81 FR 28162 - Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models
Department of Health and Human Services Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 89 (May 9, 2016)
Page Range
28162-28586
FR Document
2016-10032
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new Merit-based Incentive Payment System (MIPS) for MIPS eligible clinicians or groups under the PFS. This proposed rule would establish the MIPS, a new program for certain Medicare-enrolled practitioners. MIPS would consolidate components of three existing programs, the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for Eligible Professionals (EPs), and would continue the focus on quality, resource use, and use of certified EHR technology (CEHRT) in a cohesive program that avoids redundancies. This proposed rule also would establish incentives for participation in certain alternative payment models (APMs) and includes proposed criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations on physician-focused payment models. In this proposed rule we have rebranded key terminology based on feedback from stakeholders, with the goal of selecting terms that would be more easily identified and understood by our stakeholders.
Federal Register, Volume 81 Issue 89 (Monday, May 9, 2016)
[Federal Register Volume 81, Number 89 (Monday, May 9, 2016)]
[Proposed Rules]
[Pages 28162-28586]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-10032]
[[Page 28161]]
Vol. 81
Monday,
No. 89
May 9, 2016
Part II
Book 2 of 2 Books
Pages 28161-28686
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 414 and 495
Medicare Program; Merit-Based Incentive Payment System (MIPS) and
Alternative Payment Model (APM) Incentive Under the Physician Fee
Schedule, and Criteria for Physician-Focused Payment Models; Proposed
Rule
Federal Register / Vol. 81 , No. 89 / Monday, May 9, 2016 / Proposed
Rules
[[Page 28162]]
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Department of Health and Human Services
Centers for Medicare & Medicaid Services
42 CFR Parts 414 and 495
[CMS-5517-P]
RIN 0938-AS69
Medicare Program; Merit-Based Incentive Payment System (MIPS) and
Alternative Payment Model (APM) Incentive Under the Physician Fee
Schedule, and Criteria for Physician-Focused Payment Models
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)
repeals the Medicare sustainable growth rate (SGR) methodology for
updates to the physician fee schedule (PFS) and replaces it with a new
Merit-based Incentive Payment System (MIPS) for MIPS eligible
clinicians or groups under the PFS. This proposed rule would establish
the MIPS, a new program for certain Medicare-enrolled practitioners.
MIPS would consolidate components of three existing programs, the
Physician Quality Reporting System (PQRS), the Physician Value-based
Payment Modifier (VM), and the Medicare Electronic Health Record (EHR)
Incentive Program for Eligible Professionals (EPs), and would continue
the focus on quality, resource use, and use of certified EHR technology
(CEHRT) in a cohesive program that avoids redundancies. This proposed
rule also would establish incentives for participation in certain
alternative payment models (APMs) and includes proposed criteria for
use by the Physician-Focused Payment Model Technical Advisory Committee
(PTAC) in making comments and recommendations on physician-focused
payment models. In this proposed rule we have rebranded key terminology
based on feedback from stakeholders, with the goal of selecting terms
that would be more easily identified and understood by our
stakeholders.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on June 27, 2016.
ADDRESSES: In commenting, please refer to file code CMS-5517-P. 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 http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-5517-P, 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-5517-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments ONLY to the following addresses prior to
the close of the comment period:
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,
call telephone number (410) 786 7195 in advance to schedule your
arrival with one of our staff members. Comments erroneously mailed to
the addresses indicated as appropriate for hand or courier delivery may
be delayed and received after the comment period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Molly MacHarris, (410) 786-4461, for inquiries related to MIPS.
James P. Sharp, (410) 786-7388, for inquiries related to APMs.
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.
Acronyms
Because of the many terms to which we refer by acronym in this
proposed rule, we are listing the acronyms used and their corresponding
meanings in alphabetical order below:
ABCTM Achievable Benchmark of Care
ACA The Patient Protection and Affordable Care Act
ACO Accountable Care Organization
APM Alternative Payment Model
BPCI Bundled Payments for Care Improvement
CAH Critical Access Hospital
CAHPS Consumer Assessment of Healthcare Providers and Systems
CEHRT Certified EHR technology
CFR Code of Federal Regulations
CHIP Children's Health Insurance Program
CJR Comprehensive Care for Joint Replacement
CMMI Center for Medicare & Medicaid Innovation (Innovation Center)
CPIA Clinical Practice Improvement Activity
CPR Customary, Prevailing, and Reasonable
CPS Composite Performance Score
CPT Current Procedural Terminology
CQM Clinical Quality Measure
EHR Electronic heath record
EP Eligible professional
FFS Fee-for-Service
FQHC Federally Qualified Health Center
HIE Health Information Exchange
HIPAA Health Insurance Portability and Accountability Act of 1996
HITECH Health Information Technology for Economic and Clinical
Health
HPSA Health Professional Shortage Area
HHS Department of Health & Human Services
HRSA Health Resources and Services Administration
IT Information technology
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MACRA Medicare Access and CHIP Reauthorization Act of 2015
MEI Medicare Economic Index
MIPAA Medicare Improvements for Patients and Providers Act of 2008
MIPS Merit-Based Incentive Payment System
MLR Minimum Loss Rate
MSPB Medicare Spending per Beneficiary
MSR Minimum Savings Rate
MUA Medically Underserved Area
NPI National Provider Identifier
OCM Oncology Care Model
ONC Office of the National Coordinator for Health Information
Technology
PECOS Medicare Provider Enrollment, Chain, and Ownership System
PFPMs Physician Focused Payment Models
PFS Physician Fee Schedule
PHS Public Health Service
PQRS Physician Quality Reporting System
QCDRs Qualified Clinical Data Registries
QP Qualifying APM Professional
QRDA Quality Reporting Document Architecture
QRUR Quality and Resource Use Reports
RBRVS Resource-Based Relative Value Scale
RHC Rural Health Clinic
RVU Relative Value Unit
SGR Sustainable Growth Rate
TCPI Transforming Clinical Practice Initiative
TIN Tax Identification Number
VM Value-based Payment Modifier
VPS Volume Performance Standard
Table of Contents
Executive Summary
I. Background
A. Physician and Practitioner Payment Under Medicare
B. Current Reporting Programs and Regulations (Overview)
C. Overview of Section 101 of the MACRA
D. Stakeholder Input
II. Provisions of the Proposed Regulations
A. Establishing MIPS and the APMs Incentive
B. Program Principles and Goals
C. Changes to Existing Programs
D. Definitions
E. MIPS Program Details
F. Incentive Payments for Participating in Advanced APMs
III. Collection of Information Requirements
IV. Response to Comments
V. Regulatory Impact Analysis
A. Statement of Need
B. Overall Impact
C. Changes in Medicare Payments
D. Impact on Beneficiaries
E. Impact on Other Health Care Programs and Providers
F. Alternatives Considered
G. Assumptions and Limitations
H. Accounting Statement
Executive Summary
1. Purpose
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)
(Pub. L. 114-10, enacted April 16, 2015), amended title XVIII of the
Social Security Act (the Act) to repeal the Medicare sustainable growth
rate and strengthen Medicare access by improving physician payments and
making other improvements, to reauthorize the Children's Health
Insurance Program (CHIP), and for other purposes. This rule is needed
to propose policies to improve physician payments by changing the way
Medicare incorporates quality measurement into payments and by
developing new policies to address and incentivize participation in
alternative payment models.
This proposed rule would establish the Merit-Based Incentive
Payment System (MIPS), a new program for certain Medicare-participating
practitioners. MIPS would consolidate components of three existing
programs, the Physician Quality Reporting System (PQRS), the Physician
Value-based Payment Modifier (VM), and the Medicare Electronic Health
Record (EHR) Incentive Program for eligible professionals (EPs), and
would continue the focus on quality, resource use, and use of certified
EHR technology in a cohesive program that avoids redundancies. This
proposed rule also would establish incentives for participation in
certain alternative payment models (APMs), supporting the
Administration's goals of moving more fee-for-service payments into
APMs that focus on better care, smarter spending, and healthier people.
This proposed rule also includes proposed criteria for use by the
Physician-Focused Payment Model Technical Advisory Committee (PTAC) in
making comments and recommendations to the Secretary on physician-
focused payment models (PFPMs).
In this proposed rule we have rebranded key terminology based on
feedback from stakeholders, with the goal of selecting terms that would
be more easily identified and understood by our stakeholders. We
discuss these terminology changes in greater detail in the following
sections of this proposed rule.
2. Summary of the Major Provisions
This proposed rule would sunset payment adjustments under the
current PQRS, VM, and the Medicare EHR Incentive Program for EPs.
Components of these three programs would be carried forward into the
new MIPS program.
This proposed rule would establish a new subpart O of our
regulations at 42 CFR 414.1300 to implement the new MIPS program as
required by the MACRA.
(a) MIPS
In establishing MIPS, this rule would define MIPS program
participants as ``MIPS eligible clinicians'' rather than ``MIPS EPs''
as that term is defined at section 1848(q)(1)(C) and used throughout
section 1848(q) of the Act. MIPS eligible clinicians will include
physicians, physician assistants, nurse practitioners, clinical nurse
specialists, certified registered nurse anesthetists, and groups that
include such clinicians. The rule proposes definitions and requirements
for groups. In addition to proposing definitions for MIPS eligible
clinicians, the rule also proposes rules for the specific Medicare-
enrolled practitioners that would be excluded from MIPS, including
newly Medicare-enrolled eligible clinicians, Qualifying APM
Participants (QPs), certain Partial Qualifying APM Participants
(Partial QPs), and clinicians that fall under the proposed low-volume
threshold.
This rule proposes MIPS performance standards and a MIPS
performance period of 1 calendar year (January 1 through December 31)
for all measures and activities applicable to the four performance
categories. Further, we propose to use 2017 as the performance period
for the 2019 payment adjustment. Therefore, the first performance
period would start in 2017 for payments adjusted in 2019. This time
frame is needed to allow data and claims to be submitted and data
analysis to occur. In addition, it would allow for a full year of
measurement and sufficient time to base adjustments on complete and
accurate information.
As directed by the MACRA, this rule proposes measures, activities,
reporting, and data submission standards across four performance
categories: Quality, resource use, clinical practice improvement
activities (CPIAs), and meaningful use of certified EHR technology
(referred to in this proposed rule as ``advancing care information'').
Measures and activities would vary by category and include outcome
measures, performance measures, and global and population-based
measures. Consideration would be given to the application of measures
to non-patient facing MIPS eligible clinicians.
Quality measures would be selected annually through a call for
quality measures process. Selection of these measures is proposed to be
based on certain criteria that align with CMS priorities, and a final
list of quality measures will be published in the Federal Register by
November 1 of each year. Under the standards proposed in this rule,
there would be options for reporting as an individual MIPS eligible
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clinician or as part of a group. Some data could be submitted via
relevant third party data submission entities, such as qualified
clinical data registries (QCDRs), health IT vendors,\1\ qualified
registries, and CMS-approved survey vendors.
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\1\ We note that, for this proposed rule, a health IT vendor
that serves as a third party intermediary to collect or submit data
on behalf MIPS eligible clinicians may or may not also be a ``health
IT developer.'' Under the ONC Health IT Certification Program
(Program), a health IT developer constitutes a vendor, self-
developer, or other entity that presents health IT for certification
or has health IT certified under the Program. The use of ``health IT
developer'' is consistent with the use of the term ``health IT'' in
place of ``EHR'' or ``EHR technology'' under the Program (see 80 FR
62604; and the advancing care information performance category in
this rule). Throughout this proposed rule, we use the term ``health
IT vendor'' to refer to entities that support the health IT
requirements of a clinician participating in the proposed Quality
Payment Program.
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Within each performance category, we propose some specific
standards, including:
Quality: For most MIPS eligible clinicians, we propose to
include a minimum of six measures with at least one cross-cutting
measure (for patient-facing MIPS eligible clinicians) and an outcome
measure if available; if an outcome measure is not available, then the
eligible clinician would report one other high priority measure
(appropriate use, patient safety, efficiency, patient experience, and
care coordination measures) in lieu of an outcome measure. MIPS
eligible clinicians can meet this criterion by selecting measures
either individually or from a specialty-specific measure set.
Resource Use: Continuation of two measures from the VM:
Total per costs capita for all attributed beneficiaries and Medicare
Spending per Beneficiaries (MSPB) with minor technical adjustments. In
addition, episode-based measures, as applicable to the MIPS eligible
clinician.
CPIA: We generally encourage but are not requiring a
minimum number of CPIAs.
Advancing Care Information: Assessment based on advancing
care information measures and objectives.
We propose standards for measures, scoring, and reporting for MIPS
eligible clinicians across all four performance categories outlined in
this section. We propose that MIPS eligible clinicians who participate
in certain types of APMs will be scored using an APM scoring standard
instead of the generally applicable MIPS scoring standard.
The U.S. Department of Health & Human Services' (HHS) Office of the
Assistant Secretary for Planning and Evaluation (ASPE) is conducting
studies and making recommendations on the issue of risk adjustment for
socioeconomic status on quality measures and resource use as required
by section 2(d) of the Improving Medicare Post-Acute Care
Transformation Act of 2014 (the IMPACT Act) and expects to issue a
report to Congress by October 2016. We will closely examine the
recommendations issued by ASPE and incorporate them, as feasible and
appropriate, in future rulemaking.
We are proposing MIPS eligible clinicians have the flexibility to
submit information individually or via a group or an APM Entity group;
however, the MIPS eligible clinician would use the same identifier for
all performance categories. The proposed scoring methodology has a
unified approach across all performance categories, would allow MIPS
eligible clinicians to know in advance what they need to do to perform
well in MIPS, and eliminates the need for an ``all or nothing'' scoring
as has been the case under some other CMS programs. The four
performance category scores (quality, resource use, CPIA, and advancing
care information) would be aggregated into a MIPS composite performance
score (CPS). The MIPS CPS would be compared against a MIPS performance
threshold. The CPS would be used to determine whether a MIPS eligible
clinician receives an upward payment adjustment, no payment adjustment,
or a downward payment adjustment as appropriate. Payment adjustments
would be scaled for budget neutrality, as required by statute. The CPS
would also be used to determine whether a MIPS eligible clinician
qualifies for an additional positive adjustment factor for exceptional
performance.
To ensure that MIPS results are useful and accurate, we propose a
process for providing performance feedback to MIPS eligible clinicians.
Beginning July 1, 2017, we propose to include information on the
quality and resource use performance categories in the performance
feedback. Initially, we propose to provide performance feedback on an
annual basis. In future years, we may consider providing performance
feedback on a more frequent basis as well as adding feedback on the
performance categories of CPIA and advancing care information. We
propose to make performance feedback available using a CMS designated
system. Further, we propose to leverage additional mechanisms such as
health IT vendors, registries, and QCDRs to help disseminate data/
information contained in the performance feedback to eligible
clinicians where applicable.
We propose to adopt a targeted review process under MIPS wherein a
MIPS eligible clinician may request that we review the calculation of
the MIPS adjustment factor and, as applicable, the calculation of the
additional MIPS adjustment factor applicable to such MIPS eligible
clinician for a year. We further propose a general process by which a
MIPS eligible clinician could request targeted review.
We propose requirements for third-party data submission to MIPS.
Specifically, qualified registries, QCDRs, health IT vendors, and CMS-
approved survey vendors would have the ability to act as intermediaries
on behalf of MIPS eligible clinicians and groups for submission of data
to us across the quality, CPIA, and advancing care information
performance categories.
We also propose a process for public reporting of MIPS information
through the Physician Compare Web site. We propose public reporting of
a MIPS eligible clinician's data; in that for each program year, we
will post on a public Web site (for example, Physician Compare), in an
easily understandable format, information regarding the performance of
MIPS eligible clinicians or groups under the MIPS.
(b) APMs
In this rule, we propose standards we would use for the purposes of
the Alternative Payment Model (APM) incentive. The MACRA defines APM
for the purposes of the incentive as a model under section 1115A of the
Social Security Act (the Act) (excluding a health care innovation
award), the Shared Savings Program under section 1899 of the Act, a
demonstration under section 1866C of the Act, or a demonstration
required by federal law. We propose to define the term ``Other Payer
APMs'' to refer to arrangements in which eligible clinicians may
participate through other payers. We also propose to define the term
APM Entity as an entity that participates in an APM through a contract
with a payer.
APMs that meet the criteria to be Advanced APMs provide the pathway
through which eligible clinicians can become QPs and earn incentive
payments for participation in APMs as specified under the MACRA. This
rule proposes two types of Advanced APMs: Advanced APMs and Other Payer
Advanced APMs. To be an Advanced APM, an APM must meet three
requirements: (1) Require participants to use certified EHR technology;
(2) provide payment for covered professional services based on quality
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measures comparable to those used in the quality performance category
of MIPS; and (3) be either a Medical Home Model expanded under section
1115A of the Act or bear more than a nominal amount of risk for
monetary loses. In this rule, we propose criteria for each of the
requirements to be an Advanced APM.
To be an Other Payer Advanced APM, a commercial or Medicaid APM
must meet three requirements similar to the CMS Advanced APM
requirements: (1) Require participants to use certified EHR technology;
(2) provide payment based on quality measures comparable to those used
in the quality performance category of MIPS; and (3) be either a
Medicaid Medical Home Model that is comparable to Medical Home Models
expanded under section 1115A of the Act or bear more than a nominal
amount of risk for monetary loses.
We propose that we would notify the public of which APMs will be
Advanced APMs prior to each QP Performance Period, starting no later
than January 1, 2017. This information will be posted on our Web site.
We propose that professional services furnished at Critical Access
Hospitals (CAHs), Rural Health Clinics (RHCs) and Federally Qualified
Health Centers (FQHCs) that meet certain criteria be counted towards
the QP determination.
The MACRA sets a Medicare threshold for the level of participation
in Advanced APMs required for an eligible clinician to become a QP for
a year. The Medicare Option, based on Part B payments for covered
professional services or counts of patients furnished covered
professional services under Part B, is applicable beginning with CY
2019. The All-Payer Combination Option, based on the Medicare Option,
as well as an eligible clinician's participation in Other Payer
Advanced APMs, is applicable beginning with CY 2021. For eligible
clinicians to become QPs through the All-Payer Combination Option, an
Advanced APM Entity or eligible clinician must submit information to us
so that we can determine whether an Other Payer APM is an Other Payer
Advanced APM and whether an eligible clinician meets the requisite QP
threshold of participation. We propose a methodology and criteria to
evaluate eligible clinicians using the All-Payer Combination Option.
For purposes of evaluating Other Payer APMs, we also propose criteria
for the definition of Medicaid Medical Homes and Medical Home Model.
We propose to identify individual eligible clinicians by a unique
APM participant identifier using the individuals' TIN/NPI combinations,
and to assess as an APM Entity group all individual eligible clinicians
listed as participating in an Advanced APM Entity to determine QP
status for a year. We also propose that if an individual eligible
clinician who participates in multiple Advanced APM Entities does not
achieve QP status through participation in any single APM Entity, we
would assess the eligible clinician individually to determine QP status
based on combined participation in Advanced APMs.
We propose the method that CMS would use to calculate and disburse
the APM Incentive Payments to QPs. We propose specific rules for
calculating the APM Incentive Payment when a QP also receives non-fee-
for-service payments or payment adjustments through the Medicare EHR
Incentive Program, PQRS, VM, MIPS, or other payment adjustment
programs.
We propose a process for eligible clinicians to choose whether or
not to be subject to the MIPS payment adjustment in the event that they
are determined to be Partial QPs.
We propose that we would perform monitoring and compliance around
APM Incentive Payments.
We propose a definition for Physician-Focused Payment Models
(PFPMs), criteria that would be used by the PFPM Technical Advisory
Committee (PTAC), the Secretary, and CMS to evaluate proposals for
PFPMs, and the process by which PFPMs would be considered for testing
and implementation by CMS after review by the PTAC.
We propose to require MIPS eligible clinicians, as well as EPs,
eligible hospitals, and Critical Access Hospitals (CAHs) under the
existing EHR Incentive Programs to make a demonstration related to the
provisions concerning blocking the sharing of information under section
106(b)(2) of the MACRA and, separately, to demonstrate cooperation with
authorized ONC surveillance of certified EHR technology.
3. Summary of Costs & Benefits
Under the MACRA's requirements, MIPS would distribute payment
adjustments to between approximately 687,000 and 746,000 eligible
clinicians in 2019. Payment adjustments would be based on MIPS eligible
clinicians' performance on specified measures and activities within the
four performance categories. We estimate that MIPS payment adjustments
would be approximately equally distributed between negative adjustments
($833 million) and positive adjustments ($833 million) to MIPS eligible
clinicians, to ensure budget neutrality. Additionally, MIPS would
distribute approximately $500 million in exceptional performance
payments to MIPS eligible clinicians whose performance exceeds a
specified threshold. These payment adjustments are expected to drive
quality improvement in the provision of MIPS eligible clinicians' care
to Medicare beneficiaries and to all patients in the health care
system. However, the distribution could change based on the final
population of MIPS eligible clinicians for CY 2019 and the distribution
of scores under the program.
We estimate that between approximately 30,658 and 90,000 eligible
clinicians would become QPs through participation in Advanced APMs, and
are estimated to receive between $146 million and $429 million in APM
Incentive Payments for CY 2019. As with MIPS, we expect that APM
participation would drive quality improvement for clinical care
provided to Medicare beneficiaries and to all patients in the health
care system.
I. Background
In January 2015, the Administration announced new goals for
transforming Medicare by moving away from traditional fee-for-service
payments in Medicare towards a payment system focused on linking
physician reimbursements to quality care through APMs (http://www.hhs.gov/about/news/2015/01/26/better-smarter-healthier-in-historic-announcement-hhs-sets-clear-goals-and-timeline-for-shifting-medicare-reimbursements-from-volume-to-value.html#) and other value-based
purchasing arrangements. This is part of an overarching Administration
strategy to transform how health care is delivered in America, changing
payment structures to improve quality and patient outcomes.
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) of
2015 (Pub. L. 114-10, enacted April 16, 2015, and hereafter referred to
as the MACRA), landmark bipartisan legislation, advances a forward-
looking, coordinated framework for health care providers to
successfully take part in the CMS Quality Payment Program that rewards
value and outcomes in one of two ways:
Merit-Based Incentive Payment System (MIPS).
Advanced Alternative Payment Models (Advanced APMs).
The MACRA marks a milestone in efforts to improve and reform the health
care system. Building off of the successful coverage expansions and
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improvements to access under the Affordable Care Act, the MACRA puts an
increased focus on the quality and value of care delivered. By
incentivizing participation in certain APMs, such as Accountable Care
Organizations (ACOs), Medical Home Models, and episode payment models,
and by incentivizing quality and value for eligible clinicians under
the MIPS, we support the nation's progress toward achieving a patient-
centered health care system that delivers better care, smarter
spending, and healthier people and communities.
The Department is focused on three core strategies to drive
continued progress and improvement, and MACRA provides new tools to
that end, which build upon existing efforts, such as the CMS Quality
Strategy \2\. First, we are focused on improving the way clinicians are
paid to incentivize quality and value of care over simply quantity of
services. The Quality Payment Program replaces the SGR update formula
with Medicare PFS updates ultimately linked to participation in
Advanced APMs and also creates a new, sustainable mechanism for
calculating payment adjustments for clinicians' services that links
payments to quality and value: The Merit-based Incentive Payment System
(MIPS), with the ultimate goal of paying for value and better care. By
rewarding eligible clinicians based on their performance, MIPS
consolidates key components of the PQRS, the VM and the Medicare EHR
Incentive Program for EPs into one single, streamlined program based on
performance in the following:
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\2\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/CMS-Quality-Strategy.html.
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Quality.
Resource use.
CPIA.
Advancing care information.
Second, we are focused on improving the way care is delivered by
providing clinical practice support, data and feedback reports to guide
improvement and better decision-making. Allowing for stronger, real-
time, easy-to-understand feedback and actionable data on eligible
clinician performance on clinical quality measures (CQMs), utilization
of resources and cost can lead to stronger care coordination, help
facilitate and enhance team-based approaches, and support greater
integration within practices, improved patient communication, a
stronger focus on population health, and continuous learning and rapid-
cycle improvement.
Third, we are focused on making data more available and enabling
the use of certified EHR technology to support care delivery.
Consistent use of certified EHR technology and clinical quality
measurement in managing patient populations would help lead to
substantial improvements in our health care system, by allowing
clinicians to track and take care of their patients throughout the care
continuum and to easily and securely access electronic health
information to support care when and where it is needed.
By driving significant changes in how care is delivered and changes
in the health care system to make it more responsive to patients and
families, we believe the Quality Payment Programs would encourage
eligible clinicians to be accountable for the health of their patient
population and support interested eligible clinicians in their
successful transition into APMs. To implement this vision, we propose a
program that allows for stronger alignment across requirements while
minimizing burden on eligible clinicians. Further, we propose a program
that is meaningful, understandable and flexible with a critical focus
on transparency, effective communication with stakeholders and
operational feasibility. To aid in this process, we have sought
feedback from the health care community through various public avenues
and will seek comment through this proposed rule. As we establish
policies for effective implementation of the MACRA, we are also focused
on improving the health system by ensuring that our policies can scale
in future years. As we drive change through this proposed rule, we will
begin by laying the groundwork for expansion towards an innovative,
outcome-focused, patient-centered, resource-effective health system.
Through a staged approach we can develop our policies are operationally
feasible and made in consideration of system capabilities and of our
core strategies to drive progress and reform efforts.
A. Physician and Practitioner Payment Under Medicare
1. History
Medicare payment systems have undergone significant changes since
the Act established the Medicare program in 1965. Originally, Medicare
was modeled on the existing health insurance marketplace (See 1965
Medicare Amendment to SSA, Pub. L. 89-97). Medicare payments to
physicians and hospitals were based on the amounts that had been
historically charged by physicians and hospitals for various health
care services. Medicare initially paid for physicians' services using a
``customary, prevailing, and reasonable'' charge (CPR) payment system.
(1965 Medicare Amendment to SSA, Pub. L. 89-97). Congress later changed
the CPR system in part to counter increased charges to physicians,
leading to rapid increases in program payments.
In 1984, Medicare changed the way it paid hospitals to a
prospective payment system (Social Security Amendments of 1983, Pub. L.
98-21) that moved away from a charge-based per diem rate and introduced
the Medicare Economic Index (MEI) to modify physician payment. The MEI
was used to measure the annual increase in practice costs for updating
payment for physicians' services.
Beginning in 1992 following the passage of the Omnibus Budget
Reconciliation Act of 1989 (OBRA 89) (Pub. L. 101-239, enacted on
December 19, 1989), the historical charge-based fee schedule was
replaced with a fee schedule that used a Resource-Based Relative Value
Scale, developed at Harvard University, which attempted to assess for
each service the relative value of a physician's work effort, as well
as the practice expenses and malpractice liability expenses involved.
Under OBRA 89, the resource-based Medicare PFS aimed to establish a
rational basis for valuing payments for physicians' services.
Therefore, under the current resource-based approach, payment for a
service depends on the value of the resources involved in performing a
particular service.
Following the implementation of the resource-based PFS over several
years, the fee schedule has specified Medicare payments for physicians'
services. Each medical, surgical and diagnostic service, described by a
current procedural terminology (CPT) code is assigned relative value
units (RVUs) for three resource categories: Work, practice expense, and
malpractice expense. These three RVU values are summed, geographically
adjusted, and multiplied by a fixed-dollar conversion factor for the
payment year to determine the payment amount for each service or
procedure. Over time, we have reviewed and revised the RVU values using
our own methodologies and other information.
After the adoption of the resource-based PFS, further amendments to
the Act have led to the imposition of spending targets for physicians'
services. Initially, the spending limit was set by a Volume Performance
Standard (VPS) that tied the annual update to a target that was based
on historical trends in physician costs. Because of the way the
adjustment was
[[Page 28167]]
calculated, it produced very unstable updates, with swings that were
much greater than the changes in the underlying MEI.
The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33, enacted on
August 5, 1997) replaced the VPS with the SGR formula to update the PFS
each year. Under BBA, the SGR made several changes including a much
more aggressive measure to control spending, tying the allowable
increases in physician spending to the growth rate in real GDP per
capita. In general, under the SGR formula, if cumulative expenditures
from the current period going back to 1996 (the base year) were less
than the cumulative spending target over that same period, the annual
update was increased according to a statutory formula. However, if
spending exceeded the cumulative spending target over the same period,
the SGR methodology requires reductions in the fee schedule update to
bring spending back in line with the targeted growth rate.
In the initial years of implementation, actual expenditures did not
exceed allowed targets. But beginning in 2002, cumulative actual
expenditures began to exceed allowed targets for the year, resulting in
SGR-mandated reductions in the fee schedule update adjustment factor.
The Congress enacted a series of laws to override these reductions. The
SGR-based update adjustment factor had not been allowed to take effect
since 2003 due to consistent intervention by the Congress to avert
payment reductions.
Currently, payments under the Medicare PFS include several payment
adjustments that increase or decrease payments to practitioners based
on performance. The Tax Relief and Health Care Act of 2006 required the
establishment of the PQRS that would include an incentive payment to
EPs who satisfactorily report data on quality measures. The Medicare
Improvements for Patients and Provider Act of 2008 (MIPPA) (Pub. L.
110-275, enacted on July 15, 2008) made the PQRS program permanent. The
HITECH Act of 2009, part of the American Recovery and Reinvestment Act
(ARRA), established incentive payments to EPs to promote the adoption
and meaningful use of certified EHR technology. HITECH provided the
statutory basis for the Medicare incentive payments made to meaningful
EHR users and also established downward payment adjustments, under
Medicare, beginning with calendar year 2015, for EPs that are not
meaningful users of certified EHR technology for certain associated
reporting periods.
The Affordable Care Act (Pub. L. 111-148) required the
establishment of a value-based payment modifier that provides for
differential payment to a physician or group of physicians under the
Medicare PFS based upon the quality of care furnished compared to cost,
that is implemented in a budget-neutral manner. Beginning in 2015, the
VM applies to payments for items and services furnished by physicians
in groups of 100 or more, and will apply to all physicians and certain
types of non-physician practitioners in later years. The VM is being
phased in and will apply to all physicians in groups and individual
physicians in 2017.
2. Payment Models and Innovation
The policies proposed in this rule are intended to continue to move
Medicare away from a primarily volume based fee-for-service (FFS)
payment system for physicians and other professionals. As described in
this section of the proposed rule, for many years Medicare was
primarily a FFS payment system that paid health care providers based on
the volume of services they delivered, rather than the value of those
services. This contributed to increased costs without incentivizing
improvement in the quality of care. Over time, the Congress and CMS
have taken progressive steps to move toward paying for value, as
demonstrated by Medicare's long history of testing alternative payment
methods.
Medicare has been testing alternative payment methods since waiver
authority for Medicare demonstrations was granted through section 402
of the Social Security Amendments of 1967. Demonstrations and pilot
programs, (also called ``research studies'') are special projects that
test improvements in Medicare coverage, payment, and quality of care
(https://www.medicare.gov/sign-up-change-plans/medicare-health-plans/other-health-plans/other-medicare-health-plans.html). Demonstrations
have examined whether alternative payment methods increase the
efficiency of Medicare and Medicaid and whether payment for services
not otherwise covered increases the effectiveness of care. Medicare's
demonstration authority has allowed it to test the effect of policy
changes on Medicare on a small scale in order to inform broader policy.
The Affordable Care Act includes a number of provisions, for
example, the Medicare Shared Savings Program, designed to improve the
quality of Medicare services, support innovation and the establishment
of new payment models, better align Medicare payments with health care
provider costs, strengthen Medicare program integrity, and put Medicare
on a firmer financial footing.
The Affordable Care Act created the Center for Medicare and
Medicaid Innovation (Innovation Center). The Innovation Center was
established by section 1115A of the Act (as added by section 3021 of
the Affordable Care Act). The Innovation Center's mandate gives it
flexibility within the parameters of section 1115A of the Act to select
and test promising innovative payment and service delivery models.
Congress created the Innovation Center for the purpose of testing
innovative payment and service delivery models to reduce program
expenditures while preserving or enhancing the quality of care provided
to those individuals who receive Medicare, Medicaid, or CHIP benefits.
See https://innovation.cms.gov/about/index.html. Models that have met
those expectations may be expanded in scope through rulemaking up to a
national scale.
To better coordinate these models and demonstration projects and to
avoid duplicative efforts and expenses, the former Office of Research,
Development and Information, which oversaw statutory demonstrations and
those under section 402 etc., was merged with the Innovation Center in
early 2011. As a result, the Innovation Center oversees not only
initiatives that are authorized under section 1115A of the Act, but
also activities under several other authorities, including other
provisions of the Affordable Care Act, and other laws and projects
authorized by section 402 of the Social Security Amendments of 1967, as
amended.
The Innovation Center's portfolio of models has attracted
participation from a broad array of health care providers, states,
payers, and other stakeholders, and serves Medicare, Medicaid, and CHIP
beneficiaries in all 50 states, the District of Columbia, and Puerto
Rico. We estimate that over 4.7 million Medicare, Medicaid, and CHIP
beneficiaries are or soon will be receiving care furnished by the more
than 61,000 eligible clinicians participating in APMs tested by the CMS
Innovation Center.
Beyond the care improvements for these beneficiaries, Innovation
Center models are affecting millions of additional Americans by
engaging thousands of other health care providers, payers, and states
in model tests and through quality improvement efforts across the
country. Many payers other than CMS have implemented alternative
payment arrangements or models, or have collaborated in
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Innovation Center models. The participation of multiple payers in
alternative delivery and payment models increases momentum for delivery
system transformation and encourages efficiency for health care
organizations.
The Innovation Center works directly with other CMS components and
colleagues throughout the federal government in developing and testing
new payment and service delivery models. Other federal agencies with
which the Innovation Center has collaborated include the Centers for
Disease Control and Prevention (CDC), Health Resources and Services
Administration (HRSA), Agency for Healthcare Research and Quality
(AHRQ), Office of the National Coordinator for Health Information
Technology (ONC), Administration for Community Living (ACL), Department
of Housing and Urban Development (HUD), Administration for Children and
Families (ACF), and the Substance Abuse and Mental Health Services
Administration (SAMHSA). These collaborations help the Innovation
Center effectively test new models and execute mandated demonstrations.
B. Current Reporting Programs and Regulations (Overview)
The MACRA's passage has led to several changes with the existing
Medicare PFS, various Medicare payment programs that tie payment to
value, and the testing of alternative payment models. Specifically, the
MACRA's enactment consolidated aspects of certain quality reporting and
performance programs into the new MIPS, including the meaningful use of
certified EHR technology (section 1848(o) of the Act), the PQRS
(section 1848(k) and (m) of the Act, and the VM (section 1848(p) of the
Act). The following section provides an overview of existing programs
and the extent of their programs before and after the MACRA.
Currently, the Medicare EHR Incentive Program has been divided into
three progressive stages of meaningful use with certain specified
requirements that EPs must meet in order to qualify for Medicare EHR
incentive payments and avoid downward payment adjustments. Full
achievement of these requirements designated an EP as a ``meaningful
EHR user'' and made that EP eligible for incentive payments and not
subject to downward payment adjustments. The MACRA's enactment altered
the EHR Incentive Programs such that the existing Medicare payment
adjustment for an EP under 1848(a)(7)(A) of the Act ends after CY 2018.
Using certified EHR technology is included in MIPS as part of the
advancing care information component of the overall performance score.
Generally, the MACRA did not change hospital participation in the
Medicare EHR Incentive Program or participation for EPs in the Medicaid
EHR Incentive Program.
PQRS, as set forth in sections 1848(a), (k), and (m) of the Act, is
a quality reporting program that provides for incentive payments (which
ended in 2014) and payment adjustments (which began in 2015) to 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 EPs and group practices based on
whether they satisfactorily participate in a qualified clinical data
registry (QCDR). The MACRA ends the PQRS adjustment after CY 2018 and
provides for the inclusion of various aspects of PQRS in MIPS as part
of the quality component of the overall performance score.
Section 1848(p) of the Act, as amended by the Affordable Care Act,
required that we establish a VM that provides for differential payment
under the Medicare PFS based upon the quality of care furnished
compared to cost and apply it to specific physicians and groups of
physicians as determined appropriate by the Secretary starting in 2015
and to all physicians by 2017. In the CY 2013 PFS final rule with
comment period (77 FR 69307), we discussed the goals of the VM and also
established the specific principles that should govern the
implementation of the VM. The MACRA sunsets the VM, ending it after CY
2018 and establishing certain aspects of the VM as part of the resource
use component of MIPS in CY 2019.
C. Overview of Section 101 of the MACRA
Section 101 of the MACRA amended sections 1848(d) and (f) of the
Act to repeal the SGR formula for updating Medicare PFS payment rates
and substituted a series of specified annual update percentages.
Section 101 goes on to establish a new methodology that ties annual PFS
payment adjustments to value for MIPS eligible clinicians. Section 101
also creates an incentive program to encourage participation by
eligible clinicians in Advanced APMs.
Section 1848(q) of the Act, as added by section 101(c) of the
MACRA, requires establishment of the MIPS, applicable beginning with
payments for items and services furnished on or after January 1, 2019,
under which the Secretary is required to: (1) Develop a methodology for
assessing the total performance of each MIPS eligible clinician
according to performance standards for a performance period for a year;
(2) using the methodology, provide a CPS for each MIPS eligible
clinician for each performance period; and (3) use the CPS of the MIPS
eligible clinician 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 MIPS eligible clinician for the year. Under
section 1848(q)(2)(A) of the Act, a MIPS eligible clinician's CPS is
determined using four performance categories: (1) Quality; (2) resource
use; (3) CPIA; and (4) advancing care information. Section 1848(q)(10)
of the Act requires the Secretary to consult with stakeholders (through
a request for information (RFI) or other appropriate means) in carrying
out the MIPS, including for the identification of measures and
activities for each of the four performance categories under the MIPS,
the methodology to assess each MIPS eligible clinician's total
performance to determine their MIPS CPS, the methodology to specify the
MIPS adjustment factor for each MIPS eligible clinician for a year, and
the use of QCDRs for purposes of the MIPS.
Section 1848(q)(11) of the Act, as added by section 101(c) of the
MACRA, provides for technical assistance to MIPS eligible clinicians in
small practices, rural areas, and practices located in geographic
health professional shortage areas (HPSAs). In general, the section
requires the Secretary to enter into contracts or agreements with
appropriate entities (such as quality improvement organizations,
regional extension centers (as described in section 3012(c) of the
Public Health Service (PHS) Act), or regional health collaboratives)
(such as those identified in section 1115A of the Act) to offer
guidance and assistance to MIPS eligible clinicians in practices of 15
or fewer eligible clinicians. Priority is to be given to such practices
located in rural areas which we propose to define at Sec. 414.1305 to
include clinicians in counties designated as Micropolitan or Non-Core
Based Statistical Areas (CBSAs), using HRSA's 2014-2015 Area Health
Resource File (http://datawarehouse.hrsa.gov/data/datadownload/ahrfdownload.aspx), HPSAs (as designated under section 332(a)(1)(A) of
the PHS Act), medically underserved areas (MUAs), and practices with
low composite scores, for the MIPS performance categories or in
transitioning to the implementation of,
[[Page 28169]]
and participation in, an APM. Details regarding the technical
assistance program are outside the scope of this proposed rule, and
will be addressed in separate guidance.
Section 101(e) of the MACRA encourages participation in APMs by
eligible clinicians and other eligible clinicians, and promotes the
development of PFPMs by creating the PTAC. Specifically, this section:
(1) Creates a payment incentive that applies to eligible clinicians
from 2019 through 2024 who are Qualifying APM Participants (QPs) during
the respective performance years, and provides for a higher fee
schedule update for eligible clinicians who are QPs for a year
beginning in 2026; (2) requires the establishment of a process for
stakeholders to propose PFPMs to an independent PTAC that will review,
comment on, and provide recommendations to the Secretary on the
proposed PFPMs; and (3) requires CMS to establish criteria for PFPMs
for use by the PTAC in making comments and recommendations to the
Secretary. Additionally, section 101(c)(1) of the MACRA exempts QPs
from payment adjustments under MIPS.
D. Stakeholder Input
In developing this proposed rule, in accordance with the law, we
have sought feedback from stakeholders throughout the process such as
in the 2016 Medicare PFS Proposed Rule; the Request for Information
Regarding Implementation of the Merit-Based Incentive Payment System,
Promotion of Alternative Payment Models, and Incentive Payments for
Participation in Eligible Alternative Payment Models (hereafter
referred to as the MIPS and APMs RFI); listening sessions;
conversations with a wide number of stakeholders; and conversations
with tribes and tribal officials through CMS' Tribal Technical Advisory
Group. In addition, we note that the National Indian Health Board has
requested an opportunity for consultation with CMS, as well as that we
coordinate its standards with the Indian Health Service. Through the
MIPS and APMs RFI published in the Federal Register on October 1, 2015
(80 FR 59102, 59102-59113), the Secretary of Health and Human Services
(the Secretary) solicited comments regarding implementation of certain
aspects of the MIPS and broadly sought public comments on the topics in
section 101 of the MACRA, including the incentive payments for
participation in APMs and increasing transparency of PFPMs. We received
a high number of public comments in response to the MIPS and APMs RFI
from a broad range of sources including professional associations and
societies, physician practices, hospitals, patient groups, and health
IT vendors.
We appreciate the high level of interest expressed by commenters
and acknowledge their valued input throughout this proposed rule,
providing summaries of RFI comments in relevant sections of this rule.
In general, commenters supported the passage of regulations
implementing the MACRA and maintain optimism as we move from fee-for-
service Medicare payment towards an enhanced focus on the quality and
value of care. Public support for the MACRA focuses on the potential of
a value-based program to provide enough flexibility to be applied
meaningfully to physician practices and patient quality of care.
Commenters cautioned us to avoid elements of prior reporting programs
that have been perceived as too focused on the volume of measures
reported rather than measure relevance and impact on treatment.
Commenters also requested that we avoid implementing additional
requirements on top of the fee-for-service system, which would increase
the reporting and compliance burden for eligible clinicians. Commenters
believe the underlying goal in establishing the MACRA should be to
create a new program that combines a limited (yet meaningful) set of
requirements with choices for health care providers on how to meet
those requirements. Commenters requested that there be broad
opportunities to participate in APMs and the development of new
Advanced APMs, and that resources be made available to assist them in
moving towards participation in APMs if they do not already
participate. Commenters expressed eagerness to participate in Advanced
APMs and to be a part of transforming care.
Once again, we thank stakeholders for their considered responses
through various venues including comments to the MIPS and APMs RFI. We
intend to continue open communication with stakeholders (including
consultation with tribes and tribal officials) on an ongoing basis, and
we look forward to comments on the policies proposed in this rule.
II. Provisions of the Proposed Regulations
A. Establishing MIPS and the APM Incentive
Section 1848(q) of the Act, as added by section 101(c) of the
MACRA, requires establishment of the MIPS (see section I.C. of this
proposed rule for additional background information). Section 101(e) of
the MACRA promotes the development of, and participation in, APMs for
eligible clinicians (see section I.C. of this proposed rule for
additional background information). Further information will be
provided in future rulemaking.
B. Program Principles and Goals
Through the MACRA amendments, we believe the Congress sets broad
goals to be accomplished intended to improve care and health outcomes
for every American. More specifically, our goal with the Quality
Payment Program is to continue to support health care quality,
efficiency, and patient safety. MIPS promotes better care, healthier
people, and smarter spending by evaluating MIPS eligible clinicians
using a CPS that incorporates MIPS eligible clinicians' performance on
quality, resource use, clinical practice improvement activities, and
advancing care information. Under the incentives for participation in
Advanced APMs, our goals, described in greater detail in section II.F.
of this proposed rule, are to expand the opportunities for
participation in APMs, maximize participation in current and future
Advanced APMs, create clear and attainable standards for incentives,
promote the continued flexibility in the design of APMs, and support
multi-payer initiatives across the health care market. The Quality
Payment Program will encourage more MIPS eligible clinicians to
participate in Advanced APMs, which link quality and value to payment.
The APM Incentive Payment for eligible clinicians who qualify as QPs
will only be available through Advanced APMs, but it is a powerful
incentive to increase participation in those APMs. MIPS eligible
clinicians participating in APMs (who do not qualify as QPs) will
receive favorable scoring under certain MIPS categories.
Our strategic goals in developing the Quality Payment Program
include: (1) Design a patient-centered approach to program development
that leads to better, smarter, and healthier care; (2) develop a
program that is meaningful, understandable, and flexible for
participating clinicians; (3) design incentives that drive delivery
system reform principles and participation in APMs; and (4) ensure
close attention to CMS' excellence in implementation, effective
communication with stakeholders and operational feasibility.
[[Page 28170]]
C. Changes to Existing Programs
1. Sunsetting of Current Payment Adjustment Programs
Section 101(b) of the MACRA calls for the sunsetting of payment
adjustments under three existing programs for Medicare enrolled
physicians and other practitioners:
The PQRS that incentivizes EPs to report on quality
measures;
The VM that provides for budget neutral, differential
payment adjustment for EPs in physician groups and solo practices based
on quality of care compared to cost; and
The Medicare EHR Incentive Program for EPs that entails
meeting certain requirements for the use of certified EHR technology.
Accordingly, we propose to revise certain regulations associated
with these programs. We are not proposing to delete these regulations
entirely, as the final payment adjustments under these programs will
not occur until the end of 2018. For PQRS, we propose to revise Sec.
414.90(e) introductory text and Sec. 414.90(e)(1)(ii) to continue
payment adjustments through 2018.
Similarly, we are proposing to amend the regulation text at Sec.
495.102(d) to remove references to the payment adjustment percentage
for years after the 2018 payment adjustment year and add a terminal
limit of the 2018 payment adjustment year.
We are not proposing changes to 42 CFR part 414 subpart N--Value-
Based Payment Modifier Under the PFS (Sec. 414.1200-1285), at this
time. These regulations are already limited to certain years.
We invite comments on these proposed regulatory changes.
2. Meaningful Use Prevention of Information Blocking and Surveillance
Demonstrations for MIPS Eligible Clinicians, EPs, Eligible Hospitals,
and CAHs
a. Cooperation With Surveillance and Direct Review of Certified EHR
Technology
We are proposing to require EPs, eligible hospitals, and CAHs to
attest (as part of their demonstration of meaningful use under the
Medicare and Medicaid EHR Incentive Programs) that they have cooperated
with the surveillance of certified EHR technology under the ONC Health
IT Certification Program, as authorized by 45 CFR part 170, subpart E.
Similarly, we are proposing to require such an attestation from all
eligible clinicians under the advancing care information performance
category of MIPS, including eligible clinicians who report on the
advancing care information performance category as part of an APM
Entity group under the APM Scoring Standard, as discussed in section
II.E.5.h of this proposed rule.
On October 16, 2015, ONC published the 2015 Edition Health
Information Technology (Health IT) Certification Criteria, 2015 Edition
Base Electronic Health Record (EHR) Definition, and ONC Health IT
Certification Program Modifications final rule (``2015 Edition final
rule''). The final rule made changes to the ONC Health IT Certification
Program that strengthen the testing, certification, and surveillance of
health IT. In addition, the final rule clarified and expanded the
responsibilities of ONC-Authorized Certification Bodies (ONC-ACBs) with
respect to the surveillance of certified EHR technology and other
health IT certified under the ONC Health IT Certification Program,
including requirements for ONC-ACBs to conduct more frequent and more
rigorous surveillance of certified technology and capabilities ``in the
field'' (80 FR 62707). The purpose of in-the-field surveillance is to
provide greater assurance that health IT meets certification
requirements not only in a controlled testing environment but also when
used by health care providers in actual production environments (80 FR
62707).
In addition to these changes, on March 2, 2016, ONC published the
ONC Health IT Certification Program: Enhanced Oversight and
Accountability proposed rule, which would expand ONC's role to
strengthen oversight under the ONC Health IT Certification Program by
providing a means for ONC to directly review and evaluate the
performance of certified health IT in certain circumstances, such as in
response to potential systemic or widespread issues, or in response to
problems or issues that could pose a risk to public health or safety,
compromise the security or privacy of patients' health information, or
give rise to other exigencies (81 FR 11055).
These efforts to strengthen surveillance and other oversight of
certified health IT, including through expanded in-the-field
surveillance and ONC direct review of technology and capabilities, are
critical to the success of HHS programs and initiatives that require
the use of certified health IT to improve health care quality and the
efficient delivery of care. With respect to the use of certified EHR
technology under the Medicare and Medicaid EHR Incentive Programs and
the MIPS Program, effective surveillance and oversight is fundamental
to providing basic confidence that such technology consistently meets
applicable standards, implementation specifications, and certification
criteria adopted by the Secretary when it is used by eligible
clinicians, EPs, eligible hospitals, and CAHs, as well as by other
persons with whom eligible clinicians, EPs, eligible hospitals, and
CAHs need to exchange electronic health information to comply with
program requirements. The need to ensure that technology consistently
meets applicable standards, implementation specifications, and
certification criteria is important both at the time it is certified
and on an ongoing basis when it is implemented and used in the field by
eligible clinicians, EPs, eligible hospitals, and CAHs in order to meet
objectives and measures under the Medicare and Medicaid EHR Incentive
Program or MIPS. Efforts to strengthen surveillance and oversight of
certified EHR technology in the field will become even more important
as the types and capabilities of certified EHR technology continue to
evolve and with the onset of Stage 3 of the Medicare and Medicaid EHR
Incentive Programs and MIPS, which include heightened requirements for
sharing electronic health information with other providers and with
patients using a broad range of certified EHR technology and other
health IT.\3\ Finally, we note that effective surveillance and
oversight of certified EHR technology is necessary if eligible
clinicians, EPs, eligible hospitals, and CAHs are to be able to rely on
certifications issued under the ONC Health IT Certification Program as
the basis for selecting appropriate technologies and capabilities that
support the use of certified EHR technology while avoiding potential
implementation and performance issues.
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\3\ For example, EPs, eligible hospitals, and CAHs may meet the
Stage 3 measure for care coordination (42 CFR 495.24(d)(6)) by
providing patients with access to their health information through
the use of an API that can be used by applications chosen by the
patient and configured to the API in the provider's CEHRT. As
another example, EPs, eligible hospitals, and CAHs must satisfy
measures for health information exchange (Sec. 495.24(d)(7)) that
require receiving and incorporating health information from other
certified EHR technology.
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For all of these reasons, the effective surveillance and oversight
of certified health IT, and certified EHR technology in particular, is
necessary to enable eligible clinicians, EPs, eligible hospitals, and
CAHs to demonstrate that they are using certified EHR technology in a
meaningful manner as required by sections 1848(o)(2)(A)(i) and
1886(n)(3)(A)(i) of the Act. Yet as ONC observed in the 2015 Edition
final rule, such surveillance and oversight will not be effective
unless EPs, eligible hospitals, and CAHs are actively
[[Page 28171]]
engaged and cooperate with the authorized surveillance and oversight of
their technology, including by granting access to and assisting ONC and
ONC-ACBs to observe the performance of production systems (80 FR
62716).
Accordingly, we are proposing that as part of demonstrating that it
is using certified EHR technology in a meaningful manner, an eligible
clinician, EP, eligible hospital, or CAH must demonstrate its
cooperation with these authorized surveillance and oversight
activities. We are proposing to revise the definition of a meaningful
EHR user at Sec. 495.4, as well as the attestation requirements at
Sec. 495.40(a)(2)(i)(H) and Sec. 495.40(b)(2)(i)(H) to require EPs,
eligible hospitals, and CAHs to attest their cooperation with certain
authorized health IT surveillance and direct review activities,
described in more detail in this section of the rule, as part of
demonstrating meaningful use under the Medicare and Medicaid EHR
Incentive Programs. Similarly, we are proposing to include an identical
attestation requirement in the submission requirements for eligible
clinicians under the advancing care information performance category
proposed at Sec. 414.1375.
We propose that eligible clinicians, EPs, eligible hospitals, and
CAHs would be required to attest that they have cooperated in good
faith with the surveillance and ONC direct review of their health IT
certified under the ONC Health IT Certification Program, as authorized
by 45 CFR part 170, subpart E, to the extent that such technology meets
(or can be used to meet) the definition of CEHRT. Under the terms of
the attestation, such cooperation would include responding in a timely
manner and in good faith to requests for information (for example,
telephone inquiries, written surveys) about the performance of the
certified EHR technology capabilities in use by the provider in the
field. The provider's cooperation would also include accommodating
requests (from ONC-Authorized Certification Bodies or from ONC) for
access to the provider's certified EHR technology (and data stored in
such certified EHR technology) as deployed by the provider in its
production environment, for the purpose of carrying out authorized
surveillance or direct review, and to demonstrate capabilities and
other aspects of the technology that are the focus of such efforts, to
the extent that doing so would not compromise patient care or be unduly
burdensome for the eligible clinician, EP, eligible hospital, or CAH.
We understand that cooperating with in-the-field surveillance may
require prioritizing limited time and other resources. We note that ONC
has established safeguards to minimize the burden of surveillance on
eligible clinicians, EPs, eligible hospitals, and CAHs. In conducting
randomized surveillance, ONC-ACBs must use consistent, objective,
valid, and reliable methods to select the locations at which the
surveillance will be performed (80 FR 62715). ONC-ACBs may also use
appropriate sampling methodologies to minimize disruption to any
individual provider or class of providers and to maximize the value and
impact of surveillance activities for all providers and stakeholders
(80 FR 62715). Moreover, if an ONC-ACB makes a good faith effort but is
unable to complete in-the-field surveillance at a particular location,
it may exclude the location and substitute a different location for
surveillance (80 FR 62716).
In addition, we note that ONC has clarified, in consultation with
the Office for Civil Rights, that ONC-ACBs engaging in authorized
surveillance of certified EHR technology under the ONC Health IT
Certification Program meet the definition of a ``health oversight
agency'' in the HIPAA Privacy Rule (45 CFR 164.501), and as such a
health care provider is permitted to disclose protected health
information (PHI) (without patient authorization and without a business
associate agreement) to an ONC-ACB during the limited time and as
necessary for the ONC-ACB to perform the required on-site surveillance
of the certified EHR technology (45 CFR 164.512(d)(1)(iii)) (80 FR
62716).\4\
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\4\ See also ONC Regulation FAQ #45 [12-13-045-1], available at
http://www.healthit.gov/policy-researchers-implementers/45-question-12-13-045.
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For the foregoing reasons, we believe this proposal will support
the surveillance and oversight of certified health IT, as necessary to
support meaningful use of CEHRT for all eligible clinicians under the
MIPS program, as well as EPs, eligible hospitals and CAHs under the
Medicare and Medicaid EHR Incentive Programs, while ensuring that such
surveillance or review does not create unnecessary or unreasonable
burdens for health care providers or patients. We request public
comment on this proposal.
b. Support for Health Information Exchange and the Prevention of
Information Blocking
To prevent actions that block the exchange of information, section
106(b)(2)(A) of the MACRA amended section 1848(o)(2)(A)(ii) of the Act
to require that, to be a meaningful EHR user, an EP must demonstrate
that he or she has not knowingly and willfully taken action (such as to
disable functionality) to limit or restrict the compatibility or
interoperability of certified EHR technology. Section 106(b)(2)(B) of
MACRA made corresponding amendments to section 1886(n)(3)(A)(ii) of the
Act for eligible hospitals and, by extension, under section 1814(l)(3)
of the Act for CAHs. Sections 106(b)(2)(A) and (B) of the MACRA provide
that the manner of this demonstration is to be through a process
specified by the Secretary, such as the use of an attestation. Section
106(b)(2)(C) of the MACRA states that the demonstration requirements in
these amendments shall apply to meaningful EHR users as of the date
that is 1 year after the date of enactment, which would be April 16,
2016.
On December 16, 2014, in an explanatory statement accompanying the
Consolidated and Further Continuing Appropriations Act,\5\ Congress
urged ONC to take steps to decertify products that proactively block
the sharing of information because those practices frustrate
congressional intent, devalue taxpayer investments in certified EHR
technology, and make certified EHR technology less valuable and more
burdensome for eligible hospitals and eligible health care providers to
use.\6\ Congress also asked for a detailed report on health information
blocking, which ONC delivered on April 10, 2015. In the report, and
based on the available evidence and its own experience, ONC found that
some persons and entities--including some health care providers--are
knowingly and unreasonably interfering with the exchange or use of
electronic health information in ways that limit its availability and
use to improve health and health care.\7\
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\5\ Pub. L. 113-235.
\6\ 160 Cong. Rec. H9047, H9839 (daily ed. Dec. 11, 2014)
(explanatory statement submitted by Rep. Rogers, chairman of the
House Committee on Appropriations, regarding the Consolidated and
Further Continuing Appropriations Act, 2015).
\7\ ONC, Report to Congress on Health Information Blocking
(April 10, 2015), available at https://www.healthit.gov/sites/default/files/reports/info_blocking_040915.pdf.
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Following these activities, on April 16, 2015, the MACRA was
enacted, including section 106(b)(2), which amended sections
1848(o)(2)(A)(ii) and 1886(n)(3)(A)(ii) of the Act, as discussed in
this section of the rule. Prior to these amendments, to be treated as a
meaningful EHR user, an EP, eligible hospital, or CAH had to
demonstrate to
[[Page 28172]]
the satisfaction of the Secretary that its certified EHR technology was
connected during the relevant EHR reporting period in a manner that
provided, in accordance with law and standards applicable to the
exchange of information, for the electronic exchange of health
information to improve the quality of health care, such as promoting
care coordination. As amended, respectively, by sections 106(b)(2)(A)
and (B) of the MACRA, sections 1848(o)(2)(A)(ii) and 1886(n)(3)(A)(ii)
of the Act now require that, in addition to demonstrating such
connectivity, an eligible clinician, EP, eligible hospital, or CAH must
also demonstrate that it did not knowingly and willfully take action to
limit or restrict the compatibility or interoperability of the
certified EHR technology.
We believe that, at a minimum, such a demonstration would need to
provide substantial assurance not only that the certified EHR
technology was connected in accordance with applicable standards during
the relevant EHR reporting period, but that the eligible clinician, EP,
eligible hospital, or CAH acted in good faith to implement and use the
certified EHR technology in a manner that supported and did not
interfere with the electronic exchange of health information among
health care providers and with patients to improve quality and promote
care coordination. Accordingly, we are proposing that such a
demonstration be made through an attestation comprising three
statements related to health information exchange and information
blocking, which are set forth in our proposal in this rule. We are
proposing to revise the definition of a meaningful EHR user at Sec.
495.4 and the attestation requirements at Sec. 495.40(a)(2)(i)(I) and
Sec. 495.40(b)(2)(i)(I) to provide that, for attestations submitted on
or after April 16, 2016, an EP, eligible hospital, or CAH under the
Medicare and Medicaid EHR Incentive Programs must attest to this three-
part attestation. For the same reasons stated in this section of the
rule, we are also proposing to require such an attestation from all
eligible clinicians under the advancing care information performance
category of MIPS, including eligible clinicians who report on the
advancing care information performance category as part of an APM
Entity group under the APM Scoring Standard, as discussed in section
II.E.5.h of this proposed rule. As noted in this section, the
attestation we are proposing would consist of three statements related
to health information exchange and information blocking. First, the
eligible clinician, EP, eligible hospital, or CAH would be required to
attest that it did not knowingly and willfully take action (such as to
disable functionality) to limit or restrict the compatibility or
interoperability of certified EHR technology.
Second, the eligible clinician, EP, eligible hospital, or CAH would
be required to attest that it implemented technologies, standards,
policies, practices, and agreements reasonably calculated to ensure, to
the greatest extent practicable and permitted by law, that the
certified EHR technology was, at all relevant times: connected in
accordance with applicable law; compliant with all standards applicable
to the exchange of information, including the standards, implementation
specifications, and certification criteria adopted at 45 CFR part 170;
implemented in a manner that allowed for timely access by patients to
their electronic health information; (including the ability to view,
download, and transmit this information) and implemented in a manner
that allowed for the timely, secure, and trusted bi-directional
exchange of structured electronic health information with other health
care providers (as defined by 42 U.S.C. 300jj(3)), including
unaffiliated providers, and with disparate certified EHR technology and
vendors.
Third, the eligible clinician, EP, eligible hospital, or CAH would
be required to attest that it responded in good faith and in a timely
manner to requests to retrieve or exchange electronic health
information, including from patients, health care providers (as defined
by 42 U.S.C. 300jj(3)), and other persons, regardless of the
requestor's affiliation or technology vendor. We invite public comment
on this proposal, including whether the foregoing statements could
provide the Secretary with adequate assurances that an eligible
clinician, EP, eligible hospital, or CAH has complied with the
statutory requirements for information exchange. We also encourage
public comment on whether there are additional facts or circumstances
to which eligible clinicians, EPs, eligible hospitals, or CAHs should
be required to attest, or whether there is additional information that
they should be required to report.
D. Definitions
At Sec. 414.1305, subpart O, we are proposing definitions for the
following terms:
Additional performance threshold.
Advanced Alternative Payment Model (Advanced APM).
Advanced APM Entity.
Affiliated practitioner.
Alternative Payment Model (APM).
APM Entity.
APM Entity group.
APM Incentive Payment.
Attestation.
Attributed beneficiary.
Attribution-eligible beneficiary.
Certified Electronic Health Record Technology (CEHRT).
Clinical Practice Improvement Activity (CPIA).
CMS-approved survey vendor.
CMS Web Interface.
Composite performance score (CPS).
Covered professional services.
Eligible clinician.
Episode payment model.
Estimated aggregate payment amounts.
Group.
Health professional shortage areas (HPSA).
High priority measure.
Hospital-based MIPS eligible clinician.
Incentive payment base period.
Low-volume threshold.
Meaningful EHR user for MIPS.
Measure benchmark.
Medicaid APM.
Medical Home Model.
Medicaid Medical Home Model.
Merit-Based Incentive Payment System (MIPS).
MIPS APM.
MIPS Payment Year.
MIPS eligible clinician.
MIPS payment year.
New Medicare-Enrolled MIPS eligible clinician.
Non-patient-facing MIPS eligible clinician.
Other Payer Advanced APM.
Partial Qualifying APM Participant (Partial QP).
Partial QP patient count threshold.
Partial QP payment amount threshold.
Participation List.
Performance category score.
Performance standards.
Performance threshold.
Qualified Clinical Data Registry (QCDR).
Qualified registry.
QP patient count threshold.
QP payment amount threshold.
QP Performance Period.
Qualifying APM Participant (QP).
Rural areas.
Small practices.
Threshold Score.
Topped out measure.
Some of these terms are new in conjunction with MIPS and APMs,
while others are used in existing CMS programs. For the new proposed
terms and definitions, we note that some of
[[Page 28173]]
them have been developed alongside proposed policies of this regulation
while others are defined by statute. Specifically, the following terms
and definitions were established by the MACRA: APM, CPIA, Eligible
Alternative Payment Entity (which we have termed Advanced APM Entity),
Eligible professional or EP (which we have termed eligible clinician),
MIPS Eligible professional or MIPS EP (which we have termed MIPS
eligible clinicians), Qualifying APM Participant, and Partial
Qualifying APM Participant.
We invite public comments on all of these proposed terms and
definitions, and discuss most of them in detail in relevant sections of
this preamble.
E. MIPS Program Details
1. MIPS Eligible Clinicians
We believe a successful MIPS program fully equips clinicians
identified as MIPS eligible clinicians with the tools and incentives to
focus on improving health care quality, efficiency, and patient safety
for all their patients. Under MIPS, MIPS eligible clinicians are
incentivized to engage in proven improvement measures and activities
that impact patient health and safety and are relevant for their
patient population. One of our strategic goals in developing the MIPS
program is to advance a program that is meaningful, understandable, and
flexible for participating MIPS eligible clinicians. One way we believe
this will be accomplished is by minimizing MIPS eligible clinicians'
burden. We have made an effort to focus on policies that remove as much
administrative burden as possible from MIPS eligible clinicians and
their practices while still providing meaningful incentives for high-
quality, efficient care. In addition, we hope to balance practice
diversity with flexibility to address varied MIPS eligible clinicians'
practices. Examples of this flexibility include special consideration
for non-patient-facing MIPS eligible clinicians, an exclusion from MIPS
for eligible clinicians who do not exceed the low-volume threshold, and
other proposals discussed below.
a. Definition of a MIPS Eligible Clinician
Section 1848(q)(1)(C)(i) of the Act, as added by section 101(c)(1)
of the MACRA, outlines the general definition of a MIPS eligible
clinician for the MIPS program. Specifically, for the first and second
year for which MIPS applies to payments (and the performance period for
such years) a MIPS eligible clinician is defined as a physician (as
defined in section 1861(r) of the Act), a physician assistant, nurse
practitioner, and clinical nurse specialist (as such terms are defined
in section 1861(aa)(5) of the Act), a certified registered nurse
anesthetist (as defined in section 1861(bb)(2) of the Act), and a group
that includes such professionals. The statute also provides flexibility
to specify additional eligible clinicians (as defined in section
1848(k)(3)(B) of the Act) as MIPS eligible clinicians in the third and
subsequent years of MIPS. As discussed in section II.E.3. of this
proposed rule, section 1848(q)(1)(C)(ii) and (v) of the Act specifies
several exclusions from the definition of a MIPS eligible clinician. In
addition, section 1848(q)(1)(A) of the Act requires the Secretary to
permit any eligible clinician (as defined in section 1848(k)(3)(B) of
the Act) who is not a MIPS eligible clinician the option to volunteer
to report on applicable measures and activities under MIPS. Section
1848(q)(1)(C)(vi) of the Act clarifies that a MIPS adjustment factor
(or additional MIPS adjustment factor) will not be applied to an
individual who is not a MIPS eligible clinician for a year, even if
such individual voluntarily reports measures under MIPS.
To implement the MIPS program we must first establish and define a
MIPS eligible clinician in accordance with the statutory definition. We
propose to define a MIPS eligible clinician at Sec. 414.1305 as a
physician (as defined in section 1861(r) of the Act), a physician
assistant, nurse practitioner, and clinical nurse specialist (as such
terms are defined in section 1861(aa)(5) of the Act), a certified
registered nurse anesthetist (as defined in section 1861(bb)(2) of the
Act), and a group that includes such professionals. In addition, we
propose that Qualifying APM Participants, Partial Qualifying APM
Participants who do not report data under MIPS, low-volume threshold
eligible clinicians, and new Medicare-enrolled eligible clinicians as
defined at Sec. 414.1305 would be excluded from this definition per
the statutory exclusions defined in section 1848(q)(1)(C)(ii) and (v)
of the Act. We intend to consider using our authority under section
1848(q)(1)(C)(i)(II) of the Act to expand the definition of MIPS
eligible clinician to include additional eligible clinicians (as
defined in section 1848(k)(3)(B) of the Act) through rulemaking in
future years.
In addition, in accordance with section 1848(q)(1)(A) and
(q)(1)(C)(vi) of the Act, we propose to allow eligible clinicians who
are not MIPS eligible clinicians as defined at proposed Sec. 414.1305
the option to voluntarily report measures and activities for MIPS. We
propose at Sec. 414.1310(d) that those eligible clinicians who are not
MIPS eligible clinicians, but who voluntarily report on applicable
measures and activities specified under MIPS, would not receive an
adjustment under MIPS; however, they will have the opportunity to gain
experience in the MIPS program. We are particularly interested in
public comment regarding the feasibility and advisability of voluntary
reporting in the MIPS program for entities such as Rural Health Clinics
(RHCs) and/or Federally Qualified Health Centers (FQHCs), including
comments regarding the specific technical issues associated with
reporting that are unique to these health care providers. We anticipate
some eligible clinicians that will not be MIPS eligible clinicians
during the first 2 years of MIPS, such as physical and occupational
therapists, clinical social workers, and others that have been
reporting quality measures under the PQRS for a number of years, will
want to have the ability to continue to report and gain experience
under MIPS. We request comments on these proposals.
b. Non-Patient-Facing MIPS Eligible Clinicians
Section 1848(q)(2)(C)(iv) of the Act requires the Secretary, in
specifying measures and activities for a performance category, to give
consideration to the circumstances of professional types (or
subcategories of those types determined by practice characteristics)
who typically furnish services that do not involve face-to-face
interaction with a patient. To the extent feasible and appropriate, the
Secretary may take those circumstances into account and apply
alternative measures or activities that fulfill the goals of the
applicable performance category to such non-patient-facing MIPS
eligible clinicians. In carrying out these provisions, we are required
to consult with non-patient-facing MIPS eligible clinicians.
