should also be expanded. In addition to primary
care, we are also modifying our proposal to require that experts in
clinical trial design and statistical analysis be required members of
the team. While we do not agree that involvement from industry or
patient advocates should be required on the team, we do believe that
teams could benefit from dialogue with such stakeholders. In response
to the commenters that expressed concern about CMS restricting team
participation, we encourage teams to be inclusive and seek members with
any other relevant expertise.
Comment: Some commenters expressed concerns regarding the burden
associated with the evidence review process we proposed to require for
qualified PLEs in the AUC development process. Commenters indicated
that the evidence review process that we proposed to require would be
expensive, as commissioned systematic reviews are costly, and the
process would require a significant amount of time which would be
burdensome especially for smaller organizations. Some commenters
suggested replacing ``systematic'' with ``thorough'' in describing the
evidence review process to avoid unintentionally requiring a
commissioned systematic review, and to account for specific methods
included in systematic reviews that may not be applicable to all
advanced diagnostic imaging studies. One commenter recommended that the
cost of systematic reviews and the costs associated with AUC
development should be at least partially mitigated by government
organizations like CMS, and tax incentives or grant money should be
available to medical specialty societies to help offset the costs.
Response: While we understand the commenters' concerns about the
cost and time necessary to comply with the proposed evidence review
requirement for developing AUC, we believe that this is a fundamental
to ensuring that AUC are evidence-based to the extent feasible as
required by section 1834(q)(1)(B) of the Act. We also believe the
proposed evidence review process is essential to ensuring that the AUC
that are developed can serve their purpose, as indicated in section
1834(q)(1)(B) of the Act, to assist ordering professionals in making
the most appropriate treatment decision for specific clinical
conditions for individual patients. However, we believe some commenters
might have misinterpreted the reference in the proposed rule to a
``systematic'' review. To clarify, we did not intend to require that
the evidence review process must be accomplished by commissioning
external systematic evidence reviews or technology assessments. We
expect PLEs to undertake evidence reviews of sufficient depth and
quality to ensure that all relevant evidence-based publications on
trials, studies and consensus statements are identified, considered and
evaluated; and that such reviews are reproducible. In response to the
commenter that requested financial support in the development of AUC,
we note that section 218(b) of the PAMA included no provisions
authorizing funding tax incentives, grants, or other financial
assistance to PLEs developing AUC.
Comment: Commenters requested clarification on the requirements for
modifying and endorsing AUC. Some commenters suggested that qualified
PLEs that modify or endorse AUC should be required to go through the
same process required for initial AUC development while other
commenters recommended different requirements for modification or
endorsement of AUC. Other commenters stated that modification of AUC
should not be permitted, and that evidence-based AUC should not be
changed to fit local scenarios.
Response: We believe the same process and requirements should apply
to the AUC development process for all qualified PLEs, and that
modification of AUC should be accomplished using the same process and
requirements that apply to the development of AUC. This will ensure
that there is documented evidence for the modification. In the proposed
rule, we did not intend to differentiate between the process and
requirements for AUC development, modification, and endorsement by
qualified PLEs. We are clarifying in this rule that this is because a
PLE must be qualified to endorse another qualified PLE's AUC. Both
entities would have followed the process to become qualified and both
entities would be listed on the CMS Web site as such. Endorsement is
not intended to be duplicative. In other words it is not necessary for
the endorsing qualified PLE to duplicate the extensive evidence review
process performed by the qualified PLE that developed the AUC set or
individual criterion.
Regarding local adaption, we believe it is important to fit AUC to
local circumstances, while also ensuring application of a rigorous
process in doing so. However, only AUC modified by qualified PLEs can
become specified applicable AUC.
Comment: Some commenters recommended that CMS identify specific
evidence grading methodologies that AUC developers are required to use,
for example the GRADE, AHRQ and USPSTF grading systems.
Response: We believe that evidence grading is an essential
component of the
[[Page 71109]]
AUC development process and that AUC developers should have flexibility
when working within the requirements we have set forth. In addition,
one grading system may be more appropriate for AUC development for a
certain clinical condition while another grading system may be best for
another condition. Therefore, we will not require the use of specific
grading mechanisms.
Comment: Some commenters requested clarification regarding the
meaning of ``autonomous governance'' specific to the multidisciplinary
team.
Response: In proposing that, in order to be a qualified PLE, the
PLE's AUC development process must be led by at least one
multidisciplinary team with autonomous governance, we intended to
highlight the need for the multidisciplinary team to be independent in
its work from influence and oversight by components of the PLE not
involved or associated with the multidisciplinary team.
Comment: Some commenters requested the inclusion of a requirement
for public comment and/or stakeholder feedback on AUC developed,
modified or endorsed by qualified PLEs.
Response: We recognize that some AUC development processes could
invite public comment. While we believe this would be appropriate, we
do not believe we should establish this as a requirement for the
development of AUC by a qualified PLE. We do however believe that
public transparency of the resulting AUC and the corresponding evidence
base is critical to this program. In order to be a qualified PLE, the
PLE must post AUC on their Web site in the public domain that allows
all developed AUC to be reviewed by all stakeholders.
Comment: Some commenters requested further clarification regarding
the requirement for AUC to be reviewed and updated. Many had concerns
that some PLEs would not update AUC on a frequent enough basis to
capture changes in the medical literature. One commenter agreed with
requiring regular reviews and updating, and another commenter suggested
that review be continuous and should occur on a cycle shorter than 1
year.
Response: We agree that AUC should be reviewed and updated
frequently and have included a requirement for qualified PLEs to go
through this process at least annually. We believe that qualified PLEs
that produce quality AUC should have a process in place to evaluate the
state of the medical literature on an annual basis. These annual
reviews will not always result in changes to the AUC, rather, it will
ensure that the AUC reflect the current body of evidence.
Comment: Some commenters recommended including processes approved
by the National Guidelines Clearinghouse (NGC) as examples of a
rigorous evidence-based process, and that we grant provisional approval
as qualified to PLEs that have met the NGC inclusion criteria and whose
AUC are posted to the NGC.
Response: While the NGC serves as an important repository for
clinical practice guidelines, we believe that the CMS application
process for qualified PLE status is not overly burdensome as a stand-
alone process. We believe our application process is appropriate to
assure key aspects of AUC development. We also recognize that PLEs that
have their AUC posted to the NGC may find that they are at an advantage
in the application process to become a qualified PLE because they have
already prepared a package with some similar information.
Comment: One commenter stressed the importance of allowing expert
opinion in the AUC development process, especially when relevant
studies are limited or lacking in available literature. The commenter
also noted the importance of transparency and disclosure of conflict of
interest for experts.
Response: The process of AUC development allows for the opportunity
for expert opinion, especially as we expect the multidisciplinary team
to be populated with such experts. In addition, in the literature
review we would expect published consensus papers and similar documents
to be identified and be part of the evidentiary review. AUC developers
may choose to put their draft AUC into the public domain for comment
and receive expert opinion in that manner.
Comment: One commenter recommended that CMS should initiate the AUC
development process and use public comment, qualified PLEs and
multidisciplinary committees to develop AUC.
Response: Section 1834(q)(7) of the Act clarifies that section
1834(q) of the Act does not authorize the Secretary to develop or
initiate the development of clinical practice guidelines or AUC.
Additionally, under section 1834(q)(1)(B) of the Act, AUC are defined
as criteria only developed or endorsed by national professional medical
specialty societies or other PLEs. As such, we do not believe it would
be appropriate for us to develop or initiate the development of AUC for
purposes of the program under section 1834(q) of the Act.
Comment: One commenter recommended that CMS create a concise list
of AUC development requirements or create a template for entities to
use for their application and post the list or template to the CMS Web
site.
Response: At least for the first round of applications for
qualified PLEs, we will not be making available templates or
applications. CMS might consider developing such templates or
applications in the future if we find it would be useful, efficient or
necessary.
Comment: Some commenters expressed their confusion with the AUC
terminology used in the proposed rule. One commenter recommended, for
the sake of clarity, using the terms ``AUC'', ``AUC set'' and
``required AUC'' in the final rule and to revise the definition of AUC
accordingly.
Response: We understand that there might have been some confusion,
and we have revised the terminology used in this final rule with
comment period to provide greater clarity. In general, when we refer to
AUC we mean a set or library of AUC, and when we use the term
``individual criterion'' we are referring to a single appropriate use
criterion.
Comment: Some commenters opposed our proposal to specify applicable
AUC by first identifying qualified PLEs, and recommended instead that
we specify a small group of AUC in order to meet the timeline specified
under section 218(b) of the PAMA, and then expanding the list of AUC
over time. Other commenters requested that we adopt a phased approach
with a focus on AUC for a limited number of clinical conditions that
would be used first in larger hospitals and health systems with gradual
expansion to smaller practices.
Response: We believe some of these concerns will be addressed by
clarifying our expected timeline which allows additional time for all
impacted providers and practitioners to prepare for the AUC
consultation program specified under section 1834(q) of the Act. There
will be a delay in not only specifying applicable AUC and identifying
qualifying CDS mechanisms, but these delays will necessarily result in
a delay of the date when ordering practitioners will be expected to
report on the Medicare claim form information on their consultation
with CDS mechanisms.
Specified AUC must first exist prior to being loaded into CDS
mechanisms, and qualified CDS mechanisms must exist prior to
consultation by ordering professionals.
We fully anticipate that we will be able to finalize rules and
requirements around the CDS mechanism and approve mechanisms through
[[Page 71110]]
rulemaking in 2017. This timeline will significantly impact when we
would expect practitioners to begin using those CDS mechanisms to
consult AUC and report on those consultations. We do not anticipate
that the consultation and reporting requirements will be in place by
the January 1, 2017 deadline established in section 218(b) of the PAMA.
Again, we are not in a position to predict the exact timing of this
deliverable; however, we do not anticipate that it will take place,
conservatively, until CDS mechanisms are established through
rulemaking. We do not agree that the requirement to consult with
specified AUC should be limited to certain topics or program areas as
we believe such consultation will help to improve appropriate
utilization across-the-board. We believe that section 218(b) of the
PAMA can be rolled out in a stepwise manner to allow adequate time for
all providers and practitioners to prepare.
Comment: Some commenters recommended that priority clinical areas
be established prior to AUC development and physicians and other
practitioners be required to consult AUC only within these areas.
Commenters stated priority clinical areas should focus on areas with
AUC for which there are consistently available appropriateness ratings
and improved practices resulting from AUC consultation. Other
commenters recommended placing limitations on specified AUC, for
example limiting the number specified for each clinical condition and
limiting specified AUC to those developed by national professional
associations.
Response: We do not agree that we should limit the areas in which
AUC may be specified. We believe it is more advantageous to specify
libraries of AUC because this program is intended to assist ordering
professionals in making the most appropriate treatment decisions for a
specific clinical condition for an individual with reference to
ordering practices for all advanced diagnostic imaging services.
However, we believe that the identification of priority clinical areas
will allow for physicians and other practitioners to focus their
efforts on clinical areas for which there is strong evidence and which
may have high impact on patients and society. Our goal is to tie
outlier calculations to these high impact clinical areas.
Comment: One commenter requested that we include a process by which
AUC developed by national professional medical specialty societies that
do not seek to be qualified PLEs can be considered specified applicable
AUC and, thereby, incorporated into CDS mechanisms (for example, PLEs
with small, specific AUC libraries).
Response: We do not believe it would be appropriate either to allow
AUC to be specified that do not meet the development criteria we have
established, or to presume that AUC developed by a national
professional medical specialty society would meet the requirements of
this rule or to develop a separate process for specifying individual
appropriate use criterion other than through the PLE qualification
process. The requirements for the AUC developed process logically apply
whether the PLE is producing only a few subspecialty criteria or
hundreds of criteria to covering a large portion of all advanced
diagnostic imaging services.
Comment: Some commenters suggested that CMS ensure that PLEs
provide all specified AUC to any developers of CDS mechanisms and do so
in a similar manner in order to allow ordering professionals to choose
any AUC and any CDS mechanism, and to promote innovation. Other
commenters recommended requiring standardization of AUC for the
purposes of CDS mechanism integration.
Response: While we are not able to respond fully to these comments
in this rule, we believe comments regarding standardization of AUC and
CDS mechanisms for purposes of interoperability are very important, and
we intend to further consider these comments and address this issue
through rulemaking next year.
Comment: One commenter requested that CMS ensure that AUC
developers do not use the process to restrict the scope of practice and
limit a CRNA's ability to provide comprehensive pain management care.
Response: We are not aware of AUC developed with the goal of
limiting the scope of practice for any practitioners. However, should
this become a concern, especially to the extent that the limitations
might not be evidence-based, then we would take measures to review
these AUC, possibly including a review by the MEDCAC of their
evidentiary basis.
Comment: One commenter recommended that qualified PLEs that develop
AUC for a priority clinical area should be required to produce AUC that
reasonably encompass the entire scope of that priority clinical area,
so as to ensure that ordering professionals cannot use only a very
small number of criteria with the goal of participating in the program
as little as possible.
Response: We agree that for a qualified PLE to identify their AUC
as addressing a priority clinical area, the AUC must address the area
comprehensively; and we are revising our regulations to include
language that addresses this concern.
Comment: Some commenters requested clarification about the AUC
consultation process. For example, commenters questioned whether
ordering professionals are expected to consult all AUC developed by
qualified PLEs or just the AUC incorporated into the CDS mechanism they
use. Some commenters supported the former approach. Other commenters
recommended that ordering professionals would only be required to
consult and report on AUC included in priority clinical areas.
Response: Additional details regarding how this new program will be
operationalized and what will appear on the Medicare claim form will be
forthcoming in future rulemaking. However, section 218(b) of the PAMA
does not expressly limit consultation to only a subset (priority
clinical area) of AUC; rather, it is clear that AUC must be consulted
for all advanced imaging services. Section 218(b) of the PAMA also
recognizes the possibility that ordering practitioners could consult
CDS and find no corresponding AUC. We anticipate that more details
regarding consultation with CDS mechanisms and claims-based reporting
will be released through rulemaking in CY 2017.
Comment: Some commenters expressed concern regarding conflicting
AUC and conflicts between AUC and other policies (such as national
coverage determinations). Some commenters requested clarification as to
a reconciliation process for conflicting AUC and other commenters
suggested that specialty societies work together to publish information
regarding conflicting AUC.
Response: While we believe that qualified PLEs will be using an
evidence-based AUC development process that will reduce the likelihood
and frequency of conflicting AUC, we agree that conflicting AUC may be
of concern. Conflicting AUC are now highlighted in our rule as an
example of situations in which it might be appropriate for CMS and the
MEDCAC to review the evidence base. Dramatically conflicting AUC may be
a signal that one of them is not evidence-based. The MEDCAC could
review the underlying evidence and the committee could discuss whether
that evidence supports the conclusions of the AUC thereby exposing any
non-evidence-based AUC.
[[Page 71111]]
Comment: Some commenters recommended including a mechanism to
suspend or remove qualification for PLEs before the periodic
requalification process in the event that the PLE has non-evidence-
based AUC and does not take steps to remediate or remove those
criteria. Concerns from commenters included that a qualified PLE might
fail to follow the process, but continue to have their AUC specified
and used by ordering practitioners. Further, there was concern by
commenters that non-evidence-based AUC would continue to be used by
ordering practitioners for an extended period of time since
requalification only occurs every 5 years.
Response: We agree with this comment and have added language to
enable us to take steps to remove the qualified status of qualified
PLEs that have non-evidence-based AUC within their AUC libraries and do
not take prompt measures to resolve or remove the criteria. In addition
to this scenario of non-evidence-based AUC, it is important that we
have the ability to remove the qualified status from a PLE that fails
to meet any of the other requirements set forth in our regulations
under Sec. 414.94(c) relating to AUC development processes and
transparency.
Comment: One commenter suggested that CMS accept applications to
become a qualified PLE until March of 2016 rather than requiring them
to be submitted by January 1, 2016. Other commenters request a further
extension of the deadline, or postponement altogether of the PLE
application process.
Response: We are finalizing the proposed deadline of January 1,
2016 for PLEs to apply to become qualified PLEs because we believe it
is important that we avoid further delay of AUC specification and
program implementation. We note that PLEs will have an annual
opportunity to apply to become qualified.
Comment: Some commenters disagreed with our proposal to require
qualified PLEs to reapply for qualification every 6 years, and were
instead in favor of a shorter time frame for review.
Response: We carefully reviewed the timeline for reapplication and
have determined that an application submitted by January of the 5th
year of approval will receive a determination prior to the start of the
qualified PLE's 6th year. Therefore, the cycle of approval for
qualified PLEs is every 5 years. This is different than what was
proposed as we had originally proposed a cycle that was every 6 years.
As finalized, a PLE that becomes qualified for the first 5-year cycle
beginning July 2016 would be required to submit an application for
requalification by January 2021. A determination would be made by June
2021 and, if approved, the second 5-year cycle would begin in July
2021. For example:
Year 1 = July 2016 to June 2017
Year 2 = July 2017 to June 2018
Year 3 = July 2018 to June 2019
Year 4 = July 2019 to June 2020
Year 5 = July 2020 to June 2021 (reapplication is due by January 1,
2021)
We believe the reapplication timeline is appropriate and allows for
PLEs, CDS mechanism developers and ordering practitioners to enter into
longer term agreements without the constant concern that the PLE will
lose its qualified status. We will assess whether a qualified PLE
consistently has developed evidence-based AUC and met our other
requirements at the time of requalification. We note, however, that if
it appears that qualified PLEs are not maintaining compliance with our
requirements for AUC development, we could reevaluate the
requalification timeline in future rulemaking.
Comment: One commenter recommended listing all qualified PLEs on
the CMS Web site.
Response: We agree with this comment and will list all qualified
PLEs on the CMS Web site.
Comment: One commenter recommended a limit to the number of PLEs
that can be qualified.
Response: We do not, at this time, believe it is necessary to limit
the number of PLEs that can be qualified. If a PLE becomes qualified
and is developing evidence-based AUC we believe they should have the
opportunity for their AUC to become specified.
Comment: We received numerous comments regarding how to identify
priority clinical areas. Some commenters recommended that CMS initially
focus on a small number of high volume services. One commenter
recommended limiting the priority clinical areas to only those with a
strong evidence base rather than areas reliant on consensus opinions.
Another commenter recommended including areas where a large gap exists
between currently available AUC and studies that are ordered in the
Medicare program (for example muscular-skeletal conditions, abdominal
conditions). One commenter recommended that the priority clinical areas
should clearly define cohorts of patients with common disease processes
or symptom complexes. One commenter recommended that qualified PLEs
identify the priority clinical areas or that CMS should accept
proposals from qualified PLEs when identifying these areas. One
commenter suggested that CMS consider imaging studies that have had
high utilization rates over the past 10 years, conditions for which AUC
have been most recently adopted where significant inappropriate use may
still exist, and simple, common conditions.
Response: We appreciate these recommendations and believe that the
proposals that we are finalizing will allow for consideration of
varying elements in identifying priority clinical areas. We expect to
propose the first priority clinical areas in next year's PFS rule based
on stakeholder consultation, and hope to receive further, more specific
public comments at that time.
Comment: Some commenters suggested that CMS identify a substantial
number of priority clinical areas to ensure enough data are available
to calculate outlier ordering professionals with statistical
significance. One commenter recommended that, for the purpose of
outlier identification, these areas should include those where there is
wide clinical variance in appropriate ordering patterns.
Response: We appreciate these suggestions and will consider them
when identifying proposed priority clinical areas.
Comment: Many comments strongly supported the proposed transparency
requirements for qualified PLEs. Commenters supported the public
posting of AUC, references to the information considered in developing
AUC and AUC development, and the review and updating processes to
qualified PLE Web sites. One commenter recommended posting all AUC
development information to a Web site hosted by CMS. Another commenter
requested clarification about acceptance of alternate means of making
the information public (for example, hard copies upon request,
electronically upon request, but not posted in full to the Web site).
Response: We agree that the transparency requirements are important
and essential to this program. Public posting of the AUC and other
required information to each PLE's Web site is required; and it will
not suffice to make the information available in other, less accessible
and transparent ways. It is our goal that the information be easily
accessible and reviewable by all stakeholders. We do not anticipate
posting this information on a CMS Web site as each qualified PLE
retains
[[Page 71112]]
responsibility for public posting of the required information.
Comment: Most commenters supported our proposed policies on
transparency and conflicts of interest for multidisciplinary team
members. Some commenters recommended further strengthening these
requirements to incorporate references to AUC-related activities or
relationships specific to commercial, non-commercial, intellectual,
institutional, patient/public arenas. Other commenters recommended
requiring the exclusion of team members with any significant conflicts
of interest. Some commenters recommended that we impose transparency
requirements for individuals and organizations at the commercial level
specific to CDS mechanism sales/marketing, licensing relationships and
advisory board memberships. One commenter requested clarification
regarding conflict of interest requirements for entities that endorse
AUC.
Response: We agree that transparency and disclosure of conflicts of
interest is essential for multidisciplinary team members, and we are
clarifying in this final rule with comment period that these
requirements apply to the team and to any other party involved in
developing AUC including the qualified PLE itself. We disagree with the
commenter's suggestion to categorically exclude through our regulations
team members for whom there is a conflict of interest as those
individuals may also have the greatest knowledge base for particular
issues. Some conflicts may be unavoidable, and we believe transparency
and disclosure will go far toward promoting objectivity. We believe
that qualified PLEs should use their judgment to establish thresholds
where certain conflicts would result in recusal or removal of an
individual from the multidisciplinary team. We are aware that there are
a number of existing templates, thresholds, and mechanisms that might
reasonably apply to address conflicts of interest. We might address
this issue further, and standardization of the treatment of conflicts
could evolve through our annual rulemaking process. At this time we
believe it is appropriate for conflicts to be disclosed and for the PLE
to have a reasonable process in place to identify and address them. The
final rule with comment period also provides for the information to be
documented and available to the public upon request for a period of 5
years.
Comment: One commenter requested that transparency requirements
specific to AUC and AUC development processes be balanced with
``intellectual property protection for evidence-based content produced
by commercial entities . . .'' which could involve a process by which
interested parties request access to criteria while intellectual
property is protected. One commenter stated that CMS should not require
public release of evidence-based content published under copyright
protection.
Response: We support and have received strong support for the
required public disclosure of these processes and resulting content.
Transparency is essential to ensure all patients and stakeholders can
review and understand how and why AUC are developed, and to which types
of patients they do and do not apply. Making this information public is
particularly important for ordering professionals when they are
selecting the qualified PLEs and CDS mechanisms that best address their
practice needs. CDS mechanism developers and qualified PLEs may need to
enter into agreements for AUC to be loaded into the mechanisms and used
by ordering professionals.
Comment: One commenter recommended that we adopt a requirement for
AUC developers to disclose any participating medical specialty
societies that do not endorse the AUC being developed and the rationale
for their not endorsing.
Response: PLEs may choose to list which medical specialties
societies agree with their AUC and which ones do not. However, we do
not believe it would be appropriate for us to require this disclosure
or explanation. By having AUC in the public domain, any organization
may respond to the AUC and state their agreement or disagreement in any
format they determine is appropriate.
Comment: Many commenters expressed significant concerns regarding
the implementation timeline set forth in section 218(b) of the PAMA.
Commenters questioned whether it is feasible or reasonable to meet the
January 1, 2017 deadline to require consultation by ordering
professionals with CDS mechanisms given that we do not anticipate
finalizing requirements for CDS mechanisms until rulemaking for the CY
2017 PFS and CDS mechanism developers and ordering professionals will
need 12-18 months to incorporate the requirements into clinical
practice.
Response: We understand these concerns and agree that the timeline
set forth in section 218(b) of the PAMA is difficult to meet. As such,
we will delay implementation of certain AUC program components
including the requirement for consultation with CDS mechanisms.
Consultation with a CDS mechanism will not be required on January 1,
2017 because we do not expect to have approved CDS mechanisms by that
date. Although we will develop our plans through further rulemaking, at
this time, we do not expect to have approved CDS mechanisms until
approximately summer of 2017. In that event, consultations with CDS
mechanisms could not take place on January 1, 2017.
Comment: Some commenters supported maintaining the timeline set
forth in the PAMA for AUC program implementation. One commenter stated
that their organization was able to comply with the timeline. Some
commenters also recommended using subregulatory guidance and requests
for information (RFIs) outside of rulemaking to meet the timeline set
forth in the PAMA.
Response: We appreciate the willingness and enthusiasm of these
stakeholders in moving quickly forward in AUC program implementation;
however, we believe that it is important to take a stepwise approach to
implementation and to establish the components of this program as
proposed through notice and comment rulemaking. This approach will
ensure that we fully comply with requirements set forth in PAMA for
stakeholder consultation, and that we develop a sound implementation
plan. We will continue to engage with stakeholders to inform
development of future AUC program components and we will consider using
an RFI to help inform the next rulemaking cycle.
Comment: Many commenters encouraged CMS to engage in continued
stakeholder interactions and dialogue for all aspects of the AUC
program. Commenters particularly advocated for continued stakeholder
involvement as we develop CDS mechanism requirements during the CY 2017
rulemaking cycle. Some commenters recommended more engagement with
professional societies representing ordering physicians and one
commenter suggested representation of ordering and primary care
physicians if a MEDCAC is convened.
Response: We will continue to have an open-door policy and engage
all stakeholders to develop and refine the AUC program. Not only is
stakeholder consultation a requirement of PAMA, but we have found these
interactions to be highly informative and critical in building this
program.
Comment: Many commenters offered suggestions regarding the CDS
component of the AUC program. Commenters identified specific areas of
importance for CMS to focus on such as
[[Page 71113]]
interoperability of CDS mechanisms and electronic health records (EHRs)
and the relationship between AUC developers and CDS mechanisms.
Commenters also cautioned against a roll out of this component that
would not allow sufficient time for CDS mechanisms to comply with the
requirements yet to be established in rulemaking or the incorporation
of AUC consultation through approved CDS mechanisms into clinical
practice. Commenters further requested that CMS address the CDS
mechanisms as soon as possible, potentially via avenues outside of the
rulemaking process, to account for the short implementation timeline
specified in section 218(b) of the PAMA. Commenters provided important
and thoughtful recommendations and feedback regarding the CDS component
of this program.
Response: We understand the interest in, and concerns expressed
about the need for more information and details regarding the CDS
mechanism requirements and incorporation into clinical practice;
however, as discussed in our proposal, we anticipate that details
regarding CDS mechanisms will be the focus of rulemaking during 2016
for the CY 2017 PFS. We appreciate these comments and will use them to
inform development of future proposals. We will also continue to
consult and interact with stakeholders. We note again that we do not
expect that the AUC consultation through approved CDS mechanisms could
be required on January 1, 2017.
Comment: Some commenters expressed concern regarding the burden
placed on furnishing professionals in reporting on ordering
professionals' compliance with AUC consultation. One commenter
recommended that the furnishing professional should only be required to
report on the claim whether or not the ordering professional consulted
AUC.
Response: Under section 1834(q)(4)(B) of the Act, the furnishing
professional is required by statute to include information on the claim
(for an applicable imaging service furnished in an applicable setting
and paid under an applicable payment system) that identifies what
qualified CDS mechanism was consulted by the ordering professional,
whether the service ordered would or would not adhere to that AUC, or
was not applicable to the service, and the NPI of the ordering
professional.
Comment: Some commenters requested clarification about allowing
variations in AUC based on local populations and circumstances and
cautioned that allowing exceptions to specified AUC could work against
the goal of the AUC program. Many commenters supported flexibility in
allowing variations based on local populations and circumstances, but
some commenters suggested that processes for variations should still
meet the AUC program requirements and should be rare.
Response: We believe that allowing for variations in AUC based on
local circumstances is important to ensure that AUC consultation can be
incorporated into clinical practice throughout the country. We agree
that local variations should still meet the program requirements to
ensure that the evidence to support modification is evaluated and
graded and only performed by qualified PLEs.
Comment: Some commenters noted that section 218(b) of the PAMA
allows for an exception to the requirement to consult AUC in the case
of certain emergency services, but our proposal states that AUC applies
to various settings including the Emergency Department. Commenters
stated that this ambiguity could cause a delay in the delivery of
emergency services to patients and requested clarification on the
application of the AUC program in emergency departments and exceptions
for certain emergency services.
Response: We understand the confusion and will take these comments
into account as we further develop our policies on exceptions in the
case of certain emergency services. We anticipate addressing this issue
in rulemaking for the CY 2017 PFS.
Comment: One commenter requested clarification on whether mobile,
free-standing high tech radiology units are subject to this program.
Response: Whether the equipment is mobile or fixed, the requirement
to consult AUC is based on whether the service at issue is an
applicable imaging service ordered by an ordering professional that
would be furnished in an applicable setting and paid for under an
applicable payment system. Applicable imaging services include, in
general, advanced diagnostic imaging services for which AUC are
publicly available without charge. Applicable settings include a
physician's office, hospital outpatient department (including an
emergency department), an ambulatory surgical center, and any other
provider-led outpatient setting determined appropriate by the
Secretary. Applicable payment systems include the PFS, the hospital
outpatient prospective payment system, and the ambulatory surgical
center payment system. Although we anticipate developing further
details regarding these specifications through future rulemaking, we
believe the statutory specifications are fairly clear as to the
services for which ordering professionals will be required to consult,
and report on their consultation of, AUC. We believe the commenter can
make a good preliminary assessment as to whether its services fall
within these specifications.
Comment: One commenter stated that the proposed AUC program will
have unintended consequences on ordering professionals and creates a
burden for these practices without the promise of improved care. This
commenter stated that some professional societies were not consulted in
development of section 218(b) of the PAMA.
Response: AUC consultation by all advanced diagnostic imaging
ordering professionals is a requirement under section 218(b) of the
PAMA. We are developing this program with extensive stakeholder
consultation and input to ensure that the program is implemented in a
manner that does not create excessive burden for ordering
professionals; yet we recognize that there unavoidably will be some
underlying burden for ordering professionals in consulting AUC and
reporting on that consultation.
Comment: Some commenters recommended that physicians and hospitals
already involved in payment reform models be exempt from reporting
requirements for ordering professionals under this program.
Response: Section 218(b) of the PAMA does not include a provision
for exceptions for participants in payment reform models. We will
consider whether there is authority within the context of such models
to consider developing exceptions for model participants.
Comment: Some commenters requested clarification regarding the use
of non-evidence-based AUC, particularly when evidence-based AUC are
available. Commenters suggested that non-evidence-based AUC may be more
prevalent in the everyday practice of medicine.
Response: Section 218(b) of the PAMA requires that, to the extent
feasible, AUC must be evidence-based; and we are including that
requirement in the AUC development process. However, the process allows
for the spectrum of the hierarchy of evidence to be used as part of the
systematic review. AUC based on lower levels of evidence will be
apparent as each appropriate use criterion posted to the PLE Web site
would include the level of evidence for each of the decision node.
[[Page 71114]]
Comment: Some commenters expressed support for our proposal to
identify non-evidence-based AUC through annual rulemaking and encourage
public and stakeholder input in the process. One commenter suggested
requiring all non-evidence-based AUC to be reviewed by the MEDCAC. One
commenter recommended that CMS define and implement an additional
auditing process that could be used to identify abuses and systematic
failures.
Response: We are finalizing this proposal with additional language
stating that conflicting AUC will be incorporated into the process for
addressing non-evidence-based AUC. The MEDCAC may be convened to review
these AUC. If a non-evidence-based appropriate use criterion is
identified by the MEDCAC and the qualified PLE fails to revise the
criterion to reflect the evidence then we may take action regarding the
qualified PLE's status. In other words, we may determine that
qualification should be reconsidered outside the 5 year reapplication
process. We have not created additional auditing processes beyond those
that we already possess. We could consider this in future rulemaking if
the agency and MEDCAC become overwhelmed by the volume of non-evidence-
based AUC.
Comment: One commenter requested incorporation of a process for
hardship exemptions to consider factors that might prevent or delay
institutions from meeting the requirements of the AUC program.
Response: We will address the significant hardship exemption
(section 1834(q)(4)(C)(iii) of the Act) in future rulemaking, and
anticipate doing so in rulemaking for the CY 2017 PFS.
Comment: Some commenters recommended that ordering professionals
who follow AUC that are developed by internationally-accepted
methodologies should not have to complete prior authorizations related
to that treatment. One commenter cautioned against including new care
improvements in the identification of outliers as clinical practice
will continue to change. One commenter requested that the CMS
definition for outliers and mechanisms used to identify and penalize
outliers must have the necessary flexibility to account for differences
in volume of advanced imaging studies due to the composition of a
physician's practice.
Response: We will address outlier identification and the prior
authorization component of this program in future rulemaking.
Comment: Many commenters expressed concerns about the absence of
claims processing instructions and reporting requirements for AUC
consultation in our proposal, and the short time frame between
publication of the CY 2017 PFS and the PAMA deadline for consultation
with CDS mechanisms. Some of these commenters included suggestions for
these instructions and reporting requirements.
Response: As discussed in the proposal, we anticipate addressing
claims reporting requirements during the CY 2017 PFS rulemaking
process. The deadline for consulting CDS mechanisms and reporting such
consultations on Medicare claims will be delayed for a year consistent
with our proposals in the proposed rule.
Comment: Some commenters believed that our proposal addressed
problems encountered in the MID. One commenter specifically noted that
the proposal accomplished this by: (a) Expanding on the AUC definition
to identify AUC as link between presenting clinical conditions and
appropriate imaging services, not just based on imaging service; (b)
correctly stressing the importance of integration of the CDS into
clinical workflow; and (c) recognizing the importance of flexibility in
implementing best practices given local circumstances. Other commenters
stated that the proposal ignored some recommendations from the MID,
specifically the recommendation to include guidelines from entities
other than national specialty societies as the MID noted that societies
``have a vested interest in advising that imaging be ordered.''
Response: We have attempted to balance the findings of the MID with
the statutory requirements by specifying libraries of AUC as opposed to
individual criteria, and we hope that our transparency and conflict of
interest requirements will address concerns that commenters had
regarding conflict of interest of AUC developers. We also believe that
lessons learned in the MID will benefit CDS mechanism development, and
we encourage additional comments in that regard in the future.
Comment: One commenter requested confirmation that the AUC program
will only be applicable to Medicare FFS, and not Medicare Advantage.
Response: This program is applicable only to services for which
payment is made under the PFS, the hospital outpatient prospective
payment system, and the ambulatory surgical center payment system.
Comment: One commenter suggested that AUC should fit under the
Merit-Based Incentive Payment System and should not be a stand-alone
program.
Response: We do not believe, at this time, that it would be
feasible for this program to be incorporated under other quality or
value-based programs. However, we could explore whether there are
opportunities for consolidation in the future.
In response to comments, we are making some changes to our
proposals as well as finalizing most aspects of the policies as they
were proposed in the CY 2016 PFS proposed rule.
We are finalizing the majority of definitions as they were
proposed. However, based on public comments, we are changing the
definitions of AUC, PLE and priority clinical area.
We proposed to define AUC as criteria only developed or endorsed by
national professional medical specialty societies or other provider-led
entities, to assist ordering professionals in making the most
appropriate treatment decision for a specific clinical condition for an
individual. To the extent feasible, such criteria must be evidence-
based. AUC are a collection of individual appropriate use criteria.
Individual criteria are information presented 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). We are revising
the last two sentences of the definition in response to public comments
that expressed confusion regarding the AUC terminology used in our
proposal. We have also revised related language throughout the final
regulation accordingly.
We proposed to define PLE as a national professional medical
specialty society, or an organization that is comprised primarily of
providers and is actively engaged in the practice and delivery of
healthcare. We are revising the definition of PLE to refer to
organizations comprised primarily of providers or practitioners who,
either within the organization or outside of the organization,
predominantly provide direct patient care. The definition of PLE will
retain the direct reference to national professional medical specialty
societies, and other organizations like them are now subsumed within
the definition.
This definition of PLE will include health care collaboratives and
other similar organizations such as the National Comprehensive Cancer
Network and the High Value Healthcare Collaborative. While this is not
a dramatic change from the proposed rule, the focus is now on the role
of the members that comprise the organization and not the function of
the organization
[[Page 71115]]
itself. This definition aligns with the statute in that national
professional medical specialty societies are given as an example of a
PLE. Under the proposed definition, these societies were expressly
specified as PLEs. It is not the function of the society to deliver
care but rather their members are actively engaged in practicing
medicine in the field. This final definition appropriately encompasses
these organizations and others that are comprised of providers or
practitioners who care for patients.
We are also modifying our proposed definition of priority clinical
area. We proposed to define priority clinical area as clinical topics,
clinical topics and imaging modalities, or imaging modalities
identified by CMS through annual rulemaking and in consultation with
stakeholders which may be used in the determination of outlier ordering
professionals. We are changing the language to better describe the
breadth of clinical areas that may be the focus of priority clinical
areas. The finalized definition better reflects that priority clinical
areas may identify clinical conditions, diseases or symptom complexes
and their associated advanced diagnostic imaging services. This
definition will allow the priority clinical areas to better align with
the variety of clinical situations for which a patient may present to
the ordering practitioner.
In response to the comments we received regarding the role of
endorsement of AUC, we are adding a new Sec. 414.94(d) to the
regulations. This new section clearly describes the role of
endorsement. We note that only a qualified PLE may provide endorsement
of AUC. Further, qualified PLEs may only endorse the AUC of other
qualified PLEs. Independently, each organization must have been
qualified, and therefore, we do not envision participation by CMS in
the endorsement relationship. The primary function of endorsement is
for qualified PLEs to combine their AUC to create a larger, more
clinically encompassing library. For example, one qualified PLE may
focus on developing AUC related to neuroimaging, another may focus on
developing AUC related to abdominal imaging. The endorsement
relationship gives recognition to this type of collaboration.
While we are finalizing the requirements for developing or
modifying AUC as proposed (with the exception of grammatical, non-
substantive changes for regulatory consistency) in Sec. 414.94(c)(1),
we provide clarification in this final rule with comment period around
what is expected regarding a systematic literature review as public
commenters did not indicate a consistent understanding of this concept.
To clarify, the evidence review requirement does not mean that PLEs
must commission external systematic evidence reviews or technology
assessments. We expect many organizations will undertake their own
systematic evidence review to ensure all relevant evidence-based
information is considered and evaluated. The literature review must be
systematic, reproducible and encompass all relevant literature related
to the specific imaging study. Ideally, the review would include
evidence on analytical validity, clinical validity, and clinical
utility of the specific imaging study. In addition, the PLE must assess
the evidence using a formal, published, and widely recognized
methodology for grading evidence. We do not require that a particular
methodology be used as there may be certain methodologies better suited
to some evidentiary assessments than others.
For consistency with regulatory structure, we have revised the
proposed language throughout Sec. 414.94(c) to more clearly represent
the responsibility of the PLEs seeking qualification in demonstrating
adherence to AUC development requirements under this section.
Based on public comments, we are changing the requirements for the
multidisciplinary team that must be used in the AUC development
process. We proposed at least one multidisciplinary team with
autonomous governance, decision making and accountability for
developing, modifying or endorsing AUC. At a minimum the team must be
comprised of three members including one with expertise in the clinical
topic related to the criterion and one with expertise in the imaging
modality related to the criterion. While we proposed to require a
smaller team, we are finalizing Sec. 414.94(c)(1)(ii) to state that a
qualified PLE must utilize at least one multidisciplinary team with
autonomous governance, decision making and accountability for
developing or modifying AUC. At a minimum the team must be comprised of
seven members including at least one practicing physician with
expertise in the clinical topic related to the appropriate use
criterion being developed or modified, at least one practicing
physician with expertise in the imaging studies related to the
appropriate use criterion, at least one primary care physician or
practitioner (as defined in sections 1833(u)(6), 1833(x)(2)(A)(i)(I),
and 1833(x)(2)(A)(i)(II) of the Act), one expert in statistical
analysis and one expert in clinical trial design. A given team member
may be the team's expert in more than one domain. A team comprised in
this manner and at this size better encompasses the expertise and the
dedication needed to develop quality AUC. We encourage such teams to be
larger where appropriate, and to include experts in medical informatics
and quality improvement. These experts should contribute substantial
work to the development of the criteria, not simply review the team's
work. Teams may also consider involving other stakeholders.
Based on public comments in support of frequent review of AUC, we
are adding language to Sec. 414(c)(1)(vii) to require at least annual
review by qualified PLEs of their AUC.
In addition, since new Sec. 414.94(d) has been added to clarify
the role of qualified PLE endorsement, the term endorsement has been
removed from Sec. 414(c)(1)(ii) as it relates to the multidisciplinary
team. Since only qualified PLEs can provide endorsement, these
qualified PLEs have already demonstrated they meet the requirements of
Sec. 414.94(c)(1)(ii).
We have added language to the conflict of interest disclosure
requirement in Sec. 414.94(c)(1)(iii) to make clear that the conflict
of interest processes and disclosures would apply not only to members
of the multidisciplinary team but also the PLE and any entity that
participated in the development of AUC.
In addition, and in response to comments, we have included that the
conflict of interest process put in place by the PLE must also include
processes to recuse or exclude members of the multidisciplinary team
where appropriate. This language was not included in the proposed
language of Sec. 414.94(c)(1)(iii). We are finalizing conflict of
interest language in Sec. 414.94(c)(1)(iii) and Sec.
414.94(c)(1)(iii)(A) and Sec. 414.94(c)(1)(iii)(B).
We are finalizing language to clarify that CMS will perform a
review of each PLE's application for qualification. We have added ``for
review'' to Sec. 414.94(c)(2)(i) to make it clear that PLEs must
submit an application to CMS for review that documents adherence to
each of the AUC development requirements outlined in paragraph (c)(1)
of this section.
We proposed the requalification timeline in Sec. 414.94(c)(2)(v).
We revised the language and finalized two sections to clarify the
requirements related to qualified PLE reapplication.
[[Page 71116]]
In the proposed rule we stated that PLEs, on their Web site, must
identify when they have AUC that address a priority clinical area.
Section 414.94(c)(1)(iv) included that, if relevant to a CMS identified
priority clinical area, such a statement must be included. We have
expanded this requirement and created Sec. 414.94(c)(1)(v) to include
this requirement. This ensures that the AUC are broad enough in scope
that an ordering professional could use those AUC to satisfy the
priority clinical area.
Section 414.94(f)(3) has been added to clearly specify that CMS
will consider information related to a PLE's failure to correct non-
evidence-based AUC to determine whether CMS should terminate the PLE's
qualified status, and that the information would be used during the
PLE's re-qualification review.
To broaden the scope of which potentially non-evidence-based AUC
may be reviewed by the MEDCAC, we have revised the language so as not
to be limited to reviewing AUC that correspond to priority clinical
areas. We proposed Sec. 414.94(e)(1) to state that CMS will accept
public comment to facilitate identification of individual or groupings
of AUC that fall within a priority clinical area and are not evidence-
based. CMS may also independently identify AUC of concern. We have
added language to Sec. 414.94(f)(1) that gives priority to AUC that
correspond to priority clinical areas but does not limit review to
such. In this section, we have also identified that conflicting AUC may
receive priority in MEDCAC review.
We thank the public for their comments and believe the changes
based on these comments have improved the requirements and process that
we will follow to specify AUC under this program for advanced
diagnostic imaging services. Following the publication of this final
rule with comment period, we will post information on our Web site for
this program accessible at www.cms.gov/Medicare/Quality-Initiatives/Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program.
H. Physician Compare Web Site
1. Background and Statutory Authority
As required by section 10331(a)(1) of the Affordable Care Act, by
January 1, 2011, we developed a Physician Compare Internet Web site
with information on physicians enrolled in the Medicare program under
section 1866(j) of the Act, as well as information on other eligible
professionals (EPs) who participate in the Physician Quality Reporting
System (PQRS) under section 1848 of the Act. We launched the first
phase of Physician Compare on December 30, 2010 (http://www.medicare.gov/physiciancompare). In the initial phase, we posted the
names of EPs that satisfactorily submitted quality data for the 2009
PQRS, as required by section 1848(m)(5)(G) of the Act.
We also implemented, consistent with section 10331(a)(2) of the
Affordable Care Act, a plan for making publicly available through
Physician Compare information on physician performance that provides
comparable information on quality and patient experience measures for
reporting periods beginning no earlier than January 1, 2012. We met
this requirement in advance of the statutory deadline of January 1,
2013, as outlined below, and plan to continue addressing elements of
the plan through rulemaking.
To the extent that scientifically sound measures are developed and
are available, we are required to include, to the extent practicable,
the following types of measures for public reporting:
Measures collected under the Physician Quality Reporting
System (PQRS).
An assessment of patient health outcomes and functional
status of patients.
An assessment of the continuity and coordination of care
and care transitions, including episodes of care and risk-adjusted
resource use.
An assessment of efficiency.
An assessment of patient experience and patient,
caregiver, and family engagement.
An assessment of the safety, effectiveness, and timeliness
of care.
Other information as determined appropriate by the
Secretary.
In developing and implementing the plan, section 10331(b) requires
that we include, to the extent practicable, the following:
Processes to ensure that data made public are
statistically valid, reliable, and accurate, including risk adjustment
mechanisms used by the Secretary.
Processes for physicians and EPs whose information is
being publicly reported to have a reasonable opportunity, as determined
by the Secretary, to review their results before posting to Physician
Compare. We have established a 30-day preview period for all
measurement performance data that will allow physicians and other EPs
to view their data as it will appear on the Web site in advance of
publication on Physician Compare (77 FR 69166, 78 FR 74450, and 79 FR
67770). Details of the preview process will be communicated directly to
those with measures to preview and will also be published on the
Physician Compare Initiative page (http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/physician-compare-initiative/) in advance of the preview period.
Processes to ensure the data published on Physician
Compare provides a robust and accurate portrayal of a physician's
performance.
Data that reflects the care provided to all patients seen
by physicians, under both the Medicare program and, to the extent
applicable, other payers, to the extent such information would provide
a more accurate portrayal of physician performance.
Processes to ensure appropriate attribution of care when
multiple physicians and other providers are involved in the care of the
patient.
Processes to ensure timely statistical performance
feedback is provided to physicians concerning the data published on
Physician Compare.
Implementation of computer and data infrastructure and
systems used to support valid, reliable and accurate reporting
activities.
Section 10331(d) of the Affordable Care Act requires us to consider
input from multi-stakeholder groups, consistent with sections
1890(b)(7) and 1890A of the Act, when selecting quality measures for
Physician Compare. We also continue to get general input from
stakeholders on Physician Compare through a variety of means, including
rulemaking and different forms of stakeholder outreach (for example,
Town Hall meetings, Open Door Forums, webinars, education and outreach,
Technical Expert Panels, etc.).
We submitted a report to the Congress in advance of the January 1,
2015 deadline, as required by section 10331(f) of the Affordable Care
Act, on Physician Compare development, including information on the
efforts and plans to collect and publish data on physician quality and
efficiency and on patient experience of care in support of value-based
purchasing and consumer choice.
We believe section 10331 of the Affordable Care Act supports our
overarching goals of providing consumers with quality of care
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, we plan to continue to publicly report
physician performance information on Physician Compare.
[[Page 71117]]
2. Public Reporting of Performance and Other Data
Since the initial launch of the Web site, we have continued to
build on and improve Physician Compare, including a full redesign in
2013. Currently, Web site users can view information about approved
Medicare professionals such as name, primary and secondary specialties,
practice locations, group affiliations, hospital affiliations that link
to the hospital's profile on Hospital Compare as available, Medicare
Assignment status, education, residency, and American Board of Medical
Specialties (ABMS) board certification information. In addition, for
group practices, users can view group practice names, specialties,
practice locations, Medicare assignment status, and affiliated
professionals.
We received several comments about the enhancements made to the
Physician Compare Web site and the data currently on the Web site.
Comment: Several commenters noted the improvements made to the
Physician Compare Web site, as well as appreciation for the
transparency and easy-to-use, comprehensive information available on
the site to aid consumers in making informed health care decisions.
Some commenters suggested CMS make continued improvements to the
Intelligent Search functionality particularly around finding
professionals other than physicians and including additional specialty
labels for Advanced Practice Registered Nurses (APRNs) and allied
health professionals. One commenter encouraged CMS to continue its
discussions on how to make the Web site fully accessible and useable by
persons with a wide range of disabilities, including vision, sight, and
cognitive challenges.
Some commenters provided suggestions for additional information to
publicly report on Physician Compare, including whether a health care
professional offers patients online access to their health information,
specialist-specific training and certification data, and other
qualifications, such as the Certified Medical Director designation and
the Certificate of Added Qualifications in Geriatric Medicine,
testimony of enhanced comprehensive care services, expanded access or
non-traditional hours, and care management and coordination
information. One commenter urged CMS to include information about
accessibility.
Response: We are committed to continuing to improve the site and
its functionality to ensure it is a useful resource for Medicare
consumers, including information that can help these consumers make
informed health care decisions. We appreciate the recommendations for
specific information to consider for inclusion on the Web site and the
recommendations regarding usability. CMS works to ensure the Web site
is accessible to all users and we will continue to ensure Physician
Compare meets accessibility standards. Also, we will be sure to
consider the specific recommendations received for possible information
to add for future inclusion, if appropriate. We are continually working
to improve and enhance the Intelligent Search functionality, and we
will continue to do so. Currently, APRNs are searchable on the Web site
through this functionality, but we will continue to work with
stakeholders to further improve upon this option.
Comment: Some commenters expressed concerns with the accuracy of
demographic data including addresses, education, and hospital
affiliation. Several commenters urged CMS to continue to work to
correct any demographic data errors prior to expanding public reporting
on the Web site. Other commenters requested we implement a streamlined
process by which professionals can confirm or correct their information
in a timely manner. Some commenters urged CMS to ensure that updates
made in PECOS are reflected on Physician Compare within 30 days. One
commenter suggested a new mechanism for real-time address updates on
the Web site and several other commenters suggested a process that
allows stakeholders to review and correct information on the site.
Response: We appreciate the commenters' feedback regarding concerns
over the accuracy of the demographic information currently available on
Physician Compare. We are committed to including accurate and up-to-
date information on Physician Compare and continue to work to make
improvements to the information presented.
The underlying database for Physician Compare is generated from
PECOS, as well as fee-for-service (FFS) claims, and therefore, it is
critical that physicians, other health care professionals, and group
practices ensure that their information is up-to-date and as complete
as possible in the national PECOS database. Currently, the most
immediate way to address inaccurate PECOS data on Physician Compare is
by updating information via Internet-based PECOS at https://pecos.cms.hhs.gov/pecos/login.do. Please note that the specialties as
reported on Physician Compare are those specialties reported to
Medicare when a physician or other health care professional enrolls in
Medicare and are limited to the specialties noted on the 855i
Enrollment Form. Also, all addresses listed on Physician Compare must
be entered in and verified in PECOS. There is a lag between when an
edit is made in PECOS and when that edit is processed by the MAC and
available in the PECOS data pulled for Physician Compare. This is time
necessary for data verification. Unfortunately, this means there is a
delay. We are continually working to find ways to minimize this delay,
and, in the past year we reduced the data refresh cycle from monthly to
bi-weekly to further improve data timeliness.
To update information not found in PECOS, such as hospital
affiliation, professionals should contact the Physician Compare support
team directly at [email protected]. Information regarding how
to keep your information current is also on the Physician Compare
Initiative page on CMS.gov (//westat.com/dfs/PHYSCOMPARE/Proposed Rule
and Public Comment/2016 PFS Rule/Final Rule/CMS.gov).
We appreciate the suggestions for alternative ways to update
demographic data. However, PECOS is the sole verified source of
Medicare information, and thus, some information must come to Physician
Compare through PECOS. We are aware of PECOS' limitations and recognize
that PECOS' primary purpose is not to provide up-to-the-minute
information for a consumer Web site. For these reasons, we completely
overhauled the underlying database and began using Medicare claims data
to verify the information in PECOS in 2013. Because of this, the data
are significantly better today than they were prior to the 2013
redesign and we will continue to work to find ways to further improve
the data and the process of receiving and updating the data. We
strongly encourage all professionals and group practices listed on the
site to regularly check their data and to contact the support team with
any questions or concerns. Together, we can continue to make the Web
site better.
In addition, there is a section on each Medicare professional's
profile page indicating with a green check mark the quality programs
under which the EP satisfactorily or successfully reported. The Web
site will continue to post annually the names of individual EPs who
satisfactorily report under PQRS, EPs who successfully participate in
the Medicare Electronic Health Record (EHR) Incentive Program as
authorized by section 1848(o)(3)(D) of the Act, and
[[Page 71118]]
EPs who report PQRS measures in support of Million Hearts (79 FR
67763). A proposed change to the Million Hearts indicator for 2016 data
is discussed below.
With the 2013 redesign of the Physician Compare Web site, we added
a quality programs section to each group practice profile page, as
well. We will continue to indicate which group practices are
satisfactorily reporting in the Group Practice Reporting Option (GPRO)
under PQRS (79 FR 67763). The Physician Compare Web site also contains
a link to the Physician Compare downloadable database (https://data.medicare.gov/data/physician-compare), including information on
this quality program participation. We received comments regarding this
previously finalized policy related to quality program participation.
Comment: A commenter urged CMS to reconsider publicly reporting
participation in the Medicare EHR Incentive Program due to ongoing
issues related to the program. Some commenters suggested adding
indicators for individual health care professionals or group practices
who participate in a QCDR, participate in a quality improvement
registry for other services, or participate in other voluntary quality
improvement initiatives. One commenter requested that quality program
participation be reported at an aggregated level rather than by each
program. Another commenter noted that consumers are not familiar with
quality initiatives, so an indicator should be tested with consumers.
Response: We appreciate the commenters' feedback, and we will take
the suggestions provided regarding indicators into consideration for
possible future enhancements. However, since participation in the EHR
Incentive Program is currently included on Physician Compare, as
previously finalized, and consumers find this information interesting
and helpful, we are going to continue including an indicator for
participation in the EHR Incentive Program on the Web site. Quality
initiatives include a variety of programs with distinct goals.
Therefore, we will continue to include an indicator for each program.
We also understand that explanatory language helps inform health care
consumers as they use the Web site. We currently test all information
included on the Web site with consumers to ensure they understand the
information provided. We recently focused testing on the quality
initiative indicators. Plain language updates are forthcoming as a
result of this testing. We will continue to work to ensure that the
language included on Physician Compare helps users understand these
quality initiatives and use the information provided appropriately and
accurately.
We continue to implement our plan for a phased approach to public
reporting performance information on the Physician Compare Web site.
Under the first phase of this plan, we established that GPRO measures
collected under PQRS through the Web Interface for 2012 would be
publicly reported on Physician Compare (76 FR 73419 through 73420). We
further expanded the plan by including on the Physician Compare Web
site, the 2013 group practice-level PQRS measures for Diabetes Mellitus
(DM) and Coronary Artery Disease (CAD) reported via the Web Interface,
and planned to report composite measures for DM and CAD in 2014, as
well (77 FR 69166).
The 2012 GPRO measures were publicly reported on Physician Compare
in February 2014. The 2013 PQRS GPRO DM and GPRO CAD measures collected
via the Web Interface that met the minimum sample size of 20 patients
and proved to be statistically valid and reliable were publicly
reported on Physician Compare in December 2014.
Comment: We received one comment commending CMS for including
Diabetes quality measures.
Response: We appreciate the commenter's support, and will continue
to publicly report relevant quality measures that meet the public
reporting standards.
The composite measures were not reported, however, as some items
included in the composites were no longer clinically relevant. If the
minimum threshold is not met for a particular measure, or the measure
is otherwise deemed not to be suitable for public reporting, the
performance rate on that measure is not publicly reported. On the
Physician Compare Web site, we only publish those measures that are
statistically valid and reliable, and therefore, most likely to help
consumers make informed decisions about the Medicare professionals they
choose to meet their health care needs. In addition, we do not publicly
report first year measures, meaning new PQRS and non-PQRS measures that
have been available for reporting for less than one year, regardless of
reporting mechanism. After a measure's first year in use, we will
evaluate the measure to see if and when the measure is suitable for
pubic reporting.
Measures must be based on reliable and valid data elements to be
useful to consumers. Therefore, for all measures available for public
reporting, including both group and individual EP level measures--
regardless of reporting mechanism, only those measures that prove to be
valid, reliable, and accurate upon analysis and review at the
conclusion of data collection and that meet the established public
reporting criteria of a minimum sample size of 20 patients and that
prove to resonate with consumers will be included on Physician Compare.
For information on how we determine the validity and reliability of
data and other statistical analyses we perform, refer to the CY 2015
PFS final rule with comment period (79 FR 67764 through 79 FR 67765).
We received several comments regarding the public reporting
standards we have established for Physician Compare. The following is a
summary of the comments received about the public reporting standards.
Comment: Many commenters supported only publishing on Physician
Compare those measures that meet the public reporting standards.
Several commenters urged CMS to carefully assess if all measure data
are sufficiently reliable and valid for public reporting before posting
the data. One commenter requested CMS to publish the results of
validity and reliability studies, as well as the methodology for
choosing measures prior to posting on Physician Compare. Several
commenters are concerned that measures related to patient behavior,
preferences, or abilities do not provide a statistically valid
portrayal of a physician's performance and should not be published
unless the data is appropriately risk adjusted. Several other
commenters also strongly urge CMS to move forward with expanding its
risk adjustment methodology to account for these patient behavior,
preferences, or abilities that may influence quality and performance
measurement. Many commenters supported not publicly reporting first
year measures. Several commenters requested flexibility, noting that
some measures may be appropriate for public reporting immediately while
others may need additional time to mature. A few commenters recommended
a three-year delay in public reporting of all new measures to enable
professionals to accurately report the measures and to account for
measure testing and validity.
Response: We appreciate the commenters' feedback, and understand
the various concerns raised. As required under section 10331(b) of the
Affordable Care Act, in developing and implementing the plan to include
[[Page 71119]]
performance data on Physician Compare, we must include, to the extent
practicable, processes to ensure that the data posted on the Web site
are statistically valid, reliable, and accurate, including risk
adjustment mechanisms used by the Secretary. We understand that this
information is complex, and are committed to providing data on
Physician Compare that are useful to beneficiaries in assisting them in
making informed health care decisions, while being accurate, valid,
reliable, and complete. We will closely evaluate all quality measures
under consideration for public reporting on the Web site to ensure they
are meeting these standards. We will also only post data that meet this
standard of reliability regardless of threshold, and regardless of
measure type. Should we find a measure meeting the minimum threshold to
be invalid or unreliable for any reason, the measure will not be
reported. We will also not publicly report first year measures to allow
health care professionals to learn from the first year of reporting and
to account for measure testing and validity. After a measure's first
year in use, we will evaluate the measure to see if and when the
measure is suitable for pubic reporting. We also continue to encourage
measure developers to build in risk adjustment at this level. We will
continue to analyze the measures available for public reporting to
ensure that risk adjustment concerns are taken into consideration. This
is true for all measures, clinical quality, and patient experience.