In addition, section 1848(q)(5)(F) of the Act allows the Secretary
to re-weight MIPS performance categories if there are not sufficient
measures and activities applicable and available to each type of MIPS
eligible clinician. We assume many non-patient-facing MIPS eligible
clinicians will not have sufficient measures and activities applicable
and available to report under the performance categories under MIPS. We
refer readers to section II.E.6. of this proposed rule to discuss how
we address performance categories weighting for MIPS eligible
clinicians for whom no measures exist in a given category.
[[Page 28174]]
To establish policies surrounding non-patient-facing MIPS eligible
clinicians, we must first define the term ``non-patient-facing.''
Currently, the PQRS, VM, and Medicare EHR Incentive Program include two
existing policies for considering whether an EP is providing patient-
facing services. To determine, for purposes of PQRS, whether an EP had
a ``face-to-face'' encounter with Medicare patients, we assess 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. Under PQRS, if an EP
bills for at least one service under the PFS during the performance
period that is associated with face-to-face encounters and reports
quality measures via claims or registries, then the EP is required to
report at least one ``cross-cutting'' measure. EPs who do not meet
these criteria are not required to report a cross-cutting measure. For
the purposes of PQRS, telehealth services have not historically been
included in the definition of face-to-face encounters. For more
information, please see the CY 2016 PFS final rule for these
discussions (80 FR 71140).
In the Stage 2 final rule (77 FR 54098 through 54099), the Medicare
EHR Incentive Program established a significant hardship exception from
the meaningful use payment adjustment under section 1848(a)(7)(A) of
the Act for EPs that lack face-to-face interactions with patients and
those who lack the need to follow-up with patients. EPs with a primary
specialty of anesthesiology, pathology or radiology listed in the
Provider Enrollment, Chain, and Ownership System (PECOS) as of 6 months
prior to the first day of the payment adjustment year automatically
receive this hardship exemption (77 FR 54100). Codes associated with
these specialties include 05 Anesthesiology, 22 Pathology, 30
Diagnostic Radiology, 36 Nuclear Medicine, 94 Interventional Radiology.
EPs with a different specialty are also able to request this hardship
exception through the hardship application process. However, telehealth
services could be counted by EPs who choose to include these services
within the definition of ``seen by the EP'' for the purposes of
calculating patient encounters with the EHR Incentive Program (77 FR
53982).
In the MIPS and APMs RFI, we sought comments on MIPS eligible
clinicians that should be considered non-patient-facing MIPS eligible
clinicians and the criteria we should use to identify these MIPS
eligible clinicians. Commenters were split when it came to defining and
identifying non-patient-facing MIPS eligible clinicians. Many took a
specialty-driven approach. Commenters generally did not support use of
enrollment specialty codes alone, which is the approach used by the
Medicare EHR Incentive Program. Commenters indicated that these codes
do not necessarily delineate between the same specialists who may or
may not have patient-facing interaction. One example is cardiologists
who specialize in cardiovascular imaging which is also coded as
cardiology. On the other hand, as one commenter mentioned, physicians
with enrollment specialty codes other than ``cardiology'' (for example,
internal medicine) may perform cardiovascular imaging services.
Therefore, using the enrollment specialty code for cardiology to
identify clinicians who typically do not provide patient-facing
services would be both over-inclusive and under-inclusive. Other
commenters identified specialty types that they believe should be
considered non-patient-facing MIPS eligible clinicians. Specific
specialty types included radiologists, anesthesiologists, nuclear
cardiology or nuclear medicine physicians, and pathologists. Others
pointed out that certain MIPS eligible clinicians may be primarily non-
patient-facing MIPS eligible clinicians even though they practice
within a traditionally patient-facing specialty. The MIPS and APMs RFI
comments and listening sessions with medical societies representing
non-patient-facing MIPS eligible clinicians specified radiology/
imaging, anesthesiology, nuclear cardiology and oncology, and pathology
as inclusive of non-patient-facing MIPS eligible clinicians. Commenters
noted that roles within specific types of specialties may need to be
further delineated between patient-facing and non-patient-facing MIPS
eligible clinicians. An illustrative list of specific types of
clinicians within the non-patient-facing spectrum include:
Pathologists who may be primarily dedicated to working
with local hospitals to identify early indicators related to evolving
infectious diseases;
Radiologists who primarily provide consultative support
back to a referring physician or provide image interpretation and
diagnosis versus therapy;
Nuclear medicine physicians who play an indirect role in
patient care, for example as a consultant to another physician in
proper dose administration; or
Anesthesiologists who are primarily providing supervision
oversight to Certified Registered Nurse Anesthetists.
Some commenters believed that MIPS eligible clinicians should be
defined as non-patient-facing MIPS eligible clinicians based on whether
their billing indicates they provide face-to-face services. Commenters
indicated that the use of specific HCPCS codes in combination with
enrollment specialty codes, may be a more appropriate way to identify
MIPS eligible clinicians that have no patient interaction.
After reviewing current policies, we propose to define a non-
patient-facing MIPS eligible clinicians for MIPS at Sec. 414.1305 as
an individual MIPS eligible clinician or group that bills 25 or fewer
patient-facing encounters during a performance period. We consider a
patient-facing encounter as an instance in which the MIPS eligible
clinician or group billed for services such as general office visits,
outpatient visits, and surgical procedure codes under the PFS. We
intend to publish the proposed list of patient-facing encounter codes
on a CMS Web site similar to the way we currently publish the list of
face-to-face encounter codes for PQRS. This proposal differs from the
current PQRS policy in two ways. First, it creates a minimum threshold
for the quantity of patient-facing encounters that MIPS eligible
clinicians or groups would need to furnish to be considered patient-
facing, rather than classifying MIPS eligible clinicians as patient-
facing based on a single patient-facing encounter. Second, this
proposal includes telehealth services in the definition of patient-
facing encounters.
We believe that setting the non-patient-facing MIPS eligible
clinician threshold for individual MIPS eligible clinician or group at
25 or fewer billed patient-facing encounters during a performance
period is appropriate. We selected this threshold based on an analysis
of non-patient-facing HCPCS codes billed by MIPS eligible clinicians.
Using these codes and this threshold we identified approximately one
quarter of MIPS eligible clinicians as non-patient-facing before MIPS
exclusions, such as low-volume and newly-enrolled eligible clinician
policies, were applied. The majority of clinicians enrolled in Medicare
with specialties such as anesthesiology, nuclear medicine, and
pathology were identified as non-patient-facing in this analysis. The
addition of telemedicine to the analysis did not affect the outcome, as
it created a less than 0.01 percent change in MIPS eligible clinicians
categorized as non-patient-facing.
[[Page 28175]]
Therefore, this proposed approach allows the definition of non-
patient-facing MIPS eligible clinicians, to include both MIPS eligible
clinicians who practice within specialties traditionally considered
non-patient-facing, as well as MIPS eligible clinicians who provide
occasional patient-facing services that do not represent the bulk of
their practices. This definition is also consistent with the statutory
requirement that refers to professional types who typically furnish
services that do not involve patient-facing interaction with a patient.
We also propose to include telehealth services in the definition of
patient-facing encounters. Various MIPS eligible clinicians use
telehealth services as an innovative way to deliver care to
beneficiaries and we believe these services, while not furnished in-
person, should be recognized as patient-facing. In addition, Medicare
eligible telehealth services substitute for an in-person encounter and
meet other site requirements under the PFS as defined at Sec. 410.78.
The proposed addition of the encounter threshold for patient-facing
MIPS eligible clinicians should minimize concerns that a MIPS eligible
clinician could be misclassified as patient-facing as a result of
providing occasional telehealth services that do not represent the bulk
of their practice. Finally, this proposed definition of a non-patient-
facing MIPS eligible clinician for MIPS can be consistently used
throughout the MIPS program to identify those MIPS eligible clinicians
for whom certain proposed requirements for patient-facing MIPS eligible
clinicians (such as reporting cross-cutting measures) may not be
meaningful.
We weighed several options when considering the appropriate
definition of non-patient-facing MIPS eligible clinicians for MIPS; and
some options were similar to those we considered in implementing the
Medicare EHR Incentive Program. One option we considered was basing the
non-patient-facing MIPS eligible clinician's definition on a set
percentage of patient-facing encounters, such as 5 to 10 percent, that
is tied to the same list of patient-facing encounter codes discussed in
this section of the proposed rule. Another option we considered was the
identification of non-patient-facing MIPS eligible clinicians for MIPS
only by specialty, which might be a simpler approach. However, we do
not consider this approach sufficient for identifying all the possible
non-patient-facing MIPS eligible clinicians, as some patient-facing
MIPS eligible clinicians practice in multi-specialty practices with
non-patient-facing MIPS eligible clinician's practices with different
specialties. We would likely have had to develop a separate process to
identify non-patient-facing MIPS eligible clinicians in other
specialties, whereas maintaining a single definition that is aligned
across performance categories is simpler. Many comments from the MIPS
and APMs RFI discouraged use of enrollment specialty alone.
Additionally, we believe our proposal would allow us to more accurately
identify MIPS eligible clinicians who are non-patient-facing by
applying a threshold to recognize that a MIPS eligible clinician who
furnishes almost exclusively non-patient-facing services should be
treated as a non-patient-facing MIPS eligible clinicians despite
furnishing a small number of patient-facing services. We seek comment
on these alternative approaches.
In the MIPS and APMs RFI, we also requested comments on what types
of measures and/or CPIAs (new or from other payment systems) we should
use to assess non-patient-facing MIPS eligible clinicians' performance
and how we should apply the MIPS performance categories to non-patient-
facing MIPS eligible clinicians. Commenters were split on these
subjects. A number of commenters stated that non-patient-facing MIPS
eligible clinicians should be exempt from specific performance
categories under MIPS or should be exempt from MIPS as a whole.
Commenters who did not favor exemptions generally suggested that we
focus on process measures and work with specialty societies to develop
new, more clinically relevant measures for non-patient-facing MIPS
eligible clinicians.
We took these stakeholder comments into consideration. We note that
section 1848(q)(2)(C)(iv) of the Act does not grant the Secretary
discretion to exempt non-patient-facing MIPS eligible clinicians from a
performance category entirely, but rather to apply to the extent
feasible and appropriate alternative measures or activities that
fulfill the goals of the applicable performance category. However, we
have placed safeguards to ensure that MIPS eligible clinicians,
including non-patient facing, that do not have sufficient alternative
measures that are applicable and available in a performance category
are scored appropriately. We propose to apply the Secretary's authority
under section 1848(q)(5)(F) of the Act to reweight such performance
categories score to zero if there is no performance category score or
to lower the weight of the quality performance category score if there
are not at least three scored measures. Please refer to section
II.E.6.b.(2)(b) in this proposed rule for details on the reweighting
proposals. Accordingly, we have proposed alternative requirements for
non-patient-facing MIPS eligible clinicians across this proposed rule
(see sections II.E.5.b. II.E.5.e. and II.E.5.f. of this proposed rule
for more details). While non-patient-facing MIPS eligible clinicians
will not be exempt from any performance category under MIPS, we believe
these alternative requirements fulfill the goals of the applicable
performance categories and are in line with the commenters' desire to
ensure that non-patient-facing MIPS eligible clinicians are not placed
at an unfair disadvantage under the new program. The requirements also
build on prior program components in meaningful ways and are meant to
help us appropriately assess and incentivize non-patient-facing MIPS
eligible clinicians. We request comments on these proposals.
c. MIPS Eligible Clinicians Who Practice in Critical Access Hospitals
Billing Under Method II (Method II CAHs)
Section 1848(q)(6)(E) of the Act provides that the MIPS adjustment
is applied to the amount otherwise paid under Part B for the items and
services furnished by a MIPS eligible clinician during a year
(beginning with 2019). In the case of MIPS eligible clinicians who
practice in CAHs that bill under Method I (``Method I CAHs''), the MIPS
adjustment would apply to payments made for items and services billed
by MIPS eligible clinicians under the PFS, but it would not apply to
the facility payment to the CAH itself. In the case of MIPS eligible
clinicians who practice in Method II CAHs and have not assigned their
billing rights to the CAH, the MIPS adjustment would apply in the same
manner as for MIPS eligible clinicians who bill for items and services
in Method I CAHs.
Under section 1834(g)(2) of the Act, a Method II CAH bills and is
paid for facility services at 101 percent of its reasonable costs and
for professional services at 115 percent of such amounts as would
otherwise be paid under this part if such services were not included in
outpatient critical access hospital services. In the case of MIPS
eligible clinicians who practice in Method II CAHs and have assigned
their billing rights to the CAHs, those professional services would
constitute ``covered professional services'' under section
1848(k)(3)(A) of the Act because they are furnished by an eligible
clinician
[[Page 28176]]
and payment is ``based on'' the PFS. Moreover, this is consistent with
the precedent CMS has established by applying the PQRS and EHR-MU
adjustments to Method II CAH payments. Therefore, we propose the MIPS
adjustment does apply to Method II CAH payments under section
1834(g)(2)(B) of the Act when MIPS eligible clinicians who practice in
Method II CAHs have assigned their billing rights to the CAH. We
request comments on this proposal.
d. MIPS Eligible Clinicians Who Practice in Rural Health Clinics (RHCs)
and/or Federally Qualified Health Centers (FQHCs)
As noted previously in this proposed rule, section 1848(q)(6)(E) of
the Act provides that the MIPS adjustment is applied to the amount
otherwise paid under Part B with respect to the items and services
furnished by a MIPS eligible clinician during a year. Some eligible
clinician s may not receive MIPS adjustments due to their billing
methodologies. If a MIPS eligible clinician furnishes items and
services in an RHC and/or FQHC and the RHC and/or FQHC bills for those
items and services under the RHC's or FQHC's all-inclusive payment
methodology, the MIPS adjustment would not apply to the facility
payment to the RHC or FQHC itself. However, if a MIPS eligible
clinician furnishes other items and services in an RHC and/or FQHC and
bills for those items and services under the PFS, the MIPS adjustment
would apply to payments made for items and services. Accordingly, the
MIPS eligible clinician would need to meet the applicable MIPS
reporting requirements to avoid a downward MIPS adjustment to payments
made for items and services billed by the MIPS eligible clinician under
the PFS. Therefore, we propose services rendered by an eligible
clinician that are payable under the RHC or FQHC methodology would not
be subject to the MIPS payments adjustments. However, these eligible
clinicians have the option to voluntarily report on applicable measures
and activities for MIPS and the data received would not be used to
assess their performance for the purpose of the MIPS adjustment. We
request comments on this proposal.
e. Group Practice (Group)
Section 1848(q)(1)(D) of the Act, requires the Secretary to
establish and apply a process that includes features of the PQRS group
practice reporting option (GPRO) established under section
1848(m)(3)(C) of the Act for MIPS eligible clinicians in a group for
purposes of assessing performance in the quality performance category.
In addition, it gives the Secretary the discretion to do so for the
other three performance categories. Additionally, we will assess
performance either for individual MIPS eligible clinicians or for
groups. As discussed in section II.E.2.b of this proposed rule, we
propose to define a group at Sec. 414.1305 as a single Taxpayer
Identification Number (TIN) with two or more MIPS eligible clinicians,
as identified by their individual National Provider Identifier (NPI),
who have reassigned their Medicare billing rights to the TIN. Also, as
outlined in section II.E.2.c. of this proposed rule, we propose to
define an APM Entity group at Sec. 414.1305 identified by a unique APM
participant identifier.
2. MIPS Eligible Clinician Identifier
To support MIPS eligible clinicians reporting to a single
comprehensive and cohesive MIPS program, we need to align the technical
reporting requirements from PQRS, VM, and EHR-MU into one program. This
requires an appropriate MIPS eligible clinician identifier. We
currently use a variety of identifiers to assess an individual eligible
clinician or group under different programs. For example, under the
PQRS for individual reporting, CMS uses a combination of TIN and NPI to
assess eligibility and participation, where each unique TIN and NPI
combination is treated as a distinct eligible clinician and is
separately assessed for purposes of the program. Under the PQRS GPRO,
eligibility and participation are assessed at the TIN level. Under the
Medicare EHR Incentive Program, we utilize the NPI to assess
eligibility and participation. And under the VM, performance and
payment adjustments are assessed at the TIN level. Additionally, for
APMs such as the Pioneer Accountable Care Organization (ACO) Model, we
also assign a program-specific identifier (in the case of the Pioneer
ACO Model, an ACO ID) to the organization(s), and associate that
identifier with individual eligible clinicians who are, in turn,
identified through a combination of a TIN and an NPI.
In the MIPS and APMs RFI, we sought comments on which specific
identifier(s) should be used to identify a MIPS eligible clinician for
purposes of determining eligibility, participation, and performance
under the MIPS performance categories. In addition, we requested
comments pertaining to what safeguards should be in place to ensure
that MIPS eligible clinicians do not switch identifiers to avoid being
considered ``poor-performing'' and comments on what safeguards should
be in place to address any unintended consequences, if the MIPS
eligible clinician identifier were a unique TIN/NPI combination, to
ensure an appropriate assessment of the MIPS eligible clinician's
performance. In the MIPS and APMs RFI, we sought comment on using a
MIPS eligible clinician's TIN, NPI, or TIN/NPI combination as potential
MIPS eligible clinician identifiers, or creating a unique MIPS eligible
clinician identifier. The commenters did not demonstrate a consensus on
a single best identifier.
Commenters favoring the use of the MIPS eligible clinician's TIN
recommended that MIPS eligible clinicians should be associated with the
TIN used for receiving payment from CMS claims. They further commented
that this approach will deter MIPS eligible clinicians from ``gaming''
the system by switching to a higher performing group. Under this
approach, commenters suggest that MIPS eligible clinicians who bill
under more than one TIN can be assigned the performance and payment
adjustment for the primary practice based upon majority of dollar
amount of claims or encounters from the prior year.
Other commenters supported using unique TIN and NPI combinations to
identify MIPS eligible clinicians. Commenters suggested many eligible
clinicians are familiar with using TIN and NPI together from PQRS and
other CMS programs. Commenters also noted this approach can calculate
performance for multiple unique TIN/NPI combinations for those MIPS
eligible clinicians who practice under more than one TIN. Commenters
who supported the TIN/NPI also believe this approach enables greater
accountability for individual MIPS eligible clinicians beyond what
might be achieved when using TIN as an identifier and would provide a
safeguard from MIPS eligible clinicians changing their identifier to
avoid payment penalties.
Some commenters supported the use of only the NPI as the MIPS
identifier. They believe this approach would best provide for
individual accountability for quality in MIPS while minimizing
potential confusion because providers do not generally change their NPI
over time. Supporters of using the NPI only as the MIPS identifier also
commented that this approach would be simplest for administrative
purposes. These commenters also note the continuity inherent with the
NPI would address the safeguard issue of providers
[[Page 28177]]
attempting to change their identifier for MIPS performance purposes.
In the MIPS and APMs RFI, we also solicited feedback on the
potential for creating a new MIPS identifier for the purposes of
identifying MIPS eligible clinicians within the MIPS program. In
response, many commenters indicated they would not support a new MIPS
identifier. Commenters generally expressed concern that a new
identifier for MIPS would only add to administrative burden, create
confusion for MIPS eligible clinicians and increase reporting errors.
After reviewing the comments, we are not proposing to create a new
MIPS eligible clinician identifier. However, we appreciate the various
ways a MIPS eligible clinician may engage with MIPS, either
individually or through a group. Therefore, we are proposing to use
multiple identifiers that allow MIPS eligible clinicians to be measured
as an individual or collectively through a group's performance. We also
propose that the same identifier be used for all four performance
categories; for example, if a group is submitting information
collectively, then it must be measured collectively for all four MIPS
performance categories: Quality, resource use, CPIA, and advancing care
information. As discussed later in the CPS methodology section II.E.6.
of this proposed rule, while we have multiple identifiers for
participation and performance, we proposed to use a single identifier,
TIN/NPI, for applying the payment adjustment, regardless of how the
MIPS eligible clinician is assessed. Specifically, if the MIPS eligible
clinician is identified for performance only using the TIN, when
applying the payment adjustment we propose to use the TIN/NPI. We
request comments on these proposals.
a. Individual Identifiers
We propose to use a combination of billing TIN/NPI as the
identifier to assess performance of an individual MIPS eligible
clinician. Similar to PQRS, each unique TIN/NPI combination would be
considered a different MIPS eligible clinician, and MIPS performance
would be assessed separately for each TIN under which an individual
bills. While we considered using the NPI only, we believe TIN/NPI is a
better approach for MIPS. Both TIN and NPI are needed for payment
purposes and using a combination of billing TIN/NPI as the MIPS
eligible clinician identifier allows us to match MIPS performance and
payment adjustments with the appropriate practice, particularly for
MIPS eligible clinicians that bill under more than one TIN. In
addition, using TIN/NPI also provides the flexibility to allow
individual MIPS eligible clinician and group reporting, as the group
identifiers being proposed also include TIN as part of the identifier.
We recognize that TIN/NPI is not a static identifier and can change if
an individual MIPS eligible clinician changes practices and/or if a
group merges with another between the performance period and payment
adjustment period. Section II.E.5.h. of this proposed rule describes in
more detail how we propose to match performance in cases where the TIN/
NPI changes. We request comments on this proposal.
b. Group Identifiers for Performance
We propose the following way a MIPS eligible clinician may have
their performance assessed as part of a group under MIPS. We propose to
use a group's billing TIN to identify a group. This approach has been
used as a group identifier for both PQRS and VM. The use of the TIN
would significantly reduce the participation burden that could be
experienced by large groups. Additionally, the utilization of the TIN
benefits large and small practices by allowing such entities to submit
performance data one time for their group and develop systems to
improve performance. Groups that report on quality performance measures
through certain data submission methods must register in order to
participate in MIPS as described in section II.E.5.b. of this proposed
rule.
We are proposing to codify the definition of a group at Sec.
414.1305 as a group that would consist of a single TIN with two or more
MIPS eligible clinicians (as identified by their individual NPI) who
have reassigned their billing rights to the TIN. We request comments on
this proposal.
c. APM Entity Group Identifier for Performance
We propose the following way to identify a group to support APMs
(see section II.F.5.b. of this proposed rule). To ensure we have
accurately captured all of the eligible clinicians identified as
participants that are participating in the APM Entity, we propose that
each eligible clinician who is a participant of an APM Entity would be
identified by a unique APM participant identifier. The unique APM
participant identifier would be a combination of four identifiers: (1)
APM Identifier (established by CMS; for example, XXXXXX); (2) APM
Entity identifier (established under the APM by CMS; for example,
AA00001111); (3) TIN(s) (9 numeric characters; for example, XXXXXXXXX);
(4) EP NPI (10 numeric characters; for example, 1111111111). For
example, an APM participant identifier could be APM XXXXXX, APM Entity
AA00001111, TIN-XXXXXXXXX, NPI-11111111111.
We are proposing to codify the definition of an APM Entity group at
Sec. 414.1305 as an APM Entity identified by a unique APM participant
identifier. We request comments on these proposals. See section
II.E.5.h. of this rule for proposed policies regarding requirements for
APM Entity groups under MIPS.
3. Exclusions
a. New Medicare-Enrolled Eligible Clinician
Section 1848(q)(1)(C)(v) of the Act provides that in the case of a
professional who first becomes a Medicare-enrolled eligible clinician
during the performance period for a year (and had not previously
submitted claims under Medicare either as an individual, an entity, or
a part of a physician group or under a different billing number or tax
identifier), that the eligible clinician will not be treated as a MIPS
eligible clinician until the subsequent year and performance period for
that year. In addition, section 1848(q)(1)(C)(vi) of the Act clarifies
that individuals who are not deemed MIPS eligible clinicians for a year
will not receive a MIPS adjustment factor (or additional MIPS
adjustment factor). Accordingly, we propose at Sec. 414.1305 that a
new Medicare-enrolled eligible clinician be defined as a professional
who first becomes a Medicare-enrolled eligible clinician within the
PECOS during the performance period for a year and who has not
previously submitted claims as a Medicare-enrolled eligible clinician
either as an individual, an entity, or a part of a physician group or
under a different billing number or tax identifier. These eligible
clinicians will not be treated as a MIPS eligible clinician until the
subsequent year and the performance period for such subsequent year. As
discussed in section II.E.4. of this proposed rule, we are proposing
that the MIPS performance period would be the calendar year (January 1
through December 31) 2 years prior to the year in which the MIPS
adjustment is applied. For example, an eligible clinician who newly
enrolls in Medicare within PECOS in 2017 would not be required to
participate in MIPS in 2017, and he or she would not receive a MIPS
adjustment in 2019. The same eligible clinician would be required to
participate in MIPS in 2018 and would
[[Page 28178]]
receive a MIPS adjustment in 2020, and so forth. In addition, in the
case of items and services furnished during a year by an individual who
is not an MIPS eligible clinician, there will not be a MIPS adjustment
factor (or additional MIPS adjustment factor) applied for that year. We
also propose at Sec. 414.1310(d) that in no case would a MIPS
adjustment factor (or additional MIPS adjustment factor) apply to the
items and services furnished by new Medicare-enrolled eligible
clinicians.
We request comments on these proposals.
b. Qualifying APM Participants (QP) and Partial Qualifying APM
Participant (Partial QP)
Sections 1848(q)(1)(C)(ii)(I) and (II) of the Act provide that the
definition of a MIPS eligible clinician does not include, for a year,
an eligible clinician who is a Qualifying APM Participant (QP) (as
defined in section 1833(z)(2) of the Act) or a Partial Qualifying APM
Participant (Partial QP) (as defined in section 1848(q)(1)(C)(iii) of
the Act) who does not report on the applicable measures and activities
that are required under MIPS. Section II.F.5. of this proposed rule
provides detailed information on the determination of QPs and Partial
QPs.
We propose that the definition of a MIPS eligible clinician at
Sec. 414.1310 does not include qualifying APM participants (defined at
Sec. 414.1305) and Partial QPs defined at Sec. 414.1305 who do not
report on applicable measures and activities that are required to be
reported under MIPS for any given performance period. Partial QPs will
have the option to elect whether or not to report under MIPS, which
determines whether or not they will be subject to MIPS adjustments.
Please refer to the section II.F.5.c. of this proposed rule where this
election is discussed in greater detail. We request comments on this
proposal.
c. Low-Volume Threshold
Section 1848(q)(1)(C)(ii)(III) of the Act provides that the
definition of a MIPS eligible clinician does not include MIPS eligible
clinicians who are below the low-volume threshold selected by the
Secretary under section 1848(q)(1)(C)(iv) of the Act for a given year.
Section 1848(q)(1)(C)(iv) of the Act requires the Secretary to select a
low-volume threshold to apply for the purposes of this exclusion which
may include one or more of the following: (1) The minimum number, as
determined by the Secretary, of Part B-enrolled individuals who are
treated by the MIPS eligible clinician for a particular performance
period; (2) the minimum number, as determined by the Secretary, of
items and services furnish to Part B-enrolled individuals by the MIPS
eligible clinician for a particular performance period; and (3) the
minimum amount, as determined by the Secretary, of allowed charges
billed by the MIPS eligible clinician for a particular performance
period.
We propose at Sec. 414.1305 to define MIPS eligible clinicians or
groups who do not exceed the low-volume threshold as an individual MIPS
eligible clinician or group who, during the performance period, have
Medicare billing charges less than or equal to $10,000 and provides
care for 100 or fewer Part B-enrolled Medicare beneficiaries. We
believe this strategy is value-oriented as it retains as MIPS eligible
clinicians those MIPS eligible clinicians who are treating relatively
few beneficiaries, but engage in resource intensive specialties, or
those treating many beneficiaries with relatively low-priced services.
By requiring both criteria be met, we can meaningfully measure the
performance and drive quality improvement across the broadest range of
MIPS eligible clinician types and specialties. Conversely, it excludes
MIPS eligible clinicians who do not have a substantial quantity of
interactions with Medicare beneficiaries or furnish high cost services.
In developing this proposal we considered using items and services
furnished to Part B-enrolled individuals by the MIPS eligible clinician
for a particular performance period rather than patients but a review
of the data reflected there were nominal differences between the two
methods. We plan to monitor the proposed requirement and anticipate
that the specific thresholds will evolve over time. We request comments
on this proposal including alternative patient threshold, case
thresholds, and dollar values.
d. Group Reporting
(1) Background
As noted above, section 1848(q)(1)(D) of the Act, requires the
Secretary to establish and apply a process that includes features of
the PQRS group practice reporting option (GPRO) established under
section 1848(m)(3)(C) of the Act for MIPS eligible clinicians in a
group for the purpose of assessing performance in the quality category
and give the Secretary the discretion to do so for the other
performance categories. The process established for purposes of MIPS
must, to the extent practicable, reflect the range of items and
services furnished by the MIPS eligible clinicians in the group. We
believe this means that the process established for purposes of MIPS
should, to the extent practicable, encompass elements that enable MIPS
eligible clinicians in a group to meet reporting requirements that
reflect the range of items and services furnished by the MIPS eligible
clinicians in the group. At Sec. 414.1310(e) we propose requirements
for groups. For purposes of section 1848(q)(1)(D) of the Act, at Sec.
414.1310(e)(1) we propose the following way for individual MIPS
eligible clinicians to have their performance assessed as a group: As
part of a single TIN associated with two or more MIPS eligible
clinicians, as identified by a NPI, that have their Medicare billing
rights reassigned to the TIN (as discussed further in section II.E.1.f.
of this proposed rule).
In order to have its performance assessed as a group, at Sec.
414.1310(e)(2) we propose a group must meet the proposed definition of
a group at all times during the performance period for the MIPS payment
year. Additionally, at Sec. 414.1310(e)(3) we propose in order to have
their performance assessed as a group, individual MIPS eligible
clinicians within a group must aggregate their performance data across
the TIN. At Sec. 414.1310(e)(3), we propose a group that elects to
have its performance assessed as a group would be assessed as a group
across all four MIPS performance categories. For example, if a group
submits data for the quality performance category as a group, CMS would
assess them as a group for the remaining three performance categories.
We solicit public comments on the proposal regarding how groups will be
assessed under MIPS.
(2) Registration
Under the PQRS, groups are required to complete a registration
process to participate in PQRS as a group. During the implementation
and administration of PQRS, we received feedback from stakeholders
regarding the registration process for the various methods available
for data submission. Stakeholders indicated that the registration
process was burdensome and confusing. Additionally, we discovered that
during the registration process when groups are required to select
their group submission mechanism, groups sometimes selected the option
not applicable to their group, which has created issues surrounding the
mismatch of data. Unreconciled data mismatching can impact the quality
of data. In order to address this issue, we are proposing to eliminate
a registration process for groups submitting data using third party
entities. When groups
[[Page 28179]]
submit data utilizing third party entities, such as a qualified
registry, health IT vendor, or QCDR, we are able to obtain group
information from the third party entity and discern whether the data
submitted represents group submission or individual submission once the
data is submitted.
At Sec. 414.1310(e)(5), we propose that a group must adhere to an
election process established and required by CMS, as described below.
We do not propose to require groups to register to have their
performance assessed as a group except for groups submitting data on
performance measures via participation in the CMS Web Interface or
groups electing to report the Consumer Assessment of Healthcare
Providers and Systems (CAHPS) for MIPS survey for the quality
performance category as described further in section II.E.5.b. of this
proposed rule. For all other data submission methods, groups must work
with appropriate third party entities to ensure the data submitted
clearly indicates that the data represent a group submission rather
than an individual submission. In order for groups to elect
participation via the CMS Web Interface or administration of the CAHPS
for MIPS survey, we propose that such groups must register by June 30
of the applicable 12-month performance period (that is, June 30, 2017,
for performance periods occurring in 2017). For the criteria regarding
group reporting applicable to the four MIPS performance categories, see
section II.E.5.a. of this proposed rule.
e. Virtual Groups
(1) Implementation
Section 1848(q)(5)(I) of the Act establishes the use of voluntary
virtual groups for certain assessment purposes. The statute requires
the establishment and implementation of a process that allows an
individual MIPS eligible clinician or a group consisting of not more
than 10 MIPS eligible clinicians to elect to form a virtual group with
at least one other such individual MIPS eligible clinician or group of
not more than 10 MIPS eligible clinicians for a performance period of a
year. As determined in statute, individual MIPS eligible clinicians and
groups forming virtual groups are required to make such election prior
to the start of the applicable performance period under MIPS and cannot
change their election during the performance period. As discussed in
section II.E.4. of this proposed rule, we are proposing that the
performance period would be based on a calendar year.
As we assessed the timeline for the establishment and
implementation of virtual groups and applicable election process and
requirements for the first performance period under MIPS, we identified
significant barriers regarding the development of a technological
infrastructure required for successful implementation and the
operationalization of such provisions that would negatively impact the
execution of virtual groups as a conducive option for MIPS eligible
clinicians or groups. The development of an electronic system before
policies are finalized poses several risks, particularly relating to
the impediments of completing and adequately testing the system before
execution and assuring that any change in policy made during the
rulemaking process are reflected in the system and operationalized
accordingly. We believe that it would be exceedingly difficult to make
a successful system to support the implementation of virtual groups and
given these factors, such implementation would compromise not only the
integrity of the system, but the intent of the policies.
Additionally, we recognize that it would be impossible for us to
develop an entire infrastructure for electronic transactions pertaining
to an election process, reporting of data, and performance measurement
before the start of the performance period beginning on January 1,
2017. Moreover, the actual implementation timeframe would be more
condensed given that the development, testing, and execution of such a
system would need to be completed months in advance of the beginning of
the performance period in order to provide MIPS eligible clinicians and
groups with an election period.
During the implementation and ongoing functionality of other
programs such as PQRS, Medicare EHR Incentive Program, and VM, we
received feedback from stakeholders regarding issues they encountered
when submitting reportable data for these programs. With virtual groups
as a new option, we want to minimize potential issues for end-users and
implement a system that encourages and enables MIPS eligible clinicians
and groups to participate in a virtual group. A web-based registration
process, which would simplify and streamline the process for
participation, is our preferred approach. Given the aforementioned
dynamics discussed in this section, implementation for the calendar
year 2017 performance period is infeasible as a result of the
insufficient timeframe to develop a web-based registration process. We
have assessed alternative approaches for the first year only, such as
an email registration process, but believe that there are limitations
and potential risks for numerous errors, such as submitted information
being incomplete or not in the required format. A manual verification
process would cause a significant delay in verifying registration due
to the lack of an automated system to ensure the accuracy of the type
of information submitted that is required for registration. We believe
that an email registration process could become cumbersome and a burden
for groups to pursue participation in a virtual group. Implementation
of a web-based registration system for calendar year 2018 would provide
the necessary time to establish and implement an election process and
requirements applicable to virtual groups, and enable proper system
development and operations. We intend to implement virtual groups for
the 2018 calendar year performance period and we intend to address all
of the requirements pertaining to virtual groups in future rulemaking.
We request comments on factors we should consider regarding the
establishment and implementation of virtual groups.
(2) Election Process
Section 1848(q)(5)(I)(iii)(I) of the Act provides that the election
process must occur prior to the performance period and may not be
changed during the performance period. We propose to establish an
election process that would end on June 30 of a calendar year preceding
the applicable performance period. During the election process, we
propose that individual MIPS eligible clinicians and groups electing to
be a virtual group would be required to register in order to submit
reportable data. Virtual groups would be assessed across all four MIPS
performance categories. In future rulemaking, we intend to address all
elements relating to the election process. We solicit public comments
on this proposal. Future rulemaking will outline the criteria and
requirements regarding the formation of virtual groups.
4. MIPS Performance Period
MIPS incorporates many of the requirements of several programs into
a single, comprehensive program. This consolidation includes key policy
goals as common themes across multiple categories such as quality
improvement, patient and family engagement, and care coordination
through interoperable health information exchange. However, each of
these legacy programs included different eligibility requirements,
reporting periods, and systems for
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providers seeking to participate. This means that we must balance
potential impacts of changes to systems and technical requirements in
order to successfully synchronize reporting, as noted in the discussion
regarding the definition of a MIPS eligible clinician in section
II.E.1.a. of this proposed rule. We must take operational feasibility,
systems impacts, and education and outreach on participation
requirements into account in developing technical requirements for
participation. One area where this is particularly important is in the
definition of a performance period.
MIPS applies to payments for items and services furnished on or
after January 1, 2019. Section 1848(q)(4) of the Act requires the
Secretary to establish a performance period (or periods) for a year
(beginning with 2019). Such performance period (or periods) must begin
and end prior to such year and be as close as possible to such year. In
addition, section 1848(q)(7) of the Act provides that, not later than
30 days prior to January 1 of the applicable year, the Secretary must
make available to each MIPS eligible clinician the MIPS adjustment
(and, as applicable, the additional MIPS adjustment) applicable to the
MIPS eligible clinician for items and services furnished by the MIPS
eligible clinician during the year.
We considered various factors when developing the policy for the
MIPS performance period. Stakeholders have stated that having a
performance period as close to when payments are adjusted is
beneficial, even if such period would be less than a year. We have also
received feedback from stakeholders that they prefer having a 1 year
performance period and have further suggested that the performance
period start during the calendar year. For example, having the
performance period occurring from July 1 through June 30. We
additionally considered operational factors, such as that a 1 year
performance period may be beneficial for all four performance
categories because many measures and activities cannot be reported in a
shorter time frame. We also considered that data submission activities
and claims for items and services furnished during the 1 year
performance period (which could be used for claims- or administrative
claims-based quality or resource use measures) may not be fully
processed until the following year.
These circumstances will require adequate lead time to collect
performance data, assess performance, and compute the MIPS adjustment
so the applicable MIPS adjustment can be made available to each MIPS
eligible clinician at least 30 days prior to when the payment
adjustment is applied each year. For 2019, these actions will occur
during 2018. In other payment systems, we have used claims that are
processed within a specified time period after the end of the
performance period, such as 60 or 90 days, for assessment of
performance and application of the payment adjustment. For MIPS, we
propose at Sec. 414.1325(g)(2) to use claims that are processed within
90 days, if operationally feasible, after the end of the performance
period for purposes of assessing performance and computing the MIPS
payment adjustment. If we determine that it is not operationally
feasible to have a claims data run-out for the 90-day timeframe, then
we would utilize a 60-day duration.
This proposal does not affect the performance period per se, but
rather the deadline by which claims for items and services furnished
during the performance period need to be processed for those items and
services to be included in our calculation. To the extent that claims
are used for submitting data on MIPS measures and activities to us,
such claims would have to be processed by no later than 90 days after
the end of the applicable performance period, in order for information
on the claims to be included in our calculations. As noted above, if we
determine that it is not operationally feasible to have a claims data
run-out for the 90-day timeframe, then we will utilize a 60-day
duration. As an alternative to the above proposal, we also considered
using claims that are paid within 60 days after 2017, for assessment of
performance and application of the MIPS payment adjustment for 2019. We
are seeking comment on both approaches.
Given the need to collect and process information, we propose at
Sec. 414.1320 that for 2019 and subsequent years, the performance
period under MIPS would be the calendar year (January 1 through
December 31) 2 years prior to the year in which the MIPS adjustment is
applied. For example, the performance period for the 2019 MIPS
adjustment would be the full calendar year 2017, that is, January 1,
2017 through December 31, 2017. We propose to use the 2017 performance
year for the 2019 payment adjustment consistent with other CMS
programs. This approach allows for a full year of measurement and
sufficient time to base adjustments on complete and accurate
information.
For individual MIPS eligible clinicians and group practices with
less than 12 months of performance data to report, such as when a MIPS
eligible clinician switches practices during the performance period or
when a MIPS eligible clinician may have stopped practicing for some
portion of the performance period (for example, a MIPS eligible
clinician who is on maternity leave or has an illness), we propose that
the individual MIPS eligible clinician or group would be required to
report all performance data available from the performance period.
Specifically, if a MIPS eligible clinician is reporting as an
individual, they would report all partial year performance data.
Alternatively, if the MIPS eligible clinician is reporting with a
group, then the group would report all performance data available from
the performance period, including partial year performance data
available for the individual MIPS eligible clinician.
Under this approach, MIPS eligible clinicians with partial year
performance data could achieve a positive, neutral, or negative MIPS
adjustment based on their performance data. We propose this approach in
order to incentivize accountability for all performance during the
performance period. Two policies will help minimize the impact of
partial year data. First, MIPS eligible clinicians with volume below
the low-volume threshold would be excluded from any payment
adjustments. Second, MIPS eligible clinicians who report measures, yet
have insufficient sample size, would not be scored on those measures
and activities refer to section II.E.6. of this proposed rule for
further details.
To potentially refine this proposal in future years, we seek
comment on methods to identify accurately MIPS eligible clinicians with
less than 12-month reporting periods, notwithstanding common and
expected absences due to illness, vacation, or holiday leave. Reliable
identification of these MIPS eligible clinicians will allow us to
analyze the characteristics of this MIPS eligible clinicians' patient
population and better understand how a reduced reporting period impacts
performance.
We also seek public comment on an alternative approach for future
years for assessment of individual MIPS eligible clinicians with less
than 12 months of performance data in the performance year. For
example, if we can identify such MIPS eligible clinician's and confirm
there are data issues that led to invalid performance calculations,
then we could score the MIPS eligible clinician with a CPS equal to the
performance threshold, which would result in a zero payment adjustment.
We note this approach would not assess a MIPS eligible clinicians'
performance for partial-year performance data. We do
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not believe that consideration of partial year performance is necessary
for assessment of groups, which should have adequate coverage across
MIPS eligible clinicians to provide valid performance calculations.
We also seek comment on reasonable thresholds for considering
performance to be less than 12 months. For example, we expect that some
MIPS eligible clinicians will take leave related to illness, vacation,
and holidays. We would not anticipate applying special policies for
lack of performance related to these common and expected absences
assuming MIPS eligible clinicians' quality reporting includes measures
with sufficient sample size to generate valid and reliable scores. We
seek comment on how to account for MIPS eligible clinicians with
extended leave that may affect measure sample size.
We request comments on these proposals and approaches.
5. MIPS Category Measures and Activities
a. Performance Category Measures and Reporting
(1) Statutory Requirements
Section 1848(q)(2)(A) of the Act requires the Secretary to use four
performance categories in determining each MIPS eligible clinician's
CPS under the MIPS: Quality; resource use; CPIA; and advancing care
information. Section 1848(q)(2)(B) of the Act, subject to section
1848(q)(2)(C) of the Act, describes the measures and activities that,
for purposes of the MIPS performance standards, must be specified under
each performance category for a performance period.
Section 1848(q)(2)(B)(i) of the Act describes the measures and
activities that must be specified under the MIPS quality performance
category as the quality measures included in the annual final list of
quality measures published under section 1848(q)(2)(D)(i) of the Act
and the list of quality measures described in section 1848(q)(2)(D)(vi)
of the Act used by QCDRs under section 1848(m)(3)(E) of the Act. Under
section 1848(q)(2)(C)(i) of the Act, the Secretary must, as feasible,
emphasize the application of outcome-based measures in applying section
1848(q)(2)(B)(i) of the Act. Under section 1848(q)(2)(C)(iii) of the
Act, the Secretary may also use global measures, such as global outcome
measures and population-based measures, for purposes of the quality
performance category. Section 1848(q)(2)(B)(ii) of the Act describes
the measures and activities that must be specified under the resource
use performance category as the measurement of resource use for the
performance period under section 1848(p)(3) of the Act, using the
methodology under section 1848(r) of the Act as appropriate, and, as
feasible and applicable, accounting for the cost of drugs under Part D.
Section 1848(q)(2)(C)(ii) of the Act allows the Secretary to use
measures from other CMS payment systems, such as measures for inpatient
hospitals, for purposes of the quality and resource use performance
categories, except that the Secretary may not use measures for hospital
outpatient departments, other than in the case of items and services
furnished by emergency physicians, radiologists, and anesthesiologists.
This proposed rule seeks comment on how it might be feasible and when
it might be appropriate to incorporate measures from other systems into
MIPS for clinicians that work in facilities such as inpatient
hospitals. For example, it may be appropriate to use such measures when
other applicable measures are not available for individual MIPS
eligible clinicians or when strong payment incentives are tied to
measure performance, either at the facility level or with employed or
affiliated MIPS eligible clinicians.
Section 1848(q)(2)(B)(iii) of the Act describes the measures and
activities that must be specified under the CPIA performance category
as CPIAs under subcategories specified by the Secretary for the
performance period, which must include at least the subcategories
specified in section 1848(q)(2)(B)(iii)(I) through (VI) of the Act.
Section 1848(q)(2)(C)(v)(III) of the Act defines a CPIA as an activity
that relevant eligible clinician organizations and other relevant
stakeholders identify as improving clinical practice or care delivery
and that the Secretary determines, when effectively executed, is likely
to result in improved outcomes. Section 1848(q)(2)(B)(iii) of the Act
requires the Secretary to give consideration to the circumstances of
small practices (consisting of 15 or fewer professionals) and practices
located in rural areas and geographic HPSAs in establishing CPIAs.
Section 1848(q)(2)(B)(iv) of the Act describes the measures and
activities that must be specified under the advancing care information
performance category as the requirements established for the
performance period under section 1848(o)(2) for determining whether an
eligible clinician is a meaningful EHR user.
As discussed in section II.E.1.b. of this proposed rule, section
1848(q)(2)(C)(iv) of the Act requires the Secretary to give
consideration to the circumstances of non-patient facing MIPS eligible
clinicians in specifying measures and activities under the MIPS
performance categories and allows the Secretary, to the extent feasible
and appropriate, to take those circumstances into account and apply
alternative measures or activities that fulfill the goals of the
applicable performance category. In doing so, the Secretary is required
to consult with non-patient facing professionals.
Section 101(b) of MACRA amends certain provisions of section
1848(k), (m), (o), and (p) of the Act to generally provide that the
Secretary will carry out such provisions in accordance with section
1848(q)(1)(F) of the Act for purposes of MIPS. Section 1848(q)(1)(F) of
the Act provides that, in applying a provision of section 1848(k), (m),
(o), and (p) of the Act for purposes of MIPS, the Secretary must adjust
the application of the provision to ensure that it is consistent with
the MIPS requirements and must not apply the provision to the extent
that it is duplicative with a MIPS provision.
(2) Submission Mechanisms
We propose at Sec. 414.1325(a) that individual MIPS eligible
clinicians and groups would be required to submit data on measures and
activities for the quality, CPIA and advancing care information
performance categories. As proposed at Sec. 414.1325(f), we do not
propose any data submission requirements for the resource use
performance category and for certain quality measures used to assess
performance on the quality performance category and for certain
activities in the CPIA performance category. For the resource use
performance category, we propose that each individual MIPS eligible
clinician's and group's resource use performance would be calculated
using administrative claims data. As a result, individual MIPS eligible
clinicians and groups would not be required to submit any additional
information for the resource use performance category. In addition, we
would be using administrative claims data to calculate performance on a
subset of the MIPS quality measures and the CPIA performance category.
For this subset of quality measures and CPIAs, MIPS eligible clinicians
and groups would not be required to submit additional information. For
individual clinicians and groups that are not MIPS eligible clinicians,
such as physical therapists, but elect to report to MIPS, we would
calculate administrative claims resource use measures and quality
measures, if data is available. We are proposing multiple data
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submission mechanisms for MIPS as outlined in Tables 1 and 2 to provide
MIPS eligible clinicians with flexibility to submit their MIPS measures
and activities in a manner that best accommodates the characteristics
of their practice. We note that other terms have been used for these
submission mechanisms in earlier programs and in industry. As a result,
the terms used for the submission mechanisms may be refined in the
final rule for clarity.
[GRAPHIC] [TIFF OMITTED] TP09MY16.000
We propose at Sec. 414.1325(d) that MIPS eligible clinicians and
groups may elect to submit information via multiple mechanisms;
however, they must use the same identifier for all performance
categories and they may only use one submission mechanism per category.
For example, a MIPS eligible clinician could use one submission
mechanism for sending quality measures and another for sending CPIA
data, but a MIPS eligible clinician could not use two submission
mechanisms for a single category such as submitting three quality
measures via claims and three quality measures via registry. We believe
the proposal to allow multiple mechanisms, while restricting the number
of mechanisms per category, offers flexibility without adding undue
complexity.
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For individual MIPS eligible clinicians, we propose at Sec.
414.1325(b), that an individual MIPS eligible clinician may choose to
submit their quality, CPIA, and advancing care information data using
qualified registry, QCDR, or EHR submission mechanisms. Furthermore, we
propose at Sec. 414.1400 that a qualified registry, health IT vendor,
or QCDR could submit data on behalf of the MIPS eligible clinician for
the three performance categories: Quality, CPIA, and advancing care
information. As described in section II.E.9. of this proposed rule,
these third party intermediaries would have to be qualified to submit
for each of the performance categories. Additionally, we propose at
Sec. 414.1325(b)(4) and (5) that individual MIPS eligible clinicians
may elect to report quality information via Medicare Part B claims and
their CPIA and advancing care information performance category data
through attestation.
For groups that are not reporting through the APM scoring standard,
we propose at Sec. 414.1325(c) that these groups may choose to submit
their MIPS quality, CPIA, and advancing care information data using
qualified registry, QCDR, EHR, or CMS Web Interface (for groups of 25+
MIPS eligible clinicians) submission mechanisms. Furthermore, we
propose at Sec. 414.1400 that a qualified registry, health IT vendor
that obtains data from a MIPS eligible clinician's CEHRT, or QCDR could
submit data on behalf of the group for the three performance
categories: Quality, CPIA, and advancing care information.
Additionally, groups may elect to submit their CPIA or advancing care
information performance category data through attestation.
For those MIPS eligible clinicians participating in an APM that
uses the APM scoring standard, we refer readers to section II.E.5.h. of
this proposed rule, which describes how certain APM Entities submit
data to MIPS, including separate approaches to the quality and resource
use performance categories for APMs.
We propose one exception to the requirement for one reporting
mechanism per category. Groups consisting of two or more eligible
clinicians that elect to include CAHPS for MIPS as a quality measure
must use a CMS-approved survey vendor. Their other quality information
may be reported by any single one of the other proposed submission
mechanisms.
While we allow MIPS eligible clinicians and groups to submit data
for different performance categories via multiple submission
mechanisms, we encourage MIPS eligible clinicians to submit MIPS
information for the CPIA and advancing care information performance
categories through the same reporting mechanism that is used for
quality reporting. We believe it would reduce administrative burden and
would simplify the data submission process for MIPS eligible clinicians
by having a single reporting mechanism for all three performance
categories for which MIPS eligible clinicians would be required to
submit data: Quality, CPIA and advancing care information. However, we
were concerned that not all third party entities would be able to
implement the changes necessary to support reporting on all categories
in the first year. We seek comments for future rulemaking on whether we
should propose requiring health IT vendors, QCDRs and qualified
registries to have the capability to submit data for all MIPS
performance categories.
As we noted in this section of the proposed rule, we propose that
MIPS eligible clinicians may report measures and activities using
different submission methods across the performance categories. As we
gain experience under MIPS, we anticipate that in future years it may
be beneficial and reduce burden on MIPS eligible clinicians to require
data for multiple performance categories to come through a single
submission mechanism.
Further, we will be flexible in implementing MIPS. For example, if
a MIPS eligible clinician submits data via multiple submission
mechanisms (for example, registry and QCDR), we would score all the
options and use the highest performance score for the eligible
clinician or group as described in section II.E.6.a.(1)(b). However, we
encourage eligible clinicians to report data for a given performance
category using a single submission mechanism.
Finally, section 1848(q)(1)(E) of the Act requires the Secretary to
encourage the use of QCDRs under section 1848(m)(3)(E) of the Act in
carrying out MIPS. Section 1848(q)(5)(B)(ii)(I) of the Act requires the
Secretary, under the CPS methodology, to encourage MIPS eligible
clinicians to report on applicable measures with respect to the quality
performance category through the use of CEHRT and QCDRs. We note that
this proposed rule uses the term CEHRT and certified health IT in
different contexts. For an explanation of these terms and contextual
use within this proposed rule, we refer readers to section II.E.5.g. of
this proposed rule.
We have multiple policies to encourage the usage of QCDRs and
CEHRT. In part, we are promoting the use of CEHRT by awarding bonus
points in the quality scoring section for measures gathered and
reported electronically via the QCDR, qualified registry, Web
Interface, or CEHRT submission mechanisms (see II.E.6.b). By promoting
use of CEHRT through various submission mechanisms, we believe MIPS
eligible clinicians have flexibility in implementing electronic measure
reporting in a manner which best suits their practice.
To encourage the use of QCDRs, we have created opportunities for
QCDRs to report new and innovative quality measures. In addition,
several CPIAs emphasize QCDR participation. Finally, we allow for QCDRs
to report data on all MIPS performance categories that require data
submission and hope this will become a viable option for MIPS eligible
clinicians. We believe these flexible options will allow MIPS eligible
clinicians to more easily meet the submission criteria for MIPS, which
in turn will positively affect their CPS.
We request comments on these proposals.
(3) Submission Deadlines
For the submission mechanisms described in section II.E.5.a.(2) of
this proposed rule, we propose a submission deadline whereby all
associated data for all performance categories must be submitted. In
establishing the submission deadlines, we have taken into account
multiple considerations, including the type of submission mechanism,
the MIPS performance period, and stakeholder input and our experiences
under the submission deadlines for the PQRS, VM, and Medicare EHR
Incentive Programs.
Historically, under the PQRS, VM or Medicare EHR Incentive
Programs, the submission of data occurred after the close of the
performance periods. Our experience has shown that allowing for the
submission of data after the close of the performance period provides
either the eligible clinician or the third party intermediary time to
ensure the data they submit to us is valid, accurate and has undergone
necessary data quality checks. Stakeholders have also stated that they
would appreciate the ability to submit data to us on a more frequent
basis so they can receive feedback more frequently throughout the
performance period. We also note that, as described in section II.E.4.
of this proposed rule, the MIPS performance period for payments
adjusted in 2019 is calendar year 2017 (January 1 through December 31).
Based on the factors noted, we propose at Sec. 414.1325(e) the
data submission deadline for the qualified
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registry, QCDR, EHR, and attestation submission mechanisms would be
March 31 following the close of the performance period. We anticipate
that the submission period would begin January 2 following the close of
the performance period. For example, for the first MIPS performance
period, the data submission period would occur from January 2, 2018,
through March 31, 2018. We note that this submission period is the same
time frame as what is currently available to eligible professionals and
group practices under PQRS. We are interested in receiving feedback on
whether it is advantageous to either (1) have a shorter time frame
following the close of the performance period, or (2) have a submission
period that would occur throughout the performance period, such as bi-
annual or quarterly submissions; and (3) whether January 1 should also
be included in the submission period. We welcome comments on these
items.
We further propose that for the Medicare Part B claims submission
mechanism, the submission deadline would occur during the performance
period with claims required to be processed no later than 90 days
following the close of the performance period. Lastly, for the CMS Web
Interface submission mechanism, the submission deadline will occur
during an eight-week period following the close of the performance
period that will begin no earlier than January 1 and end no later than
March 31. For example, the CMS Web Interface submission period could
span an 8 week timeframe beginning January 16 and ending March 13. The
specific deadline during this timeframe will be published on the CMS
Web site.
We request comments on these proposals.
b. Quality Performance Category
(1) Background
(a) General Overview and Strategy
The MIPS program is one piece of the broader health care
infrastructure needed to reform the health care system and improve
health care quality, efficiency, and patient safety for all Americans.
We seek to balance the sometimes competing considerations of the health
system and minimize burdens on health care providers given the short
timeframe available under the MACRA for implementation. Ultimately,
MIPS should, in concert with other provisions of the Act, support
health care that is patient-centered, evidence-based, prevention-
oriented, outcome driven, efficient, and equitable.
Under MIPS, clinicians are incentivized to engage in improvement
measures and activities that have a proven impact on patient health and
safety and are relevant to their patient population. We envision a
future state where MIPS eligible clinicians will be seamlessly using
their certified health IT to leverage advanced clinical quality
measurement to manage patient population with the least amount of
workflow disruption and reporting burden. Ensuring clinicians are held
accountable for patients' transitions across the continuum of care is
imperative. For example, when a patient is discharged from an emergency
department to a primary care physician office, the emergency department
clinicians should have a shared incentive for a seamless transition.
Clinicians may also be working with a QCDR to abstract and report
quality measures to CMS and commercial payers and to track patients
longitudinally over time for quality improvement.
Ideally, clinicians in the MIPS program will have accountability
for quality and resource use measures that are related to one another
and will be engaged in CPIAs that directly help them improve in both
specialty-specific clinical practice and more holistic areas (for
example, patient experience, prevention, population health). Finally,
MIPS eligible clinicians will be using CEHRT and other tools which
leverage interoperable standards for data capture, usage, and exchange
in order to facilitate and enhance patient and family engagement, care
coordination among diverse care team members, and, in continuous
learning and rapid-cycle improvement leveraging advanced quality
measurement and safety initiatives.
One of our goals in the MIPS program is to use a patient-centered
approach to program development that will lead to better, smarter, and
healthier care. Part of that goal includes meaningful measurement which
we hope to achieve through:
Measuring performance on measures that are relevant and
meaningful.
Maximizing the benefits of CEHRT.
Flexible scoring that recognizes all of a MIPS eligible
clinician's efforts above a minimum level of effort and rewards
performance that goes above and beyond the norm.
Measures that are built around real clinical workflows and
data captured in the course of patient care activities.
Measures and scoring that can discern meaningful
differences in performance in each performance category and
collectively between low and high performers.
(b) The MACRA Requirements
Sections 1848(q)(1)(A)(i) and (ii) of the Act require the Secretary
to develop a methodology for assessing the total performance of each
MIPS eligible clinician according to performance standards and, using
that methodology, to provide for a CPS for each MIPS eligible
clinician. Section 1848(q)(2)(A)(i) of the Act requires us to use the
quality performance category in determining each MIPS eligible
clinician's CPS, and section 1848(q)(2)(B)(i) of the Act describes the
measures and activities that must be specified under the quality
performance category.
The statute does not specify the number of quality measures on
which a MIPS eligible clinician must report, nor does it specify the
amount or type of information that a MIPS eligible clinician must
report on each quality measure. However, section 1848(q)(2)(C)(i) of
the Act requires the Secretary, as feasible, to emphasize the
application of outcomes-based measures.
Sections 1848(q)(1)(E) of the Act requires the Secretary to
encourage the use of QCDRs, and section 1848(q)(5)(B)(ii)(I) of the Act
requires the Secretary to encourage the use of CEHRT and QCDRs for
reporting measures under the quality performance category under the CPS
methodology, but the statute does not limit the Secretary's discretion
to establish other reporting mechanisms.
Section 1848(q)(2)(C)(iv) of the Act generally requires the
Secretary to give consideration to the circumstances of non-patient-
facing MIPS eligible clinicians and allows the Secretary, to the extent
feasible and appropriate, to apply alternative measures or activities
to such clinicians.
(c) Relationship to the PQRS and VM
Previously, the PQRS, which is a pay-for-reporting program, defined
standards for satisfactory reporting and satisfactory participation to
earn payment incentives or to avoid a payment adjustment EPs could
choose from a number of reporting mechanisms and options. Based on the
reporting option, the EP had to report on a certain number of measures
for a certain portion of their patients. In addition, the measures had
to span a set number of National Quality Strategy (NQS) domains,
information related to the NQS can be found at http://www.ahrq.gov/workingforquality/about.htm. The VM built its policies off
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the PQRS criteria for avoiding the PQRS payment adjustment. Groups that
did not meet the criteria as a group to avoid the PQRS payment
adjustment or groups that did not have at least 50 percent of the EPs
that did not meet the criteria as individuals to avoid the PQRS payment
adjustment automatically received the maximum negative adjustment
established under the VM and are not measured on their quality
performance.
MIPS, in contrast to PQRS, is not a pay-for-reporting program, and
we propose that it would not have a ``satisfactory reporting''
requirement. However, in order to develop an appropriate methodology
for scoring the quality performance category, we believe that MIPS
needs to define the expected data submission criteria and that the
measures need to meet a data completeness standard. In this section we
propose the minimum data submission criteria and data completeness
standard for the MIPS quality performance category for the submission
mechanisms that were proposed earlier in section II.E.5.a. The scoring
methodology described in section II.E.6. of this proposed rule would
adjust the quality performance category scores based on whether or not
an individual MIPS eligible clinician or group met these criteria.
In the MIPS and APMs RFI, we requested feedback on numerous
provisions related to data submission criteria including: How many
measures should be required? Should we maintain the policy that
measures cover a specified number of NQS domains? How do we apply the
quality performance category to MIPS eligible clinicians that are in
specialties that may not have enough measures to meet our defined
criteria? Several themes emerged from the comments. Commenters
expressed concern that the general PQRS satisfactory reporting
requirement to report nine measures across three NQS domains is too
high and forces eligible clinicians to report measures that are not
relevant to their practices. The commenters requested a more meaningful
set of requirements that focused on patient care, with some expressing
the opinion that NQS domain requirements are arbitrary and make
reporting more difficult. Some commenters asked that we align measures
across payers and consider using core measure sets. Other commenters
expressed the need for flexibility and different reporting options for
different types of practices.
In response to the comments, and based on our desire to simplify
the MIPS reporting system and make the measurement more meaningful, we
are proposing MIPS quality criteria that focus on measures that are
important to beneficiaries and maintain some of the flexibility from
PQRS, while addressing several of the issues that concerned commenters.
To encourage meaningful measurement, we are proposing to
allow individual MIPS eligible clinicians and groups the flexibility to
determine the most meaningful measures and reporting mechanisms for
their practice.
To simplify the reporting criteria, we are aligning the
submission criteria for several of the reporting mechanisms.
To reduce administrative burden and focus on measures that
matter, we are lowering the expected number of the measures for several
of the reporting mechanisms, yet are still requiring that certain types
of measures be reported.
To create alignment with other payers and reduce burden on
MIPS eligible clinicians, we are incorporating measures that align with
other national payers.
To create a more comprehensive picture of the practice
performance, we are also proposing to use all-payer data where
possible.
As beneficiary health is always our top priority, we propose
criteria to continue encouraging the reporting of certain measures such
as outcome, appropriate use, patient safety, efficiency, care
coordination, or patient experience measures. However, we are proposing
to remove the requirement for measures to span across multiple domains
of the NQS. We continue to believe the NQS domains to be extremely
important and we encourage MIPS eligible clinicians to continue to
strive to provide care that focuses on: Effective clinical care,
communication, efficiency and cost reduction, person and caregiver-
centered experience and outcomes, community and population health, and
patient safety. While we will not require that a certain number of
measures must span multiple domains, we strongly encourage MIPS
eligible clinicians to select measures that cross multiple domains. In
addition, we believe the MIPS program overall, with the focus on
resource use, CPIAs, and advancing care information performance
categories will naturally cover many elements in the NQS.
(2) Contribution to Composite Performance Score (CPS)
For the 2019 MIPS adjustment year, the quality performance category
will account for 50 percent of the CPS, subject to the Secretary's
authority to assign different scoring weights under section
1848(q)(5)(F) of the Act. Section 1848(q)(2)(E)(i)(I)(aa) of the Act
states the quality performance category will account for 30 percent of
the CPS for MIPS. However, section 1848(q)(2)(E)(i)(I)(bb) of the Act
stipulates that for the first and second years for which MIPS applies
to payments, the percentage of the CPS applicable for the quality
performance category will be increased so that the total percentage
points of the increase equals the total number of percentage points by
which the percentage applied for the resource use performance category
is less than 30 percent. Section 1848(q)(2)(E)(i)(II)(bb) of the Act
requires that, for the first year for which MIPS applies to payments,
not more than 10 percent of the of CPS shall be based on performance to
the resource use performance category. Furthermore, section
1848(q)(2)(E)(i)(II)(bb) of the Act states that, for the second year
for which MIPS applies to payments, not more than 15 percent of the CPS
shall be based on performance to the resource use performance category.
We propose at Sec. 414.1330 for payment years 2019 and 2020, 50
percent and 45 percent, respectively, of the MIPS CPS will be based on
performance on the quality performance category. For the third and
future years, 30 percent of the MIPS CPS will be based on performance
on the quality performance category.
Section 1848(q)(5)(B)(i) of the Act requires the Secretary to treat
any MIPS eligible clinician who fails to report on a required measure
or activity as achieving the lowest potential score applicable to the
measure or activity. Specifically, under our proposed scoring policies,
a MIPS eligible clinician or group that reports on all required
measures and activities could potentially obtain the highest score
possible within the performance category, presuming they performed well
on the measures and activities they reported. A MIPS eligible clinician
or group who does not meet the reporting threshold would receive a zero
score for the unreported items in the category (in accordance with
section 1848(q)(5)(B)(i) of the Act). The MIPS eligible clinician or
group could still obtain a relatively good score by performing very
well on the remaining items, but a zero score would prevent the MIPS
eligible clinician or group from obtaining the highest possible score.
(3) Quality Data Submission Criteria
(a) Submission Criteria
The following are the proposed criteria for the various proposed
MIPS data submission mechanisms described above in section II.E.5.a. of
this
[[Page 28186]]
proposed rule for the quality performance category.
(i) Submission Criteria for Quality Measures Excluding CMS Web
Interface and CAHPS for MIPS
We propose at Sec. 414.1335 that individual MIPS eligible
clinicians submitting data via claims and individual MIPS eligible
clinicians and groups submitting via all mechanisms (excluding CMS Web
Interface, and for CAHPS for MIPS survey, CMS-approved survey vendors)
would be required to meet the following submission criteria. We propose
that for the applicable 12-month performance period, the MIPS eligible
clinician or group would report at least six measures including one
cross-cutting measure (if patient-facing) found in Table C and
including at least one outcome measure. If an applicable outcome
measure is not available, we propose that the MIPS eligible clinician
or group would be required to report one other high priority measure
(appropriate use, patient safety, efficiency, patient experience, and
care coordination measures) in lieu of an outcome measure. If fewer
than six measures apply to the individual MIPS eligible clinician or
group, then we propose the MIPS eligible clinician or group would be
required to report on each measure that is applicable.
MIPS eligible clinicians and groups will have to select their
measures from either the list of all MIPS measures in Table A or a set
of specialty-specific measure set in Table E. Note that some specialty-
specific measure sets include measures grouped by subspecialty; in
these cases, the measure set is defined at the subspecialty level.
We designed the specialty-specific measure sets to address feedback
we have received in the past that the quality measure selection process
can be confusing. A common complaint about PQRS was that EPs were asked
to review close to 300 measures to find applicable measures for their
specialty. The specialty measure sets in Table E are the same measures
that are within Table A, however these are sorted consistent with the
American Board of Medical Specialties (ABMS) specialties. Please note
that these specialty-specific measure sets are not all inclusive of
every specialty or subspecialty. We request comments on the measures
proposed under each of the specialty-specific measure sets.
Specifically, we seek comments on whether or not the measures proposed
for inclusion in the specialty-specific measure sets are appropriate
for the designated specialty or sub-specialty and whether there are
additional proposed measures that should be included in a particular
specialty-specific measure set.
Furthermore, we note that there are some special scenarios for
those MIPS eligible clinicians who select their measures from a
specialty-specific measure set at either the specialty or subspecialty
level (Table E). For example, some of the specialty-specific measure
sets have less than six measures, in these instances MIPS eligible
clinicians would report on all of the available measures including an
outcome measure or, if an outcome measure is unavailable, report
another high priority measure (appropriate use, patient safety,
efficiency, patient experience, and care coordination measures), within
the set and a cross-cutting measure if they are a patient-facing MIPS
eligible clinician. To illustrate, the subspecialty-level the
electrophysiology cardiac specialist specialty-specific measure set
only has three measures within the set, all of which are outcome
measures. MIPS eligible clinicians and groups reporting on the
electrophysiology cardiac specialist specialty-specific measure set
would report on all three measures and since these MIPS eligible
clinicians are patient-facing they must also report on a cross-cutting
measure which is defined in Table C. In other scenarios, the specialty-
specific measure sets may have six or more measures, in these instances
MIPS eligible clinicians would report on at least six measures
including at least one cross-cutting measure and at least one outcome
measure or, if an outcome measure is unavailable, report another high
priority measure (appropriate use, patient safety, efficiency, patient
experience, and care coordination measure). Specifically, the general
surgery specialty-specific measure set has eight measures within the
set, including four outcome measures, three other high priority
measures and one process measure. MIPS eligible clinicians and groups
reporting on the general surgery specialty-specific measure set would
either have the option to report on all measures within the set or
could select six measures from the set and since these MIPS eligible
clinicians are patient-facing one of their six measures must be a
cross-cutting measure which is defined in Table C.
As noted above, the submission criteria for each specialty-specific
measure set, or in the measure set defined at the subspecialty level,
if applicable. Regardless of the number of measures that are contained
in a specialty-specific measure set, MIPS eligible clinicians reporting
on a measure set would be required to report at least one cross-cutting
measure and either at least one outcome measure or, if no outcome
measures are available in that specialty-specific measure set, report
another high priority measure. MIPS eligible clinicians or groups that
report on a specialty-specific measure set that includes more than six
measures can report on as many measures as they wish as long as they
meet the minimum requirement to report at least six measures, including
one cross-cutting measure and one outcome measure, or if an outcome
measure is not available another high priority measure. We seek comment
on our proposal to allow reporting of specialty-specific measure sets
to meet the submission criteria for the quality performance category,
including whether it is appropriate to allow reporting of a measure set
at the subspecialty level to meet such criteria, since reporting at the
subspecialty level would require reporting on fewer measures.
Alternatively, we seek comment on whether we should only consider
reporting up to six measures at the higher overall specialty level to
satisfy the submission criteria. We note that our proposal to allow
reporting of specialty-specific measure sets at the subspecialty level
was intended to address the fact that very specialized clinicians who
may be represented by our subspecialty categories may only have one or
two applicable measures. Further, we note that we will continue to work
with specialty societies and other measure developers to increase the
availability of applicable measures for specialists across the board.
We propose to define a high priority measure at Sec. 414.1305 as
an outcome, appropriate use, patient safety, efficiency, patient
experience, or care coordination quality measures. These measures are
identified in Table A. We further note that measure types listed as an
``intermediate outcome'' are considered outcome measures for the
purposes of scoring; see section II.E.6.
As an alternative to the above proposals, we also considered
requiring individual MIPS eligible clinicians submitting via claims and
individual MIPS eligible clinicians and groups submitting via all
mechanisms (excluding the CMS Web Interface and, for CAHPS for MIPS
survey, CMS-approved survey vendors) to meet the following submission
criteria. For the applicable 12-month performance period, the MIPS
eligible clinician or group would report at least six measures
including one cross-cutting measure (if patient-facing) found in Table
C and one high priority measure (outcome, appropriate use, patient
safety, efficiency, patient experience, and care
[[Page 28187]]
coordination measures). If fewer than six measures apply to the
individual MIPS eligible clinician or group, then the MIPS eligible
clinician or group must report on each measure that is applicable. MIPS
eligible clinicians and groups will have to select their measures from
either the list of all MIPS Measures in Table A or a set of specialty-
specific measure set in Table E.
As discussed in section II.E.1.b. of this proposed rule, MIPS
eligible clinicians who are non-patient-facing MIPS eligible clinicians
would not be required to report any cross-cutting measures.
We intend to develop a validation process to review and validate a
MIPS eligible clinician's or group's ability to report on at least six
quality measures, or a specialty-specific measure set, with a
sufficient sample size, including at least one cross-cutting measure
(if the MIPS eligible clinician is patient-facing) and either an
outcome measure if one is available or another high priority measure.
If a MIPS eligible clinician or group had the ability to report on the
minimum required measures with sufficient sample size and elects to
report on fewer than the minimum required measures, then, as described
in the proposed scoring algorithm in section II.E.6., the missing
measures would be scored with a zero performance score.
Our proposal is a decrease from the 2016 PQRS requirement to report
at least nine measures. In addition, as previously noted, we propose to
no longer require reporting across multiple NQS domains. We believe
these proposals are the best approach for the quality performance
category because it decreases the MIPS eligible clinician's reporting
burden while focusing on more meaningful types of measures.
We also note that we believe that outcome measures are more
valuable than clinical process measures and are instrumental to
improving the quality of care patients receive. To keep the emphasis on
such measures in the statute, we plan to increase the requirements for
reporting outcome measures over the next several years through future
rulemaking, as more outcome measures become available. For example, we
may increase the required number of outcome measures to two or three.
We also believe that appropriate use, patient experience, safety, and
care coordination measures are more relevant than clinical process
measures for improving care of patients. Through future rulemaking, we
plan to increase the requirements for reporting on these types of
measures over time.
In consideration of which MIPS measures to identify as reasonably
focused on appropriate use, we have selected measures which focus on
minimizing overuse of services, treatments, or the related ancillary
testing that may promote overuse of services and treatments. We have
also included select measures of underuse of specific treatments or
services that either (1) reflected overuse of alternative treatments
and services that were are not evidence-based or supported by clinical
guidelines; or (2) where the intent of the measure reflected overuse of
alternative treatments and services that were not evidence-based or
supported by clinical guidelines. We realize there are differing
opinions on what constitutes appropriate use. Therefore, we are seeking
comments on what specific measures of over or under use should be
included as appropriate use measures.
We plan to continue developing care episode groups, patient
condition groups, and patient relationship categories (and codes for
such groups and categories). We plan to incorporate new measures as
they become available and will give the public the opportunity to
comment on these provisions through future notice and comment
rulemaking. We also will closely examine the recommendations from HHS'
Office of the Assistant Secretary for Planning and Evaluation (ASPE)
study, once they are available, on the issue of risk adjustment for
socioeconomic status on quality measures and resource use as required
by section 2(d) of the IMPACT Act and incorporate them as feasible and
appropriate through future rulemaking. In addition, we are seeking
comments on ways to minimize potential gaming, for example, requiring
MIPS eligible clinicians to report only on measures for which they have
a sufficient sample size, to address concerns that MIPS eligible
clinicians may solely report on measures that do not have a sufficient
sample size to decrease the overall weight on their quality score. More
information on the way we propose to score MIPS eligible clinicians in
this scenario is in section II.E.6.a.2. We also seek comment on whether
these proposals sufficiently encourage providers and measure developers
to move away from clinical process measures and towards outcome
measures and measures that reflect other NQS domains. We request
comments on these proposals.
(ii) Submission Criteria for Quality Measures for Groups Reporting via
the CMS Web Interface
We propose at Sec. 414.1335 the following criteria for the
submission of data on quality measures by registered groups of 25 or
more MIPS eligible clinicians who want to report via the CMS Web
Interface. For the applicable 12-month performance period, we propose
that the group would be required to report on all measures included in
the CMS Web Interface completely, accurately, and timely by populating
data fields for the first 248 consecutively ranked and assigned
Medicare beneficiaries in the order in which they appear in the group's
sample for each module/measure. If the pool of eligible assigned
beneficiaries is less than 248, then the group would report on 100
percent of assigned beneficiaries. A group would be required to report
on at least one measure for which there is Medicare patient data. We do
not propose any modifications to this reporting process. Groups
reporting via the CMS Web Interface are required to report on all of
the measures in the set. Any measures not reported would be considered
zero performance for that measure in our scoring algorithm.
Lastly, from our experience with using the CMS Web Interface under
prior Medicare programs we are aware groups may register for this
mechanism and have zero Medicare patients assigned and sampled to them.
We clarify that should a group have no assigned patients, then the
group, or individual MIPS eligible clinicians within the group, would
need to select another mechanism to submit data to MIPS. If a group
does not typically see Medicare patients for which the CMS Web
Interface measures are applicable, or if the group does not have
adequate billing history for Medicare patients to be used for
assignment and sampling of Medicare patients into the CMS Web
Interface, we advise the group to participate in the MIPS via another
reporting mechanism.
As discussed in the CY 2016 PFS final rule with comment period (80
FR 71144), beginning with the 2017 PQRS payment adjustment, the PQRS
aligned with the VM's beneficiary attribution methodology for purposes
of assigning patients for groups that registered to participate in the
PQRS Group Reporting Option (GPRO) using the CMS Web Interface
(formerly referred to as the GPRO Web Interface). For certain quality
and cost measures, the VM uses a two-step attribution process to
associate beneficiaries with TINs during
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the period in which performance is assessed. This process attributes a
beneficiary to the TIN that bills the plurality of primary care
services for that beneficiary (79 FR 67960-67964). We propose to
continue to align the 2019 CMS Web Interface beneficiary assignment
methodology with the measures that used to be in the VM: the population
quality measures discussed below in this proposed rule and total per
capita cost for all attributed beneficiaries discussed in section
II.E.5.e. of this proposed rule. As MIPS is a different program, we
propose to modify the attribution process to update the definition of
primary care services and to adapt the attribution to different
identifiers used in MIPS. These changes are discussed in section
II.E.5.e. of this proposed rule. We request comments on these
proposals.
(iii) Performance Criteria for Quality Measures for Groups Electing To
Report Consumer Assessment of Healthcare Providers and Systems (CAHPS)
for MIPS Survey
The CAHPS for MIPS survey (formerly known as the CAHPS for PQRS
survey) consists of the core CAHPS Clinician & Group Survey developed
by AHRQ, plus additional survey questions to meet CMS's information and
program needs. For more information on the CAHPS for MIPS survey,
please see the explanation of the CAHPS for PQRS survey in the CY 2016
PFS final rule with comment period (80 FR 71142 through 71143). While
we anticipate that the CAHPS for MIPS survey will closely align with
the CAHPS for PQRS survey, we may explore the possibility of updating
the CAHPS for MIPS survey under MIPS, specifically we may not finalize
all proposed Summary Survey Measures (SSM).
We propose to allow registered groups of two or more MIPS eligible
clinicians to voluntarily elect to participate in the CAHPS for MIPS
survey. Specifically, we propose at Sec. 414.1335 the following
criteria for the submission of data on the CAHPS for MIPS survey by
registered groups via CMS-approved survey vendor: For the applicable
12-month performance period, the group must have the CAHPS for MIPS
survey reported on its behalf by a CMS-approved survey vendor. In
addition, the group will need to use another submission mechanism (that
is, qualified registries, QCDRs, EHR etc.) to complete their quality
data submission. The CAHPS for MIPS survey would count as one cross-
cutting and/or a patient experience measure, and the group would be
required to submit at least five other measures through one other data
submission mechanisms. A group may report any five measures within MIPS
plus the CAHPS for MIPS survey to achieve the six measures threshold.
The administration of the CAHPS for MIPS survey would contain a
six-month look-back period. In previous years the CAHPS for PQRS survey
was administered from November to February of the reporting year. We
propose to retain the same survey administration period for the CAHPS
for MIPS survey. Groups that voluntarily elect to participate in the
CAHPS for MIPS survey would bear the cost of contracting with a CMS-
approved survey vendor to administer the CAHPS for MIPS survey on the
group's behalf, just as groups do now for the CAHPS for PQRS survey.
Under current provisions of PQRS, the CAHPS for PQRS survey is
required for groups of 100 or more eligible clinicians. Although we are
not requiring groups to participate in the CAHPS for MIPS survey, we do
still believe patient experience is important and we are therefore
proposing a scoring incentive for those groups who report via the CAHPS
for MIPS survey. As described in section II.E.3.d. of this proposed
rule, we propose that groups electing to report the CAHPS for MIPS
survey, would be required to register for the reporting of data.
Because we believe patients' experiences as they interact with the
health care system is important, our proposed scoring methodology would
give bonus points for reporting CAHPS data (or other patient experience
measures). Please refer to section II.E.6. for further details. We are
interested in receiving comments on whether the CAHPS for MIPS survey
should be required for groups of 100 or more MIPS eligible clinicians
or whether it should be voluntary.
Currently, the CAHPS for PQRS beneficiary sample is based on
Medicare claims data. Therefore, only Medicare beneficiaries can be
selected to participate in the CAHPS for PQRS survey. In future years
of the MIPS program, we may consider expanding the potential patient
experience measures to all payers, so that Medicare and non-Medicare
patients can be included in the CAHPS for MIPS survey sample. We are
seeking comments on criteria that would ensure comparable samples. We
seek comments on these proposals.
(b) Data Completeness Criteria
We want to ensure that data submitted on quality measures are
complete enough to accurately assess each MIPS eligible clinician's
quality performance. Section 1848(q)(5)(H) of the Act provides that
analysis of the quality performance category may include quality
measure data from other payers, specifically, data submitted by MIPS
eligible clinicians with respect to items and services furnished to
individuals who are not individuals entitled to benefits under Part A
or enrolled under Part B of Medicare.
To ensure completeness for the broadest group of patients, we
propose at Sec. 414.1340 the criteria below. MIPS eligible clinicians
and groups who do not meet the proposed reporting criteria noted below
would fail the quality component of MIPS.
Individual MIPS eligible clinicians or groups submitting
data on quality measures using QCDRs, qualified registries, or via EHR
need to report on at least 90 percent of the MIPS eligible clinician or
group's patients that meet the measure's denominator criteria,
regardless of payer for the performance period. In other words, for
these submission mechanisms, we would expect to receive quality data
for both Medicare and non-Medicare patients.
Individual MIPS eligible clinicians submitting data on
quality measures data using Medicare Part B claims, would report on at
least 80 percent of the Medicare Part B patients seen during the
performance period to which the measure applies.
Groups submitting quality measures data using the CMS Web
Interface or a CMS-approved survey vendor to report the CAHPS for MIPS
survey would need to meet the data submission requirements on the
sample of the Medicare Part B patients CMS provides.
We propose to include all-payer data for the QCDR, qualified
registry, and EHR submission mechanisms because we believe this
approach provides a more complete picture of each MIPS eligible
clinicians scope of practice and provides more access to data about
specialties and subspecialties not currently captured in PQRS. In
addition, we propose the QCDR, qualified registry, or EHR submission
must contain a minimum of one quality measure for at least one Medicare
patient.
We desire all-payer data for all reporting mechanisms, yet certain
reporting mechanisms are limited to Medicare Part B data. Specifically,
the claims reporting mechanism relies on individual MIPS eligible
clinicians attaching quality information on Medicare Part B claims;
therefore only Medicare Part B patients can be reported by this
mechanism. The CMS Web
[[Page 28189]]
Interface and the CAHPS for MIPS survey currently rely on sampling
protocols based on Medicare Part B billing; therefore, only Medicare
Part B beneficiaries are sampled through that methodology. We welcome
comments on ways to modify the methodology to assign and sample
patients for these mechanisms using data from other payers.
The data completeness criteria we are proposing are an increase in
the percentage of patients to be reported by each of the mechanisms
when compared to PQRS. We believe the proposed thresholds are
appropriate to ensure a more accurate assessment of a MIPS eligible
clinician's performance on the quality measures and to avoid any
selection bias that may exist under the current PQRS requirements. In
addition, we would like to align all the reporting mechanisms as
closely as possible with achievable data completeness criteria. We
intend to continually assess the proposed data completeness criteria
and will consider increasing these thresholds for future years of the
program. We request comments on this proposal.
We are also interested in data that would indicate these data
completeness criteria are inappropriate. For example, we could envision
that reporting a cross-cutting measure would not always be appropriate
for every telehealth service or for certain acute situations. We would
not want a MIPS eligible clinician to fail reporting the measure in
appropriate circumstances; therefore, we seek feedback data and
circumstances where it would be appropriate to lower the data
completeness criteria.
(c) Summary of Data Submission Criteria Proposals
Table 3 reflects our proposed Quality Data Submission Criteria for
MIPS:
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[GRAPHIC] [TIFF OMITTED] TP09MY16.001
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[GRAPHIC] [TIFF OMITTED] TP09MY16.002
(4) Application of Quality Measures to Non-Patient-Facing MIPS Eligible
Clinicians
Section 1848(q)(2)(C)(iv) of the Act provides that the Secretary
must give consideration to the circumstances of non-patient-facing MIPS
eligible clinicians and may, to the extent feasible and appropriate,
take those circumstances into account and apply alternative measures or
activities that fulfill the goals of the applicable performance
category to such clinicians. In doing so, the Secretary must consult
with non-patient-facing MIPS eligible clinicians.
In addition, section 1848(q)(5)(F) to the Act allows the Secretary
to re-weight MIPS performance categories if there are not sufficient
measures and activities applicable and available to each type of MIPS
eligible clinician. We assume many non-patient-facing MIPS eligible
clinician will not have sufficient measures and activities applicable
and available to report and will not be scored on the quality
performance category under MIPS. We refer readers to section II.E.6. of
this proposed rule to discuss how we address performance categories
weighting for MIPS eligible clinicians for whom no measures exist in a
given category.
In the MIPS and APMs RFI, we solicited feedback on how we should
apply the four MIPS performance categories to non-patient-facing MIPS
eligible clinicians and what types of measures and/or CPIAs (new or
from other payments systems) would be appropriate for these MIPS
eligible clinicians. We also engaged with seven separate organizations
representing non-patient-facing MIPS eligible clinicians in the areas
of anesthesiology, radiology/imaging, pathology, and nuclear medicine,
specifically cardiology. Organizations we spoke with representing
several specialty areas indicated that Appropriate Use Criteria (AUC)
can be incorporated into the CPIA performance category by including
activities related to appropriate assessments and reducing unnecessary
tests and procedures. AUC are distinct from clinical guidelines and
specify when it is appropriate to use a diagnostic test or procedure--
thus reducing unnecessary tests and procedures. Use of AUC is an
important CPIA as it fosters appropriate utilization and is
increasingly used to improve quality in cardiovascular medicine,
radiology, imaging, and pathology. These groups also highlighted that
many non-patient-facing MIPS eligible clinicians have multiple patient
safety and practice assessment measures and activities that could be
included, such as activities that are tied to their participation in
the Maintenance of Certification (MOC) Part IV for improving the
clinician's practice. One organization expressed concern that because
their quality measures are specialized, some members could be
negatively affected when comparing quality scores because they did not
have the option to be compared on a broader, more common set of
measures. The MIPS and APMs RFI commenters noted that the emphasis
should be on measures and activities that are practical, attainable,
and meaningful to individual circumstances and that measurement should
be as outcomes-based to the extent possible. The MIPS and APMs RFI
commenters emphasized that CPIAs should be selected from a very broad
array of choices and that ideally non-patient-facing MIPS eligible
clinicians should help develop those activities so that they provide
value and are easy to document. For more details regarding the CPIA
performance category refer to section II.E.5.f. of this proposed rule.
The comments from these organizations were considered in developing
these proposals.
We understand that non-patient-facing MIPS eligible clinicians may
have a limited number of measures on which to report. Therefore, we
propose at Sec. 414.1335 that non-patient-facing MIPS eligible
clinicians would be required to meet the otherwise applicable
submission criteria, but would not be required to report a cross-
cutting measure.
Thus we would employ the following strategy for the quality
performance criteria to accommodate non-patient-facing MIPS eligible
clinicians:
Allow non-patient-facing MIPS eligible clinicians to
report on specialty-specific measure set (which may have fewer than the
required six measures).
[[Page 28192]]
Allow non-patient-facing MIPS eligible clinicians to
report through a QCDR that can report non-MIPS measures.
Non-patient-facing MIPS eligible clinicians would be
exempt from reporting a cross-cutting measure as proposed at Sec.
414.1340.
We request comments on these proposals.
(5) Application of Additional System Measures
Section 1848(q)(2)(C)(ii) of the Act provides that the Secretary
may use measures used for payment systems other than for physicians,
such as measures used for inpatient hospitals, for purposes of the
quality and resource use performance categories. The Secretary may not,
however, use measures for hospital outpatient departments, except in
the case of items and services furnished by emergency physicians,
radiologists, and anesthesiologists.
In the MIPS and APMs RFI, we sought comment on how we could best
use this authority. Some facility-based commenters requested a
submission option that allows the MIPS eligible clinician to be scored
based on the facility's measures. These commenters noted that the care
they provide directly relates to and affects the facility's overall
performance on quality measures and that using this score may be a more
accurate reflection of the quality of care they provide than the
quality measures in the PQRS or the VM program.
We will consider an option for facility-based MIPS eligible
clinicians to elect to use their institution's performance rates as a
proxy for the MIPS eligible clinician's quality score. We are not
proposing an option for year 1 of MIPS because there are several
operational considerations that must be addressed before this option
can be implemented. We are requesting comment on the following issues:
(1) Whether we should attribute a facility's performance to a MIPS
eligible clinician for purposes of the quality and resource use
performance categories and under what conditions such attribution would
be appropriate and representative of the MIPS eligible clinician's
performance; (2) possible criteria for attributing a facility's
performance to a MIPS eligible clinician for purposes of the quality
and resource use performance categories; and (3) the specific measures
and settings for which we can use the facility's quality and resource
use data as a proxy for the MIPS eligible clinician's quality and
resource use performance categories; and (4) if attribution should be
automatic or if a MIPS eligible clinician or group should elect for it
to be done and choose the facilities through a registration process. We
may also consider other options that would allow us to gain experience.
We seek comments on these approaches.
(6) Global and Population-Based Measures
Section 1848(q)(2)(C)(iii) of the Act provides that the Secretary
may use global measures, such as global outcome measures, and
population-based measures for purposes of the quality performance
category.
Under the current PQRS program and Medicare EHR Incentive Program
quality measures are categorized by domains which include global and
population-based measures. We identified population and community
health measures as one of the quality domains related to the CMS
Quality Strategy and the NQS priorities for health care quality
improvement discussed in section II.E.5.c. of this proposed rule.
Population-based measures are also used in the Medicare Shared Savings
Program and for groups in the VM. For example, in 2015, clinicians were
held accountable for a component of the Agency for Health Care Research
(AHRQ) population-based, Ambulatory Care Sensitive Condition measures
as part of a larger set of Prevention Quality Indicators (PQIs). Two
broader composite measures of acute and chronic conditions are
calculated using the respective individual measure rates for VM
calculations. These PQIs assess the quality of the health care system
as a whole, and especially the quality of ambulatory care, in
preventing medical complications that lead to hospital admissions.
In the CY 2015 PFS final rule with comment period (79 FR 67909),
Medicare Payment Advisory Commission (MedPAC) commented that we should
move quality measurement for ACOs, Medicare Advantage (MA) plans, and
FFS Medicare in the direction of a small set of population-based
outcome measures, such as potentially preventable inpatient hospital
admissions, emergency department visits, and readmissions. In the June
2014 MedPAC Report to the Congress: Medicare and the Health Care
Delivery System MedPAC suggests considering an alternative quality
measurement approach that would use population-based outcome measures
to publicly report on quality of care across Medicare's three payment
models, FFS, Medicare Advantage, and ACOs.
In creating policy for global and population-based measures for
MIPS we considered a more broad-based approach to the use of ``global''
and ``population-based'' measures in the MIPS quality performance
category. After considering the above we propose to use the acute and
chronic composite measures of Agency for Healthcare Research and
Quality (AHRQ) Prevention Quality Indicators (PQIs) that meet a minimum
sample size in the calculation of the quality measure domain for the
MIPS total performance score; see Table B. Eligible clinicians will be
evaluated on their performance on these measures in addition to the six
required quality measures discussed previously and summarized in Table
A. Based on experience in the VM program, these measures have been
determined to be reliable with a minimum case size of 20. Average
reliabilities for the acute and chronic measures range from 0.64 to
0.79 for groups and individual MIPS eligible clinicians. We intend to
incorporate a clinical risk adjustment as soon as feasible to the PQI
composites and continue to research ways to develop and use other
population-based measures for the MIPS program that could be applied to
greater numbers of MIPS eligible clinicians going forward. In addition
to the acute and chronic composite measure, we also propose to include
the all-cause hospital readmissions measure from the VM as we believe
this measure also encourages care coordination. In the CY 2016 Medicare
PFS final rule (80 FR 71296), we did a reliability analysis that
indicates this measure is not reliable for solo clinicians or practices
with fewer than 10 clinicians; therefore, we propose to limit this
measure to groups with 10 or more clinicians and to maintain the
current VM requirement of 200 cases. Eligible clinicians in groups with
10 or more clinicians with sufficient cases will be evaluated on their
performance on this measure in addition to the six required quality
measures discussed previously and summarized in Table A.
Furthermore, the proposed claims-based population measures would
rely on the same two-step attribution methodology that is currently
used in the VM (79 FR 67961 through 67694). The attribution focuses on
the delivery of primary care services (77 FR 69320) by both primary
care physicians and specialists. This attribution logic aligns with the
total per capita measure and is similar to, but not exactly the same,
as the assignment methodology used for the Shared Savings Program. For
example, the Shared Savings Program definition of primary care services
can
[[Page 28193]]
be found at Sec. 425.20 and excludes claims for certain Skilled
Nursing Facility (SNF) services that include the POS 31 modifier). In
section II.E.5.e.3.a.i. of this proposed rule, we propose to exclude
the POS 31 modifier from the definition of primary care services. As
described in section II.E.2. of this proposed rule, the attribution
would be modified slightly to account for the MIPS eligible clinician
identifiers. We are seeking comments on additional measures or measure
topics for future years of MIPS and attribution methodology. We request
comments on these proposals.
c. Selection of Quality Measures for Individual MIPS Eligible
Clinicians and Groups
(1) Annual List of Quality Measures Available for MIPS Assessment
Under section 1848(q)(2)(D)(i) of the Act, the Secretary, through
notice and comment rulemaking, must establish an annual list of quality
measures from which MIPS eligible clinicians may choose for purposes of
assessment for a performance period. The annual list of quality
measures must be published in the Federal Register no later than
November 1 of the year prior to the first day of a performance period.
Updates to the annual list of quality measures must be published in the
Federal Register not later than November 1 of the year prior to the
first day of each subsequent performance period. Updates may include
the removal of quality measures, the addition of new quality measures,
and the inclusion of existing quality measures that the Secretary
determines have undergone substantive changes. For example, a quality
measure may be considered for removal if the Secretary determines that
the measure is no longer meaningful, such as measures that are topped
out. A measure may be considered topped out if measure performance is
so high and unvarying that meaningful distinctions and improvement in
performance can no longer be made. Additionally, we are not the measure
steward for most of the proposed quality measures available for
inclusion in the MIPS annual list of quality measures. We rely on
outside measure stewards and developers to maintain these measures.
Therefore, we also propose to give consideration in removing measures
that measure stewards are no longer able to maintain.
Under section 1848(q)(2)(D)(ii) of the Act, the Secretary must
solicit a ``Call for Quality Measures'' each year. Specifically, the
Secretary must request that eligible clinician organizations and other
relevant stakeholders identify and submit quality measures to be
considered for selection in the annual list of quality measures, as
well as updates to the measures. Although we will accept quality
measures submissions at any time, only measures submitted before June 1
of each year will be considered for inclusion in the annual list of
quality measures for the performance period beginning 2 years after the
measure is submitted. For example, a measure submitted prior to June 1,
2016 would be considered for the 2018 performance period. Of those
quality measures submitted before June 1, we will determine which
quality measures will move forward as potential measures for use in
MIPS. Prior to finalizing new measures for inclusion in the MIPS
program, those measures that we determine will move forward must also
go through notice-and-comment rulemaking and the new proposed measures
must be submitted to a peer review journal. Finally, for quality
measures that have undergone substantive changes, we propose to
identify measures including but not limited to measures that have had
measure specification, measure title, and domain changes. Through NQF's
or the measure steward's measure maintenance process, NQF-endorsed
measures are sometimes updated to incorporate changes that we believe
do not substantively change the intent of the measure. Examples of such
changes may include updated diagnosis or procedure codes or changes to
exclusions to the patient population or definitions. While we address
such changes on a case-by-case basis, we generally believe these types
of maintenance changes are distinct from substantive changes to
measures that result in what are considered new or different measures.
In the first year of MIPS, we propose to maintain a majority of
previously implemented measures in PQRS (80 FR 70885-71386) for
inclusion in the annual list of quality measures. These measures can be
found in the appendix at Table A: Proposed Individual Quality Measures
Available for MIPS Reporting in 2017. Also included in the appendix in
Table B is a list of quality measures that do not require data
submission, some of which were previously implemented in the VM (80 FR
71273-71300), that we propose to include in the annual list of MIPS
quality measures. These measures can be calculated from administrative
claims data and do not require data submission. We are also proposing
measures that were not previously finalized for implementation in the
PQRS program. These measures and their draft specifications are listed
in Table D. The proposed specialty-specific measure sets are listed in
Table E. As we continue to develop measures and specialty-specific
measure sets, we recognize that there are many MIPS eligible clinicians
who see both Medicaid and Medicare patients and seek to align our
measures to utilize Medicaid measures in the MIPS quality performance
category. We believe that aligning Medicaid and Medicare measures is in
the interest of all providers and will help drive quality improvement
for our beneficiaries. For future years, we seek comment about the
addition of a ``Medicaid measure set'' based on the CMCS Adult Core Set
(https://www.medicaid.gov/medicaid-chip-program-information/by-topics/quality-of-care/adult-health-care-quality-measures.html). Measures we
are proposing for removal can be found in Table F and measures that
will have substantive changes for the 2017 performance period can be
found in Table G. In future years, the annual list of quality measures
available for MIPS assessment will occur through rulemaking. We request
comment on these proposals. In particular, we seek comment on whether
there are any measures that commenters believe should be classified in
a different NQS domain than what was proposed or that should be
classified as a different measure type (e.g., process vs. outcome) than
what was proposed.
(2) Call for Quality Measures
Each year, we have historically solicited a ``Call for Quality
Measures'' from the public for possible quality measures for
consideration for the PQRS. Under MIPS, we propose to continue the
annual ``Call for Quality Measures'' as a way to engage eligible
clinician organizations and other relevant stakeholders in the
identification and submission of quality measures for consideration.
Under section 1848(q)(2)(D)(ii) of the Act, eligible clinician
organizations are professional organizations as defined by nationally
recognized specialty boards of certification or equivalent
certification boards. However, we do not believe there needs to be any
special restrictions on the type or make-up of the organizations
carrying out the process of development of quality measures. Any such
restriction would limit the development of quality measures and the
scope and utility of the quality measures that may be considered for
endorsement. Submission of potential quality measures regardless of
whether they
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were previously published in a proposed rule or endorsed by an entity
with a contract under section 1890(a) of the Act, which is currently
the National Quality Forum, is encouraged.
As previously noted, we encourage the submission of potential
quality measures regardless of whether such measures were previously
published in a proposed rule or endorsed by an entity with a contract
under section 1890(a) of the Act. However, consistent with the
expectations established under PQRS, we propose to request that
stakeholders apply the following considerations when submitting quality
measures for possible inclusion in MIPS:
Measures that are not duplicative of an existing or
proposed measure.
Measures that are beyond the measure concept phase of
development and have started testing, at a minimum.
Measures that include a data submission method beyond
claims-based data submission.
Measures that are outcome-based rather than clinical
process measures.
Measures that address patient safety and adverse events.
Measures that identify appropriate use of diagnosis and
therapeutics.
Measures that address the domain for care coordination.
Measures that address the domain for patient and caregiver
experience.
Measures that address efficiency, cost and resource use.
Measures that address a performance gap or measurement
gap.
We request comment on these proposals.
(3) Requirements
Section 1848(q)(2)(D)(iii) of the Act provides that, in selecting
quality measures for inclusion in the annual final list of quality
measures, the Secretary must provide that, to the extent practicable,
all quality domains (as defined in section 1848(s)(1)(B) of the Act)
are addressed by such measures and must ensure that the measures are
selected consistent with the process for selection of measures under
section 1848(k), (m), and (p)(2) of the Act.
Section 1848(s)(1)(B) of the Act defines ``quality domains'' as at
least the following domains: clinical care, safety, care coordination,
patient and caregiver experience, and population health and prevention.
We believe the five domains applicable to the quality measures under
MIPS are included in the NQS's six priorities as follows:
Patient Safety. These are measures that reflect the safe
delivery of clinical services in all health care settings. These
measures may address a structure or process that is designed to reduce
risk in the delivery of health care or measure the occurrence of an
untoward outcome such as adverse events and complications of procedures
or other interventions. We believe this NQS priority corresponds to the
domain of safety.
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 health care 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. We believe this NQS priority
corresponds to the domain of patient and caregiver experience.
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. We believe this NQS priority
corresponds to the domain of care coordination.
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. We believe this NQS priority corresponds to the domain
of clinical care.
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. We believe this NQS priority corresponds to the
domain of population health and prevention.
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 health care resources or inefficiencies in health
care delivery.
Section 1848(q)(2)(D)(viii) of the Act provides that the pre-
rulemaking process under section 1890A of the Act is not required to
apply to the selection of MIPS quality measures. Although not required
to go through the pre-rulemaking process, we have found the NQF
convened Measure Application Partnership's (MAP) input valuable. We
propose that we may consider the MAP's recommendations as part of the
comprehensive assessment of each measure considered for inclusion under
MIPS. Elements we propose to consider in addition to those listed in
the ``Call for Quality Measures'' section of this rule include a
measure's fit within MIPS, if a measure fills clinical gaps, changes or
updates to performance guidelines, and other program needs. Further, we
will continue to explore how global and population-based measures can
be expanded and plan to add additional population-based measures
through future rulemaking. We request comment on these proposals.
(4) Peer Review
Section 1848(q)(2)(D)(iv) of the Act, requires the Secretary to
submit new measures for publication in applicable specialty-
appropriate, peer-reviewed journals before including such measures in
the final annual list of quality measures. The submission must include
the method for developing and selecting such measures, including
clinical and other data supporting such measures. We believe this
opportunity for peer review helps ensure that new measures published in
the final rule are meaningful and comprehensive. We propose to use the
Call for Quality Measures process as an opportunity to gather the
information necessary to draft the journal articles for submission from
measure developers, measure owners and measure stewards since CMS does
not always develop measures for the quality programs. Information from
measure developers, measure owners and measure stewards will include
but is not limited to: Background, clinical evidence and data that
supports the intent of the measure; recommendation for the measure that
may come from a study or the United States Preventive Task Force
(USPTF) recommendations; and how this measure would align with the CMS
Quality Strategy. The Call for Quality Measures is a yearlong process;
however, to be aligned with the regulatory process, establishing the
proposed measure set for the year
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generally begins in April and concludes in July. We will submit new
measures for publication in applicable specialty-appropriate, peer-
reviewed journals before including such measures in the final annual
list of quality measures. We request comment on this proposal.
Additionally, we seek comment on mechanisms that could be used, such as
the CMS Web site, to notify the public that the requirement to submit
new measures for publication in applicable specialty-appropriate, peer-
reviewed journals is met. Additionally, we seek comment on the type of
information that should be included in such notification.
(5) Measures for Inclusion
Under section 1848(q)(2)(D)(v) of the Act, the final annual list of
quality measures must include, as applicable, measures from under
section 1848(k), (m), and (p)(2) of the Act, including quality measures
among: (1) Measures endorsed by a consensus-based entity; (2) measures
developed under section 1848(s) of the Act; and (3) measures submitted
in response to the ``Call for Quality Measures'' required under section
1848(q)(2)(D)(ii) of the Act. Any measure selected for inclusion that
is not endorsed by a consensus-based entity must have an evidence-based
focus. Further, under section 1848(q)(2)(D)(ix), the process under
section 1890A of the Act is considered optional.
Section 1848(s)(1) of the Act, as added by section 102 of the
MACRA, also requires the Secretary of Health and Human Services to
develop a draft plan for the development of quality measures by January
1, 2016. We solicited comments from the public on the ``Draft CMS
Measure Development Plan'' through March 1, 2016. The final CMS Measure
Development Plan must be finalized and posted on the CMS Web site by
May 1, 2016.
(6) Exception for QCDR Measures
Section 1848(q)(2)(D)(vi) of the Act provides that quality measures
used by a QCDR under section 1848(m)(3)(E) of the Act are not required
to be established through notice-and-comment rulemaking or published in
the Federal Register; be submitted for publication in applicable
specialty-appropriate, peer-reviewed journals, or meet the criteria
described in section 1848(q)(2)(D)(v) of the Act. The Secretary must
publish the list of quality measures used by such QCDRs on the CMS Web
site. We propose to post the quality measures for use by qualified
clinical data registries in the spring of 2017 for the initial
performance period and no later than January 1 for future performance
periods.
Quality measures that are owned or developed by the QCDR entity and
proposed by the QCDR for inclusion in MIPS but are not a part of the
MIPS quality measure set are considered non-MIPS measures. If a QCDR
wants to use a non-MIPS measure for inclusion in the MIPS program for
reporting, we propose that these measures go through a rigorous CMS
approval process during the QCDR self-nomination period. Specific
details on third party entity requirements can be found in section
II.E.9 of this proposed rule. The measure specifications will be
reviewed and each measure will be analyzed for its scientific rigor,
technical feasibility, duplication to current MIPS measures, clinical
performance gaps, as evidenced by background and/or literature review,
and relevance to specialty practice quality improvement. Once the
measures are analyzed, the QCDR will be notified of which measures are
approved for implementation. Each non-MIPS measure will be assigned a
unique ID that can only be used by the QCDR that proposed it. Although
non-MIPS measures are not required to be NQF-endorsed, we encourage the
use of NQF-endorsed measures and measures that have been in use prior
to implementation in MIPS. Lastly, we note that MIPS eligible
clinicians reporting via QCDR have the option of reporting MIPS
measures included in Table A in the Appendix to the extent that such
measures are appropriate for the specific QCDR and have been approved
by CMS. We request comment on these proposals.
(7) Exception for Existing Quality Measures
Section 1848(q)(2)(D)(vii)(II) of the Act provides that any quality
measure specified by the Secretary under section 1848(k) or (m) of the
Act and any measure of quality of care established under section
1848(p)(2) of the Act for a performance or reporting period beginning
before the first MIPS performance period (herein referred to
collectively as ``existing quality measures'') must be included in the
annual list of MIPS quality measures unless removed by the Secretary.
As discussed in section II.E.4 of this proposed rule, we are proposing
that the performance period for the 2019 MIPS adjustment would be CY
2017, that is, January 1, 2017 through December 31, 2017. Therefore
existing quality measures would consist of those that have been
specified or established by the Secretary as part of the PQRS measure
set or VM measure set for a performance or reporting period beginning
before CY 2017.
Section 1848(q)(2)(D)(vii)(I) of the Act provides that existing
quality measures are not required to be established through notice-and-
comment rulemaking or published in the Federal Register (although they
remain subject to the applicable requirements for removing measures and
including measures that have undergone substantive changes), nor are
existing quality measures required to be submitted for publication in
applicable specialty-appropriate, peer-reviewed journals.
(8) Consultation With Relevant Eligible Clinician Organizations and
Other Relevant Stakeholders
Section 1890A of the Act, as added by section 3014(b) of the ACA,
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) convenes 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 the quality
measures selected for 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 make
publicly available by December 1 of each year a list of the quality and
efficiency measures that the Secretary is considering under Medicare.
The NQF must provide the Secretary with the MAP's input on the
selection of measures by February 1 of each year. The lists of measures
under consideration for selection are available at http://www.qualityforum.org/map/.
Section 1848(q)(2)(D)(viii) of the Act provides that relevant
eligible clinician organizations and other relevant stakeholders,
including state and national medical societies, must be consulted in
carrying out the annual list of quality measures available for MIPS
assessment. Section 1848(q)(2)(D)(ii)(II) of the Act defines an
eligible clinician organization as a professional organization as
defined by nationally recognized specialty boards of certification or
equivalent certification boards. Section 1848(q)(2)(D)(viii) of the Act
further provides that the pre-rulemaking process under section 1890A of
the Act is not required to apply to the selection of MIPS quality
measures.
[[Page 28196]]
Although MIPS quality measures are not required to go through the
pre-rulemaking process under section 1890A of the Act, we have found
the MAP's input valuable. The MAP process enables us to consult with
relevant eligible professional organizations and other stakeholders,
including state and national medical societies in finalizing the annual
list of quality measures. In addition to the MAP's input this year, we
also received input from the Core Measure Collaborative, specifically
the America's Health Insurance Plans (AHIP), on core quality measure
sets. The Core Measure Collaborative was organized by CMS in
coordination with AHIP in 2014. This stakeholder workgroup has
developed several condition-specific core measure sets to help align
reporting requirements for private and public health insurance
providers. Sixteen of the newly proposed measures under MIPS were
recommended by the Core Measure Collaborative.
(9) Cross-Cutting Measures for 2017 and Beyond
Under PQRS we realized the value in requiring EPs to report a
cross-cutting measure and have proposed to continue the use of cross-
cutting measures under MIPS. The cross-cutting measures help focus our
efforts on population health improvement and they also allow for
meaningful comparisons between MIPS eligible clinicians. Under MIPS, we
are proposing fewer cross-cutting measures than those available under
PQRS for 2016 reporting; however, we believe the list contains measures
for which all patient-facing MIPS eligible clinicians should be able to
report, as the measures proposed include commonplace health improvement
activities such as checking blood pressure and medication management.
We have eliminated some measures for which the reporting MIPS eligible
clinician may not actually be providing the care, but are just
reporting another MIPS eligible clinician's performance result. An
example of this would be a MIPS eligible clinician who never manages a
diabetic patient's glucose, yet previously could have reported a
measure about hemoglobin A1c based on an encounter. This type of
reporting will likely not help improve or confirm the quality of care
the MIPS eligible clinician provides to his or her patients. Although
there are fewer proposed cross-cutting measures under MIPS, in previous
years some measures were too specialized and could not be reported on
by all MIPS eligible clinicians. The proposed cross-cutting measures
under MIPS are more broadly applicable and can be reported on by most
specialties. The proposed MIPS cross-cutting measure set will be
available on the CMS Web site. Non-patient-facing MIPS eligible
clinicians do not have a cross-cutting measure requirement. The cross-
cutting measures that were available under PQRS for 2016 reporting that
are not being proposed as cross-cutting measures for 2017 reporting
are:
PQRS #001 (Diabetes: Hemoglobin A1c Poor Control).
PQRS #046 (Medication Reconciliation Post Discharge).
PQRS #110 (Preventive Care and Screening: Influenza
Immunization).
PQRS #111 (Pneumonia Vaccination Status for Older Adults).
PQRS #112 (Breast Cancer Screening).
PQRS #131 (Pain Assessment and Follow-Up).
PQRS #134 (Preventive Care and Screening: Screening for
Clinical Depression and Follow-Up Plan).
PQRS #154 (Falls: Risk Assessment).
PQRS #155 (Falls: Plan of Care).
PQRS #182 (Functional Outcome Assessment).
PQRS #240 (Childhood Immunization Status).
PQRS #318 (Falls: Screening for Fall Risk).
PQRS #400 (One-Time Screening for Hepatitis C Virus (HCV)
for Patients at Risk).
While we are proposing to remove the above listed measures from the
cross-cutting measure set, these measures are being proposed to be
available as individual quality measures available for MIPS reporting,
some of which have proposed substantive changes. The proposed MIPS
cross-cutting measure set can be found in Table C of the appendix of
this proposed rule and will be available on the CMS Web site.
e. Resource Use Performance Category
(1) Background
(a) General Overview and Strategy
Measuring resource use is an integral part of measuring value. We
envision the measures in the MIPS resource use performance category
would provide MIPS eligible clinicians with the information they need
to provide appropriate care to their patients and enhance health
outcomes. In implementing the resource use performance category, we
propose to start with existing condition and episode-based measures,
and the total per capita costs for all attributed beneficiaries measure
(total per capita cost measure). All resource use measures would be
adjusted for geographic payment rate adjustments and beneficiary risk
factors. In addition, a specialty adjustment would be applied to the
total per capita cost measure. As detailed in section II.E.6.a.3 of
this proposed rule, all of the measures attributed to a MIPS eligible
clinician or group would be weighted equally within the resource use
performance category, and there would be no minimum number of measures
required to receive a score under the resource use performance
category. We plan to draw on standards for measure reliability, patient
attribution, risk adjustment, and payment standardization from the
Physician Value-based Payment Modifier (Value Modifier or VM) as well
as the Physician Feedback Program, as we believe many of the same
measurement principles for cost measurement in the VM are applicable
for measurement in the resource use performance category in MIPS.
All measures used under the resource use performance category would
be derived from Medicare administrative claims data and as a result,
participation would not require use of a data submission mechanism.
We plan to continue developing care episode groups, patient
condition groups, and patient relationship categories (and codes for
such groups and categories). We plan to incorporate new measures as
they become available and will give the public the opportunity to
comment on these provisions through future notice and comment
rulemaking. We also will closely examine the recommendations from the
HHS' Office of the Assistant Secretary for Planning and Evaluation
(ASPE) study, when they are available, on the issue of risk adjustment
for socioeconomic status on quality measures and resource use as
required by section 2(d) of the IMPACT Act and incorporate them as
feasible and appropriate through future rulemaking, under section
1848(q)(1)(G) of the Act.
(b) MACRA Requirements
Section 1848(q)(2)(A)(ii) of the Act establishes ``resource use''
as a performance category under the MIPS. Section 1848(q)(2)(B)(ii) of
the Act describes the measures of the resource use performance category
as the measurement of resource use for a MIPS performance period under
section1848(p)(3) of the Act, using the methodology under section
1848(r) of the Act as appropriate, and, as feasible and applicable,
accounting for the cost of drugs under Part D.
As discussed in section II.E.5.e.(1)(c) of this proposed rule, we
previously established in rulemaking a value-based
[[Page 28197]]
payment modifier, as required by section 1848(p) of the Act, that
provides for differential payment to a physician or a group of
physicians under the Physician Fee Schedule based on the quality of
care furnished compared to cost. For the evaluation of costs of care,
section 1848(p)(3) refers to appropriate measures of costs established
by the Secretary that eliminate the effect of geographic adjustments in
payment rates and take into account risk factors (such as socioeconomic
and demographic characteristics, ethnicity, and health status of
individuals, such as to recognize that less healthy individuals may
require more intensive interventions) and other factors determined
appropriate by the Secretary.
Section 1848(r) of the Act specifies a series of steps and
activities for the Secretary to undertake to involve the physician,
practitioner, and other stakeholder communities in enhancing the
infrastructure for resource use measurement, including for purposes of
MIPS and APMs. Section 1848(r)(2) of the Act requires the development
of care episode and patient condition groups, and classification codes
for such groups. That section provides for care episode and patient
condition groups to account for a target of an estimated one-half of
expenditures under Parts A and B (with this target increasing over time
as appropriate). We are required to take into account several factors
when establishing these groups. For care episode groups, we must
consider the patient's clinical problems at the time items and services
are furnished during an episode of care, such as clinical conditions or
diagnoses, whether or not inpatient hospitalization occurs, the
principal procedures or services furnished, and other factors
determined appropriate by the Secretary. For patient condition groups,
we must consider the patient's clinical history at the time of a
medical visit, such as the patient's combination of chronic conditions,
current health status, and recent significant history (such as
hospitalization and major surgery during a previous period), and other
factors determined appropriate. We are required to post on the CMS Web
site a draft list of care episode and patient condition groups and
codes for solicitation of input from stakeholders, and subsequently
post on the Web site an operational list of such groups and codes. As
required by section 1848(r)(2)(H) of the Act, not later than November 1
of each year (beginning with 2018), the Secretary shall, through
rulemaking, revise the operational list as the Secretary determines may
be appropriate.
To facilitate the attribution of patients and episodes to one or
more clinicians, section 1848(r)(3) of the Act requires the development
of patient relationship categories and codes that define and
distinguish the relationship and responsibility of a physician or
applicable practitioner with a patient at the time of furnishing an
item or service. These categories shall include different relationships
of the clinician to the patient and reflect various types of
responsibility for and frequency of furnishing care. We are required to
post on the CMS Web site a draft list of patient relationship
categories and codes for solicitation of input from stakeholders, and
subsequently post on the Web site an operational list of such
categories and codes. As required by section 1848(r)(3)(F) of the Act,
not later than November 1 of each year (beginning with 2018), the
Secretary shall, through rulemaking, revise the operational list as the
Secretary determines may be appropriate.
Section 1848(r)(4) of the Act requires that claims submitted for
items and services furnished by a physician or applicable practitioner
on or after January 1, 2018, shall, as determined appropriate by the
Secretary, include the applicable codes established for care episode
groups, patient condition groups, and patient relationship categories
under sections 1848(r)(2) and (3) of the Act, as well as the NPI of the
ordering physician or applicable practitioner (if different from the
billing physician or applicable practitioner).
Under section 1848(r)(5) of the Act, to evaluate the resources used
to treat patients, the Secretary shall, as determined appropriate, use
the codes reported on claims under section 1848(r)(4) of the Act to
attribute patients to one or more physicians and applicable
practitioners and as a basis to compare similar patients, and conduct
an analysis of resource use. In measuring such resource use, the
Secretary shall use per patient total allowed charges for all services
under Parts A and B (and, if the Secretary determines appropriate, Part
D) and may use other measures of allowed charges and measures of
utilization of items and services. The Secretary shall seek comments
through one or more mechanisms (other than notice and comment
rulemaking) from stakeholders regarding the resource use methodology
established under section 1848(r)(5) of the Act.
On October 15, 2015, as required by section 1848(r)(2)(B) of the
Act, we posted on the CMS Web site for public comment a list of the
episode groups developed under section 1848(n)(9)(A) of the Act with a
summary of the background and context to solicit stakeholder input as
required by section 1848(r)(2)(C) of the Act. That posting is available
at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html. The public comment period closed on February 15, 2016.
(c) Relationship to the Value Modifier
Currently, the physician value-based payment modifier established
under section 1848(p) of the Act utilizes six cost measures (see 42 CFR
414.1235): (1) A total per capita costs for all-attributed
beneficiaries measure (which we will refer to as the total per capita
cost measure); (2) a total per capita costs for all attributed
beneficiaries with chronic obstructive pulmonary disease (COPD)
measure; (3) a total per capita costs for all attributed beneficiaries
with congestive heart failure (CHF) measure; (4) a total per capita
costs for all attributed beneficiaries with coronary artery disease
(CAD) measure; (5) a total per capita costs for all attributed
beneficiaries with diabetes mellitus (DM) measure; and (6) a Medicare
Spending Per Beneficiary (MSPB) measure.
Total per capita costs include payments under both Part A and Part
B, but do not include Medicare payments under Part D for drug expenses.
All cost measures for the VM are attributed at the physician group and
solo practice level using the Medicare-enrolled billing TIN under a
two-step attribution methodology. They are risk-adjusted and payment-
standardized, and the expected cost is adjusted for the TIN's specialty
composition. We refer readers to our discussions of these total per
capita cost measures (76 FR 73433 through 73434, 77 FR 69315 through
69316), MSPB measure (78 FR 74774 through 74780, 80 FR 71295 through
71296), payment standardization methodology (77 FR 69316 through
69317), risk adjustment methodology (77 FR 69317 through 69318), and
specialty adjustment methodology (78 FR 74781 through 74784) in earlier
rulemaking for the VM. More information about these total per capita
cost measures may be found in documents under the links titled
``Measure Information Form: Overall Total Per Capita Cost Measure,''
``Measure Information Form: Condition-Specific Total Per Capita Cost
Measures,'' and ``Measure Information Form: Medicare Spending Per
[[Page 28198]]
Beneficiary Measure'' available at https://www.cms.gov/medicare/medicare-fee-for-service-payment/physicianfeedbackprogram/valuebasedpaymentmodifier.html.
The total per capita cost measures use a two-step attribution
methodology that is similar, but not exactly the same, as the
assignment methodology used for the Shared Savings Program. The
attribution focuses on the delivery of primary care services (77 FR
69320) by both primary care clinicians and specialists. The MSPB
measure has a different attribution methodology. It is attributed to
the TIN that provides the plurality of Medicare Part B claims (as
measured by allowable charges) during the index inpatient
hospitalization. We refer readers to the discussion of our attribution
methodologies (77 FR 69318 through 69320, 79 FR 67960 through 67964) in
prior rulemaking for the VM.
These total per capita cost measures include payments for a
calendar year and have been reported to TINs for several years through
the Quality and Resource Use Reports (QRURs), which are issued as part
of the Physician Feedback Program under section 1848(n) of the Act. The
total per capita cost measures have been used in the calculation of the
VM payment adjustments beginning with the 2015 payment adjustment
period and the MSPB measure has been used in the calculation of the VM
payment adjustments beginning with the 2016 payment adjustment period.
More information about the current attribution methodology for these
measures is available in the ``Fact Sheet for Attribution in the Value-
Based Payment Modifier Program'' document available at https://www.cms.gov/medicare/medicare-fee-for-service-payment/physicianfeedbackprogram/valuebasedpaymentmodifier.html.
In the MIPS and APMs RFI (80 FR 59102 through 59113), we solicited
feedback on the resource use performance category. Commenters directed
our attention towards the ``2015 Value-Based Payment Modifier Program
Experience Report'' (document available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Downloads/2015-VM-Program-Experience-Rpt.pdf) for data demonstrating
that physicians treating the largest shares of the Medicare's sickest
patients are most likely to incur downward adjustments under the
current program. Commenters suggested that CMS could risk adjust cost
measures for differences in beneficiary characteristics impacting
health and cost outcomes, and suggested that cost measure benchmarks
could be stratified so that groups and solo practitioners are compared
to other groups and individual practitioners treating beneficiaries
with similar risk profiles. Commenters also expressed concern that
current attribution methods are holding many clinicians accountable for
costs they have no control over, while other clinicians have no
patients attributed and no way of calculating accurate scores.
Commenters generally believe episode-based costs could provide a more
accurate measure in calculating resource use and comparing clinicians
based on the cost of patient treatment episodes. Many commenters agreed
that if properly selected and designed, measures tied to episodes of
care could increase the relevance, reliability, and applicability of
resource use measures and make feedback reports more actionable.
However, in order for clinicians to be responsible for resource use,
including episode-based costs, commenters strongly emphasized the need
for access to timely and actionable information regarding these costs.
Commenters have expressed concern that because certain VM measures were
developed for hospitals they are not properly applied to clinician
practices, which do not have Medicare patient populations large enough
or heterogeneous enough to produce an accurate picture for resource
use. Commenters requested that CMS make an effort to use resource
measures which have been tested for use in clinician practices.
Commenters supported development of new measures based on clinical
guidelines and/or appropriate use criteria (AUC), and support the
related ``Choosing Wisely'' campaign. In future years, individual
specialties might decide to use AUC or ``Choosing Wisely'' guidelines
in the creation of resource use measures applicable to their members.
In these cases, CMS could consider adoption of evidence-based measures
developed through a multi-specialty, clinician-led process.
(2) Weighting in the Composite Performance Score
As required by section 1848(q)(5)(E)(i)(II)(bb) of the Act, the
resource use performance category shall make up no more than 10 percent
of the CPS for the first MIPS payment year (CY 2019) and not more than
15 percent of the CPS the second MIPS payment year (CY 2020).
Therefore, we propose at Sec. 414.1350 that the resource use
performance category would make up 10 percent of the CPS for the first
MIPS payment year (CY 2019) and 15 percent of the CPS for the second
MIPS payment year (CY 2020). As required by section
1848(q)(5)(E)(i)(II)(aa) of the Act and proposed at Sec. 414.1350,
starting with the third MIPS payment year and for each MIPS payment
year thereafter, the resource use performance category would make up 30
percent of the CPS.
(3) Resource Use Criteria
As discussed above in section II.E.5.a. of this proposed rule,
performance in the resource use performance category would be assessed
using measures based on administrative Medicare claims data. At this
time, we are not proposing any additional data submissions for the
resource use performance category. As such, MIPS eligible clinicians
and groups would be assessed based on resource use for Medicare
patients only and only for patients that are attributed to them. MIPS
eligible clinicians or groups that do not have enough attributed cases
to meet or exceed the case minimums proposed in sections
II.E.5.e.(3)(a)(ii) and II.E.5.e.(3)(b)(ii) would not be measured on
resource use. For more discussion of MIPS eligible clinicians and
groups without a resource use performance category score, please refer
to II.E.6.a.(3)(d) and II.E.6.b.
(a) Value Modifier Cost Measures Proposed for the MIPS Resource Use
Performance Category
For purposes of assessing performance of MIPS eligible clinicians
on the resource use performance category, we propose at Sec. 414.1350
to specify resource use measures for a performance period. For the CY
2017 MIPS performance period, we propose to utilize the total per
capita cost measure, the MSPB measure, and several episode-based
measures discussed in section II.E.5.e.3.b. of this proposed rule for
the resource use performance category. The total per capita costs
measure and the MSPB measure are described above in section
II.E.5.e.(1)(c) of this proposed rule.
We propose including the total per capita cost measure as it is a
global measure of all Part A and Part B resource use during the
performance period and inclusive of the four condition specific
measures under the VM (chronic obstructive pulmonary disease,
congestive heart failure, coronary artery disease, and diabetes
mellitus) for which performance tends to be correlated and its
inclusion was supported by commenters on the MIPS and APMs RFI (80 FR
59102 through 59113). We also anticipate that MIPS eligible clinicians
are familiar with the total per capita cost measure as the measure has
been in the VM since 2015
[[Page 28199]]
and feedback has been reported through the annual QRUR to all groups
starting in 2014.
We propose to adopt the MSPB measure because by the beginning of
the initial MIPS performance period in 2017, we believe most MIPS
eligible clinicians will be familiar with the measure in the VM or its
variant under the Hospital Value Based Purchasing program. However, we
propose two technical changes to the MSPB measure calculations for
purposes of its adoption in MIPS which are discussed in the reliability
section II.E.5.e.3.a.ii. of this proposed rule.
We propose to use the same methodologies for payment
standardization, and risk adjustment for these measures for the
resource use performance category as are defined for the VM. For more
details on the previously adopted payment standardization methodology
see 77 FR 69316 through 69317. For more details on the previously
adopted risk adjustment methodology see 77 FR 69317 through 69318.
We are not proposing to include the VM total per capita cost
measures for the four condition-specific groups (chronic obstructive
pulmonary disease, congestive heart failure, coronary artery disease,
and diabetes mellitus). Instead, we are generally proposing to assess
performance as part of the episode-based measures proposed under
section II.E.5.e.3.b. of this proposed rule. This shift is in response
to feedback received as part of the MIPS and APMs RFI (80 FR 59102
through 59113). In the MIPS and APMs RFI, commenters stated that they
do not believe the existing condition-based measures under the VM are
relevant to their practice and expressed support for episode-based
measures under MIPS.
(i) Attribution
In the VM, all cost measures are attributed to a TIN. In MIPS,
however, we are proposing to evaluate performance at the individual and
group levels. Please refer to section II.E.5.e.(3)(c) of this proposed
rule, for our proposals to address attribution differences for
individuals and groups. For purposes of this section, we will use the
general term MIPS eligible clinicians to indicate attribution for
individuals or groups.
For the MSPB measure, we propose to use attribution logic that is
similar to what is used in the VM. MIPS eligible clinicians with the
plurality of claims (as measured by allowable charges) for Medicare
Part B services, rendered during an inpatient hospitalization that is
an index admission for the MSPB measure during the applicable
performance period would be assigned the episode. The only difference
from the VM attribution methodology would be that the MSPB measure
would be assigned differently for individuals than for groups. For the
total per capita cost measure, we propose to use a two-step attribution
methodology that is similar to the methodology used in the 2017 and
2018 VM. We also propose to have the same two-step attribution process
for the claims-based population measures in the quality performance
category (section II.E.5.b.6.), CMS Web Interface measures, and CAHPS
for MIPS. However, we also propose to make some modifications to the
primary care services definition that is used in the attribution
methodology to align with policies adopted under the Shared Savings
Program.
The VM currently defines primary care services as the set of
services identified by the following HCPCS/CPT codes: 99201 through
99215, 99304 through 99340, 99341 through 99350, the welcome to
Medicare visit (G0402), and the annual wellness visits (G0438 and
G0439). We propose to update this set to include new care coordination
codes that have been implemented in the Medicare Physician Fee
Schedule: Transitional care management (TCM) codes (CPT codes 99495 and
99496) and the chronic care management (CCM) code (CPT code 99490).
These services were added to the primary care service definition used
by the Shared Saving Program in June 2015 (80 FR 32746 through 32748).
We believe that these care coordination codes would also be appropriate
for assigning services in the MIPS.
In the CY 2016 PFS final rule, the Shared Saving Program also
finalized another modification to the primary care service definition:
To exclude nursing visits that occur in a skilled nursing facility
(SNF) (80 FR 71271 through 71272). Patients in SNFs (POS 31) are
generally shorter stay patients who are 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 to 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 nursing facilities (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 believe that it would be appropriate to follow a
similar policy in MIPS; therefore, we propose to exclude services
billed under CPT codes 99304 through 99318 when the claim includes the
POS 31 modifier from the definition of primary care services.
We believe that making these two modifications would help align the
primary care service definition between MIPS and Shared Savings Program
and would improve the results from the 2-step attribution process.
We note, however, that while we are aligning the definition for
primary care services, the 2-step attribution for MIPS would be
different than the one used for the Shared Saving Program. We believe
there are valid reasons to have differences between MIPS and the Shared
Savings Program attribution. For example, as discussed in CY 2015 PFS
final rule (79 FR 67960 through 67962), we eliminated the primary care
service pre-step that is statutorily required for the Shared Savings
Program from the VM. We noted that without the pre-step, the
beneficiary attribution method would more appropriately reflect the
multiple ways in which primary care services are provided, which are
not limited to physician groups. As MIPS eligible clinicians include
more than physicians, we continue to believe it is appropriate to
exclude the pre-step.
In addition, in the 2015 Shared Saving Program final rule, we
finalized a policy for the Shared Savings Program that we did not
extend to the VM 2-step attribution: to exclude select specialties
(such as several surgical specialties) from the second attribution step
(80 FR 32749 through 32754). We do not believe it is appropriate to
restrict specialties from the second attribution step for MIPS. If such
a policy were adopted under MIPS, then all specialists on the exclusion
list, unless they were part of a multispecialty group, would
automatically be excluded from measurement on the total per capita cost
measure, as well as on the claims-based population measures which rely
on the same 2-step attribution. While we do not believe that many MIPS
eligible clinicians or clinician groups with these specialties would be
attributed enough cases to meet or exceed the case minimum, we believe
that an automatic exclusion could remove some MIPS eligible clinicians
and groups that should be measured for resource use.
We request comments on these proposed changes.
(ii) Reliability
Additionally, we seek to ensure that MIPS eligible clinicians and
groups are measured reliably; therefore, we intend to use the 0.4
reliability threshold currently applied to measures under the
[[Page 28200]]
VM to evaluate their reliability. A 0.4 reliability threshold standard
means that the majority of MIPS eligible clinicians and groups who meet
the case minimum required for scoring under a measure have measure
reliability scores that exceed 0.4. We generally consider reliability
levels between 0.4 and 0.7 to indicate ``moderate'' reliability and
levels above 0.7 to indicate ``high'' reliability. In cases where we
have considered high participation in the applicable program to be an
important programmatic objective, such as the Hospital VBP Program, we
have selected this 0.4 moderate reliability standard. We believe this
standard ensures moderate reliability but does not substantially limit
participation.
To ensure sufficient measure reliability for the resource use
performance category in MIPS, we also propose at Sec.
414.1380(b)(2)(ii) to use the minimum of 20 cases for the total per
capita cost measure, the same case minimum that is being used for the
VM. An analysis in the CY 2016 PFS final rule (80 FR 71282) confirms
that this measure has high average reliability for solo practitioners
(0.74) as well as for groups with more than 10 professionals (0.80).
In the CY 2016 PFS final rule, we finalized a policy that increases
the minimum cases for the MSPB measure from 20 to 125 cases (80 FR
71295 through 71296) due to reliability concerns with the measure
including the specialty adjustment. That said, we recognize that a case
size increase of this nature also may limit the ability of MIPS
eligible clinicians to be scored on MSPB, and have been evaluating
alternative measure calculation strategies for potential inclusion
under MIPS that better balance participation, accuracy, and
reliability. As a result of this, we are proposing two modifications to
the MSPB measure.
The first technical change we are proposing is to remove the
specialty-adjustment from the MSPB measure's calculation. As currently
reported on the QRURs, the MSPB measure is risk adjusted to ensure that
these comparisons account for case-mix differences between
practitioners' patient populations and the national average. It is
unclear that the current additional adjustment for physician specialty
improves the accounting for case-mix differences for acute care
patients, and thus, may not be needed.
The second technical change we propose is to modify the cost ratio
used within the MSPB equation to evaluate the difference between
observed and expected episode cost at the episode level before
comparing the two at the individual or group level. In other words,
rather than summing all of the observed costs and dividing by the sum
of all the expected costs, we would take the observed to expected cost
ratio for each MSPB episode assigned to the MIPS eligible clinician or
group and take the average of the assigned ratios. As we did
previously, we would take the average for the MIPS eligible clinician
or group and multiply it by the average of observed costs across all
episodes nationally.
Our analysis, which is based on all Medicare Part A and B claims
data for beneficiaries discharged from an acute inpatient hospital
between January 1, 2013 and December 1, 2013, indicates that these two
changes would improve the MSPB measure's ability to calculate costs and
the accuracy with which it can be used to make clinician-level
performance comparisons. We also believe that these changes would help
ensure the MSPB measure can be applied to a greater number of MIPS
eligible clinicians while still maintaining its status as a reliable
measure. More specifically, our analysis indicates that after making
these changes to the MSPB measure's calculations, the MSPB measure
meets the desired 0.4 reliability threshold used in the VM for over 88
percent of all TINs with a 20 case minimum, including solo
practitioners. While this percentage is lower than our current policy
for the VM (where virtually all TINs with 125 or more episodes have
moderate reliability), setting the case minimum at 20 allows for an
increase in participation in the MSPB measure. Therefore, we propose at
Sec. 414.1380(b)(2)(ii) to use a minimum of 20 cases for the MSPB
measure. As noted previously, we consider expanded participation of
MIPS eligible clinicians, particularly individual reporters, to be of
great import for the purposes of transitioning to MIPS and believe that
this justifies a slight decrease of the percentage of TINs meeting the
reliability threshold.
We welcome public comment on these proposals.
(b) Episode-Based Measures Proposed for the MIPS Resource Use
Performance Category
As noted in the previous section, we are proposing to calculate
several episode-based measures for inclusion in the resource use
performance category. Groups have received feedback on their
performance on episode-based measures through the Supplemental Quality
and Resource Use Report (sQRUR), which are issued as part of the
Physician Feedback Program under section 1848(n) of the Act; however,
these measures have not been used for payment adjustments through the
VM. Several stakeholders expressed in the MIPS and APMs RFI the desire
to transition to episode-based measures and away from the general total
per capita measures used in the VM. Therefore, in lieu of using the
total per capita cost measures for populations with specific conditions
that are used for the VM, we are proposing episode-based measures for a
variety of conditions and procedures that are high cost, have high
variability in resource use, or are for high impact conditions. In
addition, as these measures are payment standardized and risk adjusted,
we believe they meet the statutory requirements for appropriate
measures of cost as defined in section 1848(p)(3) of the Act because
the methodology eliminates the effects of geographic adjustments in
payment rates and takes into account risk factors.
We also reiterate that while we transition to using episode-based
measures for payment adjustments, we will continue to engage
stakeholders through the process specified in section 1848(r)(2) of the
Act to refine and improve the episodes moving forward.
As noted earlier, we have provided performance information on
episode-based measures to MIPS eligible clinicians through the
Supplemental Quality and Resource Use Reports (sQRURs), which are
released in the Fall. The sQRURs provide groups and solo practitioners
with information to evaluate their resource utilization on conditions
and procedures that are costly and prevalent in the Medicare FFS
population. To accomplish this goal, various episodes are defined and
attributed to one or more groups or solo practitioners most responsible
for the patient's care. The episode-based measures include Medicare
Part A and Part B payments for services determined to be related to the
triggering condition or procedure. The payments included are
standardized to remove the effect of differences in geographic
adjustments in payment rates and incentive payment programs and they
are risk adjusted for the clinical condition of beneficiaries. Although
the sQRURs provide detailed information on these care episodes, the
calculations are not used to determine a TIN's VM payment adjustment
and are only used to provide feedback.
We propose to include in the resource use performance category
several clinical condition and treatment episode-based measures that
have been reported in the sQRUR or were included in the list of the
episode groups developed under section 1848(n)(9)(A)
[[Page 28201]]
of the Act published on the CMS Web site: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html. The identified
episode-based measures have been tested and previously published.