Again, all measures must meet the public reporting standards
established for Physician Compare to be included on the Web site.
As mentioned above, in previous rulemaking, we have outlined some
of the types of reliability studies that are conducted for measures (79
FR 67764 through 79 FR 67765). Additional information is also shared
annually via our Technical Expert Panel (TEP) summaries which can be
found on the Physician Compare Initiative page on www.CMS.gov. We will
evaluate the feasibility of the request to share additional
information.
Comment: Several commenters supported a minimum sample size of 20
patients. However, the majority of commenters find a patient threshold
of 20 to be too low to be statistically valid, which may result in
inaccurate quality scores based on one outlier, and some commenters
recommended increasing the threshold to 30 patients. Commenters
recommended CMS use a higher threshold to ensure validity. Several
commenters also urged CMS to provide an opportunity for the public to
review reliability and validity tests.
Response: We appreciate the commenters' feedback regarding the 20
patient minimum sample size; however, it is important to note that all
measures considered for public reporting are subject to additional
validity and reliability tests prior to being publicly reported even if
the minimum sample threshold is met. Therefore, we believe this
threshold of 20 patients is sufficient. In addition, it is a large
enough sample to protect patient privacy for reporting on the Web site,
and it is the threshold previously finalized for both the physician
value-based payment modifier (VM) for most measures and the PQRS
criteria for reporting measure groups (77 FR 69166). As mentioned, we
will evaluate the feasibility of sharing additional information about
the testing done. We will also continue to include an indicator of
which reporting mechanism was used and to only include on the site
measures deemed statistically comparable.\5\
---------------------------------------------------------------------------
\5\ By statistically comparable. CMS means that the quality
measures are analyzed and proven to measure the same phenomena in
the same way regardless of the mechanism through which they were
collected.
---------------------------------------------------------------------------
Comment: Some commenters expressed concern with the comparability
of measures reported through different reporting mechanisms and support
an indicator specifying the differences.
Response: Though we understand concerns regarding including
measures collected via different mechanisms, analyses are conducted to
ensure that the consistencies and inconsistencies across reporting
mechanisms are understood. Only those measures that are proven to be
comparable and most suitable for public reporting will be included on
Physician Compare and made publicly available. Comparability is one of
the public reporting standards established for Physician Compare that
must be met. Therefore, we will continue to report data from the
available reporting mechanisms and make public a notation of which
reporting mechanism was used.
We will continue to publicly report all measures submitted and
reviewed and found to be statistically valid and reliable in the
Physician Compare downloadable file. However, not all of these measures
will necessarily be included on the Physician Compare profile pages.
Consumer testing has shown profile pages with too much information and
measures that are not well understood by consumers can negatively
impact a consumer's ability to make informed decisions. Our analysis of
the collected measure data, along with consumer testing and stakeholder
feedback, will determine specifically which measures are published on
Web site profile pages. Statistical analyses, like those specified
above, will ensure the measures included are statistically valid and
reliable and comparable across data collection mechanisms. Stakeholder
feedback will help us to ensure that all publicly reported measures
meet current clinical standards. When measures are finalized in advance
of the time period in which the data are collected, it is possible that
clinical guidelines may have changed rendering a measure no longer
relevant. Publishing that measure can lead to consumer confusion
regarding what best practices their health care professional should be
subscribing to. We will continue to reach out to stakeholders in the
professional community, such as specialty societies, to ensure that the
measures under consideration for public reporting remain clinically
relevant and accurate.
Comment: Commenters encouraged continued involvement of measure
developers and stakeholders in the public reporting development
process. Several commenters appreciated the continued collaboration
with specialty societies via town hall meetings and other mechanisms.
Several commenters advocated for more transparency by providing the
opportunity for the public to comment on the deliberations of the
Physician Compare TEP, regular engagement with interested stakeholders,
and increased communication about the measure consideration process
including methods and consumer interpretation of performance. Some
commenters appreciated that CMS will continue to reach out to
stakeholders in the professional community to ensure that the measures
under consideration for public reporting remain clinically relevant and
accurate.
Response: As noted, section 10331(d) of the Affordable Care Act
requires that the Secretary take into consideration input provided by
multi-stakeholder groups, consistent with sections 1890(b)(7) and 1890A
of the Act, as added by section 3014 of the Act, in selecting quality
measures for use on Physician Compare. We are also dedicated to
providing opportunities for stakeholders to provide input. We will
continue to identify the best ways to accomplish this so that all
stakeholders have a voice and we are able to meet the statutory and
regulatory mandates and deadlines. We will review all recommendations
provided for future consideration, and we strongly
[[Page 71120]]
encourage all stakeholders to regularly visit the Physician Compare
Initiative (https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/physician-compare-initiative/) page for
information about the latest opportunities to engage with the Physician
Compare team. Stakeholders are also encouraged to reach out with any
questions and comments at any time via email at
[email protected].
The primary goal of Physician Compare is to help consumers make
informed health care decisions. If a consumer does not properly
interpret a quality measure and thus misunderstands what the quality
score represents, the consumer cannot use this information to make an
informed decision. Through concept testing, we will test with consumers
how well they understand measures presented using plain language. Such
consumer testing will help us gauge how measures are understood and the
kinds of measures that are most relevant to consumers. This will be
done to help ensure that the information included on Physician Compare
is as consumer friendly and consumer focused as possible.
Comment: Most commenters supported consumer testing to ensure only
meaningful measures are included on the Web site. One commenter urged
CMS to consult a broader array of stakeholders during concept testing,
including individuals with disabilities. Some commenters requested that
CMS share with professional associations or measure developers any
information obtained through consumer concept testing. A few commenters
asked for more details on concept testing plans, while another
recommended CMS use concept testing to evaluate the information
currently on the Physician Compare site. One commenter would like CMS
to assess the extent to which Physician Compare is effectively
fulfilling the Web site's goals.
Response: We will continue to conduct consumer testing in terms of
both usability testing--to ensure the site is easy to navigate and
functioning appropriately--and concept testing--to ensure users
understand the information included on the Web site and that
information included resonates with health care consumers and allows
the Web site to accomplish the goals as stated. We are continually
working to test the information planned for public reporting with
consumers and we regularly test the information currently on the Web
site with site users. Once a set of measures is finalized as available
for public reporting, we begin planning concept testing of the
measures. Therefore, the measures finalized in this rule will be tested
prior to publicly reporting in late 2017. We also continually work to
ensure that valid, reliable, and meaningful information is included on
the Web site. We will also continue to work to ensure that all
stakeholders, including consumers and health care professionals, are
included in the testing and review process as appropriate and feasible.
We will review recommendations shared regarding sharing testing results
for future consideration. It is important to note that many
stakeholders are already involved in the dissemination of testing
findings, and we are continually working to ensure the best audience
for that information.
Comment: We received several comments that supported including all
valid and reliable measures in the downloadable database while
including only a select group of measures on the Web site. Some
commenters urged CMS not to include data in a downloadable raw data
file if it has already been deemed unsuitable for profile pages. There
was concern that these data may be misused or misinterpreted by
consumers, researchers, and the public.
Response: We will continue to include all measures that meet all
stated public reporting standards that include that all measures
included on Physician Compare must be statistically valid, accurate,
reliable, and comparable in the downloadable file in order to further
transparency. However, we will continue to limit the measures available
on Physician Compare profile pages to those measures that meet these
public reporting standards and are also of the greatest value to
consumers. As noted above, consumer testing helps determine which
information resonates with health care consumers. This will ensure that
the measures presented on Physician Compare help consumers make
informed health care decisions without overwhelming them with too much
information. However, it is very possible that there are strong
measures that provide valuable clinical information that may be
difficult for consumers to understand. We believe these are the types
of measures that are more appropriately accessed in the downloadable
database, rather than the profile pages. Again, only those measures
that meet the public reporting standards established for Physician
Compare will be included in either the downloadable database or the
profile pages.
As is the case for all measures published on Physician Compare,
individual EPs and group practices will be given a 30-day preview
period to view their measures as they will appear on Physician Compare
prior to the measures being published. As in previous years, we will
fully explain the process for the 30-day preview and provide a detailed
timeline and instructions for preview in advance of the start of the
preview period. Although the 30-day preview has been previously
finalized and we were not seeking comment on this, several comments
were received. The following is a summary of the comments received on
the 30-day preview period.
Comment: We received several comments in support of the 30-day
preview period prior to publicly reporting quality data. Many
commenters urged CMS to allow physicians and group practices the
opportunity to correct and/or appeal any errors found in the
performance information before it is posted on the site. Other
commenters stated that a 30-day preview period was insufficient and
requested that CMS extend the period to 45, 60, or 90 days. Several
commenters stated the preview period should match the Informal Review
timeline of 60 days. One commenter requested that if there is a pending
PQRS Informal Review request, then public reporting should be delayed
until there is a final resolution. Several commenters recommended that
if an EP or group practice files an appeal and flags their demographic
data or quality information as problematic, CMS should postpone posting
their information until the issues are resolved. Some commenters sought
clarification on how CMS plans to notify EPs of the preview period and
requested more detail about the process in the event an error is found
during the preview period.
Response: As noted in this rule, the details of the 30-day preview
period are communicated each year via various mechanisms, such as
listserv announcements, Webinars, and other education and outreach
opportunities, and information is always available on the Physician
Compare Initiative page (https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/physician-compare-initiative/). There is currently no appeals process for data made
public on Physician Compare. If a group practice or individual EP has
any concerns regarding the data viewed during preview, they are
provided with multiple options to reach out to the Physician Compare
support team to report their concern and have the issue investigated.
Any issue raised would be addressed prior to publicly reporting of the
data. In addition, the PQRS and VM programs offer an annual Informal
[[Page 71121]]
Review Period following the release of the Quality and Resource Use
Reports (QRURs). We are currently working with the PQRS and VM programs
to ensure that if there are data concerns raised during the Informal
Review period, those concerns are taken into consideration around
public reporting. Regarding concerns around demographic data, these
data are driven primarily by the Provider Enrollment Chain and
Ownership System (PECOS). There is detailed information available on
the Physician Compare Initiative page about how to address any concerns
with the demographic data available on Physician Compare. We strongly
encourage all individual EPs and group practices to regularly review
their data on Physician Compare and ensure their PECOS records are up
to date. If there are any concerns, please contact the Physician
Compare support team at [email protected].
We also report certain Accountable Care Organization (ACO) quality
measures on Physician Compare (76 FR 67802, 67948). Because EPs that
bill under the TIN of an ACO participant are considered to be a group
practice for purposes of qualifying for a PQRS incentive under the
Medicare Shared Savings Program (Shared Savings Program), we publicly
report ACO performance on quality measures on the Physician Compare Web
site in the same way as we report performance on quality measures for
group practices participating under PQRS. Public reporting of
performance on these measures is presented at the ACO level only. The
first subset of ACO measures was also published on the Web site in
February 2014. ACO measures can be viewed by following the
``Accountable Care Organization (ACO) Quality Data'' link on the
homepage of the Physician Compare Web site at http://medicare.gov/physiciancompare/aco/search.html.
ACOs will be able to preview their quality data that will be
publicly reported on Physician Compare through the ACO Quality Reports,
which are made available to ACOs for review at least 30 days prior to
the start of public reporting on Physician Compare. The quality reports
indicate the measures that are available for public reporting. ACO
measures will be publicly reported in plain language, so a crosswalk
linking the technical language included in the Quality Report and the
plain language that will be publicly reported will be provided to ACOs
at least 30 days prior to the start of public reporting.
As part of our public reporting plan for Physician Compare, we also
have available for public reporting patient experience measures,
specifically reporting the CAHPS for PQRS measures, which relate to the
Clinician and Group Consumer Assessment of Healthcare Providers and
Systems (CG-CAHPS) data, for group practices of 100 or more EPs
reporting data in 2013 under PQRS and for ACOs participating in the
Shared Savings Program (77 FR 69166 and 69167). The 2013 CAHPS data for
ACOs were publicly reported on Physician Compare in December 2014.
We continued to expand our plan for publicly reporting data on
Physician Compare in 2015. In the CY 2014 PFS final rule with comment
period, we finalized a decision that all group practice level measures
collected through the Web Interface for groups of 25 or more EPs
participating in 2014 under the PQRS and for ACOs participating in the
Shared Savings Program were available for public reporting in CY 2015
(78 FR 74450). We also finalized a plan to make available for public
reporting performance on certain measures that group practices reported
via registries and EHRs for the 2014 PQRS GPRO (78 FR 74451).
Specifically, we finalized a decision to make available for public
reporting on Physician Compare performance on 16 registry measures and
13 EHR measures in CY 2015 (78 FR 74451). These measures are consistent
with the measures available for public reporting via the Web Interface.
After review and analysis of these data, it was determined that neither
2014 EHR or registry data would be publicly reported in CY 2015. The
2014 EHR data will not be publicly reported on Physician Compare
because CMS was unable to determine the accuracy of these data, and
2014 registry data will not be publicly reported because these data do
not meet the public reporting standards. However, we will continue to
analyze EHR and registry data for future inclusion on the Web site in
2016 and beyond.
We received comments specifically about EHR measures.
Comment: Commenters were opposed to publicly reporting EHR measures
citing the CY 2014 data inaccuracies, specifically given the number of
errors in the eCQM submission data. Some commenters stated it was too
soon to publicly report data from eCQMs without additional work to
verify the validity and accuracy of the measure results. One commenter
encouraged CMS to develop information to help the public to better
understand these data.
Response: We decided not to publicly report 2014 EHR data because
we were unable to determine the accuracy of these data. Only
comparable, valid, reliable, and accurate data will be included on
Physician Compare. In addition, all measures slated for public
reporting will be consumer tested to ensure they are accurately
understood prior to public reporting. If concerns surface from this
testing, we will evaluate the best course forward to ensure only those
measures that meet the public reporting standards established for
Physician Compare are included on the site.
In CY 2015, CAHPS measures for group practices of 100 or more EPs
who participate in PQRS, regardless of data submission method, and for
Shared Savings Program ACOs reporting through the Web Interface or
other CMS-approved tool or interface are available for public reporting
(78 FR 74452). In addition, twelve 2014 summary survey measures for
groups of 25 to 99 EPs collected via any certified CAHPS vendor
regardless of PQRS participation are available for public reporting (78
FR 74452). For ACOs participating in the Shared Savings Program, the
patient experience measures that are included in the Patient/Caregiver
Experience domain of the Quality Performance Standard under the Shared
Savings Program will be available for public reporting in CY 2015 (78
FR 74452).
In late CY 2015, certain 2014 individual PQRS measure data reported
by individual EPs are also available for public reporting.
Specifically, we finalized to make 20 individual measures collected
through a registry, EHR, or claims available for public reporting (78
FR 74453 through 74454). These are measures that are in line with those
measures reported by groups via the Web Interface. As noted above,
however, both the 2014 EHR and registry data are not being publicly
reported for either group practices or individual EPs who reported
these data.
Finally, in support of the HHS-wide Million Hearts initiative,
performance rates on measures in the PQRS Cardiovascular Prevention
measures group at the individual EP level for data collected in 2014
for the PQRS were finalized as available for public reporting in CY
2015 (78 FR 74454). Again, these data are ultimately not going to be
publicly reported in late 2015 because they are collected only via
registry.
We continue to expand public reporting on Physician Compare by
making an even broader set of quality measures available for public
reporting on the Web site in CY 2016. All 2015 group-level PQRS
measures across all group reporting mechanisms--Web Interface,
registry, and EHR--are available for public reporting on Physician
Compare in CY 2016 for
[[Page 71122]]
groups of 2 or more EPs (79 FR 67769). Similarly, we decided that all
measures reported by ACOs participating in the Shared Savings Program
will be available for public reporting on Physician Compare.
Understanding the value of patient experience data for Physician
Compare, CMS finalized to make twelve 2015 CAHPS for PQRS summary
survey measures available for public reporting for all group practices
of two or more EPs, who meet the specified sample size requirements and
collect data via a CMS-specified certified CAHPS vendor in CY 2016 (79
FR 67772).
To provide the opportunity for more EPs to have measures included
on Physician Compare, and to provide more information to consumers to
make informed decisions about their health care, we finalized to make
all 2015 PQRS measures for individual EPs collected through a registry,
EHR, or claims available for public reporting in CY 2016 on Physician
Compare (79 FR 67773).
Furthermore, in support of the HHS-wide Million Hearts initiative,
four 2015 PQRS measures reported by individual EPs in support of
Million Hearts will be available for public reporting in CY 2016.
To further support the expansion of quality measure data available
for public reporting on Physician Compare and to provide more quality
data to consumers to help them make informed decisions, CMS finalized
that 2015 Qualified Clinical Data Registry (QCDR) PQRS and non-PQRS
measure data collected at the individual EP level are available for
public reporting in late CY 2016. The QCDR is required to declare
during their self-nomination if it plans to post data on its own Web
site and allow Physician Compare to link to it or if it will provide
data to CMS for public reporting on Physician Compare. Measures
collected via QCDRs must also meet the established public reporting
criteria. Both PQRS and non-PQRS measures that are in their first year
of reporting by a QCDR will not be available for public reporting (79
FR 67774 through 67775).
See Table 25 for a summary of our previously finalized policies for
public reporting data on Physician Compare.
Table 25--Summary of Previously Finalized Policies for Public Reporting
on Physician Compare
------------------------------------------------------------------------
Data Quality measures and
collection Public reporting Reporting data for public
year year mechanism(s) reporting
------------------------------------------------------------------------
2012......... 2013............ Web Interface Include an indicator
(WI), EHR, for satisfactory
Registry, reporters under
Claims. PQRS, successful e-
prescribers under
eRx Incentive
Program, and
participants in the
EHR Incentive
Program.
2012......... February 2014... WI.............. 5 Diabetes Mellitus
(DM) and Coronary
Artery Disease (CAD)
measures collected
via the WI for group
practices reporting
under PQRS with a
minimum sample size
of 25 patients and
Shared Savings
Program ACOs.
2013......... 2014............ WI, EHR, Include an indicator
Registry, for satisfactory
Claims. reporters under
PQRS, successful e-
prescribers under
eRx Incentive
Program, and
participants in the
EHR Incentive
Program. Include an
indicator for EPs
who earn a PQRS
Maintenance of
Certification
Incentive and EPs
who report the PQRS
Cardiovascular
Prevention measures
group in support of
Million Hearts.
2013......... December 2014... WI.............. 3 DM and 1 CAD
measures collected
via the WI for
groups of 25 or more
EPs with a minimum
sample size of 20
patients.
2013......... December 2014... Survey Vendor... 6 CAHPS for ACO
summary survey
measures for Shared
Savings Program
ACOs.
2014......... Expected to be WI, EHR, Include an indicator
2015. Registry, for satisfactory
Claims. reporters under PQRS
and participants in
the EHR Incentive
Program. Include an
indicator for EPs
who earn a PQRS
Maintenance of
Certification
Incentive and EPs
who report the PQRS
Cardiovascular
Prevention measures
group in support of
Million Hearts.
2014......... Expected to be WI.............. 14 measures reported
late 2015. via the WI for group
practices of 2 or
more EPs reporting
under PQRS with a
minimum sample size
of 20 patients.
2014......... Expected to be WI, Survey All Web Interface
late 2015. Vendor. measures reported by
Shared Savings
Program ACOs, and
CAHPS for ACO
measures.
2014......... Expected to be WI, Certified 8 CAHPS for PQRS
late 2015. Survey Vendor. summary measures for
groups of 100 or
more EPs reporting
via the WI and group
practices of 25 to
99 EPs reporting via
a CMS-approved
certified survey
vendor.
2014......... Expected to be Claims.......... A sub-set of 6 PQRS
late 2015. measures submitted
by individual EPs
that align with
those available for
group reporting via
the WI and that are
collected through
claims with a
minimum sample size
of 20 patients.
2015......... Expected to be WI, EHR, Include an indicator
late 2016. Registry, for satisfactory
Claims. reporters under PQRS
and participants in
the EHR Incentive
Program. Include an
indicator for EPs
who report 4
individual PQRS
measures in support
of Million Hearts.
2015......... Expected to be WI, EHR, All PQRS measures for
late 2016. Registry. group practices of 2
or more EPs.
2015......... Expected to be WI, Survey All measures reported
late 2016. Vendor, by Shared Savings
Administrative Program ACOs,
Claims. including CAHPS for
ACOs and claims
based measures.
2015......... Expected to be Certified Survey All CAHPS for PQRS
late 2016. Vendor. measures reported
for groups of 2 or
more EPs who meet
the specified sample
size requirements
and collect data via
a CMS-specified
certified CAHPS
vendor.
[[Page 71123]]
2015......... Expected to be Registry, EHR, All PQRS measures for
late 2016. or Claims. individual EPs
collected through a
registry, EHR, or
claims.
2015......... Expected to be QCDR............ All individual EP
late 2016. QCDR measures,
including PQRS and
non-PQRS measures.
------------------------------------------------------------------------
3. Final Policies for Public Data Disclosure on Physician Compare
We are expanding public reporting on Physician Compare by
continuing to make a broad set of quality measures available for public
reporting on the Web site. We started the phased approach with a small
number of possible PQRS GPRO Web Interface measures for 2012 and have
been steadily building on this to provide Medicare consumers with more
information to help them make informed health care decisions. As a
result, we proposed (80 FR 41811-41814) to add new data elements to the
individual EP and/or group practice profile pages and to continue to
publicly report a broad set of quality measures on the Web site. We
received several comments on the phased approach to public reporting. A
summary of the comments received follows.
Comment: While many commenters supported continuing the phased
approach to public reporting of quality data, several commenters noted
concern with what they perceive is an aggressive timeline for publicly
reporting physician performance data. Commenters supported a more
gradual approach to public reporting to allow time to evaluate the
public response to data prior to widespread implementation, ensure
accuracy, and permit data to be presented in a format that is easy to
understand, meaningful, and actionable for both patients and
physicians. Some commenters opposed the extensive expansion until
existing Web site problems are addressed. Several commenters suggested
focusing on educating and implementing the Merit-based Incentive
Payment System (MIPS) program before expanding public reporting.
Response: We believe that public reporting of quality data has been
a measured, phased approach which started with publicly reporting just
five 2012 PQRS GPRO measures collected via the Web Interface for 66
group practices and 141 ACOs (76 FR 73417) and continued with a
similarly limited set of 2013 PQRS GPRO Web Interface measures (77 FR
69166). We started to build on this plan with the CY 2014 PFS final
rule with comment period (78 FR 74446). In that rulemaking, we adopted
additional PQRS measures available for public reporting, including a
subset of individual EP PQRS measures. Therefore, the proposals put
forth this year are just the next step in the process to realize the
goals of Physician Compare. We are confident that taking this phased
approach has afforded us the opportunity to prepare for this
significant expansion.
Throughout this process, we have been engaging with consumers and
stakeholders and regularly testing the site and the information to be
included to ensure it is accurately presented and understood. We are
also continually working to improve the Web site and the administrative
and demographic information included. We continue to encourage
physicians, other health care professionals, and group practices to
ensure their information is updated in PECOS so that we can ensure the
most accurate information is available on Physician Compare. We also
encourage individuals and groups to reach out to the Physician Compare
support team at [email protected] for any questions or
concerns regarding the information included on the Web site.
We are committed to public reporting to provide consumers with
information to help them make informed health care decisions. Even
though we will be moving to MIPS as required by the Medicare Access and
CHIP Reauthorization Act (MACRA), we are committed to continue
providing this useful information to consumers and to continue to be
transparent so that health care professionals can evaluate their own
performance and the performance of their peers. As we move towards
implementation of the new MIPS program, we will continue to engage and
educate our stakeholders.
a. Value Modifier
The first goal of the HHS Strategic Plan is to strengthen health
care. One of the ways to do this is to reduce the growth of health care
costs while promoting high-value, effective care (Objective D,
Strategic Goal 1).\6\ We proposed (80 FR 41811) to expand the section
on each individual EP and group practice profile page that indicates
Medicare quality program participation with a green check mark to
include the names of those individual EPs and group practices who
received an upward adjustment for the physician value-based payment
modifier (VM). This VM indicator can help consumers identify higher
quality care provided at a lower cost. The VM upward adjustment
indicates that a physician or group has achieved one of the following:
Higher quality care at a lower cost; higher quality care at an average
cost; or average quality care at a lower cost. This means this type of
quality information may be very useful to consumers as they work to
choose the best possible health care available to them. Including the
check mark is a way to share what can be a very complex concept in a
user-friendly, easy-to-understand format. We proposed to include this
on Physician Compare annually. For the 2018 VM, this information would
be based on 2016 data and included on the site no earlier than late
2017. We solicited comments on this proposal.
---------------------------------------------------------------------------
\6\ http://www.hhs.gov/strategic-plan/goal1.html.
---------------------------------------------------------------------------
The following is a summary of the comments we received on our
proposal to include a green check mark indicator of the names of those
individual EPs and group practices who receive the VM upward adjustment
on profile pages on Physician Compare.
Comment: We received both positive and negative comments on this
proposal. Supporters noted that the addition of VM data supports
transparency, encourages improvement, and provides important
information to the public. One commenter suggested adding additional VM
performance information to the Web site. Several commenters urged CMS
to include educational information about the VM for consumers or an
explanation for physicians who are not eligible for the VM. Another
commenter urged CMS to clarify which performance year data will be
published on Physician Compare to ensure the information is accurately
[[Page 71124]]
understood. One commenter suggested collaborating with consumer
advocacy groups to educate consumers about VM data if the visual
indicator is included.
However, several commenters had significant concerns that the VM is
not well-understood by the public, may be misinterpreted, or does not
provide value to consumers. Many commenters were also opposed to this
proposal due to concerns with the VM calculation methodology and the
resulting proportion of health care professionals that will receive
``average'' scores for the cost and/or quality composite. One commenter
recommended that EPs who participate in programs that exempt them from
VM should receive a checkmark because without this indicator, they
would appear lower quality. Several commenters opposed these data being
added on the profile page, but supported inclusion in a downloadable
database. Some commenters also noted that the VM program will sunset
after 2018, and suggested waiting to publicly report cost data until
the MIPS is implemented. One commenter suggested an indicator for
participating in a QCDR is a better indicator of physician quality and
overall value than the VM.
Response: We appreciate the commenters' feedback, and we appreciate
the concerns raised. We do believe that in time, information such as
this can provide consumers with valuable information to help them make
informed health care decisions and help CMS advance our overall quality
strategy. We agree that this or similar information needs to be
presented on profile pages in a way that will ensure it is accurately
understood and interpreted and is seen as valuable information from the
consumer perspective. We also appreciate that because the VM adjustment
will end after CY 2018, it may be confusing to consumers to add a new
indicator for only a short period of time followed by potentially
another indicator related to the MIPS in later years. As a result, we
are not finalizing this proposal, and therefore, will not be including
a visual indicator of the VM upward adjustment on profile pages at this
time. Regarding the recommendation to add an indicator for
participation in a QCDR, that is not something currently being
considered as we appreciate this is not a concept consumers are
familiar with. However, we will take it into consideration for
potential future evaluation.
b. Million Hearts
In support of the HHS-wide Million Hearts initiative, we included
an indicator for individual EPs who choose to report on specific
``ABCS'' (Appropriate Aspirin Therapy for those who need it, Blood
Pressure Control, Cholesterol Management, and Smoking Cessation)
measures (79 FR 67764). Based on available measures the criteria for
this indicator have evolved over time. In 2015, an indicator was
included if EPs satisfactorily reported four individual PQRS
Cardiovascular Prevention measures. In previous years, the indicator
was based on satisfactory reporting of the Cardiovascular Prevention
measures group, which was not available via PQRS for 2015. To further
support this initiative, we proposed (80 FR 41811) to include on
Physician Compare annually in the year following the year of reporting
(for example, 2016 data will be included on Physician Compare in 2017)
an indicator for individual EPs who satisfactorily report the new
Cardiovascular Prevention measures group that was proposed (and is
being finalized in this final rule) under PQRS. The Million Hearts
initiative's primary goal is to improve cardiovascular heart health,
and therefore, we believe it is important to continue supporting the
program and acknowledging those physicians and other health care
professionals working to excel in performance on the ABCS. We solicited
comments on this proposal.
The following is a summary of the comments we received on our
proposal to include an indicator on profile pages for EPs who
satisfactorily report the Cardiovascular Prevention measures group in
support of Million Hearts.
Comment: Commenters supported including an indicator on profile
pages for individual EPs who satisfactorily report the new PQRS
Cardiovascular Prevention measures group in support of Million Hearts.
One commenter suggested adding context and information about the
program to help consumers better understand the information. One
commenter recommended that the final rule reference the Million Hearts
measures by the PQRS number rather than the short name. Another
commenter suggested recognizing EPs that report other cardiovascular
PQRS measures in addition to those who report the specific measure
group.
Response: We are committed to supporting the Million Hearts
initiative and we believe that recognizing EPs who report this measures
group is aligned with promoting the Million Heats initiative. We
appreciate that some commenters would like additional measures to be
considered in support of the initiative, and we will review this
suggestion for potential future rulemaking. We are also working on a
Web site update that will provide more plain language descriptions and
context of all quality programs represented on the site to ensure
consumers have the context and understanding commenters noted is
important. We are also consumer testing this information on an ongoing
basis to ensure consumers are getting the most out of this information.
As a result, we are finalizing this proposal to include a visual
indicator on EP profile pages in support of the Million Hearts
initiative as it is deemed valuable by consumers and including this
information may incentivize health care professionals to focus on the
Million Hearts measures.
c. PQRS GPRO and ACO Reporting
Understanding the importance of including quality data on Physician
Compare to support the goals of section 10331(a) of the Affordable Care
Act, we finalized in the CY 2015 PFS final rule with comment period (79
FR 67547) a policy to make available for public reporting on Physician
Compare all PQRS GPRO measures collected in 2015 via the Web Interface,
registry, or EHR. In the proposed rule, we proposed (80 FR 41811) to
continue to make available for public reporting on Physician Compare on
an annual basis all PQRS GPRO measures across all PQRS group practice
reporting mechanisms--Web Interface, registry, and EHR--for groups of 2
or more EPs available in the year following the year the measures are
reported. Similarly, all measures reported by Shared Savings Program
ACOs, including CAHPS for ACO measures, would be available for public
reporting on Physician Compare annually in the year following the year
the measures are reported. For group practice and ACO measures, the
measure performance rate would be represented on the Web site. We
solicited comments on this proposal.
The following is a summary of the comments we received on our
proposal to make PQRS GPRO measures across all reporting mechanisms for
groups of 2 or more EPs and Shared Savings Program ACO measures
available for public reporting.
Comment: We received both positive and negative comments regarding
our group practice proposal. Commenters in support noted that publicly
reporting quality measures is helpful to consumers and supports
transparency. In general, commenters were more supportive of publicly
reporting group level measures over individual EP level measures. Some
commenters, however, opposed the continued public reporting of PQRS
data generally, noting concerns
[[Page 71125]]
such as the accuracy of current data reported via an EHR, the potential
for consumer misinterpretation, and the limited measures available for
some specialists to report. One commenter suggested CMS focus on
preparing for MIPS rather than continuing with the current public
reporting plan.
Response: We are committed to public reporting to provide consumers
with information to help them make informed health care decisions. We
are also working to fulfill the public reporting requirements of the
Affordable Care Act. Even though we will be moving to MIPS as a result
of the MACRA, we are committed to continuing our phased approach to
public reporting and providing this useful information to consumers
consistently year to year, as possible. We are also committed to
supporting transparency so that health care professionals can evaluate
their own performance and the performance of their peers. We understand
that there are concerns with the available data. As noted above, all
data must meet the public reporting standards outlined in this rule and
in previous rulemaking in order to be publicly reported. For instance,
because the accuracy of the 2014 data reported via an EHR could not be
determined, these data will not be publicly reported. Data that do
prove to be valid, reliable, accurate, comparable, and that resonate
with consumers, however, will be publicly reported.
Regarding concerns about potential consumer misinterpretation of
the data, we do conduct regular consumer testing to address this issue.
In general, consumers find this information interesting and beneficial
in their decision making process. If a measure is not accurately
interpreted or well understood, or if consumers do not find it to be
valuable, that measure is not considered for public reporting on
Physician Compare profile pages. We do appreciate that PQRS does not
contain a similar number of measures for all possible specialties; we
are working on strategies to help fill this gap. One strategy is
looking toward QCDRs, which are better able to address the needs of
specific specialties with relevant measures.
After considering the issues raised by commenters and for the
reasons we articulated, we are finalizing our proposal to continue to
make all PQRS group practice level and ACO Shared Savings Program
measures available for public reporting annually, including making the
2016 PQRS group practice and ACO data available for public reporting on
Physician Compare in late 2017.
d. Individual EP PQRS Reporting
Consumer testing indicates that consumers are looking for measures
regarding individual doctors and other health care professionals above
all other data. As a result, we decided to make individual EP level
measure data available for public reporting on Physician Compare
starting with a subset of 2014 PQRS measures (78 FR 74451). We expanded
this plan by making all 2015 individual EP level PQRS measures
collected through a registry, EHR, or claims available for public
reporting (79 FR 67773). Through stakeholder outreach and consumer
testing we have learned that these PQRS quality data provide the public
with useful information to help consumers make informed decisions about
their health care. As a result, we proposed to continue to make all
PQRS measures across all individual EP reporting mechanisms available
for public reporting on Physician Compare annually in the year
following the year the measures are reported (for example, 2016 data
would be included on Physician Compare in 2017). For individual EP
measures, the measure performance rate would be represented on the Web
site. We solicited comments on this proposal.
The following is a summary of the comments we received on our
proposal to make all individual EP level PQRS measures available for
public reporting on Physician Compare.
Comment: As with the group practice level PQRS measures, we
received both positive and negative comments regarding this proposal.
Commenters in support again noted that quality measures are helpful to
consumers and support transparency. Several commenters that supported
publicly reporting group level measures did not support reporting
individual EP level measures noting that individual level reporting may
be subject to more data accuracy issues and suffer from small sample
sizes. Another commenter asked for clarification about which
performance score is publicly reported if an EP reports PQRS data
through multiple reporting mechanisms.
Response: We appreciate the commenters' feedback on individual EP
PQRS measures. Again, as is the case with all measures under
consideration for inclusion on Physician Compare, the public reporting
standards established for Physician Compare must be met for the measure
to be publicly reported. As a result, if analyses show that the data
are not accurate, valid, reliable, comparable, or do not resonate with
consumers, they will not be publicly reported on Physician Compare
profile pages. Regarding concerns around small sample sizes, only those
measures that are reported for the accepted sample size of 20 patients
and that meet all stated public reporting standards will be publicly
reported. We understand that it may be harder to meet this minimum
sample size at the individual EP level. However, that will simply mean
the measure is not listed on the individual EP's profile page and no
performance rate is reported. PQRS does encourage EPs to report via a
single reporting mechanism. If data from multiple reporting mechanisms
are deemed eligible for public reporting and an individual EP reports
through more than one of the available mechanisms, we will look at the
reporting mechanism that is used to determine PQRS satisfactory
reporting and work to use the performance rate consistent with that
mechanism.
As a result of the comments received and the importance of
individual EP level quality measure data to consumers, we are
finalizing our proposal to continue to make all PQRS individual EP
level PQRS measures available for public reporting annually, including
making the 2016 PQRS individual EP level data available for public
reporting on Physician Compare in late 2017.
e. Individual EP and Group Practice QCDR Measure Reporting
As previously stated, stakeholder outreach and consumer testing
have repeatedly shown that consumers find individual EP quality
measures valuable and helpful when making health care decisions.
Consumers want to know more about the individual EPs when deciding who
they should make an appointment to see for their health care needs, and
expanding group practice-level public reporting ensures that more
quality data are available to assist consumers with their decision
making. We do appreciate, however, that not all specialties have a full
complement of available quality measures specific to the work they do
currently available through PQRS. As a result, we decided to make
individual EP level Qualified Clinical Data Registry (QCDR) measures--
both PQRS and non-PQRS measures--available for public reporting
starting with 2015 data (79 FR 67774 through 67775). To further support
the availability of quality measure data most relevant for all
specialties, we proposed to continue to make available for public
reporting on Physician Compare all individual EP level QCDR PQRS and
non-PQRS measure data that have been collected for at least a full year
(80 FR
[[Page 71126]]
41812). In addition, we proposed to also make group practice level QCDR
PQRS and non-PQRS measure data that have been collected for at least a
full year available for public reporting (80 FR 41812). Previously, the
PQRS program only included QCDR data at the individual EP level. In
section III.I.2.a. of this final rule with comment period, we are
finalizing, under the PQRS, a decision to expand QCDR reporting to
group practices as well. In this case, group practice refers to a group
of 2 or more EPs billing under the same Tax Identification Number
(TIN). We proposed to publicly report these data annually in the year
following the year the measures are reported. For both EP and group
level measures, the measure performance rate would be represented on
the Web site. We solicited comments on these proposals.
The following is a summary of the comments we received on our
proposal to make both group practice and individual EP level QCDR data
available for public reporting on Physician Compare.
Comment: Many commenters support publicly reporting QCDR measures
for group practices, as well as individual EPs, noting that it promotes
flexibility in reporting, provides additional information to consumers,
and addresses sample size concerns. One commenter requested that CMS
explore ways for quality reporting to be publicly available at the
level of the entire care team. Another commenter expressed concern that
attributing group practice data to an individual physician does not
provide the necessary information to allow the consumer to determine
how the individual EP performed on those measures.
There were also some general concerns about QCDR data including
concerns that QCDR data are too new, not comparable to PQRS measures,
not accurate and reliable, and potentially confusing to consumers. One
commenter suggested holding public reporting of QCDR data until more
specialties are able to report via QCDRs.
Response: We appreciate the commenters' feedback on these QCDR
proposals. We agree that making QCDR data, both PQRS and non-PQRS
measures, available for public reporting helps fill potential gaps left
by the currently available PQRS data. We also believe these measures
add great value for consumers as they provide a greater diversity of
quality information at both the group practice and individual EP
levels, and thus, further help consumers make informed decisions about
their health care. At this time, it is only possible for CMS to
consider measures attributed to either the group practice level or the
individual EP level. Other attribution options are not possible at this
time, but will be taken under consideration for the future.
It is important to note that data collected at the individual EP
level, whether through a QCDR or through other PQRS reporting mechanism
will only be publicly reported at the individual EP level, and data
collected at the group practice level will only be reported at the
group practice level. Group practice data will never be publicly
reported on an individual EP profile page because it would not be
accurate to attribute the group's performance rates to only one EP.
Regarding the general concerns raised about publicly reporting QCDR
data, it is important to emphasize that data submitted by QCDRs must
meet the same public reporting standards as all other data submitted to
CMS. If a QCDR submits a PQRS measure and that measure data is not
deemed comparable to data submitted via other PQRS reporting
mechanisms, the data will not be publicly reported because all data
publicly reported must be comparable to ensure one measure is
evaluating each EP or group in the same way regardless of how the data
were collected and submitted to CMS.
It is expected that non-PQRS measures submitted via QCDRs are
likely to be unique from the available PQRS data. This is considered
one of the greatest benefits of the QCDR data. These measures are
likely to be more specific to specialties otherwise less represented in
PQRS and to be a strong fit for those reporting them. Considering the
measures are relevant to the group or EP they are representing, we
believe this provides a benefit to consumers reviewing the data. We
appreciate that not all groups or EPs may have the opportunity to
participate in a QCDR, but we see significant value in making the data
that are now accessible available for public reporting for these
reasons. Again, as with all data under consideration for public
reporting, consumer testing will be done to ensure measures included on
Physician Compare are accurately interpreted and deemed valuable by
consumers.
Understanding the value of these data, the opportunity for these
data to fill gaps currently in the PQRS program, and the relevancy of
these data to many specialties, we are finalizing this proposal to make
group practice and individual EP level QCDR data, both PQRS and non-
PQRS measures, available for public reporting on Physician Compare
annually, including making 2016 data available for public reporting in
late 2017.
Each QCDR will be required to declare during its self-nomination if
it plans to post data on its own Web site and allow Physician Compare
to link to it or if the QDCR plans to provide data to us for public
reporting on Physician Compare. After a QCDR declares a public
reporting method, that decision is final for the reporting year. If a
declaration is not made, the data will be considered available for
public reporting on Physician Compare.
f. Benchmarking
We previously proposed (79 FR 40389) a benchmark that aligned with
the Shared Savings Program ACO benchmark methodology finalized in the
November 2011 Shared Savings Program final rule (76 FR 67898) and
amended in the CY 2014 PFS final rule with comment period (78 FR
74759). Benchmarks are important to ensuring that the quality data
published on Physician Compare are accurately understood. A benchmark
will allow consumers to more easily evaluate the information published
by providing a point of comparison between groups and between
individuals. However, given shortcomings when trying to apply the
Shared Savings Program methodology to the group practice or individual
EP setting, this proposal was not finalized. We noted we would discuss
more thoroughly potential benchmarking methodologies with our
stakeholders and evaluate other programs' methodologies to identify the
best possible option for a benchmark for Physician Compare (79 FR
67772). To accomplish this, we reached out to stakeholders, including
specialty societies, consumer advocacy groups, physicians and other
health care professionals, measure experts, and quality measure
specialists, as well as other CMS Quality Programs. Based on this
outreach and the recommendation of our TEP, we proposed (80 FR 41812-
41813) to publicly report on Physician Compare an item, or measure-
level, benchmark derived using the Achievable Benchmark of Care
(ABCTM) \7\ methodology annually based on the PQRS
performance rates most recently available. For instance, in 2017 we
would publicly report a benchmark derived from the 2016 PQRS
performance rates. The specific measures the benchmark would be derived
for would be determined once
[[Page 71127]]
the data are available and analyzed. We proposed the benchmark would
only be applied to those measures deemed valid and reliable and that
are reported by enough EPs or group practices to produce a valid result
(see 79 FR 67764 through 79 FR 67765 for a more detailed discussion
regarding the types of analysis done to ensure data are suitable for
public reporting).
---------------------------------------------------------------------------
\7\ Kiefe CI, Weissman NW, Allison JJ, Farmer R, Weaver M,
Williams OD. Identifying achievable benchmarks of care: Concepts and
methodology. International Journal of Quality Health Care. 1998 Oct;
10(5):443-7.
---------------------------------------------------------------------------
As explained, ABCTM is a well-tested, data-driven
methodology that allows us to account for all of the data collected for
a quality measure, evaluate who the top performers are, and then use
that to set a point of comparison for all of those groups or individual
EPs who report the measure.
ABCTM starts with the pared-mean, which is the mean of
the best performers on a given measure for at least 10 percent of the
patient population--not the population of reporters. To find the pared-
mean, we will rank order physicians or groups (as appropriate per the
measure being evaluated) in order from highest to lowest performance
score. We will then subset the list by taking the best performers
moving down from best to worst until we have selected enough reporters
to represent 10 percent of all patients in the denominator across all
reporters for that measure.
We proposed to derive the benchmark by calculating the total number
of patients in the highest scoring subset receiving the intervention or
the desired level of care, or achieving the desired outcome, and
dividing this number by the total number of patients that were measured
by the top performing doctors. This would produce a benchmark that
represents the best care provided to the top 10 percent of patients.
An Example: A doctor reports which of her patients with diabetes
have maintained their blood pressure at a healthy level. There are four
steps to establishing the benchmark for this measure.
(1) We look at the total number of patients with diabetes for all
doctors who reported this diabetes measure.
(2) We rank doctors that reported this diabetes measure from
highest performance score to lowest performance score to identify the
set of top doctors who treated at least 10 percent of the total number
of patients with diabetes.
(3) We count how many of the patients with diabetes who were
treated by the top doctors also had blood pressure at a healthy level.
(4) This number is divided by the total number of patients with
diabetes who were treated by the top doctors, producing the
ABCTM benchmark.
To account for low denominators, ABCTM calls for the
calculation of an adjusted performance fraction (AFP), a Bayesian
Estimator. The AFP is calculated by dividing the actual number of
patients receiving the intervention or the desired level of care plus 1
by the total number of patients in the total sample plus 2. This
ensures that very small sample sizes do not over influence the
benchmark and allows all data to be included in the benchmark
calculation. To ensure that a sufficient number of cases are included
by mean performance percent, ABCTM provides a minimum
sufficient denominator (MSD) for each performance level. Together this
ensures that all cases are appropriately accounted for and adequately
figured in to the benchmark.
The ABCTM methodology for a publicly reported benchmark
on Physician Compare would be based on the current year's data, so the
benchmark would be appropriate regardless of the unique circumstances
of data collection or the measures available in a given reporting year.
We also proposed (80 FR 41813) to use the ABCTM methodology
to generate a benchmark which could be used to systematically assign
stars for the Physician Compare 5 star rating. ABCTM has
been historically well received by the health care professionals and
entities it is measuring because the benchmark represents quality while
being both realistic and achievable; it encourages continuous quality
improvement; and, it is shown to lead to improved quality of
care.8 9 10
---------------------------------------------------------------------------
\8\ Kiefe CI, Weissman NW, Allison JJ, Farmer R, Weaver M,
Williams OD. Identifying achievable benchmarks of care: concepts and
methodology. International Journal of Quality Health Care. 1998 Oct;
10(5):443-7.
\9\ Kiefe CI, Allison JJ, Williams O, Person SD, Weaver MT,
Weissman NW. Improving Quality Improvement Using Achievable
Benchmarks for Physician Feedback: A Randomized Controlled Trial.
JAMA. 2001; 285(22):2871-2879.
\10\ Wessell AM, Liszka HA, Nietert PJ, Jenkins RG, Nemeth LS,
Ornstein S. Achievable benchmarks of care for primary care quality
indicators in a practice-based research network. American Journal of
Medical Quality 2008 Jan-Feb; 23(1):39-46.
---------------------------------------------------------------------------
To summarize, we proposed to publicly report on Physician Compare
an item or measure-level benchmark derived using the Achievable
Benchmark of Care (ABCTM) methodology annually based on the
PQRS performance rates most recently available (that is, in 2017 we
would publicly report a benchmark derived from the 2016 PQRS
performance rates), and use this benchmark to systematically assign
stars for the Physician Compare 5 star rating. We solicited comments on
this proposal.
The following is a summary of the comments we received on our
proposal to publicly report on Physician Compare an item, or measure-
level, benchmark derived using the Achievable Benchmark of Care
(ABCTM) methodology annually based on the PQRS performance
rates most recently available.
Comment: Many commenters supported the use of benchmarks to help
consumers make informed health care decisions and specifically the
proposed ABCTM methodology, noting this is a valuable and
useful tool for consumers and a valid and reliable way to approach a
benchmark and star ratings. However, some commenters stated it was too
soon to publicly report a benchmark and suggested phasing in or testing
and sharing the benchmark privately with EPs and group practices for
internal improvement first prior to making the benchmark publicly
available. Some commenters asked for up to 2 years of internal use
prior to public reporting. Other commenters would like CMS to wait to
apply a benchmark until MIPS is implemented in order to understand how
the methodology would be applied in the context of MIPS.
Some commenters noted concern that measures are currently not risk-
adjusted and that the proposed methodology may not be appropriate for
all measures. Multiple commenters, both those who support and do not
support the specific proposal, noted concerns about the need to
stratify any benchmark developed by specialty, stratify by reporting
mechanism, and risk-adjust the benchmark. Some commenters urged CMS to
educate physicians and consumers on the benchmark methodology. Several
commenters appreciated the stakeholder engagement conducted by the
Physician Compare team regarding the benchmark methodology selection
and encouraged continued engagement in the future.
Several commenters also asked for clarification on how the pared-
mean was determined and how this method can be applied to both process
measures and outcome measures. Some commenters suggested increasing the
pared-mean to 25 percent and commenters suggested other benchmark
methodologies, including an approach that recognizes self-improvement
over time and peer-to-peer performance. One commenter asked for the
opportunity to review the database and provide a clear demonstration of
the benchmark's validity. Additional commenters noted that benchmarks
using the ABCTM methodology is too complex and will be
difficult for consumers to understand,
[[Page 71128]]
and encouraged consumer testing to remedy this potential problem.
Several commenters urged CMS to use consistent benchmarking across its
programs to promote consistency and minimize confusion. Several
commenters urged CMS to allow QCDRs to determine their own benchmark
approach.
Response: We are particularly appreciative of the collaborative
effort of the many stakeholders who took the initiative to participate
in the stakeholder outreach process conducted to determine a suitable
benchmark methodology to propose for public reporting on Physician
Compare. We look forward to continuing this collaborative approach. We
also appreciate the concerns raised. Although we see the reasons why
some commenters would first like the benchmark to be viewed privately,
we reiterate the significant value in adding a benchmark to Physician
Compare now. Consumers need tools to best understand the data and to
make accurate and appropriate comparisons. A benchmark such as this can
provide this valuable tool. We are committed to continually working to
make the information on Physician Compare as easy to understand and
consumer friendly as possible, and adding a benchmark is a critical
next step in this process.
Regarding the commenters' concerns about risk adjustment, we agree
that risk adjustment will become increasingly important as we move to
more outcome measures, specifically at the individual EP level. We
actively encourage measure developers to produce measures that are risk
adjusted. We believe that it is most appropriate to approach risk
adjustment at the measure development level versus trying to adjust
after the fact at the benchmarking stage, especially when data are
submitted via reporting mechanisms that do not provide the necessary
information to risk adjust after data collection is complete. We will
continue to conduct analyses to ensure all data, including the
benchmarks, meet the stated public reporting criteria, and therefore,
are showing variation in performance and not in other factors, such as
region or population of care.
Regarding stratifying the benchmark, one consideration is the
negative effect of over-stratification. At this stage in public
reporting, looking to stratify by too many criteria can lead to data
groupings so small that there can be no meaningful or statistically
relevant comparisons made. Also, it is important to remember that
searches on Physician Compare are conducted by location and specialty.
In this way, when a consumer is evaluating data on the Physician
Compare Web site, they are generally looking at health care
professionals in the same location practicing in similar or the same
specialties. Understanding the limitations to stratifying at this time,
there is one stratification consideration that we believe is not only
valuable but necessary as we work to ensure data included on the Web
site are comparable.
We are in favor of stratifying by reporting mechanism at this time,
which would mean creating a benchmark by measure by reporting
mechanism. This would help remove the complexity and potential
differences between the same measure collected via multiple reporting
mechanisms and help solve some of the concerns raised about the
available PQRS data. It would also remove the burden of interpretation
across mechanisms from consumers. It is important to note that this
benchmark proposal does only apply to PQRS data. QCDRs are free to
develop their own benchmark methodology and submit their methodology
and benchmark rates to Physician Compare for public reporting
consideration for non-PQRS measures when and where appropriate.
One of the benefits of the ABCTM methodology is that it
has been tested in a number of scenarios and the pared-mean has been
found to be statistically reliable, valid, and accurate when producing
a truly achievable benchmark that can be used to measure and improve
quality performance. We appreciate the recommendation to look at a
pared-mean that includes more than the top 10 percent of patients
served by the top performers. However, we believe that increasing this
percentage is likely to dilute the benchmark and overstate quality
performance on a given measure. That said, we are conducting ongoing
testing evaluating this methodology as applied to the available PQRS
data, and we will actively reach out to stakeholders to share
information about the results of this statistical analysis, as well as
ongoing consumer testing, to ensure stakeholders are aware of the
specific application of the benchmark and the reliability, validity,
and accuracy of the benchmark for the available PQRS process and
outcome measures. We will use the most current data to ensure the
benchmark is the best measure of timely quality care. Therefore,
additional specifics about the application of the benchmark in terms of
the specific star attribution, including but not limited to statistical
analysis of the 2016 data, star display, and consumer testing, will
depend on data that have not been collected yet. We will provide this
information as it is available but in advance of publicly reporting the
benchmark. It is important to note that initial consumer testing
indicated an ABCTM derived benchmark could be well received
and understood by consumers on Physician Compare.
We do appreciate the comments that requested that CMS evaluate
using a consistent benchmark methodology across programs. We are
continually evaluating ways to align where and as possible, and will
take this recommendation into consideration for the future. One benefit
of the ABCTM methodology is that it is potentially
applicable across care settings and measure types.
After considering the comments and stakeholder and expert feedback,
as well as testing conducted to date, and for the reasons we noted, we
are finalizing our proposal to publicly report on Physician Compare an
item, or measure-level, benchmark derived using the ABCTM
methodology annually based on the PQRS performance rates most recently
available stratified by reporting mechanism for both group practice and
individual EP level measures.
In addition to receiving comments about using the ABCTM
methodology to derive the benchmark, we also received comments on our
proposal to use the ABCTM derived benchmark to
systematically assign stars for the Physician Compare 5 star rating.
The following is a summary of these comments.
Comment: Several commenters supported the systematic assigning of a
star rating based on the proposed benchmark methodology. Other
commenters opposed star ratings, generally, noting that they are
concerned such ratings oversimplify performance data. These commenters
also raised concerns that disparate quality scores could result in
inappropriate distinctions of quality for physicians whose performance
scores are not statistically different. Several commenters asked for
additional details on how the stars will be assigned and urged CMS to
provide clear explanations to the public about how to interpret the
star ratings.
Response: We are committed to moving to a star rating system on
Physician Compare as this is a consumer friendly way to share such
complex information as the quality measure data being made available.
As with all information available for public reporting on Physician
Compare, the benchmark information and the resulting star ratings need
to meet the public reporting standards of statistically valid,
accurate, reliable, and
[[Page 71129]]
comparable data. The goal of using a benchmark such as one derived from
the ABCTM methodology is to have a star rating system that
distinguishes statistically significant quality differences. Using this
methodology can help us ensure that five star performance is
statistically different than four star performance, etc. As noted in
this section, additional details based on ongoing analysis with the
most recently available data will be shared with stakeholders. In
addition, information about how stars will be specifically assigned
using the ABCTM methodology, star display, and plain
language will be shared when the relevant data are available. Finally,
we will continue to work to ensure that the star rating system used is
accurately understood and interpreted by consumers. Consumer testing is
therefore ongoing.
Understanding the value of a star rating system for consumers, we
are finalizing our proposal to use the ABCTM derived
benchmark to systematically assign stars for the Physician Compare 5
star rating.
g. Patient Experience of Care Measures
In the CY 2015 PFS final rule with comment period (79 FR 67547), we
adopted a policy to publicly report patient experience data for all
group practices of two or more EPs. Consumer testing shows that other
patients' assessments of their experience resonate with consumers
because it is important to them to hear about positive and negative
experiences others have with physicians and other health care
professionals. As a result, these patient experience data help them
make an informed health care decision. Understanding the value
consumers place on patient experience data and our commitment to
reporting these data on Physician Compare, we proposed (80 FR 41813) to
continue to make available for public reporting all patient experience
data for all group practices of two or more EPs, who meet the specified
sample size requirements and collect data via a CMS-specified certified
CAHPS vendor, annually in the year following the year the measures are
reported (for example, 2016 CAHPS for PQRS reported data will be
included on the Web site in 2017). The patient experience data
available that we proposed to make available for public reporting are
the CAHPS for PQRS measures, which include the CG-CAHPS core measures.
For group practices, we proposed to annually make available for public
reporting a representation of the top box performance rate \11\ for
these 12 summary survey measures:
---------------------------------------------------------------------------
\11\ Top Box score refers to the most favorable response
category for a given measure. If the measure has a scale of
``always,'' ``sometimes,'' ``never,'' the Top Box score is
``always'' if this represents the most favorable response. For the
CAHPS for PQRS doctor rating, the Top Box score is a rating of 9 or
10.
---------------------------------------------------------------------------
Getting Timely Care, Appointments, and Information.
How Well Providers Communicate.
Patient's Rating of Provider.
Access to Specialists.
Health Promotion & Education.
Shared Decision Making.
Health Status/Functional Status.
Courteous and Helpful Office Staff.
Care Coordination.
Between Visit Communication.
Helping You to Take Medication as Directed.
Stewardship of Patient Resources.
We solicited comments on this proposal.
The following is a summary of the comments we received on our
proposal to publicly report CAHPS for PQRS data for group practices of
2 or more EPs that meet all stated public reporting criteria.
Comment: Many commenters supported expanding public reporting of
CAHPS for PQRS measures, noting that patient experience data is highly
relevant to consumers. Commenters stated that other patients'
assessments of their experience with a given group practice or health
care professional are no doubt helpful in the health care decision
making process. Some commenters supported including a benchmark for the
CAHPS summary measures. Several commenters also urge CMS to collect and
report individual EP level patient experience data. Some commenters
opposed the proposal, citing concerns around consumer interpretation of
patient reported data and that these data may not capture patient
experience related to all specialties, such as hospitalists, other
hospital-based professionals, and surgical practices. One commenter had
concerns with the ``Stewardship of Patient Resources'' measure because
the measure does not address the numerous barriers to patients
accessing to care. Several commenters supported adding other types of
patient experience data to Physician Compare, including Surgical
CAHPS[supreg] and experience data collected via other sources. Another
commenter suggested reporting patient experience data for primary care
physicians and only clinical quality performance for specialists.
Response: We agree that these patient experience data are very
valuable to consumers, and as noted, consumer testing has consistently
shown that these measures aid decision making and are wanted by
consumers. Consumer testing has also shown that these measures are
generally well understood and accurately interpreted by consumers.
CAHPS measures are extensively tested and proven to be statistically
valid. We are confident these measures are an appropriate and
statistically relevant indicator of patient satisfaction.
We do appreciate the comments regarding other types of patient
experience data, as well as the inclusion of a CAHPS benchmark, and
will consider these recommendations for the future. We do understand
that not all measures under consideration for public reporting equally
apply to all types of professionals included on Physician Compare.
However, we do believe that the CAHPS for PQRS measures apply to the
large majority of professionals currently represented on the site. We
also appreciate the request for CAHPS for PQRS measures at the
individual EP level. This is something consumers have also requested in
testing. Unfortunately, at this time, CAHPS for PQRS measures are only
available and tested at the group practice level.
Again, as with all measures available for inclusion on Physician
Compare, the measures must meet the stated public reporting standards.
Any concerns about specific measures are reviewed against these
criteria prior to consideration for public reporting.
After considering the comments received and given that CAHPS for
PQRS data are highly valued by consumers, we are finalizing our
proposal to make all twelve summary survey CAHPS for PQRS measures
available for public reporting on Physician Compare annually for groups
of 2 or more EPs reporting via a CMS certified CAHPS vendor.
h. Downloadable Database
(a) Addition of VM Information
To further aid in transparency, we also proposed (80 FR 41813-
41814) to add new data elements to the Physician Compare downloadable
database at https://data.medicare.gov/data/physician-compare.
Currently, the downloadable database includes all quality information
publicly reported on Physician Compare, including quality program
participation. In addition, the downloadable database includes all
measures submitted and reviewed and found to be statistically valid and
reliable. We proposed (80 FR 41813) to add to the Physician Compare
downloadable database for group
[[Page 71130]]
practices and individual EPs the 2018 VM quality tiers for cost and
quality, based on the 2016 data, noting if the group practice or EP is
high, low, or average on cost and quality per the VM. We also proposed
(80 FR 41813) to include a notation of the payment adjustment received
based on the cost and quality tiers, and an indication if the
individual EP or group practice was eligible to but did not report
quality measures to CMS. The profile pages on Physician Compare are
meant to provide information to average Medicare consumers that can
help them identify quality health care and choose a quality clinician,
while this database is geared toward health care professionals,
industry analysts, and researchers who are familiar with more complex
data. Therefore, adding this information to the downloadable database
promotes transparency and provides useful data to the public while we
conduct consumer testing to ensure VM data can be packaged and
explained in such a way that it is accurately interpreted, understood,
and useful to average consumers. We solicited comments on this
proposal.
The following is a summary of the comments we received on our
proposal to include this additional VM data to the Physician Compare
downloadable database.
Comment: Several commenters expressed significant concerns about
adding this VM data to the Physician Compare downloadable database for
group practices and individual EPs because the VM is not well-
understood by the public, and is perceived as not providing value to
the consumer or accurately portraying quality and cost. One commenter
noted that consumers can still access this data in the downloadable
database. Several commenters were concerned that this data could be
misused by researchers or media. One commenter suggested that VM
information should be shared with specialty societies rather than
publicly reported. Many commenters were also opposed to this proposal
due to concerns with the VM calculation methodology and the portion of
group practices and health care professionals that will receive
``average'' scores for the cost and/or quality composite. One commenter
urged CMS to put in place a 30-day period for EPs and group practices
to review any VM information that will be added to the downloadable
database. Conversely, several commenters supported adding VM
information to the downloadable database, noting that it promotes
transparency and provides useful data to the public. Some commenters
also noted that these data support research and generate further
learnings about the VM methodology.
Response: We do understand the concerns raised about making VM data
publicly available. Our experience shows that average consumers are not
the primary audience for the downloadable database. In fact, testing
has shown that most average consumers do not want or believe they know
what to do with that level of detailed data. Therefore, we are not
concerned that adding these data to the downloadable database will
disadvantage consumers. We do appreciate that these or any data
provided in the downloadable database could be misused. However, we do
believe that the benefits of transparency and potential learnings for
health care professionals, specialty societies, researchers, and other
stakeholders, as noted by some commenters, outweigh these concerns. As
noted by commenters, making these data available to the informed public
could lead to improvements in the methodology and greater understanding
of cost and quality. Regarding the request for these data to be made
available for preview, we do not currently provide a preview period for
the downloadable database, but the cost and quality scores included
will match those provided in existing feedback reports. These reports
are generally made available for private review more than 30 days prior
to publicly reporting the data on Physician Compare.
As a result of our commitment to increased transparency and the
other reasons we noted, and after considering the public comments, we
are finalizing this proposal to add cost and quality tier, as well as
adjustment, information to the Physician Compare downloadable database
for the 2018 VM based on 2016 quality and cost data.
(b) Addition of Utilization Data
In addition, we proposed (80 FR 4183-4184) to add utilization data
to the Physician Compare downloadable database. Utilization data is
information generated from Medicare Part B claims on services and
procedures provided to Medicare beneficiaries by physicians and other
health care professionals; and are currently available at http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Physician-and-Other-Supplier.html. It provides counts of services and procedures rendered
by health care professionals by Health care Common Procedure Coding
System (HCPCS) code. Under section 104(e) of the Medicare Access and
CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April
16, 2015), beginning with 2016, the Secretary shall integrate
utilization data information on Physician Compare. This section of the
law discusses data that can help empower people enrolled in Medicare by
providing access to information about physician services. These data
are very useful to the health care industry and to health care
researchers and other stakeholders who can accurately interpret these
data and use them in meaningful analysis. These data are less
immediately useable in their raw form by the average Medicare consumer.
As a result, we proposed that the data be added to the downloadable
database versus the consumer-focused Web site profile pages. Including
these data in the Physician Compare downloadable database provides
transparency without taking away from the information of most use to
consumers on the main Web site. We solicited comments on this proposal.
The following is a summary of the comments we received on our
proposal to include utilization data in the Physician Compare
downloadable database.
Comment: Some commenters supported the addition of utilization data
to the public downloadable database, noting that these data support
transparency and may be useful to researchers for analysis. They do
however note that these data are not intended for the average Medicare
consumer. Several commenters expressed concern with the accuracy of
these data and the potential for misinterpretation or misuse of the
data. Some commenters request that these data include disclaimers about
the limitations of utilization data and request that physicians be
allowed to submit corrections where the data are inaccurate or
outdated. Several commenters also felt that utilization data are not
only not intended for consumer use but do not align with Physician
Compare's goals. Some commenters noted that utilization data are
already available on a different CMS Web site. One commenter suggested
developing a profile based on patient characteristics from the data.
Another commenter requests safeguards or summary conclusions from the
claims data that would be meaningful for consumers. One commenter urged
CMS to limit the release of these data to professional societies and
work to determine the most appropriate use.
Response: We agree that these data are not intended for or well
understood by the average Medicare consumer. This has been illustrated
in consumer testing
[[Page 71131]]
to date. Again, it is important to note that consumers are not a
primary audience for the downloadable data file. These data are
potentially of great value to many stakeholders. The data are already
public on another CMS Web site, as mentioned, but including them with
the other Physician Compare data could help provide useful context that
could better ensure more appropriate use of the data. As noted above,
all data shared publicly could potentially be misused. But, again, we
believe the benefits of transparency outweigh these concerns and we
will work to determine the best method for displaying the data. We
appreciate the recommendations for alternative ways to use or include
these data on the consumer-facing site or ways additional context could
be added to these data. We will review these recommendations for the
future.
Given that section 104(e) of MACRA mandates integration of these
data on Physician Compare and because we believe that adding these data
to the downloadable database advances our transparency goals, we are
finalizing our proposal to include utilization data in the Physician
Compare downloadable database. Not all available data will be included.
The specific HCPCS codes included will be determined based on analysis
of the available data, focusing on the most used codes. Additional
details about the specific HCPCS codes that will be included in the
downloadable database will be provided to stakeholders.
(i) Board Certification
Finally, we proposed (80 FR 41813) adding additional Board
Certification information to the Physician Compare Web site. Board
Certification is the process of reviewing and certifying the
qualifications of a physician or other health care professional by a
board of specialists in the relevant field. We currently include
American Board of Medical Specialties (ABMS) data as part of individual
EP profiles on Physician Compare. We appreciate that there are
additional, well respected boards that are not included in the ABMS
data currently available on Physician Compare that represent EPs and
specialties represented on the Web site. Such board certification
information is of interest to consumers as it provides additional
information to use to evaluate and distinguish between EPs on the Web
site, which can help in making an informed health care decision. The
more data of immediate interest that is included on Physician Compare,
the more users will come to the Web site and find quality data that can
help them make informed decisions. Specifically, we proposed to add to
the Web site board certification information from the American Board of
Optometry (ABO) and American Osteopathic Association (AOA). Please note
we are not endorsing any particular boards. These two specific boards
showed interest in being added to the Web site and have demonstrated
that they have the data to facilitate inclusion of this information on
the Web site. These two boards also fill a gap, as the ABMS does not
certify Optometrists and only certain types of DOs are covered by ABMS
Osteopathic certification. In general, we reviewed interest from boards
as it was brought to our attention, and if the necessary data were
available and appropriate arrangements and agreements could be made to
share the needed information with Physician Compare, additional board
information could be added to the Web site in future. At this time,
however, we specifically proposed to include ABO and AOA Board
Certification information on Physician Compare. We solicited comments
on this proposal.
The following is a summary of the comments we received on our
proposal to adding additional Board Certification information to
Physician Compare, specifically adding ABO and AOA Certification.
Comment: Commenters supported adding ABO and AOA Board
Certification to Physician Compare. One commenter recommended that the
name of the certifying board be included on the site so it is clear
whether the certificate is issued by an ABMS Member Board or another
board. Another commenter urged CMS to consider multiple certifications
within a specialty and to develop a tool for Medicare beneficiaries and
other health care consumers to view a comparison of the multiple
certifications on the site. Several commenters requested the addition
of other boards, including the American Board of Audiology (ABA), a
Certificate of Clinical Competence in Audiology (CCC-A), American Board
of Physician Specialties (ABPS), American Board of Physical Therapy
Specialties (ABPTS), ASHA Certificate of Clinical Competence in Speech-
Language Pathology (CCC-SLP), Board Certified Specialist in Child
Language and Language Disorders, Board Certified Specialist in Fluency
and Fluency Disorders, Board Certified Specialist in Swallowing and
Swallowing Disorders, and Board Certified Specialist in Intraoperative
Monitoring from ASHA. One commenter noted that there is no category for
specialized certifications for professionals other than physicians on
Physician Compare and requested the opportunity to provide input should
such a category be under consideration. Another commenter requested
that the site include information about hospitalists who choose to
pursue a Focused Practice in Hospital Medicine (FPHM) Maintenance of
Certification (MOC).
Response: We particularly appreciate the many suggestions provided
for additional Boards to consider for inclusion on the Web site and for
additional suggestions regarding how to display this information on the
Web site. We also appreciate the comment regarding the need to evaluate
including information for EPs beyond physicians. All of these
recommendations will be taken under consideration for the future to
evaluate if they are feasible and/or considered a value added through
consumer testing. For those Boards that have specifically requested
being considered for inclusion on the Web site, we will work with each
Board to assess if the Board has the data available and comparable
information needed to include the Certification information on the Web
site and consider whether such boards would be appropriate for
consideration in future rulemaking.
As a result of the overall support for adding additional Board
Certification information to Physician Compare and for the reasons we
specified above, we are finalizing our proposal to add this
specifically ABO and AOA Board Certification information.
Table 26 summarizes the Physician Compare measure and participation
data proposals finalized in this final rule.
[[Page 71132]]
Table 26--Summary of Measure and Participation Data Finalized for Public Reporting
----------------------------------------------------------------------------------------------------------------
Quality measures and
Data collection year Publication year * Data type Reporting mechanism data finalized for
* public reporting
----------------------------------------------------------------------------------------------------------------
2016................. 2017................. PQRS, PQRS GPRO, Web Interface, EHR, Include an indicator for
EHR, and Million Registry, Claims. satisfactory reporters
Hearts. under PQRS,
participants in the EHR
Incentive Program, and
EPs who satisfactorily
report the
Cardiovascular
Prevention measures
group under PQRS in
support of Million
Hearts.
2016................. 2017................. PQRS GPRO.......... Web Interface, EHR, All PQRS GPRO measures
Registry. reported via the Web
Interface, EHR, and
registry that are
available for public
reporting for group
practices of 2 or more
EPs.
Publicly report an item-
level benchmark, as
appropriate.
2016................. 2017................. ACO................ Web Interface, All measures reported by
Survey Vendor Shared Savings Program
Claims. ACOs, including CAHPS
for ACOs.
2016................. 2017................. CAHPS for PQRS..... CMS-Specified All CAHPS for PQRS
Certified CAHPS measures for groups of
Vendor. 2 or more EPs who meet
the specified sample
size requirements and
collect data via a CMS-
specified certified
CAHPS vendor.
2016................. 2017................. PQRS............... Registry, EHR, or All PQRS measures for
Claims. individual EPs
collected through a
registry, EHR, or
claims.
Publicly report an item-
level benchmark, as
appropriate.
2016................. 2017................. QCDR data.......... QCDR............... All individual EP and
group practice QCDR
measures.
2016................. 2017................. Utilization data... Claims............. Utilization data for
individual EPs in the
downloadable database.
2016................. 2017................. PQRS, PQRS GPRO.... Web Interface, EHR, The following data for
Registry, Claims. group practices and
individual EPs in the
downloadable database:
The VM quality
tiers for cost and
quality, noting if the
group practice or EP is
high, low, or neutral
on cost and quality per
the VM.
A notation of
the payment adjustment
received based on the
cost and quality tiers.
An indication if the
individual EP or group
practice was eligible
to but did not report
quality measures to
CMS.
----------------------------------------------------------------------------------------------------------------
* Note that these data are finalized to be reported annually. The table only provides the first year in which
these data would begin on an annual basis, and such dates also serve to illustrate the data collection year in
relation to the publication year. Therefore, after 2016, 2017 data would be publicly reported in 2018, 2018
data would be publicly reported in 2019, etc.
4. Public Comment Solicited on Issues for Possible Future Rulemaking
a. Quality Measures
In addition to the proposals we made in the proposed rule, we
solicited comment on several new data elements for possible inclusion
on the individual EP and group profile pages of Physician Compare
through future rulemaking. In future years, we will consider expanding
public reporting to include additional quality measures. We know there
are gaps in the measures currently available for public reporting on
Physician Compare. Understanding this, we stated that we would like to
hear from stakeholders about the types of quality measures that will
help us fill these gaps and meet the needs of consumers and
stakeholders. Therefore, we sought comment on potential measures that
would benefit future public reporting on Physician Compare. We are
working to identify possible data sources and we sought comment on the
measure concepts, as well as potential specific measures of interest.
The quality measures that would be considered for future posting on
Physician Compare are those that have been comprehensively vetted and
tested, and are trusted by the physician community.
The following is a summary of the comments we received on our
request for comment on future quality measure needs.
Comment: We received comments on potential measures to report on
Physician Compare in the future. Commenters supported including outcome
measures, including clinical outcomes and patient-reported outcomes.
One commenter noted that outcome measures must include a risk
adjustment methodology. Other commenters supported patient safety, care
coordination, cross-cutting, and patient and family experience of care
measures. Commenters suggested specialty specific measures, including
audiology, urology, and neurology measures. One commenter recommended
the continued partnership with the professional associations,
contractors, and CMS for future measure determination, and noted that
measures used for Physician Compare should be included in the proposed
rule for public comment. One commenter suggested measures for
appropriate access to the health care professional/group practice
offices, culturally and linguistically competent services including
successful trainings attended, availability of appropriate
transportation with equipment, geriatrics specialty/training, patient
experience measures with qualitative data, and patient reported
measures, including ones that capture patient activation. One commenter
suggested a common set of EP level performance measures that would
apply across all payment programs, and another urged CMS to incorporate
the Core Quality Measures Collaborative's aligned
[[Page 71133]]
measure sets. One commenter opposed the future public reporting of
performance information for any quality measures that are not reported
under federally required quality reporting programs.
Response: We will review all comments and consider these
suggestions for possible future rulemaking.
b. Medicare Advantage
We also sought comment on adding Medicare Advantage information to
Physician Compare individual EP and group practice profile pages.
Specifically, we sought comment on adding information on the relevant
EP and group practice profile pages about which Medicare Advantage
health plans the EP or group accepts and making this information a link
to more information about that plan on the Medicare.gov Plan Finder Web
site. An increasing number of Medicare clinicians provide services via
Medicare Advantage. Medicare Advantage quality data is reported via
Plan Finder at the plan level. As a result, physicians and other health
care professionals who participate in Medicare Advantage do not have
quality measure data available for public reporting on Physician
Compare. Adding a link between Physician Compare clinicians
participating in Medicare Advantage plans and the associated quality
data available for those plans on Plan Finder could help ensure that
consumers have access to all of the quality data available to make an
informed health care decision.
The following is a summary of the comments we received on our
request about possibly integrating Medicare Advantage information with
Physician Compare information in the future.
Comment: Several commenters supported adding Medicare Advantage
information to the Physician Compare individual EP and group practice
profile pages, noting that it would further assist consumers with
health care decision making and fill a current gap in the available
data. One commenter noted that certain services are provided outside of
the scope of benefits under traditional FFS Medicare, so it is critical
that Physician Compare incorporate the full scope of performance.
However, many commenters opposed adding Medicare Advantage data due
to concerns with data accuracy and comparison to FFS quality data. One
commenter suggested alignment of physician and physician group quality
measures across traditional FFS Medicare, Medicare ACOs, and Medicare
Advantage. Another commenter asked where information on Medicare
Advantage professionals would be obtained and how often the database
would be updated. Commenters were concerned that adding Medicare
Advantage data to Physician Compare would be complicated and difficult
for both consumers and health care professionals to understand. One
commenter asked for additional information on how this information
would be messaged to the consumer.
Response: We appreciate that there are many health care
professionals providing services through Medicare Advantage, and
consumers have regularly indicated an interest in knowing which
Medicare Advantage plans, if any, health care professionals on
Physician Compare are associated. However, we also appreciate the
concerns raised regarding data access and the technical concerns
regarding the ability to appropriately link to Plan Finder. We will
further evaluate all of the information shared and questions asked
concerning the inclusion of Medicare Advantage data, and we will
consider these issues for potential future rulemaking.
c. Value Modifier
We also sought comment on including additional VM cost and quality
data on Physician Compare. Specifically, we sought comment on including
in future years an indicator for a downward and neutral VM adjustment
on group practice and individual EP profile pages. We also sought
comment on including the VM quality composite or other VM quality
performance data on Physician Compare group practice and individual EP
profile pages and/or the Physician Compare downloadable database.
Similarly, we sought comment on including the VM cost composite or
other VM cost measure data on Physician Compare group practice and
individual EP profile pages and/or the downloadable database. These VM
quality and cost measures ultimately help determine the payment
adjustment and are an indication of whether the individual or group is
meeting the Affordable Care Act goals of improving quality while
lowering cost. Specifically, including this cost data is consistent
with the section 10331(a)(2) of the Affordable Care Act as it is an
assessment of efficiency. However, these data are complex and we needed
time to establish the best method for public reporting and to ensure
this information is accurately understood and interpreted by consumers.
Therefore, we only sought comment at this time.
The following is a summary of the comments we received regarding
potentially including additional VM information on Physician Compare in
the future.
Comment: A few commenters supported potentially including an
indicator of downward and neutral adjustments under the VM on physician
profile pages in the future. Several commenters opposed including
additional VM data on profile pages because of concerns around the
current VM methodology, the complexity of the program, and concerns
about the meaningfulness of the cost and quality composite scores to
consumers. One commenter noted that the VM cost and quality composites
will be of limited future utility due to the movement towards MIPS.
Response: As noted above, we appreciate the concerns raised about
sharing VM data with consumers, and we acknowledge that the payment
adjustment under the VM end after CY 2018. We will further review all
comments and suggestions regarding this data and consider for potential
future rulemaking.
d. Open Payments Data
We currently make Open Payments data available at http://www.cms.gov/openpayments/. Consumer testing has indicated that these
data are of great interest to consumers. Consumers have indicated that
this level of transparency is important to them and access to this
information on Physician Compare increases their ability to find and
evaluate the information. We sought comment about including Open
Payments data on individual EP profile pages. Although these data are
already publicly available, consumer testing has also indicated that
additional context, wording, and data display considerations can help
consumers better understand the information. We sought comment on
adding these data to Physician Compare, to the extent it is feasible
and appropriate. Prior to considering a formal proposal, we continue to
test these data with consumers to establish the context and framing
needed to best ensure these data are accurately understood and
presented in a way that assists decision making. Therefore, we only
sought comment at this time.
The following is a summary of the comments we received regarding
possible future inclusion of Open Payments data on Physician Compare.
Comment: Commenters both supported and opposed making Open Payments
data available on Physician Compare. Some commenters supported
[[Page 71134]]
public access to Open Payments data, but opposed adding it to Physician
Compare. Some commenters supported linking to the existing Open
Payments Web site, and others noted that the data are already publicly
available so adding these data to Physician Compare is redundant.
Several commenters urged CMS to provide context for the data to ensure
the data are interpreted correctly or to include general information
regarding Open Payments rather than the actual Open Payments data. A
commenter urged CMS should make clear that manufacturers are not
responsible for Physician Compare data and physicians can only log
complaints about Open Payments data through the dispute and correction
process applicable to the Open Payments program. One commenter
suggested establishing additional nature of payment categories for (i)
stock option buy outs and (ii) transfers of value not otherwise covered
by the existing nature of payment categories. Many commenters noted
that Physician Compare serves a different purpose than the Open
Payments Web site and it would be misleading to include this
information on Physician Compare as it is unrelated to the quality of
care. Commenters were also concerned with the accuracy of Open Payments
data.
Response: We understand that Open Payments data are different from
the quality of care data included on Physician Compare, and we
appreciate that these data require context to be fully understood. As
noted, we do continue to test these data with consumers, and we will
take the comments and recommendations provided under consideration and
if appropriate, address in possible future rulemaking.
e. Measure Stratification
Finally, we sought comments on including individual EP and group
practice level quality measure data stratified by race, ethnicity, and
gender on Physician Compare, if feasible and appropriate (that is,
statistically appropriate, etc.). By stratification, we mean that we
would report quality measures for each group of a given category. For
example, if we were to report a measure for blood pressure control
stratified by sex, we would report a performance score for women and
one for men. We also sought comment on potential quality measures,
including composite measures, for future postings on Physician Compare
that could help consumers and stakeholders monitor trends in health
equity. Inclusion of data stratified by race and ethnicity and gender,
as well as the inclusion of other measures of health equity, would help
ensure that HHS is beginning to work to fulfill one of the Affordable
Care Act goals of reporting data on race, ethnicity, sex, primary
language, and disability status through public postings on HHS Web
sites and other dissemination strategies (see section 4302 of the
Affordable Care Act).
The following is a summary of the comments we received about
including individual EP and group practice level quality measure data
stratified by race, ethnicity, and gender on Physician Compare.
Comment: Commenters who supported stratifying measures noted that
this information is important in determining and tracking health
equity, increasing transparency and accountability, and helping
identify and reduce known and persistent health care disparities. Some
commenters also noted this would allow consumers to make informed
choices based on their preferences and give stakeholders valuable
information on gaps and trends in the system based on demographics.
Several commenters suggested including primary language, disability
status, gender identity, and sexual orientation could also add value.
Commenters who opposed stratification noted that consumers may
misinterpret the data. Other concerns included over-diluting the data,
data collection burden, and privacy issues. One commenter noted that it
is not the function of Physician Compare to ``monitor trends in health
equity.'' Another commenter noted that calculation of stratified
quality data would require significant research to ensure that the
information provided was both meaningful and accurate.
Response: As with all items presented for comment only, we will
review the comments and suggestions and consider whether these data
sets are appropriate for inclusion on Physician Compare. Any data
recommended in these areas and found suitable for public disclosure on
Physician Compare would be addressed through separate notice-and-
comment rulemaking.
5. Additional Comments Received
We received additional comments which are summarized and addressed
below.
Comment: Commenters noted that the absence of measure data on
Physician Compare due to limited available or meaningful measures may
mislead consumers. Commenters requested disclaimers be added or
additional education be conducted to explain that there could be the
absence of measure data due to measure limitations and not poor
quality. Some commenters added that these explanations should be in
plain language at a 6th grade reading level. Several commenters
expressed concern with publicly reporting any data until measure
limitations can be analyzed or addressed. A few commenters recommended
language explaining the significance of QCDR reporting.
Response: We understand that the limited availability of PQRS
measures may make it difficult for some specialties to report. We hope
that the introduction of additional measures, such as QCDR measures and
patient experience measures, will help mitigate concerns regarding
quality data availability in the short term. It is important to realize
that most searches on Physician Compare are specialty based. If a given
specialty does not have measures, users will only evaluate physicians
or other health care professionals that do not have measures. This
specialty based search can mitigate some of these concerns. Finally, we
also understand that disclaimers and other types of explanatory
language are necessary to help inform health care consumers as they use
the Web site. We will continue to work to ensure that the language
included on Physician Compare addresses the concerns raised and helps
users understand that there are a number of reasons a physician or
other health care professional may not have quality data on the Web
site. We are continually working to update all language on the Web site
to ensure it is plain language that can be easily understood.
Comment: Several commenters are concerned with the use of
physician-centric language in the proposed rule and on Physician
Compare, noting that the name of the Web site could be more inclusive
of all eligible health care professionals. One commenter suggested
providing information throughout the Web site about the full array of
qualified professionals included on the Web site. One commenter asked
CMS to assure that audiologists are meaningfully represented and can be
easily identified by other professionals and patients.
Response: The name of the site is generally specified in section
10331(a)(1) the Affordable Care Act. Throughout the site we do note
that both physicians and other health care professionals are available
to search and view. If a professional is in approved status in PECOS
and has submitted Medicare FFS claims in their name in the last 12
months, they will be included on Physician Compare. They will be listed
by the specialty or other
[[Page 71135]]
health care professional designation that they enrolled under when
joining Medicare.
I. Physician Payment, Efficiency, and Quality Improvements--Physician
Quality Reporting System
This section contains the requirements for the Physician Quality
Reporting System (PQRS). The PQRS, as set forth in sections 1848(a),
(k), and (m) of the Act, is a quality reporting program that provides
incentive payments (which ended in 2014) and payment adjustments (which
began in 2015) to eligible professionals (EPs) and group practices
based on whether they satisfactorily report data on quality measures
for covered professional services furnished during a specified
reporting period or to individual EPs based on whether they
satisfactorily participate in a qualified clinical data registry
(QCDR). Please note that section 101(b)(2)(A) of the Medicare Access
and CHIP Reauthorization Act of 2015 (Pub. L. 114-10, enacted on April
16, 2015) (MACRA) amends section 1848(a)(8)(A) by striking ``2015 or
any subsequent year'' and inserting ``each of 2015 through 2018.'' This
amendment authorizes the end of the PQRS in 2018 and beginning of a new
program, which may incorporate aspects of the PQRS, the Merit-based
Incentive Payment System (MIPS).
The requirements primarily focus on our proposals related to the
2018 PQRS payment adjustment, which will be based on an EP's or a group
practice's reporting of quality measures data during the 12-month
calendar year reporting period occurring in 2016 (that is, January 1
through December 31, 2016). Please note that, in developing these
proposals, we focused on aligning our requirements, to the extent
appropriate and feasible, with other quality reporting programs, such
as the Medicare Electronic Health Record (EHR) Incentive Program for
EPs, the Physician Value-Based Payment Modifier (VM), and the Medicare
Shared Savings Program. In previous years, we have made various strides
in our ongoing efforts to align the reporting requirements in CMS'
quality reporting programs to reduce burden on the EPs and group
practices that participate in these programs. We continued to focus on
alignment as we developed our proposals for the 2018 PQRS payment
adjustment.
In addition, please note that, in our quality programs, we have
begun to emphasize the reporting of certain types of measures, such as
outcome measures, as well as measures within certain NQS domains.
Indeed, in its March 2015 report (available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=79068) the Measure Applications
Partnership (MAP) suggested that CMS place an emphasis on higher
quality measures, such as functional outcome measures. For example, in
the PQRS, we placed an emphasis on the reporting of the Consumer
Assessment of Healthcare Providers and Systems (CAHPS) for PQRS survey
and cross-cutting measures that promote the health of larger
populations and that are applicable to a larger number of patients. As
discussed further in this section, we proposed to require the reporting
of the CAHPS for PQRS survey for groups of 25 or more EPs who register
to participate in the PQRS Group Practice Reporting Option (GPRO) and
select the Web Interface as the reporting mechanism. In addition, we
proposed to continue to require the reporting of at least 1 applicable
cross-cutting measure if an EP sees at least 1 Medicare patient. When
reporting measures via a QCDR, we emphasized the reporting of outcome
measures, as well as resource use, patient experience of care,
efficiency/appropriate use, or patient safety measures.
Furthermore, we note that our proposals related to the 2018 PQRS
payment adjustment are similar to the requirements we previously
established for the 2017 PQRS payment adjustment. We received comments
in previous years, as well as during the comment period for the
proposed rule, requesting that CMS not make any major changes to the
requirements for PQRS, and we believe these final requirements address
these commenters' desire for stable requirements. Indeed, we received
many comments related to our proposals for the 2018 PQRS payment
adjustment, and we will address those comments with specificity below.
Please note, however, that we received comments on the PQRS that were
outside the scope of the proposed rule, as they were not related to our
specific proposals for the 2018 PQRS payment adjustment. While we will
take these comments into consideration, primarily when we begin to
develop policies and requirements for the Merit-based Incentive Payment
System (or MIPS), we will not specifically respond to those comments
here.
The PQRS regulations are specified in Sec. 414.90. The program
requirements for the 2007 through 2014 PQRS incentives and the 2015
through 2017 PQRS payment adjustments that were previously established,
as well as information on the PQRS, including related laws and
established requirements, are available at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html. In
addition, the 2013 PQRS and eRx Experience Report, which provides
information about EP participation in PQRS, is available for download
at http://cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2013_PQRS_eRx_Experience_Report_zip.zip.
1. The Definition of EP for Purposes of Participating in the PQRS
CMS implemented the first PQRS payment adjustment on January 1,
2015. Specifically, EPs who did not satisfactorily report data on
quality measures during the 12-month calendar year reporting period
occurring in 2013 are receiving a 1.5 percent negative adjustment
during CY 2015 on all of the EPs' Part B covered professional services
under the Medicare Physician Fee Schedule (PFS). The 2015 PQRS payment
adjustment applies to payments for all of the EPs' Part B covered
professional services furnished under the PFS. We received many
questions surrounding who must participate in the PQRS to avoid the
PQRS payment adjustment. As such, we sought to clarify here who is
required to participate in the PQRS for purposes of the payment
adjustments in this rule.
Please note that there are no hardship or low-volume exemptions for
the PQRS payment adjustment. All EPs who furnish covered professional
services must participate in the PQRS each year by meeting the criteria
for satisfactory reporting--or, in lieu of satisfactory reporting,
satisfactory participation in a QCDR--to avoid the PQRS payment
adjustments.
The PQRS payment adjustment applies to EPs who furnish covered
professional services. The definition of an EP for purposes of
participating in the PQRS is specified in section 1848(k)(3)(B) of the
Act. Specifically, the term ``eligible professional'' (EP) means any of
the following: (i) A physician; (ii) a practitioner described in
section 1842(b)(18)(C); (iii) a physical or occupational therapist or a
qualified speech-language pathologist; or (iv) beginning with 2009, a
qualified audiologist (as defined in section 1861(ll)(3)(B)). The term
``covered professional services'' is defined in section 1848(k)(3)(A)
of the Act to mean services for which payment is made under, or is
based on, the Medicare PFS established under section 1848 and which are
furnished by an EP.
EPs in Critical Access Hospitals Billing under Method II (CAH-IIs):
We
[[Page 71136]]
note that EPs in critical access hospitals billing under Method II
(CAH-IIs) were previously not able to participate in the PQRS. Due to a
change we made in the manner in which EPs in CAH-IIs are reimbursed by
Medicare, it is now feasible for EPs in CAH-IIs to participate in the
PQRS. EPs in CAH-IIs may participate in the PQRS using ALL reporting
mechanisms available, including the claims-based reporting mechanism.
EPs Who Practice in Rural Health Clinics (RHCs) and/or Federally
Qualified Health Centers (FQHCs): Services furnished at RHCs and/or
FQHCs for which payment is not made under, or based on, the Medicare
PFS, or which are not furnished by an EP, are not subject to the PQRS
negative payment adjustment. With respect to EPs who furnish covered
professional services at RHCs and/or FQHCs that are paid under the
Medicare PFS, we note that we are currently unable to assess PQRS
participation for these EPs due to the way in which these EPs bill for
services under the PFS. Therefore, EPs who practice in RHCs and/or
FQHCs would not be subject to the PQRS payment adjustment.
EPs Who Practice in Independent Diagnostic Testing Facilities
(IDTFs) and Independent Laboratories (ILs): We note that due to the way
IDTF and IL suppliers and their employee EPs are enrolled with Medicare
and claims are submitted for services furnished by these suppliers and
billed by the IDTF or IL, we are unable to assess PQRS participation
for these EPs. Therefore, claims submitted for services performed by
EPs who perform services as employees of, or on a reassignment basis
to, IDTFs or ILs would not be subject to the PQRS payment adjustment.
2. Requirements for the PQRS Reporting Mechanisms
The PQRS includes the following reporting mechanisms: Claims;
qualified registry; EHR (including direct EHR products and EHR data
submission vendor products); the Web Interface; certified survey
vendors, for CAHPS for PQRS survey measures; and the QCDR. Under the
existing PQRS regulation, Sec. 414.90(h) through (k) govern which
reporting mechanisms are available for use by individuals and group
practices for the PQRS incentive and payment adjustment. This section
contains our proposals to change the QCDR and qualified registry
reporting mechanisms. Please note that we did not propose to make
changes to the other PQRS reporting mechanisms.
One of our goals, as indicated in the Affordable Care Act, is to
report data on race, ethnicity, sex, primary language, and disability
status. A necessary step toward fulfilling this mission is the
collection and reporting of quality data, stratified by race,
ethnicity, sex, primary language, and disability status. The agency
intends to require the collection of these data elements within each of
the PQRS reporting mechanisms. Although we did not propose to require
the collection of these data elements, we solicited comments regarding
the facilitators and obstacles providers and vendors may face in
collecting and reporting these attributes. Additionally, we solicited
comments on preference for a phased-in approach, perhaps starting with
a subset of measures versus a requirement across all possible measures
and mechanisms with an adequate timeline for implementation.
a. Changes to the Requirements for the QCDR
We are required, under section 1848(m)(3)(E)(i) of the Act, to
establish requirements for an entity to be considered a QCDR. Such
requirements must include a requirement that the entity provide the
Secretary with such information, at such times, and in such manner as
the Secretary determines necessary to carry out this subsection.
Section 1848(m)(3)(E)(iv) of the Act, as added by section 601(b)(1)(B)
of the American Taxpayer Relief Act of 2012 (ATRA), requires CMS to
consult with interested parties in carrying out this provision. We
sought to clarify issues related to QCDR self-nomination, as well as
propose a change related to the requirements for an entity to become a
QCDR.
Who May Apply to Self-Nominate to Become a QCDR: We have received
many questions related to what entities may participate in the PQRS as
a QCDR. We noted that Sec. 414.90(b) defines a QCDR as a CMS-approved
entity that has self-nominated and successfully completed a
qualification process showing that it collects medical and/or clinical
data for the purpose of patient and disease tracking to foster
improvement in the quality of care provided to patients. A QCDR must
perform the following functions:
Submit quality measures data or results to CMS for
purposes of demonstrating that, for a reporting period, its EPs have
satisfactorily participated in PQRS. A QCDR must have in place
mechanisms for the transparency of data elements and specifications,
risk models, and measures.
Submit to CMS, for purposes of demonstrating satisfactory
participation, quality measures data on multiple payers, not just
Medicare patients.
Provide timely feedback, at least four times a year, on
the measures at the individual participant level for which the QCDR
reports on the EP's behalf for purposes of the individual EP's
satisfactory participation in the QCDR.
Possess benchmarking capacity that compares the quality of
care an EP provides with other EPs performing the same or similar
functions.
We established further details regarding the requirements to become
a QCDR in the CYs 2014 and 2015 PFS final rules (78 FR 74467 through
74473 and 79 FR 67779 through 67782). Please note that the requirements
we established were not meant to prohibit entities that meet the basic
definition of a QCDR outlined in Sec. 414.90(b) from self-nominating
to participate in the PQRS as a QCDR. As long as the entity meets the
basic definition of a QCDR provided in Sec. 414.90(b), we encourage
the entity to self-nominate to become a QCDR.
Self-Nomination Period: We established a deadline for an entity
becoming a QCDR to submit a self-nomination statement--specifically,
self-nomination statements must be received by CMS by 8:00 p.m.,
eastern standard time (e.s.t.), on January 31 of the year in which the
clinical data registry seeks to be qualified (78 FR 74473). However, we
did not specify when the QCDR self-nomination period opens. We received
feedback from entities that believed they needed more time to self-
nominate. Typically, we open the self-nomination period on January 1 of
the year in which the clinical data registry seeks to be qualified.
Although it is not technically feasible for us to extend the self-
nomination deadline past January 31, we will open the QCDR self-
nomination period on December 1 of the prior year to allow more time
for entities to self-nominate. This would provide entities with an
additional month to self-nominate.
The following is a summary of the comments we received regarding
this proposal:
Comment: We received many comments in support of our proposal to
open the QCDR self-nomination period on December 1 of the prior year to
allow more time for entities to self-nominate.
Response: Based on the rationale provided and the positive comments
we received, we are finalizing this proposal. We will open the QCDR
self-nomination period on December 1 of the prior year to allow more
time for entities to self-nominate. This would provide entities with an
additional month to self-
[[Page 71137]]
nominate. Please note, however, that the deadline for an entity
becoming a QCDR to submit a self-nomination statement is still 5:00
p.m., eastern standard time (e.s.t.), on January 31 of the year in
which the clinical data registry seeks to be qualified (78 FR 74473).
Proposed Establishment of a QCDR Entity: In the CY 2014 PFS final
rule (78 FR 74467), we established the requirement that, for an entity
to become qualified for a given year, the entity must be in existence
as of January 1 the year prior to the year for which the entity seeks
to become a QCDR (for example, January 1, 2013, to be eligible to
participate for purposes of data collected in 2014). We established
this criterion to ensure that an entity seeking to become a QCDR is
well-established prior to self-nomination. We have received feedback
from entities that this requirement is overly burdensome, as it delays
entities otherwise fully capable of becoming a QCDR from participating
in the PQRS. To address these concerns while still ensuring that an
entity seeking to become a QCDR is well-established, beginning in 2016,
we proposed to modify this requirement to require the following: For an
entity to become qualified for a given year, the entity must be in
existence as of January 1 the year for which the entity seeks to become
a QCDR (for example, January 1, 2016, to be eligible to participate for
purposes of data collected in 2016). We invited public comment on this
proposal.
Comment: Some commenters opposed this proposal. One commenter
stated this one-year waiting period ensures that the entity is
established and credible. Another commenter expressed concern that we
may be including entities that are ``untested'' should we modify this
requirement.
Response: While the commenters' concerns regarding modifying this
requirement are understood, based on our analysis of requests for
entities to become a QCDR, we believe that a ``waiting period'' is not
necessary for entities that are in existence as of January 1. From our
experience, at least some of the newer entities requesting to become a
QCDR were entities that have had previous experience under a formerly
existing QCDR. As such, we do not believe a waiting period is
necessary. Therefore, based on the rationale provided, we are
finalizing this proposal. Therefore, for an entity to become qualified
for a given year, the entity must be in existence as of January 1 the
year for which the entity seeks to become a QCDR (for example, January
1, 2016, to be eligible to participate for purposes of data collected
in 2016).
Attestation Statements for QCDRs Submitting Quality Measures Data
during Submission: In the CY 2014 PFS final rule, to ensure that the
data provided by the QCDR is correct, we established the requirement
that QCDRs provide CMS a signed, written attestation statement via
email which states that the quality measure results and any and all
data, including numerator and denominator data, provided to CMS are
accurate and complete (78 FR 74472). In lieu of submitting an
attestation statement via email, beginning in 2016, we proposed to
allow QCDRs to attest during the data submission period that the
quality measure results and any and all data including numerator and
denominator data provided to CMS will be accurate and complete using a
web-based check box mechanism available at https://www.qualitynet.org/portal/server.pt/community/pqri_home/212. We believe it is less
burdensome for QCDRs to check a box acknowledging and attesting to the
accuracy of the data they provide, rather than having to email a
statement to CMS. Please note that, if this proposal is finalized,
QCDRs will no longer be able to submit this attestation statement via
email. We invited but received no public comment on this proposal. We
are finalizing this proposal.
In addition, we noted in the CY 2015 PFS final rule (79 FR 67903)
that entities wishing to become QCDRs would have until March 31 of the
year in which it seeks to become a QCDR to submit measure information
the entity intends to report for the year, which included submitting
the measure specifications for non-PQRS measures the QCDR intends to
report for the year. However, we have experienced issues related to the
measures data we received during the 2013 reporting year. These issues
prompt us to more closely analyze the measures for which an entity
intends to report as a QCDR. Therefore, so that we may vet and analyze
these vendors to determine whether they are fully ready to be qualified
to participate in the PQRS as a QCDR, we proposed to require that all
other documents that are necessary to analyze the vendor for
qualification be provided to CMS at the time of self-nomination, that
is, by no later than January 31 of the year in which the vendor intends
to participate in the PQRS as a QCDR (that is, January 31, 2016 to
participate as a QCDR for the reporting periods occurring in 2016).
This includes, but is not limited to, submission of the vendor's data
validation plan as well as the measure specifications for the non-PQRS
measures the entity intends to report. In addition, please note that
after the entity submits this information on January 31, it cannot
later change any of the information it submitted to us for purposes of
qualification. For example, once an entity submits measure
specifications on non-PQRS measures, it cannot later modify the measure
specifications the entity submitted. Please note that this does not
prevent the entity from providing supplemental information if requested
by CMS.
We solicited and received the following public comment on this
issue:
Comment: Commenters generally opposed this proposal. The commenters
believed that vendors needed more time than proposed to gather its QCDR
measures information. As such, the commenters believe the proposed
January 31 date occurs too soon in the year.
Response: We understand the commenters concerns regarding needing
more time to gather measures information. However, in order for CMS to
more closely analyze these potential QCDR measures due to the issues we
have found in the past, we must finalize our January 31 deadline, as
proposed. Therefore, we are finalizing our proposal to require that all
other documents that are necessary to analyze the vendor for
qualification be provided to CMS at the time of self-nomination, that
is, by no later than January 31 of the year in which the vendor intends
to participate in the PQRS as a QCDR (that is, January 31, 2016 to
participate as a QCDR for the reporting periods occurring in 2016), as
proposed.
Data Validation Requirements for QCDRs: A validation strategy
details how the qualified registry will determine whether EPs and GPRO
group practices have submitted data accurately and satisfactorily on
the minimum number of their eligible patients, visits, procedures, or
episodes for a given measure. Acceptable validation strategies often
include such provisions as the qualified registry being able to conduct
random sampling of their participant's data, but may also be based on
other credible means of verifying the accuracy of data content and
completeness of reporting or adherence to a required sampling method.
The current guidance on validation strategy is available at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2015_RegistryVendorCriteria.pdf. In
analyzing our requirements, we believe adding the following additional
requirements will help mitigate issues that may occur
[[Page 71138]]
when collecting, calculating, and submitting quality measures data to
CMS. Therefore, we proposed that, beginning in 2016, a QCDR must
provide the following information to CMS at the time of self-nomination
to ensure that QCDR data is valid:
Organization Name (Specify Sponsoring Organization name
and qualified registry name if the two are different).
Program Year.
Vendor Type (for example, qualified registry).
Provide the method(s) by which the entity obtains data
from its customers: claims, web-based tool, practice management system,
EHR, other (please explain). If a combination of methods (Claims, Web
Based Tool, Practice Management System, EHR, and/or other) is utilized,
please state which method(s) the entity utilizes to collect reporting
numerator and denominator data.
Indicate the method the entity will use to verify the
accuracy of each Tax Identification Number (TIN) and National Provider
Identifier's (NPI) it is intending to submit (that is, National Plan
and Provider Enumeration System (NPPES), CMS claims, tax
documentation).
Describe the method that the entity will use to accurately
calculate both reporting rates and performance rates for measures and
measures groups based on the appropriate measure type and
specification. For composite measures or measures with multiple
performance rates, the entity must provide us with the methodology the
entity uses for these composite measures and measures with multiple
performance rates.
Describe the process that the entity will use for
completion of a randomized audit of a subset of data prior to the
submission to CMS. Periodic examinations may be completed to compare
patient record data with submitted data and/or ensure PQRS measures
were accurately reported based on the appropriate Measure
Specifications (that is, accuracy of numerator, denominator, and
exclusion criteria).
If applicable, provide information on the entity's
sampling methodology. For example, it is encouraged that 3 percent of
the TIN/NPIs be sampled with a minimum sample of 10 TIN/NPIs or a
maximum sample of 50 TIN/NPIs. For each TIN/NPI sampled, it is
encouraged that 25 percent of the TIN/NPI's patients (with a minimum
sample of 5 patients or a maximum sample of 50 patients) should be
reviewed for all measures applicable to the patient.
Define a process for completing a detailed audit if the
qualified registry's validation reveals inaccuracy and describe how
this information will be conveyed to CMS.
QCDRs must perform the validation outlined in the validation
strategy and send evidence of successful results to CMS for data
collected in the reporting periods occurring in 2016. The Data
Validation Execution Report must be sent via email to the QualityNet
Help Desk at [email protected] by 5:00 p.m. e.s.t. on June 30, 2016.
The email subject should be ``PY2015 Qualified Registry Data Validation
Execution Report.''
We received the following comments on these proposed validation
requirements:
Comment: Some commenters opposed these proposed requirements to
provide the QCDR the above data for auditing purposes. The commenters
stated that vendors do not have enough time to gather all this
information currently, as some vendors do not have this full
information. The commenters therefore requested that vendors be given
more time to implement these requirements. Commenters also believed
that EP verification of NPI and TIN information should be considered
sufficient for purposes of the data validation requirements, because
QCDRs may have different strategies to meet the data validation
requirements. Requiring all QCDRs to collect NPI and tax documentation
from each EP as part of a data validation strategy is unduly
burdensome.
Response: We understand the commenters' concerns associated with
not having received full information from its clients. We note,
however, that it is important to implement these requirements in order
for CMS to ensure the accuracy of the data collected by these vendors.
We also note that, while vendors may not have all this information
currently, the vendors have several months, until June 30, 2016, to
obtain this information from its clients. We believe this provides
vendors with enough time to gather this information. With respect to
commenters' belief that EP verification of NPI and TIN information
should be considered sufficient for purposes of the data validation
requirements, while CMS encourages vendors to check the accuracy of the
data being submitted to them, we believe it is also necessary for CMS
to have the ability to validate the data received. Therefore, based on
the rationale provided, we are finalizing these above requirements for
data validation, as proposed. Please note that a vendor will,
therefore, need to collect all necessary information by June 30, 2016.
Submission of Quality Measures Data for Group Practices: Section
101(d)(1)(B) of the MACRA amends section 1848(m)(3)(D) of the Act by
inserting ``and, for 2016 and subsequent years, subparagraph (A) or
(C)'' after ``subparagraph (A)''. This change authorizes CMS to create
an option for EPs participating in the GPRO to report quality measures
via a QCDR. As such, in addition to being able to submit quality
measures data for individual EPs, we proposed that QCDRs also have the
ability to submit quality measures data for group practices.
We received the following comments on this proposal:
Comment: Commenters were generally supportive of the newly proposed
group practice reporting option via a QCDR and its proposed
requirements. Some commenters stressed the importance of maintaining
and extending use of the QCDR reporting mechanism.
Response: Based on the positive feedback and the rationale
provided, we are finalizing this proposal, as proposed.
b. Changes to the Requirements for Qualified Registries
Attestation Statements for Registries Submitting Quality Measures
Data: In the CY 2013 PFS final rule, we finalized the following
requirement to ensure that the data provided by a registry is correct:
we required that the registry provide CMS a signed, written attestation
statement via mail or email which states that the quality measure
results and any and all data including numerator and denominator data
provided to CMS are accurate and complete for each year the registry
submits quality measures data to CMS (77 FR 69180). In lieu of
submitting an attestation statement via email or mail, beginning in
2016, we proposed to allow registries to attest during the submission
period that the quality measure results and any and all data including
numerator and denominator data provided to CMS will be accurate and
complete using a web-based check box mechanism available at https://www.qualitynet.org/portal/server.pt/community/pqri_home/212. We believe
it is less burdensome for registries to check a box acknowledging and
attesting to the accuracy of the data they provide, rather than having
to email a statement to CMS. Please note that, if this proposal is
finalized, qualified registries will no longer be able to submit this
attestation statement via email or mail.
[[Page 71139]]
We invited and received the following public comment on this
proposal.
Comment: Commenters generally supposed our proposal to use a web-
based check box mechanism as a way to allow registries to attest during
the submission period that the quality measure results and any and all
data including numerator and denominator data provided to CMS will be
accurate and complete, because it is an efficient method to attest.
Response: Based on the comments received and the rationale
provided, we are finalizing our proposals related to attestation
statements for registries submitting quality measures data, as
proposed.
In addition, so that we may vet and analyze these vendors to
determine whether they are fully ready to be qualified to participate
in the PQRS as a qualified registry, we proposed to require that all
other documents that are necessary to analyze the vendor for
qualification be provided to CMS at the time of self-nomination, that
is, by no later than January 31 of the year in which the vendor intends
to participate in the PQRS as a qualified registry (that is, January
31, 2016 to participate as a qualified registry for the reporting
periods occurring in 2016). This includes, but is not limited to,
submission of the vendor's data validation plan. Please note that this
does not prevent the entity from providing supplemental information if
requested by CMS. We invited but received no public comment on this
proposal. Therefore, we are finalizing this proposal to require that
all other documents that are necessary to analyze the vendor for
qualification be provided to CMS at the time of self-nomination, that
is, by no later than January 31 of the year in which the vendor intends
to participate in the PQRS as a qualified registry, as proposed.
Please note that we are finalizing our proposals related to
attestation statements for registries submitting quality measures data,
as proposed.
Data Validation Requirements for Qualified Registries: A validation
strategy details how the qualified registry will determine whether EPs
and GPRO group practices have submitted accurately and satisfactorily
on the minimum number of their eligible patients, visits, procedures,
or episodes for a given measure. Acceptable validation strategies often
include such provisions as the qualified registry being able to conduct
random sampling of their participant's data, but may also be based on
other credible means of verifying the accuracy of data content and
completeness of reporting or adherence to a required sampling method.
The current guidance on validation strategy is available at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2015_RegistryVendorCriteria.pdf. In
analyzing our requirements, we believe adding the following additional
requirements will help mitigate issues that may occur when collecting,
calculating, and submitting quality measures data to CMS. Therefore, we
proposed that, beginning in 2016, a QCDR must provide the following
information to CMS at the time of self-nomination to ensure that data
submitted by a qualified registry is valid:
Organization Name (specify the sponsoring entity name and
qualified registry name if the two are different).
Program Year.
Vendor Type (for example, qualified registry).
Provide the method(s) by which the entity obtains data
from its customers: claims, web-based tool, practice management system,
EHR, other (please explain). If a combination of methods (Claims, Web
Based Tool, Practice Management System, EHR, and/or other) is utilized,
please state which method(s) the entity utilizes to collect its
reporting numerator and denominator data.
Indicate the method the entity will use to verify the
accuracy of each TIN and NPI it is intending to submit (that is, NPPES,
CMS claims, tax documentation).
Describe how the entity will verify that EPs or group
practices report on at least 1 measure contained in the cross-cutting
measure set if the EP or group practice sees at least 1 Medicare
patient in a face-to-face encounter. Describe how the entity will
verify that the data provided is complete and contains the entire
cohort of data.
Describe the method that the entity will use to accurately
calculate both reporting rates and performance rates for measures and
measures groups based on the appropriate measure type and
specification.
Describe the method the entity will use to verify that
only the measures in the applicable PQRS Claims and Registry Individual
Measure Specifications (that is, the 2016 PQRS Claims and Registry
Individual Measure Specifications for data submitted for reporting
periods occurring in 2016) and applicable PQRS Claims and Registry
Measures Groups Specifications (that is, the 2016 PQRS Claims and
Registry Measures Groups Specifications for data submitted for
reporting periods occurring in 2016) are utilized for submission.
Describe the process that the entity will use for
completion of a randomized audit of a subset of data prior to the
submission to CMS. Periodic examinations may be completed to compare
patient record data with submitted data and/or ensure PQRS measures
were accurately reported based on the appropriate Measure
Specifications (that is, accuracy of numerator, denominator, and
exclusion criteria).
If applicable, provide information on the entity's
sampling methodology. For example, it is encouraged that 3 percent of
the TIN/NPIs be sampled with a minimum sample of 10 TIN/NPIs or a
maximum sample of 50 TIN/NPIs. For each TIN/NPI sampled, it is
encouraged that 25 percent of the TIN/NPI's patients (with a minimum
sample of 5 patients or a maximum sample of 50 patients) should be
reviewed for all measures applicable to the patient.
Define a process for completing a detailed audit if the
qualified registry's validation reveals inaccuracy and describe how
this information will be conveyed to CMS.
Registries must maintain the ability to randomly request
and receive documentation from providers to verify accuracy of data.
Registries must also provide CMS access to review the Medicare
beneficiary data on which the applicable PQRS registry-based
submissions are based or provide to CMS a copy of the actual data (if
requested for validation purposes).
Qualified registries must perform the validation outlined in the
validation strategy and send evidence of successful results to CMS for
data collected for the applicable reporting periods. The Data
Validation Execution Report must be sent via email to the QualityNet
Help Desk at [email protected] by 5:00 p.m. ET on June 30 of the
year in which the reporting period occurs (that is, June 30, 2016 for
reporting periods occurring in 2016). The email subject should be
``PY2015 Qualified Registry Data Validation Execution Report.''
Comment: Some commenters opposed these proposed requirements to
provide the above data for auditing purposes. The commenters stated
that vendors do not have enough time to gather all this information
currently, as some vendors do not have this full information. The
commenters therefore requested that vendors be given more time to
implement these requirements.
Response: We understand the commenters concerns associated with the
registry not having received full information from its clients. We
note,
[[Page 71140]]
however, that it is important to implement these requirements in order
for CMS to ensure the accuracy of the data collected by these vendors.
We also note that, while vendors may not have all this information
currently, the vendors have several months, until June 30, 2016, to
obtain and collect this information from its clients. We believe this
provides vendors with enough time to gather this information.
Therefore, based on the rationale provided, we are finalizing these
above requirements for data validation, as proposed.
c. Auditing of Entities Submitting PQRS Quality Measures Data
We are in the process of auditing PQRS participants, including
vendors who submit quality measures data. We believe it is essential
for vendors to cooperate with this audit process. In order to ensure
that CMS has adequate information to perform an audit of a vendor, we
proposed that, beginning in 2016, any vendor submitting quality
measures data for the PQRS (for example, entities participating the
PQRS as a qualified registry, QCDR, direct EHR, or DSV (data submission
vendor)) comply with the following requirements:
The vendor make available to CMS the contact information
of each EP on behalf of whom it submits data. The contact information
will include, at a minimum, the EP practice's phone number, address,
and, if applicable email.
The vendor must retain all data submitted to CMS for the
PQRS program for a minimum of seven years.
We invited public comment on these proposals. The following is a
summary of the comments we received regarding these proposals.
Comment: Some commenters opposed these proposed requirements that
CMS has proposed for auditing purposes. As with the proposed data
validation requirements for QCDRs and qualified registries, the
commenters stated that vendors do not have enough time to gather all
this information currently, as some vendors do not have this full
information. The commenters therefore requested that vendors be given
more time to implement these requirements.
Response: We understand the commenters concerns associated with not
having received full information from its clients. We note, however,
that it is important to implement these requirements in order for CMS
to ensure the accuracy of the data collected by these vendors. We also
note that, while vendors may not have all this information currently,
we believe these vendors have enough time to gather this information.
Therefore, based on the rationale provided, we are finalizing the
requirements we proposed for auditing purposes, as proposed. Please
note that, as proposed, these requirements will apply to all vendors
submitting PQRS data: qualified registries, QCDRs, direct EHR vendors,
or DSV vendors.
3. Criteria for the Satisfactory Reporting for Individual EPs for the
2018 PQRS Payment Adjustment
Section 1848(a)(8) of the Act, as added by section 3002(b) of the
Affordable Care Act, provides that for covered professional services
furnished by an EP during 2015 or any subsequent year, if the EP does
not satisfactorily report data on quality measures for covered
professional services for the quality reporting period for the year,
the fee schedule amount for services furnished by such professional
during the year (including the fee schedule amount for purposes of
determining a payment based on such amount) shall be equal to the
applicable percent of the fee schedule amount that would otherwise
apply to such services. For 2016 and subsequent years, the applicable
percent is 98.0 percent.
a. Criterion for the Satisfactory Reporting of Individual Quality
Measures via Claims and Registry for Individual EPs for the 2018 PQRS
Payment Adjustment
We finalized the following criteria for satisfactory reporting for
the submission of individual quality measures via claims and registry
for 2017 PQRS payment adjustment (see Table 50 at 79 FR 67796): For the
applicable 12-month reporting period, the EP would report at least 9
measures, covering at least 3 of the NQS domains, OR, if less than 9
measures apply to the EP, report on each measure that is applicable,
AND report each measure for at least 50 percent of the Medicare Part B
FFS patients seen during the reporting period to which the measure
applies. Measures with a 0 percent performance rate would not be
counted. For an EP who reports fewer than 9 measures covering less than
3 NQS domains via the claims- or registry-based reporting mechanism,
the EP would be subject to the measure application validity (MAV)
process, which would allow us to determine whether the EP should have
reported quality data codes for additional measures. To meet the
criteria for the 2017 PQRS payment adjustment, we added the following
requirement: Of the measures reported, if the EP sees at least 1
Medicare patient in a face-to-face encounter, as we defined that term
in the proposed rule, the EP would report on at least 1 measure
contained in the PQRS cross-cutting measure set.
To be consistent with the satisfactory reporting criterion we
finalized for the 2017 PQRS payment adjustment, we proposed to amend
Sec. 414.90(j) to specify the same criterion for individual EPs
reporting via claims and registry for the 2018 PQRS payment adjustment.
Specifically, for the 12-month reporting period for the 2018 PQRS
payment adjustment, the EP would report at least 9 measures, covering
at least 3 of the NQS domains AND report each measure for at least 50
percent of the EP's Medicare Part B FFS patients seen during the
reporting period to which the measure applies. Of the measures
reported, if the EP sees at least 1 Medicare patient in a face-to-face
encounter, as we proposed to define that term in this section, the EP
would report on at least 1 measure contained in the PQRS cross-cutting
measure set. If less than 9 measures apply to the EP, the EP would
report on each measure that is applicable, AND report each measure for
at least 50 percent of the Medicare Part B FFS patients seen during the
reporting period to which the measure applies. Measures with a 0
percent performance rate would not be counted.