Tables 4 and 5 list the 41 clinical condition and treatment episode-
based measures proposed for the CY 2017 MIPS performance period, as
well as whether the episodes have previously been reported in a sQRUR.
The measures listed in Table 4 were developed under section
1848(n)(9)(A) of the Act, which required the Secretary to develop an
episode grouper that combines separate but clinically related items and
services into an episode of care for an individual, as appropriate, and
provide reports on utilization to physicians (episode grouping Method
A). The proposed measures accommodate both chronic and acute procedure
episodes. The measures are also specifically designed to accommodate
episodes that are initiated by physician claims, and section 1848(r)(4)
of the Act requires claims submitted for items and services furnished
by a physician or applicable practitioner on or after January 1, 2018,
to include (as determined appropriate by the Secretary) the applicable
codes established for care episode groups, patient condition groups,
and patient relationship categories. The episodes and logic have
undergone detailed and rigorous evaluation by an independent evaluation
contractor and CMS also reviewed for clinical validity.
Attribution and reliability for the measures are discussed later in
this section. Information about how the measures are constructed can be
found at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-Feedback.html under the link for ``Method A--Technical.'' Detailed
episode logic can be found under the ``Method A'' link on the same
page.
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Table 5 shows a second set of proposed measures that were developed
to complement previous CMS efforts and to provide additional episode
types to report in the supplemental QRURs. These measures represent
acute conditions and procedures that are costly and prevalent in the
Medicare FFS population. These measures examine services independently,
regardless of other episodes a patient may be experiencing, and
episodes do not interact with each other (episode grouping Method B).
Some of the episode types listed in Table 5 have subtypes that
provide additional clinical detail and improve the actionability of
data reported on these episode types, as well as comparability to
expected costs. All episode types were developed with clinical input
and complement the existing MSPB measure currently used in the VM. In
addition, all episode types were reported in 2014 sQRURs.
Information about how the measures are constructed can be found at
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-Feedback.html under the link for ``Method B--Technical.'' Detailed
episode logic can be found under the ``Method B'' link on the same
page.
[[Page 28207]]
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While we are proposing the measures listed in Tables 4 and 5 for
the resource use performance category, we are uncertain as to how many
of these measures we will ultimately include in the final rule. As
these measures have never been used for payment purposes, we may choose
to specify a subset of these measures in the final rule. We request
public comment on which of the measures listed in Tables 4 and 5 to
include in the final rule. In addition to considering public comments,
we intend to consider the number of MIPS eligible clinicians able to be
measured, the episode's impact on Medicare Part A and Part B spending,
and whether the measure has been reported through sQRUR. In addition,
while we do not believe specialty adjustment is necessary for the
episode-based measures, we will continue to explore this further given
the diversity of episodes. We seek comment on whether we should
specialty adjust the episode-based measures.
(i) Attribution
For the episode-based measures listed in Tables 4 and 5, we propose
to use the attribution logic used in the 2014 sQRUR (full description
available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Downloads/Detailed-Methods-2014SupplementalQRURs.pdf), with modifications to adjust for whether
performance is being assessed at an individual level or group level.
Please refer to section
[[Page 28208]]
II.E.5.e.(3)(c) of this proposed rule for our proposals to address
attribution differences for individuals and groups. For purposes of
this section, we will use the general term MIPS eligible clinicians to
indicate attribution for individuals or groups.
Acute condition episodes would be attributed to all MIPS eligible
clinicians that bill at least 30 percent of inpatient evaluation and
management (IP E&M) visits during the initial treatment, or ``trigger
event,'' that opened the episode. E&M visits during the episode's
trigger event represent services directly related to the management of
the beneficiary's acute condition episode. MIPS eligible clinicians
that bill at least 30 percent of IP E&M visits are therefore likely to
have been responsible for the oversight of care for the beneficiary
during the episode. It is possible for more than one MIPS eligible
clinician to be attributed a single episode using this rule. If an
acute condition episode has no IP E&M claims during the episode, then
that episode is not attributed to any MIPS eligible clinician.
Procedural episodes would be attributed to all MIPS eligible
clinicians that bill a Medicare Part B claim with a trigger code during
the trigger event of the episode. For inpatient procedural episodes,
the trigger event is defined as the IP stay that triggered the episode
plus the day before the admission to the IP hospital. For outpatient
procedural episodes constructed using Method A, the trigger event is
defined as the day of the triggering claim plus the day before and two
days after the trigger date. For outpatient procedural episodes
constructed using Method B, the trigger event is defined as only the
day of the triggering claim. Any Medicare Part B claim or line during
the trigger event with the episode's triggering procedure code is used
for attribution. If more than one MIPS eligible clinician bills a
triggering claim during the trigger event, the episode is attributed to
each of the MIPS eligible clinicians. If co-surgeons bill the
triggering claim, the episode is attributed to each MIPS eligible
clinician. If only an assistant surgeon bills the triggering claim, the
episode is attributed to the assistant surgeon or group. If an episode
does not have a concurrent Part B claim with a trigger code for the
episode, then that episode is not attributed to any MIPS eligible
clinician.
(ii) Reliability
To ensure moderate reliability, we propose at Sec.
414.1380(b)(2)(ii) to use the minimum of 20 cases for all episode-based
measures listed in Tables 4 and 5. We propose to not include any
measures that do not have average moderate reliability (at least 0.4)
at 20 episodes.
(c) Attribution for Individual and Groups
In the VM and sQRUR, all resource use measurement was attributed at
the solo practitioner and group level, as identified by TIN. In MIPS,
however, we are proposing to evaluate performance at the individual and
group levels. For MIPS eligible clinicians whose performance is being
assessed individually across the other MIPS performance categories, we
propose to attribute resource use measures using TIN/NPI rather than
TIN. Attribution at the TIN/NPI level allows individual MIPS eligible
clinicians, as identified by their TIN/NPI, to be measured based on
cases that are specific to their practice, rather than being measured
on all the cases attributed to the group TIN. For MIPS eligible
clinicians that choose to have their performance assessed as a group
across the other MIPS performance categories, we propose to attribute
resource use measures at the TIN level (the group TIN under which they
report). The logic for attribution would be similar whether attributing
to the TIN/NPI level or the TIN level. As an alternative proposal, we
seek comment on whether MIPS eligible clinicians that choose to have
their performance assessed as a group should first be attributed at the
individual TIN/NPI level and then have all cases assigned to the
individual TIN/NPIs attributed to the group under which they bill. This
alternative would apply one consistent methodology to both groups and
individuals, compared to having a methodology that assigns cases using
TIN/NPI for assessment at the individual level and another that assigns
cases using only TIN for assessment at the group level. For example,
the general attribution logic for MSPB is to assign the MSPB measure
based on the plurality of claims (as measured by allowable charges) for
Medicare Part B services rendered during an inpatient hospitalization
that is an index admission for the MSPB measure. Our proposed approach
would determine ``plurality of claims'' separately for individuals and
groups. For individuals, we would assign the MSPB measure using the
``plurality of claims'' by TIN/NPI, but for groups we would determine
the ``plurality of claims'' by TIN. The alternative proposal, in
contrast, would determine the ``plurality of claims'' by TIN/NPI for
both groups and individuals. However, for individuals, only the MSPB
measure attributed to the TIN/NPI would be evaluated, while for groups
the MSPB measure attributed to any TIN/NPI billing under the TIN would
be evaluated.
We request comment on this proposal and alternative considered.
(d) Application of Measures to Non-Patient Facing MIPS Eligible
Clinicians
Section 101(c) of the MACRA added section 1848(q)(2)(C)(iv) to the
Act, which requires the Secretary to give consideration to the
circumstances of professional types who typically furnish services
without patient facing interaction (non-patient-facing) when
determining the application of measures and activities. In addition,
this section allows the Secretary to apply alternative measures or
activities to non-patient facing MIPS eligible clinicians that fulfill
the goals of a performance category. Section 101(c) of the MACRA also
added section 1848(q)(5)(F) to the Act, which allows the Secretary to
re-weight MIPS performance categories if there are not sufficient
measures and activities applicable and available to each type of
eligible clinician involved.
For the 2017 MIPS performance period, we are not proposing any
alternative measures for non-patient facing MIPS eligible clinicians or
groups. This means that non-patient facing MIPS eligible clinicians or
groups may not be attributed any resource use measures that are
generally attributed to clinicians who have patient facing encounters
with patients. We therefore anticipate that, similar to MIPS eligible
clinicians or groups that do not meet the required case minimum for any
resource use measures, many non-patient facing MIPS eligible clinicians
may not have sufficient measures and activities available to report and
would not be scored on the resource use performance category under
MIPS. We refer readers to section II.E.6.b.2. of this proposed rule
where we discuss how we would address performance category weighting
for MIPS eligible clinicians or groups who do not receive a performance
category score for a given performance category. We also intend to work
with non-patient facing MIPS eligible clinicians and specialty
societies to propose alternative resource use measures for non-patient
facing MIPS eligible clinicians and groups under MIPS in future years.
Lastly, we seek comment on how best to incorporate appropriate
alternative resource use measures for all MIPS eligible clinician
types, including non-patient facing MIPS eligible clinicians.
(e) Additional System Measures
Section 1848(q)(2)(C)(ii) of the Act, as added by section 101(c) of
MACRA
[[Page 28209]]
provides that the Secretary may use measures used for a payment system
other than for physicians, such as measures for inpatient hospitals,
for purposes of the quality and resource use performance categories of
MIPS. The Secretary, however, may not use measures for hospital
outpatient departments, except in the case of items and services
furnished by emergency physicians, radiologists, and anesthesiologists.
We intend to align any facility-based MIPS measure decision across
the quality and resource use performance categories to ensure
consistent policies for MIPS in future years. We refer readers back to
section II.E.5.b.5. of this proposed rule, which discusses our strategy
and solicits comments related to this provision.
(4) Future Modifications to Resource Use Performance Category
In the future, we intend to consider how best to incorporate Part D
costs into the resource use performance category, as described in
section 1848(q)(2)(B)(ii) of the Act. We seek public comments on how we
should incorporate those costs under MIPS for future years. We also
intend to continue developing and refining episode groups for purposes
of resource use performance category measure calculations.
f. Clinical Practice Improvement Activity (CPIA) Category
(1) Background
(a) General Overview and Strategy
The CPIA performance category focuses on one of our MIPS strategic
goals, to use a patient-centered approach to program development that
leads to better, smarter, and healthier care. We believe improving the
health of all Americans can be accomplished by developing incentives
and policies that drive improved patient health outcomes. CPIAs
emphasize activities that have a proven association with improved
health outcomes. The CPIA performance category also focuses on another
MIPS strategic goal which is to use design incentives that drive
movement toward delivery system reform principles and APMs. Another
MIPS strategic goal we are striving to achieve is to establish policies
that can be scaled in future years as the bar for improvement rises.
Under the CPIA performance category we are proposing baseline
requirements that will continue to have more stringent requirements in
future years, and lay the groundwork for expansion towards continuous
improvement over time.
(b) The MACRA Requirements
Section 1848(q)(2)(C)(v)(III) of the Act defines a CPIA as an
activity that relevant eligible clinician organizations and other
relevant stakeholders identify as improving clinical practice or care
delivery, and that the Secretary determines, when effectively executed,
is likely to result in improved outcomes. Section 1848(q)(2)(B)(iii) of
the Act requires the Secretary to specify CPIAs under subcategories for
the performance period, which must include at least the subcategories
specified in section 1848(q)(2)(B)(iii)(I) through (VI) of the Act, and
in doing so to give consideration to the circumstances of small
practices (consisting of 15 or fewer clinicians), and practices located
in rural areas and geographic health professional shortage areas
(HPSAs).
Section 1848(q)(2)(C)(iv) of the Act generally requires the
Secretary to give consideration to the circumstances of non-patient-
facing MIPS eligible clinicians or groups and allows the Secretary, to
the extent feasible and appropriate, to apply alternative measures and
activities to such MIPS eligible clinicians and groups.
Section 1848(q)(2)(C)(v) of the Act required the Secretary to use a
request for information (RFI) to solicit recommendations from
stakeholders to identify CPIAs and specify criteria for such CPIAs, and
provides that the Secretary may contract with entities to assist in
identifying activities, specifying criteria for the activities, and
determining whether MIPS eligible clinicians or groups meet the
criteria set. In the MIPS and APMs RFI, we requested recommendations to
identify activities and specify criteria for activities. In addition,
we requested details on how data should be submitted, the number of
activities, how performance should be measured, and what considerations
should be made for small and/or rural practices. There were two
overarching themes from the comments that we received. First, the
majority of the comments indicated that all subcategories should be
weighted equally and that MIPS eligible clinicians or groups should be
allowed to select from whichever subcategories are most applicable to
them during the performance period. Second, commenters supported
inclusion of a diverse set of activities that are meaningful for
individual MIPS eligible clinicians or groups. We have reviewed all of
the comments that we received and have taken these recommendations into
consideration while developing the proposed CPIA policies.
(2) Contribution to Composite Performance Score (CPS)
Section 1848(q)(5)(E)(i)(III) of the Act specifies that the CPIA
performance category will account for 15 percent of the CPS, subject to
the Secretary's authority to assign different scoring weights under
section 1848(q)(5)(F) of the Act. Therefore, we propose at Sec.
414.1355, that the CPIA performance category will account for 15
percent of the CPS.
Section 1848(q)(5)(C)(i) of the Act specifies that a MIPS eligible
clinician or group that is certified as a patient-centered medical home
or comparable specialty practice, as determined by the Secretary, with
respect to a performance period must be given the highest potential
score for the CPIA performance category for the performance period. For
a further description of APMs that have a certified patient centered-
medical home designation, we refer readers to section II.E.5.h.
A patient-centered medical home will be recognized if it is a
nationally recognized accredited patient-centered medical home, a
Medicaid Medical Home Model, or a Medical Home Model. The NCQA Patient-
Centered Specialty Recognition will also be recognized, which qualifies
as a comparable specialty practice. Nationally recognized accredited
patient-centered medical homes are recognized if they are accredited
by: (1) The Accreditation Association for Ambulatory Health Care; (2)
the National Committee for Quality Assurance (NCQA) PCMH recognition;
(3) The Joint Commission Designation; or (4) the Utilization Review
Accreditation Commission (URAC).\8\ We refer readers to section II.F.
of this proposed rule for further description of the Medicaid Medical
Home Model or Medical Home Model.\9\ The criteria for being a
nationally recognized accredited patient-centered medical home is that
it must be national in scope and must have evidence of being used by a
large number of medical organizations as the model for their patient-
centered medical home. We seek comment on our proposal for determining
which practices would qualify as patient-centered medical homes. We
also note that practices may receive a patient-centered medical home
designation at a practice level, and that individual TINs may be
composed of both undesignated practices and practices that have
[[Page 28210]]
received a designation as a patient-centered medical home (for example,
only one practice site has received patient-centered medical home
designation in a TIN that includes five practice sites). For MIPS
eligible clinicians who choose to report at the group level, reporting
is required at the TIN level. We solicit comment on how to provide
credit for patient-centered medical home designations in the
calculation of the CPIA performance category score for groups when the
designation only applies to a portion of the TIN (for example, to only
one practice site in a TIN that is comprised of five practice sites).
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\8\ Gans, D. (2014). A Comparison of the National Patient-
Centered Medical Home Accreditation and Recognition Programs.
Medical Group Management Association, www.mgma.com.
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Section 1848(q)(5)(C)(ii) of the Act provides that MIPS eligible
clinicians or groups who are participating in an APM (as defined in
section 1833(z)(3)(C) of the Act) for a performance period must earn at
least one half of the highest potential score for the CPIA performance
category for the performance period. For further description of CPIA
and the APM scoring standard for MIPS, we refer readers to section
II.E.5.h. For all other MIPS eligible clinicians or groups, this
section applies and we also refer readers to the scoring requirements
for MIPS eligible clinicians and groups in section II.E.6. of this
proposed rule.
Section 1848(q)(5)(C)(iii) of the Act provides that a MIPS eligible
clinician or group must not be a MIPS eligible clinician or group
required to perform activities in each CPIA subcategory or participate
in an APM to achieve the highest potential score for the CPIA
performance category.
Section 1848(q)(5)(B)(i) of the Act requires the Secretary to treat
a MIPS eligible clinician or group that fails to report on an
applicable measure or activity that is required to be reported, they
will receive the lowest potential score applicable to the measure or
activity.
(3) CPIA Data Submission Criteria
(a) Submission Mechanisms
For the purpose of submitting under the CPIA performance category,
we proposed in section II.E.5.a. of this proposed rule to allow for
submission of data for the CPIA performance category using the
qualified registry, EHR, QCDR, CMS Web Interface and attestation data
submission mechanisms. If technically feasible, we will use
administrative claims data to supplement the CPIA submission.
Regardless of the data submission method, all MIPS eligible clinicians
or groups must select activities from the CPIA Inventory provided in
Table H of the Appendices. We believe the proposed data submission
methods will allow for greater access and ease in submitting data, as
well as consistency throughout the MIPS program.
In addition, we propose at Sec. 414.1360, that for the first year
only, all MIPS eligible clinicians or groups, or third party entities
such as health IT vendors, QCDRs and qualified registries that submit
on behalf of a MIPS eligible clinician or group, must designate a yes/
no response for activities on the CPIA Inventory. In the case where a
MIPS eligible clinician or group is using a health IT vendor, QCDR, or
qualified registry for their data submission, the MIPS eligible
clinician or group will certify all CPIAs have been performed and the
health IT vendor, QCDR, or qualified registry will submit on their
behalf. An agreement between a MIPS eligible clinician or group and a
health IT vendor, QCDR, or qualified registry for data submission for
CPIA as well as other performance data submitted outside of the CPIA
performance category could be contained in a single agreement,
minimizing the burden on the MIPS eligible clinician or group. See
section II.E.9 for additional details.
We propose to use the administrative claims method, if technically
feasible, only to supplement CPIA submissions. For example, if
technically feasible, MIPS eligible clinicians or groups, using the
telehealth modifier GT, could get automatic credit for this activity.
We request comments on these proposals.
(b) Weighted Scoring
While we considered both equal and differentially weighted scoring
in this performance category, the statute requires a differentially
weighted scoring model by requiring 100 percent of the potential score
in the CPIA performance category for patient-centered medical home
participants, and a minimum 50 percent score for APM participants. For
additional activities in this category, we propose at Sec. 414.1380 a
differentially weighted model for the CPIA performance category with
two categories: Medium and high. The justification for these two
weights is to provide flexible scoring due to the undefined nature of
activities (that is, CPIA standards are not nationally recognized and
there is no entity for CPIA that serves the same function as the
National Quality Forum does for quality measures). CPIAs are weighted
as high based on alignment with CMS national priorities and programs
such as the Quality Innovation Network-Quality Improvement Organization
(QIN/QIO) or the Comprehensive Primary Care Initiative which recognizes
specific activities related to expanded access and integrated
behavioral health as important. Programs that require performance of
multiple activities such as participation in the Transforming Clinical
Practice Initiative, seeing new and follow-up Medicaid patients in a
timely manner in the provider's State Medicaid Program, or an activity
identified as a public health priority (such as emphasis on
anticoagulation management or utilization of prescription drug
monitoring programs) were weighted as high.
The statute references patient-centered medical homes as achieving
the highest score for the MIPS program. MIPS eligible clinicians or
groups may use that to guide them in the criteria or factors that
should be taken into consideration to determine whether to weight an
activity medium or high on comments for this proposal. We request
comments on this proposal, including criteria or factors we should take
into consideration to determine whether to weight an activity medium or
high.
(c) Submission Criteria
We propose at Sec. 414.1380 to set the CPIA submission criteria
under MIPS, in order to achieve the highest potential score of 100
percent, at three high-weighted CPIAs (20 points each) or six medium-
weighted CPIAs (10 points each), or some combination of high and
medium-weighted CPIAs to achieve a total of 60 points for MIPS eligible
clinicians participating as individuals or as groups (refer to Table H
of the Appendices for CPIAs and weights). MIPS eligible clinicians or
groups that select less than the designated number of CPIAs will
receive partial credit based on the weighting of the CPIA selected. To
achieve a 50 percent score, one high-weighted and one medium-weighted
CPIA or three medium-weighted CPIAs are required for these MIPS
eligible clinicians or groups.
Exceptions to the above apply for: MIPS small groups (consisting of
15 or fewer clinicians), MIPS eligible clinicians and groups located in
rural areas, MIPS eligible clinicians and groups that are located in
geographic HPSAs, non-patient-facing MIPS eligible clinicians or groups
or MIPS eligible clinicians, or groups that participate in an APM and/
or a patient-centered medical home submitting in MIPS.
For MIPS eligible clinicians and groups that are small, located in
rural areas or geographic HPSAs, or non-patient-facing MIPS eligible
clinicians or groups, in order to achieve the highest score of 100
percent, two CPIAs are required (either medium or high).
[[Page 28211]]
For MIPS eligible clinicians or groups that are small, located in rural
areas, located in HPSAs, or non-patient-facing MIPS eligible clinicians
or groups, in order to achieve a 50 percent score, one CPIA is required
(either medium or high).
MIPS eligible clinicians or groups that participate in APMs are
considered eligible to participate under the CPIA performance category
unless they are participating in an Advanced APM and they have met the
Qualifying APM Participant (QP) thresholds or are Partial QPs that
elect not to report information. A MIPS eligible clinician or group
that is participating in an APM and participating under the CPIA
performance category will receive 50 percent of the total CPIA score
(30 points) just through their APM participation. These are MIPS
eligible clinicians or groups that CMS identifies as participating in
APMs for MIPS and may participate under the CPIA performance category.
To achieve 100 percent of the total CPIA score, MIPS eligible
clinicians or groups will need to identify that they participate in an
alternative payment model (30 points) and also select additional CPIAs
for an additional 30 points to reach the 60 point CPIA highest score.
For further description of MIPS eligible clinicians or groups that
are required to report to MIPS under the APM scoring standard and their
CPIA scoring requirements, we refer readers to section II.E.5.h. For
all other MIPS eligible clinicians or groups participating in APMs that
would report to MIPS, this section applies and we also refer readers to
the scoring requirements for these MIPS eligible clinicians or groups
in section II.E.6.
Since we cannot measure variable performance within a single CPIA,
we propose at Sec. 414.1380 to compare the CPIA points associated with
the reported activities against the highest number of points that are
achievable under the CPIA performance category which is 60 points. We
propose that the highest potential score of 100 percent can be achieved
by selecting a number of activities that will add up to 60 points. MIPS
eligible clinicians and groups, including those that are participating
as an APM, and all those that select activities under the CPIA
performance category can achieve the highest potential score of 60
points by selecting activities that are equal to the 60-point maximum.
We refer readers to scoring section II.E.6 for additional rationale for
using 60 points for the first year.
If a MIPS eligible clinician or group reports only one CPIA, we
will score that activity accordingly, as 10 points for a medium-level
activity or 20 points for a high-level activity. If a MIPS eligible
clinician or group reports no CPIAs, then the MIPS eligible clinician
or group would receive a zero score for the CPIA performance category.
We believe this proposal allows us to capture variation in the total
CPIAs reported.
In addition, we believe these are reasonable criteria for MIPS
eligible clinicians or groups to accomplish within the first year for
three reasons: (1) In response to several stakeholder MIPS and APMs RFI
comments, we are not recommending a minimum number of hours for
performance of an activity; (2) we are offering a broad list of
activities from which MIPS eligible clinicians or groups may select;
and (3) also in response to MIPS and APMs RFI comments, we are
proposing that an activity must be performed for at least 90 days
during the performance period for CPIA credit. We intend to reassess
this requirement threshold in future years. We do not believe it is
appropriate to require a determined number of activities within a
specific subcategory at this time. This proposal aligns with the
requirements in section 1848(q)(2)(C)(iii) of the Act that states MIPS
eligible clinicians or groups are not required to perform activities in
each subcategory.
Lastly, we recognize that working with a QCDR could allow a MIPS
eligible clinician or group to meet the measure and activity criteria
for multiple CPIAs. For the first year of MIPS, there are several CPIAs
in the inventory that incorporate QCDR participation. Each activity
must be selected and achieved separately for the first year of MIPS. A
MIPS eligible clinician or group cannot receive credit for multiple
activities just by selecting one activity that includes participation
in a QCDR. As the CPIA inventory expands over time we are interested in
receiving comments on what restrictions, if any, should be placed
around CPIA measures and activities that incorporate QCDR
participation.
(d) Required Period of Time for Performing an Activity
We propose Sec. 414.1360 that MIPS eligible clinicians or groups
must perform CPIAs for at least 90 days during the performance period
for CPIA credit. We understand there are some activities that are
ongoing whereas others may be episodic. We considered setting the
threshold for the minimum time required for performing an activity to
longer periods up to a full calendar year. However, after researching
several organizations we believe a minimum of 90 days is a reasonable
amount of time. Two illustrative examples of organizations that used 90
days as a window for reviewing clinical practice improvements include
practice improvement activities undertaken by anesthesiologists, as
detailed in a study describing anesthesiologists' practice improvements
as part of the Maintenance of Certification in Anesthesiology Program
requiring a 90-day report back period, \10\ \11\ and a large Veteran's
Administration health care program that set a 90-day window for
reviewing improvements in the management of opioid dispensing.\12\
---------------------------------------------------------------------------
\10\ Steadman R.H, Burden AR, Huang, YM, Gaba DM, et. al,
Practice improvements based on participation in simulation for the
maintenance of certification in anesthesiology program.
Anesthesiology. 2015;122;1154-69.
\11\ABMS cite.
\12\ Westanmo A, Marshall P, Jones E, Burns K, Krebs EE., Opioid
Dose Reduction in a VA Health Care System--Implementation of a
Primary Care Population-Level Initiative. Pain Med. 2015;16(5);1019-
26.
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Additional clarification for how some activities meet the 90-day
rule or if additional time is required are reflected in the description
of that activity in Table H of the Appendices. In addition we propose
that activities, where applicable, may be continuing (that is, could
have started prior to the performance period and are continuing) or be
adopted in the performance period as long as an activity is being
performed for at least 90 days during the performance period.
We anticipate in future years that extended CPIA time periods will
be needed for certain activities. We will monitor the time period
requirement to asses if allowing for extended time requirements may
enhance the value associated with generating more effective outcomes,
or conversely, the extended time may reveal that more time has little
or no value added for certain activities when associated with desired
outcomes. We request comments on this proposal.
(4) Application of CPIA to Non-Patient-Facing MIPS Eligible Clinicians
and Groups
We understand that non-patient-facing MIPS eligible clinicians and
groups may have a limited number of measures and activities to report.
Therefore, we propose at Sec. 414.1360 allowing non-patient-facing
MIPS eligible clinicians and groups to report on a minimum of one
activity to achieve partial credit or two activities to achieve full
credit to meet the CPIA submission criteria. These non-patient-facing
MIPS eligible clinicians and groups receive
[[Page 28212]]
partial or full credit for submitting one or two activities
irrespective of any type of weighting, medium or high (for example, two
medium activities will qualify for full credit). For scoring purposes,
non-patient-facing MIPS eligible clinicians or groups receive 30 points
per activity, regardless of whether the activity is medium or high. For
example, one high activity and one medium activity could be selected to
receive 60 points. Similarly, two medium activities could also be
selected to receive 60 points.
We anticipate the number of activities for non-patient-facing MIPS
eligible clinicians or groups will increase in future years as we
gather more data on the feasibility of performing CPIAs. As part of the
process for identifying activities, we consulted with several
organizations that represent a cross-section of non-patient-facing MIPS
eligible clinicians and groups. An illustrative example of those
consulted with include organizations that represent cardiologists
involved in nuclear medicine, nephrologists who serve only in a
consulting role to other providers, or pathologists who, while they
typically function as a team, have different members that perform
different roles within their specialty that are primarily non-patient-
facing.
In the course of those discussions these organizations identified
CPIAs they believed would be applicable. Comments on activities
appropriate for non-patient-facing MIPS eligible clinicians or groups
are reflected in the proposed CPIA Inventory across multiple
subcategories. For example, several of these organizations suggested
consideration for Appropriate Use Criteria (AUC). As a result, we have
incorporated AUC into some of the activities. We encourage MIPS
eligible clinicians or groups who are already required to use AUC (for
example, for advanced imaging) to report a CPIA other than one related
to appropriate use. Another example, under Patient Safety and Practice
Assessment, is the implementation of an antibiotic stewardship program
that measures the appropriate use of antibiotics for several different
conditions (Upper Respiratory Infection (URI) treatment in children,
diagnosis of pharyngitis, bronchitis treatment in adults) according to
clinical guidelines for diagnostics and therapeutics. In addition, we
request comments on what activities would be appropriate for non-
patient-facing MIPS eligible clinicians or groups to add to the CPIA
Inventory in the future. We request comments on this proposal.
(5) Special Consideration for Small, Rural, or Health Professional
Shortage Areas Practices
As noted previously in this proposed rule, section
1848(q)(2)(B)(iii) of the Act requires the Secretary, in establishing
CPIAs, to give consideration to small practices (15 or fewer
clinicians) and practices located in rural areas (proposed definition
at Sec. 414.1305) and in geographic based HPSAs as designated under
section 332(a)(1)(A) of the Public Health Service Act. In the MIPS and
APMs RFI, we requested comments on how CPIAs should be applied to MIPS
eligible clinicians or groups in small practices, in rural areas, and
geographic HPSAs: If a lower performance requirement threshold or
different measures should be established that will better allow those
MIPS eligible clinicians or groups to perform well in this performance
category, what methods should be leveraged to appropriately identify
these practices, and what best practices should be considered to
develop flexible and adaptable CPIAs based on the needs of the
community and its population.
We engaged high performing organizations, including several rural
health clinics with 15 or fewer clinicians that are designated as
geographic HPSAs, to provide feedback on relevant QIN/QIO activities
based on their specific circumstances. Some examples provided include
participation in implementation of self-management programs such as for
diabetes, and early use of telemedicine, as in the one case for a top
performing multi-specialty rural practice that covers 20,000 people
over a 25,000-mile radius in a rural area of North Dakota. Comments on
activities appropriate for MIPS eligible clinicians or groups located
in rural areas or practices that are designated as geographic HPSAs are
reflected in the proposed CPIA Inventory across multiple subcategories.
Based on the review of comments and listening sessions, we propose
at Sec. 414.1360 to accommodate small practices and practices located
in rural areas, or geographic HPSAs for the CPIA performance category
by allowing MIPS eligible clinicians or groups to submit a minimum of
one activity to achieve partial credit or two activities to achieve
full credit. These MIPS eligible clinicians or groups receive partial
or full credit for submitting two activities of any type of weighting
(for example, two medium activities will qualify for full credit). We
anticipate the requirement on the number of activities for small
practices and practices located in rural areas, or practices in
geographic HPSAs will increase in future years as we gather more data
on the feasibility of small practices and practices located in rural
areas and practices located in geographic HPSAs to perform CPIAs.
Therefore, we request comments on what activities would be appropriate
for these practices for the CPIA Inventory in future years. We request
comments on this proposal.
(6) CPIA Subcategories
Section 1848(q)(2)(B)(iii) of the Act provides that the CPIA
performance category must include at least the subcategories listed
below. The statute also provides the Secretary discretion to specify
additional subcategories for the CPIA performance category, which have
also been included below.
Expanded practice access, such as same day appointments
for urgent needs and after-hours access to clinician advice.
Population management, such as monitoring health
conditions of individuals to provide timely health care interventions
or participation in a QCDR.
Care coordination, such as timely communication of test
results, timely exchange of clinical information to patients and other
MIPS eligible clinicians or groups, and use of remote monitoring or
telehealth.
Beneficiary engagement, such as the establishment of care
plans for individuals with complex care needs, beneficiary self-
management assessment and training, and using shared decision-making
mechanisms.
Patient safety and practice assessment, such as through
the use of clinical or surgical checklists and practice assessments
related to maintaining certification.
Participation in an APM, as defined in section
1833(z)(3)(C) of the Act.
In the MIPS and APMs RFI, we requested recommendations on the
inclusion of the following five potential new subcategories:
Promoting Health Equity and Continuity, including (a)
serving Medicaid beneficiaries, including individuals dually eligible
for Medicaid and Medicare, (b) accepting new Medicaid beneficiaries,
(c) participating in the network of plans in the Federally Facilitated
Marketplace or state exchanges, and (d) maintaining adequate equipment
and other accommodations (for example, wheelchair access, accessible
exam tables, lifts, scales, etc.) to provide comprehensive care for
patients with disabilities.
Social and Community Involvement, such as measuring
[[Page 28213]]
completed referrals to community and social services or evidence of
partnerships and collaboration with the community and social services.
Achieving Health Equity, as its own performance category
or as a multiplier where the achievement of high quality in traditional
areas is rewarded at a more favorable rate for MIPS eligible clinicians
or groups that achieve high quality for underserved populations,
including persons with behavioral health conditions, racial and ethnic
minorities, sexual and gender minorities, people with disabilities,
people living in rural areas, and people in geographic HPSAs.
Emergency preparedness and response, such as measuring
MIPS eligible clinician or group participation in the Medical Reserve
Corps, measuring registration in the Emergency System for Advance
Registration of Volunteer Health Professionals, measuring relevant
reserve and active duty military MIPS eligible clinician or group
activities, and measuring MIPS eligible clinician or group volunteer
participation in domestic or international humanitarian medical relief
work.
Integration of primary care and behavioral health, such as
measuring or evaluating such practices as: Co-location of behavioral
health and primary care services; shared/integrated behavioral health
and primary care records; or cross-training of MIPS eligible clinicians
or groups participating in integrated care. This subcategory also
includes integrating behavioral health with primary care to address
substance use disorders or other behavioral health conditions, as well
as integrating mental health with primary care.
We recognize that quality improvement is a critical aspect of
improving the health of individuals and the health care delivery system
overall. We also recognize that this will be the first time MIPS
eligible clinicians or groups will be measured on the quality
improvement work on a national scale. We have approached the CPIA
performance category with these principles in mind along with the
overarching principle for the MIPS program that we are building a
process that will have increasingly more stringent requirements over
time.
Therefore, for the first year of MIPS, we propose at Sec. 414.1365
that the CPIA performance category include the subcategories of
activities provided at section 1848(q)(2)(B)(iii) of the Act. In
addition, we propose at Sec. 414.1365 adding the following
subcategories: ``Achieving Health Equity'', ``Integrated Behavioral and
Mental Health'', and ``Emergency Preparedness and Response.'' In
response to multiple MIPS and APMs RFI comments requesting the
inclusion of ``Achieving Health Equity,'' we are proposing to include
this subcategory because: (1) It is important and may require targeted
effort to achieve and so should be recognized when accomplished; (2)
supports our national priorities and programs, such as Reducing Health
Disparities; and (3) encourages ``use of plans, strategies, and
practices that consider the social determinants that may contribute to
poor health outcomes.'' (CMS, Quality Innovation Network Quality
Improvement Organization Scope of Work: Excellence in Operations and
Quality Improvement, 2014).
Similarly, MIPS and APMs RFI comments strongly supported the
inclusion of the subcategory of ``Integrated Behavioral and Mental
Health'', citing that ``statistics show 50 percent of all behavioral
health disorders are being treated by primary care and behavioral
health integration.'' Additionally, according to MIPS and APMs RFI
comments, behavioral health integration with primary care is already
being implemented in numerous locations throughout the country. The
third additional subcategory we propose to include is ``Emergency
Preparedness and Response,'' based on MIPS and APMs RFI comments that
encouraged us to consider this subcategory to help ensure that
practices remain open during disaster and emergency situations and
support emergency response teams as needed. Additionally, commenters
were able to provide a sufficient number of recommended activities
(that is, more than one) that could be included in the CPIA Inventory
in all of these proposed subcategories and the subcategories included
under section 1848(q)(2)(B)(iii) of the Act.
We also seek public comments on two additional subcategories for
future consideration:
Promoting Health Equity and Continuity, including (a)
serving Medicaid beneficiaries, including individuals dually eligible
for Medicaid and Medicare, (b) accepting new Medicaid beneficiaries,
(c) participating in the network of plans in the Federally Facilitated
Marketplace or state exchanges, and (d) maintaining adequate equipment
and other accommodations (for example, wheelchair access, accessible
exam tables, lifts, scales, etc.) to provide comprehensive care for
patients with disabilities; and
Social and Community Involvement, such as measuring
completed referrals to community and social services or evidence of
partnerships and collaboration with community and social services.
For these two subcategories, we are requesting activities that can
demonstrate some improvement over time and go beyond current practice
expectations. For example, maintaining existing medical equipment would
not qualify for a CPIA, but implementing some improved clinical
workflow processes that reduce wait times for patients with
disabilities or improve coordination of care including activities that
regularly provide additional assistance to find other care needed for
patients with disabilities, would be some examples of activities that
could show improvement in clinical practice over time.
We request comments on these proposals.
(7) CPIA Inventory
To implement the MIPS program, we are required to create an
inventory of CPIAs. Consistent with our MIPS strategic goals, we
believe it is important to create a broad list of activities that can
be used by multiple practice types to demonstrate CPIAs and activities
that may lend themselves to being measured for improvement in future
years.
We took several steps to ensure the initial CPIA Inventory is
inclusive of activities in line with the statutory intent. We had
numerous interviews with highly performing organizations of all sizes,
conducted an environmental scan to identify existing models,
activities, or measures that met all or part of the CPIA category,
including the patient centered medical homes, the Transforming Clinical
Practice Initiative (TCPI), Consumer Assessment of Healthcare Providers
and Systems (CAHPS) surveys, and AHRQ's Patient Safety Organizations.
In addition, we reviewed the CY 2016 PFS final rule with comment period
(80 FR 70886) and the comments received in response to the MIPS and
APMs RFI regarding the CPIA performance category. The CPIA Inventory
was compiled as a result of the stakeholder input, an environmental
scan, MIPS and MIPS and APMs RFI comments, and subsequent working
sessions with AHRQ and ONC and additional communications with CDC,
SAMHSA and HRSA.
Based on the above discussions we established guidelines for CPIA
inclusion based on one or more of the following criteria (in any
order):
Relevance to an existing CPIA subcategory (or a proposed
new subcategory);
[[Page 28214]]
Importance of an activity toward achieving improved
beneficiary health outcome;
Importance of an activity that could lead to improvement
in practice to reduce health care disparities;
Aligned with patient-centered medical homes;
Representative of activities that multiple MIPS eligible
clinicians or groups could perform (for example, primary care,
specialty care);
Feasible to implement, recognizing importance in
minimizing burden, especially for small (15 or fewer clinicians)
practices, practices in rural areas, or in areas designated as
geographic HPSAs by HRSA;
CMS is able to validate the activity; or
Evidence supports that an activity has a high probability
of contributing to improved beneficiary health outcomes.
Activities that overlap with other performance categories were
excluded unless there was a strong policy rationale to include it in
the CPIA Inventory. We propose to use the CPIA Inventory for the first
year of MIPS, as provided in Table H of the Appendices. For further
description of how MIPS eligible clinicians or groups will be
designated to submit to MIPS for CPIA, we refer readers to section
II.E.6.h. For all other MIPS eligible clinicians or groups
participating in APMs that would report to MIPS, this section applies
and we also refer readers to the scoring requirements for these MIPS
eligible clinicians or groups in section II.E.5. of this proposed rule.
We request comments on the inventory and welcome suggestions for
CPIAs for future years as well.
(a) CMS Study on CPIA and Measurement
(1) Study Purpose
From our experience under the PQRS, VM, and Medicare EHR Incentive
programs we have discovered that many providers have errors within
their data sets, as well as issues understanding the data that
corresponds to their selected quality measures. To help better
understand the current processes and limitations, we propose to conduct
a study on CPIAs and measurement to examine clinical quality workflows
and data capture using a simpler approach to quality measures. The
study will allow a limited number of selected MIPS eligible clinicians
and groups to receive full credit (60 points) for the CPIA category.
The lessons learned in this study on practice improvement and
measurement may or may not influence changes to future MIPS data
submission requirements. The goals of the study are to see whether
there will be improved outcomes, reduced burden in reporting, and
enhancements in clinical care by selected MIPS eligible clinicians
desiring:
A more data driven approach to quality measurement.
Measure selection unconstrained with a CEHRT program or
system.
Improving data quality submitted to CMS.
Enabling CMS get data more frequently and provide feedback
more often.
(2) Study Participation Credit and Requirements
Eligible clinicians and groups in the CMS study on practice
improvement and measurement will receive full credit for the CPIA
category of MIPS after successfully electing, participating and
submitting data to CMS. Based on feedback and surveys from MIPS
eligible clinicians, study measurement data will be made available to
CMS throughout the study on at least a quarterly basis unless the MIPS
eligible clinician or group agrees to submit data on a more frequent
basis. Participants will be required to attend a monthly focus group to
share lessons learned along with providing survey feedback to monitor
effectiveness. The focus group will also include providing visual
displays of data, workflows, and best practices to be shared amongst
the participants to obtain feedback and make further improvements. The
monthly focus groups will be used to learn from the practices on how to
be more agile as we test new ways of measure recording and workflow.
For the 2017 performance period, the participating MIPS eligible
clinicians or groups would submit their data and workflows for a
minimum of three MIPS clinical quality measures that are relevant and
prioritized by their practice. One of the measures must be an outcome
measure, and one must be a patient experience measure. The
participating MIPS eligible clinicians could elect to report on more
measures as this would provide more options from which to select in
subsequent years for purposes of measuring improvement.
If MIPS eligible clinicians or groups calculate the measures
working with a QCDR, qualified registry, or CMS-approved third party
intermediary, CMS will use the same data validation process described
in section II.E.8.e. CMS will only collect the numerator and
denominator for the measures selected for the overall population, all
patients/all payers. This will enable the practices to build the
measures based on what is important for their area of practice while
increasing the quality of care.
In future years, participating MIPS eligible clinicians or groups
would select three of the measures for which they have baseline data
from the 2017 performance period to compare against later performance
years. Participants electing to continue in future years will be
afforded the opportunity opt-in or opt-out following the successful
submission of data to CMS. The first opportunity to continue in the
study will be at the end of the 2017 performance period. Eligible
clinicians who elect to join the study but fail to participate and/or
fail to successfully submit the data required will be removed from the
study. Unsuccessful study participants will then be subject to the full
requirements for the CPIA category.
(3) Study Participation Eligibility
Participation will be open to a limited number of MIPS eligible
clinicians in rural settings and non-rural settings. A rural area is
defined at Sec. 414.1305 and a non-rural area would be any MIPS
eligible clinicians or groups not included as part of the rural
definition. This test will be open to include up to 10 non-rural
individual MIPS eligible clinicians or groups of less than three non-
rural MIPS eligible clinician's, 10 rural individual MIPS eligible
clinicians or groups of less than three rural MIPS eligible
clinician's, 10 groups of three to eight MIPS eligible clinicians, five
groups of nine to twenty MIPS eligible clinicians, three groups of
twenty-one to one hundred MIPS eligible clinicians, two groups of
greater than 100 MIPS eligible clinicians, and two specialist groups of
MIPS eligible clinicians. Eligible clinicians and groups will need to
sign up from January 1, 2017, to January 31, 2017. The sign up process
will utilize this web-based interface-- http://oncprojectracking.org/.
Participants will be approved on a first come first served basis and
must meet all the required criteria.
We request comment on the study and welcome suggestions on future
study topics.
(8) CPIA Policies for Future Years of the MIPS Program
(a) Proposed Approach for Identifying New Subcategories and New
Activities
We propose, for future years of, MIPS, to consider the addition of
a new subcategory or activity to the CPIA
[[Page 28215]]
Inventory only when the following criteria are met:
The new subcategory represents an area that could
highlight improved beneficiary health outcomes, patient engagement and
safety based on evidence.
The new subcategory has a designated number of activities
that meet the criteria for a CPIA activity and cannot be classified
under the existing subcategories.
Newly identified subcategories would contribute to
improvement in patient care practices or improvement in performance on
quality measures and resource use performance categories.
In future years, MIPS eligible clinicians or groups will have an
opportunity to nominate additional subcategories, along with activities
associated with each of those subcategories that are based on criteria
specified for these activities, as discussed above.
We request comments on this proposal.
(b) Request for Comments on Call for Measures and Activities Process
for Adding New Activities and New Subcategories
We plan to develop a call for measures and activities process for
future years of MIPS, where MIPS eligible clinicians or groups and
other relevant stakeholders may recommend activities for potential
inclusion in the CPIA Inventory. As part of the process, MIPS eligible
clinicians or groups would be able to nominate additional activities
that we could consider adding to the CPIA Inventory. The MIPS eligible
clinician or group or relevant stakeholder would be able to provide an
explanation of how the activity meets all the criteria we have
identified. This nomination and acceptance process would, to the best
extent possible, parallel the annual call for measures process already
conducted by CMS for quality measures. The final CPIA Inventory for the
performance year would be published in accordance with the overall MIPS
rulemaking timeline and program. In addition, in future years we
anticipate developing a process and establishing criteria to remove or
add new activities to CPIA.
Additionally, prospective activities that are submitted through a
QCDR could also be included as part of a beta-test process that may be
instrumental for future years to determine whether that activity should
be included in the CPIA Inventory based on specific criteria noted
above. MIPS eligible clinicians or groups and groups that use QCDRs to
capture data associated with an activity, for example the frequency in
administering depression screening and a follow-up plan, may be asked
to voluntarily submit that same data in year 2 to begin identifying a
baseline for improvement for subsequent year analysis. This is not
intended to require any MIPS eligible clinician or group to submit
CPIAs only via QCDR from one year to the next or to require the same
activity from one year to the next. Participation in doing so, however,
can help to identify how activities can contribute to improve outcomes.
This data submission process will be considered part of a beta-test to:
(1) Determine if the activity is being regularly conducted and
effectively executed and (2) if the activity warrants continued
inclusion on the CPIA Inventory. The data will help capture baseline
information to begin measuring improvement and inform the Secretary of
the likelihood that the activity would result in improved outcomes. If
an activity is submitted and reported by a QCDR, it would be reviewed
by CMS for final inclusion in the CPIA Inventory the following year,
even if these activities are not submitted through the future call for
measures and activities process. We intend, in future performance
years, to begin measuring CPIA data points for all eligible clinicians
and to award scores based on performance and improvement. We solicit
comment on how best to collect such CPIA data and factor it into future
scoring under MIPS.
We request comments on this approach and on any other
considerations we should take into account when developing this type of
approach for future rulemaking.
(c) Request for Comments on Use of QCDRs for Identification and
Tracking of Future Activities
In future years, we expect to learn more about CPIAs and how the
inclusion of additional measures and activities captured by QCDRs could
enhance the ability of MIPS eligible clinicians or groups to capture
and report on more meaningful activities. This is especially true for
specialty groups. In the future, we may propose use of QCDRs for
identification and acceptance of additional measures and activities
which is in alignment with section 1848(q)(1)(E) of the Act which
encourages the use of QCDRs, as well as under section
1848(q)(2)(B)(iii)(II) of the Act related to the population management
subcategory. We recognize, through the MIPS and APMs RFI comments and
interviews with organizations that represent non-patient-facing MIPS
eligible clinicians or groups and specialty groups that QCDRs may
provide for a more diverse set of measures and activities under CPIA
than are possible to list under the current CPIA Inventory. This
diverse set of measures and activities, which we can validate, affords
specialty practices additional opportunity to report on more meaningful
activities in future years. QCDRs may also provide the opportunity for
longer-term data collection processes which will be needed for future
year submission on improvement, in addition to achievement. Use of
QCDRs also supports ongoing performance feedback and allows for
implementation of continuous process improvements. We believe that for
future years, QCDRs will be allowed to define specific CPIAs for
specialty and non-patient-facing MIPS eligible clinicians or groups
through the already-established QCDR approval process for measures and
activities. We request comments on this approach.
g. Advancing Care Information Performance Category
(1) Background and Relationship to Prior Programs
(a) Background
The American Recovery and Reinvestment Act of 2009 (ARRA), which
included the Health Information Technology for Economic and Clinical
Health Act (HITECH Act), amended Titles XVIII and XIX of the Act to
authorize incentive payments and Medicare payment adjustments for EPs
to promote the adoption and meaningful use of certified EHR technology
(CEHRT). Section 1848(o) of the Act provides the statutory basis for
the Medicare incentive payments made to meaningful EHR users. Section
1848(a)(7) of the Act also establishes downward payment adjustments,
beginning with calendar year (CY) 2015, for EPs who are not meaningful
users of certified EHR technology for certain associated EHR reporting
periods. (For a more detailed explanation of the statutory basis for
the Medicare and Medicaid EHR Incentive Programs, see the July 28, 2010
Stage 1 final rule titled, ``Medicare and Medicaid Programs; Electronic
Health Record Incentive Program; Final Rule'' (75 FR 44316 through
44317).)
A primary policy goal of the EHR Incentive Program is to encourage
and promote the adoption and use of certified EHR technology among
Medicare and Medicaid health care providers to help drive the industry
as a whole toward the use of certified EHR technology. As described in
the final rule titled ``Medicare and Medicaid
[[Page 28216]]
Programs; Electronic Health Record Incentive Program--Stage 3 and
Modifications to Meaningful Use in 2015 Through 2017'' (Hereinafter
referred to as the ``2015 EHR Incentive Programs Final Rule'') (80 FR
62769), the HITECH Act outlined several foundational requirements for
meaningful use and for EHR technology. CMS and ONC have subsequently
outlined a number of key policy goals which are reflected in the
current objectives and measures of the program and the related
certification requirements (80 FR 62790). Current Medicare EP
performance on these key goals is varied, with EPs demonstrating high
performance on some objectives while others represent a greater
challenge.
(b) MACRA Changes
Section 1848(q)(2)(A) of the Act, as added by section 101(c) of the
MACRA, includes the meaningful use of certified EHR technology as a
performance category under the MIPS, referred to in this proposed rule
as the advancing care information performance category, which will be
reported by MIPS eligible clinicians as part of the overall MIPS
program. As required by sections 1848(q)(2) and (5) of the Act, the
four performance categories shall be used in determining the MIPS CPS
for each MIPS eligible clinician. In general, MIPS eligible clinicians
will be evaluated under all four of the MIPS performance categories,
including the advancing care information performance category. This
includes MIPS eligible clinicians who were not previously eligible for
the EHR Incentive Program incentive payments under section 1848(o) of
the Act or subject to the EHR Incentive Program payment adjustments
under section 1848(a)(7) of the Act, such as physician assistants,
nurse practitioners, clinical nurse specialists, certified registered
nurse anesthetists, and hospital-based EPs (as defined in section
1848(o)(1)(C)(ii) of the Act). Understanding that these MIPS eligible
clinicians may not have prior experience with certified EHR technology
and the objectives and measures under the EHR Incentive Program, we
have proposed a scoring methodology within the advancing care
information performance category that provides flexibility for MIPS
eligible clinicians from early adoption of certified EHR technology
through advanced use of health IT. We note that in section II.e.5.g.8.a
of this proposed rule, we have also proposed to reweight the advancing
care information performance category to zero in the MIPS composite
performance score for certain hospital-based and other MIPS eligible
clinicians where the measures proposed for this performance category
may not be available or applicable to these types of MIPS eligible
clinicians.
(c) Considerations in Defining Advancing Care Information Performance
Category
In implementing MIPS, we intend to develop the requirements for the
advancing care Information performance category to continue supporting
the foundational objectives of the HITECH Act, and to encourage
continued progress on key uses such as health information exchange and
patient engagement. These more challenging objectives are essential to
leveraging certified EHR technology to improve care coordination and
they represent the greatest potential for improvement and for
significant impact on delivery system reform in the context of MIPS
quality reporting.
In developing the requirements and structure for the advancing care
information performance category, we considered several approaches for
establishing a framework that would naturally integrate with the other
MIPS performance categories. We considered historical performance on
the EHR Incentive Program objectives and measures, feedback received
through public comment, and the long term goals for delivery system
reform and quality improvement strategies.
One approach we considered would be to maintain the current
structure of the Medicare EHR Incentive Program and award full points
for the advancing care information performance category for meeting all
of the objectives and measures finalized in the 2015 EHR Incentive
Programs final rule, and award zero points for failing to meet all of
these requirements. This method would be consistent with the current
EHR Incentive Program and is based on objectives and measures already
established in rulemaking. However, we considered and dismissed this
approach as it would not allow flexibility for MIPS eligible clinicians
and would not allow CMS to effectively measure performance for MIPS
eligible clinicians in the advancing care information performance
category who have taken incremental steps toward the use of certified
EHR technology, or to recognize exceptional performance for MIPS
eligible clinicians who have excelled in any one area. This is
particularly important as many MIPS eligible clinicians may not have
had past experience relevant to the advancing care information
performance category and use of EHR technology because they were not
previously eligible to participate in the Medicare EHR Incentive
Program. This approach also does not allow for differentiation among
the objectives and measures that have high adoption and those where
there is potential for continued advancement and growth.
We subsequently considered several methods which would allow for
more flexibility and provide CMS the opportunity to recognize partial
or exceptional performance among MIPS eligible clinicians for the
measures under the advancing care information performance category. We
decided to design a framework that would allow for flexibility and
multiple paths to achievement under this category while recognizing
MIPS eligible clinicians' efforts at all levels. Part of this framework
requires moving away from the concept of requiring a single threshold
for a measure, and instead incentivizes continuous improvement, and
recognizes onboarding efforts among late adopters and MIPS eligible
clinicians facing continued challenges in full implementation of
certified EHR technology in their practice.
(2) Advancing Care Information Performance Category Within MIPS
In defining the advancing care information performance category for
the MIPS, we considered stakeholder feedback and lessons learned from
our experience with the Medicare EHR Incentive Program. Specifically,
we considered feedback from the Stage 1 (75 FR 44313) and Stage 2 (77
FR 53967) EHR Incentive Program rules, and the 2015 EHR Incentive
Programs final rule (80 FR 62769), as well as comments received from
the MIPS and APMs RFI (80 FR 59102). We have learned from this feedback
that clinicians desire flexibility to focus on health IT implementation
that is right for their practice. We have also learned that updating
software, training staff and changing practice workflows to accommodate
new technology can take time, and that clinicians need time and
flexibility to focus on the health IT activities that are most relevant
to their patient population. Clinicians also desire consistent
timelines and reporting requirements in order to simplify and
streamline the reporting process. Recognizing this, we have worked to
align the advancing care information performance category with the
other MIPS performance categories, which would streamline reporting
requirements, timelines and measures in an effort to reduce burden on
MIPS eligible clinicians.
[[Page 28217]]
The implementation of the advancing care information performance
category is an important opportunity to increase clinician and patient
engagement, improve the use of health IT to achieve better patient
outcomes, and continue to meet the vision of enhancing the use of
certified EHR technology as defined under the HITECH Act. As discussed
later in this section, we are proposing in section II.E.5.g.6.a. new
flexibility in how we would assess MIPS eligible clinician performance
for the advancing care information performance category. We propose to
emphasize performance in the objectives and measures that are the most
critical and would lead to the most improvement in the use of health IT
and health care quality. We intend to promote innovation so that
technology can be interconnected easily and securely, and data can be
accessed and directed where and when it is needed to support patient
care. These objectives include Patient Electronic Access, Coordination
of Care Through Patient Engagement and Health Information Exchange,
which are essential to leveraging certified EHR technology to improve
care. At the same time, we propose to eliminate reporting on objectives
and measures in which the vast majority of clinicians already achieve
high performance--which would reduce burden, encourage greater
participation and direct MIPS eligible clinicians' attention to higher-
impact measures. Our proposal balances program participation with
rewarding performance on high-impact objectives and measures, which we
believe would make the overall program stronger and further the goals
of the HITECH Act.
(a) Advancing the Goals of the HITECH Act in MIPS
Section 1848(o)(2)(A) of the Act requires that the Secretary seek
to improve the use of electronic health records and health care quality
over time by requiring more stringent measures of meaningful use. In
implementing MIPS and the advancing care information performance
category, we seek to improve and encourage the use of certified EHR
technology over time by adopting a new, more flexible scoring
methodology, as discussed in section II.E.5.g.6. of this proposed rule,
that would more effectively allow MIPS eligible clinicians to reach the
goals of the HITECH Act, and would allow MIPS eligible clinicians to
use EHR technology in a manner more relevant to their practice. This
new, more flexible scoring methodology puts a greater focus on Patient
Electronic Access, Coordination of Care Through Patient Engagement, and
Health Information Exchange--objectives we believe are essential to
leveraging certified EHR technology to improve care by engaging
patients and furthering interoperability. This methodology would also
de-emphasize objectives in which clinicians have historically achieved
high performance with median performance rates of over 90 percent for
the last 2 years. We believe shifting focus away from these objectives
would reduce burden, encourage greater participation, and direct
attention to other objectives and measures which require more
attention. Through this flexibility, MIPS eligible clinicians would be
incentivized to focus on those aspects of certified EHR technology that
are most relevant to their practice, which we believe would lead to
improvements in health care quality.
We also seek to increase the adoption and use of certified EHR
technology by incorporating such technology into the other MIPS
performance categories. For example, in section II.6.a.2.f. of this
proposed rule, we are proposing to incentivize electronic reporting by
awarding a bonus point for submitting quality measure data using
certified EHR technology. Additionally, in section II.E.5.f. of this
proposed rule, we have aligned some of the activities under the CPIA
performance category such as Care Coordination, Beneficiary Engagement
and Achieving Health Equity with a focus on enhancing the use of
certified EHR technology. We believe this approach would strengthen the
adoption and use of EHR systems and program participation consistent
with the provisions of section 1848(o)(2)(A) of the Act.
(b) Future Considerations
We note that the increased flexibility and removal of previously
established thresholds for reporting, as proposed in this section of
this proposed rule, may appear to be a lower standard than what
previously existed in the Medicare EHR Incentive Program. In reality,
this restructuring of program requirements is geared toward increasing
participation and EHR adoption. We believe this is the most effective
way to encourage the adoption of certified EHR technology, and
introduce new MIPS eligible clinicians to the use of EHR technology and
health IT overall.
We will continue to review and evaluate MIPS eligible clinician
performance in the advancing care information performance category, and
will consider evolutions in health IT over time as it relates to this
performance category. Based on our ongoing evaluation, we expect to
adopt changes to the scoring methodology for the advancing care
information performance category to ensure the efficacy of the program
and to ensure increased value for MIPS eligible clinicians, as well as
to adopt more stringent measures of meaningful use as required by
section 1848(o)(2)(A) of the Act.
Potential changes may include establishing benchmarks for MIPS
eligible clinician performance on the advancing care information
performance category measures, and using these benchmarks as a baseline
or threshold for future reporting. This may include scoring for
performance improvement over time and the potential to reevaluate the
efficacy of measures based on these analyses. For example, in future
years we may use a MIPS eligible clinician's prior performance on the
advancing care information performance category measures as comparison
for the subsequent year's performance category score, or compare a MIPS
eligible clinician's performance category score to peer groups to
measure their improvement and determine a performance category score
based on improvement over those benchmarks or peer group comparisons.
This type of approach would drive continuous improvement over time
through the adoption of more stringent performance standards for the
advancing care information performance category measures.
We are committed to continual review, improvement and increased
stringency of the advancing care information performance category
measures as directed under section 1848(o)(2)(A) of the Act both for
the purposes of ensuring program efficacy as well as ensuring value for
the MIPS eligible clinicians reporting the advancing care information
performance category measures. We seek comment on further methods to
increase the stringency of the advancing care information performance
category measures in the future.
We additionally seek comment on the concept of a holistic approach
to health IT--one that we believe is similar to the concept of outcome
measures in the quality performance category in the sense that MIPS
eligible clinicians could potentially be measured more directly on how
the use of health IT contributes to the overall health of their
patients. Under this concept, MIPS eligible clinicians would be able to
track certain use cases or patient outcomes to tie patient health
outcomes with the use of health IT.
We believe this approach would allow us to directly link health IT
adoption and use to patient outcomes, moving
[[Page 28218]]
MIPS beyond the measurement of EHR adoption and process measurement and
into a more patient-focused health IT program. From comments and
feedback we have received from the health care provider community, we
understand that this type of approach would be a welcome enhancement to
the measurement of health IT. At this time, we recognize that
technology and measurement for this type of program is currently
unavailable. We seek comment on what this type of measurement would
look like under MIPS, including the type of measures that would be
needed within the advancing care information performance category and
the other performance categories to measure this type of outcome, what
functionalities with certified EHR technology would be needed, and how
such an approach could be implemented.
(3) Clinical Quality Measurement
Section 1848(o)(2)(A)(iii) of the Act requires the reporting of
clinical quality measures (CQMs) using certified EHR technology.
Section 1848(q)(5)(B)(ii)(II) provides that under the methodology for
assessing the total performance of each MIPS eligible clinician, the
Secretary shall, with respect to a performance period for a year, for
which a MIPS eligible clinician reports applicable measures under the
quality performance category through the use of certified EHR
technology, treat the MIPS eligible clinician as satisfying the CQMs
reporting requirement under section 1848(o)(2)(A)(iii) of the Act for
such year. We note that in the context and overall structure of MIPS,
the quality performance category allows for a greater focus on patient-
centered measurement, and multiple pathways for MIPS eligible
clinicians to report their quality measure data. Therefore, we are not
proposing separate requirements for clinical quality measure reporting
within the advancing care information performance category and instead
would require submission of quality data for measures specified for the
quality performance category, in which we encourage reporting of CQMs
with data captured in certified EHR technology. We refer readers to
section II.E.5.a of this proposed rule for discussion of reporting of
CQMs with data captured in certified EHR technology under the quality
performance category.
(4) Performance Period Definition for Advancing Care Information
Performance Category
In the Medicare and Medicaid Programs; Electronic Health Record
Incentive Program--Stage 3 proposed rule, we proposed to eliminate the
90-day EHR reporting period beginning in 2017 for EPs who had not
previously demonstrated meaningful use, with a limited exception for
the Medicaid EHR Incentive Program (80 FR 16739-16740, 16774-16775). We
received many comments from respondents stating their preference for
maintaining the 90-day EHR reporting period to allow first time
participants to avoid payment adjustments. In addition, commenters
indicated that the 90-day time period reduced administrative burden and
allowed for needed time to adapt their EHRs to ensure they could
achieve program objectives. As a result, we did not finalize our
proposal and established a 90-day EHR reporting period for all EPs in
2015 and for new participants in 2016, as well as a 90-day EHR
reporting period for new participants in 2015, 2016, and 2017 with
regard to the payment adjustments (80 FR 62777-62779; 62904-62906).
Moving forward, the implementation of MIPS creates a critical
opportunity to align performance periods to ensure that quality, CPIA,
resource use, and the advancing care information performance categories
are all measured and scored based on the same period of time. We
believe this would lower reporting burden, focus clinician quality
improvement efforts and align administrative actions so that clinicians
can use common systems and reporting pathways.
Under MIPS, we propose to align the performance period for the
advancing care information performance category to the proposed MIPS
performance period of one full calendar year. Thus, the performance
period for the advancing care information performance category would be
the same as the performance periods for the other performance
categories as indicated in section II.E.4. We note that there would not
be a separate 90-day performance period for the advancing care
information performance category. Under this proposal, MIPS eligible
clinicians would need to submit data based on performance period
starting January 1, 2017, and ending December 31, 2017 for the first
year of MIPS. We recognize that stakeholders may still have concerns
related to a full year performance period. We note that, as discussed
in section II.E.4. of this proposed rule, MIPS eligible clinicians that
only have data for a portion of the year can still submit data, be
assessed and be scored for the advancing care information performance
category. Under the proposal, MIPS eligible clinicians would need to
possess certified EHR technology and report on the objectives and
measures (without meeting any thresholds) during the calendar year
performance period to achieve the advancing care information category
base score. We note that MIPS eligible clinicians would be required to
submit all of the data they have available for the performance period,
even if the time period they have data for is less than one full
calendar year.
We believe this proposal would reduce reporting burden and
streamline requirements so that MIPS eligible clinicians and third
party intermediaries, such as registries and QCDRs, would have a common
timeline for data submission to all performance categories. We refer
readers to section II.E.4. of this proposed rule for discussion of the
performance period for MIPS and solicit feedback on our proposal.
(5) Advancing Care Information Performance Category Data Submission and
Collection
(a) Definition of Meaningful EHR User and Certification Requirements
The use of certified health IT continues to be an important
component of care delivery for clinicians. Certified health IT that
advances patient engagement, interoperability, and privacy and security
are key to care coordination, and a critical component in improving
health outcomes.
We anticipate that as certified health IT and related standards
continue to evolve to support health information exchange, care
coordination (for example, referral management), and other
capabilities, we will consider updates to the certified health IT
requirements for MIPS. We continue to work with the Office of the
National Coordinator for Health IT to identify certified health IT that
would aid clinicians in MIPS.
Throughout this proposed rule, we use the terms ``certified health
IT'' and ``certified EHR technology''. These terms refer to health
information technologies and systems that are certified to various
standards and functions under the ONC Health IT Certification Program.
In general, the full range of potential technologies, functions,
standards, and systems for which ONC has established certification
criteria are referred to as ``certified health IT'' (See the 2015
Edition Health IT Certification Criteria final rule (80 FR 62604)). In
contrast, the term ``certified EHR technology'' is a statutory and
regulatory term that defines the technology that MIPS eligible
clinicians
[[Page 28219]]
and participants in Advanced APMs must use.
It is important to note that certified EHR technology is a part of
the larger category of certified health IT. Therefore when discussing
certified health IT in a broad and general manner; such a discussion
includes both the functions included in certified EHR technology and
other additional potential functions and criteria. In other words,
certified EHR technology is a subset of the broader definition of
certified health IT.
``Certified health IT'' is used in two different ways within this
proposed rule. The first is stated as ``certified health IT'' to
identify where the text is referencing a broad range of technology that
is included in the ONC Health IT Certification Program. The second use
is where the term ``a certified Health IT Module'' identifies a
technology or function used independently from the clinicians' EHR. An
example of this second use of the term includes the certified functions
leveraged by Health Information Exchange organizations, QCDRs, and
public health agencies to support actions like information exchange,
quality measurement, and data submission. These individual functions
may also be a part of the certified EHR technology definition and may
connect with the EHR, but are in these cases used independently from
the clinicians' EHR systems.
ONC and CMS worked closely to identify the set of certified health
IT that are part of the certified EHR technology definitions proposed
in this rule. For example, ONC's 2015 Edition Health Information
Technology (Health IT) Certification Criteria, 2015 Edition Base
Electronic Health Record (EHR) Definition, and ONC Health IT
Certification Program Modifications (80 FR 62602 through 62759)
hereinafter referred to as ``2015 Edition final rule'', defines the
technological requirements for health IT systems used by EHR Incentive
Program participants. In this proposed rule, we are proposing to adopt
a definition of certified EHR technology at Sec. 414.1305 for MIPS
eligible clinicians that is based on the definition that applies in the
EHR Incentive Programs under 42 CFR 495.4.
In the 2015 EHR Incentive Programs final rule (80 FR 62873) we
outlined the requirements for EPs using certified EHR technology in
2017 as it relates to the objectives and measures they select to
report. We propose at Sec. 414.1375 similar requirements for the use
of certified EHR technology in relation to the selection of objectives
and measures under the MIPS advancing care information performance
category.
For 2017, the first MIPS performance period, MIPS eligible
clinicians would be able to use EHR technology certified to either the
2014 or 2015 Edition certification criteria as follows:
A MIPS eligible clinician who only has technology
certified to the 2015 Edition may choose to report: (1) On the
objectives and measures specified for the advancing care information
performance category in section II.E.5.g.7 of this proposed rule, which
correlate to Stage 3 requirements; or (2) on the alternate objectives
and measures specified for the advancing care information performance
category in section II.E.5.g.7 of this proposed rule, which correlate
to modified Stage 2 requirements.
A MIPS eligible clinician who has technology certified to
a combination of 2015 Edition and 2014 Edition may choose to report:
(1) On the objectives and measures specified for the advancing care
information performance category in section II.E.5.g.7 of this proposed
rule, which correlate to Stage 3; or (2) on the alternate objectives
and measures specified for the advancing care information performance
category as described in section II.E.5.g.7 of this proposed rule,
which correlate to modified Stage 2, if they have the appropriate mix
of technologies to support each measure selected.