For what defines a ``face-to-face'' encounter, for purposes of
requiring reporting of at least 1 cross-cutting measure, we proposed to
determine whether an EP had a ``face-to-face'' encounter by assessing
whether the EP billed for services under the PFS that are associated
with face-to-face encounters, such as whether an EP billed general
office visit codes, outpatient visits, and surgical procedures. We
would not include telehealth visits as face-to-face encounters for
purposes of the proposal requiring reporting of at least 1 cross-
cutting measure. For our current list of face-to-face encounter codes
for the requirement to report a cross-cutting measure, please see
http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/FacetoFace_Encounter_CodeList_01302015.zip.
In addition, we understand that there may be instances where an EP
may not have at least 9 measures applicable to an EP's practice. In
this instance, like the criterion we finalized for the 2017 payment
adjustment (see Table 50 at 79 FR 67796), an EP reporting on less than
9 measures would still be able to meet the satisfactory reporting
criterion via claims and registry if the EP reports on each measure
that is applicable to the EP's practice. If an EP reports on less
[[Page 71141]]
than 9 measures, the EP would be subject to the MAV process, which
would allow us to determine whether an EP should have reported quality
data codes for additional measures. In addition, the MAV process will
also allow us to determine whether an EP should have reported on any of
the PQRS cross-cutting measures. The MAV process we are proposing to
implement for claims and registry is the same process that was
established for reporting periods occurring in 2015 for the 2017 PQRS
payment adjustment. For more information on the claims and registry MAV
process, please visit the measures section of the PQRS Web site at
http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/MeasuresCodes.html.
We solicited and received the following public comments on our
proposed satisfactory reporting criteria for individual EPs reporting
via claims or registry for the 2018 PQRS payment adjustment:
Comment: Commenters generally supported our proposed reporting
criteria for individual EPs reporting via claims or registry for the
2018 PQRS payment adjustment, primarily because commenters did not want
CMS to propose drastic changes to the criteria for satisfactory
reporting. Maintaining similar reporting criteria helps EPs and
vendors, as they are already familiar with the reporting criteria.
Commenters also generally supported continuing use of the claims-based
reporting mechanism as an option to meet the criteria for satisfactory
reporting under the PQRS.
Response: Based on the rationale provided and the comments
received, we are finalizing our proposed satisfactory reporting
criteria for individual EPs reporting via claims or registry for the
2018 PQRS payment adjustment, as proposed.
b. Criterion for Satisfactory Reporting of Individual Quality Measures
via EHR for Individual EPs for the 2018 PQRS Payment Adjustment
We finalized the following criterion for the satisfactory reporting
for individual EPs reporting individual measures via a direct EHR
product or an EHR data submission vendor product for the 2017 PQRS
payment adjustment (see Table 50 at 79 FR 67796): For the applicable
12-month reporting period, report at least 9 measures covering at least
3 of the NQS domains. If an EP's direct EHR product or EHR data
submission vendor product does not contain patient data for at least 9
measures covering at least 3 domains, then the EP must report all of
the measures for which there is Medicare patient data. Although all-
payer data may be included in the file, an EP must report on at least 1
measure for which there is Medicare patient data for their submission
to be considered for PQRS.
To be consistent with the criterion we finalized for the 2017 PQRS
payment adjustment, as well as to continue to align with the final
criterion for meeting the clinical quality measure (CQM) component of
achieving meaningful use under the Medicare EHR Incentive Program, we
proposed to amend Sec. 414.90(j) to specify the criterion for the
satisfactory reporting for individual EPs to report individual measures
via a direct EHR product or an EHR data submission vendor product for
the 2018 PQRS payment adjustment. Specifically, the EP would report at
least 9 measures covering at least 3 of the NQS domains. If an EP's
direct EHR product or EHR data submission vendor product does not
contain patient data for at least 9 measures covering at least 3
domains, then the EP would be required to report all of the measures
for which there is Medicare patient data. An EP would be required to
report on at least 1 measure for which there is Medicare patient data.
We solicited and received the following public comments on this
proposal:
Comment: Some commenters supported our proposed requirement for
satisfactory reporting for the 2018 PQRS payment adjustment via the EHR
reporting mechanism. One commenter supported our proposal to keep the
requirements similar to the requirement for satisfactory reporting for
the 2017 PQRS payment adjustment, as well as our proposal to align
reporting options with the CQM component of the EHR Incentive Program.
Response: We appreciate the commenters' positive feedback on this
proposal. Based on the rationale provided and the comments received, we
are finalizing our proposed satisfactory reporting criteria for
individual EPs reporting via direct EHR product and EHR data submission
vendor product for the 2018 PQRS payment adjustment, as proposed.
c. Criterion for Satisfactory Reporting of Measures Groups via Registry
for Individual EPs for the 2018 PQRS Payment Adjustment
We finalized the following criterion for the satisfactory reporting
for individual EPs to report measures groups via registry for the 2017
PQRS payment adjustment (see Table 50 at 79 FR 67796): For the
applicable 12-month reporting period, report at least 1 measures group
AND report each measures group for at least 20 patients, the majority
(11 patients) of which must be Medicare Part B FFS patients. Measures
groups containing a measure with a 0 percent performance rate will not
be counted.
To be consistent with the criterion we finalized for the 2017 PQRS
payment adjustment, we proposed to amend Sec. 414.90(j) to specify the
same criterion for the satisfactory reporting for individual EPs to
report measures groups via registry for the 2018 PQRS payment
adjustment. Specifically, for the 12-month reporting period for the
2018 PQRS payment adjustment, the EP would report at least 1 measures
group AND report each measures group for at least 20 patients, the
majority (11 patients) of which would be required to be Medicare Part B
FFS patients. Measures groups containing a measure with a 0 percent
performance rate would not be counted.
We solicited and received the following public comment on our
proposed satisfactory reporting criterion for individual EPs reporting
measures groups via registry for the 2018 PQRS payment adjustment:
Comment: Commenters generally supported our proposed satisfactory
reporting criterion for individual EPs reporting measures groups via
registry for the 2018 PQRS payment adjustment, primarily because
commenters did not want CMS to propose drastic changes to the criteria
for satisfactory reporting. Commenters stated that maintaining similar
reporting criteria helps EPs and vendors, as they are already familiar
with the reporting criteria.
Response: Based on the comments received and for the rationale
provided, we are finalizing our proposed satisfactory reporting
criterion for individual EPs reporting measures groups via registry for
the 2018 PQRS payment adjustment, as proposed.
4. Satisfactory Participation in a QCDR by Individual EPs
Section 601(b) of the ATRA amended section 1848(m)(3) of the Act,
by redesignating subparagraph (D) as subparagraph (F) and adding new
subparagraphs (D) and (E), to provide for a new standard for individual
EPs to satisfy the PQRS beginning in 2014, based on satisfactory
participation in a QCDR.
a. Criterion for the Satisfactory Participation for Individual EPs in a
QCDR for the 2018 PQRS payment adjustment
Section 1848(m)(3)(D) of the Act, as added by section 601(b) of the
ATRA,
[[Page 71142]]
authorizes the Secretary to treat an individual EP as satisfactorily
submitting data on quality measures under section 1848(m)(3)(A) of the
Act if, in lieu of reporting measures under section 1848(k)(2)(C) of
the Act, the EP is satisfactorily participating in a QCDR for the year.
``Satisfactory participation'' is a relatively new standard under the
PQRS and is an analogous standard to the standard of ``satisfactory
reporting'' data on covered professional services that EPs who report
through other mechanisms must meet to avoid the PQRS payment
adjustment. Currently, Sec. 414.90(e)(2) states that individual EPs
must be treated as satisfactorily reporting data on quality measures if
the individual EP satisfactorily participates in a QCDR.
To be consistent with the number of measures reported for the
satisfactory participation criterion we finalized for the 2017 PQRS
payment adjustment (see Table 50 at 79 FR 67796), for purposes of the
2018 PQRS payment adjustment (which would be based on data reported
during the 12-month period that falls in CY 2016), we proposed to
revise Sec. 414.90(k) to use the same criterion for individual EPs to
satisfactorily participate in a QCDR for the 2018 PQRS payment
adjustment. Specifically, for the 12-month reporting period for the
2018 PQRS payment adjustment, the EP would report at least 9 measures
available for reporting under a QCDR covering at least 3 of the NQS
domains, AND report each measure for at least 50 percent of the EP's
patients. Of these measures, the EP would report on at least 2 outcome
measures, OR, if 2 outcomes measures are not available, report on at
least 1 of the outcome measures and at least 1 of the following types
of measures--resource use, patient experience of care, efficiency/
appropriate use, or patient safety.
We solicited and received the following public comments on this
proposal:
Comment: We received many comments generally in support of the QCDR
reporting mechanism. Commenters also generally supported our proposed
criterion for individual EPs to satisfactorily participate in a QCDR
for the 2018 PQRS payment adjustment, as the commenters urged us not to
propose drastic changes to the criteria for satisfactory participation
in a QCDR. The commenters were especially concerned with not making
drastic changes to the QCDR option, as it is the newest reporting
option available in the PQRS.
Response: We appreciate the commenters' feedback. Based on the
comments received and the rationale provided, we are finalizing the
proposed criterion for individual EPs to satisfactorily participate in
a QCDR for the 2018 PQRS payment adjustment, as proposed.
5. Criteria for Satisfactory Reporting for Group Practices
Participating in the GPRO
In lieu of reporting measures under section 1848(k)(2)(C) of the
Act, section 1848(m)(3)(C) of the Act provides the Secretary with the
authority to establish and have in place a process under which EPs in a
group practice (as defined by the Secretary) shall be treated as
satisfactorily submitting data on quality measures. Accordingly, this
section III.I.4 contains our proposed satisfactory reporting criteria
for group practices participating in the GPRO. Please note that, for a
group practice to participate in the PQRS GPRO in lieu of participating
as individual EPs, a group practice is required to register to
participate in the PQRS GPRO. For more information on GPRO
participation, please visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Group_Practice_Reporting_Option.html. For more information on
registration, please visit http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Self-Nomination-Registration.html.
a. The CAHPS for PQRS Survey
Explanation of CAHPS for PQRS: The CAHPS for PQRS survey consists
of the core CAHPS Clinician & Group Survey developed by AHRQ, plus
additional survey questions to meet CMS' information and program needs.
The survey questions are aggregated into 12 content domains called
Summary Survey Measures (SSMs). SSMs contain one or more survey
questions. The CAHPS for PQRS survey consists of the following survey
measures: (1) Getting timely care, appointments, & information; (2) How
well your providers communicate; (3) Patient's rating of provider; (4)
Access to specialists; (5) Health promotion and education; (6) Shared
decision making; (7) Health status & functional status; (8) Courteous &
helpful office staff; (9) Care coordination; (10) Between visit
communication; (11) Helping you take medications as directed; and (12)
Stewardship of patient resources. For the CAHPS for PQRS survey to
apply to a group practice, the group practice must have an applicable
focal provider as well as meet the minimum beneficiary sample for the
CAHPS for PQRS survey.
Identifying Focal Providers: Which provider does the survey ask
about? The provider named in the survey provided the beneficiary with
the plurality of the beneficiary's primary care services delivered by
the group practice. Plurality of care is based on the number of primary
care service visits to a provider. The provider named in the survey can
be a physician (primary care provider or specialist), nurse
practitioner (NP), physician's assistant (PA), or clinical nurse
specialist (CNS).
Exclusion Criteria for Focal Providers: Several specialty types are
excluded from selection as focal provider such as anesthesiology,
pathology, psychiatry optometry, diagnostic radiology, chiropractic,
podiatry, audiology, physical therapy, occupational therapy, clinical
psychology, diet/nutrition, emergency medicine, addiction medicine,
critical care, and clinical social work. Hospitalists are also excluded
from selection as a focal provider.
Beneficiary Sample Selection: CMS retrospectively assigns Medicare
beneficiaries to your group practice based on whether the group
provided a wide range of primary care services. Assigned beneficiaries
must have a plurality of their primary care claims delivered by the
group practice. Assigned beneficiaries have at least one month of both
Part A and Part B enrollment and no months of Part A only enrollment or
Part B only enrollment. Assigned beneficiaries cannot have any months
of enrollment in a Medicare Advantage plan. Regardless of the number of
EPs, some group practices may not have a sufficient number of assigned
beneficiaries to participate in the CAHPS for PQRS survey.
We draw a sample of Medicare beneficiaries assigned to a practice.
For practices with 100 or more eligible providers, the desired sample
is 860, and the minimum sample is 416. For practices with 25 to 99
eligible providers, the desired sample is 860, and the minimum sample
is 255. For practices with 2 to 24 eligible providers, the desired
sample is 860, and the minimum sample is 125. The following
beneficiaries are excluded in the practice's patient sample:
Beneficiaries under age 18 at the time of the sample draw;
beneficiaries known to be institutionalized at the time of the sample
draw; and beneficiaries with no eligible focal provider. For more
information on CAHPS for PQRS, please visit the PQRS Web site at http:/
/www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
[[Page 71143]]
Instruments/PQRS/CMS-Certified-Survey-Vendor.html.
Requirements for CAHPS for PQRS for the 2016 Reporting Period: In
the CY 2015 PFS final rule, we required group practices of 100 or more
EPs that register to participate in the GPRO for 2015 reporting to
select a CMS-certified survey vendor to report the CAHPS for PQRS
survey, regardless of the reporting mechanism the group practice
chooses (79 FR 67794). We also stated that group practices would bear
the cost of administering the CAHPS for PQRS survey. To collect CAHPS
for PQRS data from smaller groups, for purposes of the 2018 PQRS
payment adjustment (which would be based on data reported during the
12-month period that falls in CY 2016), we proposed to require group
practices of 25 or more EPs that register to participate in the GPRO
and select the Web Interface as the reporting mechanism to select a
CMS-certified survey vendor to report CAHPS for PQRS. We believe this
is consistent with our effort to collect CAHPS for PQRS data whenever
possible. However, we excluded from this proposal group practices that
report measures using the qualified registry, EHR, and QCDR reporting
mechanisms, because we have discovered that certain group practices
reporting through these mechanisms may be highly specialized or
otherwise unable to report CAHPS for PQRS. Please note that we still
proposed to keep CAHPS for PQRS reporting as an option for all group
practices. We noted that all group practices that would be required to
report or voluntarily elect to report CAHPS for PQRS would need to
continue to select and pay for a CMS-certified survey vendor to
administer the CAHPS for PQRS survey on their behalf. We invited and
received the following public comment on this proposal:
Comment: One commenter generally supported requiring the
administration of the CAHPS for PQRS survey. However, the majority of
commenters were opposed to this requirement. Some commenters oppose
requiring the reporting of the CAHPS for PQRS survey. One commenter is
particularly concerned with the timing of the release of the final list
of vendors approved to administer the CAHPS for PQRS survey for the
2015 reporting period. The list was not released until after the GPRO
registration period closed, not providing group practices with enough
time to make a full business decision on whether to administer CAHPS
for PQRS prior to the close of GPRO registration. Other commenters are
concerned with the cost associated with administering the CAHPS for
PQRS survey, particularly for smaller group practices.
Response: We understand the commenters' concerns regarding not
being able to receive the list of CAHPS for PQRS vendors for the 2015
reporting period until after registration had closed. We will work to
make this list available earlier next year. We also understand that the
cost of administering the CAHPS for PQRS survey may be burdensome to
smaller group practices. Therefore, as a result of the comments, we are
modifying this proposal.
First, we are finalizing our proposal to allow all group practices
to voluntarily elect to administer the CAHPS for PQRS survey.
Second, regarding our proposal to require group practices of 25 or
more EPs that register to participate in the GPRO and select the Web
Interface as the reporting mechanism to select a CMS-certified survey
vendor to report CAHPS for PQRS, we are not finalizing this proposal
with respect to group practices of 25-99 EPs. We are, however,
finalizing this proposal with respect to group practices of 100 or more
EPs. Thus, we are requiring that, for the reporting periods occurring
in 2016, all group practices of 100 or more EPs that register to
participate in the GPRO select a CMS-certified survey vendor to report
CAHPS for PQRS, regardless of the reporting mechanism the group
practice uses. We note that, for reporting periods occurring in 2015,
we currently require all group practices of 100 or more EPs that
register to participate in the GPRO select a CMS-certified survey
vendor to report CAHPS for PQRS, regardless of the reporting mechanism
the group practice uses. Therefore, as it was a previously established
requirement, and as group practices of 100 or more EPs were logically
included in our proposal to require group practices of 25 or more EPs
to report CAHPS for PQRS, we believe it was foreseeable that we would
finalize this requirement with respect to group practices of 100 or
more EPs. We also believe that this modification addresses the
commenters' desire to keep the reporting requirements unchanged. As we
specify below, since we are not finalizing this proposal with respect
to group practices of 25-99 EPs, we will modify our proposed criteria
for satisfactory reporting related to requiring the administering of
the CAHPS for PQRS survey for group practices of 25-99 EPs.
In addition, we noted that we finalized a 12-month reporting period
for the administration of the CAHPS for PQRS survey. However, as group
practices have until June of the applicable reporting period (that is,
June 30, 2016 for the 12-month reporting period occurring January 1,
2016-December 31, 2016) to elect to participate in the PQRS as a GPRO
and administer CAHPS for PQRS, it is not technically feasible for us to
collect data for purposes of CAHPS for PQRS until the close of the GPRO
registration period. As such, the administration of the CAHPS for PQRS
survey only contains 6-months of data. We do not believe this
significantly alters the administration of CAHPS for PQRS, as we
believe that 6-months of data provide an adequate sample of the 12-
month reporting period.
b. Criteria for Satisfactory Reporting on PQRS Quality Measures Via the
Web Interface for the 2018 PQRS Payment Adjustment
Under our authority specified for the group practice reporting
requirements under section 1848(m)(3)(C) of the Act--to be consistent
with the criterion we finalized for the satisfactory reporting of PQRS
quality measures for group practices registered to participate in the
GPRO for the 2017 PQRS payment adjustment using the Web Interface (see
Table 51 at 79 FR 67797)--we proposed to amend Sec. 414.90(j) to
specify criteria for the satisfactory reporting of PQRS quality
measures for group practices registered to participate in the GPRO for
the 12-month reporting period for the 2018 PQRS payment adjustment
using the Web Interface for groups practices of 25 or more EPs for
which the CAHPS for PQRS survey does not apply. Specifically, the group
practice would report on all measures included in the web interface;
AND populate data fields for the first 248 consecutively ranked and
assigned beneficiaries in the order in which they appear in the group's
sample for each module or preventive care measure. If the pool of
eligible assigned beneficiaries is less than 248, then the group
practice would report on 100 percent of assigned beneficiaries. In
other words, we understand that, in some instances, the sampling
methodology CMS provides will not be able to assign at least 248
patients on which a group practice may report, particularly those group
practices on the smaller end of the range of 25-99 EPs. If the group
practice is assigned less than 248 Medicare beneficiaries, then the
group practice would report on 100 percent of its assigned
beneficiaries. A group practice would be required to report on at least
1 measure in the Web Interface. Although the criteria proposed above
are specified for groups practices of 25 or more EPs, please note
[[Page 71144]]
that, given our finalized requirement that group practices of 100 or
more EPs report the CAHPS for PQRS survey (rather than group practices
of 25 or more EPs, as originally proposed), the criteria proposed above
would apply to a group practices of 100 or more EPs only if the CAHPS
for PQRS survey does not apply to the group practice.
Comment: We solicited and received support for this reporting
criterion, mainly because commenters urged us to keep the reporting
requirements unchanged.
Response: We appreciate the commenters' feedback, and, based on the
rationale provided and the comments received, are finalizing this
proposed criterion, as proposed.
Furthermore, similar to the criteria we established for the 2017
PQRS payment adjustment (see Table 51 at 79 FR 67797), as we specified
in section III.I.4.a., we proposed to require that group practices of
25 or more EPs who elect to report quality measures via the Web
Interface report the CAHPS for PQRS survey, if applicable. Therefore,
similar to the criteria we established for the 2017 PQRS payment
adjustment in accordance with section 1848(m)(3)(C) of the Act (see
Table 51 at 79 FR 67797), we proposed to amend Sec. 414.90(j) to
specify criteria for the satisfactory reporting of PQRS quality
measures for group practices of 25 or more EPs that registered to
participate in the GPRO for the 12-month reporting period for the 2018
PQRS payment adjustment using the Web Interface and for which the CAHPS
for PQRS survey applies. Specifically, if a group practice chooses to
use the Web Interface in conjunction with reporting the CAHPS for PQRS
survey measures, we proposed to specify the following criterion for
satisfactory reporting for the 2018 PQRS payment adjustment: For the
12-month reporting period for the 2018 PQRS payment adjustment, the
group practice would report all CAHPS for PQRS survey measures via a
certified survey vendor. In addition, the group practice would report
on all measures included in the Web Interface; AND populate data fields
for the first 248 consecutively ranked and assigned beneficiaries in
the order in which they appear in the group's sample for each module or
preventive care measure. If the pool of eligible assigned beneficiaries
is less than 248, then the group practice would report on 100 percent
of assigned beneficiaries. A group practice would be required to report
on at least 1 measure for which there is Medicare patient data.
We solicited and received the following public comment on this
proposal:
Comment: We did not receive specific comments on this proposed
criterion. Please note, however, that we received general comments on
the requirement to report CAHPS for PQRS, as discussed in section
III.I.5.a. of this final rule with comment period.
Response: As we stated in section III.I.5.a. of this final rule
with comment period, because we are finalizing our proposal to require
group practices to report CAHPS for PQRS only with respect to group
practices of 100 or more EPs, we are modifying this proposal as
follows:
For group practices of 25-99 EPs that registered to participate in
the GPRO for the 12-month reporting period for the 2018 PQRS payment
adjustment using the Web Interface and for which the CAHPS for PQRS
survey applies, administration of the CAHPS for PQRS survey will be
OPTIONAL for 2016. Therefore, we are finalizing the following criterion
as an option for these group practices if they voluntarily elect to
administer the CAHPS for PQRS survey in conjunction with the Web
Interface: For the 12-month reporting period for the 2018 PQRS payment
adjustment, the group practice would report all CAHPS for PQRS survey
measures via a certified survey vendor. In addition, the group practice
would report on all measures included in the Web Interface; AND
populate data fields for the first 248 consecutively ranked and
assigned beneficiaries in the order in which they appear in the group's
sample for each module or preventive care measure. If the pool of
eligible assigned beneficiaries is less than 248, then the group
practice would report on 100 percent of assigned beneficiaries. A group
practice would be required to report on at least 1 measure for which
there is Medicare patient data.
For group practices of 100+ EPs that registered to participate in
the GPRO for the 12-month reporting period for the 2018 PQRS payment
adjustment using the Web Interface and for which the CAHPS for PQRS
survey applies, administration of the CAHPS for PQRS survey will be
REQUIRED for 2016. Therefore, we are finalizing the following criterion
for these group practices: For the 12-month reporting period for the
2018 PQRS payment adjustment, the group practice would report all CAHPS
for PQRS survey measures via a certified survey vendor. In addition,
the group practice would report on all measures included in the Web
Interface; AND populate data fields for the first 248 consecutively
ranked and assigned beneficiaries in the order in which they appear in
the group's sample for each module or preventive care measure. If the
pool of eligible assigned beneficiaries is less than 248, then the
group practice would report on 100 percent of assigned beneficiaries. A
group practice would be required to report on at least 1 measure for
which there is Medicare patient data.
For assignment of patients for group practices reporting via the
Web Interface, in previous years, we have aligned with the Medicare
Shared Savings Program methodology of beneficiary assignment (see 77 FR
69195). However, for the 2017 PQRS payment adjustment, we used a
beneficiary attribution methodology utilized within the VM for the
claims-based quality measures and cost measures that is slightly
different from the Medicare Shared Savings Program assignment
methodology that applied in 2015, namely (1) eliminating the primary
care service pre-step that is statutorily required for the Shared
Savings Program and (2) including NPs, PAs, and CNSs in step 1 rather
than in step 2 of the attribution process. We believe that aligning
with the VM's method of attribution is appropriate, as the VM is
directly tied to participation in the PQRS (79 FR 67790). Therefore, to
be consistent with the sampling methodology we used for the 2017 PQRS
payment adjustment, we proposed to continue using the attribution
methodology used for the VM for the Web Interface beneficiary
assignment methodology for the 2018 PQRS payment adjustment and future
years. We solicited and received the following public comment on this
proposal:
Comment: One commenter opposed the use of the VM's attribution
methodology for purposes of the Web Interface beneficiary assignment
and methodology. Specifically, the commenter believed that the VM's
attribution methodology penalizes providers for costs beyond their
control.
Response: We do not believe that the VM's attribution methodology
penalizes providers for costs beyond their control. Please note that
the cost measures that must be separately reported for the VM are not
reported for the PQRS. Therefore, cost is not associated with the
attribution methodology we proposed. Based on the rationale provided,
we are finalizing our proposal to continue using the attribution
methodology used for the VM for the Web Interface beneficiary
assignment methodology for the 2018 PQRS payment adjustment.
As we clarified in the CY 2015 PFS final rule with comment period
(79 FR 67790), if a group practice has no Medicare patients for which
any of the
[[Page 71145]]
GPRO measures are applicable, the group practice will not meet the
criteria for satisfactory reporting using the Web Interface. Therefore,
to meet the criteria for satisfactory reporting using the Web
Interface, a group practice must be assigned and have sampled at least
1 Medicare patient for any of the applicable Web Interface measures. If
a group practice does not typically see Medicare patients for which the
Web Interface measures are applicable, or if the group practice does
not have adequate billing history for Medicare patients to be used for
assignment and sampling of Medicare patients into the Web Interface, we
advise the group practice to participate in the PQRS via another
reporting mechanism.
c. Criteria for Satisfactory Reporting on Individual PQRS Quality
Measures for Group Practices Registered To Participate in the GPRO via
Registry for the 2018 PQRS Payment Adjustment
We finalized the following satisfactory reporting criteria for the
submission of individual quality measures via registry for group
practices of 2-99 EPs in the GPRO for the 2017 PQRS payment adjustment
(see Table 51 at 79 FR 67797): Report at least 9 measures, covering at
least 3 of the NQS domains, OR, if less than 9 measures covering at
least 3 NQS domains apply to the group practice, report up to 8
measures covering 1-3 NQS domains for which there is Medicare patient
data, AND report each measure for at least 50 percent of the group
practice's Medicare Part B FFS patients seen during the reporting
period to which the measure applies.
Consistent with the group practice reporting criteria we finalized
for the 2017 PQRS payment adjustment in accordance with section
1848(m)(3)(C) of the Act, for those group practices that choose to
report using a qualified registry, we proposed to amend Sec. 414.90(j)
to specify satisfactory reporting criteria via qualified registry for
group practices of 2+ EPs who select to participate in the GPRO for the
2018 PQRS payment adjustment. Specifically, for the 12-month 2018 PQRS
payment adjustment reporting period, the group practice would report at
least 9 measures, covering at least 3 of the NQS domains. Of these
measures, if a group practice has an EP that sees at least 1 Medicare
patient in a face-to-face encounter, the group practice would report on
at least 1 measure in the PQRS cross-cutting measure set. If the group
practice reports on less than 9 measures covering at least 3 NQS
domains, the group practice would report on each measure that is
applicable to the group practice, AND report each measure for at least
50 percent of the EP's Medicare Part B FFS patients seen during the
reporting period to which the measure applies. Measures with a 0
percent performance rate would not be counted.
In addition, if a group practice of 2+ EPs chooses instead to use a
qualified registry in conjunction with reporting the CAHPS for PQRS
survey measures, for the 12-month reporting period for the 2018 PQRS
payment adjustment, the group practice would report all CAHPS for PQRS
survey measures via a certified survey vendor, and report at least 6
additional measures, outside of the CAHPS for PQRS survey, covering at
least 2 of the NQS domains using the qualified registry. If less than 6
measures apply to the group practice, the group practice must report on
each measure that is applicable to the group practice. Of the non-CAHPS
for PQRS measures, if any EP in the group practice sees at least 1
Medicare patient in a face-to-face encounter, the group practice would
be required to report on at least 1 measure in the PQRS cross-cutting
measure set. We note that this option to report 6 additional measures,
including at least 1 cross-cutting measure if a group practice sees at
least 1 Medicare patient in a face-to-face encounter, is consistent
with the proposed criterion for satisfactory reporting for the 2018
PQRS payment adjustment via qualified registry.
As with individual reporting, we understand that there may be
instances where a group practice may not have at least 9 measures
applicable to a group practice's practice. In this instance, like the
criterion we finalized for the 2017 PQRS payment adjustment (see Table
51 at 79 FR 67797), a group practice reporting on less than 9 measures
would still be able to meet the satisfactory reporting criterion via
registry if the group practice reports on each measure that is
applicable to the group practice's practice. If a group practice
reports on less than 9 measures, the group practice would be subject to
the MAV process, which would allow us to determine whether a group
practice should have reported quality data codes for additional
measures and/or measures covering additional NQS domains. In addition,
if a group practice does not report on at least 1 cross-cutting measure
and the group practice has at least 1 EP who sees at least 1 Medicare
patient in a face-to-face encounter, the MAV will also allow us to
determine whether a group practice should have reported on any of the
PQRS cross-cutting measures. The MAV process we proposed to implement
for registry reporting is a similar process that was established for
reporting periods occurring in 2015 for the 2017 PQRS payment
adjustment. However, please note that the MAV process for the 2018 PQRS
payment adjustment will now allow us to determine whether a group
practice should have reported on at least 1 cross-cutting measure. For
more information on the registry MAV process, please visit http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2014_PQRS_Registry_MeasureApplicabilityValidation_12132013.zip.
We invited and received the following public comments on these
proposals.
Comment: We received general support for the proposed criteria for
satisfactory reporting on individual PQRS quality measures for group
practices registered to participate in the GPRO via registry for the
2018 PQRS payment adjustment. Some commenters specifically supported
continued use of the registry-based reporting mechanism. With respect
to reporting CAHPS for PQRS, please note, we received general comments
on the requirement to report CAHPS for PQRS, as discussed in section
III.I.5.a. of this final rule with comment period.
Response: As we stated in section III.I.5.a. of this final rule
with comment period, because we are finalizing our proposal to require
group practices to report CAHPS for PQRS only with respect to group
practices of 100 or more EPs, we are modifying this proposal as
follows:
For group practices of 2-99 EPs registered to participate in the
GPRO via registry for the 2018 PQRS payment adjustment: The
administration of the CAHPS for PQRS survey is OPTIONAL. Therefore, if
reporting via registry, these group practices may meet the criteria for
satisfactory reporting for the 2018 PQRS payment adjustment in one of
two ways:
OPTION 1 (group practices that do not voluntarily elect to
administer the CAHPS for PQRS survey in conjunction with the registry):
For the 12-month 2018 PQRS payment adjustment reporting period, report
at least 9 measures, covering at least 3 of the NQS domains. Of these
measures, if a group practice has an EP that sees at least 1 Medicare
patient in a face-to-face encounter, the group practice would report on
at least 1 measure in the PQRS cross-cutting measure set. If the group
practice reports on less than 9 measures covering at least 3 NQS
domains, the group practice would report on each measure that is
applicable to the group practice, AND report each measure for at least
50 percent of the EP's Medicare Part B FFS patients seen during the
[[Page 71146]]
reporting period to which the measure applies. Measures with a 0
percent performance rate would not be counted.
OPTION 2 (group practices that voluntarily elect to administer the
CAHPS for PQRS survey in conjunction with the registry): For the 12-
month reporting period for the 2018 PQRS payment adjustment, report all
CAHPS for PQRS survey measures via a certified survey vendor, and
report at least 6 additional measures, outside of the CAHPS for PQRS
survey, covering at least 2 of the NQS domains using the qualified
registry. If less than 6 measures apply to the group practice, the
group practice must report on each measure that is applicable to the
group practice. Of the non-CAHPS for PQRS measures, if any EP in the
group practice sees at least 1 Medicare patient in a face-to-face
encounter, the group practice would be required to report on at least 1
measure in the PQRS cross-cutting measure set.
For group practices of 100+ EPs registered to participate in the
GPRO via registry for the 2018 PQRS payment adjustment: The
administration of the CAHPS for PQRS survey is REQUIRED. Therefore, if
reporting via registry, these group practices must meet the following
criterion for satisfactory reporting for the 2018 PQRS payment
adjustment: For the 12-month reporting period for the 2018 PQRS payment
adjustment, report all CAHPS for PQRS survey measures via a certified
survey vendor, and report at least 6 additional measures, outside of
the CAHPS for PQRS survey, covering at least 2 of the NQS domains using
the qualified registry. If less than 6 measures apply to the group
practice, the group practice must report on each measure that is
applicable to the group practice. Of the non-CAHPS for PQRS measures,
if any EP in the group practice sees at least 1 Medicare patient in a
face-to-face encounter, the group practice would be required to report
on at least 1 measure in the PQRS cross-cutting measure set.
d. Criteria for Satisfactory Reporting on Individual PQRS Quality
Measures for Group Practices Registered To Participate in the GPRO via
EHR for the 2018 PQRS Payment Adjustment
For EHR reporting, consistent with the criterion finalized for the
2017 PQRS payment adjustment (see Table 51 at 79 FR 67797) that aligns
with the criteria established for meeting the CQM component of
meaningful use under the Medicare EHR Incentive Program and in
accordance with the group practice reporting requirements under section
1848(m)(3)(C) of the Act, for those group practices that choose to
report using an EHR, we proposed to amend Sec. 414.90(j) to specify
satisfactory reporting criteria via a direct EHR product or an EHR data
submission vendor product for group practices of 2+ EPs who select to
participate in the GPRO for the 2018 PQRS payment adjustment.
Specifically, for the 12-month reporting period for the 2018 PQRS
payment adjustment, the group practice would report 9 measures covering
at least 3 domains. If the group practice's direct EHR product or EHR
data submission vendor product does not contain patient data for at
least 9 measures covering at least 3 domains, then the group practice
must report all of the measures for which there is Medicare patient
data. A group practice must report on at least 1 measure for which
there is Medicare patient data.
In addition, if a group practice of 2+ EPs chooses instead to use a
direct EHR product or EHR data submission vendor in conjunction with
reporting the CAHPS for PQRS survey measures, for the 12-month
reporting period for the 2018 PQRS payment adjustment, the group
practice would report all CAHPS for PQRS survey measures via a
certified survey vendor, and report at least 6 additional measures,
outside of the CAHPS for PQRS survey, covering at least 2 of the NQS
domains using the direct EHR product or EHR data submission vendor
product. If less than 6 measures apply to the group practice, the group
practice must report all applicable measures. Of the non-CAHPS for PQRS
measures that must be reported in conjunction with reporting the CAHPS
for PQRS survey measures, a group practice would be required to report
on at least 1 measure for which there is Medicare patient data. We note
that this option to report 6 additional measures is consistent with the
proposed criterion for satisfactory reporting for the 2018 PQRS payment
adjustment via EHR without CAHPS for PQRS, since both criteria assess a
total of 3 domains (since CAHPS for PQRS is in one NQS domain). We
invited and received the following public comments on these proposals:
Comment: We received general support for the proposed criteria for
satisfactory reporting on individual PQRS quality measures for group
practices registered to participate in the GPRO via EHR for the 2018
PQRS payment adjustment. Some commenters specifically supported
continued use of the EHR-based reporting mechanism. With respect to
reporting CAHPS for PQRS, please note, we received general comments on
the requirement to report CAHPS for PQRS, as discussed in section
III.I.5.a. of this final rule with comment period.
Response: As we stated in section III.I.5.a. of this final rule
with comment period, because we are finalizing our proposal to require
group practices to report CAHPS for PQRS only with respect to group
practices of 100 or more EPs, we are modifying this proposal as
follows:
For group practices of 2-99 EPs registered to participate in the
GPRO via EHR for the 2018 PQRS payment adjustment: The administration
of the CAHPS for PQRS survey is OPTIONAL. Therefore, if reporting via
EHR, these group practices may meet the criteria for satisfactory
reporting for the 2018 PQRS payment adjustment in one of two ways:
OPTION 1 (group practices that do not voluntarily elect to
administer the CAHPS for PQRS survey in conjunction with EHR): For the
12-month reporting period for the 2018 PQRS payment adjustment, the
group practice would report 9 measures covering at least 3 domains. If
the group practice's direct EHR product or EHR data submission vendor
product does not contain patient data for at least 9 measures covering
at least 3 domains, then the group practice must report all of the
measures for which there is Medicare patient data. A group practice
must report on at least 1 measure for which there is Medicare patient
data.
OPTION 2 (group practices that voluntarily elect to administer the
CAHPS for PQRS survey in conjunction with EHR): For the 12-month
reporting period for the 2018 PQRS payment adjustment, report all CAHPS
for PQRS survey measures via a certified survey vendor, and report at
least 6 additional measures, outside of the CAHPS for PQRS survey,
covering at least 2 of the NQS domains using the direct EHR product or
EHR data submission vendor product. If less than 6 measures apply to
the group practice, the group practice must report all applicable
measures. Of the non-CAHPS for PQRS measures that must be reported in
conjunction with reporting the CAHPS for PQRS survey measures, a group
practice would be required to report on at least 1 measure for which
there is Medicare patient data.
For group practices of 100+ EPs registered to participate in the
GPRO via EHR for the 2018 PQRS payment adjustment: The administration
of the CAHPS for PQRS survey is REQUIRED. Therefore, if reporting via
EHR, these group practices must meet the following criterion for
satisfactory reporting for the 2018 PQRS payment adjustment: For the
12-month reporting period for the 2018 PQRS payment adjustment, report
all CAHPS for PQRS survey measures via a certified survey vendor, and
report at least 6 additional measures, outside
[[Page 71147]]
of the CAHPS for PQRS survey, covering at least 2 of the NQS domains
using the direct EHR product or EHR data submission vendor product. If
less than 6 measures apply to the group practice, the group practice
must report all applicable measures. Of the non-CAHPS for PQRS measures
that must be reported in conjunction with reporting the CAHPS for PQRS
survey measures, a group practice would be required to report on at
least 1 measure for which there is Medicare patient data.
e. Satisfactory Participation in a QCDR for Group Practices Registered
To Participate in the GPRO via a QCDR for the 2018 PQRS Payment
Adjustment
Section 101(d)(1)(B) of the MACRA amends section 1848(m)(3)(D) of
the Act by inserting ``and, for 2016 and subsequent years, subparagraph
(A) or (C)'' after ``subparagraph (A)''. This change requires CMS to
create an option for EPs participating in the GPRO to report quality
measures via a QCDR.
As such, please note that we are modifying Sec. 414.90(k) to
indicate that group practices may also use a QCDR to participate in the
PQRS.
f. Reporting Period for the Satisfactory Participation by Group
Practices in a QCDR for the 2018 PQRS Payment Adjustment
Section 1848(m)(3)(D) of the Act, as redesignated and added by
section 601(b) of the America Taxpayer Relief Act of 2012 and further
amended by MACRA, requires the Secretary to treat a group practice as
satisfactorily submitting data on quality measures under section
1848(m)(3)(A) of the Act if the group practice is satisfactorily
participating in a QCDR for the year. Given that satisfactory
participation is with regard to the year, and to provide consistency
with the reporting period applicable to individual EPs who participate
in the PQRS via a QCDR, we proposed to revise Sec. 414.90(k) to
specify a 12-month, CY reporting period from January 1, 2016 through
December 31, 2016 for group practices participating in the GPRO to
satisfactorily participate in a QCDR for purposes of the 2018 PQRS
payment adjustment. We proposed a 12-month reporting period. Based on
our experience with the 12- and 6-month reporting periods for the PQRS
incentives, we believe that data on quality measures collected based on
12 months provides a more accurate assessment of actions performed in a
clinical setting than data collected based on shorter reporting
periods. In addition, we believe a 12-month reporting period is
appropriate given that the full calendar year would be utilized with
regard to the participation by the group practice in the QCDR. We
invited public comment on the proposed 12-month, CY 2016 reporting
period for the satisfactory participation of group practices in a QCDR
for the 2018 PQRS payment adjustment.
The following is a summary of the comments we received regarding
our proposal.
Comment: Commenters generally supported the proposed 12-month
reporting period from January 1, 2016, through December 31, 2016 for
group practices participating in the GPRO to satisfactorily participate
in a QCDR for purposes of the 2018 PQRS payment adjustment, as it is
consistent with the reporting period for other criteria for
satisfactory reporting, as well as satisfactory participation in a QCDR
in the PQRS.
Response: As a result of the supportive comments, we are finalizing
this reporting period, as proposed. Therefore, we are revising Sec.
414.90(k) to specify a 12-month, CY reporting period from January 1,
2016, through December 31, 2016 for group practices participating in
the GPRO to satisfactorily participate in a QCDR for purposes of the
2018 PQRS payment adjustment.
g. Criteria for Satisfactory Participation in a QCDR for Group
Practices Registered To Participate in the GPRO via a QCDR for the 2018
PQRS Payment Adjustment
To be consistent with individual reporting criteria that we
finalized for the 2017 PQRS payment adjustment (see Table 50 at 79 FR
67796) as well as our individual reporting criteria for the 2018 PQRS
payment adjustment, for purposes of the 2018 PQRS payment adjustment
(which would be based on data reported during the 12-month period that
falls in CY 2016), we proposed to amend Sec. 414.90(j) to use the same
criterion for group practices as individual EPs to satisfactorily
participate in a QCDR for the 2018 PQRS payment adjustment.
Specifically, for the 12-month reporting period for the 2018 PQRS
payment adjustment, the group practice would report at least 9 measures
available for reporting under a QCDR covering at least 3 of the NQS
domains, AND report each measure for at least 50 percent of the group
practice's patients. Of these measures, the group practice would report
on at least 2 outcome measures, OR, if 2 outcomes measures are not
available, report on at least 1 outcome measures and at least 1 of the
following types of measures--resource use, patient experience of care,
efficiency/appropriate use, or patient safety.
We solicited and received the following public comments on these
proposals:
Comment: Commenters generally supported the option to report
quality measures data via a QCDR as a group practice. One commenter
opposed the proposal to require group practices using a QCDR to report
on at least 9 measures. The commenter noted that when the QCDR option
was first introduced to as a reporting method for individuals, EPs were
only required to report at least three measures.
Response: We appreciate the commenters' concerns regarding the
requirement to report at least 9 measures. However, we believe that
group practices should be required to report on the same amount of
measures as an individual EP. Based on the positive feedback and the
rationale provided, we are finalizing the proposed criterion for
satisfactory participation in a QCDR for group practices registered to
participate in the GPRO via a QCDR for the 2018 PQRS payment
adjustment, as proposed.
Tables 27 and 28 reflect our criteria for satisfactory reporting--
or, in lieu of satisfactory reporting, satisfactory participation in a
QCDR--for the 2018 PQRS payment adjustment:
[[Page 71148]]
Table 27--Summary of Requirements for the 2018 PQRS Payment Adjustment: Individual Reporting Criteria for the
Satisfactory Reporting of Quality Measures Data via Claims, Qualified Registry, and EHRs and Satisfactory
Participation Criterion in QCDRs
----------------------------------------------------------------------------------------------------------------
Reporting Satisfactory reporting/satisfactory
Reporting period Measure type mechanism participation criteria
----------------------------------------------------------------------------------------------------------------
12-month (Jan 1-Dec 31, 2016) Individual Claims........... Report at least 9 measures, covering at
Measures least 3 of the NQS domains AND report
each measure for at least 50 percent of
the EP's Medicare Part B FFS patients
seen during the reporting period to which
the measure applies. Of the measures
reported, if the EP sees at least 1
Medicare patient in a face-to-face
encounter, the EP will report on at least
1 measure contained in the PQRS cross-
cutting measure set. If less than 9
measures apply to the EP, the EP would
report on each measure that is
applicable), AND report each measure for
at least 50 percent of the Medicare Part
B FFS patients seen during the reporting
period to which the measure applies.
Measures with a 0 percent performance
rate would not be counted.
12-month (Jan 1-Dec 31, 2016) Individual Qualified Report at least 9 measures, covering at
Measures Registry. least 3 of the NQS domains AND report
each measure for at least 50 percent of
the EP's Medicare Part B FFS patients
seen during the reporting period to which
the measure applies. Of the measures
reported, if the EP sees at least 1
Medicare patient in a face-to-face
encounter, the EP will report on at least
1 measure contained in the PQRS cross-
cutting measure set. If less than 9
measures apply to the EP, the EP would
report on each measure that is
applicable, AND report each measure for
at least 50 percent of the Medicare Part
B FFS patients seen during the reporting
period to which the measure applies.
Measures with a 0 percent performance
rate would not be counted.
12-month (Jan 1-Dec 31, 2016) Individual Direct EHR Report 9 measures covering at least 3 of
Measures Product or EHR the NQS domains. If an EP's direct EHR
Data Submission product or EHR data submission vendor
Vendor Product. product does not contain patient data for
at least 9 measures covering at least 3
domains, then the EP would be required to
report all of the measures for which
there is Medicare patient data. An EP
would be required to report on at least 1
measure for which there is Medicare
patient data.
12-month (Jan 1-Dec 31, 2016) Measures Groups Qualified Report at least 1 measures group AND
Registry. report each measures group for at least
20 patients, the majority (11 patients)
of which are required to be Medicare Part
B FFS patients. Measures groups
containing a measure with a 0 percent
performance rate will not be counted.
12-month (Jan 1-Dec 31, 2016) Individual PQRS Qualified Report at least 9 measures available for
measures and/or Clinical Data reporting under a QCDR covering at least
non-PQRS Registry (QCDR). 3 of the NQS domains, AND report each
measures measure for at least 50 percent of the
reportable via a EP's patients. Of these measures, the EP
QCDR would report on at least 2 outcome
measures, OR, if 2 outcomes measures are
not available, report on at least 1
outcome measures and at least 1 of the
following types of measures--resource
use, patient experience of care,
efficiency/appropriate use, or patient
safety.
----------------------------------------------------------------------------------------------------------------
Table 28--Summary of Requirements for the 2018 PQRS Payment Adjustment: Group Practice Reporting Criteria for
Satisfactory Reporting of Quality Measures Data via the GPRO
----------------------------------------------------------------------------------------------------------------
Group Practice Reporting Satisfactory Reporting
Reporting Period Size Measure Type Mechanism Criteria
----------------------------------------------------------------------------------------------------------------
12-month (Jan 1-Dec 31, 2016) 25-99 EPs; 100+ Individual GPRO Web Interface.. Report on all measures
EPs (if *CAHPS Measures in included in the web
for PQRS does the Web interface; AND populate data
not apply). Interface. fields for the first 248
consecutively ranked and
assigned beneficiaries in the
order in which they appear in
the group's sample for each
module or preventive care
measure. If the pool of
eligible assigned
beneficiaries is less than
248, then the group practice
must report on 100 percent of
assigned beneficiaries. In
other words, we understand
that, in some instances, the
sampling methodology we
provide will not be able to
assign at least 248 patients
on which a group practice may
report, particularly those
group practices on the
smaller end of the range of
25-99 EPs. If the group
practice is assigned less
than 248 Medicare
beneficiaries, then the group
practice must report on 100
percent of its assigned
beneficiaries. A group
practice must report on at
least 1 measure for which
there is Medicare patient
data.
[[Page 71149]]
12-month (Jan 1-Dec 31, 2016) 25-99 EPs that Individual GPRO Web Interface + The group practice must have
elect CAHPS Measures in CMS-Certified all CAHPS for PQRS survey
for PQRS; 100+ the Web Survey Vendor. measures reported on its
EPs (if CAHPS Interface + behalf via a CMS-certified
for PQRS CAHPS for PQRS. survey vendor. In addition,
applies). the group practice must
report on all measures
included in the Web
Interface; AND populate data
fields for the first 248
consecutively ranked and
assigned beneficiaries in the
order in which they appear in
the group's sample for each
module or preventive care
measure. If the pool of
eligible assigned
beneficiaries is less than
248, then the group practice
must report on 100 percent of
assigned beneficiaries. A
group practice will be
required to report on at
least 1 measure for which
there is Medicare patient
data.
Please note that, if the CAHPS
for PQRS survey is applicable
to a group practice who
reports quality measures via
the Web Interface, the group
practice must administer the
CAHPS for PQRS survey in
addition to reporting the Web
Interface measures.
12-month (Jan 1-Dec 31, 2016) 2-99 EPs; 100+ Individual Qualified Report at least 9 measures,
EPs (if CAHPS Measures. Registry. covering at least 3 of the
for PQRS does NQS domains. Of these
not apply). measures, if a group practice
sees at least 1 Medicare
patient in a face-to-face
encounter, the group practice
would report on at least 1
measure in the PQRS cross-
cutting measure set. If less
than 9 measures covering at
least 3 NQS domains apply to
the group practice, the group
practice would report on each
measure that is applicable to
the group practice, AND
report each measure for at
least 50 percent of the
group's Medicare Part B FFS
patients seen during the
reporting period to which the
measure applies. Measures
with a 0 percent performance
rate would not be counted.
12-month (Jan 1-Dec 31, 2016) 2-99 EPs that Individual Qualified The group practice must have
elect CAHPS Measures + Registry + CMS- all CAHPS for PQRS survey
for PQRS; 100+ CAHPS for PQRS. Certified measures reported on its
EPs (if CAHPS Survey Vendor. behalf via a CMS-certified
for PQRS survey vendor, and report at
applies). least 6 additional measures,
outside of the CAHPS for PQRS
survey, covering at least 2
of the NQS domains using the
qualified registry. If less
than 6 measures apply to the
group practice, the group
practice must report on each
measure that is applicable to
the group practice. Of the
additional measures that must
be reported in conjunction
with reporting the CAHPS for
PQRS survey measures, if any
EP in the group practice sees
at least 1 Medicare patient
in a face-to-face encounter,
the group practice must
report on at least 1 measure
in the PQRS cross-cutting
measure set.
12-month (Jan 1-Dec 31, 2016) 2-99 EPs; 100+ Individual Direct EHR Report 9 measures covering at
EPs (if CAHPS Measures. Product or EHR least 3 domains. If the group
for PQRS does Data practice's direct EHR product
not apply). Submission or EHR data submission vendor
Vendor Product. product does not contain
patient data for at least 9
measures covering at least 3
domains, then the group
practice must report all of
the measures for which there
is Medicare patient data. A
group practice must report on
at least 1 measure for which
there is Medicare patient
data.
12-month (Jan 1-Dec 31, 2016) 2-99 EPs that Individual Direct EHR The group practice must have
elect CAHPS Measures + Product or EHR all CAHPS for PQRS survey
for PQRS; 100+ CAHPS for PQRS. Data measures reported on its
EPs (if CAHPS Submission behalf via a CMS-certified
for PQRS Vendor Product survey vendor, and report at
applies). + CMS- least 6 additional measures,
Certified outside of CAHPS for PQRS,
Survey Vendor. covering at least 2 of the
NQS domains using the direct
EHR product or EHR data
submission vendor product. If
less than 6 measures apply to
the group practice, the group
practice must report all of
the measures for which there
is Medicare patient data. Of
the additional 6 measures
that must be reported in
conjunction with reporting
the CAHPS for PQRS survey
measures, a group practice
would be required to report
on at least 1 measure for
which there is Medicare
patient data.
[[Page 71150]]
12-month (Jan 1-Dec 31, 2016) 2+ EPs......... Individual PQRS Qualified Report at least 9 measures
measures and/ Clinical Data available for reporting under
or non-PQRS Registry a QCDR covering at least 3 of
measures (QCDR). the NQS domains, AND report
reportable via each measure for at least 50
a QCDR. percent of the group
practice's patients. Of these
measures, the group practice
would report on at least 2
outcome measures, OR, if 2
outcomes measures are not
available, report on at least
1 outcome measures and at
least 1 of the following
types of measures--resource
use, patient experience of
care, efficiency/appropriate
use, or patient safety.
----------------------------------------------------------------------------------------------------------------
6. Statutory Requirements and Other Considerations for the Selection of
PQRS Quality Measures for Meeting the Criteria for Satisfactory
Reporting for 2016 and Beyond for Individual EPs and Group Practices
Annually, we solicit a ``Call for Measures'' from the public for
possible inclusion in the PQRS. During the Call for Measures, we
request measures for inclusion in PQRS that meet the following
statutory and other criteria.
Sections 1848(k)(2)(C) and 1848(m)(3)(C)(i) of the Act,
respectively, govern the quality measures reported by individual EPs
and group practices under the PQRS. Under section 1848(k)(2)(C)(i) of
the Act, the PQRS quality measures shall be such measures selected by
the Secretary from measures that have been endorsed by the entity with
a contract with the Secretary under section 1890(a) of the Act, which
is currently the National Quality Forum (NQF). However, in the case of
a specified area or medical topic determined appropriate by the
Secretary for which a feasible and practical measure has not been
endorsed by the NQF, section 1848(k)(2)(C)(ii) of the Act authorizes
the Secretary to specify a measure that is not so endorsed as long as
due consideration is given to measures that have been endorsed or
adopted by a consensus organization identified by the Secretary. In
light of these statutory requirements, we believe that, except in the
circumstances specified in the statute, each PQRS quality measure must
be endorsed by the NQF. Additionally, section 1848(k)(2)(D) of the Act
requires that for each PQRS quality measure, the Secretary shall ensure
that EPs have the opportunity to provide input during the development,
endorsement, or selection of measures applicable to services they
furnish. The statutory requirements under section 1848(k)(2)(C) of the
Act, subject to the exception noted previously, require only that the
measures be selected from measures that have been endorsed by the
entity with a contract with the Secretary under section 1890(a) of the
Act (that is, the NQF) and are silent as to how the measures that are
submitted to the NQF for endorsement are developed.
The steps for developing measures applicable to physicians and
other EPs prior to submission of the measures for endorsement may be
carried out by a variety of different organizations. We do not believe
there needs to be special restrictions on the type or make-up of the
organizations carrying out this process of development of physician
measures, such as restricting the initial development to physician-
controlled organizations. Any such restriction would unduly limit the
development of quality measures and the scope and utility of measures
that may be considered for endorsement as voluntary consensus standards
for purposes of the PQRS.
In addition to section 1848(k)(2)(C) of the Act, section 1890A of
the Act, which was added by section 3014(b) of the Affordable Care Act,
requires that the Secretary establish a pre-rulemaking process under
which certain steps occur for the selection of certain categories of
quality and efficiency measures, one of which is that the entity with a
contract with the Secretary under section 1890(a) of the Act (that is,
the NQF) convene multi-stakeholder groups to provide input to the
Secretary on the selection of such measures. These categories are
described in section 1890(b)(7)(B) of the Act, and include such
measures as the quality measures selected for reporting under the PQRS.
In accordance with section 1890A(a)(1) of the Act, the NQF convened
multi-stakeholder groups by creating the MAP. Section 1890A(a)(2) of
the Act requires that the Secretary must make publicly available by
December 1st of each year a list of the quality and efficiency measures
that the Secretary is considering for selection through rulemaking for
use in the Medicare program. The NQF must provide CMS with the MAP's
input on the selection of measures by February 1st of each year. The
lists of measures under consideration for selection through rulemaking
in 2015 are available at http://www.qualityforum.org/map/.
As we noted above, section 1848(k)(2)(C)(ii) of the Act provides an
exception to the requirement that the Secretary select measures that
have been endorsed by the entity with a contract under section 1890(a)
of the Act (that is, the NQF). We may select measures under this
exception if there is a specified area or medical topic for which a
feasible and practical measure has not been endorsed by the entity, as
long as due consideration is given to measures that have been endorsed
or adopted by a consensus organization identified by the Secretary.
Under this exception, aside from NQF endorsement, we requested that
stakeholders apply the following considerations when submitting
measures for possible inclusion in the PQRS measure set:
Measures that are not duplicative of another existing or
proposed measure.
Measures that are further along in development than a
measure concept.
We are not accepting claims-based-only reporting measures
in this process.
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 include the NQS domain for care coordination
and communication.
Measures that include the NQS domain for patient
experience and patient-reported outcomes.
Measures that address efficiency, cost and resource use.
As such, we may exercise our authority under section
1848(k)(2)(C)(ii) of the Act to propose and finalize a measure because
a feasible and practical measure has not been endorsed by the
[[Page 71151]]
NQF for a specified topic, as long as due consideration is given to
measures that have been endorsed or adopted by a consensus organization
identified by the Secretary.
a. PQRS Quality Measures
Taking into consideration the statutory and non-statutory criteria
we described previously, this section discusses the inclusion or
removal of measures in PQRS for 2016 and beyond. We classified all
measures against six domains based on the NQS's six priorities, as
follows:
(1) Patient Safety. These are measures that reflect the safe
delivery of clinical services in all healthcare settings. These
measures may address a structure or process that is designed to reduce
risk in the delivery of healthcare or measure the occurrence of an
untoward outcome such as adverse events and complications of procedures
or other interventions.
(2) Person and Caregiver-Centered Experience and Outcomes. These
are measures that reflect the potential to improve patient-centered
care and the quality of care delivered to patients. They emphasize the
importance of collecting patient-reported data and the ability to
impact care at the individual patient level, as well as the population
level. These are measures of organizational structures or processes
that foster both the inclusion of persons and family members as active
members of the health care team and collaborative partnerships with
providers and provider organizations or can be measures of patient-
reported experiences and outcomes that reflect greater involvement of
patients and families in decision making, self-care, activation, and
understanding of their health condition and its effective management.
(3) Communication and Care Coordination. These are measures that
demonstrate appropriate and timely sharing of information and
coordination of clinical and preventive services among health
professionals in the care team and with patients, caregivers, and
families to improve appropriate and timely patient and care team
communication. They may also be measures that reflect outcomes of
successful coordination of care.
(4) Effective Clinical Care. These are measures that reflect
clinical care processes closely linked to outcomes based on evidence
and practice guidelines or measures of patient-centered outcomes of
disease states.
(5) Community/Population Health. These are measures that reflect
the use of clinical and preventive services and achieve improvements in
the health of the population served. They may be measures of processes
focused on primary prevention of disease or general screening for early
detection of disease unrelated to a current or prior condition.
(6) Efficiency and Cost Reduction. These are measures that reflect
efforts to lower costs and to significantly improve outcomes and reduce
errors. These are measures of cost, resource use and appropriate use of
healthcare resources or inefficiencies in healthcare delivery.
In addition, CMS considers the MAP's recommendations as part of the
comprehensive assessment of each measure considered for inclusion in
the program. Additional elements under consideration include a
measure's fit within the program, if a measure fills clinical gaps,
changes or updates to clinical guidelines and other program needs. As
such, while CMS strongly considers the MAP's recommendations, MAP
support is not required for inclusion in PQRS.