A MIPS eligible clinician who only has technology
certified to the 2014 Edition would not be able to report on any of the
measures specified for the advancing care information performance
category described in section II.E.5.g.7 of this proposed rule that
correlate to a Stage 3 measure that requires the support of technology
certified to the 2015 Edition. These MIPS eligible clinicians would be
required to report on the alternate objectives and measures specified
for the advancing care information performance category as described in
section II.E.5.g.7. of this proposed rule, which correlate to modified
Stage 2 objectives and measures.
Beginning with the performance period in 2018, MIPS eligible
clinicians:
Must only use technology certified to the 2015 Edition to
meet the objectives and measures specified for the advancing care
information performance category in section II.E.5.g.7. of this
proposed rule, which correlate to Stage 3.
We welcome comments on this proposal, which is intended to maintain
consistency across MIPS, the Medicare EHR Incentive Program and the
Medicaid EHR Incentive Program.
Finally, we propose to define at Sec. 414.1305 a meaningful EHR
user under MIPS as a MIPS eligible clinician who possesses certified
EHR technology, uses the functionality of certified EHR technology, and
reports on applicable objectives and measures specified for the
advancing care information performance category for a performance
period in the form and manner specified by CMS.
We invite comments on our proposals.
(b) Method of Data Submission
Under the Medicare EHR Incentive Program, EPs attest to the
numerators and denominators for certain objectives and measures,
through a CMS web portal. For the purpose of reporting advancing care
information performance category objectives and measures under the
MIPS, we propose at Sec. 414.1325 to allow for MIPS eligible
clinicians to submit advancing care information performance category
data through qualified registry, EHR, QCDR, attestation and CMS Web
Interface submission methods. Regardless of data submission method, all
MIPS eligible clinicians must follow the reporting requirements for the
objectives and measures to meet the requirements of the advancing care
information performance category.
We note that under this proposal, 2017 would be the first year that
EHRs (through the QRDA submission method), QCDRs and qualified
registries would be able to submit EHR Incentive Program objectives and
measures (as adopted for the advancing care information performance
category) to CMS, and the first time this data would be reported
through the CMS Web Interface. We recognize that some Health IT
vendors, QCDRs and qualified registries may not be able to conduct this
type of data submission for the 2017 performance period given that the
development efforts associated with this data submission capability.
However, we are including these data submission mechanisms in 2017 to
support early adopters and to signal our longer-term commitment to
working with organizations that are agile, effective and can create
less burdensome data submission mechanisms for MIPS eligible
clinicians. We believe the proposed data submission methods could
reduce reporting burden by synchronizing reporting requirements and
data submission, and systems, allow for greater access and ease in
submitting data throughout the MIPS program. We note that specific
details about the form and manner for data submission will be addressed
by CMS in the future.
[[Page 28220]]
(c) Group Reporting
Under the Medicare EHR Incentive Program, CMS adopted a reporting
mechanism for EPs that are part of a group to attest using one common
form, or batch reporting process. Under that batch reporting process
CMS assessed the individual performance of the EPs that made up the
group, not the group as a whole, to determine whether those EPs
meaningfully used certified EHR technology.
The structure of the MIPS and our desire to achieve alignment
across the MIPS performance categories appropriately necessitates the
ability to assess the performance of MIPS eligible clinicians at the
group level for all MIPS performance categories. We believe MIPS
eligible clinicians should be able to submit data as a group, and be
assessed at the group level, for all of the MIPS performance
categories, including the advancing care information performance
category. For this reason, we are proposing a group reporting mechanism
for individual MIPS eligible clinicians to have their performance
assessed as a group for all performance categories in section II.E.1.e.
of this proposed rule, consistent with section 1848(q)(1)(D)(i)(I) &
(II) of the Act.
Under this option, we are proposing that performance on advancing
care information performance category objectives and measures would be
assessed and reported at the group level, as opposed to the individual
MIPS eligible clinician level. We note that the data submission
criteria would be the same when submitted at the group-level as if
submitted at the individual-level, but the data submitted would be
aggregated for all MIPS eligible clinicians within the group practice.
We believe this approach to data submission better reflects the team
dynamics of groups, and would reduce the overall reporting burden for
MIPS eligible clinicians that practice in groups, incentivize practice-
wide approaches to data submission, and provide enterprise-level
continuous improvements strategies for submitting data to the advancing
care information performance category. Please see section II.E.1.e. of
this proposed rule for more discussion of how to participate as a group
under MIPS.
(6) Reporting Requirements & Scoring Methodology
(a) Scoring Method
Section 1848(q)(5)(E)(i)(IV) of the Act, as added by section 101(c)
of the MACRA, states that 25 percent of the MIPS CPS shall be based on
performance for the advancing care information performance category.
Therefore, we propose at Sec. 414.1375 that performance in the
advancing care information performance category will comprise 25
percent of a MIPS eligible clinician's CPS for payment year 2019 and
each year thereafter. We received many comments in the MIPS and APMs
RFI from stakeholders regarding the importance of flexible scoring for
the advancing care information performance category and provisions for
multiple performance pathways. We agree that this is the best approach
moving forward with the adoption and use of certified EHR technology as
it becomes part of a single coordinated program under the MIPS. For the
reasons described here and previously in this preamble, we are
proposing a methodology which balances the goals of incentivizing
participation and reporting while recognizing exceptional performance
by awarding points through a performance score. In this methodology, we
are proposing at Sec. 414.1380(b)(4) that the score for the advancing
care information performance category would be comprised of a score for
participation and reporting, hereinafter referred to as the ``base
score,'' and a score for performance at varying levels above the base
score requirements, hereinafter referred to as the ``performance
score''.
(b) Base Score
To earn points toward the base score, a MIPS eligible clinician
must report the numerator and denominator of certain measures specified
for the advancing care information performance category (see measure
specifications in section II.E.5.g.7 of this proposed rule), which are
based on the measures adopted by the EHR Incentive Programs for Stage 3
in the 2015 EHR Incentive Programs Final Rule, to account for 50
percent (out of a total 100 percent) of the advancing care information
performance category score. For measures that include a percentage-
based threshold for Stage 3 of the EHR Incentive Program, we would not
require those thresholds to be met for purposes of the advancing care
information performance category under MIPS, but would instead require
MIPS eligible clinicians to report the numerator (of at least one) and
denominator (or a yes/no statement for applicable measures, which would
be submitted together with data for the other measures) for each
measure being reported. We note that for any measure requiring a yes/no
statement, only a yes statement would qualify for credit under the base
score. Under the proposal, the base score of the advancing care
information performance category would incorporate the objective and
measures adopted by the EHR Incentive Programs with an emphasis on
privacy and security. We are proposing two variations of a scoring
methodology for the base score, a primary and an alternate proposal,
which are outlined below. Both proposals would require the MIPS
eligible clinician to meet the requirement to protect patient health
information created or maintained by certified EHR technology to earn
any score within the advancing care information performance category;
failure to do so would result in a base score of zero, a performance
score of zero (discussed in section II.E.5.g of this proposed rule),
and an advancing care information performance category score of zero.
The primary proposal at section II.E.5.g.6.b.ii. of this proposed
rule would require a MIPS eligible clinician to report the numerator
(of at least one) and denominator or yes/no statement (only a yes
statement would qualify for credit under the base score) for a subset
of measures adopted by the EHR Incentive Program for EPs in the 2015
EHR Incentive Programs Final Rule. In an effort to streamline and
simplify the reporting requirements under the MIPS, and reduce
reporting burden on MIPS eligible clinicians, two objectives (Clinical
Decision Support and Computerized Provider Order Entry) and their
associated measures would not be required for reporting the advancing
care information performance category. Given the consistently high
performance on these two objectives in the EHR Incentive Program with
EPs accomplishing a median score of over 90 percent for the last 3
years, we believe these objectives and measures are no longer an
effective measure of EHR performance and use. In addition, we do not
believe these objectives and associated measures contribute to the
goals of patient engagement and interoperability, and thus believe
these objectives can be removed in an effort to reduce reporting burden
without negatively impacting the goals of the advancing care
information performance category. We note that the removed objectives
and associated measures would still be required as part of ONC's
functionality standards for certified EHR technology, however, MIPS
eligible clinicians would not be required to report the numerator and
denominator or yes/no statement for those measures. In the 2015 EHR
Incentive Programs Final Rule we also established that, for measures
that were removed, the technology requirements would still be a part of
the definition of certified EHR
[[Page 28221]]
technology. For example, in that final rule, the Stage 1 Objective to
Record Demographics was removed, but the technology and standard for
this function in the EHR were still required (80 FR 62784). This means
that the MIPS eligible clinician would still be required to have these
functions as a part of their certified EHR technology.
The alternate proposal at section II.E.5.g.6.b.iii. of this
proposed rule would require a MIPS eligible clinician to report the
numerator (of at least one) and denominator or yes/no statement (only a
yes statement would qualify for credit under the base score) for all
objectives and measures adopted for Stage 3 in the 2015 EHR Incentive
Programs Final Rule to earn the base score portion of the advancing
care information performance category, which would include reporting a
yes/no statement for Clinical Decision Support and a numerator and
denominator for Computerized Provider Order Entry objectives. We
include these objectives in the alternate proposal as MIPS eligible
clinicians may feel the continued measurement of these objectives is
valuable to the continued use of EHR technology as this would maintain
the previously established objectives under the EHR Incentive Program.
We believe both proposed approaches to the base score are
consistent with the statutory requirements and previously established
certified EHR technology requirements as we transition to MIPS. We also
believe both approaches, in conjunction with the advancing care
information performance score, recognize the need for greater
flexibility in scoring CEHRT use across different clinician types and
practice settings by allowing MIPS eligible clinicians to focus on the
objectives and measures most applicable to their practice.
(i) Privacy and Security; Protect Patient Health Information
In the 2015 EHR Incentive Programs Final Rule (80 FR 62832), we
finalized the Protect Patient Health Information objective and its
associated measure for Stage 3, which requires EPs to protect
electronic protected health information (ePHI) created or maintained by
the certified EHR technology through the implementation of appropriate
technical, administrative, and physical safeguards. As privacy and
security is of paramount importance and applicable across all
objectives, the Protect Patient Health Information objective and
measure would be an overarching requirement for the base score under
both the primary proposal and alternate proposal, and therefore would
be an overarching requirement for the advancing care information
performance category. We propose that a MIPS eligible clinician must
meet this objective and measure in order to earn any score within the
advancing care information performance category. Failure to do so would
result in a base score of zero under either the primary proposal or
alternate proposal outlined below, as well as a performance score of
zero (discussed in section II.E.5.g. of this proposed rule) and an
advancing care information performance category score of zero.
(ii) Advancing Care Information Performance Category Base Score Primary
Proposal
In the 2015 EHR Incentive Programs Final Rule (80 FR 62829-62871),
we finalized certain objectives and measures EPs would report to
demonstrate meaningful use of certified EHR technology for Stage 3.
Under our proposal for the base score of the advancing care information
performance category, MIPS eligible clinicians would be required to
submit the numerator (of at least one) and denominator, or yes/no
statement as appropriate (only a yes statement would qualify for credit
under the base score), for each measure within a subset of objectives
(Electronic Prescribing, Patient Electronic Access to Health
Information, Care of Coordination Through Patient Engagement, Health
Information Exchange, and Public Health and Clinical Data Registry
Reporting) adopted in the 2015 EHR Incentive Programs Final Rule for
Stage 3 as outlined in Table 6 to account for the base score of 50
percent of the advancing care information performance category score.
Successfully submitting a numerator and denominator or yes/no statement
for each measure of each objective would earn a base score of 50
percent for the advancing care information performance category.
Failure to meet the submission criteria (numerator/denominator or yes/
no statement as applicable) and measure specifications (as defined in
section II.E.5.g.7. of this proposed rule) for any measure in any of
the objectives would result in a score of zero for the advancing care
information performance category base score, a performance score of
zero (discussed in section II.E.5.g. of this proposed rule) and an
advancing care information performance category score of zero.
For the Public Health and Clinical Data Registry Reporting
objective there is no numerator and denominator to measure; rather, the
measure is a ``yes/no'' statement of whether the MIPS eligible
clinician has completed the measure, noting that only a yes statement
would qualify for credit under the base score. Therefore we are
proposing that MIPS eligible clinicians would include a yes/no
statement in lieu of the numerator/denominator statement within their
submission for the advancing care information performance category for
the Public Health and Clinical Data Registry Reporting objective. We
further propose that, to earn points in the base score, a MIPS eligible
clinician would only need to complete submission on the Immunization
Registry Reporting measure of this objective. Completing any additional
measures under this objective would earn one additional bonus point in
the advancing care information performance category score. For further
information on this proposed objective, we direct readers to section
II.E.5.g.7. of this proposed rule.
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(iii) Advancing Care Information Performance Category Base Score
Alternate Proposal
Under our alternate proposal for the base score of the advancing
care information performance category, a MIPS eligible clinician would
be required to submit the numerator (of at least one) and denominator,
or yes/no statement as appropriate, for each measure, for all
objectives and measures for Stage 3 in the 2015 EHR Incentives Program
Final Rule (80 FR 62829-62871) as outlined in Table 7. Successfully
submitting a numerator and denominator for each measure of each
objective would earn a base score of 50 percent for the advancing care
information performance category. Failure to meet the submission
requirements, or measure specifications for any measure in any of the
objectives would result in a score of zero for the advancing care
information performance category base score, a performance score of
zero (discussed in Section II.E.5.g.), and an advancing care
information performance category score of zero.
We propose the same approach in the alternate proposal for the
Public Health and Clinical Data Registry Reporting objective as for the
primary proposal outlined above. We direct readers to section
II.E.5.g.7. for further details on the individual objectives and
measures.
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(iv) Modified Stage 2 in 2017
In the 2015 EHR Incentive Programs final rule (80 FR 62772), we
streamlined reporting for EPs by adopting a single set of objectives
and measures for EPs regardless of their prior stage of participation.
This was the first step in synchronizing the objectives and eliminating
the separate stages of meaningful use in the EHR Incentive Program. In
doing so, we also sought to provide some flexibility and to allow
adequate time for EPs to move toward the more advanced use of EHR
technology. This flexibility included alternate exclusions and
specifications for EPs scheduled to demonstrate Stage 1 in 2015 and
2016 (80 FR 62788) and allowed clinicians to select either the Modified
Stage 2 Objectives or the Stage 3 Objectives in 2017 (80 FR 62772) with
all EPs moving to the Stage 3 Objectives in 2018. We note that in
section II.E.5.g. of this proposed rule, we proposed the requirements
for MIPS eligible clinicians using various editions of certified EHR
technology in 2017 as it relates to the objectives and measures they
select to report.
In connection with that proposal, and in an effort not to unfairly
burden MIPS eligible clinicians who are still utilizing EHR technology
certified to the 2014 Edition certification criteria in 2017, we
propose at Sec. 414.1380(b)(4) modified primary and alternate
proposals for the base score for those MIPS eligible clinicians
utilizing EHR technology certified to the 2014 Edition. We note that
these modified proposals are the same as the primary and alternate
proposals outlined above in regard to scoring and data submission, but
vary in the measures required under the Coordination of Care Through
Patient Engagement and Health Information Exchange objectives as
demonstrated in Table 8.
This approach allows MIPS eligible clinicians to continue moving
toward advanced use of certified EHR technology in 2018, but allows for
flexibility in the implementation of upgraded technology and in the
selection of measures for reporting in 2017.
We invite comments on our proposal.
[[Page 28224]]
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(c) Performance Score
In addition to the base score, which includes submitting each of
the objectives and measures in order to achieve 50 percent of the
possible points within the advancing care information performance
category, we propose to allow multiple paths to achieve a score greater
than the 50 percentage base score. The performance score is based on
the priority goals established by CMS to focus on leveraging certified
EHR technology to support the coordination of care. A MIPS eligible
clinician would earn additional points above the base score for
performance in the objectives and measures for Patient Electronic
Access, Coordination of Care through Patient Engagement, and Health
Information Exchange. These measures have a focus on patient
engagement, electronic access and information exchange, which promote
healthy behaviors by patients and lay the ground work for
interoperability. These measures also have significant opportunity for
improvement among eligible clinicians and the industry as a whole based
on adoption and performance data. We believe this approach for
achievement above a base score in the advancing care information
performance category would provide MIPS eligible clinicians a flexible
and realistic incentive towards the adoption and use of certified EHR
technology.
We are proposing at Sec. 414.1380(b)(4) that, for the performance
score, the eight associated measures under these three objectives would
each be assigned a total of 10 possible points. For each measure, a
MIPS eligible clinician may earn up to 10 percent of their performance
score based on their performance rate for the given measure. For
example, a performance rate of 95 percent on a given measure would earn
9.5 percentage points of the performance score for the advancing care
information performance category. This scoring approach is consistent
with the performance score approach outlined for other MIPS categories
in this proposed rule. Table 9 provides an example of the proposed
performance score methodology.
[[Page 28225]]
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We note that in this methodology, a MIPS eligible clinician has the
potential to earn a performance score of up to 80 percent, which, in
combination with the base score would be greater than the total
possible 100 percent for the advancing care information performance
category. This methodology allows flexibility for MIPS eligible
clinicians to focus on measures which are most relevant to their
practice to achieve the maximum performance category score, while
deemphasizing concentration in other measures which are not relevant to
their practice.
This proposed methodology recognizes the importance of promoting
health IT adoption and standards and the use of certified EHR
technology to support quality improvement, interoperability, and
patient engagement. We invite comments on our proposal.
(d) Overall Advancing Care Information Performance Category Score
To determine the MIPS eligible clinician's overall advancing care
information performance category score, we propose to use the sum of
the base score, performance score, and the potential Public Health and
Clinical Data Registry Reporting bonus point. We note that if the sum
of the MIPS eligible profession's base score (50 percent) and
performance score (out of a possible 80 percent) with the Public Health
and Clinical Data Registry Reporting bonus point are greater than 100
percent, we would apply an advancing care information performance
category score of 100 percent. For example, if the MIPS eligible
clinician earned the base score of 50 percent, a performance score of
60 percent and the bonus point for Public Health and Clinical Data
Registry Reporting for a total of 111 percent, the MIPS eligible
clinician's overall advancing care information performance category
score would be 100 percent. The total percentage score (out of 100) for
the advancing care information performance category would then be
applied to the 25 points allocated for the advancing care information
performance category and incorporated into the MIPS CPS, as described
in section II.E.6. of this proposed rule. Table 10 provides an example
of the calculation of the advancing care information performance
category score based on these proposals.
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(e) Scoring Considerations
Section 1848(q)(5)(E)(ii) of the Act, as added by section 101(c) of
the MACRA, provides that in any year in which the Secretary estimates
that the proportion of EPs (as defined in section 1848(o)(5) of the
Act) who are meaningful EHR users (as determined under section
1848(o)(2) of the Act) is 75 percent or greater, the Secretary may
reduce the applicable percentage weight of the advancing care
information performance category in the MIPS CPS, but not below 15
percent, and increase the weightings of the other performance
categories such that the total percentage points of the increase equals
the total percentage points of the reduction. We note section
1848(o)(5) of the Act defines an EP as a physician, as defined in
section 1861(r) of the Act. For purposes of applying section
1848(q)(5)(E)(ii) of the Act, we propose to estimate the proportion of
physicians as defined in section 1861(r) who are meaningful EHR users
as those physician MIPS eligible clinicians who earn an advancing care
information performance category score of at least 75 percent under our
proposed scoring methodology for the advancing care information
performance category for a performance period. This would require the
MIPS eligible clinician to earn the advancing care information base
score of 50 percent, and an advancing care information performance
score of at least 25 percent (or 24 percent plus the Public Health and
Clinical Data Registry Reporting bonus point) for an overall
performance category score of 75 percent for the advancing care
information performance category. We are alternatively proposing to
estimate the proportion of physicians as defined in section 1861(r) who
are meaningful EHR users as those physician MIPS eligible clinicians
who earn an advancing care information performance category score of 50
percent (which would only require the MIPS eligible clinician to earn
the advancing care information base score) under our proposed scoring
methodology for the advancing care information performance category for
a performance period, and we seek comments on both of these proposed
thresholds.
We propose to base this estimation on data from the relevant
performance period, if we have sufficient data available from that
period. For example, if feasible, we would consider whether to reduce
the applicable percentage weight of the advancing care information
performance category in the MIPS CPS for the 2019 MIPS payment year
based on an estimation using the data from the 2017 performance period.
We note that in section II.E.5.g.8. of this proposed rule, we have
proposed to reweight the advancing care information performance
category to zero for certain hospital-based physicians and other
physicians. These physicians meet the definition of MIPS eligible
clinicians, but would not be included in the estimation because the
advancing care information performance category would be weighted at
zero for them. We note that any adjustments of the performance category
weights specified in section 1848(q)(5)(E) of the Act based on this
policy would be established in future notice and comment rulemaking.
We invite comments on our proposals.
(7) Advancing Care Information Performance Category Objectives and
Measures Specifications
(a) MIPS Objectives and Measures Specifications
We propose the objectives and measures for the advancing care
information performance category of MIPS as outlined in this section of
the proposed rule. We note that these objectives and measures have been
adapted from the Stage 3 objectives and measures as finalized in the
2015 EHR Incentive Programs Final Rule (80 FR 62829-62871), however, we
have not proposed to maintain the previously established thresholds for
MIPS. Any additional changes to the objectives and measures are
outlined in this section of the proposed rule. For a more detailed
discussion of the Stage 3 objectives and measures, including
explanatory material and defined terms, we refer readers to the 2015
EHR Incentive Programs Final Rule (80 FR 62829-62871).
Objective: Protect Patient Health Information
Objective: Protect electronic protected health information (ePHI)
created or maintained by the certified EHR technology through the
implementation of appropriate technical, administrative, and physical
safeguards
Security Risk Analysis Measure: Conduct or review a security risk
analysis in accordance with the requirements in 45 CFR 164.308(a)(1),
including addressing the security (to include encryption) of ePHI data
created or maintained by certified EHR technology in accordance with
requirements in 45 CFR164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and
implement security updates as necessary and correct identified security
deficiencies as part of the MIPS eligible clinician's risk management
process.
Objective: Electronic Prescribing
Objective: MIPS eligible clinicians must generate and transmit
permissible prescriptions electronically.
ePrescribing Measure: At least one permissible prescription written
by the MIPS eligible clinician is queried for a drug formulary and
transmitted electronically using certified EHR technology.
[[Page 28227]]
Denominator: Number of prescriptions written for drugs
requiring a prescription in order to be dispensed other than controlled
substances during the performance period; or number of prescriptions
written for drugs requiring a prescription in order to be dispensed
during the performance period.
Numerator: The number of prescriptions in the denominator
generated, queried for a drug formulary, and transmitted electronically
using certified EHR technology.
For this objective, we note that the 2015 EHR Incentive Program
final rule included a discussion of controlled substances in the
context of the Stage 3 objective and measure (80 FR 62834), which we
understand from stakeholders has caused confusion. We are therefore
proposing for both MIPS and for the EHR Incentive Programs that health
care providers would continue to have the option to include or not
include controlled substances that can be electronically prescribed in
the denominator. This means that health care providers may choose to
include controlled substances in the definition of ``permissible
prescriptions'' at their discretion where feasible and allowable by law
in the jurisdiction where they provide care. The health care provider
may also choose not to include controlled substances in the definition
of ``permissible prescriptions'' even if such electronic prescriptions
are feasible and allowable by law in the jurisdiction where they
provide care.
Objective: Clinical Decision Support (Alternate Proposal Only)
Objective: Implement clinical decision support (CDS) interventions
focused on improving performance on high-priority health conditions
Clinical Decision Support (CDS) Interventions Measure: Implement
three clinical decision support interventions related to three CQMs at
a relevant point in patient care for the entire performance period.
Absent three CQMs related to a MIPS eligible clinician's scope of
practice or patient population, the clinical decision support
interventions must be related to high-priority health conditions.
Drug Interaction and Drug-Allergy Checks Measure: The MIPS eligible
clinician has enabled and implemented the functionality for drug-drug
and drug-allergy interaction checks for the entire performance period.
Objective: Computerized Provider Order Entry (Alternate Proposal
Only)
Objective: Use computerized provider order entry (CPOE) for
medication, laboratory, and diagnostic imaging orders directly entered
by any licensed healthcare professional, credentialed medical
assistant, or a medical staff member credentialed to and performing the
equivalent duties of a credentialed medical assistant, who can enter
orders into the medical record per state, local, and professional
guidelines.
Medication Orders Measure: At least one medication order created by
the MIPS eligible clinician during the performance period is recorded
using CPOE.
Denominator: Number of medication orders created by the
MIPS eligible clinician during the performance period.
Numerator: The number of orders in the denominator
recorded using CPOE.
Laboratory Orders Measure: At least one laboratory order created by
the MIPS eligible clinician during the performance period is recorded
using CPOE.
Denominator: Number of laboratory orders created by the
MIPS eligible clinician during the performance period.
Numerator: The number of orders in the denominator
recorded using CPOE.
Diagnostic Imaging Orders Measure: At least one diagnostic imaging
order created by the MIPS eligible clinician during the performance
period is recorded using CPOE.
Denominator: Number of diagnostic imaging orders created
by the MIPS eligible clinician during the performance period.
Numerator: The number of orders in the denominator
recorded using CPOE.
Objective: Patient Electronic Access.
Objective: The MIPS eligible clinician provides patients (or
patient authorized representative) with timely electronic access to
their health information and patient-specific education.
Patient Access Measure: For at least one unique patient seen by the
MIPS eligible clinician: (1) The patient (or the patient authorized
representative) is provided timely access to view online, download, and
transmit his or her health information; and (2) The MIPS eligible
clinician ensures the patient's health information is available for the
patient (or patient--authorized representative) to access using any
application of their choice that is configured to meet the technical
specifications of the Application Programing Interface (API) in the
MIPS eligible clinician's certified EHR technology.
Denominator: The number of unique patients seen by the
MIPS eligible clinician during the performance period.
Numerator: The number of patients in the denominator (or
patient authorized representative) who are provided timely access to
health information to view online, download, and transmit to a third
party and to access using an application of their choice that is
configured meet the technical specifications of the API in the MIPS
eligible clinician's certified EHR technology.
Patient-Specific Education Measure: The MIPS eligible clinician
must use clinically relevant information from certified EHR technology
to identify patient-specific educational resources and provide
electronic access to those materials to at least one unique patient
seen by the MIPS eligible clinician.
Denominator: The number of unique patients seen by the
MIPS eligible clinician during the performance period.
Numerator: The number of patients in the denominator who
were provided electronic access to patient-specific educational
resources using clinically relevant information identified from
certified EHR technology during the performance period.
Objective: Coordination of Care Through Patient Engagement.
Objective: Use certified EHR technology to engage with patients or
their authorized representatives about the patient's care.
View, Download, Transmit (VDT) Measure: During the performance
period, at least one unique patient (or patient-authorized
representatives) seen by the MIPS eligible clinician actively engages
with the EHR made accessible by the MIPS eligible clinician. An MIPS
eligible clinician may meet the measure by either--(1) view, download
or transmit to a third party their health information; or (2) access
their health information through the use of an API that can be used by
applications chosen by the patient and configured to the API in the
MIPS eligible clinician's certified EHR technology; or (3) a
combination of (1) and (2).
Denominator: Number of unique patients seen by the MIPS
eligible clinician during the performance period.
Numerator: The number of unique patients (or their
authorized representatives) in the denominator who have viewed online,
downloaded, or transmitted to a third party the patient's health
information during the performance period and the number of unique
patients (or their authorized representatives) in the denominator who
have accessed their health information through the use of an API during
the performance period.
Secure Messaging Measure: For at least one unique patient seen by
the MIPS eligible clinician during the
[[Page 28228]]
performance period, a secure message was sent using the electronic
messaging function of certified EHR technology to the patient (or the
patient-authorized representative), or in response to a secure message
sent by the patient (or the patient-authorized representative).
Denominator: Number of unique patients seen by the MIPS
eligible clinician during the performance period.
Numerator: The number of patients in the denominator for
whom a secure electronic message is sent to the patient (or patient-
authorized representative) or in response to a secure message sent by
the patient (or patient-authorized representative), during the
performance period.
Patient-Generated Health Data Measure: Patient-generated health
data or data from a non-clinical setting is incorporated into the
certified EHR technology for at least one unique patient seen by the
MIPS eligible clinician during the performance period.
Denominator: Number of unique patients seen by the MIPS
eligible clinician during the performance period.
Numerator: The number of patients in the denominator for
whom data from non-clinical settings, which may include patient-
generated health data, is captured through the certified EHR technology
into the patient record during the performance period.
Objective: Health Information Exchange.
Objective: The MIPS eligible clinician provides a summary of care
record when transitioning or referring their patient to another setting
of care, receives or retrieves a summary of care record upon the
receipt of a transition or referral or upon the first patient encounter
with a new patient, and incorporates summary of care information from
other health care providers into their EHR using the functions of
certified EHR technology.
Patient Care Record Exchange Measure: For at least one transition
of care or referral, the MIPS eligible clinician that transitions or
refers their patient to another setting of care or health care
provider--(1) creates a summary of care record using certified EHR
technology; and (2) electronically exchanges the summary of care
record.
Denominator: Number of transitions of care and referrals
during the performance period for which the MIPS eligible clinician was
the transferring or referring clinician.
Numerator: The number of transitions of care and referrals
in the denominator where a summary of care record was created using
certified EHR technology and exchanged electronically.
Request/Accept Patient Care Record Measure: For at least one
transition of care or referral received or patient encounter in which
the MIPS eligible clinician has never before encountered the patient,
the MIPS eligible clinician receives or retrieves and incorporates into
the patient's record an electronic summary of care document.
Denominator: Number of patient encounters during the
performance period for which a MIPS eligible clinician was the
receiving party of a transition or referral or has never before
encountered the patient and for which an electronic summary of care
record is available.
Numerator: Number of patient encounters in the denominator
where an electronic summary of care record received is incorporated by
the clinician into the certified EHR technology.
Clinical Information Reconciliation Measure: For at least one
transition of care or referral received or patient encounter in which
the MIPS eligible clinician has never before encountered the patient,
the MIPS eligible clinician performs clinical information
reconciliation. The clinician must implement clinical information
reconciliation for the following three clinical information sets: (1)
Medication. Review of the patient's medication, including the name,
dosage, frequency, and route of each medication. (2) Medication
allergy. Review of the patient's known medication allergies. (3)
Current Problem list. Review of the patient's current and active
diagnoses.
Denominator: Number of transitions of care or referrals
during the performance period for which the MIPS eligible clinician was
the recipient of the transition or referral or has never before
encountered the patient.
Numerator: The number of transitions of care or referrals
in the denominator where the following three clinical information
reconciliations were performed: Medication list, medication allergy
list, and current problem list.
Objective: Public Health and Clinical Data Registry Reporting
Objective: The MIPS eligible clinician is in active engagement with
a public health agency or clinical data registry to submit electronic
public health data in a meaningful way using certified EHR technology,
except where prohibited, and in accordance with applicable law and
practice.
Immunization Registry Reporting Measure: The MIPS eligible
clinician is in active engagement with a public health agency to submit
immunization data and receive immunization forecasts and histories from
the public health immunization registry/immunization information system
(IIS).
(Optional) Syndromic Surveillance Reporting Measure: The MIPS
eligible clinician is in active engagement with a public health agency
to submit syndromic surveillance data from a non-urgent care ambulatory
setting where the jurisdiction accepts syndromic data from such
settings and the standards are clearly defined.
(Optional) Electronic Case Reporting Measure: The MIPS eligible
clinician is in active engagement with a public health agency to
electronically submit case reporting of reportable conditions.
(Optional) Public Health Registry Reporting Measure: The MIPS
eligible clinician is in active engagement with a public health agency
to submit data to public health registries.
(Optional) Clinical Data Registry Reporting Measure: The MIPS
eligible clinician is in active engagement to submit data to a clinical
data registry.
(b) Modified Stage 2 Advancing Care Information Objectives and Measures
Specifications for MIPS
We propose the Modified Stage 2 objectives and measures for the
advancing care information performance category of MIPS as outlined in
this section of the proposed rule. We note that these objectives and
measures have been adapted from the Modified Stage 2 objectives and
measures as finalized in the 2015 EHR Incentive Programs Final Rule (80
FR 62793--62825), however, we have not proposed to maintain the
previously established thresholds for MIPS. Any additional changes to
the objectives and measures are outlined in this section of the
proposed rule. For a more detailed discussion of the Modified Stage 2
objectives and measures, including explanatory material and defined
terms, we refer readers to the 2015 EHR Incentive Programs Final Rule
(80 FR 62793--62825).
Objective: Protect Patient Health Information
Objective: Protect electronic protected health information (ePHI)
created or maintained by the certified EHR technology through the
implementation of appropriate technical, administrative, and physical
safeguards.
Security Risk Analysis Measure: Conduct or review a security risk
analysis in accordance with the requirements in 45 CFR 164.308(a)(1),
including addressing the security (to include encryption) of ePHI data
created
[[Page 28229]]
or maintained by certified EHR technology in accordance with
requirements in 45 CFR164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), and
implement security updates as necessary and correct identified security
deficiencies as part of the MIPS eligible clinician's risk management
process.
Objective: Electronic Prescribing
Objective: MIPS eligible clinicians must generate and transmit
permissible prescriptions electronically.
ePrescribing Measure: At least one permissible prescription written
by the MIPS eligible clinician is queried for a drug formulary and
transmitted electronically using certified EHR technology.
Denominator: Number of prescriptions written for drugs
requiring a prescription in order to be dispensed other than controlled
substances during the performance period; or number of prescriptions
written for drugs requiring a prescription in order to be dispensed
during the performance period.
Numerator: The number of prescriptions in the denominator
generated, queried for a drug formulary, and transmitted electronically
using certified EHR technology.
Objective: Clinical Decision Support (alternate proposal only)
Objective: Implement clinical decision support (CDS) interventions
focused on improving performance on high-priority health conditions.
Clinical Decision Support (CDS) Interventions Measure: Implement
three clinical decision support interventions related to three CQMs at
a relevant point in patient care for the entire performance period.
Absent three CQMs related to a MIPS eligible clinician's scope of
practice or patient population, the clinical decision support
interventions must be related to high-priority health conditions.
Drug Interaction and Drug-Allergy Checks Measure: The MIPS eligible
clinician has enabled and implemented the functionality for drug-drug
and drug-allergy interaction checks for the entire performance period.
Objective: Computerized Provider Order Entry
Objective: Use computerized provider order entry (CPOE) for
medication, laboratory, and diagnostic imaging orders directly entered
by any licensed healthcare professional, credentialed medical
assistant, or a medical staff member credentialed to and performing the
equivalent duties of a credentialed medical assistant, who can enter
orders into the medical record per state, local, and professional
guidelines.
Medication Orders Measure: At least one medication order created by
the MIPS eligible clinician during the performance period is recorded
using CPOE.
Denominator: Number of medication orders created by the
MIPS eligible clinician during the performance period.
Numerator: The number of orders in the denominator
recorded using CPOE.
Laboratory Orders Measure: At least one laboratory order created by
the MIPS eligible clinician during the performance period is recorded
using CPOE.
Denominator: Number of laboratory orders created by the
MIPS eligible clinician during the performance period.
Numerator: The number of orders in the denominator
recorded using CPOE.
Diagnostic Imaging Orders Measure: At least one diagnostic imaging
order created by the MIPS eligible clinician during the performance
period is recorded using CPOE.
Denominator: Number of diagnostic imaging orders created
by the MIPS eligible clinician during the performance period.
Numerator: The number of orders in the denominator
recorded using CPOE.
Objective: Patient Electronic Access
Objective: The MIPS eligible clinician provides patients (or
patient authorized representative) with timely electronic access to
their health information and patient-specific education.
Patient Access Measure: At least one patient seen by the MIPS
eligible clinician during the performance period is provided timely
access to view online, download, and transmit to a third party their
health information subject to the MIPS eligible clinician's discretion
to withhold certain information.
Denominator: The number of unique patients seen by the
MIPS eligible clinician during the performance period.
Numerator: The number of patients in the denominator (or
patient authorized representative) who are provided timely access to
health information to view online, download, and transmit to a third
party.
View, Download, Transmit (VDT) Measure: At least one patient seen
by the MIPS eligible clinician during the performance period (or
patient-authorized representative) views, downloads or transmits their
health information to a third party during the performance period.
Denominator: Number of unique patients seen by the MIPS
eligible clinician during the performance period.
Numerator: The number of unique patients (or their
authorized representatives) in the denominator who have viewed online,
downloaded, or transmitted to a third party the patient's health
information during the performance period.
Objective: Patient-Specific Education
Objective: The MIPS eligible clinician provides patients (or
patient authorized representative) with timely electronic access to
their health information and patient-specific education.
Patient-Specific Education Measure: The MIPS eligible clinician
must use clinically relevant information from certified EHR technology
to identify patient-specific educational resources and provide access
to those materials to at least one unique patient seen by the MIPS
eligible clinician.
Denominator: The number of unique patients seen by the
MIPS eligible clinician during the performance period.
Numerator: The number of patients in the denominator who
were provided access to patient-specific educational resources using
clinically relevant information identified from certified EHR
technology during the performance period.
Objective: Secure Messaging
Objective: Use certified EHR technology to engage with patients or
their authorized representatives about the patient's care.
Secure Messaging Measure: For at least one patient seen by the MIPS
eligible clinician during the performance period, a secure message was
sent using the electronic messaging function of certified EHR
technology to the patient (or the patient-authorized representative),
or in response to a secure message sent by the patient (or the patient
authorized representative) during the performance period.
Denominator: Number of unique patients seen by the MIPS
eligible clinician during the performance period.
Numerator: The number of patients in the denominator for
whom a secure electronic message is sent to the patient (or patient-
authorized representative) or in response to a secure message sent by
the patient (or patient-authorized representative), during the
performance period.
Objective: Health Information Exchange
Objective: The MIPS eligible clinician provides a summary of care
record when transitioning or referring their patient to another setting
of care, receives or retrieves a summary of care record upon the
receipt of a transition or referral or upon the first patient encounter
with a new patient, and incorporates summary of care
[[Page 28230]]
information from other health care providers into their EHR using the
functions of certified EHR technology.
Health Information Exchange Measure: The MIPS eligible clinician
that transitions or refers their patient to another setting of care or
health care provider (1) uses certified EHR technology to create a
summary of care record; and (2) electronically transmits such summary
to a receiving health care provider for at least one transition of care
or referral.
Denominator: Number of transitions of care and referrals
during the performance period for which the EP was the transferring or
referring health care provider.
Numerator: The number of transitions of care and referrals
in the denominator where a summary of care record was created using
certified EHR technology and exchanged electronically.
Objective: Medication Reconciliation
Medication Reconciliation Measure: The MIPS eligible clinician
performs medication reconciliation for at least one transition of care
in which the patient is transitioned into the care of the MIPS eligible
clinician.
Denominator: Number of transitions of care or referrals
during the performance period for which the MIPS eligible clinician was
the recipient of the transition or referral or has never before
encountered the patient.
Numerator: The number of transitions of care or referrals
in the denominator where the following three clinical information
reconciliations were performed: Medication list, medication allergy
list, and current problem list.
Objective: Public Health Reporting
Objective: The MIPS eligible clinician is in active engagement with
a public health agency or clinical data registry to submit electronic
public health data in a meaningful way using certified EHR technology,
except where prohibited, and in accordance with applicable law and
practice.
Immunization Registry Reporting Measure: The MIPS eligible
clinician is in active engagement with a public health agency to submit
immunization data.
Syndromic Surveillance Registry Reporting Measure: The MIPS
eligible clinician is in active engagement with a public health agency
to submit syndromic surveillance data.
Specialized Registry Reporting Measure: The MIPS eligible clinician
is in active engagement to submit data to a specialized registry.
We invite comments on our proposal.
(c) Exclusions
In the 2015 EHR Incentive Programs Final Rule (80 FR 62829-62871)
we outlined certain exclusions from the objectives and measures of
meaningful use for EPs who perform low numbers of a particular action
or activity for a given measure (for example, an EP who writes fewer
than 100 permissible prescriptions during the EHR reporting period
would be granted an exclusion for the Electronic Prescribing measure)
or for EPs who had no office visits during the EHR reporting period.
Moving forward, we believe that the proposed MIPS exclusion criteria as
outlined in section II.E.3. of this proposed rule, and advancing care
information performance category scoring methodology together
accomplish the same end as the previously established exclusions for
the majority of the advancing care information measures. By excluding
from MIPS those clinicians who do not exceed the low-volume threshold
(proposed in section II.E.3.c. as MIPS eligible clinicians who, during
the performance period, have Medicare billing charges less than or
equal to $10,000 and provide care for 100 or fewer Part B-enrolled
Medicare beneficiaries), we believe exclusions for most of the
individual advancing care information measures are no longer necessary.
The additional flexibility afforded by the proposed advancing care
information performance category scoring methodology eliminates
required thresholds for measures and allows MIPS eligible clinicians to
focus on, and therefore report higher numbers for, measures that are
more relevant to their practice.
We note that EPs who write less than 100 permissible prescriptions
during the EHR reporting period are allowed an exclusion for the
Electronic Prescribing measure under the EHR Incentive Program (80 FR
62834), which we do not propose for MIPS. We note that the Electronic
Prescribing objective would not be part of the performance score under
our proposals, and thus MIPS eligible clinicians who write very low
numbers of permissible prescriptions would not be at a disadvantage in
relation to other MIPS eligible clinicians when seeking to achieve a
maximum advancing care information performance category score. For the
purposes of the base score, we are proposing that those MIPS eligible
clinicians who write fewer than 100 permissible prescriptions in a
performance period may elect to report their numerator and denominator
(if they have at least one permissible prescription for the numerator),
or they may report a null value. This is consistent with prior policy
which allowed flexibility for clinicians in similar circumstances to
choose an alternate exclusion (80 FR 62789).
In addition, in the 2015 EHR Incentive Programs final rule, we
adopted a set of exclusions for the Immunization Registry Reporting
measure under the Public Health and Clinical Data Registry Reporting
objective (80 FR 62870). We recognize that some types of clinicians do
not administer immunizations, and are therefore proposing to maintain
the previously established exclusions for the Immunization Registry
Reporting measure. We are therefore proposing that these MIPS eligible
clinicians may elect to report their yes/no statement if applicable, or
they may report a null value (if the previously established exclusions
apply) for purposes of reporting the base score.
We note that we are not proposing to maintain any of the other
exclusions established under the EHR Incentive Program, however, we are
seeking comment on whether other exclusions should be considered under
the advancing care information performance category under the MIPS.
(8) Additional Considerations
(a) Reweighting of the Advancing Care Information Performance Category
for MIPS Eligible Clinicians Without Sufficient Measures Applicable and
Available
As discussed previously in this proposed rule, section 101(b)(1)(A)
of the MACRA amended section 1848(a)(7)(A) of the Act to sunset the
meaningful use payment adjustment at the end of CY 2018. Section
1848(a)(7) of the Act includes certain statutory exceptions to the
meaningful use payment adjustment under section 1848(a)(7)(A) of the
Act. Specifically, section 1848(a)(7)(D) of the Act exempts hospital-
based EPs from the application of the payment adjustment under section
1848(a)(7)(A) of the Act. In addition, section 1848(a)(7)(B) of the Act
provides that the Secretary may exempt an EP who is not a meaningful
EHR user for the EHR reporting period for the year from the application
of the payment adjustment under section 1848(a)(7)(A) of the Act if the
Secretary determines that compliance with the requirements for being a
meaningful EHR user would result in a significant hardship, such as in
the case of an EP who practices in a rural area without sufficient
internet access. The MACRA did not maintain these statutory
[[Page 28231]]
exceptions for the advancing care information performance category of
the MIPS. Thus, the exceptions under sections 1848(a)(7)(B) and (D) of
the Act are limited to the meaningful use payment adjustment under
section 1848(a)(7)(A) of the Act and do not apply in the context of the
MIPS.
Section 1848(q)(5)(F) of the Act provides, if there are not
sufficient measures and activities applicable and available to each
type of MIPS eligible clinician, the Secretary shall assign different
scoring weights (including a weight of zero) for each performance
category based on the extent to which the category is applicable to
each type of MIPS eligible clinician, and for each measure and activity
specified for each such category based on the extent to which the
measure or activity is applicable and available to the type of MIPS
eligible clinician.
We believe that under our proposals for the advancing care
information performance category of the MIPS, there may not be
sufficient measures that are applicable and available to certain types
of MIPS eligible clinicians as outlined in this section of this
proposed rule, some of whom may have qualified for a statutory
exception to the meaningful use payment adjustment under section
1848(a)(7)(A) of the Act. For the reasons stated below, we propose to
assign a weight of zero to the advancing care information performance
category for purposes of calculating a MIPS CPS for these MIPS eligible
clinicians. We refer readers to section II.E.6. of this proposed rule
for more information regarding how the quality, resource use and CPIA
performance categories would be reweighted.
(i) Hospital-Based MIPS Eligible Clinicians
Section 1848(a)(7)(D) of the Act exempts hospital-based EPs from
the application of the meaningful use payment adjustment under section
1848(a)(7)(A) of the Act. We defined a hospital-based EP for the EHR
Incentive Program under Sec. 495.4 as an EP who furnishes 90 percent
or more of his or her covered professional services in sites of service
identified by the codes used in the HIPAA standard transaction as an
inpatient hospital or emergency room setting in the year preceding the
payment year, or in the case of a payment adjustment year, in either of
the 2 years before the year preceding such payment adjustment year.
Under this definition, EPs that have 90 percent or more of payments for
covered professional services associated with claims with Place of
Service Codes 21 (inpatient hospital) or 23 (emergency department) are
considered hospital-based (75 FR 44442).
We believe there may not be sufficient measures applicable and
available to hospital-based MIPS eligible clinicians under our
proposals for the advancing care information performance category of
MIPS.
Hospital-based MIPS eligible clinicians may not have control over
the decisions that the hospital makes regarding the use of health IT
and certified EHR technology. These MIPS eligible clinicians therefore
may have no control over the type of certified EHR technology
available, the way that the technology is implemented and used, or
whether the hospital continually invests in the technology to ensure it
is compliant with ONC certification criteria. In addition, some of the
specific advancing care information performance category measures, such
as the Patient Access measure under the Patient Electronic Access
objective requires that patients have access to view, download and
transmit their health information from the EHR which is made available
by the health care provider, in this case the hospital. Thus the
measure is more attributable and applicable to the hospital and not to
the MIPS eligible clinician, as the hospital controls the availability
of the EHR technology. Further, the requirement under the Protect
Patient Health Information objective to conduct a security risk
analysis, would rely on the actions of the hospital, rather than the
actions of the MIPS eligible clinician, as the hospital controls the
access and availability and secure implementation of the EHR
technology. In this case, the measure is again more attributable and
applicable to the hospital than to the MIPS eligible clinician.
Further, certain specialists (such as pathologists, radiologists and
anesthesiologists) who often practice in a hospital setting and may be
hospital-based MIPS eligible clinicians often lack face-to-face
interaction with patients, and thus may not have sufficient measures
applicable and available to them under our proposals. For example,
hospital-based MIPS eligible clinicians who lack face-to-face patient
interaction may not have patients for which they could transfer or
create an electronic summary of care record.
In addition, we note that eligible hospitals and CAHs are subject
to meaningful use requirements under sections 1886(b)(3)(B) and (n) and
1814(l) of the Act, respectively, which were not affected by the
enactment of the MACRA. Eligible hospitals and CAHs are required to
report on objectives and measures of meaningful use under the EHR
Incentive Program, as outlined in the 2015 EHR Incentive Programs Final
Rule. We note the objectives and measures of the EHR Incentive Programs
for eligible hospitals and CAHs are specific to these facilities, and
are more applicable and better represent the EHR technology available
in these settings.
For these reasons, we propose to rely on section 1848(q)(5)(F) of
the Act to assign a weight of zero to the advancing care information
performance category for hospital-based MIPS eligible clinicians. We
propose to define a ``hospital-based MIPS eligible clinician'' at Sec.
414.1305 as a MIPS eligible clinician who furnishes 90 percent or more
of his or her covered professional services in sites of service
identified by the codes used in the HIPAA standard transaction as an
inpatient hospital or emergency room setting in the year preceding the
performance period, otherwise stated as the year three years preceding
the MIPS payment year. For example, under this proposal, hospital-based
determinations would be made for the 2019 MIPS payment year based on
covered professional services furnished in 2016. We also propose,
consistent with the EHR Incentive Program, that CMS would determine
which MIPS eligible clinicians qualify as ``hospital-based'' for a MIPS
payment year. We invite comments on these proposals.
In addition, we are seeking comment on how the advancing care
information performance category could be applied to hospital-based
MIPS eligible clinicians in future years of MIPS, and the types of
measures that would be applicable and available to these types of MIPS
eligible clinicians.
We are also seeking comment on whether the previously established
90 percent threshold of payments for covered professional services
associated with claims with Place of Service (POS) Codes 21 (inpatient
hospital) or 23 (emergency department) is appropriate, or whether we
should consider lowering this threshold to account for hospital-based
MIPS eligible clinicians who bill more than 10 percent of claims with a
POS other than 21 or 23. Although we have proposed a threshold of 90
percent, we are considering whether a lower threshold would be more
appropriate for hospital-based MIPS eligible clinicians. In particular,
we are interested in what factors should be applied to determine the
threshold for hospital-based MIPS eligible clinicians. We will continue
to evaluate the data to determine whether there are certain thresholds
which naturally define a hospital-based MIPS eligible clinician.
[[Page 28232]]
(ii) MIPS Eligible Clinicians Facing a Significant Hardship
Section 1848(a)(7)(B) of the Act provides that the Secretary may
exempt an EP who is not a meaningful EHR user for the EHR reporting
period for the year from the application of the payment adjustment
under section 1848(a)(7)(A) of the Act if the Secretary determines that
compliance with the requirements for being a meaningful EHR user would
result in a significant hardship. In the Stage 2 Final Rule (77 FR
54097-54100), we defined certain categories of significant hardships
that may prevent an EP from meeting the requirements of being a
meaningful EHR user. These categories include:
Insufficient Internet Connectivity (as specified in 42 CFR
495.102(d)(4)(i)).
Extreme and Uncontrollable Circumstances (as specified in
42 CFR 495.102(d)(4)(iii)).
Lack of Control over the Availability of certified EHR
technology (as specified in 42 CFR 495.102(d)(4)(iv)(A)).
Lack of Face-to-Face Patient Interaction (as specified in
42 CFR 495.102(d)(4)(iv)(B)).
We believe that under our proposals for the advancing care
information performance category, there may not be sufficient measures
applicable and available to MIPS eligible clinicians within the
categories above. For these MIPS eligible clinicians, we propose to
rely on section 1848(q)(5)(F) of the Act to re-weight the advancing
care information performance category to zero.
Sufficient internet access is fundamental to many of the measures
proposed for the advancing care information performance category. For
example, the ePrescribing measure requires sufficient access to the
Internet to transmit prescriptions electronically, and the Secure
Messaging measure requires sufficient Internet access to receive and
respond to patient messages. These measures may not be applicable to
MIPS eligible clinicians who practice in areas with insufficient
internet access. We propose to require MIPS eligible clinicians to
demonstrate insufficient internet access through an application process
in order to be considered for a reweighting of the advancing care
information performance category. The application would have to
demonstrate that the MIPS eligible clinicians lacked sufficient
internet access, during the performance period, and that there were
insurmountable barriers to obtaining such infrastructure, such as a
high cost of extending the internet infrastructure to their facility.
Extreme and uncontrollable circumstances, such as a natural
disaster in which an EHR or practice building are destroyed, can happen
at any time and are outside a MIPS eligible clinician's control. If a
MIPS eligible clinician's certified EHR technology is unavailable as a
result of such circumstances, the measures specified for the advancing
care information performance category may not be available for the MIPS
eligible clinician to report. We propose that these MIPS eligible
clinicians submit an application to include the circumstances by which
the EHR technology was unavailable, and for what period of time it was
unavailable, to be considered for reweighting of their advancing care
information performance category.
In the Stage 2 Final Rule (77 FR 54100) we discussed EPs who
practice at multiple locations, and may not have the ability to impact
their practices' health IT decisions. We noted the case of surgeons
using ambulatory surgery centers or a physician treating patients in a
nursing home who does not have any other vested interest in the
facility, and may have no influence or control over the health IT
decisions of that facility. If MIPS eligible clinicians lack control
over the EHR technology in their practice locations, then the measures
specified for the advancing care information performance category may
not be available to them for reporting. To be considered for a
reweighting of the advancing care information performance category, we
propose that these MIPS eligible clinicians would need to submit an
application demonstrating that a majority (50 percent or more) of their
outpatient encounters occur in locations where they have no control
over the health IT decisions of the facility, and request their
advancing care information performance category score be reweighted to
zero. We note that in such cases, the MIPS eligible clinician must have
no control over the availability of certified EHR technology. Control
does not imply final decision-making authority. For example, we would
generally view MIPS eligible clinicians practicing in a large group as
having control over the availability of certified EHR technology,
because they can influence the group's purchase of certified EHR
technology, they may reassign their claims to the group, they may have
a partnership/ownership stake in the group, or any payment adjustment
would affect the group's earnings and the entire impact of the
adjustment would not be borne by the individual MIPS eligible
clinician. These MIPS eligible clinicians can influence the
availability of certified EHR technology and the group's earnings are
directly affected by the payment adjustment. Thus, such MIPS eligible
clinicians would not, as a general rule, be viewed as lacking control
over the availability of certified EHR technology and would not be
eligible for their advancing care information performance category to
be reweighted based on their membership in a group practice that has
not adopted certified EHR technology.
In the Stage 2 Final Rule (77 FR 54099), we noted the challenges
faced by EPs who lack face-to-face interaction with patients (EPs that
are non-patient facing), or lack the need to provide follow-up care
with patients. Many of the measures proposed under the advancing care
information performance category require face-to-face interaction with
patients, including all eight of the measures that make up the three
performance score objectives (Patient Electronic Access, Coordination
of Care Through Patient Engagement and Health Information Exchange).
Because these proposed measures rely so heavily on face-to-face patient
interactions, we do not believe there would be sufficient measures
applicable to non-patient-facing MIPS eligible clinicians under the
advancing care information performance category. We propose to
automatically reweight the advancing care information performance
category to zero for a MIPS eligible clinician who is classified as a
non-patient facing MIPS eligible clinician (based on the number of
patient-facing encounters billed during a performance period) without
requiring an application to be submitted by the MIPS eligible
clinician. We refer readers to section II.E.1.b. of this proposed rule
for further discussion of non-patient facing MIPS eligible clinicians.
We are seeking comment on how the advancing care information
performance category could be applied to non-patient facing MIPS
eligible clinicians in future years of MIPS, and the types of measures
that would be applicable and available to these types of MIPS eligible
clinicians.
We propose that all applications for reweighting the advancing care
information performance category be submitted by the MIPS eligible
clinician or designated group representative in the form and manner
specified by CMS. We propose that all applications may be submitted on
a rolling basis, but must be received by CMS no later than the close of
the submission period for the relevant performance period, or a later
date specified by CMS. For example, for the 2017 performance period,
applications
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must be submitted no later than March 31, 2018 (or later date as
specified by CMS) to be considered for reweighting the advancing care
information performance category for the 2019 MIPS payment year. An
application would need to be submitted annually to be considered for
reweighting each year.
We invite comments on our proposals.
(iii) Nurse Practitioners, Physician Assistants, Clinical Nurse
Specialists, and Certified Registered Nurse Anesthetists
The definition of a MIPS EP under section 1848(q)(1)(C) of the Act
includes certain non-physician practitioners, including Nurse
Practitioners (NPs), Physicians Assistants (PAs), Certified Registered
Nurse Anesthetists (CRNAs) and Clinical Nurse Specialists (CNSs)).
CRNAs and CNSs are not eligible for the incentive payments under
Medicare or Medicaid for the adoption and meaningful use of certified
EHR technology (sections 1848(o) and 1903(t) of the Act, respectively)
or subject to the meaningful use payment adjustment under Medicare
(section 1848(a)(7)(A) of the Act), and thus they may have little to no
experience with the adoption or use of certified EHR technology.
Similarly, NPs and PAs may also lack experience with the adoption or
use of certified EHR technology, as they are not subject to the payment
adjustment under section 1848(a)(7)(A) of the Act. We further note that
only 19,281 NPs and only 1,379 PAs have attested to the Medicaid EHR
Incentive Program. Nurse practitioners are eligible for the Medicaid
incentive payments under section 1903(t) of the Act, as are PAs
practicing in a Federally Qualified Health Center (FQHC) or a rural
health clinic (RHC) that is led by a PA, if they meet patient volume
requirements and other eligibility criteria.
Because many of these non-physician clinicians are not eligible to
participate in the Medicare and/or Medicaid EHR Incentive Program, we
have little evidence as to whether there are sufficient measures
applicable and available to these types of MIPS eligible clinicians
under our proposals for the advancing care information performance
category. The low numbers of NPs and PAs who have attested for the
Medicaid incentive payments may indicate that EHR Incentive Program
measures required to earn the incentive are not applicable or
available, and thus would not be applicable or available under the
advancing care information performance category. For these reasons, we
propose to rely on section 1848(q)(5)(F) of the Act to assign a weight
of zero to the advancing care information performance category if there
are not sufficient measures applicable and available to NPs, PAs,
CRNAs, and CNSs. We would assign a weight of zero only in the event
that an NP, PA, CRNA, or CNS does not submit any data for any of the
measures specified for the advancing care information performance
category. We encourage all NPs, PAs, CRNAs, and CNSs to report on these
measures to the extent they are applicable and available, however, we
understand that some NPs, PAs, CRNAs, and CNSs may choose to accept a
weight of zero for this performance category if they are unable to
fully report the advancing care information measures. We believe this
approach is appropriate for the first MIPS performance period based on
the payment consequences associated with reporting, the fact that many
of these types of MIPS eligible clinicians may lack experience with EHR
use, and our current uncertainty as to whether we have proposed
sufficient measures that are applicable and available to these types of
MIPS eligible clinicians. We note that we would use the first MIPS
performance period to further evaluate the participation of these MIPS
eligible clinicians in the advancing care information performance
category and would consider for subsequent years whether the measures
specified for this category are applicable and available to these MIPS
eligible clinicians.
We invite comments on our proposal. We are additionally seeking
comment on how the advancing care information performance category
could be applied to NPs, PAs, CRNAs, and CNSs in future years of MIPS,
and the types of measures that would be applicable and available to
these types of MIPS eligible clinicians.
(iv) Medicaid
In the 2015 EHR Incentive Programs Final Rule we adopted an
alternate method for demonstrating meaningful use for certain Medicaid
EPs that would be available beginning in 2016, for EPs attesting for an
EHR reporting period in 2015 (80 FR 62900). Medicaid EPs who previously
received an incentive payment under the Medicaid EHR Incentive Program,
but failed to meet the eligibility requirements for the program in
subsequent years, are permitted to attest using the CMS Registration
and Attestation system for the purpose of avoiding the Medicare payment
adjustment (80 FR 62900). However, as discussed previously in this
proposed rule, section 101(b)(1)(A) of the MACRA amended section
1848(a)(7)(A) of the Act to sunset the meaningful use payment
adjustment for Medicare EHR Incentive Program EPs at the end of CY
2018. This means that after the CY 2018 payment adjustment year, there
will no longer be a separate Medicare EHR Incentive Program for EPs,
and therefore Medicaid EPs who may have used this alternate method for
demonstrating meaningful use cannot potentially be subject to a payment
adjustment under the Medicare EHR Incentive Program at that time.
Accordingly, there will no longer be a need for this alternate method
of demonstrating meaningful use after the CY 2018 payment adjustment
year.
Similarly, beginning in 2014, states were required to collect,
upload and submit attestation data for Medicaid EPs for the purposes of
demonstrating meaningful use to avoid the Medicare payment adjustment
(80 FR 62915). This form of reporting will also no longer need to
continue with the sunset of the meaningful use payment adjustment for
Medicare EHR Incentive Program EPs at the end of CY 2018. Accordingly,
we are proposing to amend the reporting requirement described at 42 CFR
495.316(g) by adding an ending date such that after the CY 2018 payment
adjustment year states would no longer be required to report on
meaningful EHR users.
We note that the Medicaid EHR Incentive Program for EPs was not
impacted by the MACRA and the requirement under section 1848(q) of the
Act to establish the MIPS program. In this rule, we do not propose any
changes to the objectives and measures previously established in
rulemaking for the Medicaid EHR Incentive Program, and thus EPs
participating in that program must continue to report on the objectives
and measures under the guidelines and regulations of that program.
Accordingly, reporting on the measures specified for the advancing
care information performance category under MIPS cannot be used as a
demonstration of meaningful use for the Medicaid EHR Incentive
Programs. Similarly, a demonstration of meaningful use in the Medicaid
EHR Incentive Programs cannot be used for purposes of reporting under
MIPS.
Therefore, MIPS eligible clinicians who are also participating in
the Medicaid EHR Incentive Programs must report their data for the
advancing care information performance category through the submission
methods established for MIPS in order to earn a score for the advancing
care information performance category under MIPS and must separately
demonstrate meaningful use in their state's Medicaid EHR Incentive
Program in order to earn a
[[Page 28234]]
Medicaid incentive payment. The Medicaid EHR Incentive Program
continues through payment year 2021, with 2016 being the final year an
EP can begin receiving incentive payments (Sec. 495.310(a)(1)(iii)).
We solicit comments on alternative reporting or proxies for EPs who
provide services to both Medicaid and Medicare patients and are
eligible for both MIPS and the Medicaid EHR Incentive Payment.
h. APM Scoring Standard for MIPS Eligible Clinicians Participating in
MIPS APMs
Under section 1848(q)(1)(C)(ii) of the Act, as added by section
101(c)(1) of the MACRA and discussed above in section II.E.3.b. of this
proposed rule, Qualifying APM Participants (QPs) are not MIPS eligible
clinicians and are thus excluded from MIPS payment adjustments. Partial
Qualifying APM Participants (Partial QPs) are also not MIPS eligible
clinicians unless they opt to report and be scored under MIPS. All
other eligible clinicians participating in APMs are MIPS eligible
clinicians and subject to MIPS requirements, including reporting
requirements and payment adjustments. However, most current APMs
already assess their participants on cost and quality of care and
require engagement in certain care improvement activities.
We propose at Sec. 414.1370 to establish a scoring standard for
MIPS eligible clinicians participating in certain types of APMs in
order to reduce participant reporting burden by eliminating the need
for such APM eligible clinicians to submit data for both MIPS and their
respective APMs. For purposes of this APM scoring standard, we propose
to consider a participant in an APM to be an entity participating in an
APM under an agreement with CMS that may either include eligible
clinicians or be an eligible clinician and that is directly tied to
beneficiary attribution, quality measurement or cost/utilization
measurement under the APM. In accordance with section 1848(q)(1)(D)(i)
of the Act, we propose to assess the performance of a group of MIPS
eligible clinicians in an APM Entity that participates in certain types
of APMs based on their collective performance as an APM Entity group,
as defined at Sec. 414.1305.
In addition to reducing reporting burden, we seek to ensure that
eligible clinicians in APM Entity groups are not assessed in multiple
ways on the same performance activities. For instance, performance on
the generally applicable resource use measures under MIPS could
contribute to upward or downward adjustments to payments under MIPS in
a way that is not aligned with the strategy in an ACO initiative for
reducing total Medicare costs for a specified population of
beneficiaries attributed through the unique ACO initiative's
attribution methodology. Depending on the terms of the particular APM,
we believe similar misalignments could be common between the MIPS
quality and resource use performance categories and the evaluation of
quality and resource use in APMs. We believe requiring eligible
clinicians in APM Entity groups to submit data, be scored on measures,
and be subject to payment adjustments that are not aligned between MIPS
and an APM could potentially undermine the validity of testing or
performance evaluation under the APM. We also believe imposition of
these requirements would result in reporting activity that provides
little or no added value to the assessment of eligible clinicians, and
could confuse eligible clinicians as to which CMS incentives should
take priority over others in designing and implementing care
activities.
We are proposing to use the APM scoring standard for MIPS eligible
clinicians in APM Entity groups participating in certain APMs that meet
the criteria listed below (and are identified as ``MIPS APMs'' on the
CMS Web site). In this section of the rule, we define the proposed
criteria for MIPS APMs, the APM scoring standard, the performance
period for APM Entity groups, the proposed MIPS scoring methodology for
APM Entity groups, and other information related to the APM scoring
standard.
(1) Criteria for MIPS APMs
We propose at Sec. 414.1370 to specify that the APM scoring
standard under MIPS would only be applicable to certain eligible
clinicians participating in MIPS APMs, which we propose to define as
APMs (as defined in section II.F.4. of this preamble) that meet the
following criteria: (1) APM Entities participate in the APM under an
agreement with CMS; (2) the APM Entities include one or more MIPS
eligible clinicians on a Participation List; and (3) the APM bases
payment incentives on performance (either at the APM Entity or eligible
clinician level) on cost/utilization and quality measures. We
understand that under some APMs the APM Entity may enter into
agreements with clinicians or entities that have supporting or
ancillary roles to the APM Entity's performance under the APM, but are
not participating under the APM Entity and therefore are not on a
Participation List. We would not consider eligible clinicians under
such arrangements to be participants for purposes of the APM Entity
group to which the APM scoring standard would apply. We understand that
this policy would not accommodate certain APMs pursuant to statute or
our regulations rather than under an agreement with CMS. We seek
comments on how the APM scoring standard should apply to those APMs as
well.
The criteria for the identification of MIPS APMs are independent of
the criteria for Advanced APM determinations discussed in section
II.F.3. of this proposed rule, so a MIPS APM may or may not also be an
Advanced APM. As such, it would be possible that an APM meets all three
proposed criteria to be a MIPS APM, but does not meet the Advanced APM
criteria listed in section II.F.4. Conversely, it would be possible,
that an Advanced APM does not meet the criteria listed above because it
does not include MIPS eligible clinicians as participants.
The APM scoring standard would not apply to MIPS eligible
clinicians involved in APMs that include only facilities as
participants (such as the Comprehensive Care for Joint Replacement
Model). APMs that do not base payment on cost/utilization and quality
measures (such as the Accountable Health Communities Model) would also
not meet the proposed criteria for the APM scoring standard. Instead,
MIPS eligible clinicians participating in these APMs would need to meet
the generally applicable MIPS data submission requirements for the MIPS
performance period, and their performance would be assessed using the
generally applicable MIPS standards, either as individual eligible
clinicians or as a group under MIPS.
As discussed above, the APM scoring standard described in this
proposed rule would require MIPS eligible clinicians to report certain
data under MIPS regardless of whether they ultimately become QPs or
Partial QPs through their participation in Advanced APMs. Although QPs
(and Partial QPs who elect not to participate in MIPS) would be
excluded from MIPS payment adjustments, we believe it is necessary, for
the operational and administrative reasons discussed in section
II.F.5.d., to treat these eligible clinicians as MIPS eligible
clinicians unless and until the QP or Partial QP determination is made.
We believe the proposed APM scoring standard would help to alleviate
certain duplicative, unnecessary, or competing data submission
requirements for MIPS eligible clinicians participating in MIPS
[[Page 28235]]
APMs. However, we are interested in public comments on alternative
methods that could reduce MIPS data submission requirements to enable
MIPS eligible clinicians participating in Advanced APMs to maximize
their focus on the care delivery redesign necessary to succeed within
the Advanced APM while maintaining the statutory framework that
excludes only certain eligible clinicians from MIPS, and reducing
reporting burden on Advanced APM participants.
We invite public comment on alternative MIPS data submission and
scoring methods. Specifically, if, during a future performance period,
we are able to make QP determinations before MIPS reporting must occur,
we seek to attain the least amount of required MIPS data submission
while avoiding unnecessary operational complexity.