Please note that the PQRS quality measure specifications for any
given PQRS individual quality measure may differ from specifications
for the same quality measure used in prior years. For example, for the
PQRS quality measures that were selected for reporting in 2016 and
beyond, please note that detailed measure specifications, including the
measure's title, for the individual PQRS quality measures for 2016 and
beyond may have been updated or modified during the NQF endorsement
process or for other reasons.
In addition, due to our desire to align measure titles with the
measure titles that have been finalized for 2013, 2014, 2015 reporting,
and potentially subsequent years of the Medicare EHR Incentive Program,
we noted that the measure titles for measures available for reporting
via EHR-based reporting mechanisms may change. To the extent that the
Medicare EHR Incentive Program updates its measure titles to include
version numbers (see 77 FR 13744), we used these version numbers to
describe the PQRS EHR measures that will also be available for
reporting for the EHR Incentive Program. We will continue to work
toward complete alignment of measure specifications across programs
whenever possible.
Through NQF's measure maintenance process, NQF-endorsed measures
are sometimes updated to incorporate changes that we believe do not
substantively change the nature 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.
Further, we believe that non-substantive maintenance changes of this
type do not trigger the same agency obligations under the
Administrative Procedure Act.
In the CY 2013 PFS final rule with comment period, we finalized our
proposal providing that if the NQF updates an endorsed measure that we
have adopted for the PQRS in a manner that we consider to not
substantively change the nature of the measure, we would use a
subregulatory process to incorporate those updates to the measure
specifications that apply to the program (77 FR 69207). We believe this
adequately balances our need to incorporate non-substantive NQF updates
to NQF-endorsed measures in the most expeditious manner possible, while
preserving the public's ability to comment on updates that change an
endorsed measure such that it is no longer the same measure that we
originally adopted. We also noted that the NQF process incorporates an
opportunity for public comment and engagement in the measure
maintenance process. We revised the Specifications Manual and posted
notices to clearly identify the updates and provide links to where
additional information on the updates can be found. Updates are also
available on the CMS PQRS Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html.
We are not the measure steward for most of the measures available
for reporting under the PQRS. We rely on outside measure stewards and
developers to maintain these measures. In Table 31, we proposed that
certain measures be removed from the PQRS measure set due to the
measure steward indicating that it will not be able to maintain the
measure. We noted that this proposal is contingent upon the measure
steward not being able to maintain the measure. Should we learn that a
certain measure steward is able to maintain the measure, or that
another entity is able to maintain the measure in a manner that allows
the measure to be available for reporting under the PQRS for the CY
2018 PQRS payment adjustment, we proposed to keep the measure available
for reporting under the PQRS and therefore not finalize our proposal to
remove the measure. We stated that we would discuss any such instances
in the CY 2016 PFS final rule with comment period.
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In addition, we noted that we have received feedback from
stakeholders, particularly first-time participants who find it
difficult to understand which measures are applicable to their
particular practice. In an effort to aide EPs and group practices to
determine what measures best fit their practice, and in collaboration
with specialty societies, we began to group our final measures
available for reporting according to specialty. The current listing of
our measures by specialty can be found on our Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/index.html. Please note that these groups of measures
are meant to provide guidance to those EPs seeking to determine what
measures to report. EPs are not required to report measures according
to these suggested groups of measures. As measures are adopted or
revised, we will continue to update these groups to reflect the
measures available under the PQRS, as well as add more specialties.
b. Cross-Cutting Measures for 2016 Reporting and Beyond
In the CY 2015 PFS final rule with comment period, we finalized a
set of 19 cross-cutting measures for reporting in the PQRS for 2015 and
beyond (see Table 52 at 79 FR 67801). The current PQRS cross-cutting
measure set is available at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2015_PQRS_CrosscuttingMeasures_12172014.pdf. In Table 29, we proposed
the following measures to be added to the current PQRS cross-cutting
measure set. Please note that our rationale for each of these measures
is found below the measure description. We solicited and received
public comments on these measures. A summary of the comments, our
responses, as well as final decisions are in Table 29. Please note that
these proposed measures in Table 30 are in addition to the 19
previously finalized cross-cutting measures. As such, for 2016, there
will be a total of 23 cross-cutting measures in PQRS.
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c. New PQRS Measures Available for Reporting for 2016 and Beyond and
Changes to Existing PQRS Measures
Table 30 contains additional measures we proposed to include in the
PQRS measure set for CY 2016 and beyond. We also indicated the PQRS
reporting mechanism or mechanisms through which each measure could be
submitted, as well as the MAP recommendations. Additional comments and
measure information from the MAP review can be found at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=78711.
Please note that, in some cases specified below, we proposed adding
a measure to the PQRS measure set that the MAP believes requires
further development prior to inclusion or does not support a measure
for inclusion in the PQRS measure set. Please note that, although we
take these recommendations into consideration, in these instances, we
believe the rationale provided for the addition of a measure outweighs
the MAP's recommendation.
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In Table 31, we provided our proposals for a NQS domain change for
measures that are currently available for reporting under the PQRS.
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In Table 32, we proposed to remove the following measures from
reporting under the PQRS.
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In Table 33, we proposed to change the mechanism(s) by which an EP
or group practice may report a respective PQRS measure beginning in
2016.
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d. PQRS Measures Groups
Section 414.90(b) defines a measures group as a subset of six or
more PQRS measures that have a particular clinical condition or focus
in common. The denominator definition and coding of the measures group
identifies the condition or focus that is shared across the measures
within a particular measures group.
We proposed to add the following 3 new measures groups as shown in
Tables 34, 35 and 36 that will be available for reporting in the PQRS
beginning in 2016. Please note that, in these tables, we provided the
PQRS measure numbers for the measures within these measures groups that
were previously finalized in the PQRS. New measures within these
measures groups that were proposed to be added, as indicated in Table
29, do not have a PQRS number. Therefore, in lieu of a PQRS number, an
``NA'' is indicated. We solicited and received the following public
comments on these proposed measures groups:
Multiple Chronic Conditions Measures Group: We proposed to
add the Multiple Chronic Conditions Measures Group in the CY 2016
proposed rule. A large proportion of the Medicare population are
impacted by Multiple Chronic Conditions, and providers that treat this
population are often not recognized for the complexity of treatment for
a patient with multiple chronic conditions. The addition of this
measures group would specifically identify those providers that address
the exponential complexity of treating the combination of these
conditions rather than a sum of the individual conditions. This
measures group addresses the complexity of care that is required for
patients that may have multiple disease processes that require clinical
management and treatment.
Comment: Commenters supported the inclusion of this measure groups
in PQRS.
Response: Based on the comments and rationale provided, CMS is
finalizing its proposal to include this measures group for reporting in
the PQRS beginning in 2016.
Cardiovascular Prevention Measures Group (Millions
Hearts): We proposed to add the Cardiovascular Prevention Measures
Group in the CY 2016 proposed rule. Prior to 2015, the PQRS included a
Cardiovascular Prevention Measures Group (Measures 2, 204, 226, 236,
241 and 317 in 2014 (78 FR 74741)). The measures group was removed for
2015 PQRS reporting due to clinical guideline changes that affected
many of the measures. Given the efficacy of cardiovascular prevention
on cardiovascular health, this measures
[[Page 71209]]
group is being re-considered with an adjustment to align with current
clinical guidelines. This measures group is also fully supported by the
Million Hearts Initiative.
Comment: Commenters supported the inclusion of this measures group
in PQRS.
Response: Based on the comments and rationale provided, CMS is
finalizing its proposal to include this measures group for reporting in
the PQRS beginning in 2016.
Diabetic Retinopathy Measures Group: We proposed to add
the Diabetic Retinopathy Measures Group in the CY 2016 proposed rule.
An increase in the frequency of Type 2 diabetes in the pediatric age
group is associated with increased childhood obesity. The implications
are significantly increased burdens of disability and complications
associated with diabetes, including diabetic retinopathy, which has a
projected prevalence of 6 million individuals with diabetic retinopathy
by the year 2020 in the United States, and a prevalence rate of 28.5%
in all adults with diabetes aged 40 and older. The addition of the
Diabetic Retinopathy Measures Group would help to address this
significant public health problem by allowing for the comprehensive
evaluation of provider performance and patient outcomes related to a
disease that threatens the eyesight of a very large population, and by
supporting improvements in quality of care and outcomes related to
diabetic retinopathy.
Comment: Commenters supported the inclusion of this measures group
in PQRS.
Response: Based on the comments and rationale provided, CMS is
finalizing its proposal to include this measures group for reporting in
the PQRS beginning in 2016.
Table 34--Cardiovascular Prevention Measures Group for 2016 and Beyond
[Millions hearts]
------------------------------------------------------------------------
Measure
NQF/ PQRS Measure title and description developer
------------------------------------------------------------------------
0419/130..... Documentation of Current Medications in Centers for
the Medical Record: Percentage of Medicare &
visits for patients aged 18 years and Medicaid
older for which the EP attests to Services/
documenting a list of current Mathematica/
medications using all immediate Quality
resources available on the date of the Insights of
encounter. This list must include ALL Pennsylvania.
known prescriptions, over-the-counters,
herbals, and vitamin/mineral/dietary
(nutritional) supplements AND must
contain the medications' name, dosage,
frequency and route of administration.
0028/226..... Preventive Care and Screening: Tobacco American
use: Screening and Cessation Medical
Intervention: Percentage of patients Association--P
aged 18 years and older who were hysician
screened for tobacco use one or more Consortium for
times within 24 months AND who received Performance
cessation counseling intervention if Improvement.
identified as a tobacco user.
0068/204..... Ischemic Vascular Disease (IVD): Use of National
Aspirin or Another Antithrombotic: Committee for
Percentage of patients 18 years of age Quality
and older who were discharged alive for Assurance.
acute myocardial infarction (AMI),
coronary artery bypass graft (CABG) or
percutaneous coronary interventions
(PCI) in the 12 months prior to the
measurement period, or who had an
active diagnosis of ischemic vascular
disease (IVD) during the measurement
period and who had documentation of use
of aspirin or another antithrombotic
during the measurement period.
0018/236..... Controlling High Blood Pressure: National
Percentage of patients 18-85 years of Committee for
age who had a diagnosis of hypertension Quality
and whose blood pressure was adequately Assurance.
controlled (<140/90 mmHg) during the
measurement period.
N/A/317...... Preventive Care and Screening: Screening Centers for
for High Blood Pressure and Follow-Up Medicare &
Documented: Percentage of patients aged Medicaid
18 years and older seen during the Services/
reporting period who were screened for Mathematica/
high blood pressure AND a recommended Quality
follow-up plan is documented based on Insights of
the current blood pressure (BP) reading Pennsylvania.
as indicated.
N/A/438...... Statin Therapy for the Prevention and Centers for
Treatment of Cardiovascular Disease: Medicare &
Percentage of the following patients-- Medicaid
all considered at high risk of Services/
cardiovascular events--who were Mathematica/
prescribed or were on statin therapy Quality
during the measurement period:. Insights of
Adults aged >= 21 years who Pennsylvania.
were previously diagnosed with or
currently have an active diagnosis of
clinical atherosclerotic cardiovascular
disease (ASCVD); OR.
Adults aged >=21 years with a
fasting or direct low-density
lipoprotein cholesterol (LDL-C) level
>= 190 mg/dL; OR.
Adults aged 40-75 years with a
diagnosis of diabetes with a fasting or
direct LDL-C level of 70-189 mg/dL.
This is a new measure described in Table
22 above.
------------------------------------------------------------------------
Table 35--Diabetic Retinopathy Measures Group for 2016 and Beyond
------------------------------------------------------------------------
Measure
NQF/ PQRS Measure title and description developer
------------------------------------------------------------------------
0059/001..... Diabetes: Hemoglobin A1c Poor Control: National
Percentage of patients 18-75 years of Committee for
age with diabetes who had hemoglobin Quality
A1c > 9.0% during the measurement Assurance.
period.
0088/018..... Diabetic Retinopathy: Documentation of American
Presence or Absence of Macular Edema Medical
and Level of Severity of Retinopathy: Association-
Percentage of patients aged 18 years Physician
and older with a diagnosis of diabetic Consortium for
retinopathy who had a dilated macular Performance
or fundus exam performed which included Improvement/
documentation of the level of severity National
of retinopathy and the presence or Committee for
absence of macular edema during one or Quality
more office visits within 12 months. Assurance.
[[Page 71210]]
0089/019..... Diabetic Retinopathy: Communication with American
the Physician Managing Ongoing Diabetes Medical
Care: Percentage of patients aged 18 Association-
years and older with a diagnosis of Physician
diabetic retinopathy who had a dilated Consortium for
macular or fundus exam performed with Performance
documented communication to the Improvement/
physician who manages the ongoing care National
of the patient with diabetes mellitus Committee for
regarding the findings of the macular Quality
or fundus exam at least once within 12 Assurance.
months.
0055/117..... Diabetes: Eye Exam: Percentage of National
patients 18-75 years of age with Committee for
diabetes who had a retinal or dilated Quality
eye exam by an eye care professional Assurance.
during the measurement period or a
negative retinal or dilated eye exam
(no evidence of retinopathy) in the 12
months prior to the measurement period.
0419/130..... Documentation of Current Medications in Centers for
the Medical Record: Percentage of Medicare &
visits for patients aged 18 years and Medicaid
older for which the EP attests to Services/
documenting a list of current Quality
medications using all immediate Insights of
resources available on the date of the Pennsylvania.
encounter. This list must include ALL
known prescriptions, over-the-counters,
herbals, and vitamin/mineral/dietary
(nutritional) supplements AND must
contain the medications' name, dosage,
frequency and route of administration.
0028/226..... Preventive Care and Screening: Tobacco American
Use: Screening and Cessation Medical
Intervention: Percentage of patients 18 Association-
years and older who were screened for Physician
tobacco use one or more times within 24 Consortium for
months AND who received cessation Performance
counseling intervention if identified Improvement.
as a tobacco user.
N/A/317...... Preventive Care and Screening: Screening Centers for
for High Blood Pressure and Follow-Up Medicare &
Documented: Percentage of patients aged Medicaid
18 years and older seen during the Services/
reporting period who were screened for Mathematica/
high blood pressure AND a recommended Quality
follow-up plan is documented based on Insights of
the current blood pressure (BP) reading Pennsylvania.
as indicated.
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Table 36--Multiple Chronic Conditions Measures Group for 2016 and Beyond
------------------------------------------------------------------------
Measure
NQF/ PQRS Measure title and description developer
------------------------------------------------------------------------
0326/047..... Care Plan: Percentage of patients aged National
65 years and older who have an advance Committee for
care plan or surrogate decision maker Quality
documented in the medical record or Assurance/
documentation in the medical record American
that an advance care plan was discussed Medical
but the patient did not wish or was not Association-
able to name a surrogate decision maker Physician
or provide an advance care plan. Consortium for
Performance
Improvement.
0041/110..... Preventive Care and Screening: Influenza American
Immunization: Percentage of patients Medical
aged 6 months and older seen for a Association-
visit between October 1 and March 31 Physician
who received an influenza immunization Consortium for
OR who reported previous receipt of an Performance
influenza immunization. Improvement.
0421/128..... Preventive Care and Screening: Body Mass Centers for
Index (BMI) Screening and Follow-Up Medicare &
Plan: Percentage of patients aged 18 Medicaid
years and older with a BMI documented Services/
during the current encounter or during Mathematica/
the previous six months AND with a BMI Quality
outside of normal parameters, a follow- Insights of
up plan is documented during the Pennsylvania.
encounter or during the previous six
months of the current encounter.
Normal Parameters: Age 65 years and
older BMI >= 23 and < 30 kg/m2; Age 18-
64 years BMI >= 18.5 and < 25 kg/m2.
0419/130..... Documentation of Current Medications in Centers for
the Medical Record: Percentage of Medicare &
visits for patients aged 18 years and Medicaid
older for which the EP attests to Services/
documenting a list of current Mathematica/
medications using all immediate Quality
resources available on the date of the Insights of
encounter. This list must include ALL Pennsylvania.
known prescriptions, over-the-counters,
herbals, and vitamin/mineral/dietary
(nutritional) supplements AND must
contain the medications' name, dosage,
frequency and route of administration.
0420/131..... Pain Assessment and Follow-Up: Centers for
Percentage of visits for patients aged Medicare &
18 years and older with documentation Medicaid
of a pain assessment using a Services/
standardized tool(s) on each visit AND Quality
documentation of a follow-up plan when Insights of
pain is present. Pennsylvania.
0418/134..... Preventive Care and Screening: Screening Centers for
for Clinical Depression and Follow-Up Medicare &
Plan: Percentage of patients aged 12 Medicaid
years and older screened for clinical Services/
depression on the date of the encounter Mathematica/
using an age appropriate standardized Quality
depression screening tool AND if Insights of
positive, a follow-up plan is Pennsylvania.
documented on the date of the positive
screen.
0101/154..... Falls: Risk Assessment: Percentage of National
patients aged 65 years and older with a Committee for
history of falls who had a risk Quality
assessment for falls completed within Assurance/
12 months. American
Medical
Association-
Physician
Consortium for
Performance
Improvement.
[[Page 71211]]
0101/155..... Falls: Plan of Care: Percentage of National
patients aged 65 years and older with a Committee for
history of falls who had a plan of care Quality
for falls documented within 12 months. Assurance/
American
Medical
Association-
Physician
Consortium for
Performance
Improvement.
0022/238..... Use of High-Risk Medications in the National
Elderly: Percentage of patients 66 Committee for
years of age and older who were ordered Quality
high-risk medications. Two rates are Assurance.
reported.
a. Percentage of patients who were
ordered at least one high-risk
medication.
b. Percentage of patients who were
ordered at least two different high-
risk medications.
------------------------------------------------------------------------
We proposed to amend the following previously finalized measures
groups (in Table 37 through Table 41) for reporting in the PQRS
beginning in 2016. Please note that, in these tables, we provided the
PQRS measure numbers for the measures within these proposed measures
groups that were previously finalized in the PQRS. New measures within
these measures groups that were proposed to be added, as indicated in
Table 29, do not have a PQRS number. Therefore, in lieu of a PQRS
number, an ``NA'' is indicated.
Table 37--Coronary Artery Bypass Graft (CABG) Measures Group for 2016
and Beyond
------------------------------------------------------------------------
Measure
NQF/ PQRS Measure title and description developer
------------------------------------------------------------------------
0134/043..... Coronary Artery Bypass Graft (CABG): Use Society of
of Internal Mammary Artery (IMA) in Thoracic
Patients with Isolated CABG Surgery: Surgeons.
Percentage of patients aged 18 years
and older undergoing isolated Coronary
Artery Bypass Graft surgery who
received an Internal Mammary Artery
graft.
0236/044..... Coronary Artery Bypass Graft (CABG): Centers for
Preoperative Beta-Blocker in Patients Medicare &
with Isolated CABG Surgery: Percentage Medicaid
of isolated Coronary Artery Bypass Services/
Graft (CABG) surgeries for patients Quality
aged 18 years and older who received a Insights of
beta-blocker within 24 hours prior to Pennsylvania.
surgical incision.
0129/164..... Coronary Artery Bypass Graft (CABG): Society of
Prolonged Intubation: Percentage of Thoracic
patients aged 18 years and older Surgeons.
undergoing isolated Coronary Artery
Bypass Graft (CABG) surgery who require
postoperative intubation > 24 hours.
0130/165..... Coronary Artery Bypass Graft (CABG): Society of
Deep Sternal Wound Infection Rate: Thoracic
Percentage of patients aged 18 years Surgeons.
and older undergoing isolated Coronary
Artery Bypass Graft surgery who, within
30 days postoperatively, develop deep
sternal wound infection involving
muscle, bone, and/or mediastinum
requiring operative intervention.
0131/166..... Coronary Artery Bypass Graft (CABG): Society of
Stroke: Percentage of patients aged 18 Thoracic
years and older undergoing isolated Surgeons.
Coronary Artery Bypass Graft surgery
who have a postoperative stroke (i.e.,
any confirmed neurological deficit of
abrupt onset caused by a disturbance in
blood supply to the brain) that did not
resolve within 24 hours.
0114/167..... Coronary Artery Bypass Graft (CABG): Society of
Postoperative Renal Failure: Percentage Thoracic
of patients aged 18 years and older Surgeons.
undergoing isolated Coronary Artery
Bypass Graft surgery (without pre-
existing renal failure) who develop
postoperative renal failure or require
dialysis.
0115/168..... Coronary Artery Bypass Graft (CABG): Society of
Surgical Re-Exploration: Percentage of Thoracic
patients aged 18 years and older Surgeons.
undergoing isolated Coronary Artery
Bypass Graft surgery who require a
return to the operating room (OR)
during the current hospitalization for
mediastinal bleeding with or without
tamponade, graft occlusion, valve
dysfunction, or other cardiac reason.
------------------------------------------------------------------------
We proposed to amend the Dementia Measures Group for reporting in
the PQRS beginning in 2016 by adding Preventive Care and Screening:
Screening for Clinical Depression and Follow-Up Plan (PQRS# 134) and
removing Dementia: Screening for Depressive Symptoms (PQRS #285). We
solicited and received the following public comment on this measures
group.
Comment: One commenter encouraged CMS to retain the nine dementia-
specific measures included in the Dementia Measures Group for continued
use in the PQRS program even though measures that are not NQF-endorsed
are typically removed. The commenter stated that these measures address
gaps in the PQRS measure set, reflect the services furnished by a
particular specialty, impact chronic conditions, and have a high impact
on health care and support CMS' priorities for improved care quality
and efficiency and should be retained in future program years.
Response: In response to the comment requesting CMS retain the nine
measures of the Dementia Measures Group, please note CMS proposed to
remove only one measure but retain the remaining eight dementia
measures in this group. CMS is finalizing its proposal to remove PQRS
#285 ``Dementia: Screening for Depressive Symptoms'' as CMS believes it
is duplicative of PQRS #134 ``Preventive Care and Screening: Screening
for Clinical Depression and Follow-up'', which includes screening for
depression and is a more robust measure. For this reason, we are
finalizing the proposed changes to this measures group for reporting in
the PQRS beginning in 2016, as proposed. The final Dementia Measures
Group is shown on Table 38.
[[Page 71212]]
TABLE 38--Dementia Measures Group for 2016 and Beyond
[CMS is finalizing its proposal to add PQRS# 134 Preventive Care and
Screening: Screening for Clinical Depression and Follow-up Plan and
delete PQRS #285 Dementia: Screening for Depressive Symptoms from this
measures group]
------------------------------------------------------------------------
Measure
NQF/ PQRS Measure title and description Developer
------------------------------------------------------------------------
0326/047..... Care Plan: Percentage of patients aged National
65 years and older who have an advance Committee for
care plan or surrogate decision maker Quality
documented in the medical record or Assurance/
documentation in the medical record American
that an advance care plan was discussed Medical
but the patient did not wish or was not Association-
able to name a surrogate decision maker Physician
or provide an advance care plan. Consortium for
Performance
Improvement.
0418/134..... Preventive Care and Screening: Screening Centers for
for Clinical Depression and Follow-Up Medicare &
Plan: Percentage of patients aged 12 Medicaid
years and older screened for clinical Services/
depression on the date of the encounter Mathematica/
using an age appropriate standardized Quality
depression screening tool AND if Insights of
positive, a follow-up plan is Pennsylvania.
documented on the date of the positive
screen.
N.A/280...... Dementia: Staging of Dementia: American
Percentage of patients, regardless of Academy of
age, with a diagnosis of dementia whose Neurology/
severity of dementia was classified as American
mild, moderate or severe at least once Psychological
within a 12 month period. Association.
N/A/281...... Dementia: Cognitive Assessment: American
Percentage of patients, regardless of Medical
age, with a diagnosis of dementia for Association-
whom an assessment of cognition is Physician
performed and the results reviewed at Consortium for
least once within a 12 month period. Performance
Improvement.
N/A/282...... Dementia: Functional Status Assessment: American
Percentage of patients, regardless of Academy of
age, with a diagnosis of dementia for Neurology/
whom an assessment of functional status American
is performed and the results reviewed Psychological
at least once within a 12 month period. Association.
N/A/283...... Dementia: Neuropsychiatric Symptom American
Assessment: Percentage of patients, Academy of
regardless of age, with a diagnosis of Neurology/
dementia and for whom an assessment of American
neuropsychiatric symptoms is performed Psychological
and results reviewed at least once in a Association.
12 month period.
N/A/284...... Dementia: Management of Neuropsychiatric American
Symptoms: Percentage of patients, Academy of
regardless of age, with a diagnosis of Neurology/
dementia who have one or more American
neuropsychiatric symptoms who received Psychological
or were recommended to receive an Association.
intervention for neuropsychiatric
symptoms within a 12 month period.
N/A/286...... Dementia: Counseling Regarding Safety American
Concerns: Percentage of patients, Academy of
regardless of age, with a diagnosis of Neurology/
dementia or their caregiver(s) who were American
counseled or referred for counseling Psychological
regarding safety concerns within a 12 Association.
month period.
N/A/287...... Dementia: Counseling Regarding Risks of American
Driving: Percentage of patients, Academy of
regardless of age, with a diagnosis of Neurology/
dementia or their caregiver(s) who were American
counseled regarding the risks of Psychological
driving and the alternatives to driving Association.
at least once within a 12 month period.
N/A/288...... Dementia: Caregiver Education and American
Support: Percentage of patients, Academy of
regardless of age, with a diagnosis of Neurology/
dementia whose caregiver(s) were American
provided with education on dementia Psychological
disease management and health behavior Association.
changes AND referred to additional
sources for support within a 12 month
period.
------------------------------------------------------------------------
We proposed to amend the Diabetes Measures Group for reporting in
the PQRS beginning in 2016 by adding Diabetes Mellitus: Diabetic Foot
and Ankle Care, Peripheral Neuropathy--Neurological Evaluation (PQRS
#126) and removing Diabetes: Foot Exam (PQRS #163). We solicited and
received the following public comment on this measures group.
Comment: One commenter supported the proposed changes to the
Diabetes Measures Group.
Response: Based on the comments and rationale provided, we are
finalizing the proposed changes to this measures group for reporting in
the PQRS beginning in 2016, as proposed. The final Diabetes Measures
Group is shown in Table 39.
TABLE 39--Diabetes Measures Group for 2016 and Beyond
[CMS is finalizing its proposal to add PQRS #126 Diabetes Mellitus:
Diabetic Foot and Ankle Care, Peripheral Neuropathy and delete PQRS #163
Diabetes: Foot Exam from this measures group]
------------------------------------------------------------------------
Measure
NQF/ PQRS Measure Title and Description Developer
------------------------------------------------------------------------
0059/001..... Diabetes: Hemoglobin A1c Poor Control: National
Percentage of patients 18-75 years of Committee for
age with diabetes who had hemoglobin Quality
A1c > 9.0% during the measurement Assurance.
period.
0041/110..... Preventive Care and Screening: Influenza American
Immunization: Percentage of patients Medical
aged 6 months and older seen for a Association-
visit between October 1 and March 31 Physician
who received an influenza immunization Consortium for
OR who reported previous receipt of an Performance
influenza immunization. Improvement.
0055/117..... Diabetes: Eye Exam: Percentage of National
patients 18-75 years of age with Committee for
diabetes who had a retinal or dilated Quality
eye exam by an eye care professional Assurance.
during the measurement period or a
negative retinal or dilated eye exam
(no evidence of retinopathy) in the 12
months prior to the measurement period.
0062/119..... Diabetes: Medical Attention for National
Neuropathy: The percentage of patients Committee for
18-75 years of age with diabetes who Quality
had a nephropathy screening test or Assurance.
evidence of nephropathy during the
measurement period.
0417/126..... Diabetes Mellitus: Diabetic Foot and American
Ankle Care, Peripheral Neuropathy-- Podiatric
Neurological Evaluation: Percentage of Medical
patients aged 18 years and older with a Association.
diagnosis of diabetes mellitus who had
a neurological examination of their
lower extremities within 12 months.
[[Page 71213]]
0028/226..... Preventive Care and Screening: Tobacco American
Use: Screening and Cessation Medical
Intervention: Percentage of patients 18 Association-
years and older who were screened for Physician
tobacco use one or more times within 24 Consortium for
months AND who received cessation Performance
counseling intervention if identified Improvement.
as a tobacco user.
------------------------------------------------------------------------
We proposed to amend the Preventative Care Measures Group for
reporting in the PQRS beginning in 2016 by adding Preventive Care and
Screening: Unhealthy Alcohol Use: Screening & Brief Counseling (NQF
#2152) and removing Preventive Care and Screening: Unhealthy Alcohol
Use--Screening (PQRS #173). We solicited and received the following
public comment on this measures group.
Comment: One commenter supported the proposed changes to the
Preventative Care Measures Group.
Response: Based on the comments and rationale provided, CMS is
finalizing the proposed changes to this measures group for reporting in
the PQRS beginning in 2016, as proposed. The final Preventative Care
Measures Group is shown in Table 40.
Table 40--Preventive Care Measures Group for 2016 and Beyond
[TMS is finalizing its proposal to add NQF #2152 Preventive Care and
Screening: Unhealthy Alcohol Use: Screening & Brief Counseling and
delete PQRS #173 Preventive Care and Screening: Unhealthy Alcohol Use--
Screening from this measures group for 2016 PQRS]
------------------------------------------------------------------------
Measure
NQF/PQRS Measure title and description developer
------------------------------------------------------------------------
0046/039..... Screening for Osteoporosis for Women National
Aged 65-85 Years of Age: Percentage of Committee for
female patients aged 65-85 years of age Quality
who ever had a central dual-energy X- Assurance/
ray absorptiometry (DXA) to check for American
osteoporosis. The title and description Medical
of this measure has been updated since Association-
appearing in the CY 2016 PFS proposed Physician
rule (originally entitled ``Screening Consortium for
or Therapy for Osteoporosis for Women Performance
Aged 65 Years and Older'' in Table 29D Improvement.
at 80 FR 41877) and conforms to the
measure steward's most current measure
specification.
N/A/048...... Urinary Incontinence: Assessment of National
Presence or Absence of Urinary Committee for
Incontinence in Women Aged 65 Years and Quality
Older: Percentage of female patients Assurance/
aged 65 years and older who were American
assessed for the presence or absence of Medical
urinary incontinence within 12 months. Association-
Physician
Consortium for
Performance
Improvement.
0041/110..... Preventive Care and Screening: Influenza American
Immunization: Percentage of patients Medical
aged 6 months and older seen for a Association-
visit between October 1 and March 31 Physician
who received an influenza immunization Consortium for
OR who reported previous receipt of an Performance
influenza immunization. Improvement.
0043/111..... Pneumonia Vaccination Status for Older National
Adults: Percentage of patients 65 years Committee for
of age and older who have ever received Quality
a pneumococcal vaccine. Assurance.
2372/112..... Breast Cancer Screening: Percentage of National
women 50 through 74 years of age who Committee for
had a mammogram to screen for breast Quality
cancer within 27 months. Assurance.
0034/113..... Colorectal Cancer Screening: Percentage National
of patients 50-75 years of age who had Committee for
appropriate screening for colorectal Quality
cancer. Assurance.
0421/128..... Preventive Care and Screening: Body Mass Centers for
Index (BMI) Screening and Follow-Up Medicare &
Plan: Percentage of patients aged 18 Medicaid
years and older with a BMI documented Services/
during the current encounter or during Mathematica/
the previous six months AND with a BMI Quality
outside of normal parameters, a follow- Insights of
up plan is documented during the Pennsylvania.
encounter or during the previous six
months of the encounter.
Normal Parameters: Age 65 years and
older BMI >= 23 and < 30 kg/m2; Age 18-
64 years BMI >= 18.5 and < 25 kg/m2.
0418/134..... Preventive Care and Screening: Screening Centers for
for Clinical Depression and Follow-Up Medicare &
Plan: Percentage of patients aged 12 Medicaid
years and older screened for clinical Services/
depression on the date of the encounter Mathematica/
using an age appropriate standardized Quality
depression screening tool AND if Insights of
positive, a follow-up plan is Pennsylvania.
documented on the date of the positive
screen.
0028/226..... Preventive Care and Screening: Tobacco American
Use: Screening and Cessation Medical
Intervention: Percentage of patients 18 Association-
years and older who were screened for Physician
tobacco use one or more times within 24 Consortium for
months AND who received cessation Performance
counseling intervention if identified Improvement.
as a tobacco user.
2152/431..... Preventive Care and Screening: Unhealthy American
Alcohol Use: Screening & Brief Medical
Counseling: Percentage of patients aged Association-
18 years and older who were screened at Physician
least once within the last 24 months Consortium for
for unhealthy alcohol use using a Performance
systematic screening method AND who Improvement.
received brief counseling if identified
as an unhealthy alcohol user..
This is a new measure described in Table
22.
------------------------------------------------------------------------
We proposed to amend the Rheumatoid Arthritis Measures Group for
reporting in the PQRS beginning in 2016 by adding Tuberculosis
Prevention for Psoriasis, Psoriatic Arthritis and Rheumatoid Arthritis
Patients on a Biological Immune Response Modifier (PQRS #337). We
solicited and received no public comment on this measures
[[Page 71214]]
group. Therefore, based on the rationale provided, we are finalizing
the proposed changes to this measures group for reporting in the PQRS
beginning in 2016, as proposed. The final Rheumatoid Arthritis Measures
Group is shown in Table 41.
Table 41--Rheumatoid Arthritis Measures Group for 2016 and Beyond
[CMS is finalizing its proposal to add PQRS #337 Tuberculosis Prevention
for Psoriasis, Psoriatic Arthritis and Rheumatoid Arthritis Patients on
a Biological Immune Response Modifier to this measures group for 2016
PQRS]
------------------------------------------------------------------------
Measure
NQF/ PQRS Measure title and description developer
------------------------------------------------------------------------
0054/108..... Rheumatoid Arthritis (RA): Disease National
Modifying Anti-Rheumatic Drug (DMARD) Committee for
Therapy: Percentage of patients aged 18 Quality
years and older who were diagnosed with Assurance.
rheumatoid arthritis and were
prescribed, dispensed, or administered
at least one ambulatory prescription
for a disease-modifying anti-rheumatic
drug (DMARD).
0421/128..... Preventive Care and Screening: Body Mass Centers for
Index (BMI) Screening and Follow-Up Medicare &
Plan: Percentage of patients aged 18 Medicaid
years and older with a BMI documented Services/
during the current encounter or during Mathematica/
the previous six months AND with a BMI Quality
outside of normal parameters, a follow- Insights of
up plan is documented during the Pennsylvania.
encounter or during the previous six
months of the encounter.
Normal Parameters: Age 65 years and
older BMI >= 23 and < 30 kg/m2 ; Age 18-
64 years BMI >= 18.5 and < 25 kg/m2.
0420/131..... Pain Assessment and Follow-Up: Centers for
Percentage of visits for patients aged Medicare &
18 years and older with documentation Medicaid
of a pain assessment using a Services/
standardized tool(s) on each visit AND Quality
documentation of a follow-up plan when Insights of
pain is present. Pennsylvania.
N/A/176...... Rheumatoid Arthritis (RA): Tuberculosis American
Screening: Percentage of patients aged College of
18 years and older with a diagnosis of Rheumatology.
rheumatoid arthritis (RA) who have
documentation of a tuberculosis (TB)
screening performed and results
interpreted within 6 months prior to
receiving a first course of therapy
using a biologic disease-modifying anti-
rheumatic drug (DMARD).
N/A/177...... Rheumatoid Arthritis (RA): Periodic American
Assessment of Disease Activity: College of
Percentage of patients aged 18 years Rheumatology.
and older with a diagnosis of
rheumatoid arthritis (RA) who have an
assessment and classification of
disease activity within 12 months.
N/A/178...... Rheumatoid Arthritis (RA): Functional American
Status Assessment: Percentage of College of
patients aged 18 years and older with a Rheumatology.
diagnosis of rheumatoid arthritis (RA)
for whom a functional status assessment
was performed at least once within 12
months.
N/A/179...... Rheumatoid Arthritis (RA): Assessment American
and Classification of Disease College of
Prognosis: Percentage of patients aged Rheumatology.
18 years and older with a diagnosis of
rheumatoid arthritis (RA) who have an
assessment and classification of
disease prognosis at least once within
12 months..
N/A/180...... Rheumatoid Arthritis (RA): American
Glucocorticoid Management: Percentage College of
of patients aged 18 years and older Rheumatology.
with a diagnosis of rheumatoid
arthritis (RA) who have been assessed
for glucocorticoid use and, for those
on prolonged doses of prednisone >= 10
mg daily (or equivalent) with
improvement or no change in disease
activity, documentation of
glucocorticoid management plan within
12 months.
N/A/337...... Tuberculosis Prevention for Psoriasis, American
Psoriatic Arthritis and Rheumatoid College of
Arthritis Patients on a Biological Rheumatology.
Immune Response Modifier: Percentage of
patients whose providers are ensuring
active tuberculosis prevention either
through yearly negative standard
tuberculosis screening tests or are
reviewing the patient's history to
determine if they have had appropriate
management for a recent or prior
positive test.
------------------------------------------------------------------------
e. Measures Available for Reporting in the Web Interface
We finalized the measures that are available for reporting in the
Web Interface for 2015 and beyond in the CY 2015 PFS final rule (79 FR
67893 through 67902). The current measures available for reporting
under the Web Interface are available at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2014_GPROWebInterface_MeasuresList_NarrativeSpecs_ReleaseNotes_12132013.zip. We proposed to adopt the Statin Therapy for the Prevention and
Treatment of Cardiovascular Disease measure in Table 42 for reporting
via the Web Interface beginning in 2016. We solicited and received the
following comments on this proposal:
Comment: Several commenters supported the concept of this measure,
noting it fills an important clinical gap in the program. Two
commenters were concerned this measure is not NQF endorsed. Other
commenters noted concern regarding adherence to clinical guidelines,
the need for additional testing and the potential for a small
denominator.
Response: This measure reflects CMS's effort to adhere to current
clinical guidelines. We are exercising our exception authority under
section 1848(k)(2)(C)(ii) of the Act to finalize this measure because a
feasible and practical measure has not been endorsed by the NQF that
has been submitted to the measures application partnership. Based on
feedback and guidance from the technical expert panel and measure
owner, CMS, this measure is the most advantageous and analytically
feasible way to address the clinical guidelines. We also appreciate the
commenters concern regarding broadening the measure to include other
therapies beyond statin; however, current clinical guidelines indicate
statin therapy is the appropriate standard of care. One commenter also
expressed concern that this measure requires further testing and may
not cover all components of the current guidelines. We require that all
measures included in the program undergo feasibility, validity, and
reliability testing. Further, we recognize the measure incorporates
three of the four components of the guidelines. However, for its
initial implementation, the measure provides an opportunity to fill a
key clinical gap in the program. After further review, we determined
this measure is not analytically feasible to
[[Page 71215]]
report through claims. The measure owner, CMS, may consider updating
this measure in future rulemaking years to address the fourth component
of the guidelines. Therefore, we are finalizing our proposal to include
this measure as Web Interface, measures groups and registry reportable
in 2016 PQRS. In addition, we are finalizing this measure under the
PREV-13 module. Please note that we do not believe finalizing this
measure under the PREV-13 module substantively impacts group practices,
as group practices must report on all measures in the Web Interface
regardless of the modules in which they are placed. This final change
is reflected in Table 42.
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7. Request for Input on the Provisions Included in the Medicare Access
and CHIP Reauthorization Act of 2015 (MACRA)
The Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L.
114-10, enacted on April 16, 2015) (MACRA) repealed the Medicare
sustainable growth rate (SGR) update formula for payments under the
Medicare physician fee schedule, established the Merit-based Incentive
Payments System (MIPS) under the physician fee schedule, established
incentive payments for participation in certain alternative payment
models (APMS), and made other changes affecting Medicare payments to
physicians and other eligible professionals. We sought public input on
the following provisions of the MACRA in the CY 2016 PFS proposed rule
(80 FR 41879 through 41880):
Section 101(b): Consolidation of Certain Current Law
Performance Programs with New Merit-based Incentive Payment System
(hereinafter MIPS)
Section 101(c): Merit-based Incentive Payment System
Section 101(e): Promoting Alternative Payment Models
a. The Merit-based Incentive Payment System (MIPS)
Section 1848(q) of the Act, added by section 101(c) of the MACRA,
requires creation of the MIPS, applicable beginning with payments for
items and services furnished on or after January 1, 2019, under which
the Secretary shall: (1) Develop a methodology for assessing the total
performance of each MIPS eligible professional according to performance
standards for a performance period for a year; (2) using the
methodology, provide for a composite performance score for each
eligible professional for each performance period; and (3) use the
composite performance score of the MIPS eligible professional for a
performance period for a year to determine and apply a MIPS adjustment
factor (and, as applicable, an additional MIPS adjustment factor) to
the professional for the year. In the proposed rule, we sought public
input on specific provisions related to the MIPS, including (80 FR
41879):
What would be an appropriate low-volume threshold for
purposes of excluding certain eligible professionals (as defined in
section 1848(k)(3)(B) of the Act) from the definition of a MIPS
eligible professional.
Whether CMS should consider establishing a low-volume
threshold using more than one or a combination of factors or,
alternatively.
Whether CMS should focus on establishing a low-volume
threshold based on one factor.
Which factors to include, individually or in combination,
in determining a low-volume threshold.
Whether a low-volume threshold similar to ones currently
used in other CMS reporting programs would be an appropriate low-volume
threshold for the MIPS and the applicability of existing low-volume
thresholds used in other CMS reporting programs toward MIPs.
What activities could be classified as clinical practice
improvement activities according to the definition under section
1848(q)(2)(C)(v)(III) of the Act.
b. Alternative Payment Models
Section 101(e) of the MACRA, Promoting Alternative Payment Models,
introduces a framework for promoting and developing alternative payment
models (APMs) and providing incentive payments for eligible
professionals who participate in certain APMs. The statutory amendments
made by this section have payment implications for eligible
professionals beginning in 2019. As part of our continued commitment to
stakeholder engagement, we broadly sought public comments on the
promotion of alternative payment models (APMs) in the proposed rule (80
FR 41879 through 41880). Specifically, we sought comment on approaches
for developing and encouraging APMs and on incentive payments for
participation in APMs by eligible professionals. We noted that we would
be requesting more detailed information in a forthcoming RFI on the
following topics: The criteria for assessing physician-focused payment
models; the criteria and process for the submission of physician-
focused payment models; eligible APMS; qualifying APM participants; the
Medicare payment threshold option and the combination all-payer and
Medicare payment threshold option for qualifying and partial qualifying
APM participants; the time period to use to calculate eligibility for
qualifying and partial qualifying APM participants; eligible
alternative payment entities; quality measures and EHR use
requirements; and the definition of nominal financial risk for eligible
alternative payment entities.
In response to our solicitation, we received over 90 insightful and
informative public comments suggesting matters to consider in our RFI
and for
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future rulemaking. In addition to seeking public comment through the
proposed rule, we published a Request for Information (RFI) on October
1, 2015, (80 FR 59102-59113) available at https://federalregister.gov/a/2015-24906, asking for additional public comment on more detailed
questions related to both MIPS and APMs. We appreciate the many
insights and comments that we received, and look forward to additional
comments in response to the RFI. We will consider these public comments
in future rulemaking.
J. Electronic Clinical Quality Measures (eCQM) and Certification
Criteria; and Electronic Health Record (EHR) Incentive Program-
Comprehensive Primary Care (CPC) Initiative and Medicare Meaningful Use
Aligned Reporting
1. Background
The Health Information Technology for Economic and Clinical Health
(HITECH) Act (Title IV of Division B of the ARRA, together with Title
XIII of Division A of the ARRA) authorizes incentive payments under
Medicare and Medicaid for the adoption and meaningful use of certified
EHR technology (CEHRT). Section 1848(o)(2)(B)(iii) of the Act requires
that in selecting clinical quality measures (CQMs) for eligible
professionals (EPs) to report under the EHR Incentive Program, and in
establishing the form and manner of reporting, the Secretary shall seek
to avoid redundant or duplicative reporting otherwise required. As
such, we have taken steps to establish alignments among various quality
reporting and payment programs that include the submission of CQMs.
Under section 1848(o)(2)(A)(iii) of the Act and the definition of
``meaningful EHR user'' under Sec. 495.4, EPs must report on CQMs
selected by CMS using CEHRT, as part of being a meaningful EHR user
under the Medicare EHR Incentive Program. For CY 2012 and subsequent
years, Sec. 495.8(a)(2)(ii) requires an EP to successfully report the
CQMs selected by CMS to CMS or the states, as applicable, in the form
and manner specified by CMS or the states, as applicable.
In the CY 2014 PFS final rule with comment period (78 FR 74756), we
finalized our proposal to require EPs who seek to report CQMs
electronically under the Medicare EHR Incentive Program to use the most
recent version of the electronic specifications for the CQMs and have
CEHRT that is tested and certified to the most recent version of the
electronic specifications for the CQMs. We stated that we believe it is
important for EPs to electronically report the most recent versions of
the electronic specifications for the CQMs as updated measure versions
to correct minor inaccuracies found in prior measure versions. We
stated that to ensure that CEHRT products can successfully transmit CQM
data using the most recent version of the electronic specifications for
the CQMs, it is important that the product be tested and certified to
the most recent version of the electronic specifications for the CQMs.
In this final rule, we summarize the comments we received based on
our proposals for the EHR Incentive Program in the CY 2016 PFS proposed
rule (80 FR 41880) and state our final policies based on these
proposals and comments. Please note that we received numerous comments
related generally to the EHR Incentive Program but not related to our
specific proposals for the EHR Incentive Program in the CY 2016 PFS
proposed rule. While we may take these comments into consideration when
developing proposals in the future, we will not address these comments
with specificity here.
2. Certification Requirements for Reporting Electronic Clinical Quality
Measures (eCQMs) in the EHR Incentive Program and PQRS
In the CY 2015 PFS final rule with comment period (79 FR 67906), we
finalized our proposal for the Medicare EHR Incentive Program that,
beginning in CY 2015, EPs are not required to ensure that their CEHRT
products are recertified to the most recent version of the electronic
specifications for the CQMs. Although we are not requiring
recertification, EPs must still report the most recent version of the
electronic specifications for the CQMs if they choose to report CQMs
electronically for the Medicare EHR Incentive Program.
In the FY 2016 IPPS proposed rule (80 FR 24611 through 24615), HHS'
Office of the National Coordinator for Health Information Technology
(ONC) proposed a certification criterion for ``CQMs--report'' at 45 CFR
170.315(c)(3). This proposal would require that health information
technology enable users to electronically create a data file for
transmission of clinical quality measurement data in accordance with
the Quality Reporting Document Architecture (QRDA) Category I
(individual patient-level report) and Category III (aggregate report)
standards, at a minimum. As part of the ``CQMs--report'' criterion, ONC
also proposed to offer optional certification for EHRs according to the
``form and manner'' that CMS requires for electronic submission to
participate in the EHR Incentive Programs and PQRS. These requirements
are published annually as the ``CMS QRDA Implementation Guide'' and
posted on CMS' Web site at http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/eCQM_Library.html. The latest set of
requirements (2015 CMS QRDA Implementation Guide for Eligible
Professional Programs and Hospital Quality Reporting) combines the
requirements for EPs, eligible hospitals, and CAHs. For a complete
discussion of these proposals, we refer readers to 80 FR 24611 through
24615.
In the FY 2016 IPPS proposed rule (80 FR 24323 through 24629), we
stated that we anticipated proposing to require EPs, eligible
hospitals, and CAHs seeking to report CQMs electronically as part of
meaningful use under the EHR Incentive Programs for 2016 to adhere to
the additional standards and constraints on the QRDA standards for
electronic reporting as described in the CMS QRDA Implementation Guide.
We stated that we anticipated proposing to revise the definition of
``certified electronic health record technology'' at Sec. 495.4 to
require certification to the optional portion of the 2015 Edition CQM
reporting criterion (proposed at 45 CFR 170.315(c)(3)) in the CY 2016
Medicare PFS proposed rule.
Accordingly, to allow providers to upgrade to 2015 Edition CEHRT
before 2018, we proposed in the CY 2016 PFS proposed rule (80 FR 41880)
to revise the CEHRT definition for 2015 through 2017 to require that
EHR technology is certified to report CQMs, in accordance with the
optional certification, in the format that CMS can electronically
accept (CMS' ``form and manner'' requirements) if certifying to the
2015 Edition ``CQMs--report'' certification criterion at Sec.
170.315(c)(3). Specifically, this would require technology to be
certified to Sec. 170.315(c)(3)(i) (the QRDA Category I and III
standards) and Sec. 170.315(c)(3)(ii) (the optional CMS ``form and
manner''). We noted that the proposed CEHRT definition for 2015 through
2017 included in the Stage 3 proposed rule published on March 30, 2015
(80 FR 16732 through 16804) allows providers to use 2014 Edition or
2015 Edition certified EHR technology. These proposed revisions would
apply for EPs, eligible hospitals, and CAHs.
We also proposed in the CY 2016 PFS proposed rule (80 FR 41880) to
revise the CEHRT definition for 2018 and subsequent years to require
that EHR technology is certified to report CQMs, in accordance with the
optional
[[Page 71261]]
certification, in the format that CMS can electronically accept.
Specifically, this would require technology to be certified to Sec.
170.315(c)(3)(i) (the QRDA Category I and III standards) and Sec.
170.315(c)(3)(ii) (the optional CMS ``form and manner''). These
proposed revisions would apply for EPs, eligible hospitals, and CAHs.
We proposed these amendments at Sec. 495.4 to ensure that
providers participating in PQRS and the EHR Incentive Programs under
the 2015 Edition possess EHRs that have been certified to report CQMs
according to the format that CMS requires for submission. We invited
comment on our proposals. We note that ONC finalized the proposal to
adopt a 2015 Edition CQM reporting certification (at 45 CFR
170.315(c)(3)) in its 2015 Edition final rule. The certification
criterion requires health IT to be certified to report CQMs using the
QRDA Category I and III standards. It also includes an optional
provision to report CQMs in the ``form and manner'' that CMS requires
for submission. We refer readers to 80 FR 62651 through 62652.
The following is a summary of the comments we received regarding
these proposals.
Comment: Commenters were supportive of our proposals to revise the
CEHRT definition at Sec. 495.4. The commenters stated that if CMS
intends to require EHR products to be able to submit this data either
directly or via a certified file format, the proposal to require the
optional portion of the CQM reporting criterion for the CEHRT
definition is necessary.
Response: We appreciate the commenters' support for our proposals.
Based on the comments received and for the reasons stated previously,
we are finalizing these proposals made in the CY 2016 PFS proposed
rule, as proposed. We are revising the regulation text under Sec.
495.4 to reflect this final policy.
3. Electronic Health Record (EHR) Incentive Program-Comprehensive
Primary Care (CPC) Initiative Aligned Reporting
The Comprehensive Primary Care (CPC) initiative, under the
authority of section 3021 of the Affordable Care Act, is a multi-payer
initiative fostering collaboration between public and private health
care payers to strengthen primary care. Under this initiative, we pay
participating primary care practices a care management fee to support
enhanced, coordinated services. Simultaneously, participating
commercial, state, and other federal insurance plans are also offering
enhanced support to primary care practices that provide high-quality
primary care. There are approximately 480 CPC practice sites across
seven health care markets in the U.S.
Under the CPC initiative, CPC practice sites are required to report
to CMS a subset of the CQMs that were selected in the EHR Incentive
Program Stage 2 final rule for EPs to report under the EHR Incentive
Program beginning in CY 2014 (for a list of CQMs that were selected in
the EHR Incentive Program Stage 2 final rule for EPs to report under
the EHR Incentive Program beginning in CY 2014, see 77 FR 54069 through
54075).
In the CY 2015 PFS final rule with comment period (79 FR 67906
through 67907), we finalized a group reporting option for CQMs for the
Medicare EHR Incentive Program under which EPs who are part of a CPC
practice site that successfully reports at least 9 electronically
specified CQMs across 2 domains for the relevant reporting period in
accordance with the requirements established for the CPC Initiative and
using CEHRT would satisfy the CQM reporting component of meaningful use
for the Medicare EHR Incentive Program. If a CPC practice site is not
successful in reporting, EPs who are part of the site would still have
the opportunity to report CQMs in accordance with the requirements
established for the Medicare EHR Incentive Program in the Stage 2 final
rule. Additionally, only those EPs who are beyond their first year of
demonstrating meaningful use may use this CPC group reporting option.
The CPC practice sites must submit the CQM data in the form and manner
required by the CPC Initiative. Therefore, whether CPC required
electronic submission or attestation of CQMs, the CPC practice site
must submit the CQM data in the form and manner required by the CPC
Initiative.
In the CY 2016 PFS proposed rule (80 9 FR 41881), we proposed to
retain the group reporting option for CPC practice sites as finalized
in the CY 2015 PFS final rule, but for CY 2016, to require CPC practice
sites to submit at least 9 CPC CQMs that cover 3 domains. In CY 2015,
the CPC CQM subset was increased from a total of 11 to 13 measures, of
which 8 measures fall in the clinical process/effectiveness domain, 3
in the population health domain, and 2 in the safety domain.
Additionally, the CPC practice sites have had ample time to obtain
measures from the CPC eCQM subset of meaningful use measures. Given the
increased number of measures in the CPC eCQM set, the addition of one
measure to the safety domain, and the sufficient time that CPC practice
sites have had to upgrade their EHR systems, it is reasonable to expect
that CPC practice sites would have enough measures to report across the
3 domains as required for the Medicare EHR Incentive Program CQM
reporting requirement. If a CPC practice site is not successful in
reporting, EPs who are part of the site would still have the
opportunity to report CQMs in accordance with the current requirements
established for the Medicare EHR Incentive Program. As finalized in the
Medicare and Medicaid Programs; Electronic Health Record Incentive
Program-Stage 3 and Modifications to Meaningful Use in 2015 through
2017 final rule (80 FR 62888), EPs in any year of participation may
electronically report clinical quality measures for a reporting period
in 2016. Therefore, we proposed that for CY 2016, EPs who are part of a
CPC practice site and are in their first year of demonstrating
meaningful use may also use this CPC group reporting option to report
their CQMs electronically instead of reporting CQMs by attestation
through the EHR Incentive Program's Registration and Attestation
System. However, we noted that EPs who choose this CPC group reporting
option must use a reporting period for CQMs of one full year (not 90
days), and that the data must be submitted during the submission period
from January 1, 2017 through February 28, 2017. This means that EPs who
elect to electronically report through the CPC practice site cannot
successfully attest to meaningful use prior to October 1, 2016 (the
deadline established for EPs who are first-time meaningful users in CY
2016) and therefore will receive reduced payments under the PFS in CY
2017 for failing to demonstrate meaningful use, if they have not
applied and been approved for a significant hardship exception under
the EHR Incentive Program. We invited public comment on these
proposals.
We received several comments in response to the proposed group
reporting option for CPC practice sites for CY 2016.
Comment: Several commenters supported the alignment between CPC and
the Medicare EHR Incentive Program. They also supported the inclusion
of EPs who are in their first year of participation in the Medicare EHR
Incentive Program in the proposal to meet the CQM reporting requirement
of the Medicare EHR Incentive Program through successful reporting to
CPC. However, a few commenters expressed concern about penalizing first
year EPs
[[Page 71262]]
who submit 12 months of data rather than 90 days.
Response: We appreciate the support for this proposal. To clarify,
we proposed that EPs who are part of a CPC practice site and are in
their first year of demonstrating meaningful use [in CY 2016] may
report CQMs through the CPC group reporting option for CY 2016, and if
submitted successfully in accordance with the requirements established
by the CPC Initiative and using CEHRT, their CPC reporting would
satisfy the CQM requirement for the Medicare EHR Incentive Program.
First-year EPs who successfully report CQMs through the CPC group
reporting option for the CY 2016 reporting period and meet all other
requirements for the Medicare EHR Incentive Program would avoid the
meaningful use payment adjustment under Medicare in CY 2018. We note
that in the Medicare and Medicaid Programs; Electronic Health Record
Incentive Program-Stage 3 and Modifications to Meaningful Use in 2015
through 2017 final rule (80 FR 62905), we established that in CY 2016,
the EHR reporting period for a payment adjustment year for EPs who are
new participants is any continuous 90-day period in CY 2016, and an EP
who successfully demonstrates meaningful use for this period and
satisfies all other program requirements will avoid the payment
adjustment in CY 2017 if the EP successfully attests by October 1,
2016. Therefore, to avoid the meaningful use payment adjustment under
Medicare in CY 2017, EPs who are demonstrating meaningful use for the
first time in CY 2016 and report CQMs through the CPC group reporting
option must also successfully report CQMs by attestation through the
EHR Incentive Program's Registration and Attestation System for a 90-
day reporting period in CY 2016 by October 1, 2016, or apply for a
significant hardship exception from the CY 2017 payment adjustment.
Comment: One commenter expressed concern that CPC practice site
vendors may not be able to support the CPC CQM reporting requirements.
Response: We understand that some practices found it challenging to
meet the CPC CQM reporting requirements due to issues involving their
vendors. However, the CPC CQM results from program year 2014
demonstrated that a substantial majority of the CPC practices were able
to meet the CPC requirements.
Comment: Two commenters suggested that electronic quality
measurement should look across longer periods of time, utilize more
data sources, and consider care in settings other than hospitals and
ambulatory care such as long-term post-acute care, behavioral health
and palliative care.
Response: The Medicare EHR Incentive Program is limited by statute
to eligible professionals, eligible hospitals, and critical access
hospitals. There are separate CMS programs, however, that require
quality reporting from other types of providers. In addition, certain
measures in the Medicare EHR Incentive Program include information
about care from other settings or for particular conditions, such as
behavioral health, and we hope to continue to add measures for a wider
range of specialties and settings with a focus on outcomes measures.
After consideration of the comments received, and for the reasons
stated previously, we are finalizing the proposals for the group
reporting option for CPC practice sites for CY 2016 as proposed.
K. Discussion and Acknowledgement of Public Comments Received on the
Potential Expansion of the Comprehensive Primary Care (CPC) Initiative
1. Background
We have been working to develop and test models of advanced primary
care under the authority of section 1115A of the Act. Through these
models, we plan to evaluate whether advanced primary care results in
higher quality and more coordinated care at a lower cost to Medicare.
We are currently testing the Comprehensive Primary Care (CPC)
initiative.