(2) APM Scoring Standard Performance Period
We propose that the performance period for MIPS eligible clinicians
participating in MIPS APMs would match the generally applicable
performance period for MIPS proposed in section II.E.4 of this
preamble. We propose this policy would apply to all MIPS eligible
clinicians participating in MIPS APMs (those that meet the criteria
specified in section II.E.5.h.1. of this proposed rule) except for a
new MIPS APM for which the first APM performance period begins after
the start of the corresponding MIPS performance period. In this
instance, the participating MIPS eligible clinicians in the new MIPS
APM would submit data to MIPS in the first MIPS performance period for
the APM either as individual MIPS eligible clinicians or as a group
using one of the MIPS data submission mechanisms for all four
performance categories, and report to CMS using the APM scoring
standard for subsequent MIPS performance period(s). Additionally, we
anticipate that there might be MIPS APMs that would not be able to use
the APM scoring standard (even though they met the criteria for the APM
scoring standard and were treated as a MIPS APMs in the prior MIPS
performance period) in their last year of operation because of
technical or resource issues. For example, a MIPS APM in its final year
may end earlier than the end of the MIPS performance period (proposed
to be December 31). CMS might not have continuing resources dedicated
or available to continue to support the MIPS APM activities under the
APM scoring standard if the MIPS APM ends during the MIPS performance
period. Therefore, if we determine it is not feasible for the MIPS
eligible clinicians participating in the APM Entity to report to MIPS
using this APM scoring standard in an APM's last year of operation, the
MIPS eligible clinicians in the MIPS APM would need to submit data to
MIPS either as individual MIPS eligible clinicians or as a group using
one of the MIPS data submission mechanisms for the applicable
performance period. We propose the eligible clinicians in the MIPS APM
would be made aware of this decision in advance of the relevant MIPS
performance period.
(3) How the APM Scoring Standard Differs From the Assessment of Groups
and Individual MIPS Eligible Clinicians Under MIPS
We believe that establishing an APM scoring standard under MIPS
would allow APM Entities and their participating eligible clinicians to
focus on the goals and objectives of the APM to improve quality and
lower costs of care while avoiding duplicative reporting that would
occur as a result of having to submit data to MIPS separately. The APM
scoring standard we propose is similar to group assessment under MIPS
as described in section II.E.3.d. of this proposed rule, but would
differ in one or more of the following ways: (1) Depending on the terms
and conditions of the MIPS APM, an APM Entity could be comprised of a
sole MIPS eligible clinician (for example, a physician practice with
only one eligible clinician could be considered an APM Entity); (2) the
APM Entity could include more than one unique TIN, as long as the MIPS
eligible clinicians are identified as participants in the APM by their
unique APM participant identifiers; (3) the composition of the APM
Entity group could include APM participant identifiers with TIN/NPI
combinations such that some MIPS eligible clinicians in a TIN are APM
participants and other MIPS eligible clinicians in that same TIN are
not APM participants. In contrast, assessment as a group under MIPS
requires a group to be comprised of at least two MIPS eligible
clinicians who have assigned their billing rights to a TIN. It also
requires that all MIPS eligible clinicians in the group to use the same
TIN.
In addition to the APM Entity group composition being potentially
different than that of a group as generally defined under MIPS, we
propose for the APM scoring standard that we will generate a MIPS CPS
by aggregating all scores for MIPS eligible clinicians in the APM
Entity that is participating in the MIPS APM to the level of the APM
Entity. We believe that aggregating the MIPS performance category
scores at the level of the APM Entity is more meaningful to, and
appropriate for, these MIPS eligible clinicians because they have
elected to participate in an APM and collectively focus on care
transformation activities to improve the quality of care.
Further, we propose below that, depending on the type of MIPS APM,
the weights associated with performance categories may be different
than the generally applicable weights for MIPS eligible clinicians. The
weights assigned to the MIPS performance categories under the APM
scoring standard for MIPS eligible clinicians who are participating in
a MIPS APM may be different from the performance category weights for
MIPs eligible clinicians not participating in a MIPS APM for the same
performance period. For example, we propose below that under the APM
scoring standard, the weight for the resource use performance category
will be zero. We also propose that for certain MIPS APMs, the weight
for the quality performance category will be zero for the 2019 payment
year. Where the weight for the performance category is zero, neither
the APM Entity nor the MIPS eligible clinicians in the MIPS APM would
need to report data in these categories, and we would redistribute the
weights for the quality and resource use performance categories to the
CPIA and advancing care information performance categories to maintain
a CPS of 100 percent.
In order to implement certain elements of the APM scoring standard,
we would need to use the Shared Savings Program (section 1899 of the
Act) and CMS Innovation Center (section 1115A of the Act) authorities
to waive specific statutory provisions related to MIPS reporting and
scoring. Section 1899(f) of the Act authorizes waivers of title XVIII
requirements as may be necessary to carry out the Shared Savings
Program, and section 1115A(d)(1) of Act authorizes waivers of title
XVIII requirements as may be necessary solely for purposes of testing
models under section 1115A of the Act. In each section below in which
we propose scoring methodologies and waivers to enable the proposed
approaches, we describe how the use of waivers is necessary under the
respective waiver authority standards. The underlying purpose of APMs
is for CMS to pay for care in ways that are unique from fee-for-service
payment and to test new ways of measuring and assessing performance. If
the data submission requirements and associated adjustments under MIPS
are not aligned
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with APM-specific goals and incentives, the participants receive
conflicting messages from CMS on priorities, which could create
uncertainty and severely degrade our ability to evaluate the impact of
any particular APM on the overall cost and quality of care. Therefore,
we believe that, for reasons stated in this section, certain waivers
are necessary for testing and operating APMs and for maintaining the
integrity of our evaluation of those APMs.
We note that for at least the first performance year, we do not
anticipate that any APMs not authorized under sections 1115A or 1899 of
the Act would meet the criteria to be MIPS APMs. In the event that we
do anticipate other Federal demonstrations will become MIPS APMs, we
will address MIPS scoring for participating eligible clinicians in
future rulemaking.
(4) APM Participant Identifier and Participant Database
To ensure we have accurately captured performance data for all of
the MIPS eligible clinicians that are participating in an APM, we would
establish and maintain an APM participant database that will include
all of the MIPS eligible clinicians who are part of the APM Entity. We
would establish this database to track participation in all APMs, in
addition to specifically tracking participation in MIPS APMs and
Advanced APMs. We propose that each APM Entity be identified in the
MIPS program by a unique APM Entity identifier. We also propose in
section II.E.2.b. that the unique APM participant identifier for a MIPS
eligible clinician would be a combination of four identifiers
including: (1) APM identifier (established for the APM by CMS; for
example, XXXXXX); (2) APM Entity identifier (established for the APM by
CMS; for example, AA00001111); (3) the eligible clinician's billing TIN
(for example, XXXXXXXXX); and (4) NPI (for example, 1111111111). For
example, this APM participant identifier for the MIPS eligible
clinician in this case would be APM XXXXXX, APM Entity AA00001111, TIN-
XXXXXXXXX, NPI-11111111111. The use of the APM participant identifier
will allow CMS to identify all MIPS eligible clinicians participating
in an APM Entity, including instances when the MIPS eligible clinicians
use a billing TIN that is shared with MIPS eligible clinicians who are
not participating in the APM Entity. We would plan to communicate to
each APM Entity the MIPS eligible clinicians who are included in the
APM Entity group in advance of the applicable MIPS data submission
deadline for the MIPS performance period.
Under the Shared Savings Program, each ACO is formed by a
collection of Medicare-enrolled TINs (ACO participants). Pursuant to
our regulation at 42 CFR 425.118, all Medicare enrolled individuals and
entities that have reassigned their rights to receive Medicare payment
to the TIN of the ACO participant must agree to participate in the ACO
and comply with the requirements of the Shared Savings Program. Because
all providers and suppliers that bill through the TIN of an ACO
participant are required to agree to participate in the ACO, all MIPS
eligible clinicians that bill through the TIN of an ACO participant are
considered to be participating in the ACO. For purposes of the APM
scoring standard, the ACO would be the APM Entity. The Shared Savings
Program has established criteria for determining the list of eligible
clinicians participating under the ACO, and we would use the same
criteria for determining the list of MIPS eligible clinicians included
in the APM Entity group for purposes of the APM scoring standard.
We recognize that there may be scenarios in which MIPS eligible
clinicians may change TINs, use more than one TIN for billing Medicare,
change their APM participation status, and/or change other practice
affiliations during a performance period. Therefore, we propose that
only those MIPS eligible clinicians who are listed as participants in
the APM Entity in a MIPS APM on December 31 (the last day of the
proposed performance period) would be considered part of the APM Entity
group for purposes of the APM scoring standard. Consequently, MIPS
eligible clinicians who are not listed as participants of an APM Entity
in a MIPS APM at the end of the performance period would need to submit
data to MIPS through one of the MIPS data submission mechanisms and
would have their performance assessed either as individual MIPS
eligible clinicians or as a group for all four performance categories.
For example, a MIPS eligible clinician who participates in the APM
Entity on January 1, 2017 and leaves the APM Entity on June 15, 2017
would need to submit data to MIPS using one of the MIPS data submission
mechanisms and would have their performance assessed either as
individual MIPS eligible clinicians or as a group. This approach for
defining the applicable group of MIPS eligible clinicians is consistent
with our proposal for identifying eligible clinician groups for
purposes of QP determinations outlined in section II.F.5.b. of this
proposed rule; the group of eligible clinicians CMS uses for purposes
of a QP determination would be the same as that used for the APM
scoring standard. This would be an annual process for each MIPS
performance period. We propose to calculate one MIPS CPS for each APM
Entity group, and that MIPS CPS would be applied to all MIPS eligible
clinicians in the group. As previously explained in section II.E.7. of
this proposed rule, the MIPS payment adjustment would be applied at the
TIN/NPI level for each of the MIPS eligible clinicians in the APM
Entity group.
(5) MIPS Eligible Clinicians Not Participating in a MIPS APM
The APM Entity group used for purposes of the APM scoring standard
would be the same APM Entity group used for QP determinations under
section II.F.5 of this proposed rule, except in the instances of APMs
that do not meet the criteria to be MIPS APMs, as discussed in section
II.E.5.h.(1) of this proposed rule. Examples of APMs that would not
meet criteria to be MIPS APMs are those that do not have MIPS eligible
clinicians as participants under the APM, or do not tie payment to
cost/utilization and quality measures. We propose that the APM scoring
standard would not apply to MIPS eligible clinicians participating in
APMs that are not MIPS APMs. MIPS eligible clinicians who participate
in an APM that is not a MIPS APM, would submit data to MIPS and have
their performance assessed either as an individual MIPS eligible
clinician or group as described in section II.E.2. of this proposed
rule. Some APMs may involve certain types of MIPS eligible clinicians
that are affiliated with an APM Entity but not included in the APM
Entity group because they are not participants of the APM Entity. We
propose that even if the APM meets the criteria to be a MIPS APM, MIPS
eligible clinicians who are not included in the list of participants
would not be considered part of the APM Entity group for purposes of
the APM scoring standard. For instance, MIPS eligible clinicians in the
Comprehensive Care for Joint Replacement Model might be involved in the
APM through a business arrangement with the APM Entity (the inpatient
hospital) but are not directly tied to beneficiary attribution, quality
measurement, or care improvement activities under the APM.
Additionally, we propose that if a MIPS eligible clinician participates
in an APM Entity during the MIPS performance period but is no longer a
participant in the APM Entity group on the last day of the
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performance period, the MIPS eligible clinician must submit either
individual or group level data to MIPS. CMS will publish the list of
MIPS APMs prior to the beginning of the MIPS performance period on the
CMS Web site.
(6) APM Entity Group Scoring for the MIPS Performance Categories
As mentioned previously, section 1848(q)(3)(A) of the Act requires
the Secretary to establish performance standards for the measures and
activities under the following performance categories: (1) Quality; (2)
resource use; (3) clinical practice improvement activities; and (4)
advancing care information. We propose at Sec. 414.1370 to calculate
one CPS that is applied to the billing TIN/NPI combination of each MIPS
eligible clinician in the APM Entity group. Therefore, each APM Entity
group (for example, the MIPS eligible clinicians in a Shared Savings
Program ACO or an Oncology Care Model practice) would receive a score
for each of the four performance categories according to the proposals
described in this section of the proposed rule, and we would calculate
one CPS for the group. The APM Entity group score would be applied to
each MIPS eligible clinician in the group, and subsequently used to
develop the MIPS payment adjustment that is applicable for each MIPS
eligible clinician in the group. Thus the APM Entity group score and
the participating MIPS eligible clinician score are the same. For
example, in the Shared Savings Program, the MIPS eligible clinicians in
each ACO would be an APM Entity group. That group would receive a
single CPS that would be applied to each of its participating MIPS
eligible clinicians. Similarly, in the Oncology Care Model, the MIPS
eligible clinicians in each oncology practice would be an APM Entity
group. That group would receive a single CPS that would be applied to
each of the MIPS eligible clinicians in the group. We note that this
APM Entity group CPS is not used to evaluate eligible clinicians or the
APM Entity for purposes of incentives within the APM, shared savings
payments, or other potential payments under the APM, and we currently
do not foresee APMs that would use the CPS for purposes of evaluation
within the APM. Rather the APM Entity group CPS would be used only for
the purposes of the APM scoring standard under MIPS for the first MIPS
performance period. As proposed in this rule, all MIPS eligible
clinicians listed as participating in the APM Entity on the last day of
the performance period would be part of the APM Entity group and thus
receive the same CPS. It should be noted that although we propose that
the APM scoring standard only applies to participants in MIPS APMs,
MIPS eligible clinicians that participate in an APM (including but not
limited to a MIPS APM) and submit either individual or group level data
to MIPS may earn a minimum score of 50 percent of the highest potential
CPIA performance category score as long as such MIPS eligible
clinicians are on the list of participants for an APM and are
identifiable by the APM participant identifier.
Several commenters on the MIPS and APMs RFI suggested, and we
generally agree, that MIPS eligible clinicians who collaborate under an
APM Entity to accomplish the APM's goals should be treated as a group
under MIPS and receive the same CPS. Furthermore, we want to avoid
situations in which different MIPS eligible clinicians in the same APM
Entity group receive different MIPS scores. APM Entities have a goal of
collective success under the terms of the APM, so having a variety of
differing MIPS adjustments for eligible clinicians within that
collective unit would undermine the intent behind the APM to test a
departure from a purely fee-for-service system based on independent
clinician activity. Lastly, we believe that measurement of the
performance for MIPS at the APM Entity level for eligible clinicians
participating in MIPS APMs will result in more statistically valid
performance scores for these eligible clinicians because the scores are
aggregated to represent a larger group of MIPS eligible clinicians.
We propose, for the first MIPS performance period, a specific
scoring and reporting approach for the MIPS eligible clinicians
participating in MIPS APMs, which would include the Shared Savings
Program, the Next Generation ACO Model, and other APMs that meet the
criteria proposed above for a MIPS APM. Specifically, we propose that
APM quality measure data submitted through the CMS Web Interface by
ACOs participating in the Shared Savings Program and the Next
Generation ACO Model would be used to evaluate performance for the MIPS
quality performance category. We believe this is appropriate because
all MIPS eligible clinicians that use the CMS Web Interface as their
quality measure submission mechanism, e.g., MIPS eligible clinicians
that report as a group and MIPS APM eligible clinicians that report as
an APM Entity group, submit data on the same quality measures. Both the
Shared Savings Program and the Next Generation ACO Model use additional
quality measures for the purpose of APM performance assessment, but
only the measures submitted to the CMS Web Interface would be used to
evaluate performance for the MIPS quality performance category.
Therefore, other measures that are required by the APM to assess APM
quality performance will continue to be used for APM performance
assessment only and not included in the MIPS quality performance
category scoring. We also propose that MIPS eligible clinicians
participating in MIPS APMs that do not use the CMS Web Interface as the
mechanism for submitting APM quality data would not submit quality
measure data to MIPS for the MIPS quality performance category until
the second MIPS performance period (2018). In this section of the rule,
we describe the APM Entity data submission requirements and propose a
scoring approach for each of the MIPS performance categories for
specific MIPS APMs (the Shared Savings Program, Next Generation ACO
Model, and all other MIPS APMs).
(7) Shared Savings Program--Quality Performance Category Scoring Under
the APM Scoring Standard
Beginning with the first MIPS performance period all Shared Savings
Program ACOs would submit their quality measures to MIPS using the CMS
Web Interface through the same process that they use to report to the
Shared Savings Program and be scored as they normally would under
Shared Savings Program rules. Shared Savings Program ACOs have used the
CMS Web Interface for submitting their quality measures since the
program's inception, making this a familiar data submission process. We
also propose that the Shared Savings Program ACO quality measure data
that is submitted through the CMS Web Interface will be submitted only
once but will be used for two purposes. The Shared Savings Program
quality measure data reported to the CMS Web Interface would be used by
CMS to calculate the MIPS quality performance category score at the APM
Entity group (ACO) level. The Shared Savings Program quality
performance data that is not submitted to the CMS Web Interface, for
example the CAHPS survey and other claims measures would not be
included in the MIPS APM quality performance category score. We believe
this will reduce the reporting burden for Shared Savings Program MIPS
eligible clinicians by requiring quality measure data to be submitted
only once and used for both programs. The MIPS quality
[[Page 28238]]
performance category requirements and performance benchmarks for
quality measures submitted via the CMS Web Interface would be used to
determine the MIPS quality performance category score at the ACO level
for the APM Entity group.
We believe that no waivers are necessary here because the quality
measures submitted via the CMS Web Interface under the Shared Savings
Program are also MIPS quality measures and will be scored under MIPS
performance standards. In the event that Shared Savings Program quality
measures depart from MIPS measures in the future, we will address such
changes including whether further waivers are necessary at such a time
in future rulemaking.
(8) Shared Savings Program--Resource Use Performance Category Scoring
Under the APM Scoring Standard
We propose that for the first MIPS performance period, we will not
assess MIPS eligible clinicians participating in the Shared Savings
Program (the MIPS APM) under the resource use performance category. We
propose this approach because: (1) Eligible clinicians participating in
the Shared Savings Program are already subject to cost and utilization
performance assessments under the APM; (2) the Shared Savings Program
measures resource use in terms of an objective, absolute total cost of
care expenditure benchmark for a population of attributed
beneficiaries, and participating ACOs may share savings and/or losses
based on that standard, whereas the MIPS resource use measures are
relative measures such that clinicians are graded relative to their
peers, and therefore different than assessing total cost of care for a
population of attributed beneficiaries; and (3) the beneficiary
attribution methodologies for measuring resource use under the Shared
Savings Program and MIPS differ, leading to an unpredictable degree of
overlap (for eligible clinicians and for CMS) between the sets of
beneficiaries for which eligible clinicians would be responsible that
would vary based on unique APM Entity characteristics such as which and
how many TINs comprise an ACO. We believe that with an APM Entity's
finite resource for engaging in efforts to improve quality and lower
costs for a specified beneficiary population, the population identified
through an APM must take priority to ensure that the goals and program
evaluation associated with the APM are as clear and free of confounding
factors as possible. The potential for different, conflicting results
across Shared Savings Program and MIPS assessments--due to the
differences in attribution, the inclusion in MIPS of episode-based
measures that do not reflect the total cost of care, and the objective
versus relative assessment factors listed above--creates uncertainty
for eligible clinicians who are attempting to strategically transform
their respective practices and succeed under the terms of the Shared
Savings Program.
For example, Shared Savings Program ACOs are held accountable for
expenditure benchmarks that reflect the total Medicare Parts A and B
spending for their assigned beneficiaries, whereas many of the proposed
MIPS resource use measures focus on spending for particular episodes of
care or clinical conditions. For the reasons stated above, we consider
it a programmatic necessity that the Shared Savings Program has the
ability to structure its own measurement and payment for performance on
total cost of care independent from other incentive programs such as
the resource use performance category under MIPS. Thus, we propose to
reduce the MIPS resource use performance category weight to zero for
all MIPS eligible clinicians in APM Entities participating in the
Shared Savings Program. Accordingly, under section 1899(f) of the Act,
we propose to waive--for MIPS eligible clinicians participating in the
Shared Savings Program--the requirement under section
1848(q)(5)(E)(i)(II) of the Act that specifies the scoring weight for
the resource use performance category. With the proposed reduction of
the resource use performance category weight to zero, we believe it
would be unnecessary specify and use resource use measures in
determining the MIPS CPS for these MIPS eligible clinicians. Therefore,
under section 1899(f) of the Act, we propose to waive--for MIPS
eligible clinicians participating in the Shared Savings Program--the
requirements under sections 1848(q)(2)(B)(ii) and 1848(q)(2)(A)(ii) of
the Act to specify and use, respectively, resource use measures in
calculating the MIPS CPS for such MIPS eligible clinicians.
Given the proposal to waive requirements under section
1848(q)(5)(E)(i)(II) of the Act in order to reduce the weight of the
resource use performance category to zero, we must subsequently specify
how that weight would be redistributed among the remaining performance
categories in order to maintain a total weight of 100 percent. We
propose to redistribute the resource use performance category weight to
both the CPIA and advancing care information performance categories as
specified in Table 12. The MIPS resource use performance category is
proposed to have a weight of 10 percent for the first performance
period. Because the MIPS quality performance category bears a
relatively higher weight than the other three MIPS performance
categories, and its weight is scheduled to be reduced from 50 to 30
percent over time, we propose to evenly redistribute the 10 percent
resource use performance category weight to the CPIA and advancing care
information performance categories so that the distribution does not
change the relative weight of the quality performance category in the
opposite direction of its future state. The redistributed resource use
performance category weight of 10 percent would result in a 5
percentage point increase (from 15 to 20 percent) for the CPIA
performance category and a 5 percentage point increase (from 25 to 30
percent) for the advancing care information performance category. We
invite comments on the proposed weights and specifically, whether we
should increase the MIPS quality performance category weight.
We understand that as the MIPS resource use performance category
evolves over time, there might be greater potential for alignment and
less potential duplication or conflict with MIPS resource use
measurement for MIPS eligible clinicians participating in APMs such as
the Shared Savings Program. We will continue to monitor and consider
how we might incorporate an assessment in the MIPS resource use
performance category into the APM scoring standard for MIPS eligible
clinicians participating in the Shared Savings Program. We also
understand that reducing the resource use performance category weight
to zero and redistributing the weight to the CPIA and advancing care
information performance categories could, to the extent that CPIA and
advancing care information scores are higher than the scores these MIPS
eligible clinicians would have received under resource use, result in
higher average scores for MIPS eligible clinicians participating in the
Shared Savings Program. We seek comment on the possibility of assigning
a neutral score to the Shared Savings Program APM Entity groups for the
resource use performance category to moderate MIPS composite
performance scores for APM Entities participating in the Shared Savings
Program. We also generally seek comment on our proposed policy, and on
whether and how we should incorporate the resource use performance
category into the APM scoring standard under MIPS for eligible
[[Page 28239]]
clinicians participating in the Shared Savings Program for future
years.
(9) Shared Savings Program--CPIA and Advancing Care Information
Performance Category Scoring Under the APM Scoring Standard
We propose that MIPS eligible clinicians participating in the
Shared Savings Program would submit data for the MIPS CPIA and
advancing care information performance categories through their
respective ACO participant billing TINs independent of the Shared
Savings Program ACO. Pursuant to section 1848(q)(5)(C)(ii) of the Act,
all ACO participant group billing TINs would receive a minimum of one
half of the highest possible score for the CPIA performance category.
Additionally, pursuant to section 1848(q)(5)(C)(i) of the Act, any ACO
participant TIN that is determined to be a patient-centered medical
home or comparable specialty practice will receive the highest
potential score for the CPIA performance category. The scores from all
of the ACO participant billing TINs would be averaged to a weighted
mean MIPS APM Entity group level score. We propose to use a weighted
mean in computing the overall CPIA and advancing care information
quality performance category score in order to account for difference
in the size of each TIN and to allow each TIN to contribute to the
overall score based on its size. Then all MIPS eligible clinicians in
the APM Entity group, as identified by their APM participant
identifiers, would receive that APM Entity score. The weights used for
each ACO participant billing TIN would be the number of MIPS eligible
clinicians in that TIN. Because all providers and suppliers that bill
through the TIN of an ACO participant are required to agree to
participate in the ACO, all MIPS eligible clinicians that bill through
the TIN of an ACO participant are considered to be participating in the
ACO. Any Shared Savings Program ACO participant billing TIN that does
not submit data for the MIPS CPIA and/or advancing care information
performance categories would contribute a score of zero for each
performance category for which it does not report; and that score would
be incorporated into the resulting weighted average score for the
Shared Savings Program ACO. All MIPS eligible clinicians in the ACO
(the APM Entity group) would receive the same score that is calculated
at the ACO level (the APM Entity).
[GRAPHIC] [TIFF OMITTED] TP09MY16.014
In this example, each eligible clinician participating in the APM
Entity (Shared Savings Program ACO) would receive a CPIA performance
category score of 78.5 and an advancing care information performance
category score of 85. We recognize that the Shared Savings Program
eligible clinicians participate as a complete TIN because all of the
eligible clinicians that have reassigned their Medicare billing rights
to the TIN of an ACO participant must agree to participate in the
Shared Savings Program. This is different from other APMs, which may
include APM Entity groups with eligible clinicians who share a billing
TIN with other eligible clinicians who do not participate in the APM
Entity. We seek comment on a possible alternative approach in which
CPIA and advancing care information performance category scores would
be applied to all MIPS eligible clinicians at the individual billing
TIN level, as opposed to aggregated to the ACO level, for Shared
Savings Program participants. If MIPS APM scores were applied to each
TIN in an ACO at the TIN level, we would also likely need to permit
those TINs to make the Partial QP election, as discussed elsewhere in
this proposed rule, at the TIN level. We propose that under the APM
scoring standard, the ACO-level APM Entity group score would be applied
to each participating MIPS eligible clinician to determine the MIPS
payment adjustment. We believe calculating the score at the APM Entity
level mirrors the way APM participants are assessed for their shared
savings and other incentive payments in the APM, but we understand
there may be reasons why a group TIN, particularly one that believes it
would achieve a higher score than the weighted average APM Entity level
score, would prefer to be scored in the CPIA and advancing care
information performance categories at the level of the group billing
TIN rather than the ACO (APM Entity level). Therefore, we seek comment
as to whether Shared Savings Program ACO eligible clinicians should be
scored at the ACO level or the group billing TIN level for the CPIA and
advancing care information performance categories. In
[[Page 28240]]
Table 12, we provide a summary of the proposed MIPS data submission
requirements and scoring under the APM scoring standard for MIPS
eligible clinicians participating in a Shared Savings Program ACO.
[GRAPHIC] [TIFF OMITTED] TP09MY16.015
(10) Next Generation ACO Model--Quality Performance Category Scoring
Under the APM Scoring Standard
Beginning with the first MIPS performance period, all Next
Generation ACO Model ACOs would submit their ACO quality measures to
MIPS using the CMS Web Interface through the same process that they use
to report to the Next Generation ACO Model and be scored as they
normally would under Next Generation ACO Model rules. Next Generation
ACO Model ACOs will have used the CMS Web Interface for submitting
their quality measures since the model's inception and would most
likely continue to use the CMS Web Interface as the submission method
in future years. We also propose that the Next Generation ACO Model
quality measure data that is submitted through the CMS Web Interface
will be submitted only once but will be used for two purposes. The Next
Generation ACO Model quality measure data reported to the CMS Web
Interface would be used by CMS to calculate the MIPS APM quality
performance score. The MIPS quality performance category requirements
and performance benchmarks for reporting quality measures via the CMS
Web Interface would be used to determine the MIPS quality performance
category score at the ACO level for the APM Entity group. The Next
Generation ACO Model quality performance data that is not submitted to
the CMS Web Interface, for example the CAHPS survey and other claims
measures would not be included in the MIPS APM quality performance
score. The MIPS APM quality performance category score would be
calculated using only quality measure data submitted through the CMS
Web Interface, while the quality reporting requirements and performance
benchmarks calculated by the Next
[[Page 28241]]
Generation ACO Model would continue to be used to assess the ACO under
the APM specific requirements. We believe this approach would reduce
the reporting burden to Next Generation ACO Model participants by
requiring quality measure data to be submitted only once and used for
both MIPS and the Next Generation ACO Model.
We believe that no waivers are necessary here because the quality
measures submitted via the CMS Web Interface under the Next Generation
ACO Model are MIPS quality measures and will be scored under MIPS
performance standards. In the event that Next Generation ACO Model
quality measures depart from MIPS measures in the future, we will
address such changes, including whether further waivers are necessary,
at such a time in future rulemaking.
(11) Next Generation ACO Model--Resource Use Performance Category
Scoring Under the APM Scoring Standard
We propose that for the first MIPS performance period, we will not
assess MIPS eligible clinicians in the Next Generation ACO Model
participating in the MIPS APM under the resource use performance
category. We propose this approach because: (1) MIPS eligible
clinicians participating in the Next Generation ACO Model are already
subject to cost and utilization performance assessments under the APM;
(2) the Next Generation ACO Model measures resource use in terms of an
objective, absolute total cost of care expenditure benchmark for a
population of attributed beneficiaries, and participating ACOs may
share savings and/or losses based on that standard, whereas the MIPS
resource use measures are relative measures such that clinicians are
graded relative to their peers and therefore different than assessing
total cost of care for a population of attributed beneficiaries; and
(3) the beneficiary attribution methodologies for measuring resource
use under the Next Generation ACO Model and MIPS differ, leading to an
unpredictable degree of overlap (for eligible clinicians and for CMS)
between the sets of beneficiaries for which eligible clinicians would
be responsible that would vary based on unique APM Entity
characteristics such as which and how many eligible clinicians comprise
an ACO. We believe that with an APM Entity's finite resources for
engaging in efforts to improve quality and lower costs for a specified
beneficiary population, the population identified through the Next
Generation ACO Model must take priority to ensure that the goals and
model evaluation associated with the APM are as clear and free of
confounding factors as possible. The potential for different,
conflicting results across the Next Generation ACO Model and MIPS
assessments--due to the differences in attribution, the inclusion in
MIPS of episode-based measures that do not reflect the total cost of
care, and the objective versus relative assessment factors listed
above--creates uncertainty for eligible clinicians who are attempting
to strategically transform their respective practices and succeed under
the terms of the Next Generation ACO Model. For example, Next
Generation ACOs are held accountable for expenditure benchmarks that
reflect the total Medicare Parts A and B spending for their attributed
beneficiaries, whereas many of the proposed MIPS resource use measures
focus on spending for particular episodes of care or clinical
conditions. For all the reasons stated above, we propose to reduce the
MIPS resource use performance category weight to zero for all MIPS
eligible clinicians participating in the Next Generation ACO Model.
Accordingly, under section 1115A(d)(1) of the Act, we propose to
waive--for MIPS eligible clinicians participating in the Next
Generation ACO Model--the requirement under section
1848(q)(5)(E)(i)(II) of the Act that specifies the scoring weight for
the resource use performance category. With the proposed reduction of
the resource use performance category weight to zero, we believe it
would be unnecessary to specify and use resource use measures in
determining the MIPS CPS for these MIPS eligible clinicians. Therefore,
under section 1115A(d)(1) of the Act, we propose to waive--for MIPS
eligible clinicians participating in the Next Generation ACO Model--the
requirements under sections 1848(q)(2)(B)(ii) and 1848(q)(2)(A)(ii) of
the Act to specify and use, respectively, resource use measures in
calculating the MIPS CPS for such eligible clinicians.
Given the proposal to waive requirements under section
1848(q)(5)(E) of the Act in order to reduce the weight of the resource
use performance category to zero, we must subsequently specify how that
weight would be redistributed among the remaining performance
categories in order to maintain a total weight of 100 percent. We
propose to redistribute the resource use performance category weight to
both the CPIA and advancing care information performance categories as
specified in Table 13. The MIPS resource use performance category is
proposed to have a weight of 10 percent. Because the MIPS quality
performance category bears a relatively higher weight than the other
three MIPS performance categories and its weight is scheduled to be
reduced from 50 to 30 percent over time, we propose to evenly
redistribute the 10 percent resource use weight to the CPIA and
advancing care information performance categories so that the
distribution does not change the relative weight of the quality
performance category in the opposite direction of its future state. The
redistributed resource use performance category weight of 10 percent
would result in a 5 percentage point increase (from 15 to 20 percent)
for the CPIA performance category and a 5 percentage point increase
(from 25 to 30 percent) for the advancing care information performance
category. We invite comments on the proposed redistributed weights and
specifically on whether we should also increase the MIPS quality
performance category weight.
We understand that as the MIPS resource use performance category
evolves over time, there might be greater potential for alignment and
less potential duplication or conflict with MIPS resource use
measurement for MIPS eligible clinicians participating in MIPS APMs
such as the Next Generation ACO Model. We will continue to monitor and
consider how we might incorporate an assessment in the MIPS resource
use performance category into the APM scoring standard for the Next
Generation ACO Model. We also understand that reducing the resource use
weight to zero and redistributing the weight to the CPIA and advancing
care information performance categories could, to the extent that CPIA
and advancing care information scores are higher than the scores MIPS
eligible clinicians would have received under resource use, result in
higher average scores for MIPS eligible clinicians in APM Entity groups
participating in the Next Generation ACO Model. We seek comment on the
possible alternative of assigning a neutral score to APM Entity groups
(ACOs) participating in the Next Generation ACO model for the resource
use performance category in order to moderate APM Entity scores. We
also generally seek comment on our proposed policy, and on whether and
how we should incorporate the resource use performance category into
the APM scoring standard for MIPS eligible clinicians in APM Entity
groups participating in the Next Generation ACO model for future years.
[[Page 28242]]
(12) Next Generation ACO Model--CPIA and Advancing Care Information
Performance Category Scoring Under the APM Scoring Standard
We propose that all MIPS eligible clinicians participating in the
Next Generation ACO Model would submit data for the CPIA and advancing
care information performance categories. Eligible clinicians in the
Next Generation ACO Model may belong to a billing TIN that includes
non-participating APM eligible clinicians. Therefore for both CPIA and
the advancing care information performance category, we propose that
these MIPS eligible clinicians would submit individual level data to
MIPS and not group level data.
For both the CPIA and advancing care information performance
categories, the scores from all of the individual MIPS eligible
clinicians in the APM Entity group would be aggregated to the APM
Entity level and averaged for a mean score. Any individual MIPS
eligible clinicians that do not report the CPIA or advancing care
information performance category would contribute a score of zero for
that performance category in the calculation of the APM Entity score.
All MIPS eligible clinicians in the APM Entity group would receive the
same APM Entity score.
As noted above, because the MIPS quality performance category bears
a relatively higher weight than the other three MIPS performance
categories, we propose to evenly redistribute the 10 percent resource
use performance category weight to the CPIA and advancing care
information performance categories. Section 1848(q)(5)(C)(i) of the Act
requires that MIPS eligible clinicians who are in a practice that is
certified as a patient-centered medical home or comparable specialty
practice, as determined by the Secretary, with respect to a performance
period shall be given the highest potential score for the CPIA
performance category. Accordingly, a MIPS eligible clinician
participating in an APM Entity that meets the definition of a patient-
centered medical home or comparable specialty practice, as discussed in
section II.E.5.f. of this proposed rule, will receive the highest
potential score. Additionally, section 1848(q)(5)(C)(ii) of the Act
requires that MIPS eligible clinicians participating in APMs that are
not patient-centered medical homes for a performance period shall earn
a minimum score of one-half of the highest potential score for CPIA.
For the APM scoring standard for the first MIPS performance period,
we propose to weight the CPIA and advancing care information
performance categories for the Next Generation ACO Model in the same
way that we propose to weight those categories for the Shared Savings
Program: 20 percent and 30 percent for CPIA and advancing care
information, respectively. We seek comment on our proposals for
reporting and scoring the CPIA and advancing care information
performance categories under the APM scoring standard. In particular,
we seek comment on the appropriate weight distributions in the first
year.
In Table 13, we provide a summary of the proposed MIPS data
submission and scoring under the APM scoring standard for MIPS eligible
clinicians participating in a Next Generation ACO.
[[Page 28243]]
[GRAPHIC] [TIFF OMITTED] TP09MY16.016
(13) MIPS APMs Other Than the Shared Savings Program and the Next
Generation ACO Model--Quality Performance Category Scoring Under the
APM Scoring Standard
For MIPS APMs other than the Shared Savings Program and the Next
Generation ACO Model, we propose that eligible clinicians or APM
Entities would submit APM quality measures under their respective MIPS
APM as usual, and those eligible clinicians or APM Entities would not
also be required to submit quality information under MIPS. Current MIPS
APMs have requirements regarding the number of quality measures,
measure specifications, as well as the measure reporting method(s) and
frequency of reporting, and have an established mechanism for
submission of these measures to CMS. We believe there are operational
considerations and constraints that would prevent us from being able to
use the quality measure data from some MIPS APMs for the purpose of
satisfying the MIPS data submission requirements for the quality
performance category in the first performance period. For example, some
current APMs use a quality measure data collection system or vehicle
that is separate and distinct from the MIPS systems. We do not believe
there is sufficient time to adequately implement changes to the current
APM quality measure data collection timelines and infrastructure to
conduct a smooth hand-off to the MIPS system that would enable use of
APM quality measure data to satisfy the MIPS quality performance
category requirements in the first MIPS performance period. As we have
noted, we are concerned about subjecting MIPS eligible clinicians who
participate in MIPS APMs to multiple performance assessments--under
MIPS and under the APMs--that are not necessarily aligned and that
could potentially undermine the validity of testing or performance
evaluation under the APM. As stated previously, our goal is to reduce
MIPS eligible clinician reporting burden by not requiring APM
participants to report quality data twice to CMS, and to avoid
misaligned performance incentives. Therefore, we propose that, for the
first MIPS performance period only, for MIPS eligible clinicians
participating in APM Entity groups in MIPS APMs (other than the Shared
Savings Program or the Next Generation ACO Model), we would reduce the
weight for the quality performance category to zero. We believe it is
necessary to do this because CMS requires additional time to make
adjustments in systems and processes related to the submission and
collection of APM quality measures in order to align APM quality
measures with the MIPS, and ensure APM quality measure data can be
submitted in a time and in a manner sufficient for use in assessing
quality performance under MIPS and under the APM. Additionally, due to
the implementation of a new program that does not account for non-MIPS
[[Page 28244]]
measures sets, the operational complexity of connecting APM performance
to valid MIPS quality performance category scores in the necessary
timeframe, as well as the uncertainty of the validity and equity of
scoring results could unintentionally undermine the quality performance
assessments in MIPS APMs. Finally, for purposes of performing valid
evaluations of MIPS APMs, we must reduce the number of confounding
factors to the extent feasible, which, in this case, would include
reporting and assessment on non-APM quality measures. Thus, we propose
to waive certain requirements of section 1848(q) of the Act for the
first MIPS performance year to avoid risking adverse operational or
program evaluation consequences for MIPS APMs while we work toward
incorporating MIPS APM quality measures into MIPS scoring for future
MIPS performance periods without. Accordingly, under section
1115A(d)(1) of the Act, we propose to waive--for MIPS eligible
clinicians participating in MIPS APMs other than the Shared Savings
Program or the Next Generation ACO Model--the requirement under section
1848(q)(5)(E)(i)(I) of the Act that specifies the scoring weight for
the quality performance category. With the proposed reduction of the
quality performance category weight to zero, we believe it would be
unnecessary to establish an annual final list of quality measures as
required under section 1848(q)(2)(D) of the Act, or to specify and use
quality measures in determining the MIPS CPS for these MIPS eligible
clinicians. Therefore, under section 1115A(d)(1) of the Act, we propose
to waive--for MIPS eligible clinicians participating in MIPS APMs other
than the Shared Savings Program or the Next Generation ACO Model--the
requirements under sections 1848(q)(2)(D), 1848(q)(2)(B)(i) and
1848(q)(2)(A)(i) of the Act to establish a final list of quality
measures (using certain criteria and processes); and to specify and
use, respectively, quality measures in calculating the MIPS CPS, for
these MIPS eligible clinicians.
We anticipate that beginning in the second MIPS performance period,
the APM quality measure data submitted during the MIPS performance
period to us would be used to derive a MIPs quality performance score
for APM Entities in all APMs that meet criteria for application of the
APM scoring standard. We anticipate that it may be necessary to propose
policies and waivers of different requirements of the statute--such as
one for section 1848(q)(2)(D) of the Act, to enable the use of non-MIPS
quality measures in the quality performance category score--through
future rulemaking. We expect that by the second MIPS performance period
we will have had sufficient time to resolve operational constraints
related to use of separate quality measure systems and adjust quality
measure data submission timelines. Therefore, beginning with the second
MIPS performance period, we anticipate that through use of the waiver
authority under section 1115A(d)(1) of the Act, the quality measure
data for APM Entities for which the APM scoring standard applies would
be used for calculation of a MIPS quality performance score in a manner
specified in future rulemaking. We seek comment on this transitional
approach to use APM quality measures for the MIPS quality performance
category for purposes of the APM scoring standard under MIPS in future
years.
(14) MIPS APMs Other Than the Shared Savings Program and Next
Generation ACO--Resource Use Performance Category Scoring Under the APM
Scoring Standard
For the first MIPS performance period, we propose that, for MIPS
eligible clinicians participating in MIPS APMs other than the Shared
Savings Program or the Next Generation ACO, to reduce the weight of the
resource use performance category to zero. We propose this approach
because: (1) APM Entity groups are already subject to cost and
utilization performance assessments under MIPS APMs; (2) MIPS APMs
usually measure resource use in terms of total cost of care, which is a
broader accountability standard inherently encompasses the purpose of
the claims-based measures that have relatively narrow clinical scopes,
and MIPS APMs that do not measure resource use in terms of total cost
of care may depart entirely from MIPS measures; and (3) the beneficiary
attribution methodologies differ for measuring resource use under APMs
and MIPS, leading to an unpredictable degree of overlap (for eligible
clinicians and for CMS) between the sets of beneficiaries for which
eligible clinicians would be responsible that would vary based on
unique APM Entity characteristics such as which and how many eligible
clinicians comprise an APM Entity. We believe that with an APM Entity's
finite resources for engaging in efforts to improve quality and lower
costs for a specified beneficiary population, the population identified
through an APM must take priority to ensure that the goals and model
evaluation associated with the APM are as clear and free of confounding
factors as possible. The potential for different, conflicting results
across APM and MIPS assessments creates uncertainty for MIPs eligible
clinicians who are attempting to strategically transform their
respective practices and succeed under the terms of an APM.
Accordingly, under section 1115A(d)(1) of the Act, we propose to
waive--for MIPS eligible clinicians participating in MIPS APMs other
than the Shared Savings Program or the Next Generation ACO Model--the
requirement under section 1848(q)(5)(E)(i)(II) of the Act that
specifies the scoring weight for the resource use performance category.
With the proposed reduction of the resource use performance
category weight to zero, we believe it would be unnecessary to specify
and use resource use measures in determining the MIPS CPS for these
MIPS eligible clinicians. Therefore, under section 1115A(d)(1) of the
Act, we propose to waive--for MIPS eligible clinicians participating in
MIPS APMs other than the Shared Savings Program or the Next Generation
ACO Model--the requirements under section under sections
1848(q)(2)(B)(ii) and 1848(q)(2)(A)(ii) of the Act to specify and use,
respectively, resource use measures in calculating the MIPS CPS for
such eligible clinicians.
Given the proposal to waive requirements of section 1848(q) of the
Act to reduce the weight of the quality and resource use performance
categories to zero, we must subsequently specify how those weights
would be redistributed among the remaining CPIA and advancing care
information categories in order to maintain a total weight of 100
percent. We propose to redistribute the quality and the resource use
performance category weights as specified in Table 14.
We understand that as the resource use performance category
evolves, the rationale we discussed earlier for establishing a weight
of zero for this performance category might not be applicable in future
years. We seek comment on whether and how we should incorporate the
resource use performance category into the APM scoring standard under
MIPS. We also understand that reducing the quality and resource use
performance category weight to zero and redistributing the weight to
the CPIA and advancing care information performance categories could,
to the extent that CPIA and advancing care information scores are
higher than the scores MIPS eligible clinicians would have received
under resource use, result in higher average scores for MIPs eligible
clinicians in
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APM Entity groups participating in MIPS APMs. We seek comment on the
possible alternative of assigning a neutral score to MIPS eligible
clinicians in APM Entity groups participating in MIPS APMs for the
quality and resource use performance category in order to moderate APM
Entity scores.
(15) MIPS APMs Other Than the Shared Savings Program and Next
Generation ACO Model--CPIA and Advancing Care Information Performance
Category Scoring Under the APM Scoring Standard
We propose that all MIPS eligible clinicians participating in a
MIPS APM other than the Shared Savings Program or the Next Generation
ACO would submit data for the CPIA and Advancing Care Information
performance categories. We propose that these MIPS eligible clinicians
would submit data for both the CPIA and advancing care information
performance categories as individual MIPS eligible clinicians. MIPS
eligible clinicians in these other APMs may belong to a billing TIN
that includes MIPs eligible clinicians that do not participate in the
APM. Therefore for both CPIA and the advancing care information
performance category, we propose that these MIPS eligible clinicians
submit individual level data to MIPS and not group level data.
For both the CPIA and advancing care information performance
categories, the scores from all of the individual MIPS eligible
clinicians in the APM Entity group would be aggregated to the APM
Entity level and averaged for a mean score. Any individual MIPS
eligible clinicians that do not submit data for the CPIA or advancing
care information performance category would contribute a score of zero
for that performance category in the calculation of the APM Entity
score. All MIPS eligible clinicians in the APM Entity group would
receive the same APM Entity group score.
Section 1848(q)(5)(C)(i) of the Act requires that MIPS eligible
clinicians who are in a practice that is certified as a patient-
centered medical home or comparable specialty practice, as determined
by the Secretary, with respect to a performance period shall be given
the highest potential score for the CPIA performance category.
Accordingly, a MIPS eligible clinician in an APM Entity group that
meets the definition of a patient-centered medical home or comparable
specialty practice, as discussed in section II.E.5.f. of this proposed
rule, will receive the highest potential score. Additionally, section
1848(q)(5)(C)(ii) of the Act requires that MIPS eligible clinicians
participating in APMs that are not patient-centered medical homes for a
performance period shall earn a minimum score of one-half of the
highest potential score for CPIA. We acknowledge that using this
increased weight for CPIA may make it easier in the first performance
period to attain a higher MIPS score. We do not have historical data to
assess the range of scores under CPIA because this is the first time
such activities are being assessed in such a manner.
With respect to the advancing care information performance
category, we believe that MIPS eligible clinicians participating in
MIPS APMs would be using certified health IT and other health
information technology to coordinate care and deliver better care to
their patients. Most MIPS APMs encourage participants to use health IT
to perform population management, monitor their own quality improvement
activities and, better coordinate care for their patients in a way that
aligns with the goals of the advancing care information performance
category. We want to ensure that where we propose reductions in weights
for other MIPS performance categories, such weights are appropriately
redistributed to the advancing care information performance category.
Therefore, for the first MIPS performance period, we propose that
the weights for the CPIA and advancing care information performance
categories would be 25 percent and 75 percent, respectively. We seek
comment on our proposals for reporting and scoring the CPIA and
advancing care information performance categories under the APM scoring
standard. In particular, we seek comment on the appropriate weight
distributions in the first year and subsequent years when we anticipate
incorporating assessment in the quality performance category for all
MIPS eligible clinicians participating in MIPS APMs.
Table 14 shows the performance category scoring and weights for
other APMs for which the APM scoring standard applies.
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(14) APM Entity Data Submission Method
Presently, CMS requires MIPS APMs to either use the CMS Web
Interface or another data submission mechanism for submitting data on
the quality measures for purposes of the APM. We are not currently
proposing to change the method used by APM Entities to submit their
data on quality measures to CMS for purposes of MIPS. Therefore, we
expect that APM Entities like the Shared Savings Program ACOs would
continue to submit their data on quality measures using the CMS Web
Interface data submission mechanism. Similarly, participants in the
Comprehensive ESRD Care (CEC) Initiative would continue to submit their
quality measures to CMS using the Quality Measures Assessment Tool
(QMAT) for purposes of the CEC quality performance assessment under the
APM. All eligible clinicians in APM Entities participating in MIPS APMs
would be required to use one of the proposed MIPS data submission
mechanisms to submit data for the CPIA and advancing care information
performance categories.
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(15) MIPS APM Performance Feedback
For the first MIPS performance feedback specified under section
1848(q)(12) of the Act to be published by July 1, 2017, we propose that
all MIPS eligible clinicians participating in MIPS APMs would receive
the same historical information prepared for all MIPS eligible
clinicians except the report would indicate that the historical
information provided to such MIPS eligible clinicians is for
informational purposes only. MIPS eligible clinicians participating in
APMs have been evaluated for performance only under the APM. Thus,
historical information may not be representative of the scores that
these MIPS eligible clinicians would receive under MIPS.
For MIPS eligible clinicians participating in MIPS APMs, we propose
that the MIPS performance feedback would consist only of the scores
applicable to the APM Entity group for the specific MIPS performance
period. For example, the MIPS eligible clinicians participating in the
Shared Savings Program and Next Generation ACO Model would receive
performance feedback for the quality, CPIA, and advancing care
information performance categories for the 2017 performance period.
Because these MIPS eligible clinicians would not be assessed for the
resource use performance category, information on MIPS performance
scores for the resource use performance category would not be
applicable to these MIPS eligible clinicians.
We also propose that, for the Shared Savings Program the
performance feedback would be available to the eligible clinicians
participating in the Shared Savings Program at the group billing TIN
level. For the Next Generation ACO Model we propose that the
performance feedback would be available to all MIPS eligible clinicians
participating in the MIPS APM Entity.
We propose that in the first MIPS performance period, the MIPS
eligible clinicians participating in MIPS APMs other than the Shared
Savings Program or the Next Generation ACO Model would receive
performance feedback for the CPIA and advancing care information only,
as they would not be assessed under the quality or resource use
performance categories. The information such as MIPS measure score
comparisons for the quality and resource use performance categories
would not be applicable to these MIPS eligible clinicians because no
such comparative data would exist. We propose the performance feedback
for all other MIPS eligible clinicians participating in APMs would be
available for each MIPS eligible clinician that submitted MIPS data for
these performance categories under their respective APM Entities. We
invite comment on these proposals.
6. MIPS Composite Performance Score Methodology
By incentivizing quality and value for all eligible clinicians,
MIPS creates a new mechanism for calculating eligible clinician
payments. To implement this vision, we propose a scoring methodology
that allows for accountability and alignment across the performance
categories and minimizes burden on MIPS eligible clinicians. Further,
we propose a scoring methodology that is meaningful, understandable and
flexible for all MIPS eligible clinicians. Our proposed methodology
allows for multiple pathways to success with flexibility for the
variety of practice types and reporting options. First, we have
proposed multiple ways that MIPS eligible clinicians may submit data to
MIPS for the quality performance category. Second, we generally do not
propose ``all-or-nothing'' reporting requirements for MIPS. Third,
bonus points would be available for reporting high priority measures
and electronic reporting of quality data. Recognizing that MIPS is a
new program, we also outline proposals which we believe are
operationally feasible for us to implement in the first year, while
maintaining our longer-term vision, as well as Congress' vision.
Section 1848(q) of the Act requires the Secretary to: (1) Develop a
methodology for assessing the total performance of each MIPS eligible
clinician according to performance standards for a performance period
for a year; (2) using the methodology, provide a composite performance
score for each MIPS eligible clinician for each performance period; and
(3) use the CPS of the MIPS eligible clinician for a performance period
to determine and apply a MIPS adjustment factor (and, as applicable, an
additional MIPS adjustment factor) to the MIPS eligible clinician for
the MIPS payment year. Section II.E.5 of this rule proposes the
measures and activities for each of the four MIPS performance
categories: Quality, resource use, CPIA, and advancing care
information. This section proposes the performance standards for the
measures and activities for each of the four performance categories
under section 1848(q)(3) of the Act, the methodology for determining a
score for each of the four performance categories (referred to as a
``performance category score''), and the methodology for determining a
CPS under section 1848(q)(5) of the Act based on the scores determined
for each of the four performance categories. The performance category
score is defined at Sec. 414.1305 as the assessment of each MIPS
eligible clinician's performance on the applicable measures and
activities for a performance category for a performance period based on
the performance standards for those measures and activities. Section
II.E.7. includes proposals for determining the MIPS adjustments factors
based on the CPS.
As noted in section II.E.2., we propose to use multiple identifiers
to allow MIPS eligible clinicians to be measured as individuals, or
collectively as part of a group or an APM Entity group (an
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APM Entity participating in a MIPS APM). Further, in section
II.E.5.a.2., we propose that data for all four MIPS performance
categories would be submitted using the same identifier (either
individual or group) and that the CPS would be calculated using the
same identifier. The scoring proposals in this section II.E.6. would be
applied in the same manner for either individual submissions, proposed
as TIN/NPI, or for the group submissions using the TIN identifier.
Unless otherwise noted, for purposes of this section, the term ``MIPS
eligible clinician'' will refer to both individual and group reporting
and scoring, but will not refer to an APM Entity group.
APM Entity group reporting and scoring for MIPS eligible clinicians
participating in MIPS APMs are described in section II.E.5.h. of this
proposed rule. All eligible clinicians that participate in APMs are
considered MIPS eligible clinicians unless and until they are
determined to be either QPs or Partial QPs who elect not to report
under MIPS, and excluded from MIPS. For the APM scoring standard to
apply to a MIPS eligible clinician, the eligible clinician must be
listed as a participant in the APM Entity that participates in a MIPS
APM as of December 31 of the performance period, as described in
section II.E.5.h. CMS will publish a list of MIPS APMs on the CMS Web
site in advance of the performance period.
MIPS eligible clinicians who participate in APMs that are not MIPS
APMs would report to MIPS as an individual MIPS eligible clinician or
group. Unless otherwise specified, the proposals in this section II.E.6
that relate to reporting and scoring of measures and activities do not
affect the APM scoring standard.
Our rationale for our scoring methodology is grounded in the
understanding that the MIPS scoring system is a complex system with
numerous moving parts. Thus, we believe it is necessary to set up key
parameters around scoring, including requiring MIPS eligible clinicians
to report at the individual or group level across all performance
categories and generally to submit information for a performance
category using a single submission mechanism. Too many different
permutations would create additional complexities that could create
confusion amongst MIPS eligible clinicians as to what is and is not
allowed.
a. Converting Measures and Activities Into Performance Category Scores
(1) Policies That Apply Across Multiple Performance Categories
The detailed policies for scoring the four performance categories
are described in this section II.E.6.a. of this rule. However, as the
four performance categories collectively create a single MIPS CPS,
there are some cross-cutting policies that we propose to apply to
multiple performance categories.
(a) Performance Standards
Section 1848(q)(3)(A) of the Act requires the Secretary to
establish performance standards for the measures and activities in the
four MIPS performance categories. Section 1848(q)(3)(B) of the Act
requires the Secretary, in establishing performance standards for
measures and activities for the four MIPS performance categories, to
consider historical performance standards, improvement, and the
opportunity for continued improvement. We propose to define the term,
performance standards, at Sec. 414.1305 as the level of performance
and methodology that the MIPS eligible clinician is assessed on for a
MIPS performance period at the measures and activities level for all
MIPS performance categories. We define the term, MIPS payment year at
Sec. 414.1305 as the calendar year in which MIPS payment adjustments
are be applied. Performance standards for each performance category are
proposed in more detail later in this section, II.E.6. MIPS eligible
clinicians would know the actual performance standards in advance of
the performance period, when possible. Further, each performance
category is unified under the principle that MIPS eligible clinicians
would know, in advance of the performance period, the methodology for
determining the performance standards and the methodology that would be
used to score their performance. Table 16 summarizes the performance
standards, which are proposed in more detail in section II.E.6.a.
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(b) Unified Scoring System
Section 1848(q)(5)(A) of the Act requires the Secretary to develop
a methodology for assessing the total performance of each MIPS eligible
clinician according to performance standards for applicable measures
and activities in each performance category applicable to the MIPS
eligible clinician for a performance period. While MIPS has four
different performance categories, we propose a unified scoring system
that enables MIPS eligible clinicians, beneficiaries, and stakeholders
to understand what is required for a strong performance in MIPS while
being consistent with statutory requirements. We sought to keep the
scoring as simple as possible, while providing flexibility for the
variety of practice types and reporting options. We would incorporate
the following characteristics into the proposed scoring methodologies
for each of the four MIPS performance categories:
For the quality and resource use performance categories,
all measures would be converted to a 10-point scoring system which
provides a framework to universally compare different types of measures
across different types of MIPS eligible clinicians. A similar point
framework has been successfully implemented in several other CMS
quality programs including the Hospital Value-Based Purchasing Program
(HVBP).
The measure and activity performance standards would be
published, where feasible, before the performance period begins, so
that MIPS eligible clinicians can track their performance during the
performance period. This transparency would make the information more
actionable to MIPS eligible clinicians.
Unlike the PQRS or the EHR Incentive Program, we generally
would not include ``all-or-nothing'' reporting requirements for MIPS.
The methodology would score measures and activities that meet certain
standards defined in section II.E.5 and this section. However, section
1848(q)(5)(B)(i) of the Act provides that under the MIPS scoring
methodology, MIPS eligible clinicians who fail to report on an
applicable measure or activity that is required to be reported shall be
treated as receiving the lowest possible score for the measure or
activity. Therefore, MIPS eligible clinicians that fail to report
specific measures or activities would receive zero points for each
required measure or activity that they do not submit to MIPS.
The scoring system would ensure sufficient reliability and
validity, by only scoring the measures that meet certain standards
(such as required case minimum). The standards are described later in
this section.
The scoring proposals provide incentives for MIPS eligible
clinicians to invest and focus on certain measures and activities that
meet high priority policy goals such as improving beneficiary health,
improving care coordination through health information exchange, or
encouraging APM Entity participation.
Performance at any level would receive points towards the
performance category scores.
For the first year of MIPS, there are some minor differences in the
proposed performance category scoring methodologies to account for
differences in the maturity of the data collection systems and the
measures and activities; however, we anticipate that the scoring in
future years would continue to align and simplify. We request comment
on the characteristics of the proposed unified scoring system.
We also propose at Sec. 414.1325 that MIPS eligible clinicians and
groups may elect to submit information via multiple mechanisms;
however, they must use the same identifier for all performance
categories and they may only use one submission mechanism per
performance category. For example, a MIPS eligible clinician could use
one submission mechanism for sending quality measures and another for
sending CPIA data, but a MIPS eligible clinician could not use two
submission mechanisms for a single performance category, such as
submitting three quality measures via claims and three quality measures
via registry. We do intend to allow flexibility, for example, in rare
[[Page 28250]]
situations where a MIPS eligible clinician submits data for a
performance category via multiple submission mechanisms (for example,
submits data for the quality performance category through a registry
and QCDR), we would score all the options and use the highest
performance category score for the eligible clinician.
In carrying out MIPS, section 1848(q)(1)(E) of the Act requires the
Secretary to encourage the use of QCDRs under section 1848(m)(3)(E) of
the Act. In addition, section 1848(q)(5)(B)(ii) of the Act provides
that under the methodology for assessing the total performance of each
MIPS eligible clinician, the Secretary shall encourage MIPS eligible
clinicians to report on applicable measures under the quality
performance category through the use of CEHRT and QCDRs. To encourage
the use of QCDRs, we have created opportunities for QCDRs to report new
and innovative quality measures. In addition, several CPIAs emphasize
QCDR participation. Finally, we propose under section II.E.5.a. for
QCDRs to be able to submit data on all MIPS performance categories. We
believe these flexible options would allow MIPS eligible clinicians to
meet the submission criteria for MIPS in a low burden manner, which in
turn may positively affect their CPS.
In addition, section 1848(q)(5)(D) of the Act lays out the
requirements for incorporating performance improvement into the MIPS
scoring methodology beginning with the second MIPS performance period,
if data sufficient to measure improvement is available. Section
1848(q)(5)(D)(ii) of the Act also provides that achievement may be
weighted higher than improvement. Stated generally, we consider
achievement to mean how a MIPS eligible clinician performs compared to
other MIPS eligible clinicians for each applicable measure and activity
in a performance category, and improvement to mean how a MIPS eligible
clinician performs compared to the MIPS eligible clinician's own
previous performance on measures and activities in a performance
category. Improvement would not be scored for the first year of MIPS,
but we seek comment on how best to incorporate improvement scoring for
all performance categories.
(c) Baseline Period
In other Medicare quality programs, such as the HVBP, we have
adopted a baseline period that occurs prior to the performance period
for a program year to measure improvement and to establish performance
standards. We view the MIPS Program as necessitating a similar baseline
period for the quality performance category. We intend to establish a
baseline period for each performance period for a MIPS payment year to
measure improvement for the quality performance category and to enable
us to calculate performance standards that we can establish and
announce prior to the performance period. As with the HVBP, we intend
to adopt baseline periods that are as close as possible in duration to
the performance period specified for a MIPS payment year. In addition,
evaluating performance compared to a baseline period may enable other
payers to incorporate MIPS benchmarks into their programs. For each
MIPS payment year, we propose at Sec. 414.1380 that the baseline
period would be two years prior to the performance period for the MIPS
payment year. Therefore, for the first MIPS payment year (CY 2019
payment adjustments), for the quality performance category, we propose
that the baseline period would be calendar year 2015 which is 2 years
prior to the proposed calendar year 2017 performance period. As
discussed in section II.E.6.a.2.a. we propose to use performance in the
baseline period to set benchmarks for the quality performance category,
with the exception of new measures for which we would set the
benchmarks using performance in the performance period. For the
resource use performance category, we propose to set the benchmarks
using performance in the performance period and not the baseline
period, as discussed in section II.E.6.a.3. For the resource use
performance category, we also have included an alternative proposal to
set the benchmarks using performance in the baseline period. We define
the term ``measure benchmark'' for the quality and resource use
performance categories at Sec. 414.1305 as the level of performance
that the MIPS eligible clinician will be assessed on for a performance
period at the measures level.
(2) Scoring the Quality Performance Category
In section II.E.5.b.3, we proposed multiple ways that MIPS eligible
clinicians may submit data for the quality performance category to
MIPS; however, we propose that the scoring methodology would be
consistent regardless of how the data is submitted. In summary, we
propose at Sec. 414.1380(b)(1) to assign 1-10 points to each measure
based on how a MIPS eligible clinician's performance compares to
benchmarks. Measures must have the required case minimum to be scored.
If a MIPS eligible clinician fails to submit a measure required under
the quality performance category criteria, then the MIPS eligible
clinician would receive zero points for that measure. MIPS eligible
clinicians would not receive zero points if the required measure is
submitted (meeting the data completeness criteria as defined in section
II.E.5.b.3.b.) but is unable to be scored for any of the reasons listed
in this section II.E.6.a.2., such as not meeting the required case
minimum or a measure lacks a benchmark). For example, if a MIPS
eligible clinician reports a measure that meets the requirements
specified in section II.E.5.b., but that measure does not meet the
required case minimum criteria or lacks a benchmark, then the measure
would not be scored under the MIPS quality performance category,
whereas a MIPS eligible clinician that did not report this measure
would have the measure scored as a zero. We describe in section
II.E.6a.2.d. examples of how points would be allocated and how to
compute the overall quality performance category score under these
scenarios. Bonus points would be available for reporting high priority
measures, defined as outcome, appropriate use, efficiency, care
coordination, patient safety, and patient experience measures.
As discussed in section II.E.6.a.2.g., the quality performance
category score would be the sum of all the points assigned for the
scored measures required for the quality performance category plus the
bonus points (subject to the cap) divided by the sum of total possible
points. Since MIPS eligible clinicians would be generally required to
submit six measures or six measures from a specialty measure set and we
would also score MIPS eligible clinicians on up to three population-
based measures calculated from administrative claims data as discussed
in section II.5.b.6, the total possible points for the quality
performance category would be 90 points (6 submitted measures x 10
points + 3 population-based measures x 10 points = 90). However, for
eligible groups reporting via CMS Web Interface, the total possible
points for the quality performance category would be 210 points (17
measures x 10 points + 3 population-based measures x 10 points = 200),
subject to CMS Web Interface reporting criteria. Further, the total
possible points for small groups of less than 10 would be 80 points (6
submitted measures x 10 points + 2 population-based measures x 10
points = 80) because under our proposals the all-cause hospital
readmissions measure
[[Page 28251]]
would not be applicable to groups of less than 10 MIPS eligible
clinicians and MIPS eligible clinicians reporting as individuals due to
reliability concerns. Therefore, small groups of less than 10 and MIPS
eligible clinicians reporting as individuals would only be scored on
two population-based measures.
In section II.E.6.b, we discuss how we would score MIPS eligible
clinicians who do not have any scored measures in the quality
performance category. The details of the proposed scoring methodology
for the quality performance category are described below.
(a) Quality Measure Benchmarks
For the quality performance category, we propose at Sec.
414.1380(b)(1) that the performance standard is measure-specific
benchmarks. Benchmarks would be determined based on performance on
measures in the baseline period. For quality performance category
measures for which there are baseline period data, we would calculate
an array of measure benchmarks based on performance during the baseline
period, breaking baseline period measure performance into deciles.
Then, a MIPS eligible clinician's actual measure performance during the
performance period would be evaluated to determine the number of points
that should be assigned based on where the actual measure performance
falls within these baseline period benchmarks. If a measure does not
have baseline period information, (for example, new measures) or if the
measure specifications for the baseline period differ substantially
from the performance period (for example, when the measure requirements
change due to updated clinical guidelines), then we would determine the
array of benchmarks based on performance on the measure in the
performance period, breaking the actual performance on the measure into
deciles. In addition, we propose to create separate benchmarks for
submission mechanisms that do not have comparable measure
specifications. For example, several electronic clinical quality
measures have specifications that are different than the corresponding
measure from registries. We propose to develop separate benchmarks for
EHR submission options, claims submission options, Qualified Clinical
Data Registries (QCDRs) and qualified registries submission options.
For CMS Web Interface reporting, we propose to use the benchmarks
from the Shared Savings Program as described at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Quality-Measures-Standards.html. We would adopt the Shared Savings Program
performance year benchmarks for measures that are reported through the
CMS Web Interface for the MIPS performance period, but would apply the
MIPS method of assigning 1 to 10 points to each measure. For example,
for the 2017 MIPS performance year, we would use the benchmarks for the
2017 Shared Savings Program performance year, as both the MIPS
performance period and the Shared Savings Program performance year use
a calendar year for CMS Web Interface reporting. Because the Shared
Savings Program does not create benchmarks below the 30th percentile,
we would assign all scores below the 30th percentile a value of 2
points, which is consistent with the mid-cluster approach we are
proposing for topped out measures. We believe using the same benchmarks
for MIPS and the Shared Savings Program for the CMS Web Interface
measures would be appropriate because, as is discussed in II.E.5.h., we
propose to use the MIPS benchmarks to score the Shared Savings Program
and the Next Generation ACO Model on the quality performance category
and believe it is important to not have conflicting benchmarks. We
would post the MIPS CMS Web Interface benchmarks with the other MIPS
benchmarks.
As an alternative approach, we considered creating CMS Web
Interface specific benchmarks for MIPS. This alternative would be
restricted to CMS Web Interface reporters and would not include other
MIPS data submission methods, which are currently used to create the
Shared Saving Program benchmarks. This alternative would also apply the
topped out cluster approach if any measures are topped out. While we
see benefit in having CMS Web Interface methodology match the other
MIPS benchmarks, we are also concerned about the Shared Saving Program
and the Next Generation ACO Model participants having conflicting
benchmark data. We request comments on building CMS Web Interface
specific benchmarks.
All MIPS eligible clinicians, regardless of whether they report as
an individual or group, and regardless of specialty, that submit data
using the same submission mechanism would be included in the same
benchmark. We propose to unify the calculation of the benchmark by
using the same approach as the VM of weighting the performance rate of
each MIPS eligible clinician and group submitting data on the quality
measure by the number of beneficiaries used to calculate the
performance rate so that group performance is weighted appropriately
(77 FR 69321-69322). We would also include APM Entity submissions in
the benchmark but would not score APM Entities using this methodology.
For APM scoring, we refer to section II.E.5.h.