In the CPC initiative, we are collaborating with commercial payers
and state Medicaid agencies to test a payment and service delivery
model that includes the payment of monthly non-visit based per
beneficiary per month care management fees and shared savings
opportunities. The model is designed to support the provision by
practices of the following five comprehensive primary care functions:
(1) Risk Stratified Care Management: The provision of care
management of appropriate intensity for high-risk, high-need, high-cost
patients.
(2) Access and Continuity: 24/7 access to the care team; use of
asynchronous communication; designation of a primary care practitioner
for patients to build continuity of care.
(3) Planned Care for Chronic Conditions and Preventive Care:
Proactive, appropriate care based on systematic assessment of patients'
needs and personalized care plans.
(4) Patient and Caregiver Engagement: Active support of patients in
managing their health care to meet their personal health goals;
establishment of systems of care that include engagement of patients
and caregivers in goal-setting and decision making, creating
opportunities for patient and caregiver engagement throughout the care
delivery process.
(5) Coordination of Care across the Medical Neighborhood:
Management by the primary care practice of communication and
information flow in support of referrals, transitions of care, and when
care is received in other settings.
The CPC initiative is testing whether provision of these five
comprehensive primary care functions by each practice site--supported
by multi-payer payment reform, the continuous use of data to guide
improvement, and meaningful use of health information technology--can
achieve improved care, better health for populations, and lower costs,
and can inform Medicare and Medicaid policy. More information on the
CPC initiative can be found on the CMS Center for Medicare and Medicaid
Innovation's Web site at http://innovation.cms.gov/initiatives/Comprehensive-Primary-Care-Initiative/.
In the CY 2016 PFS proposed rule (80 FR 41881 through 41884), we
presented a description of the CPC initiative and solicited public
comments regarding policy and operational issues related to a potential
future expansion of the CPC initiative. Section 1115A(c) of the Act, as
added by section 3021 of the Affordable Care Act, provides the
Secretary with the authority to expand through rulemaking the duration
and scope of a model that is being tested under section 1115A(b) of the
Act, such as the CPC initiative (including implementation on a
nationwide basis), if the following findings are made, taking into
account the evaluation of the model under section 1115A(b)(4) of the
Act: (1) The Secretary determines that the expansion is expected to
either reduce Medicare spending without reducing the quality of care or
improve the quality of patient care without increasing spending; (2)
the CMS Chief Actuary certifies that the expansion would reduce (or
would not result in any increase in) net Medicare program spending; and
(3) the Secretary determines that the expansion would not deny or limit
the coverage or provision of Medicare benefits. The decision of whether
or not to expand will be made by the Secretary in coordination with CMS
and the Office of the Chief Actuary based on whether findings about the
initiative meet the statutory criteria for expansion under section
1115A(c) of the Act. Given that further evaluation is needed to
[[Page 71263]]
determine its impact on both Medicare cost and quality of care, we did
not propose an expansion of the CPC initiative in the CY 2016 PFS
proposed rule.
Consistent with our continuing commitment to engaging stakeholders
in CMS's work, we solicited public comments on a variety of issues to
broaden and deepen our understanding of the important issues and
challenges regarding primary care payment and transformation in the
health care marketplace. Among other subject-matter areas, we solicited
public comments on practice readiness, practice standards and
reporting, practice groupings, interaction with state primary care
transformation initiatives, learning activities, payer and self-insured
employer readiness, Medicaid, quality reporting, interaction with the
chronic care management code, and provision of data feedback to
practices. In response to our solicitation, we received over 90 timely
and informative public comments suggesting matters to consider in a
potential future expansion of the CPC initiative, including engagement
of electronic health record vendors, coaching on leadership and change
management, documentation, beneficiary cost-sharing, care management,
further testing of the CPC initiative, eligibility for incentive
payments for participation in Alternative Payment Models under MACRA,
auditing requirements, aggregation of payer and clinical data, and
engagement with providers across the broader medical neighborhood.
These comments, submitted by a variety of stakeholders, broadly
supported CPC expansion. We appreciate the commenters' views and
recommendations. We will consider the public comments we received if
the CPC initiative is expanded in the future through rulemaking.
L. Medicare Shared Savings Program
Under section 1899 of the Act, we established the Medicare Shared
Savings Program (Shared Savings Program) to facilitate coordination and
cooperation among providers to improve the quality of care for Medicare
Fee-For-Service (FFS) beneficiaries and reduce the rate of growth in
health care costs. 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 Shared Savings Program: Accountable Care
Organizations Final Rule (76 FR 67802)).
We addressed the following policies under the Shared Savings
Program in the CY 2016 PFS proposed rule.
1. Quality Measures and Performance Standard
Section 1899(b)(3)(A) of the Act requires the Secretary to
determine appropriate measures to assess the quality of care furnished
by ACOs, such as measures of clinical processes and outcomes; patient,
and, wherever practicable, caregiver experience of care; and
utilization such as rates of hospital admission for ambulatory
sensitive conditions. Section 1899(b)(3)(B) of the Act requires ACOs to
submit data in a form and manner specified by the Secretary on measures
that the Secretary determines necessary for ACOs to report to evaluate
the quality of care furnished by ACOs. Section 1899(b)(3)(C) of the Act
requires the Secretary to establish quality performance standards to
assess the quality of care furnished by ACOs, and to seek to improve
the quality of care furnished by ACOs over time by specifying higher
standards, new measures, or both for the purposes of assessing the
quality of care. Additionally, section 1899(b)(3)(D) of the Act gives
the Secretary authority to incorporate reporting requirements and
incentive payments related to the PQRS, EHR Incentive Program and other
similar initiatives under section 1848 of the Act. Finally, section
1899(d)(1)(A) of the Act states that an ACO is eligible to receive
payment for shared savings, if they are generated, only after meeting
the quality performance standards established by the Secretary.
In the November 2011 final rule establishing the Shared Savings
Program and recent CY PFS final rules with comment period (77 FR 69301
through 69304; 78 FR 74757 through 74764; and 79 FR 67907 through
67931), we established the quality performance standards that ACOs must
meet to be eligible to share in savings that are generated. In the CY
2015 PFS final rule with comment period, we made a number of updates to
the quality requirements within the program, such as updates to the
quality measure set, the addition of a quality improvement reward, and
the establishment of benchmarks that will apply for 2 years. Through
these previous rulemakings, we worked to improve the alignment of
quality performance measures, submission methods, and incentives under
the Shared Savings Program and PQRS. Currently, eligible professionals
who bill through the TIN of an ACO participant may avoid the downward
PQRS payment adjustment when the ACO satisfactorily reports the ACO
GPRO measures on their behalf using the GPRO web interface.
We identified certain policies related to the quality measures and
quality performance standard that we proposed in the CY 2016 PFS
proposed rule. Specifically, we proposed to add a new quality measure
to be reported through the CMS web interface and to adopt a policy for
addressing quality measures that no longer align with updated clinical
guidelines or where the application of the measure may result in
patient harm.
a. Existing Quality Measures and Performance Standard
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 Shared Savings Program Final Rule,
we established a quality performance standard consisting of 33 measures
across four domains, including patient experience of care, care
coordination/patient safety, preventive health, and at-risk population.
In the CY 2015 PFS final rule with comment period, we made a number of
updates to the quality performance standard, including adding new
measures that ACOs must report, retiring measures that no longer
aligned with updated clinical guidelines, reducing the sample size for
measures reported through the CMS web interface, establishing a
schedule for the phase in of new quality measures, and establishing an
additional reward for quality improvement. In the CY 2015 PFS final
rule with comment period, we finalized an updated measure set of 33
measures.
Quality measures are submitted by the ACO through the GPRO web
interface, calculated by CMS from administrative and claims data, and
collected via a patient experience of care survey based on the
Clinician and Group Consumer Assessment of Healthcare Providers and
Systems (CG-CAHPS) survey. The CAHPS for ACOs patient experience of
care survey used for the Shared Savings Program includes the core CG-
CAHPS modules, as well as some additional modules. The measures
collected through the GPRO web interface are also used to determine
whether eligible professionals participating in an ACO avoid the PQRS
and automatic Value Modifier payment adjustments for 2015
[[Page 71264]]
and subsequent years. Eligible professionals billing through the TIN of
an ACO participant may avoid the downward PQRS payment adjustment when
the ACO satisfactorily reports all of the ACO GPRO measures on their
behalf using the GPRO web interface. Beginning with the 2017 Value
Modifier, performance on the ACO GPRO web interface measures and all
cause readmission measure will be used in calculating the quality
component of the Value Modifier for eligible professionals
participating within an ACO (79 FR 67941 through 67947).
As we previously stated (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. We believe endorsed
measures have been tested, validated, and clinically accepted, and
therefore, when selecting the original 33 measures, we had a preference
for NQF-endorsed measures. However, the statute does not limit us to
using endorsed measures in the Shared Savings Program. As a result, we
also exercised our discretion to include certain measures that we
believe to be high impact but that are not currently endorsed,
including for example, ACO#11, Percent of PCPs Who Successfully Qualify
for an EHR Incentive Program Payment.
In selecting the 33 measure set, we balanced a wide variety of
important considerations. Our measure selection emphasized prevention
and management of chronic diseases that have a high impact on Medicare
FFS beneficiaries, such as heart disease, diabetes mellitus, and
chronic obstructive pulmonary disease. We believed that the quality
measures used in the Shared Savings Program should be tested, evidence-
based, target conditions of high cost and high prevalence in the
Medicare FFS population, reflect priorities of the National Quality
Strategy, address the continuum of care to reflect the requirement that
ACOs accept accountability for their patient populations, and align
with existing quality programs and value-based purchasing initiatives.
In selecting the set of 33 measures finalized in the CY 2015 PFS
final rule with comment period, we sought to include both process and
outcome measures, including patient experience of care (79 FR 67907
through 67931). We believe it is important to retain a combination of
both process and outcomes measures, because ACOs are charged with
improving and coordinating care and delivering high quality care, but
also need time to form, acquire infrastructure and develop clinical
care processes. We noted, however, that as other CMS quality reporting
programs, such as PQRS, move to more outcomes-based measures and fewer
process measures over time, we might also revise the quality
performance standard for the Shared Savings Program to incorporate more
outcomes-based measures and fewer process measures over time.
In the CY 2015 PFS final rule with comment period, we finalized a
number of changes to the quality measures used in establishing the
quality performance standard to better align with PQRS, retire measures
that no longer align with updated clinical practice, and add new
outcome measures that support the CMS Quality Strategy and National
Quality Strategy goals. We are continuing to work with the measures
community to ensure that the specifications for the measures used under
the Shared Savings Program are up-to-date. We believe that it is
important to balance the timing of the release of specifications so
they are as up-to-date as possible, while also giving ACOs sufficient
time to review specifications. Our intention is to issue the
specifications annually, prior to the start of the reporting period for
which they will apply.
b. New Measure To Be Used in Establishing Quality Standards That ACOs
Must Meet To Be Eligible for Shared Savings
Since the November 2011 Shared Savings Program final rule, we have
continued to review the quality measures used for the Shared Savings
Program to ensure that they are up to date with current clinical
practice and are aligned with the GPRO web interface reporting for
PQRS. Based on these reviews, in the CY 2015 PFS final rule with
comment period, we retired several measures that no longer aligned with
updated clinical guidelines regarding cholesterol targets. As a result
of retiring measures that did not align with updated clinical practice,
we identified a gap in the Shared Savings Program measure set for
measures that address treatment for patients at high risk of
cardiovascular disease due to high cholesterol. Cardiovascular disease
affects a high volume of Medicare beneficiaries and the prevention of
cardiovascular disease as well as its treatment is important. Following
further analysis and coordination with agencies such as the Centers for
Disease Control and Prevention and the Agency for Healthcare Research &
Quality, in the CY 2016 PFS proposed rule we proposed to add a new
statin therapy measure for the Shared Savings Program that has been
developed to align with the updated clinical guidelines and PQRS
reporting. We proposed to add a statin therapy measure to the
Preventive Health domain, which would increase our current total number
of measures from 33 to 34 measures. Data collection for the new measure
would occur through the CMS web interface. Table 45 lists the Shared
Savings Program quality measure set, including the one measure we
proposed to add, which would be used to assess ACO quality starting in
2016.
Statin Therapy for the Prevention and Treatment of
Cardiovascular Disease
We proposed to add the Statin Therapy for the Prevention and
Treatment of Cardiovascular Disease to the Preventive Health domain.
The measure was developed by CMS in collaboration with other federal
agencies and the Million Hearts[supreg] Initiative and is intended to
support the prevention and treatment of cardiovascular disease by
measuring the use of statin therapies according to the updated clinical
guidelines for patients with high cholesterol. The measure reports the
percentage of beneficiaries who were prescribed or were already on
statin medication therapy during the measurement year and who fall into
any of the following three categories:
(1) High-risk adult patients aged greater than or equal to 21 years
who were previously diagnosed with or currently have an active
diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD);
(2) Adult patients aged greater than or equal to 21 years with any
fasting or direct Low-Density Lipoprotein Cholesterol (LDL-C) level
that is greater than or equal to 190 mg/dL; or
(3) Patients aged 40 to 75 years with a diagnosis of diabetes with
a fasting or direct LDL-C level of 70 to 189 mg/dL who were prescribed
or were already on statin medication therapy during the measurement
year.
The measure contains multiple denominators to align with the
updated clinical guidelines for cholesterol targets and would replace
the low-density lipid control measures previously retired from the
measure set. We proposed this measure to continue Shared Savings
Program alignment with the PQRS program and Million Hearts[supreg]
Initiative. We proposed that the multiple denominators would be equally
weighted when calculating the performance rate. The measure was
reviewed by the NQF Measure
[[Page 71265]]
Applications Partnership (MAP) and the MAP encouraged further
development (Measures Under Consideration (MUC) ID: X3729).
As a result, we solicited public comment on the implementation of
the measure for the Shared Savings Program. We solicited comment on
whether the measure should be considered a single measure with weighted
denominators or three measures given the multiple denominators that
were developed to adhere to the updated clinical guidelines. In
addition, the use of multiple denominators raises questions on how the
measure should be benchmarked for the Shared Savings Program.
Therefore, we solicited public feedback on the benchmarking approach
for the measure, such as whether the measure should be benchmarked as a
single measure or three measures. The measure may require larger sample
sizes to accommodate exclusions when identifying relevant beneficiaries
for each of the denominators used for CMS web interface reporting. Due
to the multiple denominators, there may be a large number of
beneficiaries who may not meet each denominator for reporting, which
could result in a low number of beneficiaries meeting the measure
denominators. Hence, we proposed to increase the size of the oversample
for this measure from the normal 616 beneficiaries for CMS web
interface reporting to an oversample of 750 or more beneficiaries. We
proposed such an oversample size for this measure to account for
reporting on the multiple denominators and to ensure a sufficient
number of beneficiaries meet the measure denominators for reporting.
The consecutive reporting requirement for measures reported through the
CMS web interface would remain at 248 beneficiaries. We proposed that
the measure will be pay for reporting for 2 years and then phase into
pay for performance in the third year of the agreement period, as seen
in Table 31 of the proposed rule (80 FR 41886 through 41888).
Previously, we finalized that new measures will have a 2-year
transition period before being phased in as pay for performance (79 FR
67910). However, we also solicited comment on whether stakeholders
believe the measure should be pay for reporting for the entire
agreement period due to the application of multiple denominators for a
single measure. In summary, we solicited comment on our proposal to
include this measure in the Preventive Health domain, whether it should
be treated as a single or multiple measures for reporting and
benchmarking, the transition of the measure into pay for performance or
if the measure should remain pay for reporting for the entire agreement
period, and the size of the oversample to ensure sufficient
identification of beneficiaries for reporting.
The quality scoring methodology is explained in the regulations at
Sec. 425.502 and in the preamble to the November 2011 final rule with
comment period (76 FR 67895 through 67900). As a result of this
proposed addition, each of the four domains will include the following
number of quality measures (See Table 44 for details.):
Patient/Caregiver Experience of Care--8 measures.
Care Coordination/Patient Safety--10 measures.
Preventive Health--9 measures.
At Risk Population--7 measures (including 6 individual
measures and a 2-component diabetes composite measure).
Table 44 provides a summary of the number of measures by domain and
the total points and domain weights that would be used for scoring
purposes with the proposed Statin Therapy measure in the Preventive
Health domain. Under our proposal, the total possible points for the
Preventive Health domain would increase from 16 points to 18 points.
Otherwise, the current methodology for calculating an ACO's overall
quality performance score would continue to apply. We also solicited
comment on whether the proposed Statin Therapy measure, with multiple
denominators, should be scored at more than 2 points if commenters
believe this measure should be treated as multiple measures within the
Preventive Health domain instead of a single measure. For instance, the
measure could be scored as 3 points, 1 point for each of the three
denominators, due to the clinical importance of prevention and
treatment of cardiovascular disease and the complexity of the measure.
Table 44--Number of Measures and Total Points for Each Domain Within the Quality Performance Standard
----------------------------------------------------------------------------------------------------------------
Number of Total
Domain individual Total measures for scoring possible Domain
measures purposes points weight
----------------------------------------------------------------------------------------------------------------
Patient/Caregiver Experience.............. 8 8 individual survey module 16 25%
measures.
Care Coordination/Patient Safety.......... 10 10 measures. Note that the 22 25%
EHR measure is double-
weighted (4 points).
Preventive Health......................... 9 9 measures................... 18 25%
At-Risk Population........................ 7 6 individual measures, plus a 12 25%
2-component diabetes
composite measure, scored as
one..
---------------------------------------------------------------------
Total in all Domains.................. 34 33........................... 68 100%
----------------------------------------------------------------------------------------------------------------
Comment: Most comments we received supported the addition of the
Statin Therapy measure to the Preventative Health domain, but some
stakeholders recommended changes to the denominators or suggested
expanding treatments beyond statins to include other effective
treatments. An example of a suggested change to the measure that we
received is a recommendation to modify the denominators to report the
percentage of the high risk population that is both on a statin and has
achieved an LDL < 100. In addition, numerous commenters urged CMS to
seek endorsement of the Statin Therapy measure from the National
Quality Forum prior to implementation in the Shared Savings Program.
Many commenters supported increasing the beneficiary oversample for
reporting the measure, but did not think it would resolve the issue of
insufficient beneficiaries meeting the multiple denominators and did
not provide alternative suggestions. Most commenters supported scoring
the measure as a single measure and retaining the measure as pay-for-
reporting for the entire agreement period due to concerns with the
measure specifications and lack of NQF endorsement. However, some
[[Page 71266]]
commenters agreed with our proposal and recommended the measure
transition to pay-for-performance after being pay-for-reporting for 2
years.
We also received many comments opposing the addition of the Statin
Therapy measure, citing concerns about specifications that are not
publicly available and about adding a process measure that has not been
tested and still does not conform to the four major statin therapy
benefit categories from the 2013 ACC/AHA clinical guidelines.
Commenters suggested CMS move toward replacing process measures with
health outcome and patient-reported outcome measures.
Response: After reviewing the comments, we are finalizing our
proposal for adding the Statin Therapy quality measure to the quality
measure set for the Shared Savings Program. As is our standard
practice, we intend to make specifications for this measure available
prior to the performance year in which it is applicable. We therefore
anticipate the final specifications for the Statin Therapy measure will
be made public prior to the 2016 performance year. In response to the
commenters who expressed concern that this measure requires further
testing and may not cover all components of the current clinical
guidelines, we note that CMS requires that all measures included in the
program undergo feasibility, validity, and reliability testing. CMS
tested the measure to assess the technical feasibility of the measure,
as well as the extent to which measure scores are valid and reliable.
In addition, the measure underwent qualitative testing activities
across multiple testing sites to assess the feasibility, face validity
and usability of the measure. The testing was conducted in accordance
with the processes and principles outlined in CMS's A Blueprint for the
Measures Management System (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/MeasuresManagementSystemBlueprint.html). This measure also reflects
CMS's effort to adhere to current clinical guidelines. The measure
incorporates three of the four components of the 2013 ACC/AHA clinical
guidelines, and thus, this initial implementation of the measure
provides an opportunity to fill a key clinical gap in the program.
Based on feedback and guidance from the technical expert panel and
measure owner, this measure is the most advantageous and analytically
feasible way to address the clinical guidelines. Although, we believe
the measure conforms to current guidelines, we understand the ACC is
convening stakeholders to further discuss and review the guidelines.
CMS will continue to monitor and review updates to guidelines and take
these into consideration in the future. We appreciate comments
suggesting the use of an NQF-endorsed measure. However, there is no
similar, feasible, and practical measure that has been endorsed by the
NQF and submitted to the Measure Applications Partnership. While some
commenters suggested expanding the measure to other effective
treatments, current clinical guidelines indicate statin therapy is the
appropriate standard of care. We believe that requiring ACOs to report
on the Statin Therapy measure is important to encourage focus on
important preventive care and effective treatment for a high prevalence
condition. Moreover, inclusion of this measure, as outlined previously,
will enhance alignment with PQRS and the Million Hearts [supreg]
Initiative, and focus on important preventive care and effective
treatments for high prevalence conditions.
We are finalizing our proposal of adding the Statin Therapy measure
as a single 3-part measure scored as 2 points with an oversample of 750
beneficiaries. We are increasing the oversample from 616 to 750
beneficiaries for this measure, but the consecutive reporting
requirement for measures reported through the CMS web interface will
remain at 248 beneficiaries. Although we proposed transitioning the
measure to pay-for-performance in the third year of the agreement
period, we are finalizing the measure as pay-for-reporting for all
reporting years because a majority of commenters supported finalizing
the measure as pay-for-reporting only and because ACC and other experts
are continuing to discuss non-statin therapy and reducing ASCVD risk.
These discussions may, in turn, cause modifications in the measure
specifications. For these reasons, we believe 2 years is too short a
timeline to transition to pay for performance in accordance with our
current rules and therefore will finalize this measure as pay for
reporting for all three years. By finalizing the measure as pay-for-
reporting in all agreement years we hope to provide ACOs and their ACO
participants and ACO providers/suppliers with an opportunity to gain
experience and become familiar with the ACC/AHA clinical guidance and
multiple denominators of the measure. However, we agree with commenters
that stated support for measures of statin therapy and the importance
of moving to pay for performance. We therefore intend to revisit this
measure in future rulemaking to propose a timeline for phasing in pay
for performance. As a result of adding this measure, the total points
possible in the Preventive Health domain will increase from 16 points
to 18 points and the total measures in the Shared Savings Program
measure set reported by ACOs will increase from 33 measures to 34
measures.
[[Page 71267]]
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[GRAPHIC] [TIFF OMITTED] TR16NO15.142
[[Page 71269]]
c. Policy for Measures No Longer Aligning With Clinical Guidelines,
High Quality Care or Outdated Measure May Cause Patient Harm
We have encountered circumstances where changes in clinical
guidelines result in quality measures within the Shared Savings Program
quality measure set no longer aligning with best clinical practice. For
instance, in the CY 2015 PFS final rule with comment period we retired
measures that were no longer consistent with updated clinical
guidelines for cholesterol targets, but we were unable to finalize
retirement of the measures for the 2014 reporting year due to the
timing of the guideline updates and rulemaking cycle. We issued an
update in the 2014 Shared Savings Program benchmark guidance document
that maintained these measures as pay-for-reporting for the 2014
reporting year due to the measures not aligning with updated clinical
evidence.
However, given the frequency of changes that occur in scientific
evidence and clinical practice, in the CY 2016 PFS proposed rule (80 FR
41889) we proposed to adopt a general policy under which we would
maintain measures as pay-for-reporting, or revert pay-for-performance
measures to pay-for-reporting measures, if the measure owner determines
the measure no longer meets best clinical practices due to clinical
guideline updates or when clinical evidence suggests that continued
measure compliance and collection of the data may result in harm to
patients. This flexibility will enable us to respond more quickly to
clinical guideline updates that affect measures without waiting until a
future rulemaking cycle to retire a measure or revert to pay for
reporting. In the proposed rule, we explained that we expected to
continue to retire measures through the annual PFS final rule with
comment period as clinical guidelines change; however, the timing of
clinical guideline updates may not always correspond with the
rulemaking cycle. Under this proposal, if a guideline update is
published during a reporting year and the measure owner determines the
measure specifications do not align with the updated clinical practice,
we would have the authority to maintain a measure as pay for reporting
or revert a pay-for-performance measure to pay for reporting and
finalize changes in the subsequent PFS final rule with comment period.
Therefore, we proposed to add a new provision at Sec. 425.502(a)(5) to
reserve the right to maintain a measure as pay for reporting, or revert
a pay-for-performance measure to pay for reporting, if a measure owner
determines the measure no longer meets best clinical practices due to
clinical guideline updates or clinical evidence suggests that continued
application of the measure may result in harm to patients. The measure
owner will inform CMS if a measure's specification does not align with
updated guidelines or if continued application of the measure may
result in patient harm. We would then implement any necessary change to
the measure in the next PFS rulemaking cycle by either retiring the
measure or maintaining it as pay for reporting. We solicited comment on
this proposal and whether there may be additional criteria we should
consider in deciding when it may be appropriate to maintain a measure
as pay-for-reporting or revert from pay-for-performance back to pay-
for-reporting.
Comment: Comments supported the proposed policy not to assess ACO
performance on measures that no longer align with clinical guidelines
or may cause patient harm; however, many commenters suggested the most
appropriate method to handle such measures is immediate suspension and
further evaluation of the measure by stakeholders or NQF rather than
maintaining the measure as pay-for-reporting.
Response: We are finalizing our proposal to maintain measures as
pay-for-reporting, or revert pay-for-performance measures to pay-for-
reporting measures, if the measure owner determines the measure no
longer meets best clinical practice due to clinical guideline changes
or clinical evidence suggesting that the continued collection of the
data may result in harm to patients. We believe that maintaining or
reverting a measure to pay-for-reporting will ensure ACOs will not be
scored on their performance on the measure while CMS and the measure
steward assess the measure specifications. CMS may propose to retire
such a measure in the next rulemaking cycle, which will offer the
public an opportunity to comment and will put ACOs on sufficient notice
about the retirement of the measure. We appreciate the comments
suggesting immediate suspension and will explore this option further
and may consider proposing such an approach in the future.
d. Request for Comment Related to Use of Health Information Technology
In the November 2011 final rule, we included a measure related to
the use of health information technology under the Care Coordination/
Patient Safety domain: The percent of PCPs within an ACO who
successfully qualify for an EHR Incentive Program incentive (76 FR
67878). In finalizing this measure, we included eligible professionals
that qualified for payments to adopt, implement, or upgrade EHR
technology, in addition to those receiving a payment for meeting
Meaningful Use Requirements. We selected this measure as opposed to
other proposed measures to focus on EHR adoption among the primary care
physicians within an ACO. Finally, we chose to focus on this measure
because it represented a structural measure of EHR program
participation that is not duplicative of measures within the EHR
Incentive program for which providers may already qualify for incentive
payments or face penalties. Although this was the only measure we
finalized related to use of health information technology, we chose to
double weight this measure for scoring purposes to signal the
importance of health information technology for ACOs (76 FR 67895).
In the CY 2015 PFS final rule with comment period, we finalized a
proposal to change the name and specification of this measure to
``Percent of PCPs who Successfully Meet Meaningful Use Requirements''
to reflect the transition from incentive payments to downward payment
adjustments in 2015 (79 FR 67912). We believe this name will more
accurately depict successful use and adoption of EHR technology. In
addition, we also updated the measure specifications to include
providers who met meaningful use requirements within the past 2 years
to account for the changes in meaningful use requirements and to
support the progression of HIT adoption and use.
We continue to believe that measures that encourage the effective
adoption and use of health information technology among participants in
accountable care initiatives are an important way to signal the
importance of technology infrastructure in supporting successful ACOs,
especially as they mature and assume additional risk. Since the initial
EHR quality measure was finalized in 2011, the EHR Incentive Program
and Meaningful Use requirements have shifted from an initial focus on
technology adoption and data capture to interoperable exchange of data
across systems and the use of more advanced health IT functions to
support care coordination and quality improvement. In October 2015,
final rules were issued for ``Stage 3'' of the EHR Incentive program
(80 FR 62761), as well as the 2015 Edition of ONC certification
criteria (80 FR 62601). Together, these rules aim to support
[[Page 71270]]
providers' ability to exchange a common clinical dataset across the
continuum of care. In addition, ONC has released a document entitled
``Connecting Health and Care for the Nation: A Shared Nationwide
Interoperability Roadmap (available at https://www.healthit.gov/sites/default/files/hie-interoperability/nationwide-interoperability-roadmap-final-version-1.0.pdf) which focuses on actions that will enable a
majority of individuals and providers across the care continuum to
send, receive, find and use a common set of electronic clinical
information at the nationwide level by the end of 2017.
We believe that the widespread inclusion of these capabilities
within health IT systems, and their adoption and effective use by
providers, will greatly enhance ACOs' ability to coordinate care for
beneficiaries with practitioners both within and outside their ACO and
more effectively manage the total cost of care for attributed patients.
Although we did not propose any changes to the current measure
``Percent of PCPs who Successfully Meet Meaningful Use Requirements''
(ACO-11), we solicited comments on how this measure might evolve in the
future to ensure we are incentivizing and rewarding providers for
continuing to adopt and use more advanced health IT functionality as
described above, and broadening the set of providers across the care
continuum that have adopted these tools. We welcomed comments on the
following questions:
Although the current measure focuses only on primary care
physicians, should this measure be expanded in the future to include
all eligible professionals, including specialists?
How could the current measure be updated to reward
providers who have achieved higher levels of health IT adoption?
Should we substitute or add another measure that would
focus specifically on the use of health information technology, rather
than meeting overall Meaningful Use requirements, for instance, the
transitions of care measure required for the EHR Incentives Program?
What other measures of IT-enabled processes would be most
relevant to participants within ACOs? How could we seek to minimize the
administrative burden on providers in collecting these measures?
We appreciate the numerous thoughtful comments on the questions we
posed regarding the current measure ``Percent of PCPs who Successfully
Meet Meaningful Use Requirements'' (ACO-11) and its evolution as a part
of the Shared Savings Program. We will use the feedback as we determine
how the measure could be updated and expanded to further incentivize
and reward providers for using and adopting more advanced health IT. We
would make any modifications necessary to permit the evolution of the
measure through future rulemaking.
e. Conforming Changes To Align With PQRS
Under the Shared Savings Program rules at Sec. 425.504, ACOs, on
behalf of their ACO providers/suppliers who are eligible professionals,
must submit quality measures using a CMS web interface (currently the
CMS Group Practice Reporting Option Web Interface) to satisfactorily
report on behalf of their eligible professionals for purposes of the
PQRS payment adjustment under the Shared Savings Program. Under Sec.
425.118(a)(4), all Medicare enrolled individuals and entities that have
reassigned their right to receive Medicare payment to the TIN of an ACO
participant must be included on the ACO provider/supplier list and must
agree to participate in the ACO and comply with the requirements of the
Shared Savings Program, including the quality reporting requirements.
Thus, each eligible professional that bills under the TIN of an ACO
participant must be included on the ACO provider/supplier list in
accordance with the requirements in Sec. 425.118.
The methodology for applying the PQRS adjustment to group practices
takes into account the services billed by all eligible professionals
through the TIN of the group practice, however, the references to ``ACO
providers/suppliers who are eligible professionals'' in Sec. 425.504
indicate that the ACO provider/supplier list should be used to
determine the eligible professionals. Our intent and current practice
is to treat the ACO and its ACO participants the same as any other
physician group electing to report for purposes of PQRS through the
GPRO Web Interface. We therefore have determined that it is necessary
to modify the language in Sec. 425.504 for clarity and to bring it
into alignment with the methodology used to determine the applicability
of the payment adjustment under the PQRS GPRO methodology so that it is
consistently applied to eligible professionals billing through an ACO
participant TIN. We proposed in the CY 2016 PFS proposed rule (80 FR
41890) to revise Sec. 425.504(a) to replace the phrase ``ACO
providers/suppliers who are eligible professionals'' and ``ACO
providers/suppliers that are eligible professionals'' with the phrase
``eligible professionals who bill under the TIN of an ACO participant''
along with conforming changes anywhere the term ACO providers/suppliers
appears in Sec. 425.504. We indicated that we believe these changes
are necessary to clarify that the requirement that the ACO report on
behalf of these eligible professionals applies in a way that is
consistent with the PQRS GPRO policies and also addresses mid-year
updates to and deletions from the ACO provider/supplier list.
Comment: We received few comments on this proposal, but all
comments supported the proposed changes because the revisions would
clarify the reporting requirement and align the policy under the Shared
Savings Program with PQRS.
Response: We appreciate the comments in support of our proposal. We
agree that the proposed revisions to Sec. 425.504(a) to replace the
phrase ``ACO providers/suppliers who are eligible professionals'' and
``ACO providers/suppliers that are eligible professionals'' with the
phrase ``eligible professionals who bill under the TIN of an ACO
participant,'' along with conforming changes anywhere the term ACO
providers/suppliers appears in Sec. 425.504, will clarify the
reporting requirement and align the Shared Savings Program policy with
PQRS. As a result, we are finalizing our proposed revisions to Sec.
425.504.
2. Assignment of Beneficiaries to ACOs
Section 1899(c) of the Act requires the Secretary to ``determine an
appropriate method to assign Medicare fee-for-service beneficiaries to
an ACO based on their utilization of primary care services provided
under this title by an ACO professional described in paragraph
(h)(1)(A).''
As we have explained in detail elsewhere (79 FR 72792), we
established the current list of codes that constitute primary care
services under the Shared Savings Program at Sec. 425.20 because we
believed the listed codes represented a reasonable approximation of the
kinds of services that are described by the statutory language which
refers to assignment of ``Medicare fee-for-service beneficiaries to an
ACO based on their utilization of primary care services'' furnished by
physicians. We proposed the following revisions to the assignment of
beneficiaries to ACOs under the Shared Savings Program.
[[Page 71271]]
a. Assignment of Beneficiaries Based on Certain Evaluation and
Management Services in Skilled Nursing Facilities (SNFs)
As discussed in detail in the November 2014 proposed rule for the
Shared Savings Program (79 FR 72792 through 72793), we welcomed comment
from stakeholders on the implications of retaining certain E/M codes
used for physician services furnished in SNFs and other nursing
facility settings (CPT codes 99304 through 99318) in the definition of
primary care services. As we noted in the November 2014 proposed rule,
in some cases, hospitalists that perform E/M services in SNFs have
requested that these codes be excluded from the definition of primary
care services so that their ACO participant TIN need not be exclusive
to only one ACO based on the exclusivity policy established in the
November 2011 final rule (76 FR 67810 through 67811). The requirement
under Sec. 425.306(b) that an ACO participant TIN be exclusive to a
single ACO applies when the ACO participant TIN submits claims for
primary care services that are considered in the assignment process.
However, ACO participant TINs upon which beneficiary assignment is not
dependent (that is, ACO participant TINs that do not submit claims for
primary care services that are considered in the assignment process)
are not required to be exclusive to a single ACO.
In response to the discussion in the Shared Savings Program
proposed rule of our policy of including the codes for SNF visits, CPT
codes 99304 through 99318, in the definition of primary care services,
some commenters objected to inclusion of SNF visit codes, believing a
SNF is more of an extension of the inpatient setting rather than a
component of the community based primary care setting. As a result,
these commenters believe that ACOs are often inappropriately assigned
patients who have had long SNF stays but would not otherwise be aligned
to the ACO and with whom the ACO has no clinical contact after their
SNF stay. Some commenters draw a distinction between such services
provided in two different places of service, POS 31 (SNF) and POS 32
(NF). Although the same CPT visit codes are used to describe these
services in SNFs (POS 31) and NFs (POS 32), the patient population is
arguably quite different. These commenters suggested excluding SNF
visit codes furnished in POS 31 to potentially relieve physicians
practicing exclusively in skilled nursing facilities from the
requirement that ACO professionals must be exclusive to a single ACO if
their services are considered in assignment. Patients in SNFs (POS 31)
are shorter stay patients who are 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 in the community. Patients in a SNF (POS 31) require more frequent
practitioner visits-often from 1 to 3 times a week. In contrast,
patients in NFs (POS 32) are almost always permanent residents and
generally receive their primary care services in the facility for the
duration of their life. Patients in the NF (POS 32) are usually seen
every 30 to 60 days unless medical necessity dictates otherwise.
We agree that it would be feasible to use POS 31 to identify claims
for services furnished in a SNF. Therefore, in the CY 2016 PFS proposed
rule we proposed to amend our definition of primary care services at
Sec. 425.20, for purposes of the Shared Savings Program, to exclude
services billed under CPT codes 99304 through 99318 when the claim
includes the POS 31 modifier. We 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 in the community to the primary care professionals who are
typically responsible for providing care to meet their true primary
needs. We indicated in the proposal that if we finalized this proposal,
we anticipated applying this revised definition of primary care
services for purposes of determining ACO eligibility during the
application cycle for the 2017 performance year, which occurs during
2016, and the revision would be then be applicable for all ACOs
starting with the 2017 performance year. This approach would align the
assignment algorithms for both new ACOs entering the program and
existing ACOs ensuring that beneficiaries are being assigned to the
most appropriate ACO and that assigned beneficiary populations are
determined using consistent assignment algorithms for all ACOs, as well
as aligning our program operations with the application cycle. We
proposed to make a conforming change to the definition of primary care
services in paragraph (2) by indicating that the current definition
will be in use for the 2016 performance year and to add a new
definition of primary care services in paragraph (4), which excludes
SNFs from the definition of primary care services effective starting
with the 2017 performance year. We believe that excluding services
furnished in SNFs from the definition of primary care services will
complement our goal to assign beneficiaries to an ACO based on their
utilization of primary care services. Further, based on preliminary
analysis, we do not expect removal of these claims from the assignment
process would result in a significant reduction in the number of
beneficiaries assigned to ACOs, although we recognize that assignment
to some ACOs may be more affected than others, depending on the
practice patterns of their ACO professionals. ACO participant TINs that
include only ACO professionals that furnish services exclusively in
SNFs would not be required to be exclusive to a single ACO. We also
note, however, that an ACO participant TIN that includes both ACO
professionals that furnish services exclusively in SNFs as well as
other ACO professionals that furnish primary care services in non-SNF
settings would continue to be required to be exclusive to a single ACO
since such an ACO participant TIN would be submitting claims for
primary care services that would continue to be used for beneficiary
assignment.
The following is a summary of the comments we received regarding
these proposals:
Comment: Nearly all commenters that submitted comments supported
the proposal to exclude services billed under CPT codes 99304 through
99318 when the claim includes the POS 31 modifier. These commenters
agreed that it would increase the accuracy of the beneficiary
assignment methodology. Although beneficiaries' care may be coordinated
during their time in a SNF, they are then transitioned back in the
community to the primary care professionals who are typically
responsible for providing care to meet their true primary care needs.
Hospitalists and other physicians providing services in SNFs also
indicated their support for the proposal, agreeing that in some
circumstances it could relieve them from the requirement that they must
be exclusive to a single ACO if their services are considered in
assignment. In addition, a commenter opposed the proposal, believing
that the proposal fails to recognize the importance in rural areas of
SNFs as a vital site of primary care services. This commenter reported
that SNF residents in rural areas often have longer stays for chronic
conditions requiring intensive maintenance and coordination efforts. As
a result, the commenter believes the
[[Page 71272]]
proposal would deprive ACO attribution and benefits to a significant
portion of the rural ``Medicaid'' population and those in most need of
such patient-centered service delivery. Another commenter questioned
the validity of excluding SNF visits from the beneficiary assignment
process while including any cost savings generated by ACOs through
collaborative affiliation with SNFs.
Response: We recognize that SNF patients are shorter stay patients
who are generally receiving continued acute medical care and
rehabilitative services. While their care may be coordinated during
their time in the SNF, they are then transitioned back in the community
to the primary care professionals who are typically responsible for
providing care to meet their true primary care needs. Further, based on
our preliminary analysis and input from commenters, we do not believe
removal of these claims will result in a significant reduction of
assigned beneficiaries from an ACO, although we recognize that
assignment to some ACOs may be more affected than others, depending on
the practice patterns of their ACO provider/suppliers.
We disagree with the comment that this approach would deprive ACO
attribution and benefits to a significant portion of the rural Medicaid
population and those in most need of such patient-centered service
delivery. While residing in a SNF, patients are primarily receiving
continued acute medical care and rehabilitative services. Further,
assignment under the Shared Savings Program is only available to
Medicare beneficiaries, and the assignment methodology includes primary
care services furnished in RHCs. We believe that it is more appropriate
for such patients to be assigned to ACOs based on the primary care
professionals in the community (including NFs) who are typically
responsible for providing care to meet their true primary care needs.
We also disagree with the commenter who questioned the validity of
excluding the SNF visits from the beneficiary assignment process while
including the cost savings generated by an ACO through collaborative
affiliation with SNFs. We believe that including such expenditures as
part of determining an ACO's shared savings or losses provides an
appropriate incentive for ACOs to coordinate and manage a patient's
overall care. We also note this is consistent with the statutory
requirements in section 1899(c) of the Act, which requires that
beneficiaries be assigned to ACOs based on their utilization of primary
care services, and requires that ACOs be accountable for the total cost
of the beneficiary's care (that is, both part A and B expenditures).
After considering the comments, we are finalizing the proposal to
amend paragraph (2) under Sec. 425.20 to exclude from our definition
of primary care services claims billed under CPT codes 99304 through
99318 when the claim includes the POS code 31 modifier. We believe that
excluding these services furnished in SNFs from the definition of
primary care services will complement our goal of assigning
beneficiaries to an ACO based on their utilization of primary care
services. We are also finalizing our proposal to make a conforming
change to the definition of primary care services by indicating that
the current definition will be in use for the 2016 performance year and
to add a new definition of primary care services, which excludes
services furnished in SNFs from the definition of primary care services
effective starting with the 2017 performance year. To conform to the
precedent set by the June 2015 Shared Savings Program final rule (80 FR
32758), we will adjust all benchmarks at the start of the first
performance year in which the new assignment rules are applied so that
the benchmark for an ACO reflects the use of the same assignment rules
as would apply in the performance year.
b. Assignment of Beneficiaries to ACOs that Include ETA Hospitals
We have developed special operational instructions and processes
(79 FR 72801 through 72802) that enable us to include primary care
services performed by physicians at ETA hospitals in the assignment of
beneficiaries to ACOs under Sec. 425.402. ETA hospitals are hospitals
that, under section 1861(b)(7) of the Act and Sec. 415.160, have
voluntarily elected to receive payment on a reasonable cost basis for
the direct medical and surgical services of their physicians in lieu of
Medicare PFS payments that might otherwise be made for these services.
We use institutional claims submitted by ETA hospitals in the
assignment process under the Shared Savings Program because ETA
hospitals are paid for physician professional services on a reasonable
cost basis through their cost reports and no other claim is submitted
for such services. However, ETA hospitals bill us for their separate
facility services when physicians and other practitioners provide
services in the ETA hospital and the institutional claims submitted by
ETA hospitals include the HCPCS code for the services provided. To
determine the rendering physician for ETA institutional claims, we use
the NPI listed in the ``other provider'' NPI field on the institutional
claim. Then we use PECOS to obtain the CMS specialty for the NPI listed
on the ETA institutional claim.
These institutional claims do not include allowed charges, which
are necessary to determine where a beneficiary received the plurality
of primary care services as part of the assignment process.
Accordingly, we use the amount that would otherwise be payable under
the PFS for the applicable HCPCS code, in the applicable geographic
area as a proxy for the allowed charges for the service.
The definition of primary care services at Sec. 425.20 includes
CPT codes in the range 99201 through 99205 and 99211 through 99215, and
certain other codes. For services furnished prior to January 1, 2014,
we use the HCPCS code included on the institutional claim submitted by
an ETA hospital to identify whether the primary care service was
rendered to a beneficiary in the same way as for any other claim.
However, we implemented a change in coding policy under the Outpatient
Hospital Prospective Payment System (OPPS) that inadvertently affects
the assignment of beneficiaries to an ACO when the beneficiary receives
care at an ETA hospital. Effective for services furnished on or after
January 1, 2014, outpatient hospitals, including ETA hospitals, were
instructed to use the single HCPCS code G0463 and to no longer use CPT
codes in the ranges of 99201 through 99205 and 99211 through 99215.
(For example, see our Web site at http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM8572.pdf, page 3). In other words, for ETA hospitals, G0463 is a
replacement code for CPT codes in the ranges of 99201 through 99205 and
99211 through 99215.
We continue to believe that it is appropriate to use ETA
institutional claims for purposes of identifying primary care services
furnished by physicians in ETA hospitals and to allow these services to
be included in the stepwise methodology for assigning beneficiaries to
ACOs. We believe including these claims increases the accuracy of the
assignment process by helping ensure that beneficiaries are assigned to
the ACO or other entity that is actually managing the beneficiary's
care. ETA hospitals are often located in underserved areas and serve as
providers of primary care for the beneficiaries they serve. Therefore,
we proposed to consider HCPCS code
[[Page 71273]]
G0463 when submitted by ETA hospitals as a code designated by us as a
primary care service for purposes of the Shared Savings Program. We
recently updated our existing operational guidance on this issue so
that we can continue to consider services furnished in ETA hospitals
for beneficiary assignment purposes using the new G code until we
codify a change to our definition of primary care services. This
approach allows us to continue to accurately assign Medicare FFS
beneficiaries to ACOs based on their utilization of primary care
services furnished by ACO professionals, including those ACOs that may
include ETA hospitals.
We would note that to promote flexibility for the Shared Savings
Program and to allow the definition of primary care services used in
the Shared Savings Program to respond more quickly to HCPCS/CPT coding
changes made in the annual PFS rulemaking process, we recently adopted
a policy of making revisions to the definition of primary care service
codes for the Shared Savings Program through the annual PFS rulemaking
process, and we amended the definition of primary care services at
Sec. 425.20 to include additional codes designated by CMS as primary
care services for purposes of the Shared Savings Program, including new
HCPCS/CPT codes or revenue codes and any subsequently modified or
replacement codes. Therefore, we proposed to amend the definition of
primary care services at Sec. 425.20 by adding HCPCS code G0463 for
services furnished in an ETA hospital to the definition of primary care
services that will be applicable for performance year 2016 and
subsequent performance years.
We also proposed to revise Sec. 425.402 by adding a new paragraph
(d) to provide that when considering services furnished by physicians
in ETA hospitals in the assignment methodology, we would use an
estimated amount based on the amounts payable under the PFS for similar
services in the geographic location in which the ETA hospital is
located as a proxy for the amount of the allowed charges for the
service. In this case, because G0463 is not payable under the PFS, we
proposed to use the weighted mean amount payable under the PFS for CPT
codes in the range 99201 through 99205 and 99211 through 99215 as a
proxy for the amount of the allowed charges for HCPCS code G0463 when
submitted by ETA hospitals. The weights needed to impute the weighted
mean PFS payment rate for HCPCS code G0463 would be derived from the
relative number of services furnished at the national level for CPT
codes 99201 through 99205 and 99211 through 99215. This approach is
consistent with our current practice and guidance and would continue to
allow for beneficiaries to be attributed to the ACO responsible for
their care. Additional details regarding computation of the proxy
amount for G0463 would be provided through sub-regulatory guidance.
In addition, because we are able to consider claims submitted by
ETA hospitals as part of the assignment process, we also proposed to
amend Sec. 425.102(a) to add ETA hospitals to the list of ACO
participants that are eligible to form an ACO that may apply to
participate in the Shared Savings Program.
The following is a summary of the comments we received regarding
these ETA proposals:
Comment: We received very few comments on these ETA proposals; all
these comments supported the proposals.
Response: We appreciate the support for our proposals. We continue
to believe that including claims for primary care services furnished in
ETA hospitals increases the accuracy of the assignment process by
helping ensure that beneficiaries are assigned to the ACO or other
entity that is actually managing the beneficiary's care. ETA hospitals
are often located in underserved areas and serve as providers of
primary care for the beneficiaries they serve.
Accordingly, we are finalizing our proposals to codify our current
practice and guidance regarding the treatment of claims for primary
care services submitted by ETA hospitals in the assignment process. We
are amending the definition of primary care services at Sec. 425.20 by
adding HCPCS code G0463 for services furnished in an ETA hospital to
the definition of primary care services to codify our current practice
for performance year 2016 and subsequent performance years. We are
revising Sec. 425.402 by adding a new paragraph (d) to provide that
when considering services furnished by physicians in ETA hospitals in
the assignment methodology, we will use an estimated amount based on
the amounts payable under the PFS for similar services in the
geographic location in which the ETA hospital is located as a proxy for
the amount of the allowed charges for the service. We are also
finalizing our proposal to amend Sec. 425.102(a) to add ETA hospitals
to the list of ACO participants that are eligible to form an ACO that
may apply to participate in the Shared Savings Program. In addition, we
are also correcting a typographical error in Sec. 425.102(b) by
revising ``eligible participate'' to read ``eligible to participate.''
3. Technical Correction
In the 2015 PFS final rule with comment period (79 FR 67931), we
finalized corrections to a technical error and a typographical error at
Sec. 425.502(d)(2)(ii) that were not subsequently reflected in the
regulations text. Specifically, we proposed and finalized a technical
correction to eliminate the specific reference to paragraph (c) of
Sec. 425.216. The provision at Sec. 425.216, which addresses the
actions we may take prior to termination of an ACO from the Shared
Savings Program, does not include paragraph (c). We also finalized a
correction to a typographical error in Sec. 425.502(d)(2)(ii) by
revising ``actions describe'' to read ``actions described.'' In the
2015 PFS final rule with comment period, we noted that we did not
receive any objections to correcting the typographical error or the
other minor technical correction to Sec. 425.502(d)(2)(ii), and stated
that we intended to finalize them as proposed (79 FR 67931). However,
we inadvertently neglected to include these corrections in the
regulations text section of the 2015 PFS final rule. As a result of
this oversight, the CFR was not updated to reflect our final policies.
At this time, therefore, we are correcting the oversight by including
the previously finalized revisions to Sec. 425.502(d)(2)(ii) in this
final rule as they were finalized in the 2015 PFS final rule with
comment period.
M. Value-Based Payment Modifier and Physician Feedback Program
1. Overview
Section 1848(p) of the Act requires that we establish a value-based
payment modifier (VM) and apply it to specific physicians and groups of
physicians the Secretary determines appropriate starting January 1,
2015, and to all physicians and groups of physicians by January 1,
2017. On or after January 1, 2017, section 1848(p)(7) of the Act
provides the Secretary discretion to apply the VM to eligible
professionals (EPs) as defined in section 1848(k)(3)(B) of the Act.
Section 1848(p)(4)(C) of the Act requires the VM to be budget neutral.
The VM and Physician Feedback program continue CMS' initiative to
recognize and reward providers based on the quality and cost of care
provided to their patients, increase the transparency of health care
[[Page 71274]]
quality information and to assist providers and beneficiaries in
improving medical decision-making and health care delivery.
2. Governing Principles for VM Implementation
In the CY 2013 PFS final rule with comment period, we discussed the
goals of the VM and also established that specific principles should
govern the implementation of the VM (77 FR 69307). We refer readers to
that rule for a detailed discussion and list those principles here for
reference.
A focus on measurement and alignment. Measures for the VM
should consistently reflect differences in performance among groups or
solo practitioners, reflect the diversity of services furnished, and
should be consistent with the National and CMS Quality Strategies and
other CMS quality initiatives, including PQRS, the Medicare Shared
Savings Program (Shared Savings Program), and the Medicare EHR
Incentive Program.
A focus on physician and eligible professional choice.
Physicians and other nonphysician EPs should be able to choose the
level (individual or group) at which their quality performance will be
assessed, reflecting EPs' choice over their practice configurations.
The choice of level should align with the requirements of other
physician quality reporting programs.
A focus on shared accountability. The VM can facilitate
shared accountability by assessing performance at the group level and
by focusing on the total costs of care, not just the costs of care
furnished by an individual professional.
A focus on actionable information. The Quality and
Resource Use Reports (QRURs) should provide meaningful and actionable
information to help groups and solo practitioners identify clinical,
efficiency and effectiveness areas where they are doing well, as well
as areas in which performance could be improved by providing groups and
solo practitioners with QRURs on the quality and cost of care they
furnish to their patients.
A focus on a gradual implementation. The VM should focus
initially on identifying high and low performing groups and solo
practitioners. As we gain more experience with physician measurement
tools and methodologies, we can broaden the scope of measures assessed,
refine physician peer groups, create finer payment distinctions, and
provide greater payment incentives for high performance.
3. Overview of Existing Policies for the Physician VM.
In the CY 2013 PFS final rule with comment period (77 FR 69310), we
finalized policies to phase-in the VM by applying it beginning January
1, 2015, to Medicare PFS payments to physicians in groups of 100 or
more EPs. A summary of the existing policies that we finalized for the
CY 2015 VM can be found in the CY 2014 PFS proposed rule (78 FR 43486
through 43488). Subsequently, in the CY 2014 PFS final rule with
comment period (78 FR 74765 through 74787), we finalized policies to
continue the phase-in of the VM by applying it starting January 1,
2016, to payments under the Medicare PFS for physicians in groups of 10
or more EPs. Then, in the CY 2015 PFS final rule with comment period
(79 FR 67931 through 67966), we finalized policies to complete the
phase-in of the VM by applying it starting January 1, 2017, to payments
under the Medicare PFS for physicians in groups of 2 or more EPs and to
physician solo practitioners. We also finalized that beginning in
January 1, 2018, the VM will apply to nonphysician EPs in groups with 2
or more EPs and to nonphysician EPs who are solo practitioners.
4. Provisions of This Final Rule With Comment Period
As a general summary, in the CY 2016 PFS proposed rule (80 FR 41892
through 41908) we proposed the following VM policies:
Beginning with the CY 2016 payment adjustment period, a
TIN's size would be determined based on the lower of the number of EPs
indicated by the Medicare Provider Enrollment, Chain, and Ownership
System (PECOS)-generated list or our analysis of the claims data for
purposes of determining the payment adjustment amount under the VM.
For the CY 2018 payment adjustment period, to apply the VM
to nonphysician EPs who are physician assistants (PAs), nurse
practitioners (NPs), clinical nurse specialists (CNSs), and certified
registered nurse anesthetists (CRNAs) in groups and those who are solo
practitioners, and not to other types of professionals who are
nonphysician EPs.
For the CY 2018 payment adjustment period, to identify
TINs as those that consist of nonphysician EPs if either the PECOS-
generated list or our analysis of the claims data shows that the TIN
consists of nonphysician EPs and no physicians.
For the CY 2018 payment adjustment period, to not apply
the VM to groups and solo practitioners if either the PECOS-generated
list or claims analysis shows that the groups and solo practitioners
consist only of nonphysician EPs who are not PAs, NPs, CNSs, and CRNAs.
To continue to apply a two-category approach for the CY
2018 VM based on participation in the PQRS by groups and solo
practitioners.
For the CY 2018 payment adjustment period, to apply the
quality-tiering methodology to all groups and solo practitioners in
Category 1. Groups and solo practitioners would be subject to upward,
neutral, or downward adjustments derived under the quality-tiering
methodology, with the exception finalized in the CY 2015 PFS final rule
with comments period (79 FR 67937), that groups consisting only of
nonphysician EPs and solo practitioners who are nonphysician EPs will
be held harmless from downward adjustments under the quality-tiering
methodology in CY 2018.
Beginning with the CY 2017 payment adjustment period, to
apply the VM adjustment percentage for groups and solo practitioners
that participate in two or more ACOs during the applicable performance
period based on the performance of the ACO with the highest quality
composite score.
For the CY 2018 payment adjustment period, to apply the VM
for groups and solo practitioners that participate in an ACO under the
Shared Savings Program during the applicable performance period as
described under Sec. 414.1210(b)(2), regardless of whether any EPs in
the group or the solo practitioner also participated in an Innovation
Center model during the performance period.
For the CY 2018 payment adjustment period, if the ACO does
not successfully report quality data as required by the Shared Savings
Program, all groups and solo practitioners participating in the ACO
will fall in Category 2 for the VM and will be subject to a downward
payment adjustment.
Beginning in the CY 2017 payment adjustment period, to
apply an additional upward payment adjustment of +1.0x to Shared
Savings ACO Program participant TINs that are classified as ``high
quality'' under the quality-tiering methodology, if the ACOs in which
the TINs participated during the performance period have an attributed
patient population that has an average beneficiary risk score that is
in the top 25 percent of all beneficiary risk scores nationwide as
determined under the VM methodology.
[[Page 71275]]
Beginning with the CY 2017 payment adjustment period, to
waive application of the VM for groups and solo practitioners, as
identified by TIN, if at least one EP who billed for PFS items and
services under the TIN during the applicable performance period for the
VM participated in the Pioneer ACO Model, CPC Initiative, or other
similar Innovation Center models during the performance period.
To set the maximum upward adjustment under the quality-
tiering methodology for the CY 2018 VM to +4.0 times an upward payment
adjustment factor (to be determined after the performance period has
ended) for groups with 10 or more EPs; +2.0 times an adjustment factor
for groups with between 2 to 9 EPs and physician solo practitioners;
and +2.0 times an adjustment factor for groups and solo practitioners
that consist of nonphysician EPs who are PAs, NPs, CNSs, and CRNAs.
To set the amount of payment at risk under the CY 2018 VM
to 4.0 percent for groups with 10 or more EPs, 2 percent for groups
with between 2 to 9 EPs and physician solo practitioners, and 2 percent
for groups and solo practitioners that consist of nonphysician EPs who
are PAs, NPs, CNSs, and CRNAs.
To not recalculate the VM upward payment adjustment factor
after it is made public unless there was a significant error made in
the calculation of the adjustment factor.
To use CY 2016 as the performance period for the CY 2018
VM.
To align the quality measures and quality reporting
mechanisms for the CY 2018 VM with those available to groups and
individuals under the PQRS during the CY 2016 performance period.
To separately benchmark the PQRS electronic clinical
quality measures (eCQMs) beginning with the CY 2018 VM.
To include Consumer Assessment of Healthcare Providers and
Systems (CAHPS) Surveys in the VM for Shared Savings Program ACOs
beginning with the CY 2018 VM.
To apply the VM to groups for which the PQRS program
removes individual EPs from that program's unsuccessful participants
list beginning with the CY 2016 VM.
Beginning with the CY 2017 payment adjustment period, to
increase the minimum number of episodes for inclusion of the MSPB
measure in the cost composite to 100 episodes.
Beginning with the CY 2018 VM, to include hospitalizations
at Maryland hospitals as an index admission for the MSPB measure for
the purposes of the VM program.
Beginning in the CY 2016 payment adjustment period, a
group or solo practitioner subject to the VM would receive a quality
composite score that is classified as average under the quality-tiering
methodology if the group or solo practitioner does not have at least
one quality measure that meets the minimum number of cases required for
the measure to be included in the calculation of the quality composite.
To make technical changes to Sec. 414.1255 and Sec.
414.1235.
We also solicited comment on, but made no proposals regarding
stratifying cost measure benchmarks by beneficiary risk score.
a. Group Size
The policies to identify groups and solo practitioners that are
subject to the VM during a specific payment adjustment period are
described in Sec. 414.1210(c). Our previously-finalized policy is
that, beginning with the CY 2016 payment adjustment period, the list of
groups and solo practitioners subject to the VM is based on a query of
the PECOS that occurs within 10 days of the close of the PQRS group
registration process during the applicable performance period described
at Sec. 414.1215. Groups and solo practitioners, respectively, are
removed from the PECOS-generated list if during the performance period
for the applicable CY payment adjustment period, based on our analysis
of claims, the group did not have the required number of EPs that
submitted claims or the solo practitioner did not submit claims. In the
CY 2013 PFS final rule with comment period, we stated that for the CY
2015 payment adjustment period, we will not add groups to the PECOS-
generated list based on the analysis of claims (77 FR 69309 through
69310). In the CY 2014 PFS final rule with comment period, we finalized
that we will continue to follow this procedure for the CY 2016 payment
adjustment period and subsequent adjustment period (78 FR 74767).
In the CY 2014 PFS final rule with comment period (78 FR 74767
through 74771), we established different payment adjustment amounts
under the 2016 VM for (1) groups with between 10 to 99 EPs, and (2)
groups with 100 or more EPs. Similarly, in the CY 2015 PFS final rule
with comment period (79 FR 67938 through 67941 and 67951 through
67954), we established different payment adjustment amounts under the
2017 VM for: (1) Groups with between 2 to 9 EPs and physician solo
practitioners; and (2) groups with 10 or more EPs. However, we have not
addressed how we would handle scenarios where the size of a TIN as
indicated on the PECOS-generated list is not consistent with the size
of the TIN based on our analysis of the claims data. Therefore, we
proposed that, beginning with the CY 2016 payment adjustment period,
the TIN's size would be determined based on the lower of the number of
EPs indicated by the PECOS-generated list or by our analysis of the
claims data for purposes of determining the payment adjustment amount
under the VM. In the event that our analysis of the claims data
indicates that a TIN had fewer EPs during the performance period than
indicated by the PECOS-generated list, and the TIN is still subject to
the VM based on its size, then we would apply the payment adjustment
amount under the VM that is applicable to the size of the TIN as
indicated by our analysis of the claims data. In the event that our
analysis of the claims data indicates that a TIN had more EPs during
the performance period than indicated by the PECOS-generated list, then
we would apply the payment adjustment amount under the VM that is
applicable to the size of the TIN as indicated by the PECOS-generated
list.
For example, for the CY 2016 payment adjustment period, if the
PECOS list indicates that a TIN had 100 EPs in the CY 2014 performance
period, but our analysis of claims shows that the TIN had 90 EPs based
in CY 2014, then we would apply the payment policies to the TIN that
are applicable to groups with between 10 to 99 EPs, instead of the
policies applicable to groups with 100 or more EPs. Alternatively, if
the PECOS list indicates that a TIN had 90 EPs in the CY 2014
performance period, but our analysis of claims shows that the TIN had
100 EPs based in CY 2014, then we would apply the payment policies to
the TIN that are applicable to groups with between 10 to 99 EPs,
instead of the policies applicable to groups with 100 or more EPs. We
proposed to update Sec. 414.1210(c) accordingly.
The following is a summary of the comments we received on these
proposals.
Comment: Several commenters supported our proposal to determine a
TIN's size based on the lower of the number of EPs indicated by the
PECOS-generated list or by our analysis of the claims data for purposes
of determining the payment adjustment amount under the VM, recognizing
that the result would be that the group would be subject to the lower
amount at risk and also lower possible upward payment adjustment.
[[Page 71276]]
Response: We appreciate these commenters' support.
Comment: We received a comment suggesting that we consider
alternative ways to define ``group'', other than using a single TIN,
and allow options for groups to define themselves and use both TIN and
NPI as unique identifiers.
Response: In the CY 2013 PFS final rule with comment period (77 FR
69309), we discussed our rationale for identifying a group for purposes
of the VM by its Medicare-enrolled TIN. We stated that using TINs makes
it possible for us to take advantage of infrastructure and
methodologies already developed for PQRS group-level reporting and
evaluation and affords us flexibility and statistical stability for
monitoring and evaluating quality and outcomes for beneficiaries
assigned to the group for quality reporting purposes. As discussed in
section III.M.4.h. of this final rule with comment period, CY 2018 will
be the final payment adjustment period under the VM; therefore, we do
not believe it would be appropriate for us to consider revising how we
identify groups during the last year of program. We may take these
comments under consideration as we develop policies for the Merit-based
Incentive Payment System (MIPS) through future notice and comment
rulemaking.
Final Policy: After considering the comments received, we are
finalizing our proposal that, beginning with the CY 2016 payment
adjustment period, the TIN's size would be determined based on the
lower of the number of EPs indicated by the PECOS-generated list or the
number of EPs indicated by our analysis of the claims data for purposes
of determining the payment adjustment amount under the VM. We are also
finalizing the proposed updates to Sec. 414.1210(c) without
modification.
In section III.M.4.b. of the proposed rule (80 FR 41895), we
proposed to apply the VM in the CY 2018 payment adjustment period to
nonphysician EPs who are PAs, NPs, CNSs, and CRNAs in groups with two
or more EPs and to those who are solo practitioners. In section
III.M.4.f. of the proposed rule (80 FR 41901-41903), we proposed to
apply different payment adjustment amounts under the CY 2018 VM based
on the composition of a group. Specifically, in that section, we
proposed that the PAs, NPs, CNSs, and CRNAs in groups that consist of
nonphysician EPs (that is, groups that do not include any physicians)
and those who are solo practitioners would be subject to different
payment adjustment amounts under the CY 2018 VM than would groups
composed of physicians and nonphysician EPs and physician solo
practitioners. We proposed to identify TINs that consist of
nonphysician EPs as those TINs for which either the PECOS-generated
list or our analysis of the claims data shows that the TIN consists of
nonphysician EPs and no physicians. We noted that under our proposal
the VM would only apply to the PAs, NPs, CNSs, and CRNAs who bill under
these TINs, and not to the other types of nonphysician EPs who may also
bill under these TINs. We proposed that the VM would not apply to a TIN
if either the PECOS-generated list or our analysis of the claims data
shows that the TIN consists of only nonphysician EPs who are not PAs,
NPs, CNSs, and CRNAs. We provided the following examples to illustrate
our proposals.
If the PECOS-generated list shows that a TIN consists of
physicians and NPs and the claims data show that only NPs billed under
the TIN, then we would apply the payment adjustments in section
III.M.4.f. of the proposed rule that are applicable to PAs, NPs, CNSs,
and CRNAs in TINs that consist of nonphysician EPs.
If the PECOS-generated list shows that a TIN consists of
PAs, NPs, CNSs, or CRNAs, and no physicians, and the claims data show
that the TIN also consists of physicians, then we would still apply the
payment adjustments applicable to PAs, NPs, CNSs, and CRNAs in TINs
that consist of nonphysician EPs. This would be consistent with our
policy to apply the payment adjustments applicable to the lower group
size when there is a discrepancy in the group size between PECOS and
claims analysis, in that it would result in the group being subject to
the lower amount at risk and lower possible upward payment adjustment,
when there is a difference between the PECOS and claims analyses.
If the PECOS-generated list shows that a TIN consists of
physicians and the claims data shows, for example that PAs and
physicians billed under the TIN then we would apply the payment
adjustments in section III.M.4.f. of the proposed rule for TINs with
physicians and nonphysician EPs depending on the size of the TIN.
If the PECOS-generated list shows, for example, that a TIN
consists of PAs and the claims data shows that only physical therapists
billed under the group, then the TIN would not be subject to the VM in
CY 2018. Conversely, if the PECOS-generated list shows, for example,
that a TIN consists of physical therapists and the claims data shows
that only PAs billed under the group, then the TIN would not be subject
to the VM in CY 2018.
We welcomed public comment on these proposals. We proposed to
revise Sec. 414.1210(c) accordingly. The following is a summary of the
comments we received on these proposals.
Comment: One commenter supported our proposal to not apply the VM
in CY 2018 to a TIN if either the PECOS-generated list or our analysis
of the claims data shows that the TIN consists of only nonphysician EPs
who are not PAs, NPs, CNSs, and CRNAs, while another commenter
indicated that the VM should apply to all groups and solo practitioners
regardless of whether or not the groups and solo practitioners consist
only of nonphysician EPs.
Response: In section III.M.4.b. of this final rule with comment
period, we are finalizing that we will apply the VM in the CY 2018
payment adjustment period to nonphysician EPs who are PAs, NPs, CNSs,
and CRNAs in groups with two or more EPs and to those who are solo
practitioners, and not to other types of nonphysician EPs who bill
under a group's TIN or who are solo practitioners. Therefore, we do not
believe it would be consistent with this final policy to apply the VM
to a TIN if either the PECOS-generated list or our analysis of the
claims data shows that the TIN consists of only nonphysician EPs who
are not PAs, NPs, CNSs, and CRNAs. As noted in the proposed rule, this
would be consistent with our policy to apply the payment adjustments
applicable to the lower group size when there is a discrepancy in the
group size between PECOS and claims analysis.
Final Policy: After considering the comments received, we are
finalizing our proposal for the CY 2018 payment adjustment period to
identify TINs that consist of nonphysician EPs as those TINs for which
either the PECOS-generated list or our analysis of the claims data
shows that the TIN consists of nonphysician EPs and no physicians.
Under the policy finalized in section III.M.4.b. of this final rule
with comment period, the CY 2018 VM will only apply to the PAs, NPs,
CNSs, and CRNAs who bill under these TINs, and not to the other types
of nonphysician EPs who may also bill under these TINs. We are also
finalizing that the VM will not apply to a TIN if either the PECOS-
generated list or our analysis of the claims data shows that the TIN
consists of only nonphysician EPs who are not PAs, NPs, CNSs, and
CRNAs. We are also finalizing the proposed revisions to Sec.
414.1210(c) without modification.
[[Page 71277]]
b. Application of the VM to Nonphysician EPs who are PAs, NPs, CNSs,
and CRNAs
Section 1848(p)(7) of the Act provides the Secretary discretion to
apply the VM on or after January 1, 2017 to EPs as defined in section
1848(k)(3)(B) of the Act. In the CY 2015 PFS final rule with comment
period (79 FR 67937), we finalized that we will apply the VM beginning
in the CY 2018 payment adjustment period to nonphysician EPs in groups
with two or more EPs and to nonphysician EPs who are solo
practitioners. We added Sec. 414.1210(a)(4) to reflect this policy.
Also in that prior rule, we finalized that we will apply the VM
beginning in CY 2018 to the items and services billed under the PFS by
all of the physicians and nonphysician EPs, as specified in section
1848(k)(3)(B) of the Act, that bill under a group's TIN based on the
TIN's performance during the applicable performance period and that
during the payment adjustment period, all of the nonphysician EPs who
bill under a group's TIN will be subject to the same VM that will apply
to the physicians who bill under that TIN. We finalized the
modification to the definition of ``group of physicians'' under Sec.
414.1205 to also include the term ``group'' to reflect these policies.
Additionally, in the CY 2015 PFS final rule with comment period, we
finalized that beginning in CY 2018, physicians and nonphysician EPs
will be subject to the same VM policies established in earlier
rulemakings and under subpart N. For example, nonphysician EPs will be
subject to the same amount of payment at risk and quality-tiering
policies as physicians. We finalized modifications to the regulations
under subpart N accordingly.
Subsequent to our having finalized the preceding policies in the CY
2015 PFS final rule with comment period, the MACRA was enacted on April
16, 2015. Under section 1848(p)(4)(B)(iii) of the Act, as amended by
section 101(b)(3) of MACRA, the VM shall not be applied to payments for
items and services furnished on or after January 1, 2019. Section
1848(q) of the Act, as added by section 101(c) of MACRA, establishes
the MIPS that shall apply to payments for items and services furnished
on or after January 1, 2019. Under section 1848(q)(1)(C)(i)(I) of the
Act, with regard to payments for items and services furnished in 2019
and 2020, the MIPS will only apply to:
A physician (as defined in section 1861(r) of the Act);
A PA, NP, and CNS (as defined in section 1861(aa)(5) of
the Act);
A CRNA (as defined in section 1861(bb)(2) of the Act); and
A group that includes such professionals.
Then, under section 1848(q)(1)(C)(i)(II) of the Act, beginning with
payments for items and services furnished in 2021, the MIPS will apply
to such other EPs as defined in section 1848(k)(3)(B) of the Act as
specified by the Secretary. As noted above, section 1848(p)(7) of the
Act provides the Secretary discretion to apply the VM on or after
January 1, 2017 to EPs as defined in section 1848(k)(3)(B) of the Act.
After the enactment of MACRA in April 2015, we believe it would not be
appropriate to apply the VM in CY 2018 to any nonphysician EP who is
not a PA, NP, CNS, or CRNA because payment adjustments under the MIPS
would not apply to them until 2021. Therefore, we proposed (80 FR
41895) to apply the VM in the CY 2018 payment adjustment period to
nonphysician EPs who are PAs, NPs, CNSs, and CRNAs in groups with two
or more EPs and to PAs, NPs, CNSs, and CRNAs who are solo
practitioners. We proposed to revise Sec. 414.1210(a)(4) to reflect
this proposed policy. We proposed to define PAs, NPs, and CNSs as
defined in section 1861(aa)(5) of the Act and to define CRNAs as
defined in section 1861(bb)(2) of the Act. We proposed to add these
definitions under Sec. 414.1205.
Under our proposal, we would apply the VM in CY 2018 to the items
and services billed under the PFS by all of the PAs, NPs, CNSs, and
CRNAs who bill under a group's TIN based on the TIN's performance
during the applicable performance period. We noted that the VM would
not apply to other types of nonphysician EPs (that is, nonphysician EPs
who are not PAs, NPs, CNSs, or CRNAs) who may also bill under the TIN.
As noted above, we finalized in the CY 2015 PFS final rule with
comment period (79 FR 67937) that beginning in CY 2018, all of the
nonphysician EPs who bill under a group's TIN will be subject to the
same VM that will apply to the physicians who bill under that TIN, and
physicians and nonphysician EPs will be subject to the same VM policies
established in earlier rulemakings and under subpart N. For example,
nonphysician EPs who are in groups containing one or more physicians
will be subject to the same amount of payment at risk and quality-
tiering policies as physicians. We did not propose to revise these
policies; however, we noted that if a group is composed of physicians
and nonphysician EPs, only the physicians and the nonphysician EPs who
are PAs, NPs, CNSs, and CRNAs would be subject to the VM in CY 2018.
In the CY 2015 PFS final rule with comment period (79 FR 67937), we
also finalized that we will apply the VM beginning in CY 2018 to groups
that consist only of nonphysician EPs (for example, groups with only
NPs or PAs) and to nonphysician EPs who are solo practitioners.
However, since CY 2018 will be the first year that groups that consist
only of nonphysician EPs and solo practitioners who are nonphysician
EPs will be subject to the VM, we finalized a policy to hold these
groups and solo practitioners harmless from downward adjustments under
the quality-tiering methodology in CY 2018. We stated that we would add
regulation text under Sec. 414.1270 to reflect this policy when we
established the policies for the VM for the CY 2018 payment adjustment
period in future rulemaking. Accordingly, we proposed (80 FR 41895) to
add Sec. 414.1270(d) to codify that PAs, NPs, CNSs, and CRNAs in
groups that consist of nonphysician EPs and PAs, NPs, CNSs, and CRNAs
who are solo practitioners will be held harmless from downward
adjustments under the quality-tiering methodology in CY 2018. In
section III.M.4.f. of this final rule with comment period, we discuss
the proposed CY 2018 payment adjustment amounts for groups that consist
of nonphysician EPs and solo practitioners who are nonphysician EPs
that fall in Category 1 and Category 2 for the CY 2018 VM. As discussed
above, we proposed to apply the VM in CY 2018 only to nonphysician EPs
who are PAs, NPs, CNSs, and CRNAs.
The following is a summary of the comments we received on these
proposals.
Comment: Many commenters supported our proposal and agreed that it
would not be appropriate to apply the VM in CY 2018 to any nonphysician
EP who is not a PA, NP, CNS, or CRNA. Several commenters noted the
proposal allows a more coordinated transition from the VM to the MIPS
in CY 2019 by extending the VM only to the nonphysician EPs who will be
transitioned into the MIPS directly and ensuring that the remaining
nonphysician EPs are transitioned to a value-based payment program only
once (that is, in 2021 under the MIPS).
Few commenters opposed our proposal and stated that CMS is not
required by the statute to apply the VM to nonphysician EPs;
nonphysician practices typically have fewer resources than physician
practices and struggle to meet reporting requirements; and that
subjecting the nonphysician EPs to the
[[Page 71278]]
VM for only one year is not a valuable use of their practice time and
resources since they will need to learn about the MIPS requirements for
CY 2019. Two commenters urged CMS to exclude all nonphysician EPs from
the VM in CY 2018.
Response: We appreciate the comments that supported our proposal to
apply the VM in the CY 2018 payment adjustment period to nonphysician
EPs who are PAs, NPs, CNSs, and CRNAs in groups with two or more EPs
and to PAs, NPs, CNSs, and CRNAs who are solo practitioners. We believe
that it would be appropriate to apply the VM to PAs, NPs, CNSs, and
CRNAs in CY 2018, and not to other nonphysician EPs, because PAs, NPs,
CNSs, and CRNAs are the only nonphysician EPs the MIPS will apply to in
CY 2019 and CY 2020. With regard to commenters' concerns about
nonphysician EPs, we note that nonphysician EPs are subject to the
reporting requirements under the PQRS and must meet the criteria to
avoid the PQRS payment adjustment in CY 2018, as discussed in section
III.I. of this final rule with comment period. We are finalizing the
two-category approach for the CY 2018 VM based on participation in the
PQRS by groups and solo practitioners (as discussed in section
III.M.4.c. of this final rule with comment period). We will also hold
harmless PAs, NPs, CNSs, and CRNAs in groups that consist of
nonphysician EPs and PAs, NPs, CNSs, and CRNAs who are solo
practitioners from downward adjustments under the quality-tiering
methodology in CY 2018 (as discussed in section III.M.4.b. of this
final rule with comment period). We believe that application of the VM
to PAs, NPs, CNSs, and CRNAs in CY 2018 would provide them with
incentives to provide high quality and low cost care similar to the
incentives offered to physicians under the VM. Consequently, we do not
agree with the comments that stated that the VM should not apply to
nonphysician EPs in CY 2018.
Comment: A few commenters asked for clarification of the impact of
not applying the CY 2018 VM to nonphysician EPs who are not PAs, NPs,
CNSs, and CRNAs.
Response: If the VM were not applied to these nonphysician EPs,
they would not be subject to any adjustment (upward, downward, or
neutral) under the VM in CY 2018. However, these nonphysician EPs are
still subject to the reporting requirements under the PQRS. We
encourage these EPs to actively participate in the PQRS and become
familiar with the criteria they must meet to avoid the PQRS payment
adjustment in CY 2018, as discussed in section III.I. of this final
rule with comment period. We also encourage these nonphysician EPs to
review our future rulemaking for the MIPS in anticipation of the
application of the MIPS to them.
Comment: One commenter stated that since quality and cost
benchmarks for NPs must be specific to a NP's specialty, we should
adopt meaningful specialty designations for NPs.
Response: The quality and cost benchmarks are based on the national
mean and are not specialty-specific. Specifically, we finalized in the
CY 2013 PFS final rule with comment period (77 FR 69322) that the
benchmark for each quality measure would be the national mean of each
measure's performance rate during the year prior to the performance
year and that the benchmark for each cost measure is the national mean
of each measure's performance rate during the performance year. As
related to PQRS measures, because we are allowing flexibility on the
quality measures that groups and solo practitioners can report, we
believe the most appropriate peer group consists of other groups and
solo practitioners reporting the same measure regardless of specialty.
We note that we finalized in the CY 2014 PFS final rule with comment
period (78 FR 74784) that we will use the specialty adjustment
methodology to calculate the expected cost for each cost measure,
beginning with the CY 2016 VM. This methodology takes into account the
differential costs of specialties in making cost comparisons, and the
cost measures are also risk adjusted to account for differences in
patient characteristics not directly related to patient care, but that
may increase or decrease the costs of care.
We appreciate the concerns raised by the commenter and encourage
the commenter to review the procedures for obtaining a CMS specialty
code, which are available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/Taxonomy.html.
As noted above, CY 2018 is the final payment adjustment period for the
VM. Policies for application of the MIPS to nonphysician EPs in
subsequent years would be finalized through future notice and comment
rulemaking.
Comment. Several commenters supported our policy to hold groups
that consist of nonphysician EPs and solo practitioners who are
nonphysician EPs harmless from downward adjustments under the quality-
tiering methodology in CY 2018.
Response: We appreciate the comments supporting the policy we
finalized in the CY 2015 PFS final rule with comment period (79 FR
67937) to hold groups and solo practitioners consisting of nonphysician
EPs harmless from downward adjustment under the quality-tiering
methodology in CY 2018. Because we are finalizing that the VM will
apply in CY 2018 only to those nonphysician EPs who are PAs, NPs, CNSs,
and CRNAs, we are also finalizing our proposed addition of Sec.
414.1270(d) to codify that PAs, NPs, CNSs, and CRNAs in groups that
consist of nonphysician EPs and PAs, NPs, CNSs, and CRNAs who are solo
practitioners will be held harmless from downward adjustments under the
quality-tiering methodology in CY 2018.
In section III.M.4.f. of this final rule with comment period, we
discuss the final CY 2018 payment adjustment amounts for groups that
consist of nonphysician EPs and solo practitioners who are nonphysician
EPs that fall in Category 1 and Category 2 for the CY 2018 VM.
Final Policy: After considering the comments received, we are
finalizing our proposal to apply the VM in the CY 2018 payment
adjustment period to nonphysician EPs who are PAs, NPs, CNSs, and CRNAs
in groups with two or more EPs and to PAs, NPs, CNSs, and CRNAs who are
solo practitioners. We are finalizing the proposed revisions to Sec.
414.1210(a)(4) to reflect this policy without modification. Under this
policy, we will apply the VM in CY 2018 to the items and services
billed under the PFS by all of the physicians, PAs, NPs, CNSs, and
CRNAs who bill under a group's TIN based on the TIN's performance
during the applicable performance period, which we are finalizing as CY
2016 in section III.M.4.h. of this final rule with comment period. The
CY 2018 VM will not apply to other types of nonphysician EPs (that is,
nonphysician EPs who are not PAs, NPs, CNSs, or CRNAs) who may also
bill under the TIN.
We finalized in the CY 2015 PFS final rule with comment period (79
FR 67937) that, beginning in CY 2018, all of the nonphysician EPs who
bill under a group's TIN will be subject to the same VM that will apply
to the physicians who bill under that TIN, and physicians and
nonphysician EPs will be subject to the same VM policies established in
earlier rulemakings and under subpart N. Because the CY 2018 VM will
apply only to certain types of nonphysician EPs, all of the PAs, NPs,
CNSs, and CRNAs who bill under a group's TIN will be subject to the
same VM adjustment that will apply to the
[[Page 71279]]
physicians who bill under that TIN in CY 2018, and physicians, PAs,
NPs, CNSs, and CRNAs billing under the same TIN will be subject to the
same VM policies established in earlier rulemakings and under subpart
N. For example, PAs, NPs, CNSs, and CRNAs who are in groups containing
one or more physicians will be subject to the same amount of payment at
risk and quality-tiering policies as physicians.
We are also finalizing our proposal to define PAs, NPs, and CNSs as
defined in section 1861(aa)(5) of the Act and to define CRNAs as
defined in section 1861(bb)(2) of the Act. We are codifying these
definitions under Sec. 414.1205 without modification. We are also
codifying in Sec. 414.1270(d) without modification that PAs, NPs,
CNSs, and CRNAs in groups that consist of nonphysician EPs and PAs,
NPs, CNSs, and CRNAs who are solo practitioners will be held harmless
from downward adjustments under the quality-tiering methodology in CY
2018.
c. Approach to Setting the VM Adjustment Based on PQRS Participation
Section 1848(p)(4)(B)(iii)(II) of the Act requires the Secretary to
apply the VM to items and services furnished under the PFS beginning
not later than January 1, 2017, for all physicians and groups of
physicians. Therefore, in the CY 2015 PFS final rule with comment
period (79 FR 67936), we established that, beginning with the CY 2017
payment adjustment period, the VM will apply to physicians in groups
with two or more EPs and to physicians who are solo practitioners based
on the applicable performance period. In the CY 2015 PFS final rule
with comment period (79 FR 67938 to 67939), we adopted a two-category
approach for the CY 2017 VM based on participation in the PQRS by
groups and solo practitioners. For purposes of the CY 2017 VM, we
finalized that Category 1 includes those groups that meet the criteria
for satisfactory reporting of data on PQRS quality measures via the
GPRO (through use of the web-interface, EHR, or registry reporting
mechanism) for the CY 2017 PQRS payment adjustment. We finalized that
Category 1 also includes groups that do not register to participate in
the PQRS as a group practice participating in the PQRS GPRO in CY 2015
and that have at least 50 percent of the group's EPs meet the criteria
for satisfactory reporting of data on PQRS quality measures as
individuals (through the use of claims, EHR, or registry reporting
mechanism) for the CY 2017 PQRS payment adjustment, or in lieu of
satisfactory reporting, satisfactorily participate in a PQRS-qualified
clinical data registry (QCDR) for the CY 2017 PQRS payment adjustment.
Lastly, we finalized that Category 1 includes those solo practitioners
that meet the criteria for satisfactory reporting of data on PQRS
quality measures as individuals (through the use of claims, registry,
or EHR reporting mechanism) for the CY 2017 PQRS payment adjustment, or
in lieu of satisfactory reporting, satisfactorily participate in a PQRS
QCDR for the CY 2017 PQRS payment adjustment. We finalized that
Category 2 includes those groups and solo practitioners that are
subject to the CY 2017 VM and do not fall within Category 1. The CY
2017 VM payment adjustment amount for groups and solo practitioners in
Category 2 is -4.0 percent for groups with 10 or more EPs and -2.0
percent for groups with between 2 to 9 EPs and solo practitioners.
We proposed (80 FR 41896) to use a similar two-category approach
for the CY 2018 VM based on participation in the PQRS by groups and
solo practitioners. However, we note that during the 2014 PQRS
submission period, we received feedback from groups who experienced
difficulty reporting through the reporting mechanism they had chosen at
the time of 2014 PQRS GPRO registration. For example, some groups
registered for the group EHR reporting mechanism and were subsequently
informed that their EHR vendor could not support submission of group
data for the group EHR reporting mechanism. To address these concerns
and continue to accommodate the various ways in which EPs and groups
can participate in the PQRS, for purposes of the CY 2018 VM, we
proposed that Category 1 would include those groups that meet the
criteria to avoid the PQRS payment adjustment for CY 2018 as a group
practice participating in the PQRS GPRO, as proposed in Table 21 of the
proposed rule. We also proposed to include in Category 1 groups that
have at least 50 percent of the group's EPs meet the criteria to avoid
the PQRS payment adjustment for CY 2018 as individuals, as shown in
Table 20 of the proposed rule. We proposed to add corresponding
regulation text to Sec. 414.1270(d)(1).
We note that the proposed criteria for groups to be included in
Category 1 for the CY 2018 VM differ from the criteria we finalized for
the CY 2017 VM in the CY 2015 PFS final rule with comment period. Under
the policy for the CY 2017 VM, we would only consider whether at least
50 percent of a group's EPs met the criteria to avoid the PQRS payment
adjustment as individuals if the group did not register to participate
in a PQRS GPRO. In contrast, under our proposal for the CY 2018 VM, in
determining whether a group would be included in Category 1, we would
consider whether the 50 percent threshold has been met regardless of
whether the group registers for a PQRS GPRO. We believe this proposal
would allow groups that register for a PQRS GPRO but fail as a group to
meet the criteria to avoid the PQRS payment adjustment an additional
opportunity for the quality data reported by individual EPs in the
group to be taken into account for purposes of applying the CY 2018 VM.
We also proposed to revise the criteria for groups to be included
in Category 1 for the CY 2017 VM, if it is operationally feasible for
our systems to utilize data reported through a mechanism other than the
one through which a group registered to report under PQRS GPRO. At this
time of the proposed rule, it was unclear whether CMS systems could
support this type of assessment as soon as the CY 2017 VM, and thus our
proposal was contingent upon operational feasibility. For the CY 2017
VM, we proposed that Category 1 would include those groups that meet
the criteria to avoid the PQRS payment adjustment for CY 2017 as a
group practice participating in the PQRS GPRO in CY 2015. We also
proposed to include in Category 1 groups that have at least 50 percent
of the group's EPs meet the criteria to avoid the PQRS payment
adjustment for CY 2017 as individuals. We proposed that if
operationally feasible, we would apply these criteria to identify which
groups would fall in Category 1 for the CY 2017 VM regardless of
whether or how the group registered to participate in the PQRS as a
group practice in CY 2015. We proposed that, if our systems were not
able to accomplish this, then we would apply our existing policy for
the CY 2017 VM, as finalized in the CY 2015 PFS final rule with comment
period (79 FR 67938 through 67939), to consider whether at least 50
percent of a group's EPs meet the criteria to avoid the PQRS payment
adjustment for CY 2017 as individuals only in the event that the group
did not register to report as a group under the PQRS GPRO.
We proposed to include in Category 1 for the CY 2018 VM those solo
practitioners that meet the criteria, in Table 20 of the proposed rule,
to avoid the CY 2018 PQRS payment adjustment as individuals,
We proposed that Category 2 would include those groups and solo
[[Page 71280]]
practitioners that are subject to the CY 2018 VM and did not fall
within Category 1. As discussed in section III.M.4.f. of this final
rule with comment period, we proposed to apply the following VM
adjustment to payments for groups and solo practitioners that fall in
Category 2 for the CY 2018 VM: a -4.0 percent VM to physicians, PAs,
NPs, CNSs, and CRNAs in groups with 10 or more EPs; a -2.0 percent VM
to physicians, PAs, NPs, CNSs, and CRNAs in groups with between 2 to 9
EPs and to physician solo practitioners; and a -2.0 percent VM to PAs,
NPs, CNSs, and CRNAs in groups that consist of nonphysician EPs and
solo practitioners who are PAs, NPs, CNSs, and CRNAs. As discussed in
section III.M.4.b. of this final rule with comment period, we proposed
to apply the VM in CY 2018 to the nonphysician EPs who are PAs, NPs,
CNSs, and CRNAs.
We proposed that for a group or solo practitioner that would be
subject to the CY 2018 VM to be included in Category 1, the criteria
for satisfactory reporting (or the criteria for satisfactory
participation, in the case of solo practitioners and the 50 percent
option described above for groups) would need to be met during the
reporting periods occurring in CY 2016 for the CY 2018 PQRS payment
adjustment. In section III.M.4.h. of the proposed rule, we proposed to
use CY 2016 as the performance period for the VM adjustments that will
apply during CY 2018. We solicited comment on these proposals.
The following is a summary of the comments we received on these
proposals.
Comment: One commenter stated that despite being based on PQRS
data, the VM and PQRS programs would continue to have their own sets of
regulations, payment adjustments, feedback reports, and deadlines,
which result in administrative complexity and redundancy across federal
quality programs.
Response: As we stated in the CY 2014 PFS final rule with comment
period (78 FR 74767), one of the principles governing our
implementation of the VM is to align program requirements to the extent
possible. Thus, our proposals for the CY 2018 payment adjustment period
for the VM sought to continue to align the VM with the PQRS program
requirements and reporting mechanisms to ensure individual EPs s and
groups report data on quality measures that reflect their practice.
However, the VM and PQRS were created under different statutory
authorities and thus must have their own regulations and policies.
As discussed above, under section 101 of the MACRA, CY 2018 will be
the final year of the separate PQRS and VM payment adjustments, and the
MIPS will apply to payments for items and services furnished on or
after January 1, 2019. We believe the creation of the MIPS may help
alleviate the concerns raised in the comment, and we encourage the
commenter to review our future rulemaking for the MIPS.
Comment: Many commenters supported our proposal to continue to use
a two-category approach for the CY 2018 VM based on participation in
the PQRS by groups and solo practitioners. Commenters also supported
our proposals to consider whether the 50 percent threshold has been met
regardless of whether the group registers for a PQRS GPRO, in
determining whether a group would be included in Category 1 for the CY
2017 and CY 2018 VM.
Response: We appreciate the commenters' support for our proposals.
Final Policy: We are finalizing all of the policies as proposed. We
are finalizing the two-category approach for the CY 2018 VM based on
participation in the PQRS by groups and solo practitioners. For
purposes of the CY 2018 VM, Category 1 will include those groups that
meet the criteria to avoid the PQRS payment adjustment for CY 2018 as a
group practice participating in the PQRS GPRO, as finalized in Table 28
of this final rule with comment period. We are also finalizing to
include in Category 1 groups that have at least 50 percent of the
group's EPs meet the criteria to avoid the PQRS payment adjustment for
CY 2018 as individuals, as finalized in Table 27 of this final rule
with comment period. Under our final policies for the CY 2018 VM, in
determining whether a group will be included in Category 1, we will
consider whether the 50 percent threshold has been met regardless of
whether the group registers for a PQRS GPRO. As noted in the proposed
rule, we believe this policy will allow groups that register for a PQRS
GPRO but fail as a group to meet the criteria to avoid the PQRS payment
adjustment an additional opportunity for the quality data reported by
individual EPs in the group to be taken into account for purposes of
applying the CY 2018 VM. Please note that if a group registers for a
PQRS GPRO and meets the criteria to avoid the PQRS payment adjustment
as a group, then the group-level quality data reported through the GPRO
reporting mechanism would be taken into account for purposes of
applying the CY 2018 VM. Lastly, we are finalizing to include in
Category 1 for the CY 2018 VM those solo practitioners that meet the
criteria to avoid the CY 2018 PQRS payment adjustment as individuals,
as finalized in Table 27 of this final rule with comment period.
Category 2 will include those groups and solo practitioners that are
subject to the CY 2018 VM and do not fall within Category 1. We are
finalizing the corresponding regulation text at Sec. 414.1270(d)(1)
that reflect these policies without modification.
For a group or solo practitioner subject to the CY 2018 VM to be
included in Category 1, the criteria for satisfactory reporting (or the
criteria for satisfactory participation, in the case of solo
practitioners and the 50 percent option described above for groups)
must be met during the reporting periods occurring in CY 2016 for the
CY 2018 PQRS payment adjustment. As finalized in section III.M.4.h. of
this final rule with comment period, CY 2016 will be the performance
period for the VM adjustments that will apply during CY 2018. In
section III.M.4.f. of this final rule with comment period, we discuss
the CY 2018 payment adjustment amounts for groups and solo
practitioners that fall in Category 1 and Category 2 for the CY 2018
VM.
We are also finalizing our proposal to revise the criteria for
groups to be included in Category 1 for the CY 2017 VM. We determined
that it is operationally feasible for our system to utilize data
reported through a mechanism other than the one through which a group
registered to report under PQRS GPRO. Therefore, for the CY 2017 VM, we
are finalizing that Category 1 will include those groups that meet the
criteria to avoid the PQRS payment adjustment for CY 2017 as a group
practice participating in the PQRS GPRO in CY 2015. Category 1 will
also include groups that have at least 50 percent of the group's EPs
meet the criteria to avoid the PQRS payment adjustment for CY 2017 as
individuals. Under our final policies for the CY 2017 VM, in
determining whether a group will be included in Category 1, we will
consider whether the 50 percent threshold has been met regardless of
whether the group registered to participate in the PQRS GPRO in CY
2015. We believe this policy will allow groups that register for a PQRS
GPRO, but fail as a group to meet the criteria to avoid the PQRS
payment adjustment an additional opportunity for the quality data
reported by individual EPs in the group to be taken into account for
purposes of applying the CY 2017 VM. Please note that if a group
registers for a PQRS GPRO and meets the criteria to avoid the PQRS
payment adjustment as a group, then the quality data reported
[[Page 71281]]
by the group would be taken into account for purposes of applying the
CY 2017 VM. We are revising Sec. 414.1270(c)(1)(i) to reflect this
change in policy for the CY 2017 VM.
In the CY 2015 PFS final rule with comment period (79 FR 67939 to
67941), we finalized that the quality-tiering methodology will apply to
all groups and solo practitioners in Category 1 for the VM for CY 2017,
except that groups with between 2 to 9 EPs and solo practitioners would
be subject only to upward or neutral adjustments derived under the
quality-tiering methodology, while groups with 10 or more EPs would be
subject to upward, neutral, or downward adjustments derived under the
quality-tiering methodology. That is, groups with between 2 to 9 EPs
and solo practitioners in Category 1 would be held harmless from any
downward adjustments derived from the quality-tiering methodology for
the CY 2017 VM.
As stated earlier in this final rule with comment period, in CY
2018, the same VM would apply to all of the physicians, PAs, NPs, CNSs,
and CRNAs who bill under a TIN. The VM would not apply to other types
of nonphysician EPs who may also bill under the TIN. For the CY 2018
VM, we proposed to continue to apply the quality-tiering methodology to
all groups and solo practitioners in Category 1. We proposed that
groups and solo practitioners would be subject to upward, neutral, or
downward adjustments derived under the quality-tiering methodology,
with the exception finalized in the CY 2015 PFS final rule with comment
period (79 FR 67937), that groups consisting only of nonphysician EPs
and solo practitioners who are nonphysician EPs will be held harmless
from downward adjustments under the quality-tiering methodology in CY
2018. Based on our proposal to apply the CY 2018 VM only to certain
types of nonphysician EPs, only the PAs, NPs, CNSs, and CRNAs in groups
consisting of nonphysician EPs and those who are solo practitioners
will be held harmless from downward adjustments under the quality-
tiering methodology in CY 2018. We proposed to revise Sec. 414.1270 to
reflect these proposals. We solicited comments on these proposals. In
section III.M.4.f. of this final rule with comment period, we discuss
the CY 2018 payment adjustment amounts for groups and solo
practitioners that fall in Category 1 and Category 2 for the CY 2018
VM.
For groups with between 2 to 9 EPs and physician solo
practitioners, we stated our belief in the proposed rule that it is
appropriate to begin both the upward and downward payment adjustments
under the quality-tiering methodology for the CY 2018 VM. As stated in
the CY 2015 PFS final rule with comment period (79 FR 67935), in
September 2014, we made available QRURs based on CY 2013 data to all
groups of physicians and physicians who are solo practitioners. These
QRURs contain performance information on the quality and cost measures
used to calculate the quality and cost composites of the VM and show
how TINs fare under the policies established for the VM for the CY 2015
payment adjustment period. As discussed in section III.M.5.a. of this
final rule with comment period, in April 2015, we made available 2014
Mid-Year QRURs to groups of physicians and physician solo practitioners
nationwide. The Mid-Year QRURs provide interim information about
performance on the claims-based quality outcome measures and cost
measures that are a subset of the measures that will be used to
calculate the CY 2016 VM and are based on performance from July 1, 2013
through June 30, 2014. As we stated that we intended to do, in
September of 2015, we made annual QRURs, based on CY 2014 data,
available to all groups and solo practitioners. The reports show TINs
their performance during CY 2014 on all of the quality and cost
measures that were used to calculate the CY 2016 VM. Thus, we believe
groups with between 2 to 9 EPs and physician solo practitioners will
have had adequate data to improve performance on the quality and cost
measures that will be used to calculate the VM in CY 2018. We note that
the quality and cost measures in the QRURs that these groups received
are similar to the measures that will be used to calculate the CY 2018
VM. In addition, we believe that these groups and solo practitioners
have had sufficient time to understand how the VM works and how to
participate in the PQRS. As a result, we expressed our belief that it
would be appropriate to apply both upward and downward adjustments
under the quality-tiering methodology to groups with between 2 to 9 EPs
and physician solo practitioners in CY 2018.
We stated that we would continue to monitor the VM program and
continue to examine in the VM Experience Report the characteristics of
those groups and solo practitioners that would be subject to an upward
or downward payment adjustment under our quality-tiering methodology to
determine whether our policies create anomalous effects in ways that do
not reflect consistent differences in performance among physicians and
physician groups.
The following is a summary of the comments we received on these
proposals.
Comment: Some commenters supported our proposal to apply the
quality-tiering methodology to all groups and solo practitioners that
are in Category 1 for the CY 2018 VM. However, other commenters were
opposed to the application of the quality-tiering methodology in
general. Many commenters had concerns about our proposal to apply the
downward adjustment to groups with between 2 to 9 EPs and physician
solo practitioners under the quality-tiering methodology in CY 2018 and
urged CMS to continue to hold these groups and solo practitioners
harmless from downward adjustments under the quality-tiering
methodology in CY 2018. Commenters noted methodological concerns (that
is, potential small sample size, lack of specialist-specific measures,
and episode-based cost measures); perceived lack of awareness of or
resources to interpret the QRURs; and need to become familiar with the
MIPS requirements after only one year of being subject to downward
adjustments under the quality-tiering methodology under the VM.
Response: We appreciate the commenters' support for our proposal to
apply upward and downward adjustments under quality-tiering for groups
of two to nine EPs consisting of at least one physician and to
physician solo practitioners. We disagree that we should not apply
downward adjustments under the quality-tiering methodology to physician
groups with between 2 to 9 EPs and physician solo practitioners. We
believe that applying full quality-tiering to these groups and solo
practitioners, coupled with the lower adjustment rates and changes to
improve measure reliability, continues momentum to prepare smaller
groups and solo practitioners for value-based payment including a
smoother transition to the MIPS.
For the comments concerning small sample size, we note that in
recent analyses based on the measure specifications used for the 2016
VM and the proposed case sizes for the 2017 VM, average reliabilities
for TINs with less than 10 EPs for all claims-based measures, except
the all-cause hospital readmissions measure and the Medicare Spending
per Beneficiary (MSPB) measure, exceeded the threshold for moderate
reliability (that is, 0.4). The average reliability for the all-cause
hospital readmissions measure and MSPB measure were near the threshold
[[Page 71282]]
for moderate reliability. We were, however, persuaded by commenters'
concerns to perform a reliability analysis at a more granular level
than the analyses we had previously conducted. We utilized the most
recently available performance data, CY 2014, for this analysis, and we
looked not only at groups of fewer than ten EPs, but also further broke
down the data into a reliability analysis for solo practitioners,
groups of two to five EPs, and groups of fewer than ten EPs. The
results of this analysis are displayed in Table 46.
Table 46--Average Reliability of Claims-Based Measures Used for the 2016 VM Payment Adjustment, by TIN size
----------------------------------------------------------------------------------------------------------------
Minimum Fewer than 10 or more
Measure Case Size 1 EP 2-5 EPs 10 EPs EPs
----------------------------------------------------------------------------------------------------------------
ACSC Acute Composite........................... 20 0.64 0.72 0.67 0.78
ACSC Chronic Composite......................... 20 0.67 0.71 0.68 0.79
All-Cause Hospital Readmissions................ 200 0.34* 0.37* 0.37* 0.56
Per Capita Costs for All Attributed 20 0.74 0.71 0.73 0.80
Beneficiaries.................................
Medicare Spending per Beneficiary.............. 125 0.40 0.48 0.48 0.67
Medicare Spending per Beneficiary.............. 100 0.37 0.44 0.45 0.64
----------------------------------------------------------------------------------------------------------------
Note: All measures were computed based on 2014 data using measure specifications for the 2016 Value Modifier.
Our new analysis reveals that, in order for solo practitioners and
groups with two to five EPs to meet the average reliability threshold
of 0.4 that we discussed in the CY 2013 PFS rulemaking (77 FR 45009,
69322), a minimum number of 125 episodes is required for the MSPB
measure, and even at 200 cases, the reliability of the all-cause
hospital readmission measure does not meet our threshold for these solo
practitioners and small groups. Because these measures do not meet the
threshold for what we consider to be moderate reliability for solo
practitioners and groups of two to five EPs, we are finalizing our
proposed policy to apply upward, neutral, and downward adjustments
under quality-tiering in CY 2018 to all physician solo practitioners
and groups of physicians, with modifications to address reliability
concerns for smaller groups and solo practitioners. For the CY 2017 and
CY 2018 payment adjustment periods, we will increase the minimum number
of episodes required for inclusion of the MSPB measure in the cost
composite of the VM to 125 episodes (discussed in section III.M.4.k. of
this final rule), and we will not include the all-cause hospital
readmission measure in the calculation of the quality composite of the
VM for solo practitioners or groups of two to nine EPs. For 2018 VM
payment adjustments, the policies to increase the minimum number of
episodes required for inclusion of the MSPB measure to 125 episodes and
to remove the all-cause hospital readmission measure in the calculation
of the 2018 VM will also apply for nonphysician Eps who are solo
practitioners and groups consisting of nonphysician EPs. We continue to
believe it is important to apply upward, neutral, or downward
adjustments under quality-tiering to these solo practitioners and
groups of EPs, in order to maintain the momentum of improving quality
and to continue to emphasize the importance of quality and cost
performance under the VM and the upcoming MIPS.
With regard to comments that there are an insufficient number of
specialist-specific measures, we do not believe that this would
disadvantage smaller groups or solo practitioners. We note that our
current policies for the VM, as well as our proposals for the CY 2018
payment adjustment period, include all available PQRS reporting
mechanisms, including registries that may be specialty-focused. We also
note that the VM methodology includes additional safeguards to guard
against misclassification--we finalized in the CY 2013 PFS final rule
with comment period (77 FR 69325) the adoption of the quality-tiering
model where we classify quality composite scores and cost composite
scores each into high, average, and low categories based on whether
these scores are at least one standard deviation from the mean and are
also statistically significantly different from the mean at the 5.0
percent level of significance, in order to apply the VM upward or
downward adjustment only when a group's performance is significantly
different from the national mean. The result of this focus on outliers
is that quality-tiering leads to a small percentage of TINs receiving
downward adjustments based on performance-- for the 2015 VM, out of the
106 groups that elected quality-tiering and had sufficient data, 11
groups (10.4 percent) received a downward VM adjustment and 14 groups
(13.2 percent) received an upward VM adjustment based on performance.
Cost measures are also risk-adjusted (77 FR 69318) and specialty-
adjusted (78 FR 74784) to account for patient characteristics and
specialty-composition of the group, respectively.
As discussed in section III.M.4.m. of this final rule with comment
period, we are finalizing the policies that, beginning with the CY 2016
payment adjustment period, a group or solo practitioner subject to the
VM will receive a quality composite score that is classified as average
under the quality-tiering methodology if the group or solo practitioner
does not have at least one quality measure that meets the minimum
number of cases required for the measure to be included in the
calculation of the quality composite. This policy is consistent with
the policy we previously finalized in the CY 2015 PFS final rule with
comment period (79 FR 67934) that, beginning with the CY 2016 payment
adjustment period, a group or solo practitioner subject to the VM will
receive a cost composite score that is classified as average under the
quality-tiering methodology if the group or solo practitioner does not
have at least one cost measure that meets the minimum number of cases
required for the measure to be included in the calculation of the cost
composite.
With regard to commenters' concern about lack of episode-based cost
measures, we believe that the total per capita cost measure, condition-
specific total per capita cost measures, and MSPB measure provide
sufficient cost performance data for VM cost composite calculation and
are inclusive of episode cost-based measures.
In the proposed rule (80 FR 41896-41897), we stated that we believe
it is appropriate to apply both the upward and the downward payment
adjustments under the quality-tiering methodology for the CY 2018 VM to
these groups and solo practitioners and also stated the reasons for our
belief. We
[[Page 71283]]
noted that the proposal to apply both upward and downward adjustments
under the quality-tiering methodology to groups with between 2 to 9 EPs
and physician solo practitioners in CY 2018 is consistent with gradual
implementation of the VM, wherein groups with between 10 to 99 EPs (79
FR 67941) and groups with 100 or more EPs (78 FR 74769-74770),
consecutively were subject to both upward and downward adjustments
under quality-tiering during the second year that the VM applied to
them. As discussed in section III.M.4.f. of this final rule with
comment period, we are finalizing a policy to set the maximum downward
adjustment under the quality-tiering methodology in CY 2018 to -2.0
percent for groups with between 2 to 9 EPs and physician solo
practitioners. We expect this level of payment at risk to not have a
significant financial impact on small groups and solo practitioners in
CY 2018 and is consistent with our approach to gradually phase in the
VM over time and increase the amount at risk.
With regard to the commenters' suggestion that smaller groups lack
awareness of the VM program, we believe that they have been given
sufficient time and data with which to become familiar with the
program. In September 2015, we made available QRURs based on CY 2014
data to all groups and solo practitioners. These QRURs contain
performance information on the quality and cost measures used to
calculate the quality and cost composites of the VM and show how all
TINs fare under the policies established for the VM for the CY 2016
payment adjustment period. As discussed in section III.M.5.a. of this
final rule with comment period, in April 2015, we made available 2014
Mid-Year QRURs to groups of physicians and physician solo practitioners
nationwide. The Mid-Year QRURs provide interim information about
performance on the claims-based quality outcome measures and cost
measures that are a subset of the measures that will be used to
calculate the CY 2016 VM and are based on performance from July 1, 2013
through June 30, 2014. Then, during spring of 2016, we intend to
disseminate the 2015 Mid-Year QRURs to all groups and solo
practitioners. Thus, we believe groups with between 2 to 9 EPs and
physician solo practitioners will have adequate data to improve
performance on the quality and cost measures that will be used to
calculate the VM in CY 2018. We note that the quality and cost measures
in the QRURs that these groups will receive are similar to the measures
that will be used to calculate the CY 2018 VM. We strongly encourage
EPs subject to the VM to proactively educate themselves about the VM
program and QRURs by visiting the VM/QRUR Web site http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/index.html. The VM/QRUR Web site contains information on the VM
policies for each payment adjustment period, including a link to the
2014 QRURs Web site that contains detailed information on the
methodology used to calculate the CY 2016 VM shown in the CY 2014 QRURs
and how to use the information contained in the QRURs.
We note that we work with medical and specialty associations and
have National Provider Calls throughout the year to educate physicians
and other professionals about the VM program and the QRURs. Further
outreach also will be undertaken by our Quality Improvement
Organizations (QIOs), which will provide technical assistance to
physicians and groups of physicians in an effort to help them improve
quality and consequently, performance under the VM program.
Final Policy: After considering the comments received, we are
finalizing that we will apply the quality-tiering methodology to all
groups and solo practitioners in Category 1 for the CY 2018 VM. We are
also finalizing our proposal that groups and solo practitioners will be
subject to upward, neutral, or downward adjustments derived under the
quality-tiering methodology (with the exception discussed in section
III.M.4.b. of this final rule with comment period, that PAs, NPs, CNSs,
and CRNAs in groups that consist of nonphysician EPs and PAs, NPs,
CNSs, and CRNAs who are solo practitioners will be held harmless from
downward adjustments under the quality-tiering methodology in CY 2018),
with the following modifications: We are finalizing an increase to the
minimum episode number requirement for the MSPB measure in the CY 2017
and 2018 payment adjustment periods to 125 episodes, for solo
practitioners and for groups of all sizes, in section III.M.4.k of this
final rule with comment period. In that section, we discuss our
proposal in the CY 2016 Medicare PFS proposed rule, to raise the
episode minimum for inclusion of this measure in the cost composite to
100 episodes (80 FR 41906) and our final policy to raise the minimum
number of episodes to 125. We are also finalizing that we will not
include the all-cause hospital readmissions measure in the quality
composite for solo practitioners and groups of two to nine EPs for the
CY 2017 and 2018 payment adjustment periods. We believe that his final
policy best addresses commenters' concerns with small sample sizes for
solo practitioners and groups of two to nine EPs, while preserving the
emphasis on provision of high quality efficient and effective care. We
are finalizing revisions to Sec. Sec. 414.1230, 414.1270, and 414.1265
to reflect these final policies.
d. Application of the VM to Physicians and Nonphysician EPs Who
Participate in ACOs under the Shared Savings Program
In the CY 2015 PFS final rule with comment period, we finalized a
policy to apply the VM, beginning with the CY 2017 payment adjustment
period, to physicians in groups with two or more EPs and physicians who
are solo practitioners that participate in an ACO under the Shared
Savings Program, and beginning with the CY 2018 payment adjustment
period, to nonphysician EPs in groups with two or more EPs and
nonphysician EPs who are solo practitioners that participate in an ACO
under the Shared Savings Program. We finalized that the determination
of whether a group or solo practitioner is considered to be in an ACO
under the Shared Savings Program would be based on whether that group
or solo practitioner, as identified by TIN, was an ACO participant in
the performance period for the applicable payment adjustment period for
the VM. For groups and solo practitioners determined to be ACO
participants, we finalized a policy that we would classify the group or
solo practitioner's cost composite as ``average'' and calculate its
quality composite based on the quality-tiering methodology using
quality data submitted by the Shared Savings Program ACO for the
performance period and apply the same quality composite to all of the
groups and solo practitioners, as identified by TIN, under that ACO.
For further explanation of the final policies for applying the VM to
ACO participants in Shared Savings Program ACOs, we refer readers to 79
FR 67941 through 67947 and 67956 through 67957.
(1) Application of the VM to groups and solo practitioners who
participate in multiple Shared Savings Program ACOs
Under the Shared Savings Program regulations (Sec. 425.306(b)), an
ACO participant TIN upon which beneficiary assignment is dependent may
only participate in one Shared Savings Program ACO. ACO participant
TINs that do not bill for primary care services, however, are not
required to be exclusive to one Shared Savings
[[Page 71284]]
Program ACO. As a result, there are a small number of TINs that are ACO
participants in multiple Shared Savings Program ACOs. We did not
previously address how the VM will be applied to these TINs.
Beginning with the CY 2017 payment adjustment period, we proposed
that TINs that participate in multiple Shared Savings Program ACOs in
the applicable performance period would receive the quality composite
score of the ACO that has the highest numerical quality composite
score. For this determination, we will only consider the quality data
of an ACO that completes quality reporting under the Shared Savings
Program. We proposed to apply this policy in situations where the VM is
determined based on quality-tiering or the ACO's failure to
successfully report quality data as required by the Shared Savings
Program. We provided several examples to illustrate the proposal.
We believe our proposed approach is appropriate because it is
straightforward for TINs participating in multiple Shared Savings
Program ACOs to understand. The policy is transparent and would allow
Shared Savings Program ACO participant TINs the ability to compare the
performance of the highest-performing ACO in which they participate to
national benchmarks. It also allows us to determine peer group means
for the purposes of determining statistical significance and
determining whether a given quality composite score is at least one
standard deviation from the peer group mean. We proposed to make
corresponding changes to Sec. 414.1210(b)(2).
In developing this policy, we considered several alternative
options. We considered proposing that the above policy would apply as
long as all ACOs in which the TIN participates complete reporting under
the Shared Savings Program. If one of the ACOs failed to report, the
TIN would be categorized as Category 2 even though it participated in
another ACO that successfully reported. We believe this would create
unnecessary complexity and would not be fair to TINs that were not made
aware of this policy prior to the start of the CY 2015 performance
period for the 2017 payment adjustment period. We also considered
proposing a policy under which the TIN would be required to indicate
which ACO it wanted to be associated with for purposes of the VM. We
did not make this proposal because we believed it created additional
operational complexity for the TINs and us, and would put the TIN in a
position of having to predict which ACO would perform better under the
VM, which we do not believe would be appropriate. We solicited comments
on our proposal as well as the alternatives we considered.
The following is a summary of the comments we received on the
proposal and alternatives considered:
Comment: We received a few comments in support of our proposal to
assign practices the highest quality composite score of the multiple
ACOs in which they participated. One commenter expressed the belief
that in the instance where a group or individual EP participates in two
or more ACOs, it is more appropriate and straightforward to compare the
VM adjustments associated with each ACO and apply the highest VM
adjustment to the group or individual EP. We received no comments on
the alternatives we considered.
Response: We appreciate commenters' support of our proposal to
assign TINs participating in multiple Shared Savings Program ACOs the
quality composite score of the ACO with the highest numerical quality
composite score. We acknowledge the comment that it would be more
straightforward to apply the highest VM adjustment instead; however, it
would not be possible to assign the highest VM adjustment to these
TINs, because movement of a given TIN from one quality designation to
another (from average to high quality, for example) would result in
recalculation of the peer group mean against which all other TINs
subject to the VM are compared, for the purpose of determining their
quality designations. Such a recalculation would necessitate an
additional analysis of which Shared Savings Program ACO had the highest
numerical quality composite score. Likewise, movement of another TIN
from one quality designation to another would necessitate the same
recalculation. Thus, it would not be feasible for us to concurrently
recalculate the VM for every TIN, with each iteration of moving a given
TIN in and out of a peer group mean.
Final Policy: After consideration of the comments received, we are
finalizing our proposal that, beginning with the CY 2017 payment
adjustment period, TINs that participate in multiple Shared Savings
Program ACOs in the applicable performance period will receive the
quality composite score of the ACO that has the highest numerical
quality composite score. We believe that this is the most
straightforward and advantageous methodology to acknowledge the highest
quality performance among the Shared Savings Program ACOs in which
these TINs participate.
(2) Application of VM to Participant TINs in Shared Savings Program
ACOs That Also Include EPs who Participate in Innovation Center Models
Under the Shared Savings Program statute and regulations, ACO
participants may not participate in another Medicare initiative that
involves shared savings payments (Sec. 425.114(b)). As noted above,
ACO participants who do not provide primary care services may
participate in multiple Shared Savings Program ACOs, but under section
1899(b)(4) of the Act, providers and suppliers that participate in a
Shared Savings Program ACO may not participate in an Innovation Center
model that involves shared savings, or any other program or
demonstration project that involving shared savings. There are Medicare
initiatives, including models authorized by the Innovation Center that
do not involve shared savings payments, and in some cases a TIN that is
a Shared Savings Program participant may also include EPs who
participate in an Innovation Center model. Because the Shared Savings
Program identifies participants by a TIN and many Innovation Center
models allow some EPs under a TIN to participate in the model while
other EPs under that TIN do not, we believe it is more appropriate to
apply the VM policies finalized for Shared Savings Program participants
to these TINs than to apply the policies for Innovation Center models
in section III.M.4.e. of this final rule with comment period. We
proposed that, beginning with the 2017 payment adjustment period for
the VM, we would determine the VM for groups and solo practitioners (as
identified by TIN) who participated in a Shared Savings Program ACO in
the performance period in accordance with the VM policies for Shared
Savings Program participants under Sec. 414.1210(b)(2), regardless of
whether any EPs under the TIN also participated in an Innovation Center
model during the performance period. We proposed to make corresponding
changes to Sec. 414.1210(b)(2)(i)(E). We solicited comment on this
proposal.