To ensure that we have robust benchmarks, we propose that each
benchmark must have a minimum of 20 MIPS eligible clinicians who
reported the measure meeting the data completeness requirement defined
in section II.E.5.b.3, as well as meeting the required case minimum
criteria for scoring that is defined later in this section. We selected
a minimum of 20 because, as discussed below, our benchmarking
methodology relies on assigning points based on decile distributions
with decimals. A decile distribution requires at least 10 observations.
We doubled the requirement to 20 so that we would be able to assign
decimal point values and minimize cliffs between deciles. We did not
want to increase the benchmark sample size requirement due to concerns
that an increase could limit the number of measures with benchmarks.
We also propose that MIPS eligible clinicians who report measures
with a performance rate of 0 percent would not be included in the
benchmarks. In our initial analysis, we identified some measures that
had a large cluster of eligible clinicians with a 0 percent performance
rate. We are concerned that the 0 percent performance rate represents
clinicians who are not actively engaging in that measurement activity.
For example, it could be clinicians reporting the measures that are
programmed into their EHR and that are submitted unintentionally,
rather than measures the eligible clinician has actively selected for
quality improvement. We do not want to inappropriately skew the
distribution. We seek comment on whether or not to include 0 percent
performance in the benchmark.
We propose at Sec. 414.1380(b)(1)(i) to base the benchmarks on
performance in the baseline period when possible, and to publish the
numerical benchmarks when possible, prior to the start of the
performance period. In those cases where we do not have comparable data
from the baseline period, we propose to use information from the
performance period to establish benchmarks. While the benchmark
methodology would be established in a final rule in advance of the
performance period, the actual numerical benchmarks would not be
published until after the performance period for quality measures that
do not
[[Page 28252]]
have comparable data from the baseline period. The methodology for
creating the benchmarks is discussed below in this section.
We considered not scoring measures that either are new to the MIPS
program or do not have a historical benchmark based on performance in
the baseline period. This policy would be consistent with the VM policy
in which we do not score measures that have no benchmark (77 FR 69322).
However, we are concerned that such a policy could stifle reporting on
innovative new measures because it would take several years for the
measure to be incorporated into the performance category score. We also
believe that any issues related to reporting a new measure would not
disproportionately affect the relative performance between MIPS
eligible clinicians.
We also considered a variation on the scoring methodology that
would provide a floor for a new MIPS measure. Under this variation, if
a MIPS eligible clinician reports a new measure under the quality
performance category, the MIPS eligible clinician would not score lower
than 3 points for that measure. This would encourage reporting on new
measures, but also prevent MIPS eligible clinicians from receiving the
lowest scores for a new measure, while still measuring variable
performance. Finally, we also considered lowering the weight of a new
measure, so that new measures would contribute relatively less to the
score compared to other measures. In the end, we are not proposing
these alternatives we considered, because we want to encourage adoption
and measured performance of new measures, however, we do request
comment on these alternatives, including comments on what the lowest
score should be for MIPS eligible clinicians who report a new measure
under the quality performance category and protections against
potential gaming related to reporting of new measures only. We also
seek comments on alternative methodologies for scoring new measures
under the quality performance category, which would assure equity in
scoring between the methodology for measures for which there is
baseline period data and for new measures which do not have baseline
period data available.
Finally, we want to clarify that some PQRS reporting mechanisms
have limited experience with all-payer data. For example, under PQRS,
all-payer data was permitted only when reporting via registries for
measure groups; reporting via registries for individual measures was
restricted to Medicare only. Under MIPS however, we intend to have more
robust data submissions, as described in section II.E.5.b.3. We
recognize that comparing all-payer performance to a benchmark that is
built, in part, on Medicare data is a limitation and would monitor the
benchmarks to see if we need to develop separate benchmarks. This data
issue would resolve in a year or two, as new MIPS data becomes the
historical benchmark data in future years.
(b) Assigning Points Based on Achievement
We propose at Sec. 414.1380(b)(1)(x) to establish benchmarks using
a percentile distribution, separated by decile categories, because it
translates measure-specific score distributions into a uniform
distribution of MIPS eligible clinicians based on actual performance
values. For each set of benchmarks, we propose to calculate the decile
breaks for measure performance and assign points for a measure based on
which benchmark decile range the MIPS eligible clinician's performance
rate on the measure falls between. For example, MIPS eligible
clinicians in the top decile would receive 10 points for the measure,
and MIPS eligible clinicians in the next lower decile would receive
points ranging from 9 to 9.9. We propose to assign partial points to
prevent performance cliffs for MIPS eligible clinicians near the decile
breaks. The partial points would be assigned based on the percentile
distribution.
Table 17 illustrates an example of using decile points along with
partial points to assign achievement points for a sample quality
measure. The methodology in this example could apply to measures where
the benchmark is based on the baseline period or for new measures where
the benchmark is based on the performance period.
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In the example above, a MIPS eligible clinician with a measure
performance rate of 41 percent would receive 6.0 points based on the
benchmark. MIPS eligible clinicians with measure performance rates of
85 percent or above would receive 10 points because they were in the
top benchmark decile. We believe that MIPS eligible clinicians within
the top decile in performance would warrant receiving the maximum
number of points. This is a similar concept to the HVBP ``benchmark''
level. We note that 85 percent is solely illustrative. Any MIPS
eligible clinician who reports some level of performance would receive
a minimum of one point for reporting if the measure has the required
case minimum, assuming the measure has a benchmark.
In Table 17 we described our scoring approach, using deciles. We do
not propose to base scoring on decile distributions for the same
measure
[[Page 28253]]
ranges as described in Table 17 when performance is clustered at the
high end (that is, ``topped out'' measures), as true variance cannot be
assessed. MIPS eligible clinicians report on different measures and
often elect to submit measures on which they expect to perform well.
With MIPS eligible clinicians electing to report on measures where they
expect to perform well, we anticipate many measures would have
performance distributions clustered near the top. We propose to
identify ``topped out'' measures by using a definition similar to the
definition used in the HVBP: Truncated Coefficient of Variation \13\ is
less than 0.10 and the 75th and 90th percentiles are within 2 standard
errors; \14\ or median value for a process measure that is 95 percent
or greater (80 FR 49550).\15\
---------------------------------------------------------------------------
\13\ The 5% of MIPS eligible clinicians with the highest scores,
and the 5% with lowest scores are removed before calculating the
Coefficient of Variation.
\14\ This is a test of whether the range of scores in the upper
quartile is statistically meaningful.
\15\ This last criterion is in addition to the HVBP definition.
---------------------------------------------------------------------------
Using 2014 PQRS quality reported data measures, we modeled the
proposed benchmark methodology and identified that approximately half
of the measures proposed under the quality performance category are
topped out. Several measures have a median score of 100 percent, which
makes it difficult to assess relative performance needed for the
quality performance category score.
However, we do not believe it would be appropriate to remove topped
out measures at this time. As not all MIPS eligible clinicians would be
required to report these measures under our proposals for the quality
performance category in section II.E.5.b. it would be difficult to
determine whether a measure is truly topped out or if only excellent
performers are choosing to report the measure. We also believe removing
such a large volume of measures would make it difficult for some
specialties to have enough applicable measures to report. At the same
time, we do not believe that the highest values on topped out measures
convey the same meaning of relative quality performance as the highest
values for measures that are not topped out. In other words, we do not
believe that eligible clinicians electing to report topped out process
measures should be able to receive the same maximum score as eligible
clinicians electing to report preferred measures, such as outcome
measures.
Therefore, we propose to modify the benchmark methodology for
topped out measures. Rather than assigning up to 10 points per measure,
we propose to limit the maximum number of points a topped out measure
can achieve based on how clustered the scores are. We propose to
identify clusters within topped out measures and would assign all MIPS
eligible clinicians within the cluster the same value, which would be
the number of points available at the midpoint of the cluster. That is,
we would take the midpoint of the highest and lowest scores that would
pertain if the measure was not topped out and the values were not
clustered. We would only apply this methodology for benchmarks based on
the baseline period. When we develop the benchmarks, we would identify
the clusters and state the points that would be assigned when the
measure performance rate is in a cluster. We would notify MIPS eligible
clinicians when those benchmarks are published with regard to which
measures are topped out.
Table 18 illustrates this hypothetical example. In developing the
benchmark, we identified that the top five deciles (50 percent of
eligible clinicians reporting the measure) of MIPS eligible clinicians
are clustered at 100 percent. We would identify the middle of that
cluster (in this example, the top 25 percent or the middle of the
eighth decile) and then assign all MIPS eligible clinicians with
performance rates in the cluster the same number of points for the
measure. The decile points for the hypothetical topped out measure in
Table 18 shows that the maximum a MIPS eligible clinician can receive
for the topped out measure is 8.5 points in this example.
[GRAPHIC] [TIFF OMITTED] TP09MY16.021
We propose this approach because we want to encourage MIPS eligible
clinicians not to report topped out measures, but to instead choose
other measures that are more meaningful. We also seek feedback on
alternative ways and an alternative scoring methodology to address
topped out measures so that topped out measures do not
disproportionately affect a MIPS eligible clinician's quality
performance category score. Other alternatives could include placing a
limit on the number of topped out measures MIPS eligible clinicians may
submit or reducing the weight of topped out measures. We also
considered whether we should apply a flat percentage in building the
benchmarks, similar to the Shared Savings Program, where MIPS eligible
clinicians are scored on their percentage of their performance rate and
not on a decile distribution and request comment on how to apply such a
methodology without providing an incentive to report topped out
measures. Under the Shared Savings Program, 42 CFR 425.502, there are
circumstances when benchmarks are set using flat percentages. For some
measures, benchmarks are set using flat percentages when the 60th
percentile was equal to or greater than 80.00 percent, effective
beginning with the 2014 reporting year (78 FR 74759-74763). For other
measures benchmarks are set using flat percentages when the 90th
percentile was equal to or greater than 95.00 percent, effective
beginning in 2015 (79 FR 67925). Flat percentages
[[Page 28254]]
allow those with high scores to earn maximum or near maximum quality
points while allowing room for improvement and rewarding that
improvement in subsequent years. Use of flat percentages also helps
ensure those with high performance on a measure are not penalized as
low performers. We also note that we anticipate removing topped out
measures over time, as we work to develop new quality measures that
will eventually replace these topped out measures. We request feedback
on these proposals.
(c) Case Minimum Requirements and Measure Reliability and Validity
We seek to ensure that MIPS eligible clinicians are measured
reliably; therefore, we propose at Sec. 414.1380(b)(1)(v) to use for
the quality performance category measures the case minimum requirements
for the quality measures used in the 2018 VM (see Sec. 414.1265): 20
cases for all quality measures, with the exception of the all-cause
hospital readmissions measure, which has a minimum of 200 cases. We
refer readers to Table 46 of the CY 2016 PFS final rule (80 FR 71282)
which summarized our analysis of the reliability of certain claims-
based measures used for the 2016 VM payment adjustment. MIPS eligible
clinicians that report measures with fewer than 20 cases (and the
measure meets the data completeness criteria) would receive recognition
for submitting the measure, but the measure would not be included for
MIPS quality performance category scoring. Since the all-cause hospital
readmissions measure does not meet the threshold for what we consider
to be moderate reliability for solo practitioners and groups of less
than ten MIPS eligible clinicians for purposes of the VM (see Table 46
of the CY 2016 PFS final rule, referenced above), for consistency, we
propose to not include the all-cause hospital readmissions measure in
the calculation of the quality performance category for MIPS eligible
clinicians who individually report, as well as solo practitioners or
groups of two to nine MIPS eligible clinicians.
We also propose that if we identify issues or circumstances that
would impact the reliability or validity of a measure score, we would
also exclude those measures from scoring. For example, if we discover
that there was an unforeseen data collection issue that would affect
the integrity of the measure information, we would not want to include
that measure in the quality performance category score. If a measure is
excluded, we would recognize that the measure had been submitted and
would not disadvantage the MIPS eligible clinicians by assigning them
zero points for a non-reported measure. In this instance, if the MIPS
eligible clinician, as a solo practitioner, scored 10 out of 10 on each
of the remaining five measures submitted, and the two population-based
measures applicable to solo practitioners, the MIPS eligible clinician
would receive a perfect score in the quality performance category (5
measures x 10 points) + (2 population-based measures x 10 points) or 70
out of 70 possible points.
(d) Scoring for MIPS Eligible Clinicians that Do Not Meet Quality
Performance Category Criteria
Section II.E.5.b. of this proposed rule outlines our proposed
quality performance category criteria for the different reporting
mechanisms. The criteria vary by reporting mechanism, but generally we
propose to include a minimum of six measures with at least one cross-
cutting measure (for patient facing MIPS eligible clinicians) (Table C)
and an outcome measure if available. If an outcome measure is not
available, then the eligible clinician would report one other high
priority measure (appropriate use, patient safety, efficiency, patient
experience, and care coordination measures) in lieu of an outcome
measure. MIPS eligible clinicians and groups would have to select their
measures from either the list of all MIPS Measures in Table A or a set
of specialty specific measures in Table E.
We note that there are some special scenarios for those MIPS
eligible clinicians who select their measures from the Specialty Sets
(Table E) as discussed in section II.E.5.b.
For groups using the CMS Web Interface and MIPS APMs, we propose to
have different quality performance category criteria described in
sections II.E.5.b. and II.E.5.h. Additionally, as described in section
II.E.5.b. we also propose to score MIPS eligible clinicians on up to
three population-based measures.
Previously in PQRS, EPs had to meet all the criteria or be subject
to a negative payment adjustment. We heard from numerous commenters a
desire to move away from ``all-or-nothing'' scoring. Therefore, in
MIPS, we propose that MIPS eligible clinicians receive credit for
measures that they report, regardless of whether or not the MIPS
eligible clinician meets the quality performance category submission
criteria. Section 1848(q)(5)(B)(i) of the Act provides that under the
MIPS scoring methodology, MIPS eligible clinicians who fail to report
on an applicable measure or activity that is required to be reported
shall be treated as receiving the lowest possible score for the measure
or activity; therefore, for any MIPS eligible clinician who does not
report a measure required to satisfy the quality performance category
submission criteria, we propose that the MIPS eligible clinician would
receive zero points for that measure. For example, a MIPS eligible
clinician who is able to report on six measures, yet reports on four
measures, would receive two ``zero'' scores for the missing measures.
In another example, a patient facing MIPS eligible clinician reports
more than six measures, but does not elect to report a cross-cutting
measure and an outcome measure, or if one is not available, another
high priority measure. The MIPS eligible clinician in that scenario
would receive at least two ``zero'' scores for not reporting measures
required by the quality performance category criteria.
However, MIPS eligible clinicians who report a measure that does
not meet the required case minimum would not be scored on the measure
but would also not receive a ``zero'' score. For example, a MIPS
eligible clinician who submits six measures as part of a group with 10
or more clinicians, one of which does not meet the required case
minimum, would be scored on the five remaining measures and the three
population-based measures based on administrative claims data. If the
MIPS eligible clinician scored 10 out of 10 on each of these measures,
the MIPS eligible clinician would receive a perfect score in the
quality performance category (5 measures x 10 points) + (3 population-
based measures x 10 points) or 80 out of 80 possible points.
We also note that if MIPS eligible clinicians are able to submit
measures that can be scored, we want to discourage them from continuing
to submit the same measures year-after-year that cannot be scored due
to not meeting the required case minimum. Rather, to the fullest extent
possible, MIPS eligible clinicians should select measures that would
have a required case minimum. We seek comment on any safeguards we
should implement in future years to minimize any gaming attempts. For
example, if the measures that a MIPS eligible clinician submits for a
performance period are not able to be scored due to not meeting the
required case minimum, we seek comment on whether we should require
these MIPS eligible clinicians to submit different measures with
sufficient cases for the next performance period (to the
[[Page 28255]]
extent other measures are applicable and available to them).
MIPS eligible clinicians who report a measure where there is no
benchmark due to less than 20 MIPS eligible clinicians reporting on the
measure would not be scored on the measure but would also not receive a
``zero'' score. Instead, these MIPS eligible clinicians would be scored
according to the following example: A MIPS eligible clinician who
submits six measures through a group of 10 or more clinicians, with one
measure lacking a benchmark, would be scored on the five remaining
measures and the three population-based measures based on
administrative claims data. If the MIPS eligible clinician scored 10
out of 10 on each of these measures, the MIPS eligible clinician would
receive a perfect score in the quality performance category (5 measures
x 10 points) + (3 population-based measures x 10 points) or 80 out of
80 possible points.
We intend to develop a validation process to review and validate a
MIPS eligible clinician's inability to report on the quality
performance requirements as proposed in section II.E.5.b. We anticipate
that this process would function similar to the Measure Applicability
Validity (MAV) process that occurred under PQRS, with a few exceptions.
First, the MAV process under PQRS was a secondary process after an EP
was determined to not be a satisfactory reporter. Under MIPS, we intend
to build the process into our overall scoring approach to reduce
confusion and burden on MIPS eligible clinicians by having a separate
process. Second, as the requirements under PQRS are different than
those proposed under MIPS, the process must be updated to account for
different measures and different quality performance requirements. More
information on the MAV process under PQRS can be found at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2016_PQRS_MAV_ProcessforClaimsBasedReporting_030416.pdf. We request
comments on these proposals.
(e) Incentives To Report High Priority Measures
Consistent with other CMS value-based payment programs, we propose
that MIPS scoring policies would emphasize and focus on high priority
measures that impact beneficiaries. These high priority measures are
defined as outcome, appropriate use, patient safety, efficiency,
patient experience and care coordination measures; see Tables A-D for
these measures. We propose these measures as high priority measures
given their critical importance to our goals of meaningful measurement
and our measure development plan. We note that many of these measures
are grounded in NQS domains. For patient safety, efficiency, patient
experience and care coordination measures, we refer to the measures
within the respective NQS domains and measure types. For outcomes
measures, we include both outcomes measures and intermediate outcomes
measures. For appropriate use measures, we have noted which measures
fall within this category in Tables A-D and provided criteria for how
we identified these measures in section II.E.5.b. For non-MIPS measures
reported through QCDRs, we propose to classify which measures are high
priority during the measure review process.
We are proposing scoring adjustments to create incentives for MIPS
eligible clinicians to submit certain high priority measures and to
allow these measures to have more impact on the total quality
performance category score.
We propose to create an incentive for MIPS eligible clinicians to
voluntarily report additional high priority measures. We propose to
provide two bonus points for each outcome and patient experience
measure and one bonus point for other high priority measures reported
in addition to the one high priority measure (an outcome measure, but
if one is not available, then another high priority measure) that would
already be required under the proposed quality performance category
criteria. For example, if a MIPS eligible clinician submitted two
outcome measures, and two patient safety measures, the MIPS eligible
clinician would receive two bonus points for the second outcome measure
reported and two bonus points for the two patient safety measures. The
MIPS eligible clinician would not receive any bonus points for the
first outcome measure submitted since that is a required measure. We
selected two bonus points for outcome measures given the statutory
requirements under section 1848(q)(2)(C)(i) of the Act to emphasize
outcome measures. We selected two bonus points for patient experience
measures given the importance of patient experience measures to our
measurement goals. We selected one bonus point for all other high
priority measures given our measurement goals around each of those
areas of measurement. We believe the number of bonus points provides
extra credit for submitting the measure, yet would not mask poor
performance on the measure. For example, a MIPS eligible clinician with
poor outcomes receives only two points for performance for a particular
high priority measure. The bonus points would increase the MIPS
eligible clinician's points to three (or four if the measure is an
outcome measure or patient experience measure), but that amount is far
less than the ten points a top performer would receive. We note that
population-based measures would not receive bonus points.
We note that a MIPS eligible clinician who submits a high priority
measure but had a performance rate of 0 percent would not receive any
bonus points. Eligible clinicians would only receive bonus points if
the performance rate is greater than zero. Bonus points are also
available for measures that are not scored (not included in the top 6
measures for the quality performance category score) as long as the
measure has the required case minimum and data completeness. We believe
these qualities would allow us to include the measure in future
benchmark development.
For groups submitting data through the CMS Web Interface, including
MIPS APMs that report through the CMS Web Interface, groups are
required to submit a set of predetermined measures and groups are
unable to submit additional measures. For that submission mechanism, we
propose to apply bonus points based on the finalized set of measures.
We would assign two bonus points for each outcome measure (after the
first required outcome measure) and for each patient experience
measure. We would also have one additional bonus point for each other
high priority measure (patient safety, efficiency, appropriate use,
care coordination). We believe MIPS eligible clinicians or groups
should have the ability to receive bonus points for reporting high
priority measures through all submission mechanisms, including the CMS
Web Interface. In the final rule, we will publish how many bonus points
the CMS Web Interface measure set would have available based on the
final list of measures.
We propose to cap the bonus points for the high priority measures
(outcome, appropriate use, patient safety, efficiency, patient
experience, and care coordination measures) at 5 percent of the
denominator of the quality performance category score. Tables 19 and 20
illustrate examples of how to calculate the bonus cap. We also propose
an alternative approach of capping bonus points for high priority
measures at 10 percent of the denominator of the quality performance
category score. Our rationale for the 5
[[Page 28256]]
percent cap is that we do not want to mask poor performance by allowing
an MIPS eligible clinician to perform poorly on a measure but still
obtain a high quality performance category score by submitting numerous
high priority measures in order to obtain bonus points; however, we are
also concerned that 5 percent may not be enough incentive to encourage
reporting. We request comment on the appropriate threshold for this
bonus cap.
(f) Incentives To Use CEHRT To Support Quality Performance Category
Submissions
Section 1848(q)(5)(B)(ii) of the Act provides that under the
methodology for assessing the total performance of each MIPS eligible
clinician, the Secretary shall: (I) Encourage MIPS eligible clinicians
to report on applicable measures under the quality performance category
through the use of CEHRT and QCDRs; and (II) with respect to a
performance period for a year, for which a MIPS eligible clinician
reports applicable measures under the quality performance category
through the use of CEHRT, treat the MIPS eligible clinician as
satisfying the clinical quality measures reporting requirement under
section 1848(o)(2)(A)(iii) of the Act for such year. To encourage the
use of CEHRT for quality improvement and reporting on measures under
the quality performance category, we are proposing a scoring incentive
to MIPS eligible clinicians who use their CEHRT systems to capture and
report quality information.
We propose to allow one bonus point under the quality performance
category score, up to a maximum of 5 percent of the denominator of the
quality performance category score if:
The MIPS eligible clinician uses CEHRT to record the
measure's demographic and clinical data elements in conformance to the
standards relevant for the measure and submission pathway, including
but not necessarily limited to the standards included in the CEHRT
definition proposed in 414.1305;
The MIPS eligible clinician exports and transmits measure
data electronically to a third party using relevant standards or
directly to CMS using a submission method as defined at Sec. 414.1325;
and
The third party intermediary (for example, a QCDR) uses
automated software to aggregate measure data, calculate measures,
perform any filtering of measurement data, and submit the data
electronically to CMS using a submission method as defined at Sec.
414.1325.
These requirements are referred to as ``end-to-end electronic
reporting.''
We note that this bonus would be in addition to the high priority
bonus. MIPS eligible clinicians would be eligible for both this bonus
option and the high priority bonus option with separate bonus caps for
each option. We also propose an alternative approach of capping bonus
points for this option at 10 percent of the denominator of the quality
performance category score. Our rationale for the 5 percent cap is that
we do not want to mask poor performance by allowing a MIPS eligible
clinician to perform poorly on a measure but still obtain a high
quality performance category score by submitting numerous measures in
order to obtain bonus points; however, we are also concerned that 5
percent may not be enough incentive to encourage end-to-end electronic
reporting. We seek comment on the appropriate threshold for this bonus
cap. We propose the CEHRT bonus would be available to all submission
mechanisms except claims submissions. This incentive would also be
available for MIPS APMs reporting through the CMS Web Interface.
Specifically, MIPS eligible clinicians who report via qualified
registries, QCDRs, EHR submission mechanisms, and CMS Web Interface may
receive one bonus point for each reported measure with a cap as
described. We do not propose to allow this option for claims
submission, because there is no mechanism for MIPS eligible clinicians
to identify the information was pulled using an EHR.
This approach supports and encourages innovative approaches to
measurement using the full array of standards ONC adopts, and the data
elements MIPS eligible clinicians capture and exchange, to support
patient care. Thus, approaches where a qualified registry or QCDR
obtains data from a MIPS eligible clinician's CEHRT using any of the
wide range of ONC-adopted standards and then uses automated electronic
systems to perform aggregation, calculation, filtering, and reporting
would qualify each such measure for the CEHRT bonus point. In addition,
measures submitted using the EHR submission mechanism or the EHR
submission mechanism through a third party would also qualify for the
CEHRT bonus.
We request comment on this proposed approach.
(g) Calculating the Quality Performance Category Score
The next two subsections provide a detailed description of how the
quality performance category score would be calculated under our
proposals.
(i) Calculating the Quality Performance Category Score for Non-APM
Entity, Non-CMS Web Interface Reporters
To calculate the quality performance category score, we propose at
Sec. 414.1380(b)(1)(xv) to sum the weighted points assigned for the
measures required by the quality performance category criteria plus the
bonus points and divide by the weighted sum of total possible points.
If a MIPS eligible clinician elects to report more than the minimum
number of measures to meet the MIPS quality performance category
criteria, then we would only include the scores for the measures with
the highest number of assigned points. For example, if a patient facing
MIPS eligible clinician's quality submission criteria is to report six
measures with at least one cross-cutting measure and a high priority
measure, and the MIPS eligible clinician reports eight process measures
(three using CEHRT), one cross-cutting measure, and one outcome
measure, then we propose to use the four process measures with the
highest number of assigned points, plus the cross-cutting measure and
the outcome measure, in addition to the two population-based measures
(the all-cause readmission measure would not apply to an MIPS eligible
clinician reporting individually), to calculate the quality performance
category score. Allowing MIPS eligible clinicians to report additional
measures without including them in the scoring allows MIPS eligible
clinicians to become familiar with new measures and gain experience
with those measures. It also provides the foundation for the MIPS
eligible clinician to receive credit for improvement on those measures
in future years.
If a MIPS eligible clinician has met the quality performance
category submission criteria for reporting quality information, but
does not have any scored measures as discussed in section II.E.6.b.2.,
then a quality performance category score would not be calculated.
Refer to section II.E.6.a.2.d. for details on how we propose to address
scenarios where a quality performance category score is not calculated
for a MIPS eligible clinician.
The following example illustrates a sample scoring methodology. In
this scenario, a MIPS eligible clinician submits individually via
registry three process measures, one outcome measure, and one other
high priority measure. Two of the process measures and one outcome
measure qualify for
[[Page 28257]]
the CEHRT bonus. The patient facing MIPS eligible clinician did not
submit on an expected cross-cutting measure and therefore would receive
zero points for that requirement. Measures that do not meet the
required case minimum or do not have a benchmark are not used for
scoring. We reiterate that a measure that is not scored due to not
meeting the required case minimum or lack of a measure benchmark would
be treated differently than a required measure that is not reported.
Any required measure that is not reported, or reported in a way that
does not meet the data completeness requirements, would receive a score
of zero points and be considered a scored measure. Table 19 illustrates
the example.
BILLING CODE P
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BILLING CODE C
The total possible points for the eligible clinician is 70 points.
The eligible clinician has 48.2 points based on performance. The
eligible clinician also qualifies for one bonus point for reporting an
additional high priority patient safety measure and three bonus points
for end-to-end electronic reporting of quality measures. The bonus
points for high priority measures and CEHRT reporting are both under
two separate caps which is 5 percent of 70 possible points or 3.5
points per bonus category). The quality performance category score for
this MIPS eligible clinician is (48.2 points + 4 bonus points = 52.2)/
70 total possible points = 74.6 percent. The quality performance
category score would be capped at 100 percent.
The following example in Table 20 illustrates how to calculate the
bonus cap for the high priority measure bonus and the CEHRT bonus. In
the scenario below, the MIPS eligible clinician has submitted six
measures and would also be scored on two of the three population-based
measures. The MIPS eligible clinician below successfully submitted five
quality measures using end-to-end electronic reporting, and therefore,
qualifies for the CEHRT bonus of one point for each of those measures.
In addition to CEHRT bonus points, the MIPS eligible clinician reported
outcome measures for high priority bonus points. The MIPS eligible
clinician reported two outcome measures and receives two bonus points
for the second outcome measure, given that no bonus points are given
for the first required measure. However, both bonus categories are over
the cap (which is 5 percent of 80 possible points or four points per
bonus category). The quality performance category score for this MIPS
eligible clinician is 68.8 (60.8 + 4 CEHRT bonus points after the cap +
4
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high priority bonus points after the cap) or 86 percent (68.8/80).
Note, in section II.E.5.b.(2), we propose to weight the quality
performance category at 50 percent of the MIPS CPS, so an 86 percent
quality performance category score would account for 50 percent of the
CPS.
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We request comment on our proposals to calculate the quality
performance category score.
(ii) Calculating the Quality Performance Category for CMS Web Interface
Reporters
CMS Web Interface reporters have different quality performance
category submission criteria; therefore, we propose to modify our
scoring logic slightly to accommodate this submission mechanism. CMS
Web Interface users report on the entire set of measures specified for
that mechanism. Therefore, rather than scoring the top six reported
measures, we propose to score all measures. If a group does not meet
the reporting requirements for one of the measures, then the group
would receive zero points for that measure. We note that since groups
reporting through the Web Interface are required to report on all
measures, and since some of those measures are ``high priority,'' these
groups would always have some bonus points for the quality performance
category score if all the measures are reported. That is, the group
would either report on less than all web interface measures, in which
case the group would receive zeros for unreported measures, or the
group would report on all measures, in which case the group would
automatically be eligible for bonus points. The other proposals for
scoring discussed in section II.E.6.a.2.g.i., including bonus points,
would still apply for CMS Web Interface. We request comment on this
proposal.
(h) Measuring Improvement
Section 1848(q)(3)(B) of the Act requires the Secretary, in
establishing performance standards for measures and activities for the
MIPS performance categories, to consider: Historical performance
standards; improvement; and the opportunity for continued improvement.
In addition, under section 1848(q)(5)(D) of the Act, beginning with the
second year of the MIPS, if data sufficient to measure improvement are
available, the CPS methodology shall take into account improvement of
the MIPS eligible clinician in calculating the performance score for
the quality and resource use performance categories and may take into
account improvement for the CPIA and advancing care information
performance categories.
We are soliciting public comments on potential ways to incorporate
improvement into the scoring methodology moving forward. We are
especially interested in feedback on the following three options, with
the assumption that eligible clinicians would report the same measures
year-to-year (where possible). We are also interested in feedback on
how to score improvement given that a MIPS eligible clinician can
change measures and submission mechanisms from year-to-year. In
addition, a MIPS eligible clinician can elect to report as an
individual or a member of a group and that election can vary from year
to year. Finally, we seek feedback on whether to score improvement
where MIPS eligible clinicians do not have the required case minimum
for measures to be scored.
Option 1: We could adopt the approach for assessing improvement
currently used for the HVBP, where we assign from 1-10 points for
achievement and from 1-9 points for improvement for each measure. We
would compare the achievement and improvement points for each measure
in the quality performance category and score whichever is greater.
Specifically, we would determine two scores for a MIPS eligible
clinician at the measure level for the quality performance category.
First, we would assess the MIPS eligible clinician's achievement score,
which measures how the MIPS eligible clinician performed compared to
benchmark performance scores for each applicable measure in the quality
performance category. Second, we would assess the MIPS eligible
clinician's improvement score, which measures how much a MIPS eligible
clinician has improved compared to the MIPS eligible clinician's own
previous performance during a baseline period for each applicable
measure in the quality performance category. Under this methodology, we
would compare the achievement and improvement scores for each measure
and only use whichever is greater, but only those eligible clinicians
with the top
[[Page 28259]]
achievement would be able to receive the maximum number of points. If a
MIPS eligible clinician's practice was not open during the baseline
period but was open during the performance period, points would be
awarded based on achievement only for that performance period. For a
more detailed description of the HVBP methodology, we refer readers to
Sec. 412.160 and Sec. 412.165.
Option 2: We could adopt the approach for assessing improvement
currently used in the Shared Savings Program, where eligible clinicians
or groups would receive a certain number of bonus points for the
quality performance category for improvement, although the total points
received for the performance may not exceed the maximum total points
for the performance category in the absence of the quality improvement
points. Under this methodology, we would score individual measures and
determine the corresponding number of points that may be earned based
on the MIPS eligible clinician's performance. We would add the points
earned for the individual measures within the quality performance
category and divide by the total points available for the performance
category to determine the quality performance category score. MIPS
eligible clinicians that demonstrate quality improvement on established
quality measures from year-to-year would be eligible for up to four
bonus points for the quality performance category. Bonus points would
be awarded based on a MIPS eligible clinician's net improvement in
measures within the quality performance category, which would be
calculated by determining the total number of significantly improved
measures and subtracting the total number of significantly declined
measures. Up to four bonus points would be awarded based on a
comparison of the MIPS eligible clinician's net improvement in
performance on the measures to the total number of individual measures
in the quality performance category. When bonus points are added to
points earned for the quality measures in the quality performance
category, the total points received for the quality performance
category may not exceed the maximum total points for the performance
category in the absence of the quality improvement points. For a more
detailed description of the Shared Savings Program methodology, we
refer readers to Sec. 425.502, as well as CY 2015 PFS final rule with
comment (79 FR 67928-67931) for a discussion of how CMS will determine
whether the improvement or decline is significant.
Option 3: We could adopt the approach similar to that for assessing
improvement for the Medicare Advantage 5-star rating methodology. Under
this approach, we would identify an overall ``improvement measure
score'' by comparing the underlying numeric data for measures from the
prior year with the data from measures for the performance period. To
obtain an ``improvement measure score'' MIPS eligible clinicians would
need to have data for both years in at least half of the required
measures for the quality performance category. The numerator for the
overall ``improvement measure'' would be the net improvement, which is
a sum of the number of significantly improved measures minus the number
of significantly declined measures. The denominator is the number of
measures eligible for improvement since to qualify for use in the
``improvement measure'' calculation, a measure must exist in both years
and not have had a significant change in its specification. This
``improvement measure'' would be included in the quality performance
category. We recognize that high performing MIPS eligible clinicians
may have less room for improvement and consequently may have lower
scores on the overall ``improvement measure''. Therefore, under this
option we would propose the following rule, which is similar to how the
5-star rating methodology treats highly rated plans in connection with
the improvement measure to avoid penalizing consistently high-
performing eligible clinicians: We would calculate a MIPS eligible
clinician's score with the ``improvement measure'' and without, and use
the MIPS eligible clinician's best score. We request comments on these
proposals.
(3) Scoring the Resource Use Performance Category
As we described in section II.E.6.a.1. of this rule, we proposed to
align scoring across the MIPS performance categories. For the resource
use performance category, we propose to score the resource use measures
similarly to the quality performance category. Specifically, we propose
at Sec. 414.1380(b)(2) to assign one to ten points to each measure
based on a MIPS eligible clinician's performance compared to a
benchmark. However, we note that for the resource use performance
category (unlike the quality performance category), the benchmark is
based on the performance period, rather than the baseline period. The
details of the scoring for resource use measures are described below.
(a) Resource Use Measure Benchmarks
For the resource use performance category, we propose at Sec.
414.1380(b)(2) that the performance standard is measure-specific
benchmarks. We would calculate an array of measure benchmarks based on
performance. Then, a MIPS eligible clinician's actual measure
performance during the performance period would be evaluated to
determine the number of points that should be assigned based on where
the actual measure performance falls within these benchmarks.
We propose at Sec. 414.1380(b)(2) to create benchmarks for the
resource use measures based on the performance period. Changes in
payment policies, including changes in relative value units, and
changes that affect how hospitals, clinicians and other health care
providers are paid under Medicare Parts A and B, can make it
challenging to compare resource use in a performance period with a
historical baseline period. In addition, for HVBP and VM, we use the
performance period to establish the benchmarks for scoring HVBP's
efficiency measures and VM's cost measures (80 FR 49562, 80 FR 71280).
If we use the performance period, we would publish the benchmark
methodology in a final rule, but would not be able to publish the
actual numerical benchmarks in advance of the performance period. We
believe that it is important for MIPS eligible clinicians to know in
advance how they might be scored and can track their performance so we
would continue to provide performance feedback with information on the
MIPS eligible clinician's relative performance.
We considered an alternative to base the resource use performance
category measure benchmarks on the baseline period proposed in section
II.E.6.a.1.c., rather than the performance period. This option would
further align the resource use performance category benchmark
methodology with the quality performance category benchmark
methodology. This option would also allow us to publish the numerical
benchmarks before the performance period ends; however, we believe the
benefits of earlier published benchmarks are more limited for resource
use measures. MIPS eligible clinicians would not be able to track their
daily progress because they would not have all the necessary
information to determine the attribution, price standardization, and
otherwise adjust the measures. We believe the relative performance that
we provide through
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feedback reports would provide MIPS eligible clinicians the information
they need to track performance and to learn about their resource
utilization. In addition, we believe that using benchmarks based in the
performance period is a better approach than using benchmarks based in
the baseline period because different payment policies could apply
during the baseline period than during the performance period which
could affect a MIPS' eligible clinician's resource use. We would also
have to identify the baseline benchmark and trend it forward so that
the dollars in the baseline period are comparable to the performance
period, whereas we would not have to make a trending adjustment for
benchmarks based on the performance period. For these reasons, we
elected to propose to base the benchmarks on the performance period
rather than the baseline period.
We propose to create a single set of benchmarks for each measure
specified for the resource use performance category. All MIPS eligible
clinicians that are attributed sufficient cases for the measure would
be included in the same benchmark. In addition, we would require a
minimum of 20 MIPS eligible clinicians or groups to be attributed the
case minimum in order to develop the benchmark. If a measure does not
have enough eligible clinicians or groups that are attributed enough
cases to create a benchmark, then we would not include that measure in
the scoring for the resource use performance category.
We request comment on the proposal to establish resource use
measure benchmarks based on the performance period as well as the
alternative proposal.
(b) Assigning Points Based on Achievement
For each set of benchmarks, we propose to calculate the decile
breaks based on measure performance during the performance period and
assign points for a measure based on which benchmark decile range the
MIPS eligible clinician's performance on the measure is between. We
propose that for resource use measures, lower costs represent better
performance. In other words, MIPS eligible clinicians in the top decile
would have the lowest resource use. We propose to use a methodology
generally consistent with the methodology proposed for the quality
performance category. We refer readers to Tables 21 and 22 for details
on assigning points based on decile distribution. We request comments
on the methodology for assigning points based on performance period
deciles for the resource use performance category and solicit comments
on alternative methodologies for assigning points for performance under
this performance category for future rulemaking.
Table 21 illustrates an example of using decile points along with
partial points to assign achievement points for a sample resource use
measure.
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(c) Case Minimum Requirements
We seek to ensure that MIPS eligible clinicians are measured
reliably; therefore, we proposed in section II.E.5.e.3. to establish a
20 case minimum for each resource use measure. We note that this would
include the Medicare Spending Per Beneficiary (MSPB) measure. In the CY
2016 PFS final rule, we finalized a policy that increases the required
case minimum for MSPB from 20 to 125 cases (80 FR 71295-71296).
However, due to the proposed changes to the MSPB measure, discussed in
section II.E.5.e.(3)(a)., we believe we can appropriately use a
required case minimum of 20 for the revised MSPB measure. Refer to
section II.E.5.e.(3) for our rationale for this proposal.
(d) Calculating the Resource Use Performance Category Score
To calculate the resource use performance category score, we
propose at Sec. 414.1380(b)(2)(iii) to average all the scores of all
the resource use measures attributed to the MIPS eligible clinician.
All measures in the resource use performance category as described in
section II.E.5.e would be weighted equally. If a MIPS eligible
clinician has only one resource use measure with a required case
minimum to be scored, we would score that measure accordingly, and the
MIPS eligible clinician's resource use performance category score would
consist of the score for that one measure. We note that MIPS eligible
clinicians cannot receive a zero score for any resource use measure for
failure to submit the measure since none of the resource use
performance category measures are submitted by MIPS eligible
clinicians. Rather, these measures are attributed to MIPS eligible
clinicians through claims data. However, if a MIPS eligible clinician
is not attributed any resource use measures (for example, because the
case minimum requirements have not been met for any measure or there is
not a sufficient number of MIPS eligible clinicians to create a
benchmark for any measure), then a resource use performance category
score would not be calculated. Refer to section II.E.6.b for details on
how we propose to address scenarios where a performance category score
is not calculated for a MIPS eligible clinician. MIPS eligible
clinicians would receive performance feedback as
[[Page 28261]]
required under section 1848(q)(12) of the Act and discussed in section
II.E.8.a of this proposed rule. Over time, performance feedback may
include a list of attributed cases for each measure by MIPS eligible
clinician. We request comment on our proposals to calculate the
resource use performance category score.
Table 22 illustrates a sample scoring methodology for a limited set
of measures. A MIPS eligible clinician is attributed resource use
measures as described above and receives a score for measures where the
eligible clinician has a sufficient number of cases attributed.
The MIPS eligible clinician described in Table 22 did not have the
required case minimum for Measure 4 (Episode 2), and therefore is not
scored on this measure. Similarly, the MIPS eligible clinician was not
attributed any cases for Measure 5 (Episode 3) and was not scored on
the measure. Measures that do not meet the required case minimum are
not used for scoring.
[GRAPHIC] [TIFF OMITTED] TP09MY16.025
In the example above, making the assumption that all measures
listed have a median performance falling between the fifth and sixth
deciles and would provide a score of six points, the MIPS eligible
clinician with a value above the median would receive a score lower
than six points. For example, Measure 1 has a performance of $15,000
which is higher than the median performance of $13,000, therefore the
number of points assigned (4.0) is lower than six points.
Based on the resource use measures available for scoring, the MIPS
eligible clinician is scored against the total number of points
available. The resource use performance category score for this
eligible clinician is (22.3 performance points/40 possible points) =
55.8 percent.
Unlike the quality performance category score, we are not proposing
bonus points as part of the resource use performance category score.
(4) Scoring the CPIA Performance Category
Section 1848(q)(5)(C) of the Act outlines specific scoring rules
for the CPIA performance category. Section 1848(q)(5)(C)(i) of the Act
provides that a MIPS eligible clinician who is in a practice that is
certified as a patient-centered medical home or comparable specialty
practice with respect to a performance period shall receive the highest
potential score for the CPIA performance category for such period.
Section 1848(q)(5)(C)(ii) of the Act provides that MIPS eligible
clinicians participating in an APM with respect to a performance period
shall earn a minimum score of one-half of the highest potential score
for the CPIA performance category for such period. We refer readers to
section II.E.5.h of this preamble for a description of the APM scoring
standard. Section 1848(q)(5)(C)(iii) of the Act states that MIPS
eligible clinicians are not required to perform activities in each
subcategory or participate in an APM in order to receive the highest
possible score for the CPIA performance category. Based on these
criteria, we propose a scoring methodology that assigns points for the
CPIA performance category (based on patient-centered medical home
participation and the CPIAs reported by the MIPS eligible clinician). A
MIPS eligible clinician's performance would be evaluated by comparing
the reported CPIAs to the highest possible score.
(a) Assigning Points to Reported CPIAs
CPIA is a new performance category that has not been implemented in
our previous programs. Therefore, in year 1, we cannot assess how well
the MIPS eligible clinician has performed on the activity against data
from a baseline year. We can only assess whether the MIPS eligible
clinician has participated sufficiently to receive credit in the CPIA
performance category. Therefore, we propose at Sec. 414.1380(b)(3) to
assign points for each reported activity within two categories: Medium-
weighted and high-weighted activities. Medium-weighted activities are
worth 10 points. High-weighted activities are worth 20 points. Table 23
lists all of the proposed CPIAs that are high-weighted. All other
activities not listed as high-weighted activities would be considered
medium activities. Table H in the Appendices provides the CPIA
Inventory of all activities, both medium-weighted and high-weighted.
Consistent with our unified scoring system principles, MIPS eligible
clinicians would know in advance how many potential points they could
receive for each CPIA.
Activities are proposed to be weighted as high based on the extent
to which they align with activities that support the patient-centered
model home, since that is the standard under section 1848(q)(5)(C)(i)
of the Act for achieving the highest potential score for the CPIA
performance category, as well as with CMS priorities for transforming
clinical practice. Additionally, activities that require performance of
multiple actions, such as participation in the
[[Page 28262]]
Transforming Clinical Practice Initiative, participation in a MIPS
eligible clinician's state Medicaid program, or an activity identified
as a public health priority (such as emphasis on anticoagulation
management or utilization of prescription drug monitoring programs) are
justifiably weighted as high. We seek comment on which activities
should receive a high weight as opposed to a medium weight.
We also considered an approach of equal weighting for all CPIAs. We
seek comment on a multi-tier weighting approach such as low, medium and
high activity categories for future years of MIPS.
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(b) CPIA Performance Category Highest Potential Score
Although there is variability in the level that each MIPS eligible
clinician would perform a CPIA, we currently do not have a standard way
of measuring that variability. In future years, we plan to capture data
to begin to develop a baseline for measuring CPIA improvement. Because
we cannot measure variable performance within a CPIA, we propose at
Sec. 414.1380(b)(3)(v) to compare the points associated with the
reported activities against the highest potential score. We propose the
highest potential score to be 60 points for the CY 2017 performance
period given the following rationale.
Based on discussions with several high performing organizations, we
believe that MIPS eligible clinicians would be able to report on as
many as six activities of medium weight. Examples of these
organizations include one that led a major redesign of patient workflow
after Hurricane Katrina, implementing clinical practice improvements to
ensure patients receive faster treatment in the event of future
disasters, ranked nationally in 6 adult specialties and high-performing
in 6
[[Page 28266]]
adult specialties; \16\ a second that was recognized by a leading
medical association that achieved: 6.7 percent 30-day all cause
readmissions, 42 percent fewer ED visits with implementation of a 60-
day intensive home care program, costs of 15 percent-28 percent below
regional average and significant improvement in patient surveys from
CAHPS; \17\ and a third recognized as a leader in rural health with the
highest award for excellence from the National Rural Primary Care
Association.
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\16\ U.S. News and World Report 2015-2016 Best Hospitals
Ranking. Retrieved from https://www.ochsner.org/patients-visitors/about-us/outcomes-and-honors/us-news-and-world-report.
\17\ California Association of Physicians Groups in Medicare
Advantage (2014). Retrieved from http://www.ehcca.com/presentations/capgma1/cohen_b2.pdf.
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We also believe that a top performing small practice (consisting of
15 or fewer professionals) or practice in a rural or health
professional shortage area, or a non-patient facing MIPS eligible
clinician would be able to report on at least two activities. In
consideration of special circumstances for these small practices, as
well as practices located in rural areas and in Health Professional
Shortage Areas (HPSAs) or non-patient facing MIPS eligible clinicians,
we propose that the weight for any activity selected would be 30
points. For any MIPS eligible clinician, the maximum total points
achievable in this performance category is 60 points. Based on the
above rationale, we believe it is reasonable to expect all MIPS
eligible clinicians to be able to report CPIAs, and as such, a MIPS
eligible clinician reporting no CPIA would receive a zero score for the
CPIA performance category. We believe this proposal allows us to
capture variation in reporting the CPIA performance category.
(c) Points for Certified Patient-Centered Medical Home or Comparable
Specialty Practice
Section 1848(q)(5)(C)(i) of the Act specifies that a MIPS eligible
clinician who is in a practice that is certified as a patient-centered
medical home or comparable specialty practice, as determined by the
Secretary, with respect to a performance period must be given the
highest potential score for the CPIA performance category for the
performance period. We propose that patient-centered medical home
practices are those that have received accreditation from any of the
following four nationally recognized accreditation organizations (the
Accreditation Association for Ambulatory Health Care, the National
Committee for Quality Assurance (NCQA), The Joint Commission, and the
Utilization Review Accreditation Commission (URAC)); \18\ or are a
Medicaid Medical Home Model or Medical Home Model. We propose that
CMS's proposed comparable specialty practices are those that include
the NCQA Patient-Centered Specialty Recognition. We refer readers to
section II.F. of this proposed rule for further description of the
Medicaid Medical Home Model or Medical Home Model. The four
accreditation organizations listed above all have evidence of being
used by a large number of medical organizations as the model for their
patient-centered medical home and are national in scope. No other
criteria are required for receiving recognition as a certified patient
patient-centered medical home or comparable specialty practice except
for being recognized by one of the above organizations.
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\18\ The name was officially shortened to URAC in 1996.
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Section II.E.5.f. of this rule outlines the policy for certified
patient-centered medical homes. The organizations identified above
maintain a list of certified patient-centered medical homes, including
the Medicaid Medical Home and Medical Home Models, that would be used
to determine whether a MIPS eligible clinician qualifies for the
highest potential score for the CPIA performance category because the
MIPS eligible clinician is in a certified patient-centered medical
home. NCQA maintains a list of practices that have received the
Patient-Centered Specialty Recognition which would be used to determine
whether a MIPS eligible clinician qualifies for the highest potential
score for the CPIA performance category because the MIPS eligible
clinician is in a comparable specialty practice.
We propose at Sec. 414.1380(b)(3) that a MIPS eligible clinician
who is in a practice that is certified as a patient-centered medical
home, including a Medicaid Medical Home or Medical Home Model, or
comparable specialty practice in accordance with those proposals would
receive the highest potential score (in accordance with section
1848(q)(5)(C)(i) of the Act) of 60 points for the CPIA performance
category.
(1) Section II.E.5.f. of this rule presents the CMS Study on CPIA
and Measurement. Given the burden for participants completing the year-
long study and the value of collectively examining innovation and
practice activities to improve clinical quality data submissions and
further reduce time requirements for eligible clinicians and groups to
report, we propose that MIPS eligible clinicians and groups that
successfully participate and submit data to fulfill study requirements
would receive the highest potential score of 60 points for the CPIA
performance category.
(d) Calculating the CPIA Performance Category Score
To determine the CPIA performance category score, we propose to sum
the points for all of the MIPS eligible clinician's reported activities
and divide by the proposed CPIA performance category highest potential
score of 60. A perfect score would be 60 points divided by 60 possible
points, which equals 100 percent. If MIPS eligible clinicians have more
than 60 CPIA points, then we propose to cap the resulting CPIA
performance category score at 100 percent.
Table 24 illustrates a sample scoring methodology for the CPIA
performance category. The MIPS eligible clinician below was not an APM
participant and does not immediately earn the minimum score of one-half
of the highest potential score or 30 points that are available for APM
participation. The MIPS eligible clinician below completed two high-
weighted activities worth 20 points each and two medium-weighted
activities for 10 points each in order to receive the maximum 60 points
available in the performance category for a CPIA performance category
score of 100 percent.
[[Page 28267]]
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Alternatively, the MIPS eligible clinician could have selected
three high-weighted activities for 20 points each, six medium-weighted
activities for ten points each, or some combination to reach 60 points.
The score however is capped at 100 percent (60/60). This means that a
MIPS eligible clinician who selects four high-weight activities (80
possible points) would still be given a score of 100 percent (60/60).
Section 1848(q)(2)(B)(iii) of the Act requires the Secretary to
give consideration to the circumstances of small practices (consisting
of 15 or fewer professionals) and practices located in rural areas and
in geographic health professional shortage areas (HPSAs) (as designated
under section 332(a)(1)(A) of the Public Health Service Act) in
defining activities. Section 1848(q)(2)(C)(iv) of the Act also requires
the Secretary to give consideration to non-patient-facing MIPS eligible
clinicians. Further, section 1848(q)(F)(5) of the Act allows the
Secretary to assign different scoring weights for measures, activities,
and performance categories, if there are not sufficient measures and
activities applicable and available to each type of eligible clinician.
For MIPS eligible clinicians and groups that are small practices
(consisting of 15 or fewer professionals), practices located in rural
areas, practices located in geographic HPSAs, or non-patient facing
MIPS eligible clinicians or non-patient facing MIPS eligible clinician
groups, we propose alternative scoring requirements for the CPIA
performance category. The rationale for this alternative scoring is
grounded in the resource constraints these MIPS eligible clinicians
face which was further discovered during listening sessions with small,
rural and geographic HPSAs and medical societies for non-patient facing
MIPS eligible clinicians and groups. We believe that while non-patient
facing MIPS eligible clinicians and non-patient facing groups could
select activities from some sub-categories (such as care coordination
and patient safety), for other sub-categories (such as beneficiary
engagement and population management) non-patient facing MIPS eligible
clinicians and groups will need to consider novel practice activities
that are within their scope and can improve beneficiary care. We will
continue to work with non-patient facing MIPS eligible clinician
professional organizations to further develop activities relevant for
these clinicians in future years. Our rationale for small practices and
practices located in rural areas and in HPSAs is grounded in the
resource constraints that these MIPS eligible clinicians face. This
rationale is especially compelling given that each activity requires at
least 90 days and may not necessarily be conducted in parallel, with
time allocated to pre-planning and post-planning, which would impact
the practice's limited resources.
All MIPS eligible clinicians would be allowed to self-identify as
part of an APM, a patient-centered medical home or comparable specialty
practice, a Medicaid Medical Home or Medical Home Model, a non-patient
facing professional, a small practice (consisting of 15 or fewer
professionals), a practice located in a rural area, or a practice in a
geographic HPSA or any combination thereof as applicable during
attestation following the performance period. We refer readers to
https://innovation.cms.gov/Medicare-Demonstrations/Medicare-Medical-Home-Demonstration.html for more information on the Medical Home Model.
We would validate these self-identifications as appropriate. We
propose that the following scoring would apply to MIPS eligible
clinicians who are a non-patient facing professional, a small practice
(consisting of 15 or fewer professionals), a practice located in a
rural area, or practice in a geographic HPSA or any combination
thereof:
Reporting of one medium-weighted or high-weighted activity
would result in 50 percent of the highest potential score.
Reporting of two medium-weighted or high-weighted
activities would result in 100 percent of the highest potential score.
In future years, we may adjust the weighting of activities at the
MIPS eligible clinician level based on initial patterns of CPIA
reporting. For example, if a MIPS eligible clinician reports on the
same medium-weighted activity over several performance periods, in a
subsequent year that MIPS eligible clinician may not be allowed to
continue to select that same activity. This is because the intent of
the CPIA performance category is to demonstrate improvement over time
and not just demonstrate same benefit from year to year. For example,
continuing to provide expanded practice access does not demonstrate
improvement over time. Further, should the weighting of activities
change in future years, we may also adjust the CPIA performance
category point target accordingly. We request comment on our proposed
approach to score the CPIA performance category. We also seek comment
on alternative methodologies for the CPIA performance category. We seek
to assure equity in scoring MIPS eligible clinicians while still
considering activity variation, impact and burden.
(5) Scoring the Advancing Care Information Performance Category
We refer readers to section II.E.5.g.6. for our proposed
methodology for scoring the advancing care information performance
category. We reiterate that this methodology has many of the features
of the unified scoring system described above. Specifically, we are
moving away from the ``all-or-nothing'' scoring approach of the
Medicare EHR Incentive Program. In addition, MIPS
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eligible clinicians would know in advance what they have to do to
achieve points under the advancing care information performance
category in MIPS. We provide a brief summary of our proposed scoring
methodology here.
In the advancing care information performance category, we propose
to score for both participation and performance. We refer to these
scoring methods as the ``base score'' and the ``performance score''.
To earn points toward the base score, a MIPS eligible clinician or
group must report the numerator and denominator (or yes/no statement as
applicable) for certain measures adopted by the EHR Incentive Programs
in the 2015 EHR Incentive Programs Final Rule to achieve 50 percent of
the total advancing care information performance category score. For
measures that previously included a percentage-based threshold, we are
not requiring MIPS eligible clinicians or groups to meet those
thresholds. Instead we propose to require eligible clinicians and
groups to report the numerator (of at least one) and denominator (or a
yes/no statement for applicable measures) for each measure being
reported.
For the base score, MIPS eligible clinicians or groups must meet
Objective 1: Protect Patient Health Information and its associated
measure in 2015 EHR Incentive Programs Final Rule. Additionally,
eligible clinicians would be required to report the numerator and
denominator, or a yes/no statement as appropriate, for each measure for
Electronic Prescribing, Patient Electronic Access to Health
Information, Coordination of Care Through Patient Engagement, Health
Information Exchange, and Public Health and Clinical Data Registry
Reporting-- as adopted in the 2015 EHR Incentive Programs Final Rule.
Failure to meet any of the objectives would result in a base score of
zero and an advancing care information performance category score of
zero.
For the Public Health and Clinical Data Registry Reporting
objective, an eligible clinician or group is only required to report on
the Immunization Registry Reporting measure. Completing any additional
measures under the objective would earn one additional bonus point
after calculation of the performance score.
The performance score is then determined in addition to the base
score. The performance score methodology would implement a decile scale
for the application of additional points based on performance in the
objectives and measures for Patient Electronic Access, Coordination of
Care through Patient Engagement, and Health Information Exchange. There
are eight associated measures under these three objectives; each has a
maximum of ten percentage points available. The total available
performance score would be 80 percent which is, in combination with the
base score of 50 percent, greater than the total possible performance
category score of 100 percent. We have taken this approach in order to
provide flexibility toward achieving the maximum score in the advancing
care information performance category--however, a MIPS eligible
clinician or group's score is capped at 100 percent.
This summary only represents the primary advancing care information
performance category scoring proposal. For full details on the
advancing care information performance category scoring and an
explanation of alternatives considered, as well as accommodation for
eligible clinicians planning to report Modified Stage 2 or use 2014
Edition CEHRT in 2017 please refer to II.E.5.g.4.
b. Calculating the Composite Performance Score (CPS)
Section II.E.6.a. of this rule describes our proposed methodology
for assessing and scoring MIPS eligible clinician performance for each
of the four performance categories. In this section, we propose the
methodology to determine the CPS based on the scores for each of the
four performance categories. We define at Sec. 414.1305 the CPS as a
composite assessment (using a scoring scale of 0 to 100) for each MIPS
eligible clinician for a specific performance period determined using
the methodology for assessing the total performance of each MIPS
eligible clinician according to the performance standards with respect
to the applicable measures and activities for each applicable
performance category. The CPS is the sum of the products of each
performance category score and each performance category's assigned
weight multiplied by 100.
(1) Formula To Calculate the CPS
Section 1848(q)(5)(A) of the Act requires the Secretary to develop
a methodology for assessing the total performance of each MIPS eligible
clinician according to the performance standards with respect to the
applicable measures and activities with respect to each performance
category applicable to such clinician for a performance period, and
using the methodology, provide for a CPS (using a scoring scale of 0 to
100) for each MIPS eligible clinician for the performance period.
Additionally, sections 1848(q)(5)(E) and (F) of the Act address the
weights for each of the performance categories in the CPS.
To create a CPS from 0-100 based on the individual performance
category scores, we propose to multiply the score for each performance
category by the assigned weight for the performance category. We
provide in Table 25 the weights for each performance category for the
2019, 2020 and 2021 MIPS payment years. The resulting weighted
performance category scores would be summed to create a single CPS. As
described in section II.E.2 of this preamble, we propose that the
identifier for MIPS performance would be the same for all four
performance categories, and therefore, the methodology to calculate a
CPS would be the same for both individual and group performance.
The following equation summarizes the proposed CPS calculation at
Sec. 414.1380(c):
CPS = [(quality performance category score x quality performance
category weight) + (resource use performance category score x resource
use performance category weight) + (CPIA performance category score x
CPIA performance category weight) + (advancing care information
performance category score x advancing care information performance
category weight)] x 100.
(a) Accounting for Risk Factors
Section 1848(q)(1)(G) of the Act requires us to consider risk
factors in our scoring methodology. Specifically, that section provides
that the Secretary, on an ongoing basis, shall, as the Secretary
determines appropriate and based on individuals' health status and
other risk factors, assess appropriate adjustments to quality measures,
resource use measures and other measures used under MIPS and assess and
implement appropriate adjustments to payment adjustments, CPSs, scores
for performance categories or scores for measures or activities under
the MIPS. In doing this, the Secretary is required to take into account
the relevant studies conducted and recommendations made in reports
under section 2(d) of the Improving Medicare Post-Acute Transformation
(IMPACT) Act of 2014 and, as appropriate, other information, including
information collected before completion of such studies and
recommendations. HHS' Office of the Assistant Secretary for Planning
and Evaluation (ASPE) is conducting studies and making recommendations
on the issue of risk adjustment for socioeconomic status on quality
measures and resource use as required by section 2(d) of the IMPACT Act
and
[[Page 28269]]
expects to issue a report to Congress by October 2016. We will closely
examine the recommendations issued by ASPE and incorporate them as
feasible and appropriate through future rulemaking. We also note that
several MIPS measures, as appropriate, include risk adjustment in their
measure specifications. For example, outcome measures in the quality
performance category generally have risk adjustment embedded in the
measure calculation specification, while process measures generally do
not. Similarly, in the resource use performance category, the proposed
total per capita costs for all attributed beneficiaries measure is
adjusted for demographic and clinical factors. That measure also has a
specialty adjustment that is applied after the measure calculation to
account for differences in specialty mix within a practice. The MSPB
measure and other resource use measures have different risk adjustments
that are specific to the individual measure. For the first year of
MIPS, for the quality and resource use performance categories, we
propose to use the measure-specific risk adjustment for all measures
(where applicable), as well as the additional specialty adjustment for
the total per capita costs for all attributed beneficiaries.
We invite public comments on this proposal.
(2) CPS Performance Category Weights
(a) General Weights
Section 1848(q)(5)(E)(i) of the Act specifies weights for the
performance categories included in the MIPS CPS: In general, 30 percent
for the quality performance category, 30 percent for the resource use
performance category, 25 percent for the advancing care information
performance category, and 15 percent for the CPIA performance category.
However, that section also specifies different weightings for the
quality and resource use performance categories for the first and
second years for which the MIPS applies to payments. Section
1848(q)(5)(E)(i)(II)(bb) of the Act specifies that for year 1, not more
than 10 percent of the CPS will be based on the resource use
performance category and for year 2, not more than 15 percent will be
based on resource use performance category. Under section
1848(q)(5)(E)(i)(I)(bb) of the Act, the weight of the quality
performance category for each of the first two years will increase by
the difference of 30 percent minus the weight specified for the
resource use performance category for the year.
In previous sections of this rule, we have proposed the performance
category weights for the first MIPS payment year of 2019. In section
II.E.5.e.2., we propose to set the resource use performance category
weight at 10 percent for the 2019 payment year and 15 percent for the
2020 payment year. Correspondingly, in section II.E.5.b.2., we propose
to set the quality performance category weight to 50 percent for the
2019 payment year and 45 percent for the 2020 payment. The quality
performance category weight proposal is based on the 30 percent
required by statute for the quality performance category plus 30
percent minus the weight of the resource use performance category, as
required by section 1848(q)(5)(E)(i)(I)(bb) of the Act. As specified in
section 1848(q)(5)(E)(i) of the Act, the weights for the other
performance categories are 25 percent for the advancing care
information performance category; and 15 percent for the CPIA
performance category. Section 1848(q)(5)(E)(ii) of the Act provides
that in any year in which the Secretary estimates that the proportion
of eligible professionals (as defined in section 1848(o)(5) of the Act)
who are meaningful EHR users (as determined under in section 1848(o)(2)
of the Act) is 75 percent or greater, the Secretary may reduce the
applicable percentage weight of the advancing care information
performance category in the CPS, but not below 15 percent, and adjust
the weighting of the other performance categories. We refer readers to
our proposals concerning section 1848(q)(5)(E)(ii) of the Act in
section II.E.5.g.(6)(e).
Table 25 summarizes the weights specified for each performance
category under section 1848(q)(5)(E)(i) of the Act and in accordance
with our proposals.
[GRAPHIC] [TIFF OMITTED] TP09MY16.030
(b) Flexibility for Weighting Performance Categories
Under section 1848(q)(5)(F) of the Act, if there are not sufficient
measures and activities applicable and available to each type of
eligible clinician involved, the Secretary shall assign different
scoring weights (including a weight of zero) for each performance
category based on the extent to which the category is applicable and
for each measure and activity based on the extent to which the measure
or activity is applicable and available to the type of eligible
clinician involved.
In section II.E.6.a and section II.E.5.g.8., we describe scenarios
where certain MIPS eligible clinicians might not receive a performance
category score in the quality, resource use, or advancing care
information performance categories. We propose that in such scenarios
we would use the authority under section 1848(q)(5)(F) of the Act to
assign a weight of zero to the performance category and redistribute
the weight for that performance category or categories as described in
the next section.
For the quality and resource use performance categories, we believe
having sufficient measures applicable
[[Page 28270]]
and available means that we are able to reliably calculate a score for
the measures that adequately captures and reflects the performance of
the MIPS eligible clinician. For the quality and resource use
performance categories, we propose in sections II.E.6.a.2.d.,
II.E.6.3.a., and II.E.6.a.3.d. that we would not calculate a
performance category score if a MIPS eligible clinician does not have
any measures with the required case minimum or any measures with a
sufficient number of MIPS eligible clinicians to create a benchmark.
Measures that do not meet the required case minimum or a sufficient
number of MIPS eligible clinicians to create a benchmark would be
excluded from scoring, and the MIPS eligible clinician would not
receive a quality or resource use performance category score. (Note,
this situation is different from a MIPS eligible clinician who elects
not to submit any quality measures. A MIPS eligible clinician who
elects not to submit any quality measures would receive a quality
performance category score of zero.) We believe MIPS eligible
clinicians who would have no scored measures for a performance category
under our proposals would not have sufficient measures applicable and
available for that performance category.
For the quality performance category, we anticipate that most MIPS
eligible clinicians would select the measures most relevant to their
practice and that in most cases, the measures they select would meet
the required case minimum. We plan to monitor measure selection trends
under the performance category and will revise this policy if it
appears MIPS eligible clinicians are reporting measures that are not
relevant to their practice or measures that do not meet the required
case minimum. In the resource use performance category, we believe MIPS
eligible clinicians who are not attributed enough cases to be reliably
measured should not be scored for the performance category. We have
proposed to include many resource use measures that we believe are
sufficiently developed and ready for evaluating resource use by MIPS
eligible clinicians; however, if a MIPS eligible clinician is not
attributed any (or very few) cases for the measure, then we do not
believe the MIPS eligible clinician should be measured on performance.
We refer readers to section II.E.5.g.8. of this proposed rule for a
detailed discussion of the scenarios in which a MIPS eligible clinician
may not have sufficient measures applicable and available under the
advancing care information performance category. For the CPIA
performance category, however, we envision that all MIPS eligible
clinicians would have sufficient activities applicable and available
and do not propose any scenario where a MIPS eligible clinician would
not receive a CPIA performance category score.
In addition to scenarios where a MIPS eligible clinician would have
no scored measures for a performance category, we believe there may be
scenarios in which a MIPS eligible clinician would have too few scored
measures under the quality performance category for us to reliably
calculate a performance category score that is worth half the weight of
the CPS for the 2019 MIPS payment year. We propose that if a MIPS
eligible clinician has fewer than three scored quality measures (either
submitted measures or measures calculated from administrative claims
data) for a performance period, we would consider the MIPS eligible
clinician not to have a sufficient number of measures applicable and
available for the 2019 MIPS payment year quality performance category
weight and would therefore lower the weight of the quality performance
category. In this situation, the MIPS eligible clinician has a quality
performance category score, but has data for only one or two scored
measures, which is not a sufficient number of measures for the quality
performance category because the quality performance category would
constitute half of the CPS for the 2019 MIPS payment year. In addition,
as described in the next section, for MIPS eligible clinicians that are
not scored on the resource use or advancing care information
performance category, we propose to increase the weight of the quality
performance category. For these reasons, we believe that for the first
year of MIPS, the quality performance category requires a sufficient
number of measures to justify its weight in the CPS. We will reconsider
this policy in future years as the weights for the performance
categories change. We may consider implementing a similar policy for
the resource use performance category for future years, but not for the
first year of MIPS based upon the lower weighting of the resource use
performance category.
In section II.E.5.b., we are proposing for the quality performance
category, generally, that MIPS eligible clinicians submit a minimum of
six measures for scoring in MIPS. In addition, we propose to include up
to three population-based measures derived from claims data. As
described in section II.E.6.a.2., a MIPS eligible clinician may submit
a measure that is not scored, either because the measure did not meet
the required case minimum to be reliably measured or because fewer than
20 MIPS eligible clinicians with sufficient volume submitted a measure
through a similar reporting mechanism and a benchmark could not be
created for the performance or baseline period. We reiterate that a
measure that is not scored due to not meeting the required case minimum
or lack of a measure benchmark, is different than a required measure
that is not reported. Any required measure that is not reported or
reported with in a way that does not meet the data completeness
requirements would receive a score of zero points and would be
considered a scored measure.
We are concerned that if a large percentage of the expected
measures are not able to be scored due to not meeting the required case
minimums or a missing benchmark, then just one or two measures would
contribute disproportionately to the CPS because the quality
performance category score is worth 30 to 50 percent (depending on the
year) of the CPS under section 1848(q)(5)(E)(i) of the Act. We do not
believe a score for one or two quality measures can capture all the
elements of quality performance during a performance period. We believe
the lack of a sufficient number of measures for scoring limits the
value of quality performance measurement toward the CPS. Therefore, we
propose that if a MIPS eligible clinician has only two scored measures
(including both submitted measures and measures derived from
administrative claims data) to reduce the weight of the quality
performance category by one-fifth (for example, from 50 percent to 40
percent in year 1) and redistribute the weight (for example, 10 percent
in year 1) proportionately to the other performance categories for
which the MIPS eligible clinician did receive a performance category
score. If a MIPS eligible clinician has only one scored quality
measure, then we propose to reduce the weight of the quality
performance category by two-fifths (for example, from 50 percent to 30
percent in year 1) and redistribute the weight (for example, 20 percent
in year 1) proportionately to the other performance categories for
which the MIPS eligible clinician did receive a performance category
score. Lowering the weight of the quality performance category would be
consistent with the relatively low percentage of expected quality
measures that are able to be scored.
We request comment on these proposals to identify MIPS eligible
clinicians without sufficient measures and activities applicable and
available
[[Page 28271]]
and our proposals to reweight those performance categories. We also
seek comment on alternative methods for reweighting performance
categories for MIPS eligible clinicians without sufficient measures and
activities in certain performance categories. We seek to ensure that
reweighting would not cause an eligible clinician to be either
advantaged or disadvantaged due to a lack of sufficient measures and
activities applicable and available, and a corresponding inability to
generate a score for a certain performance category.
(c) Redistributing Performance Category Weights
We propose at Sec. 414.1380(c)(3) to reweight the performance
categories for MIPS eligible clinicians when there are not sufficient
measures and activities applicable and available to them. We propose to
reweight the performance categories in the following situations.
If the MIPS eligible clinician does not receive a resource use or
advancing care information performance category score, and has at least
three scored measures (either submitted measures or those calculated
from administrative claims) in the quality performance category, then
we propose to reassign the weights of the performance categories
without a score to the quality performance category. We believe this
policy is appropriate for several reasons. First, section
1848(q)(5)(E)(i)(I)(bb) of the Act redistributes weight from the
resource use performance category to the quality performance category
in the first two years of MIPS. This proposal is consistent with that
redistribution logic. In addition, MIPS eligible clinicians have
experience reporting quality measures through the PQRS program and
measurement in this performance category is more mature. Finally, for
the 2019 MIPS payment year, quality performance would be worth at least
half of the CPS. By requiring the MIPS eligible clinician to have at
least three scored quality measures, we believe the quality performance
category would be robust enough to support more weight reassigned to it
than other performance categories. We may revisit this policy in future
years as the weight for the resource use performance category increases
and the weight for the quality performance category decreases.
We also propose an alternative that does not reassign all the
weight to the quality performance category, but rather reassigns the
weight proportionately to each of the other performance categories for
which the MIPS eligible clinician has received a performance category
score.
We request public comments on the proposal to reassign the weights
to the quality performance category, as well as the alternate proposal
to redistribute proportionately to other performance categories.
If the MIPS eligible clinicians have fewer than three scored
measures in the quality performance category score, then we propose to
reassign the weights for the performance categories without scores
proportionately to the other performance categories for which the MIPS
eligible clinician has received a performance category score. We
request comment on this proposal.
Finally, because the CPS is a composite score, we believe the
intention of section 1848(q)(5) of the Act is for MIPS eligible
clinicians to be scored based on multiple performance categories.
Basing a CPS on a single performance category, even a robust and
familiar performance category like quality, would frustrate that
intent. In our proposals, CPIA is the only performance category which
would always have a performance category score. We are particularly
concerned about the possibility that a MIPS eligible clinician might,
for the reasons discussed above, not have sufficient measures
applicable and available for the quality, resource use, and advancing
care information performance categories, and would only receive a score
for the CPIA performance category. The CPIA performance category is
based on activities that are reported by attestation, not on measured
performance. In addition, because CPIA is not as mature as the other
performance categories, each of which include certain aspects of
existing CMS programs, we are unsure how much variation we will have in
the CPIA performance category. We do not think it would be equitable to
allow MIPS eligible clinicians that attest to receive the maximum
points for that performance category and then base the CPS solely on
the CPIA performance category. Such a scenario may result in higher CPS
and payment adjustment factors for some MIPS eligible clinicians based
solely on the CPIA performance category, while other MIPS eligible
clinicians are measured based on their performance under the other
performance categories. Therefore, we propose that if a MIPS eligible
clinician receives a score for only one performance category, we would
assign the MIPS eligible clinician a CPS that is equal to the
performance threshold described in section II.E.5., which means the
eligible clinician would receive a MIPS adjustment factor of 0 percent
for the year. We anticipate this proposal would affect very few MIPS
eligible clinicians in year 1 and even fewer in future years as more
eligible clinicians are able to report on and receive scores for more
of the performance categories.
We welcome public comment on this proposal.
7. MIPS Payment Adjustments
a. Payment Adjustment Identifier and CPS Used in Payment Adjustment
Calculation
i. Payment Adjustment Identifier
As we describe in section II.E.2 of this preamble, we propose to
allow MIPS eligible clinicians to measure performance as an individual,
as a group defined by TIN, or as an APM Entity group using the APM
scoring standard, yet for purposes of the application of the MIPS
adjustment factors to payments in accordance with section 1848(q)(6)(E)
of the Act (referred to as the payment adjustment), we are proposing to
use a single identifier, TIN/NPI, for all MIPS eligible clinicians,
regardless of whether the TIN/NPI was measured as an individual, group
or APM Entity group. In other words, a TIN/NPI may receive a CPS based
on individual, group, or APM Entity group performance, but the payment
adjustment would be applied at the TIN/NPI level.
We are proposing to use the single identifier, TIN/NPI, for the
payment adjustment for a few reasons. First, the final eligibility
status of some clinicians would not be known until after the
performance period ends. For example, the calculations to determine
which clinicians would be excluded from MIPS, such as identifying
clinicians that are QPs or are below the low-volume threshold, occur
after the performance period ends. Using TIN/NPI would allow us to
correctly identify which TIN/NPIs are still MIPS eligible clinicians
after the exclusion criteria have been applied.
Second, the identifiers for measurement are not mutually exclusive
and using TIN/NPI to apply the payment adjustment would allow us to
resolve any inconsistencies that arise from the measurement
identifiers. For example, a TIN may have 40 percent of its eligible
clinicians participating in a MIPS APM and the remaining 60 percent are
not participating in any APM. The TIN elects to submit performance
information for all the eligible clinicians in the TIN, including those
that are participating in the MIPS APM, so that it can ensure all of
its eligible clinicians are being measured in MIPS. We cannot simply
use the APM
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Entity and TIN identifiers because we either have eligible clinicians
with duplicative data and overlapping scores, or we have portions of
the measurement identifier carved out if we eliminate the overlap. In
our example, the eligible clinicians participating in the MIPS APM
would have data for two CPSs (one based on the APM Entity group
performance and one based on the group TIN performance). The eligible
clinicians not participating in the MIPS APM would have only one CPS
(one based on the group TIN performance). Applying the payment
adjustment at the TIN/NPI level provides us the flexibility to
correctly identify and resolve the conflicts emerging when measurement
identifiers overlap. The TIN/NPI identifier is mutually exclusive on
all of our measurement identifier options; therefore, we believe this
identifier can be consistently used for individual, group, or APM
scoring standard identifiers. We refer readers to section II.E.2 for a
discussion of identifiers and our proposals related to them.
ii. CPS Used in Payment Adjustment Calculation
Because we are proposing to use only TIN/NPI to apply the MIPS
payment adjustments and because there is a gap between the performance
period and the MIPS payment year, we believe we should assign the
historical CPS to each TIN/NPI that is subject to MIPS for the payment
year.
In general, we propose to use the CPS associated with the TIN/NPI
combination in the performance period. For groups submitting data using
the TIN identifier, we propose to apply the group CPS to all the TIN/
NPI combinations that bill under that TIN during the performance
period. For individual MIPS eligible clinicians submitting data using
TIN/NPI, we propose to use the CPS associated with the TIN/NPI that is
used during the performance period. For eligible clinicians in MIPS
APMs, we propose to assign the APM Entity group's CPS to all the APM
Entity Participant Identifiers that are associated with the APM Entity
on December 31 of the performance period. We refer readers to section
II.E.5.h for more information about the process to identify
participating APM Entities. For eligible clinicians that participate in
APMs for which the APM scoring standard does not apply, we propose to
assign a CPS using either the individual or group data submission
assignments described above.
In the case where a MIPS eligible clinician starts working in a new
practice or otherwise establishes a new TIN that did not exist during
the performance period, there would be no corresponding historical
performance information or CPS for the new TIN/NPI. Because we want to
connect actual performance to the individual MIPS eligible clinician as
often as possible, in cases where there is no CPS associated with a
TIN/NPI from the performance period, we propose to use the NPI's
performance for the TIN(s) the NPI was billing under during the
performance period. If the MIPS eligible clinician has only one CPS
associated with the NPI from the performance period, then we propose to
use that CPS. For example, if a MIPS eligible clinician worked in one
practice (TIN A) in the performance period, but is working at a new
practice (TIN B) during the payment year, then we would use the CPS for
the old practice (TIN A/NPI) to apply the MIPS payment adjustment for
the NPI in the new practice (TIN B/NPI). This proposal most closely
links the MIPS eligible clinician's performance during the performance
period to the payment adjustment. It also ensures that MIPS eligible
clinicians who qualify for a positive payment adjustment are able to
keep it, even if they change practices. For those who have a negative
payment adjustment, this proposal also ensures MIPS eligible clinicians
are still accountable for their performance.
In scenarios where the MIPS eligible clinician billed under more
than one TIN during the performance period, and the MIPS eligible
clinician starts working in a new practice or otherwise establishes a
new TIN that did not exist during the performance period, we propose to
use a weighted average CPS based on total allowed charges associated
with the NPI from the performance period. This proposal would provide a
CPS that is based on all the services the NPI billed to Medicare during
the performance period. Table 26 presents an example of how this
proposed approach would work. In this example, a MIPS eligible
clinician (NPI) was assigned a CPS for two unique TIN/NPI combinations
from the performance period (TIN A/NPI and TIN B/NPI). In the MIPS
payment year, the eligible clinician is now billing for Medicare
services under a third TIN/NPI combination without a previously
calculated CPS (TIN C/NPI). In this case, the eligible clinician's MIPS
adjustment for payments made to TIN C/NPI would be based on a weighted
average of CPSs for TIN A/NPI and TIN B/NPI.
[GRAPHIC] [TIFF OMITTED] TP09MY16.031
If an NPI did not have any allowed charges in the performance
period, then the clinician would not be included in MIPS due to the
low-volume exclusion.
We also propose an alternative proposal where in lieu of taking the
[[Page 28273]]
weighted average, we take the highest CPS from the performance period,
which would be a CPS of 67.5 in the above example which is the CPS for
TIN A/NPI. We believe the alternative approach rewards eligible
clinicians for their prior performance and may be easier to implement
in year 1 of MIPS. Our concern with this approach is that the highest
CPS may represent a relatively small portion of the eligible
clinician's practice during the performance period.
We request comment on the proposal to use the CPSs associated with
the TIN(s) the NPI was billing under during the performance period when
the TIN/NPI does not have a CPS from the performance period. We also
request comment on our proposal to use a weighted average, and the
alternative proposal to select the highest CPS from the performance
period.
We also considered, but are not proposing, a policy to have the
performance follow the group (TIN) rather than the individual (NPI). In
other words, the MIPS eligible clinician's performance would be based
on the historical performance of the new TIN that the MIPS eligible
clinician moved to after the performance period, even though the MIPS
eligible clinician was not part of this group during the performance
period. This policy is consistent with the policy for the VM and would
create incentives for MIPS eligible clinicians to move to higher
performing practices (77 FR 69308). We also believe this policy would
provide a lower burden for practice administrators as all MIPS eligible
clinicians in the TIN would have the same payment adjustment. On the
other hand, having performance follow the TIN creates some challenges.
We are concerned that MIPS eligible clinicians who earned a positive
adjustment based on their performance during the performance period
would not retain the positive adjustment if the new TIN had a lower
CPS. Finally, we believe that having performance follow the TIN could
create some unanticipated issues with budget neutrality if high-
performing TINs expand. For all of these reasons, we are not proposing
to have performance follow the TIN, but rather have performance follow
the NPI; however, we seek comment on this option.
In some cases, a TIN/NPI could have more than one CPS associated
with it from the performance period, if the eligible clinician
submitted duplicative data sets. In this situation, the MIPS eligible
clinician has not changed practices, rather for example, a MIPS
eligible clinician has a CPS for an APM Entity and a CPS for a group
TIN. If a MIPS eligible clinician has multiple CPSs, we propose a
multi-pronged approach to select the CPS that would be used to
determine the MIPS payment adjustment. First, we propose that if a MIPS
eligible clinician is a participant in MIPS APM, then the APM Entity
CPS would be used instead of any other CPS (such as a group TIN CPS or
individual CPS). We propose that if a MIPS eligible clinician has more
than one APM Entity CPS for the same TIN (by participating in multiple
MIPS APMs), we would apply the highest APM Entity CPS to the eligible
clinician. Second, if a MIPS eligible clinician reports as a group and
as an individual, we would calculate a CPS for the group and individual
identifier and use the highest CPS for the TIN/NPI. We request comment
on this proposed approach.
b. MIPS Adjustment Factors
Section 1848(q)(6)(A) of the Act requires the Secretary to specify
a MIPS adjustment factor for each MIPS eligible clinician for a year
determined by comparing the CPS of the MIPS eligible clinician for such
year to the performance threshold established under paragraph (D)(i)
for such year, in a manner such that the adjustment factors specified
for a year result in differential payments. Section 1848(q)(6)(A)(iii)
of the Act provides that MIPS eligible clinicians with CPS at or above
the performance threshold receive a zero or positive adjustment factor
on a linear sliding scale such that an adjustment factor of 0 percent
is assigned for a CPS at the performance threshold and an adjustment
factor of the applicable percent is assigned for a CPS of 100. Section
1848(q)(6)(A)(iv) of the Act provides that MIPS eligible clinicians
with CPS below the performance threshold receive a negative payment
adjustment factor on a linear sliding scale such that an adjustment
factor of 0 percent is assigned for a CPS at the performance threshold
and an adjustment factor of the negative of the applicable percent is
assigned for a CPS of 0; further, MIPS eligible clinicians with CPS
that are equal to or greater than zero, but not greater than one-fourth
of the performance threshold, receive a negative payment adjustment
factor that is equal to the negative of the applicable percent.
Section 1848(q)(6)(B) of the Act defines the applicable percent for
each year as follows: (i) For 2019, 4 percent; (ii) for 2020, 5
percent; (iii) for 2021, 7 percent; and (iv) for 2022 and subsequent
years, 9 percent.
Section 1848(q)(6)(C) of the Act provides for an additional
positive MIPS adjustment factor for exceptional performance, for each
of the years 2019 through 2024, for each MIPS eligible clinician with a
CPS for a year at or above the additional performance threshold under
paragraph (D)(ii) for such year. The additional MIPS adjustment factor
shall be in the form of a percent and determined in a manner such that
eligible clinicians having higher CPS above the additional performance
threshold receive higher additional MIPS adjustment factors.
c. Determining the Performance Thresholds
(1) Establishing the Performance Threshold
Under section 1848(q)(6)(D)(i) of the Act, for each year of the
MIPS, the Secretary shall compute a performance threshold with respect
to which the CPS of MIPS eligible clinicians are compared for purposes
of determining the MIPS adjustment factors under section 1848(q)(6)(A)
of the Act for a year. The performance threshold for a year must be
either the mean or median (as selected by the Secretary, which may be
reassessed every three years) of the CPS for all MIPS eligible
clinicians for a prior period specified by the Secretary. Section
1848(q)(6)(D)(iii) of the Act outlines a special rule for the initial
two years of MIPS, which requires the Secretary, prior to the
performance period for such years, to establish a performance threshold
for purposes of determining the MIPS adjustment factors under paragraph
(A) and an additional performance threshold for purposes of determining
the additional MIPS adjustment factors under paragraph (C), each of
which shall be based on a period prior to the performance periods and
take into account data available with respect to performance on
measures and activities that may be used under the performance
categories and other factors determined appropriate by the Secretary.
We define the term performance threshold at Sec. 414.1305, as the
level of performance that is established for a performance period at
the CPS level. CPSs above the performance threshold receive a positive
MIPS adjustment factor and CPSs below the performance threshold receive
a negative MIPS adjustment factor. CPSs that are equal to or greater
than 0, but not greater than one-fourth of the performance threshold
receive the maximum negative MIPS adjustment factor for the MIPS
payment year. CPSs at the performance threshold
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receive a neutral MIPS adjustment factor.
To establish the performance threshold for the 2019 MIPS payment
year, we propose to model 2014 and 2015 Part B allowed charges, 2014
and 2015 PQRS data submissions, 2014 and 2015 QRUR and sQRUR feedback
data, and 2014 and 2015 Medicare and Medicaid EHR Incentive Program
data to inform where the performance threshold should be. We would use
this data to estimate the impact of the quality and resource use
scoring proposals. We would also use the EHR Incentive Program
information to estimate which MIPS eligible clinicians are likely to
receive points for the advancing care information performance category.
Because of the lack of historical data for the CPIA performance
category, we would apply some sensitivity analyses to help inform where
the performance threshold should be.
For the 2019 MIPS payment year, we propose to set the performance
threshold at a level where approximately half of the eligible
clinicians would be below the performance threshold and half would be
above the performance threshold, which we believe is consistent with
the intent of section 1848(q)(6)(D)(i) of the Act which requires the
performance threshold in year 3 and beyond to be equal to the mean or
median of CPS from a prior period. We also considered other policy
options when setting the performance threshold. For example, we
considered setting the performance threshold so that the scaling factor
(which is described in section II.E.7.b) is 1.0. We could set the
performance threshold based on policy goals to ensure a minimum number
of points are earned before an eligible clinician is able to receive a
positive adjustment factor and potentially an additional adjustment
factor for exceptional performance. We seek comment on the policy
options for setting the performance threshold.
We would determine the performance threshold in accordance with the
methodology established in the final rule. We intend to publish the
performance threshold on the CMS Web site prior to the performance
period.
(2) Additional Performance Threshold for Exceptional Performance
In addition to the performance threshold, section 1848(q)(6)(D)(ii)
of the Act requires the Secretary to compute, for each year of the
MIPS, an additional performance threshold for purposes of determining
the additional positive MIPS adjustment factors for exceptional
performance under paragraph (C). For each such year, the Secretary
shall apply either of the following methods for computing the
additional performance threshold: (1) The threshold shall be the score
that is equal to the 25th percentile of the range of possible CPS above
the performance threshold determined under section 1848(q)(6)(D)(i) of
the Act; or (2) the threshold shall be the score that is equal to the
25th percentile of the actual CPS for MIPS eligible clinicians with CPS
at or above the performance threshold with respect to the prior period
described in section 1848(q)(6)(D)(i) of the Act.
We define at Sec. 414.1305 the additional performance threshold as
an additional level of performance, in addition to the performance
threshold, for a performance period at the CPS level at or above which
a MIPS eligible clinician may receive an additional positive MIPS
adjustment factor. For each year of the MIPS, we will compute an
additional performance threshold for purposes of determining the
additional MIPS adjustment factors under section 1848(q)(6)(C) of the
Act. We propose at Sec. 414.1405(e) the following methods for
computing the additional performance threshold: the threshold shall be
equal to the 25th percentile of the range of possible CPS above the
performance threshold; or it shall be equal to the 25th percentile of
the actual CPS for MIPS eligible clinicians with CPS at or above the
performance threshold with respect to the prior period used to
determine the performance threshold.
As discussed above, section 1848(q)(6)(D)(iii) of the Act outlines
a special rule for establishing the additional performance threshold
for the initial two years of MIPS. Because 2019 is the first MIPS
payment year, we do not have any actual CPS for MIPS eligible
clinicians to use for purposes of defining an additional performance
threshold under the methodology proposed above. Therefore, we propose
to establish the additional performance threshold at the 25th
percentile of the range of possible CPS above the performance
threshold. For example, if the performance threshold is 60, then the
range of possible CPS above the performance threshold would be 61-100.
The 25th percentile of those possible values is 70. We intend to
publish the exceptional performance threshold with the performance
threshold prior to the performance period.
d. Scaling/Budget Neutrality
Section 1848(q)(6)(F)(i) of the Act provides, with respect to
positive MIPS adjustment factors for eligible clinicians whose CPS is
above the performance threshold under paragraph (D)(i) for such year,
the Secretary shall increase or decrease such adjustment factors by a
scaling factor (not to exceed 3.0) in order to ensure that the budget
neutrality requirement of clause (ii) is met. Stated generally, budget
neutrality as required by section 1848(q)(6)(F)(ii) of the Act means
the estimated increase in the aggregate allowed charges resulting from
the application of positive MIPS adjustment factors under paragraph (A)
(after application of the scaling factor) is equal to the estimated
decrease in the aggregate allowed charges resulting from the
application of negative MIPS adjustment factors under paragraph (A).
Under section 1848(q)(6)(F)(iii) of the Act, budget neutrality
requirements shall not apply if all MIPS eligible clinicians receive
CPS for a year that are below the performance threshold under paragraph
(D)(i) for such year, or if the maximum scaling factor (3.0) is applied
for a year.
e. Additional Adjustment Factors
Section 1848(q)(6)(C) of the Act requires, for each of the years
2019 through 2024, the Secretary to specify an additional positive MIPS
adjustment factor for each MIPS eligible clinician whose CPS for a year
is at or above the additional performance threshold established under
paragraph (D)(ii) for that year. This additional adjustment factor is
required to take the form of a percentage and to be determined by the
Secretary such that MIPS eligible clinicians with higher CPS above the
additional performance threshold receive higher additional MIPS
adjustment factors. Section 1848(q)(6)(F)(iv)(I) of the Act provides,
in specifying the additional adjustment factors under paragraph (C) for
each applicable MIPS eligible clinician for a year, the Secretary shall
ensure that the estimated aggregate increase in payments under Part B
resulting from the application of such additional adjustment factors
shall be equal to $500,000,000 for each year beginning with 2019 and
ending with 2024. We refer to the $500,000,000 increase in payments as
aggregate incentive payments. Section 1848(q)(6)(F)(iv)(II) of the Act
provides that the additional adjustment factor for each applicable MIPS
eligible clinician shall not exceed 10 percent, which may result in an
aggregate increase in payments that is less than $500,000,000 as
described in subclause (I).
To be consistent with the MIPS adjustment factors under section
1848(q)(6)(A) of the Act, we propose to
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apply a linear sliding scale where MIPS eligible clinicians with a CPS
at the additional performance threshold would receive 0.5 percent
additional adjustment factor and MIPS eligible clinicians with a CPS
equal to 100 would receive a 10 percent maximum additional adjustment
factor. Similar to the adjustment factor, we would apply a scaling
factor that is greater than 0 and less than or equal to 1.0 if needed
to ensure distribution of the $500,000,000 increase in payments. The
scaling factor must be greater than 0 to ensure that MIPS eligible
clinicians with higher CPS receive a higher additional adjustment
factor. The scaling factor cannot exceed 1.0; the 10 percent maximum
additional adjustment factor could only decrease and not increase
because section 1848(q)(6)(F)(iv)(II) of the Act provides that the
additional adjustment factor shall not exceed 10 percent. We are
proposing the starting point for the additional adjustment factor at
0.5 percent for a CPS at the additional performance threshold because
this would provide a large enough incentive for MIPS eligible
clinicians to strive for the additional performance threshold, while
still providing the opportunity for a positive slope on the linear
sliding scale. If we are unable to achieve a linear sliding scale
starting at 0.5 percent (because the estimated aggregate increase in
payments for a year would exceed $500 million), then we propose to
lower the starting percentage for a CPS at the additional performance
threshold until we are able to create the linear sliding scale with a
scaling factor greater than 0 and less than or equal to 1.0. A MIPS
eligible clinician with a CPS that is below the additional performance
threshold would not be eligible for an additional adjustment factor. We
request comments on these proposals.
f. Application of the MIPS Adjustment Factors
Section 1848(q)(6)(E) of the Act provides that for items and
services furnished by a MIPS eligible clinician during a year
(beginning with 2019), the amount otherwise paid under Part B with
respect to such items and services and MIPS eligible clinician for such
year, shall be multiplied by 1 plus the sum of the MIPS adjustment
factor determined under paragraph (A) divided by 100, and as
applicable, the additional MIPS adjustment factor determined under
paragraph (C) divided by 100. We would apply the adjustment factors in
accordance with section 1848(q)(6)(E) of the Act.
We request comment on our proposals.
g. Example of Adjustment Factors
Figure A provides an example of how various CPS would be converted
to an adjustment factor and potentially an additional adjustment
factor, using the statutory formula. In this example, the performance
threshold is 60. The applicable percentage is 4 percent for 2019. The
adjustment factor is determined on a linear sliding scale from zero to
100, with zero being the lowest negative applicable percentage
(negative 4 percent for 2019), and 100 being the highest positive
applicable percentage. However, there are two modifications to this
linear sliding scale. First, there is an exception for a CPS between 0
and \1/4\ of the performance threshold (0-15 in our example). All MIPS
eligible clinicians with a CPS in this range would receive the lowest
negative applicable percentage (negative 4 percent for 2019). Second,
the linear sliding scale line for the positive adjustment factor is
adjusted by the scaling factor (which is determined by the formula
described in section II.E.7.c.) If the scaling factor is greater than 0
and less than or equal to 1.0, then the adjustment factor for a CPS of
100 would be less than or equal to 4 percent. If the scaling factor is
above 1.0, but less than or equal to 3.0, then the adjustment factor
for a CPS of 100 would be higher than 4 percent. Only those MIPS
eligible clinicians with a CPS equal to 60 (which is the performance
threshold in this example) would receive no adjustment. In Figure A,
the scaling factor for the adjustment factor is 1.37. MIPS eligible
clinicians with a CPS equal to 100 would have an adjustment of 5.5
percent (4.0 percent x 1.37).
For the performance threshold of 60, the additional performance
threshold for exceptional performance is 70. A CPS of 70 would have an
additional adjustment factor of 0.5 percent, and the amount of the
additional adjustment factor would increase to 10 percent times a
scaling factor that is greater than 0 and less than or equal to 1.0. In
Figure A, the scaling factor for the additional adjustment factor is
0.32. Therefore, MIPS eligible clinicians with a CPS of 100 would have
an additional adjustment of 3.2 percent (10 percent x 0.32). The total
adjustment for a MIPS eligible clinician with a CPS equal to 100 would
be 1 + 0.055 + 0.032 = 1.087, for a total positive adjustment of 8.7
percent.
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[GRAPHIC] [TIFF OMITTED] TP09MY16.032
Note: The adjustment factor for CPS values above the performance
threshold is illustrative. For MIPS eligible clinicians with a CPS
of 100, the adjustment factor would be 4 percent times a scaling
factor greater than 0 and less than or equal to 3.0. The scaling
factor is intended to ensure budget neutrality, but cannot be higher
than 3.0. The additional adjustment factor is also illustrative. The
additional adjustment factor starts at 0.5 percent and cannot exceed
10 percent.
The final MIPS payment adjustments would be determined by the
distribution of CPS across MIPS eligible clinicians and the performance
threshold. More MIPS eligible clinicians above the performance
threshold means the scaling factors would decrease because more MIPS
eligible clinicians receive a positive adjustment. More MIPS eligible
clinicians below the performance threshold means the scaling factors
would increase because more MIPS eligible clinicians would have
negative adjustments and relatively fewer MIPS eligible clinicians
receive positive adjustments.
We request comment on our proposals.
8. Review and Correction of MIPS Composite Performance Score
a. Feedback and Information To Improve Performance
Through the MIPS and APMs RFI, we solicited comment on various
questions related to performance feedback under section 1848(q)(12) of
the Act, such as what type of information should be contained in the
performance feedback data, how often the feedback should be made
available, and who should be able to access the data. Several
commenters stated that it would be beneficial if the performance
feedback under MIPS contained all the data that contributes to an EP's
CPS and any MIPS adjustment. Further, several commenters suggested that
performance feedback allow for interactive use of the data. Commenters
supported frequent availability of such data and many noted that a
minimum of quarterly feedback data would be preferred. Commenters also
noted that access to PQRS Feedback Reports currently was a challenge
and some suggested that the EPs should be able to control who can
access the feedback reports.
(1) Performance Feedback
(a) MIPS Eligible Clinicians
Under section 1848(q)(12)(A)(i) of the Act, as added by section
101(c)(1) of the MACRA, we are at a minimum required to provide MIPS
eligible clinicians with timely (such as quarterly) confidential
feedback on their performance under the quality and resource use
performance categories beginning July 1, 2017, and we have discretion
to provide such feedback regarding the CPIA and advancing care
information performance categories.
Beginning July 1, 2017, we propose to include information on the
quality and resource use performance categories in the performance
feedback. Within these performance categories, we propose to use fields
similar (that is, quality and resource use) to those currently
available in the Quality and Resource Use Reports (QRURs). Since the
QRURs already provide information on quality and resource use we
believe this is a good starting point for the data fields to be
included in the performance feedback. Additional information on the
current QRURs can be found at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeedbackProgram/Obtain-2013-QRUR.html.
The first performance feedback is due on July 1, 2017. As this is
prior to us having received any MIPS data, we propose to initially
provide feedback to MIPS eligible clinicians who are participating in
MIPS using historical data set(s), as available and applicable. For
example, these historical data set(s) could be a baseline report, using
data based off performance that occurred in CY 2015 or CY 2016 for
applicable and available quality and resource use data. In the event
that 2017 is the first MIPS performance period (as proposed in section
II.E.4. of this rule), we would not anticipate receiving the first set
of
[[Page 28277]]
data for MIPS until 2018 (as proposed in section II.E.5. of this rule).
At a minimum for the first year, we propose to provide performance
feedback on an annual basis since the first performance feedback,
required on July 1, 2017 would be based on historic data set(s). As the
program evolves, and we can operationally assess/analyze the MIPS data,
we may consider in future years providing performance feedback on a
more frequent basis, such as quarterly. Section 1848(q)(12)(A)(i) of
the Act requires the performance feedback to be provided ``timely''
(such as quarterly), which is our goal as MIPS evolves. In addition, we
seek comments on whether we should include first year measures in the
performance feedback, meaning new measures that have been in use for
less than 1 year, regardless of submission methods. The reasoning
behind first-year measures potentially not being reported is we need to
review the data from the measure before this data is incorporated into
performance feedback, as we want to ensure the data we are providing in
the performance feedback is useful and has usability for our
stakeholders. We request comments on these proposals.
In future years and as the program evolves, we intend to seek
comment on the template, including but not limited to the data fields,
for performance feedback. While section 1848(q)(12)(A)(i) of the Act
only requires us to provide performance feedback for the quality and
resource use performance categories, we understand that the CPIA and
advancing care information performance categories are important MIPS
data. Commenters to the MIPS and APMs RFI noted that CMS should consult
with stakeholders to ensure this performance feedback is useful before
this data is provided to MIPS eligible clinicians. Therefore, we may
consider including feedback on the performance categories of CPIA and
advancing care information in future years. Further, before we consider
adding CPIA and advancing care information data to the performance
feedback we would like to engage in stakeholder outreach to understand
what data fields might be helpful and usable to MIPS eligible
clinicians. Regarding the MIPS CPS, this is something we are targeting
to provide annually as part of the performance feedback as the program
evolves. As technically feasible, we are also planning to provide data
fields such as the CPS and each of the four performance categories in
future performance feedback once MIPS data becomes available. In
addition, we plan to explore the possibility of including the MIPS
adjustment factor (and, as applicable, the additional MIPS adjustment
factor) in future performance feedback. We seek comment on the
frequency with which this performance feedback should be provided,
considerations for including CPIA and advancing care information, and
data fields that should be included in the performance feedback as this
program evolves.
(b) APM Entities
We proposed in section II.E.5.h.(15) of this rule that MIPS
eligible clinicians who participate in APM Entities would receive
performance feedback, as technically feasible.
(2) Mechanisms
Under section 1848(q)(12)(A)(ii) of the Act, the Secretary may use
one or more mechanisms to make performance feedback available, which
may include use of a web-based portal or other mechanisms determined
appropriate by the Secretary. For the quality performance category,
described in section 1848(q)(2)(A)(i) of the Act, the feedback shall,
to the extent an eligible clinician chooses to participate in a data
registry for purposes of MIPS (including registries under sections
1848(k) and (m)) of the Act, be provided based on performance on
quality measures reported through the use of such registries. With
respect to any other performance category (that is, resource use, CPIA,
or advancing care information), the Secretary shall encourage provision
of feedback through qualified clinical data registries (QCDRs) as
described in sections 1848(m)(3)(E) of the Act.
We understand that the PQRS and VM programs have employed various
communication strategies to notify health care providers of the
availability of their PQRS Feedback Reports and QRURs, respectively,
through the CMS portal. However, many health care providers are still
unaware of these reports and/or have difficulty accessing their reports
in the portal. Further, we are aware that some health care providers
perceive the current reports as complex and often difficult to
understand; while others find the QRURs, and the drill down data
included in them on the Medicare beneficiaries they serve, very useful.
We are continuing to work with stakeholders to improve the usability of
these reports. As we transition to MIPS, we are committed to ensuring
that eligible clinicians are able to access their performance feedback,
and that the data are easy to understand while providing information
that will help drive quality improvement. We propose to initially make
performance feedback available using a CMS designated system, such as a
web-based portal; if technically feasible perhaps an interactive
dashboard. As further discussed in section II.E.7.e. of this proposed
rule, we also propose to leverage additional mechanisms such as health
IT vendors, registries, and QCDRs to help disseminate data/information
contained in the performance feedback to eligible clinicians, where
applicable. At this time, we believe that these additional mechanisms
will only be able to provide information on the quality performance
category for MIPS in regard to performance feedback.
We plan to coordinate with third party intermediaries such as
health IT vendors and QCDRs as MIPS evolves to enable additional
feedback to be sent on the resource use, advancing care information and
CPIA performance categories. We seek comment on this for future
rulemaking.
Comments received through the MIPS and APMs RFI noted issues
associated with access to the current Feedback Reports for PQRS.
Specifically, comments were received noting issues with Enterprise
Identity Management (EIDM) and access to the portal to view PQRS
Feedback Reports. Commenters also noted the need for a mechanism to be
put in place to notify EPs when their PQRS Feedback Report is
available. We propose to use the information contained in the provider
or supplier's Medicare enrollment records, and stored in the Provider
Enrollment, Chain, and Ownership System (PECOS), as the system of
records for eligible clinicians' contact information that should be
used when the MIPS performance feedback is available. It is therefore
critical that eligible clinicians ensure that their Medicare enrollment
records (especially in regard to phone and email contact information)
are updated, meaning current, on a consistent basis in PECOS. If more
than one email address is listed, then the email address that should be
used for communication should be designated. We also intend to provide
education and outreach on how to access performance feedback. We seek
comment on additional means that could be used to notify or contact
MIPS eligible clinicians and groups when their performance feedback is
available.
(3) Use of Data
Under section 1848(q)(12)(A)(iii) of the Act, for purposes of
providing performance feedback, the Secretary may use data, for a MIPS
eligible clinician, from periods prior to the
[[Page 28278]]
current performance period and may use rolling periods in order to make
illustrative calculations about the performance of such professional.
We believe ``illustrative calculations'' means an interim, snap shot in
time of performance, or perhaps a ``dry-run'' of the data including
measure rates. This would provide an indication of how a MIPS eligible
clinician might be performing, but would not be conclusive. Since MIPS
will not likely have comparable data until year 3 of the program, these
``illustrative calculations'' could be based on historical data sets
available to CMS until actual data for MIPS is available.
(4) Disclosure Exemption
As stated under section 1848(q)(12)(A)(iv) of the Act, feedback
made available under section 1848(q)(12)(A) of the Act shall be exempt
from disclosure under 5 U.S.C. 552 (the Freedom of Information Act).
(5) Receipt of Information
Section 1848(q)(12)(A)(v) of the Act, states that the Secretary may
use the mechanisms established under section 1848(q)(12)(A)(ii) of the
Act to receive information from professionals. This allows for expanded
use of the feedback mechanism to not only provide feedback on
performance to eligible clinicians, but to also receive information
from professionals.
We intend to explore the possibility of adding this feature to the
CMS designated system, such as a portal, in future years under MIPS.
This feature could be a mechanism where eligible clinicians can send
their feedback (that is, if they are experiencing issues accessing
their data, technical questions about their data, etc.) to CMS. We
appreciate that eligible clinicians may have questions regarding the
information contained in their performance feedback. In order to assist
eligible clinicians, we intend to establish resources, such as a
helpdesk or offer technical assistance, to help address questions with
the goal of linking these resource features to the CMS designated
system, such as a portal.
Additionally, we seek comment on the types of information eligible
clinicians would like to send to CMS via this mechanism.
(6) Additional Information--Type of Information
Section 1848(q)(12)(B)(i) of the Act, states that beginning July 1,
2018, the Secretary shall make available to MIPS eligible clinicians
information about the items and services for which payment is made
under Title 18 that are furnished to individuals who are patients of
MIPS eligible clinicians by other suppliers and providers of services.
This information may be made available through mechanisms determined
appropriate by the Secretary, such as the proposed CMS designated
system that would also provide performance feedback. Section
1848(q)(12)(B)(ii) of the Act specifies that the type of information
provided may include the name of such providers, the types of items and
services furnished, and the dates items and services were furnished.
Historical data regarding the total, and components of, allowed charges
(and other figures as determined appropriate by the Secretary) may also
be provided. We seek comment on the type of information MIPS eligible
clinicians would find useful and the preferred mechanisms to provide
such information, as well as, arrangements that should be in place
regarding this data (that is, eligible clinicians sharing data). We
also seek comment as to whether additional information regarding
beneficiaries attributed to a MIPS eligible clinician under the
resource use performance category or information about which MIPS
eligible clinician(s) beneficiaries to whom a given MIPS eligible
clinician provides services were attributed would be useful feedback in
regards to quality improvement efforts.
(7) Performance Feedback Template
The performance feedback under section 1848(q)(12)(A) of the Act is
meant to be meaningful and usable to eligible clinicians. In an effort
to ensure these data are tailored to the needs of eligible clinicians,
we solicited comment through the MIPS and APMs RFI and received
numerous comments regarding overall format of the performance feedback
template. Suggestions were made on what this feedback should include
for MIPS. We intend to collaborate with stakeholders outside of notice-
and-comment rulemaking on how the performance feedback should look for
MIPS; as well as, what data elements would be useful for eligible
clinicians. We seek comment on the fields that should be included in
the performance feedback template for MIPS eligible clinicians.
b. Announcement of Result of Adjustments
Section 1848(q)(7) of the Act requires that under the MIPS, the
Secretary shall, not later than 30 days prior to January 1 of the year
involved, make available to MIPS eligible clinicians the MIPS
adjustment factor (and, as applicable, the additional MIPS adjustment
factor) applicable to the eligible clinician for items and services
furnished by the professional for such year. The Secretary may include
such information in the confidential feedback under section 1848(q)(12)
of the Act.
If technically feasible, we propose to include the MIPS adjustment
factor (and, as applicable, the additional MIPS adjustment factor) in
the performance feedback for eligible clinicians provided under section
1848(q)(12)(A) of the Act. If it is not technically feasible to provide
this information in the performance feedback, we propose to make it
available through another mechanism as determined appropriate by the
Secretary (such as a portal or a CMS designated Web site) and seek
comment on mechanisms that might be appropriate. The first announcement
will be available no later than December 1, 2018 to meet statutory
requirements. We request comment on these proposals.
c. Targeted Review
Section 1848(q)(13)(A) of the Act requires the establishment of a
process under which a MIPS eligible clinician may seek an informal
review of the calculation of the MIPS adjustment factor (or factors)
applicable to such MIPS eligible clinician for a year.
We recognize that a principled approach to requesting and
conducting a targeted review is required under the MACRA in order to
minimize burdens on MIPS eligible clinicians and ensure transparency
under MIPS. We also believe it is important to retain the flexibility
to modify MIPS eligible clinicians' CPS or payment adjustment based on
the results of targeted review. This will lend confidence to the
determination of the CPS and payment adjustments, as well as, providing
finality for the MIPS eligible clinician after the targeted review is
completed. It will also minimize the need for claims reprocessing. We
are proposing an approach below that outlines the factors that we would
use to determine if a targeted review may be conducted. In keeping with
the statutory direction that this process be ``informal,'' we have
attempted to minimize the associated burden on the MIPS eligible
clinician to the extent possible.
In accordance with section 1848(q)(13)(A) of the Act, we propose at
Sec. 414.1385 to adopt a targeted review process under MIPS wherein a
MIPS eligible clinician may request that we review the calculation of
the MIPS adjustment factor under section 1848(q)(6)(A) of the Act and,
as applicable, the calculation of the additional MIPS adjustment factor
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under section 1848(q)(6)(C) of the Act applicable to such MIPS eligible
clinician for a year. Because this review will be limited to the
calculation of the MIPS adjustment factor and, as applicable, the
additional MIPS adjustment factor, we anticipate we may find it
necessary to review data related to the measures and activities and the
calculation of the CPS according to the defined methodology. The
following are examples of circumstances under which a MIPS eligible
clinician may wish to request a targeted review. This is not a
comprehensive list of circumstances:
The MIPS eligible clinician believes that measures or
activities submitted to CMS during the submission period and used in
the calculations of the CPS and determination of the adjustment factors
have calculation errors or data quality issues. These submissions could
be with or without the assistance of a third party intermediary; or
The MIPS eligible clinician believes that there are
certain errors made by CMS, such as performance category scores were
wrongly assigned to the MIPS eligible clinician (for example, the MIPS
eligible clinician should have been subject to the low-volume threshold
exclusion and should not have received a performance category score).
We believe that a fair targeted review request process requires
accessibility to all MIPS eligible clinicians within a reasonable
period of time and provides electronic and telephonic communication for
questions regarding the targeted review process, as well as for the
actual request for review and receipt of the decision on that request.
The targeted review process will use the same help desk support
mechanism as is provided for MIPS as a whole.
We further propose at Sec. 414.1385 to adopt the following general
process for targeted reviews under section 1848(q)(13)(A):
A MIPS eligible clinician electing to request a targeted
review may submit their request within 60 days (or a longer period
specified by us) after the close of the data submission period. All
requests for targeted review must be submitted by July 31 after the
close of the data submission period or by a later date that we specify
in guidance.
We will provide a response with our decision on whether or
not a targeted review is warranted. If a targeted review is warranted,
the timeline for completing that review may be dependent on the number
of reviews requested (for example, multiple reviews versus a single
review by one MIPS eligible clinician) and general nature of the
review.
As this process is informal and the statute does not
require a formal appeals process, we will not include a hearing
process. The MIPS eligible clinician may submit additional information
to assist in their targeted review at the time of request. If we or our
contractors request additional information from the MIPS eligible
clinician, the supporting information must be received from the MIPS
eligible clinician by us or our contractors within 10 calendar days of
the request. Non-responsiveness to the request for additional
information will result in the closure of that targeted review request,
although another review request may be submitted if the targeted review
submission deadline has not passed.
Since this is an informal review process and given the
limitations on review under section 1848(q)(13)(B) of the Act,
decisions based on the targeted review will be final, and there will be
no further review or appeal.
If a request for targeted review is approved, the outcome of such
review may vary. For example, we may determine that the clinician
should have been excluded from MIPS, re-distribute the weights of
certain performance categories within the CPS (for example, if a
performance category should have been weighted at zero), or recalculate
a performance category score in accordance with the scoring methodology
for the affected category, if technically feasible.
We request comments on these proposals.
d. Review Limitation
Section 1848(q)(13)(B) of the Act, as added by section 101(c)(1) of
the MACRA, provides there shall be no administrative or judicial review
under sections 1869 and 1878 of the Act, or otherwise of the following:
The methodology used to determine the amount of the MIPS
adjustment factor and the amount of the additional MIPS adjustment
factor and the determination of such amounts;
The establishment of the performance standards and the
performance period;
The identification of measures and activities specified
for a MIPS performance category and information made public or posted
on our Physician Compare Web site; and
The methodology developed that is used to calculate
performance scores and the calculation of such scores, including the
weighting of measures and activities under such methodology.
We propose at Sec. 414.1385 to implement these provisions as
written in the statute.
We would reject any requests for targeted review under section
1848(q)(13)(A) of the Act that focus on the areas precluded from review
under section 1848(q)(13)(B) of the Act. We request comments on this
proposal.
e. Data Validation and Auditing
Our experience with the PQRS, VM and Medicare EHR Incentive
Programs, has demonstrated the value of data validation and auditing as
an important part of program integrity, which is necessary to ensure
valid, reliable data. The current voluntary data validation process for
PQRS and the audit process for the Medicare EHR Incentive Program are
multi-step processes. We communicate the types of data elements that
may be included for data validation across multiple Web sites and our
documents. This includes defining specific data that may be abstracted
from the certified EHR technology, as well as other documented records.
As we begin the MIPS, our strategy is to combine our past program
integrity processes of the data validation process used in PQRS, and
the auditing process used in the Medicare EHR Incentive Program into
one set of requirements for MIPS eligible clinicians and groups, which
we refer to as ``data validation and auditing.'' Based on our need for
valid and reliable data on which to base a MIPS eligible clinician's or
group's payment, we propose certain requirements for MIPS eligible
clinicians and groups submitting data for the 2017 performance period
(see section II.E.4) under MIPS. Further, we propose at Sec. 414.1390
to selectively audit MIPS eligible clinicians on a yearly basis, and
that if a MIPS eligible clinician or group is selected for audit, the
MIPS eligible clinician or group would be required to do the following
in accordance with applicable law:
Comply with data sharing requests, providing all data as
requested by us or our designated entity. All data must be shared with
CMS or our designated entity within 10 business days or an alternate
time frame that is agreed to by CMS and the MIPS eligible clinician or
group. Data would be submitted via email, facsimile, or an electronic
method via a secure Web site maintained by CMS.
Provide substantive, primary source documents as
requested. These documents may include: Copies of claims, medical
records for applicable patients, or other resources used in the data
calculations for MIPS measures, objectives and activities. Primary
source documentation also may include verification of records for
Medicare and
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non-Medicare beneficiaries where applicable.
We propose that we would monitor MIPS eligible clinicians and
groups on an ongoing basis for data validation, auditing, program
integrity issues and instances of non-compliance with MIPS
requirements. If a MIPS eligible clinician or group is found to have
submitted inaccurate data for MIPS, we propose that we would reopen,
revise, and recoup any resulting overpayments in accordance with the
rules set forth at Sec. 405.980 (re-opening rules), Sec. 450.982 and
Sec. 450.984 (revising rules); and Sec. 405.370 and Sec. 405.373
(recoupment rules). It is important to note that at Sec. 405.980(b)(3)
there is an exception whereby we have the authority to re-open at any
time for fraud or similar fault. If we re-open the initial
determination we must revise it, and send out a notice of the revised
determination under Sec. 450.982. We also propose that we would recoup
any payments from the MIPS eligible clinician by the amount of any
debts owed to us by the MIPS eligible clinician and likewise, we would
recoup any payments from the group by the amount of any debts owed to
us by the group. We also note that we would need to limit each such
data validation and audit request to the minimum data necessary to
conduct validation.
We propose all MIPS eligible clinicians and groups that submit data
to CMS electronically must attest to the accuracy and completeness to
the best of their knowledge of any data submitted to us. This
attestation will occur prior to any electronic data submissions, via a
Web site maintained by CMS.
We request comments on these proposals.
9. Third Party Data Submission
One of our strategic goals in developing MIPS includes developing a
program that is meaningful, understandable, and flexible for
participating MIPS eligible clinicians. One way we believe this will be
accomplished is through flexible reporting options to accommodate
different practices and make measurement meaningful. We believe this
goal can be accomplished by allowing MIPS eligible clinicians the
flexibility of using third party intermediaries to collect or submit
data on their behalf. Specifically, qualified registries, QCDRs, health
IT vendors that obtain data from an eligible clinician's certified EHR
technology, and CMS-approved survey vendors as discussed in the
following proposed policies. In this section, we are specifying the
requirements that must be met to become a third party intermediary.
In the PQRS program, quality measures data may be collected or
submitted by third party vendors on behalf of an individual EP or group
by: (1) A registry; (2) a QCDR; or (3) an EHR vendor that obtains data
from an EP's certified EHR technology; or (4) a CMS-approved survey
vendor. We propose at Sec. 414.1400(a)(1) that MIPS data may be
submitted by third party intermediaries on behalf of a MIPS eligible
clinician or group by: (1) A qualified registry; (2) a QCDR; (3) a
health IT vendor; or (4) a CMS-approved survey vendor. Furthermore, we
propose at Sec. 414.1400(a)(3) that third party intermediaries must
meet all the requirements designated by CMS as a condition of their
qualification or approval to participate in MIPS as a third party
intermediary. As proposed at Sec. 414.1400(a)(3)(ii), all submitted
data must be submitted in the form and manner specified by CMS.
In the MIPS and APMs RFI, we solicited feedback on how we should
address data integrity, testing and standards, and review and
qualification processes for QCDRs. Subsequently, we also met with
several organizations that were either a QCDR or are in the process of
becoming a QCDR. Commenters agreed that data quality is a critical
issue for QCDRs. To address some of the data quality concerns, some
commenters suggested having processes in place in advance of reporting
that could mitigate data errors. For example, this could include a
process to reconcile TIN and NPI combinations. Several commenters also
suggested limiting submission mechanisms to one submission mechanism
per performance category to the extent possible. Commenters generally
agreed that QCDRs should be required to submit data using uniform
submission standards, with several suggesting the use of the Quality
Reporting Document Architecture (QRDA) standard, which certified EHR
technology is required to support.
Most commenters noted that uniform standards would ease
participation by MIPS eligible clinicians and reduce barriers to entry.
Others noted that we should work with ONC and the standards development
organization Health Level Seven (HL7) to improve the QRDA standard for
current submissions, and that in the future, we should prepare to
support emerging standards such as Fast Healthcare Interoperability
Resources. Commenters also noted that use of QRDA will align CMS
requirements and ONC certification requirements as ONC's 2015 Edition
Certification requires that all health information technology (IT)
modules used for the submission of CQM data must at least be certified
to the QRDA standard. Requiring QCDRs to use QRDA could help reduce
vendor interface costs for MIPS eligible clinicians already using
certified EHR technology and who desire to participate in registry
reporting. Commenters also directed our attention towards the 2015
Edition Certification for additional information on improved test
methods and to address historic issues and inaccuracies observed with
past calculation and reporting of quality and performance data. With
regard to testing, commenters were divided about whether we should
require QCDR-specific testing. Several noted that certified EHR
technology that support QCDRs have been tested already and that onerous
testing may discourage participation. Commenters in favor of testing
recommended a degree of flexibility in the early years of the program.
Suggestions for testing included the use of comprehensive
specifications and accurate testing tools far enough in advance of the
performance period to allow developers and implementers to conduct
robust testing. These specifications could be included in an
Implementation Guide. Opportunities for early testing, using sample
data was also emphasized. Commenters did express concern on the amount
of time needed for troubleshooting and fixing errors early enough in
the testing process such as format, content, and measure accuracy.
Commenters suggested several ways we might implement testing,
recommending that we:
Test the accuracy, completeness, and reliability of
measure calculations for specific, individual measures.
Test the feasibility of data collection requirements.
Pilot new CQMs before release; establish a regular
schedule of CQM revisions, and ensure adequate time is allowed for
implementation of the revisions.
Align the ONC Health IT Certification program and CMS
testing requirements for data submission.
Expand the test data sets used by the Cypress Testing
Tool. More information on the Cypress Testing Tool is available at:
http://projectcypress.org/about.html.
There was a strong consensus that MIPS eligible clinicians should
not be penalized for signing up with an entity that purported to offer
reliable services but then was unable to accurately submit data to us.
Several commenters suggested that entities that do not meet
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standards move to a probationary phase and eventually be prohibited
from periods of future participation until standards are met. However,
commenters also cautioned us not to move too quickly in moving entities
to a probationary phase because many QCDRs are run by medical specialty
societies and if they were to be disqualified to the detriment of
physicians participating, it would also diminish physician enthusiasm
for future submission of data.
Commenters had mixed responses regarding how to resolve inaccurate
data submission problems when time did not allow for continued review.
Commenters felt we should use a ``trust but validate'' methodology,
allowing the QCDR to recalculate the performance rate or authorizing us
to do so, but also that we should have validation processes in place as
well once the recalculation of the performance rate occurs. Ultimately,
we would need to be able to calculate all rates based on a submitted
numerator and denominator. Commenters suggested that MIPS eligible
clinicians should be assessed an average score or a ``pass'' for the
MIPS quality performance category if data problems cannot be resolved
in a timely manner or at the least not be penalized due to data errors
outside their control. One commenter suggested use of a Data Quality
Management (DQM) program for MIPS eligible clinicians that includes
early data qualification evaluation processes to take advantage of
feedback and assessments with thresholds for acceptance of data. MIPS
eligible clinicians who demonstrate effort toward achieving high
quality data submissions but were not able to meet the threshold should
be chaperoned to that target and provided with guidance.
Commenters were also divided about our review and qualification of
QCDRs to ensure our form and manner requirements are met. Several
commenters were concerned with a CMS process in addition to an ONC
certification process and recommended we work with ONC to align their
certification to address our requirements for QCDRs. Commenters
suggested that we also develop more robust implementation guides, and
enhance our submission engine validation tool (SEVT).
a. Qualified Clinical Data Registries (QCDRs)
Section 1848(q)(1)(E) of the Act requires the Secretary to
encourage the use of QCDRs under section 1848(m)(3)(E) of the Act in
carrying out MIPS. Section 1848(q)(5)(B)(ii)(I) of the Act requires the
Secretary, under the CPS methodology, to encourage MIPS eligible
clinicians to report on applicable measures with respect to the quality
performance category through the use of certified EHR technology and
QCDRs. Section 1848(q)(2)(B)(iii)(II) of the Act requires that the CPIA
subcategories specified by the Secretary include population management,
such as monitoring health conditions of individuals to provide timely
health care interventions or participation in a QCDR. Section
1848(q)(12)(A)(ii) of the Act requires the Secretary to encourage the
provision of performance feedback through QCDRs.
Section 1848(m)(3)(E)(i) of the Act requires the Secretary to
establish requirements for an entity to be considered a QCDR, which
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 section 1848(m) of the Act. Section
1848(m)(3)(E)(iv) of the Act requires the Secretary to consult with
interested parties in carrying out section 1848(m)(3)(E) of the Act.
Currently, the QCDR reporting mechanism provides a method to
satisfy PQRS requirements based on satisfactory participation. We
propose that entities interested in becoming a QCDR for MIPS go through
a qualification process. This includes the QCDR meeting the definition
of a QCDR, self-nomination requirements, and the requirements of a
QCDR, including the deadlines listed below. This qualification process
allows us to ensure that the entity has the capability to successfully
report MIPS eligible clinicians' data to us and allows for review and
approval of the QCDR's proposed non-MIPS quality measures. We intend to
compile and post a list of entities that we ``qualify'' to submit data
to us as a QCDR for purposes of MIPS on a Web site maintained by CMS.
Section 1848(q)(1)(E) of the Act encourages the use of QCDRs in
carrying out the MIPS. Although section 1848(q)(5)(B)(ii)(I) of the Act
specifically requires the Secretary to encourage MIPS eligible
clinicians to use QCDRs to report on applicable measures with respect
to the quality performance category and section 1848(q)(12)(A)(ii) of
the Act requires the Secretary to encourage the provision of
performance feedback through QCDRs, the statute does not specifically
address usage of QCDRs for the other MIPS performance categories.
Although we could limit the usage of QCDRs to assessing the quality
performance category under MIPS and providing performance feedback, we
believe it would be less burdensome for MIPS eligible clinicians if we
expand the QCDRs capabilities. By allowing QCDRs to report on the
quality, advancing care information, and CPIA performance categories we
would alleviate the need for individual MIPS eligible clinicians and
groups to use a separate mechanism to report data for these performance
categories. It is important to note that no data will need to be
reported for the resource use performance category since these measures
are administrative claims-based. Therefore, we are proposing at Sec.
414.1400(a)(2) to expand QCDRs' capabilities by allowing QCDRs to
submit data on measures, activities, or objectives for any of the
following MIPS performance categories:
(i) Quality;
(ii) CPIA; or
(iii) Advancing care information, if the MIPS eligible clinician or
group is using certified EHR technology.
We believe this approach would permit a single QCDR to report on
the quality, advancing care information, and CPIA performance category
requirements for MIPS and should mitigate the risks, costs, and burden
of MIPS eligible clinicians having to report multiple times to meet the
requirements of MIPS.
We propose to define a QCDR at Sec. 414.1305 as a CMS-approved
entity that has self-nominated and successfully completed a
qualification process to determine whether the entity may collect
medical and/or clinical data for the purpose of patient and disease
tracking to foster improvement in the quality of care provided to
patients. Examples of the types of entities that may qualify as QCDRs
include, but are not limited to, regional collaboratives and specialty
societies using a commercially available software platform, as
appropriate.
(1) Establishment of an Entity Seeking To Qualify as a QCDR
We propose at Sec. 414.1400(c) the establishment of a QCDR entity
is required as follows: for an entity to become qualified for a given
performance period as a QCDR, the entity must be in existence as of
January 1 of the performance period for which the entity seeks to
become a QCDR (for example, January 1, 2017, to be eligible to
participate for purposes of performance periods beginning in 2017). The
QCDR must have at least 25 participants by January 1 of the performance
period. These participants do not need to be using the QCDR to report
MIPS data to us; rather, they need to be submitting data to the QCDR
for quality improvement.
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(2) Self-Nomination Period
For the 2017 performance period we propose at Sec. 414.1400(b) a
self-nomination period from November 15, 2016 until January 15, 2017.
For future years of the program, starting with the 2018 performance
period, we propose to establish the self-nomination period from
September 1 of the prior year until November 1 of the prior year.
Entities that desire to qualify as a QCDR for the purposes of MIPS for
a given performance period would need to self-nominate for that year
and provide all information requested by CMS at the time of self-
nomination. Having qualified as a QCDR in a prior year does not
automatically qualify the entity to participate in MIPS as a QCDR in
subsequent performance periods. For example, a QCDR may choose not to
continue participation in the program in future years, or the QCDR may
be precluded from participation in a future year due to multiple data
or submission errors as noted below. Finally, QCDRs may want to update
or change the measures or services or performance categories they
intend to provide. As such, CMS believes an annual self-nomination
process is the best process to ensure accurate information is conveyed
to MIPS eligible clinicians and accurate data is submitted to MIPS.
We propose to require other information (described below) of QCDRs
at the time of self-nomination. If an entity becomes qualified as a
QCDR, they will need to sign a statement confirming this information is
correct prior to listing it on their Web site. Once we post the QCDR on
our Web site, including the services offered by the QCDR, we will
require the QCDR to support these services/measures for its clients as
a condition of the entity's qualification as a QCDR for purposes of
MIPS. Failure to do so will preclude the QCDR from participation in
MIPS in the subsequent year.
(3) Information Required at the Time of Self-Nomination
We propose that a QCDR must provide the following information to us
at the time of self-nomination to ensure that QCDR data is valid:
Organization Name (Specify Sponsoring Organization name
and software vendor name if the two are different. For example, a
specialty society in collaboration with a software vendor).
MIPS performance categories (that is, categories for which
the entity is self-nominating. For example, quality, advancing care
information, and/or CPIA).
Performance Period.
Vendor Type (for example, qualified clinical data
registry).
Provide the method(s) by which the entity obtains data
from its customers for each performance category for which it is
approved: Claims, web-based tool, practice management system, certified
EHR technology, other (please explain). If a combination of methods
(Claims, web-based tool, Practice Management System, certified EHR
technology, and/or other) is utilized, the entity should state which
method(s) it utilizes to collect data (for example, performance
numerator and denominator).
Indicate the method the entity will use to verify the
accuracy of each TIN/NPI it is intending to submit (for example,
National Plan and Provider Enumeration System (NPPES), CMS claims, tax
documentation).
Describe the method that the entity will use to accurately
calculate performance rates for quality measures 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 to calculate these composite
measures and measures with multiple performance rates. The entity
should be able to report to us a calculated composite measure rate if
applicable.
Describe the method that the entity will use to accurately
calculate performance data for CPIA and advancing care information
based on the appropriate parameters or activities.
Describe the process that the entity will use for
completion of a randomized audit of a subset of data prior to the
submission to us (for all performance categories the QCDR is submitting
data on, that is, quality, CPIA, and advancing care information, as
applicable). Periodic examinations may be completed to compare patient
record data with submitted data and/or ensure MIPS quality measures or
other performance category (CPIA, advancing care information)
activities were accurately reported and performance calculated based on
the appropriate measure specifications (that is, accuracy of numerator,
denominator, and exclusion criteria) or performance category
requirements.
Provide information on the entity's process for data
validation for both individual MIPS eligible clinicians and groups
within a data validation plan. For example, for individuals it is
encouraged that 3 percent of the TIN/NPIs submitted to us by the QCDR
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 five patients or a
maximum sample of 50 patients) should be reviewed for all measures
applicable to the patient.
Provide the results of the executed data validation plan
by May 31 of the year following the performance period. If the results
indicate the QCDR's validation reveals inaccuracy or low compliance
provide to CMS an improvement plan. Failure to implement improvements
may result in the QCDR being placed in a probationary status or
disqualification from future participation.
For non-MIPS quality measures, if the measure is risk-
adjusted, the QCDR is required to provide details to CMS on their risk
adjustment methodology (risk adjustment variables, and applicable
calculation formula) at the time of the QCDR's self-nomination. The
QCDR must submit the risk adjusted results to CMS when submitting a
risk-adjusted measure on behalf of the QCDR's MIPS eligible clinicians
for the performance period.
(4) QCDR Requirements for Data Submission
In addition, we propose that a QCDR must perform the following
functions:
For measures under the quality performance category and as
proposed at Sec. 414.1400(a)(4)(i), if the data is derived from
certified EHR technology, the QCDR must be able to indicate this data
source.
QCDRs must provide complete quality measure specifications
including data elements to us for non-MIPS quality measures intended
for reporting from certified EHR technology.
QCDRs must provide a plan to risk adjust (if appropriate
for the measure) the non-MIPS quality measures data for which it
collects and intends to transmit to us and must submit the risk-
adjusted results (not the non-risk adjusted rates), to CMS. The risk
adjustment methodology (formula and variables) must be integrated with
the complete quality measure specifications. Specifically, for risk-
adjusted non-MIPS quality measures, a QCDR is required to provide
details to CMS on their risk adjustment methodology. The data elements
used for risk adjustment may vary by measure and measure type. The risk
adjustment methodology, including the risk adjustment variables, must
be posted along with the measure's specifications on the QCDR's Web
site. CMS believes risk-adjustment for certain outcomes measures is
important to account for the differences in the complexities of care
provided to
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different patients. That is, some patients may have additional
comorbidities which could affect their response to treatment and
subsequently their outcome. Risk adjustment will help offset potential
poorer outcomes for those MIPS eligible clinicians caring for sicker
patients.
QCDRs submitting MIPS quality measures that are risk-
adjusted (and have the risk-adjusted variables and methodology listed
in the measure specifications) must submit the risk-adjusted measure
results to CMS when submitting the data for these measures.
Submit quality, advancing care information, or CPIA data
and results to us in the applicable MIPS performance categories for
which the QCDR is providing data.
A QCDR must have in place mechanisms for the transparency
of data elements and specifications, risk models, and measures. That
is, we expect that the non-MIPS measures and their data elements (that
is, specifications) comprising these measures be listed on the QCDR's
Web site unless the measure is a MIPS measure, in which case the
specifications will be posted by us.
Submit to us data on measures, activities, and objectives
for all patients, not just Medicare patients.
Provide timely feedback, at least 6 times a year, on all
of the MIPS performance categories that the QCDR will report to us.
That is, if the QCDR will be reporting on data for the CPIA, advancing
care information, or quality performance category, all results as of
the feedback report date should be included in the information sent
back to the MIPS eligible clinician. The feedback should be given to
the individual MIPS eligible clinician or group (if participating as a
group) at the individual participant level or group level, as
applicable, for which the QCDR reports. The QCDR is only required to
provide feedback based on the MIPS eligible clinician's data that is
available at the time the feedback report is generated.
Possess benchmarking capacity (for non-MIPS quality
measures) that compares the quality of care a MIPS eligible clinician
provides with other MIPS eligible clinicians performing the same
quality measures. For non-MIPS measures the QCDR must provide us, if
available, data from years prior (for example, 2015 data for the 2017
MIPS performance period) before the start of the performance period. In
addition, the QCDR must provide us, if available, with the entire
distribution of the measure's performance broken down by deciles. As an
alternative to supplying this information to us, the QCDR may post this
information on their Web site prior to the start of the performance
period, to the extent permitted by applicable privacy laws.
QCDRs must comply with any request by us to review the
data submitted by the QCDR for purposes of MIPS in accordance with
applicable law. Specifically, data requested would be limited to the
minimum necessary for us to carry out, for example, health care
operations or health oversight activities.
Mandatory participation in ongoing support conference
calls hosted by us (approximately one call per month), including an in-
person QCDR kick-off meeting (if held) at our headquarters in
Baltimore, MD. More than one unexcused absence could result in the QCDR
being precluded from participation in the program for that year. If a
QCDR is precluded from participation in MIPS, the individual MIPS
eligible clinician or group would need to find another QCDR or utilize
another data submission mechanism to submit their MIPS data.
Agree that data inaccuracies including (but not limited
to) TIN/NPI mismatches, formatting issues, calculation errors, data
audit discrepancies affecting in excess of 3 percent of the total
number of MIPS eligible clinicians submitted by the QCDR may result in
notations on our qualified QCDR posting of low data quality and would
place the QCDR on probation (if they decide to self-nominate for the
next program year). If the QCDR does not reduce their data error rate
below 3 percent in the subsequent year, they would continue to be on
probation and have their listing on the CMS Web site continue to note
the poor quality of the data they are submitting for MIPS. Data errors
affecting in excess of 5 percent of the MIPS eligible clinicians
submitted by the QCDR may lead to the disqualification of the QCDR from
participation in the following year's program. As we gain additional
experience with QCDRs, we intend to revisit and enhance these
thresholds in future years.
Be able to submit results for at least six quality
measures including one cross-cutting measure and one outcome measure.
If an outcome measure is not available, be able to submit results for
at least one other high priority measure (appropriate use, patient
safety, efficiency, patient experience, and care coordination
measures). If no outcome measure is available, then the QCDR must
provide a justification for not including an outcome measure.
QCDRs may request to report on up to 30 quality measures
not in the annual list of MIPS quality measures. Full specifications
will need to be provided to us at the time of self-nomination. CMS will
review the quality measures and determine if they are appropriate for
QCDR reporting.
Enter into and maintain with its participating clinicians
an appropriate Business Associate agreement that provides for the
QCDR's receipt of patient-specific data from an individual MIPS
eligible clinician or group, as well as the QCDR's disclosure of
quality measure results and numerator and denominator data and/or
patient specific data on Medicare and non-Medicare beneficiaries on
behalf of MIPS eligible clinicians and groups.