The following is a summary of the comments we received on this
proposal.
Comment: We received one comment in support of our proposal of
applying the VM to groups and solo practitioners who participate in the
Medicare Shared Savings Program, even if they also participate in an
Innovation Center model. Two commenters were of the opinion that the
proposed policy would be a barrier to fostering innovation and
expressed the concern that a TIN's performance might be counted
multiple
[[Page 71285]]
times if it participates in the Shared Savings Program, an Innovation
Center initiative, and the VM. Though we made no proposals to do so,
the majority of comments on proposals surrounding application of the VM
to Shared Savings Program ACO participant TINs expressed support for
waiving the VM for these TINs entirely.
Response: We appreciate the commenter's support for our proposal to
apply the VM to Shared Savings Program participants, even if they also
participate in Innovation Center models, as it would incentivize the
provision of high quality care to assigned beneficiaries. We also note
that the quality measures used for calculating the VM quality composite
score for Shared Savings Program ACO participants are the same measures
under which their quality is measured within the Shared Savings
Program, and they are assigned a cost composite score of ``average''
under the VM. Consequently, they do not face conflicting quality or
cost performance incentives or increased reporting burden. With regard
to the comment that application of the VM to Shared Savings Program ACO
participants would create a barrier to innovation under Innovation
Center models, we disagree. The quality performance of these TINs under
the Shared Savings Program is used for purposes of calculating the VM
quality composite score. No additional requirements related to cost or
quality reporting are imposed on these TINs for purposes of the VM,
above what they are already doing under the Shared Savings Program, so
no additional barriers to innovation would be created by applying the
VM. A TIN's performance under an Innovation Center model is not
considered under the VM and is therefore not counted multiple times.
Final Policy: After consideration of the public comments received,
we are finalizing our proposal, beginning with the CY 2017 payment
adjustment period, to determine the VM for groups and solo
practitioners (as identified by TIN) who participated in a Shared
Savings Program ACO in the performance period in accordance with the VM
policies for Shared Savings Program participants under Sec.
414.1210(b)(2), regardless of whether any EPs under the TIN also
participated in an Innovation Center model during the performance
period. We revised Sec. 414.1210(b)(2)(i)(E) to reflect this policy.
This will avoid the need to create multiple polices for application of
the VM to Shared Savings Program participant TINs and will continue to
reinforce the importance of quality performance.
(3) Application of VM to Participant TINs in Shared Savings Program
ACOs that Do Not Complete Quality Reporting
In the CY 2015 PFS proposed rule, we did not specifically address
the scenario in which a Shared Savings Program ACO does not
successfully report on quality as required under the Shared Savings
Program during the performance period for the VM. We clarified in the
CY 2015 PFS final rule with comment period that we intended to adopt
for groups and solo practitioners that participate in a Shared Savings
Program ACO the same policy that is generally applicable to groups and
solo practitioners that fail to satisfactorily report or participate
under PQRS and thus fall in Category 2 and are subject to an automatic
downward adjustment under the VM in CY 2017 (79 FR 67946). We stated
that, consistent with the application of the VM to other groups and
solo practitioners that report under PQRS, if the ACO does not
successfully report quality data as required by the Shared Savings
Program under Sec. 425.504, all groups and solo practitioners
participating in the ACO will fall in Category 2 for the VM, and
therefore, will be subject to a downward payment adjustment. We
finalized this policy for the 2017 payment adjustment period for the VM
at Sec. 414.1210(b)(2)(i)(C). We proposed to continue this policy in
the CY 2018 payment adjustment period for all groups and solo
practitioners subject to the VM, including groups composed of
nonphysician EPs and solo practitioners who are nonphysician EPs. We
proposed corresponding revisions to Sec. 414.1210(b)(2)(i)(D). This
policy is consistent with our policy for groups and solo practitioners
who are subject to the VM and do not participate in the Shared Savings
Program, and we believe it would further encourage quality reporting.
We solicited comment on this proposal.
The following is a summary of the comments we received on this
proposal.
Comment: We received one comment questioning this proposal, in
which the commenter expressed the belief that the proposal would
discourage participation in Shared Savings Program ACOs due to the
potential to earn a downward payment adjustment under the VM.
Response: We disagree that the proposed policy would discourage
participation in Shared Savings Program ACOs. Shared Savings Program
ACOs are required to report on quality on behalf of all participants
and this provision reinforces that reporting requirement. If these TINs
did not participate in a Shared Savings ACO, they would be required to
meet quality reporting requirements for the VM through another
mechanism. We believe that the proposed policy would emphasize the
importance of quality performance while treating Shared Savings Program
participant TINs the same as other TINs with regard to the consequence
of failing to report quality data.
Final Policy: After consideration of the comments received, we are
finalizing our proposal for the CY 2018 payment adjustment period, that
if a Shared Savings Program ACO does not successfully report quality
data as required by the Shared Savings Program during the performance
period for the VM, all groups and solo practitioners participating in
the ACO will fall in Category 2 for the VM and will be subject to an
automatic downward payment adjustment. We are finalizing the
corresponding revisions to Sec. 414.1210(b)(2)(i)(D).
(4) Application of an Additional Upward Payment Adjustment to High
Quality Participant TINs in Shared Savings Program ACOs for Treating
High-Risk Beneficiaries
In the CY 2015 PFS final rule with comment period, we finalized at
Sec. 414.1275(d)(2) that groups and solo practitioners that are
classified as high quality/low cost, high quality/average cost, or
average quality/low cost under the quality-tiering methodology for the
CY 2017 payment adjustment period would receive an additional upward
payment adjustment of +1.0x, if their attributed patient population has
an average beneficiary risk score that is in the top 25 percent of all
beneficiary risk scores nationwide. We proposed a similar policy for
the CY 2018 payment adjustment period as discussed in section
III.M.4.f. of this final rule with comment period.
Beginning in the CY 2017 payment adjustment period, we proposed to
apply a similar additional upward adjustment to groups and solo
practitioners that participated in high performing Shared Savings
Program ACOs that cared for high-risk beneficiaries (as evidenced by
the average HCC risk score of the ACO's attributed beneficiary
population as determined under the VM methodology) during the
performance period. We finalized in the CY 2015 PFS final rule with
comment period that the quality composite score for TINs that
participated in Shared Savings Program ACOs during the performance
period will be calculated using the quality data
[[Page 71286]]
reported by the ACO through the ACO GPRO Web Interface and the ACO all-
cause hospital readmission measure, and the cost composite will be
classified as ``average'' (79 FR 67941 through 67947). We believe this
policy would be appropriate because attribution on the quality measures
used in the VM calculation for Shared Savings Program ACO TINs is done
at the ACO level. Further, under the Shared Savings Program ACO
participants are responsible for coordinating the care of beneficiaries
assigned to the ACO, so it is appropriate to determine whether those
beneficiaries are in the highest risk category, at the ACO level.
Therefore, beginning in the CY 2017 payment adjustment period, we
proposed to apply an additional upward payment adjustment of +1.0x to
Shared Savings Program ACO participant TINs that are classified as
``high quality'' under the quality-tiering methodology, if the
attributed patient population of the ACO in which the TINs participated
during the performance period has an average beneficiary risk score
that is in the top 25 percent of all beneficiary risk scores nationwide
as determined under the VM methodology. We proposed corresponding
revisions to Sec. 414.1210(b)(2). We solicited comment on this
proposal.
In the CY 2015 PFS proposed rule (79 FR 40500), we proposed that
groups and solo practitioners participating in ACOs under the Shared
Savings Program would be eligible for the additional upward payment
adjustment +1.0x for caring for high-risk beneficiaries; however, the
proposal was not finalized in the CY 2015 PFS final rule with comment
period. We noted that our proposal above is based on using the ACO's
assigned beneficiary population; whereas, our proposal in the CY 2015
PFS proposed rule was based on using the group or solo practitioner's
attributed beneficiary population.
The following is a summary of the comments we received on this
proposal.
Comments: Commenters were very supportive of this proposal. One
commenter encouraged CMS to include aspects of social risk or community
risk in the calculations, stating that achieving good quality results
for patients who are socially complex (for example, low income,
homeless, living alone) or living in unsupportive community
environments would justify the same kind of enhanced payment that
achieving similar outcomes for clinically complex patients does, which
supports the idea of adding an upward payment adjustment in 2017 and
subsequent years of the VM program to those treating high-risk
beneficiaries.
Response: We acknowledge that beneficiaries' social support systems
could potentially have an impact on quality performance. We did not
make any proposals to change the definition of high-risk beneficiaries,
however, and make no changes in this final rule with comment period.
Final Policy: After consideration of the comments received, we are
finalizing our proposal beginning in the CY 2017 payment adjustment
period to apply an additional upward payment adjustment of +1.0x to
Shared Savings Program ACO participant TINs that are classified as
``high quality'' under the quality-tiering methodology, if the
attributed patient population of the ACO in which the TINs participated
during the performance period has an average beneficiary risk score
that is in the top 25 percent of all beneficiary risk scores nationwide
as determined under the VM methodology. We are finalizing corresponding
revisions at Sec. 414.1210(b)(2). We note that Shared Savings Program
ACO participant TINs are eligible for the +1.0x adjustment under Sec.
414.1210(b)(2) based on the average beneficiary risk score of the
attributed patient population of their ACO; they are not eligible for
the similar +1.0x adjustment under Sec. 414.1275(d).
e. Application of the VM to Physicians and Nonphysician EPs that
Participate in the Pioneer ACO Model, the CPC Initiative, or Other
Similar Innovation Center Models or CMS Initiatives
We established a policy in the CY 2013 PFS final rule with comment
period (77 FR 69313) to not apply the VM in the CY 2015 and CY 2016
payment adjustment periods to groups of physicians that participate in
Shared Savings Program ACOs, the Pioneer ACO Model, the Comprehensive
Primary Care (CPC) initiative, or other similar Innovation Center
models or CMS initiatives. We stated in the CY 2014 PFS final rule with
comment period (78 FR 74766) that from an operational perspective, we
will apply this policy to any group of physicians that otherwise would
be subject to the VM, if one or more physician(s) in the group
participate(s) in one of these programs or initiatives during the
relevant performance period (CY 2013 for the CY 2015 payment adjustment
period, and CY 2014 for the CY 2016 payment adjustment period). In the
CY 2015 PFS final rule with comment period (79 FR 67949), we finalized
a policy that for solo practitioners and groups subject to the VM with
at least one EP participating in the Pioneer ACO Model or CPC
Initiative during the performance period, we will classify the cost
composite as ``average cost'' and the quality composite as ``average
quality'' for the CY 2017 payment adjustment period. We did not
finalize a policy for any payment adjustment period after CY 2017. We
believed this policy was appropriate because it would enable groups and
solo practitioners participating in these Innovation Center models to
focus on the goals of the models and would minimize the risk of
potentially creating conflicting incentives with regard to the
evaluation of the quality and cost of care furnished for the VM and
evaluation of cost and quality under these models. In addition, given
that these models include groups in which some EPs participate in the
model and others do not participate, it is challenging to meaningfully
evaluate the quality of care furnished by these groups. and the timing
and availability of that quality data may not be aligned with the
availability of quality data under PQRS that is used in the VM
calculations.
(1) Application of the VM to Solo Practitioners and Groups with EPs Who
Participate in the Pioneer ACO Model and CPC Initiative
We received many comments on the proposals made in the CY 2015 PFS
proposed rule indicating that we should exempt Pioneer ACO Model and
CPC Initiative participants from the VM. As we noted in response to
comments in the CY 2015 final rule with comment period (79 FR 67947), a
few commenters also suggested that the application of the VM to
Innovation Center initiatives should be waived under section 1115A of
the Act. In considering potential policy options to include in the CY
2016 PFS proposed rule, and in consideration of comments previously
received, we believed that it would be appropriate to use the waiver
authority with regard to the Pioneer ACO Model and CPC Initiative.
Accordingly, under section 1115A(d)(1) of the Act, we proposed to waive
application of the VM as required by section 1848(p) of the Act for
groups and solo practitioners, as identified by TIN, if at least one EP
who billed for PFS items and services under the TIN during the
applicable performance period for the VM participated in the Pioneer
ACO Model or CPC Initiative during the performance period. This policy,
as well as the use of the waiver authority under section 1115A(d)(1) of
the Act for this purpose, will no longer apply in CY 2019 when the
Value Modifier adjustment under section 1848(p) of the Act has ended.
We believe a waiver is necessary to test these models because their
effectiveness would be impossible to isolate from the
[[Page 71287]]
confounding variables of quality and cost metrics and contrasting
payment incentives utilized under the VM. We refer readers to the
proposed rule (80 FR 41900) for an explanation of our rationale for
proposing to waive the VM for the CPC Initiative and the Pioneer ACO
Model.
We believe we could have waived application of the VM for these
models with regard to the CY 2017 payment adjustment period, and we
proposed the waiver would apply beginning with the CY 2017 payment
adjustment period. We noted that in practice, this proposal would not
affect a TIN's payments differently as compared with the current policy
for the CY 2017 payment adjustment period. A TIN that is classified as
``average cost'' and ``average quality'' would receive a neutral (0
percent) adjustment, and thus its payments during the CY would not
increase or decrease as a result of the application of the VM. We also
noted that we have established a policy to apply the VM at the TIN
level (77 FR 69308-69310), and as a result, this proposed waiver would
affect the payments for items and services billed under the PFS for the
CY 2017 and 2018 payment adjustment periods for the EPs who participate
in the Pioneer ACO Model and the CPC Initiative during the performance
period, as well as the EPs who do not participate in one of these
models but bill under the same TIN as the EPs who do participate. We
proposed to revise Sec. 414.1210(b)(3) to reflect these proposals and
sought comment on these proposals.
(2) Application of the VM to Solo Practitioners and Groups with EPs Who
Participate in Similar Innovation Center Models
In the CY 2015 PFS final rule with comment period (79 FR 67949-
67950), we finalized criteria that we will use to determine if future
Innovation Center models or CMS initiatives are ``similar'' to the
Pioneer ACO Model and CPC Initiative. We finalized that we will apply
the same VM policies adopted for participants in the Pioneer ACO Model
and CPC Initiative to groups and solo practitioners who participate in
similar Innovation Center models and CMS initiatives. The previously
finalized criteria are: (1) The model or initiative evaluates the
quality of care and/or requires reporting on quality measures; (2) the
model or initiative evaluates the cost of care and/or requires
reporting on cost measures; (3) participants in the model or initiative
receive payment based at least in part on their performance on quality
measures and/or cost measures; (4) potential for conflict between the
methodologies used for the VM and the methodologies used for the model
or initiative; or (5) other relevant factors specific to a model or
initiative. We noted that a model or initiative would not have to
satisfy or address all of these criteria to be considered a similar
model or initiative.
We proposed that in the event we finalize our proposal to waive
application of the VM under section 1115A(d)(1) of the Act for the
Pioneer ACO Model and CPC Initiative as discussed in the preceding
section, we would also waive application of the VM for Innovation
Center models that we determine are similar models based on the
criteria above and for which we determined such a waiver would be
necessary for purposes of testing the model in accordance with section
1115A(d)(1) of the Act. For models that we determine are similar and
require a waiver, we would waive application of the VM as required by
section 1848(p) of the Act for groups and solo practitioners, as
identified by TIN, if at least one EP who billed for PFS items and
services under the TIN during the applicable performance period for the
VM participated in the model during the performance period. We noted
that this policy and use of the waiver authority under section
1115A(d)(1) of the Act would sunset prior to CY 2019 when the VM is
replaced by MIPS. We would publish a notice of the waiver in the
Federal Register and also provide notice to participants in the model
through the methods of communication that are typically used for the
model. We proposed to revise Sec. 414.1210(b)(4) to reflect this
proposal. We solicited comment on this proposal.
(a) Application of the VM to Solo Practitioners and Groups with EPs
Who Participate in the Comprehensive ESRD Care Initiative (CEC),
Oncology Care Model (OCM), and the Next Generation ACO Model.
There are several new Innovation Center models starting in 2015 or
2016, including the Comprehensive ESRD Care Initiative, Oncology Care
Model, and the Next Generation ACO Model. We evaluated these models
based on the criteria for ``similar'' models and initiatives described
in the preceding section and determined that they are similar to the
Pioneer ACO Model and CPC Initiative. We believe a waiver of the VM
under section 1115A(d)(1) of the Act is necessary to test these models.
These new models may include groups in which some EPs participate in
the model and others do not, which will make it challenging to
meaningfully calculate the quality and cost composite for these TINs
needed for the application of the VM. We refer readers to the proposed
rule (80 FR 41901) for an explanation of our determination that these
models are similar to the Pioneer ACO Model and the CPC Initiative and
our belief that a waiver is necessary to test these models.
We proposed that in the event we finalize our proposal to waive
application of the VM as required by section 1848(p) of the Act under
section 1115A(d)(1) of the Act for the Pioneer ACO Model and CPC
Initiative, we would also waive application of the VM for the Next
Generation ACO Model, the Oncology Care Model, and the Comprehensive
ESRD Care Initiative as similar models. Specifically, we would waive
application of the VM for the CY 2018 payment adjustment period for
groups and solo practitioners, as identified by TIN, if at least one EP
who billed for PFS items and services under the TIN during the CY 2016
performance period for the VM participated in the Next Generation ACO
Model, the Oncology Care Model, or the Comprehensive ESRD Care
Initiative during the CY 2016 performance period. We solicited comment
on this proposal.
The following is a summary of the comments we received on the
proposals to waive application of the VM for the Pioneer ACO Model; CPC
Initiative; and other similar Innovation Center models, including the
Next Generation ACO Model, Oncology Care Model, and Comprehensive ESRD
Care Initiative.
Comment: We received many comments on this proposal, all of which
were in support of waiving the VM if at least one EP participated in
the Pioneer ACO Model, CPC Initiative, or other similar Innovation
Center model, such as Next Generation ACO, Oncology Care Model, or the
Comprehensive ESRD Care Initiative. Though we did not make any proposal
to do so, several of the commenters also requested that CMS also waive
the VM for EPs who participate in the Medicare Shared Savings Program.
A few commenters suggested that the Value Modifier be waived for
participants in any Alternative Payment Model (APM), even for private
(non-CMS) demonstrations, and also suggested waiving the Value Modifier
for the Bundled Payments for Care Improvement (BPCI) initiative.
Response: We appreciate commenters' support for our proposal to
waive the VM for these models. With regard to the suggestion that we
also waive the VM for Shared Savings Program ACO participants, we
disagree that such a waiver would be appropriate or necessary to carry
out the Shared Savings Program. As stated in the CY
[[Page 71288]]
2015 final rule with comment period (79 FR 67941), we believe that
alignment of the VM and the Shared Savings Program emphasizes the
importance of quality reporting and quality measurement, for
improvement of the quality of care provided to Medicare beneficiaries.
The Shared Savings Program requires quality reporting through the PQRS
GPRO Web Interface, so we have readily available quality data for use
in calculating a quality composite score for the VM, whereas such data
may not be available for TINs that participate in Innovation Center
models. The VM does not impose any different quality performance
requirements on Shared Savings Program ACO participants, and thus does
not create conflicting quality performance incentives for them. We
disagree with the commenters' suggestion that we waive the VM for
participants in any APM, BPCI or private (non-CMS) demonstrations. If
the commenters are referring to APMs as defined in section 101(e) of
MACRA, we note the statutory amendments made by this section have
payment implications for EPs beginning in 2019, after the VM has
sunset. We established specific criteria for a model to be considered
``similar,'' for the purpose of waiving the VM. The VM is an important
initiative for incentivizing high quality efficient care for Medicare
beneficiaries. We established specific criteria wherein it could be
waived and we do not believe that it would be appropriate to waive this
important adjustment in cases where the criteria do not apply. We do
not believe BPCI is a ``similar'' model according to the criteria
established in the CY 2015 PFS final rule with comment period (79 FR
67949 through 67950), because the model does not require reporting on
quality measures outside of the PQRS, does not require reporting on
cost measures, and its methodology is not in conflict with the cost and
quality metrics used under the VM.
Final Policy: After considering the public comments received, we
are finalizing our proposals to waive application of the VM for the
Pioneer ACO Model; CPC Initiative; and other similar Innovation Center
models, including the Next Generation ACO Model, the Oncology Care
Model, and the Comprehensive ESRD Care Initiative, all as proposed
without modification. We are finalizing the corresponding revisions to
the regulation text at Sec. 414.1210(E)(3)(i)(ii) (b) Application of
VM to Similar CMS initiatives that are not Innovation Center models
In the CY 2015 PFS final rule with comment period (79 FR 67949-
67950), we finalized criteria that we will use to determine if future
Innovation Center models or CMS initiatives are ``similar'' to the
Pioneer ACO Model and CPC Initiative. We finalized that we will apply
the same VM policies adopted for participants in the Pioneer ACO Model
and CPC Initiative to groups and solo practitioners who participate in
similar Innovation Center models and CMS initiatives. We are finalizing
in section III.M.4.e.1. of this final rule with comment period our
proposal to waive the VM for solo practitioners and groups with at
least one EP participating in the Pioneer ACO Model or CPC Initiative
under section 1115A(d)(1) of the Act. The waiver authority under
section 1115A(d)(1) of the Act does not apply to CMS initiatives that
are not Innovation Center models. Therefore, we stated in the event
that we finalize the waiver, we proposed to remove the references to
``CMS initiatives'' from Sec. 414.1210(b)(4). We solicited comment on
this proposal, but did not receive comments specific to this proposal.
Final Policy: As a result, we are finalizing our proposal to remove
the references to ``CMS initiatives'' from Sec. 414.1210(b)(4).
f. Payment Adjustment Amount
Section 1848(p) of the Act does not specify the amount of payment
that should be subject to the adjustment for the VM; however, section
1848(p)(4)(C) of the Act requires the VM be implemented in a budget
neutral manner. Budget neutrality means that payments will increase for
some groups and solo practitioners based on high performance and
decrease for others based on low performance, but the aggregate
expected amount of Medicare spending in any given year for physician
and nonphysician EP services paid under the Medicare PFS will not
change as a result of application of the VM.
In the CY 2015 PFS final rule with comment period (79 FR 67952 to
67954), we finalized that we will apply a -2.0 percent VM to groups
with between 2 to 9 EPs and physician solo practitioners that fall in
Category 2 for the CY 2017 VM. We also finalized that the maximum
upward adjustment under the quality-tiering methodology in CY 2017 for
groups with between 2 to 9 EPs and physician solo practitioners that
fall in Category 1 will be +2.0x if a group or solo practitioner is
classified as high quality/low cost and +1.0x if a group or solo
practitioner is classified as either average quality/low cost or high
quality/average cost. These groups and solo practitioners will be held
harmless from any downward adjustments under the quality-tiering
methodology in CY 2017, if classified as low quality/high cost, low
quality/average cost, or average quality/high cost.
For groups with 10 or more EPs, we finalized for CY 2017 that we
will apply a ``-4.0'' percent VM to a group that falls in Category 2.
In addition, we finalized that we will set the maximum downward
adjustment under the quality-tiering methodology in CY 2017 to ``-4.0''
percent for groups with 10 or more EPs classified as low quality/high
cost and set the adjustment to ``-2.0'' percent for groups classified
as either low quality/average cost or average quality/high cost. We
finalized that we will also set the maximum upward adjustment under the
quality-tiering methodology in CY 2017 to +4.0x for groups with 10 or
more EPs classified as high quality/low cost and set the adjustment to
+2.0x for groups classified as either average quality/low cost or high
quality/average cost. We also finalized that we will continue to
provide an additional upward payment adjustment of +1.0x to groups with
two or more EPs and solo practitioners that care for high-risk
beneficiaries (as evidenced by the average HCC risk score of the
attributed beneficiary population).
As noted in section III.M.4.b. of this final rule with comment
period, under section 1848(p)(4)(B)(iii) of the Act, as amended by
section 101(b)(3) of MACRA, the VM shall not be applied to payments for
items and services furnished on or after January 1, 2019. Section
1848(q) of the Act, as added by section 101(c) of MACRA, establishes
the MIPS that shall apply to payments for items and services furnished
on or after January 1, 2019. To maintain stability in the payment
adjustment amounts applicable under the VM as we transition to the MIPS
in 2019, we proposed to maintain the payment adjustment amounts in CY
2018 that we finalized for the CY 2017 VM in the CY 2015 PFS final rule
with comment period for groups with 2 or more EPs and physician solo
practitioners, with the exception discussed in section III.M.4.c. of
this final rule with comment period that in CY 2018 we proposed to
apply both the upward and downward adjustments under the quality-
tiering methodology to groups with 2 to 9 EPs and physician solo
practitioners that are in Category 1.
For CY 2018, we proposed to apply a -4.0 percent VM to physicians,
PAs, NPs, CNSs, and CRNAs in groups with 10 or more EPs that fall in
Category 2. In addition, we proposed to set the maximum downward
adjustment under the quality-tiering methodology in CY
[[Page 71289]]
2018 to -4.0 percent for physicians, PAs, NPs, CNSs, and CRNAs in
groups with 10 or more EPs classified as low quality/high cost and to
set the adjustment to -2 percent for groups classified as either low
quality/average cost or average quality/high cost. We also proposed to
set the maximum upward adjustment under the quality-tiering methodology
in CY 2018 to +4.0x for physicians, PAs, NPs, CNSs, and CRNAs in groups
with 10 or more EPs classified as high quality/low cost and to set the
adjustment to +2.0x for groups classified as either average quality/low
cost or high quality/average cost. Table 33 (80 FR 41903) of the
proposed rule shows the quality-tiering payment adjustment amounts for
CY 2018 for physicians, PAs, NPs, CNSs, and CRNAs in groups with 10 or
more EPs. These payment amounts would be applicable to all of the
physicians, NPs, PAs, CNSs, and CRNAs who bill under a group's TIN in
CY 2018.
For CY 2018, we proposed to apply a negative ``-2.0'' percent VM to
physicians, PAs, NPs, CNSs, and CRNAs in groups with between 2 to 9 EPs
and physician solo practitioners that fall in Category 2. In addition,
we propose to set the maximum downward adjustment under the quality-
tiering methodology in CY 2018 to negative ``-2.0'' percent for
physicians, PAs, NPs, CNSs, and CRNAs in groups with between 2 to 9 EPs
and physician solo practitioners classified as low quality/high cost
and to set the adjustment to negative ``-1.0'' percent for groups and
physician solo practitioners classified as either low quality/average
cost or average quality/high cost. We also proposed to set the maximum
upward adjustment under the quality-tiering methodology in CY 2018 to
+2.0x for physicians, PAs, NPs, CNSs, and CRNAs in groups with between
2 to 9 EPs and physician solo practitioners classified as high quality/
low cost and to set the adjustment to +1.0x for groups and physician
solo practitioners classified as either average quality/low cost or
high quality/average cost. Table 34 of the proposed rule (80 FR 41903)
shows the quality-tiering payment adjustment amounts for CY 2018 for
physicians, PAs, NPs, CNSs, and CRNAs in groups with between 2 to 9 EPs
and physician solo practitioners. These payment adjustment amounts
would be applicable to all of the physicians, NPs, PAs, CNSs, and CRNAs
who bill under a group's TIN and to physician solo practitioners in CY
2018.
For CY 2018, we proposed to apply a negative ``-2.0'' percent VM to
PAs, NPs, CNSs, and CRNAs in groups that consist of nonphysician EPs
and solo practitioners who are PAs, NPs, CNSs, and CRNAs that fall in
Category 2 for the CY 2018 VM. As noted in section III.M.4.b. of this
final rule with comment period, the nonphysician EPs to which the CY
2018 VM payment adjustments would apply are PAs, NPs, CNSs, and CRNAs.
We also proposed that the maximum upward adjustment under the quality-
tiering methodology in CY 2018 for PAs, NPs, CNSs, and CRNAs in groups
that consist of nonphysician EPs and solo practitioners who are PAs,
NPs, CNSs, and CRNAs that fall in Category 1 would be +2.0x if a group
or solo practitioner is classified as high quality/low cost and +1.0x
if a group or solo practitioner is classified as either average
quality/low cost or high quality/average cost. As established in the CY
2015 PFS final rule with comment period (79 FR 67937), these groups and
solo practitioners will be held harmless from any downward adjustments
under the quality-tiering methodology in CY 2018, if classified as low
quality/high cost, low quality/average cost, or average quality/high
cost. Table 35 of the proposed rule (80 FR 41903) shows the quality-
tiering payment adjustment amounts for CY 2018 for PAs, NPs, CNSs, and
CRNAs in groups that consist of nonphysician EPs and PAs, NPs, CNSs,
and CRNAs who are solo practitioners. These groups and solo
practitioners will have had less time to become familiar with the QRURs
since they have received QRURs for the first time in the Fall of 2015;
whereas, groups consisting of both physicians and nonphysician EPs and
physician solo practitioners received QRURs in fall of 2014 or in
previous years, which enable them to understand and improve performance
on the measures used in the VM. We believe our proposed approach would
reward groups and solo practitioners that provide high-quality/low-cost
care. In addition, a smaller increase in the maximum amount of payment
at risk would be consistent with our stated focus on gradual
implementation of the VM.
We also proposed to continue to provide an additional upward
payment adjustment of +1.0x to groups and solo practitioners that are
eligible for upward adjustments under the quality-tiering methodology
and have average beneficiary risk score that is in the top 25 percent
of all beneficiary risk scores. Lastly, we proposed to revise Sec.
414.1270 and Sec. 414.1275(c)(4) and (d)(3) to reflect the changes to
the payment adjustments under the VM for the CY 2018 payment adjustment
period. We solicited comments on all of these proposals.
Consistent with the policy adopted in the CY 2013 PFS final rule
with comment period (77 FR 69324 through 69325), we noted that the
estimated funds derived from the application of the downward
adjustments to groups and solo practitioners in Category 1 and Category
2 would be available to all groups and solo practitioners eligible for
upward adjustments under the VM. Consequently, the upward payment
adjustment factor (``x'' in Tables 33, 34, and 35 of the proposed rule)
would be determined after the performance period has ended based on the
aggregate amount of downward payment adjustments.
The following is a summary of the comments we received on these
proposals.
Comment: Several commenters expressed appreciation for our efforts
to maintain stability in the payment adjustment amounts applicable
under the VM in CY 2018 as we transition to the MIPS in CY 2019 and
supported our proposal to maintain the payment adjustment amounts in CY
2018 at the same levels as that for the CY 2017 VM. Some commenters
suggested alternatives that included maintaining lower downside risk
while establishing different upward adjustments based on group size;
keeping adjustments constant, regardless of group size; and
establishing a 2.0 percent maximum amount at risk for all groups, so
that combined with the PQRS adjustment, the total would be consistent
with the 4.0 percent at risk under the first year of the MIPS.
Response: We appreciate the commenters' support of our proposals.
We believe that any significant change in the payment adjustment
amounts under the VM from CY 2017 to CY 2018, which is the final year
in which the VM will apply to payments, would not be consistent with
our intention to maintain stability as we transition to the MIPS in CY
2019.
Final Policy: As discussed in section III.M.4.c. of this final rule
with comment period, for the CY 2018 VM, we are finalizing that we will
continue to apply the quality-tiering methodology to all groups and
solo practitioners in Category 1. We are also finalizing that groups
and solo practitioners will be subject to upward, neutral, or downward
adjustments derived under the quality-tiering methodology, with the
exception finalized in the CY 2015 PFS final rule with comment period
(79 FR 67937), that groups consisting of nonphysician EPs and solo
practitioners who are nonphysician EPs will be held harmless from
downward adjustments under the quality-tiering methodology in CY 2018.
We finalized modifications to ensure that the measures used to
[[Page 71290]]
calculate the VM for solo practitioners and groups of all sizes are
reliable, in sections III.M.4.c. and III.M.4.k. of this final rule with
comment period.
For CY 2018, we are finalizing that we will apply a negative ``-
4.0'' percent VM to physicians, PAs, NPs, CNSs, and CRNAs in groups
with 10 or more EPs that fall in Category 2. In addition, we will set
the maximum downward adjustment under the quality-tiering methodology
in CY 2018 to negative ``-4.0'' percent for physicians, PAs, NPs, CNSs,
and CRNAs in groups with 10 or more EPs classified as low quality/high
cost and set the adjustment to negative ``-2.0'' percent for groups
classified as either low quality/average cost or average quality/high
cost. We will also set the maximum upward adjustment under the quality-
tiering methodology in CY 2018 to +4.0x for physicians, PAs, NPs, CNSs,
and CRNAs in groups with 10 or more EPs classified as high quality/low
cost and set the adjustment to +2.0x for groups classified as either
average quality/low cost or high quality/average cost. Table 47 shows
the final quality-tiering payment adjustment amounts for CY 2018 for
physicians, PAs, NPs, CNSs, and CRNAs in groups with 10 or more EPs.
These payment amounts will be applicable to all of the physicians, NPs,
PAs, CNSs, and CRNAs who bill under a group's TIN in CY 2018.
For CY 2018, we are finalizing that we will apply a negative ``-
2.0'' percent VM to physicians, PAs, NPs, CNSs, and CRNAs in groups
with between 2 to 9 EPs and physician solo practitioners that fall in
Category 2. In addition, we will set the maximum downward adjustment
under the quality-tiering methodology in CY 2018 to negative ``-2.0''
percent for physicians, PAs, NPs, CNSs, and CRNAs in groups with
between 2 to 9 EPs and physician solo practitioners classified as low
quality/high cost and set the adjustment to negative ``-1.0'' percent
for groups and physician solo practitioners classified as either low
quality/average cost or average quality/high cost. We will also set the
maximum upward adjustment under the quality-tiering methodology in CY
2018 to +2.0x for physicians, PAs, NPs, CNSs, and CRNAs in groups with
between 2 to 9 EPs and physician solo practitioners classified as high
quality/low cost and set the adjustment to +1.0x for groups and
physician solo practitioners classified as either average quality/low
cost or high quality/average cost. Table 48 shows the final quality-
tiering payment adjustment amounts for CY 2018 for physicians, PAs,
NPs, CNSs, and CRNAs in groups with between 2 to 9 EPs and physician
solo practitioners. These payment adjustment amounts will be applicable
to all of the physicians, NPs, PAs, CNSs, and CRNAs who bill under a
group's TIN and to physician solo practitioners in CY 2018.
For CY 2018, we are finalizing that we will apply a negative ``-
2.0'' percent VM to PAs, NPs, CNSs, and CRNAs in groups that consist of
nonphysician EPs and solo practitioners who are PAs, NPs, CNSs, and
CRNAs that fall in Category 2 for the CY 2018 VM. As finalized in
section III.M.4.b. of this final rule with comment period, the
nonphysician EPs to which the CY 2018 VM payment adjustments would
apply are PAs, NPs, CNSs, and CRNAs. We are also finalizing that the
maximum upward adjustment under the quality-tiering methodology in CY
2018 for PAs, NPs, CNSs, and CRNAs in groups that consist of
nonphysician EPs and solo practitioners who are PAs, NPs, CNSs, and
CRNAs that fall in Category 1 will be +2.0x if a group or solo
practitioner is classified as high quality/low cost and +1.0x if a
group or solo practitioner is classified as either average quality/low
cost or high quality/average cost. As established in the CY 2015 PFS
final rule with comment period (79 FR 67937), these groups and solo
practitioners will be held harmless from any downward adjustments under
the quality-tiering methodology in CY 2018, if classified as low
quality/high cost, low quality/average cost, or average quality/high
cost. Table 49 shows the final quality-tiering payment adjustment
amounts for CY 2018 for PAs, NPs, CNSs, and CRNAs in groups that
consist of nonphysician EPs and PAs, NPs, CNSs, and CRNAs who are solo
practitioners. Consistent with the policy adopted in the CY 2013 PFS
final rule with comment period (77 FR 69324 through 69325), we note
that the estimated funds derived from the application of the downward
adjustments to groups and solo practitioners in Category 1 and Category
2 will be available to all groups and solo practitioners eligible for
upward adjustments under the VM. Consequently, the upward payment
adjustment factor (``x'' in Tables 47, 48, and 49) will be determined
after the performance period has ended based on the aggregate amount of
downward payment adjustments.
TABLE 47--Final CY 2018 VM Amounts for the Quality-Tiering Approach for
Physicians, PAs, NPs, CNSs, and CRNAs in Groups of Physicians with Ten
or More EPS
------------------------------------------------------------------------
Average High
Cost/quality Low quality quality quality
------------------------------------------------------------------------
Low cost......................... +0.0% +2.0x* +4.0x*
Average cost..................... -2.0% +0.0% +2.0x*
High cost........................ -4.0% -2.0% +0.0%
------------------------------------------------------------------------
* Groups eligible for an additional +1.0x if reporting PQRS quality
measures and average beneficiary risk score is in the top 25 percent
of all beneficiary risk scores, where `x' represents the upward
payment adjustment factor.
TABLE 48--Final CY 2018 VM Amounts for the Quality-Tiering Approach for
Physicians, PAs, NPs, CNSs, and CRNAs in Groups of Physicians with 2 To
9 EPs and Physician Solo Practitioners
------------------------------------------------------------------------
Average High
Cost/quality Low quality quality quality
------------------------------------------------------------------------
Low cost......................... +0.0% +1.0x* +2.0x*
Average cost..................... -1.0% +0.0% +1.0x*
High cost........................ -2.0% -1.0% +0.0%
------------------------------------------------------------------------
* Groups and solo practitioners eligible for an additional +1.0x if
reporting PQRS quality measures and average beneficiary risk score is
in the top 25 percent of all beneficiary risk scores, where `x'
represents the upward payment adjustment factor.
[[Page 71291]]
TABLE 49--Final CY 2018 VM Amounts for the Quality-Tiering Approach for
PAs, NPS, CNSs, and CRNAs in Groups Consisting of Nonphysician EPs and
PAs, NPs, CNSs, and CRNAs Who are Solo Practitioners
------------------------------------------------------------------------
Average High
Cost/quality Low quality quality quality
------------------------------------------------------------------------
Low cost......................... +0.0% +1.0x* +2.0x*
Average cost..................... +0.0% +0.0% +1.0x*
High cost........................ +0.0% +0.0% +0.0%
------------------------------------------------------------------------
* Groups and solo practitioners are eligible for an additional +1.0x if
reporting PQRS quality measures and average beneficiary risk score is
in the top 25 percent of all beneficiary risk scores, where `x'
represents the upward payment adjustment factor.
Comment: Commenters supported our proposal to continue to provide
an additional upward payment adjustment of +1.0x to groups and solo
practitioners that are eligible for upward adjustments under the
quality-tiering methodology and treated the most complex beneficiaries.
One commenter urged CMS to apply the additional upward payment
adjustment to all providers that serve high-risk patients, and another
stated that CMS should include aspects of social risk or community risk
in the determination of whether beneficiaries fall into the highest
risk category.
Response: The additional upward payment adjustment is intended to
be an incentive for groups and solo practitioners that treat high-risk
beneficiaries to provide them with higher quality of care at lower
costs. Therefore, we do not believe it would be appropriate to provide
the additional upward payment adjustment to all groups and solo
practitioners that treat high-risk beneficiaries. As discussed in
section III.M.4.d. of this final rule with comment period, we did not
make proposals to include aspects of social or community risk in the
determination of whether a beneficiary would be classified as falling
in the top 25 percent of risk scores, such that a TIN treating the
beneficiary would be eligible for the additional +1.0X adjustment, and
thus make no such adjustments in this final rule with comment period.
Final Policy: We are finalizing our proposal to continue to provide
an additional upward payment adjustment of +1.0x to groups and solo
practitioners that are eligible for upward adjustments under the
quality-tiering methodology and have average beneficiary risk score
that is in the top 25 percent of all beneficiary risk scores.
Comment: One commenter noted the following clarification provided
for the PQRS program in section III.I.1. of the proposed rule: ``With
respect to EPs who furnish covered professional services at RHCs and/or
FQHCs that are paid under the Medicare PFS, we note that we are
currently unable to assess PQRS participation for these EPs due to the
way in which these EPs bill for services under the PFS. Therefore, EPs
who practice in RHCs and/or FQHCs would not be subject to the PQRS
payment adjustment.'' The commenter requested that we also clarify that
EPs who practice in RHCs and/or FQHCs would not be subject to the VM.
Response: As discussed in the CY 2013 PFS final rule with comment
period (77 FR 69309), the VM provides for differential payment to a
physician or a group of physicians under the Medicare PFS for items and
services furnished. Groups and solo practitioners who furnish items and
services paid under the Medicare PFS are subject to the VM for these
items and services, regardless of whether they practice in RHCs and/or
FQHCs. However, as explained in section III.I.1. of the proposed rule
(80 FR 41816), we are currently unable to assess PQRS participation for
EPs billing under the PFS who practice in RHCs and/or FQHCs and do not
also practice in other settings, such as in physician offices. Under
the PQRS, these EPs will be treated as having avoided the PQRS payment
adjustment if the EP billing under the PFS reports only place of
service codes 50 (FQHC) and/or 72 (RHC) during the applicable reporting
period. As discussed in section III.M.4.c. of this final rule with
comment period, a TIN will be included in Category 1 if the TIN meets
the criteria to avoid the PQRS payment adjustment as a group or at
least 50% of the EPs in the TIN meet the criteria to avoid the PQRS
payment adjustment as individuals. Further, consistent with the policy
we are finalizing in section III.M.4.m. of this final rule with comment
period, a group or solo practitioner will receive a quality composite
score that is classified as average under the quality-tiering
methodology if the group or solo practitioner does not have at least
one quality measure that meets the minimum number of cases required for
the measure to be included in the calculation of the quality composite.
Comment: One commenter was concerned that there is no process that
would permit nonparticipating physicians to receive an upward
adjustment under the VM.
Response: We refer the commenter to the CY 2015 PFS final rule with
comment period (79 FR 67950-67951), in which we explained that the VM
will apply to all assigned claims, including those submitted by both
participating and non-participating physicians, and nonphysician EPs to
the extent the VM is applied to them. Therefore, the VM will affect
nonparticipating physicians to the extent that they submit assigned
claims, and they may qualify for an upward adjustment under the
quality-tiering methodology the same as a participating physician. We
will monitor these issues, but we continue to believe that these
policies are reasonable. As explained in previous rulemaking (79 FR
67950-67951), if the VM were to be applied to non-assigned services,
then the VM would directly affect beneficiary cost sharing and not
Medicare payments to physicians, contrary to our intent. We further
note that over 99 percent of Medicare physician services are billed on
an assignment related basis by both participating and non-participating
physicians and other suppliers, with the remainder billed as non-
assigned services by non-participating physicians and other suppliers
(79 FR 40505).
Final Policy: After considering the comments received, we are
finalizing all of the policies discussed in section III.M.4.f. of the
proposed rule. We are also finalizing the revisions at Sec. 414.1270
and Sec. 414.1275(c)(4) and (d)(3) to reflect these policies without
modification.
g. Finality of the VM Upward Payment Adjustment Factor
Beginning with the CY 2015 VM (77 FR 69324 through 69325), we
established that the upward payment adjustment factor (``x'') would be
determined after the performance period has ended based on the
aggregate amount of downward payment adjustments. We also proposed a
similar
[[Page 71292]]
policy for the CY 2018 VM as discussed in section III.M.4.f. of the
proposed rule (80 FR 41903). In the interest of providing EPs that are
eligible for an upward payment adjustment under the VM with finality,
and to minimize the cost of reprocessing claims, we proposed that we
would not recalculate the upward payment adjustment factor for an
applicable payment adjustment period after the adjustment factor is
made public, unless CMS determines that a significant error was made in
the calculation of the adjustment factor. We solicited public comment
on this proposal.
Final Policy: We did not receive any comments on this proposal.
Therefore, we are finalizing our proposal and will not recalculate the
upward payment adjustment factor for an applicable payment adjustment
period after the adjustment factor is made public, unless CMS
determines that a significant error was made in the calculation of the
adjustment factor.
h. Performance Period
In the CY 2014 PFS final rule with comment period (78 FR 74772), we
adopted a policy that we will use performance on quality and cost
measures during CY 2015 to calculate the VM that would apply to items
and services for which payment is made under the PFS during CY 2017.
Likewise, we proposed to use CY 2016 as the performance period for the
VM adjustments that will apply during CY 2018. Accordingly, we proposed
to add Sec. 414.1215(d) to indicate that the performance period is CY
2016 for VM adjustments made in the CY 2018 payment adjustment period.
We solicited comment on this proposal.
The following is a summary of the comments we received on this
proposal.
Comment: One commenter supported our proposal to use CY 2016 as the
performance period for the 2018 VM, while another commenter objected
stating that it is difficult for groups to translate how performance
affects payments two years later and urged CMS to eliminate the gap
between performance and payment years. One commenter asked that we
clarify whether CY 2016 will be the last performance period for the VM
program.
Response: In the CY 2012 PFS final rule with comment period (76 FR
73435), CY 2013 PFS final rule with comment period (77 FR 69313-69314),
and CY 2014 PFS final rule with comment period (78 FR 74771-74772), we
addressed how we considered shortening the gap between the performance
period and the payment adjustment period. As we explained in the CY
2012 PFS final rule with comment period (76 FR 73435), we explored
different options to close the gap between the performance period and
the payment adjustment period, but found that none of them would have
permitted sufficient time for physicians and groups of physicians to
report measures or have their financial performance measured over a
meaningful period, or for us to calculate a VM and notify physicians
and groups of physicians of their quality and cost performance and VM
prior to the payment adjustment period.
As discussed in section III.M.5.a. of this final rule with comment
period, in April 2015, we made available 2014 Mid-Year QRURs to groups
of physicians and physician solo practitioners nationwide based on
performance from July 1, 2013, through June 30, 2014. We plan to make
available the 2015 and 2016 Mid-Year QRURs during the spring of 2016
and 2017, respectively. The Mid-Year QRURs are intended to provide
groups and solo practitioners with interim information about their
performance on the claims-based quality outcome measures and cost
measures that are a subset of the measures that were used to calculate
the VM. Therefore, we are finalizing our proposal to use CY 2016 as the
performance period for the VM adjustments that will apply during CY
2018.
As discussed in section III.M.4.b. of this final rule with comment
period, under section 1848(p)(4)(B)(iii) of the Act, as amended by
section 101(b)(3) of MACRA, the VM shall not be applied to payments for
items and services furnished on or after January 1, 2019. Therefore, CY
2018 will be the final payment adjustment period and CY 2016 will be
the final performance period under the VM.
Final Policy: After considering public comments received, we are
finalizing our proposal to use CY 2016 as the performance period for
the VM adjustments that will apply during CY 2018 and finalizing the
addition of Sec. 414.1215(d) without modification.
i. Quality Measures
(1) PQRS Reporting Mechanisms
In the CY 2016 PFS proposed rule (80 FR 41904), we stated our
belief that it is important to continue to align the VM for CY 2018
with the requirements of the PQRS, because quality reporting is a
necessary component of quality improvement. We also sought to avoid
placing an undue burden on EPs to report such data. Accordingly, for
purposes of the VM for CY 2018, we proposed to continue to include in
the VM all of the PQRS GPRO reporting mechanisms available to groups
for the PQRS reporting periods in CY 2016 and all of the PQRS reporting
mechanisms available to individual EPs for the PQRS reporting periods
in CY 2016. These reporting mechanisms are described in Tables 20 and
21 of the proposed rule (80 FR, 41825).
(2) PQRS Quality Measures
We proposed to continue to use all of the quality measures that are
available to be reported under these various PQRS reporting mechanisms
to calculate a group or solo practitioner's VM in CY 2018 to the extent
that a group (or individual EPs in the group, in the case of the ``50
percent option'') or solo practitioner submits data on these measures.
These PQRS quality measures are described in Tables 22 through 30 of
the proposed rule (80 FR 41830).
The following is the summary of comments we received on these
proposals.
Comment: Commenters supported the continued alignment of the VM
with PQRS requirements. However, some commenters raised concerns about
the lack of applicable measures for multiple specialties.
Response: We thank the commenters for their support of our
continued alignment with PQRS. In previous rulemakings we have
committed to expanding the specialty measures available in PQRS to more
accurately measure the performance on quality of care furnished by
specialists; PQRS now has specialty measure sets (for example;
Pathology preferred measure set, radiology preferred measure set, and
ophthalmology preferred measure set) that can be utilized as a guide to
assist eligible professionals in choosing measures applicable to their
specialty. We reaffirm our commitment to using measures of performance
across specialties that are valid and reliable for the VM. As discussed
in section III.M.4.m. of this final rule with comment period, we are
finalizing that beginning in the CY 2016 payment adjustment period, a
group or solo practitioner subject to the VM will receive a quality
composite score that is classified as average under the quality-tiering
methodology if the group or solo practitioner does not have at least
one quality measure that meets the minimum number of cases required for
the measure to be included in the calculation of the quality composite.
Final Policy: After consideration of the comments received, we are
finalizing our proposal for the CY 2018 VM to include all of the PQRS
GPRO
[[Page 71293]]
reporting mechanisms available to groups for the PQRS reporting periods
in CY 2016 and all of the PQRS reporting mechanisms available to
individual EPs for the PQRS reporting periods in CY 2016. These
reporting mechanisms are described in Tables 27 and 28 of this final
rule with comment period. Additionally, we are finalizing our proposal
to use all of the quality measures that are available to be reported
under these various PQRS reporting mechanisms to calculate a group or
solo practitioner's VM in CY 2018 to the extent that a group (or
individual EPs in the group, in the case of the ``50 percent option'')
or solo practitioner submits data on these measures. These quality
measures are described in Table 29 through 42 of this final rule with
comment period.
(3) Benchmarks for eCQMs
Currently, the VM program utilizes quality of care measure
benchmarks for a given performance year that are calculated as the
case-weighted mean of the prior year's performance rates, inclusive of
all available PQRS reporting mechanisms for that measure (claims,
registries, Electronic Health Record (EHR), or Web Interface (WI)). We
finalized this policy in CY 2013 and stated we would consider the
effects of our policy as we implemented the VM and that we may consider
changes and refinements in the future (77 FR 69322).
From experience in utilizing PQRS measures in the VM, we have
become aware that a given measure may be calculated differently when it
is collected through an EHR, and made a proposal to address this issue.
We referred to quality measures collected through EHRs as ``eCQMs.'' We
noted several variances with eCQMs compared to equivalent measures
reported via a different reporting mechanism. First, the inclusion of
all-payer data for the eCQMs differentiates them sufficiently from
their equivalent measures reported via the other PQRS reporting
mechanisms, which utilize Medicare FFS data. The inclusion of all-payer
data may increase the cohort size and incorporate a pool of
beneficiaries with different characteristics than those captured with
Medicare FFS data. As our goal is to focus on how groups of EPs or
individual EPs' performance differs from the benchmark on a measure-by-
measure basis, we recognize the need to utilize separate eCQM
benchmarks that allow us to compare eCQM measure performance rates to a
benchmark that better reflects the measures' specifications. Second,
eCQMs follow a different annual update cycle than do other versions of
measures, and consequently, they are not always consistent with the
current version of a measure as it is reported via claims, registries,
or Web Interface. For example, during a given performance period, an
eCQM's specifications might require data collection on a different age
range than the specifications of the same measure reported via other
reporting mechanisms. This means that the eCQM version of a measure may
differ from the specifications of the all-mechanism benchmark, to which
it is currently compared. Because of these differences, we proposed to
change our benchmark policy to indicate that eCQMs, as identified by
their CMS eMeasure IDs, which are distinct from the CMS/PQRS measure
numbers for other reporting mechanisms, will be recognized as distinct
measures under the VM. As such, we would exclude eCQM measures from the
overall benchmark for a given measure and create separate eCQM
benchmarks, based on the CMS eMeasure ID. We proposed to make this
change beginning with the CY 2016 performance period, for which the
eCQM benchmarks would be calculated based on CY 2015 performance data.
We solicited comment on this proposal. The following is a summary
of the comments we received on this proposal:
Comment: Commenters were unanimous in their support of this
proposal. However, while not directly related to this proposal several
commenters asked for clarification on how benchmarks for quality of
care measures reported via PQRS QCDRs will be calculated. Specifically,
they asked whether QCDR measures would only be benchmarked against
identical measures that are reported via a different QCDR or other
reporting mechanism. Commenters also requested clarification on whether
QCDRs will be allowed to develop their own benchmarking methodology or
if CMS plans to calculate the benchmarks using its current methodology.
Response: PQRS measures reported via QCDRs will be benchmarked
according to our current VM benchmarking methodology which is defined
as follows. The benchmark for quality of care measures reported through
the PQRS using the claims, registries, QCDR, or web interface is the
national mean for that measure's performance rate (regardless of the
reporting mechanism) during the year prior to the performance period.
Benchmarks for non-PQRS quality of care measures reported via QCDRs
would also be calculated as the national mean of the measure's
performance rate across all EPs reporting the measure via different
QCDRs during the year prior to the performance period. It is important
to note that measures reported through a QCDR that are new to PQRS
would not be included in the quality composite for the VM because we
would not be able to calculate benchmarks for them.
Final Policy: After consideration of the comments received, we are
finalizing our proposal to exclude eCQM measures from the overall
benchmark for a given measure and create separate eCQM benchmarks,
based on the CMS eMeasure ID beginning with the CY 2016 performance
period for which the eCQM benchmarks would be calculated based on CY
2015 performance data. We will finalize corresponding changes to Sec.
414.1250(a).
(4) CAHPS Reporting
In our efforts to maintain alignment with the PQRS quality
reporting requirements, we noted in the proposed rule that the criteria
for administration of the CAHPS for PQRS survey for the CY 2016
performance period will contain 6 months of data (80 FR 41904). We
believe that the CAHPS for PQRS data administered during this 6-month
period would be sufficiently reliable so that we could meaningfully
include it in a group's quality composite score under the VM, should
they elect to have CAHPS for PQRS included in their VM calculation. For
us to use the data to calculate the score, we would require data for
each summary survey measure on at least 20 beneficiaries which is the
reliability standard for the VM (77 FR 69322-69323). We noted that we
took a similar approach in the CY 2014 PFS final rule with comment
period (78 FR 74772) with regard to the 6-month reporting period for
individual eligible professionals reporting via qualified registries
under PQRS for the CY 2014 PQRS incentive and CY 2016 payment
adjustment. Additionally, in the CY 2015 PFS final rule with comment
period (79 FR 67956), we noted that groups with two or more EPs could
elect to include the patient experience of care measures collected
through the PQRS CAHPS survey for CY 2015 in their VM for CY 2017. We
proposed to continue this policy for the CY 2016 performance period for
the CY 2018 VM. We did not receive comments on this proposal, and
therefore, are finalizing our policy that groups with 2 or more EPs
could elect to include the patient experience of care measures
collected through the PQRS CAHPS survey for the CY 2016 performance
period for the CY 2018 VM. We note that this policy for the VM is
separate from the CAHPS reporting requirements under the PQRS.
[[Page 71294]]
(5) Quality Measures for the Shared Savings Program
In the CY 2015 PFS final rule with comment period (79 FR 67957), we
finalized a policy to use the ACO GPRO Web Interface measures and the
Shared Savings Program ACO all-cause readmission measure to calculate a
quality composite score for groups and solo practitioners who
participate in an ACO under the Shared Savings Program. Also, we
finalized a policy to apply the benchmark for quality measures for the
VM as described under Sec. 414.1250 to determine the standardized
score for quality measures for groups and solo practitioners
participating in ACOs under the Shared Savings Program.
We believe patient surveys are important tools for assessing
beneficiary experience of care and outcomes. Accordingly, we proposed
that starting with the CY 2018 payment adjustment period, the ACO CAHPS
survey will be required as an additional component of the VM quality
composite for TINs participating in the Shared Savings Program. CAHPS
surveys for Shared Savings Program ACOs have been collected since 2013,
for the 2012 reporting period. In the 2014 reporting period, we
provided two versions of the CAHPS for ACOs survey to assess patient
experience ACO-8 and ACO-12, with Shared Savings Program ACOs having
the option to use either survey. We note that under the VM CAHPS for
PQRS is optional for groups that report it and these groups must elect
to have their CAHPS performance used in their VM quality composite
calculations. As both PQRS and Shared Savings Program ACOs report on
CAHPS for their Medicare FFS populations, there is an overlap between
the CAHPS survey data collected for both programs and we have
calculated 2014 performance period prior year benchmarks on 11 of the
12 ACO CAHPS summary survey measures for the VM. We believe that by the
CY 2016 performance period, we will have sufficient data and experience
with calculating these survey measures in the VM, to require the ACO
CAHPS measures in conjunction with the GPRO WI measures and the all-
cause readmission measure in the calculation of a quality composite
score for groups and solo practitioners participating in an ACO under
Shared Savings Program. We proposed to include the CAHPS for ACOs
survey in the quality composite of the VM for TINs participating in
ACOs in the Shared Savings Program, beginning with the CY 2016
performance period and the CY 2018 payment adjustment period. We
proposed that whichever version of the CAHPS for ACOs survey the ACO
chooses to administer will be included in the TIN's quality composite
for the VM. We proposed to make corresponding changes to Sec.
414.1210(b)(2)(i)(B). We solicited comment on this proposal.
The following is a summary of the comments we received on this
proposal.
Comment: One commenter supported this proposal, and we did not
receive any opposing comments.
Response: We thank the commenter for their support.
Final Policy: After consideration of the comments received, we are
finalizing our proposal to include the CAHPS for ACOs survey in the
quality composite of the VM for TINS participating in ACOs in the
Shared Savings Program, beginning with the CY 2016 performance period
and the CY 2018 payment adjustment period. We are also finalizing that
whichever version of the CAHPS for ACOs survey the ACO chooses to
administer will be included in the TIN's quality composite for the VM.
We finalized corresponding changes to Sec. 414.1210(b)(2)(i)(B).
j. Expansion of the Informal Inquiry Process To Allow Corrections for
the Value-Based Payment Modifier
Section 1848(p)(10) of the Act provides that there shall be no
administrative or judicial review under section 1869 of the Act,
section 1878 of the Act, or otherwise of the following:
The establishment of the VM.